biodex 058-820, Instructions For Use Manual

Page 1: ...3D IMAGING C ARM TABLE INSTRUCTIONS FOR USE 058 820 058 825 FN BIOMNL 6 CLR Rev A 8 21 ...

Page 2: ...iodex website www biodex com If the desired information is not found contact a local distributor or Biodex directly at supportservices biodex com Thank you Biodex Medical Systems Inc Contact information Manufactured by Biodex Medical Systems Inc Part of Mirion Technologies 20 Ramsey Road Shirley New York USA 11967 4704 Tel 800 224 6339 Int l 631 924 9000 Fax 631 924 9241 email supportservices biod...

Page 3: ... Use 8 Indications for Use 8 Contraindications 8 Control Made Easy 8 2 Operating Instructions 10 The Locking Brakes and Swivel Casters 10 Using the Hand Held Controller 12 Using the Foot Controller 12 Tabletop Extensions 13 Disposable Skirt Optional Component 14 I V Pole Optional Component 15 Charging the Battery 15 3 Maintenance and Cleaning 16 4 Specifications 17 ...

Page 4: ...4 Definition of Symbols The following symbols and their associated definitions are used and implied throughout this manual ...

Page 5: ...or IEC 60601 1 2012 reprint ANSI AAMI ES60601 1 2005 A1 2012 C1 2009 A2 2010 CAN CSA C22 2 No 60601 1 14 CE Class I Non measuring FDA Class II Equipment IEC 60601 2 46 Edition 3 0 Type B Applied Part Electromagnetic Compatibility This equipment complies with the Medical Equipment IEC 60601 1 2 2014 EMC Standard Authorized European Community Representative Emergo Europe Prinsessegracht 20 2514 AP T...

Page 6: ...d or patient Do not modify this equipment without authorization from the manufacturer CAUTION If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of equipment NOTE Any serious incidents occurring with the use of this device should be reported to the manufacturer and appropriate local regulatory agency by end user operator or patient Examp...

Page 7: ...ed for use in a client environment For product specifications refer to the Table of Contents This medical electrical equipment requires special precautions regarding EMC and must be assembled and placed into service according to EMC information provided in this manual CAUTION Operation for 058 820 115 VAC CAUTION Operation for 058 825 230 VAC CAUTION Only use approved power supplies CAUTION To avo...

Page 8: ...ns The 3D Imaging C Arm Table 820 should not be used for bariatric patients who weigh more than 500 lb Control Made Easy The portable hand held and foot operated controllers ensure quick and safe tabletop positioning and can be positioned from any point around the table Both the Hand and Foot Controllers operate table movements for X Y tabletop motion Trendelenburg motion table height and Lateral ...

Page 9: ...d Held Controller 2 Foot Controller 3 Body Restraining Straps 4 Accessory Rail 5 Low Profile Base 6 Open Leg Design 7 Accessory Rail 8 Head End Locking Brakes and Swivel Casters 9 Left and Right Knee Crutches Optional Component 10 Foot End Individual Locking Casters 11 Battery Pack ...

Page 10: ...trolled patient The Locking Brakes and Swivel Casters The locking brakes and swivel casters allow this table to glide effortlessly on hard surfaces The foot end casters are locked from either side of the table while the head end casters are locked together using the Caster Brake Locking Bar 1 To lock the foot end brakes and swivel casters step down on the foot end caster brake locking lever on eit...

Page 11: ...11 Figure 2 1 Locking Brakes and Swivel Casters Figure 2 2 Ergonomically designed leg supports to allow easy access and comfort ...

Page 12: ...ions when pressed as follows Trendelenburg Lateral roll tilt Height Up Down and Round switch activates X Y motion Releasing the rocker switch at any time immediately stops the motion NOTE When the table is used in a wet environment it is recommended that the Foot Controller be covered with a plastic bag and sealed as watertight as possible Note for Hand Held and Foot Controllers NOTE The table can...

Page 13: ... imaging as it contains no metal cross members The Head End Extension is also used to extend the length of the table but is non viewable and cannot be used for imaging The radiolucent leg extension inserts into access doors below the abdominal seat section Pull on the extension to ensure it is secure Figure 2 4 Foot Controller ...

Page 14: ...as described below 1 Slide the plastic skirt underneath the clip at the foot end of the table 2 Close the magnetic clip 3 Work around the table tucking the top edge of the plastic skirt under each clip and lowering the clip to secure the plastic until the bellows are completely covered Be sure to overlap the skirt across the entire length of the table s foot end 4 Remove and replace the plastic sk...

Page 15: ...n if the table is being used An optional wall mounted battery charger is also available NOTE The table must remain plugged into an outlet when the battery is removed or reinstalled If the battery is removed for any reason while the table is not plugged into a working outlet the battery will discharge at a faster rate Once the battery has been reinstalled and it has been verified that the table is ...

Page 16: ...y inspect all welds 9 Periodically check bolts on table tighten if necessary 10 Periodically inspect all strap holders Any holder that feels loose should be removed and reattached after adding a spot of Loctite Threadlocker Blue 242 to the bolt threads This should ensure that the bolt will not loosen CAUTION Disconnect power from source before removing panel or covers Reliable grounding achieved o...

Page 17: ... activates all motions Wheels Head End 3 7 62 cm swivel casters integral locking system on base Foot End 5 12 7 cm swivel casters with central locking Accessory Rails Standard OR accessory rails 1 12 x 375 2 86 x 95 cm Head End 30 l 75cm Patient Restraints Body straps Finish Stainless Steel Patient Capacity 500 lb 227 kg Weight 641 lb 291 kg Shipping Weight 865 lb 392 kg Power 115 VAC or 230 VAC a...

Page 18: ...r 058 865 Arm Board Standard pair 058 866 Cassette Tray 11 x 14 Replacement 056 802 Bellows Skirt disposable plastic 250 roll Fits Surgical C Arm Tables 840 800 810 and 820 046 275 Dispenser Disposable Protective Roll 056 857 Drain Bags 058 842 U503 Pad 97 5 247 65 cm Rectangular tabletop 058 842 U501 Pad 97 5 247 65 cm Contoured tabletop with face cutout NOTE To replace a part contact our Service...

Page 19: ...nts the purchaser of this product the right to copy any material in this document for the purchaser s own use including as part of a submission to regulatory or legal authorities pursuant to the purchaser s legitimate business needs No material in this document may be copied by any third party or used for any commercial purpose or for any use other than that granted to the purchaser without the wr...

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