Gyrus ACMI, Inc
Gyrus Electro Surgery Units
PlasmaKinetic SuperPulse Generator Service Manual Issue B Dec 2004
Service Manual
24 Pages
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Page 1
Section I
SERVICE MANUAL ELECTROSURGICAL GENERATOR PlasmaKinetic SuperPulse Federal law (USA) restricts this device to sale by or on the order of a physician or hospital. Customer/Technical Service USA: Gyrus Medical Inc. 6655 Wedgwood Road Suite 160 Maple Grove, MN 55311-6502 USA Tel: 763-416-3000 Fax: 763-416-3070 Toll Free: 800-852-9361
Customer Service International: Gyrus International Ltd. 410 Wharfedale Road Winnersh Triangle Wokingham Berkshire RG41 5RA United Kingdom Tel: 44 118 921 9700 Fax: 44 118 921 9800
Original Equipment Manufacturer Gyrus Medical Ltd. Fortran Road St Mellons Cardiff CF3 0LT United Kingdom Tel: 44 29 2077 6300 Fax: 44 29 2077 6301
Website: www.gyrusmedical.com
The contents of this document are copyright and should not be copied or used without the written permission of Gyrus Medical.
Gyrus Medical Ltd Issue: 844071-B
SERVICE MANUAL 20 DECEMBER 2004
Page 1 of 24
AMENDMENTS
I SSUE:
AMENDMENT
A
First issue
B
Re-write
Gyrus Medical Ltd Issue: 844071-B
PAGE No.
SERVICE MANUAL 20 DECEMBER 2004
Page 2 of 24
Section II TABLE OF CONTENTS
Section I...1 AMENDMENTS...2 Section II... 3 TABLE OF CONTENTS... 3 Section III... 4 INTRODUCTION...4 Intention...4 Purpose of document... 4 Electrosurgery...4 Legal notices and copyright...5 Use of this document...6 Equipment Safety ... 6 Diagnostic Test Equipment... 7 Working Practises...8 Section IV...9 SYSTEM DESCRIPTIONS...9 Principles of Operation and Generator outputs... 9 Generator Internal description...9 Section V... 11 SERVICE PROCEDURES... 11 Periodic Service...11 RF output & RF leakage checks...11 Mains electrical safety checks...13 Section VI...14 GENERATOR FAULT DIAGNOSIS AND REPAIR...14 Fault and Error Diagnosis...14 Generator Disassembly...18 Section VII...19 Decontamination of returned product...19 Section VIII... 20 Generator service report ... 20 Section IX...23 Technical Reference Drawings...23
Section III INTRODUCTION
Intention This document must be used in conjunction with the SuperPulse Operating Manual 244012, which is shipped with all new SuperPulse generators. It is assumed that all service personnel are familiar with and understand the contents of the operator manual.
Purpose of document This service manual is intended expressly for the use of qualified biomedical engineers to perform basic output checks and safety tests to establish product conformity for the purpose of acceptance testing and annual maintenance. There are no user serviceable parts inside the generator. The manufacturer recommends that SuperPulse generators be inspected at least every 12 months to ensure continued safety of operation. The “case open” calibration and repair requirements will be met by utilising appointed service centres, working under the auspices of the Gyrus Medical Ltd Service Department. Possession of this document does not constitute the right to perform any repair related work upon SuperPulse electro-surgical generators. All drawings are supplied for reference only. Any persons making use of this document to inspect or test the electro-surgical equipment so described will be expected to have attained an appropriate level of technical knowledge and skill such that all work is carried out in a fashion that neither constitutes a risk to the personal health of the service engineer nor compromises the electrical safety of the equipment. The use of this document for the test and safety check tasks must be carried out utilising appropriate items of test equipment. At all times, the persons carrying out these functions must be aware of the implications of end user and patient safety.
Electrosurgery The equipment described within this document is an electrosurgical generator. Electrosurgery functions by applying high frequency electrical power to the patient under surgeon command. In some instances, electrical powers of 300 W or more can be applied to the patient to implement the requisite tissue effect. Safety of the equipment is governed by compliance with internationally recognised standards such as IEC60601-1, IEC60601-1-1, IEC60601-2-2 and IEC60601-1-2 dated 1998, 1998, 1998 and 2001 respectively. The user is referred to the instrument rear label. All applied parts, cables and handpieces used within the vicinity of the operating table will be sterilised. The electro-surgical generator and footswitch are considered non-sterile.
Since electro-surgery involves the application of direct electrical energy to the patient, this will naturally constitute a potential hazard in the case of equipment malfunction. In common with all other approved systems, the design and construction of the SuperPulse generators have been subjected to rigorous safety tests. Each generator has undergone a stringent test regime during its manufacture and ensure that any generator will possess a commensurate level of safety integrity.
Legal notices and copyright Gyrus Medical Ltd authorises the copying of the pro-forma sheets for the sole purpose of recording the servicing activity. The material presented within this document is provided for reference purposes only. All reasonable effort has been made to ensure that its content is accurate and factual. Gyrus Medical Limited does not warrant or make any representations or conditions regarding the use, validity, completeness, accuracy, or reliability of, or otherwise respecting, the information contained in this manual. Under no circumstances will Gyrus Medical Ltd or any of their affiliated organisations be held liable for any personal injury, commercial loss or loss of profit, whether real, consequential or prospective, which is claimed to be due to be resulting from the use of this document. The information contained in this manual is subject to change at any time without notice. Later editions of this manual will contain revised and updated material. Any third party undertaking SuperPulse generator testing must agree to comply with all pertinent regulatory issues in respect of the maintenance of the equipment. This may encompass mandatory compliance with those aspects of the manufacturer’s quality system dealing with generator service. Gyrus Medical Ltd does not accept any responsibility for any SuperPulse generator which has been subject to any unauthorised repair or modification by a third party or end user. The manufacturer’s warranty is void once the lid seal is broken unless permission is granted in advance to allow the breaking of the seal. All liability, howsoever arising, is transferred to the customer if a device is opened, repaired or modified in any way by nonauthorised personnel and the end user or other third party by its conduct shall be deemed to have agreed to indemnify and hold harmless Gyrus Medical Ltd for any liability, costs, expenses, or losses which may arise as a result of the end user’s or third party’s action. The exclusions, restrictions and limitations contained in this manual are intended to operate to the greatest extent permitted by any and all applicable laws
Use of this document Performing basic output and safety tests, first line diagnosis may be attempted following a reported failure of the equipment during normal use. It is strongly recommended that any testing effort uses the tests outlined in the succeeding section.
Equipment Safety CAUTION:
Any attempt to first line diagnose a generator should only be carried out by a suitably qualified person who has adequate training, knowledge and practical experience.
WARNING:
Every precaution should be taken to avoid contact with the generator internal components whilst switched on, especially on the non-isolated side of the PSU board. Working on any live equipment is potentially dangerous.
Diagnostic Test Equipment The list of recommended test equipment to perform the routine checks of the generator is as follows:
1. Approved Electro-surgical analyser* ++ 2. Approved instrument (IEC60601) to perform equipment safety tests 3. Capacitors and lead to simulate electrode. Where applicable the equipment must have a recognised calibration certificate. *The SuperPulse has RF output modalities that are very difficult for most electro-surgical analysers to measure. The Gyrus Medical Ltd technical authority has stated that testing the continuous wave and blended output modalities of the generator are sufficient to confirm full equipment functionality. ++ Gyrus Medical Ltd can also recommend the use of a Fluke 8920A True RMS RF voltmeter or equivalent, non-inductive load resistors and Pearson Current Transformer model 411 to measure the current output of the generator and calculate the delivered power. The 411 current transformer has a transfer function of 100mV per Amp. The calculated delivered power may be derived from:
Pm = (10*IV)2 * RL Where : Pm is the measured power in Watts IV is the voltage measurement on the Fluke 8920A representing true RMS current (volts) RL is the non-inductive load resistor in ohms
Example
100W = (10 * 81.7x10-3V)2 * 150Ω
Working Practises FUSES There are two mains fuses fitted to the generator; care must be taken to ensure any replacements fitted are approved types directly equivalent to the ones supplied by the original manufacturer of the generator. The fuse details are on the rear panel label. ESD PRECAUATIONS The generator contains electrostatic discharge sensitive components. Care should be taken to minimise the risk of electrostatic discharge.
Section IV SYSTEM DESCRIPTIONS
Principles of Operation and Generator outputs. The reader is referred to the operator manual.
Generator Internal description The SuperPulse generator casework is comprised of the front fascia, rear panel, top and bottom panels, side extrusions and isolation board. The isolation board carries all of the Printed Circuit Boards (PCBs): Power Supply Unit (PSU), Plasmakinetic (PKRF) and the SuperPulse (SPRF). A Central Processing Unit (CPU) is a daughter board to the PKRF. The PKRF also carries the ID and the Socket Select PCBs as daughter boards. The ID PCB is the board closest to the PKRF PCB. The front fascia caries the Vacuum Fluorescent Display (VFD), membrane keypad and the loudspeaker. There is a rear panel mounted circulating fan that is activated by the electronics when required. There is an additional fan fitted to the PKRF heatsink and a smaller circulating fan above the SPRF PCB. The latter has been removed in the photograph below for clarity.
The figure below illustrates the interaction of the PCBs and some other sub assemblies. RF 1,2 socket
VFD and MEMBRANE
spkr
RF (PK) SUPERPULSE OUTPUT BOARD
ID
SOCK’ SELECT
C P U
PSU
Fan
comms
footsw
mains inlet
The communication port on the rear panel is for use by Gyrus personnel only or appointed representatives working under the auspices of Gyrus Medical Ltd.
Section V SERVICE PROCEDURES
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 recommends the return of damaged generators to an appointed service centre. The Gyrus Sales 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 section IX.
RF output & RF leakage checks The SuperPulse generator has a number of operating modes that have defaults depending on the value of a capacitor embedded in the applied electrodes. The connection of a valid handpiece and 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 SuperPulse 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 essential to simulate electrodes by applying a capacitor as in the following diagrams. Any doubt about the performance of the generator must be referred to the nearest service centre.
Electro-surgical analyser
Electro-surgical analyser
The PK & PK/SP RF output sockets utilise 4mm and 2mm sockets. A test lead may be fabricated using 2mm and 4mm plugs to interface to the electrosurgical analyser. Alternatively, a handpiece lead may be modified at the electrode end to connect to the electrosurgical analyser. The latter is more preferable as this more closely mimics the additional capacitance of the handpiece lead, which is more critical at lower values of capacitor CE. Warning- there is a risk of electric shock, RF burn risk, personnel injury and equipment damage if safe working practises are not adhered to.
By selection of CE capacitor value, a desirable output modality can be instigated. A CE value of 68nF +/- 5% 60V will enable outputs that are useful for checking performance. 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. It is very unlikely that third party electrosurgical-analysers will be able to measure the pulsing outputs of the VP and SP waveforms to a true RMS value. The SP outputs are continuous wave at certain load impedances. 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 least voltage limiting followed by PK2 then PK1. This is reflected in the expected power delivery at 1000 ohm load tests. Output checks should be prompted by the settings in the enclosed generator service report in section IX. In short the test involves selecting the appropriate modality (PK1, PK2, PK3 etc) and nominal output power in watts via the keyboard and display. The power output check limits in the Generator Service report section IX represent the published load curves for the SuperPulse 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 CUT and DES outputs. The SP output of the generator may be instigated by using the right hand socket and a CE value of 4.7nF 60V.
Mains electrical safety checks Perform the appropriate electrical safety tests outlined in IEC60601-1-1 using a calibrated and approved safety tester designed for this purpose. The test limits for the SuperPulse generator are appropriate to Class1 type BF. Applied parts are all of the 4mm sockets within the RF socket assemblies. The 2mm ID socket within the RF socket assembly is not deemed an applied part. Record the test values and safety tester details on the form in section IX.
Section VI GENERATOR FAULT DIAGNOSIS AND REPAIR
FAULT AND ERROR DIAGNOSIS The generator incorporates extensive internal system monitoring which allows it to self-determine potential errors and problems. Most error checks are performed during the power-up sequence. Any anomaly found will be reported on the front panel display. Certain checks can only be accomplished whilst electrosurgical power is being output. Any errors or faults falling into this category would only appear during activation. The term ‘ERROR’ is used to denote a likely hardware fault that will require investigation. If the unit displays a ‘FAULT’ code then the cause of the problem could be either transient or external and not due to any problem with the generator per se. IMPORTANT: CERTAIN PARTS OF THE GENERATOR PSU ARE LIVE WITH RESPECT TO THE LOCAL EARTH AS THE PSU IS OF THE RECTIFIED MAINS SWITCHMODE TYPE. Full diagnosis of a SuperPulse generator requires specialised equipment that is unavailable to third parties. However, annual system level testing and safety checks provide a very high confidence factor for the functionality and safety of the generator. Fault Symbol Interpretation Most technical problems are indicated by an error symbol that appears in the Generator display window. Fault Symbols Three levels of fault reporting exist within the generator. “Soft” describes events bringing the attention of the user to an attempt to use the Generator outside the specification. This will be annunciated by a warning beep. Recoverable [R] describes a fault that is a transient, non-hazardous event recoverable using a Generator reset function. To reset the Generator after a fault occurs, first depress and release the mode key once. The fault symbol on the display should flash. Depress and release the mode key once more to complete the reset. The error symbol on the display will be of the form: “Error Code X00 REF XX” IMPORTANT Remember to take notes of all of displayed fault symbols to aid fault diagnosis before completing the reset.
Fatal [F] describes a fault that is not recoverable and should be investigated by a Gyrus appointed service centre. Recoverable [R] error codes, particularly in the range 400 REF XX, may be attributable to accessories (footswitches. handpieces, electrodes etc.). These should be eliminated as the source of the error code by means of substitution. Generators that repeatedly give recoverable error codes and have had their accessories swapped out may have an underlying problem requiring further investigation. An error symbol is displayed as for the Level 2 faults, except that it indicates that a service is required. WARNING
An error symbol indicates an equipment malfunction that may be hazardous. Disconnect all accessories and switch the Generator off. Switch the Generator back on and if the self-test is completed satisfactorily as evidenced by the “ATTACH CABLE” symbol on the display, the failure occurred in the accessories which should be discarded and replaced. If the self-test fails, then all functions will be inhibited and no attempt should be made to use the generator. Contact the appropriate address located on the front of the manual for assistance.
In the following list, where indicated as recoverable, this would be displayed as a fault symbol as described above. ERROR CODE 100
REF
TEXT STRING
TYPE
DESCRIPTION
10
SYSTEM RESET
[R]
Software execution failure (watchdog reset)
100
11
100
12
INTERNAL FAILURE
[F]
ROM checksum failure
SETTINGS CORRUPT
[R]
13
INTERNAL FAILURE
[F]
100
14
OUTPUT POWER FAIL
[R]
Non volatile memory corrupt or not initialised Program failure (unexpected value or state) Power generation fault on start up (PK)
100
100
15
INTERNAL FAILURE
[F]
Power generation shutdown fault
100
16
OUTPUT POWER FAIL
[R]
Power generation fault on start up (SP)
100
17
SYSTEM RESET
[R]
Software execution failure
100
18
INTERNAL ERROR
[F]
Background loop timing
100
19
INTERNAL ERROR
[F]
Continuous test timing
200
10
INTERNAL FAILURE
[F]
PWM signal: shorted high
200
11
INTERNAL FAILURE
[F]
PWM signal: shorted low
200
12
INTERNAL FAILURE
[F]
SYNC signal: shorted high
200
13
INTERNAL FAILURE
[F]
SYNC signal: shorted low
200
14
INTERNAL FAILURE
[F]
ENERGY signal: stuck high
200
15
INTERNAL FAILURE
[F]
IOUT signal: stuck high (comparator in)
200
16-17
Not used
---
----
200
18
INTERNAL FAILURE
[F]
CUT/COAG signal: stuck high
200
19
INTERNAL FAILURE
[F]
CUT/COAG signal: stuck low
200
20
INTERNAL FAILURE
[F]
CLAMP signal error (DAC output)
200
21
INTERNAL FAILURE
[F]
BOOST signal error (DAC output)
200
22
INTERNAL FAILURE
[F]
PEAKSET signal error (DAC output)
200
23
INTERNAL FAILURE
[F]
200
24
INTERNAL FAILURE
[F]
PEAK signal error: stuck high (comparator in) RF_DET signal error: stuck low
200
25
INTERNAL FAILURE
[F]
OVERDOSE signal error: permanently ON
ERROR CODE 100
REF 10
200
26
200
TEXT STRING
TYPE
DESCRIPTION
SYSTEM RESET
[R]
Software execution failure (watchdog reset)
INTERNAL FAILURE
[F]
ENERGY signal error: stuck low
27
Not used
---
----
200
28
INTERNAL FAILURE
[F]
Temperature monitor inoperative
200
29
------
----
Reserved for audio fault detection
200
30
Not used
----
-----
200
31
INTERNAL FAILURE
[F]
CURRLIM signal error (DAC output)
200
32
INTERNAL FAILURE
[F]
VOLTLIM signal error (comparator input)
200
33
INTERNAL FAILURE
[F]
BUSVOLTS signal error (analogue input)
200
34
INTERNAL FAILURE
[F]
Incorrect PK RF board installed
200
35
INTERNAL FAILURE
[F]
RF relay 1 (socket) not operating
200
36
INTERNAL FAILURE
[F]
RF relay 2 (poles) not operating
200
37
INTERNAL FAILURE
[F]
SP board RF_ACTIVE stuck on
200
38
INTERNAL FAILURE
[F]
SP board Output relay non-functional
200
39
INTERNAL FAILURE
[F]
SP board BUS relay non-functional
200
40-2
Not used
---
-----
200
43
INTERNAL FAILURE
[F]
CPU POST failure
200
44
RAM
[R]
RAM test failure [POST check]
200
45
INTERNAL FAILURE
[F]
Crystal failure [POST check]
200
47
INTERNAL FAILURE
[F]
Analogue reference failure [POST check]
200
48
INTERNAL FAILURE
[F]
CLAMP_SET failure [POST check]
200
49
INTERNAL FAILURE
[F]
BOOST_SET failure [POST check]
200
50
INTERNAL FAILURE
[F]
CURRLIM_SET failure [POST check]
200
51
INTERNAL FAILURE
[F]
PEAK_SET failure [POST check]
200
52
INTERNAL FAILURE
[F]
COAG_CUT failure [POST check]
200
53
INTERNAL FAILURE
[F]
PK_CUT_COAG failure [POST check]
200
54
INTERNAL FAILURE
[F]
PK_SKT_SET failure [POST check]
200
55
INTERNAL FAILURE
[F]
200
56
INTERNAL FAILURE
[F]
SUPERPULSE_RELAY failure [POST check] NO_RF failure [POST check]
200
65
INTERNAL FAILURE
[R]
RFBUS_VOLTS failure [POST check]
200
66
INTERNAL FAILURE
[R]
POST AUDIO Setup [POST check]
200
67
INTERNAL FAILURE
[F]
PSU_STATUS failure [POST check]
200
68
INTERNAL FAILURE
[F]
Mains input failure [POST check]
200
69
INTERNAL FAILURE
[F]
OVERDOSE failure [POST check]
200
70
INTERNAL FAILURE
[F]
PWM low failure [POST check]
200
71
INTERNAL FAILURE
[F]
ID CAL circuit failure [POST check]
200
72
INTERNAL FAILURE
[F]
BUSLIM failure [POST check]
200
73
INTERNAL FAILURE
[F]
CURRLIM failure [POST check]
200
74
INTERNAL FAILURE
[F]
VOLTLIM failure [POST check]
200
75
INTERNAL FAILURE
[F]
SPRF_ACTIVE failure [POST check]
200
76
INTERNAL FAILURE
[F]
VCC_ANA_DIV_2 failure [POST check]
200
77
INTERNAL FAILURE
[F]
12V failure [POST check]
ERROR CODE 100
REF 10
200
78
200
TEXT STRING
TYPE
DESCRIPTION
SYSTEM RESET
[R]
Software execution failure (watchdog reset)
INTERNAL FAILURE
[F]
0V failure [POST check]
79
INTERNAL FAILURE
[F]
Thermistor failure [POST check]
200
80
INTERNAL FAILURE
[F]
RF_VOLTAGE [POST check]
200
81
INTERNAL FAILURE
[F]
RF_CURRENT failure [POST check]
200
82
INTERNAL FAILURE
[F]
ANALOGUE_REF failure
200
83
INTERNAL FAILURE
[F]
VCC_ANA_DIV_2 failure
200
84
INTERNAL FAILURE
[F]
12V failure
200
85
INTERNAL FAILURE
[F]
0V failure
200
86
INTERNAL FAILURE
[F]
RF_DET stuck high failure
200
87
INTERNAL FAILURE
[F]
PSU_STATUS failure
200
88
INTERNAL FAILURE
[F]
Mains input failure
200
89
INTERNAL FAILURE
[F]
BUSLIM failure
200
90
INTERNAL FAILURE
[F]
CURRLIM_SET failure
200
91
INTERNAL FAILURE
[F]
SP_PSU_OR_PK_RELAY failure
200
92
INTERNAL FAILURE
[F]
Electrode ID Failure
300
10
THERMAL SHUTDOWN
[R]
Internal overheating
300
11
INTERNAL FAILURE
[F]
300
12-13
Not used
---
Excess RF input voltage error (RFBUS > set) -----
300
14
OUTPUT SHORTED
[R]
300
15
INTERNAL ERROR
[F]
Accessory error : excessive RF output current Impedance V,I feedback circuit error
300
16
INTERNAL ERROR
[R]
SP board not supplying RF energy
300
17-19
300
20
INVALID ELECTRODE
300
21
SP OUTPUT ERROR
[R]
Persistent over voltage or current error
400
10
FOOTPEDAL STUCK
[R]
Footswitch BLUE pedal stuck
400
11
FOOTPEDAL STUCK
[R]
Footswitch YELLOW pedal stuck
400
12
FOOTPEDAL STUCK
[R]
Footswitch MODE pedal stuck
400
14
INTERNAL FAILURE
[F]
Electrode identification circuit fault
400
15
BUTTON STUCK
[R]
Front panel : CUT (left) UP button stuck
400
16
BUTTON STUCK
[R]
400
17
BUTTON STUCK
[R]
Front panel : CUT (left) DOWN button stuck Front panel : blue UP button stuck
400
18
BUTTON STUCK
[R]
Front panel : blue DOWN button stuck
400
19
BUTTON STUCK
[R]
Front panel : MODE button stuck
400
20
BUTTON STUCK
[R]
Front panel : STANDBY button stuck
400
21
FOOTPEDAL STUCK
[R]
Footswitch pedal state indeterminate
400
30
Not used
---
----
500
10
SERIAL COMMS
[R]
Serial port error
Reserved [SOFT] Unsupported electrode type
**To report an accessory failure, contact the appropriate address located on the front of the manual for assistance.
GENERATOR DISASSEMBLY The Super Pulse generator has a manufacturer’s warranty seal that when broken, will invalidate the warranty of the generator. There are no customer serviceable components inside the generator case. The generator casework is assembled with security screws that require special tooling that is unavailable to third parties.
Section VII Decontamination of returned product Neither the generator or footswitch may be sterilised. To clean the generator or footswitch surfaces, use a mild antibacterial detergent on a damp clove. Do not allow fluids to enter the generator or footswitch connectors. Do not use caustic, or abrasive cleaning materials. All equipment received by a service facility from the user, should be accompanied by a relevant certificate of decontamination. This certificate should detail the method of decontamination, the date of process and the name and signature of the person responsible. Handpiece/Connector Cables may be steralised according to the product's Instructions for Use If the equipment is already free from contamination, as in the case of a brand new generator being returned, a signed certificate is still required with a statement as to why the generator is believed to be free from contamination. WARNING: Gyrus makes no claims as to the effectiveness of the suggested decontamination methods contained within this manual as a means of infection control. If suspicion of a particular risk exists then contact should be made with the relevant Hospital Infection Control Manager or Epidemiologist whilst the equipment in question is quarantined.
Section VIII Generator service report Model Serial number Registered Manufacturer European representative
Gyrus Plasmakinetic SuperPulse system generator Gyrus Medical Ltd.
Supplier / contact
Approvals
CE mark in accordance with MDD 93/42/EEC IEC60601-1 (1998-2001) IEC60601-1-1 (1998-2001) IEC60601-1-2 (2001) IEC60601-2-2 (1998-2001) UL Mark File – E176665
Equipment class as per IEC60601-1 (1998-2001) Equipment category Date of acquisition Inventory Number Location of equipment
Class I
Service Centre Service contract reference Additional information
Type BF