105
Fig. 7
Protocolo de verificação para o controlo técnico da segurança
Inspection protocol –
safety inspection
TEST INTERVAL:
1 Year
TYPE OF DEVICE:
MANUFACTURED BY:
High frequency surgical device GN060
, from serial number 4000
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
SN: ...............................
INVENTORY NO.:
...............................
RESPONSIBLE
ORGANIZATION: ..........................................................................
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1.) VISUAL INSPECTION
PASS FAIL
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
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4
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1
1.5
Check fuse links for prescribed values
1.6
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
(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
= 50
m
A
2.8 Insulation
resistance
according IEC62353:2007 (Preparation according Service Manual)
test voltage = 500 V DC
2.8.1
Mains against bipolar HF-output
R
min
= 7 M
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2
.
8
.
2
R
min
= 2 M
2.8.3
Bipolar HF-output against housing
R
min
= 2 M
2.9
HF-output power measurement with induction-free resistor
HF-output
Operational mode
Dosage
R
Load
Rated value
Bipolar
MICRO
5.0
50
5.0 Watt
±
20 %
MICRO
9.9
50
9.9 Watt
±
20 %
MACRO
25
100
25 Watt
±
20 %
MACRO
50
100
50 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
2.11
Function test according to instructions for use
Performed:
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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
Содержание Aesculap GN060
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