Fe - Dinamap Procare - Service Manual PDF
Fe - Dinamap Procare - Service Manual PDF
Fe - Dinamap Procare - Service Manual PDF
Our obligation under this guarantee is limited to repairing, or, at our option, replacing any
defective parts of our equipment, except fuses or batteries, without charge, if such defects
occur in normal service.
Claims for damage in shipment should be filed promptly with the transportation company. All
correspondence covering the instrument should specify the model and serial numbers.
NOTE: In addition to software version RAI, the information in this manual also applies to earlier DINAMAP® ProCare
Monitor software versions. There are no user-apparent differences among these software versions. Due to continuing
product innovation, specifications in this manual are subject to change without notice.
GE Medical Systems Information Technologies will make available on request such circuit
diagrams, component diagrams, component parts lists, descriptions, calibration instructions,
or other information which will assist the users or appropriately qualified technical personnel
to repair those parts of the equipment which are classified by GE Medical Systems Information
Technologies as repairable.
DINAMAP, CLASSIC-CUF, SOFT-CUF, AND SENSA-CUF are registered trademarks of GE Medical Systems Information
Technologies. GE is a registered trademark of General Electric Company. All other product and brand names are
trademarks or registered trademarks of their respective companies. ©2005-2008 GE Medical Systems Information
Technologies. All rights reserved. No part of this manual may be reproduced without the permission of GE Medical
Systems Information Technologies.
Equipment ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Right-Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3
Powering the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Power Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Battery Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
4 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Integrity of Hoses and Cuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Cleaning the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Cleaning Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Monitor Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Cuffs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Temperature Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
5 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Alarm Code Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
System Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Alarm Conditions and Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
Procedure to View and Print Error Code History Log: . . . . . . . . . . . . .5-3
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
BP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Factory Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Critikon US Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
European Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Nellcor SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Measurement Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Revision History
Each page of this manual has a revision letter located at the bottom of the page.
This letter identifies the revision level of the entire manual. This may be important
if you have different manuals and you do not know which is the most current.
For the initial release, all pages have the revision letter A. For the second update,
all pages receive the revision letter B. The latest letter of the alphabet added to
the table below corresponds to the most current revision.
Revision Comment
A Initial Release
Manual Purpose
This manual supplies technical information for service representatives and
technical personnel so they can maintain the equipment to the assembly level.
Use it as a guide for maintenance and electrical repairs considered field
repairable. Where necessary the manual identifies additional sources of relevant
information and technical assistance. See the operator's manual for the
instructions necessary to operate the equipment safely in accordance with its
function and intended use.
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.
Safety Information
The information presented in this section is important for the safety of both the
patient and operator. This chapter describes how the terms Danger, Warning,
Caution, Important, and Note are used throughout the manual. In addition,
standard equipment symbols are defined.
General
This device is intended for use under the direct supervision of a licensed health
care practitioner.
This device is not intended for home use. Federal law restricts this device to be
sold by or on the order of a physician.
Contact GE for information before connecting any devices to the equipment that
are not recommended in this manual.
Parts and accessories used must meet the requirements of the applicable IEC/
EN 60601 series safety standards, and/or the system configuration must meet
the requirements of the IEC 60601-1-1 medical electrical systems standard.
Periodically, and whenever the integrity of the device is in doubt, test all
functions.
The use of ACCESSORY equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the
resulting system. Consideration relating to the choice shall include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been performed
in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1
harmonized national standard.
If the installation of the equipment, in the USA, will use 240V rather than 120V,
the source must be a center-tapped, 240V, single-phase circuit.
DANGER indicates an imminent hazard which, if not avoided, will result in death
or serious injury.
NOTE provides application tips or other useful information to assure that you get
the most from your equipment.
Cautions
Do not use replacement batteries other than the type supplied with the
Monitor. Replacement batteries are available from GE Medical Systems -
Accessories and Supplies.
Equipment Symbols
The following symbols are associated with the ProCare Monitor. Some of the
symbols may not appear on all equipment.
NOTE: The model of the Monitor determines which symbols appear on it.
Silence
Alarms
+/-
Menu
Inflate/Stop
Cycle
History
On/Off
Battery Power
Charging
Service Requirements
Follow the service requirements listed below.
Refer equipment servicing to GE Medical Systems Information Technologies
authorized service personnel only.
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 Medical
Systems Information Technologies or to one of GE’s 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.
Equipment ID
The following graphic illustrates the components of the monitor’s serial number.
13- Digit
### ## ## #### ##
Intended Audience
This manual is intended for service representatives and technical personnel who
maintain, troubleshoot, or repair this equipment.
Intended Use
General Use
The ProCare Monitor is intended to monitor one patient at a time in a clinical
setting.
Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE Medical Systems Information Technologies. Parts and
accessories used shall meet the requirements of IEC 60601-1-1.
Disposable devices are intended for single use only. They should not be
reused.
Periodically, and whenever the integrity of the monitor is in doubt, test all
functions.
Related Manuals
Manual Title
Service Policy
The warranty for this product is enclosed with the product in the shipper carton.
All repairs on products under warranty must be performed or approved by
Product Service personnel. Unauthorized repairs will void the warranty. Only
qualified electronics service personnel should repair products not covered by
warranty.
Service Contracts
Extended warranties can be purchased on most products. Contact your Sales
Representative for details and pricing.
Assistance
If the product fails to function properly, or if assistance, service or spare parts
are required, contact Customer Support. Before contacting Customer Support, it
is helpful to attempt to duplicate the problem and to check all accessories to
ensure that they are not the cause of the problem. If you are unable to resolve
the problem after checking these items, contact GE Medical Systems Information
Technologies. Prior to calling, please be prepared to provide:
product name, model number, and serial number
a complete description of the problem
If repair parts or service are necessary, you will also be asked to provide:
the product serial number
the facility's complete name, address, and account number
a purchase order number if the product is to need of repair or when you
order spare parts
the facility's GE Medical Systems Information Technologies account number,
if possible
the appropriate part number for spare or replacement parts
Service
If your product requires warranty, extended warranty or non-warranty repair
service, call Customer Support and a representative will assist you. To facilitate
prompt service in cases where the product has external chassis or case
damage, please advise the Customer Support representative when you call.
The Customer Support representative will record all necessary information and
will provide you with a Return Merchandise Authorization Number (RMA). Prior to
returning any product for repair, you must have a RMA number. Contact GE
Medical Systems Information Technologies at 1-800-558-7044.
Monday through Friday, 8:00 a.m. to 6:00 p.m. EST, excluding holidays.
Packing Instructions
Follow these recommended packing instructions.
Remove all hoses, cables, sensors, and power cords from the monitor before
packing.
Pack only the accessories you are requested to return; place them in a
separate bag and insert the bag and the product inside the shipping carton.
Use the original shipping carton and packing materials, if available.
Insurance
Insurance is at the customer's discretion. The shipper must initiate claims for
damage to the product.
All loaners provided to customers must be returned within the specified time
stated on the loaner agreement or a rental fee will be incurred.
Repair Parts
Repair parts can be ordered from GE Medical Systems Information Technologies:
Please allow one working day for confirmation of your order. All orders must
include the following information.
Facility's complete name, address, and phone number
FAX number
Your purchase order number
Your GE Medical Systems Information Technologies account number
Batteries
CAUTION
Do not incinerate batteries.
The sealed, rechargeable backup battery contains lead and can be recycled. The
rechargeable memory battery is of the Sealed Lead Acid form. Discharge this
battery prior to disposal. Place the battery in packaging which electrically
isolates its contents. Do not puncture or place the battery in a trash compactor.
Do not incinerate the battery or expose it to fire or high temperatures. Dispose in
accordance with regional body controlled guideline.
Other patient applied parts, such as blood pressure cuffs, should be cleaned
according to instructions. Inspect reusable applied parts for wear, replace as
necessary, and dispose of used product as medical waste in accordance with
regional body controlled guideline.
Packaging Material
Retain original packaging materials for future use in storing or shipping the
Monitor and accessories. This recommendation includes corrugated shippers
and inserts.
Monitor
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 such products. If you have questions concerning disposal of the
product, please contact GE Medical Systems Information Technologies or its
representatives.
Equipment Description
The ProCare Monitor provides a small, portable, easy-to-use monitoring
alternative for sub-acute hospital and non-hospital settings. The DC-operated
Monitor offers noninvasive determination of systolic blood pressure, diastolic
blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and
temperature. Monitors are available with or without integrated printers. ProCare
Monitors are intended for use in various markets, from the physician’s office to
sub-acute triage and medical/surgical units.
All devices are tested and calibrated during manufacturing and are certified for
operation at installation.
Product Configurations
Each ProCare Monitor is supplied with an accessory pack. The contents of the
pack vary according to model. Unpack the items carefully, and check them
against the checklists enclosed within the accessory boxes. If an accessory is
missing or if an item is in a nonworking condition, contact GE Medical Systems
Information Technologies Customer Service immediately.
Basic Components
Front Panel Controls and Indicators
Buttons
1. Silence button: Press to mute audible alarms. Any alarm active that is
acknowledgeable is also removed whenever this key is pressed. When
pressed after alarm sounds (silence active), the silence icon (bell) lights to
indicate that audible alarms have been silenced for 2 minutes.
2. Alarms button: Press to view or adjust parameter alarm settings.
3. +/- button (Plus/Minus): These buttons are active when the following user
modes are active: limit, menu, cycle, and history. When limit or menu mode
is active, pressing the + button increases an adjustable setting and the -
button decreases an adjustable setting. When the cycle or history mode is
active, pressing the +/- buttons displays the next or previous cycle selection
or entry in the history list, respectively. When you reach the beginning or
ending of a list, a key-click sounds.
4. Menu button: Press to access menu settings that can be adjusted while in
clinical mode (i.e., ALARM VOLUME, PULSE VOLUME, INFLATE PRESSURE;
refer to Operating Modes in this section for a description of clinical mode).
5. SpO2 sensor connector: SpO2 sensor extension cable attaches here.
6. BP connector: BP cuff hose attaches here.
7. Inflate/Stop button: Press to start a manual BP determination or stop any BP
determination.
8. Temperature probe holster: Temperature probe is stored here.
9. Cycle button: Press to start Auto Cycle or STAT mode.
10. Temperature probe cover storage: Box of probe covers is stored here.
11. History button: Press to activate the History mode to view stored patient
data. The most recent entries are displayed first. Press and hold the button
for 2 seconds to clear all entries stored. Refer to the History section of this
manual for more information.
12. Print button: Press to print currently displayed values or all stored entries
when in history mode.
13. On/Off button: Controls on/off state of monitor; push for power on and push
again for power off.
14. Temperature probe connector: Temperature probe cable attaches here.
Front Panel
15. Silence icon: when Silence button is pressed after alarm sounds (silence
active), silence icon (bell) lights to indicate that audible alarms have been
silenced for 2 minutes.
16. Systolic window: 3-digit red LED indicates measured systolic BP in mmHg.
17. Diastolic window: 3-digit red LED indicates measured diastolic BP in mmHg.
18. Alarm volume indicator: lights to indicate you are making a change to the
alarm volume.
19. Pulse volume: lights to indicate you are making a change to the pulse
volume.
20. Inflate pressure: lights to indicate you are making a change to the inflation
pressure.
21. Pulse Rate window: 3-digit yellow LED shows pulse rate in beats per minute.
22. SpO2 pulse indicator: Red LED bar flashes to indicate that real-time pulse
rate measurements are being derived from SpO2 signals.
23. SpO2 window: 3-digit red LED indicates oxygen saturation in %.
24. MAP/Cuff window: 3-digit red LED indicates measured MAP in mmHg and
shows instantaneous cuff pressure during BP determination.
25. Min window: Displays the BP mode if manual or STAT is the cycle time when
in Auto Cycle mode.
26. Battery power indicator: Green LED indicates the Monitor is operating on
battery power.
27. Low battery power indicator: Yellow LED indicates LOW charge status of
internal battery.
28. Charging indicator: Green LED indicates presence of external power source
and battery charging.
29. Temperature window: 4-digit red LED indicates measured temperature.
Product Compliance
The DINAMAP® ProCare Monitor is classified in the following categories for
compliance with IEC 60601-1:
Internally powered or Class II when powered from external supply
Transportable
For continuous operation
Not suitable for use in the presence of flammable anesthetics
Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent)
Type BF applied parts
IPX1, degree of protection against ingress of water
Sterilization/Disinfection, see Appendix B
Software is developed in accordance with IEC 60601-1-4.
This equipment is suitable for connection to public mains via power
adaptors as defined in CISPR 11.
The SpO2 parameter conforms to ISO 9919:2005.
Defibrillation protected. When used with the recommended accessories, the
Monitor is protected against the effects of defibrillator discharge. If
monitoring is disrupted by the defibrillation, the Monitor will recover.
Theory of Operation
Introduction
This section provides overall theory of operation and functional description of
the ProCare Monitor. The ProCare Monitor comes in six different configurations:
ProCare 100: capable of monitoring Blood Pressure (BP) and Pulse
ProCare 200: capable of monitoring Blood Pressure (BP), Pulse, and
Temperature
ProCare 300 Nellcor: capable of monitoring Blood Pressure (BP), Pulse and
SPO2 (Nellcor technology)
ProCare 300 Masimo: capable of monitoring Blood Pressure (BP), Pulse and
SPO2 (Masimo technology)
ProCare 400 Nellcor: capable of monitoring Blood Pressure (BP), Pulse, SPO2
(Nellcor technology), and Temperature
ProCare 400 Masimo: capable of monitoring Blood Pressure (BP), Pulse, SPO2
(Masimo technology), and Temperature
The model of your monitor determines which parameters are in your monitor.
Using the ProCare Monitor, a clinician can view, print and recall data that is
derived from each parameter. The Monitor is also capable of alerting the
clinician to changes in the patient's condition. All of the main operations of the
ProCare Monitor are easy-to-use and only a button-touch away. Please review
the factory default settings and, where applicable, enter settings appropriate for
your use.
When the ON/OFF button is pressed, the Main Board is brought out of a sleep
mode and turns on the power regulators. The power regulators provide
conditioned power from the Lead Acid Battery. The external DC source is used
only to charge the Lead Acid Battery. Once the ProCare Monitor is energized, a
self-test is performed. The self-test automatically tests the main functions of the
ProCare Monitor. Failure of the self-test will set the ProCare Monitor into a fail-
safe mode with an audio alarm.
Under normal operating conditions, the ProCare Monitor is ready to record the
patient vital signs using three external attachments: the temperature probe,
SPO2 sensor, and cuff. Interface with a central station or other device is
accomplished through the host communication port on the back of the ProCare
Monitor.
NOTES
Prior to each use, inspect the power supply cord to ensure proper
connection and condition.
Be sure to unplug the Monitor before transport.
A reset signal to the SpO2 PWA is also provided so that power up sequencing is
correct. If the SpO2 circuit quits communicating to the Main Board, the Main
Board will attempt to reset the SpO2 PWA.
The Monitor deflates the cuff one step each time it detects two pulsations of
relatively equal amplitude. The time between deflation steps depends on the
frequency of these matched pulses (pulse rate of the patient). However, if the
Monitor is unable to find any pulse within several seconds, it will deflate to the
next step. The process of finding two matched pulses at each step provides
artifact rejection due to patient movement and greatly enhances the accuracy
of the Monitor. The figure shows the NIBP determination sequence.
At each step the microprocessor stores cuff pressure, the matched pulse
amplitude, and the time between successive pulses. The stepped deflation and
matched pulse detection continues until diastolic pressure is determined or total
cuff pressure falls below 7 mmHg. The Monitor then deflates the cuff (to zero
detected pressure), analyzes the stored data, and updates the screen.
The operating cycle is composed of four parts: inflation time, deflation time,
evaluation time, and wait time. Wait time, which varies from mode to mode, is
affected by the cycle time (auto mode) or operator intervention (manual mode).
The figure shows the basic operating cycle.
Systolic Search
If systolic pressure is not found, the NIBP parameter can search at cuff pressures
higher than the initial target pressure. The parameter will inflate the cuff above
the initial target pressure to get more data in the systolic region. The maximum
pressure allowed in systolic search is limited by the normal range for cuff
pressures. In any operating mode, if a patient's systolic pressure exceeds the
inflation pressure, the parameter will begin a normal deflation sequence, detect
the absence of a systolic value, stop deflation, reinflate to a cuff pressure higher
than the initial inflation pressure, and resume the normal deflation sequence.
If a previous valid systolic pressure is displayed and less than 2 minutes old, and
the new systolic pressure oscillations are compared with the previous valid
determination and the Monitor "thinks" that the systolic was not obtained, the
Monitor will inflate the cuff to a pressure of an additional 50 mmHg above the
immediately preceding inflation. This additional inflation will occur only once per
determination.
CAUTION
Do not use an infant cuff with an auscultatory reference
DINAMAP® ProCare Monitor. The neonatal #5 cuff and neonatal
hose may be used on patients with an arm circumference of
8 - 15 cm.
Functional Description
The following paragraphs provide the functional interface relationship. The
ProCare Monitor contains a number of electrical & electro-mechanical
assemblies. These assemblies are:
Main Board PWA
User Interface (UI) Board PWA
SPO2 PWA (optional)
Printer (optional)
Pneumatic Valve/Manifold (PVM)
Optical Switch (optional)
Upon entering a FAILSAFE condition, the Main Board will perform the following
tasks:
Parameter monitoring disabled
Alarm tone sounding from speaker
Pneumatic FAILSAFE (deflate the cuff, pump off)
Normal communications interface disabled
Remote alarm control inactive
Hard keys except ON/OFF key inactive
The ON/OFF key can reset the Monitor and end the FAILSAFE condition. The
FAILSAFE condition will terminate automatically after 10 minutes to preserve
battery power.
The UI assembly also provides hardkey switches for the ProCare Main Board. The
primary processor asserts a HIGH on the 16 outputs of the 1-of-16 decoder/
demultiplexer one at a time and then reads at the signal on SW_MUX. A LOW on
SW_MUX indicates that the switch is asserted.
SPO2 PWA
The ProCare Monitor can be configured for use with either a Nellcor or Masimo
SPO2 PWA. The SPO2 PWA provides continuous readings of oxygen saturation
and pulse rate. Additional circuitry on the Main Board provides power, data
communications, and isolation between SPO2 PWA and primary processor.
Patient data received from the finger sensor is filtered, amplified, and analyzed
on the SPO2 PWA. The information is sent to the Main Board via the optically
coupled electrically isolated serial connection. The primary processor receives
the data and routes it to the UI board for display. The data is also sent to the
printer if specified
Printer
The printer receives power from the Main Board and communicates with the
primary processor. Printer presence and print head temperature is indicated by
PR_TH signal to the primary processor. When a print command is sent to the
printer from the primary processor, the following will occur:
Together these signals (CONTROL DATA) cause the printer to print a graphic
hardcopy of the patient vital sign values and trend data. It also causes the
printer to print a hardcopy of error logging and service record data.
The printer has a built-in sensor to monitor the printer paper presence. When the
printer is out of paper, it sends a PAPER OUT signal to the primary processor.
Optical Switch
The optical switch indicates whether the temperature probe is inserted in the
probe holder or not. The Main Board powers the switch.
2009381-001
Temp Probe Temp Control/Data
(optional) Temp Control
Optical Switch
Control/Data
Speaker Printer
2-15
Equipment Overview: Functional Description
Connections
Rear Panel
1. Data interface connector: Host communications port (15 pin D-type RS-232
serial port) for use only with equipment conforming to IEC 60601-1,
configured to comply with IEC 60601-1-1.
Right-Side Panel
Battery Charging
The Monitor charges the Lead-Acid battery whenever the AC power supply is in
use. The Monitor automatically senses if the battery needs recharging. Battery
charging will continue as long as the Monitor is connected to the AC power
supply, even when the Monitor is turned off.
Batteries should be charged before first use or after long periods of storage.
The battery should be charged before use, as a charged battery loses some
charge when left in storage.
The battery should be charged at room temperature (59° F - 86° F; 16° C -
30° C).
It is normal for the battery to become warm during charging or after use.
Batteries can be charged or topped-off at any time. Battery should not be
fully discharged.
If the Monitor is idle for extended periods, it should be fully charged once a
month to ensure optimum performance.
Prior to each use, inspect the power supply cord to ensure proper
connection and condition.
NOTE:Before the ProCare Monitor is used for the first time, the battery should
be charged in the Monitor for at least 8 hours.
With external DC power connected, the green CHARGING indicator will light to
indicate that the battery is charging.
When the Monitor is operating on battery power and the BATTERY LOW alarm is
not active, the BATTERY indicator is backlit green. When the Monitor is operating
on battery power and the BATTERY LOW alarm is active, the BATTERY indicator
flashes green, the LOW indicator flashes amber, and the medium priority alarm
sounds until it is acknowledged. Press the Silence button to acknowledge this
alarm. Once it is acknowledged, the indicators continue to flash, but the audible
alarm is silenced for 10 minutes. Once the BATTERY LOW condition becomes
active, the Monitor should be connected to a DC power supply to recharge the
battery (refer to “Power Requirements” in Product Overview section). If the
Monitor continues to be used without charging the battery, the Monitor
eventually enters a fail-safe mode (E13: BATTERY TOO LOW TO OPERATE). Refer
to the Alarms Section for information of an E13 error code.
Prior to usage it is necessary to charge the Monitor for 12 hours. This charge
calibrates the battery charging circuitry with the charge status of the battery.
Clinical Mode
Clinical mode is the Monitor’s normal operating mode. While this mode is active,
alarm limits and a few other commonly used settings are adjustable. All
parameters are available for monitoring in this mode.
Configuration Mode
Configuration and advanced configuration modes display the software revision
and allow you to configure defaults for some settings that are available in
clinical mode, as well as some less commonly used settings that are only
adjustable in these modes. A fatal error history is also available in the advanced
configuration mode. No parameters are operable in these modes, therefore,
patient monitoring should be suspended.
To enter the configuration mode: with the Monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds. The Monitor enters the configuration mode.
For a few seconds immediately after power up in this mode, the Systolic and
Diastolic windows display the major and minor version codes. The version codes
are numbers that represent the letters of the English alphabet, which are
designated to the currently loaded version of the monitor firmware (e.g., 1
indicates A, 2 indicates B, etc.).
At the same time, AUSC appears in the “min” (minutes display) window if the
monitor is configured with auscultatory BP. That area appears blank for a
monitor with classic DINAMAP BP configuration.
Display Window
Major software revision Systolic
Minor software revision Diastolic
Type of BP technology min
These displays appear only during the first part of the power up sequence and
are not selectable and cannot be changed. After a moment, this version
information is cleared, and the monitor displays the 1st page of configuration
mode which simply displays CFG in the Systolic window.
The Menu selections appear in the following order. Refer the each manual
section for settings options.
NOTE:Menu selections for a Masimo unit have three SpO2 settings. Refer to the
Masimo SpO2 section for options.
Setting the Date and Time – To set the date and time on the ProCare Monitor,
you must access the configuration mode. Press Menu to skip the default settings
that do not require changes. The following list shows the windows in which the
date/time settings appear.
1. Press the Menu button to move from one setting to another. Use the +/-
buttons to increment or decrement the setting.
NOTE: For the date and time to be saved, you must advance the menu
through the minute setting.
2. To exit the configuration mode, press the On/Off button.
3. To continue with other changes, press the Menu button. CFG will appear in
the Systolic window. To change parameter settings, press the Menu button
and select the parameter function. To change alarm settings, press the
Alarms button.
1. Enter the configuration mode: with the Monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds, or press Menu until the Inflate Pressure is lit on the display and the
pressure is displayed in the Diastolic window.
2. Use the +/- buttons to increment or decrement the inflate pressure default
setting. Increments are 5mmhg from 100mmhg to 250mmhg.
3. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press Menu.
1. Enter the configuration mode: with the Monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds. After the unit enters the configuration mode, press Alarms. At any
point in the configuration mode menu, Alarms default can be selected.
2. To set or change the default setting, press the Alarms button to select alarm
setting. Use the +/- buttons to increment or decrement the individual
settings.
NOTE: For the Alarms default setting to be saved, you must advance the
menu through the SPO2 settings.
3. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press Menu.
1. Enter the configuration mode: with the Monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds.
2. Press the menu button until n0d appears in the Pulse Rate window.
3. Use the +/- buttons to select the option.
4. Press the Menu button once. SAt appears in the Pulse Rate window.
5. Use the +/- buttons to select the option.
6. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press Menu.
1. Enter the configuration mode: with the Monitor off, press and hold the Menu
button at the same time as pressing and holding the On/Off button for 3
seconds.
2. Press the Menu button until n0d appears in the Pulse Rate window.
3. Use the +/- buttons to select the option.
4. Press the Menu button once. SAt appears in the Pulse Rate window.
5. Use the +/- buttons to select the option.
6. Press the Menu button once. SEn appears in the Pulse Rate window.
7. Use the +/- buttons to select the option.
8. To exit the configuration mode, turn the unit off. To continue with additional
configuration settings, press Menu.
For a couple of seconds immediately after power up in this mode the Systolic
and Diastolic display windows will display the major and minor version codes.
The version codes are numbers that represent the letters of the English alphabet
which are designated to the currently loaded version of the monitor firmware
(e.g., 1 indicates A, 2 indicates B, etc.).
After a moment, this version information is cleared, and the monitor displays the
1st page of configuration mode which simply displays ACF in the Systolic display
window indicating that the monitor is in advanced configuration mode.
You can then press the Menu button to cycle through all the advanced
configuration mode option pages. After all options pages have been displayed,
the display will return to the 1st advanced configuration mode page (displaying
ACF). You can use the + and - buttons to make changes to settings. After
making changes, simply cycle the power to return to normal operation mode.
Changes are automatically be retained.
0 : 300 bps
1 : 600 bps
2 : 1200 bps
3 : 2400 bps
4 : 4800 bps
6 : 19200 bps
Service Mode
Service mode is entered by holding the Cycle button while powering on with the
On/Off button. You can press the Cycle button to advance through the available
service mode pages.
NOTES
Only transducer calibration pages are available until calibration is valid.
Calibration and other service mode setting changes will not be retained
unless the “Save Settings” operation is executed (on the final Service Mode
options page).
After all options pages have been displayed, the display will return to the 1st
service mode page (initial calibration page). To save service mode settings the
Service Mode option pages are as follows:
2: Auscultatory NIBP
0: No SpO2
1: NellCor
2: Masimo
0: No Temp
1: Turbo Temp
NOTE: When using remote alarm, the ProCare Monitor should be considered
the primary alarm source. The secondary alarm is used for secondary
purposes only.
NOTE: When using remote alarm, the ProCare Monitor should be considered
the primary alarm source. The secondary alarm is used for secondary
purposes only.
Pin # Function
1 Common
4 +5 volts
5 No connection
6 No connection
7 Common
8 Remote Alarm
9 No connection
10 No connection
12 No connection
14 No connection
15 No connection
Preventative Maintenance
WARNING
Failure on the part of all responsible individuals, hospitals or
institutions, employing the use of this device, to implement the
recommended maintenance schedule may cause equipment
failure and possible health hazards. The manufacturer does
not, in any manner, assume the responsibility for performing
the recommended maintenance schedule, unless an
Equipment Maintenance Agreement exists. The sole
responsibility rests with the individuals, hospitals, or institutions
utilizing the device.
General
Preventative maintenance tasks include cleaning the ProCare Monitor, checking
pressure calibration, pneumatic leakage, pneumatic system overpressure point,
temperature calibration (200 and 400), and verification of the SpO2 system (300
and 400). Perform the following maintenance procedures as required.
Visual Inspection
The monitor and its components should be carefully inspected prior to
installation, once every 12 months thereafter and each time the equipment is
serviced.
Carefully inspect the equipment for physical damage to the case, the display
screen, and the keypad. Do not use the monitor if damage is determined.
Refer damaged equipment to qualified service personnel.
Inspect all external connections for loose connectors or frayed cables.
Have any damaged connectors or cables replaced by qualified service
personnel.
Inspect the display face for marks, scratches, or other damage.
Physical damage to a flat panel display glass may pose an implosion
hazard. Have the flat panel display replaced by qualified service personnel if
necessary.
Safety labels and inscription on the device are clearly legible.
Cleaning
Cleaning the Monitor
CAUTIONS
Never pour or spray water or any cleaning solution on the
equipment or permit fluids to run behind switches, into
connectors, into the recorder, into the temperature probe
well, or into any ventilation openings in the equipment.
WARNING
Failure to follow these cleaning recommendations may melt,
distort, or dull the finish of displays and cases; blur lettering on
labels; embrittle cases and lead to cracks and breakage; or
cause equipment failures. Use of non-approved cleaning
agents is not considered normal wear and repair or
replacement of parts is not covered under warranty.
Cleaning Recommendations
Monitor Exterior
Disconnect the monitor from AC power before cleaning or disinfecting its
surface. The exterior surfaces of DINAMAP Monitors may be cleaned with a
dampened, lint-free cloth. Wipe off all cleaning solutions with a clean, dry cloth
and let air dry for at least 15 minutes. Use one of the following approved
solutions:
Mild soap (diluted)
Commercial diluted bleach solution or bleach wipe
Commercial diluted ammonia solution
10% solution of household bleach (5.25% sodium hypochlorite) in distilled
water
Display
To clean the display screen, use a soft, clean cloth dampened with a glass
cleaner. Never spray the glass cleaner directly onto the display, and never use
alcohol or petroleum based products.
Cuffs
General
The cuff must be thoroughly cleaned with the specified detergent before reuse.
The additional use of household bleach as described below provides at least
intermediate-level disinfection.
Apply cuff hose plugs before cleaning.
The following cleansing procedure was repeated 20 times on DURA-CUF®
Blood Pressure Cuffs and once on SOFT-CUF® Blood Pressure Cuffs without
affecting the performance of the cuff.
While this procedure is adequate for cleaning/disinfection, it may not
remove all stains.
Do not immerse hoses.
Do not immerse cuffs without prior application of cuff hose caps.
Materials
Enzymatic detergent such as ENZOL* enzymatic detergent (US) or
Cidezyme* enzymatic detergent (UK)
Distilled water
10% solution of household bleach (5.25% sodium hypochlorite) in distilled
water
Soft cloths and soft-bristled brushes
Spray bottles
Procedure
1. Prepare the enzymatic detergent according to the manufacturer’s
instructions and the 10% bleach solution, in separate spray bottles.
2. Spray the detergent liberally on device. If the material is dried on, allow the
cuff to sit for 1 minute. For soil on the soft part of the closure or the cuff
itself, wipe the material off with a soft cloth. For persistent contamination on
the soft part of the closure, use a soft-bristled brush to loosen particles.
Rinse with copious amounts of distilled water. Repeat until no visible
contamination remains. For soil on the hook part of the closure, use a soft-
bristled brush to remove the material, and rinse with copious amounts of
distilled water. Repeat until no visible contamination remains.
3. Spray the 10% bleach solution on the affected area until the area is
saturated. Allow the cuff to sit for 5 minutes.
4. Wipe away any excess solution and rinse the cuff again with distilled water.
Allow 2 hours for drying.
The user has the responsibility to validate any deviations from the
recommended method of cleaning and disinfection.
Temperature Devices
Do not immerse predictive temperature probes. The probe may be cleaned with
a solution of 10% bleach in water. Use a cloth or sponge—just damp, not wet—
and avoid getting any liquid into the interior of the probe.
SpO2 Sensors
Adhesive sensors are sterile and for single use only. Reusable sensors should be
cleaned before reuse with a 70% alcohol solution. If low-level disinfection is
required, use a 1:10 bleach solution. Do not use undiluted bleach (5% - 5.25%
sodium chlorite) or any cleaning solution other than those recommended here
because permanent damage to the sensor could occur. Do not sterilize the
sensor by irradiation, steam, or ethylene oxide. If disposable sensors or their
packaging are damaged, they must be disposed of as advised in this appendix.
Long-Term Storage
If it becomes necessary to store the Monitor for an extended period of time,
remove all attached accessories. Attach the original packing inserts, and place
the Monitor into the original shipping container.
Battery life is significantly reduced if the battery is left in a discharged state. For
long-term storage, fully charge the battery, then remove the battery from the
unit and periodically charge the battery. For more information, refer to the
“Storage and Battery Care” section below.
Battery Care
If it becomes necessary to store the Monitor for an extended period of time, first
fully charge, then remove the battery. Then store the Monitor and the battery in
the original packaging materials.
It is best to keep the battery charged as fully as practical and never store the
Monitor with the battery in a discharged condition. When the battery will no
longer hold a charge, remove and replace it. Failure to replace the battery with
the same GE Medical Systems Information Technologies part number may result
in shorter battery life. Battery charging will take place as long as the Monitor
remains connected to an external DC power source.
NOTE:After replacing batteries, an E00 error code is normal. The user settings
and date/time revert to the factory default setting.
CAUTIONS
To ensure that the battery will be ready for portable
operation, keep the Monitor connected to a mains supply
whenever possible.
4. Remove the old battery and disconnect the wires. Attach the battery wires
to the new battery, ensuring the red terminal (+) is connected to the red wire
and the black terminal (-) is connected to the black wire.
5. Insert the battery into the compartment.
6. Then replace the cover, help card tray, and screws. Insert the external DC
power converter plug into the external DC power socket and plug into an AC
outlet.
NOTE: Error code E00 appears (Memory Lost) alerting you that the user
settings (including alarm limits and inflation pressure) and date/
time will go back to factory default values.
7. Reset the date/time and applicable user settings.
CAUTION
Do not touch either the pin of the DC input connector or the
terminals within the battery compartment and the patient at
the same time.
Fuses
The Monitor contains four fuses. The fuses are auto-resettable and mounted
within the Monitor. The fuses protect the low voltage DC input, the battery, the
remote alarm output, and the +5 V output on the host port connector.
BP
Perform a blood pressure by connecting the supplied hose and cuff together,
then attaching to the front of the ProCare Monitor. Press the Start button on the
front to begin the BP cycle.
Temperature
Connect the supplied temperature probe to the corresponding connection. A
predictive temperature will begin once the probe is removed from its holster.
Place the probe in the holster after completion of the Temp cycle.
To adequately test the safety and integrity of the ProCare Monitor, the
following test equipment is recommended:
12VDC power supply
IEC 60601-1 approved leakage tester
Digital manometer (with range to 350 mmHg)
Stopwatch/timer (capable of measuring seconds)
Adult BP cuff, Neonate BP cuff, hose, inflation bulb, and associated tubing
Calibration kit (p/n 320246, available through GE Medical Systems
SpO2 cable (for appropriate SpO2 type, if SpO2 is installed)
TE 1811 Temperature Probe Simulator (if TEMP is installed) available from
Alaris™
Printer paper (if PRINTER is installed)
3” diameter rigid cylinder (mandrel)
CAUTION
Calibration equipment should always be kept dry and free of
particulate matter. Moisture or foreign substances
introduced to the pneumatic system will likely cause
damage to the Monitor and/or the accessories.
Annual Procedures
Perform the following test procedures every 12 months, or whenever the
accuracy of any reading is in doubt.
NOTES
This test is written so that a knowledgeable technician who is familiar with
the ProCare Monitor and the test equipment and will be able to follow the
test procedure.
To enter Service Mode press and hold Cycle button while pressing the On/
Off button.
Setup
1. Connect manometer to unit as shown.
2. ‘T’ an inflation bulb into the pneumatic setup.
MANDREL
2 TUBE
BP CUFF
Leakage Testing
NOTE:To enter Service Mode press and hold the Cycle button while pressing
the On/Off button.
NOTE:To enter service mode press and hold Cycle button while pressing the
On/Off button.
6. Close valve on bulb and slowly inflate pressure to 200 mmHg (using the
manometer as reference).
7. Press Menu button when pressure reads exactly 200 mmHg to save
calibration setting.
8. Press Cycle button until 6 appears in the min window.
9. Press and hold Menu button until monitor beeps, which acknowledges that
data was saved.
10. Turn the Monitor off.
Overpressure Verification
NOTE:: To enter service mode press and hold Cycle button while pressing the
On/Off button.
1. Wait a few seconds after entering service mode. Press Cycle button so that
the min window changes from 0 to 1.
2. Use the inflation bulb to inflate close to 300 mmHg. Slowly inflate (1 to 2
mmHg/sec) until valve opens and pressure is released.
3. Record and verify pressure at which valve opens.
4. Press Cycle button and 2 should appear in the min window.
5. Use the inflation bulb to inflate close to 150 mmHg. Slowly inflate (1 to 2
mmHg/sec) until valve opens and pressure is released.
6. Record and verify pressure at which valve opens.
7. Turn unit off.
Button Testing
1. Disconnect the cuff/hose assembly and power on the unit.
2. Press Inflate/Stop button.
3. Verify a BP determination has been initiated.
4. Block pump port and verify E80 alarm.
5. Verify flashing red indicator of Silence button.
6. Press Silence button, verify alarm has been removed.
7. Press Alarm button several times, verify unit cycles through all alarm
settings (i.e., SYS, DIA, SpO2).
LED Tests
1. Power on the Monitor.
2. During the power-up self-test verify all 7 segment LED display segments and
all discrete LEDs (except CHARGING LEDs) illuminate.
3. Repeat power up cycle until all LEDs are checked.
External DC Verification
1. Plug the power brick into the Monitor.
2. Verify that the CHARGING indicator is illuminated.
BP Determination
NOTE:For best results, it is important to be seated and not moving, talking,
eating, and/or smoking, etc. while taking your blood pressure. If you are
uncertain as to the proper technique, consult the operation manual.
1. Remove the calibration set up and attach a normal adult cuff and hose (be
sure to select the correct cuff size).
2. Press Start/Stop button on monitor to begin a determination.
3. Record Systolic, Diastolic, map and heart rate from the Monitor display.
4. Wait 1 minute, then press Cycle button to initiate a determination in Auto BP
mode.
5. Record Systolic, Diastolic, map and heart rate from the Monitor display.
6. Wait 1 minute, then press Cycle button until st is displayed in the min
window to initiate a determination in STAT mode.
7. Record Systolic, Diastolic, map and heart rate from the Monitor display.
8. Press Start/Stop button, end STAT mode.
BP Overpressure Verification
1. Remove the cuff/hose from the monitor, restrict airflow from cuff hose port.
2. Press Start/Stop to begin BP determination.
3. Verify E80 is displayed on the Systolic window and audible alarm sounds.
4. Remove the air restriction.
5. Press Start/Stop and verify that the pump does not start.
6. Press the Silence button.
7. Press the Silence button again.
8. Verify the alarm condition is cleared from the Systolic window.
The Alaris Turbo Temp probes cannot be calibrated. These probes must be
discarded after 2 years from the date of manufacture stamped into the RJ45
connector (first two digits=year, second two digits=week). Refer to the illustration
example (0520=fw20 in 2005).
1. Turn Monitor off. Make sure the temp probe is properly stored in the probe
well.
2. Disconnect the temp probe cable from the monitor.
3. Connect Temp simulator; set to 80.2°F.
4. Turn the Monitor on.
5. Put the Monitor into temp monitor mode:
a. partially remove the probe from the well (stop when you hear the
Monitor beep).
b. Quickly re-insert the probe and remove again (you should hear two
beeps of a different tone).
c. A temperature value should appear quickly, if not, repeat Step 5b.
6. Record and verify the reading in the temp display is 80.2°F ±0.2°F.
7. Set the simulator to 98.6°F.
8. Record and verify the reading in the temp display is 98.6°F ±0.2°F.
9. Set the simulator to 107.8°F.
10. Record and verify the reading in the temp display is 107.8°F ±0.2°F.
11. Calibration is complete. If the monitor does no pass the calibration
verification then contact Technical Support.
1. Connect the appropriate SpO2 probe and cable to the SpO2 connector. Place
the probe on your finger.
2. Verify the unit displays a:
Pulse value
Saturation value
Signal Strength Bar Graph
3. Remove the sensor from your finger to generate an E23 alarm and to sound
the speaker.
4. Press the Silence button.
5. Verify the sound has stopped and the E23 error is cleared.
6. Re-apply the SpO2 sensor to your finger.
7. Verify the unit displays a:
Pulse Value
Saturation value
Signal Strength bar Graph
System Failures
When a system failure is encountered, the error code is displayed on the screen
for five seconds and the system enters failsafe mode. The error code is logged in
the history log.
General system error codes are listed below. If any other SY or similar code
appears, report it to Customer Support.
Error Log
You can view and print an error log that stores up to 40 error code entries. The
log is a “rolling” list that—once 40 entries are stored—deletes the oldest entry in
order to add the most recent entry. The error log is saved until the monitor
experiences a memory loss, then all entries are deleted.
930 SPO2 No status from module for 30 ±10 sec. No Check cable and sensor
Fatal error reported by module Parameter turned on - no
hardware installed in unit
940 Temp TEMP data samples less than 45 in 5 No Incorrect or failed temperature
sec while idle probe
950 NIBP NIBP pump on during idle or over No Pneumatic assembly failure
current detected
951 NIBP NIBP valve stuck closed during cuff No Pneumatic assembly failure
typing
952 NIBP NIBP PT2 higher than 150 for greater No Pneumatic assembly failure
than 15 seconds while idle
975 System Calibration data storage exhausted No Return to depot for software
while saving data in CAL Mode installation
E13 Battery Battery too low to operate the unit No Charge battery
External DC source failed
Replace battery
E83 NIBP NIBP inflation time out Yes Leak in cuff or o-ring in hose
Internal leak in tubing or
pneumatic valve
Pump not turning on
E84 NIBP NIBP total time out Yes Pneumatic assembly failure
E85 NIBP NIBP level time out Yes Cuff placement on patient
Minor leak in cuff
Pneumatic assembly failure
E89 NIBP NIBP no pulse detected Yes Cuff placement on patient
*Acknowledging an alarm by pressing the Silence button, cancels the alarm.
** Call Technical Support for definitions and instructions.
Ordering Parts
This section of the manual provides parts lists for the ProCare Monitor. Parts lists
should be used in conjunction with the other chapters of this manual.
Battery 633178CR
BP:
TEMPERATURE:
SPO2:
NELLCOR**:
Masimo***:
WARNING
REPAIR TO THE FRU LEVEL - Field repairs are recommended to
the field replaceable unit (FRU) only. Attempting a field repair
on a PCB or a factory sealed component or assembly could
jeopardize the safe and effective operation of the monitor.
FRU List
The following table offers details of each of the corresponding bubble numbers
that appear on the exploded engineering-assembly drawing (drawing is located
after this table).
Bubble
Part Number Description
Number
20 2010429-001 KIT, FRU, SIDE LABEL AND FASCIA, ENGLISH, DPC400, PRINT
Bubble
Part Number Description
Number
20 2008329-001 PLASTIC DISPLAY COVER 400 ENGLISH 2010371-001 PLASTIC DISPLAY COVER,
DPC200, NORWEGIAN
20 2008330-001 PLASTIC DISPLAY COVER 300 ENGLISH 2010372-001 PLASTIC DISPLAY COVER,
DPC100, NORWEGIAN
20 2008331-001 PLASTIC DISPLAY COVER 200 ENGLISH 2010381-001 PLASTIC DISPLAY COVER,
DPC400, FINNISH
20 2008332-001 PLASTIC DISPLAY COVER 100 ENGLISH 2010382-001 PLASTIC DISPLAY COVER, DPC
300, FINNISH
20 2008498-001 PLASTIC DISPLAY COVER 400 FRENCH 2010383-001 PLASTIC DISPLAY COVER, DPC
200, FINNISH
20 2008499-001 PLASTIC DISPLAY COVER 300 FRENCH 2010384-001 PLASTIC DISPLAY COVER, DPC100,
FINNISH
20 2008500-001 PLASTIC DISPLAY COVER 200 FRENCH 2010385-001 PLASTIC DISPLAY COVER, DPC400,
PORTUGUESE
20 2008501-001 PLASTIC DISPLAY COVER 100 FRENCH 2010386-001 PLASTIC DISPLAY COVER, DPC300,
PORTUGUESE
20 2008502-001 PLASTIC DISPLAY COVER 400 GERMAN 2010387-001 PLASTIC DISPLAY COVER,
DPC200, PORTUGUESE
20 2008503-001 PLASTIC DISPLAY COVER 300 GERMAN 2010388-001 PLASTIC DISPLAY COVER,
DPC100, PORTUGUESE
20 2008504-001 PLASTIC DISPLAY COVER 200 GERMAN 2010390-001 PLASTIC DISPLAY COVER,
DPC400, RUSSIAN
20 2008505-001 PLASTIC DISPLAY COVER 100 GERMAN 2010391-001 PLASTIC DISPLAY COVER,
DPC300, RUSSIAN
20 2008506-001 PLASTIC DISPLAY COVER 400 SPANISH 2010392-001 PLASTIC DISPLAY COVER,
DPC200, RUSSIAN
20 2008507-001 PLASTIC DISPLAY COVER 300 SPANISH 2010393-001 PLASTIC DISPLAY COVER,
DPC100, RUSSIAN
20 2008508-001 PLASTIC DISPLAY COVER 200 SPANISH 2010399-001 PLASTIC DISPLAY COVER,
DPC400, HUNGARIAN
20 2008509-001 PLASTIC DISPLAY COVER 100 SPANISH 2010400-001 PLASTIC DISPLAY COVER,
DPC300, HUNGARIAN
Bubble
Part Number Description
Number
20 2008510-001 PLASTIC DISPLAY COVER 400 ITALIAN 2010401-001 PLASTIC DISPLAY COVER, DPC200,
HUNGARIAN
20 2008511-001 PLASTIC DISPLAY COVER 300 ITALIAN 2010402-001 PLASTIC DISPLAY COVER, DPC100,
HUNGARIAN
20 2008512-001 PLASTIC DISPLAY COVER 200 ITALIAN 2010403-001 PLASTIC DISPLAY COVER, DPC400,
CZECH
20 2008513-001 PLASTIC DISPLAY COVER 100 ITALIAN 2010404-001 PLASTIC DISPLAY COVER, DPC300,
CZECH
20 2008514-001 PLASTIC DISPLAY COVER 400 SWEDISH 2010405-001 PLASTIC DISPLAY COVER,
DPC200, CZECH
20 2008515-001 PLASTIC DISPLAY COVER 300 SWEDISH 2010406-001 PLASTIC DISPLAY COVER,
DPC100, CZECH
20 2008516-001 PLASTIC DISPLAY COVER 200 SWEDISH 2010407-001 PLASTIC DISPLAY COVER,
DPC400, SLOVAK
20 2008517-001 PLASTIC DISPLAY COVER 100 SWEDISH 2010408-001 PLASTIC DISPLAY COVER,
DPC300, SLOVAK
20 2008518-001 PLASTIC DISPLAY COVER 400 DUTCH 2010409-001 PLASTIC DISPLAY COVER, DPC200,
SLOVAK
20 2008519-001 PLASTIC DISPLAY COVER 300 DUTCH 2010410-001 PLASTIC DISPLAY COVER, DPC100,
SLOVAK
20 2008520-001 PLASTIC DISPLAY COVER 200 DUTCH 2010411-001 PLASTIC DISPLAY COVER, DPC400,
POLISH
20 2008521-001 PLASTIC DISPLAY COVER 100 DUTCH 2010412-001 PLASTIC DISPLAY COVER, DPC300,
POLISH
20 2009481-001 LABEL, DISPLAY COVERS, CHINESE, 400 2010413-001 PLASTIC DISPLAY COVER,
DPC200, POLISH
20 2009482-001 LABEL, DISPLAY COVERS, CHINESE, 300 2010414-001 PLASTIC DISPLAY COVER,
DPC100, POLISH
20 2009483-001 LABEL, DISPLAY COVERS, CHINESE, 200 2010349-001 PLASTIC DISPLAY COVER, DPC
400,GREEK
20 2009484-001 LABEL, DISPLAY COVERS, CHINESE, 100 2010350-001 PLASTIC DISPLAY COVER,
DPC300, GREEK
20 2010365-001 PLASTIC DISPLAY COVER, DPC400, DANISH 2010351-001 PLASTIC DISPLAY COVER,
DPC 200,GREEK
20 2010366-001 PLASTIC DISPLAY COVER, DPC300, DANISH 2010352-001 PLASTIC DISPLAY COVER,
DPC100, GREEK
20 2010367-001 PLASTIC DISPLAY COVER, DPC200, DANISH 2010353-001 PLASTIC DISPLAY COVER,
DPC 400,JAPANESE
Bubble
Part Number Description
Number
20 2010368-001 PLASTIC DISPLAY COVER, DPC100, DANISH 2010354-001 PLASTIC DISPLAY COVER,
DPC 300, JAPANESE
20 2008333-001 LABEL FASCIA PRO CARE 400 ENGLISH 2009407-001 LABEL FASCIA, NORWEGIAN 200
20 2008334-001 LABEL FASCIA PRO CARE 300 ENGLISH 2009409-001 LABEL FASCIA, NORWEGIAN 100
20 2008335-001 LABEL FASCIA PRO CARE 200 ENGLISH 2009414-001 LABEL, FASCIA, PROCARE,
FINNISH 400
20 2008336-001 LABEL FASCIA PRO CARE 100 ENGLISH 2009415-001 LABEL, FASCIA, PROCARE,
FINNISH 300
20 2008405-001 LABEL FASCIA PRO CARE 400 FRENCH 2009416-001 LABEL, FASCIA, PROCARE,
FINNISH 200
20 2008406-001 LABEL FASCIA PRO CARE 300 FRENCH 2009417-001 LABEL, FASCIA, PROCARE,
FINNISH 100
20 2008407-001 LABEL FASCIA PRO CARE 200 FRENCH 2009418-001 LABEL, FASCIA, PORTUGUESE 400
20 2008408-001 LABEL FASCIA PRO CARE 100 FRENCH 2009419-001 LABEL, FASCIA, PORTUGUESE 300
20 2008409-001 LABEL FASCIA PRO CARE 400 GERMAN 2009420-001 LABEL, FASCIA, PORTUGUESE 200
20 2008410-001 LABEL FASCIA PRO CARE 300 GERMAN 2009421-001 LABEL, FASCIA, PORTUGUESE 100
20 2008411-001 LABEL FASCIA PRO CARE 200 GERMAN 2009422-001 LABEL, FASCIA, PROCARE,
RUSSIAN 400
20 2008412-001 LABEL FASCIA PRO CARE 100 GERMAN 2009423-001 LABEL, FASCIA, PROCARE,
RUSSIAN 300
20 2008413-001 LABEL FASCIA PROCARE 400 SPANISH 2009424-001 LABEL, FASCIA, PROCARE,
RUSSIAN 200
20 2008414-001 LABEL FASCIA PROCARE 300 SPANISH 2009425-001 LABEL, FASCIA, PROCARE,
RUSSIAN 100
20 2008415-001 LABEL FASCIA PROCARE 200 SPANISH 2009426-001 LABEL, FASCIA, HUNGARIAN 400
20 2008416-001 LABEL FASCIA PROCARE 100 SPANISH 2009427-001 LABEL, FASCIA, HUNGARIAN 300
20 2008417-001 LABEL FASCIA PROCARE 400 ITALIAN 2009428-001 LABEL, FASCIA, HUNGARIAN 200
20 2008418-001 LABEL FASCIA PRO CARE 300 ITALIAN 2009429-001 LABEL, FASCIA, HUNGARIAN 100
20 2008419-001 LABEL FASCIA PRO CARE 200 ITALIAN 2009430-001 LABEL, FASCIA, CZECH 400
20 2008420-001 LABEL FASCIA PRO CARE 100 ITALIAN 2009431-001 LABEL, FASCIA, CZECH 300
20 2008421-001 LABEL, FASCIA, PRO CARE 400, SWEDISH 2009432-001 LABEL, FASCIA, CZECH 200
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Part Number Description
Number
20 2008422-001 LABEL, FASCIA, PRO CARE 300, SWEDISH 2009433-001 LABEL, FASCIA, CZECH 100
20 2008423-001 LABEL, FASCIA, PRO CARE 200, SWEDISH 2009434-001 LABEL, FASCIA, SLOVAK 400
20 2008424-001 LABEL, FASCIA, PRO CARE 100, SWEDISH 2009435-001 LABEL, FASCIA, SLOVAK 300
20 2008425-001 LABEL FASCIA PRO CARE 400 DUTCH 2009436-001 LABEL, FASCIA, SLOVAK 200
20 2008426-001 LABEL FASCIA PRO CARE 300 DUTCH 2009438-001 LABEL, FASCIA, SLOVAK 100
20 2008427-001 LABEL FASCIA PRO CARE 200 DUTCH 2009439-001 LABEL,FASCIA, POLISH 400
20 2008428-001 LABEL FASCIA PRO CARE 100 DUTCH 2009440-001 LABEL,FASCIA, POLISH 300
20 2009402-001 LABEL FASCIA, DANISH 200 2009396-001 LABEL FASCIA, JAPANESE 400
20 2009403-001 LABEL FASCIA, DANISH 100 2009397-001 LABEL FASCIA, JAPANESE 300
20 2009404-001 LABEL FASCIA, NORWEGIAN 400 2009398-001 LABEL FASCIA, JAPANESE 200
20 2009406-001 LABEL FASCIA, NORWEGIAN 300 2009399-001 LABEL FASCIA, JAPANESE 100
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Part Number Description
Number
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Part Number Description
Number
21 2010733-001 LABEL,KEYPAD,DPC400,ENGLISH,PRINTERLESS
21 2010734-001 LABEL,KEYPAD,DPC300,ENGLISH,PRINTERLESS
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Part Number Description
Number
21 2010735-001 LABEL,KEYPAD,DPC200,ENGLISH,PRINTERLESS
21 2010736-001 LABEL,KEYPAD,DPC100,ENGLISH,PRINTERLESS
21 2010737-001 LABEL,KEYPAD,DPC400,FRENCH,PRINTERLESS
21 2010738-001 LABEL,KEYPAD,DPC300,FRENCH,PRINTERLESS
21 2010739-001 LABEL,KEYPAD,DPC200,FRENCH,PRINTERLESS
21 2010740-001 LABEL,KEYPAD,DPC100,FRENCH,PRINTERLESS
21 2010741-001 LABEL,KEYPAD,DPC400,GERMAN,PRINERLESS
21 2010742-001 LABEL,KEYPAD,DPC300,GERMAN,PRINTERLESS
21 2010743-001 LABEL,KEYPAD,DPC200,GERMAN,PRINTERLESS
21 2010744-001 LABEL,KEYPAD,DPC100,GERMAN,PRINTERLESS
21 2010745-001 LABEL,KEYPAD,DPC400,SPANISH,PRINTERLESS
21 2010746-001 LABEL,KEYPAD,DPC300,SPANISH,PRINTERLESS
21 2010747-001 LABEL,KEYPAD,DPC200,SPANISH,PRINTERLESS
21 2010748-001 LABEL,KEYPAD,DPC100,SPANISH,PRINTERLESS
21 2010749-001 LABEL,KEYPAD,DPC400,ITALIAN,PRINTERLESS
21 2010750-001 LABEL,KEYPAD,DPC300,ITALIAN,PRINTERLESS
21 2010751-001 LABEL,KEYPAD,DPC200,ITALIAN,PRINTERLESS
21 2010752-001 LABEL,KEYPAD,DPC100,ITALIAN,PRINTERLESS
21 2010753-001 LABEL,KEYPAD,DPC400,SWEDISH,PRINTERLESS
21 2010767-001 LABEL,KEYPAD,DPC200,JAPANESE,PRINTERLESS
21 2010768-001 LABEL,KEYPAD,DPC100,JAPANESE,PRINTERLESS
21 2010770-001 LABEL,KEYPAD,DPC400,DANISH,PRINTERLESS
21 2010771-001 LABEL,KEYPAD,DPC300,DANISH,PRINTERLESS
21 2010772-001 LABEL,KEYPAD,DPC200,DANISH,PRINTERLESS
21 2010773-001 LABEL,KEYPAD,DPC100,DANISH,PRINTERLESS
21 2010774-001 LABEL,KEYPAD,DPC400,NORWEGIAN,PRINTRLESS
21 2010775-001 LABEL,KEYPAD,DPC300,NORWEGIAN,PRINTRLESS
21 2010776-001 LABEL,KEYPAD,DPC200,NORWEGIAN,PRINTRLESS
21 2010777-001 LABEL,KEYPAD,DPC100,NORWEGIAN,PRINTRLESS
21 2010782-001 LABEL,KEYPAD,DPC400,FINNISH,PRINTERLESS
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Part Number Description
Number
21 2010783-001 LABEL,KEYPAD,DPC300,FINNISH,PRINTERLESS
21 2010784-001 LABEL,KEYPAD,DPC200,FINNISH,PRINTERLESS
21 2010785-001 LABEL,KEYPAD,DPC100,FINNISH,PRINTERLESS
21 2010786-001 LABEL,KEYPAD,DPC400,PORTUGUESE,PRINTLESS
21 2010788-001 LABEL,KEYPAD,DPC300,PORTUGUESE,PRINTLESS
21 2010789-001 LABEL,KEYPAD,DPC200,PORTUGUESE,PRINTLESS
21 2010790-001 LABEL,KEYPAD,DPC100,PORTUGUESE,PRINTLESS
21 2010791-001 LABEL.KEYPAD,DPC400,RUSSIAN,PRINTERLESS
21 2010792-001 LABEL,KEYPAD,DPC300,RUSSIAN,PRINTERLESS
21 2010793-001 LABEL,KEYPAD,DPC200,RUSSIAN,PRINTERLESS
21 2010794-001 LABEL,KEYPAD,DPC100,RUSSIAN,PRINTERLESS
21 2010795-001 LABEL,KEYPAD,DPC400,HUNGARIAN,PRINTRLESS
21 2010796-001 LABEL,KEYPAD,DPC300,HUNGARIAN,PRINTRLESS
21 2010797-001 LABEL,KEYPAD,DPC200,HUNGARIAN,PRINTRLESS
21 2010798-001 LABEL,KEYPAD,DPC100,HUNGARIAN,PRINTRLESS
21 2010799-001 LABEL,KEYPAD,DPC400,CZECH,PRINTERLESS
21 2010800-001 LABEL,KEYPAD,DPC300,CZECH,PRINTERLESS
21 2010801-001 LABEL,KEYPAD,DPC200,CZECH,PRINTERLESS
21 2010802-001 LABEL,KEYPAD,DPC100,CZECH,PRINTERLESS
21 2010803-001 LABEL,KEYPAD,DPC400,SLOVAK,PRINTERLESS
21 2010804-001 LABEL,KEYPAD,DPC300,SLOVAK,PRINTERLESS
21 2010805-001 LABEL,KEYPAD,DPC200,SLOVAK,PRINTERLESS
21 2010806-001 LABEL,KEYPAD,DPC100,SLOVAK,PRINTERLESS
21 2010807-001 LABEL,KEYPAD,DPC400,POLISH,PRINTERLESS
21 2010808-001 LABEL,KEYPAD,DPC300,POLISH,PRINTERLESS
21 2010809-001 LABEL,KEYPAD,DPC200,POLISH,PRINTERLESS
21 2010810-001 LABEL,KEYPAD,DPC100,POLISH,PRINTERLESS
21 2010811-001 LABEL,KEYPAD,DPC400,GREEK,PRINTERLESS
21 2010812-001 LABEL,KEYPAD,DPC300,GREEK,PRINTERLESS
21 2010813-001 LABEL,KEYPAD,DPC200,GREEK,PRINTERLESS
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Part Number Description
Number
21 2010814-001 LABEL,KEYPAD,DPC100,GREEK,PRINTERLESS
21 2010819-001 LABEL,KEYPAD,DPC400,ENGLISH,AUSC,PRNTLSS
21 2010820-001 LABEL,KEYPAD,DPC300,ENGLISH,AUSC,PRNTLSS
21 2010821-001 LABEL,KEYPAD,DPC200,ENGLISH,AUSC,PRNTLSS
21 2010822-001 LABEL,KEYPAD,DPC100,ENGLISH,AUSC,PRNTLSS
1
20
5,6
23
21
20
23
12
12
5,6
4
12
2,3
8,9,10
12
5,6 12
14
12
12
14
14
19
14
12
14
12
14
12
12
18
5,6
25
5, 6
14
12
5,6,7
12
5,6,7
5,6
15
5
12
13,5,24
Assembly/Disassembly of FRUs
Monitor Disassembly Procedure
The following procedure is sequential (i.e., you must remove the battery and rear
case to remove the printer, etc.
Battery
1. Remove 4 screws securing the instruction cards.
Rear Case
1. Remove remaining four screws from the bottom of the monitor.
2. Set monitor upright.
Printer
1. Unplug air hose from valve and 2 elbow joints.
2. Remove 3 cable assemblies.
SpO2 Board
Main Board
1. Remove 5 phillips screws.
Display Board
1. Carefully lift the Main board away from the Display board.
2. Collect the 5 spacers used to align the Main and Display Boards.
3. Lift the display board away from the front panel.
Specifications
Mechanical
Dimensions Height: 9.7 in (24.7 cm)
Width: 8.6 in (21.9 cm) without Temperature
10.0 in (25.4 cm) with Temperature
Depth: 5.3 in (13.5 cm)
Power Requirements
Power Converter US P/N: 2018859-001
Protection against electrical shock: Class II
AC input: 100-250 VAC/50-60 Hz 12W
DC output voltage: 12VDC at 1.0A
The AC mains power adapter contains a
nonresettable and nonreplaceable fuse.
Environmental
Operating Temperature + 5 °C to + 40 °C
(+ 41 °F to + 104 °F)
Operating Atmospheric
Pressure 700 hPa to 1060 hPa
Storage Temperature – 20 °C to + 50 °C
(– 4 °F to + 122 °F)
Storage/Transportation
Atmospheric Pressure 500 hPa to 1060 hPa
BP
Cuff Pressure Range 0 to 290 mmHg (adult/ped)
(Normal operating range) 0 to 140 mmHg (neonate)
All DINAMAP® Monitor regulatory and accuracy studies have been performed
using CRITIKON® Blood Pressure Cuffs. Use only CRITIKON® Blood Pressure
Cuffs. The size, shape, and bladder characteristics can affect the
performance of the instrument. Inaccurate readings may occur unless
CRITIKON® Blood Pressure Cuffs are used.
Critikon US Patents
4,360,029; 4,501,280; 4,546,775; 4,638,810; 5,052,397; 4,349,034; 4,543,962;
4,627,440; 4,754,761; 5,170,795
European Patents
EP122123, EP205805, EP207807
Nellcor SpO2
Measurement Range
SpO2 1 to 100%
Pulse Rate 20 to 250 beats/min
Saturation
Adults* 70 to 100% ±2 digits
Neonate* 70 to 100% ±3 digits
Low Perfusion** 70 to 100% ±2 digits
0 to 69% unspecified
Pulse Rate
Adult and Neonate 20 to 250 beats/min ±3 digits
Low Perfusion** 20 to 250 beats/min ±3 digits
*Adult specifications are shown for OxiMax® MAX-A and MAX-N sensors with the N-600. Neonate
specifications are shown for OxiMax® MAX-N with the N-600. Saturation accuracy will vary by sensor
type.
NOTE: All NELLCOR® sensors must be used with the NELLCOR® DOC-10 cable;
the SCP-10 cable is not compatible with the ProCare Monitor.
OxiMax®
MAX-A*, MAX-AL* ±2 digits
MAX-N*† (Adult) ±2 digits
MAX-N*† (Neonate) ±3 digits
MAX-P* ±2 digits
MAX-I* ±2 digits
MAX-R*‡ ±3.5 digits
OxiCliq®
OxiCliq A ±2.5 digits
OxiCliq P ±2.5 digits
OxiCliq N† (Adult) ±2.5 digits
OxiCliq N† (Neonate) ±3.5 digits
OxiCliq I ±2.5 digits
* The accuracy specification under motion conditions is ±3. For a definition of motion, contact
NELLCOR® Technical Services or your local representative.
† The MAX-N and the OxiCliq N were tested on patients >40 kg.
‡
The accuracy specification has been determined between saturations of 80%-100%.
NELLCOR® Patents
US Patent No. 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136; 5,485,847;
5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310; 6,591,123; 6,675,031;
6,708,049; 6,801,797; Re. 35,122 and foreign equivalents.
Masimo SpO2
Measurement Range
SpO2 1 to 100%
Pulse Rate 25 to 240 beats/min
Perfusion Range 0.02 to 20%
Saturation
Without Motion - Adult/Ped* 70 to 100% ±2 digits
Without Motion - Neonate* 70 to 100% ±3 digits
With Motion - Adult/Ped/Neo**†70 to 100% ±3 digits
Low Perfusion‡ 70 to 100% ±2 digits
0 to 69% unspecified
Pulse Rate
Without Motion 25 to 240 beats/min ±3 digits
With Motion normal physiologic range
25 to 240 beats/min ±5 digits
* The Masimo SET® SpO2 parameter with LNOP-Adt sensors has been validated for no motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a
laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or
minus one standard deviation encompasses 68% of the population.
**The Masimo SET® SpO2 parameter with LNOP-Adt sensors has been validated for motion accuracy in
human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and
tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a nonrepetitive motion between 1 to 5 Hz at
an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory
co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
†The Masimo SET® SpO2 parameter with LNOP-Neo Pt sensors has been validated for neonatal motion
accuracy in human blood studies on neonates while moving the neonate’s foot at 2 to 4 cm against a
laboratory co-oximeter and ECG monitor. This variation equals plus or minus, one standard deviation.Plus or
minus one standard deviation encompasses 68% of the population.
‡The Masimo SET® SpO2 parameter has been validated for low perfusion accuracy in bench top testing
against a Biotek Index 2 stimulator and Masimo’s simulator with signal strengths of greater than 0.02% and
a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or
minus, one standard deviation.Plus or minus one standard deviation encompasses 68% of the population.
Resolution
Saturation (% SpO2) 1%
Pulse Rate (bpm) 1
Interfering Substances
Carboxyhemoglobin may erroneously increase readings. The level of increase is
approximately equal to the amount of carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change usual arterial pigmentation may cause
erroneous readings.
Masimo Patents
5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952;
6,036,642; 6,067,462; 6,206,830; 6,157,850, and international equivalents.
Temperature
Scale °Fahrenheit (F)
°Celsius (C)
Range
Predictive mode Max: 41.1° C; 106.0° F
Min: 35.6° C; 96.0° F
Monitor mode Max: 41.1° C; 106.0° F
Min: 26.7° C; 80.0° F
Use only IVAC® probes and P850A probe covers. The size, shape, and thermal
characteristics of the probe covers can affect the performance of the
instrument. Inaccurate readings or retention problems may occur unless
IVAC® probes and probe covers are used. Refer to Appendix D for reorder
codes.
IVAC® Patents
U.S. D300,728, D300,909
Pulse Rate
Factory Default Settings
Pulse Rate HIGH: 150
LOW: 50
GE Healthcare has established accuracy using the AAMI SP-10 standard (2) and
a similar standard exists in Europe (3). The AAMI standard specifies that the
accuracy of NIBP monitors can be determined using either an invasive (intra-
arterial) or noninvasive (auscultatory) blood pressure reference. Over the last 30
years, DINAMAP® accuracy has been established using an invasive central
aortic blood pressure reference. More recently, the DINAMAP ProCare Monitor
has also been validated against a manual auscultatory reference.
Unlike the transducers/electrodes used in these devices, the NIBP cuff has two
functions. In addition to sensing the pressure pulses in the cuff, the cuff occludes
and then releases the patient's artery to create the conditions that allow blood
pressure to be measured.
An "artificial arm" would need to test both the sensing and occluding functions of
the cuff, and mimic the nonlinear dynamics of the artery to provide an effective
clinical simulation. While this has been attempted (4), there are no effective
"arms" available.
Commercial NIBP simulators do attempt to test either function of the NIBP cuff.
Pressure signals are generated by the simulator in response to the inflation and
deflation cycles of the monitor. While the cuff may be in the system, it is
wrapped on a mandrel. The ability of the cuff to transducer pressure signals or
to occlude the artery is not tested.
There are further limitations to the pressure pulses used by simulators. During
the deflation of the cuff, the shape of the generated pressure oscillations
changes as the cuff goes from systolic to diastolic pressures. This is due to the
fact that the artery is only open when the arterial pressure is above cuff
pressure. As can be seen in Figures 1A-1C, the shape of the oscillation changes
as the cuff pressure changes, and the artery opens. Commercial NIBP simulators
use one waveform shape at all pressure levels, which is simply scaled to reflect
the oscillometric envelope.
"Since the CuffLink produces the same response independent of the inflate/
deflate cycle or the algorithm used by the monitor, we offer the term "Target
Value" as an approximation of the patient's actual blood pressure" (5)
"Neither the monitor or the BP Pump 2 is broken. Some monitors were designed
to give readings close to those obtained by the Auscultatory method of blood
pressure determinations. Other monitors have been designed to agree with
Invasive blood pressure readings. It is well known that Invasive and Auscultatory
BP readings on the same subject can be quite different" (6)
Simulators can also be used to test for leaks and conduct static pressure
calibration of NIBP monitors and as part of preventive maintenance programs.
Summary
The accuracy of an NIBP monitor can only be determined by comparison to a
clinical blood pressure reference. NIBP simulators are useful for certain types of
testing, but should not be used for accuracy testing.
References
1. FDA, CDRH, Non-Invasive Blood Pressure (NIBP) Monitor Guidance, March 10,
1997
2. ANSI/AAMI SP10:2002, Manual, Electronic or Automated
Sphygmomanometers
CAUTION
Use of portable phones or other radio frequency (RF) emitting
equipment near the system may cause unexpected or adverse
operation.
RF Emissions Group 1 The equipment uses RF energy only for its internal function.
EN 55011 Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF Emissions Class B
EN 55011
Harmonic Emissions Class A The equipment is suitable for use in all establishments, including
IEC 61000-3-2 domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic
Discharge (ESD) tile. If floors are covered with synthetic
IEC 61000-4-2 ± 8 kV air ± 8 kV air material, the relative humidity should be at
least 30%.
Electrical Fast ± 2 kV for power supply ± 2 kV for power Mains power should be that of a typical
Transient/Burst lines supply lines commercial or hospital environment.
IEC 61000-4-4
±1 kV for input/output ±1 kV for input/
lines output lines
Surge ± 1 kV differential mode ± 1 kV differential Mains power should be that of a typical
IEC 61000-4-5 mode commercial or hospital environment.
Voltage dips, <40% Ut (>60% dip in Ut) <40% Ut (>60% dip Mains power should be that of a typical
short for 5 cycles in Ut) for 5 cycles commercial or hospital environment. If the
interruptions user of the equipment requires continued
and voltage <70% Ut (>30% dip in Ut) <70% Ut (>30% dip operation during power mains interruptions,
variations on for 25 cycles in Ut) for 25 cycles it is recommended that the equipment be
power supply powered from an uninterruptible power
input lines supply or a battery.
IEC 61000-4-11
NOTE:
Ut is the AC mains voltage prior to application of the test level.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by reflection from
structures, objects, and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the equipment is used
exceeds the applicable RF compliance level above, the equipment should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the equipment.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
Rated Maximum Output 150 kHz to 80 MHz a 80 MHz to 800 MHz a 800 MHz to 2.5 GHz a
Power of Transmitter in
Watts d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
100 12 12 23
a
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
For transmitters rated at a maximum output power not listed above, the
recommended separation distance [d] in meters (m) can be estimated using the
equitation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE:
These guidelines may not apply in all instances. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
CAUTION
The use of accessories, transducers and cables other than
those specified may result in increased emissions or decreased
immunity performance of the equipment or system.
The table below lists cables, transducers, and other applicable accessories with
which GE Medical Systems claims EMC compliance.
NOTE: Any supplied accessories that do not affect EMC compliance are not
included.
Accessories
0459