|
|
|  DSH 425
. p+ ~- Y$ n* t+ H O V$ |' V' }5 I# ?
| Temperature limit applied part. t% z6 [1 x. J" q4 G
| 2.1.51 i: B8 `! C/ S6 F; p: K W
| 60601-1(ed.2);am1;am29 w5 d; C0 j/ }+ }$ d- o
|
% j, m+ K" k* w W6 H( @! x% J
Standard(s)- (year and edition):9 V4 I/ r' `2 p0 @' _+ X
60601-1:1988 Ed.2 Am1+Am2% c# ?; d! ^5 ?8 f" U
Sub clause(s): 2.1.5
# G4 y- k2 k1 [/ q3 B& iSheet n°: DSH-4254 ~$ l' e5 y3 ^6 U; D
Subject: Temperature limit applied part
, |& A6 y w' D+ y" F0 j: iKey words: Applied part, temperature limit7 L( y) }" p5 l$ t* y# S3 C
Confirmed by CTL at its 39th meeting, in Cologne
9 x- j" O+ k% Q+ bQuestion:
0 ?. V# d* p( p4 d9 ]) FThe EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or4 t$ u8 k. G I* q7 i$ F6 U
AMBULATORY RECORDER is now considered as a APPLIED PART in addition to the4 x4 h. ^" `; `- T
associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature
4 p% d/ c/ |% s1 texceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause+ D6 z3 x$ a( m& A: p
no safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often, Z2 n: e) u/ f
the EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
' N/ K" G2 @) @Decision:. ] _6 X8 b5 @; }9 H( o
The instructions for use shall advise that the recorder is not to be worn in contact with the skin.5 k- T* e9 J2 a8 x, D) m
The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
+ S1 \9 u* O3 Y. }withTable Xa "Equipment parts which may in normal use have a brief contact with a patient% U ]2 v& ]0 n! g
50°C".
& [2 e3 U( Q; m$ V2 C
+ X, e+ `9 y* M2 v& V& s" o3 R
7 ^" A2 W, K9 g+ I |
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