Description

The Philips M2636B Telemon is indicated for use in the monitoring, recording, and alarming of multiple physiologic parameters in adult and pediatric patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. TeleMon is a prescription device for use in healthcare facilities by trained healthcare professionals. TeleMon is not intended for home use.

Safety Standards

The M2636B TeleMon B Monitor complies with the Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices, and carries CE marking accordingly (CE 0123).

The following accessories and system components are independently CEmarked:

• Power Supply accessory
• Battery and Battery Reconditioner accessory

Telemetry System

Note—The Battery Reconditioner is not for use in the patient vicinity.

The M2636B TeleMon B also complies with the following international safety regulations for medical electrical equipment:

• IEC 60601-1/ EN 60601-1
• IEC 60601-1-1/ EN 60601-1-1
• IEC 60601-1-2/ EN 60601-1-2
• CAN/ CSA C22.2 No. 601.1-M90
• UL 2601-1

This CISPR-11 Class A, Group 1 device is not suitable for use in a domestic establishment or one that is connected directly to the low voltage public mains. The monitor is a Class 1 device and has an IPX 1 rating (excluding the power supply). The device has BF and CF applied parts. The system provides continuous operation when in use.

Non-invasive blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or automated sphygmomanometers. Diastolic values correspond to Phase 5 Korotkoff sounds. The NPB portion of the device also meets all relevant parts of the following safety standards:

• ANSI/AAMI SP10
• IEC 60601-2-30

NBP internal operating software ensures that:

• Maximum cuff inflation time is limited to 60 seconds.
• Duration of blood pressure reading is limited to 170 seconds.