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| DSH 425/ y2 ^9 T( R" y
, |! I2 v* B" Q. `1 J# x
| Temperature limit applied part7 _- ~! g U4 u
| 2.1.5
9 [& r8 b; A7 h4 I1 Y' _. Z | 60601-1(ed.2);am1;am26 m$ i& ]( P4 U6 m
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: v6 q# f$ y: C! Z+ e+ ^/ _( gStandard(s)- (year and edition):3 G3 b/ T, h* D1 Q$ ^' Z$ T
60601-1:1988 Ed.2 Am1+Am2
# U8 w" K$ D8 c6 M8 r6 _Sub clause(s): 2.1.59 g/ z% e7 O% y! H' k
Sheet n°: DSH-425; g4 u' c9 ^' V' R& _, x; k9 p
Subject: Temperature limit applied part
& ~0 |8 G+ t# w, D) H, l' V/ sKey words: Applied part, temperature limit0 J6 }5 U, p" j, @( ]
Confirmed by CTL at its 39th meeting, in Cologne; w' y! _. ]2 q5 b) n
Question:8 z: F/ ]" X v* V& `
The EQUIPMENT worn by the patient, such as AMBULATORY ECG SYSTEM or& _7 M. J9 Z. s
AMBULATORY RECORDER is now considered as a APPLIED PART in addition to the- u2 m a7 ^7 w8 `
associated ELECTRODES and cables. Clause 42.3 does not allow surface temperature
! h9 N. x! L e2 f' Q' X, I' iexceeding 41 °C for an APPLIED PART and according to clause 3.1 EQUIPMENT shall cause
3 [3 n. M( i w& O: K# }5 P6 x4 j$ C# ?no safety hazard in NORMAL CONDITION and in SINGLE FAULT CONDITION. Very often+ A) Q9 N" ]# W. `
the EQUIPMENT exceeds the temperature limit of 41 °C under the above testing conditions.
# ~7 Z* `7 |1 M" z) O2 J0 |Decision:
: a* Q0 {3 n0 u$ D& K x* ]The instructions for use shall advise that the recorder is not to be worn in contact with the skin.6 c- S9 r! u% h. t) M9 p
The ENCLOSURE is therefore not considered as an APPLIED PART and should comply# k9 L2 z6 k8 _% h
withTable Xa "Equipment parts which may in normal use have a brief contact with a patient0 h9 O% A$ x: ~6 s7 ~
50°C".5 Q/ r2 K9 t& w' V
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& q6 `3 s* m) Y \9 }
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