1 - AS 2684-1984 MEDICAL EQUIPMENT - HUMIDIFIERS FOR MEDICAL USE
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE.
6 - 2 APPLICATION.
6 - 3 REFERENCED DOCUMENTS.
6 - 4 DEFINITIONS.
6 - 4.1 Absolute humidity
6 - 4.2 Accessible surface temperature
6 - 4.3 Delivery tube
6 - 4.4 Delivery tube heater
6 - 4.5 Delivery tube outlet
6 - 4.6 Humidifier
6 - 4.7 Humidifier heater
6 - 4.8 Humidifier outlet
6 - 4.9 Maximum/ minimum water volume
6 - 4.10 Nebulizing humidifier
6 - 4.11 Operator control
6 - 4.12 Operation indicator
6 - 4.13 Pre-filled
6 - 4.14 Relative humidity
6 - 4.15 Saturated vapour pressure
6 - 4.16 Vaporizing humidifier
6 - 4.17 Humidification chamber
6 - 4.18 Water content (of humidified gas)
6 - 4.19 Water reservoir
6 - 4.20 Breathing system
6 - 4.21 Humidified gas
6 - 4.22 Humidifier tank
6 - 4.23 Steady gas flow
6 - 4.24 Shall, should, may
6 - 5 PERFORMANCE- WATER OUTPUT.
7 - 6 GENERAL DESIGN (INCLUDING MATERIALS AND BIO-COMPATIBILITY.
7 - 6.1 Construction.
7 - 6.2 Condensate drainage.
7 - 6.3 Resistance to gas flow.
7 - 6.4 Sterilization and disinfection.
7 - 6.5 Controls.
7 - 6.6 Surface temperature of accessible parts.
7 - 7 INTERNAL COMPLIANCE.
7 - 8 BREATHING CONNECTIONS.
7 - 8.1 General.
7 - 8.2 Delivery tubes.
8 - 9 HUMIDIFIER CHAMBER AND/OR WATER RESERVOIR.
8 - 9.1 Maximum operating volume.
8 - 9.2 Filling.
8 - 9.3 Water level indicator.
8 - 9.4 Tilting.
8 - 9.5 Water level.
8 - 9.6 Wick assembly.
8 - 9.7 Internal pressure.
8 - 10 TEMPERATURE.
8 - 10.1 General.
8 - 10.2 Normal temperature control.
8 - 10.3 Overtemperature cutout and alarm.
8 - 10.4 Temperature monitor.
8 - 10.5 Calibrated temperature control.
8 - 11 PRESSURE RELIEF.
9 - 12 OPERATOR CONTROLS.
9 - 12.1 Accuracy.
9 - 12.2 Integral oxygen concentration control.
9 - 12.3 Movement of controls.
9 - 12.4 Protection of controls.
9 - 12.5 Legibility of marking.
9 - 13 ELECTRICAL REQUIREMENTS.
9 - 13.1 General.
9 - 13.2 Electrical patient-circuits.
9 - 13.3 Delivery tube electrical circuits.
9 - 13.4 Safety during filling or emptying.
9 - 13.5 Protection against hazards of explosions and fire
9 - 13.6 Electromagnetic radiation.
9 - 14 NOISE LEVELS.
9 - 15 ALARMS.
9 - 15.1 General.
9 - 15.2 Muting of alarms.
9 - 16 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER.
9 - 16.1 General.
10 - 16.2 Humidifier performance.
10 - 17 MARKING.
10 - 17.1 General markings.
11 - 17.2 Electrical ratings and specifications.
11 - 17.3 Instructions.
12 - APPENDIX A - GENERAL TEST CONDITIONS AND APPARATUS REQUIREMENTS
12 - A1 SCOPE.
12 - A2 GENERAL CONSIDERATIONS.
12 - A2.1 Ambient conditions.
12 - A2.2 Test gas.
12 - A2.3 Gas flow.
12 - A2.4 Water container.
12 - A2.5 Test chamber.
12 - A2.6 Analysis of gas concentrations.
12 - A2.7 Test setting combinations.
14 - APPENDIX B - METHOD FOR DETERMINING CONTAINER OVERFLOW
14 - B1 SCOPE.
14 - B2 PRINCIPLE.
14 - B3 APPARATUS.
14 - B4 PROCEDURE.
14 - B4.1 Tilting.
14 - B4.2 Reverse connections.
14 - B5 REPORT.
15 - APPENDIX C - METHOD FOR DETERMINING THE OUTPUT TEMPERATURE
15 - C1 SCOPE.
15 - C2 PRINCIPLE.
15 - C3 APPARATUS.
15 - C4 PROCEDURE.
15 - C5 REPORT.
16 - APPENDIX D - METHOD FOR DETERMINING PRESSURE RELIEF
16 - D1 SCOPE.
16 - D2 PRINCIPLE.
16 - D3 APPARATUS.
16 - D4 PROCEDURE.
16 - D5 REPORT.
17 - APPENDIX E - METHOD FOR DETERMINING THE NOISE LEVELS PRODUCED DURING HUMIDIFIER OPERATION
17 - E1 SCOPE.
17 - E2 PRINCIPLE.
17 - E3 APPARATUS.
17 - E4 PROCEDURE.
17 - E5 REPORT.
18 - APPENDIX F - METHOD FOR DETERMINING WATER OUTPUT
18 - F1 SCOPE.
18 - F2 PRINCIPLE.
18 - F3 APPARATUS.
18 - F4 PROCEDURE.
18 - F5 CALCULATION OF WATER OUTPUT.
18 - F6 REPORT.
19 - APPENDIX G - METHOD FOR DETERMINING INTERNAL COMPLIANCE
19 - G1 SCOPE.
19 - G2 PRINCIPLE.
19 - G3 APPARATUS.
19 - G4 PROCEDURE.
19 - G5 REPORT.
20 - APPENDIX H - METHOD FOR DETERMINING RESISTANCE TO FLOW
20 - H1 SCOPE.
20 - H2 PRINCIPLE.
20 - H3 APPARATUS.
20 - H4 PROCEDURE.
20 - H5 REPORT.
21 - APPENDIX J - METHOD FOR DETERMINING OXYGEN CONCENTRATION
21 - J1 SCOPE.
21 - J2 PRINCIPLE.
21 - J3 APPARATUS.
21 - J4 PROCEDURE.
21 - J5 REPORT.