X Series Service Manaul Rev A April 2012

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X Series Service Manual

™

9650-001356-01 Rev. A

Page 2

The issue date for the X Series Service Manual (REF 9650-001356-01 Rev. A) is April, 2012.

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 © 2012 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.

Oridion and Microstream are trademarks or registered trademarks of Oridion Systems, Ltd. 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

0197

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TABLE OF CONTENTS

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Preface

Overview

ZOLL® Medical Corporation’s 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 two 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 the Annual Calibration Tests for NIBP and EtCO2

modules, Functional Tests that need to be run when a module has been repaired, and

Operational Tests that need to be performed at regular intervals to augment the automatic

testing the X Series does to ensure readiness.

Chapter 2—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 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: techsupport@zoll.com

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.

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Chapter 1

Maintenance Tests

X Series Overview

This chapter includes step-by-step procedures for the following types of maintenance tests:

•

•

•

•

Calibration and Calibration Checks

NIBP Valve, Pump, and Tubing Integrity Tests

Operational Tests

Functional Verification 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 Functional Verification 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.) It is highly

recommended that the Operational Tests be performed at regular intervals to augment the

automatic testing the X Series unit does to ensure readiness.

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CHAPTER 1 MAINTENANCE TESTS

This chapter describes the following maintenance tests:

Calibration and Calibration Checks

• CO2 Calibration Procedure

• CO2 Calibration Check

• NIBP Calibration Check

NIBP Valve, Pump, and Tubing Integrity Tests

• Leak Test

• Deflation Test

• Inflation Test

Operational Tests

• Physical Inspection of the Unit

• Keypad Test

• LED Test

• LCD Test

• RFU Indicator Test

• Audio Test

• Printer Test

• Battery Test

• Fan Test

• NIBP Test

• USB Test

Functional Verification Tests

• Leads Test

• Heart Rate Display Test

• Heart Rate Alarm Test

• Leakage Current Test

• Shock Test

• Advisory Test

• Synchronized Cardioversion Test

• Pacer Test

• Printer Test

• USB File Transfer Test

• Treatment Report Test

• SpO2 Monitor Test

• EtCO2 Monitor Test

• IBP Monitor Test

• NIBP Monitor Test

• Temperature Test

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Calibration and Calibration Checks

Calibration and Calibration Checks

CO2 Calibration Procedure (required for annual calibration)

Equipment

5% CO2 calibration gas cylinder with CO2 sample line (kit available from Scott Medical

Products, PN 4653ORF-BD)

Procedure

1. Turn on the X Series unit.

2. On the X Series unit, select Supervisor>Service>Diagnostic>CO2>Calibration to enter

the CO2 Calibration control panel.

3. Connect the X Series unit to the 5% CO2 calibration gas cylinder using the sample line

included with the calibration kit.

4. From the CO2 Calibration Menu, select Calibration.

5. Activate the calibration gas flow by pressing the top valve on the calibration gas canister.

6. Continue to apply the calibration gas until the status in the CO2 Calibration control panel

displays: CALIBRATION GAS CAN BE REMOVED.

• When the calibration is complete, the status in the CO2 Calibration control panel

displays: CALIBRATION DONE - OK OR CALIBRATION DONE - ERROR.

7. To verify calibration, perform “CO2 Calibration Check Procedure” on page 8.

The calibration date will be updated upon exiting the CO2 Test control panel.

Corrective Action

If an error is reported, refer to the table below for possible causes.

If readings fail to meet the required accuracy, the CO2 module requires replacement or factory

analysis and realignment.

The following table describes possible calibration errors and likely causes.

Table 1-1.

Calibration Errors

Error Message

Cause

No gas or wrong gas

concentration

The concentration of supplied gas is not close to the expected

value.

No stable gas flow and

Calibration failure

The gas sample is not stable, i.e. due to leak or noise.

Measurement error

Occlusion detection during known gas sampling.

Measurement error

Sample line disconnection during gas sampling.

AZ fail

The Auto Zero that is part of the calibration process failed.

Calibration aborted by

user

Calibration mode canceled during gas sampling.

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CO2 Calibration Check Procedure

Equipment

5% CO2 calibration gas cylinder with CO2 sample line (kit available from Scott Medical

Products, PN 4653ORF-BD)

If you have previously run the CO2 Calibration Procedure, start at step 3.

Procedure

1. On the X Series unit, select Supervisor>Service>Diagnostic>CO2>Calibration to enter

the CO2 Calibration control panel.

2. Connect the X Series unit to the 5% CO2 calibration gas cylinder using the sample line

included with the calibration kit.

3. From the CO2 Calibration control panel, select Verify Calibration.

4. Activate the calibration gas flow by pressing the top valve on the calibration gas canister.

5. Continue to apply the calibration gas until the status in the CO2 Calibration control panel

displays: CALIBRATION GAS CAN BE REMOVED.

• When the calibration check is complete, the status in the CO2 Calibration control panel

displays: VERIFICATION DONE - OK OR VERIFICATION DONE - ERROR.

• When the calibration check completes successfully, the measured gas value displays in

the CO2 Calibration control panel.

Acceptable Results

The message displays: VERIFICATION DONE - OK.

The measured gas reading passes if it is between 4.8 and 5.2 (Vol%).

6. Exit out of calibration by pressing the Back arrow key (

Display/Home button (

) three times or pressing the

).

Corrective Action

If an error is reported, refer to Table 1-1 on page 7 for possible causes.

If the measured gas reading is outside the acceptable range, or if calibration is due, complete

the following CO2 calibration procedure.

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Calibration and Calibration Checks

NIBP Calibration Check

Equipment

Double lumen BP hose, a 500 cc volume, and a calibrated manometer or pressure gauge

(< = 1mmHg accuracy). If a 500 cc volume is not available, an Adult BP cuff wrapped around a

rigid cylinder (such as a glass jar) will suffice.

Note:

This test is to be performed for the following target pressures: 50 +/- 5 mmHg,

150 +/- 5 mmHg, and 250 +/- 5 mmHg.

Procedure

1. Power 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. Connect the X Series unit to the double lumen hose and the 500 cc volume. Alternatively,

replace the 500 cc volume with a standard Adult cuff wrapped around a rigid cylinder, such

as a glass jar. Connect a calibrated manometer to the air line using a T-fitting.

3. On the X Series unit, do the following to enter the NIBP Test control panel:

• Press the More (

) then the Setup (

) quick access keys.

• Use the navigation keys to select Supervisor>Service>Device Tests>NIBP Test.

Note:

You need a supervisor passcode to enter the Supervisor menu.

4. From the X Series NIBP Test control panel, use the navigation keys to select:

• Close Valve

• Turn Pump On

5. Monitor the pressure reported by the external pressure standard.

6. Once the pressure reaches the target pressure of 50 +/- 5 mmHg, use the navigation keys to

select Turn Pump Off.

7. Allow the system to stabilize for at least 10 seconds.

8. Record the pressure reported by the external pressure standard as Pa.

9. Record the pressures reported by the primary and safety transducers (displayed in the NIBP

Test control panel) as P1 and P2 respectively.

10. Calculate the absolute pressure differences between the applied pressure (Pa) and each of the

transducer pressures.

• Pd-Primary = abs(Pa-P1)

• Pd-safety = abs(Pa-P2)

11. From the NIBP Test control panel, select Open Valve to release the pressure.

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12. Repeat steps 3 to 11 to test for the remaining target pressures of 150 +/- 5 mmHg and

250 +/- 5 mmHg.

13. Once complete, use the navigation keys to select Update NIBP Cal Check Date to save the

date of the most recent calibration check.

14. Press

twice and select Diagnostic>NIBP>Calibration Info. Verify that the last NIBP

Cal date is today’s date.

Acceptable Results

The unit passes the test if Pd-Primary is less than or equal to 3.0 mmHg and Pd-Safety is less than

or equal to 4.0 mmHg for all three target pressures.

Corrective Action

If readings fail to meet the required accuracy, the NIBP module requires replacement or factory

analysis and realignment.

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NIBP Valve, Pump, and Tubing Integrity Tests

NIBP Valve, Pump, and Tubing Integrity Tests

NIBP Leak Test

Equipment

Double lumen BP hose, a 500 cc volume, and a calibrated manometer.

Note:

If a 500 cc volume is not available, an Adult BP cuff wrapped around a rigid cylinder

(such as a glass jar) will suffice.

Procedure

1. Turn on the X Series unit.

2. Connect the X Series unit to the single lumen hose and the 500 cc volume. Alternatively,

replace the 500 cc volume with a standard Adult cuff wrapped around a rigid cylinder, such

as a glass jar. If available, connect a calibrated manometer to the air line using a T-fitting.

3. Using the X Series unit, do the following to enter the NIBP Test control panel:

• Press the More (

) then the Setup (

) quick access keys.

• Use the navigation keys to select Supervisor>Service>Device Tests>NIBP Test.

Note:

You need a supervisor passcode to enter the Supervisor menu.

4. From the X Series NIBP Test control panel, use the navigation keys to select:

• Close Valve

• Turn Pump On

5. Monitor the pressure reported by NIBP Test control panel or the external pressure standard.

6. Select Turn Pump Off as soon as the pressure reaches the target pressure of 250 +/- 5 mmHg.

7. Allow the system to stabilize for 10 seconds.

8. Select Mark P1 to mark the starting pressure. If available, measure the starting pressure

reported by the external pressure standard. Record the starting pressure as PS.

9. Wait 15 seconds.

10. Select Mark P2 to mark the ending pressure. If available, measure the ending pressure

reported by the external pressure standard. Record the ending pressure as PE.

11. From the NIBP Test control panel, select Open Valve to release the pressure.

12. Calculate the leak rate: L = (P1 - Pa) / (15 seconds).

Note:

If using the pressure reported in the NIBP Test control panel, calculate the Leak Rate

using the Primary transducer pressures.

13. Select Clear to clear Mark P1 and Mark P2.

Acceptable Results

The unit passes the test if the system leaks less than 5 mmHg over the 15-second time interval

(Leak Rate is less than 1/3).

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Corrective Action

If the unit fails the test, the most likely cause is damaged or disconnected internal tubing. The

device needs to be disassembled to replace or reattach the appropriate segment of NIBP tubing.

The NIBP valves should also be inspected.

NIBP Deflation Test

Equipment

Double lumen BP hose, a 500 cc volume, a timer, and a calibrated manometer (optional).

Note:

If a 500 cc volume is not available, an Adult BP cuff wrapped around a rigid cylinder

(such as a glass jar) will suffice.

If you have previously run the NIBP Leak Test, you can go to step 4.

Procedure

1. Turn on the X Series unit.

2. Connect the X Series unit to the double lumen hose and the 500 cc volume. Alternatively,

replace the 500 cc volume with a standard Adult cuff wrapped around a rigid cylinder, such

as a glass jar. If available, connect a calibrated manometer to the air line using a T-fitting.

3. Using the X Series unit, do the following to enter the NIBP Test control panel:

• Press the More (

) then the Setup (

) quick access keys.

• Use the navigation keys to select Supervisor>Service>Device Tests>NIBP Test.

Note:

You need a supervisor passcode to enter the Supervisor menu.

4. From the X Series NIBP Test control panel, use the navigation keys to select:

• Close Valve

• Turn Pump On

5. Monitor the pressure reported by the NIBP Test control panel or the external pressure

standard.

6. Select Turn Pump Off as soon as the pressure reaches the target pressure of 265 +/- 5 mmHg.

7. Allow the system to stabilize for 5 seconds.

8. Use the navigation keys to select Open Valve and immediately start the timer.

9. Stop the timer as soon as pressure drops below 15 mmHg.

10. Record the Deflation Time as TD.

Acceptable Results

The unit passes the test if the time to release pressure from 265 +/- 5 mmHg to 15 mmHg is less

than 10 seconds.

Corrective Action

If the unit fails the test, the most likely cause is kinked or obstructed internal tubing, or

obstructed filter. The device needs to be disassembled to replace or reposition the appropriate

segment of NIBP tubing.

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NIBP Valve, Pump, and Tubing Integrity Tests

NIBP Inflation Test

Equipment

Double lumen BP hose, a 250 cc volume, a timer, and a calibrated manometer (optional).

Note:

If you have previously run the NIBP Deflation Test, you can go to step 6.

Procedure

1. Turn on the X Series unit.

2. Connect the X Series unit to the double lumen hose and the 250 cc volume. If available,

connect a calibrated manometer to the air line using a T-fitting.

3. Using the X Series unit, do the following to enter the NIBP Test control panel:

• Press the More (

) then the Setup (

) quick access keys.

• Use the navigation keys to select Supervisor>Service>Device Tests>NIBP Test.

Note:

You need a supervisor passcode to enter the Supervisor menu.

4. Wait 10 seconds to allow the system to vent any residual pressure.

5. Verify that the pressure reported by the NIBP Test control panel or the external pressure

standard system is less than 5 mmHg.

6. From the NIBP Test control panel, use the navigation keys to select Close Valve.

7. Select Turn Pump On and immediately start the timer.

8. Stop the timer as soon as pressure exceeds 210 mmHg.

9. Select Turn Pump Off, then Open Valve.

10. Record the Inflation Time as TI.

Note:

The pump will automatically turn off if pressure exceeds 310 mmHg during this test.

Acceptable Results

The unit passes the test if the time to increase pressure to 210 mmHg is less than 7 seconds.

Corrective Action

If the unit fails the test, the most likely cause is a faulty pump or a kinked internal hose. The

device needs to be disassembled to replace the pump or reposition the appropriate segment of

NIBP tubing.

11. Exit the Service menu and turn off the unit.

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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.

Physical Inspection of the Unit

Observe this...

Pass/Fail

Housing

1.

Is the unit clean and undamaged?

o

o

2.

Does the unit show signs of excessive wear?

o

o

3.

Does the handle work properly?

o

o

4.

Does the recorder drawer open and close properly?

o

o

5.

Are input connectors clean and undamaged?

o

o

6.

Are there any cracks in the housing?

o

o

7.

Does the front panel have any damage or cracks?

o

o

8.

Are there any loose housing parts?

o

o

Do the adult and pedi plates have major scratches or show signs of damage?

o

o

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

o

o

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

o

o

12. Are all cables free of cracks, cuts, exposed or broken wires?

o

o

13. Are all bend/strain reliefs undamaged and free of excessive cable wear?

o

o

14. Is the X Series battery fully charged?

o

o

15. Is the battery seated in the battery well correctly?

o

o

16. Is battery housing free of cracks and damage?

o

o

17. Are connectors free of damage and excessive wear?

o

o

Paddles (if applicable)

9.

Cables

Battery

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Operational Tests

Accessing the Operational 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

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.

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:

16

The speed of the flash varies by color.

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Operational Tests

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.

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

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.

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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Operational Tests

Battery Test

This test checks the battery to make sure it is working correctly.

Follow the instructions on the display.

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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NIBP Test

This test allows the operator to perform various checks of the NIBP module to make sure it is

working correctly.

Follow the instructions in the NIBP Calibration Check procedure and other procedures outlined

in this manual. Use the navigation keys to move around the display and make selections as

required to execute the procedures.

USB Test (Optional)

Note:

Before starting this test, contact the ZOLL Technical Service Department to obtain a

test file.

This test allows the operator 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.

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Functional Verification Tests

Functional Verification Tests

Before You Begin the Functional Verification Tests

• Assemble the tools listed in following section, “Equipment You Need to Perform the

•

•

•

•

•

Functional Verification 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.

Equipment You Need to Perform the Functional Verification Tests

For testing purposes, you can substitute an equivalent device.

• Fluke Impulse 7000DP Analyzer, or equivalent, with appropriate interface adapter

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

IBP/Temp Simulator, or equivalent

NIBP Simulator

Single or dual lumen NIBP hose

Adult NIBP cuff and a rigid cylinder to wrap it around

5% CO2 calibration gas cylinder with CO2 sample line (kit available from Scott Medical

Products, PN 4653ORF-BD)

• ECG Simulator; 12 Lead Simulator for 12 Lead test (e.g., Symbio CS1201)

•

•

•

•

•

Accessories You Need for the X Series Options Functional Verification Tests

• 3-lead, 5-lead and 12-lead ECG cables. (12-lead cable needed if 12-lead option is

•

•

•

•

•

•

•

•

installed.)

NIBP cuff and hose

IBP cable

SpO2 cable and sensor

EtCO2 cable and sensor

Paddles

Printer paper

Battery

Auxiliary power source

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