B125B105 Technical Manual

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GE Healthcare

B125/B105 Patient Monitor


Technical Manual

B125/B105 Patient Monitor


English
2105518-001 E

© 2019 General Electric Company


All rights reserved.
The information in this manual applies to the software version listed on the first page of the manual. Due to continuing product innovation,
specifications in this manual are subject to change without notice.

2 B125/B105 Patient Monitor 2105518-001


2019-02-25
Contents
1 About this manual .......................................................................................15
Intended use of this manual......................................................................... 15
Intended audience of this manual ............................................................... 15
About these devices...................................................................................... 15
Safety precautions ........................................................................................ 15
Manual conventions ..................................................................................... 15
Related documents....................................................................................... 16
Ordering manuals ......................................................................................... 16
Manufacturer responsibility ......................................................................... 16
Product availability ....................................................................................... 16
2 System overview..........................................................................................19
General safety statements ........................................................................... 19
Safety message signal words..................................................................... 19
IEC 60601-1 ................................................................................................... 19
System components ..................................................................................... 20
Network central station ................................................................................ 21
Other devices............................................................................................... 21
Controls and connectors .............................................................................. 22
Front view .................................................................................................... 22
Main side view ............................................................................................. 22
Main back view............................................................................................ 23
Hemodynamics connectors ....................................................................... 24
E-COP module.............................................................................................. 24
E-miniC module ........................................................................................... 25
E-sCAiO, E-sCO and N-CAiO module .......................................................... 25
E-Entropy module........................................................................................ 26
B1X5-F2 Frame............................................................................................ 26
Recorder ...................................................................................................... 27
Keypad ......................................................................................................... 27
Service information....................................................................................... 28
Service requirements .................................................................................. 28

2105518-001 B125/B105 Patient Monitor 3


Equipment identification............................................................................. 28
Equipment symbols ...................................................................................... 29
User interface symbols ................................................................................. 35
3 Theory of operation.....................................................................................37
System block diagram .................................................................................. 37
Main components ......................................................................................... 38
CPU board.................................................................................................... 38
Carrier board ............................................................................................... 40
AC/DC unit ................................................................................................... 41
Display subsystem ...................................................................................... 41
Recorder unit ............................................................................................... 42
Battery ......................................................................................................... 42
User interface parts .................................................................................... 42
Hemo module.............................................................................................. 42
Non-standard connectors and signals........................................................ 52
Multi I/O connector ..................................................................................... 52
Nurse call connector................................................................................... 53
Serial port connector .................................................................................. 54
Recorder connectors................................................................................... 54
Defibrillator synchronization connector .................................................... 55
Measurement principle................................................................................. 55
ECG measurement principle ....................................................................... 55
Respiration measurement principle........................................................... 55
Pulse oximetry measurement principle ..................................................... 56
NIBP measurement principle...................................................................... 57
Invasive blood pressure measurement principle ...................................... 58
Temperature measurement principle ........................................................ 58
4 Pre-installation requirements....................................................................59
Unpacking ..................................................................................................... 59
Checking the compatibility of all system components............................... 59
Network infrastructure ................................................................................. 60
Checking MC Network infrastructure......................................................... 60
Checking wireless MC Network infrastructure .......................................... 60
Checking HL7 Network infrastructure ....................................................... 60

4 B125/B105 Patient Monitor 2105518-001


Installing the mounting hardware ............................................................... 60
Power and environmental requirements..................................................... 61
Checking environmental requirements ..................................................... 61
Checking power requirements ................................................................... 61
Checking EMI & RFI interference ................................................................ 61
5 Hardware installation .................................................................................63
Hardware installation ................................................................................... 63
Installing battery ........................................................................................... 64
Battery test button ...................................................................................... 64
Inserting and removing battery ................................................................. 65
Checking the battery charge with monitor software................................ 65
Mounting the monitor and frame ................................................................ 65
Installing L-type mounting plate to B1X5-F2 Frame ................................. 66
Connecting a display .................................................................................... 66
Connecting B1X5-F2 module ....................................................................... 66
Connecting E-module ................................................................................... 67
Connecting the recorder............................................................................... 67
Inserting the recorder ................................................................................. 68
Removing the recorder ............................................................................... 68
Connecting Multi I/O adapter....................................................................... 69
Connecting to the mains power................................................................... 69
Connecting network...................................................................................... 69
Network compatibility................................................................................. 69
Network diagram ........................................................................................ 70
Connecting to the MC Network .................................................................. 71
Connecting iCollect ....................................................................................... 71
After hardware installation........................................................................... 71
6 Using service interface ...............................................................................73
Service interface ........................................................................................... 73
Parameters.................................................................................................... 74
Gas Unit ....................................................................................................... 75
STP module .................................................................................................. 77
ECG module ................................................................................................. 78
NIBP module ................................................................................................ 78

2105518-001 B125/B105 Patient Monitor 5


COP module ................................................................................................. 79
Entropy module ........................................................................................... 81
Country settings ............................................................................................ 83
License........................................................................................................... 83
Service log ..................................................................................................... 85
Enter/Exit Demo Mode.................................................................................. 86
Set/test .......................................................................................................... 86
Network ......................................................................................................... 87
Network configuration ................................................................................ 87
TCP/IP ........................................................................................................... 88
HL7 configuration........................................................................................ 89
Diagnosis ....................................................................................................... 90
Wireless ......................................................................................................... 91
WLAN status ................................................................................................ 91
WLAN Configuration — Basic ..................................................................... 92
WLAN Configuration — Advanced.............................................................. 96
Software management................................................................................. 99
Software upgrade ....................................................................................... 99
Module upgrade ........................................................................................ 100
USB disk upgrade ...................................................................................... 100
7 Configuration .............................................................................................103
Platform Configuration ............................................................................... 103
Adjusting display ......................................................................................... 103
Adjusting the display brightness .............................................................. 103
Adjusting the slave display ....................................................................... 103
Configuring wired CARESCAPE Network .................................................... 103
Configuring HL7 Network ........................................................................... 104
Configuring wireless CARESCAPE Network................................................ 104
Configuring wireless network via USB disk.............................................. 104
Configuring wireless Network basic settings manually .......................... 105
Configuring wireless Network advanced settings manually .................. 109
Setting time and date ................................................................................. 110
Setting time zone ........................................................................................ 110
Setting national requirements.................................................................... 111

6 B125/B105 Patient Monitor 2105518-001


Setting power frequency ............................................................................ 111
Changing passwords .................................................................................. 111
Resetting password................................................................................... 111
Transferring settings from a monitor to another ...................................... 112
Exporting settings ..................................................................................... 112
Importing settings ..................................................................................... 112
License management ................................................................................. 112
Software management............................................................................... 113
Software download................................................................................... 113
Activating the software............................................................................. 113
8 Installation check ......................................................................................115
Installation check procedure...................................................................... 115
Performing visual inspection...................................................................... 115
Functional check ......................................................................................... 115
Checking the startup................................................................................. 116
Checking display ....................................................................................... 116
Checking the time and date ..................................................................... 116
Checking the device information ............................................................. 116
Testing the B1X5-F2 frame ....................................................................... 117
Checking parameters................................................................................ 117
Testing the recorder .................................................................................. 117
Testing MC Network .................................................................................. 118
Testing wireless LAN configuration.......................................................... 118
Completing the check procedure............................................................. 118
Verification procedure for wireless MC Network infrastructure............... 118
Purpose and scope.................................................................................... 118
Test equipment and documentation needed.......................................... 119
Test plan..................................................................................................... 119
Test setup................................................................................................... 120
Test execution ........................................................................................... 121
Summary and reporting ........................................................................... 121
9 Electrical safety tests ................................................................................123
Electrical safety tests .................................................................................. 123
Test setup................................................................................................... 123

2105518-001 B125/B105 Patient Monitor 7


Verifying power outlet............................................................................... 124
Verifying power cord and plug ................................................................. 124
Ground earth integrity check ................................................................... 124
Testing ground continuity......................................................................... 124
Checking impedance of protective earth connection ............................ 125
Testing earth leakage current .................................................................. 125
Testing enclosure (touch) leakage current............................................... 127
Patient leakage current tests ................................................................... 128
Testing patient (source) leakage current ................................................. 129
Testing patient (sink) leakage current ...................................................... 130
Completing electrical safety tests ............................................................ 131
10 Maintenance check....................................................................................133
Planned and corrective maintenance procedures ................................... 133
Planned maintenance............................................................................... 133
Corrective maintenance ........................................................................... 134
Performing visual inspection...................................................................... 134
Functional check ......................................................................................... 134
Checking the startup................................................................................. 134
Checking display ....................................................................................... 135
Checking the time and date ..................................................................... 135
Checking the device information ............................................................. 135
Testing the B1X5-F2 frame ....................................................................... 136
Checking parameters................................................................................ 136
Testing MC Network .................................................................................. 142
Testing wireless LAN configuration.......................................................... 143
Testing the recorder .................................................................................. 143
Testing defibrillator synchronization marker out signals........................ 143
Completing the check procedure............................................................. 144
11 Calibration and adjustments ...................................................................145
NIBP calibration........................................................................................... 145
Required tools for NIBP ............................................................................. 145
Making connections.................................................................................. 145
Calibrating NIBP ........................................................................................ 146
Invasive pressure calibration ..................................................................... 146

8 B125/B105 Patient Monitor 2105518-001


Required tools............................................................................................ 147
Making connections.................................................................................. 147
Calibrating invasive pressure ................................................................... 147
Calibrating invasive pressure (by simulator)............................................ 148
Temperature calibration............................................................................. 148
Required tools............................................................................................ 148
Making connections.................................................................................. 149
Calibrating temperature ........................................................................... 149
12 Troubleshooting.........................................................................................151
Troubleshooting guidelines ........................................................................ 151
Performing basic troubleshooting............................................................ 151
Viewing and downloading service log ..................................................... 152
Checking the battery charge with monitor software.............................. 153
Network diagnostics ................................................................................. 153
Messages..................................................................................................... 154
Messages related to various situations ................................................... 154
Messages related to ECG measurement ................................................. 157
Messages related to impedance respiration measurement .................. 158
Messages related to SpO2 measurement ................................................ 158
Messages related to NIBP measurement ................................................ 160
Messages related to invasive pressures measurement.......................... 162
Messages related to temperature measurement ................................... 164
Problems and solutions .............................................................................. 165
Start-up failures......................................................................................... 165
Battery issue .............................................................................................. 166
User interface issues................................................................................. 166
B1X5-F2 frame issues ............................................................................... 167
Recorder issue ........................................................................................... 167
Acquisition module problems................................................................... 167
Troubleshooting CARESCAPE Network communication ......................... 168
Parameter issues....................................................................................... 171
13 Disassembly and reassembly...................................................................173
Disassembly guidelines .............................................................................. 173
ESD precautions ........................................................................................ 173

2105518-001 B125/B105 Patient Monitor 9


Reassembly precautions........................................................................... 174
Required tools............................................................................................ 174
Preparing for disassembly ........................................................................ 175
Replacing the main fuses ........................................................................... 175
Detaching the extension rack, hemo module and wireless
module......................................................................................................... 176
Detaching the frame................................................................................... 177
LCD converter board connectors ............................................................. 178
Replacing the user interface parts........................................................... 178
Replacing LCD converter board, display, and front cover ...................... 179
Detaching the middle cover ..................................................................... 179
Replacing the handle ................................................................................ 180
Detaching the battery chamber............................................................... 180
Replacing the AC/DC module ................................................................... 180
Replacing the carrier board...................................................................... 181
Detaching the recorder .............................................................................. 181
14 Service parts...............................................................................................183
Service parts................................................................................................ 183
Ordering parts ........................................................................................... 183
Front cover................................................................................................. 183
Back cover ................................................................................................. 184
Frame......................................................................................................... 185
Hemo box .................................................................................................. 185
Rack and recorder..................................................................................... 186
List of FRUs ................................................................................................ 186
15 E-COP module.............................................................................................191
About this chapter ...................................................................................... 191
Maintenance check..................................................................................... 191
About the maintenance check procedures ............................................. 191
Performing visual inspection .................................................................... 192
Performing electrical safety test *............................................................ 192
Performing functional check .................................................................... 192
Configuration .............................................................................................. 195
Calibration and adjustments...................................................................... 195

10 B125/B105 Patient Monitor 2105518-001


Invasive pressure calibration.................................................................... 195
16 E-sCAiO, E-sCO, N-CAiO module...............................................................199
About this chapter ...................................................................................... 199
Maintenance check..................................................................................... 199
About the maintenance check procedures ............................................. 199
Replacement of planned maintenance parts.......................................... 200
Performing visual inspection .................................................................... 202
Performing functional check .................................................................... 202
Configuration .............................................................................................. 206
Calibration and adjustments...................................................................... 206
Sample flow rate adjustment ................................................................... 206
Gas calibration .......................................................................................... 207
17 E-miniC module..........................................................................................211
About this chapter ...................................................................................... 211
Maintenance check..................................................................................... 211
About the maintenance check procedures ............................................. 211
Replacement of planned maintenance parts.......................................... 212
Performing visual inspection .................................................................... 213
Performing functional check .................................................................... 213
Configuration .............................................................................................. 216
Calibration and adjustments...................................................................... 216
Sample flow rate adjustment ................................................................... 216
Gas calibration .......................................................................................... 217
18 E-Entropy module ......................................................................................221
About this chapter ...................................................................................... 221
Maintenance check..................................................................................... 221
About the maintenance check procedures ............................................. 221
Planned maintenance............................................................................... 221
Corrective maintenance ........................................................................... 222
Performing visual inspection .................................................................... 222
Performing electrical safety test *............................................................ 222
Performing functional check .................................................................... 222
Configuration .............................................................................................. 223
Calibration and adjustments...................................................................... 223

2105518-001 B125/B105 Patient Monitor 11


19 Product privacy and security ...................................................................225
Introduction ................................................................................................. 225
Privacy & Security Environment ................................................................. 225
Privacy & Security capabilities ................................................................... 225
Access controls.......................................................................................... 226
Privacy & security audit logging and accountability controls ................ 227
Information protection ............................................................................... 227
Network security ....................................................................................... 228
Wireless Security ....................................................................................... 229
Removable media security ....................................................................... 229
Data integrity capabilities......................................................................... 230
De-identification capabilities ................................................................... 230
Business continuity .................................................................................. 230
System protection ...................................................................................... 230
Malicious software protection ................................................................. 230
System (product) change management .................................................. 231
Personal information collected by the product......................................... 231
Additional privacy & security considerations ........................................... 232
MDS2............................................................................................................ 232
20 Networking disclosure to facilitate network risk management ...........233
Purpose and scope ..................................................................................... 233
Purpose for B125/B105 monitor connection to network ......................... 233
Network interface technical specifications ............................................... 233
Network information flows......................................................................... 235
Required characteristics and configuration for support .......................... 236
Potential risks to safety, effectiveness or security resulting from failure
of IT network to provide the required ........................................................ 236
A Software download instruction................................................................239
Introduction ................................................................................................. 239
Contents of the USB storage device .......................................................... 239
Tools needed ............................................................................................... 239
Installing software with PC ......................................................................... 239
Connecting a service PC to a patient monitor or to the Network for
multiple patient monitors ......................................................................... 239

12 B125/B105 Patient Monitor 2105518-001


Checking the network settings of the patient monitors ......................... 240
Checking and configuring the network settings of the service
PC ............................................................................................................... 240
Launching the Software Transfer Utility .................................................. 240
Specifying the IP addresses of the target patient monitors ................... 241
Entering the IP addresses manually......................................................... 241
Uploading the IP addresses from text file................................................ 242
Transferring the software ......................................................................... 243
Installing software with USB....................................................................... 244
Preparing the USB disk.............................................................................. 244
Transferring the software with USB ......................................................... 245
Activating the software............................................................................... 245
Performing post software activation checkout......................................... 246
B Installation checkform ..............................................................................247
B125/B105 Patient Monitor installation check.......................................... 247
C Electrical safety tests checkform ............................................................251
Electrical safety tests .................................................................................. 251
D Maintenance checkform ...........................................................................255
B125/B105 Patient Monitor maintenance check ...................................... 255
E E-COP module checkform .........................................................................259
Maintenance check form, E-COP ............................................................... 259
F E-sCAiO, E-sCO, N-CAiO modules checkform .........................................261
Maintenance check form, E-sCAiO, E-sCO, N-CAiO ................................... 261
G E-miniC module checkform ......................................................................265
Maintenance check form, E-miniC ............................................................. 265
H E-Entropy module checkform...................................................................267
Maintenance check form, E-Entropy ......................................................... 267
I Wireless network infrastructure checkform ..........................................269
Wireless MC Network infrastructure checkform ....................................... 269

2105518-001 B125/B105 Patient Monitor 13


14 B125/B105 Patient Monitor 2105518-001
About this manual
1
Intended use of this manual
As the monitor configuration may vary, some menus, displays and functions described
may not be available in the monitor you are using.
This manual contains instructions necessary to install, maintain and service the device
to the assembly level. It gives an overview of the patient monitoring system and
contains information needed for system installation. Information for the planned and
corrective maintenance of the device is also provided.
Use the manual as a guide for installation, maintenance and repairs considered field
repairable. Where necessary the manual identifies additional sources of relevant
information and technical assistance.
See each module’s Technical Manual for introduction, troubleshooting, disassembly
and reassembly, service parts section.
See the supplemental information manual for the technical specifications, default
settings and compatibility information, including electromagnetic compatibility.
See the user’s manual for the instructions necessary to operate the device safely in
accordance with its function and intended use.

Intended audience of this manual


This manual is intended for service representatives and technical personnel who
install, maintain, troubleshoot, or repair this device.

About these devices


Refer to the user’s manual for important information about the Patient Monitor
B125/B105, including intended use of these devices, important safety information and
detailed instructions for clinical use of these products.

Safety precautions
Refer to the user’s manual for important system safety messages. Safety messages
specific to parts of the system are found in the relevant section. Read all the safety
information before using the monitor for the first time.

Manual conventions
This manual uses the following styles to emphasize text or indicate action.

2105518-001 B125/B105 Patient Monitor 15


About this manual

Item Description
bold Indicates hardware terms.
bold italic Indicates software terms.
italic Indicates terms for emphasis.
> Indicates menu options to select consecutively.
CARESCAPE Network CARESCAPE Network is used to refer to the MC Network.
select The word select means choosing and confirming.

NOTE Note statements provide application tips or other useful


information.

Related documents
● B125/B105 Patient Monitor User’s Manual
● B125/B105 Patient Monitor Supplemental Information Manual
● B125/B105 Patient Monitor Supplies and accessories
● B125/B105 Patient Monitor Software Installation Instructions
● WLAN configuration guide
● WLAN Deployment Guide
● iCollect user’s manual
● CARESCAPE Network Configuration Guide
● CIC Pro Clinical Information Center Operator's Manual
● CARESCAPE Central Station User’s Manual
● HL7 Reference Manual
● B125/B105 Patient Monitor service for depot instruction

Ordering manuals
A paper copy of this manual will be provided upon request. Contact your local GE
representative and request the part number on the first page of the manual.

Manufacturer responsibility
GE is responsible for the effects on safety, reliability, and performance of the
equipment only if:
● Assembly operations, extensions, readjustments, modifications, servicing, or
repairs are carried out by authorized service personnel.
● The electrical installation of the relevant room complies with the requirements
of the appropriate regulations.
● The equipment is used in accordance with the instructions for use.

Product availability
NOTE Due to continual product innovation, design and specifications
for these products are subject to change without notice.

16 B125/B105 Patient Monitor 2105518-001


About this manual

Some of the products mentioned in this manual may not be available in all countries.
Please consult your local representative for the availability.

2105518-001 B125/B105 Patient Monitor 17


About this manual

18 B125/B105 Patient Monitor 2105518-001


System overview
2
General safety statements
This device is intended for use under the direct supervision of a licensed health care
practitioner.
Contact GE for information before connecting any devices to the equipment that
are not recommended in this manual.
Parts and accessories used must meet the requirements of the applicable IEC 60601
series safety standards, and/or the system configuration must meet the requirements
of the IEC 60601-1 Clause 16 medical electrical systems standard. Refer to the patient
monitor’s supplemental information manual for compatible parts and accessories.
Periodically, and whenever the integrity of the product is in doubt, test all functions.
The use of accessory equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the resulting
system. Consideration relating to the choice shall include:
● use of the accessory in the patient vicinity
● evidence that the safety certification of the accessory has been performed
in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1 Clause 16
harmonized national standard.

Safety message signal words


Safety message signal words designate the severity of a potential hazard.
DANGER Indicates a hazardous situation that, if not avoided, will result
in death or serious injury.

WARNING Indicates a hazardous situation that, if not avoided, could


result in death or serious injury.

CAUTION Indicates a hazardous situation that, if not avoided, could


result in minor or moderate injury.

NOTICE Indicates a hazardous situation not related to personal injury


that, if not avoided, could result in property damage.

IEC 60601-1
Monitor

2105518-001 B125/B105 Patient Monitor 19


System overview

● Type of protection against electrical shock: Class I. Internally powered ME


equipment.
● Degree of protection against electrical shock: applied parts are marked with a
symbol indicating degree of protection.
● Degree of safety of application in the presence of flammable anesthetic mixture
with air or with oxygen or nitrous oxide: Not suitable.
● Degree of protection against harmful ingress of water: IP21.
● Mode of operation: Continuous.
● Method(s) of sterilization or disinfection recommended by the manufacturer: see
the User’s Manual.
● Portable monitor.
B1X5–F2 Frame
● Type of protection against electrical shock: Class I.
● Degree of protection against electrical shock: applied parts are marked with a
symbol indicating degree of protection.
● Degree of safety of application in the presence of flammable anesthetic mixture
with air or with oxygen or nitrous oxide: Not suitable.
● Degree of protection against harmful ingress of water: IP21.
● Mode of operation: Continuous.
● Method(s) of sterilization or disinfection recommended by the manufacturer: see
the User’s Manual.
● Portable frame.

System components
All components listed below can be used within the patient environment as long as
an additional transformer providing at least basic isolation is used with non-medical
grade secondary displays and printers.
Your system may not include all these components. Consult your local representative
for the available components.
NOTE It is not recommended the system be connected to other
non-isolated monitoring equipment or communication
networks. In this event it is the end user's responsibility to
ensure compliance with IEC60601-1 or other IEC standards.

20 B125/B105 Patient Monitor 2105518-001


System overview

1. B125 monitor, 12.1’ LED display


2. B105 monitor, 10.1’ LED display
3. Recorder
4. B1X5-F2 Frame
5. Acquisition modules
Software name: VSP
Release version: 2.0

Network central station


Central stations Description

CIC Pro Clinical Information Center


The MC Network establishes communication and allows patient data
to be sent to an optional CIC Pro Clinical Information Center (central
station). See the CIC Pro Clinical Information Center Operator’s
Manual for operating instructions.

CARESCAPE Central Station


The MC Network establishes communication and allows patient
data to be sent to an optional CARESCAPE Central Station. See the
CARESCAPE Central Station User’s Manual for operating instructions.

Other devices
Other devices Description

External display
The monitor has the DVI port for the commercial display, which
resolution should be 1280*800.

USB storage device (file system: FAT32)


To save and load the settings.

2105518-001 B125/B105 Patient Monitor 21


System overview

Controls and connectors


Front view

B105 front view (full configuration) B125 front view

1. Alarm light
2. Transportation handle
3. Hemo connectors
4. Keypad
5. Trim knob

Main side view

B105 side view (full configuration) B125 side view

1. Guide rail for GCX mounting


2. Battery compartment
3. Guide rail for recorder

22 B125/B105 Patient Monitor 2105518-001


System overview

Main back view

B105 back view (full configuration) B125 back view

Multi I/O

1. Extension rack
2. E-miniC module
3. Receptacle for power cord
4. Equipotential connector
5. Multi I/O connector
6. DVI connector
7. Recorder/B1X5-F2 Frame connector
8. USB connector
9. Network connector
10. Nurse call connector
11. Defibrillator connector
12. Serial port

2105518-001 B125/B105 Patient Monitor 23


System overview

Hemodynamics connectors
1. IBP connector
2. Temperature connector
3. SpO2 connector
4. ECG and impedance respiration connector
5. NIBP connector

Hemodynamics parameters
The monitor provides different configurations for hemodynamics measurement. The
user can identify the configurations from connectors and label.
Identifier Basic feature Optional feature
ECG NIBP SpO2 IBP Temperature
SpO2_IBP_T X X GE X X
MasimoSpO2_IBP_T X X Masimo X X
NellcorSpO2_IBP_T X X Nellcor X X
SpO2_T X X GE X
MasimoSpO2_T X X Masimo X
NellcorSpO2_T X X Nellcor X
SpO2 X X GE
MasimoSpO2 X X Masimo
NellcorSpO2 X X Nellcor

E-COP module

24 B125/B105 Patient Monitor 2105518-001


System overview

1. Module’s key
2. IBP connector
3. C.O. connector

E-miniC module

1. Water trap
2. Sample gas inlet
3. Gas outlet

E-sCAiO, E-sCO and N-CAiO module

2105518-001 B125/B105 Patient Monitor 25


System overview

E-sCAiO E-sCO N–CAiO

1. Water trap release/locking latch


2. Gas sampling line connector (sampling gas in)
3. Water trap container
4. Gas exhaust line connector (sampling gas out)

E-Entropy module

1. Module keys
2. Entropy connector

B1X5-F2 Frame
WARNING Do not touch the electrical connector located within the
module housing or frame.

The B1X5-F2 Frame provide an interface between the monitor and E-modules. Frames
allow additional parameters to be monitored.
The B1X5-F2 Frame has 2 module slots that support E-module acquisition modules.

26 B125/B105 Patient Monitor 2105518-001


System overview

1. Communication indicator
2. Power indicator
3. 15-pin connector: connect to monitor
4. Power connector
5. Equipotential connector
6. Guide rail for GCX mounting

Recorder

1. Recorder door.
2. Tab for removing recorder
3. Power on indicator: Illuminates when connected to power.
4. Symbol indicate the paper install direction.
5. 9-pin connector: connect to monitor.

Keypad

1. On/Off key.
2. AC power status indicator.

2105518-001 B125/B105 Patient Monitor 27


System overview

3. Battery status indicator.


4. Audio pause key. Temporary audio pause active alarms.
5. Snapshot key. Take up snapshot, which is a set of measured data for this moment.
6. Manual NIBP key. Start a manual NIBP measurement.

Service information
Service requirements
Follow the service requirements listed below.
● Refer servicing of the equipment to qualified service personnel only. Service
personnel servicing this product must have an appropriate technical qualification,
or equivalent work experience, and be familiar with the service requirements
described in this manual and in any related service documentation. Service training
for the product is recommended.
● Any unauthorized attempt to repair equipment under warranty voids that warranty.
● It is the user's responsibility to report the need for service to GE or to one of their
authorized agents.
● Failure on the part of the responsible individual, hospital, or institution using this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
● Regular maintenance, irrespective of usage, is essential to ensure that the
equipment will always be functional when required.
WARNING Do not perform any service activities on the monitor in the
patient vicinity while a patient is being connected to the
monitor.

CAUTION DISPOSAL. At the end of its service life, the product described
in this manual, as well as its accessories, must be disposed of
in compliance with the guidelines regulating the disposal of
each product. If you have any questions concerning disposal
of a product, please contact GE or its representatives.

Equipment identification
Every GE device has a unique serial number for identification. The serial number is
written in a device label.
The product code for B125 is SQF.
The product code for B105 is SQE.
The device plate is located on the rear of the patient monitor.
### ## ## #### # #
A B C D E F

A product code

B year manufactured

28 B125/B105 Patient Monitor 2105518-001


System overview

C fiscal week manufactured

D production sequence number

E manufacturing site

F miscellaneous characteristic

Equipment symbols
For user interface keys and symbols, please refer to “Monitoring basics” chapter.
On the Hemo connectors:
WARNING Protection against cardiac defibrillator
discharge is due in part to the accessories
for pulse oximetry (SpO2), temperature (T)
and invasive pressure (P) measurement.

On the X1, X2, X3 connector, and recorder:


CAUTION Electric shock hazard. Do not open the cover
or the back. Refer servicing to qualified
personnel.

On the power label at the rear cover:


CAUTION For continued protection against fire hazard,
replace the fuse only with one of the same
type and rating.

CAUTION Disconnect from the power supply before


servicing.

On the battery cover:


CAUTION Make sure to use the compatible battery:
FLEX-3S3P; Close the battery door to aviod
battery drop out.

Follow instructions for use.

Consult operating instructions.

Electrostatic sensitive device. Connections should not be made to


this device unless ESD precautionary procedures are followed.

Non-ionizing electromagnetic radiation. Interference may occur in


the vicinity of this device.

2105518-001 B125/B105 Patient Monitor 29


System overview

Type BF (IEC 60601-1) protection against electric shock. Isolated


(floating) applied part suitable for intentional external and internal
application to the patient, excluding direct cardiac application.
Type BF (IEC 60601-1) defibrillator-proof protection against electric
shock. Isolated (floating) applied part suitable for intentional external
and internal application to the patient, excluding direct cardiac
application.

Type CF (IEC 60601-1) protection against electric shock. Isolated


(floating) applied part suitable for intentional external and internal
application to the patient, including direct cardiac application.
Type CF (IEC 60601-1) defibrillator-proof protection against electric
shock. Isolated (floating) applied part suitable for intentional external
and internal application to the patient including direct cardiac
application.

Power On/Off key.

Alternating current.
Power indicator. The device is being used on main power.

Battery.
Green lit. Monitor is operated on battery power.
Orange lit. Battery is charging. The indicator goes off when the
battery is fully charged.
Orange flashing. Battery failure or AC/DC failure.

Audio pause key. Temporary audio off.

Snapshot key.

Manual NIBP key. Start a manual NIBP measurement.

Equipotentiality. Connect device to a potential equalization


conductor.

Multi I/O connector.

DVI connector. Video output connector for digital source.

30 B125/B105 Patient Monitor 2105518-001


System overview

Recorder and B1X5-F2 connector.

USB connector.

Ethernet connector.

Battery cover open/close indication.


The operator should align the up and down arrow, then push the
cover to close.

B1X5-F2 connector.

Gas inlet.

Gas outlet.

Mini D-fend: Add date.

Recorder.

Recorder paper install direction.

B1X5-F2 communication indicator.

Fuse. Replace with identical type and rating fuse.

Degree of ingress protection.

Date of manufacture. This symbol indicates the date of manufacture


of this device. The first four digits identify the year and the last two
digits identify the month.

Manufacturer name and address.

2105518-001 B125/B105 Patient Monitor 31


System overview

Abbreviation for product number.

Device serial number.

Every device has a unique marking for identification. The UDI


marking appears on the device label.

Atmospheric pressure limitations.

Temperature limitations.

China only. Temperature limitations.

Humidity limitations.

Keep dry. Protect from rain.

China only. Keep dry. Protect from rain.

Fragile. Handle with care.

China only. Fragile. Handle with care.

This way up.

32 B125/B105 Patient Monitor 2105518-001


System overview

China only. This way up.

This symbol indicates that the waste of electrical and electronic


equipment must not be disposed as unsorted municipal waste
and must be collected separately. Please, contact an authorized
representative of the manufacturer for information concerning the
decommissioning of your equipment.
The separate collection symbol is affixed to a battery, or its
packaging, to advise you that the battery must be recycled
or disposed of in accordance with local or country laws. To
minimize potential effects on the environment and human health,
it is important that all marked batteries that you remove from
the product are properly recycled or disposed. For information
on how the battery may be safely removed from the device,
please consult the service manual or equipment instructions.
Information on the potential effects on the environment and human
health of the substances used in batteries is available at this url:
http://www.gehealthcare.com/euen/weeerecycling/ index.html

Recycled materials or may be recycled.

Recyclable Lithium-Ion.

FCC. USA only. Complies with applicable US government (Federal


Communications Commission) radio-frequency interference
regulations.

Prescriptive Device. USA only. For sale by or on the order of a


Physician.

Russia only. GOST-R mark.

Eurasian Economic Union countries only. Eurasian Conformity mark.


Conformity to applicable technical regulations of Customs Union.

2105518-001 B125/B105 Patient Monitor 33


System overview

China only.
This symbol indicates the product contains hazardous materials
in excess of the limits established by the Chinese standard GB/T
26572 Requirements for Concentration Limits for Certain Hazardous
Substances in Electronic Information Products. The number in
the symbol is the Environment-friendly User Period (EFUP), which
indicates the period during which the toxic or hazardous substances
or elements contained in electronic information products will not
leak or mutate under normal operating conditions so that the use
of such electronic information products will not result in any severe
environmental pollution, any bodily injury or damage to any assets.
The unit of the period is "Year".
In order to maintain the declared EFUP, the product shall be operated
normally according to the instructions and environmental conditions
as defined in the product manual, and periodic maintenance
schedules specified in Product Maintenance Procedures shall be
followed strictly.
Consumables or certain parts may have their own label with an
EFUP value less than the product. Periodic replacement of those
consumables or parts to maintain the declared EFUP shall be done in
accordance with the Product Maintenance Procedures. This product
must not be disposed of as unsorted municipal waste, and must be
collected separately and handled properly after decommissioning.
China only. China Ministry of Industry and Information Technology
identification number for Radio Transmission Equipment Type
Approval.

Brazil only. Approved under ANATEL (Agência Nacional de


Telecomunicações) requirements.

Brazil only. INMETRO certificate.

Australia only. Regulatory Compliance Mark (RCM). The product


comply the ACMA (Australian Communications and Media Authority)
regulatory requirement.

This product is restricted to indoor use, Restricted Member States as


below:
Belgium (BE), Bulgaria (BG), Czech Republic (CZ), Denmark (DK),
Germany (DE), Estonia (EE), Ireland (IE), Greece (EL), Spain (ES), France
(FR), Croatia (HR), Italy (IT), Cyprus (CY), Latvia (LV), Lithuania (LT),
Luxembourg (LU), Hungary (HU), Malta (MT), Netherlands (NL), Austria
(AT), Poland (PL), Portugal (PT), Romania (RO), Slovenia (SI), Slovakia
(SK), Finland (FI), Sweden (SE) and United Kingdom (UK).

34 B125/B105 Patient Monitor 2105518-001


System overview

South Africa only. Approved under ICASA (Independent


Communications Authority of South Africa) requirements.

Philippines only. The product comply the NTC (National


Telecommunications Commission) requirements.

User interface symbols


The following symbols appear in the software user interface.
Alarm off indicator - Displays in the upper right corner of the digit
field when physiological alarms for this parameter are turned off.
The symbol may not display at the central station.
Audio alarms off indicator - Displays in the upper left corner of
the message field when physiological audible alarms are turned
off.

Alarm pause indicator - Displays in the upper left corner of the


message field and indicates that alarms are audio paused.

Alarms audio pause indicator. Displays in the upper left corner


of each alarm message and indicates that alarm audio pause
has been activated.

Network connection indicator. Indicates the monitor is connected


to the Local Area Network (LAN).

Network (WLAN) signal strength. The number of segments


corresponds to the signal strength: four segments indicate
strong signal, one segment weak signal.

Network (WLAN) is failed.

Monitor battery is full.

Monitor battery is less than 87.5% of run time left.

Monitor battery is less than 62.5% of run time left.

Monitor battery is less than 37.5% of run time left.

Monitor battery is empty when there is less than 12.5% of run


time left.

2105518-001 B125/B105 Patient Monitor 35


System overview

The following symbols appear in the software user interface.

Monitory battery failure or missing battery.

Monitor battery is charging.

Night mode indicator. Indicates the monitor is on the night mode.

Snapshot indicator. Indicates the event has an associated


snapshot.

Beat volume icon. Adjust the volume of the QRS beep tone.
Also the beat source indicator. Displays next to the selected beat
source.

Respiration indicator. Indicates a breath is detected by the


impedance respiration algorithm.

Lock indicator. Indicates the screen has been locked.

Masimo SpO2 only. SpO2 signal strength indicator. Indicates the


signal strength, with three asterisks indicating the strongest
signal.
NIBP progress bar. Indicates the amount of time remaining until
the next automatic measurement.

36 B125/B105 Patient Monitor 2105518-001


Theory of operation
3
System block diagram

2105518-001 B125/B105 Patient Monitor 37


Theory of operation

Main components
CPU board
CPU board block diagram

The board is based on AT91 ARM microprocessor. The functions include LVDS display
driver, 10/100Mbps on board Ethernet, WLAN communication, USB function, Alarm
Light function, Keyboard and Trim Knob control, Audio driver function, nurse call
function. The CPU section takes care of the central processing.

38 B125/B105 Patient Monitor 2105518-001


Theory of operation

The main features are:


● AT91 ARM
● 266 MHz Main CPU clock
● 128 MB SDRAM
● 1 GB NAND flash memory
● 8 MB Data flash memory

2105518-001 B125/B105 Patient Monitor 39


Theory of operation

Carrier board
Carrier board block diagram

The Carrier board functions include the power supply function, UMBC function.

40 B125/B105 Patient Monitor 2105518-001


Theory of operation

● The power supply subsystem converts the output voltage of AC/DC unit and battery
voltage to various supply voltages for the electronics of monitor. It provides:
■ 3.3V power for monitor system
■ 15V power for UMBC
■ 9V and 15V power for LCD interface board
● The UMBC subsystem provides:
■ RS-485 module bus communication for the Hemo module, E-module, and
recorder.
■ A digital marker-out signal for defibrillator.

AC/DC unit
AC/DC insulation diagram

The AC/DC unit is a compact medical power supply based on high-efficiency


technology. It is designed for 65 watt continuous output power, universal AC input
and 15V output voltage.

Display subsystem
Display
The B105 patient monitor has an integrated 10.1" active matrix color TFT LCD panel
with a LED backlight unit.
The B125 patient monitor has an integrated 12.1" active matrix color TFT LCD panel
with a LED backlight unit.
They provide wide viewing angle and supports WXGA (1024 * 800 pixels) resolution.
The video controller is integrated into the CPU board and it provides LVDS output to
the LCD panel through the carrier board. The LCD interface board converts the output
voltage from carrier board to various supply voltage for the LCD.
LED backlight unit
The LCD/TP (touch panel) module has an integrated, long-life LED backlight unit that is
used to illuminate the LCD display. The LED backlight unit receives the +12 V input
voltage from the LCD interface board. The backlight enable signal and brightness
control is received from the CPU board.
Touchscreen sensor
The device has a capacitive touchscreen sensor in the front of the LCD panel. The
touchscreen sensor detects the presence and location of a touch within the display

2105518-001 B125/B105 Patient Monitor 41


Theory of operation

area and communicates the information through the LCD interface board to the
carrier board.

Recorder unit
The optional recorder assembly consists of a 50 mm recorder and a recorder board.
The recorder connect to the carrier board. The RS_485 module bus communication is
on the UMBC sybsystem of the carrier board.

Battery
The monitor has a lithium-ion battery, located in the battery compartment. When no
power is received from the AC/DC unit, the carrier board connects battery to be the
power source. The battery charging is controlled by the power supply subsystem on
carrier board.
The screen symbols and monitor LED indicators indicate the battery charging level
and possible failure.
NOTE When the monitor is battery powered, the green battery LED
is on. When the monitor is mains powered, the green mains
LED is on.

User interface parts


The device has a carrier interface board connect the following user interface parts to
the carrier board
● Horizontal membranes keypad containing 4 keys, and 2 power indicator LEDs
● Trim knob
● Speaker
● Alarm board
● LCD touch panel

Hemo module
1. IBP connector
2. Temperature connector
3. SpO2 connector
4. ECG and impedance respiration connector
5. NIBP connector

42 B125/B105 Patient Monitor 2105518-001


Theory of operation

The Hemodynamic module including the NIBP measurement, 5-lead ECG with the
Impedance Respiration measurement, SpO2 with the plethysmographic waveform,
two invasive pressure measurements (IBP1 and IBP2) and two temperature
measurements (T1 and T2).
There are four parameter circuit boards inside the hemodynamic module for
processing the measurement signals. Each processing board has a microcontroller
with software.
● NIBP parameter board with pneumatic system, valve and pump unit.
● SpO2 board for Masimo or Nellcor SpO2 measurement. This is the optional board.
And according to different configuration, using different board, options are:
■ Masimo MS-2011 board
■ Covidien NELL1GE-S board
● STP board for GE SpO2, IBP and Temperature measurement. According to different
configuration, using different board, options are:
■ STP board
■ TP board for Nellcor
■ TP board for Masimo
■ GE SpO2 board
● The ECG board is for 3/5-lead ECG with the Impedance Respiration measurement.
All boards are connected together via module bus flex board connecting voltage and
module communication, the module communicates with frame through RS-485 bus.
Serial communication
An RS485 type bus driver makes the serial communication between the module and
the frame. The data transmission rate is 500 kbps.

2105518-001 B125/B105 Patient Monitor 43


Theory of operation

Serial communication diagram of hemo module

Signals and isolation barrier


The communication signals transfer over the isolation barrier by using high isolation
voltage (6kV) opto isolators.
Power supply section
● The power for the electronics on the floating part of the STP and the ECG boards
is made on each board with the switching power supplies connected to a high
voltage isolated transformer. The switching power supplies on the STP and ECG
boards are synchronized to the frequency, about 340kHz of the switching power
supply on the NIBP board. The NIBP board supplies non-isolated 5 V to the ECG and
STP boards. The module uses only Vmod 13.8 to 16 V voltage of the frame.
● The other voltages of the measuring boards are made by the switching power
supplies and regulators or the linear regulators. The measuring board is protected
against overloading with PTC type automatic fuses.

44 B125/B105 Patient Monitor 2105518-001


Theory of operation

ECG board
The ECG measurement consists of the functions shown in the diagram. All functions
are located in the ECG board except the ECG input unit.

● ECG input unit


■ The ECG input unit consists of the front panel connector and the ECG input
connector board with the high voltage protection resistors. The connector for
the ECG cable is a green 11-pin rectangle shaped connector.
● Input protection and filtering
■ The input protection is implemented with high voltage protection resistors in the
ECG input unit and with protection diodes in the ECG board. The input filtering
for ECG measurement is done with passive RC filtering.
● ECG preamplifiers
■ The buffer amplifiers are used for each lead. The “Leads off” detection is
implemented by measuring the output level of the input buffer amplifiers with
the A/D converter of the CPU. The ECG signals are measured using differential
amplifiers.

2105518-001 B125/B105 Patient Monitor 45


Theory of operation

● ECG amplifiers and baseline restoration


■ The function of the ECG amplifiers and baseline restoration is to amplify the
signal and to restore the baseline of the signal in the middle of the display after
the change of the signal level, e.g. after the change of the DC offset voltage.
● Pacer detection
■ Pacer detection has been made by using four slew rate detector circuits. The
pacer detection amplifiers have been realized at the front of the slew rate
detectors independently of the ECG measuring channels.
● Respiration impedance supply
■ The 31.25 kHz sine wave generator is used as the respiration measurement
signal supply. Analog switches are used for connecting the sine wave to the ECG
leads to be measured.
● Respiration impedance amplifiers
■ Buffer amplifiers are used in respiration measurement. Analog switches are
used for selecting the measurement leads. There are also additional amplifiers
for increasing the respiration signal gain. When ECG measurement is 5-lead, the
respiration measurement is always done between R and F, independently on
the ECG lead selection. When ECG measurement is 3-lead, then the respiration
measurement is happened at the same lead as the ECG measurement (I, II, or III).
● ECG CPU
■ The CPU is a 16 bit H8/3052 single-chip microcomputer. It contains 128 kbytes
of flash memory and 4 kbytes of RAM. The clock frequency is 16 MHz.
● RS485 communication
■ The communication to the CPU board of the monitor uses RS485 protocol. The
RS485 driver circuits are optically isolated from the processor of the module.
● Power supply
■ The ECG board has a driver-controlled half-bridge switching power supply with
5 kV isolation. The supply voltages have been regulated with linear regulators.
● ECG filtering
■ There are three ECG filtering modes:
MONITORING 0.5 to 40 Hz
DIAGNOSTIC 0.05 to 145 Hz
ST FILTER 0.05 to 40 Hz
MODERATE 0.5 to 20 Hz

■ The purpose of filtering is to reduce high frequency noise and low frequency
(e.g. respiratory) movement artifacts.
■ The monitor filter is used in normal monitoring. The diagnostic filter is used
if more accurate diagnostic information is needed. The ST filter gives more
accurate information of ST segment, but reduces high frequency noise.
■ The high-pass filters 0.5 Hz and 0.05 Hz are done with software. The monitor
sends a command to the hemodynamic module determining which of the
corner frequencies 0.5 Hz or 0.05 Hz is to be used.
■ In diagnostic mode the upper frequency is 150 Hz and it is limited by software.

46 B125/B105 Patient Monitor 2105518-001


Theory of operation

STP board
STP board block diagram

Microprocessor unit
● The CPU is a 16 bit H8/3052 single-chip microcomputer. It contains 128 kbytes of
flash memory and 4 kbytes of RAM. The clock frequency is 16 MHz.
● High speed I/O is used to obtain a pulse control sequence necessary for pulse
oximetry measurement. Timing for the clock is from the oscillator.
Temperature measurement unit
● The NTC-resistor value in the probe depends on the patient’s temperature. It is
measured with the following principle.
● The constant current source supplies about 38 µA current through the temperature
sensor (400 series NTC resistor). The constant current causes a voltage over the
temperature sensor (NTC resistor). The voltage over the temperature sensor is
amplified in a differential amplifier stage. The amplified voltage is transferred to a
controller of the STP board through an A/D converter.

2105518-001 B125/B105 Patient Monitor 47


Theory of operation

Temperature measurement principle

Invasive blood pressure measurement unit


● An isolated +5 V voltage is supplied to the pressure transducer. The differential
voltage, which depends on the pressure and the supplied voltage, is calculated
from the bridge connection (see the formula below).
Uout = Uin x pressure x 5 µV, where Uin is 5 V
-> Uout = 25 µV x pressure [mmHg]
● Pressure amplification is realized in the instrumentation amplifier. The gain of the
amplifier is set to keep the level of the signal transferred to the A/D converter within
the measurement range even when there are circumstantial offsets or offsets
caused by the transducer. There is a filter before the amplifier to attenuate high
frequency disturbances.

48 B125/B105 Patient Monitor 2105518-001


Theory of operation

Invasive pressure measurement principle

Pulse oximetry measurement section


● LED control signals
■ The D/A converters of the microcontroller on the STP board set the LED intensity
adjustment values for the infrared and red LEDs of the SpO2 probe. The
microcontroller on the STP board switches the SpO2 probe LEDs ON (to the
adjusted intensity) and OFF according to the predetermined sequence.
● LED driving circuit
■ Differential amplifiers measure the LED currents (LED current indication) of the
SpO2 probe over the shunt resistors placed in the LED current paths. The LED
driving voltages (LED voltage indication) are measured from the driver circuitry.
The LED driving circuits also have MOSFET transistor matrix to enable the use of
different probe configurations.
● Measured signal preamplification
■ The preamplifier is a bipolar/single-ended current-to-voltage converter
with adjustable gain. A higher gain is used for measuring thin tissue. The
preamplification stage has also ambient light reduction and a second amplifier
stage.
● Red and infrared channel separation
■ It is possible to multiplex the detector signal to four different channels depending
on the content of the signal. The detector signal must at least multiplex into
infrared and red signals. Other channels are e.g. for diagnostic purposes.

2105518-001 B125/B105 Patient Monitor 49


Theory of operation

Pulse oximetry measurement principle

NIBP board
NIBP board block diagram

● Signal processing

50 B125/B105 Patient Monitor 2105518-001


Theory of operation

■ Two signals from the pressure transducers are amplified and sent to the A/D
converter. After the converter, digitized signals are sent to the microprocessor
for data processing.
■ The NIBP board is controlled with an H8/3052 microprocessor at 16 MHz
oscillator frequency.
● Memory
■ The NIBP program memory (processor flash memory) size is 512k x 8. The
processor has 4 kBytes RAM and there is also an external RAM memory, the size
of which is 128k x 8. Variable values of the NIBP measurement are stored into the
external RAM. The EEPROM size is 512 x 8 and it is used to store the calibration
values for the pressure transducers, the pulse valve constants gained during
measurements, the PC board identification, and the module serial number.
● Software control
■ The software controls valves and a pump. In addition to the individual on/off
signals for each component there is a common power switch for the valves and
the pump that can be used at pump/valve failures.
■ In addition to external RS485 reset line, the microprocessor system is equipped
with its own power-up reset.
● Safety circuit
■ The NIBP board is equipped with an independent safety circuit to disconnect
supply voltages from the pump and the valves if the cuff has been pressurized
longer than the preset maximum measurement time, or if the pressure of the
cuff is inflated over the specified pressure limit. The maximum measurement
time values and pressure limits for different measurement modes have been
specified in the technical specifications.
● Pneumatics

The module have the following pneumatics parts:


1. NIBP air filter for preventing dust and other parts from entering the air pump
and the valves.
2. Air pump for pumping the measuring pressure of the cuff.
3. Deflation valve for producing a linear pressure fall (bleeding) in order to
measure the blood pressure of the patient.

2105518-001 B125/B105 Patient Monitor 51


Theory of operation

4. Safety (Dump) valve. The safety valve is intended to be used for deflating the
cuff in single fault case, i.e. to prevent too long a measurement time or too
high an inflation pressure of the cuff.
5. Main pressure sensor for measuring the pressure of the blood pressure cuff
and the pressure fluctuations caused by arterial wall movement.
6. Safety pressure sensor for detecting the cuff loose, cuff occlusion situations,
etc. and for recognizing the pressure sensor fault.
7. Cuff connector for connection and hose identification.
■ NIBP pneumatics diagram:

● Power supply section of the NIBP board


■ All connections are established via a module bus connector. The module needs
a +15 V power supply to operate. The supply voltage (+15V) is generated in
the power supply section of the monitor. The other voltages needed for the
operation of the NIBP measurement are made on the NIBP board.

Non-standard connectors and signals


Multi I/O connector
Multi I/O Pin
connector (X1) number Signal Name Signal Description
1 GND Ground
2 HHSDME Reserve for future use
3 HHSDPE Reserve for future use
4 NC Reserve
5 D_RXD Serial Data Receiver for
debug
6 NC Reserve
7 SERIAL_TXD Serial Data Transmitter
8 SERIAL_CTS# Handshake signal, ready to
send data
9 GND Ground

52 B125/B105 Patient Monitor 2105518-001


Theory of operation

Multi I/O Pin


connector (X1) number Signal Name Signal Description
10 GND Ground
11 REMOTE_ON Reserve for remote on
12 NC Reserve
13 DFB_OUT Defibrillation output
14 NC Reserve
15 NC Reserve
16 SERIAL_RXD Serial Data Receiver
17 SERIAL_RTS# Handshake signal, ready to
receive data
18 GND Ground
19 GND Ground
20 NURSE_CALL_CON Nurse call output
21 V_REMOTE Reserve for remote on
22 V_REMOTE Reserve for remote on
23 D_TXD Serial Data Transmitter for
Debug
24 NC Reserve
25 SERIAL_+3v3 3.3V Power Supply
26 GND Ground

Nurse call connector


Nurse call connector Pin number Signal
1 GND
2 NURSE_CALL
3 NURSE_CALL

Nurse call connector schematics:

Recommended cable design:

2105518-001 B125/B105 Patient Monitor 53


Theory of operation

Serial port connector


Serial port connector Pin number Signal Name
1 GND
2 SERIAL_TXD
3 SERIAL_RXD
4 NC
5 GND
6 NC
7 SERIAL_CTS
8 SERIAL_RTS
9 NC

Recorder connectors
Recorder
connector
(X2, On the Pin
monitor) number Signal Name Signal Description
1 RS485– Modbus RS485–
2 RS485+ Modbus RS485+
3 GND Ground
4 GND Ground
5 F2_EN Reserve
6 F2_DET Reserve
7 VMOD +15V power supply
8 VMOD +15V power supply
9 GND Ground

54 B125/B105 Patient Monitor 2105518-001


Theory of operation

Serial port
connector Pin
(On the recorder) number Signal Name Signal Description
1 NC Not connect
2 GND Ground
3 MOD_VDD +15V power supply
4 GND Ground
5 RS485+ Modbus RS485+
6 NC Not connect
7 GND Ground
8 MOD_VDD +15V power supply
9 RS485– Modbus RS485–

Defibrillator synchronization connector


Defibrillator
Synchronization connector Pin number Signal
1 Digital defibrillator synchronization marker
out signal
2 NC
3 GND
4 GND
5 GND
6 GND
7 GND

Measurement principle
ECG measurement principle
Electrocardiography analyzes the electrical activity of the heart by measuring the
electrical potential produced with electrodes placed on the surface of the body.
ECG reflects:
● electrical activity of the heart
● normal/abnormal function of the heart
● effects of anesthesia on heart function
● effects of surgery on heart function
See the user’s manual for electrodes’ positions and other information.

Respiration measurement principle


Impedance respiration is measured across the thorax between ECG electrodes. The
respiration signal is made by supplying current between the electrodes and by

2105518-001 B125/B105 Patient Monitor 55


Theory of operation

measuring the differential current from the electrodes. The signal measured is the
impedance change caused by breathing. The respiration rate is calculated from these
impedance changes, and the respiration waveform is displayed on the screen.

Pulse oximetry measurement principle


A pulse oximeter measures the light absorption of blood at two wavelengths, one in
the near infrared (about 940 nm) and the other in the red region (about 660 nm) of the
light spectrum. These wavelengths are emitted by LEDs in the SpO2 probe, the light is
transmitted through peripheral tissue and is finally detected by a PIN-diode opposite
the LEDs in the probe. The pulse oximeter derives the oxygen saturation (SpO2) using
an empirically determined relationship between the relative absorption at the two
wavelengths and the arterial oxygen saturation SaO2.
In order to measure the arterial saturation accurately, pulse oximeters use the
component of light absorption giving variations synchronous with heart beat as
primary information on the arterial saturation.
A general limitation of pulse oximetry is that due to the use of only two wavelengths,
only two hemoglobin species can be discriminated by the measurement.
The modern pulse oximeters are empirically calibrated either against fractional
saturation SaO2frac;

Formula 1

or against functional saturation SaO2func;

Formula 2

Functional saturation is more insensitive to changes of carboxyhemoglobin and


methemoglobin concentrations in blood.
The oxygen saturation percentage SpO2 measured by the module is calibrated against
functional saturation SaO2func. The advantage of this method is that the accuracy
of SpO2 measurement relative to SaO2func can be maintained even at rather high
concentrations of carboxyhemoglobin in blood. Independent of the calibration
method, pulse oximeters are not able to correctly measure oxygen content of the
arterial blood at elevated carboxyhemoglobin or methemoglobin levels.
Plethysmographic pulse wave
The plethysmographic waveform is derived from the IR signal and reflects the blood
pulsation at the measuring site. Thus the amplitude of the waveform represents the
perfusion.
Pulse rate
The pulse rate calculation is done by peak detection of the plethysmographic pulse
wave. The signals are filtered to reduce noise and checked to separate artifacts.
The following illustration shows the absorption of infrared light in the finger:

56 B125/B105 Patient Monitor 2105518-001


Theory of operation

The following illustration shows the layout and schematic diagram of pulse oximetry
probe parts:

The standard probe is a finger clamp probe which contains the light source LEDs
in one half and the photodiode detector in the other half. Different kinds of probes
are available from GE.

NIBP measurement principle


NIBP (Non-Invasive Blood Pressure) is an indirect method for measuring blood
pressure.

2105518-001 B125/B105 Patient Monitor 57


Theory of operation

The NIBP measurement is performed according to the oscillometric measuring


principle. The cuff is inflated with a pressure slightly higher than the presumed systolic
pressure, and deflated at a speed based on the patient’s pulse, collecting data from
the oscillations caused by the pulsating artery. Based on these oscillations, values for
systolic, mean, and diastolic pressures are calculated.
The following parts are necessary for the NIBP measurement:
● a parameter module
● twin hose (adult or infant model)
● blood pressure cuffs (various sizes)

Invasive blood pressure measurement principle


To measure invasive blood pressure, a catheter is inserted into an artery or vein. The
invasive pressure setup, consisting of a connecting tubing, a pressure transducer, an
intravenous bag of normal saline, all connected together by stopcocks, is attached
to the catheter. The transducer is placed at the same level with the heart, and is
electrically zeroed.
The transducer is a piezo-resistive device that converts the pressure signal to a
voltage. The monitor interprets the voltage signal so that pressure data and pressure
waveforms can be displayed.

Temperature measurement principle


The temperature is measured by a probe whose resistance varies when the
temperature changes, called NTC (Negative Temperature Coefficient) resistor.
The resistance can be measured by two complementary methods:
● Applying a constant voltage across the resistor and measuring the current that
flows through it.
● Applying a constant current through the resistor and measuring the voltage that
is generated across it.
These modules use the constant current method. The NTC resistor is connected in
series with a normal resistor and a constant current is applied through them. The
temperature dependent voltage can be detected at the junction of the resistors, thus
producing the temperature signal from the patient. The signal is amplified by analog
amplifiers and further processed by digital electronics.

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Pre-installation requirements
4
Unpacking
WARNING EXCESSIVE LEAKAGE CURRENT. If the device has been
transported or stored outside operating temperature range
allow it to stabilize back to operating temperature range
before removing it from the plastic bag.

CAUTION PACKAGING DISPOSAL. Dispose of the packaging material,


observing the applicable waste control regulations.

1. Confirm that the packing box is undamaged. If the box is damaged, contact the
shipper.
2. Open the top of the box and carefully unpack all components.
3. Confirm that all components are undamaged. If any of the components is
damaged, contact the shipper.
4. Confirm that all components are included. If any of the components is missing,
contact your GE Healthcare distributor.

Checking the compatibility of all system


components
WARNING BEFORE INSTALLATION. Compatibility is critical to safe and
effective use of this device. Please contact your local sales or
service representative prior to installation to verify equipment
compatibility.

WARNING INTERFACING OTHER EQUIPMENT. Connect only items that are


specified as part of the system and as compatible. For more
information, see the supplemental information manual.

WARNING The use of accessories, transducers and cables other


than those specified may result in increased emissions or
decreased immunity performance of the equipment or
system.

WARNING For detailed instructions and information regarding supplies


and accessories, always refer to their own instructions for use.

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Pre-installation requirements

Verify the compatibility of all system components prior to the installation of the patient
monitor. For a list of the compatible devices, supplies and accessories, see the
Supplemental Information Manual, and Supplies and accessories.
1. Check the compatibility of the displays and display cables.
2. Check the compatibility of the network.
3. Check the compatibility of the supplies and accessories.
4. Check the compatibility of the peripheral devices. For a list of the compatible
peripheral devices, see the supplemental information manual.

Network infrastructure
Ensure that an applicable network infrastructure is in place before the installation
of a monitor.
Collect the network configuration information from the hospital IT or the related
project documentation and installation files.

Checking MC Network infrastructure


The MC Network infrastructure must be installed according to the CARESCAPE Network
Configuration Guide.
1. Ensure that the installation site of the monitor has a wall jack and a network
patch cable for the MC Network.
2. Collect the required information ready for network configurations: refer to
Configuration chapter.

Checking wireless MC Network infrastructure


The wireless MC Network infrastructure must be installed according to the
2000716-003 WLAN Configuration Guide and DOC1314463 WLAN Deployment Guide.
1. Ensure that the wireless coverage area is adequate for the installation.
2. Collect the required information ready for network configurations: refer to
Configuration chapter.

Checking HL7 Network infrastructure


The HL7 Network infrastructure must be installed according to HL7 reference manual.
1. Collect the required information ready for network configurations: refer to
Configuration chapter.

Installing the mounting hardware


Refer to the Supplies and accessories for compatible mounting hardware.
1. Ensure that all the applicable/required mounting hardware is properly installed
prior to the installation of the monitor:
● Mounting hardware for the patient monitor, either for a stand-alone installation
or for an installation to an anesthesia machine or to a ventilator.

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Pre-installation requirements

Power and environmental requirements


Check the patient monitor’s supplemental information manual for power and
environmental requirements.
WARNING Operation of the monitor outside the specified performance
range may cause inaccurate results.

CAUTION Do not use or store equipment outside the specified


temperature, humidity, or altitude ranges.

Checking environmental requirements


1. Install the monitor to a location that meets the specified environmental
requirements of operating temperature, humidity and atmospheric pressure.
2. Place each device in a location with sufficient ventilation. Observe the ventilation
openings of a device and make sure not to obstruct them.

Checking power requirements


WARNING EXCESSIVE LEAKAGE CURRENT. A display or printer that is
a non-medical grade device and is used within the patient
environment, must always be powered from an additional
transformer providing at least basic isolation (isolating
or separating transformer). Using without an isolating
transformer could result in unacceptable enclosure leakage
currents.

1. Ensure that he installation site has hospital-grade grounded power outlets and
power cords for all system components.

Checking EMI & RFI interference


WARNING Do not use the monitor in high electromagnetic fields (for
example, during magnetic resonance imaging).

WARNING Other equipment may interfere with the system, even if that
other equipment complies with CISPR emission requirements.

CAUTION EMC. Magnetic and electrical fields are capable of interfering


with the proper performance of the device. For this reason
make sure that all external devices operated in the vicinity of
the monitor comply with the relevant EMC requirements. X-ray
equipment or MRI devices are a possible source of interference
as they may emit higher levels of electromagnetic radiation.
Changes or modifications to this device/system not expressly
approved by GE may cause EMC issues with this or other
equipment. This device/system is designed and tested to
comply with applicable standards and regulations regarding
EMC and needs to be installed and put into service according
to the EMC information stated as follows: This device/system
is suitable for use in all establishments other than domestic
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes. Mains power should be that of a typical commercial
or hospital environment. Device is compliant to Class A.

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Pre-installation requirements

CAUTION Use of known RF sources, such as cell/portable phones,


or other radio frequency (RF) emitting equipment near the
system may cause unexpected or adverse operation of
this device/system. Consult qualified personnel regarding
device/system configuration.

1. Ensure that the monitor is isolated from sources of strong electromagnetic and
radio frequency interference.
Refer to the patient monitor’s supplemental information manual for more
information.

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5
Hardware installation
WARNING The parameter modules are not able to withstand unpacked
drops from a height of 1 m without damage. If a module is
dropped, please service it before taking it back into use.

WARNING After transferring or reinstalling the monitor, always check that


it is properly connected and all parts are securely attached.

WARNING SITE REQUIREMENTS - Do not route cables or tubing in a way


that they may present a stumbling hazard.

WARNING EXPLOSION - Do not use this equipment in the presence of


flammable anesthetics, vapors or liquids.

WARNING EXCESSIVE TOUCH CURRENT - To avoid excessive patient


leakage current, do not simultaneously touch the patient
and the electrical connectors located at the rear panel of the
monitor or within the module housing or frames.

WARNING Never install equipment above the patient.

WARNING Use only manufacturer approved mounts.

WARNING To prevent liquids from entering the monitor, do not tilt the
monitor.

WARNING Do not connect a monochrome display to the monitor. Visual


alarm indicators may not appear properly.

WARNING PHYSICAL INJURY- Take care when mounting devices to an IV


pole. If a device is mounted too high the IV pole may become
unbalanced and tip over.

WARNING Use only AC power cords recommended or manufactured


by GE.

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Hardware installation

WARNING EXCESSIVE LEAKAGE CURRENT To avoid summation of leakage


currents when interfacing the device with other equipment,
the devices may only be interconnected with each other
or to parts of the system when it has been determined by
qualified biomedical personnel that there is no danger to the
patient, the operator, or the environment as a result. In those
instances where there is any element of doubt concerning
the safety of the connected devices, the user must contact
the manufacturers concerned (or other informed experts) for
proper use. In all cases, safe and proper operation should
be verified with the applicable manufacturer’s instructions
for use, and system standards IEC60601-1 clause 16 must
be complied with.

WARNING POWER SUPPLY - The device must be connected to a properly


installed power outlet with protective earth contacts only. If
the integrity of the protective earth conductor is in doubt,
disconnect the monitor from the power line, and use it with
the battery option, if available. All devices of a system must be
connected to the same power supply circuit. Devices which
are not connected to the same circuit must be electrically
isolated when operated.

WARNING MISSED ALARMS - Do not use with Mobile Care Server Version
5.2 and earlier.

CAUTION LOSS OF MONITORING. Leave space for circulation of air to


prevent the monitor from overheating. The manufacturer
is not responsible for damage to equipment caused by
improperly vented cabinets, improper or faulty power, or
insufficient wall strength to support equipment mounted on
such walls.

CAUTION The device/system should not be used adjacent to, or stacked


with, other equipment. Consult qualified personnel regarding
device/system configuration.

CAUTION Before connecting the device to the power line, check that
the voltage and frequency ratings of the power line are the
same as those indicated on the device's label. If this is not
the case, do not connect the system to the power line until
you adjust the device to match the power source. In U.S.A.,
if the installation of this equipment will use 240V rather than
120V, the source must be a center-tapped, 240V, single-phase
circuit. This equipment is suitable for connection to public
mains as defined in CISPR 11.

Installing battery
Battery test button
When the battery is not inserted into the monitor, you can check its status by using the
TEST button on the battery itself. Push the button and check the green charging level
indicators to see how much charge is left:
● Four LEDs illuminated: 75% to 100% of full-charge capacity.

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Hardware installation

● Three LEDs illuminated: 50% to 74.9% of full-charge capacity.


● Two LEDs illuminated: 25% to 49.9% of full-charge capacity.
● One LED illuminated: 10% to 24.9% of full-charge capacity.
● One LED flashing: < 10% of full-charge capacity.

Inserting and removing battery


1. Open the battery cover by pressing the battery cover and slide out.
2. Insert the battery with the test indicator side up and the connector end first all
the way into the battery slot.
3. Close the battery door carefully. Align the up and down arrow, then slide battery
cover to the left to close.

4. To remove the battery, open the battery cover and pull the battery out from the
cord.

Checking the battery charge with monitor software


You can check the monitor battery status using the monitor software:

1. Select the > Battery .


2. Check the battery status that appears.
NOTE When the battery charge complete, the Capacity Percent
may not reach to 100%.

Mounting the monitor and frame


The monitor and frame have the integrated GCX mounting plate. This facilitates
mounting options for the monitor and frame. You also can install the L-type mounting
plate to the B1X5-F2 frame, to apply to more frame mounting options.
Refer to the Supplies and accessories to identify the compatible mounting hardware
for the patient monitor and frame.

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Install the monitor and frame to the mounting hardware according to the installation
instructions included with the mounting hardware.

Installing L-type mounting plate to B1X5-F2 Frame


1. Put the L-type mounting plate to the bottom of the B1X5-F2 Frame, install 4
screws.

Connecting a display
NOTE All installations must be compliant with IEC 60601-1 clause
16 and local electrical codes.

NOTE Make sure that all cables are securely connected.

You can connect one secondary, clone display to the monitor.


1. Check the compatibility of the display.
The resolution of the external display should be 1280*800.
2. Ensure that the display is installed to the mounting hardware according to the
installation instructions included with the mounting hardware.
3. Refer to the display's user manual for more information about the display
installation.

Connecting B1X5-F2 module


1. Using a Y-Type line, connect B1X5-F2’s X3 connector to monitor’s X2 connector
and recorder’s connector. Or, using a single F2 connector line, connect X3 and X2.
NOTE If you use a single connector line, please note the line for
recorder and B1X5-F2 is difference.

2. Using power cord connect B1X5-F2 to the wall outlet.


3. Check whether power LED lit.
4. Turn on the monitor, check whether communication LED lit.

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Y-Type line

Single F2 connector line

Connecting E-module
To use the E-module, your device need to be pre-configured with the extension rack.
Or, connect the B1X5-F2 frame.
1. With the module properly oriented (module release latch facing down), align the
insertion guide slot in the module with the insertion guide in the extension rack.
2. Push the module into the module frame until it clicks.

Connecting the recorder


Please make sure the monitor is pre-configured with recorder fixing plate.
1. Using a Y-Type line, connect B1X5-F2’s X3 connector to monitor’s X2 connector
and recorder’s connector. Or, using a single recorder connector line, connect
the recorder connector to X2.
NOTE Please note the line for recorder and B1X5-F2 is difference.

2. When the monitor is power on, make sure the power indicator on recorder is lit.

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Y-Type line

Single recorder connector line

Inserting the recorder


1. Align the recorder to the insertion guides.
2. Push down the recorder until it clicks.

Removing the recorder


1. Pull the recorder outwards by the tab. Make sure not to drop it when it comes out.

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Connecting Multi I/O adapter


1. Using Multi I/O connect line connect Multi I/O adapter and monitor.

Connecting to the mains power


1. Connect power cords to the mains power supply inlet and to a wall outlet on all
system components that require AC mains power input.
2. Secure all power cords by routing through the retaining clips or cable clamps,
as applicable.
NOTE Before taking the monitor into use for first time, the battery
should be fully charged. Keep the monitor connected to the
mains until the battery charge symbol disappears.

Connecting network
Network compatibility
The monitor has been verified to be able to work in CARESCAPE* Network environment.
The monitor has EMR connectivity. The monitor HL7 (Health Level Seven) message
match with IHE PCD-01 OBR/OBX format. There are three ways to acquire trended
vital sign data from patient monitor:

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● HL7 directly from monitor


● HL7 from the CARESCAPE Gateway
On the CARESCAPE network,
● The monitor is compatible with the following devices:
■ CARESCAPE Central Station v1, v2
■ CARESCAPE Gateway v2
■ IHE Gateway v1
■ Mobile Care Server v6.0
■ Ascom Mobile Monitoring Gateway (MMG) version 3.03
■ CARESCAPE CIC Pro Clinical Information Center v5.1.0
● The bedside monitor can simultaneously respond with:
■ 10 data requests with WLAN feature
■ 16 data requests without WLAN feature
NOTE Select Disabled for the Radio Enable in service menu, can't
switch to 16 data requests support. To switch to 16 data
requests support, you need to inactive the WLAN license.

Network diagram
CARESCAPE Network

● HL7 outbound from monitor though CNI V2 switch.


NOTE Need unity network and HL7 network license.

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Hardware installation

Hospital Network

● HL7 outbound from monitor though hospital switch.


NOTE Need HL7 network license.

Connecting to the MC Network


Tools needed:
● a MC Network patch cable
1. Connect the one RJ-45 connector to the network port in the rear panel of the
patient monitor.
2. Connect the other RJ-45 connector to the corresponding port on the wallbox.
3. Turn on the monitor and setup the network configuration, if needed.
4. Check that the network symbol and message Network made are displayed in
the screen.

Connecting iCollect
iCollect and other data acquisition systems can be connected to serial connector
of the monitor, the Multi-I/O is needed.
Tools needed:
● 9 pin serial port connect line
1. Connect the Multi I/O adapter the monitor, if needed.
2. Using 9 pin serial port connect line to connect the monitor and PC.
NOTE Refer to the iCollect User's Manual for more information about
the iCollect.

After hardware installation


After hardware installation, please:
● Perform installation checkout: refer to Chapter 8: Installation check
● Configure the monitor: refer to Chapter 7: Configuration

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Using service interface
6
Service interface
The monitor has a Basic Service menu, which is a useful tool to example monitor
functions and troubleshoot in case a fault occurs.

To access the service menu, select > Service > enter Username (service),
Password (Wh1teF1sh) > select Login.
Page 1

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Page 2

NOTE The pictures in this chapter are for reference only. Details on
the menu page can vary depending on the software version
and the configuration of your device.

Parameters
NOTE Parameter values in this section are only for reference.

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Gas Unit

Module Configuration Shows which measurement are available

Gas Control

Sample Flow Gain Displays the sampling pump gain value and gives access to adjust
the sampling pump gain.

Zero Valve Displays the state of zero valve, and gives access to control the
zero valve.

Pump Displays the state of sampling pump, and gives access to control
sampling pump on/off.

Confirm Confirm the sample flow gain adjustment.

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Gases

O2, CO2, N2O, AA % Displays real-time concentrations.

Noise % Displays the standard deviation of concentrations.

Gain User gain. It is scaled as (User gain)/(Factory gain).

mV Gases channel A-E signal scaled to mV.

ID Identified agent.

ID unrel. Displays the value to tell how unreliable of the identification is.
With pure agent the value is normally <50.

Sample Flow Calculate from differential pressure and is adjusted by the module.

Sample Flow Zero Value as measured during initialization when the pump is off.

Sample Flow Gain Sample flow measurement can be calibrated by adjusting the gain.

Ambient Ambient pressure is measured every 30 min.

Amb-Work Ambient pressure, sampling system internal pressure.

Pump Displays pump state, PWM output, and pump voltage.

Lamp Displays lamp state, PWM control, and current of the lamp.

Fan Displays fan state.

Zero and Occl Valve Displays measurement state (MEAS) and zeroing/occlusion states
(ZERO/OCCL).

Temp Temperature measured by the module from TPX, CPU and OM.

Time after module In minutes after power on.


power on

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STP module

Cable Display the connection state of P1, P2, T1, T2 and GE SpO2

Value Display the value of P1, P2, T1, T2

SpO2 Display the value of GE SpO2

STP calibration

Protection Protection for the configuration and calibrations.

Calibrate T1/T2 Calibrating the temperature channels T1 and T2.

Calibrate P1/P2 Calibrating the invasive blood pressure channels P1 and P2.

Start Calibration A wizard item to finish calibration operations.

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ECG module

Cable type Shows the leadwire set connected: 3 lead or 5 lead.

Electrode Shows ON when each of these electrodes is connected.

NIBP module

Calibration Check On/off the calibration check.

Pressure(mmHg) Display the real time cuff pressure.

Protection On/off calibration protection.

Calibration Start/stop the calibration.

Pressure(mmHg) Adjust the measured pressure with arrows.

Confirm Confirm the measured pressure.

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NIBP pneumatics

Start Pump Start/Stop the pump

Open Safe. Valve Open/Close the safety valve

Open Defl. Valve Open/Close the deflation valve

Reset Clock Reset the timer valve for the Interval 20 mmHg –> 185 mmHg

Pressure Display the measured pressure multiplied by 10. This value is


automatically zero-drift compensated.

Zero Display the difference between the zeroing value in the memory
and the current automatic zero-drift compensation multiplied by
10. The value can change between +20 to -20 mmHg. If the zero
drift exceeds ±10 mmHg, the module should be recalibrated.

Pump, Safety Valve, Display their states.


Deflate Valve

Interval 20 mmHg –> Display the time value for the Interval 20 mmHg –> 185 mmHg
185 mmHg

Pressure (mmHg) Display the real-time pressure value for Interval 20 mmHg –>
185 mmHg

COP module

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Using service interface

Gain A coefficient to compensate for gain error. Typically the value is


between 17000 and 25000. Calibrate if the zero and/or gain value
is outside the ranges.

Zero Indicates the offset compensation value of each parameter in the


A/D converter. Usually the value is within ±1000.

Cable Display the cable connection state of P4

Probe Display the probe connection state of P4

Value Display the real-time value of P4

Button The Zero P4 and Start C.O. module key functions can be confirmed
by pressing the key and checking that the relevant OFF message
turns to ON.

Cathether, Injectate Display the probe connection state of C.O.


Display the real-time value of measured temperatures.

Timeouts A cumulative number that indicates how many times the module
has not responded to the monitor’s inquiry.

Bad checksums A cumulative number that indicates how many times


communication from the module to the monitor has failed.

Bad c-s by mod A cumulative number that indicates how many communication
errors the module has detected.
The monitor starts counting these items at power up and resets
to zero at power off. The nonzero values do not indicate a failure,
but the continuous counting (more than 5 per second) indicates
either a serial communication failure or a module not in place.
Also failures in other modules may cause these numbers to rise

RAM Indicates the state of the RAM memory.

ROM Indicates whether the checksum at the EPROM is in accordance


with the software calculated value.

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EEPROM Indicates if the values stored in the permanent memory are


valid. The state is either OK, Fail or ? (module not in place or a
communication error).

COP calibrations

Calibrate P4 Calibrating the invasive blood pressure channels P4.

Entropy module

Measurement Displays measurement status.

Last Service Displays service log.

Entropy Check Sensor Check the module keys. Press the module keys, these 2 items
will highlight.

Mains If the pulse search is being done.

BSR status Display the status for Burst suppression classification.

Artifact Artifact whether detected.

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Diathermy Diathermy whether detected.

AD clipped AD-converted value whether clipped

Alg.ver.(Mon), Displays version of entropy algorithm.


Alg.ver.(Mod),
Alg.ver.used

Timeouts A cumulative number that indicates how many times the module
has not responded to the monitor’s inquiry.

Mod Mon Bad A cumulative number that indicates how many times
Checksum communication from the module to the monitor has failed.

Mon Mod Bad A cumulative number that indicates how many communication
Checksum errors the module has detected.
The monitor starts counting these items at power up and resets
to zero at power off. The nonzero values do not indicate a failure,
but the continuous counting (more than 5 per second) indicates
either a serial communication failure or a module not in place.
Also failures in other modules may cause these numbers to rise

RAM Indicates the state of the RAM memory.

ROM Indicates whether the checksum at the EPROM is in accordance


with the software calculated value.

EEPROM Indicates if the values stored in the permanent memory are


valid. The state is either OK, Fail or ? (module not in place or a
communication error).

Entropy sensor

Entropy Check sensor Check the module keys. Press the module keys, these 2 items
will highlight.

Cable, Sensor, Counter Displays status of cable, sensor and counter connection.

Sensor S/N, Sensor Lot Displays the sensor information

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Lead Whether detected each of 3 points of sensor

Imped. Imped. value of each of 3 points of sensor

Imp. Meas. Whether Imped. measurement on.

Imp. Whether is ok for Imped. measurement.

Country settings

National Reqs Select software features that include national requirements.

Power Frequency Set power frequency 50Hz or 60Hz.

Language Select the software languages.

License

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Import license from Select to import license from USB storage device.
USB Disk

Restart monitor Select to restart the monitor.

GESP GE SpO2

NELL Nellcor SpO2

MASI Masimo SpO2

INVP IBP

TEMP Temperature

Restart monitor Select to restart the monitor.

OxyCRG OxyCRG

NRES Neonatal Respiration

FARR Full Arrhythmia

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NEWS National Early Warning Score

FDIS Full Disclosure

Restart monitor Select to restart the monitor.

NHL7 HL7 Network

UNTY Unity + HL7 network

WLAN Wireless network

Restart monitor Select to restart the monitor.

Service log

Error Log Display the error history view.

Alarm Log Display the alarm history view.

Keyboard Log Display the keyboard file name.

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WLAN Log Disoplay the WLAN history view.

Current file Display which button on the left you have chosen.

Buttons on the left Press the button, the content of related keyboard file shall be
shown on the right. Each file can contain 100 logs.

Enter/Exit Demo Mode


This selection allows you to enter/exit the demo mode.
Under Demo Mode, the monitor displays the main vital signs’ values and waveforms.
No need accessories, central station or any other peripheral equipment connect to the
monitor.
NOTE All the values and waveforms the monitor displays are
fictional.

NOTE The Demo Mode is only designed for the use of training and
demo of operation. It is not intended for clinical use or paitent
monitoring and diagnosis.

Set/test

Watchdog Give access to test the watchdog, the monitor will stop refreshing
the watchdog after pressing the item

Factory Reset The monitor restores the factory default settings and reset the
monitor.

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Network
Network configuration

Unit Name Set the unit name for the monitor.

Bed Name Set the bed name for the monitor.

Rtclin DSCP Tag outgoing packets with a DSCP (Differentiated Services


Code Point) marking: realtime clinical information (waveforms,
parameters, alarms), realtime network control information (time).

NRtclin DSCP Tag outgoing packets with a DSCP marking: non-realtime clinical
decision support information (admission, histories, full disclosure,
printing).

NRtNclin DSCP Tag outgoing packets with a DSCP marking: non-realtime


non-clinical decision support information (service, insite).

MCS IP Address Set the MCS (Mobile Care Server)’s IP address.

Save Changes Save changes. When save changes, the monitor will require a
restart except MCS IP address changed.

Cancel Changes Cancel changes.

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TCP/IP

IP Address Set the static IP address of monitor.

Subnet Mask Set the static subnet mask of monitor.

Default Gateway Set the static default gateway of monitor.

Speed and Duplex Set speed and duplex of monitor.

Save changes Save changes.

Ping

Address Set the destination IP address for the ping command.

Ping Press to enable the ping command: send Internet Control Message
Protocol (ICMP) echo request packets to the target host and wait
for an ICMP response.

Ping Result Display ping result.

NetFuse LAN Set the wired network threshold for received packets per every
Threshold second

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Using service interface

NetFuse WLAN Set the wireless network threshold for received packets per every
Threshold second

NOTE When network traffic overload threshold, the network will


disconnect automatically.

HL7 configuration

HL7 Receiver Ip Set HL7 receiver IP address.

HL7 Receiver Port Set HL7 receiver port.

HL7 Interval Set HL7 interval value.

HL7 Patient Class Set HL7 patient class.

Acknowledgment Enable/disable acknowledgment check to HL7 server.

Save Changes Save Changes.

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Diagnosis
LED

Red Led Test the red alarm light on the monitor.

Yellow Led Test the yellow alarm light on the monitor.

Cyan Led Test the cyan alarm light on the monitor.

Touch Screen

Display the touch screen status.

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Wireless
WLAN status

Radio Enabled Display the if WLAN radio enabled

Connection Status Display the WLAN connection status.

Auth Result Display the authentication status.

AP SSID Display the access point’s SSID.

AP BSSID Display the access point’s MAC address.

Channel/Freq Display the connected channel and frequency.

IP-address Display the device IP address (same as in wired MC network).

MAC Display the device MAC address (same as in wired MC network).

Security Type Display the security type to be used.

Region Display the region of device connected in.

Supplicant version Display the supplicant version which device used.

Driver version Display the WLAN module driver version.

Firmware version Display the WLAN module firmware version.

Packets Display the quantity of packets for Rx and Tx.

Bytes Display the size of packets for Rx and Tx.

Errors Display the quantity of error packets for Rx and Tx.

Quality dBm Display the WLAN Received signal strength indication (RSSI) (dBm):
Signal, Noise and Signal-Noise Raito (SNR).

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Using service interface

Tx Rate Mbps Display the WLAN transmit rate (Mbps).

Tx Power dBm Display the WLAN transmit power (dBm).

QoS Mode Display the Quality of Service (Qos) mode.

RTS Threshold Display the RTS threshold value.

Frag. Threshold Display the Fragmentation Threshold value.

Access Point Display the AP’s BSSID.

Channel Display the AP used channel.

Quality Display the AP signal quality.

Authentication Display the AP used authentication method.

WLAN Configuration — Basic

Manual Config Enter the manually WLAN configuration menu.

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Using service interface

Use File Config Use the USB file to configure WLAN settings.

Config File Choose the configuration files from USB storage device.

Apply Apply changes.

WLAN radio

Radio Enabled Enable or disable the WLAN radio.

SSID Set the device Service Set Identifier (SSID).

Frequency Band Set the WLAN raido frequency band.

Roaming Set the WLAN radio back ground scan cycle: Off, Normal, Medium,
Aggressiveness Aggressive.

Safe Mode Enable or disable the WLAN safe mode.

Select Channel Open the Channel Select menu.

Apply Apply changes.

In Channel Select menu:


2.4 GHz Select 1 to 14 channel

5 GHz Select 36 to 165 channel

NOTE Please confirm the channel list for your own region. Not all the
channels suit for your country.

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Using service interface

WLAN security
Security

Security Set the security method.

Encryption Display the encryption type.

Security Key Set the security key. Only available when Security is WPA-Personal,
or WAP2-Personal.

HEX Set the security key whether use HEX string.

EAP method Set the Extensible Authentication Protocol (EAP) method.

Select Certificate Open the Certificate Select menu. Only available when Security is
WPA-Enterprise, or WPA2-Enterprise.

User Name Enter the user name. Only available when Security is
WPA-Enterprise, or WPA2-Enterprise.

Password Enter the password. Only available when Security is


WPA-Enterprise, or WPA2-Enterprise.

Enable 802.11r Enable the fast roaming feature.

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Using service interface

Apply Apply changes.

Certificate Select

Enable CA Certificate Enable the Certificate authority (CA) Certificate

Select CA Certificate Select one CA certificate. Only available when Enable CA


Certificate is selected.

Enable Client Enable the Client Certificate.


Certificate

Select Client Select one Client certificate. Only available when Enable Client
Certificate Certificate is selected.

Enable Private Key Enable the private key.

Private Key Select one Private Key. Only available when Enable Private Key
is selected.

Enable Key Password Enable the key password.

Private Key Password Enter the key password. Only available when Enable Key
Password is selected.

Enable Anonymous Enable the Anonymous access.

Anonymous Identity Enter the Anonymous Identity. Only available when Enable
Anonymous is selected.
NOTE The Anonymous Identity should be given
by hospital.

Enable Fast Reauth Enable the Fast Reauth. Speed up the authentication process.

Apply Apply changes.

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Using service interface

WLAN Configuration — Advanced

QoS Enter the QoS configuration menu.

Security Build Enter the private key and CSR create menu.

Antenna Config Enter the Antenna configuration menu.

USB Enter the WLAN USB disk import menu.

WLAN QoS

Real-Time Clinical Tag outgoing packets with a DSCP marking: realtime clinical
Data DSCP information (waveforms, parameters, alarms), realtime network
control information (time).

Non-Real Time Clinical Tag outgoing packets with a DSCP marking: non-realtime clinical
Data DSCP decision support information (admission, histories, full disclosure,
printing).

Non-Real Time Tag outgoing packets with a DSCP marking: non-realtime


Non-Clinical Data non-clinical decision support information (service, insite).
DSCP

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Using service interface

RTS Threshold Set the RTS Threshold value.

Fragmentation Set the Fragmentation Threshold value.


Threshold

Apply Apply changes.

WLAN security build


Private Key

Algorithm Select the algorithm for private key.

Enable Password Enable the private key password

Password Enter the password, if the select the Enable Password.

Create Create the private key.

CSR

NOTE This menu is available only when private key have been
created.

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Using service interface

Private Key Display the private key.

Country Name (2 letter Enter the country name (2 letter code).


code)

State or Province Enter the state or province name.


Name

Locality Name Enter the locality name.

Organization Name Enter the organization name.

Organization Unit Enter the organization unit name.


Name

Common Name Enter the common name.

Email Address Enter the email address.

Create Create the CSR.

WLAN antenna configure

2.4 G Set the 2.4 G antenna type.

5G set the 5 G antenna type..

Apply Apply changes.

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Using service interface

WLAN USB

Select Certificate Select the CA or Client certificate.

Import Certificate Import the CA or Client certificate to the monitor.

Select Wlan Config Select the WLAN configuration files.

Import WLAN Config Import the WLAN configuration files to the monitor.

Export CSR Export CSR to USB disk.

Software management
Software upgrade

IP Address Display the IP address of the monitor.

Active Version Display the active version of the main software.

Inactive Version Display the inactive version of the main software.

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Using service interface

SW Download Enable: Select to enable the main software download.

SW Activate Enable: Select to enable the main software activation.

Module upgrade

IP Address Display the IP address of the monitor.

Upgrade Module Type Select the which type of firmware to upgrade.

Active Version Display the active version of the module firmware.

Inactive Version Display the inactive version of the module firmware.

Module Download Select to enable the module firmware download.


Enable

Module Upgrade Select to enable the module firmware activation.


Enable

USB disk upgrade

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Using service interface

Software Select Version: Select the version of the main software.


Download: Download the main software from USB.

NIBP Firmware Select Version: Select the version of the NIBP firmware.
Download: Download the NIBP firmware from USB.

ECG Firmware Select Version: Select the version of the ECG firmware.
Download: Download the ECG firmware from USB.

RECX Firmware Select Version: Select the version of the RECX firmware.
Download: Download the RECX firmware from USB.

TP Firmware Select Version: Select the version of the TP firmware.


Download: Download the TP firmware from USB.

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Using service interface

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Configuration
7
Platform Configuration
The configuration of a monitor consists of platform configuration and clinical
configuration.
This chapter describes:
● How to configure the platform ready to take the monitor into use for the first time.
● The configuration tasks need for administration and maintenance.

For information on how to perform the clinical configuration, including modes’


settings, refer to the monitor’s Supplemental Information Manual.

Adjusting display
Adjusting the display brightness
You can set the display brightness level according to your needs.

1. Select the .

2. Adjust the display brightness with the Brightness.

Adjusting the slave display


If needed, use the display’s OSD menu to adjust the picture on the slave display.
Refer to the display's user manual for details.

Configuring wired CARESCAPE Network


1. Select the > Service > enter Username and Password.
2. Select Basic Service tab > Network.

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Configuration

3. Setup below items for Network Config, then select Save Changes.
a. Enter Unit Name.
b. Enter Bed Name.
c. Enter MCS IP Address to setup the Mobile Care Server’s IP address which
monitor will talk to.
4. Select TCP/IP tab.
5. Setup below items for TCP/IP Configuration, then select Save Changes.
a. Enter a IP Address.
b. Enter a valid Subnet Mask level.
c. Enter a valid Default Gateway.
d. Select the applicable Speed and Duplex option.
NOTE The B125/B105 monitors can’t be as the Time Master,
don’t setup B125/B105 monitors with the highest IP
address in CARESCAPE network.

The network configurations will be saved and active when the patient monitor is
restarted.

Configuring HL7 Network


1. Select the > Service > enter Username and Password.
2. Select Basic Service tab > Network > HL7 Config tab.
3. Setup below items, then select Save Changes.
a. Enter HL7 Receiver Ip for HL7 receiver IP address.
b. Enter HL7 Receiver Port for HL7 receiver port.
c. Select values for HL7 Interval.
d. Select the HL7 Patient Class.

Configuring wireless CARESCAPE Network


Configuring wireless network via USB disk
NOTE The configuration files should be stored in following path in
USB disk: /wlancfg/.

1. Insert the USB disk to the monitor.

2. Select the > Service > enter Username and Password.


3. Select the Basic Service tab > Page2 vertical tab > WLAN Config.
4. Select the Advanced tab > USB Disk.
5. Import the WLAN configuration files by Select Wlan Config and Import WLAN
Config.

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Configuration

6. Select the go back arrow > Basic tab.


7. Select Use File Config check box.
8. Select Config File and Apply .

Configuring wireless Network basic settings manually


1. Select the > Service > enter Username and Password.
2. Select the Basic Service tab > Page2 vertical tab > WLAN Config > Manual Config.
3. Select Radio tab. Setup the following settings, and select Apply.
Radio
Item Description Comments
Radio Enabled Enable/disable the WLAN
radio.
SSID Enter the Service Set Identifier The SSID of the wireless
(SSID), also known as network client must match the SSID
name. of the wireless infrastructure.
A valid SSID includes up
to 32 case-sensitive ASCII
characters, including space
(ASCII decimal 32 to 126).
Adjust the following setting if needed.
Frequency Band Select the frequency band for The WLAN radio can
the WLAN radio: communicate on the following
frequency bands, protocols
● 2.4 GHz
and data rates:
● 5 GHz
● 2.4 GHz, IEEE 802.11b, up to
● 2.4 and 5 GHz 11 Mbps
● 2.4 GHz, IEEE 802.11g, up
to 54 Mbps
● 5 GHz, IEEE 802.11a, up to
54 Mbps
● 2.4 and 5 GHz, IEEE 802.11n,
up to 540 Mbps
Roaming Select the back ground scan ● Low: when rssi > -75 dbm,
Aggressiveness cycle: every 10 seconds will do
scan once, when rssi < -75
● OFF
dbm, every 5 seconds will
● Low do scan once
● Medium ● Medium: when rssi > -70
dbm, every 10 seconds will
● High do scan once, when rssi <
-70 dbm, every 5 seconds
will do scan once.
● High: when rssi > -65 dbm,
every 7 seconds will do
scan once, when rssi < -65

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Configuration

Item Description Comments


dbm, every 2 seconds will
do scan once.
Safe Mode Enable/disable the safe mode. When safe mode enabled, the
monitor
● Only passively scan all
supported channels.
Select Channel Select channels for 2.4 GHz or Please confirm the available
5 GHz. channels for your region. Not
all the channels are suit for
your country.

4. Select Security tab. Setup the following settings, and select Apply.
Security
Item Description Comments
Security Choose the confidentiality
method.
● Open
● WPA-Personal
● WPA2-Personal
● WPA-Enterprise
● WPA2-Enterprise
Encryption Choose the Encryption Please consult Hospital IT for
method. Encryption.
● TKIP
● AES-CCMP
Security Key and HEX Enter the Wifi security Only available when
password. security is WPA-Personal,
Select HEX to use HEX string or WPA2-Personal.
for the password. The valid security key should
be 8-63 ASCII case-sensitive
characters (ASCII decimal 32
to 126), or 64 HEX characters
(0-9 and A-F), if HEX have been
selected.
Please consult Hospital IT for
the security key.
EAP method Select the Extensible Only available when
Authentication Protocol Authentication is
(EAP) method: WPA-Enterprise, or
WPA2-Enterprise.
● EAP-TLS
Different EAP method will
● TTLS-MSCHAPv2 have difference Certificate
● PEAP-MSCHAPv2 selection. Please consult
Hospital IT for EAP method.
● PEAP-GTC

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Configuration

Item Description Comments


User Name and Enter the User Name and Only available when
Password Password. Authentication is
WPA-Enterprise, or
WPA2-Enterprise.
Please consult Hospital IT for
User Name and password.
Select Certificate ● Enable the certificate need Refer to the table below for
to configure details.
● Select the certificate
from USB storage
device, or enter the
password/identity.
Enable 802.11r Enable/disable the fast Roaming performance can
roaming. be negatively impacted (e.g.
additional waveform dropout)
when using non-fast roaming
supported security methods
(e.g. WPA-Enterprise).

Certificate Select
Enable CA Certificate 1. Import the CA Certificate by USB disk. The Certificate should
Select CA Certificate be provided by hospital IT.
For more information, see “Importing and exporting files via
USB disk” below.
2. Enable the Certificate Authority (CA) Certificate.
3. Select one CA certificate.
Enable Client 1. The monitor generator CSR.
Certificate For more information, see “Creating private key and CSR”
Select Client below.
Certificate 2. Export CSR files to USB disk, deliver to hospital IT.
For more information, see “Importing and exporting files via
USB disk” below.
3. Hospital IT generate the Client Certificate, save to USB disk.
4. Import the Client Certificate files to monitor.
For more information, see “Creating private key and CSR”
below.
5. Enable the Client Certificate.
6. Select one Client certificate.
Enable Private Key 1. The monitor generator Private Key, and Private Key Password
Private key (If have).
For more information, see “Creating private key and CSR”
Enable Key Password below.
Private Key 2. The Private Key will be automatically filled in blank.
Password
3. Enable Private Key.
4. If have the Private Key Password, enable the key password.
5. Enter the Private Key Password.

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Configuration

Enable Anonymous Enable the Anonymous access.


Anonymous Identity Enter the Anonymous Identity, which should be provided by
hospital IT.
Enable Fast Reauth Enable the Fast Reauth. Speed up the authentication process

Select Apply after certificate selecting.


Creating private key and CSR
1. Select the > Service > enter Username and Password.
2. Select the Basic Service tab > Page2 vertical tab > WLAN Config.
3. Select the Advanced tab > Security Build.
4. Select the Algorithm for private key.
5. If needed, select Enable Password and enter the Password for private key.
NOTE Remember or recorder the password for private key.
When configure certificate, this Private Key Password
should be input.

6. Select Create to create the private key.


7. Select CSR tab, enter the related information.
NOTE This tab is available only when Private Key have been
created.

8. Select Create to create the CSR.


Importing and exporting files via USB disk
1. Insert the USB disk to the monitor.

2. Select the > Service > enter Username and Password.


3. Select the Basic Service tab > Page2 vertical tab > WLAN Config.
4. Select the Advanced tab > USB Disk.
5. Import or export files via USB disk.
Item Description Comments
Select Certificate Select the CA or Client The Certificate file should be
Certificate file to import. provided by hospital IT.
NOTE: The Certificate
files should be stored in
following path in USB disk:
/ssl/certs/.
Import Certificate Import the CA or Client
Certificate file from USB disk.
Select WLAN Config Select the WLAN Configuration The configuration files should
files to import. be created by hospital IT.
NOTE: The configuration files
should be stored in following
path in USB disk: /wlancfg/.

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Configuration

Item Description Comments


Import WLAN Config Import the WLAN
Configuration files from
USB disk.
Export CSR Export the CSR to USB. The file’s path in USB disk is
display in the window.

Configuring wireless Network advanced settings manually


1. Select the > Service > enter Username and Password.
2. Select the Basic Service tab > Page2 vertical tab > WLAN Config > Advanced tab.
3. Select the QoS. Setup the following settings, and select Apply.
QoS
Item Description Comments
Real-Time Clinical Enter tag outgoing packets Recommended value is 48.
Data DSCP with a DSCP marking: Range is 48 to 63.
realtime clinical information
(waveforms, parameters,
alarms), realtime network
control information (time).
Non-Real Time Enter tag outgoing packets Recommended value is 0.
Clinical Data DSCP with a DSCP marking: Range is 0 to 7.
non-realtime clinical
decision support information
(admission, histories, full
disclosure, printing).
Non-Real Time Enter tag outgoing packets Recommended value is 8.
Non-Clinical Data with a DSCP marking: Range is 8 to 23.
DSCP non-realtime non-clinical
decision support information
(service, insite).
RTS Threshold Configure the RTS Threshold Use the default RTS Threshold
value. value, unless otherwise
specified in the wireless
network design. A valid RTS
Threshold is a numeric value
within the range of 64 to 2347.
Fragmentation Configure the Fragmentation Fragmentation Threshold
Threshold Threshold value. specifies the maximum frame
size a wireless device can
transmit without fragmenting
the frame. Use the default
Fragmentation Threshold
value, unless otherwise
specified in the wireless
network design. A valid
Fragmentation Threshold is
a numeric value within the
range of 64 to 2346.

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Configuration

4. Back to the previous menu, select the Antenna Config. Setup the following
settings, and select Apply
Item Description Comments
2.4 G Configure the antenna The antenna configuration
configuration in 2.4 GHz options are:
frequency band.
● Primary and Secondary
● Pri. & Sec. antenna worked in the
same time
● Pri. only
● Primary antenna only
5G Configure the antenna The antenna configuration
configuration in 5 GHz options are:
frequency band.
● Primary and Secondary
● Pri. & Sec. antenna worked in the
same time
● Pri. only
● Primary antenna only

5. Restart the monitor.

Setting time and date


NOTE The monitor can’t be the TIME MASTER in network. If the
monitor is connected to the network, it follows the Central
Station’s time settings and the Time and Date is gray.

1. Select the > Service > enter Username and Password.


2. Select Clinical tab > Time and Date.
3. Set up following items, then select Confirm.
● Hour
● Minutes
● Year
● Month
● Day
4. Select Time Format tab, and select the Time Format, if needed.
The manual time configuration takes effect immediately.

Setting time zone


The Time Zone is enable only when the monitor is not connected to the network and
patient is discharged.

1. Select the > Service > enter Username and Password.


2. Select Clinical tab > Time Zone.
3. Select Daylight Savings settings.
4. Select DST adjustment tab to setup DST settings.
5. Select Time Source tab to setup time sync source.

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Configuration

6. Select NTP Config tab to setup NTP settings


For more details, see Supplemental Information Manual.

Setting national requirements


Activate France specific defaults for the ECG HR adjustment range and the reminder
beep behavior.

1. Select the > Service > enter Username and Password.


2. Select Basic Service tab > Country Settings > National Reqs.
3. Select the applicable option:
Value Description
None Normal defaults
France Enables:
● Heart Rate high alarm limit maximum 280.
● No Reminder Volume item in Alarm Options.
● Reminder beep will sound every 2 minutes when alarms have been
silenced permanently.
Germany Normal defaults

Setting power frequency


WARNING Incorrect power line frequency setting could adversely affect
ECG processing.

1. Select the > Service > enter Username and Password.


2. Select Basic Service tab > Country Settings > Power Frequency.
3. Select the applicable power line frequency.

Changing passwords
Each account can change the password for itself and the lower level access.
NOTE Username and password are case sensitive.

1. Select the > Service > enter Username and Password.


2. Select Change Password.
3. Select clinical or service radio button as required.
4. Enter and retype the new passwords, then select Confirm.

Resetting password
The authorized service personnel can reset the password to factory default password.
It need the activation code. Please contact GE service for activation code.

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Configuration

1. Select the > Service > enter Username and Password.


2. Select Reset Password.
3. Enter the Expiration Date and Activation Code.
4. Select Confirm.

Transferring settings from a monitor to another


Exporting settings
You can save the user modes’ settings to the USB storage device.
1. Discharge the patient. Insert the USB storage device to the USB port of the
monitor.

2. Select the > Service > enter Username and Password.


3. Select Save Modes > Export all modes to USB Disk.
When finish to export settings, the screen return back and a message “ Export modes
successfully.” displays on the menu.

Importing settings
You can import the saved user modes’ settings from the USB storage device to the
monitor.
1. Discharge the patient. Insert the USB storage device to the monitor’s USB port.

2. Select the > Service > enter Username and Password.


3. Select Save Modes > Import all modes from USB Disk.
When finish to export settings, the screen return back and a message “ Import
modes successfully. Please restart.” displays on the menu.
4. Restart the monitor.

License management
● You can upload a license file that contains all acquired activation codes for license
by the USB storage device.
1. Insert the USB storage device with license file.

2. Select the > Service > enter Username, Password > Basic Service
tab > License > Import license from USB Disk.
When finish to export settings, the screen return back and a message “ Import
license successfully. Please restart.” displays on the menu.
● You can manually enter the required activation codes for license one by one, from
License menu.
Restart is needed after import the license.
Contact authorized service personnel to acquire license file or activation codes for
licenses.

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Configuration

NOTE The license file should be named as SN and stored in following


path in USB disk: /license/SQXXXXXXXXXXX.txt.

Software management
Software download
Their two methods for software download.
● From USB storage device. Insert the USB storage device to the monitor directly to
transfer software.
● From PC. Transfer software by GE Healthcare Software Transfer Utility (STU), which
runs on a service PC. With this application, you can transfer new software to the
patient monitor over the CARESCAPE Network or a crossover cable.
The new transferred software is inactive in the patient monitor(s) until you activate it.
For details about software download procedure, please refer to Appendix A: Software
Download Instruction.

Activating the software


Before you start:
● Verify the compatibility of the connected bedside and network devices with the
new software version that you are activating.
● For traceability – Record the serial number of the monitor where the software is
installed to your local service database.
● Contact GE Healthcare to get the latest version of the user and service
documentation.
NOTE Loss of monitoring - Software is activated only when the
patient monitor is in a patient discharged state. Normal
patient monitoring is unavailable until the software activation
is completed.

1. For main software: > Service > enter the username and password > Basic
Service tab > Page2 vertical tab > SW Management > SW Upgrade tab. Or,
For firmware: SW Management > Module Upgrade tab > select Upgrade Module
Type:
The software status displays.
2. Check that the software to be activated is listed in the status.
3. For main software: Select SW Activate Enable: > Yes to activate the new software.
For firmware: Select Module Upgrade Enable: > Yes to activate the new software.
4. Wait until the software activation completes.
5. Restart the monitor.

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Configuration

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Installation check
8
Installation check procedure
The purpose of the installation check is to ensure that the system is properly installed
and configured for use.
Service personnel shall perform the following checkout procedure for the monitoring
system after the hardware installation and platform configuration is completed:
● Visual inspection
● Electrical safety test
NOTE The manufacturer has performed the electrical safety
test for the patient monitor and acquisition modules
during final inspection. You do not have to perform the
electrical safety tests during installation checkout, if there
is less than 12 months since the patient monitor was
manufactured. Check the manufacturing week and year
from the device plate.

● Functional check

Performing visual inspection


Perform the following visual inspection to the installed monitoring system:
1. Carefully inspect the patient monitor if any damage.
2. Verify that the patient monitor are properly mounted with specified mounting
solutions.
3. Verify that the cables between the patient monitor and the connected peripheral
devices are intact, properly connected and secured to the right connectors.
4. Verify that all the network cables, are intact and properly connected to the right
connectors.
5. Verify that the module are properly connected and locked.
6. Verify that the battery door are properly locked.

Functional check
The purpose of this functional check is to ensure that the system is properly installed
and configured.
Skip the tests that are not applicable for the installed patient monitor.

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Installation check

Checking the startup


1. Turn on the power by press ON/OFF button more than 2 seconds.
2. Verify that the patient monitor starts up normally:
● The yellow, red and blue alarm lights are lit momentarily.
● The speaker gives an audible beep.
● The normal welcoming screen appears with a status bar indicating the
progress of the startup procedure.
● Normal monitoring screen appears and there are no error messages on the
screen.
NOTE If you receive a Condition battery or a Battery failure
message, refer to the troubleshooting instructions for
battery conditioning or replacement.

3. Verify that the battery is fully charged.


If the battery is not fully charged, keep the monitor connected to the mains until
the battery is fully charged. The battery must be fully charged before taking the
monitor into use for the first time.

Checking display
Testing picture quality
Perform this test both for the integrated main display and for the connect external
display.
1. Verify that all text is readable and all images are clear.
2. Verify that the brightness is good. Adjust if necessary.
Testing touchscreen control
1. Verify the operation of a touchscreen by touching an active digit field. Verify that
the related menu is opened.

Checking the time and date


1. Select the > Service > enter Username and Password.
2. Select Clinical tab > Time and Date.
3. Check the Current Time is correct, adjust the time and date if necessary.
NOTE The monitor can’t be set as TIME MASTER in network. You
should adjust the time and date from the central station,
if needed.

4. Select back arrow, select Time Zone.


5. Check and adjust the settings if necessary.

Checking the device information


1. Select > Monitor Info.

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Installation check

2. Verify the following:


a. The version information are identified.
b. The network information are identified.

Testing the B1X5-F2 frame


1. Ensure the frame is connected to the monitor.
2. Ensure one module is connected to the frame.
3. Using power cord connect the frame to the wall outlet.
4. Verify that the power LED and communication LED lit.

Checking parameters
Connect the accessories (no need to connect to simulator or patient), check the
monitor displays the following messages or activities.
1. Connect the accessories to monitor (no need to connect to simulator or patient).
2. Admit a patient.
3. Verify the following:
a. ECG: Leads off will display in the waveform field.
b. SpO2: After connecting the SpO2 cable and sensor, the sensor will be lit.

c. NIBP: Press button, NIBP cuff loose will display in message field.
d. IBP: After connecting IBP cable and transducer, InvBP’s not Zeroed will display
in message field.
e. Temperature: After connecting the Temperature cable and sensor, Performing
temp test will display in Temperature digit field for a few seconds.
f. C.O.: After connecting IBP cable and transducer, InvBP’s not Zeroed will
display in message field.
g. Gas: After installing the gas module, Calibrating gas sensor will display in CO2
waveform field for about 1 minutes.
h. Entropy: After installing the E-Entropy module and cable, No sensor message
will display in Entropy digital field.

Testing the recorder


1. Select the Printing Setup.
2. Configure the waveforms:
● Waveform 1: I
● Waveform 2: II
● Waveform 3: Resp
3. Select Print Waveforms.
4. Verify that the recorder starts printing.
5. Let the recorder print for approximately 10 seconds.

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Installation check

6. Select the Stop Printing to stop printing.


7. Verify the following things from the printout:
● The header line contains the date, time and some other applicable status.
● The grid is clear.
● The waveforms labels appear in the printout as configured.

Testing MC Network
Perform the following test only if the patient monitor is connected to a wired MC
Network.
1. Check that the CAT-5 cable connector is clean and intact, connect it to the
Ethernet network connector.
2. Check that a network symbol is displayed in the upper right corner of the screen.

Testing wireless LAN configuration


Perform the following test only if the patient monitor is connected to a wireless MC
Network.
NOTE The wireless network must be properly installed and the
patient monitor must be within the wireless coverage area.

1. Check that a network symbol is displayed in the upper right corner of the screen.
2. Reconnect the MC Network cable back to the MC Network connector, if applicable.

Completing the check procedure


1. Select > Discharge tab > Discharge > YES to discard any changes made to
the patient monitor configuration during checkout.
2. Disconnect the test setup.
3. Complete the check form.

Verification procedure for wireless MC Network


infrastructure
Purpose and scope
The purpose of this verification procedure is to test the operation of the wireless
network infrastructure with a wireless transport monitor. To verify the operation, you
move the transport monitor throughout the predetermined wireless coverage area
and observe that a constant ECG waveform in the central station (CIC/CSCS) which
display the view of the wireless monitor during the transport.
Due to the dynamic nature of a wireless environment this test provides only a
snapshot of the wireless network at the time of performing the test. This is not a
comprehensive test that covers all possible use situations, network traffic situations,
radio frequency interferences or takes into account possible other changes in the
wireless environment.

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Installation check

Test equipment and documentation needed


Ensure that you have the following equipment and documentation available.
CIC/CSCS
CIC/CSCS with full disclosure license.
NOTE CIC/CSCS with full disclosure license is enable you to view
afterwards potential network connectivity issues between the
transport monitor and the wireless MC Network, and to print
reports about waveform loss situations.

Wireless B125/B105 monitor


● B125/B105 patient monitor with wireless MC Network connection.
● A compatible 5-lead ECG trunk cable and 5-leadwire set.
● A battery operated patient simulator.
● A plastic roll cart for the patient monitor, and the simulator. To avoid RF impairment,
do not use metal roll carts.
Documentation about the Wireless LAN infrastructure
● GE WLAN pre-quote questionnaire with all applicable attachments.
● Wireless LAN design documentation, including site survey results.

Test plan
Each wireless installation is unique. As it is often impractical and uneconomical to
verify the whole wireless coverage area and all the installed access points, prepare a
site specific test plan that covers the areas that are most likely to encounter issues
with the wireless communication.
Utilize the information provided in the pre-quote questionnaire, existing design
documentation and site survey results, and discuss with the hospital IT specialists and
clinical staff to identify the areas that are riskiest for poor wireless communication,
and prepare a test plan accordingly.
Take into account the following aspects when preparing a test plan:
● Identify areas with known or obvious low signal strength.
● Identify areas with known sources of radio frequency interference, causing high
noise floor and/or poor signal-to-noise ratio.
● Identify the special characteristics in the building layout (floors, wings patient
rooms) and construction material used.
● Identify the time and areas of congestion, with high number of wireless clients and
a lot of network traffic.
● Identify intended clinical workflow paths, including bedside locations and transport
routes.
Prepare the test plan by documenting the intended walking path and test points to
the floor plan, preferably to copy of a site survey document that shows the wireless
coverage area, the location of wireless access points, signal strengths and sources
of known radio frequency interferences.

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Installation check

NOTE In the sample floor plan below, EG1- EG20 represent possible
test points. Take into account in your plan that some rooms
and areas may not be accessible at the time of performing
the survey.

Test setup
The patient monitors and the CIC/CSCS shall be installed, configured and tested to
operate in the same MC Network.
CIC/CSCS setup
Configure the CIC/CSCS to capture full disclosure data from the wireless monitor
B125/B105. Refer to CIC/CSCS Clinical Information Center Service Manual and
CIC/CSCS Clinical Information Center Operator's Manual for detailed instructions.
Setup the wireless B125/B105 monitor
NOTE The ECG cables and patient simulator for the wireless
B125/B105 monitors are needed only, if a CIC/CSCS with full
disclosure license is available in the MC Network.

NOTE Ensure that the patient monitor battery, the service PC battery
and the patient simulator battery are fully charged.

Set up the connections:


1. Set up the monitor and the patient simulator on a roll cart.
2. Connect the ECG cables to the monitor and to the patient simulator.
3. Turn on the patient monitor, and the patient simulator.

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Installation check

4. Configure the patient simulator to output ECG waveform: normal sinus rhythm,
hearth rate 80 bpm, amplitude 1mV.
Refer to the simulator documentation for details on how to use and configure
the simulator.
Configure the patient simulator:
1. Configure the ECG1, ECG2 and ECG3 waveform fields to the monitor screen with
adequate priority.
2. Select the Setup tab in the ECG menu and configure: ECG1 lead: II, ECG2 lead:
V1, ECG3 lead: aVL.
3. Admit a patient in Admit/Discharge menu.

Test execution
Execute the test procedure according to the test plan. Contact the nursing staff to
ensure access to the needed areas before starting the test.
1. Move the roll cart to the starting point of the planned test route.
2. Stop at each test point and perform the following tasks:
a. On the CIC/CSCS: Verify that ECG waveforms from the transport monitor
without any losses.
b. Mark the network time, RSSI and Transmit Rate to the test form.
c. If there is a waveform loss situation or the RSSI or the Transmit Rate is lower
than specified:
● Observe the length of the waveform loss and, if possible, potential cause of
it, for example roaming or out of range situations.
● Take a photo of the refreshed WLAN Status screen.
3. Move the roll cart to the following test point along the walking path and repeat
the step 2 at each test point until you have completed the test plan. While moving
the roll cart from one test point to another, at all times, verify that there are no
losses in the ECG waveforms.
NOTE A momentary, up to 5 seconds waveform loss is normal
during roaming. If longer, or repeating waveform losses occur
between test points, make this an extra test point and report
it the same way as observations in step 2.

Summary and reporting


Include the following documents to the test results:
1. Print the full disclosure reports from the CIC/CSCS about the observed waveform
loss situations.
2. Print the snapshots of the WLAN diagnostics screens that you saved into the
service PC.
3. Mark to the printouts the id of the test point.
Review and evaluate the test results together with GE personnel and the hospital
IT specialists. Summarize, if additional testing is needed and/or if the WLAN
infrastructure needs to be changed.

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Installation check

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Electrical safety tests
9
Electrical safety tests
Electrical safety tests provide a method of determining if potential electrical health
hazards to the patient or operator of the device exist.

Test setup
Test conditions
Perform electrical safety tests under normal ambient conditions of temperature, humidity
and pressure.
Test equipment
The test equipment required to perform electrical safety tests is listed below.

Tool Part number / requirement


Safety Analyzer / Leakage Current Tester Equivalent to the circuits shown.
Safety Test Body Kit * P/N M1155870 or equivalent

* Instead of the test bodies included in the safety test body kit, other applicable test
bodies with all pins connected together may be used.
Perform electrical safety tests using an electrical safety analyzer according to IEC
60601-1, ANSI/AAMI ES60601-1, EN 60601-1 or CSA C22.2 No. 601.1. The schematics
in this section provide a general understanding of the test equipment. Actual
configuration of test equipment may vary. Refer to the instructions delivered with
the safety analyzer to perform each test.
The patient monitor being tested should be placed on an insulating surface.
NOTE Before proceeding, make sure that all test equipment is
properly calibrated, maintained and functioning.

NOTE GE recommends that the qualified personnel performing the


tests should record the test results of each electrical safety
test, for example by using the installation / maintenance
check forms included in this manual.

System setup
These instructions are intended for every component in the system. Ensure that all system
components are properly connected to the patient monitor.

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Electrical safety tests

Verifying power outlet


1. Verify that the power outlet is wired correctly according to the country’s electrical
code standard before starting the following electrical safety tests.
The results of the following tests will be inaccurate unless a properly wired power
outlet is used.

Verifying power cord and plug


1. Verify that the power cord being used with the patient monitor is undamaged:
a. Inspect the power cord for wear or damage. If damage is suspected, test for
continuity through each conductor of the power cord connector.
b. Replace the power cord, as necessary, with a regulatory-approved cord for
the country of use.
WARNING Use only AC power cords recommended or
manufactured by GE.

Ground earth integrity check


There are two alternative methods for checking the ground (earth) integrity: a)
Ground continuity test and b) Impedance of protective earth connection. These tests
determine whether the device's exposed metal and power inlet's earth (ground)
connection has a power ground fault condition.
Perform either test a) or test b) in accordance to your local regulations.
NOTE Refer to the instructions delivered with the safety analyzer
to perform each test.

Testing ground continuity


The measuring device (MD) in the diagram below may be a digital multimeter or part of
the safety analyzer.

Acceptance criteria:
● For equipment without a power supply cord, the impedance between the protective
earth terminal and any accessible metal part which is protectively earthed shall
not exceed 0.1 ohms.

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Electrical safety tests

● For equipment with a power supply cord, the impedance between the protective
earth pin in the mains plug and any accessible metal part which is protectively
earthed shall not exceed 0.2 ohms.

Checking impedance of protective earth connection


This test is normally only required as a manufacturing production test to receive safety
agency compliance. Some country agencies do require this test after field equipment repairs
(i.e., Germany’s DIN VDE 0751 standards). Consult your country/local safety agency if
in doubt.

Check compliance as follows:


1. A current of 25A from a current source with a frequency of 50 or 60 Hz with a
no-load voltage not exceeding 6 V is passed for at least 5 seconds, but not more
than 10 seconds, through the protective earth terminal or the protective earth pin
in the mains plug and each accessible metal part which could become live in case
of failure in basic insulation.
2. The voltage drop between the parts described is measured and the impedance
determined from the current and voltage drop. It shall not exceed the values
indicated.
When taking this measurement, flex the unit’s power cord along its length. There
should be no fluctuations in resistance.
Acceptance criteria:
● For equipment without a power supply cord, the impedance between the protective
earth terminal and any accessible metal part which is protectively earthed shall
not exceed 0.1 ohms.
● For equipment with a power supply cord, the impedance between the protective
earth pin in the mains plug and any accessible metal part which is protectively
earthed shall not exceed 0.2 ohms.

Testing earth leakage current


This test measures the current leakage flowing from the mains part through or across
the insulation into the protective earth conductor of the device under test.
Perform this test both in Normal Condition (NC) and in a Single Fault Condition (SFC),
where one of the supply conductors is open at a time. Perform the test with normal
and reverse polarity
NOTE Refer to the instructions delivered with the safety analyzer to
perform this test.

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Electrical safety tests

1. Configure the safety analyzer as follows (NC):


● Polarity: NORMAL
● Neutral: CLOSED
2. Power on the device under test.
3. Read and record the current leakage indicated on the safety tester.
4. Configure the safety analyzer as follows (SFC):
● Polarity: NORMAL
● Neutral: OPEN
5. Read and record the current leakage indicated on the safety tester.
6. Configure the safety analyzer as follows (SFC):
● Polarity: REVERSED
● Neutral: OPEN
7. Read and record the current leakage indicated on the safety tester.
8. Configure the safety analyzer as follows (NC):
● Polarity: REVERSED
● Neutral: CLOSED
9. Read and record the current leakage indicated on the safety tester.
10. Power off the device under test.
Acceptance criteria in Normal Condition (NC):
● All readings shall be less than or equal to 300 µA for installations that require
compliance to ANSI/AAMI ES60601-1 requirements.
● All readings shall be less than or equal to 500 µA for installations that require
compliance to EN 60601-1 / IEC 60601-1 requirements.
Acceptance criteria in Single Fault Condition (SFC) – one of the supply conductors
open at a time:
● All readings shall be less than or equal to 1 mA.

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Electrical safety tests

Testing enclosure (touch) leakage current


This test measures current leakage through the exposed conductive parts on the
device under test.
Perform the test in Normal Condition (NC) and in two different Single Fault Conditions
(SFC): 1) earth open and 2) one of the supply conductors open at a time. Perform
the test with normal and reverse polarity.
NOTE Refer to the instructions delivered with the safety analyzer to
perform this test.

1. Configure the safety analyzer as follows (NC):


● Polarity: NORMAL
● Neutral: CLOSED
● Earth (GND): CLOSED
2. Power on the device under test.
3. Read and record the current leakage indicated on the safety tester.
4. Configure the safety analyzer as follows (SFC):
● Polarity: NORMAL
● Neutral: OPEN
● Earth (GND): CLOSED
5. Read and record the current leakage indicated on the safety tester.
6. Configure the safety analyzer as follows (SFC):
● Polarity: NORMAL
● Neutral: CLOSED
● Earth (GND): OPEN
7. Read and record the current leakage indicated on the safety tester.

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Electrical safety tests

8. Configure the safety analyzer as follows (SFC):


● Polarity: REVERSED
● Neutral: CLOSED
● Earth (GND): OPEN
9. Read and record the current leakage indicated on the safety tester.
10. Configure the safety analyzer as follows (SFC):
● Polarity: REVERSED
● Neutral: OPEN
● Earth (GND): CLOSED
11. Read and record the current leakage indicated on the safety tester.
12. Configure the safety analyzer as follows (NC):
● Polarity: REVERSED
● Neutral: CLOSED
● Earth (GND): CLOSED
13. Read and record the current leakage indicated on the safety tester.
14. Power off the device under test.
Acceptance criteria in Normal Condition (NC):
● All readings shall be less than or equal to 100 µA
Acceptance criteria in Single Fault Condition (SFC) – earth open or one of the supply
conductors open at a time:
● All readings shall be less than or equal to 300 µA for installations that require
compliance to ANSI/AAMI ES60601-1 requirements.
● All readings shall be less than or equal to 500 µA for installations that require
compliance to EN 60601-1 / IEC 60601-1 requirements.

Patient leakage current tests


The following table specifies the monitor’s component and the related patient
connectors to be tested in the Patient (source) leakage current tests and in the Patient
(sink) leakage current tests.
Use the safety test body kit, P/N M1155870 (or equivalent), to perform patient leakage
current tests. This safety test body kit contains various patient connectors where all
pins are shorted out together. For information on which test body to use for each
patient connector, refer to the service instructions included in the safety test body kit.
NOTE If not otherwise stated in the table below, each test body is
connected directly to the specified connector in the patient
module.

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Electrical safety tests

Patient connectors to be tested


Component Patient connector
Host ECG & SpO2
E-COP P4/P8
E-Entropy 1. Connect an Entropy sensor cable to the module.
2. Connect the specified test body to the Entropy sensor cable.

Testing patient (source) leakage current


This procedure measures the leakage current from an applied part connector of the
device to ground.
Perform the test in Normal Condition (NC) and in two different Single Fault Conditions
(SFC): 1) earth open and 2) one of the supply conductors open at a time.
Perform the test with normal and reverse polarity.
NOTE Refer to the instructions delivered with the safety analyzer to
perform this test.

NOTE Perform this test for all the connected parameter modules
and patient connectors specified Table Patient connectors to
be tested with each module.

1. Configure the safety analyzer as follows (NC):


● Polarity: NORMAL
● Neutral: CLOSED
● Earth (GND): CLOSED
2. Power on the device under test.
3. Read and record the current leakage indicated on the safety tester.

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Electrical safety tests

4. Configure the safety analyzer as follows (SFC):


● Polarity: NORMAL
● Neutral: OPEN
● Earth (GND): CLOSED
5. Read and record the current leakage indicated on the safety tester.
6. Configure the safety analyzer as follows (SFC):
● Polarity: NORMAL
● Neutral: CLOSED
● Earth (GND): OPEN
7. Read and record the current leakage indicated on the safety tester.
8. Configure the safety analyzer as follows (SFC):
● Polarity: REVERSED
● Neutral: CLOSED
● Earth (GND): OPEN
9. Read and record the current leakage indicated on the safety tester.
10. Configure the safety analyzer as follows (SFC):
● Polarity: REVERSED
● Neutral: OPEN
● Earth (GND): CLOSED
11. Read and record the current leakage indicated on the safety tester.
12. Configure the safety analyzer as follows (NC):
● Earth (GND): REVERSED
● Neutral: CLOSED
● Earth (GND): CLOSED
13. Read and record the current leakage indicated on the safety tester.
14. Power off the device under test.
15. Repeat this test for all the connected parameter modules and patient connectors
specified in Table Patient connectors to be tested with each module.
Acceptance criteria in Normal Condition (NC):
● All readings shall be less than or equal to 10 µA.
Acceptance criteria in Single Fault Condition (SFC) – earth open or one of the supply
conductors open at a time:
● All readings shall be less than or equal to 50 µA.

Testing patient (sink) leakage current


This procedure measures the leakage current from an applied part connector of the
device to ground. Perform the test in Normal Condition (NC) with normal and reverse
polarity.

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Electrical safety tests

NOTE Refer to the instructions delivered with the safety analyzer to


perform this test.

WARNING SHOCK HAZARD. The following step causes high voltage at the
test body. Do not touch the test body.

NOTE Perform this test for all the connected parameter modules
and patient connectors specified in Table Patient connectors
to be tested with each module.

1. Configure the safety analyzer as follows:


● Polarity: NORMAL
● Neutral: CLOSED
● GND: CLOSED
2. Power on the device under test.
3. Read and record the current leakage indicated on the safety tester.
4. Configure the safety analyzer as follows:
● Polarity: REVERSED
● Neutral: CLOSED
● GND: CLOSED
5. Read and record the current leakage indicated on the safety tester.
6. Power off the device under test.
7. Repeat this test for all the connected parameter modules and patient connectors
specified in Table Patient connectors to be tested with each module
Acceptance criteria:
● All readings shall be less than or equal to 50 µA.

Completing electrical safety tests


1. Disconnect the safety analyzer from the power outlet.
2. Disconnect the test equipment from the patient monitor.

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Electrical safety tests

3. Disconnect the patient monitor’s power cord from the leakage tester.

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Maintenance check
10
Planned and corrective maintenance procedures
This chapter describes the check procedure and the maintenance activities for the
device during planned maintenance and after corrective maintenance.
This chapter also covers the battery maintenance information for the patient
monitor’s lithium-ion battery.
Refer to “E-COP module”, “E-sCAiO, E-sCO, N-CAiO module”, “E-miniC module”,
and “E-Entropy module” chapter for planned and corrective maintenance check
procedures of the related module.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions for the monitor are described in the patient
monitor’s user’s manual. For details about cleaning, disinfecting and sterilizing the
accessories, see the instructions for use in the accessory package.
WARNING Only perform maintenance procedures specifically described
in the manual.

WARNING Planned maintenance should be carried out every 2 years.


Failure to implement the recommended maintenance
schedule may cause equipment failure and possible health
hazards.

NOTE The manufacturer does not, in any manner, assume the


responsibility for performing the recommended maintenance
schedule, unless an Equipment Maintenance Agreement
exists. The sole responsibility rests with the individuals,
hospitals, or institutions utilizing the device.

Record the results of the planned and the corrective maintenance check procedures
to the Checkforms.

Planned maintenance
Perform the planned maintenance procedure completely every 2 years after
installation. Perform the procedure in the following order:
1. Visual inspection
2. Electrical safety test
3. Functional check

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Maintenance check

Corrective maintenance
Service personnel shall perform the following checkout procedure steps after any
corrective maintenance, before taking the monitor back into clinical use:
The detached, Required check procedure
replaced or
upgraded FRU: Visual inspections Electrical safety test Functional check

Recorder unit (FRU / Yes No Start-up


Upgrade) Recorder
Module rail unit Yes No Start-up
Mains fuses Yes No Start-up
Monitor battery (FRU)
After detaching Yes Yes All functional check
or replacing any steps
other part inside the
patient monitor.

Performing visual inspection


Perform the following visual inspection to the installed monitoring system:
1. Carefully inspect the patient monitor if any damage.
2. Verify that the patient monitor are properly mounted with specified mounting
solutions.
3. Verify that the cables between the patient monitor and the connected peripheral
devices are intact, properly connected and secured to the right connectors.
4. Verify that all the network cables, are intact and properly connected to the right
connectors.
5. Verify that the module are properly connected and locked.
6. Verify that the battery door are properly locked.

Functional check
The purpose of this functional check is to ensure that the system is properly installed
and configured.
Skip the tests that are not applicable for the installed patient monitor.

Checking the startup


1. Turn on the power by press ON/OFF button more than 2 seconds.

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Maintenance check

2. Verify that the patient monitor starts up normally:


● The yellow, red and blue alarm lights are lit momentarily.
● The speaker gives an audible beep.
● The normal welcoming screen appears with a status bar indicating the
progress of the startup procedure.
● Normal monitoring screen appears and there are no error messages on the
screen.
NOTE If you receive a Condition battery or a Battery failure
message, refer to the troubleshooting instructions for
battery conditioning or replacement.

3. Verify that the battery is fully charged.


If the battery is not fully charged, keep the monitor connected to the mains until
the battery is fully charged. The battery must be fully charged before taking the
monitor into use for the first time.

Checking display
Testing picture quality
Perform this test both for the integrated main display and for the connect external
display.
1. Verify that all text is readable and all images are clear.
2. Verify that the brightness is good. Adjust if necessary.
Testing touchscreen control
1. Verify the operation of a touchscreen by touching an active digit field. Verify that
the related menu is opened.

Checking the time and date


1. Select the > Service > enter Username and Password.
2. Select Clinical tab > Time and Date.
3. Check the Current Time is correct, adjust the time and date if necessary.
NOTE The monitor can’t be set as TIME MASTER in network. You
should adjust the time and date from the central station,
if needed.

4. Select back arrow, select Time Zone.


5. Check and adjust the settings if necessary.

Checking the device information


1. Select > Monitor Info.

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Maintenance check

2. Verify the following:


a. The version information are identified.
b. The network information are identified.

Testing the B1X5-F2 frame


1. Ensure the frame is connected to the monitor.
2. Ensure one module is connected to the frame.
3. Using power cord connect the frame to the wall outlet.
4. Verify that the power LED and communication LED lit.

Checking parameters
Required tools for functional check
NOTE See the Supplies and accessories for compatible accessories.

● A multiparameter patient simulator that supports ECG, invasive pressure, and


temperature measurements.
● Adapter cables to GE invasive pressure and temperature connectors.
● For ECG:
■ Multi-Link 5-lead ECG trunk cable, IEC or AHA
■ Multi-Link 5-leadwire set, IEC or AHA
● For invasive pressure:
■ Dual IP adapter cable
● For temperature:
■ Dual temperature adapter cable.
● For SpO2:
■ SpO2 interconnect cable
■ SpO2 finger sensor
● For NIBP:
■ Adult NIBP hose
■ Adult NIBP cuff
■ Infant NIBP cuff hose
■ A rigid cylinder or pipe
■ Digital manometer with a range of at least 0 to 1000 mmHg and accuracy
0.5% FS.
■ Tubing parts to connect a manometer to the NIBP cuff and hose.
● For Defib sync:
■ Multi-Link 5-lead ECG trunk cable, IEC or AHA
■ Multi-Link 5-leadwire set, IEC or AHA
■ Oscilloscope
■ Analog output cable (2000633-001)

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Maintenance check

NOTE You can alternatively use the GE defib sync tester,


2040582-001, together with the Analog output cable,
2000633-001 and a multiparameter simulator to
perform this test. Follow the instructions included with
the tester.

Making connections for functional check


1. Turn the monitor on and wait until the normal screen appears.
2. Connect ECG and impedance respiration cables:
a. Connect the 5-lead ECG trunk cable to the ECG connector.
b. Connect 5-leadwire set to the trunk cable and to the simulator.
3. Connect SpO2:
a. Connect the SpO2 simulator to the SpO2 connector on the monitor with the
applicable SpO2 and/or simulator accessories.
4. Connect NIBP:
a. Connect an adult NIBP hose to the NIBP connector.
b. Connect an adult NIBP cuff to the hose.
c. Wrap the cuff around a rigid cylinder or pipe.
d. Connect the pressure manometer with pressure pump to the NIBP hose and
NIBP cuff with a piece off tubing.
e. Ensure that all of the connections are leak-proof.

5. Connect invasive pressure cables:


a. Connect the dual invasive pressure adapter cable to the invasive pressure
connector.
b. Connect the multiparameter patient simulator with its invasive pressure
adapter cables to the dual invasive pressure adapter cable.

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Maintenance check

6. Connect temperature cables:


a. Connect the dual temperature adapter cable to the temperature connector.
b. Connect the multiparameter patient simulator with its temperature adapter
cables to the dual temperature adapter cable.
c. Check that the simulator is configured for 400 series probes.
7. Connect the analog output cable to the monitor’s defibrillator synchronization
connector, located on the Multi I/O.

Defibrillator Synchronization connector Analog output Cable (2000633-


001). Related wire color in the Pin
number Signal open end of the
Pin number Signal cable 1)
1 Digital defibrillator syncronization Black
marker out signal
2 NC Green
3 GND Red
4 GND Blue
5 GND White
6 GND Yellow
7 GND Grey

Configuring monitor for functional check


1. Configure ECG measurement:

a. Select the > Screen Setup. Configure the ECG1, ECG2 and ECG3
waveform fields to the screen with adequate priority.
b. Select the HR digit field and configure:
● ECG1 Lead: II
● ECG2 Lead: V1
● ECG3 Lead: aVL
● Beat Volume: 1 or greater
● Size: 1x
c. Select the Advanced tab and configure:
● Pacemaker Detection: Show
● Primary HR Source: ECG

1. Brown wire is not connected.

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Maintenance check

2. Configure impedance respiration:

a. Select the > Screen Setup. Configure the Resp waveform field to the
screen with adequate priority.
b. Select Respiration digit field and configure:
● Measurement: ON.
3. Configure SpO2:

a. Select the > Screen Setup. Select SpO2 waveform field to the screen
with adequate priority.
4. Configure NIBP:

a. Select the > Screen Setup. Select NIBP digit field to the screen with
adequate priority.
b. Select the NIBP digit field and configure:
● Select Use Default Inflation Pressure
5. Configure invasive pressure measurement:

a. Select the > Screen Setup. Select IBP1, IBP2, waveform fields to the
screen with adequate priority.
b. Select IBP1 digit field and configure:
● Label: IBP1
● Scale (mmHg): 0-250 mmHg
● Display Format: Mean
c. Repeat step b. for IBP2 waveform.
6. Configure temperature:

a. Select the > Screen Setup. Select T1 and T2 parameter windows to the
screen with adequate priority.
Configuring simulator for functional check
For instructions on how to use and configure the simulators, refer to the simulators'
documentation.
1. Configure the ECG settings as follows:
● ECG Rhythm: a normal sinus rhythm
● Heart Rate: 80–90 bpm
● Amplitude: 1 mV
2. Configure the impedance respiration settings as follows:
● Baseline impedance: 1000 Ω
● Amplitude: 1 Ω
● Respiration rate: 20 breaths per minute
● Lead selection: II (LA or LL)

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Maintenance check

3. Configure the simulator’s SpO2 settings as follows:


● SpO2: 90–100
4. Configure the simulator’s invasive pressure channels IBP1, IBP2 as follows:
● Sensitivity: 5 µV/V/mmHg
● InvBP output: 0 mmHg static pressure or atmosphere
5. Configure the simulator’s temperature settings for all temperature channels as
follows:
● Temperature: 32 — 40 °C/ 89.6 — 104 °F
Testing ECG measurement
1. Test for normal sinus rhythm.
a. Check that the monitor displays the ECG leads II, V1 & aVL and the waveforms
are noise-free.
The monitor shall display a 80± 5 bpm heart rate and an audible QRS tone
sounds with each QRS complex. If necessary, turn up the QRS volume.
2. Check pacemaker detection:
a. Configure the simulator’s ECG output to Asynchronous Pacemaker Pulse.
b. Check that pacemaker spikes are shown on the ECG waveform.
c. Configure the simulator’s ECG output to 80 beats per minute, Normal Sinus
Rhythm.
3. Check Asystole detection:
a. Configure the simulator’s ECG output to Asystole.
b. Check that the Asystole alarm appears on the monitor screen.
c. Configure the simulator’s ECG output to 80 beats per minute, Normal Sinus
Rhythm.
4. Check leads off detection:
a. Detach the RA/R leadwire from the simulator.
b. Check that the Lead II waveform disappears from the ECG1 waveform field,
followed by an RA/R lead off message.
c. Check that Lead II is replaced by Lead III in the ECG1 waveform field after
a while.
d. Reconnect the RA/R leadwire to the simulator.
e. Check that Lead III is replaced with Lead II in the ECG waveform field.
Testing impedance respiration measurement
1. Check the respiration rate:
a. Check that the RESP waveform is shown.
b. Check that the RR value is 20 (±5).

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Maintenance check

2. Check the apnea detection:


a. Configure the simulator’s Apnea Simulation to 32 sec.
b. Check that the monitor activates the Apnea alarm.
c. Configure the simulator’s Apnea Simulation to OFF.
Testing SpO2 measurement
1. Connect the SpO2 sensor to your finger and wait until a pulse is found.
2. Check that:
● The SpO2 reading appears in the digit field.
● The plethysmographic waveform appears on the screen.

You can verify the functionality of a pulse oximeter probe and monitor with a
functional SpO2 tester but you cannot evaluate their accuracy with such a device.
However, if a particular calibration curve is accurate for the combination of a pulse
oximeter monitor and probe, a functional tester can measure the contribution of a
monitor to the total error of a monitor/probe system. The functional tester can
then measure how accurately a particular pulse oximeter monitor is reproducing
that calibration curve.
Testing NIBP measurement
1. Check the NIBP tubing system for leaks and check if NIBP calibration is required.

a. Select the > Service > enter Username and Password.


b. Select Basic Service > Parameters > NIBP.
c. Select ON for the Calibration Check.
d. Pump a 200 mmHg static pressure according to the manometer. The pressure
measured by the device is updated in real-time to the calibration menu. Wait
for a while until the pressure stabilizes.
e. Use the following table to evaluate the NIBP leakage and NIBP calibration
status.
Observed results Conclusion Recommended action
NIBP is leaking. Test failed. Troubleshoot the root cause for the
The NIBP tubing is leaking if the NIBP leakage and correct the problem.
pressure does not stabilize and drops 1. Check that the external NIBP test
at a rate of 1 mmHg or more for every setup is not leaking. Correct the root
five seconds. cause for the leak and repeat the
NIBP measurement test.
2. Check that the internal NIBP tubing
is not leaking. Re-perform all the
check out procedures required after
performing corrective maintenance
to the module.
NIBP is out of calibration. Test failed. 1. Calibrate NIBP.
NIBP calibration is required, if the 2. Perform functional check to retest
readings in the manometer and in the the NIBP measurement.

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Maintenance check

Observed results Conclusion Recommended action


NIBP calibration menu differ more than
±1 mmHg.
No leakage and NIBP is Test passed. Perform the next step of this procedure.
accurate. NIBP is working properly, if it is not
leaking and it shows accurate readings.

2. Disconnect the NIBP cuff and manometer from the module.


Testing invasive pressure measurement
1. Zero the tested pressure channel:
a. Ensure that the simulator’s invasive pressure output channel is configured
to 0 mmHg static.
b. Select the digit field of the tested invasive pressure channel, Select Zero.
c. Check that a Zeroing message followed by a Zeroed message is shown in
the menu.
2. Test a static pressure:
a. Configure the simulator’s invasive pressure output channel to 200 mmHg
static pressure.
b. Check that a flat pressure line appears on the related waveform field.
c. Check that the reading in the digit field is 200 ± 10 mmHg.
● If the measured value is not within the specification limits, recalibrate the
measurement.
3. Check the pressure waveform:
a. Configure the simulator’s invasive pressure output channel to Arterial 120/80.
b. Check that the pressure waveform for the tested invasive pressure channel
appears in the waveform window.
c. Check that the Sys/Dia (Mean) pressure values are shown in the related digit
field.
Testing temperature measurement
Perform the following steps to both the temperature channels.
NOTE The 'x' in the Tx refers to the temperature channel being tested.

1. Check that:
a. Tx temperature matches the configured simulator value chosen earlier ± 0.1
°C/ ± 0.18 °F.
b. There are no error messages on the screen.
● If the measured value is not within the specification limits, recalibrate the
measurement.

Testing MC Network
Perform the following test only if the patient monitor is connected to a wired MC
Network.

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Maintenance check

1. Check that the CAT-5 cable connector is clean and intact, connect it to the
Ethernet network connector.
2. Check that a network symbol is displayed in the upper right corner of the screen.

Testing wireless LAN configuration


Perform the following test only if the patient monitor is connected to a wireless MC
Network.
NOTE The wireless network must be properly installed and the
patient monitor must be within the wireless coverage area.

1. Check that a network symbol is displayed in the upper right corner of the screen.
2. Reconnect the MC Network cable back to the MC Network connector, if applicable.

Testing the recorder


1. Select the Printing Setup.
2. Configure the waveforms:
● Waveform 1: I
● Waveform 2: II
● Waveform 3: Resp
3. Select Print Waveforms.
4. Verify that the recorder starts printing.
5. Let the recorder print for approximately 10 seconds.
6. Select the Stop Printing to stop printing.
7. Verify the following things from the printout:
● The header line contains the date, time and some other applicable status.
● The grid is clear.
● The waveforms labels appear in the printout as configured.

Testing defibrillator synchronization marker out signals


1. Test the frequency of the Marker Out signal:
a. Change the oscillocope Volts scale:
Digital defibrillator synchronization
marker out signal: Black
Ground: Red
Probe Type: x10
Time/Division: 200 ms
Volts/Division: 2V

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Maintenance check

b. Check that the signal shown on the oscilloscope screen corresponds with
the preceding picture.
2. Test the pulse width of the Marker Out signal:
a. Change the Time scale on the oscilloscope:
Digital defibrillator synchronization
marker out signal: Black
Ground: Red
Probe Type: x10
Time/Division: 5 ms
Volts/Division: 2V

b. Check that the signal shown on the oscilloscope screen corresponds to the
preceding picture.
● If the test fails, replace the Multi I/O or Carrier board.

Completing the check procedure


1. Select > Discharge tab > Discharge > YES to discard any changes made to
the patient monitor configuration during checkout.
2. Disconnect the test setup.
3. Complete the check form.

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Calibration and adjustments
11
NIBP calibration
NIBP calibration shall be performed:
● If the NIBP Calibration Check failed.
● If the measured value is not within the specification limits.

Required tools for NIBP


● Adult NIBP hose
● Adult NIBP cuff
● Infant NIBP cuff hose
● A rigid cylinder or pipe
● Digital manometer with a range of at least 0 to 1000 mmHg and accuracy 0.5% FS.
● Tubing parts to connect a manometer to the NIBP cuff and hose.
NOTE Use only accurate, properly maintained, calibrated and
traceable calibration tools for the parameter calibration to
ensure measurement accuracy.

NOTE See the Supplies and accessories for compatible accessories.

Making connections
1. Connect an adult NIBP hose to the NIBP connector.
2. Connect an adult NIBP cuff to the hose.
3. Wrap the cuff around a rigid cylinder or pipe.
4. Connect the pressure manometer with pressure pump to the NIBP hose and NIBP
cuff with a piece off tubing.

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Calibration and adjustments

5. Ensure that all of the connections are leak-proof.

Calibrating NIBP
1. Select the > Service > enter Username and Password.
2. Select Basic Service tab > Parameters > NIBP.
3. Disconnect the hoses from the NIBP connector to enable proper zeroing.
4. Set the Protection to OFF.
Menu selection Start for Calibration now is enabled.
5. Select Start to start calibration. The NIBP calibration sequence starts with
automatic zeroing. Wait until the message Zeroing is replaced by the message
Zeroed.
6. Pump a 200 mmHg static pressure according to the manometer. The pressure
measured by the monitor is updated in real time to the calibration menu.
7. When the pressure is stabilized, check the pressure reading from the manometer.
8. Use arrows to adjust the reading measured by the monitor to match with the
manometer reading.
9. Select Confirm to complete the calibration when the two readings match each
other.
10. Wait until a message Calibrated is shown.
11. Set the Protection back to ON.
NOTE Calibration protection is set automatically On after 30 seconds
of inactivity, after the NIBP calibration menu is closed,
and after zeroing or calibration failure. Set the calibration
protection Off to restart the calibration.

NOTE You can use the calibration check function to verify the
calibration after the calibration is completed.

Invasive pressure calibration


Invasive pressure calibration shall be performed:

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Calibration and adjustments

● Whenever the pressure transducer in use is replaced with a new type of transducer.
● if the invasive pressure functional check failed.
● If the measured value is not within the specification limits.

Required tools
● Pressure manometer with a pressure pump
● Transducer adapter cable
● Invasive pressure transducer

NOTE See the Supplies and accessories for compatible accessories.

NOTE Use only accurate, properly maintained, calibrated and


traceable calibration tools for the parameter calibration to
ensure measurement accuracy.

NOTE The pressure transducer is a key component in the


measurement setup. If possible, perform the invasive pressure
calibration with the same type of pressure transducer that is
used in daily clinical use.

Making connections
1. Connect the transducer adapter cable to the red Inv BP connector.
2. Connect the invasive pressure transducer to the transducer adapter cable.
3. Connect the pressure manometer with a pressure pump to the transducer's
pressure line with a piece of tubing.

Calibrating invasive pressure


For channel P4’s calibration, please refer to “E-COP module” Chapter.

1. Select the > Service > enter Username and Password.


2. Select Basic Service tab > Parameters > STP > Calibrations.
3. Select Calibrate P1 or Calibrate P2.
4. Select Start Calibration.

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Calibration and adjustments

5. Prepare the transducer for the zeroing by opening the dome stopcock to room air.
6. The monitor will start automatic zeroing of the invasive pressure channel. Wait
until the message Zeroing is replaced by value arrows.
7. Pump a 200 mmHg ± 100 mmHg static pressure with the pressure pump. The
pressure measured by the monitor is updated in real-time to the calibration menu.
8. When the pressure is stabilized, check the pressure reading from the manometer.
9. Use arrows to adjust the reading measured by the monitor to match with the
manometer reading.
10. Select OK.
11. Wait until the message Calibrated is shown.
Repeat the above procedure, steps 3 through 11, for the other invasive pressure
channel.

Calibrating invasive pressure (by simulator)


There is another method to calibrate IBP by simulator:
● Tools: IBP accessories and simulator.
● Connection: Connect IBP accessories to the monitor and simulator.

1. Select the > Service > enter Username and Password.


2. Select Basic Service tab > Parameters > STP > Calibrations.
3. Select Calibrate P1 or Calibrate P2.
4. Select Start Calibration.
5. Set the P1 or P2 channel to 0 mmHg on the simulator.
6. The monitor will start automatic zeroing of the invasive pressure channel. Wait
until the message Zeroing is replaced by value arrows.
7. Set a pressure of 200 mmHg ± 100 mmHg on the simulator. The pressure
measured by the monitor is updated in real-time to the calibration menu.
8. Use arrows to adjust the reading measured by the monitor to match with the
simulator.
9. Select OK.
10. Wait until the message Calibrated is shown.
Repeat the above procedure, steps 3 through 11, for the other invasive pressure
channel.

Temperature calibration
Temperature calibration shall be performed:
● After STP/TP board replacement.
● If the measured value is not within the specification limits.

Required tools
● P/N 884515-HEL Temperature calibration plugs

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Calibration and adjustments

● Dual temperature adapter cable


NOTE See the Supplies and accessories for compatible accessories.

NOTE Use only accurate, properly maintained, calibrated and


traceable calibration tools for the parameter calibration to
ensure measurement accuracy.

Making connections
1. Connect the dual temperature adapter cable to the brown temperature connector.
2. Check that the dual temperature adapter cable is configured for 400 series probes.

Calibrating temperature
1. Select the > Service > enter Username and Password.
2. Select Basic Service tab > Parameters > STP > Calibrations.
3. Select OFF for Protection.
4. Select Calibrate T1 or Calibrate T2.
5. Select Start Calibration.
6. Plug in the temperature calibration plug labelled with TEMP 25°C/77°F to the dual
temperature adapter cable connector T1 or T2.
7. Select Next.
8. Wait until the value is shown, and select Next.
9. Plug in the temperature calibration plug labelled with TEMP 45°C/113°F to the
dual temperature adapter cable connector T1 or T2.
10. Select Next.
11. Wait until the value is shown.
12. Wait until the message Done is shown.
Repeat the above procedure, steps 3 through 12, for the other temperature channel.

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Calibration and adjustments

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Troubleshooting
12
Troubleshooting guidelines
CAUTION Make sure the patient is disconnected from the monitor before
performing any service on the device.

NOTE For the module troubleshooting, please refer to Modules


Technical Manual.

This chapter focuses on troubleshooting technical problems. Refer to the user’s


manual for troubleshooting monitoring problems and clinical configuration issues.
If a problem remains, contact technical support for service. To ensure accurate
problem solving, please be prepared to provide the following information:
● Product name and serial number or UDI
● Hardware and software versions
● Detailed problem description
● Error messages, if any
● Service Logs
● The troubleshooting you have done so far
Perform the specified corrective maintenance check after any corrective maintenance
to the product.

Performing basic troubleshooting


Before beginning any detailed troubleshooting, complete the following steps:
1. Perform visual inspection to be sure that:
● There is no physical damage.
● All peripheral devices are connected properly.
● The patient monitor and the connected peripheral devices are properly
powered.
2. Verify the compatibility of all system components.
For a list of the compatible devices, see the Supplemental Information Manual.
For a list of the compatible supplies and accessories, see the Supplies and
accessories.

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Troubleshooting

3. Verify that the platform and clinical configurations are correct.


For the clinical configuration see user’s manual and for the platform configuration
see Configuration chapter.
4. If you suspect loose parts or cable connections inside the monitor, disassemble
the monitor to a level needed to perform an internal visual check. Check that:
● All screws are tightened properly.
● All cables are connected properly.
● There are no loose objects inside the patient monitor.
Perform the electrical safety test and the checkout procedure every time you
have disassembled the patient monitor.

Viewing and downloading service log


Viewing service log
1. Select the > Service > enter Username and Password.
2. Select Basic Service tag >Service Log.
You can view the Error Log, Alarm Log, Keyboard Log, and WLAN Log.
Downloading logs to USB disk
You can download the error log, alarm log, keyboard log, and WLAN log, supplicant log
to the USB disk for service use.
1. Discharge the patient first.

2. Select > USB Disk.


3. To download log: select Export logs to USB Disk.
When finish to download logs, a message “Export logs successfully.” displays
on the menu.
4. To empty all the files in USB storage device: select Empty USB Disk.
NOTE All items on the USB disk will be deleted.

When finish to empty the USB disk, a message “Empty successfully.” displays
on the menu.
5. To remove the USB Disk: select Safe to remove USB Disk, then remove the USB
disk.
Viewing log files
You can download log files to your service PC if needed. To view the log files in USB
storage device:
1. Insert the USB storage device to the service PC.
2. Open the log folder in USB storage device, Computer > USB Disk Driver > logs
You can see alarmlog, keyboardlog, servicelog, wlanlog, and supplicantlog
folders.

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Troubleshooting

3. Open the folder and choose logs, there are 4 kinds of log files in the folder.
● alarmlog-SN-timestamp.zip
● keyboardlog-SN-timestamp.zip
● servicelog-SN-timestamp.zip
● wlanlog-SN-timestamp.zip
● supplicantlog-SN-timestamp.zip
4. To open the file, double click the .zip file > double click the .tar file > enter
password (123456).
The supplicantlog-SN-timestamp.zip file not have .tar file, please direct enter
password (123456).

Checking the battery charge with monitor software


You can check the monitor battery status using the monitor software:

1. Select the > Battery .


2. Check the battery status that appears.
NOTE When the battery charge complete, the Capacity Percent
may not reach to 100%.

Network diagnostics
Pinging a TCP/IP network device
You can verify connectivity with a network device on the MC Network using Ping.

1. Select the > Service > enter Username and Password.


2. Select Basic Service tag >Network > TCP/IP tag > Ping vertical tag.
3. In the Address field enter the IP address of a known device on the network.
4. Select Ping.
If you receive a reply, the monitor is able to connect to the network device.
If you do not receive a reply, make sure that the monitor is connected to an active
network.
NOTE The monitor withstands a maximum packet loss of 5 packets
per 1 million and maximum latency of 250 ms without
performance degradation.

Viewing Wireless status


You can view the WLAN status and detected access points for troubleshooting WLAN
related problems.

1. Select the > Service > enter Username and Password.


2. Select Basic Service tag >Page2 vertical tag > WLAN Status.
For more information, see WLAN status (91)

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Troubleshooting

Messages
Messages related to various situations
For information regarding alarm priorities and escalation times, see the supplemental
information manual.
Make sure you are familiar with the generic layout of the screen. This will help you identify
where on screen the following messages appear. The message location is indicated with the
following abbreviations:
● MF = message field
● WF = waveform field
● DF = digit field

Message Location Explanation What to do


● Alarm setup changed ● MF The alarm setup is retrieved from ● Check the alarm settings and
from Central the central station. adjust if necessary.
● Alarms reset from ● MF The alarms were remotely ● You can activate the alarms
Central paused from the central station. by pressing the audio pause
key.
● Battery empty ● MF The monitor is battery powered ● Charge the battery by using
and less than 5 min of monitoring the monitor on main power.
time is available with battery.
● Battery low ● MF The monitor is battery powered ● Charge the battery by using
and less than 20 min of the monitor on main power.
monitoring time is available with
battery.
● Battery temperature ● MF The battery’s temperature is too ● Replace the battery.
high high.
● If the problem persists,
replace the carrier board.
● Call service UMBC ● MF UMBC communication error, ● Replace the carrier board.
error and UMBC communication is
disabled.
● Condition battery ● MF Battery is not working properly. ● Replace or remove the
battery for conditioning.
● DEMO MODE ● MF DEMO mode has been enabled. ● To exit the DEMO mode:
Contact authorized service
personnel.
● Default settings ● MF The monitor settings is returned. ● Check the settings adjust if
returned necessary.
● Entering standby ● MF Activate standby has been ● No action required.
selected.

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Troubleshooting

Message Location Explanation What to do


● Frame temperature ● MF The temperature inside the ● Turn off the monitor, wait for
high frame is over 60°C/140 °F. it cool down.
● Make sure there is sufficient
ventilation.
● Check monitor ventilation
holes.
● Identical IP address ● MF Two or more monitors on the ● Disconnect the patient
noticed network have the same IP monitor that has the identical
address. IP address.
● Change the IP address of the
patient monitor that has the
duplicate IP address.
● Identical unit&bed ● MF Two or more monitors in the ● Disconnect the patient
name noticed network have the same unit and monitor that has the identical
bed name. unit and bed name.
● Change the unit and bed
name of the duplicate patient
monitor unit and bed name.
● License invalid ● MF License is invalid doing start up. ● Check and reset the license.
Contact GE service for correct
license if required.
● Loading failed ● MF Loading mode from network has ● Check device or network
been interrupted. cable connections.
● Loading from ● MF Patient data is being loaded from ● No action required.
network the network.
● Memory ERROR ● MF Displays after software ● Restart the monitor.
download.
● Mode data reset ● MF There is error when loading ● Replace the CPU board.
settings from the flash file. This
failure may occur during cold
start, warm start, upgrade start,
revert mode, etc,.
● Network: HL7 ● MF When network connection ● No action required.
between HL7 TCP Client
application and monitor is
made.
● Network down ● MF CARESCAPE Network connection ● Try to re-establish the
has failed. connection.
● Check the configuration of
network.
● For more information, see
network troubleshooting.

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Troubleshooting

Message Location Explanation What to do


● Network down: HL7 ● MF No HL7 TCP Client is configured ● Try to re-establish the
to connect to monitor on the connection.
network.
● Check the configuration of
network.
● For more information, see
network troubleshooting.
● Network made ● MF When CARESCAPE network is ● No action required.
connected.
● No battery backup ● MF There is no battery inserted. ● Insert a battery.
The battery is not compatible. ● Check battery model whether
is FLEX-3S3P.
● Patient admitted ● MF The current patient has been ● No action required.
admitted.
● Patient discharged ● MF The patient has been discharged. ● No action required.
● Printing... ● MF Printing is occurring. ● Wait for the printing to finish.
● Printing Alarm ● MF An alarm has triggered printing. ● Wait for the printing to finish.
● Recorder: cover open ● MF The recorder cover is open. ● Close the recorder cover.
● Recorder: input ● MF There are problems with the ● Replace recorder.
voltage high / recorder input voltage.
● Replace the carrier board.
Recorder: input
voltage low
● Recorder: out of ● MF The recorder is out of paper or ● Replace recorder paper.
paper the recorder cover is open.
● Close the recorder cover.
● Recorder system ● MF The local recorder is not working. ● Disconnect and reconnect
error x the recorder cable.
● Replace recorder.
● Recorder thermal ● MF There are problems with the ● Try stopping the recording as
array overheat recorder temperature. it may help.
● Replace the recorder.
● Recorder module ● MF Recorder module has been ● Reconnect the recorder
removed removed. module if you need.
● Replace battery ● MF Battery is not working properly. ● Replace the battery.
● Restart needed ● MF The monitor should be restarted. ● Restart the monitor.
● Saving ● MF The printing device is not ● Check the printing device.
available, and the records are
● Select a printing location.
saved for later printing.
● Saving to network ● MF Saving trend and information to ● No action required.
Network.

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Troubleshooting

Messages related to ECG measurement


For information regarding alarm priorities and escalation times, see the supplemental
information manual.
Make sure you are familiar with the generic layout of the screen. This will help you identify
where on screen the following messages appear. The message location is indicated with the
following abbreviations:
● MF = message field
● WF = waveform field
● DF = digit field

Message Location Explanation What to do


● Alarm setup changed ● MF Any of the ECG alarms (HR, ST ● Check the alarm settings at
from Central alarms) are turned ON/OFF or the Central.
its limits are adjusted from the
Central.
● Arrhythmia Paused ● WF ECG channels have not been ● Check the patient status.
available for analysis for the
● Arrh Paused ● MF ● Check electrode placement.
last 20 seconds or the internal
HR calculation has not been ● Prepare the patient’s skin at
updated for the last 30 seconds electrode sites.
due to excessive artifact.
● Change or move electrodes.
● Artifact ● WF Muscle artifact or high/low ● Check electrode contact.
frequency noise.
● Check lead placement.
● Perform skin preparation.
● Reposition/replace
electrodes.
● Request the patient to remain
still.
● ECG measurements ● MF The ECG module inside host has ● Open the device, check the
removed lost ECG communication. Hemo module connection..
● ECG module error ● MF The ECG module communication ● Open the device, check the
problem. Hemo module connection.
● Replace the hemo module.
● LA/L lead off ● WF An electrode is disconnected. ● Check the electrodes.
● LL/F lead off
● RA/R lead off
● RL/N lead off
● V/C lead off
● Lead changed ● WF The monitor automatically ● Note that the ECG waveform
switches the ECG1 waveform changes according to the
selection to a measurable ECG lead it is measured from.
Lead (I, II, III, aVR, aVL, aVF, Check the lead.
V1, V2, V3, V4, V5 or V6) if the
current ECG1 waveform is not
measurable.

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Troubleshooting

Message Location Explanation What to do


● Leads off ● MF, WF One or more of the connected ● Check the connections.
electrodes is disconnected and
arrhythmia detection is not
possible.
● Learning ● WF ST algorithm is in learning phase, ● No action required.
message shown e.g. when ECG
measurement is started.

Messages related to impedance respiration measurement


For information regarding alarm priorities and escalation times, see the supplemental
information manual.
Make sure you are familiar with the generic layout of the screen. This will help you identify
where on screen the following messages appear. The message location is indicated with the
following abbreviations:
● MF = message field
● WF = waveform field
● DF = digit field

Message Location Explanation What to do


● Apnea deactivated ● DF The case has recently been ● Wait. The message
patient admitted on the monitor, disappears after the monitor
● No breath
or the measurement has just detects breaths.
deactivated been started.
● LA/L-lead off ● WF, DF One of the electrodes is off. ● Check the electrodes and
their connections.
● LL/F-lead off
● RA/R-lead off
● Measurement off ● WF, DF ECG leads are not connected to ● Connect the ECG leads to
the patient. the patient to start the
impedance respiration
measurement.
● Small resp curve ● DF Signal amplitude < 0.4 Ohm ● Check the patient status.
● Check the electrodes
placement.

Messages related to SpO2 measurement


For information regarding alarm priorities and escalation times, see the supplemental
information manual.
Make sure you are familiar with the generic layout of the screen. This will help you identify
where on screen the following messages appear. The message location is indicated with the
following abbreviations:
● MF = message field
● WF = waveform field
● DF = digit field

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Troubleshooting

Message Location Explanation What to do


● Check Device ● DF Only for Masimo type. ● Open the device, reconnect
Module malfunction. the Hemo module.
● If the problem persists,
replace the Hemo module.
● Check Probe ● DF There is no detectable SpO2 ● Check the sensor and
signal, the sensor is faulty or is connections.
detached from the patient.
● Check SpO2 probe ● MF There is no detectable SpO2 ● Check the sensor and
signal, the sensor is faulty or is connections.
detached from the patient.
● Faulty Probe ● DF The sensor has failed, or not ● Replace the sensor. See the
compatible. Suppliers and accessories.
● Identical SpO2 ● MF There are two or more identical ● Remove identical SpO2
modules SpO2 modules are connected to modules.
the same monitor.
● Incompatible Probe ● DF The sensor is not compatible. ● Replace the sensor. See the
Suppliers and accessories.
● Incompatible SpO2 ● MF
Probe
● Interference ● DF The measurement is disturbed. ● Check the sensor.
● Low Perfusion ● DF Low perfusion at the ● Check the sensor and sensor
measurement point. positioning.
● Relocate the sensor to a
better measurement site, if
possible.
● Make sure the patient is not
shivering.
● Low signal quality ● DF Only for Masimo type. ● Check the sensor and sensor
The quality of the signal is positioning.
questionable. ● Relocate the sensor to a
better measurement site, if
possible.
● Make sure the patient is not
shivering.
● No SpO2 probe ● MF Sensor is not connected to the ● Check connection between
monitor. the sensor and the monitor.
● No Probe ● DF
Sensor is not compatible. ● Replace the sensor. See the
Suppliers and accessories.
● No SpO2 pulse ● MF No pulses detected. ● Try another measuring site.
● No Pulse ● DF

2105518-001 B125/B105 Patient Monitor 159


Troubleshooting

Message Location Explanation What to do


● Poor Signal ● DF When the low perfusion is ● Check the sensor and sensor
detected. positioning.
● Relocate the sensor to a
better measurement site, if
possible.
● Make sure the patient is not
shivering.
● Probe Off ● DF The sensor may be defective. ● Check the patient status.
● Reposition the SpO2 sensor.
● Replace the SpO2 sensor.
● Pulse Search ● DF Defective or damaged sensor ● Check the sensor and cable.
or cable. Sensor is off of
● Reposition or replace sensor.
the patient. Detection of a
repeatable pulse has stopped.
● SpO2 faulty probe ● MF The sensor has failed, or not ● Replace the sensor. See the
compatible. Suppliers and accessories.
● SpO2 measurement ● MF Only for Nellcor or Masimo type. ● Open the device, check Hemo
removed Hemo module of measuring module connection.
SpO2 removed.
● SpO2 module error ● MF Only for Nellcor or Masimo type. ● Open the device, check Hemo
SpO2 module recognize a module connection.
communication problem. ● Replace the Hemo module
connection.
● SpO2 probe off ● MF The finger or earlobe may be ● Check the patient status.
too thin or the sensor is off the
● Reposition the SpO2 sensor.
patient.
● Replace the SpO2 sensor.

Messages related to NIBP measurement


For information regarding alarm priorities and escalation times, see the supplemental
information manual.
Make sure you are familiar with the generic layout of the screen. This will help you identify
where on screen the following messages appear. The message location is indicated with the
following abbreviations:
● MF = message field
● WF = waveform field
● DF = digit field

160 B125/B105 Patient Monitor 2105518-001


Troubleshooting

Message Location Explanation What to do


● Call service: Error x ● DF 0 = RAM test failure ● Open the device, reconnect
where x = 0 - 99 1 = ROM checksum failure the Hemo module, and
acknowledge the alarm.
● NIBP call service error ● MF 2 = Pump on during idle or over
current detected ● If the problem persists,
replace the Hemo module.
3 = Startup communication
failure with safety CPU
4 = EEPROM protection is off
5 = EEPROM read/write error
6 = Valve stuck closed during
cuff typing
7 = Could not save calibration
data
8 = PT2 higher than 150 for
greater than 15 seconds while
idle
9 = Determination time too long
10 = RTK 400Hz timer re-entry
11 = RTK 50Hz timer re-entry
12 = Not in use
13 = RTK overrun
14 = Too early AUTO START
according to module check
15 = Calibration data invalid
on initialization or unit never
calibrated
16 = Communication timeout
between main and safety CPU
17 = Safety CPU report
communication timeout
18 = Wrong message rate in
communication between main
and safety CPU ><+/–2% (480
msg/s)
● Check NIBP ● MF Systolic and/or diastolic results ● Check the patient status.
missing.
● Check NIBP cuff and hoses.
● Repeat the measurement.
● Cuff loose ● DF Loose cuff or cuff hose. ● Check the cuff and cuff hose.
● Cuff occlusion ● DF Occlusion during measurement ● Check the cuff.
or overpressured cuff.
● Cuff overpressure ● DF NIBP cuff has exceeded the ● Check NIBP cuff and hoses.
maximum cuff pressure during
● NIBP cuff ● MF ● Repeat the measurement.
an NIBP measurement.
overpressure
● Incompatible NIBP ● MF NIBP module with firmware ● Upgrade the NIBP firmware.
version lower than 1.06 inserted
● Replace the Hemo module.

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Troubleshooting

Message Location Explanation What to do


● Long measurement ● MF, DF The measurement time is long. ● Check the patient status.
time The triggering values vary
● Check the cuff and hose
according to the module and
inflation limits in use: connections.
● Restart the measurement.
● >2 min for adult/ child, 75 s
to 80 s for infant
● NIBP manual ● MF During auto cycling ● Check the cuff and cuff hose
whether loose.
● Loose cuff or cuff hose.
● Long measurement time
● NIBP cuff loose ● MF Loose cuff or cuff hose. ● Check the cuff and cuff hose
whether loose.
● NIBP cuff occlusion ● MF Occlusion during measurement ● Check the cuff.
or overpressured cuff.

● NIBP measurement ● MF Hemo module has lost NIBP ● Open the device, check Hemo
removed communication. module connection.
● Select cuff size ● MF Try to start NIBP measurement ● Select a valid cuff size from
with invalid cuff size selection. NIBP menu.
● Unstable zero ● DF Pressure is unstable at start of ● Check the patient status.
pressure the NIBP measurement.
● Check hose and cuff position.
● Repeat the measurement.
● Calibrate NIBP
● Weak pulsation ● MF, DF Weak or unstable oscillation ● Check the patient status.
signal.
● Reposition the cuff.
● Repeat the measurement.

Messages related to invasive pressures measurement


For information regarding alarm priorities and escalation times, see the supplemental
information manual.
Make sure you are familiar with the generic layout of the screen. This will help you identify
where on screen the following messages appear. The message location is indicated with the
following abbreviations:
● MF = message field
● WF = waveform field
● DF = digit field

162 B125/B105 Patient Monitor 2105518-001


Troubleshooting

Message Location Possible causes Suggested actions


● P1 over range / P2 ● MF Measurement is over range, or ● Check the patient’s pressure
over range / P4 over the sensor is faulty. by alternative means.
● DF
range Transducer has not been zeroed ● Check the cable and
● Over range > 320 correctly. connections.
mmHg or Over range
● Rezero the transducer.
> 43 kPa
● Replace the sensor.
● Replace the transducer.
● Calibrate IBP.
● P1 under range / P2 ● MF Measurement is under range, or ● Check the patient’s pressure
under range / P4 the sensor is faulty. by alternative means.
● DF
under range Transducer has not been zeroed ● Check the cable and
● Under range < -40 correctly. connections.
mmHg or Under
● Rezero the transducer.
range < -5 kPa
● Replace the sensor.
● Replace the transducer.
● Calibrate IBP.
● Calibrated ● Menu Channel calibrated successfully. ● Wait until the message
disappears before starting a
measurement.
● Calibrating ● Menu Calibration of a channel is in ● Wait until the calibration is
progress. succesfully completed.
● Failed ● Menu Pressure calibration failure due ● Recalibrate. Start inflating the
to time-out. pressure within 45 seconds
Pulsating waveform detected after the automatic zeroing is
during calibration. completed.
Gain is beyond the limits (±20% ● Check the manometer
of the default gain. reading to ensure that a
static 100 to 300 mmHg
pressure is present for
calibration.
● Replace the transducer and
recalibrate.
● Failed: P<100 ● Menu Calibration reference value user ● Recalibrate. Check the
entered is less than 100 manometer reading to
ensure that a static 100
to 300 mmHg pressure is
present for calibration.
● InvBP's not zeroed ● MF There is at least one invasive ● Perform zeroing for all
pressure channel that has not channels.
● Not Zeroed ● DF
been zeroed.

2105518-001 B125/B105 Patient Monitor 163


Troubleshooting

Message Location Possible causes Suggested actions


● No x transducer ● MF No transducer connected to ● Connect a transducer.
the channel indicated in the
● Check the cable and
message, or the sensor is faulty.
connections.
● Replace the sensor.
● Replace the transducer.
● STP measurements ● MF The Hemo parameters have ● Open the device, check Hemo
removed been removed. module connection.
● Zero adj > 100 mmHg ● DF IBP channel zeroed to over 100 ● Repeat the transducer
mmHg pressure. zeroing.
● Replace the sensor.
● Replace the transducer.
● Re-zero the pressure channel.
● Zeroed ● DF Zeroing was successful. ● No action required.
Message is automatically
removed after 10 seconds.
● Zeroing ● DF IBP channel is currently being ● No action required.
zeroed. Message is automatically
removed and replaced with the
zeroing results after completion.
● Zeroing failed ● DF Pulsating waveform detected. ● Open the transducer to room
Defective transducer air and zero the channel.
Offset is >150 mmHg. ● Replace the transducer, open
it to room air, and zero the
channel.
● Zero ICP separately ● MF The ICP channel must be ● Zero the channel using the
zeroed separately from all other Zero option found under the
invasive pressures. ICP channel setup menu.

Messages related to temperature measurement


For information regarding alarm priorities and escalation times, see the supplemental
information manual.
Make sure you are familiar with the generic layout of the screen. This will help you identify
where on screen the following messages appear. The message location is indicated with the
following abbreviations:
● MF = message field
● WF = waveform field
● DF = digit field

164 B125/B105 Patient Monitor 2105518-001


Troubleshooting

Message Location Explanation What to do


● Performing temp test ● DF Temperature is calibrating. ● Wait until the self-check is
completed.
● Check that no error messages
appear.
● STP measurements ● MF The Hemo parameters have ● Open the device, check the
removed been removed. Hemo module connection.
● Temperature error ● DF Hardware or calibration test ● Perform calibration.
failure in the measurement
● T1 temperature error / ● MF ● Replace the STP module.
device.
T2 temperature error

Problems and solutions


Start-up failures
Problem Possible causes Recommended action
Failure to turn on Power cord is loose. Ensure that the power cord is connected properly to
the patient monitor, the wall outlet and to the patient monitor.
when the following
conditions apply: Blown fuses. Check the status of the fuses and replace them, if
necessary.
● The patient monitor ● Use only fuses with correct rating.
is connected to AC
mains. ● If the fuses are blown repeatedly, investigate the
patient monitor carefully for possible short circuits.
● The Mains voltage
indicator is not lit. Power cord is faulty. Check the power cord for wear and damage, and
replace if necessary.
● Monitor battery is
not installed. The power outlet does Check the power outlet being used
not meet specified
requirements.
The related cable is loose or Check the following cable is intact and properly
fault. connected.
● Cable between AC/DC module and the AC inlet
● Cable between AC/DC module and the carrier
board
AC/DC module issue Replace AC/DC module.
Carrier board issue Replace the carrier board.
Failure to turn on Battery empty Check battery status.
the patient monitor, Battery failure Charge or replace the battery.
when the following
conditions apply: Missing battery

● The patient monitor Battery interface board Check battery interface board is intact connected.
is not connected to loose or fault. Replace the battery interface board.
AC mains.
Carrier board issue Replace the carrier board.
● The monitor is
powered from
battery.

2105518-001 B125/B105 Patient Monitor 165


Troubleshooting

Problem Possible causes Recommended action


Failure to turn on On/Off key fault Check the related cables is intact connected.
the patient monitor, Replace membrane keyboard
when the following
conditions apply: Replace LCD interface board

● The patient monitor Carrier board issue Replace the carrier board.
is connected to AC
mains.
● A full charged
battery is installed.
The monitor starts The display cables are loose Check the display cable is intact and properly
(hear an beep), but the connected.
display remains black,
or white. The display issue Replace the display panel.
LCD interface board issue Replace the LCD interface board.

Battery issue
Problem Possible cause Recommended action
The battery LED AC Power input over voltage. ● Replace the AC/DC module.
indicator (on the
● Replace the carrier board.
monitor front panel)
orange flashing. Battery over voltage. ● Replace the battery.
● Replace the carrier board.
Battery precharge time-out ● Replace the battery.
fault
● Replace the carrier board.
Battery fast charge time-out
fault

User interface issues


Problem Possible cause Recommended action
Touchscreen is Touchscreen cable is loose. Check the touchscreen cable is intact and properly
inoperative. connect to LCD interface board.
Faulty touchscreen sensor. Replace the touch display panel.
Alarm light does not Alarm interface cable is Check the alarm interface cable is intact and properly
illuminate. (audible loose or fault. connect to LCD interface board.
alarms work and
alarm message is Alarm LED board is fault. Replace the Alarm LED board.
visible)
Keyboard not working, Keyboard cable is loose or Check the keyboard cable is intact and properly
or party working. fault. connect to LCD interface board.
Membrane keypad is fault. Replace the membrane keypad.
Trim knob not working. Trim knob cable is loose or Check the cable is intact and properly connect to LCD
fault. interface board.
Trim knob issue. Replace the trim knob

166 B125/B105 Patient Monitor 2105518-001


Troubleshooting

Problem Possible cause Recommended action


Audible alarms do not Audible alarm are turned off. Enable audible alarms from Alarms Setup.
work.
Speaker failure Replace the speaker.
Speaker cable loose or fault Check the cable is intact and properly connect to LCD
interface board.
Tone generator or audio Replace carrier board.
amplifier failure

B1X5-F2 frame issues


Problem Possible cause Recommended action
The parameter module The parameter module is Go to corresponding module troubleshooting.
data is not shown on defective.
the monitor display.
The module is not connected Reconnect the module.
properly.
The cable connecting frame Check the cable connections, or replace the cable.
to host is not properly
connected, or is defective.
The monitor’s display screen Go to Screen Setup to verify that the parameter is
is not configured to display selected to show on the screen.
the parameter.
The frame is defective. Send the frame to repair.
The module can not The E-Module rail or module Send the frame or the module to repair.
be placed properly to connector (inside the frame)
frame is defective.
The frame have a The AC/DC is defective. Replace the AC/DC. (same as monitor’s AC/DC FRU)
power issue.

Recorder issue
Problem Possible cause Recommended action
Recorder does not The recorder connect cable Check the recorder connect cable is intact and
work. is loose or fault. properly connected.
Recorder unit failure. Replace the recorder unit.
Carrier board issue Replace the carrier board.
Recorder works but Paper installed upsidedown. Turn the paper roll over.
nothing appears on
the paper.

Acquisition module problems


Problem: an acquisition module does not work with the patient monitor.

● Select the > Screen Setup, check that the parameters are configured to
the display.
● Do a visual check to the accessories used with the module. If in doubt, replace
the accessories with known good ones.

2105518-001 B125/B105 Patient Monitor 167


Troubleshooting

● Connect another, similar, known good module to the suspect patient monitor and
check if the module works normally:
■ YES: The suspect module is most likely faulty. Refer to module’s troubleshooting
instructions.
■ NO: The problem is most likely in the patient monitor. Continue troubleshooting
the problem according to the related troubleshooting chart below.
Or,
● Connect the suspect acquisition module to another, similar, known good patient
monitor and check if the module works normally:
■ YES: The problem is most likely in the patient monitor. Continue troubleshooting
the problem according to the related troubleshooting chart below.
■ NO: The suspect module is most likely faulty. Refer to module’s troubleshooting
instructions.
Possible cause Recommended action
Incompatible module Refer to the patient monitor’s supplemental information
manual document to see the list of compatible modules.
Connection issue ● Check the related cable connection
● Replace the interface board
■ E-module: Replace the E-module interface board
■ Hemo module: Replace the Hemo interface board
Carrier board is faulty. Replace the user interface board.

Troubleshooting CARESCAPE Network communication

Traffic types
Two main types of communication occurs in the CARESCAPE Network: Broadcast
and Unicast.
● Broadcast traffic is sent from one device to all devices on the network.
Examples of CARESCAPE broadcast traffic are device discovery, alarms, and time
synchronization.
● Unicast traffic is sent from one device to another specific device on the network.
An example of CARESCAPE unicast traffic is patient waveforms.

Flow
● Upstream broadcast: The monitor sends broadcasts to other network devices.
● Downstream broadcast: The monitor receives broadcasts from other network
devices.

168 B125/B105 Patient Monitor 2105518-001


Troubleshooting

Problem: No waveforms or parameters are displayed at


the Central Station
Network troubleshooting flowchart

2105518-001 B125/B105 Patient Monitor 169


Troubleshooting

Network troubleshooting flowchart A

170 B125/B105 Patient Monitor 2105518-001


Troubleshooting

Parameter issues
NIBP
Problem Possible cause Recommended action
Air leakage Hose or cuff leaking. ● Replace cuff.
● Replace cuff hose.
Leakage inside the Replace the Hemo module.
module.

IBP
Problem Possible cause Recommended action
Abnormally low Transducer wrongly Check mid-heart level and reposition
pressure. positioned transducer.
No pressure. Defective transducer. Check or replace transducer.
Module not connected. Reconnect the Hemo module.
Transducer adapter Connect the transducer adapter cable with
cable not connected to the transducer to the monitor.
the monitor.
Invasive pressure Configure the invasive pressure channel to
channel not configured the screen.
to the screen.

Temperature
Problem Possible cause Recommended action
No temperature Temperature channel Configure the temperature channel to the
displayed. not configured to the screen.
screen.
Temperature out of The measurement range is between 10 and
measurable range. 45 °C.
Incompatible Replace temperature probe.
temperature probe.

2105518-001 B125/B105 Patient Monitor 171


Troubleshooting

172 B125/B105 Patient Monitor 2105518-001


Disassembly and reassembly
13
Disassembly guidelines
Field repair of the monitor is limited to replacing Field Replaceable Units (FRUs).
WARNING Attempting a field repair on a PCB or a factory sealed
component or assembly could jeopardize the safe and
effective operation of the module, and void the warranty.

WARNING DISCONNECTION FROM MAINS. When disconnecting the


device from the power line, remove the plug from the wall
outlet first. Then you may disconnect the power cord from the
device. If you do not observe this sequence, there is a risk
of coming into contact with line voltage by inserting metal
objects, such as the pins of leadwires, into the sockets of the
power cord by mistake.

WARNING SAFETY GROUND. Remove power cord from the mains source
by grasping the plug. Do not pull on the cable.

WARNING ELECTRIC SHOCK. Always unplug the grounded cables when


not in use. Leaving them connected could result in an electric
shock from the ground contact in the other end.

NOTE Only a qualified service technician should perform field


replacement procedures.

NOTE Perform the specified corrective maintenance check after any


corrective maintenance to the product.

ESD precautions
WARNING Pins of connectors identified with the ESD warning symbol
should not be touched. Connections should not be made
to these connectors unless electrostatic discharge (ESD)
precautions are used.

All external connectors of the device are designed with protection from ESD damage.
However, if the device requires service, exposed components and assemblies inside
are susceptible to ESD damage. This includes human hands, non-ESD protected work
stations or improperly grounded test equipment. The following guidelines may not
guarantee a 100% static-free workstation, but can greatly reduce the potential for
failure of any electronic assemblies being serviced:

2105518-001 B125/B105 Patient Monitor 173


Disassembly and reassembly

● Discharge any static charge you may have built up before handling semiconductors
or assemblies containing semiconductors.
● Wear a grounded, antistatic wristband or heel strap at all times while handling or
repairing assemblies containing semiconductors.
● Use properly grounded test equipment.
● Use a static-free work surface while handling or working on assemblies containing
semiconductors.
● Do not remove semiconductors or assemblies containing semiconductors from
antistatic containers until absolutely necessary.
● Do not slide semiconductors or electrical/electronic assemblies across any surface.
● Do not touch semiconductor leads unless absolutely necessary.
● Store the semiconductors and electronic assemblies only in antistatic bags or
boxes.
● Handle all PCB assemblies by their edges.
● Do not flex or twist a circuit board.

Reassembly precautions
Reassembly the monitor in reverse order of following disassembly instruction.
Pay attention to the following generic precautions when reassembling the patient
monitor:
● Note the positions of any wires, cables or connectors. Mark them if necessary to
ensure that they are reassembled correctly.
● Save and set aside all hardware for reassembly.
● GE recommends using the new fasteners (screws, washers, etc.) provided in the
FRU kits rather than reusing the old fasteners. Some fasteners are not intended to
be re-used .
● When you attach self-tapping screws to light metal parts without existing threads
(new light metal FRU parts), use a higher torque than is recommended for
reassembled parts, but still not more than 1.6 Nm.
NOTE When you fasten the screws:
● Ensure visually that the screws are properly attached.
● Avoid over tightening by using excess force, as this may
damage the existing thread patterns.
● If you use a battery-operated tool, ensure that it is equipped
with torque limiter and the torque is properly adjusted.

Required tools
WARNING Due to possible high voltage present, use an insulated
screwdriver at all times.

NOTE Use torque wrench and torque screwdriver to comply with


the given torques.

● insulated PH1, PH2 screwdrivers, recommended length > 65 mm


● two socket wrenches (5.5 mm and 13 mm)

174 B125/B105 Patient Monitor 2105518-001


Disassembly and reassembly

● an insulated flat blade screwdriver (width 2.5 mm / 0.1 in)


● an antistatic ESD wristband

Preparing for disassembly


1. Turn the monitor off.
2. Disconnect the monitor power cord, first from the wall outlet and then from the
monitor.
3. Remove the monitor battery.
4. Disconnect all external cables connected to the monitor.
5. Remove the parameter module.
6. If a mounting is installed, detach the monitor from it.
7. Detach the multi I/O.

Replacing the main fuses


The mains fuses are located on the back of the monitor, inside the AC inlet.
1. Press the snap in the fuse holder of the AC inlet with a flat blade screwdriver
to release it.
2. Prize up fuses with a flat blade screwdriver.
3. Replace the fuses with new ones.
NOTE Use only fuses with the same rating.

2105518-001 B125/B105 Patient Monitor 175


Disassembly and reassembly

Detaching the extension rack, hemo module and


wireless module
● Detaching the extension rack:
1. Remove the sheet of the rack, there
3 holes inside the rack can help to
remove.
2. Remove three screws holding rack.
3. Disconnect the rack cable.

● Replacing the hemo module:


1. Remove two screw rubbers.
2. Remove two screws.
3. Remove the hemo cover.
4. Pull out the hemo module with the
metal sheet.

176 B125/B105 Patient Monitor 2105518-001


Disassembly and reassembly

● Replacing the wireless module:


1. For no rack device, remove two screws,
then open the cover.
2. Remove two screws of the wireless
board.
3. Disconnect two antennas.
NOTE: When reassemble the wireless module,
use the clips to fix the antennas.

Detaching the frame


1. Remove four screws on the back of the
monitor.
2. Open the frame box.
3. Disconnect the cable from carrier board to
LCD converter board.
4. Disconnect the cable from speaker to LCD
converter board.

2105518-001 B125/B105 Patient Monitor 177


Disassembly and reassembly

LCD converter board connectors

1. TP (touch panel) connector


2. 10.1’ LCD display connector
3. Membrane keypad connector
4. Speaker connector
5. 12.1’ LCD display connector
6. Alarm light connector
7. Trim knob connector

Replacing the user interface parts


● Replace the speaker:
1. Remove 2 screws of the mounting.
2. Replace the speaker.

● Replace the Trim Knob:


1. Disconnect the Trim Knob cable (#7).
2. Remove the Trim Knob cover.
3. Release the encoder by the socket
wrench (13 mm).
4. Replace the Trim Knob.

178 B125/B105 Patient Monitor 2105518-001


Disassembly and reassembly

● Replace the alarm light:


1. Disconnect the alarm light cable (#6).
2. Replace the alarm light board.
● Replace the membrane keypad:
1. Disconnect the cable (#3) and shield
line.
2. Tear down the membrane keypad on
the front cover, and replace.

Replacing LCD converter board, display, and front cover


● Replace the LCD converter board:
1. Disconnect all the cables on the LCD
converter board.
2. Remove 5 screws on the LCD converter
board.
3. Remove the LCD converter board.
● Replace the touch display panel:
1. After remove the LCD converter board,
remove 9 screws.
2. Replace the touch display panel.
● Replace the front cover.

NOTE The front cover FRU including membrane keypad, please


replace the membrane keypad also.

Detaching the middle cover


1. Remove two screws on the mounting
plate.
2. Remove four screws on the middle cover.
3. Lift the middle cover up.

2105518-001 B125/B105 Patient Monitor 179


Disassembly and reassembly

Replacing the handle


1. Remove two screws for the handle.
2. Replace the handle.

Detaching the battery chamber


1. Remove two screws on the mounting
plate.
2. Remove the mounting plate.
3. Disconnect the cable from battery board
to carrier board.
4. Remove the screw for shield line.
5. Lift the battery chamber up.

Replacing the AC/DC module


WARNING When remove the AC/DC module, don’t touch the capacitor
and the heat sink. It is highly recommended you to wear the
insulating glove to avoid electric shock and overheating.

180 B125/B105 Patient Monitor 2105518-001


Disassembly and reassembly

1. Remove three screws for the AC/DC


module.
2. Disconnect the cable.
3. Lift up the AC/DC module.

Replacing the carrier board


1. Remove three screws on the metal cover.
2. Open the metal cover.
3. Remove five screws for carrier board.

NOTE Replace the carrier board battery every 5 years.

Detaching the recorder


1. Open the recorder door and remove the paper roll if installed.
2. Remove two screws and drag the tab out.
3. Remove four screws.
4. Release the cover (side) of the recorder by pressing with a flat blade screwdriver.
5. Remove two screws inside the recorder.
6. Remove 4 screws of the back board.

2105518-001 B125/B105 Patient Monitor 181


Disassembly and reassembly

7. Pull the recorder out of the housing.

182 B125/B105 Patient Monitor 2105518-001


Service parts
14
Service parts
Perform the specified corrective maintenance check after any corrective maintenance
to the product.

Ordering parts
To order parts, contact your local GE representative. Contact information is available
at www.gehealthcare.com. Make sure you have all necessary information at hand.

Front cover

2105518-001 B125/B105 Patient Monitor 183


Service parts

Back cover

184 B125/B105 Patient Monitor 2105518-001


Service parts

Frame

Hemo box

2105518-001 B125/B105 Patient Monitor 185


Service parts

Rack and recorder

List of FRUs
Item Part number Description
1 2098800-002 FRU Value Monitor B105 Front Cover with Touch Panel1
● B105 Front Cover with 10.1’ touch screen
2 2098800-101 FRU Value Monitor B125 V1.5 Front Cover with Touch Panel2
● B125 Front Cover with 12.1’ touch screen
3 2098800-004 FRU Value Monitor B105 LCD Display and Sheet Metal
● 10.1’ LCD and frame
4 2098800-102 FRU Value Monitor B125 V1.5 LCD Display and Sheet Metal
● 12.1’ LCD and frame
5 2098800-103 FRU Value Monitor B125B105 V1.5 Display Converter
● LCD interface board
● Connect cables and screws
6 2098800-007 FRU Value Monitor Trim Knob
● Trim Knob, encoder
● Encoder grounding cable
● Spring clip

1. When service person replace the B105 front cover, please order 2098800-008 FRU Value Monitor B105 membrane keypad also.
2. When service person replace the B125 front cover, please order 2098800-009 FRU Value Monitor B125 membrane keypad also.

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Service parts

Item Part number Description


7 2098800-008 FRU Value Monitor B105 membrane keypad
● B105 membrane keypad
8 2098800-009 FRU Value Monitor B125 membrane keypad
● B125 membrane keypad
9 2098800-010 FRU Value Monitor Alarm Light and Speaker
● Alarm LED board
● Speaker
● Connect cables
10 2098800-011 FRU Value Monitor Carrier Board
● Carrier board
11 2098800-104 FRU Value Monitor B125B105 V1.5 Frame Connector and Cables
● Hemo interface board
● Battery interface board
● Alarm interface cable
● Battery interface cable, battery grounding cable
● 10.1 LCD interface cable, 12.1 LCD interface cable
● Carrier board to front cover interface cable
● Clarmp cable
● Hemo interface board bracket
● Equipotential plug
● Related kinds of screws, nuts, and washers
12 2098800-013 FRU Value Monitor B105 Middle Cover
● B105 middle cover
● Hemo removal handle, Hemo cover and 2 plugs
● B105 Handle foams
● Foot pads
13 2098800-014 FRU Value Monitor B125 Middle Cover
● B125 middle cover
● Hemo removal handle, Hemo cover and 2 plugs
● B125 handle waterproof foams
● Foot pads
14 2098800-015 FRU Value Monitor AC/DC module
● AC/DC module
15 2098800-016 FRU Value Monitor Wireless module with antennas
● Wireless module board
● 2 antennas and clips

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Service parts

Item Part number Description


16 2098800-119 FRU Value Monitor B125B105 RACK
● RACK connection board
● RACK shell, RACK cover and plastic sheet
● RACK connection cable
● 2 waterproof foams
17 2098800-018 FRU Value Monitor Multi-I/O adapter with cable
● Multi I/O module
● Multi I/O cable
18 2098800-105 FRU Value Monitor B125B105 V1.5 Stand Alone Printer
● Assembly: Thermal recorder with module housing
● Fixing plastic plate
● Recorder connection cable
● Y-Type connection cable
19 2098800-106 FRU Value Monitor B125B105 V1.5 Printer Cover, board and cable
● Thermal recorder module housing
● Recorder connection cable
● Y-Type connection cable
20 2098800-022 FRU Value Monitor Handle
● Handle
21 M1168356 FRU BATTERY B650
22 2098800-109 FRU B125B105 V1.5 HEMO GE STP (SpO2, Temp and IBP)3
● Hemo module: GE STP (with GE SpO2, Temp and IBP)
23 2098800-110 FRU B125B105 V1.5 HEMO GE SPO2 (SpO2 only)4
● Hemo module: GE SpO2 (with GE SpO2 only)
24 2098800-111 FRU B125B105 V1.5 HEMO NELLCOR (SPO2, TEMP, IBP)5
● Hemo module: Nellcor (with Nellcor SpO2, Temp and IBP)
25 2098800-108 FRU B125B105 V1.5 HEMO MASIMO (SPO2, TEMP, IBP)6
● Hemo module: Masimo (with Masimo SpO2, Temp and IBP)
27 2053489-080 FRU B40B20 HEMO Labels
● Multi languages HEMO labels
28 2053489-005 FRU B40B20 CPU BATTERY
29 2098800-117 FRU Value Monitor B125B105 V1.5 second frame
- 2061869-088 FRU BX0 FILTER POROUS PLASTIC 20U7
● Filter porous plastic 20U

3. When service person replace the hemo module, please order 2053489-080 FRU B40B20 HEMO Labels also.
4. When service person replace the hemo module, please order 2053489-080 FRU B40B20 HEMO Labels also.
5. When service person replace the hemo module, please order 2053489-080 FRU B40/B20 HEMO Labels also.
6. When service person replace the hemo module, please order 2053489-080 FRU B40/B20 HEMO Labels also. Please notice the part
number of B125/B105 Masimo Hemo, don’t misuse with B40/20 Masmio Hemo module.
7. Instruction for 2061869-088 refer to Technical Bulletin DOC1815812.

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Service parts

Item Part number Description


- 2053489-066 FRU B20B40 HEMO DUMP VALVE SUB ASSY8
- 2098800-107 FRU Value Monitor Main Software Recovery USB9

8. Instruction for 2053489-066 refer to accompanying document with the FRU.


9. The software download instruction refer to accompanying document with the FRU.

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190 B125/B105 Patient Monitor 2105518-001


E-COP module
15
About this chapter
This chapter contains instructions for the planned and corrective maintenance,
configuration and calibration of the acquisition module.
For the module instruction, troubleshooting, disassembly and reassembly and service
parts section, please refer to Module’s Service Manual.

Maintenance check
About the maintenance check procedures
This chapter describes the planned and corrective maintenance check procedures
for the product. To help ensure the equipment remains in proper operational and
functional order and maintains its essential performance and basic safety, follow the
corrective and planned maintenance recommendations. The tests that are related to
the essential performance and basic safety are marked with the *.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions are described in the monitor’s user’s manual.
For details about cleaning, disinfecting and sterilizing the accessories, see the
instructions for use in the accessory package.
Record the results of the planned and the corrective maintenance check procedures
to the eCheckforms delivered in the electronic manual media.
WARNING SAFETY HAZARD. To avoid risks to personnel and patient,
or damage to the equipment, only perform maintenance
procedures described in this manual. Unauthorized
modifications can lead to safety hazards.

Planned maintenance
WARNING Planned maintenance should be carried out at recommended
interval. Failure to implement the recommended maintenance
schedule may cause equipment failure and possible health
hazards.

Perform the planned maintenance procedure completely every 2 years after


installation. Perform the procedure in the following order:
1. Visual inspection
2. Electrical safety test *

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E-COP module

3. Functional check
Corrective maintenance
Service personnel shall perform the following checkout procedure after any corrective
maintenance, before taking the module back into clinical use:
Required checkout procedure
Performed service activity Visual inspection Functional check
Product casing opened All steps All steps
either for troubleshooting
purpose or for replacing any
of the internal parts.
Front cover, or an other All steps Not applicable
external part, replaced.

Performing visual inspection


1. Remove the module and check that:
a. The front cover is intact.
b. All connectors are intact, clean and attached properly.
c. The module casing and the latch are clean and intact.
d. The patient cables are clean and intact.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions for the monitor are described in the monitor’s user
manual. For details about cleaning, disinfecting and sterilizing the accessories, see the
instructions for use in the accessory package.

Performing electrical safety test *


Perform the electrical safety tests described in the monitor technical manual,
“Electrical safety test” chapter. Perform both patient leakage current tests:
1. Patient (source) leakage current test
2. Patient (sink) leakage current test

Performing functional check


Required tools for E-COP module functional check
For a list of compatible accessories, see the Supplies and Accessories.
● A multiparameter patient simulator with adapter cables to GE invasive pressure
and cardiac output connectors.
● Catheter connecting cable
● One of the following simulators depending on the module version:
■ P/N 2089334–001 SvO2 simulator is compatible with all E-COPSv-00 and
COPSv-01 modules.

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E-COP module

■ P/N 890121 SvO2 simulator is compatible with all the E-COPSv-00 modules,
but only with those E-COPSv-01 modules with serial number SGQ14462015HA
or lower.
Making connections for the functional check
1. Turn on or restart the monitor and wait until the normal screen appears.
2. Ensure that the module is connected to the monitor.
3. Connect the multiparameter patient simulator with its invasive blood pressure
adapter cable to the red invasive pressure connector in the module.
The invasive pressure connector in the E-COP module is labelled either as a P4 or
as a P4/P8. However, the monitor software always identifies this invasive pressure
port as a P4 channel.
4. Connect the C.O. cables:
a. Connect the catheter connecting cable to the C.O. connector in the module.
b. Connect the catheter connecting cable's injectate probe connector and blood
catheter (blood temperature) connector to the simulator according to the
instructions in the patient simulator's manual.
Configuring monitor for E-COP module functional check
1. Configure invasive pressure measurement:
a. Select IBP4 waveform field to the screen with adequate priority.
b. In the Invasive Pressures menu configure:
● Label: IBP4
● Scale (mmHg): 0-200 mmHg
● Digit Format: S/D/M
2. Configure cardiac output measurement:
a. Select C.O. and Temp lower field to the monitor screen with adequate priority.
b. In the Cardiac output menu configure:
● Catheter Type: User defined
● Computation Constant: 0.542
● Measurement Type: Manual
● Injectate Volume: 10 ml
● Ref Measurement: Deselect
Configuring simulator for E-COP module functional check
For instructions on how to use and configure the simulators, refer to the simulators'
documentation.
1. Configure the invasive pressure channels of the simulator as follows:
● Sensitivity: 5 µV/V/mmHg
● InvBP output: 0 mmHg static pressure or atmosphere

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E-COP module

2. Configure the cardiac output channels of the simulator as follows:


● Baseline Temperature/Blood Temperature: 37 °C
● Injectate temperature: 0 °C or 2 °C
Testing invasive pressure measurement
1. Zero the tested pressure channel:
a. Ensure that the simulator’s invasive pressure output channel is configured
to 0 mmHg static.
b. Select the digit field of the tested invasive pressure channel, Select Zero.
c. Check that a Zeroing message followed by a Zeroed message is shown in
the menu.
2. Test a static pressure:
a. Configure the simulator’s invasive pressure output channel to 200 mmHg
static pressure.
b. Check that a flat pressure line appears on the related waveform field.
c. Check that the reading in the digit field is 200 ± 10 mmHg.
● If the measured value is not within the specification limits, recalibrate the
measurement.
3. Check the pressure waveform:
a. Configure the simulator’s invasive pressure output channel to Arterial 120/80.
b. Check that the pressure waveform for the tested invasive pressure channel
appears in the waveform window.
c. Check that the Sys/Dia (Mean) pressure values are shown in the related digit
field.
Testing cardiac output measurement *
NOTE This test is for functional check purpose only. Results can't be
used for accuracy checking.

NOTE Check that the T injectate and Tblood values in the C.O. menu
are close to the set values to ensure successful measurement.
Adjust simulator, if necessary.

1. Select Cardiac output digit field > Measurement tab.


2. Select START C.O. to start a manual C.O. measurement.
3. Wait until the Inject now! message appears and inject a 5 l/min C.O. wave from
the simulator.

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4. Check that:
a. A thermodilution curve appears on the C.O. menu and the curve returns to the
base level after the measurement is completed.
b. The measured C.O. value is updated and close to the simulator’s set value.
c. There are no error messages on the screen.
NOTE To reject any noisy or erroneous measurement results,
select the Cancel/Reject Injection

5. Repeat steps from 2) to 4) until you have 3 good measurement results.


6. Select Confirm C.O. to complete the C.O. measurement.
7. Check that the average of the measured C.O. values and the Tblood reading are
updated to the C.O. and Tblood digit field.
Completing the check procedure
1. Select > Discharge tab > Discharge > YES to discard any changes made to
the patient monitor configuration during checkout.
2. Disconnect the test setup.
3. Complete the check form.

Configuration
There is no service configuration for this module.

Calibration and adjustments


CAUTION Make sure the patient is disconnected from the monitor before
performing any service on the device.

Invasive pressure calibration


Invasive pressure calibration shall be performed:
● Whenever the pressure transducer in use is replaced with a new type of transducer.
● if the invasive pressure functional check failed.
● If the measured value is not within the specification limits.
Required tools
● Pressure manometer with a pressure pump
● Transducer adapter cable
● Invasive pressure transducer
NOTE See the Supplies and accessories for compatible accessories.

NOTE Use only accurate, properly maintained, calibrated and


traceable calibration tools for the parameter calibration to
ensure measurement accuracy.

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E-COP module

NOTE The pressure transducer is a key component in the


measurement setup. If possible, perform the invasive pressure
calibration with the same type of pressure transducer that is
used in daily clinical use.

Making connections
1. Connect the transducer adapter cable to the red Inv BP connector.
2. Connect the invasive pressure transducer to the transducer adapter cable.
3. Connect the pressure manometer with a pressure pump to the transducer's
pressure line with a piece of tubing.

Calibrating invasive pressure


1. Select the > Service > enter Username and Password.
2. Select Basic Service tab > Parameters > COP > Calibrations tab.
3. Prepare the transducer for the zeroing by opening the dome stopcock to room air.
4. Select Calibrate P4.
5. The monitor will start automatic zeroing of the invasive pressure channel. Wait
until the message Zeroing is replaced by the message Zero Ok.
6. Pump a 200 mmHg ± 100 mmHg static pressure with the pressure pump when
the message Create 200 mmHg pressure is shown. The pressure measured by
the module is updated in real-time to the calibration menu.
7. When the pressure is stabilized, check the pressure reading from the manometer.
8. Use the up-down spinner control in the calibration menu to adjust the reading
measured by the module to match with the manometer reading. Select Confirm
to complete the calibration when the two readings match each other.
9. Wait until the message Calibrated is shown.
NOTE The Zero Failure message is shown if the zeroing fails.

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NOTE The Calibration Error message is shown, if you do not start


inflating the pressure within 45 seconds after the automatic
zeroing is completed, or if the calibration fails.

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E-COP module

198 B125/B105 Patient Monitor 2105518-001


E-sCAiO, E-sCO, N-CAiO module
16
About this chapter
This chapter contains instructions for the planned and corrective maintenance,
configuration and calibration of the acquisition module.
For the module instruction, troubleshooting, disassembly and reassembly and service
parts section, please refer to Module’s Service Manual.

Maintenance check
About the maintenance check procedures
This chapter describes the planned and corrective maintenance check procedures
for the product. To help ensure the equipment remains in proper operational and
functional order and maintains its essential performance and basic safety, follow the
corrective and planned maintenance recommendations. The tests that are related to
the essential performance and basic safety are marked with the *.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions are described in the monitor’s user’s manual.
For details about cleaning, disinfecting and sterilizing the accessories, see the
instructions for use in the accessory package.
Record the results of the planned and the corrective maintenance check procedures
to the eCheckforms delivered in the electronic manual media.
WARNING SAFETY HAZARD. To avoid risks to personnel and patient,
or damage to the equipment, only perform maintenance
procedures described in this manual. Unauthorized
modifications can lead to safety hazards.

Planned maintenance
WARNING Planned maintenance should be carried out at recommended
interval. Failure to implement the recommended maintenance
schedule may cause equipment failure and possible health
hazards.

Perform the planned maintenance procedure completely every 12 months after


installation. Perform the procedure in the following order:
1. Replacement of planned maintenance parts
2. Visual inspection

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E-sCAiO, E-sCO, N-CAiO module

3. Functional check
Corrective maintenance
Perform the following checkout procedure after any corrective maintenance, before
taking the module back into clinical use:
Required checkout procedure
Performed service activity Visual inspection Functional check
Front cover, or an other All steps Not applicable
external part, replaced.

OM reference gas filter All steps Check sample flow rate. *


assembly

Module case opened either All steps All steps


for troubleshooting purpose
or for replacing any of the
internal parts.

Replacement of planned maintenance parts


Replace the following parts that wear in use at the recommended interval.
Description Pieces Replacement interval
Nafion tube, 230 mm (mainflow) 1 Once a year
OM reference gas filter assembly including O-ring 1 Once a year
PM sticker 1 Once a year
Nafion tube, 85 mm (zero line) 1 Once a year
CO2 absorber 1 Once every 4 years

GE Healthcare recommends that you replace the D-fend Pro water trap, the gas
sampling line and the spirometry tube as part of the planned maintenance procedure.
NOTE See the user documentation delivered with the monitor for
compatible accessories.

Planned maintenance kits


The required planned maintenance parts are included in PM kits.
Part number Description
2093610-001 One year Planned Maintenance Kit for CARESCAPE Respiratory
modules.
The PM kit includes the required Nafion tube, 230 mm (mainflow), the
OM reference gas filter assembly with an O-ring and a PM sticker.
NOTE: The one year PM kit does not include the CO2 absorber and
Nafion tube, 85 mm (zero line).
2093594-001 Four year Planned Maintenance Kit for CARESCAPE Respiratory
modules.
NOTE: The four year PM kit contains all required PM parts.

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E-sCAiO, E-sCO, N-CAiO module

Replacing planned maintenance parts


Replace the specified planned maintenance parts according to the chapter
Disassembly and reassembly.
1. Replace the CO2 absorber every 4 years.

2. Replace the special tubes (Nafion) and check the condition of the internal tubing.
a. Check that the tubing inside the module is not contaminated. Any
contamination inside the tubing may indicate that the valves or sensors are
contaminated, too. This can increase a risk of faulty operation in valves or
sensors. The valves or gas sensors are not possible to clean in the field.
Therefore, if you noticed any contamination in the module tubing, send the
module to GE Healthcare for factory service.

NOTE The Nafion tubes do not include the silicon fittings


they connect to. Use the original silicon fittings unless
they are damaged or leaking.

3. Replace the OM reference gas filter assembly.


4. Check that the fan and ventilation hole are not covered in dust.

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E-sCAiO, E-sCO, N-CAiO module

Performing visual inspection


1. Remove the module and check that:
a. The front cover is intact.
b. All connectors are intact, clean and attached properly.
c. The module casing and the latch are clean and intact.
d. The patient cables are clean and intact.
2. Check that the D-fend Pro and its connectors are clean and intact.

Performing functional check


Required tools for the functional check
For a list of compatible accessories, see the Supplies and Accessories.
● A barometer
● A mass flowmeter for measuring air flow, minimum measurement range from 0 to
200ml/min, accuracy 5% or better in the 0 to 200 ml/min range.
● P/N: 755534-HEL Calibration Gas Regulator
● P/N: 755583-HEL Calibration gas, CO2, O2, N2O, DESF, package of 1 can (with
E-sCAiO, sCAiOV, and E-sCAiOVX modules)
● P/N: 755581-HEL QUICK CAL calibration gas, CO2, O2, N2O, package of 4 cans
(with sCO, E-sCOV, and E-sCOVX modules)
● P/N: M1006864, Calibration Gas Regulator, US only
● P/N: 755571-HEL, Calibration Gas, 5% CO2, 54.5% O2, 36.0% N2O, 2.0%
DESFLURANE, BAL N2 (with E-sCAiO, E-sCAiOV, and E-sCAiOVX modules) US only
● P/N: 755587, Calibration Gas, CO2, O2, Balance, 4 cans/pkg (with E-sCO, E-sCOV,
and sCOVX modules) US only
● D-fend Pro water trap
● 3 m / 10 ft anesthesia gas sampling line
● Spirometry tube, 3 m/10 ft (with E-sCOV, E-sCOVX, E-sCAiOV, and E-sCAiOVX
modules)
● Adult D-Lite sensor
● A pressure manometer with either an integrated or a separate pressure pump
● Tubing for spirometry leak tests
● Forceps
Making connections for the functional check
1. Disconnect the module from the monitor for the first test.
‒ gas sampling system leak test
For the rest of the functional check steps:
2. Turn the monitor on and wait until the normal screen appears.
3. Ensure that the module is connected to the monitor.
4. Let the module warm up for at least 5 minutes.

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E-sCAiO, E-sCO, N-CAiO module

Configuring monitor for functional check


1. Configure the CO2, O2, AA, and Flow waveform fields to the monitor screen with
adequate priority.
Testing gas module features
Mark each task as complete on the checkout form.
1. Gas sampling system leak test. *
NOTE Disconnect the gas module from the monitor during the
leak test.

Check the gas sampling system for possible leakages.


a. Disconnect the module from the monitor.
b. Detach the module front cover and casing.
c. Block the OM reference tube with the forceps. Correct positioning of the
forceps is indicated by the figure below.
NOTE Be careful when attaching the forceps to the tube
and avoid stretching the tube. Short pieces of silicone
tubing on the forcep jaws can be used to protect the
tube from breaks that may appear when the tube is
compressed between the jaws.

d. Connect a new D-fend Pro water trap to the module.


e. Connect a new gas sampling line to the sampling line connector in the water
trap.
f. Connect the other end of the gas sampling line to a pressure manometer
and a pressure pump.
g. Block the sample gas out (gas exhaust) connector.
h. Carefully pump 80 mmHg ± 20 mmHg pressure to the gas sampling system.
Let the pressure stabilize for 10 - 20 seconds.
i. Check that the pressure reading does not drop more than 2 mmHg during
25 seconds.
j. Release the forceps, and attach the module casing. Make sure that the tubing
fits nicely into the module casing.

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E-sCAiO, E-sCO, N-CAiO module

2. Sample flow rate check *


Check the sample flow rate.
Connect the module to the monitor.
NOTE Anesthetic gas measurement is not available during the
first 1 to 5 minutes after the module is connected due
to warming up. A message 'Calibrating Gas Sensor'
is shown in the waveform field. Wait until warm-up is
completed before proceeding with the next steps.

NOTE The ambient temperature and air pressure influence the


flow rate measured by the flow meter. A flow meter, which
has been calibrated at 21.11°C (70°F) and 760 mmHg
(1013 mbar), measures the flow rate correctly under the
same conditions, i.e. in room temperature at sea level. A
flow rate correction as instructed by the manufacturer of
the flow meter needs to be performed when measuring
flow rate under other conditions, for example in high
altitude.

a. Connect the gas sampling line to the sampling line connector.


b. Connect the other end of the gas sampling line to a flowmeter.
c. Check the sample flow rate reading from the flowmeter. The flow rate should
be within the specification limit 120 ± 20 ml/min.
NOTE Readjustment is needed, if the measured value is not
within the specification limit.

3. Reference gas flow rate check *


Check the flow rate in reference gas inlet:
a. Connect the gas sampling line to the sampling line connector.
b. Leave the other end of the gas sampling line open to room air.
c. Connect the flowmeter to the OM reference gas inlet on the side of the module
with a piece of tubing.
d. Check that the Reference Flow is within the following range: 10 - 50 ml/min.
e. Detach the water trap.
f. Attach the front cover.
4. Fan *
a. Check that the gas module's fan is running behind the D-fend Pro water trap.
b. Attach the water trap.

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5. Zero valve operation *


Test the zero valve functionality:
a. Connect the gas regulator to the calibration gas container.
b. Connect the gas sampling line to the sampling line connector.
c. Connect the end of the gas sampling line to the regulator on the gas container.
Leave the regulator overflow port open to room air.

d. Select the > Service > enter Username and Password.


e. Select the Basic Service tab > Parameters > Gas Unit > Gases tab.
f. Start feeding the specified calibration gas. Wait until the gas values shown in
the Gases menu rise approximately to the level indicated in the labelling of
the calibration gas container.
NOTE The gas values in the Gases menu is in percentages
(%).

g. Open the zero valve to room air by selecting Gas Control tab > Zero valve ctrl.
h. Check that the CO2, N2O and anesthesia agent values drop back near 0% and
the O2 reading near 21% (room air).
i. Stop feeding the calibration gas.
j. Turn the zero valve back to the normal measurement position by selecting
Zero valve ctrl.
6. Gas calibration *
Perform gas calibration according to the instructions in section Gas Calibration.
7. Agent identification *
NOTE Perform this test only for E-sCAiO, and N-CAiO modules.

Check agent ID unreliability:


a. Feed the specified calibration gas for at least 30 seconds.
b. Select Gases tab, check that the anesthesia agent is identified as Desflurane
and the IDu value (=agent ID unreliability) is lower than 75.
If the value is higher, repeat the gas calibration and check the value again.
8. Ambient pressure *
Use a barometer to check the operation of the absolute pressure sensor.
Check that the ambient pressure value shown in the Gases menu does not differ
more than ± 13.33 mbar from the value shown by the barometer.
9. Occlusion detection *
a. Block the tip of the sampling line by your finger.
b. Check that a Sample line blocked and a Low gas sample flow message
appear on the screen within 30 seconds.

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E-sCAiO, E-sCO, N-CAiO module

10. Air leak detection *


a. Detach the D-fend Pro water trap.
b. Check that the message Check D-Fend appears on the screen within 30
seconds.
c. Attach the water trap.
11. Gas exhaust blockage *
a. Block the gas exhaust connector with your finger.
b. Check that the message Check sample gas out appears on the screen within
30 seconds.
12. Airway gases *
a. Breathe a minimum of 5 times to the tip of the sampling line.
b. Check that a normal CO2 waveform appears to the waveform field and the
EtCO2 and FiCO2 values are updated to the digit field.
13. Apnea detection
a. Stop breathing to the gas sampling line.
b. Check that an Apnea alarm appears to the message field within 30 seconds.
Completing the check procedure
1. Select > Discharge tab > Discharge > YES to discard any changes made to
the patient monitor configuration during checkout.
2. Disconnect the test setup.
3. Complete the check form.

Configuration
There is no service configuration for this module.

Calibration and adjustments


CAUTION Make sure the patient is disconnected from the monitor before
performing any service on the device.

Sample flow rate adjustment


Sample flow rate shall be adjusted:
● if the sample flow rate check failed.
Required tools
● A mass flowmeter for measuring air flow, minimum measurement range from 0 to
200ml/min, accuracy 5% or better in the 0 to 200 ml/min range.
● 3 m / 10 ft anesthesia gas sampling line.
NOTE See the supplemental information manual for compatible
accessories.

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NOTE Use only accurate, properly maintained, calibrated, and


traceable calibration tools for the parameter calibration to
ensure measurement accuracy.

NOTE If the flowmeter unit is not ml/min, it shall be converted


to ml/min according to the instructions of the flow meter
manufacturer.

NOTE Refer to the flowmeter documentation for user instructions.

Making connections
1. Ensure that the module is connected to the monitor.
2. Ensure that you have a new water trap in use.
3. Connect a new gas sampling line to the sampling line connector in the water trap.
4. Connect the other end of the gas sampling line to the flow meter.
NOTE Before checking or adjusting the sample flow, make sure there
is no leakage in the sampling system.

Adjusting sample flow rate


1. Select the > Service > enter Username and Password.
2. Select Basic Service tab > Parameters > Gas Unit > Gas Control tab.
3. Adjust the sample flow to the nominal value 120 ml/min by using the Sample
Flow Gain up-down spinner controls:
a. To decrease the sample flow rate measured by the flow meter by
approximately 7.5 ml / min, lower the gain value by 0.05.
b. To increase the sample flow rate measured by the flow meter by approximately
7.5 ml / min, lower the gain value by 0.05.
4. Select Confirm, then select Gases tab to check the effect of the gain adjustment.
Wait until the sample flow value shown in the menu returns near to the nominal
value 120 ml/min and then check the actual measured flow rate from the flow
meter.
5. Repeat steps 3 and 4 until the flow meter shows a 120 ± 20 ml /min flow rate.
NOTE Adjust the flow rate according to the reading in the flow meter.
The flow rate reading in the calibration menu is measured
by the internal electronics and settles always back to the
nominal 120 ml /min independent on the real flow rate.

Gas calibration
WARNING A failure in zeroing or calibrating airway gases may cause
inaccurate readings.

Gas calibration shall be performed:


● each time planned maintenance is performed.
● each time corrective maintenance is performed.

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E-sCAiO, E-sCO, N-CAiO module

NOTE Gas calibration is a normal user action. Refer to the monitor’s


user’s manual for the recommended gas calibration interval
in clinical use.

Required tools
● P/N: 755534-HEL Calibration Gas Regulator
● P/N: 755583-HEL Calibration gas, CO2, O2, N2O, DESF, package of 1 can (with
E-sCAiO and N-CAiO modules)
● P/N: 755581-HEL QUICK CAL calibration gas, CO2, O2, N2O, package of 4 cans
(with E-sCO module)
● P/N: M1006864, Calibration Gas Regulator, US only
● P/N: 755571-HEL, Calibration Gas, 5% CO2, 54.5% O2, 36.0% N2O, 2.0%
DESFLURANE, BAL N2 (with E-sCAiO and N-CAiO modules) US only
● P/N: 755587, Calibration Gas, CO2, O2, Balance, 4 cans/pkg (with E-sCO module)
US only
● 3 m / 10 ft anesthesia gas sampling line
NOTE Use only the specified GE Healthcare calibration gas for the
gas calibration to ensure measurement accuracy. Do not
use any other calibration gases. Check the calibration gas
container's labeling to ensure that the calibration gas has not
expired.

NOTE Ensure that the gas regulator is functioning properly before


gas calibration. Refer to the gas regulator's Instructions for
Use letter for the annual maintenance instructions.

Making connections
1. Ensure that the module is connected to the monitor.
2. Ensure that you have a new water trap in use.
3. Connect the gas regulator to the calibration gas container.
4. Connect a new gas sampling line to the sampling line connector in the water trap.
5. Connect the other end of the gas sampling line to the regulator on the gas
container. Leave the regulator overflow port open to room air.
The following illustrates how to connect a gas regulator to the calibration gas
container and a sampling line to the gas regulator:

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Calibrating gases
NOTE Gas calibration is not available during the first five minutes
after the module is connected. For maximum accuracy, let the
monitor warm up for 30 minutes before starting calibration.

NOTE Gas calibration is not available during a Sample line blocked,


Check D-Fend and Check sample gas out alarm condition.
Resolve the alarm condition before starting calibration.

1. Select the gas digit field > Calibrations.


2. The monitor will start automatic zeroing of the gas sensors. Wait until the
message Zeroing is replaced by the message Zero OK for all the measured gases.
3. Wait until the message Feed gas appears.
4. Open the regulator and feed the gas. The measured gas concentrations are
displayed in real-time in the gas calibration menu. Wait until the measured
gas concentrations are stabilized and the Adjust message appears for all the
measured gases, then close the regulator.
5. Use the up-down spinner controls to adjust the gas value displayed in the
calibration menu until they match the values on the calibration gas container.
6. Confirm by selecting Accept.
7. If the calibration is successful, the message Calibration OK is displayed for a few
seconds. If the calibration fails, the message Calibr. error appears instead. In this
case, start a new calibration by selecting Recalibrate.
NOTE The message Zero error is shown in case the zeroing fails.

NOTE The message Calibr. error is shown, if you do not start


feeding gas within one minute after the automatic zeroing
is completed, or if the calibration fails due to too large gain
adjustment.

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E-miniC module
17
About this chapter
This chapter contains instructions for the planned and corrective maintenance,
configuration and calibration of the acquisition module.
For the module instruction, troubleshooting, disassembly and reassembly and service
parts section, please refer to Module’s Service Manual.

Maintenance check
About the maintenance check procedures
This chapter describes the planned and corrective maintenance check procedures
for the product. To help ensure the equipment remains in proper operational and
functional order and maintains its essential performance and basic safety, follow the
corrective and planned maintenance recommendations. The tests that are related to
the essential performance and basic safety are marked with the *.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions are described in the monitor’s user’s manual.
For details about cleaning, disinfecting and sterilizing the accessories, see the
instructions for use in the accessory package.
Record the results of the planned and the corrective maintenance check procedures
to the eCheckforms delivered in the electronic manual media.
WARNING SAFETY HAZARD. To avoid risks to personnel and patient,
or damage to the equipment, only perform maintenance
procedures described in this manual. Unauthorized
modifications can lead to safety hazards.

Planned maintenance
WARNING Planned maintenance should be carried out at recommended
interval. Failure to implement the recommended maintenance
schedule may cause equipment failure and possible health
hazards.

Perform the planned maintenance procedure completely every 12 months after


installation. Perform the procedure in the following order:
1. Replacement of planned maintenance parts
2. Visual inspection

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3. Functional check
Corrective maintenance
Perform the following checkout procedure after any corrective maintenance, before
taking the module back into clinical use:
Required checkout procedure
Performed service activity Visual inspection Functional check
Front cover, or an other All steps Not applicable
external part, replaced.
Mini D-fend O-rings All steps Perform the following tests:
● Check the gas sampling system for
possible leakages. *
● Check sample flow rate. *
Module case opened either All steps All steps
for troubleshooting purpose
or for replacing any of the
internal parts.

Replacement of planned maintenance parts


Required parts
Replace the following parts that wear in use at the recommended interval.
Part number Description Pieces Replacement interval
733382-HEL Nafion Tube (#11) 1 Once a year
656565 Mini D-fend™ O-ring (#4) 2 Once a year
M1011471 Zero valve air filter (#16) 1 Once every 3 years

GE recommends that you replace the Mini D-fend water trap and the gas sampling
line as part of the planned maintenance procedure.
NOTE See the Supplies and accessories for compatible accessories.

Replacing the parts


Refer to following “Service parts” section for details about exploded views.
1. Replace the zero valve air filter once every 3 years.
a. Use a small flat blade screwdriver to pull the old zero line air filter.
b. Attach a new zero line air filter into place.

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2. Replace the special tube (Nafion) and check the condition of the internal tubing.
a. Replace the 300 mm nafion tube in the sample gas in line between the Mini
D-fend water trap and the zero valve unit.
b. Check that the tubing inside the module is not contaminated. Any
contamination inside the tubing may indicate that the valve or sensor is
contaminated, too. This can increase a risk of faulty operation in valve or
sensor. The gas sensor is not possible to clean in the field. Therefore, replace
the whole miniCO2 assembly with a new one.
NOTE The nafion tube do not include the silicon fittings they
connect to. Use the original silicon fittings unless they
are not damaged or leaking.

3. Replace the Mini D-fend O-rings:


a. Detach the Mini D-fend.
b. Detach the old rubber O-rings that are around the metal Mini D-fend
connectors e.g. using a small flat blade screwdriver. Pay special attention not
to scratch the metal Mini D-fend connectors and thus causing leaking.
c. Set the new rubber O-rings into place and attach a new Mini D-fend.

Performing visual inspection


1. Remove the module and check that:
a. The front cover is intact.
b. All connectors are intact, clean and attached properly.
c. The module casing and the latch are clean and intact.
d. The metal D-fend connectors and the D-fend O-rings are clean and intact.
e. The module and the applied parts are clean.

Performing functional check


Required tools for the functional check
For a list of compatible accessories, see the Supplies and accessories.
● A barometer
● A mass flowmeter for measuring air flow, minimum measurement range from 0 to
200 ml/min, accuracy 5% or better in the 0 to 200 ml/min range.
● P/N: 755534-HEL Calibration Gas Regulator
● P/N: M1006864, Calibration Gas Regulator, US only
● P/N: 755580 Calibration Gas, 5% CO2 and air, package of 4 cans
● P/N: 755587 Calibration Gas, CO2, O2, Balance, package of 4 cans, US only
● Mini D-Fend water trap
● 3 m / 10 ft gas sampling line
● A pressure manometer with either an integrated or a separate pressure pump

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Making connections for the functional check


1. Disconnect the module from the monitor for the first test.
‒ gas sampling system leak test
For the rest of the functional check steps:
2. Turn the monitor on and wait until the normal screen appears.
3. Ensure that the module is connected to the monitor.
4. Let the module warm up for at least 5 minutes.
Configuring monitor for functional check
1. Configure CO2 waveform to the screen with adequate priority.
2. Select the gas digit field.
3. Select 21–40% for FiO2 level.
Testing CO2 measurement
1. Gas sampling system leak test *
Check the gas sampling system for possible leakages.
a. Disconnect the module from the monitor.
b. Connect a new Mini D-fend water trap to the module.
c. Connect a new gas sampling line to the sampling line connector in the water
trap.
d. Connect the other end of the gas sampling line to a pressure manometer
and a pressure pump.
e. Block the "Sample Gas Out" connector.
f. Pump 100 mmHg ± 20 mmHg pressure to the gas sampling system. Let the
pressure stabilize for approximately 10 seconds.
g. Check that the pressure reading does not drop more than 6 mmHg during 1
minute.
2. Sample flow check *
Check the sample flow rate.
a. Connect the module with the gas sampling line to the monitor.
b. Connect the gas sampling line to the sampling line connector in the water trap.
c. Connect the other end of the gas sampling line to a flowmeter.
d. Check the sample flow rate reading from the flowmeter. The flow rate shall
be within the specification limit 150 ± 25 ml/min.
NOTE Readjustment is needed, if the measured value is not
within the specification limits. Adjust the sample gas
flow rate according to the instructions “Sample flow rate
adjustment”.

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NOTE If the sampling pump is noisy it indicates possible


problems with motor bearing. In this case it is
recommended to replace the noisy sampling pump with a
new one.

3. Zero valve operation *


Test the zero valve functionality.
a. Connect the gas regulator to the calibration gas container.
b. Connect the end of the gas sampling line to the regulator on the gas container.
Leave the regulator overflow port open to room air.

c. Select the > Service > enter Username and Password.


d. Select the Basic Service tab > Parameters > Gas Unit.
e. Select the Gases tab.
f. Start feeding calibration gas. Wait until the CO2 value in the Gases menu
rises to approximately 5%.
g. Open the zero valve to room air by selecting Gas Control tab > Zero Valve ctrl.
h. Check that the CO2 value in the menu drops back near to 0%.
i. Stop feeding the calibration gas.
j. Turn the zero valve back to the normal measurement position by selecting
Zero Valve ctrl.
4. Gas calibration *
Perform gas calibration according to the instructions in “Gas calibration”.
5. Ambient pressure *
Use a barometer to check the operation of the absolute pressure sensor.
a. Check that the ambient pressure value shown in the Gas service menu does
not differ more than ± 10 mmHg from the value shown by the barometer.
6. Occlusion detection *
a. Block the tip of the sampling line by your finger.
b. Check that message 'Sample line blocked' appears to the digit field within
30 seconds.
7. Air leak detection *
a. Detach the Mini D-fend water trap.
b. Check that message Check Water Trap appears to the digit field within 30
seconds.
8. Gas exhaust blockage *
a. Block the gas exhaust connector with your finger.
b. Check that the Sample gas out message appears in the digit field within 30
seconds.

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9. Airway gases *
a. Breathe a minimum of 5 times to the tip of the sampling line.
b. Check that a normal CO2 waveform appears to the waveform field and the
EtCO2 and FiCO2 values are updated to the digit field.
10. Apnea detection
a. Stop breathing to the gas sampling line.
b. Check that an 'Apnea' alarm appears to the message field within 30 seconds.
Completing the check procedure
1. Select > Discharge tab > Discharge > YES to discard any changes made to
the patient monitor configuration during checkout.
2. Disconnect the test setup.
3. Complete the check form.

Configuration
There is no service configuration for this module.

Calibration and adjustments


CAUTION Make sure the patient is disconnected from the monitor before
performing any service on the device.

Sample flow rate adjustment


Sample flow rate shall be adjusted:
● if the sample flow rate check failed.
Required tools
● A mass flowmeter for measuring air flow, minimum measurement range 100-300
ml/min, accuracy 5% or better in the 100-300 ml/min range.
● 3 m / 10 ft gas sampling line
NOTE See the Supplies and accessories for compatible accessories.

NOTE Use only accurate, properly maintained, calibrated and


traceable calibration tools for the parameter calibration to
ensure measurement accuracy.

NOTE If the flowmeter unit is not ml/min, it shall be converted


to ml/min according to the instructions of the flow meter
manufacturer.

NOTE Refer to the flowmeter documentation for user instructions.

Making connections
1. Ensure that the module is connected to the monitor.

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2. Ensure that you have a new water trap in use.


3. Connect a new gas sampling line to the sampling line connector in the water trap.
4. Connect the other end of the gas sampling line to the flow meter.
NOTE Before checking or adjusting the sample flow, make sure there
is no leakage in the sampling system.

Adjusting sample flow rate


1. Select the > Service > enter Username and Password.
2. Select the Basic Service tab > Parameters > Gas Unit
3. Select the Gas Control tab.
4. Adjust the sample flow close to the nominal value 150 ml/min by using the Sample
Flow Gain up-down spinner controls:
a. To decrease the sample flow rate measured by the flow meter by
approximately 7.5 ml / min, add gain value by 0.05.
b. To decrease the sample flow rate measured by the flow meter by
approximately 7.5 ml / min, add gain value by 0.05.
5. Select Confirm to check the effect of the gain adjustment. Wait until the sample
flow value shown in the menu returns near to the nominal value 150 ml/min and
then check the actual measured flow rate from the flow meter.
6. Repeat steps 3 and 4 until the flow meter shows a 150 ± 25 ml /min flow rate.
NOTE Adjust the flow rate according to the reading in the flow meter.
The flow rate reading in the menu is measured by the internal
electronics and settles always back to the nominal 150 ml
/min independent on the real flow rate.

Gas calibration
WARNING A failure in zeroing or calibrating airway gases may cause
inaccurate readings.

Gas calibration shall be performed:


● each time planned maintenance is performed.
● each time corrective maintenance is performed.
NOTE Gas calibration is a normal user action. Refer to the monitor’s
user’s manual for the recommended gas calibration interval
in clinical use.

Required tools
● P/N: 755534-HEL Calibration Gas Regulator
● P/N: M1006864, Calibration Gas Regulator, US only
● P/N: 755580 Calibration gas 5% CO2 and air, package of 4 cans
● 3 m / 10 ft Gas sampling line
● P/N 755587 QUICK CAL calibration gas, US only

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NOTE Use only the specified GE Healthcare calibration gas for the
gas calibration to ensure measurement accuracy. Do not
use any other calibration gases. Check the calibration gas
container's labeling to ensure that the calibration gas has not
expired.

NOTE Ensure that the gas regulator is functioning properly before


gas calibration. Refer to the gas regulator's Instructions for
Use letter for the annual maintenance instructions.

Making connections
1. Ensure that the module is connected to the monitor.
2. Ensure that you have a new water trap in use.
3. Connect the gas regulator to the calibration gas container.
4. Connect a new gas sampling line to the sampling line connector in the water trap.
5. Connect the other end of the gas sampling line to the regulator on the gas
container. Leave the regulator overflow port open to room air.
The following illustrates how to connect a gas regulator to the calibration gas
container and a sampling line to the gas regulator:

Calibrating gases
NOTE Gas calibration is not available during the first five minutes
after the module is connected. For maximum accuracy, let the
monitor warm up for 30 minutes before starting calibration.

NOTE Gas calibration is not available during a Sample line blocked,


Check D-Fend and Check sample gas out alarm condition.
Resolve the alarm condition before starting calibration.

1. Select the gas digit field.


2. Select Gas Calibration .
3. The monitor will start automatic zeroing of the gas sensor. Wait until the message
Zeroing is replaced by the Zero Ok message.

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4. Open the regulator after the message Feed gas is shown. The measured gas
concentration is shown in real-time in the gas calibration menu. Wait until the
measured gas concentration is stabilized and the adjust menu is shown. Close
the regulator.
5. Use the CO2 up-down spinner controls to adjust the CO2 reading shown in the
calibration menu to match with the CO2 reading in the labeling of the calibration
gas container. Select Accept to accept the adjusted value when the two CO2
readings match each other.
6. Wait until the message Ok is shown.
NOTE The message Zero Error is shown in case the zeroing fails.

NOTE The message Calibr. error is shown, if you do not start


feeding gas within one minute after the automatic zeroing
is completed, or if the calibration fails due to too large gain
adjustment.

NOTE If zeroing or calibration failed, select Recalibrate to restart the


calibration procedure from the beginning.

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E-Entropy module
18
About this chapter
This chapter contains instructions for the planned and corrective maintenance,
configuration and calibration of the acquisition module.
For the module instruction, troubleshooting, disassembly and reassembly and service
parts section, please refer to Module’s Service Manual.

Maintenance check
About the maintenance check procedures
This chapter describes the planned and corrective maintenance check procedures
for the product. To help ensure the equipment remains in proper operational and
functional order and maintains its essential performance and basic safety, follow the
corrective and planned maintenance recommendations. The tests that are related to
the essential performance and basic safety are marked with the *.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions are described in the monitor’s user’s manual.
For details about cleaning, disinfecting and sterilizing the accessories, see the
instructions for use in the accessory package.
Record the results of the planned and the corrective maintenance check procedures
to the eCheckforms delivered in the electronic manual media.
WARNING SAFETY HAZARD. To avoid risks to personnel and patient,
or damage to the equipment, only perform maintenance
procedures described in this manual. Unauthorized
modifications can lead to safety hazards.

Planned maintenance
WARNING Planned maintenance should be carried out at recommended
interval. Failure to implement the recommended maintenance
schedule may cause equipment failure and possible health
hazards.

Perform the planned maintenance procedure completely every 2 years after


installation. Perform the procedure in the following order:
1. Visual inspection

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2. Electrical safety test *


3. Functional check

Corrective maintenance
Service personnel shall perform the following checkout procedure after any corrective
maintenance, before taking the module back into clinical use:
Required checkout procedure
Performed service activity Visual inspection Functional check
Product casing opened All steps All steps
either for troubleshooting
purpose or for replacing any
of the internal parts.
Front cover, or an other All steps Not applicable
external part, replaced.

Performing visual inspection


1. Remove the module and check that:
a. The front cover is intact.
b. All connectors are intact, clean and attached properly.
c. The module casing and the latch are clean and intact.
d. The patient cables are clean and intact.
The cleaning precautions, cleaning requirements, cleaning procedures, and
recommended cleaning solutions for the monitor are described in the monitor’s user
manual. For details about cleaning, disinfecting and sterilizing the accessories, see the
instructions for use in the accessory package.

Performing electrical safety test *


Perform the electrical safety tests described in the monitor technical manual,
“Electrical safety test” chapter. Perform both patient leakage current tests:
1. Patient (source) leakage current test
2. Patient (sink) leakage current test

Performing functional check


Required tools for Entropy module functional check
For a list of compatible accessories, see the Supplies and Accessories.
● Entropy simulator, P/N: N-ES
● Entropy sensor cable
Making connections for the functional check
1. Turn on or restart the monitor and wait until the normal screen appears.
2. Ensure that the module is connected to the monitor.

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Configuring monitor for Entropy module functional check


1. Configure Entropy waveform to the screen with adequate priority.
2. Press the Entropy module key to open the Entropy setup menu and select:
● Scale µV: 250.
● Display format: RE+SE
● Automatic ssensor check: ON
CAUTION Automatic sensor check may need to be disabled if the 70
Hz impedance check signal interferes with other equipment,
such as EEG module with evoked potentials measurement.

Testing entropy measurement *


1. To check the module and sensor recognition:
a. Connect the entropy sensor cable to the module.
b. Check that the Entropy EEG waveform field and related information appears
on the screen.
c. Check that No sensor message appears in the Entropy digit field.
2. To check the sensor:
a. Connect the Entropy simulator to the Entropy sensor cable.
b. Check that Checking sensor message appears in the Entropy digit field after
a while.
c. Wait until all 3 electrodes are checked.
d. Check that all 3 sensors pass the check successfully: there is a green circle
with a check mark for each tested electrode.
NOTE The monitor may show No Entropy sensor and Demo
data messages when using Entropy simulator.

3. To check the measurement:


a. Wait about 30 seconds after the sensor check is completed and check that the
EntrEEG waveform and RE & SE values appear on the screen.
Completing the check procedure
1. Select > Discharge tab > Discharge > YES to discard any changes made to
the patient monitor configuration during checkout.
2. Disconnect the test setup.
3. Complete the check form.

Configuration
There is no service configuration for this module.

Calibration and adjustments


No calibration or adjustments are needed for this module.

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Product privacy and security
19
Introduction
This section describes Privacy & Security considerations of the use of device. This
section describes the expected intended use, the Privacy & Security capabilities
included, and how they are configured and used appropriately.
This section assumes that the reader understands the concepts of Privacy & Security.
Privacy is the property of protecting the personal private interests of patients. Security
protects both system and information from risks to confidentiality, integrity, and
availability. Security protects Privacy but also protects more broadly against these
risks. Privacy requires security. In Healthcare one must balance privacy, security, and
safety. Most of the time there isn’t a conflict between these three domains of risk. The
healthcare provider organization is encouraged to use risk management procedures
to assess and prioritize privacy, security, and safety risks. Through the use of risk
management one can determine how to best leverage the capabilities provided in
the device.
Privacy & Security relevant information can be found at
http://productsecurity.gehealthcare.com.

Privacy & Security Environment


The device has been designed for an intended use with the following expectations
of Privacy & Security protections included in the environment where this product
will be used:
The monitor is a portable multi-parameter unit to be used for monitoring, recording,
and to generate alarms for multiple physiological parameters of adult, pediatric, and
neonatal patients in a hospital environment and during intra-hospital transport.
The monitor is intended for use under the direct supervision of a licensed health
care practitioner.
The monitor can be interfaced to other devices via network. The monitor shall reside
on an isolated monitoring network (GE CARESCAPE network).

Privacy & Security capabilities


The device incorporates a broad assortment of capabilities to enable Privacy &
Security. This section describes the capability and use of these Privacy & Security
capabilities.

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Access controls
The access control features of the device may be used to help control access to
sensitive information. Access control includes user account creation, assigning
privileges
Identity provisioning
The provisioning of user accounts includes the steps of account creation, maintenance,
and suspension of the account when it is no longer needed. A user account is created
for the use by a specific individual. This user account is associated with access rights,
and is recorded in security audit logging.
The monitor is intended to be used on one patient at a time and always in emergency
mode, so no need user accounts in normal operation in a hospital environment.
Clinical or service users are pre-defined for advanced configurations and system
maintenance only.
User authentication
This section covers the administration of the authentication system to be used.
Role based user
The monitor defined three role based users: clinical, basic service and advanced
service, for access control of advanced functions. The users are authenticated by
main application with local password.
There is an independent password for each role. the default password could be
changed by user. Each user can only change the password of current role or the role
with lower priority. For example, the basic service user can change the password for
basic service and clinical access.
For more information about how to change or reset password, refer to “Configuration”
chapter.
Assigning access rights
The Assigning of Access Rights is the administrative process to associate permissions
with user accounts.
Username Password Access to
clinical Change Me Clinical
service Wh1teF1sh Clinical, Basic Service

For advanced service password, please refer to the Service for Depot Instruction.
The user functions are defined as follow:
User level
Functions
Clinical Basic Service Advanced Service
Alarm Options • • •
Snapshot • • •
Units • • •
Colors • • •
Save Modes • • •

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User level
Functions
Clinical Basic Service Advanced Service
Time and Date • • •
Time Zone • • •
Parameter Settings • • •
Parameters • •
Country Settings • •
Licenses • •
Service Log • •
Enter/Exit Demo • •
Mode
Set/Test • •
Network • •
WLAN Config • •
WLAN Status • •
SW Management • •
Use configuration file •

Patient privacy consent management


Patient privacy consent management is the process of supporting the patient
expressing their privacy requirements. This is distinct from other forms of consent
such as the consent to treat.
User can only view the authenticated information by different role.

Privacy & security audit logging and accountability controls


Privacy & security audit logging and accountability controls support security
surveillance and privacy investigations and reporting.
System audit records include alarm logging, keyboard logging, service (system)
logging and wireless logging.
These logs can be viewed through:

● The service menu: > Service > Basic Service tab > Service Log.
● Downloading the logs from the device, and being viewed on PC.

Information protection
This section of the manual focuses on Privacy & Security operations, and contains
information to guide in the preparation of a secure environment for the device.
Security operations is best implemented as part of an overall “defense in depth”
information assurance strategy are used throughout an Information Technology
system that addresses personnel, physical security and technology. The layered
approach of defense in depth limits the risk that the failure of a single security
safeguard will allow compromise of the system.

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Network security
GE strongly recommends that medical devices are operated in a network environment
that is separate from an organization’s general purpose computing network. There
are many effective techniques for isolating medical devices on a secure sub network,
including implementing firewall protection, Virtual Local Area Networks (VLANs) and
network enclaves.
To assist in secure network design, the following network profile outlines the required
network services for the device.
Ports, protocols and services required by system:

Network Source/
Port Protocol Direction service Destination
2000, 7000, udp outbound CARESCAPE All trusted hosts
7001 inbound (Unity) network

6000 tcp outbound HL7 All trusted hosts

Firewall integration:
● IP table in file system.
System supports NTP (Network Time Protocol) to synchronize time from time server via
network.
Network diagram
CARESCAPE Network

● HL7 outbound from monitor though CNI V2 switch.


NOTE Need unity network and HL7 network license.

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Hospital Network

● HL7 outbound from monitor though hospital switch.


NOTE Need HL7 network license.

Wireless Security
Due to the broadcast nature of wireless communication, wireless devices require
special security consideration. There are effective techniques and tools for improving
the security of wireless communication devices.
● Transmission methods
■ WiFi

● Use of Transport Controls


■ Mutually-Authenticated-TLS

● Network Transmission Encryption


■ WPA–Persional

■ WPA2–Persional

■ WPA–Enterprise

■ WPA2–Enterprise

● Access Controls
■ WPA2-PSK

■ WPA2-Enterprise

● SSID Broadcasting
● Transmission power/range
● MAC address filtering
● VPN over wireless

Removable media security


System supports removable USB storage device.
All functions of removable media need authentication by password. Sanity of
removable media is supported in menu.
All the exported logs have been encrypted.

2105518-001 B125/B105 Patient Monitor 229


Product privacy and security

Boot, execute and auto-run from USB media have been disabled.
Serial port can only be used for S5 iCollect through multi-I/O adapter.

Data integrity capabilities


The device contains capabilities that ensure the system data are not modified
accidently or maliciously.
System data integrity check is performed during device start-up and user will be
alerted if there is any error.
During downloading device software or importing system settings, the related data
integrity check will also be performed.
Use key log to confirm user operation.

De-identification capabilities
The device contains de-identification (anonymization and pseudonymization)
capabilities to limit Privacy & Security risks to sensitive information.
Personal information is not included in data exported.

Business continuity
System watchdog is used to keep monitoring main application activity.
System will be automatically reset if main application stops response.
System can be recovered from the system upgrade failure through the backup of
main application.
System can restore system settings and data after an outage within 2 hours.
System supports backup storage for all settings.

System protection
The system needs to be configured and maintained in a way that continually protects
Privacy & Security.

Malicious software protection


The computing environment is increasingly hostile, and threats continue to grow
from malicious software, including computer viruses, worms, Trojan horses, denial
of service attacks, and other malware. Vigilant defense on many levels is required to
keep systems free from compromise by malicious software. In most cases, effective
protection requires cooperation and partnership between GE and our customers.
Commercial Anti-virus software is commonly used on general-purpose computers to
detect the presence of malicious software (virus, Trojan horse, worm, etc). Anti-Virus
software is useful on general-purpose computers as they typically cannot be
sufficiently hardened against the attack vectors used by malicious software.
Medical Devices however are single purpose (dedicated) devices that have controlled
intended use, and thus often can be well hardened. For medical devices, the patient
safety risk introduced by using commercial Anti-virus software outweighs any security
benefit. Such risks include:
● Real-time scanning affecting system performance.

230 B125/B105 Patient Monitor 2105518-001


Product privacy and security

● Introducing false positives


● Quarantining of clinical data that randomly appear to match a virus signature
● The Anti-virus software itself is another popular attack vector
● Support of the Anti-virus software throughout the life cycle of the medical device
(Operating System support and virus signatures/libraries)
Due to the cited risks, the use of anti-virus software is not part of this product security
strategy.
For more information on Malicious Software Protection, refer to the following two
whitepapers by the Joint NEMA/COCIR/JIRA Security and Privacy Committee:
● “Defending Medical Information Systems
Against Malicious Software”, December 2003,
http://www.medicalimaging.org/policy-and-positions/joint-security-and-privacy-committee-2/
● “Patching Off-the-Shelf Software Used in
Medical Information Systems”, October 2004,
http://www.medicalimaging.org/policy-and-positions/joint-security-and-privacy-committee-2/

System (product) change management


System OS: Linux Kernel: linux3.18
File system: Buildroot 2015.05
System supports the following upgrade options:
● Main application
● Module software
Only service user is allowed to upgrade the main application and module software.
For Software Upgrade Procedure, refer to software upgrades instruction.
OS updates and release will be reviewed by GE Healthcare periodically. System
patches will be released and upgraded if needed.
No additional software is allowed to be installed on system.
No files in system is allowed to be changed by unauthorized user.
FDA Guidance - Content of Premarket Submissions for Management of Cybersecurity
in Medical Devices, Document issued on: October 2, 2014
FDA guidance - Guidance for Industry - Cybersecurity for Networked Medical Devices
Containing Off-the-Shelf (OTS) Software FDA-1553:2005, document issued on January
14, 2005
For more information on communication with GE, refer to the following URLs:
http://ge.com

Personal information collected by the product


The device mainly collects patient demographics and health information, for intended
use, which including:
● Patient ID
● Patient Name
● Patient Age

2105518-001 B125/B105 Patient Monitor 231


Product privacy and security

● Patient assigned Room/Bed


● Physiological information (e.g., ECG)
● Vital Signs
● Alerts (Type of patient related alert such as a code blue, etc.)
The device protects this information by technical safeguards like authentication, and
retains this information.
The action of personal information collection will be recorded into audit logging.
For more information on IHE Integration statements, refer to the following URLs:
http://ge.com/ihe
http://ge.com/hl7

Additional privacy & security considerations


The device has been designed with Privacy & Security functionality integrated
into the core design. However, there exist Privacy & Security residual risks that
must be mitigated once the device is integrated into the work environment. This
section contains some risks that should be imported into the Risk Assessment of the
deployment of the device for proper mitigation.
● Users should be trained to use the data destruction feature of the device when
returning it for service, or other Privacy & Security awareness training needs.
● If this product is used in an environment where robust authentication methods
are an impediment to clinical workflow, physical access restrictions to the device
are encouraged.
● If the device persists data beyond the clinical encounter, notify the customer of the
default retention period for this data and whether the retention period should
be configured.

MDS2
The MDS2 is provided as a statement of the security and privacy capabilities using a
well-known standard disclosure format. The MDS2 and other information Privacy &
Security relevant information can be found at http://productsecurity.gehealthcare.com

232 B125/B105 Patient Monitor 2105518-001


Networking disclosure to facilitate
20
network risk management

Purpose and scope


This disclosure is intended to satisfy the requirements of IEC 60601-1:2005 clause
14.13 and IEC/ISO 80001-1:2010 clause 3.5 for disclosure of network-related
specifications, requirements, and residual risks in order to facilitate the responsible
organization’s risk management activities (e.g. pursuant to 80001-1) for their networks
incorporating the monitor.

Purpose for B125/B105 monitor connection to


network
The B125/B105 monitor is intended to be connected to a network in order to support
the following functionality:
● Providing realtime patient data (i.e. parameters, waveforms and alarms) to
compatible network devices such as central stations.
● Remote configuration (patient admission, alarm settings, etc.) from compatible
network devices.

Network interface technical specifications


Connection Name Mission Critical (MC) network port
Physical network connection type IEEE 802.3-1998 10/100BaseT Ethernet
Speeds and duplex modes supported 100 Mbps half and full deplex
Default IP Address (from factory) IP address: 172.16.X.X
Subnet mask: 255.255.0.0
Gateway: 172.16.254.254
IP Addressing IPV4 Static
QoS Support IP layer DSCP tagging

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Networking disclosure to facilitate network risk management

Connection Name WLAN


General WLAN Standards / Certifications Protocols: 802.11a/b/g/n
Radio RF standards:
● USA: FCC Part 15.247, 15.407
● EU: EN300328, EN301893
EMI/EMS standards:
● USA: FCC Part 15.207, 15.209
● EU: EN 301 489-1, EN 301 489-17
Safety Compliance: IEC 60950-1:2005 (2nd
Edition)/EN 60950-1:2006
Antenna Gain 2.4 GHz: +2.2dBi Maximum
5 GHz: +4.5dBi Maximum
Supported Channel Range 2.4 GHz: 1-14
5 GHz: 36-165
RF Output Power Range 2.4 GHz EIRP: up to +18.83dBm
5 GHz EIRP: up to +16.42dBm
NOTE: May be further restricted on some
channels according to regulatory domain.
Supported Data Rates [Mbps] and 2.4 GHz (802.11 b):
Corresponding Receive Sensitivity [dBm, 11Mbps: Channel 1/ -79 dBm, Channel 6/
referenced to radiated output] -81dBm , Channel 11/ -78 dBm
(Sensitivity corresponds to 8% max packet
error rate with 1024 byte MPDU)
2.4 GHz (802.11 g):
54Mbps: Channel 1/ -68 dBm, Channel 6/ -67
dBm , Channel 11/ -66 dBm
(Sensitivity corresponds to 10% max packet
error rate with 1024 byte MPDU)
5 GHz (802.11 a):
54Mbps: Channel 36/ -67 dBm, Channel 48/
-67 dBm , Channel 60/ -68 dBm, Channel
100/ -67 dBm, , Channel 140/ -68 dBm,
Channel 165/ -69 dBm
(Sensitivity corresponds to 10% max packet
error rate with 1024 byte MPDU)
Minimum Expected RSSI in Coverage Area -65dBm ±5dB
Dynamic Frequency Selection 802.11h DFS
Transmit Power Control None
MAC-layer QoS and Power Save Support 802.11e WMM: Customizable DSCP settings
Data Encryption Support Wi-Fi Protected Access with TKIP and
AES-CCMP
Authentication Support WPA-Personal, WPA2–Personal,
WPA-Enterprise, and WPA2–Enterprise

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Networking disclosure to facilitate network risk management

Connection Name WLAN


Over-the-air Configuration Support None
Fast roaming Support 802.11 r
IP Addressing IPv4 statically configured
IP Layer QoS DSCP tagging per dataflow, 802.11e, WMM

Network information flows


Flow Name Realtime patient data
Network Connection on device MC network
Usage Type/Function/Purpose Clinical/Waveforms, parameters, trends,
alarms, admit/discharge patient/Transmit
clinical data to other devices on the network
Licensed/optional/required Licensed
Communication Partner Unity Devices / MC Network
Device/IP Address/Network
Middle Layer Protocols UDP
Application Layer Protocol and Encoding Unity
Ports 2000, 7000, 7001
Traffic characterization and Bandwidth Outgoing unicast traffic is approximately 50
Requirements Kbps per patient view.
Maximum of 10 views supported on wireless
network.
Maximum of 11 views supported on wired
network.
Latency max 250 ms

Flow Name Ping


Network Connection on device MC network
Usage Type/Function/Purpose Network troubleshooting
Licensed/optional/required Required
Communication Partner PC, Other Medical Devices / MC Network
Device/IP Address/Network
Middle Layer Protocols ICMP
Application Layer Protocol and Encoding NA
Ports NA
Traffic characterization and Bandwidth On-demand, User-initiated
Requirements

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Networking disclosure to facilitate network risk management

Flow Name HL7


Network Connection on device MC network
Usage Type/Function/Purpose HL7 outbound to EMR system
Licensed/optional/required Licensed
Communication Partner HL7 Server
Device/IP Address/Network
Middle Layer Protocols TCP
Application Layer Protocol and Encoding HL7
Ports Customer defind, default port is 6000
Traffic characterization and Bandwidth On-demand, 720 bps
Requirements

Flow Name Software Transfer


Network Connection on device MC network
Usage Type/Function/Purpose Performs software upgrades
Licensed/optional/required Required
Communication Partner PC
Device/IP Address/Network
Middle Layer Protocols TCP
Application Layer Protocol and Encoding HTTP
Ports 10001
Traffic characterization and Bandwidth 10 Mbps
Requirements

Required characteristics and configuration for


support
● The network must meet the specific requirements above for all traffic flows
associated with the subset of features, use cases and workflows required by the
responsible organization’s users.
● In addition, the network must be ‘flat’ (i.e. limited to a single IP broadcast domain).

Potential risks to safety, effectiveness or security


resulting from failure of IT network to provide
the required
Loss of network connectivity can result in the following hazardous situations:
● Missed alarm at a remote viewing station (bedside or display).
● Complete or partial loss or deterioration of remote monitoring of waveform and
parameter data at remote viewing device.
Product mitigations:

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Networking disclosure to facilitate network risk management

● Low alarm volume is increased if network communication fails.


● Audio off, audio pause are interrupted if network communication fails.
● User is notified of network communication failure, message is displayed until user
acknowledges it.
● User is notified if a duplicate IP address is detected.
● User is notified if a duplicate unit/bed name.
In addition to the hazardous situations identified above, connection of the monitor
to a network that includes other equipment could result in other unidentified risks to
patients, operators or third parties. The responsible organization should identify,
analyze, evaluate and control these risks on an ongoing basis including after changes
to the network, which could introduce new risks and require additional analysis.
● changes in network configuration
● connection of additional items to the network
● disconnecting items from the network
● update of equipment connected to the network
● upgrade of equipment connected to the network

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Networking disclosure to facilitate network risk management

238 B125/B105 Patient Monitor 2105518-001


Software download instruction
A
Introduction
This instruction describes how to upgrade the software to the B125/B105 patient
monitor.
Their two method for software download.
● For USB storage device. Insert the USB storage device to the monitor directly to
transfer software.
● From PC. Transfer software by GE Healthcare Software Transfer Utility (STU), which
runs on a service PC. With this application, you can transfer new software to the
patient monitor over the CARESCAPE Network or a crossover cable.

Contents of the USB storage device


● STU software package with all versions
● USB software package with all versions
● Download instruction: this document

Tools needed
● For USB: USB storage device (file system: FAT32) with related version of software.
● For PC:
■ Service PC with: Windows XP, 7 or 10, Ethernet network card, Internet Explorer v
6.0 or greater
■ Ethernet Cable

■ STU software package with related version

Installing software with PC


Connecting a service PC to a patient monitor or to the
Network for multiple patient monitors
Connection method to be used Procedure
Direct connection: 1. Connect a service PC to the monitor’s
Ethernet connector with an Ethernet
cable.

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Software download instruction

Connection method to be used Procedure


This connection method lets you transfer 2. Verify that the service PC can perform a
software to one patient monitor at the time. network ping to the patient monitor.

Network connection: 1. Connect a service PC to the Network with


This connection method lets you transfer an Ethernet cable.
software to multiple patient monitors at a 2. Verify that the service PC can perform a
time. network ping to the patient monitor.

Checking the network settings of the patient monitors


Check the Network settings of the patient monitors. Contact the biomed or hospital IT
to obtain the network settings of the patient monitors, or check the settings from the
patient monitors by following these instructions:
1. Turn on the patient monitor(s).

2. Select the > Service > enter Username and Password.


3. Select the Basic Service tab > Network > TCP/IP tab.
4. Record the following information:
● IP Address: ______________________
● Subnet Mask: ____________________
● Default Gateway: _____________________

Checking and configuring the network settings of the


service PC
Configure the service PC to communicate with the patient monitors in the same
subnet. Use the information that you gathered about the network configuration of the
patient monitors.
Refer to the Windows documentation to see how to verify and configure the network
settings in your service PC.
NOTE It’s recommended you to disable the firewall protection or
networking services, such as Cisco Systems VPN, Sophos,
McAfee on the service PC before you use Software Transfer
Utility. Refer to Technical Bulletin DOC1397399 and
DOC1020271 or contact IT support engineer for details.

1. Configure the service PC’s network settings to operate in a manual configuration


mode. Configure a unique IP address and a valid subnet mask.
Use the same subnet that is in use in the patient monitors network.
2. If default gateway is in use in Network, configure also the default gateway
address to the service PC.

Launching the Software Transfer Utility


Launch the GE Healthcare Software Transfer Utility (STU) to transfer software
packages to target patient monitors.

240 B125/B105 Patient Monitor 2105518-001


Software download instruction

1. Insert the software USB disk into the service PC.


2. Open the USB disk and the target STU software folder on the PC.
3. Double click the auto.bat file to run the STU.

The STU has an on-screen help. Select Help for more information about the use of
the tool.

Specifying the IP addresses of the target patient monitors


Define the set of target patient monitors under the Add Target IP Addresses section.
You have two options how to specify the IP addresses of the target patient monitors.
You can either enter the IP addresses manually or import a text file that contains
the IP addresses.

Entering the IP addresses manually


1. In the IP Address field, enter the IP address of the patient monitor where you want
to transfer the software. For the IP address, use the X.X.X.X address format where
X is a decimal number from 1 to 254. Any additional text added after a space
following the IP address is treated as a comment.
2. Select the down arrow button to add the IP address to the list.
3. Repeat the steps 1. and 2. for each additional patient monitor.

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Software download instruction

NOTE To remove an incorrect IP address from the displayed list,


select the IP address and click the up arrow button. To remove
all IP addresses, select Clear all IP addresses.

NOTE To save the list of displayed IP addresses into a text file (.txt) for
future use, select File > Export IP File. Specify the destination
and file name of the .txt file and select Save.

Uploading the IP addresses from text file


1. Select File > Import IP File.
2. In the Open dialog box, browse and select the text file (*.txt) that contains the
IP addresses of the patient monitors.
3. Select Open.
NOTE IP addresses that are in incorrect format in the text file
are not imported. The IP address must be in the X.X.X.X
address format where X is a decimal number from 1 to
254. Any additional text added after a space following the
IP address is treated as a comment. There must be one
IP address per line. See the on-screen help for additional
information.

242 B125/B105 Patient Monitor 2105518-001


Software download instruction

4. Verify that the IP addresses are correctly listed in the Add Target IP Addresses list.
Make sure that they are the IP addresses of the target patient monitors.
NOTE To remove an incorrect IP address from the displayed list,
select the IP address and click the up arrow button. To remove
all IP addresses, select Clear all IP addresses.

Transferring the software


After the IP addresses of the target patient monitors are entered or imported, transfer
the selected software packages to the inactive software storage of the target patient
monitors.
1. Enable the software download mode from monitor.

● For main software: > Service > enter and username and password >
Basic Service tab > Page2 vertical tab > SW Management > SW Download
Enable: > Yes
● For firmware: SW Management > Module Upgrade tab > Module Download
Enable: > Yes
NOTE The monitor will display Restart Needed message, please
ignore this message. Restart the monitor(s) after the
software has been successfully transferred.

2. On the STU, select the software package you want to transfer for Select Software
Packages.
You can hold the Control key to select several software packages.

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Software download instruction

3. Select Transfer.
Software can only be transferred to a limited number of target monitors at a time.
As a result, the software transfer may occur in sequential groupings.
Transfer status is shown in the Transfer Status list at the bottom of the STU
window. The transfer status can be:
● Queued: A submitted transfer that is not in progress yet.
● Started: Communicating with a target device and transfer is in progress.
● Success: A successfully completed transfer.
● <Failure Message>: A failed transfer that is detailed in a failure message.

To cancel a software transfer, select Cancel. Selecting Cancel only cancels the
transfer of the queued software packages shown in the Transfer Status list.
When a software package transfer starts, you cannot cancel it.
4. Verify that the transfer status of all selected software packages for all selected
target patient monitors indicate Success.
5. Select Exit.
6. Restart the monitor(s).

Installing software with USB


Preparing the USB disk
If need to copy the electronic package to your own USB disk, should follow specific
folder structure and naming rules.

244 B125/B105 Patient Monitor 2105518-001


Software download instruction

1. Make sure the file system format for USB disk should be FAT32, if not, please
format the disk.
2. Create the related folder in the root of the disk, the folder name as following:
● “software”: for device main software
● “NIBP”: for NIBP firmware
● “ECG”: for ECG firmware
● “RECX”: for recorder firmware
● “STP”: for TP firmware
3. Copy the target version of software/firmware package to the above related folder,
rename the target package name:
● “VSP_x.x.x.x”: for device main software
● “NIBP_x.xx”: for NIBP firmware
● “ECG_x.xx”: for ECG firmware
● “RECX_x.xx”: for recorder firmware
● “TPMx.x”: for Masimo TP firmware
● “TPNx.x”: for Nellcor TP firmware
X is the version number.
For example:
/software/VSP_1.0.5.0/detailed files
/NIBP/NIBP_1.06/detailed files
/ECG/ECG_1.05/detailed files
/RECX/RECX_1.02/detailed files
/STP/TPM1.4/detailed files
/STP/TPN1.1/detailed files

Transferring the software with USB


1. Insert the USB disk with the target software to monitor.

2. Select the > Service > enter Username and Password.


3. Select the Basic Service tab > Page 2 vertical tab > SW Management > USB Disk
Upgrade tab.
4. Select the version of each target software.
5. Select Download of each target software.
6. Restart the monitor.

Activating the software


Before you start:
● Verify the compatibility of the connected bedside and network devices with the
new software version that you are activating.
● For traceability – Record the serial number of the monitor where the software is
installed to your local service database.
● Contact GE Healthcare to get the latest version of the user and service
documentation.

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Software download instruction

NOTE Loss of monitoring - Software is activated only when the


patient monitor is in a patient discharged state. Normal
patient monitoring is unavailable until the software activation
is completed.

1. For main software: > Service > enter the username and password > Basic
Service tab > Page2 vertical tab > SW Management > SW Upgrade tab. Or,
For firmware: SW Management > Module Upgrade tab > select Upgrade Module
Type:
The software status displays.
2. Check that the software to be activated is listed in the status.
3. For main software: Select SW Activate Enable: > Yes to activate the new software.
For firmware: Select Module Upgrade Enable: > Yes to activate the new software.
4. Wait until the software activation completes.
5. Restart the monitor.

Performing post software activation checkout


Verify that the software activation is successful and the patient monitor runs the
activated software.

1. Select > Monitor Info.


2. Select the related vertical tab, if needed.
3. Verify that the active software version is correct.
NOTE There is no need to do any electrical safety tests and
maintenance checkout after software download.

246 B125/B105 Patient Monitor 2105518-001


Installation checkform
B
B125/B105 Patient Monitor installation check
Customer Monitor type S/N
Service record # Software version
Service engineer

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.

Measuring equipment / test gases used:


Equipment / tool / Manufacturer Model / Type / Part Serial number / ID Calibration date
gas No.

PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.

Visual inspection (Acceptance criteria) Observed result Pass Fail


The monitor and the connected peripheral devices
are undamaged.
The monitor is properly mounted with specified
mounting solutions.
The cables between the patient monitor and the
connected devices are intact, properly connected
and secured to the right connectors.
The modules are properly connected and locked.

Electrical safety tests


The manufacturing week and year of the device:
Is there less than 12 months since the device was manufactured?

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Installation checkform

Electrical safety tests


Yes You do not have to perform the electrical safety tests. To continue the
installation check, mark the electrical safety test completion N.A. and
proceed to Functional check.
No Refer to “Electrical safety tests checkform” to perform the electrical
safety tests.

Functional check Observed result Acceptance criteria Pass N.A. Fail


Start-up Monitor starts up
normally.
Display: picture quality Text is readable,
images are clear and
brightness is good.
Display: touchscreen control Touchscreen
operates correctly.
Time and date Time and date is
correct.
Device information Device information is
correct.
F2 frame Power and
communication LED
lit
Parameters measurements
ECG Leads off will display.
SpO2 SpO2 sensor will lit.
NIBP Adult/Pediatric or
Neonatal will display.
IBP InvBP’s not Zeroed
will display.
Temperature Performing temp
test will display.
C.O. InvBP’s not Zeroed
will display.
Gas Calibrating gas
sensors will display.
Entropy No sensor will
display.
Recorder Quality of the
recording is
acceptable.
MC Network connection Network symbol is
correctly shown on
the screen.

248 B125/B105 Patient Monitor 2105518-001


Installation checkform

Functional check Observed result Acceptance criteria Pass N.A. Fail


Wireless LAN WLAN network
symbol is correctly
shown on the screen.
Test completion

Wireless MC network infrastructure (WLAN configuration device only)


Refer to “Wireless MC Network infrastructure checkform” to perform the wireless network infrastructure
verification.

Notes

Used service parts

Signature Date

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Installation checkform

250 B125/B105 Patient Monitor 2105518-001


Electrical safety tests checkform
C
Electrical safety tests
Customer Monitor type S/N
Service record # Software version
Service engineer

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.

Measuring equipment / test gases used:


Equipment / tool / Manufacturer Model / Type / Part Serial number / ID Calibration date
gas No.

PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.

Observed
Electrical safety tests result Acceptance criteria Pass N.A. Fail
Power outlet is correctly wired.
Power cord and plug are undamaged and all conductors are properly connected.
Ground (earth) integrity
Ground continuity test without power ≤ 0.1 ohms
cord
with power cord ≤ 0.2 ohms
Impedance protective without power ≤ 0.1 ohms
earth connection cord
with power cord ≤ 0.2 ohms
Earth leakage current test
Normal Condition (NC) Polarity: Normal ≤ 500 μA EN /IEC
≤ 300 μA UL

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Electrical safety tests checkform

Observed
Electrical safety tests result Acceptance criteria Pass N.A. Fail
Single Fault Condition Polarity: Normal ≤ 1 mA
(SFC)
Polarity: ≤ 1 mA
Reversed
Normal Condition (NC) Polarity: ≤ 500 μA EN /IEC
Reversed ≤ 300 μA UL
Enclosure leakage current (touch current) test
Normal Condition (NC) Polarity: Normal ≤ 100 μA
Single Fault Condition Ground closed ≤ 500 μA EN /IEC
(SFC) (normal) ≤ 300 μA UL
Ground open ≤ 500 μA EN /IEC
(normal) ≤ 300 μA UL
Ground open ≤ 500 μA EN /IEC
(reverse) ≤ 300 μA UL
Ground closed ≤ 500 μA EN /IEC
(reverse) ≤ 300 μA UL
Normal Condition (NC) Polarity: ≤ 100 μA
Reversed
Patient (source) leakage current tests — ECG
Normal Condition (NC) Polarity: Normal ≤ 10 μA
Single Fault Condition Ground closed ≤ 50 μA
(SFC) (normal)
Ground open ≤ 50 μA
(normal)
Ground open ≤ 50 μA
(reverse)
Ground closed ≤ 50 μA
(reverse)
Normal Condition (NC) Polarity: ≤ 10 μA
Reversed
Patient (sink) leakage current test — ECG
Polarity: Normal ≤ 50 μA
Polarity: ≤ 50 μA
Reversed
Test completion
Patient (source) leakage current tests — SpO2/IP
Normal Condition (NC) Polarity: Normal ≤ 10 μA

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Electrical safety tests checkform

Observed
Electrical safety tests result Acceptance criteria Pass N.A. Fail
Single Fault Condition Ground closed ≤ 50 μA
(SFC) (normal)
Ground open ≤ 50 μA
(normal)
Ground open ≤ 50 μA
(reverse)
Ground closed ≤ 50 μA
(reverse)
Normal Condition (NC) Polarity: ≤ 10 μA
Reversed
Patient (sink) leakage current test — SpO2/IP
Polarity: Normal ≤ 50 μA
Polarity: ≤ 50 μA
Reversed
Patient (source) leakage current tests — C.O.
Normal Condition (NC) Polarity: Normal ≤ 10 μA
Single Fault Condition Ground closed ≤ 50 μA
(SFC) (normal)
Ground open ≤ 50 μA
(normal)
Ground open ≤ 50 μA
(reverse)
Ground closed ≤ 50 μA
(reverse)
Normal Condition (NC) Polarity: ≤ 10 μA
Reversed
Patient (sink) leakage current test — C.O.
Polarity: Normal ≤ 50 μA
Polarity: ≤ 50 μA
Reversed
Patient (source) leakage current tests — Entropy
Normal Condition (NC) Polarity: Normal ≤ 10 μA
Single Fault Condition Ground closed ≤ 50 μA
(SFC) (normal)
Ground open ≤ 50 μA
(normal)
Ground open ≤ 50 μA
(reverse)
Ground closed ≤ 50 μA
(reverse)

2105518-001 B125/B105 Patient Monitor 253


Electrical safety tests checkform

Observed
Electrical safety tests result Acceptance criteria Pass N.A. Fail
Normal Condition (NC) Polarity: ≤ 10 μA
Reversed
Patient (sink) leakage current test — Entropy
Polarity: Normal ≤ 50 μA
Polarity: ≤ 50 μA
Reversed
Test completion

Notes

Used service parts

Signature Date

254 B125/B105 Patient Monitor 2105518-001


Maintenance checkform
D
B125/B105 Patient Monitor maintenance check
Customer Monitor type S/N
Service record # Module type S/N
Service engineer Software version
Planned maintenance / Corrective maintenance Start date

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.

Measuring equipment / test gases used:


Equipment / tool / Manufacturer Model / Type / Part Serial number / ID Calibration date
gas No.

PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.

Visual inspection (Acceptance criteria) Observed result Pass Fail


The monitor and the connected peripheral devices
are undamaged.
The monitor is properly mounted with specified
mounting solutions.
The cables between the patient monitor and the
connected devices are intact, properly connected
and secured to the right connectors.
The modules are properly connected and locked.

Refer to “Electrical safety tests checkform” to perform the electrical safety tests.
Functional check Observed result Acceptance criteria Pass N.A. Fail
Start-up Monitor starts up normally.
Display: picture quality Text is readable, images are
clear and brightness is good.

2105518-001 B125/B105 Patient Monitor 255


Maintenance checkform

Functional check Observed result Acceptance criteria Pass N.A. Fail


Display: touchscreen Touchscreen operates
control correctly.
Time and date Time and date is correct.
Device information Device information is correct.
F2 frame Power and communication
LED lit
ECG measurement
1. Normal Sinus rhythm Monitor displays the ECG leads
II, V1 & aVL and the waveforms
are noise-free.
HR is 80 ± 5 bpm.
bpm
An audible QRS tone sounds
with each QRS complex.
2. Pacemaker detection Pacemaker spikes are shown
on the ECG waveform.
3. Asystole detection Asystole alarm appears on
the screen.
4. Leads Off detection RA/R lead off, Lead changed
and Learning messages
appear on screen one by one.
Lead III is replaced back to
Lead II.
Respiration measurement
1. Respiration Rate RESP waveform appears.
RR value is 20 ±5 bpm.
bpm
2. Apnea detection Apnea alarm appears on the
screen.
SpO2 measurement
1. Test measurement % 90 - 100 %
HR value calculation HR is calculated from SpO2
when ECG and InvBP (ABP or
Art) is not measured.
Non Invasive Blood Pressure measurement
1. NIBP calibration check NIBP is working properly, the
mmHg pressure is stabile, not leak,
and the pressure drops ≤ 1
mmHg.
Invasive blood pressure measurement
1. Zeroing Zeroing and Zeroed messages
appear correctly on screen.
2. Static Pressure mmHg 200 ± 10 mmHg

256 B125/B105 Patient Monitor 2105518-001


Maintenance checkform

Functional check Observed result Acceptance criteria Pass N.A. Fail


3. Pressure Waveforms IBP waveform and Sys/Dia
(Mean) pressure values are
shown on the screen.
Temperature measurement
1. Temperature Temperature value is 37 ± 0.1
detection °C °C.
No error messages on the
screen.
MC Network Network symbol is correctly
shown on the screen.
Wireless LAN WLAN network symbol is
correctly shown on the screen.
Recorder Quality of the recording is
acceptable.
Synchronization Marker Out signals are correct.
connector test
Test completion

Notes

Used service parts

Signature Date

2105518-001 B125/B105 Patient Monitor 257


Maintenance checkform

258 B125/B105 Patient Monitor 2105518-001


E-COP module checkform
E
Maintenance check form, E-COP
Customer Monitor type S/N

Service record # Module type S/N


Service engineer Software version
Planned maintenance / Corrective maintenance Start date

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.

Measuring equipment / test gases used:


Equipment / tool / Manufacturer Model / Type / Part Serial number / ID Calibration date
gas No.

PASS = Test passed NA = Test is not applicant, a component or FAIL = Test failed
a feature is not part of tested system.

Visual inspection (Acceptance criteria) Observed result Pass Fail


Module front cover is intact.
All connectors are intact and attached properly.
Module box and latch are intact.
Module and the applied parts are clean.

Electrical safety tests


Perform the electrical safety tests by following the instruction in Technical Manual, chapter “Electrical safety
tests”. Perform Patient (source) leakage current test and Patient (sink) leakage current test. Use the “Electrical
safety test checkform” to record test results.

Functional check Observed result Acceptance criteria Pass N.A. Fail


IBP tests: Zeroing Zeroing and Zeroed
messages appear
correctly on screen.
IBP tests: Static Pressure 200 ± 10 mmHg

2105518-001 B125/B105 Patient Monitor 259


E-COP module checkform

Functional check Observed result Acceptance criteria Pass N.A. Fail


IBP tests: Pressure Waveforms IBP waveform and
Sys/Dia (Mean)
pressure values are
shown on the screen.
C.O. tests C.O. value is updated
and no errors are
shown.
Average of the
measured C.O. values
and Tblood reading
are updated
Test completion

Notes

Used service parts

Signature Date

260 B125/B105 Patient Monitor 2105518-001


E-sCAiO, E-sCO, N-CAiO modules
F
checkform

Maintenance check form, E-sCAiO, E-sCO, N-CAiO


Customer Monitor type S/N

Service record # Module type S/N


Service engineer Software version
Planned maintenance / Corrective maintenance Start date

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.

Measuring equipment / test gases used:


Equipment / tool / Manufacturer Model / Type / Part Serial number / ID Calibration date
gas No.

PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.

Replacement of planned maintenance parts Replaced N.A.


Nafion tube, 230 mm (mainflow)
OM reference gas filter assembly including O-ring
PM sticker
Nafion tube, 85 mm (zero line)
CO2 absorber

Visual inspection (Acceptance criteria) Observed result Pass Fail


Module front cover is intact.
All connectors are intact and attached properly.
Module box and latch are intact.

2105518-001 B125/B105 Patient Monitor 261


E-sCAiO, E-sCO, N-CAiO modules checkform

Visual inspection (Acceptance criteria) Observed result Pass Fail


The metal D-fend connectors and D-fend O-rings are
clean and intact.
Module and the applied parts are clean.

Functional check Observed result Acceptance criteria Pass N.A. Fail


Gas sampling system leak test The pressure reading
does not drop more
than 2 mmHg during
25 seconds.
Sample flow rate check The flow rate within
the specification limit
120 ±20 ml/min.
Reference gas flow rate check 10–50 ml/min
Fan Fan is running.
Zero valve operation The CO2, N2O and AA
value drop back near
0%. O2 value drop
back near 21%
Gas calibration The gas calibration
completed.
Agent identification: Identified Agent is identified as
Agent Desflurane.
Agent Identification: IDu IDu value < 75
Ambient pressure The ambient pressure
value in menu is
differ from barometer
within 10 mmHg.
Occlusion detection Sample line blocked
appears to the
digit field within 30
seconds.
Air leak detection Check Water Trap
appears to the
digit field within 30
seconds.
Airway gases A normal CO2
waveform and EtCO2,
FiCO2 values are
shown.
Apnea detection Apnea appears to the
message field within
30 seconds.
Test completion

262 B125/B105 Patient Monitor 2105518-001


E-sCAiO, E-sCO, N-CAiO modules checkform

Notes

Used service parts

Signature Date

2105518-001 B125/B105 Patient Monitor 263


E-sCAiO, E-sCO, N-CAiO modules checkform

264 B125/B105 Patient Monitor 2105518-001


E-miniC module checkform
G
Maintenance check form, E-miniC
Customer Monitor type S/N

Service record # Module type S/N


Service engineer Software version
Planned maintenance / Corrective maintenance Start date

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.

Measuring equipment / test gases used:


Equipment / tool / Manufacturer Model / Type / Part Serial number / ID Calibration date
gas No.

PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.

Replacement of planned maintenance parts Replaced N.A.


Zero valve air filter (every 3rd year)
Nafion Tube
Mini D-fend O-ring

Visual inspection (Acceptance criteria) Observed result Pass Fail


Module front cover is intact.
All connectors are intact and attached properly.
Module box and latch are intact.
The metal D-fend connectors and D-fend O-rings are
clean and intact.
Module and the applied parts are clean.

2105518-001 B125/B105 Patient Monitor 265


E-miniC module checkform

Functional check Observed result Acceptance criteria Pass N.A. Fail


Gas sampling system leak test The pressure reading
does not drop more
than 6 mmHg during
1 minute.
Sample flow rate check The flow rate within
the specification limit
150 ±25 ml/min.
Zero valve operation The CO2 value drop
back near 0%.
Gas calibration The gas calibration
completed.
Ambient pressure The ambient pressure
value in menu is
differ from barometer
within 10 mmHg.
Occlusion detection Sample line blocked
appears to the
digit field within 30
seconds.
Air leak detection Check Water Trap
appears to the
digit field within 30
seconds.
Airway gases A normal CO2
waveform and EtCO2,
FiCO2 values are
shown.
Apnea detection Apnea appears to the
message field within
30 seconds.
Test completion

Notes

Used service parts

Signature Date

266 B125/B105 Patient Monitor 2105518-001


E-Entropy module checkform
H
Maintenance check form, E-Entropy
Customer Monitor type S/N

Service record # Module type S/N


Service engineer Software version
Planned maintenance / Corrective maintenance Start date

Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.

Measuring equipment / test gases used:


Equipment / tool / Manufacturer Model / Type / Part Serial number / ID Calibration date
gas No.

PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.

Visual inspection (Acceptance criteria) Observed result Pass Fail


Module front cover is intact.
All connectors are intact and attached properly.
Module box and latch are intact.
Module and the applied parts are clean.

Electrical safety tests


Perform the electrical safety tests by following the instruction in Technical Manual, chapter “Electrical safety
tests”. Perform Patient (source) leakage current test and Patient (sink) leakage current test. Use the “Electrical
safety test checkform” to record test results.

2105518-001 B125/B105 Patient Monitor 267


E-Entropy module checkform

Functional check Observed result Acceptance criteria Pass N.A. Fail


Module and sensor recognition Entropy EEG
waveform field and
related information
appears to the
screen.
No sensor appears to
the Entropy digit field.
Sensor checking Checking sensor
appears to the
Entropy digit field.
A green circle with a
check mark for each
tested electrode is
shown in the Entropy
digit field.
Functional check with a The EntrEEG
simulator waveform and RE
and SE values appear
on the screen.
Test completion

Notes

Used service parts

Signature Date

268 B125/B105 Patient Monitor 2105518-001


Wireless network infrastructure
I
checkform

Wireless MC Network infrastructure checkform


Observations
Transmit rate
Test point # Time (hh:mm:ss) RSSI (dBm) (Mbps) Observations

Test summary and recommended actions

2105518-001 B125/B105 Patient Monitor 269


Wireless network infrastructure checkform

Signature Date

270 B125/B105 Patient Monitor 2105518-001


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