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ANUAL FOR ESU-X 400 HT (CL II B CEE 93/42) ACCORDING TO Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen / Germany Tel.: +49-7461-96624-0 FAX: +49-7461-96624-22 E-Mail: info@geister.com Read Instruction for use Medical product higher class I and shortcut for Notified Body TÜV SÜD Production 0123 Service GmbH, München, Germany...
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MEMORY MONOPOLAR BIPOLAR PURE FULG PURE MICRO COAG COAG ALARM BLEND 1 PIN POINT BLEND PRECISE BLEND 2 SOFT AUTO MODE MODE MODE MODE A. PURE SPRAY MACRO A. BLEND SEALING A. ENDO MONO BIPOLAR A HF LEAKAGE BIPOLAR B MONO Control devices, Connection sockets, and Symbols Alarm Led for the neutral plate safety circuit (red)
GEISTER MEDIZINTECHNIK GMBH guarantees safety, reliability and performances of this unit only if installation, recalibrations and repairs are carried out, using original spare parts, by personnel authorized by GEISTER and if the unit is used in compliance with given instructions in an area that meets all the applicable IEC or CEI requirements.
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GYNAECOLOGY, HEART SURGERY, ORTHOPAEDICS, NEUROSURGERY, OTORHINOLARYNGOLOGY, UROLOGY, MAXILLOFACIAL SURGERY, DERMATOLOGY, PLASTIC SURGERY, VASCULAR SURGERY, GENERAL AND THORACIC SURGERY, PAEDIATRIC SURGERY, EMERGENCY SURGERY, GASTROENTEROLOGY, VETERINARY, AND OTHER. GENERAL PRECAUTIONS – It is dangerous to ignore the following warnings! Every electro-surgical unit has its own characteristics and therefore, before using it, it is advisable to check its functioning, without taking into consideration the previous experiences with other devices only.
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Fix it in a reliable way, without placing anything in-between, nor pressing too much, in order to avoid ischemic zones. Establish the best possible contact over the entire surface, and make sure it remains constant, especially if the patient is moved or when liquids are poured. As a matter of fact, a non homogeneous and/or insufficient contact of the neutral electrode generates both an increase of the current density in the contact points (which produces a higher temperature into the tissues, and creates burns), and a decrease of the output power into the application point (which leads the operator to raise it,...
When the contact further decreases, the circuit completely stops the delivery of the power, by giving a luminous alarm signal (The Red Led is lit, Error Code “no Np”) and also a buzzer (loud, intermittent). When only the memories for the bipolar use (it does not require any neutral electrode) are selected (memories from 96 to 99), the circuit does not intervene (the 3 Led are lit, but only to show that the electrode is not connected).
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The monopolar functioning requires the use of two electrodes (an active one, and a neutral one). The current flows from the active electrode towards the neutral electrode, so that the process concerns all the tissues around the specific point where the active electrode operates. For the use with HF currents in open sky surgery or in laparoscopy, the unit can be used: With 1 or 2 electrodes-holder handle/s (they can be both hand-switch type with twin key cut/coag, or just one can be hand-switch type with twin key cut/coag, while the other is normal type for use by twin pedal...
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Just in case of a cable with a different plug from Alsa standard type, ask for: - GEISTER cables, by specifying the model and the instrument connector type - Adaptor (34-9590), for the cables with non insulated plugs from 2 to 8mm, or with insulated plug 4mm);...
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This current is controlled by an automatic system (ADC System) for the self regulation of the functioning, which guarantees that the power selected by the operators remains constant according to the characteristics of the tissues. Control devices to be used (area C): With the selection key, select the current BLEND-1, then adjust the power with the regulation keys UP/DOWN;...
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For the delivery (loud acoustic signal, and yellow Led), press on the yellow pedal of the foot-switch, or the yellow key of the hand-switch handle. Instructions for use, adjustments and electrodes Ideal for flexible endoscopic surgery (i.e. polipectomy or papillotomy). CURRENTS FOR COAGULATION “FULGURATION”...
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With the selection key, select the current SOFT, then adjust the power with the regulation keys UP/DOWN; For the delivery (acute acoustic signal, and blue Led), press on the blue pedal of the twin foot-switch, or the blue key of the hand-switch electrodes-holder handle. It is also possible to deliver the current by simply closing the coagulation forceps, just in case a hand-switch forceps is used.
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FUNCTIONING FOR THE FLEXIBLE ENDOSCOPIC SURGERY In order to favour this kind of use, the unit is equipped with 5 specific pre-set programs (See Par. “PROGRAMS AND MEMORIES”, programs from 91 to 95), where the following features are already memorized: Activation mode and output available In these programs are not set output powers or currents for the normal monopolar use because this choice depends on the operator.
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With the selection key, select the current BLEND-1, then adjust the power with the regulation keys UP/DOWN; For the delivery (loud acoustic signal, and yellow Led), press on the yellow pedal of the twin foot-switch. Instructions for use, adjustments and electrodes Use the flexible electrodes of the endoscopes, from 20-30W for the papillotomy, from 20-30W for the polipectomy with polypus ...
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This current is controlled by an automatic system (ADC System) for the self regulation of the functioning, which guarantees that the power selected by the operators remains constant according to the characteristics of the tissues. Control devices to be used (area D): With the selection key, select the current FULG, then adjust the power with the regulation keys UP/DOWN;...
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This current is controlled by an automatic system (ADC System) for the self regulation of the functioning, which guarantees that the power selected by the operators remains constant according to the characteristics of the tissues. Control devices to be used (area D): With the selection key, select the current SPRAY, then adjust the power with the regulation keys UP/DOWN;...
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B. !!! BIPOLAR FUNCTIONING!!! The bipolar functioning is always possible. See Par. “BIPOLAR MODE”. MONOPOLAR CURRENTS, ELECTRODES, ADJUSTMENT OF THE POWERS, ADVICE CURRENTS FOR CUT PURE CUT (PURE) – Cut without coagulating effect This current is controlled by an automatic system (ADC System) for the self regulation of the functioning, which guarantees that the power selected by the operators remains constant according to the characteristics of the tissues.
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This current guarantees a strong coagulating effect, both deep and superficial. It is suitable for coagulations performed by forceps/surgical instrument and for coagulations performed grazing the tissues by the active electrode. This current is controlled by an automatic system (ADC System) for the self regulation of the functioning, which guarantees that the power selected by the operators remains constant according to the characteristics of the tissues.
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Current BLEND-1, from 90-100W on the prostate, for a cut with soft coagulating effect. For the Cut with ribbon loop electrodes, use as follows: Current PURE, from 160-180W into the bladder or on soft tissues, for a coagulating cut; Current BLEND-1, from 160-180W into the bladder or on soft tissues, for a cut with stronger coagulating effect; Current PURE, from 200-210W on the prostate, for a coagulating cut;...
Impossibility to switch on the Argon section. Activation modes and outputs available according to the different settings Just in case of cables with connection plugs which are different from GEISTER standard type, ask for: - GEISTER cables, by specifying the model and the instrument connector type;...
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120-130W, with the bipolar loop electrodes of the bipolar resectoscope, for soft tissues (i.e. into the bladder); 140-160W, with the bipolar loop electrodes of the bipolar resectoscope (i.e. for TUR). COAGULATING CUT – Cut with coagulating effect This current is controlled by an automatic system (ADC System) for the self regulation of the functioning, which guarantees that the power selected by the operators remains constant according to the characteristics of the tissues.
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For safety reasons, the unit is also provided with an automatic stop control, which is activated after approximately 6 seconds of functioning (if the forceps remains on the tissues, it starts again after a stop interval which is exactly the same as the delay set for the start).
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PROGRAMS AND MEMORIES The unit is provided with 100 memories (99 programmable memories and 1 for the storage of the data at the switching off), which allow to set 99 complete functioning programs, that can be selected by simply pressing the shifting keys UP/DOWN until the desired memory is chosen.
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The activation modes and the outputs available can not be changed, but all the currents and the output powers can obviously be changed by setting the desired levels and by pressing the memorisation key MEM of the area B. The pre-setting of these memories allows to use the unit as follows: With 2 active electrodes: One active electrode or by hand-switches (connected to the socket 3-A) or by foot-switches ( connected to the socket 5-A ).
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In order to activate the different active electrodes shall be pressed (on the handles or on the twin foot switch) the yellow key/pedal for the pure/coagulating cut and the blue key/pedal for the coagulation currents. In order to use two electrodes-holder handles (as above described) at the same time by two different operators, it must be selected a coagulation mode without contact (Fulg or Spray), as stated by the International Safety Rules for the HF electro-surgical equipments (IEC 60601-2-2, par.
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PRE-SET MEMORIES (from 96 to 99) – Use in bipolar mode only. The pre-setting does not concern the current types that have to be used, nor their powers, which have to be set according to the operators’ needs, and therefore memorised as shown at points 3 and 4 of the previous paragraph. The pre-setting of these memories allows to use the unit as follows: A.
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Control of the Error Codes The unit stores the last 32 Error Codes that have been detected, in order to help the operators in finding a solution for the problems/faults. The procedure to follow for this control is detailed into the Service Manual. PROM hexadecimal value corresponding to one of error codes reported on “Error code”...
Stored code in Error description Error code PROM (select “0d” in CAL mode) Err 68 Slave microcontroller connection failed Errors related to HF power section Err 39 Failure in internal dummy load used for selftest Err 51 Failure in HF output current measurement (lower than expected) Err 52 Failure in HF output current measurement (higher than expected) Err 43...
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- The cables and the forceps for bi-coagulation, the cables and the forceps (scissors, cannulae) for monopolar coagulation; - The cables and the monopolar/bipolar electrodes for laparoscopy; - The reusable type neutral electrodes (electrodes and cables) can be sterilized only with cold solutions (i.e. “Amuchina”).
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TECHNICAL FEATURES Electronic generator according to the Standards CEI EN 60601-2-2 (IEC 601-2-2 ed. 1991); General mains switch; Monopolar and Bipolar working frequency: 435Hz +- 10%; Classification CEI/IEC: Class I - Type CF, Classification 93/42 CEI/EEC: IIB; ...
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Conformity EMC/Directive 89/336/CEE: Category A Suggested distances to keep from not vital devices Distance Source of the Current RF Typical Power (W) Microcellular telephones CT1,CT2,CT3 0.01 Mobile telephones DECT, Wireless devices (modems, LANs) 0.25 Mobile telephones (USA) Hand mobile telephones (GSM, NMT, Europe) (DECS 1800) Walkie-talkie (police, firemen , protection, maintenance) Bag mobile telephones...
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MONOPOLAR CURRENTS (Variation of the output power from 50 to 2000Ω by selecting 100% and 50% of maximum power) (Increase in the output power with nominal load according to the power adjustment) (Increase of the Voltage according to the power adjustment). Dateiname mit Revisionsstand: erstellt am: erstellt von:...
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BIPOLAR CURRENTS (Variation of the output power from 10 to 1000Ω by selecting 100% and 50% of maximum power) (Increase in the output power with nominal load according to the power adjustment) (Increase of the Voltage according to the power adjustment). Dateiname mit Revisionsstand: erstellt am: erstellt von:...
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ACCESSORIES ELECTRODES-HOLDER HANDLES (nominal voltage: 4000 V) Electrodes-holder handle (electrodes with stem Ø 2,3/2,4 mm) with cable 3.5m long; Electrodes-holder handle (electrodes with stem Ø 2,3/2,4 mm) with hand-switches, reusable 100 times. Ø4 mm cm 18 ACTIVE ELECTRODES STANDARD SERIES (see next page for details) (Nominal voltage: 4000 V) E 1 - Straight knife electrode...
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