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Classification
Patent
Technical information is subject to change without notification to allow for updates.
• This blood pressure monitor complies with European Standard EN60601-1-2 and is subject to parti-
cular precautions with regard to electromagnetic compatibility. Please note that portable and mobile
HF communication systems may interfere with this unit. More details can be requested from the sta-
ted Customer Services address or found at the end of the instructions for use.
• The blood pressure monitor complies with the EU Medical Devices Directive 93/42/EEC, the Ger-
man Medical Devices Act (Medizinproduktgesetz) and the standards EN1060-1 (non-invasive sphyg-
momanometers – Part 1: General requirements), EN1060-3 (non-invasive sphygmomanometers –
Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems) and
IEC80601-2-30 (Medical electrical equipment – Part 2 – 30: Particular requirements for the basic saf-
ety and essential performance of automated non-invasive sphygmomanometers).
The ECG stick complies with the EU Medical Devices Directive 93/42/EEC, the German Medical
Devices Act (Medizinproduktgesetz) and the standards IEC 60601-2-25 (Medical electrical equipment
- part 2-25: Particular requirements for the safety of electrocardiographs) and IEC 60601-2-47 (Medi-
cal devices - part 2-47: Particular requirements for the safety, including essential performance cha-
racteristics of ambulatory electrocardiographic systems).
The safety class of the ECG stick is CF.
• The accuracy of this blood pressure monitor has been carefully checked and developed with regard
to a long useful life. If using the device for commercial medical purposes, it must be regularly
tested for accuracy by appropriate means. Precise instructions for checking accuracy may be
requested from the service address.
Internal supply, IPX0, no AP or APG, continuous operation
Blood pressure: Application part, type BF
ECG stick: Application part type CF
TWM474484, TW201233370 / CN102631193A, CN203539335U /
US20130345575 / EP2676599 / JP2014039800
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