Ophthalmobipolar E - augenarztbedarf.de & ophthalworld.de
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1. ussnnsusnnnenennnnnnnnnnennnnnnnn 19 Technical Data 2 ann 21 SEIVICE Re a nein ae eh ies 23 Service and Warranty sirsie aaa iaia E aaa 25 CHAPTER 1 Intended use Technical Data Meaning of the safety instructions Intended use Technical Data ATTENTION The Ophthalmobipolar E is of modular design and affords e high frequency bipolar coagulation current for the coagulation of intraocular hemorrhages and for coagulation preparatory to sclerotomy e high frequency bipolar coagulation current for coagulating vessels The rating plate fixed at the bottom of the instrument lists the most important information of the Ophthalmobipolar E Besides pertinent technical data the necessary type and serialnumbers are recorded here In the event of claims servicing requirements etc always state the type number and serial number specified on the rating plate The Safety instructions mean The safety instruction WARNING denotes a danger which can cause damage to persons The safety instruction CAUTION denotes a danger which can cause damage to property The safety instruction ATTENTION denotes a danger which can cause failure of the device CHAPTER 2 Inspection on Delivery and Installation of the Unit Inspection on Delivery Installation On delivery instruments should be checked immediately for damage caused in transit and subjected to a performance test In the event that an instrument has suffer2. as not to touch the patient or other lines Only those lines which are intended by the manufacturer for use with the instrument may be used During high frequency surgery sparking can occur on the active electrode which can ignite flammalble or explosive materials In patients with pacemaker or pacemaker electrode implants the use of high frequency surgery is apt to cause irreparable damage to the implants and to effect their functioning possible to the extent of causing ventricular fibrillation The monitoring of such patient with measuring instruments is recommended CHAPTER 7 Maintenance Cleaning Disinfection and Sterilization Precautions Against Damage of the Instrument Cleaning and Disinfection of the Instrument Precautions Against Damage of the Accessories Cleaning Disinfecting and Sterilizing of the Accessories Maintenance of the unit Protecting the instrument effectvely from damage involves operating it properly and having it properly serviced and setting the instrument up in a safe place This means attaching the ophthalmosurgical instrument securely to its base keeping moisture and dirt out of the instrument and keeping it away from flammable and explosive materials To ensure good radiation of heat produced by the instrument during operation the circulation of air through the cooling vents must not be blocked The housing of the Ophthalmobipolar E should be cleaned only with nonflammable non e
3. the pedal Only explosion proof pedal switches may be used in potentially explosive areas The ERBEBUS is an interface system by means of which various instruments from the ERBE line can be linked with each other and depending on combination and preset operated with a single pedal switch Only Units of the ERBE System may be connected to the ERBEBUS Units of the ERBE System are Aspimat E Phakotom E Vitrektom E Erbokombi E Ophthalmobipolar E Ophthalmotom Erbokryo AE Diacapsutom CHAPTER 4 Description of Accessories Here the functions and characteristics of the most important accessories for high frequency surgery with the Ophthalmobipolar E are described For our entire line of accessories see the latest ERBE brochures Bipolar Coagulation Forceps 20739 061 20739 017 20739 062 Bipolar coagulation forceps are connected to the bipolar outlet 2 of the Ophthalmobipolar E and can be activated with the footswitch The wide range of uses of bipolar coagulation forceps both in dissection and in the coagulation of tissue necessitates a variety of types of forceps all of which however are basically of the same design The blades of the forceps are insulated with a coating of electrically nonconductive plastic to prevent inadvertent coagulations in the orbity Bipolar coagulation forceps can be connected to the Ophthalmobipolar E with a 3 0 m electrode cable The bipolar coagulation f
4. Ophthalmobipolar E User Manual RBE OPHTHALMOBIPOLAR E 11 1998 OPHTHALMOBIPOLAR E User Manual ISO 9001 EN 46001 oia Instruction manual no 80172 001 Ophthalmobipolar E no 10739 002 All rights reserved for this instruction manual particularly the right of reproduction and distribution as well as translation No part of this instruction manual may be reproduced or processed using electronic systems copied or distributed in any form by photocopy microfilm or other method without the previous written agreement of ERBE Elektromedizin GmbH The information contained in this instruction manual may be changed or supplemented without previous notification and represents no obligation on the part of ERBE Elektromedizin GmbH Printed by ERBE Elektromedizin Printed in Germany Copyright ERBE Elektromedizin GmbH T bingen 1998 Contents Chapter 10 Intended use Technical Data Meaning of the safety instructions 244uss4r nn nnnnnnennnnnnnnnnnnnnnnnnnnennnnnnnnnnnn nn 7 Inspection on Delivery and Installation of the Unit uu nennen 8 Operating Elements ruir ne nr een 11 Description of Accessories u2440uunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnen nenn 13 Performance Testini aeeoea oiai e Ga aaa EO aa EE E 15 Safety of High Frequency Surgery uuuunseesssseensnnnnnnsnnnnennnnnnnnnnnnennnnnnnnnnn nn 16 Maintenance of the Unit and the Accessories
5. ation the surface of a bipolar forceps is invariably moistened with body fluid After the procedure while the forceps are not being used the body fluid dries on the surface of the forceps and leaves an electrically nonconductive film If the forceps are used again before they have been 17 18 Pacemaker cleaned the flow of HF current will be inadequate especially if the tissue is dry It is therefore advisable to wipe off bipolar forceps between coagulations with a sterile wet cloth When one is done using them bipolar forceps should be treated as described in the section on cleaning disinfecting and sterilizing accessories Please note During high frequency surgery the patient must not come into contact with electrically conductive objects the operating table mountings wet cloths etc A thick dry electrically nonconductive pad must be laid between the patient and the operating table and mountings This pad must not become moist during high frequency surgery IIS FIT WI TWIT IAS Tt IIPS 4 Areas of the body that perspire freely arms laid at the sides of the trunk and skin in contact with skin should be insulated by interposing dry towels When injection cannulae are used as ECG electrodes the metal cones must not lie on the skin the same applies to leads to monitoring instruments as well The leads to the bipolar high frequency electrodes should be as short as possible and without loops and should be laid so
6. ed damage in transit a complaint should be lodged at once with the carrier and a certificate of damage should be prepared to secure the recipient s rights of recovery the certificate should contain the date of delivery the type and serial numbers of the instrument delivered and a description of the damage The original packaging should be kept till the end of the warranty period so that if necessary the instrument can be returned in it The instructions pertaining to installation in Chapters 6 Precautions against fire and explosion and 7 Precautions against damage of the unit must be followed TheOphthalmobipolar E ophthalmosurgical unit must be connected to a properly installed shock proof socket by means of mains cable supplied by the manufacturer or of the same quality as those supplied by the manufacturer For safety s sake multiple sockets and extension cords should not be used if at all possible When their use cannot be avoided these too should have proper earthing contacts OPHTHALMOBIPOLAR E gt o ooog 1 Mains switch Socket for Bipolar Coagulation Electrodes and Forceps a gt U N YS Output Preset less 4 Output Preset more 5 Output Display 6 IEC Symbol type BF 7 Symbol for Danger see Accompanying Documents 10 ERBEBUS 230V TO AA 115V T1 0A i Dooe Electric Mains Connection Mains Safety Fuses Name Plate on
7. ent is activated with the pedalswitch an acoustic signal sounds Whether high frequency current is present at the bipolar outlet can be checked with a wet sponge If the generator is functioning properly steam will be produced as soon as the tips of the bipolar forceps touch the sponge 15 CHAPTER 6 Risks and Safety of High Frequency Surgery 16 WARNING IN General notes 1 Patients should be prevented from touching metal parts that are earthed or have an appreciable earth capacitance operating table mountings etc The use of antistatic towels is recommended for this purpose 2 Skin with skin contact e g between a patient s arms and trunk should be avoided e g by interposing dry gauze 3 When simultaneously performing High Frequency Surgery and using physiological monitoring devices on a patient any monitoring electrode should be attached as far from the surgery electrodes as possible Needle electrodes for monitoring are not recommended The use of monitoring electrodes with HF current limiting provisions is recommended in all cases 4 The leads to the surgery electrodes should be routed such that they touch neither the patient or other leads Temporaly unused Active electrodes should be positioned such that they are not touching the patient 5 Use of the bipolar technique is sometimes indicated for surgery on body parts with comparatively small cross sections to prevent inadvertent coagulation 6 O
8. er turning the power off briefly and back on again the intensity can again be preset and the unit activated 11 High frequency surgical instruments always produce sparks on their active electrodes while in operation For this reason one must be careful not to use flammable or explosive anesthetics skin cleaners oil removers or disinfectants during high frequency surgery At all events before a high frequency surgical instrument is switched on such agents should be removed from the area of the active electrode or allowed to evaporate entirely The same holds for gauze bandages and dry triangular swabs Important notes on bipolar surgery Bipolar surgery is expecially well suited for the thermal coagulation of blood vessels i e for hemostasis When it is performed for this purpose the following complications can occur During a coagulation procedure the coagulum may stick more or less firmly to the tips of the bipolar forceps so that when the electrode is removed the coagulum is detached in part or in its entirety from the surrounding tissue and the blood vessel is reopened Adhesion results primarily from the ther mal conversion of collagen into glucose and the rapid dessication of the coagulum which will contain a greater or less amount of glucose To prevent or at least to minimize adhesion the HF current should be switched off as soon as there is a large enough coagulum especially as there is no benefit to be gained from
9. id only when the warranty certificate has been properly completed The warranty covers free repair of the unit provided that the deficiency has been caused by material or manufacturing faults Other claims particularly claims for compensation are excluded Repairs may only be performed by the equipment s manufacturer or by authorised service agents Claims under warranty are invalidated if improper modifications or repairs have been undertaken Repair work performed under warranty neither extends nor renews the warranty 25
10. l documentation will be provided to authorized persons Before changing the fuses remove the mains cable from the Mains Connection Socket 8 Remove the caps of the fuses by turning anticlockwise with a screw driver or a coin Replace the fuses and tighten the caps by turning clockwise Connect the mains cable to Socket 8 The mains safety fuses must only be replaced by fuses according to the values pretended on the Name Plate Obsolete equipment and accessories can be disposed of wherever electronic waste products are accepted for processing CHAPTER 10 Service and Warranty Transport damage Equipment warranty Service In order to prevent accidental injuries due to faults occurring in or to failures of the equipment or of any of its accessories the equipment and all of its accessories should be regularly checked for proper and safe operation These checks should be performed exclusively by personnel whose knowledge training and practical experience qualifies them to perform such checks A maintenance contract with ERBE is thus advisable after the warranty period Warranty The unit and accessories must be inspected immediately on receipt for deficiencies and transport damage Claims for compensation can only be enforced when the seller or carrier are notified without delay A damage report must be compiled The warranty period for the unit is 1 year from the date of delivery Claims under warranty are val
11. l else fails tissue that is burned onto an active electrode should be removed carefully with fine metal wool The electrodes can be sterilized by steam at temperatures of up to 134 C 19 20 Footswitches Because the risk of fire or explosion footswitches that are not explosion proof should be cleaned only with soap suds or other nonflammable agents The surfaces of explosion proof footswitches can be disinfected with ordinary disinfectants CHAPTER 8 Technical Data Line Voltage and Frequency Line Fuse Class according to EN 60601 1 Output Type according to EN 60601 1 Power Consumption LF Leakage Current from ground from housing from bipolar output Max Spitzenausgangsspannung HF Output Rated Frequency Output Adjustment Acoustic Signals HF Surgery On Signal Error Optical Signals Activation of HF Output Measurements Weight Aussetzbetrieb Conditions for transport and storage ambient temperature air humidity relative Conditions for operation ambient temperature air humidity relative 230 V 10 50 60 Hz TO4A I BF max 90 W max 0 5 mA max 0 1 mA max 0 1 mA 160 Vp 40 W bei 75 Ohm 2 2 MHz Continuously from 0 bis 100 Continuous tone Three tone sequence Modulated tone 1 Signal Lamp By footswitch W x H x D 230 x 100 x 330mm 6 0 kg 10 Sek on 30 Sek off 25 40 C 70 C 30 95 10 C 40 C 30 75 non condensi
12. ng 21 Intensity 50 and 100 HF Output Power Leistung Einstellbereich bei 75 ohm Lastwiderstand 22 CHAPTER 9 Service Safety Inspections Servicing of the instrument including accessories comprises preventive and corrective measures for keeping the instrument in good working condition This the safety inspections which be performed regularly are preventive measures modifications and repairs fall under the heading of corrective servicing The purpose of regular servicing is to keep the instrument including all reusable accessories in the satisfactory condition defined by the ratings and to ensure the operability and safety of the instrument at least until the next servicing date The regular performace of safety inspections can prevent accidents that can occur as a result of the aging wear or malfunction of medicotechnical instruments The Ophthalmobipolar E ophthalmosurgical instrument must be inspected at least once a year for compliance with safety regulations The following norms are pertinent to the performance of the safety inspections e EN 60601 1 e EN 60601 2 2 Safety inspections of the Ophthalmobipolar E must include in particular e Visual inspection for defects in the instrument and accessories e Test of gr
13. orceps and the cable can be autoclaved at temperatures of up 134 C 13 Bipolar Coagulation Probes 20790 060 Se 20750 064 20738 054 20738 028 Bipolar endocoagulators with or without an unfusion aspiration connection are available for intra ocular coagulation in retonal hemorrhage Bipolar probes with or without an infusion connection are available for scleral coagulation preparatory to opening the anterior chamber Bipolar rather than monopolar coagulation should be performed whenever possible Footswitch Either of two footswitches of ERBE can be used to activate high frequency output Explosion Proof Footswitch 20711 008 Non Explosion Proof Footswitch 20711 009 This pedal may be used only where there is no risk of explosion The agents used to clean and disinfect the pedal switch must be nonflammable and non explosive e g soap suds 14 CHAPTER 5 Performance Test Before every use the operability of the instrument should be checked as follows Mains switch When an Ophthalmobipolar E ophthalmosurgical instrument is properly connected to an a c mains supply with the mains cable supplied with the instrument the signal lamp in the mains switch should light up when the switch is on Output of the bipolar generator To test the output of the bipolar generator connect the bipolar forceps to the generator and set the generator at maximum output When the bipoar high frequency curr
14. ound lead in accordance with EN 60601 1 e Test of insulation e Test of leakage current in accordance with IEC 601 1 e Performance test e Test activation of HF output with the footswitch e HF output test e Measurement of current consumption with and without load In the event that defects are discovered by a safety inspection that could endanger patients employees or third persons the instrument must not be used until such time as these defects have been corrected through expert servicing Dies gilt als erf llt wenn die konstruktiven und funktionellen Merkmale nicht sicherheitsmindernd ver ndert wurden Modifications and repairs must not diminish the safety ofthe instrument or 23 24 Modifications and Repairs Changing the Mains Safety Fuses WARNUNG IN Obsolete equipment accessories for patients the user or third persons This conditions is satisfied so long as the structural and functional characteristics of the instrument are not altered so as to diminish its safety In view of the special safety requirements in HF surgery modifications and repairs may be performed only by the manufacturer or by persons expressly authorized by the manufacturer to perform repairs Should either the instrument or the accessories be modified or repaired incorrectly by an unauthorized person the manufacturer will not be liable for any resulting damages and all rights under the warranty are nullified If necessary technica
15. polar E ophthalmosurgical unit must be connected to a correctly installed grounded socket by means of a mains cable supplied by the manufacturer or comparable to those supplied by the manufacturer i e bearing a national seal of approval As a safety precaution multiple sockets and extension cords should not be used if possible If used they should be properly earthed The device is protected by two super surge proof fuses In the event that either of these fails an authorized technician should check the unit before it is put into service again The type plate fixed to the bottom of the instrument lists the most important ratings of the Ophthalmobipolar E Other ERBE instruments can be linked here to the Ophthalmobipolar E with a short cable This outlet is not protected by a fuse 11 12 Equipotential Boning Pin 13 Loudspeaker 14 Volume Control 15 Connection for Pedal Switch 12 WARNING IN 16 ERBEBUS CAUTION IN The Ophthalmobipolar E can be connected to the ground terminal in the operating room by means of the earthng line supplied with each unit The connection is marked with this symbol v The Ophthalmobipolar E produces an acoustic signal during activation of the high frequency generator the volume of the signal is adjustable by a screw driver Amplifies acoustic signals A pedal switch is connected to this socket High frequency current for bipo lar coagulation can be switched on with
16. prolonging the duty cycle after coagulation has occurred Further one must take care that the bipolar forceps and eletrodes are always clean i e that there are no remnants of tissue from revious coagulations clinging to the surfaces of the electrodes Adhesion is most apt to occur when even fairly dry tissue is coagulated Before coagulation it is wise to moisten dry tissue with sterilized water or physiological saline Blood that flows during hemostasis from the vessel that is to be coagulated is unsuited for this purpose since it too will coagulate during the procedure Should a forceps or electrode stick to the coagulum despite these precautions it is better to switch off the current and wait a few seconds than to try tearing the forceps or elctrode free Fluids from tissue surrounding the coagulum and the will flow through capillary action to the surfaces between the coagulum and the tips of the forceps and dissolve the adhesion In a pinch a drop of sterile water or phsiological saline may help If the high frequency output is set too high during bipolar coagulation the intensity of the HF current flowing between the tips of the bipolar forceps and through the coagulum will be so great as to cause a sudden sharp rise in the temperature of the tissue vapour pressure will be generated which is strong enough to burst the coagulum as if by explosion This undesirable effect is easily prevented by setting the HF output correctly During coagul
17. the bottom of the unit Mains Outlet Mains Outlet Loudspeaker Volume Control Pedal Switch Socket ERBEBUS Interface CHAPTER 3 Operating Elements 1 Mains Switch 2 Socket for bipolar Coagulation Forceps and Electrodes 3 4 Output Preset Buttons 5 Output Display 6 IEC Symbol BF 7 Symbol for Danger See Accompanying Documents 8 Mains Connection 9 Mains Safety fuses 10 Type Plate 11 Mains Outlet WARNUNG IN The Ophthalmobipolar E is operative as soon as the mains switch is actuated The green lamp in the mains switch signals that the device is operative Should the signal lamp go out after actuation of the mains switch either there is no power or the mains fuse is defective Hier k nnen sowohl bipolare Pinzetten Bipolarstifte als auch intraokulare Elektroden angeschlossen werden Display 5 reads 00 when the device is switched on The output can be increased by pushing button 4 A too high a preset output can be reduced by pushing button 3 The intensity of the output is shown as a percentage of the maximum output This display continuously shows the value of the preset output The Ophthalmobipolar E is a BF unit by the standards of IEC 601 Part 1 This means that the patient can be defibrillated safely and that the neutral electrode therefore can remain on patients during defibrillation The operating instructions must be read before initial operation The Ophthalmobi
18. utput should be set at the lowest value sufficient for one s purpose 7 The use of flammable anesthetics e g laughing gas N 0 and oxygen should be avoided during surgery in the areas of the thorax and head unless these gases can be pumped off or an instrument approved for use with anesthetics is to be used Flammable cleaners disinfectants and solvents for adhesives should be allowed to evaporate prior to HF surgery Flammable liquids are apt to collect under a patient or in bodily depressions or cavities e g navel vagina Liquids that have collected in these places should be wiped up before a HF instrument is used Surgeons are also warned of the risk of igniting endogenous gases Such materials as cotton wadding and gauze if saturated with oxygen can be ignited by the sparks that occur even when HF surgical instrument is used correctly 8 In patients with pacemakers or pacemaker electrodes there is a risk of a disturbance of pacemaker function or of the pacemakers being damaged When in doubt one should consult the cardiology department 9 Use of a HF surgical unit is apt to interfere with other electromedical units 10 The unit is equipped with elecronic sagety functions wich can be triggered by severe disturbances in the power supply and which can reset the unit to Adhesion Burst Coagulum Absence of the Coagulation Effect stand by operation with the intensity 00 Audible alarms can be issued as a result Aft
19. xplosive agents Care should be taken not to allow moisture to enter the instrument Should one have no choice but to use a flammable or explosive agent this agent must be completely evaporated before the instrument is switched on Maintenance of the accessories To prevent premature wear of the accessories the following steps are advised Always handle and store bipolar electrodes in such a way that they will not be damaged Store bipolar coagulation forceps in such a way that the tips will not be damaged These forceps are best stored and transported in a special sterilization container Forceps with insulated blades should not be cleaned or stored with other hard or pointed instruments as this may damage the insulation Bending the blades of the forceps apart may cause the insulation to split Do not carry the footswitch by its cable Do not wind the cable tightly around the footswitch Cable and Plug Do not kink or fold the cable or wind it tightly Never remove a plug from the Ophthalmobipolar E by tugging sharply on the cable pull on the shaft of the plug Bipolar Active Electrodes Remnants of tissue and dried on body fluids should not be scraped off electrodes with any hard sharp object such as a scalpel scissors or a knife This could damage both the insulation and the contact surfaces of the electrodes Dried on tissue or body fluids usually can be softened in warm water and then easily wiped off with soft towels If al
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