Table of Contents

1 -  AS/NZS 3200.2.202:1996 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-INFANT
4 -  PREFACE
5 -  CONTENTS
7 -  SECTION 1 GENERAL
7 -  1 Scope and object
7 -  1.1 Scope
7 -  1.2 Object
7 -  1.3 Particular Standards
7 -  2 Definitions
7 -  2.1 Apnoea
7 -  2.2 Health care practitioner
7 -  2.3 Infant apnoea monitor
8 -  2.4 Medical electrical equipment
8 -  2.5 Patient
8 -  2.6 Operation
8 -  2.7 Status indicator
8 -  3 General requirements
8 -  4 General requirements for tests
8 -  5 Classification
8 -  6 Identification, marking and documents
8 -  7 Power input
9 -  SECTION 2 ENVIRONMENTAL CONDITIONS
9 -  SECTION 3 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
9 -  SECTION 4 PROTECTION AGAINST MECHANICAL HAZARDS
9 -  SECTION 5 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
9 -  36 Electromagnetic compatibility
9 -  SECTION 6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
10 -  SECTION 7 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
10 -  SECTION 8 ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
10 -  SECTION 9 ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
11 -  SECTION 10 CONSTRUCTIONAL REQUIREMENTS
11 -  59.101 Status indicators
11 -  59.102 Battery condition
11 -  59.103 Apnoea measurement
11 -  59.104 Biting
11 -  59.105 Toxicity
11 -  59.106 Inadvertent changing of settings
11 -  59.107 Tamper-proof power off protection
11 -  59.108 Settings
11 -  59.109 Terminals and connectors
11 -  59.110 Alarms
11 -  59.1101 ACTIVATION
12 -  59.110.2 VISUAL INDICATORS
12 -  59.110.3 AUDIBLE INDICATORS
12 -  59.110.4 REMOTE ALARMS
14 -  APPENDIX LL - REFERENCED DOCUMENTS
15 -  APPENDIX MM - ADDITIONAL REQUIREMENTS NOT SUBJECT TO TECHNICAL TESTING
15 -  MM1 RE-SALE OR LEASING
15 -  MM2 OPERATING INSTRUCTIONS
15 -  MM2.1 For the user
16 -  MM2.2 For the health care practitioner
17 -  MM3 DAILY CHECK
17 -  MM4 MONITOR SETTINGS
17 -  MM5 TRAINING
17 -  MM6 SUPPORT
18 -  APPENDIX NN - FOR THE USER ESSENTIAL SAFETY PRACTICES
18 -  NN1 MONITORING CHECK DURING USE
18 -  NN2 MONITOR PLACEMENT
18 -  NN3 ELECTRICAL INTERFERENCE
18 -  NN4 INFANT'S BED
18 -  NN5 CORDS, TUBING AND WIRES STRANGULATION
18 -  NN6 A SAFE SLEEPING ENVIRONMENT
19 -  NN7 TO PARENTS, AND OTHER CLOSE ASSOCIATES OF THE INFANT, WHO SMOKE
20 -  APPENDIX PP - RESOURCES-OTHER SOURCES OF ADVICE
20 -  SIDA ORGANIZATION LOCATIONS

Abstract

Specifies general requirements for the safety of infant apnoea monitoring equip ment, for domestic use. This Standard is to be read in conjunction with AS 3200.1.0-1990.

Scope

This Standard specifies general safety requirements for infant apnoea monitors, either single or dual modality, for domestic use. This Standard applies to both battery-powered equipment and mains-powered equipment. This equipment should only be used under the supervision of a health care practitioner. An intending purchaser of equipment should be able to gather sufficient information from the Appendices of this Standard to evaluate the quality of equipment being offered and gain helpful advice on the safe use of the equipment.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Pages
ISBN
Committee	HE-003
Under Revision	DR 06447 CP
Supersedes	DR 95394