Safety Inspection Report
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Safety Inspection Report for BOWA HF-Surgery unit ARC 250/303 up to version 2.2 Hospital:
Data:
Department:
Contact person:
Serial No.:
Article-No.:
Device type (IEC): CF
Remarks
Protect. class (IEC): I
Failed
Software version:
Passed
Device type
Visual inspection
Remarks
Failed
Passed
Device and accessories without recognizable damage All inscriptions, CE marks and rating label legible Mains fuses correspond to the specified value Potential equalization and -Connection present and functional Operating manual present
Function check All displays and indicator lights Activation of monopolar Cut / Coag output 1 with finger switch * Activation of monopolar Cut / Coag output 2 with finger switch Activation of monopolar Cut / Coag output 2 with foot switch Activation of Bipolar / Coag output 3 Activation of monopolar SimCoag with finger switch at output 1 & 2 * No simultaneous activation of foot switch and finger switch possible
Remarks
Failed
Passed
Touch monitor - AUTOSTART function (reference value 0,8 – 1,2 kΩ) ARC PLUS communication interface
EASY neutral electrode monitoring
Remarks
Failed
Neutral electrode, standby two-part green Neutral electrode, NE flashing yellow NE-monitoring, NE yellow flashing at +50% deviation from measured value (R = 50 Ohm, → reference value 75 Ohm) Neutral electrode, NE off (red) Passed
Measured value [Ω]
Reference value [Ω]
Description
8 ... 15 Ω 120 ... 160 Ω 75 Ω ± 20% 180 ... 220 Ω
Measurement of the HF output power for cutting / coagulation Reference Program [No.] / name RL value [W] [ 0 ] Standard - Cut
Blend 9 RL = 500 Ω
Measured value [W]]
ARC 250
250 W ± 20 % ARC 303
[ 0 ] Standard - Forced / Mixed COAG Mode [ 0 ] Standard - Forced / Cutting Mode [ 0 ] Standard - Forced / Non Cutting Mode [ 0 ] Standard - Spray [ 0 ] Standard - Moderate [ 5 ] Argon Flex (optional) [ 1 ] Macro - Bipolar [ 0 ] Standard - Bipolar
RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 75 Ω RL = 500 Ω RL = 75 Ω RL = 75 Ω
300 W ± 20 % 120 W ± 20 % 75 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 75 W ± 20 % 120 W ± 20 %
= coagulation = cut
* Must be tested only at ARC 303!
BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Strasse 4-10, D-72810 Gomaringen
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This test report refers to service manual 900-301_SM_V2.2_10715-S2-20111024-EN
Device type:
Software version:
Protect. class (IEC): I
Article-No.:
Device type (IEC): CF
Serial No.: Electrical safety tests 1)
= Measured with power supply cord, resistance power supply cord < 100 mΩ, resistance HF-device < 200 mΩ. = Test must be performed with service program 24: Mono sinus mode, mono spray mode and bipolar mode. The highest value must be recorded. 3) = Test must be performed with service program 24: Mono sinus mode and mono spray mode. The lowest value must be recorded. 4) = Test must be performed with service program 24: Bipolar mode
Remarks
Failed
Passed
2)
Ground wire test (according IEC 62353)
Limit value
Measured value
Ground → POAG 1)
max. 0,3 Ω
[Ω]
Device leakage current 2)
max. 0,5 mA
[mA]
Patient leakage current 2)
max. 50 µA
[µA]
min.
2 MΩ
[MΩ]
min.
2 MΩ
[MΩ]
Leakage current measurement (according IEC 62353)
DC resistance measurement (according IEC 62353) Measurement between monopolar connectors – NE (measurement with 500 V DC) 3) Measurement between bipolar connectors 4) Final activities Replacement of inspection sticker Customer advised to save this protocol until next inspection.
Test devices Type
Serial-No.
Calibration valid to
Electro surgery Analyser: Electrical Safety Analyser: Adjustable resistor decade: Overall Evaluation Inspection seal issued The HF device has no safety-relevant defects and may continue to be used. The HF device has no direct safety-relevant defects; detected defects should be remedied quickly!
Inspection seal not issued The HF device must be taken out of operation until the faults have been rectified!
Remarks
Acceptance inspection
Inspector:
Date, signature:
BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Strasse 4-10, D-72810 Gomaringen
Customer:
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Date, signature:
This test report refers to service manual 900-301_SM_V2.2_10715-S2-20111024-EN