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Idiomas disponibles
TEST INTERVAL:
TYPE OF DEVICE:
MANUFACTURED BY:
SN: ...............................
SCOPE OF INSPECTION
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),
check the fitting of the plug connector
1.4
Type plate still present and readable
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
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
Monopolar
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 of the monitoring circuit for the neutral electrode
according IEC60601-2-2:2009 sction 201.8.4.101
2.12
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
Рис. 17 Протокол контроля технической безопасности
Inspection protocol – safety inspection
1 Year
High frequency surgical device GN300, from serial number 4000
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
...............................
INVENTORY NO.:
Mains against HF output
Mains against housing
HF output against housing
Bipolar HF output against housing
Monopolar HF output against housing
Operational mode
Dosage
CUT 1 (M1)
300
CUT 2 (M2)
200
CUT 3 (M3)
150
CUT 4 (M4)
100
COAG normal
120
COAG spray
80
CUT
80
COAG
80
Inspector/Signature
RESPONSIBLE
ORGANIZATION: ....................................................................
R
= 0,3
(at 0,2 A)
max
N.C.
I
= 0,50
m
max
S.F.C.
I
= 1,00
m
max
N.C.
I
= 0,10
m
max
S.F.C.
I
= 0,50
m
max
N.C.
I
= 0,01
m
max
S.F.C.
I
= 0,05
m
max
I
= 1,00
m
max
I
= 0,05
m
max
monopolar
I
= 150
m
max
bipolar
I
= 63
m
max
test voltage = 500 V DC
R
= 7 M
min
R
= 2 M
min
R
= 2 M
min
R
= 2 M
min
R
Rated value
Load
500
300 Watt
20 %
500
200 Watt
20 %
500
150 Watt
20 %
500
100 Watt
20 %
500
120 Watt
20 %
1000
80 Watt
20 %
1000
80 Watt
20 %
100
80 Watt
20 %
R
= 2 M
min
Responsible Organization
Verdict
PASS
FAIL
Verdict
Measured value
PASS / FAIL
A
A
A
A
A
A
A
A
A
A
Performed:
Performed:
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