User's Manual Part 2

5-13

Irregular Rhythm Responses

Per AAMI EC13-5.1.2.1(e)

Regulatory Standards

VitalSense-XHR Sensor will be tested according to the following

standards:

ECG Complex Waveform VitalSense-XHR

Response

(Avg BPM)

Expected

(BMP)

3a: Ventricular bigeminy AAMI 3a 83 80

3b: Slow alternating ventricular

bigeminy

AAMI 3b 58 60

3c: Rapid alternating ventricular

bigeminy

AAMI 3c 58 120

3d: Bidirectional systoles AAMI 3d 123 90

Test Standard Description VS-

XHR

Sensor

Multi-

charger

Reader/

Charger

IEC60601-1 Medical Electrical Equipment - Part 1:

General Requirements for Safety

IEC60601-1-2 Medical Electrical Equipment - Part 1-2:

General Requirements for Safety - Collateral

Standard: Electromagnetic Compatibility -

Requirements and Tests

3 3 3

IEC60950-1 Information Technology Equipment - Safety -

Part 1: General Requirements

3 3

47 CFR 15.229 Intentional Radiator Permissive Change

ASTM/AAMI-

ESI:1993

Safe current limits for electromedical

apparatus

AAMI-EC13:2002 Cardiac Monitors, Heart Rate Meters, and

Alarms