Gyrus ACMI, Inc
Gyrus Electro Surgery Units
PlasmaKinetic SuperPulse Generator G400 model 744000 Service Manual Oct 2010
Service Manual
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000 0344 Manufactured for: Gyrus ACMI Inc. 136 Turnpike Road Southborough MA 01772-2104
USA
Gyrus Medical Ltd Fortran Road St Mellons Cardiff CF3 0LT United Kingdom Tel: +44(0) 29 2077 6300 Fax: + 44(0) 29 2077 6301
Part Number: 177079-AB 2010-10
Rx only Caution-Federal law (USA) restricts the G400 for sale by, or on the order of, a physician or hospital. The contents of this document are copyright and should not be copied or used without the written permission of Gyrus ACMI.
Website: www.gyrusacmi.com
Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
4 SERVICE PROCEDURES 4.1
PERIODIC SERVICE Inspect the Generator and Footswitch for obvious signs of mechanical damage or wear. Ensure that the generator case shows no sign of tampering. Evidence of damaged casework needs to be investigated to ensure that the internals of the generator are safe. Gyrus ACMI recommends the return of damaged generators to an approved service centre. The Gyrus ACMISales representative handling the generator account will be able to advise. Check the generator back panel label is present and decipherable and that the front panel markings and symbols are still legible. Retract the fuse drawer of the mains inlet connector and verify that both fuses are intact and match the rated current and breaking characteristics as per the back panel label. Switch on the Generator, ensuring that the initial internal Power On Self Test (POST) is completed normally, as reported on the front panel display. Check that the audio alarm, front panel warning indicator and vacuum fluorescent display are functioning normally via the user verification sequence, which follows initialisation. All servicing activity should be documented in accordance with local documented procedures. A typical format for service activity recording is included in the Generator Service Report in this manual. .
4.2
PKRF OUTPUT & RF LEAKAGE CHECKS GENERAL PREAMBLE Whilst in standby mode, the generator constantly monitors the A and B RF sockets to detect valid electrodes. The G400 generator has a number of operating modes that have defaults depending on the value of capacitors embedded in the applied electrodes. The connection of a valid electrode will cause the generator to select the appropriate default power settings for that particular electrode. Alternative power settings and modalities within a certain range may be alternatively selected by the user. The G400 generator identifies electrodes with an internal oscillator that changes frequency depending on the value of capacitance in the applied electrodes. To be able to measure the RF output of the generator, it is desirable to invoke the generator biomed test band by inserting the biomed test cable in to the generator output socket.
The use of the biomed test band is not to be used for clinical use. The biomed test band permits modalities that would be hazardous in a clinical application. For safety reasons, the biomed test band will time out after a short period. Any doubt about the performance of the generator must be referred to the nearest service centre.
Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
WarningThere is a risk of electric shock, RF burns, personnel injury and equipment damage if safe working practises are not adhered to. Deployment of a Biomed Test Cable for the purpose of testing the RF output power of Gyrus ACMI G400 generators shall not cause Gyrus ACMI or any approved supplier, to be liable for direct, indirect consequential and/or injury and/or damages, even if Gyrus ACMI or such approved supplier have advised the possibility of such damages arising from any cause whatsoever, including negligence. Applying a Biomed Test Cable to either the A or B output socket will enable the biomed test band full power PK1, PK2, PK3, T1, T2, PB1, PB2, PB3, PB4, VP1, VP2, VP3, TRIDES, TRIVP1, TRIVP2, TRIVP3, PBDES, PBVP1, PBVP2, PBVP3 & DES modalities with a time-out function. To date, Gyrus has not received any data concerning unsuitability of third party electrosurgical analysers to perform basic RF output and RF leakage tests. As a guide, the analyser must have selectable non-reactive loads and have means to perform the RF leakage tests in accordance with IEC 60601-2-2 1998-2001. It is very unlikely that third party electrosurgical-analysers will be able to measure the pulsing or balanced outputs to a true RMS value. The PK1, PK2 and PK3 modes may be checked with relative ease, as these are nominally sinusoidal continuous waveforms. The PK3 is the most aggressive cut waveform as this has the highest voltage limit, followed by PK2 then PK1. Output checks should be prompted by the settings in the enclosed Generator Service Report in this manual. In short the test involves selecting the appropriate modality (PK1, PK2, PK3 etc) and nominal output power via the keyboard and display. The power output checks limits in the Generator Service report represent part of the published load curves for the G400 generator +/20%. It is assumed that the user is familiar with their electrosurgical analyser to select the appropriate non-reactive load impedance and measurement methodology. An appropriate footswitch is required to instigate RF outputs.
PB RF output checks In this modality, RF energy may be split between three connections within the RF socket. It is unlikely that any commercially available electrosurgical analyzer can fully test this modality.
Any doubt about the performance of the PB output of the generator must be referred to the nearest service centre.
Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
4.3
QUICK START BRIEF G400 OUTPUT CHECK (OPTION 1) 1. Familiarization with the “PKRF output & RF leakage checks general preamble” & “Diagnostic Test equipment” sections detailed above are assumed. 2. Obtain a “Biomed Test Cable” PN: BTK-G400 from your account representative or your local Technical support representative (see image below). This cable is suitable for testing the G400 (777000) RF output.
Prepare the Biomed Test Cable ends in a suitable manner to reduce the risk of electric shock or RF burns that also facilitates easy connection to the loads in the output test equipment. 3. When the test cable is plugged-into the front of the G400, the display will read: “BioMed Non-Human-Use” PK3 – 200 (watts), DES – 120 (watts). There is an automatic timeout for the non human use Biomed Test Band. 4. Connect the Biomed Test Cable red and black wires to the RF output test equipment [Electrosurgical Analyzer (ESU) or fixed loads]. These wires are not polarity sensitive. 5. Adjust the coagulation mode and wattage on the right side of the generator display to DES 60 (watts), set the ESU to 150 ohms input impedance and test for output. While depressing the blue footpedal, the output should measure as per the table in the Generator Service Report in this manual. 6. Adjust the coagulation mode and wattage on the right side of the generator display to DES 120 (watts), set the ESU to 150 ohms input impedance and test for output. While depressing the blue footpedal, the output should measure as per the table in the Generator Service Report. 7. Adjust the cut mode and wattage on the left side of the generator display to PK3 100 (watts), set the ESU to 150 ohms input impedance and test for output. Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
While depressing the yellow footpedal, the output should measure as per the table in the Generator Service Report. 8. Adjust the cut mode and wattage on the left side of the generator display to PK3 200 (watts), set the ESU to 150 ohms input impedance and test for output. While depressing the yellow footpedal, the output should measure as per the table in the Generator Service Report. 9. It is permissible to mark all the other power output tests in the Generator Service Report as N/A. If any questions or the generator does not meet the identified output specification(s), call Gyrus ACMI Technical Services detailed on the contacts page.
Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
4.4
DETAILED G400 OUTPUT CHECK (OPTION 2) 1. Familiarization with the “PKRF output & RF leakage checks general preamble” & “Diagnostic Test equipment” sections detailed above are assumed. 2. Obtain a “Biomed Test Cable” PN: BTK-G400 from your account representative or your local Technical support representative (see image below). This cable is suitable for testing the G400 (777000) RF output
.
3. Prepare the Biomed Test Cable ends in a suitable manner to reduce the risk of electric shock or RF burns that also facilitates easy connection to the loads in the output test equipment. 4. When the test cable is plugged-into the front of the G400, the display will read: “BioMed Non-Human-Use” PK3 – 200 (watts), DES – 120 (watts). There is an automatic timeout for the non human use Biomed Test Band. 5. Use the “Generator Service Report” in as a prompt to select the required generator modes, load impedance and measurement points on the biomed test cable to perform the designated power output checks. 6. Perform an RF output leakage test in accordance with a test regime to IEC60601-2-2. Most electrosurgical analysers simulate IEC60601-2-2 RF leakage test with a fixed value capacitance to ground. The PKRF leakage may be performed on the black and red wires of the Biomed Test Cable (set the generator to PK3 200W). The PB RF leakage may be performed on the black and white wires of the Biomed Test Cable (set the generator to PB3 200W 100% CUT). Record the maximum leakage current for each case on the “Generator Service Report” in . 7. If any questions or the generator does not meet the identified output specification(s), call Gyrus ACMI Technical Services detailed on the contacts page. Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
4.5
VIDEO INPUT OUTPUT CHECKS This generator may be configured to superimpose information on to a Colour Video Blanking & Sync (CVBS) video source presented at the VIDEO IN BNC. A mixed CVBS signal is then available at the VIDEO OUT BNC. This functionality is covered in the user manual for the generator. To test the video function of the generator, connect the video output of the generator to a monitor. With no electrodes attached, the generator should indicate Attach Instrument. Hold down the keypad Mode switch until the display intensity screen appears. Continue to press the Mode switch until Video OSD Select appears. Set the option to ON then press Mode to return to Attach Instrument. A blue screen should appear on the monitor with the text Attach Instrument superimposed. If a CVBS video source is now connected to the Video In BNC of the generator, the blue screen will change to the input video source with Attach Instrument text superimposed.
Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
4.6
MAINS ELECTRICAL SAFETY CHECKS Perform the electrical safety tests detailed in the Generator Service Report and outlined in IEC60601-1-1. Use a calibrated and approved safety tester designed for this purpose. The test limits for the G400 generator are appropriate to Class1 type BF. Use the Biomed Test Cable PN:BTK-G400 red, black and white wires to access the patient applied parts of the generator.
Note that generator RF output power is available on demand when the Biomed Test Cable is connected so observe all precautions cited in “PKRF output & RF leakage checks general preamble”. Record the test values and safety tester details on the form in the Generator Service Report .
Gyrus ACMI G400 Workstation Part Number: 177079-AB
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000 G400 Generator Test Results Page 2 of 3 IEC IEC Limits(s) 60601-1 60601-2-2 Protective Earth Impedance (PE) 18(f) ---0.1 ohm (0.2 inc mains lead) Parameter
Measured Value
PE test current
18(f)
----
10 - 25A
A
Input voltage (V)
----
----
----
V
Input current: activating (I)
----
----
----
A
Input current: standby (IQ)
----
----
----
A
Input power (V x I)
7.1
----
440VA
VA
Earth leakage current (NC)
19.1(e)
----
500uA
uA
Earth leakage current (SFC)
19.2(a)
----
1mA
mA
Enclosure leakage current (NC)
19.1(d)
----
100uA
uA
Enclosure leakage current (SFC)
19.2(c)
----
500uA
uA
Patient leakage current (NC)
19.1(e)
----
100uA
uA
Patient auxiliary leakage current (NC)
19.1(f)
----
100uA
uA
Patient auxiliary leakage current (SFC)
19.1(f)
----
500uA
uA
Patient leakage (mains on applied part)
19.2(b)
----
5mA
mA
----
----
----
----
PK RF output power checks Modality
Set Watt
Load
----
----
----
----
PK3
200W
68 (Bk – Rd)
----
50.2
169.8 – 220.3W
W
PK3
200W
150 (Bk – Rd)
----
50.2
162.2 – 223.3W
W
PK3
200W
1000 (Bk – Rd)
----
50.2
90 – 136.9W
W
PK3
100W
150 (Bk – Rd)
----
50.2
83 – 121W
W
DES
120W
68 (Bk – Rd)
----
50.2
89.9 – 137.1W
W
DES
120W
150 (Bk – Rd)
----
50.2
69.4 – 96W
W
DES
120W
1000 (Bk – Rd)
----
50.2
12.1 – 16.9W
W
DES
60W
68 (Bk – Rd)
----
50.2
51 – 76.1W
W
DES
60W
150 (Bk – Rd)
----
50.2
49.6 – 74.1W
W
DES
60W
1000 (Bk – Rd)
----
50.2
11.4 – 16.9W
W
PB1 100% CUT
200W
5 (Bk – Rd)
----
50.2
>80W
W
PB1 100% CUT
200W
500 (Bk – Rd)
----
50.2
156.8 – 211.3W
W
PB1 100% CUT
100W
5 (Bk – Rd)
----
50.2
56.4 – 76.1W
W
PB1 100% CUT
100W
500 (Bk – Rd)
----
50.2
84.1 – 115.2W
W
PBDES
200W
20 (Bk – Wh)
----
50.2
161.3 – 219.1W
W
PBDES
200W
300 (Bk – Wh)
----
50.2
31.5 – 47W
W
PBDES
100W
20 (Bk – Wh)
----
50.2
84.1 – 113.3W
W
PBDES
100W
300 (Bk – Wh)
----
50.2
31.5 – 47W
W
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BIOMED SERVICE MANUAL Electrosurgical Generator G400 Workstation Model 777000
G400 Generator Test Results Page 3 0f 3 PBDES
50W
20 (Bk – Wh)
----
50.2
42.1 – 56.4
W
PBDES
50W
300 (Bk – Wh)
----
50.2
29 – 39.3W
W
PBDES
50W
1000 (Bk – Wh)
----
50.2
9.9 – 13.4W
W
PKRF leakage current
----
19.101(c)
100mA
mA
PB RF leakage current
----
19.101(c)
100mA
mA
Video check pass/fail Electrosurgical analyser model number Electrosurgical analyser serial number Electrosurgical analyser calibration
Start date
Expiry date
Electrical safety tester calibration
Start date
Expiry date
Biomedical Engineer details
Name
Signature
Quality reviewer details
Name
Signature
Electrical safety tester model number Electrical safety tester serial number
Gyrus ACMI G400 Workstation Part Number: 177079-AB
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