HeartStart MRx Service Library. Service Manual. HeartStart MRx M3535A/M3536A

Transcription

1 HeartStart MRx Service Library Service Manual HeartStart MRx M3535A/M3536A

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3 Notice About This Edition Publication number Edition 3; Printed in the USA The information in this document applies to the HeartStart MRx versions 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 M Copyright 1 A.00/A.01 Dec., A.02 June, B.03 Nov., B.04 Jan., B.05 Oct., Sept., Sept., F.01 Apr., 2010 Copyright Koninklijke Philips Electronics N.V. All rights are reserved. Permission is granted to copy and distribute this document for your organization s internal educational use. Reproduction and/or distribution outside your organization in whole or in part is prohibited without the prior written consent of the copyright holder. SMART Biphasic is a registered trademark of Philips. Q-CPR is a trademark of Laerdal Medical. Nellcor is a registered trademark of Nellcor Puritan Bennett, Inc. FilterLine is a registered trademark and CapnoLine is a trademark of Oridion Medical Ltd. Rosetta-Lt is a trademark of General Devices. The HeartStart MRx contains an Ezurio PC Card with Bluetooth wireless technology. The Bluetooth wordmark and logos are owned by the Bluetooh SIG, Inc. and any use of such marks by Ezurio is under license. Other trademarks and trade names are those of their respective owners. Warning: Radio frequency (RF) interference coming from devices other than the HeartStart MRx may degrade the performance of the MRx. Electromagnetic compatibility with surrounding devices should be assessed prior to using the monitor/defibrillator. 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 0123 mark accordingly. Manufacturer: Philips Medical Systems 3000 Minuteman Road Andover, MA USA (978) Authorized EU-representative: Philips Medizin Systeme Böblingen GmbH Hewlett Packard Str Böblingen Germany U.S. FCC and Industry Canada Radio Compliance: Contains FCC ID: PQC-WMTS-MODULE When using with IntelliVue Networking Option, 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 frequency interference and void your authority to operate this equipment. Canada EMC: ICES-001 China: After-Sales Service: Beijing MEHECO-PHILIPS Medical Equipment Service Center. After-Sales Service Address: No. 208, 2nd District, Wang Jing Li Ze Zhong Yuan, Chao Yang District, Beijing. Postal code: Telephone: Registration number: SFDA(I) Product Standard number: YZB/USA Chemical Content: REACH requires Philips Healthcare to provide chemical content information for Substances of Very High Concern (SVHC) if they are present above 0.1% of the product weight. Components of/within electric and electronic equipment may contain phthalates above the threshold (e.g. bis(2-ethyl(hexyl)phthalate), CAS nr.: ). The REACH SVHC list is updated on a regular basis. Therefore, please refer to the following Philips REACH website for the most up-to-date information on products containing SVHC above the threshold: i

4 Conventions Used in This Manual This book contains 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 using or servicing this product. The bull s eye icon indicates a process or a procedure (a set of steps to achieve a certain goal) Screen Text Label Text or Label Text On-line viewing only represents text that appear on the device screen, including the softkey labels. represent other keywords. Hypertext represents hypertext links, which will display as blue; click on the blue link to go to that destination. Click for quick access Abbreviations Name Acute Cardiac Ischemia Time-Insensitive Predictive Instrument Batch LAN Data Transfer Dial-Up Networking Abbreviation ACI-TIPI BLDT DUN End-tidal carbon dioxide EtCO 2, CO 2 File Transfer Protocol FTP HeartStart MRx Monitor/Defibrillator HeartStart MRx; device Invasive Pressure IP Invasive Pressure/Temperature IP/Temp Non-invasive Blood Pressure NBP Periodic Clinical Data Transmission PCDT Pulse Oximetry SpO 2 Thrombolytic Predictive Instrument TPI ii

5 Contents Chapter 1 Introduction 1 Who Should Use this Manual How to Obtain Training Overview Features and Capabilities Tour of the Device General Service Information Accessing Service Mode Navigating in Service Mode Service Mode Functions Device Information Other Resources Chapter 2 Maintenance 13 Introduction HeartStart MRx Calibration Overview NBP Module Calibration NBP Calibration Setup NBP Safety Features NBP Calibration Procedure NBP Module Tests Accuracy Test Leakage Test Linearity Test EtCO 2 Module Calibration EtCO 2 Calibration Equipment EtCO 2 Calibration Setup EtCO 2 Calibration Procedure EtCO 2 Module Checks EtCO 2 Module Check Setup EtCO 2 Status Display Check Ambient Pressure Check Leakage Check Pump Check Flow Rate Check Noise Check Calibration Check iii

6 Table of Content Chapter 3 Troubleshooting 29 Overview Troubleshooting Tools and Equipment Obtaining Replacement Parts Ready For Use Indicator Automated Tests Automated Test Summary Weekly Shock Test and Operational Check Shift Check Weekly Shock Test Operational Check Service Mode Tests Configuration Password Management Troubleshooting Methodology Troubleshooting Flowcharts M3538A Lithium Ion Battery Troubleshooting Faulty Batteries Troubleshooting Tables Audio Tones Device Status Log Messages Access Log Messages Startup Messages General Problems ECG Monitoring Problems NBP Monitoring Problems SpO 2 Monitoring Problems CO 2 Monitoring Problems Q-CPR Problems Defibrillation Problems Pacing Problems Display Problems Printing Problems Audio Problems Controls Problems Internal Memory Problems External Data Card Problems iv

7 Table of Content Chapter 4 Repair 81 Overview Who Should Perform Repairs Repair Philosophy Calling for Service Repair Notes Safety Precautions Disposal Repair Tools and Equipment Key Components External Assemblies Bedrail Hook Mount CPR Meter Rear Cover Handle and Cap Plate Labels Paddle Tray and Plates Paddle Tray 50-ohm Load Resistor Printer Assembly Therapy Cable Stabilizing Collar Therapy Knob Top Assemblies Bluetooth Card Internal Assemblies Introduction Opening the Case Internal Assemblies Front Case Overview of Front Case PCMCIA Hole Plug Speaker and Microphone Assembly Internal Memory Card SpO 2 PCA Invasive Pressure/Temperature (IP/Temp) PCA Measurement Module Panel Therapy Switch Fan Assembly Processor PCA Clock Battery Printer Connector PCA Display Assembly Ready For Use Indicator Front Panel Buttons Front Case Assembly v

8 Table of Content Chapter 4 Repair (Continued) Internal Assemblies Rear Case Overview of Rear Case Therapy Capacitor Power PCA NBP and CO 2 Module Tray Therapy PCA Therapy Port NBP Module CO 2 Module CO 2 Compartment Door Battery Connector PCA Rear Case Assembly Closing the Case Chapter 5 Networking and Data Transfer 161 Overview About the IntelliVue Networking Option About Periodic Clinical Data Transmission About Batch LAN Data Transfer IntelliVue Networking Option Installation Configuring the HeartStart MRx for IIC Connection Connecting to the Network Installation Verification Service Service Menu IntelliVue Network Troubleshooting Periodic Clinical Data Transmission Troubleshooting Batch LAN Data Transfer Troubleshooting WMTS Device Registration Chapter 6 Performance Verification 181 Overview Required Testing Levels Verification Test Equipment Test and Inspection Matrix Performance Verification Procedures Visual Inspection Service Mode Tests Functional Checks Safety Tests vi

9 Table of Content Appendix A Parts and Accessories 203 Overview Parts and Accessories Notes Ordering Replacement Parts Ordering Supplies and Accessories Key Component Tracking Replacement Parts Electrical Assemblies Processor PCA and Software Support Tool Other Replacement PCAs Other Electrical Assemblies Individual Electrical Parts External Electrical Components Internal Cables Paddles Mechanical Assemblies Replacement Mechanical Assemblies Individual Mechanical Parts Labels Instruction Label Sets Hazardous Shock Warning Label Set Branding Label Set Speaker Label Set Connector Label Set Supplies and Accessories Key Components Appendix B Theory of Operation 223 Overview Schematic Diagrams System Level Interconnections Signal and Data Flow ECG Signal Flow Functional Descriptions Processor PCA Therapy PCA Power PCA Battery Connector PCA Power/Batteries Display Assembly Indicators RFU Indicator Front Panel Buttons Therapy Knob vii

10 Table of Content Appendix B Theory of Operation (Continued) Paddle Indicators and Controls Printer Assembly and PCA ECG Monitoring Functions Defibrillation Transcutaneous Pacing Audio Data Storage Clock Backup Battery NBP Module IP/Temp PCA SpO 2 PCA CO 2 Module Bluetooth Card Q-CPR Waveforms Index 241 viii

11 1 Introduction This Service Manual provides the information needed to successfully service the M3535A/M3536A HeartStart MRx monitor/defibrillator. This manual provides you with information on troubleshooting, repairing, and performance verification and safety testing of the monitor/defibrillator. There is also information on the theory of operation, maintenance procedures, and ordering parts and supplies. NOTE: This manual describes all optional features. If your HeartStart MRx does not have some of the optional features listed in this manual, disregard the features, controls, and related information described in the manual. Who Should Use this Manual The intended users of this manual are technical personnel who have been trained in the safe and proper servicing of the HeartStart MRx. How to Obtain Training Overview To assist in training, the Service Training DVD ( ) is available. Philips IntelliVue Clinical Network Information Center (IIC), Patient Monitoring System, and Telemetry System and other training is available through Philips Technical Education at In this chapter, you will find general information that you should know before servicing the HeartStart MRx. Detailed information regarding controls, operation, and capabilities of the device can be found in the HeartStart MRx Instructions for Use that was shipped with the product and provides information on setting up the device and regular maintenance procedures, such as performing operational checks and battery maintenance. We recommend you review the HeartStart MRx Instructions for Use before servicing this device. This Service Manual assumes you are familiar with the controls and basic operations. This chapter is organized into the following sections: Topic Page Topic Page Features and Capabilities 2 Accessing Service Mode 8 Tour of the Device 3 Navigating in Service Mode 10 General Service Information 6 Other Resources 12 1

12 1: Introduction Features and Capabilities Features and Capabilities The HeartStart MRx is a lightweight, portable, monitor/defibrillator. It provides four modes of operation: Monitor, Manual Defib, AED, and Pacer (optional). In Monitor Mode you can monitor up to four ECG waveforms, acquired through a 3-, 5-, or 10-lead ECG set or multifunction electrode pads. Optional monitoring of pulse oximetry (SpO 2 ), invasive pressure (IP), non-invasive blood pressure (NBP), temperature (Temp), and carbon dioxide (EtCO 2 ) are also available. Measurements from these parameters are presented on the display and alarms are available to alert you to changes in the patient s condition. Monitor Mode also provides an optional 12-Lead ECG function, enabling you to preview, acquire, store, transmit, and print 12-Lead ECG reports, with or without analysis/interpretation. Manual Defib Mode offers simple, 3-step defibrillation. You analyze the patient s ECG and, if appropriate: 1) select an energy setting, 2) charge, and 3) deliver the shock. Defibrillation may be performed using paddles or multifunction electrode pads. Manual Defib Mode also allows you to perform synchronized cardioversion and internal defibrillation. In AED Mode, the HeartStart MRx analyzes the patient s ECG and determines whether a shock is advised. Voice prompts guide you through the 3-step defibrillation process, providing easy-to-follow instructions and patient information. Voice prompts are reinforced by messages that appear on the display. Both Manual Defib and AED Mode incorporate the Philips low energy SMART Biphasic waveform for defibrillation, Q-CPR, and audio recording. Optional Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction electrode pads, using a monophasic waveform. The HeartStart MRx is powered by rechargeable lithium ion batteries. Available battery power is easily determined by viewing the convenient battery power indicators located on the device display or by checking the indicators on the battery itself. Additionally, an external AC or DC power supply may be applied as a secondary power source and for continual battery charging. The HeartStart MRx performs Automated Tests on a regular basis. The status of the device s critical functions are reported to the Ready For Use (RFU) indicator. Prominently displayed, the RFU indicator communicates the status of your device, letting you know if it is operating correctly, needs attention, or is unable to deliver therapy. In addition, performing the specified Operational Check ensures that the HeartStart MRx is functioning properly. The HeartStart MRx M3535 model with the IntelliVue Networking Option can connect to the Philips IntelliVue Clinical Network. The HeartStart MRx automatically stores critical event and trend data in its internal memory, such as Event Summaries and 12-Lead Reports. The HeartStart MRx also enables you to copy data and event information to an optional external data card for downloading to Philips data management solution, HeartStart Event Review Pro, as well as transfer data using Bluetooth Card. 12-Lead reports can also be transferred using Rosetta-Lt. The HeartStart MRx is highly configurable to better meet the needs of diverse users. Be sure to familiarize yourself with the device s configuration before using the HeartStart MRx. 2

13 Tour of the Device 1: Introduction Tour of the Device This section gives an overview of the outside of the device. Front of the Device Figure 1 Front View External Power Indicator Synchronized Cardioversion (Sync) button Network Ready label (optional) Ready For Use (RFU) Indicator Mark Event button Therapy Knob Lead Select button Sync b De Manual Adult Dose Select Energy 1 CHARGE button SHOCK button Display Pacer On O Monitor On AED Charge Shock 2 3 Printer Printer door Printer door latch Print button Speaker Alarm Pause button Event Summary button Softkeys (4 total) Navigation buttons Menu Select button 3

14 1: Introduction Tour of the Device Right Side Figure 2 Right Side View Data Card Therapy port (behind connector) Therapy connector Left Side Figure 3 Left Side View CO 2 Inlet port CO 2 Outlet port IP ports 1 Temp port CO 2 2 NBP port Microstream ECG ECG port ECG Out (Sync) jack SpO 2 port ECG Measurement Module Panel 4

15 Tour of the Device 1: Introduction Figure 4 Rear Side Rear Side View Battery / AC / Radio module Compartment B Bed Rail Hook Mount Battery Compartment A Therapy Connector and Cable LAN Connector Battery RS-232 Serial Port AC Power Module DC Power Input Top Side Figure 5 Top Side View Top access panel PCMCIA card slots Bluetooth card slot Internal memory card slot 5

16 1: Introduction General Service Information General Service Information Keep the following points in mind when servicing this product. Installation The HeartStart MRx does not require installation (for HeartStart MRx installation on the IntelliVue Clinical Network, see IntelliVue Networking Option Installation on page 163). The HeartStart MRx Instructions for Use describe the setup required before placing the device into service, as well as configuration options. All setup activities are designed to be performed by personnel trained in the proper operation of the product. To obtain a copy of the HeartStart MRx Instructions for Use and other HeartStart MRx documentation in your local language visit: and follow links to Product Downloads > Resuscitation > M3535A/M3536A Philips HeartStart MRx > Instructions for use. Display Menus To display a menu, press the Menu Select button. Then use the up or down Navigation buttons to scroll through the available choices until the desired selection is highlighted. To activate the selection, press the Menu Select button. Press Exit to close the menu without activating a selection. Passwords In order to access different modes within the monitor/defibrillator, a password is required. The passwords are listed below: Service Mode: Configuration Mode: (default password) Upgrades Upgrades are available to add specific functionality to the device after purchase. These upgrades are: M3530A SpO 2 M3531A NBP M3532A EtCO 2 M3533A Pacing M3534A 12-lead Option B02: Acquisition Option B04: 75-mm printer Option B05: Asian 75-mm printer M3549A Wide bedrail hook M3801A 12-lead transmission (Bluetooth) M3802A 12-lead transmission (RS-232 and Bluetooth) M3806A Software M3808A Therapy PCA M4737A Display cover M4760A Handle and Cap Plate M4765A B-level Hardware, option B02 6

17 General Service Information 1: Introduction M4770A Q-CPR (with Compression Sensor) M4771A Q-CPR Data Capture M4772A Audio Recording M4773A 256 MB Data Card (internal and external) NOTE: If your HeartStart MRx still has a smaller data card, then it is recommended to perform this upgrade next time you perform an internal repair. M5527A External Paddles with tray Option C01: Standard Option C02: Water-resistant Event Summary, Bluetooth Lead Transmission, Rosetta-Lt interface (available in the USA only) IntelliVue Networking Option (wired, available for M3535A only) IntelliVue Networking Option (wired and wireless, available in the USA for M3535A only) Invasive Pressures Temperature ACI-TIPI & TPI Periodic Clinical Data Transmission (PCDT) Q-CPR (with CPR meter) Batch LAN Data Transfer (BLDT) Internal Bluetooth Card Consult your sales representative, dealer, or distributor for the latest details. See Ordering Supplies and Accessories on page 203. Preventive Maintenance Preventive maintenance and periodic operational checks are intended to be performed by the user. Both topics are covered in the Maintenance chapter of the Instructions for Use. The Maintenance chapter of this manual provides EtCO 2 and NBP calibration and testing procedures. Experienced and trained HeartStart MRx users (e.g. nurses and paramedics) may perform the calibration using the NBP and EtCO 2 calibration kits ( and respectively). The training material is included in the kits. Only qualified service personnel should perform the testing procedures. Repair Philosophy Monitor/Defibrillator The repair philosophy of the HeartStart MRx is subassembly replacement. Examples of subassemblies are the printer, the Processor Printed Circuit Assembly (PCA), Therapy PCA, and selected connectors and other items. Repairs that involve replacing components on a PCA are not supported. CAUTION: Individual component replacement should not be attempted. Component level repair is inadvisable due to the extensive use of surface mount technology and the high parts-density on the circuit boards. Unauthorized component replacement can impair performance of the HeartStart MRx. 7

18 1: Introduction Accessing Service Mode WARNING: Remove all power sources (AC, battery, DC) before opening the device. Failure to do so may allow the device to charge without warning and could result in serious injury or death. Batteries The M3538A Lithium-Ion battery is rechargeable. The battery periodically requires a calibration. At the end of the battery s useful life, it should be recycled or discarded according to local regulations and replaced. Refer to the HeartStart MRx Instructions for Use for additional information. For information on ordering replacements, see Ordering Supplies and Accessories on page 203. WARNING: Never crush, penetrate, or attempt to open lithium-ion batteries. Never incinerate lithium-ion batteries. High case temperatures resulting from abuse of the battery could cause physical injury. The electrolyte is highly flammable. Rupture of the battery pack may cause venting and flame. CAUTION: Due to their high energy density, lithium-ion batteries can deliver significant power. Use care when working with or testing lithium-ion batteries. Do not short-circuit the terminals. Accessing Service Mode CAUTION: Be sure that the monitor/defibrillator is not connected to a patient when performing any function in Service Mode. NOTE: Make sure that you insert a battery charged to at least 20% into the device or connect external power when you are performing functions in Service Mode. To access Service Mode: 1 Turn the Therapy Knob to Monitor. 2 Press the Menu Select button to display the Main menu. 3 Select Other. 4 From the Other menu select Service. The message appears: Leaving Normal Operating Mode. Patient Monitoring Is Off. To Return To Normal Operating Mode, Press The Exit Softkey. 5 Press the Menu Select button to acknowledge the message. You are prompted to enter a password. 6 Enter the password (27689) by scrolling through the list until the desired number is highlighted. 7 Press the Menu Select button to activate each selection. 8 Select Done when you have entered all of the numbers. 9 Press the Menu Select button to display the Service Mode Main menu, as shown in Figure 6. 8

19 Accessing Service Mode 1: Introduction Figure 6 Service Mode Main Menu 02 Mar :52 A B Service - MAIN Cycle Counter : Last Calibration : 50, Jun :42 Replacement recommended Calibration recommended Exit Service Calibrate Service Operational Check Status Log NBP CO2 Controls Display Printer CPR Audio Recording Instrument Telemetry Device Info Software Upgrade 9

20 1: Introduction Navigating in Service Mode Navigating in Service Mode Service Mode uses the same navigation controls as normal operating mode: To select a menu item, use the Navigation buttons to highlight your choice, then select that choice by pressing the Menu Select button. To exit Service Mode and return to clinical mode, press the Exit Service softkey. To return to the Service Mode Main menu from any service screen press the Main Service softkey. NOTE: The device s default configuration settings are restored when you return to clinical mode after exiting Service Mode. Service Mode Functions You can perform a variety of service-related activities from Service Mode, as follows: Run an Operational Check Operational Check on page 34. View, print and clear the Device, Network, and PCDT Status logs See Device Status Log Messages on page 54. Perform maintenance on the NBP module See NBP Module Calibration on page 14. Perform maintenance on the EtCO 2 module See EtCO 2 Module Calibration on page 18. Run the Controls test See Controls Test on page 190. Run the Display test (Version B.05 and greater) See Display Test on page 191. Run the Printer test See Printer Test on page 192. Run the CPR Test See CPR Meter and Compression Sensor Tests on page 193. Run the Audio Recording Test See Audio Recording Test on page 194. Install software and change the device s language using the Software Support Tool See Installing Software on page 125. View information about the device, such as model number, serial number, options enabled on the device, and the device s language See Device Information below. Use the Device Info menu to enter the serial number and to enable options on the device after a Processor PCA repair. See Entering the Serial Number on page 124 for more information. NOTE: You can print detailed information on board and module levels through the Print Device Info option, available in normal operating mode. See Printing the Device Information on page

21 Navigating in Service Mode 1: Introduction Device Information To view information about the device: From the Service Mode Main menu, select Device Info. Figure 7 Device Info Screen 02 Mar :52 A B Service - DEVICE INFO Model Number : Serial Number : Language : Options : M3535A US American English SpO2, NBP, EtCO2, IBP, Temp, 12-Lead, 12-LTx Serial, 12-LTx Bluetooth, Pacing, Q-CPR, vdata, Audio Rec, 75mm Printer, EventSum Bluetooth, IntelliVue Net, Per Data Tx Main Service MENU Printing the Device Information You can print detailed information on software versions, board and module levels, and internal memory card capacity from the Print Device Info menu option. This option is available from the Other menu in clinical modes. To print the device information: 1 Be sure a battery charged to at least 20% is in place, or that external power is connected. 2 Turn the Therapy Knob to Monitor. 3 Press the Menu Select button to access the Main menu. 4 From the Main menu, select Other. 5 From the Other menu, select Print Device Info. Detailed information about the device is printed. NOTE: Run an Operational Check after you have updated software, enabled an option, or performed a repair to update the Device information. 11

22 1: Introduction Other Resources Hardware Version (Primary) Label TheHeartStart MRx ships with a Hardware version label (also known as a Primary label) affixed to battery compartment B, as shown in Figure 8. Figure 8 Rear Case Labels Generic labels Hardware Version (Primary) label Hardware Version B2 Other Resources For additional information on the HeartStart MRx, refer to the following Learning Products: HeartStart MRx Instructions for Use ( ) HeartStart MRx Service Training DVD ( ) M3538 Lithium Ion Battery Characteristics and Care Application Note ( ) Other documentation can be found on the Philips website at: 12

23 2 Maintenance Introduction This chapter describes routine maintenance on the HeartStart MRx monitor/defibrillator. Most routine maintenance, including periodic operational checks, paper replacement, lithium ion battery maintenance and charge, etc. is performed by the user. Refer to the Instructions for Use for detailed information on these maintenance procedures. Service personnel are responsible for the following routine maintenance: Yearly calibration (or every 10,000 cycles) of the Non-invasive Blood Pressure (NBP) module. 1 NBP module testing. Yearly calibration (or every 4000 hours) of the End-tidal Carbon Dioxide (EtCO 2 ) module. 2 EtCO 2 module checking. Click these links to access the maintenance procedures: Topic Page Topic Page NBP Module Calibration 14 EtCO 2 Module Calibration 18 NBP Module Tests 17 EtCO 2 Module Checks 23 HeartStart MRx Calibration Overview Consider reviewing the HeartStart MRx Calibration instructional video available online at Perform calibration when prompted by the CO2 Calibration Overdue and NBP Calibration Overdue inops. If a calibration is overdue, then the HeartStart MRx Operational Check fails with the code 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 in Table 1 if necessary: Table 1 Units of Pressure Conversion 1 unit = mmhg 1 kpa = 7.5 mmhg 1 mb =.75 mmhg 1 psi = 51.7 mmhg 1 atm. = 760 mmhg 1 inhg = 25.4 mmhg 1. The users may perform NBP calibration themselves if they obtain the NBP Calibration Kit, part # The users may perform EtCO 2 calibration themselves if they obtain the EtCO 2 Calibration Kit, part #

24 2: Maintenance NBP Module Calibration NBP Module Calibration This section describes how to calibrate the HeartStart MRx NBP module. To calibrate the HeartStart MRx NBP module you need: A manometer and cuff assembly or 500 ml expansion chamber. These instructions refer to the cuff assembly, but can be used with the expansion chamber as well. A plastic container to wrap the cuff around. Both the manometer/cuff assembly and plastic container are provided in the NBP Calibration Kit, part # NBP Calibration Setup To prepare for NBP calibration: 1 Access the Service Mode Main menu as described in Accessing Service Mode on page 8. 2 From the Service Mode Main menu, select NBP. 3 The NBP Service screen is displayed (see Figure 9). You may hear a soft, high-pitch tone, this is normal NBP pump operation. Figure 9 NBP Service Screen 02 Mar :52 A B Service - NBP Cycle Counter : Last Calibration : 50, Jan :42 Replacement recommended Calibration recommended Pressure in Cuff : 0 Main Service Calibrate 4 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. 5 Connect the test cuff assembly to the NBP port and wrap the cuff around the container (see Figure 10). 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 hook-and-loop fastener. 14

25 NBP Module Calibration 2: Maintenance Figure 10 NBP Calibration Setup Container Loosely fitted NBP cuff Manometer Pump 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. To reset the module if a safety feature is triggered during calibration: 1 Press the Main Service softkey 2 Access the NBP Service screen to restart the calibration. 15

26 2: Maintenance NBP Module Calibration NBP Calibration Procedure Complete the calibration process within three minutes to avoid the NBP module timeout. To calibrate NBP: 1 Press the Calibrate softkey. The message Apply 0 mmhg. Select Next when ready is displayed. 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. NOTE: The message instructing you to perform the accuracy and leakage tests is for troubleshooting only (see NBP Module Tests on page 17). These tests are not performed as part of calibration. 7 After several seconds the message clears, and the NBP Service screen is displayed. Release the pressure in the cuff to avoid the safety timeout. 8 Run an operational check to update the calibration status. See the Troubleshooting chapter of HeartStart MRx Service Manual for 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 on page 16, making sure that the applied pressures are correct. 6 Call for service if you cannot successfully complete the calibration. 16

27 NBP Module Tests 2: Maintenance NBP Module Tests Perform NBP Module Tests only if there is an uncertainty about the module performance. Each of the procedures assumes the monitor/defibrillator, the manometer, and the cuff assembly are still set up as they were at the end of the previous test. If all results are as described, the device passes that portion of the test. Return to the Service Mode Main menu by pressing the Main Service softkey. If there is any failure, begin troubleshooting and repairing the device as needed. See Troubleshooting on page 29. Accuracy Test To test the NBP Module accuracy: 1 Connect the NBP tubing to the NBP port on the monitor/defibrillator, and connect the test manometer and cuff to the tubing. See Figure 10 NBP Calibration Setup on page Pressurize the cuff to approximately 250 mmhg. 3 Wait for 30 seconds to allow the pressure in the unit to equalize. 4 When the pressure stabilizes, compare the displayed pressure reading to the pressure indicated by the manometer. 5 If the difference between the manometer and the displayed pressure is more than 2 mmhg, calibrate the NBP module as described in NBP Module Calibration on page 14 and repeat the test. 6 Release the pressure in the cuff before proceeding to the next test to avoid the safety timeout. Leakage Test To test the NBP Module for leaks: 1 Pressurize the cuff to approximately 250 mmhg. 2 Wait for 30 seconds to allow the pressure in the unit to equalize. 3 Watch the displayed pressure for 60 seconds. 4 Record the pressure drop at the end of 60 seconds. 5 If the pressure decreases by more than 6 mmhg, there is a leak. Replace the tubing and cuff assembly and try the leakage test again. If the pressure still decreases by more than 6 mmhg, begin troubleshooting and repairing the device as needed. 6 Release the pressure in the cuff before proceeding to the next test to avoid the safety timeout. Linearity Test To test the NBP Module linearity: 1 Pressurize the expansion chamber to approximately 150 mmhg. 2 When the pressure is stabilized, compare the displayed pressure reading to the pressure indicated by the manometer. 3 If the difference between the manometer and the displayed pressure is more than 2 mmhg, calibrate the NBP module as described in NBP Module Calibration on page 14 and repeat the test. 17

28 2: Maintenance EtCO 2 Module Calibration EtCO 2 Module Calibration This section describes how to calibrate the HeartStart MRx EtCO 2 (sometimes called CO 2 ) module. EtCO 2 Calibration Equipment To calibrate the HeartStart MRx EtCO 2 module you need: Gas flow valve Modified Filterline set with T-shaped tubing assembly 5% calibration gas cylinder ( , six cans per case) Calculator 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 2 Calibration Kit, part # The CO 2 Calibration Kit, also contains a flow tube and two air plugs that are used for troubleshooting only (see EtCO 2 Module Checks on page 23) and not used in calibration. EtCO 2 Calibration Setup To prepare for the calibration: 1 Access the Service Mode Main menu as described in Accessing Service Mode of the Introduction chapter of HeartStart MRx Service Manual. 2 Connect the Modified FilterLine from the kit to the CO 2 inlet marked. See Figure 11. Figure 11 CO 2 Preparation Setup! Modified FilterLine 3 From the Service Mode Main menu, select CO2. After a few seconds delay, the CO 2 Service screen is displayed, as shown in Figure

29 EtCO 2 Module Calibration 2: Maintenance Figure 12 CO 2 Service Screen 02 Mar :52 A B Service - CO2 CO2 Operating Hours : Last Calibration : Ambient Pressure : Cell Pressure : 15,004 hours 30 Jan : mmhg 733 mmhg Replacement recommended Calibration recommended Main Service CO2 Ambient Pressure Leakage Check Pump Check Flow Rate Check Noise Check Calibration Check Exit You may hear a soft, low-pitch tone, this is normal EtCO 2 pump operation. Another indication of the EtCO 2 pump activity is the difference between the Ambient and Cell pressures. Subtract the Cell pressure from the Ambient pressure and consult Figure 2 to interpret the difference. Table 2 Modified FilterLine Connection Checking and Troubleshooting Ambient Pressure Cell Pressure Possible Cause Suggested Solution 0 Bad connection 1 Reconnect the Modified FilterLine. 2 Go back to Main Service and reselect EtCO 2. Pump malfunction 9 mmhg or less Modified FilterLine is broken Pump malfunction Call for service. Replace the Modified FilterLine. Call for service 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. 4 Older models of the EtCO 2 sensor must warm up for at least 20 minutes before the calibration. a Check Device Info. b If EtCO 2 Module SW version is 01.xx, then warm up the sensor before calibration. Note the warm-up time. You can use the HeartStart MRx screen clock. Do not start calibration until the EtCO 2 sensor has been warmed up. Continue the preparation. c If EtCO 2 Module SW version is 02.xx or above, then proceed with calibration without waiting for warm-up. 19

30 2: Maintenance EtCO 2 Module Calibration 5 Check the CO 2 Operating Hours. If the CO 2 module has clocked more than 15,000 hours, replacement is recommended. Do not proceed with the calibration. Call for service. 6 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 HeartStart MRx. 7 Press the Menu Select button and select Ambient Pressure. 8 Using and buttons, adjust the HeartStart MRx s Ambient Pressure setting to the measurement obtained in Step 6. 9 Press the Menu Select button again to accept the adjusted Ambient Pressure value. 10 Calculate the expected CO 2 reading. The expected CO 2 reading depends on both the gas concentration you are using (5.0%) and the ambient pressure. Calculate as follows: a Cal. Gas Concentration ambient pressure = Expected CO 2 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 CO 2 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 2 reading in our case should be between 36 and 40 mmhg. d Save your calculations. You will compare the numbers with the actual CO 2 sensor reading during the calibration validation. 11 Fit the 5% CO 2 gas cylinder with the valve. Screw the valve on tightly. 12 Watch the manometer on the valve. While the gas pressure does not have to be high for successful calibration, it should be present. 13 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

31 EtCO 2 Module Calibration 2: Maintenance Figure 13 CO 2 Calibration Setup Do not touch this regulator Gas flow valve Gas flow regulator Manometer 5% EtCO 2 calibration gas cylinder Modified FilterLine EtCO 2 Calibration Procedure If you warm up the sensor as determined in Step 4 of EtCO 2 Calibration Setup, then make sure the EtCO 2 sensor has been warmed up for at least 20 minutes before starting the calibration steps. To calibrate the EtCO 2 module: 1 From the CO2 Service menu, select Calibration Check. The CO 2 Calibration screen is displayed. 2 Wait a few seconds until the softkeys become active. See Figure 14. Figure 14 CO 2 Calibration Screen 02 Mar :52 A B Service - CO2 CO2 : 37 mmhg Main Service Calibrate Done 21

32 2: Maintenance EtCO 2 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 2 value to stabilize. 5 Press the Calibrate softkey. 6 Use the Menu Select button to confirm that you are using the 5% CO 2 gas mix. See Figure 15. You can calibrate the CO 2 module with 4% or 6% CO 2 gas mix, but Philips recommends and provides instructions for the 5% calibration gas. Figure 15 CO 2 Calibration Gas Selection Cal Main Service Cancel Done 5 % MENU 7 Do not turn off gas or touch any buttons or tubing until completion. The CO2 calibration in progress message indicates that the calibration has started. The Calibration complete message indicates that the calibration is successful. 8 Turn off the gas. 9 Validate the calibration by checking the displayed CO 2 value against the expected value calculated in the section Step 10 on page 20 of the EtCO 2 Calibration Setup 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 operational check is completed. See Figure 16. Figure 16 Successful CO 2 Calibration 02 Mar :52 A B Service - CO2 Calibration is successful, but the Calibration recommended message does not disappear until the Operational Check is completed. CO2 Operating Hours : Last Calibration : Ambient Pressure : Cell Pressure : 1504 hours 02 Mar : mmhg 739 mmhg Calibration recommended 11 Run an operational check to update the calibration status. See the Troubleshooting chapter of HeartStart MRx Service Manual for guidance. 22

33 EtCO 2 Module Checks 2: Maintenance EtCO 2 Calibration Failure If the error message Calibration failed. Please restart calibration appears at any moment during CO 2 calibration, then: 1 Recheck the Modified FilterLine, gas cylinder, and valve connections. 2 Recheck gas presence in the gas cylinder. While the gas pressure does not have to be high for successful calibration, it should be present. 3 If the warm-up process if necessary, and the CO 2 module is off, then restart the warm-up process and wait for 20 minutes. See the section EtCO 2 Calibration Setup on page Restart the calibration as described in EtCO 2 Calibration Procedure on page If you cannot successfully complete the calibration, call for service. EtCO 2 Module Checks Perform the EtCO 2 Module checks only if there is an uncertainty about the module performance. In addition to the equipment listed in EtCO 2 Calibration Equipment on page 18, for EtCO 2 Module checks you will need: Electronic flowmeter, part # A flow tube and two air plugs. The flow tube and air plugs are provided in the CO 2 Calibration Kit, part # Each of the procedures assumes that the HeartStart MRx, flowmeter, and tubing are still set up as they were at the end of the previous test. If all results are as described, the device passes that portion of the test. Return to the Service Mode Main menu by pressing the Main Service softkey. If there is any failure, then troubleshoot and repair the device as needed. See the Troubleshooting chapter of HeartStart MRx Service Manual. EtCO 2 Module Check Setup To prepare for EtCO 2 checks: 1 Access the Service Mode Main menu as described in Accessing Service Mode on page 8. 2 Connect the FilterLine to the HeartStart MRx CO 2 inlet marked. See Figure 11 CO 2 Preparation Setup on page From the Service Mode Main menu, select CO2. After a few seconds delay, the CO 2 Service screen is displayed, as shown in Figure 12 CO 2 Service Screen on page Follow the steps of EtCO 2 Calibration Setup on page 18. The CO 2 Service screen is displayed, as shown in Figure 12 CO 2 Service Screen on page 19. TIP: To check the EtCO 2 module, you do not need to wait for the module warm up, except for the Calibration Check. 23