Description
Estándares de seguridad
The M2636B TeleMon B Monitor complies with Council Directive 93/42 / EEC of 14 June 1993 on medical devices and bears the corresponding CE marking (EC 0123).
The following accessories and system components have an independent CEmarked:
- Power supply accessory
- Accessory for recharging batteries and batteries
Telemetry system
Note: The battery reconditioner should not be used in the vicinity of the patient.
The M2636B TeleMon B also complies with 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 establishment or directly connected to the public low-voltage network. The monitor is a Class 1 device and has an IPX 1 rating (excluding power supply). The device has BF and CF parts applied. The system provides continuous operation when in use.
The noninvasive measurements of blood pressure determined with this device are equivalent to those obtained by a trained observer using the auscultation method of the cuff / stethoscope, within the limits prescribed by the American national standard, electronic or automatic sphygmomanometers. The diastolic values correspond to the Korotkoff sounds of phase 5. The NPB part of the device also complies with all relevant parts of the following safety standards:
- ANSI / AAMI SP10
- IEC 60601-2-30
The internal operating software of NBP ensures that:
- The maximum inflation time of the cuff is limited to 60 seconds.
- The duration of the blood pressure reading is limited to 170 seconds.
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