35
14. Power supply
Model no.: LXCP12-006060BEH
Input: 100–240 V~, 50 – 60 Hz, 0.5A max
Output: 6 V DC, 600 mA, only in conjunction with the
Veroval
®
duo control blood pressure monitor
Manufacturer: Globalcare Medical Technology Co., Ltd.
Protection: The device is double-insulated and has a primary
fuse that disconnects the device from the mains in
the event of a fault.
Polarity of the DC voltage connection
Protective insulation/protection class 2
Housing and protective
covers:
The power supply unit housing protects against
touching parts that can carry a current (fingers,
needles, test hooks). The user must not touch the
patient and the outlet plug of the AC/DC power
supply unit at the same time.
Legal requirements and guidelines
■ The Veroval
®
duo control blood pressure monitor conforms to the European
regulations that are subject to the Medical Device Directive 93/42/EEC and
also bears the CE mark.
■ The device also complies with the requirements of European standard
EN 1060: Non-invasive sphygmomanometers – Part 1: General requirements
and Part 3 – Supplementary requirements for electro-mechanical blood
pressure measuring systems; as well as standard EN 80601-2-30.
■ Clinical testing of the measuring accuracy was carried out in accordance with
EN 1060-4 and EN 81060-2. The requirements of ANSI/AAMI test protocol
SP10-1992 are also met.
■ Beyond the legal requirements, the device has been clinically validated in
accordance with the ESH-IP2 protocol of the European Society of Hypertension
(ESH), the protocol of British Hypertension Society (BHS) and the protocol of
the Deutsche Hochdruckliga (DHL).
IFU_Veroval_dc_SK2_0307661_EN_TR_AE_CN_200918.indd 35 17.10.18 18:04
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