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AKRUS SC 5010 HS Instructions For Use Manual

Mobile surgical chair
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M
OBILE SURGICAL CHAIR
SC 5010 HS / ES
I
NSTRUCTIONS FOR USE

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Summary of Contents for AKRUS SC 5010 HS

  • Page 1 OBILE SURGICAL CHAIR SC 5010 HS / ES 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 TABLE OF CONTENTS GENERAL INFORMATION ......................... 5 1.1..........................5 XCLUSION OF LIABILITY 1.2........................5 XPLANATION OF SYMBOLS USED 1.2.1..........................5 AFETY PRECAUTIONS 1.2.2..........................5 THER INFORMATION 1.3............................6 YMBOLS USED REPORTING INCIDENTS ..........................8 REQUIREMENTS FOR SAFE OPERATION ....................8 PRODUCT SERVICE LIFE AND WARRANTY CONDITIONS ................
  • Page 4 12.2.2.......................... 27 ISINFECTION PROCEDURE 12.2.3........................27 OMPLETION OF PROCESSING CHECKS BEFORE USE ........................... 28 DEVICE MAINTENANCE AND REPAIR ....................28 SAFETY INSPECTIONS.......................... 29 DISPOSAL ............................29 TECHNICAL DATA ..........................31 ENVIRONMENTAL CONDITIONS ......................32 TROUBLESHOOTING ........................... 32 275g001d_SC5010_HS_rev.9_EN.docx 2023-11-15 Page 4 of 33...
  • Page 5 1. G ENERAL INFORMATION A thorough understanding of this IFU is essential for use of the SC 5010 HS / ES surgical chair. Please familiarise yourself fully with its contents, paying special attention to all guid- ance 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: Nameplates 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 au- thority 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 WARNING Risk of death and injury due to improper patient positioning Only place patients in the positions intended to be used with the product  and do not leave patients unattended. Fasten the patient with a suitable accessory if necessary. ...
  • Page 10 Instructions for use (IFU) 6. I NTENDED US E The SC 5010 HS / ES surgical chair is a medical device for use in human medicine. The sur- gical chair may only be operated by qualified personnel. 6.1. I NTENDED P URP OS E AND INDICATIONS...
  • Page 11 Ophthalmology  ENT (ear, nose and throat)  Oral and maxillofacial surgery  Plastic, reconstructive and aesthetic surgery, primarily in the head area  Dentistry  Dermatology  Nerve stimulation  Blood donation  Due to its design, functionality and accessories, the surgical chair only allows the following positioning of patients: Supine position ...
  • Page 12 9. A CCES S ORIES The SC 5010 HS / ES surgical chair is equipped with rails along the backrest and lying sur- face for attaching accessories such as infusion stands, anaesthesia screens, etc. To attach these accessories, check that the clamp is secure.
  • Page 13 AKRUS I CCES S ORIES Multi-articulated armrest (max. 10 kg) Please ensure that the front edges of the armrests cannot come into contact with 241.030250 the rail of the seat when the backrest is upright IV stands 240.030501 Anaesthesia screen, rigid, stainless 240.030500...
  • Page 14 10.2. B (100-925) ATTERY All electric motors of the SC 5010 HS / ES are powered by a rechargeable battery. The bat- tery has a capacity of approx. 40 operations per charging cycle when used with a typical load profile.
  • Page 15  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 16 Fig. 4 Location of the battery holder 10.5. E LECTRIC DRIVES AND CONTROL UNIT The SC 5010 HS / ES chair is powered by low voltage motors. The control unit is located in the seat frame under the seat cushion. 10.6. O (275.012400...
  • Page 17 1. Backrest UP 2. Backrest DOWN 3. Bed height UP 4. Bed 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 18 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 19 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 20 Fig. 15 Maximum height of the surgical Fig. 16 Minimum 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 21 Fig. 21 Vertical seat position Fig. 22 Horizontal seat position 11.4.5. DJUSTMENT OF ELECTRIC HEAD LIFTER Fig. 23 Positioning the headrest 11.4.6. 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.
  • Page 22 (101-152) 11.4.7. ROGRAMMING THE MEMORY BUTTONS To save a position, please proceed as follows: 1. Place the chair, including the headrest, in the de- sired position using the operating buttons. 2. Briefly press and release the "S" button at the bot- tom left - you should hear a triple beep.
  • Page 23 11.5. A DJ US TING THE HEADRES T Various headrests are available for the SC 5010 HS / ES . With a universal adapter, all head- rests can be replaced in just a few seconds without tools. (241.030690) 11.5.1. DJUSTING THE STANDARD HEADREST Both the length extension and the self-levelling tilt angle of the headrest (max.
  • Page 24 The head is always optimally supported thanks to the two-point mounting. The visco- elastic padding can be adjusted in width us- ing an adjusting screw and thus individually adapted to any head size. By briefly opening the locking screw, the headrest automatically falls into a comforta- ble position for the patient.
  • Page 25 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 26 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 27 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  and remove contamination. Dispose of used wipes. Wipe surfaces with CLEANISEPT WIPES until fully wetted. Allow ...
  • Page 28 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 re- sponsible distributor: Description of the defect ...
  • Page 29 Calf pad for SC 5010 ES only (viscoelastic) 242.950100 Calf pad for SC 5010 HS only 275.950000 Calf pad for SC 5010 HS only (viscoelastic) 275.950100 15. S AFETY INS P ECTIONS A safety check of the bed is NOT prescribed by the manufacturer; however, the operator must observe any deviations from this in accordance with national regulations for Class I medical devices in their currently valid version.
  • Page 30 Section 12. 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 31 Chair cushion depth SC 5010 ES (eye surgery) max. Länge Rückenlehne waagerecht Max. chair length, back rest horizontal 2050 SC 5010 HS (head surgery) max. Länge Rückenlehne waagerecht Max. chair length, back rest horizontal 2050 Patientengewicht maximal Max. patient weight 200/300 Masse (abhängig von Optionen) ca.
  • Page 32 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...
  • Page 33 275g001d_SC5010_HS_rev.9_EN.docx 2023-11-15 Page 33 of 33...

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Sc 5010 es