AS/NZS 3200.2.202:1996

AS/NZS 3200.2.202:1996 APPROVAL AND TEST SPECIFICATION—MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY—INFANT

PREFACE

CONTENTS

SECTION 1 GENERAL

1 Scope and object

1.1 Scope

1.2 Object

1.3 Particular Standards

2 Definitions

2.1 Apnoea

2.2 Health care practitioner

2.3 Infant apnoea monitor

2.4 Medical electrical equipment

2.5 Patient

2.6 Operation

2.7 Status indicator

3 General requirements

4 General requirements for tests

5 Classification

6 Identification, marking and documents

7 Power input

SECTION 2 ENVIRONMENTAL CONDITIONS

SECTION 3 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

SECTION 4 PROTECTION AGAINST MECHANICAL HAZARDS

SECTION 5 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION

36 Electromagnetic compatibility

SECTION 6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION 7 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS

SECTION 8 ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT

SECTION 9 ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS

SECTION 10 CONSTRUCTIONAL REQUIREMENTS

59.101 Status indicators

59.102 Battery condition

59.103 Apnoea measurement

59.104 Biting

59.105 Toxicity

59.106 Inadvertent changing of settings

59.107 Tamper-proof power off protection

59.108 Settings

59.109 Terminals and connectors

59.110 Alarms

59.1101 ACTIVATION

59.110.2 VISUAL INDICATORS

59.110.3 AUDIBLE INDICATORS

59.110.4 REMOTE ALARMS

APPENDIX LL - REFERENCED DOCUMENTS

APPENDIX MM - ADDITIONAL REQUIREMENTS NOT SUBJECT TO TECHNICAL TESTING

MM1 RE-SALE OR LEASING

MM2 OPERATING INSTRUCTIONS

MM2.1 For the user

MM2.2 For the health care practitioner

MM3 DAILY CHECK

MM4 MONITOR SETTINGS

MM5 TRAINING

MM6 SUPPORT

APPENDIX NN - FOR THE USER ESSENTIAL SAFETY PRACTICES

NN1 MONITORING CHECK DURING USE

NN2 MONITOR PLACEMENT

NN3 ELECTRICAL INTERFERENCE

NN4 INFANT'S BED

NN5 CORDS, TUBING AND WIRES STRANGULATION

NN6 A SAFE SLEEPING ENVIRONMENT

NN7 TO PARENTS, AND OTHER CLOSE ASSOCIATES OF THE INFANT, WHO SMOKE

APPENDIX PP - RESOURCES—OTHER SOURCES OF ADVICE

SIDA ORGANIZATION LOCATIONS