Philips Lifeline AutoAlert Help Button

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Philips Lifeline AutoAlert Help Button | Manualzz

20

Regulatory Compliance

Safety Standards

The AutoAlert Help Button complies with the following safety standards for medical devices and home healthcare equipment:

UL1637 – Home Healthcare Signaling Equipment

CSA C22.2 NO 205-M1983 – Signal Equipment

IEC60601-1 2005 (3rd Edition) – Medical Electrical Equipment –

General Requirements for Basic Safety and Essential Performance

IEC60601-1-1 – System Safety

IEC60601-1-2 – Electromagnetic Compatibility

IEC Regulations

The AutoAlert Help Button is medical electrical (ME) equipment. Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC

60601-1-2:2003, the international standard for EMC for medical electrical equipment.

The AutoAlert Help Button must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

FCC Regulations

The AutoAlert Help Button complies with Part 15 of the FCC Rules.

Operation is subject to the following two conditions: (1) The AutoAlert

Help Button may not cause harmful interference, and (2) the AutoAlert

Help Button must accept any interference received, including interference that may cause undesired operation. Pursuant to Part 15.21 of the FCC

Rules, any changes or modifications to this equipment not expressly approved by Philips Lifeline may cause harmful interference.

Essential Performance

The AutoAlert Help Button provides essential performance (EP) under normal operating conditions (includes EMC exposure) only as a complete system, consisting of the AutoAlert Help Button and the DT1000 series or

6900 series CarePartner Communicator. The system achieves its essential performance by sending Help Calls to the Lifeline Response Center. If the system is incapable of sending Help Calls, it will periodically send a status alarm to the Lifeline Response Center.

System Classification

The AutoAlert Help Button is an FDA Class II device. It is an internally powered device for continuous operation, with a water resistance classification of IPX7.

Radio Specifications

The AutoAlert Help Button has a radiofrequency transmitter with the following characteristics: maximum power over an antenna load: 12 dBm, frequency: 312 MHz ± 75 KHz, modulation: OOK. It fully complies with

FCC Part 15, Section 15.231 for periodic operation above 70 MHz.

Regulatory Compliance 21

Electromagnetic Immunity

The AutoAlert Help Button is intended for use in an electromagnetic environment in which RF disturbances are controlled. The user of the

AutoAlert Help Button can help prevent electromagnetic interference by maintaining a minimum distance between portable and RF communications equipment (transmitters) and the AutoAlert Help Button, as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of the transmitter

Separation distance according to frequency of the transmitter

0.01 W

0.1 W

1 W

10 W

100 W

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

4.6” (12 cm) 4.6” (12 cm) 9.2” (23 cm)

14.5” (37 cm) 14.5” (37 cm) 20” (74 cm)

3ft 10” (1.17 m) 3ft 10” (1.17 m) 7ft 8” (2.33 m)

12ft 1” (3.7 m) 12ft 1” (3.7 m) 24ft 2” (7.4 m)

38ft 4” (12 m) 38ft 4” (12 m) 76ft 8” (23.3 m)

22

Regulatory Compliance 23

Philips Lifeline

111 Lawrence Street

Framingham, MA 01702-8156

Tel: 1-800-451-0525

www .lifelinesystems .com

Philips Lifeline Canada

95 Barber Greene Road, Suite 105

Toronto, Ontario, Canada M3C 3E9

Tel: 1-800-387-8120

www .lifeline .ca

P/N 0940718, Rev. 05

© 2011. All rights reserved. Signal range may vary due to environmental factors.

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