B125B105 Technical Manual
B125B105 Technical Manual
B125B105 Technical Manual
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.
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.
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.
Some of the products mentioned in this manual may not be available in all countries.
Please consult your local representative for the availability.
IEC 60601-1
Monitor
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.
Other devices
Other devices Description
External display
The monitor has the DVI port for the commercial display, which
resolution should be 1280*800.
1. Alarm light
2. Transportation handle
3. Hemo connectors
4. Keypad
5. Trim knob
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
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
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-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.
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.
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
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.
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.
Snapshot key.
USB connector.
Ethernet connector.
B1X5-F2 connector.
Gas inlet.
Gas outlet.
Recorder.
Temperature limitations.
Humidity limitations.
Recyclable Lithium-Ion.
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.
Beat volume icon. Adjust the volume of the QRS beep tone.
Also the beat source indicator. Displays next to the selected beat
source.
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.
Carrier board
Carrier board block diagram
The Carrier board functions include the power supply function, UMBC function.
● 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
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
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.
Hemo module
1. IBP connector
2. Temperature connector
3. SpO2 connector
4. ECG and impedance respiration connector
5. NIBP connector
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.
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.
■ 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.
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.
NIBP board
NIBP board block diagram
● Signal processing
■ 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
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:
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
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–
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.
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.
Formula 1
Formula 2
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.
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.
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.
1. Ensure that he installation site has hospital-grade grounded power outlets and
power cords for all system components.
WARNING Other equipment may interfere with the system, even if that
other equipment complies with CISPR emission requirements.
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.
WARNING To prevent liquids from entering the monitor, do not tilt the
monitor.
WARNING MISSED ALARMS - Do not use with Mobile Care Server Version
5.2 and earlier.
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.
4. To remove the battery, open the battery cover and pull the battery out from the
cord.
Install the monitor and frame to the mounting hardware according to the installation
instructions included with the mounting hardware.
Connecting a display
NOTE All installations must be compliant with IEC 60601-1 clause
16 and local electrical codes.
Y-Type 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.
2. When the monitor is power on, make sure the power indicator on recorder is lit.
Y-Type line
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:
Network diagram
CARESCAPE Network
Hospital Network
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.
To access the service menu, select > Service > enter Username (service),
Password (Wh1teF1sh) > select Login.
Page 1
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.
Gas Unit
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.
Gases
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.
Lamp Displays lamp state, PWM control, and current of the lamp.
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.
STP module
Cable Display the connection state of P1, P2, T1, T2 and GE SpO2
STP calibration
Calibrate P1/P2 Calibrating the invasive blood pressure channels P1 and P2.
ECG module
NIBP module
NIBP pneumatics
Reset Clock Reset the timer valve for the Interval 20 mmHg –> 185 mmHg
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.
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
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.
Timeouts A cumulative number that indicates how many times the module
has not responded to the monitor’s inquiry.
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
COP calibrations
Entropy module
Entropy Check Sensor Check the module keys. Press the module keys, these 2 items
will highlight.
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
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.
Country settings
License
Import license from Select to import license from USB storage device.
USB Disk
GESP GE SpO2
INVP IBP
TEMP Temperature
OxyCRG OxyCRG
Service log
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.
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.
Network
Network configuration
NRtclin DSCP Tag outgoing packets with a DSCP marking: non-realtime clinical
decision support information (admission, histories, full disclosure,
printing).
Save Changes Save changes. When save changes, the monitor will require a
restart except MCS IP address changed.
TCP/IP
Ping
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.
NetFuse LAN Set the wired network threshold for received packets per every
Threshold second
NetFuse WLAN Set the wireless network threshold for received packets per every
Threshold second
HL7 configuration
Diagnosis
LED
Touch Screen
Wireless
WLAN status
Quality dBm Display the WLAN Received signal strength indication (RSSI) (dBm):
Signal, Noise and Signal-Noise Raito (SNR).
Use File Config Use the USB file to configure WLAN settings.
Config File Choose the configuration files from USB storage device.
WLAN radio
Roaming Set the WLAN radio back ground scan cycle: Off, Normal, Medium,
Aggressiveness Aggressive.
NOTE Please confirm the channel list for your own region. Not all the
channels suit for your country.
WLAN security
Security
Security Key Set the security key. Only available when Security is WPA-Personal,
or WAP2-Personal.
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.
Certificate Select
Select Client Select one Client certificate. Only available when Enable Client
Certificate Certificate is selected.
Private Key Select one Private Key. Only available when Enable Private Key
is selected.
Private Key Password Enter the key password. Only available when Enable Key
Password is selected.
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.
Security Build Enter the private key and CSR create 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).
CSR
NOTE This menu is available only when private key have been
created.
WLAN USB
Import WLAN Config Import the WLAN configuration files to the monitor.
Software management
Software upgrade
Module upgrade
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.
Adjusting display
Adjusting the display brightness
You can set the display brightness level according to your needs.
1. Select the .
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.
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
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.
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
Changing passwords
Each account can change the password for itself and the lower level access.
NOTE Username and password are case sensitive.
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.
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.
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.
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.
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.
● Functional check
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 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 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 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.
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.
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.
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.
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.
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.
* 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.
System setup
These instructions are intended for every component in the system. Ensure that all system
components are properly connected to the patient monitor.
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.
NOTE Perform this test for all the connected parameter modules
and patient connectors specified Table Patient connectors to
be tested with each module.
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.
3. Disconnect the patient monitor’s power cord from the leakage tester.
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
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
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 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 parameters
Required tools for functional check
NOTE See the Supplies and accessories for compatible accessories.
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
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)
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.
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.
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.
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.
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.
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.
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.
● 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
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.
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.
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
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.
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.
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).
Network diagnostics
Pinging a TCP/IP network device
You can verify connectivity with a network device on the MC Network using Ping.
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
● 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.
● 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.
● 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
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.
● 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.
● 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.
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.
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.
WARNING SAFETY GROUND. Remove power cord from the mains source
by grasping the plug. Do not pull on the cable.
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:
● 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.
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
Back cover
Frame
Hemo box
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.
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.
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.
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.
■ 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
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.
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
Configuration
There is no service configuration for this module.
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.
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.
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.
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.
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.
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.
Configuration
There is no service configuration for this module.
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.
Gas calibration
WARNING A failure in zeroing or calibrating airway gases may cause
inaccurate readings.
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.
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.
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.
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.
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.
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.
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.
Making connections
1. Ensure that the module is connected to the monitor.
Gas calibration
WARNING A failure in zeroing or calibrating airway gases may cause
inaccurate readings.
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
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.
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.
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.
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.
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.
Configuration
There is no service configuration for this module.
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 • • •
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 •
● 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.
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
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
Hospital Network
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
■ WPA2–Persional
■ WPA–Enterprise
■ WPA2–Enterprise
● Access Controls
■ WPA2-PSK
■ WPA2-Enterprise
● SSID Broadcasting
● Transmission power/range
● MAC address filtering
● VPN over wireless
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.
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.
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
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
The STU has an on-screen help. Select Help for more information about the use of
the tool.
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.
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.
● 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.
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).
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
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.
Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.
Notes
Signature Date
Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
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
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
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)
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
Signature Date
Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.
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.
Notes
Signature Date
Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
PASS = Test passed NA = Test is not applicant, a component or FAIL = Test failed
a feature is not part of tested system.
Notes
Signature Date
Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.
Notes
Signature Date
Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.
Notes
Signature Date
Prior to testing, verify that all equipment is calibrated via “Cal” labeling and record Cal Due Dates.
PASS = Test passed NA = Test is not applicant, a component or a FAIL = Test failed
feature is not part of tested system.
Notes
Signature Date
Signature Date