M Series Invasive Blood Pressure Service Manual Rev A PDF download

Page 1

ZOLL M S ERIES S ERVICE M ANUAL

Invasive Blood

Pressure

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The issue date or revision level for this operation guide is shown on the front cover.

ZOLL and M Series are trademarks of ZOLL Medical Corporation.

Page 3

Table of Contents

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ZOLL Medical Corporation’s M Series Service Manual is intended for the service technician

who identifies malfunctions and makes repairs at the subassembly level. Place this insert

into the three-ring binder containing the M Series Service Manual and all other M Series

option inserts.

This document provides information required for maintenance of the Invasive Blood

Pressure (IBP) option on the M Series CCT unit, and contains the following sections:

Principles of Operation on page 1 — provides a general overview of IBP functionality.

Maintenance Tests on page 3 — describes procedures for verifying IBP operation and

integrity.

Disassembly Procedures on page 12 — describes the procedure for removing the IBP

assembly from the M Series CCT unit.

Replacement Parts on page 16 — lists the field-replaceable parts for the IBP option and

provides information on ordering replacement parts from ZOLL.

Troubleshooting on page 17 — describes error messages related to IBP functionality and

their corresponding corrective action.

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This M Series Service Manual insert uses the following 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 and maintaining the M Series unit.

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For more information on M Series operation and configuration, see the following

documents:

• Invasive Blood Pressure insert (part number 9650-0219-01) of the M Series Operator’s Guide —

describes user tasks for operating the IBP option.

• M Series Operator’s Guide (part number 9650-0200-01) — describes user tasks for general

operation of the M Series unit.

• M Series Configuration Guide (part number 9650-0201-01) — describes M Series features and

functions whose operation can be customized by authorized users.

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Service technicians should review these safety considerations prior to servicing any

equipment and read the manual carefully before attempting to disassemble the unit. Only

qualified personnel should service the M Series unit.

Federal (U.S.A.) law restricts this unit for use by or on the order of a physician.

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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 on 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.

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All persons near the equipment must be warned to “STAND CLEAR” prior to discharging

the defibrillator.

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SHOCK HAZARD!

The M Series CCT unit can generate up to 2400 volts with

sufficient current to cause lethal shocks.

Do not discharge the M Series unit’s energy internally more than three times in one minute

or damage to the unit may result.

Do not discharge a battery pack except in a Base PowerCharger4x4, a compatible ZOLL

Battery Charging/Testing unit, or an M Series unit.

Do not use the M Series unit 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 M Series unit near or within puddles of water.

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The M Series unit is protected against interference from radio frequency emissions typical

of two-way radios and cellular phones (digital and analog) used in emergency service/public

safety activities.

Users of the M Series should assess the unit’s performance in their typical environment of

use for the possibility of radio frequency interference from high-power sources. Radio

Frequency Interference (RFI) may be observed as shifts in monitor baseline, trace

compression, or transient spikes on the display.

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For terms and conditions associated with your warranty, consult your purchasing agreement

(for customers in North America) or a ZOLL authorized representative (for customers

outside North America).

To maintain this warranty, the instructions and procedures contained in this manual must

be strictly followed. For more information, please contact ZOLL Medical Corporation’s

Technical Service Department at 1-800-348-9011 (North America). If calling from outside

North America, contact ZOLL Medical Corporation headquarters at 1-781-229-0020.

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If the M Series unit requires service, contact the ZOLL Technical Service Department:

Telephone: 1-800-348-9011

1-781-229-0020

FAX:

781-229-0758

When requesting service for the M Series unit, please provide the following information to

the Technical Service representative:

• unit serial number

• description of the problem

• department using the equipment

• sample chart recorder strips documenting the problem, if applicable

• purchase order to allow tracking of loan equipment

• purchase order for a unit with an expired warranty

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If you need to send the unit to ZOLL Medical Corporation for repair, you must obtain a

service request (SR) number from the Technical Service representative. Units are available

on loan while your unit is being repaired.

For customers ...

Return the unit in its original container to ...

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The Invasive Blood Pressure (IBP) option on the M Series CCT unit allows for invasive

monitoring of arterial (ART), pulmonary arterial (PA), central venous (CV), and

intracranial (ICP) pressures on two channels. The M Series CCT unit displays systolic,

diastolic, and mean pressure measurements, and displays up to two IBP waveforms along

with one ECG trace.

The IBP/Temperature module resides in the lower housing assembly of the M Series CCT

unit. A transducer connects to the M Series CCT unit through one of two pressure channel

connectors on the front of the unit.

Figure 1-1: M Series with IBP option

NI BP

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You can assign labels to each pressure channel to indicate the type of pressure being

measured. You can also assign each IBP waveform to a trace position on the

M Series CCT display, and set the amplitude scale for displaying the waveform.

See the Invasive Blood Pressure insert of the M Series Operator’s Guide for details on operating

the IBP option.

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The M Series IBP function measures systolic, diastolic, and mean pressure by processing

electrical signals from a resistive bridge transducer with 5 µV/V/mmHg sensitivity

connected to the patient through a catheter.

Note: Transducers with 40 µV/V/mmHg sensitivity are NOT compatible with the

M Series CCT unit.

Pulsatile pressures (ART, PA, P1) display systolic, diastolic, and mean values. Non-pulsatile

pressures (CVP, ICP, P2) display mean values only.

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When the M Series CCT unit detects a connection to a transducer through one or both of

the pressure channel connectors, the unit prompts the user to zero the pressure channel(s).

Pressure measurement does not begin until the pressure channels have been zeroed.

The IBP measurement cycle proceeds as follows:

Stage Description

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You can change default settings for IBP parameters such as pressure channel labels and

waveform display scale at power-up, and alarm thresholds. See the M Series Configuration

Guide for more information.

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It is important that users conduct the Operator’s Shift Checklist procedure at the beginning

of every shift to maintain the M Series unit ready for immediate use. This checkout

procedure can be completed in a few minutes and requires no additional test equipment.

See the M Series Operator’s Guide for the Operator’s Shift Checklist.

For the IBP option, a qualified biomedical technician should perform the following

maintenance procedures every six months to ensure that the M Series IBP function is

operating properly:

• “IBP Monitor Test” on page 5

• “IBP Noise Test” on page 7

• “IBP Static Pressure Test” on page 10

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Photocopy the checklist at the back of the M Series Service Manual and use the copy to record

the results of the maintenance tests. As you complete each step in a procedure, mark the

appropriate Pass/Fail/NA box, and keep the checklist for your maintenance file. Complete

all the steps of the procedure before evaluating the test results.

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Follow these steps to prepare the M Series CCT unit for the IBP maintenance tests.

Step Action

Expected Result

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The IBP monitor test verifies proper pressure channel zeroing and the accuracy of blood

pressure measurements.

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You need the following equipment to complete the IBP monitor test:

• M Series CCT unit with IBP option (with fully-charged battery installed)

• DNI Nevada 214B Patient Simulator (or equivalent) with M Series (or Protocol Propaq)

interface cables

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Before you begin the IBP monitor test:

• Set the IBP channel labels to P1 and ART respectively (see “Test set-up” on page 3

• Set the BP output sensitivity scale to 5 µV/V/mmHg on the Patient Simulator.

• Connect the Patient Simulator cables to the IBP connectors on the M Series CCT unit.

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Follow these steps to perform the IBP monitor test.

Note: These instructions apply to the DNI Nevada 214B Patient Simulator; for equivalent

devices, follow the manufacturer’s instructions.

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Expected Result

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The IBP noise test verifies that there is no excessive noise in the blood pressure circuitry on

the M Series CCT unit.

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You need the following equipment to complete the IBP noise test:

• M Series CCT unit with IBP option (with fully-charged battery installed)

• DNI Nevada 214B Patient Simulator (or equivalent) with M Series (or Protocol Propaq)

interface cables

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Before you begin the IBP noise test:

• Set the IBP channel labels to P1 and ART respectively (see “Test set-up” on page 3

• Set the BP output sensitivity scale to 5 µV/V/mmHg on the Patient Simulator.

• Connect the Patient Simulator cables to the IBP connectors on the M Series unit.

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Follow these steps to perform the IBP noise test.

Note: These instructions apply to the DNI Nevada 214B Patient Simulator; for equivalent

devices, follow the manufacturer’s instruction.

Step Action

Expected Result

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Step Action

Expected Result

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The IBP static pressure test verifies the accuracy of both positive and negative static

pressure measurements.

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You need the following equipment to complete the IBP static pressure test:

• M Series CCT unit with IBP option (with fully-charged battery installed)

• Fogg BP-28 Pressure Transducer Simulator (or equivalent)

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Before you begin the IBP static pressure test:

• Set the IBP channel labels to P1 and ART respectively (see “Test set-up” on page 3

• Set the input and output resistance to 350 Ω on the Transducer Simulator, and set the

gain to x10.

• Connect the Transducer Simulator cable to the P1 connector on the M Series CCT unit.

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Follow these steps to perform the IBP static pressure test.

Note: These instructions apply to the Fogg BP-28 Pressure Transducer Simulator; for

equivalent devices, follow the manufacturer’s instructions.

Step Action

Expected Result

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mmHg

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Page 19

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Step Action

Expected Result

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Page 20

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The IBP/Temperature module resides in the lower housing assembly of the M Series CCT

unit. This section describes the following procedure:

• “Disassembling the IBP module” on page 12

For instructions on removing the lower housing assembly from the M Series CCT unit or

on replacing the multi-parameter interface cable, see the Non-Invasive Blood Pressure insert

(part number 9653-0455-01) of the M Series Service Manual.

Only properly trained technicians should service the M Series CCT unit. Ensure that you

take the appropriate safety precautions before disassembling any part of the M Series CCT

unit.

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SHOCK HAZARD!

Take necessary precautions to guard against shock or injury before

conducting defibrillator tests or repairs. The M Series CCT unit

can contain lethal voltages even when turned off.

In addition:

• Wear a conductive wrist strap that touches your skin and is connected to a grounding

mat and to an earth ground when working with static-sensitive units. Remove the wrist

strap when you discharge high voltage or when you are working on energized

equipment.

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The IBP/Temperature module resides in the lower housing assembly of the M Series CCT

unit, and connects to the M Series main system board through the multi-parameter

interface cable.

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You need the following tools to disassemble the IBP/Temperature module:

• #2 Phillips screwdriver

• small pliers

• small wood stick

• Exacto knife

• anti-static wrist strap

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Page 21

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Follow these steps to disassemble the IBP/Temperature module.

Step Action

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Page 22

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Page 23

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Step Action

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To reassemble the IBP components in the CCT lower housing assembly, reverse Steps 1

through 12 of the above disassembly procedure.

Note: When re-inserting the NIBP pump and

tubing assembly into the CCT lower

housing assembly, place the tubing gently

into the plastic guides to avoid pinching.

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Page 24

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You can order replacement parts through an authorized ZOLL distributor or directly from

ZOLL Medical Corporation. Pricing information is available from ZOLL Medical

Corporation’s Technical Service Department.

Note: ZOLL reserves the right to substitute different parts to reflect modifications and

improvements in ZOLL M Series circuitry and design.

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When ordering parts, please provide the following information:

• ZOLL M Series device model and serial number

• field-replaceable unit part number

• description of the replacement part

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To order by mail from ZOLL Medical Corporation, address your request to:

ZOLL Medical Corporation

32 Second Avenue

Burlington, MA 01803-4420

Attention: Technical Service Department

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For more information, contact ZOLL Medical Corporation at 1-781-229-0020 or

1-800-348-9011 (Fax: 1-781-229-0758).

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The following table lists the replacement parts available with the IBP option on the

M Series CCT unit.

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Description

Part Number

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Page 25

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The M Series CCT unit displays certain error messages to alert the user to problems

detected in IBP operation. The following table lists IBP error messages and their associated

corrective action.

For further assistance, contact ZOLL Technical Service at 1-800-348-9011. International

customers should call the nearest authorized ZOLL Medical Corporation distributor.

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Message/Symptom

Possible Causes

Corrective Action

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ZOLL

Defibrillators M-Series

M Series Invasive Blood Pressure Service Manual Rev A

Available for download in the BioClinical Services library

If you already belong to a hospital with access, please login via your intranet.