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TITLE: Gyrus ACMI G400 Workstation USER MANUAL
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Various changes to sections 2,4,6,13 due to software upgrade version 1.03.
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Page 10-1 nominal voltage changed from 220-230 volts to 230 volts
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Page 1-5 new ref to Plasma Morcellator
Page 2-4 Caution statement updated.
Additional sections added 4E and 4F ref software version V1.04.
Minor text corrections to section 4.
Page 10-2 MR2 added to Max Voltage. Page 10-7 new MR2 load curve added.
Page 12-1 WEEE and storage symbols/description added.
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CE mark changed from 0123 to 0344, minor text changes throughout the manual for
consistency
102758
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Remove the option to not display the impedance baragraph, Change to the standby button
fuction & state. Display the generator serial number on start-up & addition of cutting
progress indicator setup
100606
H
Replace Gyrus Medical Inc with Gyrus ACMI Inc; replace Maple Grove address with
Southborough address. Remove reference to customer service international (non USA)
and Winnersh address, replace manufacturer with EC REP symbol and add ACMI to
footers and throughout document were Gyrus is present. Warning added
monopolar dispersive electrodes are removed from the patient. Omni software added.
M Matthews
177012-HH
Gyrus ACMI G400 Workstation
USER MANUAL
177012-HH
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DATE:
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09-JAN-2008
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Summary of Contents for Gyrus Acmi G400
- Page 1 & state. Display the generator serial number on start-up & addition of cutting progress indicator setup 100606 Replace Gyrus Medical Inc with Gyrus ACMI Inc; replace Maple Grove address with M Matthews 05-AUG-2008 Southborough address. Remove reference to customer service international (non USA) and Winnersh address, replace manufacturer with EC REP symbol and add ACMI to footers and throughout document were Gyrus is present.
- Page 2 New Fault codes 600/14 and 600/15 have been added on page 11-6. Fig. 4-2 to show the Omni default settings HC3 25 & VP3 100. As a result of the introduction of a new instrument of the portfolio of device used on the G400 117942...
- Page 3 TITLE: Gyrus ACMI G400 Workstation USER MANUAL PART NO./ISSUE: 177012-HH 122364 To specify voltage overshoot for BiLL and HC modes, the maximum voltages M Matthews 03-May-2012 table (Section 10, page 3) is updated. Update to the HC load curve graphs (Section 10, page 10) to incorporate additional data points.
- Page 4 G400 Workstation USER MANUAL Manufactured for: Gyrus ACMI, 136 Turnpike Road Southborough MA 01772-2104 Gyrus Medical Ltd St Mellons Cardiff CF3 0LT United Kingdom 0344 Rx only Customer Service USA: Customer Service: 1-888-524-7266 Technical Service: 1-800-621-3739 www.gyrusacmi.com 777000 177012-HH 2013-01...
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Page 5: Table Of Contents
4-17 Cutting Progress Indicator Set Up. 4-19 BEFORE SURGERY Power up the G400 Workstation Attach Gyrus ACMI PC & PK Instrument to the G400 Workstation DURING SURGERY Recommendations During Surgery PC/PK Default Settings Activation: Output Selection and Audible Tones Changing Output Mode and Power Setting During Surgery... - Page 6 ………OVERVIEW OF THE GYRUS ACMI G400 GENERATOR This user manual will familiarize you with the controls and output functions available from your Gyrus ACMI G400 Generator and instruct you on its proper use. Copyright Gyrus Medical, Ltd. 2010. All rights reserved. No part of this...
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Page 7: Introduction
SECTION 1 INTRODUCTION Gyrus Medical Ltd, Gyrus Medical Inc and Gyrus International Ltd are referred to as Gyrus ACMI in this user manual. This user’s manual will familiarize you with the controls and output functions available from your G400 Workstation and instruct you on its proper use. - Page 8 The G400 Workstation’s PlasmaCision and PlasmaKinetic technologies overcome this problem and provide a predictable repeatable tissue effect throughout the procedure. In order for the system to produce this effect, the G400 Workstation has integral feedback systems. The size of the working tip geometry determines the amount of power needed to ensure optimal performance.
- Page 9 THERMOKINETIC-T1/T2 (YELLOW PEDAL) A blended waveform is also available on selected instruments that combined cutting and Coagulation to provide a degree of hemostasis when cutting. Gyrus ACMI G400 Workstation USER MANUAL Page 1-3 Part Number: 177012-HH...
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Page 10: Indications For Use
Cardiology Department. Clinical Judgment The use of the G400 Workstation is contraindicated when in the judgment of the physician; electrosurgical procedures would be contrary to the best interest of the patient. SYSTEM DESCRIPTION The G400 Workstation (figure 1.1) is designed for use in surgery for the cutting and... -
Page 11: Instrument Description
INTRODUCTION INSTRUMENT DESCRIPTION The instruments below are designed and rated to be used with the G400 Workstation. For convenience and to improve safety during use, all the dedicated instruments have an internal classification code, which is recognized by the G400 Workstation when the instrument is attached. - Page 12 It is not possible to insert and use multiple instruments from the same instrument product group on the G400 Workstation. i.e. 2 PKS PlasmaSpatulas The G400 Workstation will display an “Invalid Instrument” message on its display if two instruments from the same product group are inserted.
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Page 13: Patient And Operating Room Safety
No modification to the equipment is allowed. WARNING Electrical shock hazard: The G400 Workstation is not user-serviceable. Do not attempt to remove the cover of the G400 Workstation or perform servicing on its parts. Refer servicing to qualified Gyrus ACMI personnel only. WARNING Only use normal saline for irrigation. -
Page 14: Servicing
Do not insert fingers or objects other than the correct cables into the socket. Only activate the footswitch with an instrument attached. CAUTION The G400 Workstation is not designed to be used or operated under dust or sterile covers. WARNING All high frequency electrosurgical devices can potentially cause muscle stimulation during use. -
Page 15: Equipment Disposal
PATIENT AND OPERATING ROOM SAFETY 2C. EQUIPMENT DISPOSALS CAUTION The G400 Workstation contains electronic printed circuit assemblies. At the end of the useful life of the equipment, it should be disposed of in accordance with any applicable policies relating to obsolete electronic equipment. -
Page 16: Before Surgery
Do not use power plug adapters. WARNING Fire Hazard. Do not use extension cords. WARNING In the unlikely event the video signal from the G400 Workstation fails, the incoming camera video signal may not be present on the monitor. Gyrus ACMI G400 Workstation USER MANUAL... -
Page 17: During Surgery
The use of antistatic sheeting is recommended for this purpose WARNING If the electrosurgical effect is not as expected do not continue to use the G400 Workstation or Gyrus ACMI instruments CAUTION Skin to skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze. - Page 18 CAUTION Should a power supply interruption occur, with the instrument connected, the G400 Workstation will prompt the user to confirm the selection of the default settings when power is re-established. CAUTION Use caution when overriding the default power settings. Always use the lowest power setting to achieve the required surgical effect.
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Page 19: After Surgery
• The EMC classification of the G400 Workstation system (class A) is suitable for use on dedicated electrical supply systems not connected to the public electrical network. The system is designed for hospital use. - Page 20 SECTION 2 PATIENT AND OPERATING ROOM SAFETY • Provide as much separation as possible between the G400 Workstation and other electronic equipment (such as monitors). When activating the G400 Workstation, unintended electromagnetic coupling may cause interference with the other equipment.
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Page 21: Installation
The power connector meets all requirements for safe grounding. Its purpose should not be defeated by using extension cords or any form of adaptor. When disconnecting from the mains socket or from the G400 Workstation, cords should always be grasped by the plug. Do not pull on the cord itself. -
Page 22: General Information
To place the generator into standby press the standby button. When prompted press the button again, this confirms entry into Standby. Following an error condition the G400 Workstation may be reset by pressing the Standby/On button twice. Up/Down Arrows Depressing the up or down arrow button when parameter change is permitted increases or decreases the parameter step-wise. - Page 23 Enter PIN code NOTE If there is no user activity for a short period, the G400 Workstation will exit the menu and return to the previous state. Entry back to the previous state is also possible by a long press of the button.
- Page 24 SECTION 4 GENERAL INFORMATION Instrument Tip Cleanliness The G400 Workstation can detect an excess build up of debris on the tip of certain instruments e.g. the Plasma J-Hook. This is indicated to the user via the following screen: RF Off Please Clean Tip Fig 4.3...
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Page 25: Output Mode Selection And Power Controls
GENERAL INFORMATION OUTPUT MODE SELECTION AND POWER CONTROLS The G400 Workstation allows the surgeon to adjust the various power and waveforms from the default setting for the selected instrument Power Up/Down - These buttons adjust the power setting; the yellow arrow buttons for the PlasmaKinetic (PK), PlasmaCision (PC) and ThermoKinetic (T) outputs, and the blue arrow buttons for the Vapor Pulse Coagulation (VPC) and Desiccate (DES)/100% COAG output. - Page 26 The modified JH presets will be retained if the Plasma J-Hook is removed from the G400 and then re-inserted into the same socket. All modified JH presets will be lost and the G400 will return to factory defaults when the G400 is switched off or the Plasma J-Hook is removed and a different type of instrument inserted into the same socket.
- Page 27 At any time the adjustment state can be exited by pressing and holding the Black Mode Footswitch for greater than one second. This will return the G400 to its normal Ready state where depressing either the Yellow and Blue footpedal will once again result in an electrosurgical output.
- Page 28 DES/100% COAG provides a conventional continuous bipolar coagulation output. Vapor Pulse Coagulation (VPC) In VPC mode, the G400 Workstation produces discrete pulses of RF energy. The Gyrus ACMI Vapor pulse mode (VP1, VP2, VP3) provided is not adjustable. The frequency of pulses in VPC mode will also vary depending on the type of instrument attached: generally, the larger the tissue contact area, the slower the pulses.
- Page 29 When the desired mode is displayed, a further press on the Mode / Menu button will complete the selection Select Mode Fig 4.5 Screen for coag waveform selection Gyrus ACMI G400 Workstation USER MANUAL Page 4-8 Part Number: 177012-HH...
- Page 30 The G400 Workstation permits two instruments to be fitted simultaneously, via the two 9-pin connectors. Only one socket can deliver RF at any one time. When the G400 Workstation is switched on from the standby state, it initially operates an automatic socket selection mechanism, and assists primary connection by selecting whichever socket first had an instrument attached.
- Page 31 Hemostasis G400 Workstation Switch On The power switch is located on the rear panel. The G400 Workstation is switched on by pressing the side marked l. The G400 Workstation will display the SERIAL number of the generator, and then the internal tests are performed. The green LED below the Mode / Menu button will come on continuously, and the screen will show “Attach Instrument”...
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Page 32: G400 Workstation Indicators, Set-Up And Malfunction Displays
Standby state if it is not used for a period of 4 hours. It is advisable to switch off the G400 Workstation whenever it is not in use for any extended period, by using the rear panel rocker switch. The side marked “0” should be pressed to do this. - Page 33 If the condition does not resolve itself, the G400 Workstation after a few seconds, interrupts RF activation and then re-applies RF, (Fig 4.10 Screen for power limit message).
- Page 34 WARMING UP Fig 4.11 Screen for a cold condition Foot pedals stuck on – The G400 Workstation will detect where one or both foot pedals appears to be stuck on, and will wait until the condition disappears before resuming normal behaviour.
- Page 35 The PK and PlasmaCision instruments cable is connected to the G400 Workstation through either of the two sockets on the front panel of the G400 Workstation (Fig 4.1). The main power cord; footswitch cable and protective earth cable are connected to the G400 Workstation through fittings on the rear panel (Fig 4.27).
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Page 36: Video On Screen Display (Osd) Feature
Fig 4.14 Example of video display Selection of the video on screen display (OSD) option From the G400 Workstation Idle or Ready states press and hold the Mode / Menu button on the G400 Workstation control panel for 3 seconds. -
Page 37: Changing The Display Language
From the G400 workstation idle state (Showing the “Attach Instrument” screen) press and hold the Mode / Menu button on the G400 control panel for 3 seconds. The G400 Workstation display screen will show the “Display Intensity” screen, press and release the Mode / Menu button three more times, so the G400 Workstation display screen shows the Select Language Mode.. -
Page 38: Enabling Additional Instruments Via A Pin Code
As additional instruments are released for use with the G400 Workstation the settings for these can be added to the G400 workstation and enabled for use. This is done by entering a PIN code into the G400 Workstation using the control panel buttons. The PIN code must be entered twice in succession to enable these instruments. - Page 39 Fig 4.18 Re-enter the PIN code using the same procedure. Once this is correctly displayed press the Mode / Menu button, the G400 Workstation will tone to acknowledge the PIN code entry. If the PIN code is entered incorrectly then the following display will be shown Invalid Pin code ...
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Page 40: Cutting Progress Indicator Setup
While pressing and holding the Yellow pedal, a progress bar will appear on the display screen representing the time remaining for bargraph setup to complete refer to Fig 4.24 SETUP Press and hold Yellow pedal Fig 4.23 Gyrus ACMI G400 Workstation USER MANUAL Page 4-19 Part Number: 177012-HH... - Page 41 Press Mode to Proceed Fig 4.26 Alternatively, if required, this setup procedure can be re-performed at any time by selecting it from the extended menu (refer to section 4A) Gyrus ACMI G400 Workstation USER MANUAL Part Number: 177012-HH Page 4-20...
- Page 42 Conductor terminates at this point. Provides information on correct fuse to Power Switch use for fuse replacement Switch to turn the G400 Workstation on/off. Footswitch Connector Video OUT (Monitor) The Footswitch is used to control the delivery BNC 75 ohm (Composite Video) of RF energy.
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Page 43: Before Surgery
• Ensure that the G400 Workstation is standing on a flat, firm surface and that it is not at risk of being accidentally dislodged during the course of operating theatre activity. •... -
Page 44: During Surgery
The G400 Workstation incorporates a Vapor Pulse Coagulation (VPC) mode, which is the default applied to many of the Gyrus ACMI PK instruments. This mode is designed to reduce both thermal margins and tissue sticking, providing controlled and repeatable outcomes under a variety of surgical situations. -
Page 45: Changing Output Mode And Power Setting During Surgery
When using a Gyrus ACMI PC instrument adjustment of PC settings can be done at any time other than while activating or while the G400 Workstation displays a malfunction. The permissible range of output mode and PlasmaCision settings adjustment will be limited by the identification code of the instrument. -
Page 46: Changing Accessories Between Procedures
Once the instrument is disconnected, the G400 Workstation will revert to the display showing “Attach Instrument”. The G400 Workstation can be left in this idle state between procedures. If the G400 Workstation is not used for a period of four hours it will enter a standby state. Press the standby/on button on the G400 Workstation front panel to return the G400 Workstation to the previous idle state. -
Page 47: Techniques To Optimize Performance
• When using the PK modes with the Gyrus ACMI PK L-Hook, try to avoid excessive build up of coagulum between the electrodes/hooks. This will diminish coagulation performance and increase smoke production during cutting. -
Page 48: After Surgery
CLEANING THE G400 WORKSTATION Use a mild antibacterial detergent on a damp cloth to clean the G400 Workstation. Do not allow fluids to enter the G400 Workstation connectors. Do not use caustic, corrosive, or abrasive cleaning materials. -
Page 49: Operating Room Troubleshooting
Accessory” after instrument Move cables away from any possible source of attached interference e.g. other active electrosurgical systems. Allow G400 Workstation to cool down before re-use. G400 Workstation overheats Check that sufficient ventilation is provided around G400 Workstation. -
Page 50: Performance Specifications
(Footswitch Only IPX8). Intermittent operation Under maximum power setting and rated load conditions the G400 Workstation will provide full power output with the minimum constraint of 10 seconds on, 30 seconds off, duty cycle for 1 hour. Output Waveform and Characteristics... - Page 51 315kHz and 480kHz, corresponding to minimum and maximum load impedance respectively. Crest Factor A constant crest factor of 1.4 nominal for all vaporize outputs; 1.4 to 6.3 for desiccate waveforms. Gyrus ACMI G400 Workstation USER MANUAL Page 10-2 Part Number: 177012-HH...
- Page 52 CAUTION The following load curves apply to the fundamental power delivery capability of the G400 Workstation alone. They do not imply a given power output for any given instrument and connector cable configuration when used with the G400 Workstation. Each accessory will self-impose an upper set power limit for the G400 Workstation.
- Page 53 The PKS BiLL has 2 available waveforms. Upon connections to the G400 generator the BiL1 waveform will be default. BiL1 will provide optimum cut performance however BiL2 will provide a slower cut performance. Selection of BiL2 can be accessed by pressing the Mode button on the G400 then pressing the yellow arrows.
- Page 54 CAUTION The following loads curves apply to the fundamental power delivery capability of the G400 Workstation alone. They do not imply a given power output for any given instrument configuration when used with the generator. Each accessory will self- impose an upper set power limit for the G400 Workstation.
- Page 55 PK Load Curve Full Power 110Vac 60Hz (PK 200W & DES 120W) 1000 Impedance (R) PK Load Curve Half Power 110Vac 60Hz (PK 100W & DES 60W) 1000 Impedance (R) Gyrus ACMI G400 Workstation USER MANUAL Part Number: 177012-HH Page 10-6...
- Page 56 (VP 90W) 1000 Impedance (R) VP Load Curve Half Power 230Vac 50Hz (VP 45W) 1000 Impedance (R) VP Load Curve Full power 110Vac 60Hz (VP 90W) 1000 Impedance (R) Gyrus ACMI G400 Workstation USER MANUAL Page 10-7 Part Number: 177012-HH...
- Page 57 230Vac 50Hz & 110Vac 60Hz MR2 230Vac 50Hz MR2 110Vac 60Hz 1000 Impedance (R) T Load Curve Full Power 230Vac 50Hz T1 200W & T2 200W 1000 Impedance (R) Gyrus ACMI G400 Workstation USER MANUAL Page 10-8 Part Number: 177012-HH...
- Page 58 T Load Curve Full Power 110Vac 60Hz T1 200W & T2 200W 1000 Impedance (R) T Load Curve Half Power 110Vac 60Hz T1 100W & T2 100W 1000 Impedance (R) Gyrus ACMI G400 Workstation USER MANUAL Page 10-9 Part Number: 177012-HH...
- Page 59 SECTION 10 PERFORMANCE SPECIFICATIONS JH Load curve Full Power 230Vac 50Hz JH 40W 1000 Impedance (R) Gyrus ACMI G400 Workstation USER MANUAL Page 10-10 Part Number: 177012-HH...
- Page 60 JH 20W 1000 Impedance (R) JH Load curve Full Power 110Vac 60Hz JH 40W 1000 Impedance (R) JH Load curve Half Power 110Vac 60Hz JH 20W 1000 Impedance (R) Gyrus ACMI G400 Workstation USER MANUAL Page 10-11 Part Number: 177012-HH...
- Page 61 PKS BIL 2 (100W) BIL 1 Bill 2 1000 Impedance (R) Bil load curve 230Vac 50Hz PKS BiL 1 (200W) PKS BiL 2 (100W) Bill 1 Bill 2 1000 Impedance (R) Gyrus ACMI G400 Workstation USER MANUAL Page 10-12 Part Number: 177012-HH...
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Page 62: Error And Fault Codes
ERROR AND FAULT CODES Fault Type Interpretation Most technical problems are indicated by either a fault or error symbol that appears in the G400 Workstation display window and an associated indication on the video on screen display (OSD). The G400 system constantly performs self-checking to ensure its correct operation. Fault codes are reported to the user based on time and weighting of those self checks. - Page 63 Reserved for manufacture/engineer diagnostics 600 - 699 Internal Switching Faults All alarm conditions produced by the G400 system are LOW PRIORITY as per IEC60601- 1-8 table 1. There are no user defined alarms used in the G400 system ...
- Page 64 INTERNAL !!!! INTERNAL FAULT!!!! ENERGY signal error : FAILURE stuck low SYSTEM !!!! INTERNAL FAULT!!!! PlasmaBlend Transformer RESET feedback failure INTERNAL !!!! INTERNAL FAULT!!! [SOFT] G400 Workstation too cold, Gyrus ACMI G400 Workstation USER MANUAL Page 11-3 Part Number: 177012-HH...
- Page 65 INTERNAL !!!! INTERNAL FAULT!!!! RFBUS_VOLTS failure FAILURE [POST check] Reserved INTERNAL !!!! INTERNAL FAULT!!!! PSU_STATUS failure FAILURE [POST check] INTERNAL !!!! INTERNAL FAULT!!!! Mains input failure [POST FAILURE check] Gyrus ACMI G400 Workstation USER MANUAL Page 11-4 Part Number: 177012-HH...
- Page 66 !!!! INTERNAL FAULT!!!! External Watchdog unable FAILURE to reset CPU INTERNAL !!!! INTERNAL FAULT!!!! Internal Watchdog unable FAILURE to reset CPU INTERNAL !!!! INTERNAL FAULT!!!! Invalid PlasmaBlend Board FAILURE Gyrus ACMI G400 Workstation USER MANUAL Page 11-5 Part Number: 177012-HH...
- Page 67 Handswitch Yellow button STUCK stuck [POST check] HANDSWITCH HANDSWITCH STUCK! [AF] Handswitch Blue button STUCK stuck [POST check] HANDSWITCH HANDSWITCH STUCK! [AF] Handswitch Mode button STUCK stuck [POST check] Reserved Gyrus ACMI G400 Workstation USER MANUAL Page 11-6 Part Number: 177012-HH...
- Page 68 400-14 alarm which takes up to 1 minute. This fault code reports a fault in the electrode identification circuit. This is also checked on power-up, at which time a fault would be detected and reported immediately (200-71). Gyrus ACMI G400 Workstation USER MANUAL Page 11-7...
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Page 69: Explanation Of Symbols
Represents the quantity of salable units inside the package. Manufactured for: When a product is manufactured for Gyrus ACMI. Rx only CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a Physician or Dentist. -
Page 70: Periodic Equipment Safety Checks
12 months by a qualified person who has adequate training, knowledge and practical experience to perform such tests. NOTE There are no user serviceable items within the G400 Workstation. Do not attempt to remove the cover of the generator or perform servicing on its parts. ... - Page 71 This configuration allows access to the biomedical test band and any RF output can be selected for an activation period of up to 60 seconds in total. Electro To obtain further RF power for test purposes, the G400 must be switched Surgical off and on again.
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Page 72: Emc Tables
Guidance and Manufacturer's Declaration - Electromagnetic Emissions The G400 Workstation is intended for use in the electromagnetic environment specified below. The customer or the user of the G400 Workstation should assure that it is used in such an environment. Emissions Test... - Page 73 Guidance and Manufacturer's Declaration - Electromagnetic Immunity The G400 Workstation is intended for use in the electromagnetic environment specified below. The customer or the user of the G400 Workstation should assure that it is used in such an environment. Immunity Test...
- Page 74 Guidance and Manufacturer's Declaration - Electromagnetic Immunity The G400 Workstation is intended for use in the electromagnetic environment specified below. The customer or the user of the G400 Workstation should assure that it is used in such an environment. Immunity Test...
- Page 75 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the G400 Workstation The G400 Workstation is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the G400 Workstation can help prevent...
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Page 76: Limited Warranty
The warranty periods for the components of the PlasmaKinetic G400 Workstation are as follows: Component... - Page 77 CONTACTER VOTRE REPRESENTANT LOCAL POWER CORD. POUR UNE UTILISATION A UN AUTRE VOLAGE. WARNING ATTENTION RISK OF FIRE RISQUE D’INCENDIE REPLACE FUSE AS MARKED REMPLACER LE FUSIBLE COMME INDIQUE Gyrus ACMI G400 Workstation USER MANUAL Page 16-1 Part Number: 177012-HH...