DSH 425 Temperature limit applied part

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DSH 425 , m) i, H5 Z8 N8 _

Temperature limit applied part 3 Q& j- \# I6 f5 G" s+ _

2.1.5 - R9 }; h2 F6 k" \

60601-1(ed.2);am1;am2 ! h9 f* {4 @( j; o5 a+ Q3 t

' M' A5 q/ ?' a% {7 J; S( W( Q5 S! ~Standard(s)- (year and edition):
1 D9 i- I/ f' d6 F! {60601-1:1988 Ed.2 Am1+Am2
" K$ ?# G/ t4 a6 K2 L3 x0 YSub clause(s): 2.1.5
: z8 H8 F! k* }Sheet n°: DSH-425
) `9 q( F0 R7 N% O2 U8 ^0 KSubject: Temperature limit applied part
! Q1 ~: z9 h* t( ^9 g. oKey words: Applied part, temperature limit
Confirmed by CTL at its 39th meeting, in Cologne
$ ?! ]- o. a8 ?; L' f, T8 PQuestion:
The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or
8 ?' F$ b# B/ eAMBULATORY RECORDER is now considered as a APPLIED PART in addition to the
associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature
exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause
no safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often
% h% v9 f' `9 @  u: Nthe EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
. W+ y2 j8 @# N2 HDecision:
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.
8 |( j8 A& y3 o! L) r, _The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
. C9 R( k* y3 ewithTable Xa "Equipment parts which may in normal use have a brief contact with a patient
1 A# Z) E8 L1 f! ~, k50°C".
  _5 r' x% y1 {+ e: M
9 l4 e( m" W7 A, q( V, B1 A" R. _% ^, W
, F: N" C9 E9 Y% g0 d/ q  ~