Critikon Dinamap Pro1000V3, Dinamap Pro1000V Pre-Service manual
PRO 1000V3 Monitor
Pre-Service and
Calibration
Manual
DINAMAP PRO 1000V3 Monitor
Pre-Service & Calibration Manual
List of Effective Pages
Part No./Rev. Page No. Date of Latest Revision
2012820-001 A
CAUTION: Federal (U.S.A.) law restricts this device to sale
by or on the order of a health care practitioner.
The content of this document, including all figures and
drawings, is proprietary information of General Electric
Medical Systems Information Technologies, provided
solely for purposes of operation, maintenance or repair of
PRO 1000V3 Monitors. Dissemination for other purposes
or copying thereof without the prior written consent of
General Electric Medical Systems Information
Technologies, Tampa, Florida, is prohibited. Illustrations
may show design models; production units may
incorporate changes.
© Copyright 2003, GE Medical Systems Information
Technologies. All rights reserved.
Printed in U.S.A.
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Tel: +414.355.5000
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Fax:+414.355.3790
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All Original. 2003
TABLE OF CONTENTS
GENERAL MAINTENANCE
1.1. Introduction ............................................................................................... 1-3
1.2. Setting up the PRO 1000V3 Monitor for the First Time ............................. 1-3
1.2.1 Unpacking and Preparation for Installation................................................ 1-3
1.2.2 Set the Date and the Clock ....................................................................... 1-5
1.2.3 Parameter Level Functional Testing.......................................................... 1-6
1.3. Periodic Maintenance................................................................................ 1-8
1.3.1. Required.................................................................................................... 1-8
1.3.1.1 Integrity of Cuffs and Hoses .................................................................. 1-8
1.3.1.2 Cleaning of the Monitor .........................................................................1-8
1.3.1.3 Cleaning of Accessories....................................................................... 1-8
1.3.1.4 Long-Term Storage ............................................................................ 1-10
1.3.2 Annual Procedures ................................................................................. 1-10
1.4. Care of Storage Batteries ....................................................................... 1-11
1.4.1. Procedures for First Use......................................................................... 1-11
1.4.2 Battery Charging..................................................................................... 1-11
1.4.3 Battery Troubleshooting.......................................................................... 1-12
1.5 Safety Resistance Testing ...................................................................... 1-13
1.6. Hi-Pot Tests............................................................................................ 1-14
1.6.1. AC Mains Hi-Pot ..................................................................................... 1-15
1.6.2. ECG/SpO
1.7. Service Mode Operation ......................................................................... 1-16
1.7.1 SpO2 Tests ............................................................................................. 1-18
1.7.1.1 For Monitors With Nellcor SpO
1.7.1.2 For Monitors With Nellcor SpO
1.7.2 NIBP Tests ............................................................................................. 1-20
1.7.2.1 Leak Test............................................................................................ 1-21
1.7.2.2 NIBP Calibration Check ...................................................................... 1-23
1.7.2.3 Pressure Recalibration ....................................................................... 1-24
1.7.2.4 Overpressure Test .............................................................................. 1-26
1.7.3 ECG Tests .............................................................................................. 1-27
1.7.4 RESP Tests ............................................................................................ 1-29
1.7.5 TEMP Tests............................................................................................ 1-29
1.7.6 Recorder Tests ....................................................................................... 1-30
1.7.7 Battery Tests .......................................................................................... 1-32
1.7.8 Failsafe Logic Test ................................................................................. 1-34
1.7.9 Keypad LED Test ................................................................................... 1-34
1.7.10 Keypad KEY Test ................................................................................... 1-34
1.7.11 Sound Test ............................................................................................. 1-35
1.7.12 Communications Tests........................................................................... 1-35
1.7.12.1 Set up Terminal ................................................................................1-35
1.7.12.2 Configure UUT for Communication................................................... 1-35
/TEMP Hi-Pot ........................................................................ 1-15
2
.......................................................... 1-18
2
.......................................................... 1-19
2
1.7.12.3 Communication Test......................................................................... 1-35
1.7.14 Turn off System ...................................................................................... 1-36
1.8 Service Mode Exit................................................................................... 1-36
APPENDIX A: Test Record
APPENDIX B: Monitor Configuration Log
APPENDIX C: Error Codes
APPENDIX D: Required Service Equipment
APPENDIX E: Troubleshooting
APPENDIX F: Field Replacement Units (FRUs)
DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
GENERAL MAINTENANCE
1.1 INTRODUCTION This section contains general DINAMAP PRO 1000V3
Monitor service procedures, including alarm code
interpretation, service mode operation, periodic
maintenance, and battery care.
1.2 SETTING UP THE DINAMAP PRO 1000V3
MONITOR FOR THE FIRST TIME
1.2.1
Unpacking
and
Preparation
for
Installation
Unpack and identify the contents of all shipping materials:
1. Remove the Monitor.
2. Unpack the AC cord but do not plug the Monitor in at this time.
3. Turn the Monitor to the backside for access to the Host Comms
Cover.
Rear View of Monitor
4. Use a Phillips-head screwdriver to remove the single screw that
secures the Host Comms cover.
5. The Battery fuse and the Fuse Holder are not connected at time of
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
shipment. Locate and remove the fuse and fuse.
6. Identify the Battery Fuse holder located within the Host Comms
well, behind the Host Comms cover, near the lower left side.
Note: The battery is not located behind the Host Comms cover.
7. Insert the Battery Fuse into the Battery Fuse holder.
8. Press the Battery Fuse Holder into the Battery Fuse mount using
thumb pressure until it is securely snapped in place.
9. Replace the Host Comms cover; refasten the Phillips screw.
Tighten using hand-tools only.
10. Plug the AC cord into the AC Mains input at the back of the
Monitor.
Rear View of Monitor
11. Plug the AC cord into a Hospital Grounded AC receptacle. A green
LED illuminates on the front of the Monitor indicating that an AC
source is available.
Prior to usage, it is necessary to charge the Monitor for 12 hours.
This calibrates the battery circuitry with the charge status of the
battery.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
1.2.2 Set the Date and
the Clock The Monitor uses a SelectKnob to navigate through
the menu systems. Rotating the SelectKnob moves
the arrow cursor, and pressing the SelectKnob makes
the selection.
1. Power on the Monitor using the OFF/ON
button.
2. Use the SelectKnob to select the no option
when the Monitor prompts to admit a new
patient.
3. Press or turn the SelectKnob to access the
main menu.
4. Turn the SelectKnob to scroll down the
menu. The arrow at the bottom of the list
indicates that the list continues on a second
screen. Highlight the other system
settings option and press the SelectKnob.
5. Turn the SelectKnob to scroll down the
menu to highlight the Adjust date & time
option. Press the SelectKnob to continue.
6. Turn the SelectKnob to scroll down and
highlight the appropriate date and time
components to be changed if necessary
(Month, Day, Year, Hour, Minute, Second).
Press the SelectKnob. The field is
displayed in a box. Turn the SelectKnob to
the desired number and press the
SelectKnob.
7. After all of the settings are changed, use
the SelectKnob to scroll down and highlight
the set new time and date option. Press
the SelectKnob to save the settings and
continue.
8. The message, CAUTION! This will delete
all trends, and stored waveforms. Are you
sure you want to do this?, displays.
Highlight the yes option and press the
SelectKnob.
A pop-up window displays the message,
Clearing all trends, and waveforms, to
confirm that the function is processing.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
1.2.3 Parameter Level
Functional Testing After the initial configuration is complete, perform
functional testing of each of the parameters. Using
the accessories supplied with the Monitor, initialize
the Monitor in such a way that only one parameter is
functioning at a time.
Left Side View of Monitor
Functional tests to be performed:
• A blood pressure test is carried out by
connecting the supplied hose and cuff
together, then attaching them to the NIBP
Connector on the left side of the Monitor.
Press the GO/STOP hardkey on the front to
begin the NIBP cycle.
• Connect the supplied temperature probe to the
corresponding connection (see illustration
above). A predictive temperature begins once
the probe is removed from the holster on the
left side. Replace the probe after completion of
the Temp cycle.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
The SpO2 sensor used depends on the Monitor
configuration.
Nellcor SpO
configured monitors use an
2
assembly consisting of two parts: the
DS-100A, and the extender cable
DOC-10.
Masimo SpO
configured monitors use an
2
assembly consisting of an interface
cable and a sensor.
• Connect the cables prior to attaching to the
Monitor. An SpO2 reading displays within
moments of attaching the sensor to either an
SpO
simulator or to your finger.
2
• Connect the ECG lead connector to the ECG
trunk cable prior to connecting to the Monitor.
The simplest way to function test the ECG
circuits is through the usage of an ECG
simulator.
1. Set the simulator to normal heart rate.
2. Set ECG amplitude to 1.5mV, BPM to
80.
3. Set respirations to 20 RPM and the
delta ohms to 1.0.
4. Verify that the ECG waveform is
displayed.
5. Sequentially remove and reattach leads
I, II, and III, and verify each time that
LEAD OFF displays.
6. From the ECG menu, select turn
parameter off option.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
1.3 PERIODIC
MAINTENANCE
1.3.1 Required Perform the following maintenance procedures as
required.
1.3.1.1 Integrity of
Hoses and Cuffs When the pneumatic integrity of any NIBP cuff or
hose is in doubt, replace the cuff and hose, and
discard the questionable accessories.
1.3.1.2 Cleaning of
the Monitor
CAUTION! Do not clean Monitor with isopropyl alcohol or
other solvents.
Do not immerse unit.
Wipe the exterior of the Monitor with a cloth slightly
dampened with a mild detergent or normal hospital
bactericides. Use dishwashing detergents such as:
IVORY
®
and JOY® (registered trademarks of
Procter & Gamble Corp.)
PALMOLIVE
®
(registered trademark of
Colgate-Palmolive Corp.).
1.3.1.3 Cleaning of
Accessories
Clean the adult cuffs supplied for use with the Monitor
by hand washing in warm, soapy water. However,
take care to avoid entry of water into the cuff and
hoses at any time. If water enters the cuff, dry the
cuff by passing air through it.
The neonatal cuffs are for single patient use - discard
if they become soiled.
Clean cuffs and hoses with a cloth slightly dampened
with mild detergent.
Do not immerse hoses.
Do not immerse cuffs without prior application of cuff
hose caps.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
Clean SpO2 sensor surface before and after each
patient use. Reusable sensors can be wiped with a
70% alcohol solution. If low level subsection is
required, wipe with a 1:10 bleach solution. Do not
use undiluted bleach (5-5.25% sodium hypochlorite)
or any other cleaning solution other than those
recommended here or in the directions for use for the
sensor being used. Permanent damage to the sensor
could occur. Do not immerse the sensor in water or
these cleaning solutions because the sensor and its
connector are not liquid proof. Do not sterilize the
sensor by irradiation, steam autoclave, or with
ethylene oxide. Refer to directions or use for the
appropriate NELLCOR
®
sensor.
Follow manufacturer's instructions for cleaning ECG
lead wires and cable. Compatible cleaning and
disinfecting solutions are dishwashing detergents
such as:
• IVORY
®
and JOY® (registered trademarks of
Procter & Gamble Corp.)
®
• PALMOLIVE
(registered trademark of Colgate-
Palmolive Corp.).
• Chlorine bleach disinfectant, 5.25%, three-quarter
cup per gallon of water.
CAUTION! Do not apply isopropyl alcohol to the Monitor -
some parts can become marred and cracked.
• Isopropyl alcohol (for accessories only).
• Cidex Formula 7 (registered trademark of Johnson
& Johnson Medical Products, Inc.) or pHisoHex
(registered trademark of Winthrop-Breon
Laboratories).
Quaternary-based germicidal detergents such as:
• VESTAL INSURANCE
®
(registered trademark of
the Vestal Corp.).
• HI-TOR PLUS
®
(registered trademark of the
Huntington Corp.).
®
• VIREX
(registered trademark of S.C. Johnson &
Son Corp.).
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
For the above, follow manufacturers'
recommendations for dilution rate and use. These
recommendations are not an endorsement of the
manufacturers or of the effectiveness of these
materials for cleaning or disinfecting.
1.3.1.4 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.
Generally, long-term storage of a nickel-metal hydride
battery in either a charged or discharged condition
has no permanent effect on capacity. Capacity loss
due to self-discharge is reversible, and nickel-metal
hydride batteries can recover to full capacity by
proper recharging. For example, cycling through
repeated charge/discharge cycles can restore a full
capacity of a nickel-metal hydride battery that was
stored at room temperature for up to one year.
Long-term storage at high temperatures can lead to
deterioration of seals and separators and should be
avoided.
1.3.2 Annual
Procedures Perform the test procedures described in paragraph
1.7 every twelve months, or whenever the accuracy of
any reading is in doubt.
NOTE:
An internal, 3.6V NiMh battery acts as an alarm
backup and maintains the nonvolatile RAM memory
when the Monitor is off or away from AC mains. A
system alarm message is generated if backup battery
replacement is required.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
1.4 CARE OF STORAGE
BATTERIES The Monitor uses one nickel-metal-hydride (NiMH)
storage battery. The battery can be charged at any
time without reducing the charging capacity.
1.4.1 Procedures For
First Use Follow these procedures to condition a new NiMH
battery and optimize its performance:
The internal battery automatically charges when the
AC power supply is in use. When the battery is
charged for the first time, the charger may indicate
prematurely that charging is complete. This is normal
and can happen with all rechargeable batteries when
first charged.
1.4.2 Battery Charging The Monitor charges the NiMH battery whenever the
AC power supply is in use. The Monitor automatically
senses if the battery needs recharging. Battery
charging continues whenever it’s needed while 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 prolonged 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. It is not necessary to wait until
they are fully discharged.
• If the Monitor is idle for extended periods, it
should be fully charged once a month to
ensure optimum performance.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
1.4.3 Battery Troubleshooting
Trouble Probable Cause Remedy
Battery inoperative
or does not last very
long.
Battery will not
charge.
Battery not fully
charged.
Battery in long-term
storage or nonuse.
Charging battery in
unusually cold or hot
temperatures.
Charge and discharge battery up
to three times for optimum
performance.
Charge at basic room temperature
of 59° F (16° C) to 86° F (30° C).
Slowly bring battery to basic room
temperature before recharging.
Batteries cannot be fully charged
unless internal temperatures
between 57° F (15° C) and 109° F
(40° C).
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
1.5 SAFETY
RESISTANCE TESTING Using a safety analyzer (Dynatech Nevada Model
235A or equivalent), check the ground resistance of
the Monitor. Refer to the Rear View graphic for
locations of test points.
Rear View of Monitor with Safety Connection Exposed
Earth-To-Secondary
Continuity
AC Mains Leakage –
Normal Polarity
Verify that the resistance between the AC Mains ground
pin and the External DC connector ground is less than 1Ω.
For the following tests, 260 VAC is applied at the Monitor’s
AC Mains input in normal polarity.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
No Fault
Open Ground
Open Neutral
AC Mains Leakage –
Reverse Polarity
No Fault
Open Ground
Open Neutral
Verify that the leakage from line to ground pin is less than
500 µA.
Disconnect the Monitor’s ground lead from earth ground
(for the duration of this test only) and verify that the
leakage from line to ground pin is less than 500 µA.
Open the Monitor’s neutral lead (for this test only) and
verify that the leakage from line to ground is less 500 µA.
For the following tests, 260 VAC is applied at the Monitor’s
AC Mains input in reverse polarity (inputs to line pin and
Neutral pin reversed).
Verify that the leakage from line to ground pole is less than
500 µA.
Disconnect the Monitor’s ground lead from earth ground
(for the duration of this test only) and verify that the
leakage from line to ground is less than 500 µA.
Open the Monitor’s Neutral lead (for the duration of this
test only) and verify that the leakage from line to the
ground is less than 500 µA.
ECG Leakage
Temperature Leakage
SPO2 Leakage
1.6 HI-POT TESTS
CAUTION!
Using ECG probe adapter, verify that the leakage from the
ECG circuit to earth ground is less than 50 µA.
Using Temperature probe adapter, verify that the leakage
from the Temperature circuit to earth ground is less than
150 µA.
Using SPO2 probe adapter, verify that the leakage from
the SPO2 circuit to earth ground is less than 150 µA.
Hi-Pot testing is done on every unit at the factory and
should not be repeated unnecessarily nor performed
more often than required. (If unit is opened for repair,
Hi-Pot testing is required otherwise hi-pot test may be
exempted.)
High voltage will be applied to the monitor under test
when the hi-pot START switch is activated.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
1.6.1 AC Mains Hi-Pot
1. Set the hi-pot timer for 1 minute.
2. If not already set, set the hi-pot TEST VOLTAGE to 1.5
kilovolts AC. To set the hi-pot TEST VOLTAGE for the
first time:
a. Turn the hi-pot power switch off.
b. Disconnect the cables from the front of the hi-
pot.
c. Shut off the timer.
d. Push on the START switch.
e. Adjust the TEST VOLTAGE knob until the
meter reads 1.5 kilovolts AC.
f. Push STOP and turn timer back on.
g. Connect the hi-pot cables to the front of the hi-
pot.
3. Turn the hi-pot power switch off.
4. Plug a power cord into the monitor.
5. Connect the HOT lead from the hi-pot tester to the power
cord line and neutral leads.
6. Connect the GND lead from the hi-pot tester to the power
cord earth ground lead.
7. Turn the hi-pot power switch on.
8. Momentarily raise the hi-pot START switch to start the
test.
9. If the hi-pot does not alarm before the timer expires, the
monitor passed the test.
10. Turn the hi-pot power switch off.
1.6.2 ECG / SPO2 / Temp Hi-pot
1. Turn the hi-pot switch off.
2. Set-up the hi-pot tester to test at 1.5 kilovolts AC for 1
minute (as in the previous test).
3. Insert the ECG, SPO2 and Temperature test adapters
into the monitor under test.
4. Connect the GND hi-pot test cable to the AC MAINS
cable earth ground.
5. Connect the HOT hi-pot test cable to the ECG test
adapter.
6. Turn the hi-pot power switch on.
7. Momentarily raise the hi-pot START switch to start the
test.
8. If the hi-pot does not alarm before the timer expires, the
monitor passed the test.
9. Repeat steps 5 through 8 individually for the SPO2 and
Temperature adaptors.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
10. Turn the hi-pot power switch off and remove hi-pot
cables.
11. Disconnect the probe adapters from the monitor under
test.
1.7 SERVICE MODE
OPERATION The Monitor service mode exercises the built-in
diagnostic features of the Monitor and the installed
parameters. Access the service mode from a cold
start by proceeding as follows:
1. Power on the Monitor using the OFF/ON
button.
2. Use the SelectKnob to select the no option
when the Monitor prompts to admit a new
patient.
3. Press or turn the SelectKnob to access the
main menu.
4. Turn the SelectKnob to scroll down the menu.
The arrow at the bottom of the list indicates
that the list continues on a second screen.
Highlight the other system settings option
and press the SelectKnob.
5. Highlight the go to service mode option and
press the SelectKnob. Turn the SelectKnob
and press the knob again to answer yes at the
prompt to display the dialog box.
6. A row of numbers is displayed at the bottom of
the screen. Turn the SelectKnob and move the
arrow to the desired number, then press the
knob to select the number. Enter the service
mode password, 2-2-1-3.
7. After the password is selected, turn the
SelectKnob to the DONE option and press the
knob.
8. In the process of entering the Service Mode,
the Monitor resets itself. Successful entry into
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
the Service Mode is indicated by the Service
Menu title displayed on the upper left side of
the display.
NOTE:
The service mode can also be entered directly from a
cold start by pressing and holding the following two
keys until full power-up: OFF/ON and AUTO-BP. To
make any changes to the Service Menu, the
password has to be entered: press the SelectKnob to
enter service password.
9. At this point the Service Mode main screen
should be present in the main display, as
shown below. The service menu service
parameters area displays a list that
corresponds to the number and type of
parameters that have been detected by the
Monitor. If the service mode was entered
directly (as described in the NOTE above),
enter service password appears above the
service parameters on the service menu. The
password MUST be entered (as described in
Steps 5 and 6) before any changes to
calibration can be made.
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
For each parameter, there are one or more service
screens that display operating values and tests that
are applicable to the parameter type. Refer to the
following paragraphs for information about each
parameter. At the conclusion of the tests, select go to
service menu at the top of the screen to return to the
Service Menu main screen.
NOTE:
Additional resources depend on the configuration of
the Monitor.
1.7.1 SpO2 Tests
1.7.1.1 For Monitors With Nellcor SpO2:
On occasion when testing the integrity of the Nellcor
oximetry system, abnormal results may occur when
introducing large changes in the pulse rate and/or
pulse amplitude. Extreme changes in rate sent to the
Nellcor sensor by the SpO
algorithm to completely miss finding the pulse rate.
Main Service Menu
may cause the SpO2
2
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
This is an expected result. To work around this,
incrementally step up or down the settings on your
SpO
simulator and allow the monitor to detect and
2
display the new pulse rate or saturation.
Nellcor recommends use of the SRC-MAX Portable
Tester for use with PRO Monitors equipped with the
Nellcor SpO
system.
2
1.7.1.1 For Monitors With Masimo SpO2:
Masimo recommends BIO-TEK SpO2 simulators.
Test Procedure:
1. Disconnect all sensor cables from the SpO
Parameter, and ensure that the SpO
parameter is
2
2
listed within the main Service Menu.
2. From the Service Menu, turn and press the
SelectKnob to select the SpO
The SpO
service menu displays. The text under
2
service parameter.
2
Error and Version sections reflects the installed
type of SpO
The illustration shows both text
2.
examples.
Service Menu
SpO
2
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DINAMAP® PRO 1000V3 Pre-Service & Calibration Manual
3. All SpO
mode operations take place with Masimo
2
and Nellcor power-up defaults. No menu settings
are reflected.
4. Connect the appropriate SpO
to the side interface panel SpO
simulator and cable
2
connector. Be
2
sure it is fully seated in the socket.
5. Set simulator for 98% saturation and 80BPM.
Verify that the Monitor responds accordingly by
displaying the proper heart rate value and
saturation value.
1.7.2 NIBP Tests
NIBP Service Menu
Perform the following tests to determine that the NIBP
parameter is functioning normally.
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