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Geister ESU-X 500 TT User Manual
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Geister ESU-X 500 TT User Manual

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U
M
SER
ANUAL FOR
ESU-X 500 TT (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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Summary of Contents for Geister ESU-X 500 TT

  • Page 1 ANUAL FOR ESU-X 500 TT (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 INTRODUCTION AND DIRECTIONS OF USE - Physical and electrical principles of HF currents – Related risks When electrical currents flow across biological tissues, they produce 3 effects: Electrolytic, Faradic and Thermal. By applying a current, with frequency higher than 300kHz (named HF current), the electrolytic / faradic phenomena either disappear or are very limited and the thermal one remains.
  • Page 3 These units are intended to be used for GYNAECOLOGY, ORTHOPAEDICS, ORL, UROLOGY, MAXILLOFACIAL SURGERY, DERMATOLOGY, PLASTIC SURGERY, VASCULAR SURGERY, GENERAL OR THORACIC SURGERY, PAEDIATRIC SURGERY, EMERGENCY SURGERY, GASTROENTEROLOGY, VETERINARY AND OTHER. BASIC WARNINGS The HF electrosurgical units are basic to solve many surgical needs, but the use of the HF currents also causes specific risks and undesired side effects.
  • Page 4 ELECTRO‐MAGNETIC INTERFERENCES The unit complies with all EMC standards, but it can, mainly during the monopolar use, damage the functioning  Other devices used in O.T. (i.e. monitoring devices, video‐cameras, and so on). To reduce this problem, connect the ESU to a mains socket different from that used to supply these devices and, if necessary, ask for qualified technical assistance.
  • Page 5  Remember that, mainly when high powers are used, if a “Split” NE is not used, the control circuit of the unit can’t verify the contact between the NE and patient’s tissues; that is, it does not guarantee the intended safety. ...
  • Page 6 CHECK OF THE BIPOLAR INSTRUMENT BEFORE THE USE  Set a coagulation current (20/30)  Wet a gauze with physiological solution, and hold it without touching the wet part.  Touch the wet gauze with both ends of the instrument and activate the delivery. The smoke produced signals the good functioning, otherwise check the connecting cable, the connections among different parts of the instrument and the insulation of the ends For example the damage of the insulation of bipolar scissors causes a short circuit which does not allow the current to reach tissues).
  • Page 7  ADC System – Self ‐ control with constant power. The power of these currents is shown, on the touch‐ screen, as Watts regarding the rated load.  ‐ ‐ APC System Self control with constant voltage. The power of these currents is shown, on the touch‐ screen, as effects (10 for each current) and, for each effect, it is also shown the maximum power.
  • Page 8 CURRENTS AND RELATED FEATURES Frequency (F) – Crest Factor (CF) Rated Acoustic and Monopolar Currents Power Load Modulation (M) ‐ Duty Cycle (DT) luminous signals 400 Ω F: 440 kHz ‐ CF: 1,46 ‐ M: 0 ‐ DT: 100% PURE CUT 400 W 2550 Low sound, Yellow light...
  • Page 9 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 10 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 500TT_EN B 01.06.15 cgro cgro 10 von 45...
  • Page 11 NEUTRAL PLATE socket  (When the 7a NP‐1 light is ON) The related socket allows the use of a cable with the standard, European, connector (Jack Ø6,35 mm).  (When the 7b NP‐2 light is ON) The related socket allows the use of a cable with the American connector “Valleylab”...
  • Page 12 MONOPOLAR – 2 socket  When the 4a HAND‐SWITCHED light is ON. It allows the use of a hand‐switched handle or instrument. The socket allows the use of accessories with the connector “3 pins ‐ international type”. BIPOLAR – 1 and BIPOLAR ‐2 sockets ...
  • Page 13 TOUCH SCREEN GENERAL IMAGE In this case the unit allows the use of the monopolar and bipolar currents. standby key – It allows the selection of the STANDBY mode. See the paragraph STANDBY menu key – It allows the selection of the GENERAL MENU of functioning. See, in the next page, the paragraph GENERAL MENU.
  • Page 14 SECTION: SOUND By rotating the control when the BEEP is ON, users can change the level of the sounds which signal both the delivery of currents and the use of keys. All acoustic alarm signals are fixed, not adjustable. SECTION: BEEP ON/OFF By pushing the key, users can set the acoustic signal of the keys on the panel.
  • Page 15 The unit stores the detected error codes to help the Technicians in finding a solution for the problems. The procedure to perform the related control is detailed in the Service Manual. BECAUSE OF THE PREVIOUS REASONS, DURING THE USE Users must not both increase too much the power and think that the problem depends on the unit: ...
  • Page 16  It informs users by an alarm signal (HF LEAKAGE light ON). CONTROL CIRCUIT OF THE NEUTRAL ELECTRODE The unit is provided with a control circuit which allows the users the following:  The use with electrodes for adults (Dimensions of, at least, 136 cm 2). ...
  • Page 17  If the cable is broken. The circuit operates as follows: POWER MAXIMUM CABLE ALARM SIGNALS DELIVERY DELIVERED POWERS Acoustic Visual Mode LARGE Mode SMALL Well connected. Not limited. Max.150W. Lights 1, 2, 3, 4 Broken. Continuous Symbols EL and Power Power Not connected...
  • Page 18 The circuit operates as follows: CONTACT POWER MAXIMUM ALARM SIGNALS Electrode/Tissues DELIVERY DELIVERED POWERS Acoustic Visual Mode LARGE Mode SMALL Good. Not. Yes. Not limited. Max.150W. Light 1 ON. (1) Fairly good. Not. Symbols EL and Yes. Not limited. Max.150W. ES OFF.
  • Page 19  If surgeons press two pedals simultaneously, the self‐check system of the unit blocks the power delivery and it informs users by an acoustic alarms with and additional visual information (Error code Simultaneous handle or pedal activation). The unit allows the users the choice of four modes to use the foot‐switches: ...
  • Page 20  The unit allows the fast selection of a program before use.  The unit includes 15 memories for the bipolar use only, without the neutral electrode.  The unit includes some programs with a specific presetting to facilitate their use. ...
  • Page 21 The memory number stops blinking (See the following paragraph):  When users, during the first setting of a memory, memorize the settings.  When users, during use, either cancel or memorize the changes of setting. CANCELLATION OR MEMORIZATION OF THE CHANGES OF SETTING Whenever users like, they can both change settings and cancel or memorize the changes.
  • Page 22 MONOPOLAR CUT AND COAGULATING CUT MONOPOLAR COAGULATION BIPOLAR COAGULATION AND VESSEL‐SEALING BIPOLAR CUT Users, to set the currents of each section, have to do the following Users can set a corrent only.  By the CS keys, select the current. ...
  • Page 23 Currents with APC System Currents with ADC System In this case the power is shown as follows: In this case the power is shown as follows: Effects (10 for each current) and PWR. Watts in relation to the rated load. PWR = Max power deliverable for each effect.
  • Page 24 Memorization of the setting When arranging one program only.  By the 4 key, memorize the setting of the memory. The memory number stops blinking. When arranging more programs.  By the 4 key, memorize the setting of the first memory. The memory number stops blinking. ...
  • Page 25 To change the MONOPOLAR PURE CUT current, do the following:  Push the PS keys on the panel. On the area (1) the watts change. To change the AUTO PURE MICRO current, do the following:  Push the PS keys on the panel. On the area (1), the following changes: The effects (from 1 to 10) and the PWR (max.
  • Page 26  BIP word by digital speech, BIP 1 image ON for 2 seconds on the touch‐screen. (1b – BIP light) of the PEDAL‐1 socket ON.  Use of the foot‐switches 34-9333 and 34-9331.  The monopolar currents are activated by the 34-9333, the bipolar ones by the 34-9331. When connecting both foot‐switches, the unit selects this mode automatically.
  • Page 27 AUTO PURE MICRO ‐ Current for delicate cut without coagulating effect. It is suitable for the following:  For the same uses of the PURE CUT current (starting from the effect nr. 6) when users prefer a more delicate effect. AUTO BLEND CUT MICRO ‐...
  • Page 28 AUTO SOFT MICRO BICOAG ‐ Current identical to the SOFT MICRO BICOAG, with automatic “impedance sensing” start/stop. The delivery starts, with a delay adjustable form 0,1 to 5 seconds in the GENERAL MENU (Section 2.6), when the ends of the instruments come in contact with damp or bleeding tissues. The delivery stops either when the surgeon opens the ends of the instrument or when tissues are coagulated.
  • Page 29  To reduce the, well known, phenomenon of the sticking of the tissue on the tips of instruments: See the par: STICKING OF THE TISSUE ON THE TIPS OF THE BIPOLAR INSTRUMENTS FOR COAGULATION.  To check the functioning of the bipolar instruments when starting the operation: See the par: CHECK OF THE BIPOLAR INSTRUMENTS BEFORE THE USE.
  • Page 30  “BLEND CUT 2”: current for the cut with very strong coagulating effect. It is suitable for the polipectomy (starting from 25/40 in case of small polyps)(starting from 40/60 in case of larger polyps) .  “BLEND CUT PULSED”: current identical to the BLEND CUT 1 current, but provided with a pulsed delivery which allows the users the better control of the cut phase.
  • Page 31 The unit can be used by 1 or 2 twin foot‐switches (See the paragraph USE OF THE FOOT‐SWITCHES”). The unit, for this endoscopy, is normally used by the 34-9333 model which is provided with a foot selector to activate either the monopolar currents or the bipolar currents. ...
  • Page 32 See the TABLE I of the paragraph SELF‐CHECK SYSTEM where the complete operation of the self‐check system is detailed. Use for the, in saline, endoscopy and arthroscopy of the bipolar currents (MEMORIES FROM 85 TO 92) These memories allow the delivery of the only currents suitable for this use: The SALINE current for cut and the SOFT MICRO or FORCED MACRO currents for coagulation which usable by a foot‐switched bipolar accessory: a resectoscope, another instrument (for example a flexible, 5Cr, needle for gynaecology) and an instrument for arthroscopy.
  • Page 33 TURVis or GYNAECOLOGY with normal resectoscopes SALINE URO‐GYN CUT: Effect 4/7 Wire loop / Ribbon loop. (Continuous delivery or Pulsed delivery) COAGULATION Wire loop / Ribbon loop. SOFT MICRO BICOAG: 125 COAGULATION Ball / Roll SOFT MICRO BICOAG: 125 SALINE URO‐GYN CUT: Effect 8 (Continuous delivery) VAPORIZATION Ball / Roll SALINE URO‐GYN CUT: Effect 3/5...
  • Page 34 CONNECTION AND USE OF THE FOOT‐SWITCHES The unit can be used by 1 or 2 twin foot‐switches.  The standard 34-9333 model (On request it is also available the large 34-9332 model for endoscopy) provided with a foot selector to activate either the monopolar currents or the bipolar currents. ...
  • Page 35  The current is not suitable for the laparoscopic surgery since the automatic start/stop is not safe in this case. SEALING ‐ Current, to coagulate/seal vessels with diameter up to 8 mm, with activation by foot‐switch and automatic “impedance sensing” stop. It is suitable, in open or laparoscopic surgery, to use clamps with jaws from 3 to 10 mm.
  • Page 36 During the use, in case of breakages, problems or mistakes of use, the self‐check system stops the power delivery and it informs users by acoustic and visual signals. In case of immediately solvable problems, users can intervene to eliminate causes. For other signals users can switch the unit OFF/ON to verify them and ask for technical assistance.
  • Page 37 RD/5 UNIVERSAL ADAPTOR FOR MONOPOLAR CABLES. The adaptor allows the connection of all kinds of plugs:  IMAGE 1: The MARTIN (Similar cables) with plug diameter 4 mm. can be connected.  IMAGE 2: The cables with plug having a diameter from 2 to 4 mm. can be connected.
  • Page 38 According to the article no. 13 of the Legislative Decree no. 151 dated 25th July 2005 “Fulfillment of the Directives 2002/95/CE, 2002/96/CE and 2003/108/CE, for the reduction in the use of dangerous substances in electric and electronic devices, as well as for the waste disposal”: The symbol on the left is present either on the unit or on its packaging and it indicates that the product must be separately disposed of.
  • Page 39 DIAGRAMS OF THE MONOPOLAR CURRENTS Values measured within 3 seconds, by excluding the transients lower than 1 second, as established in IEC 60601‐2‐2. With regard to the powers, we stress the following:  The allowed tolerance is 20% for the powers higher than the 10% of the maximum power of the current.
  • Page 40 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 500TT_EN B 01.06.15 cgro cgro 40 von 45...
  • Page 41 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 500TT_EN B 01.06.15 cgro cgro 41 von 45...
  • Page 42 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 500TT_EN B 01.06.15 cgro cgro 42 von 45...
  • Page 43 DIAGRAMS OF THE BIPOLAR CURRENTS Values measured within 3 seconds, by excluding the transients lower than 1 second, as established in IEC 60601‐2‐2. With regard to the powers, we stress the following:  The allowed tolerance is 20% for the powers higher than the 10% of the maximum power of the current.
  • Page 44 Dateiname mit Revisionsstand: erstellt am: erstellt von: geprüft von: freigegeben von: Seite ESU-X 500TT_EN B 01.06.15 cgro cgro 44 von 45...
  • Page 45 Accessories ELECTRODES-HOLDER HANDLES (nominal voltage: 4000 V) 34-9524 Electrodes-holder handle (electrodes with stem Ø 2,3/2,4 mm) with hand-switches, reusable 100 times 34-9525 Electrode Holder 3.5m cable 34-9526 Electrodes-holder handle (electrodes with stem Ø 2,3/2,4 mm) with cable 3.5m long Ø4 mm cm 18 ACTIVE ELECTRODES STANDARD SERIES (Nominal voltage: 4000 V)