X Series Service Manual Rev H March 2021

The issue date for the X Series Service Manual (REF 9650-001356-01 Rev. H) is March 2021. If more than 3 years have elapsed since the issue date, contact ZOLL Medical Corporation to determine if additional product information updates are available. Copyright © 2021 ZOLL Medical Corporation. All rights reserved. Rectilinear Biphasic, SurePower, X Series, and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Masimo and Rainbow are trademarks or registered trademarks of Masimo Corporation in the United States and/or other countries.

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105 ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands

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Table of Contents Preface

OVERVIEW ...1 SAFETY CONSIDERATIONS ...2 ADDITIONAL REFERENCE MATERIAL...2 CONVENTIONS ...3 SERVICE POLICY WARRANTY ...3 TECHNICAL SERVICE ...3 TECHNICAL SERVICE FOR INTERNATIONAL CUSTOMERS ...4 TAMPER PROOF LABELS ...4 Chapter 1

Maintenance Tests

X SERIES OVERVIEW ...5

Before You Begin the Maintenance Tests ... 6 Equipment You Need to Perform the Maintenance Tests ... 7 Accessories You Need for the X Series Options Maintenance Tests ... 7

MAINTENANCE TESTS ...8 Physical Inspection of the Unit ... 8 Operational Tests ... 9 Leads Test ... 15 Heart Rate Display Test ... 16 Heart Rate Alarm Test ... 17 Power Supply Test ... 19 Leakage Current Test ... 21 Shock Test ... 22 Advisory Test ... 25 Synchronized Cardioversion Test ... 26 Pacer Test ... 27 Printer Test ... 28 Treatment Report Test ... 29 SpO2 Test (for SpO2 feature without SpCO and SpMet) ... 30 SpO2, SpCO, and SpMet Test (for SpO2 feature with SpCO, or SpCO and SpMet) ... 31 EtCO2 Calibration (required for annual calibration) ... 33 EtCO2 Calibration Check ... 34 EtCO2 Test ... 35 IBP Test ... 36 NIBP Calibration Check ... 37 NIBP Leak Test ... 40 Deflation Test ... 41 Inflation Test ... 42 NIBP Test ... 43

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Temperature Test ... 44 Wi-Fi Test (Optional) ... 45 Audio Recording Test (Optional) ... 47 Real BVM Help Test ... 48 Chapter 2

Troubleshooting

OVERVIEW ...51 X SERIES ERROR MESSAGES ...51 Chapter 3

Disassembly Procedures

OVERVIEW ...63 REQUIRED EQUIPMENT ...63 SAFETY PRECAUTIONS...64 MODULES ...64 REMOVING THE HANDLE ...65 REMOVING THE PRINTER MODULE ...66 DISASSEMBLING THE MAIN UNIT ...68 REMOVING THE FRONT ENCLOSURE MODULE ...73 REMOVING THE DISPLAY MODULE ...75 REMOVING THE ETCO2 AND NIBP MODULES ...79 REMOVING THE MONITOR BOARD AND SPO2 MODULES ...83 REMOVING THE CP CARRIER MODULE ...87 REMOVING THE DEFIBRILLATOR BOARDS AND CAPACITOR BANK MODULES ...91 REMOVING THE AUX POWER CONNECTOR ...97 REMOVING THE DOCK CONNECTOR ...99 REPLACING THE MULTIFUNCTION CABLE GASKET ...101 Chapter 4

Replacement Parts

OVERVIEW ...103 Replacement Parts List ... 103 Pictures and Diagrams ... 109

Chapter 5

Functional Description

OVERVIEW ...125 Circuit Distribution ... 125

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Monitor Board ... 125 Defibrillator Pacer Module ... 128 Printer ... 129 Lithium Ion Battery ... 130

Appendix A OVERVIEW ...131 X SERIES ELECTRICAL HARDWARE INTERCONNECT DIAGRAM ...132 X SERIES SIGNAL AND POWER INTERCONNECT SCHEMATIC ...133 Appendix B OVERVIEW ...135 NIBP Simulator Performance ... 135 Fluke Biomedical BP Pump/Bio-Tek Instruments BP Pump ... 136 ... 136 Fluke Biomedical BP Pump/Bio-Tek Instruments BP Pump2 ... 136 Fluke Biomedical BP Pump/Dynatech Nevada Inc. CuffLink ... 137 Clinical Dynamics Smart Arm ... 137

Maintenance Test Checklist OVERVIEW ...139

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Preface Overview The ZOLL® X Series™ Service Manual is intended for the trained biomedical technician whose responsibility is to identify malfunctions and/or make repairs at the subassembly level. The X Series Service Manual has five main sections and two appendixes. Preface-Contains safety warnings and an overview of the manual’s contents. Be sure to review this section thoroughly before attempting to use or service the X Series unit. Chapter 1-Maintenance Tests describes step-by-step procedures for various maintenance tests. Chapter 2-Troubleshooting provides a listing of error messages to help the service technician detect faults and repair them. Chapter 3-Disassembly Procedures describes step-by-step procedures for disassembling modules in the X Series unit. Chapter 4-Replacement Parts List displays a complete list of ZOLL part numbers for field replaceable parts available for the X Series unit, allowing the service person to identify and order replacement parts from ZOLL. Chapter 5-Functional Description provides technical descriptions for the X Series major subassembly modules. Appendix A-X Series Electrical Hardware Interconnect Diagram and X Series Signal and Power Interconnect Schematic. Appendix B-Contains simulators and settings that may be used to assess the performance of the NIBP module.

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PREFACE

Safety Considerations The following section describes general warnings and safety considerations for operators and patients. Service technicians should review the safety considerations prior to servicing any equipment and read the manual carefully before attempting to disassemble the unit. Only qualified personnel should service the X Series unit. Federal (U.S.A.) law restricts this unit for use by or on the order of a physician. Safety and effectiveness data submitted by ZOLL Medical Corporation to the Food and Drug Administration (FDA) under section 510(K) of the Medical Device Act to obtain approval to market is based upon the use of ZOLL accessories such as disposable electrodes, patient cables and batteries. The use of external pacing/defibrillation electrodes and adapter units from sources other than ZOLL is not recommended. ZOLL makes no representations or warranties regarding the performance or effectiveness of its products when used in conjunction with pacing/defibrillation electrodes and adapter units from other sources. If unit failure is attributable to pacing/defibrillation electrodes or adapter units not manufactured by ZOLL, this may void ZOLL's warranty. Only qualified personnel should disassemble the X Series unit.

WARNING!

This unit can generate up to 2775 volts with sufficient current to cause lethal shocks. All persons near the equipment must be warned to “STAND CLEAR” prior to discharging the defibrillator. Do not discharge the unit’s internal defibrillator energy more than three times in one minute or damage to the unit may result. Do not discharge a battery pack except in a ZOLL SurePowerTM Charging Station. Do not use the X Series in the presence of flammable agents (such as gasoline), oxygen-rich atmospheres, or flammable anesthetics. Using the unit near the site of a gasoline spill may cause an explosion. Do not use the unit near or within puddles of water.

Additional Reference Material In addition to this guide, there is a X Series Operator’s Guide which is a comprehensive reference work that describes all the user tasks needed to operate the X Series.

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Conventions

Conventions WARNING! Warning statements describe conditions or actions that can result in personal injury or death.

Caution

Caution statements describe conditions or actions that can result in damage to the unit. Note:

Notes contain additional information on using the defibrillator.

Service Policy Warranty In North America: Consult your purchasing agreement for terms and conditions associated with your warranty. Outside of North America, consult a ZOLL authorized representative. In order to maintain this warranty, the instructions and procedures contained in this manual must be strictly followed. For additional information, please call the ZOLL Technical Service Department 1-800-348-9011 in North America.

Technical Service If the ZOLL X Series unit requires service, contact the ZOLL Technical Service Department: Telephone: 1-978-421-9655; 1-800-348-9011 Fax: 1-978-421-0010 Email: [email protected] Have the following information available for the Technical Service representative: • Unit serial number.

• Description of the problem.

• Department where equipment is used.

• Sample chart recorder strips or electronic log files documenting the problem, if applicable. • Purchase Order to allow tracking of loan equipment. • Purchase Order for a unit with an expired warranty.

If the unit needs to be sent to ZOLL Medical Corporation, obtain a service request number (SR#) from the Technical Service representative. Return the unit in its original container to: ZOLL Medical Corporation 269 Mill Road Chelmsford, Massachusetts 01824-4105 Attn: Technical Service Department (SR#) Telephone: 1-800-348-9011; 1-978-421-9655 FAX: 978-421-0010

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PREFACE

Technical Service for International Customers International customers should return the unit in its original container to the nearest authorized ZOLL Medical Corporation Service Center. To locate an authorized service center, contact the International Sales Department at ZOLL Medical at the above address.

Tamper Proof Labels

ZOLL products must be repaired by qualified individuals. The removal of the tamper proof label could result in voiding the factory warranty. Please contact the Technical Service Department if you have any questions or concerns prior to removing the label.

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X Series Overview

Chapter 1 Maintenance Tests X Series Overview This chapter includes step-by-step procedures for various maintenance tests. At a minimum, a trained biomedical technician must perform a CO2 calibration and an NIBP calibration check once per year. A CO2 calibration check may be performed at any time to verify the CO2 calibration. It is necessary to perform maintenance tests after a module is repaired to ensure that the functions of the X Series unit work properly. Use the checklist at the back of this document (ZOLL X Series Maintenance Tests Checklist) to record your results of the maintenance tests. Because the X Series units must be maintained ready for immediate use, it is important for users to conduct the Operator’s Shift Checklist procedure at the beginning of every shift. This procedure can be completed in a few minutes and requires no additional test equipment. (See the ZOLL X Series Operator’s Guide for the Operator’s Shift Checklist.)

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CHAPTER 1 MAINTENANCE TESTS This chapter describes the following maintenance tests: • 1.0 Physical Inspection of the Unit • 2.0 Operational TestsOperational Tests • 3.0 Leads Test • 4.0 Heart Rate Display Test • 5.0 Heart Rate Alarm Test • 6.0 Power Supply Test • 7.0 Leakage Current Test • 8.0 Shock Test • 9.0 Advisory Test • 10.0 Synchronized Cardioversion Test • 11.0 Pacer Test • 12.0 Printer Test • 13.0 Treatment Report Test • 14.0 SpO2 Test (for SpO2 feature without SpCO and SpMet) • 15.0 SpO2, SpCO, and SpMet Test (for SpO2 feature with SpCO, or SpCO and SpMet) • 16.0 EtCO2 Calibration (required for annual calibration) • 17.0 EtCO2 Calibration Check • 18.0 EtCO2 Test • 19.0 IBP Test • 20.0 NIBP Calibration Check • 21.0 NIBP Leak Test • 22.0 Deflation Test • 23.0 Inflation Test • 24.0 NIBP Test • 25.0 Temperature Test • 26.0 Wi-Fi Test (Optional) • 27.0 Audio Recording Test (Optional) • 28.0 Real BVM Help Test

Before You Begin the Maintenance Tests • Assemble the tools listed in following section, “Equipment You Need to Perform the

Maintenance Tests.”

• Keep an extra fully charged X Series battery available. • Schedule an hour to conduct the entire maintenance test. • Perform the tests in the order presented. • Perform all the steps of each test procedure. • Complete all the steps of the procedure before evaluating the test results.

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X Series Overview

Equipment You Need to Perform the Maintenance Tests The equipment listed below is used in the maintenance procedures in this chapter. You can substitute an equivalent device; however, not all simulators and analyzers will produce the same results. Be sure to follow the manufacturer’s recommendations for conducting the maintenance tests. • Fluke Impulse 7000DP Analyzer, with appropriate interface adapter (Fluke Biomedical

BP Pump/Dynatech Nevada Inc. part number 3010-0378)

• ECG simulator • Fluke Index 2 SpO2 simulator • IBP/Temp simulator • NIBP simulator • 5% CO2 calibration gas cylinder with CO2 sample line (kit available from Scott Medical

Products, PN T4653ORF-2BD)

• CO2 sampling line airway adapter • Stop watch • Battery Current Test Fixture 9100-3055-TF • Agilent E3633A Power Supply (12V rated for 10A) • Agilent 34401 Digital Multi-meter • Adult BVM

Accessories You Need for the X Series Options Maintenance Tests • 3-lead, 5-lead and 12-lead ECG cables. (12-lead cable needed if 12-lead option is

installed.)

• Dual lumen NIBP hose • IBP cable • SpO2 cable and sensor • EtCO2 cable and sensor • Paddles • Printer paper • Battery • Auxiliary power source • USB thumb drive • PC w/ Windows media player and speakers • AccuVent cable and sensor

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CHAPTER 1 MAINTENANCE TESTS

Maintenance Tests 1.0 Physical Inspection of the Unit Observe this...

Pass/Fail

Housing 1.1 Is the unit clean and undamaged?

o o

1.2 Does the unit show signs of excessive wear?

o o

1.3 Does the handle work properly?

o o

1.4 Does the recorder drawer open and close properly?

o o

1.5 Are input connectors clean and undamaged?

o o

1.6 Are there any cracks in the housing?

o o

1.7 Does the front panel have any damage or cracks?

o o

1.8 Are there any loose housing parts?

o o

1.9 Paddles (if applicable) Do the adult and pedi plates have major scratches or show signs of damage?

o o

1.10 Do the adult shoes slide on and off easily to expose the covered pedi plates?

o o

1.11 Are the paddles clean (e.g., free of gel) and undamaged? (if applicable)

o o

1.12 Cables

o o

Are all cables free of cracks, cuts, exposed or broken wires? 1.13 Are all bend/strain reliefs undamaged and free of excessive cable wear?

o o

1.14 Battery

o o

Is the X Series battery fully charged? 1.15 Is the battery seated in the battery well correctly?

o o

1.16 Is battery housing free of cracks and damage?

o o

1.17 Are connectors free of damage and excessive wear?

o o

1.18 MFC Cable Gasket

o o

Verify MFC cable gasket is in place and intact. (If replacement is needed, see instructions Replacing the Multifunction Cable Gasket on page 99)

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Maintenance Tests

2.0 Operational Tests The X Series unit comes equipped with routine operational tests that can be performed periodically. With the exception of the Physical Inspection of the Unit test, these tests contain instructions within them that provide guidance during the tests. The operational tests on the unit can be accessed by doing the following: 1. Turn on the X Series unit. Note:

If the unit is in AED mode, press the Manual quick access key to go into manual mode. Use the navigation keys to select the four digits in the Manual Mode pass code. Press SAVE when you are finished. If the unit has not been configured to enter a pass code, the message Exit to Manual Mode is displayed. Use the navigation keys to select Yes.

2. Press the More (

) then the Setup (

) quick access keys.

3. Use the navigation keys to select Supervisor>Service>Device Tests. The operational tests

are displayed. Use the navigation keys to select one of the tests.

Note:

You need a supervisor passcode to enter the Supervisor menu.

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CHAPTER 1 MAINTENANCE TESTS 2.1 Keypad Test This test checks all the front panel buttons on the unit to make sure they are working correctly. Follow the instructions and use the navigation keys to move around the display and make selections.

Note:

To exit screen after test is complete, press the “Enter” button 3 times to display arrow.

2.2 LED Test This test checks all the Light Emitting Diodes in the unit to make sure they are working correctly. Follow the instructions and use the navigation keys to move around the display and make selections.

Note:

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The speed of the flash varies by color.

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Maintenance Tests 2.3 LCD Test This test checks the colors of the Liquid Crystal Display on the unit. Follow the instructions and use the navigation keys to move around the display and make selections.

2.4 RFU Indicator Test This test checks the Ready For Use Indicator on the unit to make sure it is working correctly. Follow the instructions shown on the display.

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CHAPTER 1 MAINTENANCE TESTS 2.5 Audio Test This test checks the audio tones on the unit to make sure they are working correctly. Follow the instructions and use the navigation keys to move around the display and make selections.

2.6 Printer Test This test checks the printer to make sure it is working correctly. Follow the instructions shown on the display.

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Maintenance Tests 2.7 Battery Test This test checks the battery to make sure it is working correctly. Follow the instructions on the display.

2.8 Fan Test This test checks the fan in the unit to make sure it is working correctly. Follow the instructions and use the navigation keys to move around the display and make selections.

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CHAPTER 1 MAINTENANCE TESTS 2.9 USB Test (Optional) Note:

Before starting this test, contact the ZOLL Technical Service Department to obtain a test file, or create a file (see instructions below). Once you have obtained a copy, save it on a USB thumb drive.

This test allows you to perform the USB test to make sure it is working correctly. Follow the instructions and use the navigation keys to move around the display and make selections.

When these tests are completed, use the navigation keys to exit out of the Service menu. Creating a Test File

1. Create a Text file using Microsoft Notepad. 2. Open new file in Notebook. 3. Click in the first line of the file and type “Thunderbolt Testfile". 4. Save file as Tbolt_usb.txt.

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Maintenance Tests

3.0 Leads Test Equipment

3-lead, 5-lead, and 12-lead cables, Fluke Impulse 7000DP Analyzer Note:

Test Setup

Test each cable separately.

Connect the lead wires appropriate for each test to the Fluke Impulse 7000DP Analyzer or equivalent, then connect the ECG cable to the X Series unit. Do this...

Observe this...

Pass/Fail

3.1 Turn on the X Series unit. Note: Make sure the lead is not displayed.

No ECG LEAD FAULT message displayed.

o o

3.2 Disconnect one lead from the simulator.

The ECG LEAD FAULT message displays within 3 seconds (if configured).

o o

3.3 Reconnect the lead. Repeat step 2 with the remaining leads.

Wait for ECG LEAD FAULT message to clear from the display (if configured).

o o

3.4 Repeat steps 2 and 3 for 5 lead and 12 Note: If heart rate alarm sounds, on the lead cables. X Series unit:

o o

Press the More quick access key ( ) key to access the second set of quick access keys. Press the Alarm quick access key (

).

Press the Alarm Cancel quick access key ( ).

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