High frequency surgical device
INSPECTION PERFORMED:
TYPE OF DEVICE:
MANUFACTURED BY:
SN: ............................................................................................. INVENTORY NO.: .............................................................
OPERATOR: ..............................................................................
SCOPE OF INSPECTION
1. VISUAL INSPECTION
1.1 Inspection of power cable for visually detectable damage
1.2 Inspection of foot pedal 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 Rating plate still present and readable
1.5 Test to ensure device achieves default values
1.6 Overall condition of device: Dirt, damage
2. ELECTRICAL INSPECTION
2.1 LF ground leakage current s.f.c. according to DIN EN 60601-1
2.2 LF substitute device leakage current acc. to VDE 0751-1
2.3 LF patient leakage current s.f.c. acc. to DIN EN 60601-1
2.4 LF substitute patient leakage current with mains voltage at the
application unit acc. to VDE 0751-1
2.5 HF leakage current monopolar DIN EN 60601-2-2
2.6 HF leakage current bipolar DIN EN 60601-2-2
2.7 Insulation resistance (test voltage = 500 V DC)
2.7.1 Mains against HF output
2.7.2 Mains against housing
2.7.3 HF output against housing
2.8 Ground wire resistance incl. power cord acc. to VDE 0751-1
2.9 HF output with induction-free resistance
HF output
Monopolar
Bipolar
2.10 DC resistance between the two HF output poles, DIN EN 60601-2-2; section 59.105
2.11 Function test of the monitoring circuit for the neutral electrode, DIN EN 60601-2-2, section 59.101 Performed
2.12 Function test according to instructions for use
Place/Date
Inspection protocol – safety inspection
annually
High-frequency surgical device (GN 640) from serial number 2000
AESCULAP AG & CO. KG, Am Aesculap-Platz, 78532 Tuttlingen/Germany
1. Bipolar HF output against housing
2. Bipolar HF output against housing
1. Monopolar HF output against housing
2. Monopolar HF output against housing
Operational mode
Dos-
age
MICROCUT 1/2
300
POWERCUT 1
300
POWERCUT 2
250
POWERCUT 3
200
POWERCUT 4
150
SEALCUT
100
CONTACTOCOAG
120
SOFTCOAG
100
SPRAYCOAG
120
FORCEDCOAG
120
BICUT 1
100
BICUT 2
100
BICOAG
100
Inspector
Operator
(GN 640)
I
= 1 mA
max
I
= 1 mA
max
I
= 0.05 mA
max
I
= 0.05 mA
max
I
= 150 mA
max
I
= 71 mA
max
R
= 7 MΩ
min
R
= 2 MΩ
min
R
= 2 MΩ
min
R
= 2 MΩ
min
R
= 2 MΩ
min
R
= 2 MΩ
min
0,3 Ω at ≥ 0.2 A
R
Rated value
load
500 [Ω]
300 watt ± 20 %
500 [Ω]
300 watt ± 20 %
500 [Ω]
250 watt ± 20 %
500 [Ω]
200 watt ± 20 %
500 [Ω]
150 watt ± 20 %
150 [Ω]
100 watt ± 20 %
500 [Ω]
120 watt ± 20 %
300 [Ω]
100 watt ± 20 %
800 [Ω]
120 watt ± 20 %
1 000 [Ω] 120 watt ± 20 %
600[Ω]
100 watt ± 20 %
100 [Ω]
100 watt ± 20 %
100 [Ω]
100 watt ± 20 %
Finding
Satisfactory
Unsatisfactory
Measured value
OK
Yes/No
Performed
53