Synthes UNIUM Instructions For Use Manual
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Synthes UNIUM Instructions For Use Manual

Power tool for small bone traumatology, orthopedic surgery and sternotomies
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UNIUM™
POWER TOOL FOR SMALL BONE TRAUMATOLOGY,
ORTHOPEDIC SURGERY AND STERNOTOMIES
Instructions for Use

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Summary of Contents for Synthes UNIUM

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

  • Page 2: Table Of Contents

    UNIUM™ Handpieces Modular Handpiece Reciprocating Saw Handpiece UNIUM™ Power Unit UNIUM™ Power Unit Charging, Storage and Use Aseptic Transfer Technique Attachments for UNIUM™ Modular Handpiece Introduction Drill Attachments Ream Attachments Screw Attachment and Quick Coupling for Kirschner Wires Burr Attachment...
  • Page 3 Emission Sound Pressure, Sound Power, Vibration Electromagnetic Compatibility Explanation of Symbols Used Symbols for Operating the Device General Symbols Troubleshooting Ordering Information Glossary The following abbreviations are used in the UNIUM™ Instructions for Use: Abbreviation Description Watt Revolutions per minute Newtonmeter osc./min Oscillations per minute...

  • Page 4: Unium™ Portfolio Overview

    Protection against water ingress: IPX6 / IPX8 / IPX9 The handpiece is compatible with a full range of attachments and Small Bone Cutting Tools. Attachments for UNIUM™ Modular Handpiece To be used for drilling, reaming, screwing, wire setting, burring and sawing. Cutting Tools Detailed ordering information on the cutting tools can be found in the brochure “Small Bone Cutting Tools”.
  • Page 5 Saw 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 511.910S** Reciprocating Saw Blade 41.5 ×...
  • Page 6 A label placed on the underside of the charger indicates which firmware it has (see page 13). The image shows the UNIUM Adapter for UBC II inserted in the charger * Technical data is subject to tolerances. and the UNIUM Power Unit connected to it.
  • Page 7 UNIUM™ Modular Handpiece (68.001.653) All items 68.001.650, 68.001.653 and 68.001.654 need to be ordered separately. Washing and Sterilization Basket for the UNIUM™ Reciprocating Saw Handpiece items 68.001.651 + 68.001.652 Lid for Washing and Sterilization Basket, size ½, for UNIUM™...

  • Page 8: General Information

    Adverse Tissue Reaction •  Intended Use Injury to Patient •  UNIUM is a battery-driven Power Tool intended for use in Injury to User •  traumatology and orthopedic surgery which may include drilling, reaming, burring, screwing, tapping, sawing and Unusual Transmissible Pathogens setting pins and wires.
  • Page 9 (EMC) please refer to the corresponding Safety Measures During Use “Electromagnetic Compatibility” section. It is recommended to have a back-up UNIUM Handpiece Both handpieces are classified as type BF against electri- readily available to use during surgery, as the potential for cal shock and leakage current and are certified according technical problems can never be completely avoided.
  • Page 10 For safety reasons, please read the Instructions for Use •  •  to charge the UNIUM Power Unit. Using a charger that carefully before using the device. does not originate from Synthes can damage the Do not use any device if the packaging is damaged or if • ...

  • Page 11: Modular Handpiece

    532.011, 532.012) or the K-wire attachment (05.001.188). Never use the oscillating drilling mode with any other attachment to avoid injuries. Never use the saw attachments (532.021, 532.023 and •  532.026) in oscillating drilling mode to avoid injuries. UNIUM™ • Instruction for Use...

  • Page 12: Reciprocating Saw Handpiece

    2 seconds, and then turn it back to either ON or FWD ONLY before checking the battery level indicator (7) on the casing cover. The UNIUM Handpiece is automatically switched off •  after two hours of inactivity. To reactivate it, switch it OFF and ON again with the mode switch.

  • Page 13: Unium™ Power Unit

    Example label found on the underside of the charger with firmware 16.0 For further information on the UBC II and the UNIUM Adapter for UBC II, consult the Instructions for Use of UBC II or contact your local DePuy Synthes Office.

  • Page 14: Charging, Storage And Use

    The Power Unit must be fully charged before first use. This standard, initial charging UNIUM Power Units perform best when they are oper- operation must only be carried out by the end user (hos- ated at normal ambient temperature (20 °C +/- 5 °C;...

  • Page 15: Aseptic Transfer Technique

    Aseptic Transfer Technique The aseptic transfer technique allows a non-sterile click Power Unit to be inserted into UNIUM Handpieces whilst preserving the sterile barrier in the operating room. Not submitting a power unit or a battery to a steam sterilization process after each use will maximize its lifespan and shorten the turnaround time.
  • Page 16 To avoid injuries, always switch OFF the handpiece •  before every manipulation (e.g. inserting/ removing the power unit, attachments and/or cutting tools) and before placing it back down. Figure 13 Instruction for Use • UNIUM™...

  • Page 17: Introduction

    Attachments for UNIUM™ Modular Handpiece Introduction The UNIUM Portfolio offers a broad range of attachments which are described in the following pages. Some of the attachments have been color coded between drill (blue) and ream (red) speed. Inserting and Removing the...

  • Page 18: Drill Attachments

    Attachments for UNIUM™ Modular Handpiece Drill Attachments AO/ASIF Quick Coupling Drill Attachment, 1,255 rpm Inserting and Removing the Cutting Tools To connect the cutting tool, insert it into the attachment by applying a light pressure while rotating it slightly until it AO/ASIF Quick Coupling (05.001.250)

  • Page 19: Ream Attachments

    Attachments Ream Attachments All UNIUM Reaming attachments provide a maximum torque of approximately 6.0 Nm at maximum load and a maximum speed of 340 rpm with no load. Quick Coupling Ream Attachments AO/ASIF Quick Coupling (05.001.257) Inserting and Removing the Cutting Tools...

  • Page 20: Screw Attachment And Quick Coupling For Kirschner Wires

    6. To adjust the grip on the wire, reduce the clamping force and slide the attachment along the wire to the desired length. Reclamp the wire by pulling on the tension lever. Quick Coupling for Kirschner Wires (05.001.188) Instruction for Use • UNIUM™...

  • Page 21: Burr Attachment

    Attachments Burr Attachment Burr Attachment, 17,000 rpm The burr attachment for UNIUM is compa tible with Small Bone Small Torx coupling burrs, sizes Medium (M) and Long (L). Burr Attachment (05.001.187) Changing Burrs Turn the release sleeve for burrs (1) until it engages in the UNLOCK position and remove the burr.

  • Page 22: Saw Attachments

    Very precise cuts can be made when the saw blade is guided steadily. Imprecise cuts arise due to used saw blades, excess pressure or the saw blade jamming on the bone. Figure 3 Instruction for Use • UNIUM™...
  • Page 23 Figure 2: Crescentic Saw Blades e.g. (03.000.313S) Pull the sliding sleeve (2) back and remove the saw blade. 70 mm Figure 3: 105° Angled Saw Blades e.g. (03.000.341S) UNIUM™ • Instruction for Use...
  • Page 24 Figure 3 ▲ Precaution: Avoid applying high pressure onto the saw blade. Removing the Saw Attachment Turn the locking sleeve (2) to the unlock position then push both release buttons on the handpiece. Instruction for Use • UNIUM™...

  • Page 25: Radiolucent Drive

    Attachments Radiolucent Drive Radiolucent Drive (511.300, 511.30*), 1,255 rpm The Radiolucent Drive can be used with the UNIUM Modular Handpiece in combination with the AO/ASIF Quick Coupling (05.001.250) and the Adapter (05.001.250) (532.031) for the Radiolucent Drive (532.031). Coupling the Radiolucent Drive Connect the AO/ASIF Quick Coupling to the UNIUM (511.300, 511.30*)
  • Page 26 Depending on the setting of the image intensifier, •  a zone may appear in the rear of the Radiolucent Drive that is not radiolucent. However, this does not inhibit aiming and working with the device. Instruction for Use • UNIUM™...

  • Page 27: General Information

    DePuy Synthes. plastic, and rubber seals. Unusual Transmissible Pathogens A visual overview of the Care and Maintenance proce- dures can be found on the UNIUM Care and Maintenance ▲ WARNING: Poster. Surgical patients identified as at-risk of Creutzfeldt- Jakob disease (CJD) and related infections should be treated ▲...
  • Page 28 All three tests were performed with the handpiece casing cover and front lid fully closed. The UNIUM Power Unit has an IPX4 rating against •  water ingress in accordance with IEC 60528: – IPX4: protected against splashing water.

  • Page 29: Cleaning And Disinfection

    Disassembly Before cleaning, remove all attachments and cutting tools from the Power Tool. Remove the Power Unit from the UNIUM Modular Handpiece and Reciprocating Saw Handpiece. Cleaning and Disinfection of the Power Unit, Adapter for UBC II and UBC II Directly After the Surgery: 1.

  • Page 30: Manual Cleaning Instructions

    Figure 3 (265 mm) (78 mm) (61 mm) Cleaning brush (519.400, 519.40*) for the cannulation of UNIUM Modular handpiece and attachments (150 mm) (15 mm) (35 mm) Cleaning Brush (532.024) for Oscillating saw attachment (532.023) * available in USA only...
  • Page 31 Figure 6 coupling, switches, etc. under running water (Fig. 10). Figure 7 Figure 8 Figure 9 Figure 10: Quick Coupling for Kirschner Wires B 0.6 to 3.2 mm for UNIUM™ (05.001.188) UNIUM™ • Instruction for Use...
  • Page 32 If smaller devices or can- nulations contain residual water, blow them dry with medical grade compressed air. Ensure that all parts are dry including the inside of the handpiece. Figure 13 Instruction for Use • UNIUM™...

  • Page 33: Automated Cleaning Instructions With Manual Pre-Cleaning

    Alternative cleaning procedures other than the one •  described (including manual pre-cleaning) have not been validated. The automated cleaning instructions with manual pre- •  cleaning are valid for the UNIUM Washing and Sterilization Baskets, Insert Tray and Lids. UNIUM™ • Instruction for Use...
  • Page 34 Basket (68.001.651) with Lid (68.001.652) Dimensions (Length  Width  Height): Figure 3: Loading plan diagram on the Washing and Sterilization Basket, size ½, for UNIUM Reciprocating Saw Handpiece Basket without Lid: 240  250  100 mm Basket with Lid: 240 ...
  • Page 35 J-Latch Coupling The insert tray should be kept inside the basket during the automated washing and sterilization procedure. *available in USA only Loading Plan of Washing and Sterilization Basket, size ½, for UNIUM™ Reciprocating Saw Handpiece (68.001.651) 05.001.611 UNIUM™ Reciprocating Saw Handpiece ■...
  • Page 36 Such damage will not be covered by warranty. ▲ Precaution: •  Automated cleaning is an additional stress for devices, especially for seals and bearings. Therefore, devices must be properly lubricated after automated cleaning as indicated on page 37. Instruction for Use • UNIUM™...

  • Page 37: Maintenance And Lubrication

    Figure 2 ments must be lubricated after each use with 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.
  • Page 38 •  Opening of the attachment coupling and the unlocking ring. Mini Quick Coupling (532.011) J-Latch Coupling (532.012) Adapters (511.787, 511.788, 310.930, 338.490 and 310.93K* and 338.49*) •  Opening of the attachment coupling and the unlocking ring. * available in USA only. Instruction for Use • UNIUM™...
  • Page 39 •  To ensure a long service life and reduce repairs, the •  lubricated with Synthes Special Oil (519.970, 519.97*). handpieces and attachments must be lubricated after Oil from another manufacturer must not be used. each use. Only lubricate the devices when they are Lubricants with different compositions may cause clean to ensure the best possible outcome.

  • Page 40: Inspection And Function Test

    For further information on the inspection and function test, please refer to the UNIUM Care and Maintenance Poster. ▲ WARNINGS: Visually inspect for damage and wear (e.g. un- • ...

  • Page 41: Packaging, Sterilization And Storage

    ▲ Precautions: UNIUM Devices must be resterilized using either ISO 17665 methods or national standards. •  DePuy Synthes recommendations for packed devices are as shown in the table above.

  • Page 42: Repairs And Technical Service

    Care and Maintenance Repairs and Technical Service The Power Tool needs to be sent to the DePuy Synthes Transporting UNIUM™ Power Unit Service Center for repair if it is faulty or malfunctions or The Power Unit is classified as a “Li-Ion battery contained at least once a year for regular maintenance.

  • Page 43: Disposal Of Waste And Materials

    Please send devices that are no longer used to your local complete reprocessing procedure in order to rule out DePuy Synthes Representative. This ensures that they are any risk of infection in case of disposal. disposed of in accordance with the national application of Risk of fire and burns.
  • Page 44 The UNIUM Handpiece is equipped with a thermal over- load safety system that shuts off the device if it becomes too hot during use. After cooling, the device can be used again.
  • Page 45 38 °C; 100 °F 72 h 85 % 60 °C; 140 °F 30 % *products have been tested according to ISTA 2A or ISTA 3A. ▲ WARNING: UNIUM Devices must not be stored or operated in an explosive atmosphere. UNIUM™ • Instruction for Use...
  • Page 46 ** Handpiece 05.001.611 at idle speed (12,400 Osc./min) Technical data is subject to tolerances. The values were determined with Synthes Saw Blades with the exception of 511.920S which is manufactured by Gebr. Brasseler GmbH & Co. KG with Synthes acting as the exclusive distributor.
  • Page 47 ** Handpiece 05.001.611 at idle speed (12,400 Osc./min) Technical data is subject to tolerances. The values were determined with Synthes Saw Blades with the exception of 511.920S which is manufactured by Gebr. Brasseler GmbH & Co. KG with Synthes acting as the exclusive distributor.
  • Page 48 Guidance and manufacturer’s declaration – electromagnetic emissions UNIUM Devices are intended for use in the electromagnetic environment of surgery rooms of hospitals except for near active HF surgical equipment. The customer or user of UNIUM Devices should ensure that they are used in such an environment.
  • Page 49 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electro- magnetic site survey should be considered. If the measured field strength in the location in which UNIUM Devices are used exceeds the applicable RF compliance level above, the UNIUM Devices should be observed to verify normal operation.
  • Page 50 Recommended separation distances between portable and mobile RF communications equipment and UNIUM Devices UNIUM Devices are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the UNIUM Devices can help prevent electromagnetic interference by...
  • Page 51 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 the Attachment UNIUM™ • Instruction for Use...
  • Page 52 Sterilized using irradiation marked with the following symbol (Ref. 5.2.4 ISO 15223-1) (IEC 60601-1-2, clause 5.1.1) 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) Instruction for Use • UNIUM™...
  • Page 53 Shaft geometry of the attachment Replace the attachment or handpiece or burr etc.) cannot be coupled or handpiece is damaged. send it to your DePuy Synthes Service or only with difficulty. Center. Oscillating saw attachment The saw blade locking mechanism is Tighten the locking knob of the saw blade vibrates too much.
  • Page 54 05.001.252 Chuck (Drilling Speed), with Key, clamping range up to 511.788 Harris Adapter B 4.0 mm, for Colibri II / Small Battery Drive II and UNIUM™ 310.930 Drill Chuck, small, with Key, for Small Air Drill 05.001.253 Chuck (Drilling Speed), with Key, clamping range up to 338.490...
  • Page 55 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.

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