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AKRUS SC 5010 SEK Instructions For Use Manual

Mobile surgical chair
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M
OBILE SURGICAL CHAIR
SC 5010 SEK
I
(IFU)
NSTRUCTIONS FOR USE

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Summary of Contents for AKRUS SC 5010 SEK

  • Page 1 OBILE SURGICAL CHAIR SC 5010 SEK (IFU) NSTRUCTIONS FOR USE...
  • Page 2 HANGES TO THE INS TRUCTIONS FOR US E We reserve the right to make changes in the interests of further technical development; the instructions for use are not subject to revisions. ANUFACTURER AKRUS GmbH & Co KG Otto-Hahn-Straße 3 25337 Elmshorn Germany Tel.
  • Page 3 (101-152) ....................... 16 EYPAD CONTROLS 10.2. (100-925) ..........................16 ATTERY 10.3. (100-924) ....................17 HARGING STATION ATTERY 10.4. SC 5010 SEK ................18 ATTERY HOLDER ON THE SURGICAL CHAIR 10.5......................18 LECTRIC DRIVES AND CONTROL UNIT 10.6. (275.012020 ) ..........18...
  • Page 4 12.2........................30 EPROCESSING INSTRUCTIONS 12.2.1..........................30 LEANING PROCEDURE 12.2.2........................31 ISINFECTION PROCEDURE 12.2.3........................31 OMPLETION OF PROCESSING CHECKS BEFORE USE ........................... 32 DEVICE MAINTENANCE AND REPAIR ....................32 SAFETY INSPECTIONS.......................... 33 DISPOSAL ............................33 TECHNICAL DATA ..........................35 ENVIRONMENTAL CONDITIONS ......................
  • Page 5 1. G ENERAL INFORMATION A thorough understanding of this IFU is essential for use of the SC 5010 SEK surgical chair. Please familiarise yourself fully with its contents, paying special attention to all guidance and instructions on how to use the device safely. Keep these instructions for use near the product so that they are accessible to all users.
  • Page 6 1.3. S YMBOLS US ED The following symbols may be used on products, signs and packaging: Nameplate 1. Name/rating plates 2. Weight label 3. Service label 4. “Do not sit” prohibition sign 5. “Do not load” prohibition sign SYMBOL MEANING SYMBOL MEANING Date of manufacture (YYYY-...
  • Page 7 SYMBOL MEANING SYMBOL MEANING Indicates that the product can Applied part type B, in accord- only be used indoors ance with IEC 60601-1 Indicates that the product can Disposal in the EU: do not dis- only be operated by direct cur- pose of with household waste rent from the battery supplied Warning: crushing hazard...
  • Page 8 2. R EP ORTING INCIDENTS Any complaints about the product's safety, efficacy or performance must be reported to AKRUS (info@akrus.com) or to their local distributor. If necessary, the local competent author- ity must also be informed. 3. R EQUIREMENTS FOR S AFE OP ERATION Please familiarise yourself with contents of this IFU before putting into service the device for the first time.
  • Page 9 5. C ONTENTS AT DELIVERY The delivery of the SC 5010 SEK includes the following items: UMBER 288g001d_SC5010_SEK_rev.9_EN.docx 2023-11-15 Page 9 of 36...
  • Page 10 Instructions for use (IFU) 6. I NTENDED US E The SC 5010 SEK surgical chair is a medical device for use in human medicine. The surgical chair may only be operated by qualified personnel. 6.1. I NTENDED P URP OS E AND INDICATIONS...
  • Page 11 for neurosurgical procedures or for medical fields and procedures not listed above  to place patients in positions for which the surgical chair is not intended  for prolonged patient transport  with or in the same room as an X-ray machine or MRI machine ...
  • Page 12 9. A CCES S ORIES The SC 5010 SEK surgical chair is equipped with rails along the backrest and sitting surface for attaching accessories such as infusion stands, anaesthesia screens, etc. To attach these accessories, check that the clamp is secure.
  • Page 13 AKRUS CCES S ORIES Anaesthesia screen, 240.030500 rigid, stainless steel Park bench position 276.032400 Goepel leg rests (max. 30 The Goepel leg rests can be 276.050100 adjusted in all spatial planes via several articulations. Knee support, manually ad- justable 276.032500 (max.
  • Page 14 AKRUS CCES S ORIES Knee support, electrically adjustable 276.032700 (max. 30 kg) Armrests with versatile ad- justment options 275.030250 (max. 10 kg) Arm support table 276.032800 Armrest without adjustment options 241.030260 288g001d_SC5010_SEK_rev.9_EN.docx 2023-11-15 Page 14 of 36...
  • Page 15 AKRUS CCES S ORIES Back extension with pad- ding 276.030660 Armrest for lateral and prone position 276.032300 288g001d_SC5010_SEK_rev.9_EN.docx 2023-11-15 Page 15 of 36...
  • Page 16 9. Call up Trendelenburg position 10.2. B (100-925) ATTERY All electric motors of the SC 5010 SEK are powered by a rechargeable battery. The battery has a capacity of approx. 40 operations per charging cycle when used with a typical load pro- file. CAUTION The battery must be charged regularly.
  • Page 17  If any of the above occur, please replace the old battery with a new battery. Please contact your local AKRUS authorised distributor. The battery should be charged approximately every 3 days by the user or maintenance staff, or daily if used intensively (> 30 uses/day). It can be...
  • Page 18 Fig. 4 Location of the battery holder 10.5. E LECTRIC DRIVES AND CONTROL UNIT The SC 5010 SEK surgical chair is powered by low voltage motors. The control unit is located in the seat frame under the seat cushion. 10.6. O (275.012020...
  • Page 19 1. Backrest UP 2. Backrest DOWN 3. Seat height UP 4. Seat height DOWN Fig. 5 Foot-controlled switch 10.7. O (649.012020 P ERATING CONTROLS OOT J OYS TICK OP TIONAL The foot joystick is fixed and should be operated with the feet. 1.
  • Page 20 10.8. W HEEL BAS E LEVER The surgical chair has 4 smooth-running castors. The castors can be locked in three positions using the central foot lever. Fig. 7 Position of the foot lever on the surgical chair The following positions are available: All wheels move freely and rotate ...
  • Page 21 11. O P ERATING THE S URGICAL CHAIR For the purposes of single fault safety, we offer a replacement battery to enable the shock positions (Trendelenburg position and zero position) to be reached. 11.1. C ONTINUOUS OP ERATION OF THE MOTORS IMPORTANT The electric motors are designed for brief operation for a maximum of 6 minutes.
  • Page 22 Fig. 15 Minimum height of the surgical Fig. 16 Maximum height of the surgical chair chair 11.4.2. ACKREST ADJUSTMENT The backrest can be continuously adjusted from vertical to horizontal position by pressing the corresponding button. Fig. 17 Vertical backrest position Fig.
  • Page 23 11.4.4. RENDELENBURG POSITION The Trendelenburg position is set either by pressing the individual buttons for the seat and backrest or by pressing the button outlined in red. The shock position is already saved and can be called up here. Fig. 21 Trendelenburg position of the surgical chair (101-152) 11.4.5.
  • Page 24 Fig. 23 Backrest segment re- Fig. 24 Position of the locking Fig. 25 Backrest segment re- moved on the right. button. moved on the left. 11.6. A (276.032950, 276.032960) DJ US TING THE LEG RES TS The leg rests are individually adjustable and removable. The leg rests can be individually ad- justed using clamps and a ratchet and can also be completely removed.
  • Page 25 11.7. A DJ US TING THE HEADRES T Various headrests are available for the SC 5010 SEK . With a universal adapter, all headrests can be replaced in just a few seconds without tools. (241.030690) 11.7.1. DJUSTING THE STANDARD HEADREST Both the length extension and the self-levelling tilt angle of the headrest (max.
  • Page 26 The head is always optimally supported thanks to the two-point mounting. The viscoelastic padding can be adjusted in width using an adjusting screw and thus individually adapted to any head size. By briefly opening the locking screw, the headrest automatically falls into a comfortable position for the patient.
  • Page 27 "H " (276.030700) 11.7.4. DJUSTING THE EADREST LATERALLY ADJUSTABLE The padded headrest (max. 20 kg) can be adjusted vertically with a tommy screw. Patients can be positioned correctly in the supine, lateral or prone position. The headrest can be moved to the correct place for each position by sliding it sideways. Fig.
  • Page 28 "TCHR " (276.030850) 11.7.5. DJUSTING THE HEAD STABILISER With the TCHR head stabiliser (max. 20 kg), the head and upper body of anaesthetised pa- tients can be fixed in a stable position for seated or semi-seated procedures. After loosening the clamping screws, the upper and lower headrest can be tilted and moved in all directions. First, position the head correctly in the lower recessed head cushion.
  • Page 29 12. D EVICE CARE AND REP ROCES S ING The product is a reusable medical device. Repeated reprocessing of these products usually has little effect. The service life of the product is generally determined by normal wear and tear and damage caused by use. The product should be cleaned and disinfected after each use.
  • Page 30 WARNING Electric shock due to contact of the battery with moisture. The battery must be removed before the chair is cleaned. The chair must be  completely dry before the battery is reinserted. The battery itself should only be cleaned with slightly damp cloths in excep- ...
  • Page 31 For manual cleaning, use ready-to-use “Cleanisept Wipes Maxi” by manufacturer Dr. Schumacher GmbH. Please proceed as follows: Follow the instructions from manufacturer Dr. Schumacher on  using personal protective equipment. Clean visibly contaminated surfaces with a CLEANISEPT WIPE  Cleaning and remove contamination.
  • Page 32 The product is subject to the regular service intervals specified in the current product service report sheet. It is prohibited to use a defective product or to carry out repairs yourself. If device defects occur, please have the following information ready for AKRUS or the respon- sible distributor: Description of the defect ...
  • Page 33 Charger 100-924 Multi-articulated headrest 276.030648 Back cushion - centre SC 5010 SEK 277.930000 Back segment cushion - left SC 5010 SEK 276.960000 Back segment cushion - right SC 5010 SEK 276.970000 Seat cushion SC 5010 SEK 288.920000 Control unit CU20 288.999005...
  • Page 34 The basis for disposing of waste in the European Union is the European Waste List. In some cases, countries and even municipalities issue their own waste regulations, which must be complied with. Outside the European Union, the relevant country-specific regulations for waste disposal must be complied with.
  • Page 35 17. T ECHNICAL DATA The device fulfils the requirements of IEC 60601-1-2/EN 60601-1-2 "Electromagnetic compat- ibility - Medical electrical equipment" without deviation or restriction. Technische Daten Technical data Value Unit Maße und Gewicht Dimensions and weight Gesamtlänge Fahrwerk (R-Lehne senk- Wheel base length (backrest vertical) recht) Gesamtbreite Fahrwerk...
  • Page 36 18. E NVIRONMENTAL CONDITIONS NVIRONMENTAL CONDITIONS FOR INTENDED USE Air temperature +10°C to +40°C Rel. max. humidity 50 % non-condensing Air pressure 700 – 1060 hPa NVIRONMENTAL CONDITIONS FOR STORAGE Air temperature -10°C to +55°C Rel. humidity 10% to 95% non-condensing NVIRONMENTAL CONDITIONS FOR STORAGE AND TRANSPORT IN ORIGINAL PACKAGING Air temperature -40°C to +70°C...