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EN ISO 9001 EN ISO 13485

User Manual Art. No. 80113-901

All rights to this User Manual, in particular rights of duplication, dissemination and translation, are reserved. No part of this
User Manual may be reproduced in any form (by photocopying, microfilming or other methods) or processed, duplicated or
disseminated by the use of electronic systems without the written consent of ERBE Elektromedizin GmbH.

The information contained in this User Manual can be changed or expanded without prior notice and without obligation on
the part of ERBE Elektromedizin GmbH.

Printed by ERBE Elektromedizin

Printed in Germany

Copyright © ERBE Elektromedizin GmbH, Tübingen 2011

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Содержание VIO 300 D

Страница 1: ...VIO 300 D Configured for da Vinci User Manual 08 11 V 2 5 x ERBE ISI PN 551150 01 Rev A English...

Страница 2: ......

Страница 3: ...VIO 300 D Configured for da Vinci User Manual...

Страница 4: ...hotocopying microfilming or other methods or processed duplicated or disseminated by the use of electronic systems without the written consent of ERBE Elektromedizin GmbH The information contained in...

Страница 5: ...essories 16 Notes 17 2 Safety Features 19 Automatic monitoring of equipment output error 19 Automatic monitoring of the ON time 19 Protection from operating errors 19 3 Accessories 21 VIO 300 D exampl...

Страница 6: ...ctions 39 10 Status Messages Error Messages 41 11 General Technical Data 45 12 Information on electromagnetic compatibility EMC 47 Guidelines for avoiding recognizing and rectifying unwanted electroma...

Страница 7: ...ld re sult in death or serious injury CAUTION indicates a potentially hazardous situation which if not avoided may re sult in minor or moderate injury CAUTION used without the safety alert symbol indi...

Страница 8: ...arge extent on the training of medical personnel and correct operation of the equipment The safety instructions in this chapter must be read understood and applied by everyone who is working with the...

Страница 9: ...t at an unsuitable temperature or level of humidity it may sustain damage fail or not perform properly Operate the equipment at a suitable temperature and level of humidity You will find the tolerance...

Страница 10: ...patient and medical personnel Risk of damage to property Connect the unit the equipment cart to a properly installed grounded power outlet Only connect the unit to a power supply network with proper...

Страница 11: ...l tract Risk of explosion to the patient Extract the gases before performing electrosurgery or irrigate with CO2 DANGER Combustion supporting gases e g oxygen nitrous oxide The gases can accumulate in...

Страница 12: ...es such as the vagina Remove any liquids before performing elec trosurgery WARNING Ignition of anesthetics skin cleansers and disinfectants in potentially explosive atmospheres If you place the device...

Страница 13: ...electrodes for monitoring during electrosur gery Where possible use monitoring electrodes that contain devices to limit high frequency current WARNING HF leakage current flows through skin to skin poi...

Страница 14: ...patient Turn off the power switch on the electrosurgical unit immediate ly Only then should the instrument be removed from the pa tient s body WARNING Capacitive coupling between the cords of two ins...

Страница 15: ...y checks not being done Risk of injury or death for patients and medical staff Risk of damage to property Have the device checked for safety at least once a year You must not use a device that is not...

Страница 16: ...ice may only use the internal cables that are listed in the service manual for the device CAUTION Stacked devices If you stack the device next to other equipment or with other equip ment the devices c...

Страница 17: ...t can be connected to the external grounding sys tem of the room with the grounding pin on the back of the unit and or Cart using a connecting cable designed for this purpose Affects of low frequency...

Страница 18: ...1 Safety Instructions 18 54 80113 901 08 11...

Страница 19: ...s a few seconds A defect in the unit in the accessories or in usage may cause the high frequency generator to be switched on unintentionally To prevent major damage being caused by accidental activati...

Страница 20: ...stically and by an error number and message after switch on of the power switch If a contact of the footswitch has short circuited due to an error or a pedal is jammed or a pedal was pressed while the...

Страница 21: ...21 54 3 Accessories 80113 901 08 11 CHAPTER 3 Accessories VIO 300 D example accessories ERBE Junction Box VIO 300 D to ICB Cable ERBE 300 D F...

Страница 22: ...3 Accessories 22 54 80113 901 08 11...

Страница 23: ...is shown on the display Take note of the function toward which the button points Adjustment buttons 10 Up down These buttons always have a function when they appear in the display For example the butt...

Страница 24: ...apter Installation The controls described below are important for installation of the unit Sockets 1 Footswitch socket You connect the ERBE Junction Box at this socket 2 ECB socket ECB means ERBE Comm...

Страница 25: ...s 80113 901 08 11 Power connection 5 Power connection Connect the unit to a properly installed grounded outlet Only use the ERBE power cord or an equivalent power cord for this purpose The power cord...

Страница 26: ...4 Description of the Controls 26 54 80113 901 08 11...

Страница 27: ...on The unit carries out a performance test The version number of the software appears on the display 3 The Guide window Fig 5 1 Once the performance test has been completed you will see the Guide win...

Страница 28: ...n Selection of the button volume in 16 levels Viewing angle Setting of the viewing angle on the display from top from bottom from front Example Set the brightness Fig 5 2 1 Press the selection button...

Страница 29: ...54 5 Working with the Electrosurgical Unit 80113 901 08 11 Fig 5 4 3 Select a brightness level with the Up Down buttons example brightness level 9 Fig 5 5 4 Press the selection button 1 next to Retur...

Страница 30: ...5 Working with the Electrosurgical Unit 30 54 80113 901 08 11...

Страница 31: ...ction with multi functional receptacle Instruments with instrument detection are identified only at multifunctional recepta cles Cutting and coagulation modes Bipolar BiClamp Instrument compatibility...

Страница 32: ...6 Description of receptacle hardware 32 54 80113 901 08 11...

Страница 33: ...lation BiClamp is a modulated current waveform with alternating pulse and rest periods This ratio is set using Modulation This means the larger the Modulation value the longer the rest period is compa...

Страница 34: ...7 Bipolar Mode 34 54 80113 901 08 11 Diagrams Fig 7 1 BiClamp 0 50 100 150 200 250 300 350 10 100 1000 Resistance Ohm Power W Effect 4 Effect 3 Effect 2 Effect 1...

Страница 35: ...uipment and the equipment at the end of this User Manual CAUTION Unsuitable temperature or level of humidity during opera tion If you operate the equipment at an unsuitable temperature or level of hum...

Страница 36: ...t If liquid penetrates the device can sustain damage and fail Make sure no liquid can penetrate the device Do not place vessels containing liquids on top of the device Electrical installation WARNING...

Страница 37: ...damaged accessories modified device and modified accessories Risk of burns and injury to the patient and medical personnel Risk of damage to property Check the unit and accessories for damage every t...

Страница 38: ...et has no function Potential equalization 3 Potential equalization terminal Connect a potential equalization line and connect this to the potential equalization system of the operating room Power conn...

Страница 39: ...manufacturer Safety Instructions WARNING Connection of unit equipment cart and power supply dur ing cleaning and disinfection Risk of electric shock to the medical personnel Switch off the device Unpl...

Страница 40: ...t for fast disinfection With membrane keyboards and paint surfaces there is the risk of cracks Propanol and ethanol will erode surfaces Do not use these substances CAUTION Alternate use of disinfectan...

Страница 41: ...witch disconnected from system B 88 Single pedal footswitch ready for operation B 89 Single pedal footswitch disconnected from system B 93 Multifunctional footswitch ready for operation B 94 Multifunc...

Страница 42: ...died inform Technical Service B 1F NESSY symmetry When applying neutral electrode patient plate ensure that neutral electrode line of symmetry runs towards the operating field B 8E VIO socket 1 fault...

Страница 43: ...tact B B1 NESSY contact Please check contact between skin and neutral electrode patient plate B B3 Recalibrating glass keyboard Do not touch B B7 The AUTO START function is only permissible up to a ma...

Страница 44: ...10 Status Messages Error Messages 44 54 80113 901 08 11...

Страница 45: ...T 4 A Operating mode Intermittent operation ON time 25 e g activated for 10 sec deactivated for 30 sec Dimensions and weight Width x height x depth 410 x 165 x 380 mm Weight 9 5 kg Ambient conditions...

Страница 46: ...11 General Technical Data 46 54 80113 901 08 11 Standards Classification according to EC Directive 93 42 EEC II b Protection class as per EN 60 601 1 I Type as per EN 60 601 1 CF...

Страница 47: ...urther away and or carrying out suitable shielding measures on the equipment or system experiencing disturbance When the VIO electrosurgical unit is in the non activated state interference with oth er...

Страница 48: ...used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environ ment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV...

Страница 49: ...specified below The customer or the user of the equipment should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance...

Страница 50: ...sured field strength in the location in which the equipment is used exceeds the applicable compliance level above the equipment should be observed to verify normal operation If abnormal performance is...

Страница 51: ...r Note 1 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the fre quency bands between 80 MHz and 2 5 GHz to decrease the likelihood that mob...

Страница 52: ...12 Information on electromagnetic compatibility EMC 52 54 80113 901 08 11...

Страница 53: ...cal safety checks must be performed For this device the following technical safety checks have been stipulated Checking of labels and User Manual Visual inspection of unit and accessories for damage T...

Страница 54: ...13 Maintenance Disposal 54 54 80113 901 08 11 If you have any questions about disposal of the product please contact ERBE Elek tromedizin or your local distributor...

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