Philips M1013A IntelliVue G1 Manuel utilisateur

Patient Monitoring

Service Guide

M1013A / M1019A IntelliVue G1/G5

IntelliVue G1/G5

M1013A/M1019A

Part Number 4535 643 23271

Issued in Germany 02/2012

*453564323271*

S PHI

1Table of Contents

1Introduction 7

Who Should Use This Guide 7

How To Use This Guide 7

Description 7

Responsibility of the Manufacturer 8

Warnings and Cautions 8

Physical Specifications 8

Environmental Specifications 9

MDD Classification 9

Performance Specifications 9

CO2 Measurement 10

AWRR derived from CO2 Waveform 10

N2O Measurement 10

O2 Measurement 10

Anesthetic Agent Measurement 10

Alarm Ranges 11

Alarm Delay 11

awRR Alarm Delay 11

Apnea Alarm 11

INOP Alarms 12

Theory of Operation 12

General Measurement Principles 12

O2 Sensor 12

Measurement Principle 12

Pump 13

Watertrap 13

2Installation and Patient Safety 15

Site Preparation - Introduction 15

IntelliVue G1/G5 Site Requirements 15

Environment 16

Initial Inspection 16

Mechanical Inspection 16

Electrical Inspection 16

Claims for Damage and Repackaging 17

Claims for Damage 17

Repackaging for Shipment or Storage 17

Making Connections to the IntelliVue G1/G5 17

Connecting the IntelliVue G1/G5 to AC Mains 18

Securing the Power Cord 19

Connections to the Sample Gas Exhaust 20

Returning the Gas Sample 20

Setting Up the Gas Return 20

Removing the Gas Sample 21

Installing the Top Mount 21

Mounting Instructions 22

Setup and Configuration Procedures 23

IntelliVue Serial Port Configuration 23

Altitude Configuration 23

Connect Sample Input Tubing 23

Post-Installation Checks 23

Safety Requirements Compliance and Considerations 23

Explanation of Symbols Used 24

Electrical and Safety Requirements (Customer or Philips) 24

Power Supply Requirements 24

Protective Earthing of the System 25

Equipotential Grounding 25

Combining Equipment 25

Connecting Non-Medical Devices 25

3Software Uploads 27

Checking the Unit for Functionality 28

Uploading the Software 32

4Testing and Maintenance 41

Introduction 41

Terminology and Definitions 41

Recommended Frequency 42

When to perform Tests 42

Testing Sequence 43

Visual Inspection 43

Before Each Use 43

After Each Service, Maintenance or Repair Event 43

Power On Test 44

Safety Tests 44

Warnings, Cautions, and Safety Precautions 44

Safety Test Procedures 45

Hints for Correct Performance of Safety Tests 47

Guideline for Performance of Safety Tests 47

Electrical Safety Testing 48

S(1): Protective Earth Resistance Test 48

S(2) Equipment Leakage Current Test - Normal Condition 49

S(3) Equipment Leakage Current Test - Single Fault Condition 50

Reference: Allowable Values for IEC 60601-1:1998 and UL 60601-1 Measurements 51

Insulation Resistance 51

System Test 51

What is a Medical Electrical System 51

General Requirements for a System 52

Preventive Maintenance Procedures 52

Cleaning 52

Replace PM Parts 53

Replacing the Fan Filter 53

Replacing the Watertrap Manifold Seals 53

Performance Assurance Tests - Checking and Calibrating the Gas Analyzer 54

Access Service Functions of the Gas Analyzer 54

When and how to check the Gas Analyzer 54

Equipment required for checking 54

Annual Checks 56

Connecting the Gas Analyzer to a PC/Laptop 56

Getting started with the VISIA software 56

Zero Calibration 59

Zero Calibration Test 59

Component Status Check 60

Pneumatic Tests 61

Equipment needed: 61

Leak Check 61

Checking for leaks between inlet and pump 61

Flow Rate Check 64

Pressure Sensor Test 64

Flow Rate Adjustment 65

Gas Calibration Test 66

Disposal of Empty Gas Cylinder 69

Mounting Integrity Test 69

Reporting of Test Results 69

Carrying Out and Reporting Tests 70

Te s t Re p or t 7 0

Test and Inspection Matrix - Checks with Patient Monitor 71

Checks with VISIA Tool 73

Evaluation 73

Evaluation of Test Results 74

Other Regular Tests 74

After Installation, Testing or Repair 74

5Troubleshooting the Gas Analyzer 75

Technical Alarm Messages (INOPs) 76

Troubleshooting 78

6Repairing the Gas Analyzer 79

Introduction 79

Who Should Perform Repairs 79

Tools required 79

Removing the Bottom Quick Release Mount 80

7Parts List 81

Exchange Parts 81

Replacement Parts 81

1Introduction

This book is intended for personnel authorized to install, service or repair an IntelliVue G1 or

IntelliVue G5 gas analyzer. A good understanding of the English language is a requirement.

This chapter contains the following information on the M1013A IntelliVue G1 and the M1019A

IntelliVue G5:

• A description of the module, including its physical, environmental and performance specifications

• A general explanation of the measurement principles that the module uses to measure gas

concentrations

• The theory of operation of the module, its components and how they work.

Who Should Use This Guide

This guide is for biomedical engineers or technicians responsible for troubleshooting, repairing, and

maintaining Philips’ patient monitoring systems.

How To Use This Guide

This guide is divided into seven sections. Navigate through the table of contents at the left of the screen

to select the desired topic. Links to other relevant sections are also provided within the individual

topics. In addition, scrolling through the topics with the page up and page down keys is also possible.

Description

The Philips M1013A IntelliVue G1 and the M1019A IntelliVue G5 work together with the IntelliVue

patient monitors through an RS232 serial interface. They measure the airway gases of ventilated

patients who are under general gas anesthesia, or emerging from it.

The modules produce graphical wave data, and inspired and end-tidal numeric data for the following

gases:

•CO

•N

• One volatile anesthetic agent (IntelliVue G1) / Two volatile anesthetic agents (IntelliVue G5)

•O

2(optional with IntelliVue G1, standard with IntelliVue G5)

It also generates numerics for MAC (Minimum Alveolar Concentration) and the patient’s airway

respiration rate (awRR).

1 Introduction Responsibility of the Manufacturer

Responsibility of the Manufacturer

Philips only considers itself responsible for any effects on safety, EMC, reliability and performance of

the equipment if:

• assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons

authorized by Philips, and

• the electrical installation of the relevant room complies with national standards, and

• the instrument is used in accordance with the instructions for use.

To ensure safety and EMC, use only those Philips parts and accessories specified for use with the

monitor. If non-Philips parts are used, Philips is not liable for any damage that these parts may cause to

the equipment.

Reproduction, adaptation, or translation without prior written permission is prohibited, except as

allowed under the copyright laws.

Philips Medizin Systeme Böblingen GmbH

Hewlett-Packard Str. 2

71034 Böblingen, Germany

The information contained in this document is subject to change without notice.

Philips makes no warranty of any kind with regard to this material, including, but not limited to, the

implied warranties or merchantability and fitness for a particular purpose.

Philips shall not be liable for errors contained herein or for incidental or consequential damages in

connection with the furnishing, performance, or use of this material.

Warnings and Cautions

In this guide:

•Awarning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to

observe a warning may result in death or serious injury to the user or patient.

•Acaution alerts you where special care is necessary for the safe and effective use of the product.

Failure to observe a caution may result in minor or moderate personal injury or damage to the

product or other property, and possibly in a remote risk of more serious injury.

Physical Specifications

Size (H x W x D): 93 x 306 x 232 mm (3.66 x 12.05 x 9.13 in).

Weight: less than 4 kg (7.94 lb)

Environmental Specifications 1 Introduction

Environmental Specifications

MDD Classification

According to the Council Directive 93/42/EEC (Medical Devices Directive) the device classification is

2A, Rule 10.

Performance Specifications

All Performance and accuracy specifications are valid based on gas sample tubing M1658A, including

watertrap M1657B, and airway adapter 13902A.

Humidity Correction: For CO2the humidity correction can be set to “wet” or “dry”.

Wet: p [mmHg] = c [Vol%] * (p_abs - p_H2O)/100

Dry: p [mmHg] = c [Vol%] * p_abs /100

Where p = partial pressure, c = gas concentration, p_abs = pressure in breathing circuit,

p_H2O = 21mmHg, partial pressure of water vapor of room temperature gas (23 oC, 100% rh).

For all other gases the readings are always given as dry values.

Sample Flow Rate:200 ml/min 201

Sample Delay Time: All measurements and alarms are subject to a delay of 5 seconds.

Total System Response Time = the sum of the delay time and the parameter specific rise time.

Operating Temperature: 10 to 40C (50 to 104F)

Storage Temperature: -20 to 65C (-4 to 149F)

Humidity Limit (Operating): 5 to 90% RH max @ 40C (104F).

non-condensing

Humidity Limit (Storage): 5 to 95% RH max @ 65C (149F).

non-condensing

Altitude Range (Operating): -305 to 2900m (-1,000 to 9,515ft)

Altitude Range (Storage): -305 to 5000m (-1,000 to 16,404ft)

Warm-up Time: 1-2 minutes to measure CO2, less than 6 minutes for full

accuracy specifications

1. After warm up or zero the flow rate may be higher than 200 ml/min for about 30 minutes.

1 Introduction Performance Specifications

CO2Measurement

AWRR derived from CO2Waveform

N2O Measurement

O2Measurement

Anesthetic Agent Measurement

Range: 0 to 76 mmHg

Accuracy: 0.5 vol% or 12% relative, whichever is greater

Resolution: 1 mmHg

Rise-time: 350 msec typical

Range: 0 to 60 rpm

Accuracy: ± 1 rpm

Resolution: 1 rpm

Detection Criteria: adaptive threshold

Range: 0 to 100vol%

Accuracy: 2.0 vol% + 8% relative

Resolution: 1 vol%

Rise-time: 500 msec typical

Range: 5 to 100vol%

Accuracy: ± 3 vol%

Resolution: 1 vol%

Rise-time: 500 msec typical

Agent Range (vol%) Accuracy Resolution Rise Time

Halothane 0 - 8.5 0.15 vol% + 15.0% relative 0.05 < 500

Enflurane 0 - 10.0 0.15 vol% + 15.0% relative 0.05 < 500

Isoflurane 0 - 8.0 0.15 vol% + 15.0% relative 0.05 < 500

Sevoflurane 0 - 10.0 0.15 vol% + 15.0% relative 0.05 < 500

Desflurane 0 - 20.0 0.15 vol% + 15.0% relative 0.05 < 500

Ce manuel convient aux modèles suivants

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