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el
TEST INTERVAL:
TYPE OF DEVICE:
MANUFACTURED BY:
SN: ...............................
INVENTORY NO.:
Measurement
equipment: ...........................................................................................................................................................................................
S
C
O
E P
O
F
N I
S
E P
T C
O I
N
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 .
y T
e p
p
a l
e t
s
l i t
p l
e r
e s
t n
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 .
M
i a
s n
a
a g
n i
t s
H
2
8 .
2 .
M
i a
s n
a
a g
n i
t s
h
2
8 .
3 .
H
- F
u o
p t
t u
a
a g
n i
2.9
HF-output power measurement with induction-free resistor
Instrument
C
5
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
E T
T S
R
S E
U
T L
Deficiencies were determined, by which patient, user or other individuals can be endangered
Repair
P
a l
e c
D /
a
e t
* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005
Εικ. 13 Τεχνικοί έλεγχοι ασφαλείας πρωτοκόλλου ελέγχου
222
Inspection protocol – safety inspection
1 Year
Bipolar Electrosurgical Unit GN200
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
RESPONSIBLE
...............................
ORGANIZATION: ..........................................................................
a
d n
e r
d a
b a
e l
F
u o
p t
t u
u o
i s
g n
t s
h
u o
i s
g n
Channel
R
Load
Ω
1
0 5
50 Ω
1
Ω
2
0 5
..............................................................
I
s n
e p
t c
r o
S /
g i
a n
u t
e r
PASS
Measured value
= 0,3 Ω (at
R
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 MΩ
min
R
= 2 MΩ
min
R
= 2 MΩ
min
Rated value
145 Watt ± 20 %
150 Watt ± 20 %
150 Watt ± 20 %
R
= 2 MΩ
min
Performed:
No
Next date of inspection
Responsible Organization
V
r e
i d
t c
FAIL
Verdict
Pass / Fail
Yes
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