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TEST INTERVAL:
TYPE OF DEVICE:
MANUFACTURED BY:
SN: ...............................
S
C
O
E P
O
F
N I
S
E P
1.) VISUAL INSPECTION
1.1
Inspection of power cable for visually detectable damage
1.2
Inspection of foot control for visually detectable damage
1.3
Inspection of coagulation cable for visible signs of damage (record their number)
and check the fitting of the plug connector
1
4 .
y T
e p
p
a l
1.5
Check fuse links for prescribed values
1.6
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
2
8 .
2 .
2.8.3
2.9
HF-output power measurement with induction-free resistor
HF-output
Bipolar
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
l P
c a
/ e
a D
e t
* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005
Fig. 7
Certificado de revisión de la supervisión técnica de seguridad
Inspection protocol – safety inspection
1 Year
High frequency surgical device GN060, from serial number 4000
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
...............................
INVENTORY NO.:
T C
O I
N
e t
s
l i t
p l
e r
e s
t n
a
d n
e r
d a
b a
e l
Mains against bipolar HF-output
M
i a
s n
a
a g
n i
t s
h
u o
i s
g n
Bipolar HF-output against housing
Operational mode
Dosage
MICRO
5.0
MICRO
9.9
MACRO
MACRO
I
s n
e p
t c
r o
S /
RESPONSIBLE
ORGANIZATION: ..........................................................................
R
= 0,3
max
N.C.
S.F.C.
N.C.
S.F.C.
N.C.
S.F.C.
test voltage = 500 V DC
R
Load
5.0 Watt ± 20 %
50
9.9 Watt ± 20 %
50
25 Watt ± 20 %
25
100
50 Watt ± 20 %
50
100
g i
a n
u t
e r
Responsible Organization
PASS
Measured value
(at
0,2 A)
I
= 0,50
A
m
max
I
= 1,00
A
m
max
I
= 0,10
A
m
max
I
= 0,50
A
m
max
I
= 0,01
A
m
max
I
= 0,05
A
m
max
I
= 1,00
A
m
max
I
= 0,05
A
m
max
I
= 50
A
m
max
R
= 7 M
min
R
= 2 M
min
R
= 2 M
min
Rated value
R
= 2 M
min
Performed:
V
r e
i d
t c
FAIL
Verdict
PASS / FAIL
69
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