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APPENDIX C

– PART 2

Summary of Contents for Iron Assistant

Page 1: ...INSTRUCTIONS FOR USE IRON ASSISTANT PNEUMATIC ENDOSCOPE HOLDER ...

Page 2: ... von Seite 29 5000 Pneumatik holder_EN C 04 06 12 03 12 2018 ssta cgro cgro 2 von 28 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 Non sterile Medical device Class I Article No 29 5000 ...

Page 3: ...INFORMATION S 5 III ASSEMBLY AND OPERATION S 7 IV CLEANING DISINFECTION STERILIZATION S 11 V PREPARING BEFORE USE FOR A SURGERY S 13 VI TECHNICAL SPECIFICATIONS CARE MAINTENANCE S 18 APPENDIX A Optional accessories description S 20 B Part Descriptions and Codes Accessories S 21 C Assembling instrument holder with the pneumatic S 22 D Adapting the firmness of the proximal ball joint S 25 E Spare pa...

Page 4: ...on on receipt As you receive the parcel containing your Pneumatic Endoscope Holder by the forwarding agent check that packing is in good condition In case of damages note the damage on the forwarding agent s receipt before you sign Open the parcel containing the device and check it immediately after receipt Check if it is complete and in good working order Any damage faulty working order or missin...

Page 5: ...Before use they have to be cleaned and sterilized according to the instructions in section IV of this manual I 2 Accessories checklist Unless otherwise specified your Pneumatic Endoscope Holder 29 5000 must be delivered with the following accessories 1 Pneumatic Endoscope Holder Central stand Instrument holder 20 21 1 A one meter Silicone Hose with quick Stäubli connector 30 1 Tightening Ball with...

Page 6: ...ic Endoscope Holder and a maximal holding power of 5 kg in case of 7 5 bar The holding power is related to the gas pressure II 1 Description of parts The Pneumatic Endoscope Holder consists of The pneumatic central stand fixed to the OR table rail which can either be used below a sterile drape or can be sterilized by autoclaving The instrument holder which can be completely dismantled and steriliz...

Page 7: ...at the distal end with on finger releases all the 3 ball joints simultaneously Now it is possible to place the endoscope in the desired position only with one hand The Pneumatic Endoscope Holder will become tightened as soon as the control lever is released III ASSEMBLY AND OPERATION The assembling the fixation on the table the operation with pressure as well as the functional handling should firs...

Page 8: ...e mesh to the Stäubli connector on the base below the central stand The connector has a check valve 31 and can be swivelled however do not remove the connector from the central stand HOW TO FIX the swivelling rail clamp on the OR table III 2 Assemly of the instrument holder to the pneumatic central stand First Assembling the instrument holder Select the proper inlay for the tightening ball and ins...

Page 9: ...e slot Push it to the end and turn the spanner 90 until the pins are adapted to the slots III 3 Connecting the Instrument Holder with the pneumatic central stand IMPORTANT The system must be without pneumatic pressure The Instrument Holder is prepared according to part III 2 The pneumatic central stands housing ends in a lock nut distally 16 This nut is marked with a dot point the housing is marke...

Page 10: ...ct the end of the hose 32 directly to the connector of the pressure reducer if the bottle is placed under the OR table or use an extension hose with quick connectors 34 33 Always keep the pressure cylinder in an upright position with the tap facing up IMPORTANT Never use pressure cylinders in horizontal position or with tap facing down Never lubricate the joints or pressure reducer rings Never try...

Page 11: ...nt or Endoscope reduces the life expectancy of the ball joint III 6 End of test Deflate the gas turn off the tap or disconnect the hose from the central compressed air supply and disconnect the quick connector 32 33 press the remote lever to deflate the gas circuit remove the instrument holder from the stand and remove the stand from the OR table Chapter II Warning Avoid removing the instrument ho...

Page 12: ...econtamination with a liquid first dismantle and soak and then thoroughly rinse in distilled sterile water Pneumatic Central Stand Wipe off any liquid on the device with a gauze pad dipped in alcohol or water Dry with a dry cloth Do not use solvents ATTENTION Never expose the central stand to liquids that might penetrate the ball joints never put it in a washing machine or ultra sound cleaning sys...

Page 13: ...e of sterilizing the pneumatic central stand with instrument holder only the part of the hose joined to the stand can be sterilized by autoclave white translucent woven silicone hose 30 The rubber extension hose connection supply hose is not autoclavable The pressure reducer cannot be sterilized or soaked DO NOT STERILIZE THE PRESSURE REDUCER OR THE BLACK RUBBER EXTENSION HOSE ...

Page 14: ...at are likely to entail particular risks The specifications described below could help in evaluating possible device compatibilities The compression resistance of instruments held by the Pneumatic Instrument Holder Supplied with 8 bars the linear force which can be applied to the articulated DISTAL joint can reach 1000 N 10kg This strength could cause the elastic ball joint to break if the Pneumat...

Page 15: ...ure deflation gas will be emitting The volume in case of simple repositioning under normal atmospheric pressure is between 2 to 3 litres per minute When using a sterile cover the emitted gas will float to the rail clamp Energy emission No emission at all from electromagnetic energy no power supply consumption or emission V 2 Postioning of the Pneumatic Endoscope Holder The easiest way to manipulat...

Page 16: ...st position from the patient This is limited by the working space of the distal ball point 13 The surgeon is placing the sterile covers in a common way On the side where the Pneumatic Endoscope Holder is mounted the cover has to be placed on the base over the distal ballpoint The Assistant now moves the pneumatic central stand to a vertical position the proximal ball point should be directed towar...

Page 17: ...position down or on top before he places the endoscope in the tightening ball The positioning is to realize by a half turn IMPORTANT For laparoscopic procedures Before fixing the endoscope with the Pneumatic Endoscope Holder all trocars should be on place otherwise this activity can destroys the endoscope V 4 Pneumatik Endoskope Holderused as a sterile device the whole arm is autoclaved Sterile pn...

Page 18: ...doboy autoclaved set up over operating drapes ATTENTION surgeon are sterile assistant are non sterile After positioning of patient and anaesthesia the surgeon drapes the table with sterile covers in a common way The surgeon is mounting the sterile Pneumatic Endoscope Holder on the rail passing through the sterile cover Now he can give out the sterile gas supply hose 30 to the non sterile assistant...

Page 19: ...umatic Endoscope Holder all trocars should be on place otherwise this activity can destroys the endoscope V 5 On the end of the procedure Stop the pressure supply Close the swivel valve on the pressure cylinder or disconnect the wall connector Press the lever 17 Open the tightening ball fixation and remove the endoscope Disconnect the instrument holder from the pneumatic central stand Disassemble ...

Page 20: ...f following cleaning instructions see section IV and regular inspection of all sensitive parts such as seals mobile parts and pneumatic hoses IMPORTANT An annual general inspection by the manufacturer is necessary to keep the device in good working order This maintenance procedure includes a complete inspection of the device replacement of worn parts and the final factory inspection is repeated On...

Page 21: ...eprüft von freigegeben von Seite 29 5000 Pneumatik holder_EN C 04 06 12 03 12 2018 ssta cgro cgro 21 von 28 The firmness of the proximal joint can be adjusted with the help of a screwdriver at the base of the arm 50 to allow more or less free movement of this joint ...

Page 22: ...name mit Revisionsstand erstellt geändert am erstellt von geprüft von freigegeben von Seite 29 5000 Pneumatik holder_EN C 04 06 12 03 12 2018 ssta cgro cgro 22 von 28 APPENDIX A Index of Spare Parts 29 5000 ...

Page 23: ...older_EN C 04 06 12 03 12 2018 ssta cgro cgro 23 von 28 This drawing shows possible connections of pressure supply are not an part of 29 5000 Appendix B Installation of pneumatic central stand with swivel clamp on the rail of operation table Diagram for fixation of swivel clamp on the rail of operating table MONTAGE ...

Page 24: ...t von geprüft von freigegeben von Seite 29 5000 Pneumatik holder_EN C 04 06 12 03 12 2018 ssta cgro cgro 24 von 28 Appendix C Assembling instrument holder with the neumatic central stand Follow step by step assembling the instrument holder before adapting it ...

Page 25: ...teiname mit Revisionsstand erstellt geändert am erstellt von geprüft von freigegeben von Seite 29 5000 Pneumatik holder_EN C 04 06 12 03 12 2018 ssta cgro cgro 25 von 28 follow next page APPENDIX C PART 2 ...

Page 26: ... mit Revisionsstand erstellt geändert am erstellt von geprüft von freigegeben von Seite 29 5000 Pneumatik holder_EN C 04 06 12 03 12 2018 ssta cgro cgro 26 von 28 For more details please read chapter III 2 III 3 ...

Page 27: ...evisionsstand erstellt geändert am erstellt von geprüft von freigegeben von Seite 29 5000 Pneumatik holder_EN C 04 06 12 03 12 2018 ssta cgro cgro 27 von 28 APPENDIX D Adjusting the firmness of the proximal ball joint ...

Page 28: ...4 06 12 03 12 2018 ssta cgro cgro 28 von 28 APPENDIX E Spare parts and accessories 29 5000 IRON ASSISTANT Pneumatic Endoscope Holder complete Standard length instrument holder with push to release system Spring for instrument holder Manual tightening ball set One ball with locking nut 5 mm sheath 10 mm sheath 10 and 5 mm steath ...

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