124
sv
Fig. 13 Provningsprotokoll säkerhetsteknisk kontroll
Inspection protocol –
safety inspection
TEST INTERVAL:
1 Year
TYPE OF DEVICE:
MANUFACTURED BY:
Bipolar Electrosurgical Unit GN200
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
SN: ...............................
INVENTORY NO.:
...............................
RESPONSIBLE
ORGANIZATION: ..........................................................................
Measurement
equipment: ...........................................................................................................................................................................................
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S
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P
O
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S
1.) VISUAL INSPECTION
PASS FAIL
1.1
Inspection of power cable for visually detectable damage
1.2
Inspection of foot switch for visually detectable damage
e
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3
.
1
1.4
Check fuse links for prescribed values
1.5
Overall condition of device: dirt, damage
2.) ELECTRICAL INSPECTION
Measured value
Verdict
Pass / Fail
2.1
Protective earth resistance incl. mains cable
according IEC62353:2007
R
max
= 0,3
Ω
(at
≥
0,2 A)
2.2
Earth leakage current
according IEC60601-1*
N.C.
S.F.C.
I
max
= 0,50
m
A
I
max
= 1,00
m
A
2.3
Enclosure leakage current/touch current
according IEC60601-1*
N.C.
S.F.C.
I
max
= 0,10
m
A
I
max
= 0,50
m
A
2.4
Patient leakage current
according IEC60601-1*
N.C.
S.F.C.
I
max
= 0,01
m
A
I
max
= 0,05
m
A
2.5
Equipment leakage current - alternative method
according IEC62353:2007
I
max
= 1,00
m
A
2.6
Applied part leakage current - alternative method
according IEC62353:2007
I
max
= 0,05
m
A
2.7
HF-leakage current bipolar
according IEC60601-2-2:2009
I
max
= 122
m
A
2.8 Insulation
resistance
according IEC62353:2007 (Preparation according Service Manual)
test voltage = 500 V DC
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F
H
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M
1
.
8
.
2
R
min
= 7 M
Ω
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M
2
.
8
.
2
R
min
= 2 M
Ω
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-
F
H
3
.
8
.
2
R
min
= 2 M
Ω
2.9
HF-output power measurement with induction-free resistor
Instrument
Channel
R
Load
Rated value
0
5
1
5
C
Ω
145 Watt
±
20 %
C24/44
1
50
Ω
150 Watt
±
20 %
0
5
2
Ω
150 Watt
±
20 %
2.10
DC resistance between the two HF output poles
according IEC60601-2-2:2009 section 201.8.4.102
R
min
= 2 M
Ω
2.11
Function test according to instructions for use
Performed:
T
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S
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R
T
S
E
T
Deficiencies were determined, by which patient, user or other individuals can be endangered
No
Yes
Repair
…………………………………………………….. Next
date of inspection
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Responsible Organization
* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005
