R Series Service Manual Rev N

© 2020 ZOLL Medical Corporation. All rights reserved. R Series, CodeNet, SurePower, OneStep and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Masimo is a registered trademark of Masimo Corporation in the United States and/or other countries. All other trademarks are the property of their respective owners.

Warranty (U.S. Only) (a) ZOLL Medical Corporation warrants to the original equipment purchaser that beginning on the date of installation, or thirty (30) days after the date of shipment from ZOLL Medical Corporation's facility, whichever first occurs, the equipment (other than accessories and electrodes) will be free from defects in material and workmanship under normal use and service for the period of one (1) year. During such period ZOLL Medical Corporation will, at no charge to the customer, either repair or replace (at ZOLL Medical Corporation's sole option) any part of the equipment found by ZOLL Medical Corporation to be defective in material or workmanship. If ZOLL Medical Corporation's inspection detects no defects in material or workmanship, ZOLL Medical Corporation's regular service charges shall apply. (b) ZOLL Medical Corporation shall not be responsible for any equipment defect, the failure of the equipment to perform any function, or any other nonconformance of the equipment, caused by or attributable to: (i) any modification of the equipment by the customer, unless such modification is made with the prior written approval of ZOLL Medical Corporation; (ii) the use of the equipment with any associated or complementary equipment, (iii) installation or wiring of the equipment other than in accordance with ZOLL Medical Corporation's instructions. (c) This warranty does not cover items subject to normal wear and burnout during use, including but not limited to lamps, fuses, batteries, patient cables and accessories. (d) The foregoing warranty constitutes the exclusive remedy of the customer and the exclusive liability of ZOLL Medical Corporation for any breach of any warranty related to the equipment supplied hereunder. (e) Limitation of Liability: ZOLL shall not in any event be liable to Purchaser, nor shall Purchaser recover, for special, incidental or consequential damages resulting from any breach of warranty, failure of essential purpose, or under any other legal theory including but not limited to lost profits, lost savings, downtime, goodwill, damage to or replacement of equipment and property, even if ZOLL has been advised of the possibility of such damages. THE WARRANTY SET FORTH HEREIN IS EXCLUSIVE AND ZOLL MEDICAL CORPORATION EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES WHETHER WRITTEN, ORAL, IMPLIED, OR STATUTORY, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. For additional information, please call ZOLL Medical Corporation at 1-800-348-9011 (in Massachusetts 1-978-421-9655). International customers should call the nearest authorized ZOLL Medical Corporation service center.

Software License

Read this License agreement carefully before operating any of the R Series

®

products.

Software incorporated into the system is protected by copyright laws and international copyright treaties as well as other intellectual property laws and treaties. This software is licensed, not sold. By taking delivery of and using this system, the Purchaser signifies agreement to and acceptance of the following terms and conditions: Grant of License: In consideration of payment of the software license fee which is part of the price paid for this product ZOLL Medical Corporation grants the Purchaser a non-exclusive license, without right to sublicense, to use the system software in object-code form only. Ownership of Software/Firmware: Title to, ownership of and all rights and interests in the system software and all copies thereof remain at all times vested in the manufacturer, and Licensors to ZOLL Medical Corporation and they do not pass to Purchaser. Assignment: Purchaser agrees not to assign, sub-license or otherwise transfer or share its rights under the license without the express written permission of ZOLL Medical Corporation. Use Restrictions: As the Purchaser, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not disclose, publish, translate, release or distribute copies of the software/firmware to others. You may not modify, adapt, translate, reverse engineer, decompile, crosscompile, disassemble or create derivative works based on the software/ firmware. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA USA 01824-4105

0123

ZOLL International Holding B.V. Newtonweg 18 6662 PV ELST The Netherlands

TABLE OF CONTENTS Preface Safety Considerations ...i Additional Reference Material ...ii Conventions ...ii Service Policy Warranty ...iii Technical Service...iii Technical Service Outside of the United States...iv

Chapter 1

Maintenance Tests Overview ...1 Before You Begin the Maintenance Tests...2 Equipment You Need to Perform the Maintenance Tests...2 Physical Inspection of the Unit ...4 Ready For Use Test ...6 Front Panel Button Test ...8 ECG Test ...10 Print Calibration Test ...11 Notch Filter Test ...12 Shock Test ...13 Synchronized Cardioversion ...16 Remote Cardioversion Test (Optional) ...17 Pacer Output Test ...19 Synchronized Pacing Test ...21 SpO2 Function Check (If Applicable) ...22 EtCO2 Functional Test (If Applicable) ...23 CO2 Accuracy Check (If Applicable) ...24 Paddles Test (If Applicable) ...26 NIBP Leak Test (If Applicable) ...29 NIBP Calibration Test (If Applicable) ...30 Leakage Current Test ...31 CPR Feedback Test (If Applicable) ...34

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Chapter 2

Troubleshooting Overview ...1 ZOLL R Series Error Messages ...1

Chapter 3

Disassembly Procedures Required Equipment...1 Safety Precautions...2 Removing the Cable Caddy ...3 Removing the Handle ...6 Removing the Recorder, AC Charger and Battery Well...7 Removing the Front Panel Assembly ...12 Front Panel Disassembly ...14 Removing the Side Panels ...16 Removing the Connector Panel and Bezel...18 Removing the ECG Input Connector...20 Removing the NIBP Assembly...21 Removing the System Brick Assembly ...23 Disassembling the System Brick Assembly ...28 Discharging Capacitor...34 Removing the Communication Module ...35

Chapter 4

Replacement Parts List of Replacement Parts...2 Diagrams... 11

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TABLE OF CONTENTS Chapter 5

Functional Description AC Charger ...1 SurePower Battery...1 Parameter Power Supply (SpO2, EtCO2, NIBP) ...2 Digital System Board...2 Analog System Board...3 Pace/Defib Core Engine ...4 Front Panel Controls ...4 Peripherals ...4 Accessories...5 Power Management Support Functions ...5 WiFi ...6

Appendix Interconnect Diagram for the R Series Biphasic Unit ...2 Delivered Energy at Every Defibrillator Setting into a Range of Loads ...3 SYNC Connectors Diagram...4

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Preface ZOLL® Medical Corporation’s R Series® Service Manual is intended for the service technician whose responsibility is to maintain and inspect the R Series defibrillators. The ZOLL R Series Service Manual has five main sections and one appendix. 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 R Series unit. Chapter 1-Maintenance Tests explains how to check the defibrillator’s performance using a series of recommended checkout procedures to be conducted every 12 months. Chapter 2-Troubleshooting provides a listing of the procedures and error messages to help the service technician detect faults and repair them. Chapter 3-Disassembly Procedures describes step-by-step procedures for removing assemblies and subassemblies from the R Series unit Chapter 4-Replacement Parts List displays a complete list of ZOLL part numbers for field replaceable parts available for the R Series unit, allowing the service person to identify and order replacement parts from ZOLL. Chapter 5-Functional Description provides technical descriptions for the R Series major subassembly modules. Appendix-R Series interconnect diagram; table for delivered energy loads; maintenance checklists.

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 R 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 R Series unit.

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WARNING!

This unit can generate up to 2,850 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 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 Battery Charger Station. Do not use the R 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 are several other components to the ZOLL R Series documentation. They include: • ZOLL R Series Operator’s Guide - describes all the user tasks needed to operate the R Series.

• ZOLL R Series Configuration Guide - describes the R Series features and functions whose operation can be customized by authorized users.

• ZOLL R Series Operator’s Guide - Pulse Oximetry (SpO2) Insert - describes all the user tasks needed to operate the R Series Pulse Oximetry option. • ZOLL R Series Operator’s Guide - Non-Invasive Blood Pressure (NIBP) Insert - describes all the user tasks needed to operate the R Series NIBP

option. • ZOLL R Series Operator’s Guide - End Tidal Carbon Dioxide (EtCO2) Insert - describes all the user tasks needed to operate the R Series EtCO2 option.

Conventions

ii

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.

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Service Policy Warranty In North America: Consult your purchasing agreement for terms and conditions associated with your warranty. Outside of North America, consult 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 R 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

• Purchase Order to allow tracking of loan equipment • Purchase Order for a unit with an expired warranty

• Sample chart recorder strips documenting the problem, if applicable • Full disclosure file from the unit, if applicable (.FUL extension) • Ready code file from the unit, if applicable (.DCK extension) • Activity log file from the unit, if applicable (.RAL extension)

If the unit needs to be sent to ZOLL Medical Corporation, obtain a Service Request number from the Technical Service representative. Return the unit in its original container to: ZOLL Medical Corporation 269 Mill Road Chelmsford, Massachusetts 01824-4105

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Attn: Technical Service Department, SR# XXXXXX Telephone: 1-800-348-9011; 1-978-421-9655 FAX: 978-421-0010

Technical Service Outside of the United States Customers outside of the United States 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.

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Chapter 1 Maintenance Tests Overview The R Series has two checkout procedures: the R Series Operator’s Guide defibrillator testing checklist and the extensive 12-month maintenance test checkout procedures. Because the R Series units must be maintained ready for immediate use, regular readiness testing is required. It can either be performed manually or automatically. Refer to the R Series Operator’s Guide for details. A qualified biomedical technician must perform a more thorough maintenance test checkout every 12 months to ensure that the functions of the R Series unit work properly. This chapter describes the step by step procedures for performing the 12 month maintenance test checkout. Use the checklist at the back of this document (ZOLL R Series Maintenance Test Checklist) to record your results of the maintenance tests. This chapter describes the following maintenance tests: • 1.0 Physical Inspection of the Unit • 2.0 Ready For Use Test

• 3.0 Front Panel Button Test • 4.0 ECG Test

• 5.0 Print Calibration Test • 6.0 Notch Filter Test • 7.0 Shock Test

• 8.0 Synchronized Cardioversion

• 9.0 Remote Cardioversion Test (Optional) • 10.0 Pacer Output Test

• 11.0 Synchronized Pacing Test

• 12.0 SpO2 Function Check (If Applicable)

• 13.0 EtCO2 Functional Test (If Applicable) • 14.0 CO2 Accuracy Check (If Applicable) • 15.0 Paddles Test (If Applicable)

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R Series Service Manual • 16.0 NIBP Leak Test (If Applicable)

• 17.0 NIBP Calibration Test (If Applicable) • 18.0 Leakage Current Test

• 19.0 CPR Feedback Test (If Applicable)

Before You Begin the Maintenance Tests • Assemble the tools or specialized testing equipment listed in the “Equipment You Need to Perform the Maintenance Tests” section shown below. • Keep an extra fully charged ZOLL SurePower defibrillator battery available. • Schedule an hour to conduct the entire maintenance test.

• Photocopy the checklist at the back of this document and use the copy to record your results. As you conduct each step of a procedure, mark the Pass/

Fail/NA check boxes on your checklist and then save it for your maintenance file.

• 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.

Equipment You Need to Perform the Maintenance Tests This section lists equipment that we use to perform the maintenance tests that we describe in this chapter. You can substitute an equivalent device for a listed 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. We recommend the use of the following equipment when performing R Series Maintenance Tests • MFC to Analyzer Adapter - ZOLL Part Number 9100-3039-TF. • Defib Analyzer (Fluke Impulse 7000DP or equivalent device). • Electrical Safety Analyzer.

• SpO2 cable and sensor (if option is installed).

• NIBP Simulator/Analyzer (Fluke Prosim 8 or equivalent device).

• CAPNOSTAT 5 Mainstream cable with airway adapter (if EtCO2 option is installed). • Stop watch. • Paddles.

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R Series Service Manual • Printer paper. • Battery.

• AC line cord.

• 3 lead adapter (part # 8009-0762-XX) or 3 lead ECG cable, and 5 lead ECG cable.

• Gas Regulator (if EtCO2 option is installed). See Note on page 1-25 for more information.

• Calibration Gas (if EtCO2 option is installed). See Note on page 1-25 for more information. • OneStep Training Cable ZOLL P/N: 8900-0180 (CPR Test Option 1)

• OneStep to CPR-D Adapter PN: 8009-0020 & ZOLL AED Simulator PN: 8000-000925 (CPR Test Option 2)

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1.0 Physical Inspection of the Unit Tools Needed: None. Test Setup: 1. Ensure the R Series is plugged into AC power and a fully charged battery is installed. Procedure

Pass/Fail/NA

Main Housing 1.1

Inspect the device to ensure it is clean and without any obvious signs of damage, loose housing parts, cracks or excessive wear.

o o o

1.2

Inspect the printer door to ensure it can open and close properly.

o o o

1.3

Remove all accessories and ensure that the input connectors are clean and undamaged.

o o o

Control Dials 1.4

Ensure the main control knob can easily rotate and switch into all available modes.

o o o

1.5

Ensure the pacer “OUTPUT” dial is able to rotate freely in both directions.

o o o

1.6

Ensure the pacer “RATE” dial is able to rotate freely in both directions.

o o o

Paddles (if Applicable) 1.7

Do the adult shoes slide on and off easily to expose the pediatric plates?

o o o

1.8

Do the paddle plates show any deep scratches or show signs of damage?

o o o

1.9

Ensure paddles are clean and free of any paddle gel.

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1.10

Ensure the OneStep cable cannot be inserted with reversed polarity (up- side down).

o o o

Cables.

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Procedure

Pass/Fail/NA

1.11

o o o

Inspect all cables (Including Accessories) for cuts, cracks or exposed wires.

Battery & Power 1.12

Ensure the battery seats properly into the battery well.

1.13

Verify the AC Power LED is illuminated as a solid green LED.

o o o

1.14

Verify the battery LED shows either a solid green or solid amber LED.

o o o

Note:

If the battery LED is flashing, ensure the battery is properly seated into the battery well and that the battery is not displaying a fault indicator. Inspect the pins and contacts both on the battery and within the battery well to ensure they are not damaged or in need of cleaning.

Record your results on the Maintenance Test Checklist.

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2.0 Ready For Use Test

SHOCK HAZARD!

TAKE THE NECESSARY PRECAUTIONS TO GUARD AGAINST SHOCK OR INJURY BEFORE YOU START CONDUCTING THE DEFIBRILLATOR TESTS. Keep hands and all other objects clear of the multi-function cable connections and defibrillator analyzer when discharging the defibrillator. Before you discharge the defibrillator, warn everyone near the equipment to STAND CLEAR.

Caution

Do NOT internally discharge the unit more than 3 times in 1 minute. Note that multiple rapidly repeating internal discharges at more than 30 Joules may damage the unit.

Tools Needed: Battery, AC Power, and OneStep Cable Test Setup: 1. Ensure the R Series is plugged into AC power and a fully charged battery is installed. 2. Power the R Series into either the “On” or “Defib” positions. Confirm “Manual” mode if required. 3. Ensure the OneStep MFC is connected to the R Series. Procedure

Pass/Fail

2.1

Connect the OneStep cable to the right side panel test port. Verify “DEFIB PAD SHORT” appears on the display.

o o

2.2

Using the energy select and charge buttons, charge the device to 30 Joules.

o o

2.3

Verify that the charging tone sounds.

o o

2.4

Press the SHOCK button and verify that the “30J TEST OK” message displays on the screen. (Note this message is only briefly displayed).

o o o o

2.5 Verify a green check mark appears within the RFU window.

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2.6

Procedure

Pass/Fail

On the print out, verify the following values: TEST_CUR=10-14A and DEFIB_IMPED = 0-5 Ohms.

o o

Note: If the device shows a persistent Red “X” in the RFU window, access the device test log to identify any recorded faults. This log can be accessed by turning the main control dial into either the “ON” or “Monitor” positions, then pressing Report Data > Test Log. 2.7

Unplug the OneStep cable from the test port and verify that the “Check Pads” message appears on the display.

o

o

2.8

Disconnect AC Power from the R Series.

o

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2.9

Remove the battery from the battery well. Verify that a Red X appears in the RFU

o

o

o

o

window. 2.10

Replace the battery back into the battery well, and confirm that the RFU window now reverts back to a green check mark.

Record your results on the Maintenance Test Checklist.

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3.0 Front Panel Button Test Tools Needed: ECG Cable, OneStep Cable Test Setup: 1. Ensure the R Series is plugged into AC power and a fully charged battery is installed. 2. Power the R Series into either the “On” or “Defib” positions. Confirm “Manual” mode if required. 3. Connect both ECG cables and the OneStep MFC to the analyzer. Enter the appropriate mode on the analyzer to receive defibrillation energy. Procedure

Pass/Fail

3.1

Press the “LEAD” button, and verify that the ECG Lead changes. Press the button again until “PADS” is the selected choice.

o o

3.2

Press the “SIZE” button, and verify that the ECG size value changes. Press the button again until “x1” is the selected choice.

o o

3.3

Press the “ALARM SUSPEND” button, and verify that the alarm bell state changes. If alarms begin to sound, press and hold the button for at least 4 seconds. Alarms will now be disabled.

o o

3.4

Press the “RECORDER” button, and verify that the recorder begins to print. You may press the button again to cancel printing.

o

o

3.5

Press the “ENERGY SELECT” button once up, and once down. Verify energy selection changes in both directions.

o

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3.6

Press the “CHARGE” button and verify that R Series begins to charge.

o

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3.7

Verify the “SHOCK” button illuminates and then press the shock button to discharge into the analyzer.

o

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3.8

Press the “ANALYZE” button and confirm an ECG analysis begins.

o

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3.9

Turn the main control knob down into “PACER” mode.

o

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3.10

Press and Hold the 4:1 button. Visually verify that the distance between stimulus markers widen on the display while the button is held.

o

o

3.11

Rotate the OUTPUT and RATE dials. Verify that the mA and PPM values change correspondingly.

o

o

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3.12

Procedure

Pass/Fail

(If Applicable) Press the NIBP button and confirm the NIBP system begins to inflate. You may press the NIBP button a second time to cancel the reading.

o

o

Record your results on the Maintenance Test Checklist.

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4.0 ECG Test Tools Needed: ECG Simulator and ECG Cable. Test Setup: 1. Power the R Series into “On” or “Monitor” position. Confirm “Manual” mode is required. 2. Connect ECG Leads to the simulator. If possible the simulator should be operating on battery power. 3. Press the “LEAD” button on the R Series and select ECG Lead II. 4. Ensure that the alarms enabled and activated on the device. Procedure

Pass/Fail

4.1

Simulate a Normal Sinus Rhythm at 60 BPM.

4.2

Verify the ECG signal appears on the display.

o

o

4.3

Verify the HR is between 59-61 BPM.

o

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4.4

Disconnect a single lead from the simulator and verify the “ECG LEAD OFF” message displays within 3 seconds.

o

o

4.5

Verify that the HR alarm sounds. You may press and hold the alarm suspend button for 4 seconds to permanently deactivate the alarm.

4.6

Reconnect the ECG Lead, and then repeat these steps for the remaining leads. When each lead is removed, verify the “ECG LEAD OFF” message displays.

Note:

If the “ECG LEAD OFF” message does not appear during this test, check the supervisor configuration, and ensure the setting under the ECG menu “Enable Leads Off” is set to “Yes”. Be sure to restore the original configuration setting after testing is complete.

Record your results on the Maintenance Test Checklist.

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5.0 Print Calibration Test Tools Needed: Paper Test Setup: 1. Power the R Series into either the “On” or “Monitor” position. Confirm “Manual” mode if required. 2. Ensure paper is correctly installed into recorder tray.

Procedure 5.1

Press and hold the “SIZE” button on the R Series to introduce a 1mV square wave at 300 per minute onto the display.

5.2

Activate the recorder to print a strip. (Note the recorder prints on a 6 second delay.

5.3

The strip chart displays a signal of 300 ppm with an amplitude of 10 mm +/- 1 mm. The signal also appears on the video display. (You can verify that the rate is 300ppm by measuring 5mm from the left edge of one pulse to the left edge of the following pulse.) See the illustration below for reference.

Pass/Fail

o

o

Record your results on the Maintenance Test Checklist.

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