The M2636B Telemon B Monitor Complies With Directive 93/42 / EEC of 14 June 1993 Concerning Medical Devices and bears the CE marking Corresponding (CE 0123).
The following accessories and system components Have an independent CEmarked:
- Accessory power supply
- Batteries and battery recharger accessory
Note: The battery Reconditionador not be used in the vicinity of the patient.
The M2636B Telemon B Also meets the following international safety standards 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 or Directly connected to the public low-voltage property. The monitor is a Class 1 device and have an IPX 1 classification (excluding the power supply). The device has BF and CF applied parts. The system Provides continuous operation When in use.
Noninvasive measurements of blood pressure Determined With this device are equivalent to Those Obtained by a trained observer using the auscultatory method the sleeve / stethoscope, Within the limits prescribed by the American National Standard, Electronic or automated sphygmomanometers. Diastolic values Correspond to Korotkoff sounds phase 5. Also NPB of the device meets all Relevant parts of the following safety rules:
- ANSI / AAMI SP10
- IEC 60601-2-30
Software internals of NBP Ensures that:
- The maximum cuff inflation is limited to 60 seconds.
- The duration of the blood pressure reading is limited to 170 seconds.