AS/NZS 3200.2.202:1996
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Infant apnoea monitors for domestic use
Specifies general requirements for the safety of infant apnoea monitoring equipment, for domestic use.
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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
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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
AS/NZS 3200.2.202:1996
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.