Identification Label Of The Ci-Ca Module; Electrical Safety - Fresenius Medical Care multiFiltrate Instructions For Use Manual

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12.2.3 Identification label of the Ci-Ca module

12.3 Electrical safety

Type of protection against
electric shock
Applied part
Degree of protection
against electric shock
Defibrillator-proof applied
part
Degree of protection
against ingress of liquids
Leakage currents
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
The identification label shown is only an example. Always go by the
information shown on the identification label affixed to the Ci-Ca module
itself.
1
2
Legend
1
Manufacturer and year of manufacture
2
Serial number
3
Connected load
Classification according to EN 60601-1, IEC 60601-1
Protection class I with internal power source
Depending on the treatment mode, the applied part comprises the
extracorporeal blood circuit, the dialysate, substituate, and plasma
circuits, and all components with a permanent, conductive connection
to these circuits.
220 V / 230 V / 240 V
60 Hz, type BF applies
100 V / 110 V / 115 V / 120 V / 127 V
60 Hz, type CF applies
100 V / 110 V / 115 V / 120 V / 127 V / 220 V / 230 V / 240 V
50 Hz, type CF applies
A defibrillator-proof applied part prescribes the exclusive application of
disposables as approved by the manufacturer.
Samples of approved tubing systems are listed in chapter 8
(see chapter 8.1.1 on page 8-2).
Drip-proof, IP 21
According to EN 60601-1
Chapter 12: Specifications
3
12-3

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