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Synthes Colibri II Instructions For Use Manual
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Synthes Colibri II Instructions For Use Manual

Synthes Colibri II Instructions For Use Manual

Battery driven power tool system for small bone and sports medicine surgeries
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Battery Driven Power Tool System for Small Bone and Sports Medicine Surgeries
Colibri II
Instructions for Use
SYNTHES
Colibri
DePuy Synthes
PART
OF THE
FAMILY OF COMPANIES

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Summary of Contents for Synthes Colibri II

  • Page 1 Battery Driven Power Tool System for Small Bone and Sports Medicine Surgeries Colibri II Instructions for Use SYNTHES Colibri DePuy Synthes PART OF THE FAMILY OF COMPANIES...
  • Page 2 Manuals are subject to change; the most current version of each manual is always available online. Printed on: Feb 19, 2025...
  • Page 3 • Preparation Prior to Reprocessing • Manual Cleaning Instructions • Automated Cleaning Instructions with Manual Pre-Cleaning Maintenance and Lubrication Function Control Packaging, Sterilization and Storage Repairs and Technical Service Service Intervals Disposal of Waste and Materials Colibri II Instructions for Use DePuy Synthes...
  • Page 4 Table of Contents Troubleshooting System Specifications Electromagnetic Compatibility Ordering Information DePuy Synthes Instructions for Use Colibri II...
  • Page 5 II and UNIUM™ 338.490 Adapter for AO/ASIF, small, DHS/DCS Triple 532.026 Large Oscillating Saw Attachment, for Reamer Colibri II/Small Battery Drive II and UNIUM™ 510.191 Key for Drill Chuck, clamping range up 532.027 Key, for No. 532.026 and 511.802 to 7.3 mm 532.031...
  • Page 6 Introduction General Information Introduction Intended Use The Colibri II consists of a handpiece, a battery casing, The Colibri II Handpiece is intended for drilling, a battery, a range of attachments and accessories reaming and sawing bone and other bone-related tissue designed for the system.
  • Page 7 The contraindications are based upon the implant devices patient with CJD after surgery by incineration and/ rather than the instruments. Specific contra  i ndications  or follow current national recommendations. for implants can be found in the Synthes implant instruc- tions for use. Locating of the instrument or fragments of instruments...
  • Page 8 Battery (532.103) in accordance with the regulations. Sterile Cover (532.104) Please note that if the Colibri II (532.103) Li-Ion battery is Universal Battery Charger II (05.001.204) damaged it cannot be transported by aircraft cargo. For de- At least one attachment of the system tailed instructions, please refer to the UBC II Instructions for Use or contact your Depuy Synthes Representative.
  • Page 9 • The tool must only be operated with a fully charged battery. Therefore, ensure that the battery is charged in good time. • Should the system have corroded parts, do not use it anymore and send it to the Synthes Service Center. Colibri II Instructions for Use DePuy Synthes...
  • Page 10 The European directive 2012/19/EU on waste electrical and electronic equipment (WEEE) applies to this device. This device contains materials that should be disposed of in accor- dance with environment protection require- ments. Observe national and local regulations. DePuy Synthes Instructions for Use Colibri II...
  • Page 11 Manufacturing date Non sterile STERILE Reference number Lot number Serial number Material MATERIAL MADE IN Made in Expiration date  Packaging unit ISO 7000-2794 (2009-02) Medical Device in the European Community/Union Seguranga INMETRO certified INMETRO 0004 Colibri II Instructions for Use DePuy Synthes...
  • Page 12 7 Release buttons for battery casing 8 Knob for the battery casing cover Safety system The Colibri II is equipped with a safety system that pre- vents the machine from being unintentionally started. To lock and unlock the tool, turn the mode selector...
  • Page 13 VDC battery pack (532.033 with battery casing 532.032) casing, attachment and/or the cutting tool. Fur- thermore, ensure that the attachment and cutting can both be used with the new Colibri II handpiece tool coupling are not worn and closed. Replace (532.101).
  • Page 14 2. The scrubbed person places the sterile cover on the battery casing (Fig. 4) and checks if it is seated correctly. The sterile cover ensures that the unsterile battery does not contact the outside of the sterile casing. DePuy Synthes Instructions for Use Colibri II...
  • Page 15 • Do not insert the non-sterile battery into the battery casing whilst a handpiece is attached. Colibri II Instructions for Use DePuy Synthes...
  • Page 16 Removing the battery pack from the power tool Simultaneously press the release buttons for the battery casing with one hand (Fig. 12) and use the other hand to remove the battery pack from the handpiece. DePuy Synthes Instructions for Use Colibri II...
  • Page 17 No other sterilization methods • Never store the battery in the battery casing are allowed. (532.132) when it is connected to the Colibri II hand- • Never expose batteries to temperature over piece (532.101) as this will discharge the battery.
  • Page 18 Colibri II Oscillating drilling ( ) mode To protect soft tissue when drilling and inserting Kirschner wires, the Colibri II has an electronically controlled oscillating mode. To preset the oscillating mode, switch the mode selector switch to position. Pressing the bottom trigger causes the tool to rotate clockwise as usual.
  • Page 19 Attachments General Information The Colibri II system offers a broad range of attach- ments. A wide range of rotating attachments has color-coded rings, so that they can easily be identified. The table on  the next page lists the different types of attachments  available, the color coding as well as the speed of each attachment. Mounting the attachments Insert the attachment into the attachment coupling (Fig. 1). If the positioning pins do not lock into place ...
  • Page 20 Torque Limiter, 0.4 Nm, with AO/ASIF Quick Coupling – N/A* * Color coding on Torque Limiters does not refer to speed. Technical data is subject to tolerances. Specifications are approximate and may  vary from one device to another or as a result of power supply fluctuations. DePuy Synthes Instructions for Use Colibri II...
  • Page 21 To disconnect, push the coupling sleeve of the attach- ment back and remove the tool. Chucks There are two Drill Attachments Chucks available as Drill Attachments for the Colibri II system. Article number Clamping range Spare key Comments 05.001.252...
  • Page 22 Screws with a large diameter may not be able to be inserted with the AO/ASIF Quick Cou- pling as the torque may not suffice. DePuy Synthes Instructions for Use Colibri II...
  • Page 23 Quick Coupling for DHS/DCS Triple Reamers (532.015) For DHS/DCS Triple Reamers; can also be used to open the medullary cavity with most of the Synthes nailing systems. Mounting and removing the tools To connect the tool, push the coupling sleeve forward and then introduce the tool while turning slightly.
  • Page 24 Attachments Ream Attachments Chucks There are two chucks available as Ream Attachments for the Colibri II system. Article number Clamping range Spare key Comments 05.001.254 0.5–7.3 mm 510.191 For drilling and medullary reaming, with reverse motion Inserting cutting tools Open the jaws of the chuck using the appropriate key or by hand.
  • Page 25 6. To adjust the grip on the wire, reduce the clamping force and move the tool to the desired length. Rec- lamp the wire by pulling on the tension lever. Colibri II Instructions for Use DePuy Synthes...
  • Page 26 Attachments Other Rotating Attachments Radiolucent Drive (511.300) The Radiolucent Drive can be used with the Colibri II in combination with the AO/ASIF Quick Coupling (05.001.250) and the Adapter for the Radiolucent Drive (532.031). Coupling the Radiolucent Drive to the power tool Connect the AO/ASIF Quick Coupling to the Colibri II and the adapter to the Quick Coupling.
  • Page 27 Swing the drive up and center it precisely so that the drill bit appears as a round point and the locking hole is visi- ble around it. The target ring also assists the centering. The locking hole can now be drilled directly. Colibri II Instructions for Use DePuy Synthes...
  • Page 28 • 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. DePuy Synthes Instructions for Use Colibri II...
  • Page 29 M on the burr shank is no longer visible. Information on handling burrs Synthes recommends using a new sterile burr for each operation. This prevents health risks to the patient. Used burrs present the following risks: • Necrosis due to excess heat • Longer cutting time due to reduced performance of...
  • Page 30 5. Place your thumb on the saw blade coupling to hold the saw blade and turn the locking mechanism clockwise until the saw blade is fixed. Figure 2 6. Unlock the power tool. Precaution: Saw blades labeled “Single Use” should not be reused. Colibri Figure 3 DePuy Synthes Instructions for Use Colibri II...
  • Page 31 Figure 4 Instructions for handling the saw blades Synthes recommends using a new blade for each opera- tion to ensure that the saw blade is optimally sharpened and clean. The following risks are associated with used blades: • Necrosis caused by excessive heat build­up...
  • Page 32 Crescentic Technique. Precautions: • The saw attachments may only be used with the handpiece in the ON mode. • Do not use the saw attachments in oscillating drilling mode ( DePuy Synthes Instructions for Use Colibri II...
  • Page 33 Large Oscillating Saw attachment in the oscillating drilling mode ( ). Removing the saw attachment Turn the locking sleeve to the unlock position before pushing both release buttons on the handpiece. Colibri II Instructions for Use DePuy Synthes...
  • Page 34 Clinical Processing”. Concerning the clinical re- the device. The manufacturer assumes no warranty for processing of the Colibri II system please refer to damages arising from improper use, neglected or unauthor- the following section of this document.
  • Page 35 • These devices can only be reused when processed according to the manufacturer’s cleaning and ster- ilization instructions below and have been vali- dated by Synthes in accordance with ISO 17664 and ANSI/AAMI ST81. • Surgically used devices may be considered bio-...
  • Page 36 • Do not to spray the contacts. When using a damp cloth to wipe off the contacts, ensure that they are completely dry before inserting the battery into the handpiece. Residual moisture could cause a short- circuit. DePuy Synthes Instructions for Use Colibri II...
  • Page 37 Figure 1 Battery Charger Figure 2 Figure 3 Colibri II Instructions for Use DePuy Synthes...
  • Page 38 Care and Maintenance Cleaning and Disinfection Manual Cleaning Instructions Warning: The Colibri II batteries must not be cleaned following the Manual Cleaning Instructions. 1. Remove debris. Rinse the device under running old tap water for a minimum of 2 minutes. Use a soft lint-free cloth or soft-bristled brush to assist in removing gross soil.
  • Page 39 7. Visually inspect device. Inspect the cannulations, coupling sleeves, etc. for visible soil. Repeat steps 1–7 until no visible soil remains. Figure 4 Colibri II Instructions for Use DePuy Synthes...
  • Page 40 2 minutes. Figure 5 9. Dry. Dry device using a soft lint-free cloth or medical grade compressed air. If smaller devices or cannula- tions contain residual water, blow dry with medical grade compressed air. Confirm that all parts are dry. Figure 6 DePuy Synthes Instructions for Use Colibri II...
  • Page 41 Care and Maintenance Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-Cleaning Warnings: The Colibri II batteries must not be cleaned following the Mechanical / Automated Cleaning Instructions with Manual Pre-Cleaning. Important: Manual pre-cleaning prior to automated cleaning / disinfection is important to ensure that cannulations and other difficult to access areas are clean.
  • Page 42 7. Visually inspect device. Inspect the cannulations, coupling sleeves, etc. for visible soil. Repeat steps 1–7 until no visible soil remains. Figure 4 DePuy Synthes Instructions for Use Colibri II...
  • Page 43 A lid (68.001.602) is available for the washing basket. This can be used for sterilization, but is not required for machine washing. Warning: Do not wash the system in the Synthes Vario Cases (68.001.255, 68.001.253). Dimensions of the Washing Basket (Length  Width  Height): Washing Basket without Lid: 500 ...
  • Page 44 Therefore, devices must be properly lubri- cated after automated cleaning. Furthermore, the device must be serviced at least once per year as specified under the section “Repair and Technical Services”. DePuy Synthes Instructions for Use Colibri II...
  • Page 45 It is recommended that the accessible moving parts of the handpiece, the battery casing and attach- ments are lubricated with 1 drop of Synthes special oil (519.970); distribute the oil by moving the components. Colibri Wipe off the excess oil with a cloth.
  • Page 46 • Place oil on the seal of the cover and then evenly distribute the oil on the seal. • Lubricate the lock, hinge and knob, then actuate it several times. Figure 3 SYNTHES Figure 4 DePuy Synthes Instructions for Use Colibri II...
  • Page 47 First lubricate and then move all movable parts: • Saw blade coupling (slot between the saw blade coupling and attachment) • Locking sleeve of the attachment coupling (slots on both sides) • Coupling pins • Opening of the attachment coupling Colibri II Instructions for Use DePuy Synthes...
  • Page 48 The Radiolucent Drive (511.300) does not require lubrication. • The power tools and attachments must only be lu- bricated with Synthes Special Oil (519.970). No oil from other manufacturer must be used. Lubricants with other compositions may cause jamming, have a toxic effect or have a negative impact on the ster- ilization results.
  • Page 49 • Should the system have corroded parts, do not use it anymore and send it to the Synthes service center. • Devices should be inspected after processing, prior to sterilization for end of life indicators.
  • Page 50 Sterile Barrier System. Sterilization Note: For the sterilization of the Colibri II system, Synthes recommends the use of the specifically designed Synthes Vario Case (68.001.255) or of the specifically designed Washing Basket (68.001.610).
  • Page 51 Packaged and sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests and extremes of temperature and humidity.   Use products in the order in which they are received (“first­in, first­out principle“), taking note of any expira- tion date on the label. Colibri II Instructions for Use DePuy Synthes...
  • Page 52 17.2 will allow the user to charge the cal service. Colibri II (532.103) Li-Ion battery to 30% state of charge in order that it can be shipped by aircraft in accordance Please use the original packaging to send devices back with the regulations.
  • Page 53 Service Intervals The table below indicates the required Service Interval in years. Colibri II Instructions for Use DePuy Synthes...
  • Page 54 Devices must be disposed of as a healthcare medical de- vice in accordance with hospital procedures. Please send devices that are no longer used to your local Synthes representative. This ensures that they are disposed of in accordance with the national application of the respec- tive directive.
  • Page 55 The saw blade locking mechanism Tighten the locking knob of the saw vibrates too much. is not tight. blade coupling. The mode selector switch is set to Turn the mode selector switch to ON. Colibri II Instructions for Use DePuy Synthes...
  • Page 56 Universal Battery Charger II. If the recommended solutions do not work, send the power tool to your local Synthes service center. For further technical questions or information on our services, please contact your Synthes representative. DePuy Synthes Instructions for Use Colibri II...
  • Page 57 Collateral Standard: Electromagnetic disturbances – Requirements and tests: IEC 60601-1-2 (2020) (Ed. 4.1), EN 60601-1-2 (2021) Medical electrical equipment – Part 1–6: Collateral Standard: Usability: IEC 60601-1-6 (2010) (Ed. 3.0) + A1 (2013) Colibri II Instructions for Use DePuy Synthes...
  • Page 58 60 °C; 140 °F 30 % *products have been tested according to ISTA 2A Warning: Do not use this equipment in the presence of oxygen, nitrous oxide or a mixture consisting of flammable anesthetics and air. DePuy Synthes Instructions for Use Colibri II...
  • Page 59 Synthes has established the performance and safety of Colibri II and that it represents a state of the art medical  surgical power tool and performs as intended for the function according to their instructions for use and labeling. Colibri II: 532.101 Battery: 532.103 Battery Casing: 532.132 Continuously adjustable speed: 0–3500 rpm Weight (w. battery and...
  • Page 60 These recommendations for times of use for the attach- temperatures above 20 °C (68 °F). This needs to be ments of the Colibri II have been determined under taken into consideration during the planning of average load with an ambient air temperature of 20 °C the surgical intervention.
  • Page 61 9 h 33 min Attachment (03.000.313) (532.023) Saw blade (03.000.316) Large Oscillating Saw blade 12 h (03.000.394) Attachment Saw blade (532.026) (03.000.396) Precaution: Carefully observe the above recom- mended maximum daily exposure time. Colibri II Instructions for Use DePuy Synthes...
  • Page 62 1 h 18 min (03.000.316) Large Oscillating Saw Saw blade 14.02 15 min Attachment (532.026) (03.000.394) Saw blade 18.44 8 min (03.000.396) Precaution: Carefully observe the above recom- mended maximum daily exposure time. DePuy Synthes Instructions for Use Colibri II...
  • Page 63 The Synthes Colibri II system is intended for use in the electromagnetic environment of surgery rooms of hospitals except for near active HF surgical equipment.  The customer or user of the Synthes Colibri II system should ensure that it is used in such an environment. Emission test Compliance Electromagnetic environment –...
  • Page 64 The Synthes Colibri II system is intended for use in the electromagnetic environment of surgery rooms of hospitals except for near active HF surgical equipment. The customer or user of the Synthes Colibri II system should ensure that it is used in such an environment. Immunity test standard...
  • Page 65 RF compliance level above, the Synthes Colibri II system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Synthes Colibri II system. c    O ver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
  • Page 66 Synthes Colibri II system The Synthes Colibri II system is intended for use in the electromagnetic environment in which radiated RF distur- bances are controlled. The customer or user of the Synthes Colibri II system can help prevent electromagnetic in- terference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Synthes Colibri II system as recommended below, according to the maximum output power ...
  • Page 67 532.015 Quick Coupling for DHS/DCS triple reamers, Detailed ordering information on the cuttings tools for the Colibri II system with original size pictures can be found in the brochure “Small Bone Cutting Tools”. for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175 Detailed ordering information on the special 3­flute drill bits for the Radio lucent...
  • Page 72 4436 Oberdorf This publication is not intended for distribution in the USA. Switzerland DePuy Synthes All Synthes implant instructions for use as well as general Tel: +41 61 965 61 11 0123 www.jnjmedtech.com instructions for use are available as PDF files at www.e-ifu.com...