Technical Information; Technical Data, Standards, Certification; Guidelines And Manufacturer Declaration For Electromagnetic Compatibility - Sutter Curis Bedienungsanleitung

NOTE
Disposables used with the device, such as bipolar cord and tubing sets, have to be
disposed of according to the clinic's procedures and rules.

10 Technical information

10.1 Technical data, standards, certification

Mains connection
Power consumption
Protection class
Type
Protection level
Classification acc. to
2017/745/EU (MDR)
Signal level
Weight
Dimensions
Standards
Environmental
conditions for
transportation and
storage
Environmental
conditions for
operation

10.2 Guidelines and manufacturer declaration for electromagnetic compatibility

Appropriate operating environment:
The CURIS flow Irrigation pump is suitable for operation in the electromagnetic environment in
®
professional healthcare facilities, for example, clinics (emergency rooms, sickrooms, intensive care,
operating rooms, outside the HF-shielded room for magnetic resonance imaging, first aid facilities).
The customer and/or user of the CURIS
electromagnetic environment as described below.
The CURIS flow Irrigation pump is not approved for use in aircraft or the military field. The
®
appropriate EMC requirements for these environments have not been tested.
100 - 240 V; 50 / 60 Hz
Max. 30 VA
I
CF (Cardiac Floating); defibrillator safe
IP21 (protection against finger contact/foreign objects larger than 12 mm.
Protection against vertically dripping water)
Class I
Approx. 50 dB(A)
Approx. 3.0 kg
W x H x D 230 mm x 125 mm x 250 mm
IEC 60601-1: 2005, AMD1:2012, AMD2:2020
IEC 60601-1-2: 2014, AMD1:2022
IEC 60601-1-6: 2010, AMD1:2013, AMD2:2020
Ambient temperature
Relative humidity
Atmospheric pressure
Ambient temperature
Relative humidity
Atmospheric pressure
Compliant with Regulation 2017/745/EU (MDR)
Sale restricted to attending physicians (USA)
flow Irrigation pump should ensure that it is used in an
®
- 25 °C to +70 °C
5 % to 90 %
500 hPa to 1060 hPa
+10 °C to +40 °C
30 % to 75 %
700 hPa to 1060 hPa
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