Synthes UNIUM Instructions For Use Manual Download Page 55 | Manualshive

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© DePuy Synthes Power Tools, a division of Synthes GmbH. 2021. All rights reserved.
SE_793265 AA 2021/08

Some devices listed in these Instructions for Use may not have been licensed in accordance with Canadian law and may not be for sale in Canada.
Please contact your DePuy Synthes Representative for items approved for sale in Canada.
Not all products are currently available in all markets. Data available on request.
Please contact your DePuy Synthes Representative for more information.
All DePuy Synthes Implant Instructions for Use as well as general Instructions for Use are available as PDF files at www.e-ifu.com
The trademarks used herein are trademarks of DePuy Synthes.
www.jnjmedicaldevices.com/en-US/patentmarking

*

Synthes GmbH
Eimattstrasse 3
4436 Oberdorf
Switzerland
Tel: +41 61 965 61 11

* Refer to product label for legal manufacturer.

Contact us (USA): 800-327-6887
Contact us (Canada): 855-946-8999

www.depuysynthes.com

*

Synthes USA, LLC.
1101 Synthes Avenue Monument,
CO 80132
USA
Tel: +1 719-481-5300

www.e-IFU.com
US/Canada 800-255-2500
EU: +800 888 2020
EU: +32 2 4037222

*

Synthes USA, LLC.
1302 Wrights Lane East
West Chester, PA 19380
USA
Tel: +1 610-719-5000

*

Synthes GmbH
Luzernstrasse 21
4528 Zuchwil
Switzerland
Tel: +41 32 720 40 60

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Summary of Contents for UNIUM

Page 1: ...UNIUM POWER TOOL FOR SMALL BONE TRAUMATOLOGY ORTHOPEDIC SURGERY AND STERNOTOMIES Instructions for Use...

Page 2: ...Attachment and Quick Coupling for Kirschner Wires 20 Burr Attachment 21 Saw Attachments 22 Radiolucent Drive 25 Care and Maintenance General Information 27 Cleaning and Disinfection 29 Preparation Pri...

Page 3: ...hooting 53 Ordering Information 54 Glossary The following abbreviations are used in the UNIUM Instructions for Use Abbreviation Description W Watt rpm Revolutions per minute Nm Newtonmeter osc min Osc...

Page 4: ...nst water ingress IPX6 IPX8 IPX9 The handpiece is compatible with a full range of attachments and Small Bone Cutting Tools Introduction UNIUM Portfolio Overview Attachments for UNIUM Modular Handpiece...

Page 5: ...Handpiece 05 001 612 Size 91 35 29 mm L W H Weight 40 g 0 09 lbs The Top for Sternum is compatible with the UNIUM Reciprocating Saw Handpiece and the following saw blades Reciprocating Saw Blades 511...

Page 6: ...data is subject to tolerances UNIUM Sterile Cover 05 001 603 To be used for the aseptic transfer technique of the Power Unit detailed on page 15 UNIUM Adapter for UBC II 05 001 604 To charge the Powe...

Page 7: ...terilization Basket size for UNIUM Reciprocating Saw Handpiece without lid 68 001 651 The insert tray is placed in the basket to hold the attachments during automated washing and sterilization procedu...

Page 8: ...r the Power Unit Adapter for UBC II and UBC II as described in the Instructions for Use Introduction The UNIUM Portfolio consists of the following items Modular handpiece Reciprocating Saw handpiece P...

Page 9: ...g always respect the specified Duty Cycles described in this manual For important information regarding electromagnetic compatibility EMC please refer to the corresponding Electromagnetic Compatibilit...

Page 10: ...se and send it to the DePuy Synthes Service Center Using a damaged device may cause harm to the user or patient If a product falls on the floor fragments may break off This may cause harm to the patie...

Page 11: ...increase the oscillating drilling speed press down both triggers simultaneously To decrease the speed simultaneously reduce the pressure on both trig gers The oscillating drilling mode helps protect...

Page 12: ...e slot of the guard The Top for Sternum can be mounted in 4 different positions to accommodate the chosen surgical technique To release the Top for Sternum press both release buttons 4 simultaneously...

Page 13: ...laced on the underside of the charger indicates which firmware it has If neces sary send the charger to a DePuy Synthes Representative for a firmware update The UBC II includes four independent chargi...

Page 14: ...he condition of the Power Unit run the self test If the self test has been run and the Service Indicator does not illuminate the Power Unit can be used However if the Power Unit still does not functio...

Page 15: ...t Fig 1 2 This step is marked on the front lid by an arrow and the words Press and Open Ensure that the casing cover is fully opened Fig 3 2 The scrubbed person places the sterile cover 05 001 603 on...

Page 16: ...as described in step 1 The circulating person removes the Power Unit by holding the handle while the scrubbed person holds the handpiece firmly Fig 12 Ensure that the Power Unit does not touch the ou...

Page 17: ...d by the warranty Never use an attachment in reverse mode e g 05 001 254 05 001 257 05 001 258 05 001 259 and 05 001 260 532 015 with a legacy series flexible reamer shaft as this may lead to serious...

Page 18: ...key Make sure that the teeth of the key engage correctly in the toothed rim of the chuck To remove the cutting tool open the chuck with the key WARNINGS To ensure secure insertion of the cutting tool...

Page 19: ...ng tool push the coupling sleeve forward and then insert the cutting tool while rotating slightly until it locks in place To disconnect push the coupling sleeve forward and remove the cutting tool The...

Page 20: ...nt as the torque may not be sufficient AO ASIF Quick Coupling 05 001 251 2 1 Quick Coupling for Kirschner Wires 1 700 rpm Kirschner Wires of any length with a diameter of 0 6 3 2mm can be used with th...

Page 21: ...the UNLOCK position and remove the burr Insert the new burr as far as possible rotate it slightly until it locks in place and then turn the release sleeve for burrs 1 into the LOCK position until it...

Page 22: ...aw blade and turn the locking knob 2 clockwise until the saw blade is secured 5 Put the mode switch of the handpiece in the ON or FWD ONLY position Precautions Saw blades labeled Single Use should not...

Page 23: ...serting and Removing the Saw Blades Pull the sliding sleeve 2 back and then insert the saw blade until it locks into the saw blade coupling 1 Release the sliding sleeve 2 and check that the saw blade...

Page 24: ...t is set to the unlock position Fig 3 Insert the saw attachment in any position into the attachment coupling of the handpiece until it locks into place To prevent vibrations during operation and to in...

Page 25: ...slightly Pull back the ring on the attachment to fix the drill Check if the drill bit is seated correctly by gently pulling on it Fig 2 Removing the Drill Bit Follow the same procedure in reverse ord...

Page 26: ...drill bit are completely in the bone Hitting the medullary nail with the drill bit If overload occurs drilling can be continued after having made the following corrections Correcting the drilling angl...

Page 27: ...ade of materials such as aluminum titanium and its alloys plastics and compound materials The use of such cleaners should be subject to the data regarding material compatibility in the corresponding d...

Page 28: ...d equipment materials and personnel in the processing unit Any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequenc...

Page 29: ...times using a new clean soft and lint free cloth dampened with a minimum 70 alcohol based disinfectant each time Precautions Do not use solvents to disinfect the Power Unit Sockets must not contact w...

Page 30: ...se a soft lint free cloth or soft bristled brush to assist in removing gross soil Fig 2 and Fig 3 For cannulations of the handpiece and attachments the cleaning brushes 519 40 519 40 and 532 024 below...

Page 31: ...nse device with cold tap water for a minimum of 2 minutes Fig 7 Use a syringe or pipette to flush lumens and channels 5 Clean with Detergent Manually clean device under running warm water for a minimu...

Page 32: ...loth damp ened with a minimum 70 alcohol based disinfectant each time 8 Visually Inspect Device Inspect the device including cannulations sliding sleeves attachment release rings etc for visible soil...

Page 33: ...e washing basket for the automated cleaning procedure Notes Manual pre cleaning prior to automated cleaning is important to ensure cannulations and other difficult to access areas are clean Alternativ...

Page 34: ...r Handpiece Basket 68 001 650 with Insert Tray 68 001 654 and Lid 68 001 653 Dimensions Length Width Height Basket without Lid 480 250 100mm Basket with Lid 480 250 108mm Weight Basket 68 001 650 1 46...

Page 35: ...nside the basket during the automated washing and sterilization procedure available in USA only 532 021 Oscillating Saw Attachment 6 spots for various UNIUM Attach ments 05 001 601 UNIUM Modular Handp...

Page 36: ...4 F Cleaning agent Rinse 2 Warm deionized water or purified water 40 C 104 F N A Thermal disinfection 5 93 C 199 F N A Dry 40 90 C 194 F N A 4 Inspect Device Remove all devices from the washing basket...

Page 37: ...th one 1 drop of Synthes Special Oil Fig 1 Once the oil has been ap plied move e g press open close the moving parts sev eral times to properly spread the oil Wipe off excess oil with a cloth This app...

Page 38: ...nt hole and on the holder of the lever Move the tension lever several times 1 1 1 1 AO ASIF Quick Coupling 05 001 250 05 001 251 Quick Coupling for DHS DCS Triple Reamers 532 015 Quick Coupling for Me...

Page 39: ...s to be performed by the original manufacturer or an authorized site Do not use excessive oil when lubricating the parts as this may affect the reprocessing Wipe off any excess oil with a cloth Precau...

Page 40: ...oded devices but return them to the DePuy Synthes Service Center Failing to follow these instructions may lead to damage and malfunction increasing the risk of harm to the user and patient For further...

Page 41: ...packaging materials Sterile Barrier System e g wraps or re usable rigid container environmental conditions steam quality device materials total mass sterilizer performance and varying cool down time...

Page 42: ...echnical Service Transporting UNIUM Power Unit The Power Unit is classified as a Li Ion battery contained in equipment according to the International Air Transport Association IATA regulation UN 3481...

Page 43: ...is 72 hours Do not dismantle open short circuit or shred the Power Unit Precaution Faulty devices must not be reused and should be dis posed of in an environmentally friendly manner and in accordance...

Page 44: ...cribed If longer periods of constant use are required an additional handpiece and or attachment should be used Depending on the cutting tool used and the load applied the heat generated by the handpie...

Page 45: ...104 F 10 C 50 F 40 C 104 F 10 C 50 F Relative humidity 95 10 No condensation 95 10 No condensation Atmospheric pressure 1060 hPa 1 06 bar 500 hPa 0 5 bar 1060 hPa 1 06 bar 500 hPa 0 5 bar Altitude 0...

Page 46: ...manufactured by Gebr Brasseler GmbH Co KG with Synthes acting as the exclusive distributor Handpiece Attachment Cutting Tool Sound Pressure Level LpA in dB A Sound Power Level LwA in dB A Max daily ex...

Page 47: ...Emission According to EU Directive 2002 44 EC Vibration emissions m s2 tested according to EN ISO 5349 1 Handpiece Attachment Tool Vibration emission m s2 Max daily exposure UNIUM Modular Handpiece 0...

Page 48: ...cturer s declaration electromagnetic immunity UNIUM Devices are intended for use in the electromagnetic environment of surgery rooms of hospitals except for near active HF surgical equipment The custo...

Page 49: ...ion distance in meters m Field strengths from xed RF transmitters as determined by an electromagnetic site survey b should be less than the compliance level in each frequency range c Interference may...

Page 50: ...ut power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power ratin...

Page 51: ...ront lid should be rotated to open the casing cover Indicates how the sterile cover is placed on top of the handpiece and removed from it during the aseptic transfer Reverse Function is possible with...

Page 52: ...rradiation Ref 5 2 4 ISO 15223 1 Do not use if package is damaged Ref 5 2 8 ISO 15223 1 Do not re use Ref 5 4 2 ISO 15223 1 Caution United States Federal law restricts this device to sale by or on the...

Page 53: ...piece or send it to your DePuy Synthes Service Center Oscillating saw attachment vibrates too much The saw blade locking mechanism is not tight Tighten the locking knob of the saw blade coupling Both...

Page 54: ...I Small Battery Drive II and UNIUM 532 023 Oscillating Saw Attachment II Crescentic Technique for Colibri II Small Battery Drive II and UNIUM 532 026 Large Oscillating Saw Attachment for Colibri II Sm...

Page 55: ...structions for Use as well as general Instructions for Use are available as PDF files at www e ifu com The trademarks used herein are trademarks of DePuy Synthes www jnjmedicaldevices com en US patent...

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