NBP and CO2 Calibration Instructions
M3535A/M3536A HeartStart MRx
PHILIPS
Notice
About This Edition
Edition 1
Printed in the USA
Publication number 453564067081.
The information in this document applies to the
HeartStart MRx, product version indicated below. This
information is subject to change without notice.
Philips shall not be liable for errors contained herein or
for incidental or consequential damages in connection
with the furnishing, performance, or use of this material.
Edition History
Pub. Number Ed. S/W Version Print Date
453564067081
1 9.00 and earlier Sept., 2007
Copyright
Copyright © 2007
Koninklijke Philips Electronics N.V.
All rights are reserved. Permission is granted to copy and
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prohibited without the prior written consent of the
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Use of supplies or accessories other than those
recommended by Philips may compromise product
performance.
Medical Device Directive
The HeartStart MRx complies with the requirements of
the Medical Device Directive 93/42/EEC and carries the
mark accordingly.
0123
Manufacturer:
Philips Medical Systems
3000 Minuteman Road
Andover, MA USA 01810-1099
(978) 687-1501
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Philips Medizin Systeme Böblingen GmbH
Hewlett Packard Str. 2
71034 Böblingen
Germany
U.S. FCC and Industry Canada Radio Compliance:
Contains FCC ID: PQC-WMTS-MODULE
Operation of this equipment requires the prior coordination with a
frequency coordinator designated by the FCC for the Wireless Medical
Telemetry Service. This device complies with Part 15 of the FCC rules
and RSS-210 of Industry Canada. Operation is subject to the
following conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including
interference that may cause undesired operation.
Any changes or modifications to this equipment not expressly
approved by Philips Medical Systems may cause harmful radio
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Equipment Service Center.
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Telephone: 010-64392415.
Registration number: SFDA(I)20043211207.
Product Standard number: YZB/USA 52-21.
ii
Conventions Used in This Manual
These upgrade instructions contain the following conventions:
WARNING Warning statements describe conditions or actions that can result in personal injury or loss of life.
CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of
data.
NOTE Notes contain additional information on usage.
TIP Tips provide hands-on insight into servicing this product.
Text represents messages that appear on the display
[Softkey] represents softkey labels that appear on the display above or below the button
to which they correspond.
On-line viewing only
* Hypertext represents hypertext links, which will display as blue; click on the blue link to go
to that destination, then click on the blue destination to return.
Abbreviations
Name Abbreviation
HeartStart MRx Monitor/Defibrillator monitor/defibrillator
device
Carbon dioxide CO
End-tidal carbon dioxide EtCO
Non-invasive Blood Pressure NBP
2
2
iii
iv
Introduction
Introduction
CAUTION These instructions are intended for users trained in the safe and proper HeartStart MRx operation.
HeartStart MRx NBP and EtCO2 calibration is part of the HeartStart MRx maintenance routine that
also includes operational checks, lithium ion battery maintenance, etc. described in HeartStart MRx
Instructions for Use. NBP and EtCO
not covered in the Instructions for Use.
This document covers the following calibration procedures:
• Yearly calibration (or every 10,000 cycles, whichever is sooner) of the Non-invasive Blood Pressure
(NBP) module
• Yearly calibration (or every 4000 hours, whichever is sooner) of the End-tidal Carbon Dioxide
(EtCO
Use these quick links to access the calibration procedures:
) module.
2
* NBP Module Calibration
calibration is the only HeartStart MRx maintenance procedure
2
* EtCO
Module Calibration
2
HeartStart MRx Calibration Overview
Consider reviewing the “HeartStart MRx Calibration” instructional video included in your calibration
kit before proceeding with the calibration. To watch the DVD on your PC, you may need to install the
latest version of Windows Media Player
http://www.microsoft.com/windows/windowsmedia/download/.
center
The video is also available online at
Perform calibration when prompted by the
Overdue
Fail/D (Versions B.05 and above) or Fail/NC (Versions prior to B.05).
Regardless of your configuration settings, millimeters of mercury are the unit of measure for pressure in
the HeartStart MRx calibration. Use the conversion formulae from Ta b le 1 if necessary:
Table 1 Units of Pressure Conversion
inops. If a calibration is overdue, then the HeartStart MRx Op. Check fails with the code
1 unit = __ mmHg
1 kPa = 7.5 mmHg
1 mb
1 psi
1 atm.
1 inHg = 25.4 mmHg 30 inHg = 30 × 25.4 mmHg = 762 mmHg
.75 mmHg
=
51.7 mmHg
=
760 mmHg
=
®
available for free download from Windows Media download
http://theonlinelearningcenter.com/schtml/mrx/calibration/.
CO2 Calibration Overdue and NBP Calibration
Example:
Accessing Service Mode
The calibration activities are accessed through the Service Mode. To access the Service Mode:
1 From the Main Menu select Other, then Service.
2 Enter the “27689” password when prompted by the device.
1
NBP Module Calibration
This section describes how to calibrate the HeartStart MRx NBP module.
To calibrate the HeartStart MRx NBP module you need:
• the manometer and cuff assembly
• the plastic container to wrap the cuff around
Both the manometer / cuff assembly and plastic container are provided in the “NBP Calibration Kit,”
part # 453564063841.
NBP Calibration Setup
To prepare for NBP calibration:
1 Access the Service Mode Main menu as described in “Accessing Service Mode” on page 1.
2 From the Service Mode Main menu, select NBP.
The NBP Service screen is displayed (see Figure 1). You may hear a soft, high-pitch tone, this is
normal NBP pump operation.
Figure 1 NBP Service Screen
NBP Module Calibration
Service
Cycle Counter :
Last Calibration :
Pressure in Cuff :
- NBP
02 Jul 2007 10:52
50,010
30 Jun 2006 09:42
0
B
A
Replacement recommended
Calibration recommended
Main
Service
Calibrate
3 Check the Cycle Counter.
If the NBP module has executed more than 50,000 cycles, replacement is recommended.
Do not proceed with the calibration. Call for service.
2
NBP Module Calibration
4
Connect the test cuff assembly to the NBP port and wrap the cuff around the container (see
Figure 2).
Do not overtighten the cuff. It should have space for about 500 mL of air. Leave room for two
fingers between the cuff and container before connecting the velcro.
Figure 2 NBP Calibration Setup
Container
Loosely fitted NBP cuff
Manometer
NBP Safety Features
The NBP module is equipped with the Timeout and Overpressure safety features that prevent injury to
the patient and damage to the device.
NBP Timeout
The NBP module times out when the pressure remains greater than 10 mmHg for 3 minutes. Do not
keep the cuff pressurized for more than 3 minutes during the calibration.
NBP Overpressure
The NBP module overpressure occurs when the cuff pressure reaches 300 mmHg. Do not raise the
pressure in the cuff to more than 280 mmHg during the calibration.
The safety features cause the valve to open and the pressure to drop. If a safety feature is triggered
during calibration, then reset the module:
1 Press the [Main Service] softkey
Pump
2 Access the NBP Service screen to restart the calibration.
3
NBP Calibration Procedure
Complete the calibration process within three minutes to avoid the NBP module timeout.
To c al ib ra te :
1 Press the [Calibrate] softkey.
The message
2 Release all of the pressure in the cuff so that the manometer reads 0 mmHg.
3 Press the [Next] softkey.
The message Apply 250 mmHg. Select Next when ready is displayed.
4 Increase the pressure so that the manometer reads 250 mmHg.
Take time to allow the pressure in the unit to equalize and stabilize. One way to do this is to
pressurize the cuff to 255 or 260 mmHg and wait for 30 seconds, then gently adjust the pressure
with the pump and valve.
5 When the pressure is stable at 250 mmHg, press the [Next] softkey again.
6 Wait until the message Calibration complete. Please perform the accuracy and leakage
tests to check the results is displayed.
Apply 0 mmHg. Select Next when ready is displayed.
NBP Module Calibration
NOTE The message instructing you to perform the accuracy and leakage tests is for field service engineers
only. These tests do not need to be performed as part of calibration.
After several seconds the message clears, and the NBP Service screen is displayed.
7 Release the pressure in the cuff to avoid the safety timeout.
8 Run an operational check to update the calibration status.
See HeartStart MRx Instructions for Use for op.check guidance.
NBP Calibration Failure
If the error message Calibration failed. Check that the pressure applied is correct. Please
restart calibration appears at any moment during NBP calibration, then:
1 Recheck the manometer and cuff assembly connections.
2 Loosen the cuff. If less than ten pump compressions fill the cuff, then it is too tight.
3 Press the [Main Service] softkey.
4 Select NBP from the Service Main Menu.
5 Restart the NBP Calibration Procedure, making sure that the applied pressures are correct.
6 Call for service if you cannot successfully complete the calibration
4
EtCO2 Module Calibration
EtCO2 Module Calibration
This section describes how to calibrate the HeartStart MRx EtCO2 (here called CO2) module.
To calibrate the HeartStart MRx CO
• Gas flow valve
• Modified Filterline set with T-shaped tubing assembly
• 5% calibration gas cylinder (15210-64010)
•A calculator
• A barometer to measure ambient pressure or other means of determining the ambient pressure.
Both the gas flow valve and Modified Filterline are provided in the “CO
# 453564063851. The CO
for troubleshooting only and not used in calibration.
CO2 Calibration Setup
Before performing calibration, the CO2 sensor must warm up for at least 20 minutes. Do not start
calibration until the CO
Warm Up the CO2 Sensor
To w ar m u p t he CO2 sensor:
1 Access the Service Mode Main menu as described in “Accessing Service Mode” on page 1.
2 Connect the Modified FilterLine from the kit to the HeartStart MRx CO
See Figure 3.
module you need:
2
Calibration Kit,” part
Calibration Kit also contains a flow tube and two air plugs that are used
2
sensor has been warmed up.
2
2
inlet marked .
2
Figure 3 CO
Modified FilterLine
Warm-Up Setup
2
!
5
EtCO2 Module Calibration
3
From the Service Mode Main menu, select CO
.
2
After a few seconds delay, the CO2 Service screen is displayed, as shown in Figure 4.
Figure 4 CO
Service
CO2 Operating Hours :
Last Calibration :
Ambient Pressure :
Cell Pressure :
You may hear a soft, low-pitch tone, this is normal CO
the CO
pump activity is the difference between the Ambient and Cell pressures. Subtract the Cell
2
Service Screen
2
- CO2
02 Jul 2007 10:52
15,004 hours
30 Jun 2006 09:42
760 mmHg
733 mmHg
B
A
Replacement recommended
Calibration recommended
pump operation. Another indication of
2
pressure from the Ambient pressure and consult Ta bl e 2 to interpret the difference.
Table 2 Modified FilterLine Connection Checking and Troubleshooting
Ambient Pressure
Possible Cause Suggested Solution
– Cell Pressure
Bad connection 1 Reconnect the Modified FilterLine.
0
2 Go back to Main Service and reselect CO2.
Pump malfunction Call for service.
9 mmHg or less
Modified FilterLine
is broken
Replace the Modified FilterLine.
Pump malfunction Call for service.
10 - 30 mmHg The pump is operating normally, and the sensor is warming up.
31 mmHg or more Modified FilterLine
is blocked
Check that the Modified FilterLine is not kinked
and free of blockages. Replace if necessary.
3 When the pump starts working as expected, clock the warm-up time. You can use the
HeartStart MRx screen clock.
6
EtCO2 Module Calibration
Prepare for the Calibration
Perform the following preparatory steps while the CO2 sensor is warming up:
1 Check the CO
If the CO
Operating Hours.
2
module has clocked more than 15,000 hours, replacement is recommended.
2
Do not proceed with the calibration. Call for service.
2 Obtain a reliable measurement of local atmospheric pressure by using a barometer or by getting the
local atmospheric pressure data from the Internet, local airport, or weather station located at the
same altitude as your lab.
3 Press the Menu Select button and select Ambient Pressure.
4 Using Up and Down buttons, adjust the HeartStart MRx’s Ambient Pressure setting to the
measurement obtained in Step 2.
5 Press the Menu Select button again to accept the adjusted Ambient Pressure value.
6 Calculate the expected CO
The expected CO
reading depends on both the gas concentration you are using (5.0%) and the
2
reading.
2
ambient pressure. Calculate as follows:
a.
Cal. Gas Concentration × ambient pressure = Expected CO2 value
For example:
[0.05] × [760 mmHg] = 38 mmHg
b. Calculate the allowable tolerance, which is ± 5% of the expected reading. Calculate as follows:
[±0.05] × Expected CO2 value = ± tolerance (mmHg)
For example:
[±0.05] × 38 = ± 1.9 (mmHg)
In this example, the displayed reading is expected to be 38 ± 1.9 mmHg.
c. Round to the nearest whole number because HeartStart MRx does not show fractions. The
expected CO
d. Save your calculations. You will compare the numbers with the actual CO
reading in our case should be between 36 and 40 mmHg.
2
sensor reading
2
during the calibration validation.
7 Fit the 5% CO
8 Watch the manometer on the valve.
gas cylinder with the valve. Screw the valve on tightly.
2
While the gas pressure does not have to be high for successful calibration, it should be present.
9 Connect the soft tubing at one end of the modified Filterline to the gas valve outlet, and leave the
other end open to atmosphere. See Figure 5.
7
Figure 5 CO2 Calibration Setup
Do not touch
this regulator
EtCO2 Module Calibration
Gas flow valve
Modified FilterLine
CO2 Calibration Procedure
Make sure the CO2 sensor has been warmed up for at least 20 minutes before starting the calibration
steps.
To c al ib ra te th e C O
1 From the CO
The CO
2
2 Wait a few seconds until the softkeys become active. See Figure 6.
module:
2
Service menu, select Calibration Check.
2
Calibration screen is displayed.
Gas flow
regulator
Manometer
5% CO
calibration
2
gas cylinder
Figure 6 CO2 Calibration Screen
02 Jul 2007 10:52
Service
CO2 : 37 mmHg
Main
Service
- CO2
DoneCalibrate
B
A
8
EtCO2 Module Calibration
3
Fully open the gas flow valve.
Turn the regulator on the side of the valve counterclockwise. Do not touch the regulator on the top
of the valve.
4 Allow the CO
value to stabilize.
2
5 Press the [Calibrate] softkey.
6 Use the Menu Select key to confirm that you are using the 5% CO
While it is recommended that you use the 5% gas, you can calibrate CO
CO
gas mix.
2
Figure 7 CO
Main
Service
Cal Gas Selection
2
Cancel
Done
Cal CO2
5 %
MENU
gas mix. See Figure 7.
2
module with 4% or 6%
2
7 Do not turn off gas or touch any buttons or tubing until completion.
CO2 calibration in progress message indicates that the calibration has started.
The
The
Calibration complete message indicates that the calibration is successful.
8 Turn off the gas.
9 Validate the calibration by checking the displayed CO
value against the expected value calculated
2
in the Prepare for the Calibration section.
The displayed value should match the expected value within the calculated allowable tolerance.
10 Press the [Done] softkey.
Note that even though the calibration is successful (the time of last calibration is updated), the
calibration status does not get updated until the op. check is completed. See Figure 8.
Figure 8 Successful CO
02 Jul 2007 10:52
Calibration
2
B
A
Calibration is successful, but the
Service
- CO2
Calibration recommended
message does not disappear until
CO2 Operating Hours :
Last Calibration :
Ambient Pressure :
Cell Pressure :
1504 hours
02 Jul 2007 10:50
760 mmHg
739 mmHg
Calibration recommended
the Op. Check is completed.
11 Run an Operational Check to update the calibration status.
See HeartStart MRx Instructions for Use for Op. Check guidance.
9
CO2 Calibration Failure
If the error message Calibration failed. Please restart calibration appears at any moment during
CO
calibration, then:
2
1 Recheck the Modified FilterLine, gas cylinder, and valve connections.
EtCO2 Module Calibration
2 If the CO
See the War m Up th e C O
3 Restart the CO
4 If you cannot successfully complete the calibration, call for service.
module is off, restart the warm-up process and wait for 20 minutes.
2
Sensor section.
2
Calibration Procedure.
2
10
453564067081
Edition 1
September, 2007
*453564067081*
*1*
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