BOWA-electronic
BOWA ARC 300 and 350 Safety Inspection Report Ver 2.6 June 2010
Safety Inspection Report
2 Pages
![Safety Inspection Report for BOWA HF-Surgery unit ARC 300 / 350 Hospital: Data: Department: Contact person: Device type: Remarks Failed Passed Serial No.: Software version: Protect. class (IEC): I Article-No.: Device type (IEC): CF Visual inspection 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 Remarks Remarks Failed Failed Passed Passed 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 Cut1) / Coag output 3 Activation of Bipolar Cut1) / Coag output 4 No simultaneous activation of foot switch and finger switch possible Touch monitor - autostart function (reference value 1000 – 1800 Ω) ARC PLUS communication interface (optional) EASY neutral electrode monitoring Description Reference value [Ω] Neutral electrode, standby two-part green Neutral electrode, NE flashing Neutral electrode, NE off (red) 8 ... 15 Ω 130 ... 170 Ω 170 ... 250 Ω Measurement of the HF output power for cutting / coagulation Reference Program [No.] / name RL value [W] [ 0 ] Standard - Cut Blend 9 [ 0 ] Standard - Forced / Mixed COAG Mode [ 0 ] Standard - Spray [ 0 ] Standard - Moderate [ 0 ] Standard - Moderate/Desiccate Mode 1*) [ 0 ] Standard - Forced / Cutting Mode [ 0 ] Standard - Moderate / Desiccate Mode 4 [ 0 ] Standard - Forced - Non Cutting Mode [ 8 ] Local Anesthesia - Forced [12] DryCut Blend 9 **) [18] Bipolar TUR - Bipolar Cut Eff. 9 [18] Bipolar TUR - Bipolar Coag **) Eff. 9 [ 7 ] Micro Plastic - Bipolar [ 0 ] Standard - Bipolar [ 0 ] Standard - Bipolar Cut **) Blend 9 RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 75 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 75 Ω RL = 75 Ω RL = 75 Ω RL = 500 Ω Measured value [Ω] Measured value [W]] 300 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 40 W ± 20 % 200 W ± 20 % 380 W +5 / -20 % 170 W ± 20 % 50 W ± 20 % 120 W ± 20 % 150 W ± 20 % = coagulation = cut *) = During this measurement it is necessary to produce a spark before the measured value can be read. This means that during the activation the test lead must be plugged out and in at the output socket. **) = only ARC 350 BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Strasse 4-10, D-72810 Gomaringen page 1 of 2 This inspection protocol referring to service manual 900-350_SM_V2.6_10590-S7-20100620-EN](https://images.bioclinicalservices.com.au/0d9f7yy6m0poblsbvrx7xbtv5txf/320w/BOWA-electronic%20-%20900-350%20-%20BOWA%20ARC%20300%20and%20350%20Safety%20Inspection%20Report%20Ver%202.6%20June%202010%20-%202010-06.png)
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Page 1
Safety Inspection Report for BOWA HF-Surgery unit ARC 300 / 350 Hospital:
Data:
Department:
Contact person:
Device type:
Remarks
Failed
Passed
Serial No.:
Software version:
Protect. class (IEC): I
Article-No.:
Device type (IEC): CF
Visual inspection 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
Remarks Remarks
Failed Failed
Passed
Passed
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 Cut1) / Coag output 3 Activation of Bipolar Cut1) / Coag output 4 No simultaneous activation of foot switch and finger switch possible Touch monitor - autostart function (reference value 1000 – 1800 Ω) ARC PLUS communication interface (optional)
EASY neutral electrode monitoring Description
Reference value [Ω]
Neutral electrode, standby two-part green Neutral electrode, NE flashing Neutral electrode, NE off (red)
8 ... 15 Ω 130 ... 170 Ω 170 ... 250 Ω
Measurement of the HF output power for cutting / coagulation Reference Program [No.] / name RL value [W] [ 0 ] Standard - Cut Blend 9 [ 0 ] Standard - Forced / Mixed COAG Mode [ 0 ] Standard - Spray [ 0 ] Standard - Moderate [ 0 ] Standard - Moderate/Desiccate Mode 1*) [ 0 ] Standard - Forced / Cutting Mode [ 0 ] Standard - Moderate / Desiccate Mode 4 [ 0 ] Standard - Forced - Non Cutting Mode [ 8 ] Local Anesthesia - Forced [12] DryCut Blend 9 **) [18] Bipolar TUR - Bipolar Cut Eff. 9 [18] Bipolar TUR - Bipolar Coag **) Eff. 9 [ 7 ] Micro Plastic - Bipolar [ 0 ] Standard - Bipolar [ 0 ] Standard - Bipolar Cut **) Blend 9
RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 75 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 500 Ω RL = 75 Ω RL = 75 Ω RL = 75 Ω RL = 500 Ω
Measured value [Ω]
Measured value [W]]
300 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 120 W ± 20 % 40 W ± 20 % 200 W ± 20 % 380 W +5 / -20 % 170 W ± 20 % 50 W ± 20 % 120 W ± 20 % 150 W ± 20 %
= coagulation = cut *) = During this measurement it is necessary to produce a spark before the measured value can be read. This means that during the activation the test lead must be plugged out and in at the output socket. **) = only ARC 350
BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Strasse 4-10, D-72810 Gomaringen
page 1 of 2
This inspection protocol referring to service manual 900-350_SM_V2.6_10590-S7-20100620-EN
Device type:
Software version:
Protect. class (IEC): I
Article-No.:
Device type (IEC): CF
Serial No.: Electrical safety tests Remarks
Failed
Passed
2)
= Test must be performed according IEC 62353; measured with power supply cord, resistance power supply cord < 100 mΩ, resistance HF-device < 200 mΩ. = Test must be performed according IEC 62353. 4) = with Service program 26 (all relays on) 3)
Ground wire test 2)
Limit value
Ground → POAG
max. 0,3 Ω
[Ω]
max. 0,5 mA
[mA]
max.
Measured value
Leakage current measurement 3) Ground leakage current N.C. 4) Ground leakage current S.F.C.
4)
1 mA
[mA]
Patient leakage current N.C. 4)
max. 10 µA
[µA]
Patient leakage current S.F.C. 4)
max. 50 µA
[µA]
2 MΩ
[MΩ]
DC resistance measurement 3) Measurement between AP – NE 500 V DC 4)
min.
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:
page 2 of 2
Date, signature:
This inspection protocol referring to service manual 900-350_SM_V2.6_10590-S7-20100620-EN