Colibri II. Universal battery power tool system for use in traumatology, hand and foot surgery. Instructions for Use This publication is not intended for distribution in the USA.
Contents Introduction General Information 3 Colibri II Handpiece 6 Use 8 Attachments Care and Maintenance General Information 13 Drill Attachments 15 Screw Attachments 16 Ream Attachments 17 Other Rotating Attachments 19 Saw Attachments 24 Other Attachments 28 General Information 29 Preparation Prior to Cleaning 30 Manual Cleaning Instruction 31 Mechanical/Automated Cleaning Instruction with Manual Pre-cleaning 33 Lubrication 36 Function Control 40 Packaging, Sterilizati
Contents Troubleshooting 45 System Specifications 47 Accompanying Documents Electromagnetic Compatibility Ordering Information 57 Warning This description alone does not provide sufficient background for the direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended.
Introduction General Information Intended use The Colibri II is a battery-driven power tool for use in traumatology and foot surgery, involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue. Safety instructions The Colibri II is only to be used for patient treatment after careful consultation of the instructions for use.
Introduction General Information Accessories/scope of delivery The Colibri II consists of a handpiece, one or several battery casings and batteries and a range of attachments and accessories designed for the system. For the system to operate properly, only Synthes cutting tools should be used. Special auxiliaries such as cleaning brushes and Synthes oil are available for cleaning and servicing the system. No oils from other manufacturers must be used. Only Synthes oil (519.970) must be used.
Explanation of the general symbols used Caution Read the provided Instructions for Use before operating the device. 2 Reuse or reprocessing (e.g. cleaning and resterilization) may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury, illness or death. Consult the Instructions for Use before operating the device. The device is classified as type BF against electrical shock and leakage current.
Colibri II Handpiece 1 2 3 4 5 6 7 8 Attachment coupling Trigger for speed regulation Trigger for switching to reverse/oscillating drilling Mode selector switch Battery pack (battery casing with inserted battery) Release buttons for attachment Release buttons for battery casing Knob for the battery casing cover 6 1 4 3 2 Safety system The Colibri II is equipped with a safety system that prevents the machine from being unintentionally started.
Mode selector switch in the oscillating drilling position ( ) When the bottom and top triggers 2 and 3 are pressed at the same time, the tool immediately switches to oscillating rotation. When the top trigger 3 is released, the tool returns to normal forward rotation. Compatibility between Colibri and Colibri II Existing Colibri battery packs are compatible with Colibri II handpiece The small 12 VDC battery pack of the Colibri (532.003 with battery casing 532.002) as well as the large 14.
Colibri II Use Before initial use, brand-new tools and accessories must undergo the entire reprocessing process and the batteries should be charged. Completely remove protective caps and films. Inserting the battery in the battery casing To ensure sterility, the battery is inserted into the battery casing by two people, one of whom is wearing sterile garments: 1. The person with the sterile garments holds the sterile battery casing.
3. The person not wearing sterile garments carefully guides the unsterile battery through the sterile cover (Fig. 5). As an orientation, the two symbols of the battery and the sterile cover should face each other (Fig. 6). The same person presses it completely into the battery casing to ensure a correct seat (Fig. 7). This person may not contact the outside of the battery casing. 4. The person not wearing sterile garments grasps the flanges on the sterile cover and removes it from the battery casing (Fig.
Colibri II Use Precautions: – Normally, one battery is sufficient for one surgery. For safety, two battery packs (battery casing with the battery) should be kept ready ensuring fast intraoperative changing of batteries under sterile conditions if necessary. – Never open a battery casing intraoperatively to insert a new battery. Always replace the whole battery pack by another battery pack which should have been prepared before the start of the surgery.
Charging, storing and using Colibri II batteries (532.103) Charging – The batteries should always be charged before use. – Only use the Synthes Universal Battery Charger II (05.001.204) to charge the batteries. Using another charger can damage the battery. – Detailed information on the Universal Battery Charger II can be found in the Instructions for Use (036.000.500) Precautions: – Place the battery into the charger immediately after surgery. – Do not expose batteries to heat or fire.
Colibri II Use Using the Colibri II with mains current The Colibri II can also be operated with mains current. When the Colibri II is operated with mains current it is classified as type B against electrical shock and leakage current. When operated with mains current use the Colibri adapter (05.001.108) and one of the electrical consoles belonging to the Electric Pen Drive (05.001.000, 05.001.002 or 05.001.006).
Attachments General Information The Colibri II system offers a broad range of attachments. 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).
Attachments General Information Article Number Drill Attachments Product Max. Speed Color coding 05.001.250 AO/ASIF Quick Coupling 05.001.252 Chuck (Drilling Speed), with Key, clamping range up to ⭋ 4.0 mm 1440 rpm 1440 rpm Blue Blue 05.001.253 Chuck (Drilling Speed), with Key, clamping range up to ⭋ 7.3 mm 1440 rpm Blue Screw Attachments 05.001.251 Screw Attachment with AO/ASIF Quick Coupling 384 rpm Red Ream Attachments 532.017 532.
Attachments Drill Attachments AO/ASIF Quick Coupling (05.001.250) For tools with an AO/ASIF coupling shaft. Mounting and removing the tools Insert the tool into the attachment from the front applying slight pressure and turning slightly. It is not necessary to operate the coupling sleeve of the attachment. To disconnect, push the coupling sleeve of the attachment back and remove the tool. Chucks There are two Drill Attachments Chucks available as Drill Attachments for the Colibri II system.
Attachments Screw Attachments Screw Attachment, with AO/ASIF Quick Coupling (05.001.251) Mounting and removing the tools Insert the tool into the attachment from the front by applying slight pressure and turning slightly. It is not necessary to operate the coupling sleeve of the attachment. To disconnect, push the coupling sleeve of the attachment back and remove the tool. Precautions: – Care should be taken when inserting screws with the drive unit. – Never fully insert screws with the drive unit.
Attachments Ream Attachments All Colibri II Ream Attachments provide an approximative maximal torque of 7.5 Nm (with battery 532.103). Quick Couplings for Medullary Reaming AO/ASIF Quick Coupling (532.017) Hudson Quick Coupling (532.018) Trinkle Quick Coupling (532.019) Trinkle Quick Coupling, modified (532.020) The Quick Couplings for Medullary Reaming enable the use of flexible shafts with the appropriate coupling geometry.
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 – 7.3 mm 510.191 For drilling and medullary reaming, with reverse motion 05.001.255 0 – 7.3 mm 510.191 For drilling and medullary reaming, without reverse motion Inserting cutting tools Open the jaws of the chuck using the appropriate key or by hand.
Attachments Other Rotating Attachments Mini Quick Coupling (532.011) J-Latch Coupling (532.012) For tools with a Mini Quick or J-Latch coupling shaft. Mounting and removing the tools To connect the tool, pull the coupling sleeve back and then introduce the tool while rotating slightly. To disconnect, push the coupling sleeve of the attachment back and remove the tool. Quick Coupling for Kirschner Wires (532.022) Kirschner Wires of any length with a diameter of 0.6 – 3.
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.
Using the Radiolucent Drive Before positioning the Radiolucent Drive, align the image intensifier until the distal locking hole of the medullary nail is round and easily visible. After the incision, position the Radiolucent Drive and center the drill bit tip over the locking hole. On the monitor of the image intensifier, you can see both the drill bit and the target rings of the drive.
Attachments Other Rotating Attachments Precautions: – Grip the coupled Radiolucent Drive tightly when switching on the power tool, particularly if the power tool is held face down. – Only special 3-flute spiral drill bits can be used. Your Synthes representative will be glad to provide you with additional information on which drill bits can be used. – Handle the Radiolucent Drive with great care. Do not allow contact between the drill bit and the medullary nail.
Burr Attachment (05.001.187) The Burr Attachment is size M. It can be used with Burrs for Burr Attachments of the Electric Pen Drive and Air Pen Drive systems. It is compatible with burr types M and L, but it is recommended to use burrs of size M. M Changing burrs 1. Lock unit. 2. Turn the release sleeve for burrs M until it engages in the UNLOCK position and remove the tool. 3.
Attachments Saw Attachments Precaution: Even if lines and measurements are indicated on the saws, these articles should not be used as measuring instruments. Oscillating Saw Attachment (532.021) Positioning the saw attachment The attachment can be locked in eight different positions (45° steps) when coupled: Lock the machine, shove the sliding sleeve N toward the saw blade coupling and rotate the attachment into the desired position (Fig. 1).
Positioning the saw blade The saw blade can be adjusted in the desired position vertically and horizontally at an angle of 45º (see the earlier sections “Positioning the saw attachment” and “Changing the saw blade”). Using the oscillating saw attachment The saw blade must already be oscillating when the saw is applied to the bone. Do not apply strong pressure to the saw blade as this will delay the cutting process and the saw teeth will catch in the bone.
Attachments Saw Attachments Oscillating Saw Attachment II (Crescentic Technique) (532.023) The Oscillating Saw Attachment II is essentially designed for use with semicircular saw blades (for example 03.000.313S) guided by a 1.6 mm Kirschner Wire. It can also be used with saw blades with a shaft extension (for example 03.000.340S) for reaching difficult-to-access sites (such as intraoral).
Large Oscillating Saw Attachment (532.026) The Large Oscillating Saw Attachment is a specially designed saw attachment for performing a crescentic saw cut, e.g. while performing a Tibial Plateau Leveling Osteotomy in the canine proximal tibia. The attachment is approved for use in both humans and animals. Inserting the saw blade Insert the saw blade in the saw blade coupling and tighten the screw in the saw blade with the key (532.
Attachments Other Attachments Torque Limiter 1.5 Nm (511.773) Torque Limiter 0.8 Nm (511.776) Torque Limiter 0.4 Nm (511.777) Coupling the Torque Limiter to the power tool Torque Limiters are connected to the Colibri II using the AO/ASIF Quick Coupling (05.001.251). Mounting and removing a screwdriver shaft Insert the screwdriver shaft while rotating it slightly until it locks into place. To remove it, pull back the unlocking ring and pull out the screwdriver shaft.
Care and Maintenance General Information Power tool units and attachments are frequently exposed to high mechanical loads and shocks during use and should not be expected to last indefinitely. Proper handling and maintenance help extend the useful life of surgical instruments. Gentle care and maintenance with proper lubrication can substantially increase the reliability and life of the system components.
Care and Maintenance Preparation Prior to Cleaning Disassembly Disassemble device if applicable. Remove all instruments and attachments from the power tool and remove battery from casing or handpiece. To clean the batteries and the charger, wipe them off with a clean, soft and lint-free cloth dampened with disinfectant or deionized water (Fig. 1 and 2). Important: Do not use solvents to disinfect the batteries.
Care and Maintenance Manual Cleaning Instruction 1. Remove debris. Rinse the device under running cold tap water for a minimum of 2 minutes. Use a sponge, soft lint-free cloth or soft-bristled brush to assist in removing gross soil. For cannulations of the handpiece and attachments, the cleaning brush (519.400) should be used. Note: Do not use pointed objects for cleaning. 2. Manipulate moving parts.
Care and Maintenance Manual Cleaning Instruction 5. Rinse with tap water. Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes. Use a syringe, pipette or water jet to flush lumens and channels. Actuate joints, handles and other movable device features in order to rinse thoroughly under running water. 6. Visually inspect device. Inspect the cannulations, coupling sleeves, etc. for visible soil. Repeat steps 1 – 6 until no visible soil remains. 7.
Care and Maintenance Mechanical/Automated Cleaning Instruction with Manual Pre-cleaning Important: – Manual pre-cleaning prior to mechanical/automated cleaning/disinfection is important to ensure that cannulations and other difficult to access areas are clean. – Alternative cleaning/disinfection procedures other than in the procedure described below (including manual precleaning) have not been validated by Synthes. 1. Remove debris.
Care and Maintenance Mechanical/Automated Cleaning Instruction with Manual Pre-cleaning 4. Clean with detergent. Clean the device manually under running warm water using an enzymatic cleaner or detergent for a minimum of 5 minutes. Manipulate all moving parts under running water. Use a soft-bristled brush and/or soft lint-free cloth to remove all visible soil and debris.
8. Automated cleaning cycle parameters Note: The washer/disinfector should fulfill the requirements as specified in ISO 15883. Step Duration (minimum) Cleaning instructions Rinse 2 minutes Cold tap water Pre-wash 1 minute Warm water (≥ 40 °C); use detergent Cleaning 2 minutes Warm water (≥ 45 °C); use detergent Rinse 5 minutes Rinse with de-ionized (DI) or purified water (PURW) Thermal disinfection 5 minutes Hot DI water, ≥ 93 °C Dry 40 minutes ≥ 90 °C 9. Inspect the device.
Care and Maintenance Lubrication The power tool and attachments should be regularly lubricated to ensure a long service life and smooth operation. It is recommended that the accessible moving parts of the handpiece, the battery casing and attachments are lubricated with 1 drop of Synthes special oil (519.970); distribute the oil by moving the components. Wipe off the excess oil with a cloth. For detailed information, please refer to the Colibri II Care and Maintenance Poster (036.001.383).
Lubricating the battery casing (Fig. 3 and 4) – 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.
Care and Maintenance Lubrication Attachments All moving parts of all the attachments. Exception: the Radiolucent Drive (511.300) does not require lubrication. Chuck (05.001.252 – 05.001.255) Lubricate the jaws and toothed rim. Open and close the drill chuck several times. 1 Quick Coupling for Kirschner Wires (532.022) Lubricate the tension lever and clamping mechanism. 1 Hold the Quick Coupling up and add one drop of oil into the attachment hole and on the holder of the lever (Fig. 5).
Precautions: – To ensure a long service life and reduce repairs, the power tool and all attachments must be lubricated after each use. Exception: The Radiolucent Drive (511.300) does not require lubrication. – The power tool and accessories may only be lubricated with Synthes special oil (519.970). The composition of the vapor-permeable and biocompatible oil is optimized for the specific requirements of the power tool. Lubricants with other compositions can cause the power tool to jam and be toxic.
Care and Maintenance Function Control – Visually inspect for damage and wear. – Check the handpiece controls for smooth operation and function. – All movable parts should be moving smoothly. Check that the triggers do not remain blocked in the handpiece when pressing on them. Check that no residuals prevent the movable parts from moving smoothly. – Check the coupling sleeves of the handpiece and attachments for smooth operation and check for function together with instruments such as cutting tools.
Care and Maintenance Packaging, Sterilization and Storage Packaging Put cleaned, dry products into the proper places in the Synthes case. Additionally, use an appropriate sterilization wrap or reusable rigid container system for sterilization, such as a Sterile Barrier System according to ISO 11607. Care should be taken in order to protect implants as well as pointed or sharp instruments from contact with other objects that may damage the surface or the Sterile Barrier System.
Care and Maintenance Packaging, Sterilization and Storage Storage Storage conditions for products labeled “STERILE” are printed on the packaging label. 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 (“first-in, first-out principle“), taking note of any expiration date on the label.
Care and Maintenance Repairs and Technical Service The tool should be sent to the Synthes office for repair if it is faulty or malfunctions. Contaminated products have to run through the complete reprocessing procedure before being sent to the Synthes office for repair or technical service. Faulty devices may not be used. If it is no longer possible or feasible to repair the tool it should be disposed of (refer to the following section “Disposal”).
Care and Maintenance Disposal In most cases, faulty tools can be repaired (refer to the previous section “Repairs and Technical Service”). Li-Ion This device contains Lithium-Ion batteries that should be disposed of in an environmentally friendly manner. The European Battery Directive 2006/66/EC applies to this device. Precautions: – Contaminated products have to run through the complete reprocessing procedure, so that there is no danger of infection in case of disposal.
Troubleshooting Problem Possible causes Solution Handpiece does not start up. Battery is dead. Charge the battery or replace it with a charged battery. The tool was not cooled off after sterilization. Let the tool cool to room temperature. Mode selector switch is on OFF. Turn the mode selector switch to ON or . No contact between the handpiece and the battery pack. Reinsert the battery pack or replace it. Handpiece does not have enough power. Battery is dead.
Troubleshooting Problem Possible causes Solution It is difficult to close the battery casing. The battery casing seal has become dry from repeated cleaning. Lubricate the seal as described on page 37. The battery casing knob is difficult to turn. The locking mechanism needs to be lubricated. Lubricate the locking mechanism as described on page 37. The knob mechanism needs to be lubricated. Lubricate the knob mechanism as described on page 37. The triggers are difficult to move.
System Specifications Applicable Standards The device meets the following standards: IEC 60601-1:2005, 3rd Edition IEC 60601-1: 1988/ A2:1995, 2nd Edition UL 60601-1: 2003, 1st Edition 10PB Colibri II With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1 / CAN / CSA C22.2 No. 601.1 IEC 60601-1:2005, ANSI/AAMI ES60601-1 (2005), CAN/CSA-C22.2 No.
System Specifications Environmental Conditions Operation Temperature Transportation 40 °C 104 °F 10 °C 50 °F Relative humidity 90 % Atmospheric pressure max. 5000 m Caution: The machine must not be stored or operated in explosive atmospheres. DePuy Synthes 90 % 1060 hPa Altitude Colibri II Instructions for Use 40 °C 104 °F 10 °C 50 °F 10 % 500 hPa 48 60 °C 140 °F –29 °C – 20 °F 10 % Storage 90 % 10 % 1060 hPa 500 hPa – 1060 hPa 500 hPa max.
Technical Data Colibri II: 532.101 Continuously adjustable speed: 0 – 3500 rpm Weight (w. battery): 925 g Operating voltage: 14.4 VDC Battery capacity: 1.2 Ah Battery type: Li-Ion Cannulation: ⭋ 3.2 mm Empty battery charging time: max. 60 min Degree of protection against electrical shock: BF Degree of protection against the penetration of water: IPX4 Noise level in the operating position: approx. 65 dB(A) Technical data is subject to tolerances.
System Specifications Duty Cycles: Intermittent operation type S9, according to IEC 60034-1 Xs on Ys off Cycles Drilling and tapping threads and reaming 60 sec 60 sec 9 Burring 60 sec 60 sec 3 Kirschner Wire setting 30 sec 60 sec 6 Sawing 532.021 532.023 532.026 30 sec 15 sec 30 sec 60 sec 60 sec 60 sec 5 4 4 Other attachments 60 sec 60 sec 7 Generally, electrical systems can heat up if in constant use.
Declaration of the emission sound pressure level and the power level according to the EU Directive 2006/42/EC Annex I Measurements of the sound pressure level [LpA] are carried out in accordance with standard EN ISO 11202. Measurements of the sound power level [LwA] are carried out in accordance with standard EN ISO 3746. Information according to test protocol no.: 1711-5323/03.10, date of testing: 17 February 2011.
System Specifications Declaration of vibration emission according to the EU Directive 2006/42/EC Annex I The assessment of the vibration emissions [m/s2] is to be made to the hand-arm system according to EN ISO 8662. Information according to test protocol no.: 1711-5323/03.10, date of testing: 18 February 2011. Handpiece Attachment Tool Declaration [m/s2] Max. daily exposure Colibri II (532.101) – – < 2.5 No limitation AO/ASIF Quick Coupling (05.001.250) – < 2.
Electromagnetic Compatibility Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6 Table 1: Emission Guidance and manufacturer’s declaration – electromagnetic emissions The Synthes Colibri II system is intended for use in the electromagnetic environment specified below. The customer or user of the Synthes Colibri II system should ensure that it is used in such an environment.
Electromagnetic Compatibility Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6 Table 2: Immunity (all devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Synthes Colibri II system is intended for use in the electromagnetic environment specified below. The customer or user of the Synthes Colibri II system should ensure that it is used in such an environment.
Table 3: Immunity (not life-supporting devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Synthes Colibri II system is intended for use in the electromagnetic environment specified below. The customer or user of the Synthes Colibri II system should ensure that it is used in such an environment.
Electromagnetic Compatibility Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6 Table 4: Recommended separation distances Recommended separation distances between portable and mobile RF communications equipment and the Synthes Colibri II system The Synthes Colibri II system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
Ordering Information Drive unit 532.101 Consoles Colibri II 05.001.002 Basic Console for Electric Pen Drive and Small Electric Drive 05.001.108 Light Adapter, for Colibri (II) Charger, Battery and Accessories for Battery 532.132 Battery Casing for Nos. 532.101 and 532.110, with Locking for Lid 532.103 Battery for Nos. 532.101 and 532.110 532.104 Sterile Cover for Nos. 532.101 and 532.110 689.507 Lid (Stainless Steel), size 1/1, for Vario Case 05.001.204 Universal Battery Charger II 68.001.
Ordering Information Cutting tools Detailed ordering information on the cuttings tools for the Colibri II system with original size pictures can be found in the brochure “Saw blades” (036.000.172). Detailed ordering information on burrs compatible with the Colibri II system can be found in the brochure “Burrs for Electric Pen Drive and Air Pen Drive”, section “Burrs for Burr Attachments” (036.000.096). Precaution: Saw blades labeled “Single Use” should not be used repeatedly due to cleaning problems.
Colibri II Instructions for Use DePuy Synthes 59
60 DePuy Synthes Colibri II Instructions for Use
Synthes and Vario Case are trademarks of Synthes, Inc. or its affiliates Subject to modifications © Synthes, Inc. or its affiliates 40100206 60087351 This publication is not intended for distribution in the USA. All technique guides are available as PDF files at www.synthes.com/lit 0123 SE_476817 AB 02/2013 Synthes GmbH Eimattstrasse 3 CH-4436 Oberdorf www.synthes.com 036.001.387 Ö036.001.