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.