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TEST INTERVAL:
TYPE OF DEVICE:
MANUFACTURED BY:
SN: ............................... INVENTORY NO.: ...............................
SCOPE OF INSPECTION
1.) VISUAL INSPECTION
1.1
Inspection of power cable for visually detectable damage
1.2
Inspection of foot switch for visually detectable damage
1.3
Type plate still present and readable
1.4
Check fuse links for prescribed values
1.5
Overall condition of device: dirt, damage
2.) ELECTRICAL INSPECTION
Protective earth resistance incl. mains cable
2.1
according IEC62353:2007
Earth leakage current
2.2
according IEC60601-1*
Enclosure leakage current/touch current
2.3
according IEC60601-1*
Patient leakage current
2.4
according IEC60601-1*
Equipment leakage current - alternative method
2.5
according IEC62353:2007
Applied part leakage current - alternative method
2.6
according IEC62353:2007
2.7
HF-leakage current bipolar
according IEC60601-2-2:2009
2.8
Insulation resistance
according IEC62353:2007 (Preparation according Service Manual)
2.8.1
Mains against HF output
2.8.2
Mains against housing
2.8.3
HF-output against housing
2.9
HF-output power measurement with induction-free resistor
Instrument
C5
C24/44
2.10
DC resistance between the two HF output poles
according IEC60601-2-2:2009 section 201.8.4.102
2.11
Function test according to instructions for use
Place/Date
* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005
Rys. 11 Protokół kontroli bezpieczeństwa technicznego
Inspection protocol – safety inspection
1 Year
Bipolar Electrosurgical Unit GN200
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
Channel
R
Load
1
50
1
50
2
50
Inspector/Signature
RESPONSIBLE
ORGANIZATION: ..........................................................................
R
= 0,3
(at 0,2 A)
max
N.C.
I
= 0,50
A
m
max
S.F.C.
I
= 1,00
A
m
max
N.C.
I
= 0,10
A
m
max
S.F.C.
I
= 0,50
A
m
max
N.C.
I
= 0,01
A
m
max
S.F.C.
I
= 0,05
A
m
max
I
= 1,00
A
m
max
I
= 0,05
A
m
max
I
= 122
A
m
max
test voltage = 500 V DC
R
= 7 M
min
R
= 2 M
min
R
= 2 M
min
Rated value
145 Watt
20 %
150 Watt
20 %
150 Watt
20 %
R
= 2 M
min
Responsible Organization
Verdict
PASS
FAIL
Verdict
Measured value
Pass / Fail
Performed:
193
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