85
Fig. 11 Protocollo di prova - Controllo tecnico di sicurezza
Inspection protocol –
safety inspection
TEST INTERVAL:
1 Year
TYPE OF DEVICE:
MANUFACTURED BY:
Bipolar Electrosurgical Unit GN200
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
SN: ............................... INVENTORY NO.: ...............................
RESPONSIBLE
ORGANIZATION: ..........................................................................
SCOPE OF INSPECTION
Verdict
1.) VISUAL INSPECTION
PASS FAIL
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.) ELE
C
TRICAL INSPECTION
Measured value
Verdict
Pass / Fail
2.1
Protective earth resistance incl. mains cable
according IEC62353:2007
R
max
= 0,3
:
(at
t
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
= 122
m
A
2.8
Insulation resistance
according IEC62353:2007 (Preparation according Service Manual)
test voltage = 500 V DC
2.8.1
Mains against HF output
R
min
= 7 M
:
2.8.2
Mains against housing
R
min
= 2 M
:
2.8.3
HF-output against housing
R
min
= 2 M
:
2.9
HF-output power measurement with induction-free resistor
Instrument
Channel
R
Load
Rated value
C5 1
50
:
1
4
5 Watt
r
20 %
C24/44
1
50
:
150 Watt
r
20 %
2
50
:
150 Watt
r
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:
Place/Date
Inspector/Signature
Responsible Organization
* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005
Summary of Contents for Aesculap Lektrafuse GN200
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