1 - AS 3655-1989 SPHYGMOMANOMETERS
4 - PREFACE
5 - CONTENTS
6 - FOREWORD
7 - 1 SCOPE.
7 - 2 APPLICATION.
7 - 3 REFERENCED DOCUMENTS.
7 - 4 DEFINITIONS.
7 - 4.1 Sphygmomanometer
7 - 4.2 Cuff
7 - 4.3 Manual device
7 - 4.4 Semi-automated device
7 - 4.5 Fully automated device
7 - 4.6 Audible alarm
7 - 5 DESCRIPTIONOF SPHYGMOMANOMETER.
7 - 6 GENERAL REQUIREMENTS.
7 - 6.1 Environmental performance and stability.
7 - 6.1.1 Operating conditions.
8 - 6.1.2 Durability and resistance to shock.
8 - 6.2 Pressure sensing device.
8 - 6.2.1 Markings.
8 - 6.2.2 Range.
8 - 6.2.3 Resolution.
8 - 6.2.4 Accuracy.
8 - 6.2.5 Repeatability.
8 - 6.3 Requirements for the inflation system.
8 - 6.3.1 Air leakage.
8 - 6.3.2 Overpressure.
8 - 6.3.3 Pressure release valve.
8 - 6.4 Requirements for the cuff.
8 - 6.4.1 Inflatable bladder.
9 - 6.4.2 Cuff sleeves.
9 - 6.4.3 Cuff closures and construction.
9 - 7 SPECIFIC REQUIREMENTS.
9 - 7.1 Manometers.
9 - 7.1.1 Aneroid.
9 - 7.1.2 Mercury gravity.
9 - 7.2 Inflating device.
9 - 8 ELECTRICALLY POWERED DEVICES.
9 - 8.1 General requirements.
10 - 8.2 Display for digital read-out devices.
10 - 8.3 Front panel controls.
10 - 8.4 Data communication.
10 - 9 REQUIREMENTS FOR DEVICES WITH AUTOMATED SYSTOLIC AND DIASTOLIC PRESSURE DETECTION.
10 - 9.1 Electrical safety.
10 - 9.2 Functions.
10 - 9.3 Overall system efficacy.
10 - 9.4 Switch-on behaviour.
10 - 9.5 Power failure.
10 - 9.6 Pressure cycling.
11 - 9.7 Alarms.
11 - 10 REQUIREMENTS FOR SEMI-AUTOMATIC DEVICES.
11 - 11 REQUIREMENTS FOR SPECIFIC TYPES OF DEVICES.
11 - 11.1 Ultrasonic devices.
11 - 11.2 Oscillometric devices.
11 - 11.3 Commercial ‘vending machine’ or ‘coin-in-the-slot’ devices.
11 - 11.4 Korotkoff sound processing devices.
11 - 12 PRODUCT LITERATURE.
12 - 13 MARKING.
12 - 13.1 Device.
12 - 13.2 Cuff marking.
13 - APPENDIX A - TEST FOR DURABILITY OF INFLATION SYSTEM
13 - A1 SCOPE.
13 - A2 PRINCIPLE.
13 - A3 APPARATUS.
13 - A4 PROCEDURE.
13 - A5 REPORT.
14 - APPENDIX B - TEST FOR STATIC AND DYNAMIC ACCURACY OF PRESSURE SENSING DEVICE
14 - B1 SCOPE.
14 - B2 PRINCIPLE.
14 - B3 APPARATUS.
14 - B4 PROCEDURE.
14 - B4.1 Static testing of mercury and anaeroid devices.
14 - B4.2 Dynamic testing of mercury and anaeroid devices.
14 - B4.3 Static testing of devices with a di gital pressure display.
14 - B4.4 Dynamic testing of semi-automated devices with a digital pressure di splay.
15 - B5 CRITERIA FOR PASSING OR FAILING SEMI-AUTOMATED DIGITAL DISPLAY DEVICES
15 - B6 CALCULATION.
15 - B6.1 Static testing of mercury, anaeroid and digital di splay devices.
15 - B6.2 Dynamic testing of mercury, anaeroid and digital display devices.
15 - B7 REPORT.
15 - B7.1 Static testing.
15 - B7.2 Dynamic testing.
16 - APPENDIX C - TEST FOR AIR LEAKAGE
16 - C1 SCOPE.
16 - C2 PRINCIPLE.
16 - C3 APPARATUS.
16 - C4 PROCEDURE
16 - C4.1 Non-automated devices (including self-bleed devices).
16 - C4.2 Devices with electronic displays.
16 - C5 REPORT.
17 - APPENDIX D - TEST FOR EFFECTS OF OVERPRESSURE
17 - D1 SCOPE.
17 - D2 PRINCIPLE.
17 - D3 APPARATUS.
17 - D4 PROCEDURE.
17 - D4.1 Non-automated devices.
17 - D4.2 Devices with electronic displays.
17 - D5 REPORT.
18 - APPENDIX E - TEST FOR PRESSURE RELEASE RATE OF MANUALLY OPERATED VALVES
18 - E1 SCOPE.
18 - E2 PRINCIPLE.
18 - E3 APPARATUS.
18 - E4 PROCEDURE.
18 - E5 REPORT.
19 - APPENDIX F - TEST FOR VENTING
19 - F1 SCOPE.
19 - F2 PRINCIPLE.
19 - F3 APPARATUS.
19 - F4 PROCEDURE.
19 - F5 REPORT.
20 - APPENDIX G - TEST FOR PRESSURE RELEASE RATE OF SELF-BLEEDING VALVES
20 - G1 SCOPE.
20 - G2 PRINCIPLE.
20 - G3 APPARATUS.
20 - G4 PROCEDURE.
20 - G5 REPORT.
21 - APPENDIX H - CYCLIC TESTING OF PRESSURE RELEASE VALVE
21 - H1 SCOPE.
21 - H2 PRINCIPLE.
21 - H3 APPARATUS.
21 - H3.1 Manually operated rotating pressure release valve.
21 - H3.2 All other pressure release valves.
21 - H4 PROCEDURE.
21 - H4.1 Manually operated rotating pressure release valve.
21 - H4.2 All other pressure release valves.
21 - H5 REPORT.
22 - APPENDIX I - INTEGRITY OF INFLATABLE BLADDER AND CUFF
22 - I1 SCOPE.
22 - I2 PRINCIPLE.
22 - I3 APPARATUS.
22 - I4 PROCEDURE.
22 - I5 REPORT.
22 - APPENDIX J - TEST FOR MERCURY SPILLAGE
22 - J1 SCOPE.
22 - J2 PRINCIPLE.
22 - J3 APPARATUS.
22 - J4 PROCEDURE.
22 - J5 REPORT.
23 - APPENDIX K - TEST FOR TUBE DIAMETER
23 - K1 SCOPE.
23 - K2 PRINCIPLE.
23 - K3 APPARATUS.
23 - K4 PROCEDURE.
23 - K5 REPORT.
23 - APPENDIX L - TEST FOR INFLATION SOURCE
23 - L1 SCOPE.
23 - L2 PRINCIPLE.
23 - L3 APPARATUS.
23 - L4 PROCEDURE.
23 - L5 REPORT.
24 - APPENDIX M - METHOD FOR TESTING SPHYGMOMANOMETER (SYSTEM) ACCURACY BY THE INTRA-ARTERIAL COMPARISON METHOD
24 - M1 SCOPE.
24 - M2 PRINCIPLE.
24 - M3 APPARATUS AND SUBJECTS.
24 - M3.1 Apparatus.
24 - M3.2 Subjects.
24 - M4 PROCEDURE.
26 - M5 DATA ANALYSIS.
26 - M6 REPORT.
29 - APPENDIX N - METHOD FOR TESTING SPHYGMOMANOMETER (SYSTEM) ACCURACY BY THE INDIRECT COMPARISON METHOD.
29 - N1 SCOPE.
29 - N2 PRINCIPLE.
29 - N3 APPARATUS AND SUBJECTS.
29 - N3.1 Apparatus.
29 - N3.2 Subjects.
29 - N4 PROCEDURE.
29 - N5 DATA ANALYSIS.
30 - N6 REPORT.
31 - APPENDIX O - BLOOD PRESSURE UNITS
31 - O1 SCOPE.
31 - O2 GENERAL.
33 - COMMENTARY - RATIONALE FOR SPHYGMOMANOMETER ACCURACY/PERFORMANCE TESTING REQUIREMENTS
33 - Intra-arterial pressure measurement.
34 - Indirect pressure measurement.
34 - Cuff dimensions.
35 - Testing procedure.
35 - Accuracy requirements.
36 - Sample size.
36 - Hypothesis testing.
36 - Data reporting and statistical analysis.