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Standard(s)- (year and edition):& D$ @& b' j9 ~% t7 u8 ^- ?
60601-1:1988 Ed.2 Am1+Am2- f2 R9 L: B0 X# u
Sub clause(s): 2.1.5: z/ f- S4 J2 I* ^2 n, F
Sheet n°: DSH-425* C8 S" T3 z8 g3 E0 {6 K5 f8 I: {
Subject: Temperature limit applied part7 L* ~/ _* Z6 a5 `+ o
Key words: Applied part, temperature limit 4 O: `% A" d% c6 O9 `6 n$ PConfirmed by CTL at its 39th meeting, in Cologne ; R$ m. E7 W1 p& |+ G) u+ BQuestion:' k& d/ S- f- K0 y. P E
The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or 0 u% i7 i) P* o! J! {AMBULATORY RECORDER is now considered as a APPLIED PART in addition to the; |0 }9 p4 O: E$ K
associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature9 y, q8 _% s" L) u
exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause7 N n6 _: N: N7 f' ^4 V) N/ @
no safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often ; ~* s: M! q2 J* B4 Y+ bthe EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions. ! j |; N- I; F4 lDecision:0 p0 C) W; E) T; O \7 n
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.7 _$ V! F( i+ b! A2 T2 C/ X
The ENCLOSURE is therefore not considered as an APPLIED PART and should comply' A: |. Y$ S; A$ l
withTable Xa "Equipment parts which may in normal use have a brief contact with a patient / B& B z9 n. H- N5 Z50°C".) |0 t) ^7 a$ X l
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[attach]77082[/attach] 5 ^& s( S9 P% f/ k0 u5 f
DSH 425