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|  DSH 425" S2 u0 Z1 k; e8 q7 q
' i. D1 H4 v' t% w | Temperature limit applied part
1 ~7 B, F( `+ e, K | 2.1.5% Y% @0 @2 X; q! o" n5 K( X
| 60601-1(ed.2);am1;am2$ m- [; N: P4 w6 ?5 G
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Standard(s)- (year and edition):
& w5 Y. D& |5 ]) F60601-1:1988 Ed.2 Am1+Am2
0 c6 w9 G/ A4 {3 sSub clause(s): 2.1.5& `9 ], {3 n2 H7 {3 M
Sheet n°: DSH-425, l: g# n' F9 t) b+ u) H1 D
Subject: Temperature limit applied part4 B3 a$ _, i; {5 F* D7 e# k
Key words: Applied part, temperature limit2 ~! D1 V& M, \
Confirmed by CTL at its 39th meeting, in Cologne
+ D' m+ ?! t$ r" X( A2 t4 ?& _Question:9 R1 A6 K! S' O& v9 _+ T4 N
The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or! P* N; Z( V- ?
AMBULATORY RECORDER is now considered as a APPLIED PART in addition to the) f2 E; }# |8 n, R$ X' X; L
associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature# Y4 M3 D! U/ t1 r2 ]2 d9 q7 y0 t
exceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause
& N" y8 ?8 r0 f! ono safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often
, N; L% N) y4 n* Fthe EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
6 `. o9 ]4 v- t$ b- fDecision:
1 D( ], x0 q: ^4 g VThe instructions for use shall advise that the recorder is not to be worn in contact with the skin.; f6 s; w3 r/ [( ~* r
The ENCLOSURE is therefore not considered as an APPLIED PART and should comply
: ^) F3 C' x% a0 e1 ^withTable Xa "Equipment parts which may in normal use have a brief contact with a patient
j' p& n1 V. q& m, b9 p50°C".2 L& a. s' L ?: I4 _/ T/ N
5 T, Z' n: T$ ?9 C: I+ B- E: g: k1 i% @" x# G
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