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Geister ESU-X 300 NT User Manual

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U
M
SER
ANUAL FOR
ESU-X 300 NT (CL II B
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
Non sterile
Batch code
Catalogue number
Prescription - U.S. federal law restricts this device to sale by or on the order of a
physician or properly licensed practitioner
Protect from rain
Do not expose to sunlight
GEISTER Medizintechnik GmbH
Tel +49 (0) 7461 966 240
|
Fax +49 (0) 7461 966 24 22
ACCORDING TO
|
Föhrenstrasse 2
|
D-78532 Tuttlingen
|
Mail info@geister.com
CEE 93/42)
|
Germany
|
www.geister.com

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  • Page 1 ANUAL FOR ESU-X 300 NT (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...
  • Page 2 MEMORY MONOPOLAR BIPOLAR PURE FULG PURE MICRO COAG COAG ALARM BLEND 1 PIN POINT BLEND AUTO BLEND 2 SOFT MACRO MODE MODE MODE MODE ENDO SPRAY MONO HF LEAKAGE MONO Control devices, Connection sockets, and Symbols Alarm Led for the neutral plate safety circuit (red) Area for memories setting (storage key and selection/shifting keys Area of selection...
  • Page 3 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.
  • Page 4 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.
  • Page 5 and a decrease of the output power into the application point (which leads the operator to raise it, dangerously); Never exceed 1/3 of the max. output power for each monopolar current when using the paediatric neutral electrodes, or 1/5 when using the electrodes for babies; Use the disposable neutral electrodes only once, by paying attention to the instructions on the packaging.
  • Page 6 DATA STORING AT THE SWITCHING ON When switched on, or after a temporary leak of current: The unit always stores all the settings/regulations used when switched off (see also Par. “PROGRAMS AND MEMORIES”); The unit does not keep the selection of the bipolar coagulation AUTO, and it automatically sets the coagulation MICRO.
  • Page 7 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);...
  • Page 8 Alternatively, two active electrodes (two handles, or one handle and one forceps for coagulation, or other), both of them by foot-switches (This mode is possible by selecting the pre-set programs 6 and 7 “See Par. “PROGRAMS AND MEMORIES”); !!! BIPOLAR FUNCTIONING !!! The unit can always be used for the bipolar functioning.
  • Page 9 Use cutting electrodes (blade, needle, Hook type, or the external part of the dissector, in laparoscopy) from 30- 40W. COMBINATED CUT (CUT ALTERNATED TO COAGULATION) (ENDO) – For flexible endoscopy with cutting phases alternated to coagulation phases This is a constant voltage current and it is controlled by an automatic power self adjustment system (APC System) according to the characteristics of the tissues.
  • Page 10 “SOFT” COAGULATION – Low superficial sparkling effect, and good deep coagulating effect This current guarantees a good deep coagulating effect, and a very low superficial coagulating effect.. It is suitable for coagulations performed or by forceps/surgical instrument or touching the tissues by an active ball electrode of 4-5mm at least. 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.
  • Page 11 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 300NT_EN B 18.04.2018 ssta cgro cgro 11 von 35...
  • Page 12 FUNCTIONING FOR THE FLEXIBLE ENDOSCOPIC SURGERY In order to favour this kind of use, the unit is equipped with 1 specific pre-set program (See Par. “PROGRAMS AND MEMORIES”, program 8), where the following features are already memorized: Activation mode and output available In this program are not set output powers or currents for the normal monopolar use because this choice depends on the operator.
  • Page 13 Use the flexible electrodes of the endoscopes, from 20-30W for the papillotomy, from 20-30W for the polipectomy with polypus  5mm, and from 40-50W for polypus  6mm or more. COAGULATING CUT (BLEND-2) – Not suitable at all. COMBINATED CUT (CUT ALTERNATED TO COAGULATION) (ENDO) – For flexible endoscopy with cutting phases alternated to coagulation phases This is a constant voltage current and it is controlled by an automatic power self adjustment system (APC System) according to the characteristics of the tissues.
  • Page 14 “SOFT” COAGULATION AT LOW VOLTAGE – Low superficial sparkling effect, and good deep coagulating effect This current guarantees a good deep coagulating effect, and a very low superficial coagulating effect. It is suitable for coagulations performed or by forceps/surgical instrument or by touching the tissues with an active ball electrode of 4-5mm at least.
  • Page 15 FUNCTIONING FOR THE UNDER LIQUID ENDOSCOPIC SURGERY (TUR, TURP, TURV, etc.) In order to favour this kind of use, the unit is equipped with 1 specific pre-set program (See Par. “PROGRAMS AND MEMORIES”, programs 8), where the following features are already memorized: Activation mode and output available for the connection of the resectoscope In this program are not set output powers or currents because this choice depends on the operator.
  • Page 16 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 MODE, select the current BLEND-1, then adjust the power with the regulation keys UP/DOWN;...
  • Page 17 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 MODE, select the current SPRAY, then adjust the power with the regulation keys UP/DOWN;...
  • Page 18 Impossibility to use the monopolar currents (the displays for the monopolar currents powers are switched off); 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;...
  • Page 19 CURRENTS FOR COAGULATION “MICRO” COAGULATION – Very soft coagulating effect This is a constant voltage current and it is controlled by an automatic power self adjustment system (APC System) according to the characteristics of the tissues. It is the most suitable current when operating on extremely delicate tissues (i.e for neurosurgery).
  • Page 20 ADVICE For the Cut: In order to optimize the functioning of the bipolar cut and obtain the perfect cut without any “sticking” of the tissues on the electrode, the above mentioned powers maybe have to be changed through small variations of 10/15W each time.
  • Page 21 PROGRAMS AND MEMORIES The unit is provided with 10 memories (9 programmable memories and 1 for the storage of the data at the switching off), which allow to set 9 complete functioning programs, that can be selected by simply pressing the shifting keys UP/DOWN until the desired memory is chosen.
  • Page 22 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 ). 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.
  • Page 23 Another active electrode, for the normal electro-surgery by hand-switches (connected to the socket 4-B ) pressing the yellow keyl for the pure/coagulating cut and the blue key for the coagulation currents.(See Par. “CONNECTION AND USE OF THE PEDAL FOOT-SWITCHES”); C. !!! BIPOLAR FUNCTIONING !!! The bipolar functioning is always available.
  • Page 24 When the device is turned on, this control system carries out a complete self-test cycle over the hardware and the software (all the Led and displays light up, and the loudspeaker is activated). If everything works properly, this phase ends by a short acoustic signal. If the system detects any problem, the faults are indicated as described above, and the operator must either try to eliminate all the possible causes, or switch the equipment off and ask for a technical assistance.
  • Page 25 Stored code in Error description Error code PROM (select “0d” in CAL mode) 6 slow sound CBUS connection lost (during the use) repeatitions; after fast repeatitions 7 slow sound Master-Slave connection lost (during selftest phase) repeatitions; after fast repeatitions 8 slow sound Slave microcontroller failure repeatitions;...
  • Page 26 Its disposal must be done according to the different National Rules, by bearing in mind that the accessories (notably the active and neutral ones) get in contact with the patients tissues, and therefore require a special attention. CLEANING AND STERILIZATION Clean the unit with a neutral soap solution, by taking care that no liquid goes inside, and then wipe it by a dry cloth.
  • Page 27 BIPOLAR CURRENTS Frequency (F) - Acoustic and Crest Factor (CF) – Modulation (M) - Maximum Load Vp/p CURRENT Luminous Signals Power Duty Cycle (DT) Loud tone, Yellow 310  F: 435 kHz- CF: 1.5 – M: No – DT: no PURE 140 W 840 V...
  • Page 28 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:...
  • Page 29 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 300NT_EN B 18.04.2018 ssta cgro cgro 29 von 35...
  • Page 30 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 300NT_EN B 18.04.2018 ssta cgro cgro 30 von 35...
  • Page 31 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 300NT_EN B 18.04.2018 ssta cgro cgro 31 von 35...
  • Page 32 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:...
  • Page 33 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 300NT_EN B 18.04.2018 ssta cgro cgro 33 von 35...
  • Page 34 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 300NT_EN B 18.04.2018 ssta cgro cgro 34 von 35...
  • Page 35 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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