Colibri. Universal Battery Power Tool System for Use in Traumatology, Spine and Maxillofacial.
Contents Introduction Using the Colibri Care and Maintenance General Information 2 System Specifications 3 Handpiece 4 Use 6 Attachments 10 General Information 21 Preparation for Cleaning and Disinfection 22 Cleaning and Disinfection 23 Lubrication 25 Inspection and Sterilization 27 Troubleshooting 28 Ordering Information 30 Synthes 1
Introduction General Information Intended Use The Colibri is a battery-driven power tool for use in traumatology, maxillofacial and spinal column surgery. To ensure proper operation of the Colibri, use only Synthes original accessories. Patient safety The Colibri may only be used on patients after the medical personnel have read the instructions. Since it is impossible to fully exclude the possibility of technical problems, always ensure that an alternative system is ready when using the unit on patients.
System Specifications The device meets the following standards EN 60601-1 / IEC 601-1 EN 60601-1-2 / DIN EN 60601-1-2, (VDE 0750 part 1–2) EN 55011 / DIN VDE 0875 part 11, class B, group 1 thresholds Medical electrical devices UL 2601-1 Only in conformance with UL 2601-1 and CAN/CSA C22.2 No. 601.1 in reference to electrical shock, fire, mechanical danger.
Using the Colibri Handpiece 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 Safety system The Colibri is equipped with a safety system that prevents the machine from being unintentionally started.
Important notes – To prevent injury, the machine must be locked with the mode selector switch when coupling and removing attachments and tools, and before laying it down (see page 4). – Never place the Colibri on a magnetic surface since the machine might start unintentionally. – Pay particular attention to all instructions in the individual sections that are identified with “Caution”. – Components that are no longer useful must be disposed of in accordance with local and national regulations.
Using the Colibri Use Before initial use, brand-new tools and accessories should 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 and opens the cover (Fig. 1).
Caution – If the unsterile battery contacts the outside of the casing, the casing must be resterilised before being used in the OR. – To close the casing cover, press it firmly to ensure that it is completely closed (Fig. 6 and 7) so that the locking mechanism properly engages. – Sterilize the sterile cover after each use to ensure aseptic conditions when inserting the unsterile battery into the sterile battery casing. Fig. 6 Fig.
Using the Colibri Charging, storing and using batteries Charging – The batteries should always be charged before use. – Only use chargers recommended by Synthes to charge the batteries. Using a charger that does not originate from Synthes can damage the battery. – Charge the batteries within an ambient temperature range of 0 °C to 40 °C. Storage – When the battery is not being used, store it in the appropriate Synthes charger.
Using the Colibri with mains current The Colibri can also be operated with mains current. When the Colibri is operated with mains current it is classified as type B against electrical shock and leakage current. When operated with mains current use the corresponding adapter (Art. 05.001.024) and an electrical console belonging to the Electric Pen Drive (Art. 05.001.000, 05.001.001 or 05.001.002). The adapter can be inserted into the Colibri handpiece and removed like a battery pack as described above.
Using the Colibri Attachments Mounting the attachments Insert the attachment into the attachment coupling (Fig. 1). If the positioning pins do not lock into place right away, twist the attachment a bit to the right or left until it locks into the correct position. Check if the attachment is seated correctly by gently pulling on it. Removing the attachments Press the attachment release buttons (see Fig. page 4) simultaneously, and remove the attachment from the coupling.
Quick Coupling for Kirschner Wires (532.022) (Speed: 0–800 rpm) Kirschner Wires of any length with a diameter of 0.6–3.2 mm can be used with the Quick Coupling for Kirschner Wires. 1. Adjust the Kirschner Wire diameter according to the label on the adjusting sleeve . Slightly press the adjusting sleeve axially against the tool and rotate the sleeve. 2. Apply a slight amount of pressure to insert the Kirschner Wire from the front or back into the cannulation . The wire is held automatically. 3.
Using the Colibri Jacobs Chuck (532.014 and 532.016) The following Jacobs Chucks are available for the Colibri system: Article number Clamping area Speed Spare key 532.014 0–6.0 mm 0–800 rpm 510.190 532.016 0–4.0 mm 0–920 rpm 310.932 Inserting cutting tools Open the jaws of the Jacobs Chuck using the appropriate key or by hand. Insert the shaft of the tool into the open drill chuck, and close it by twisting the chuck. Make sure that the shaft lies central to the three jaws.
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 toward the saw blade coupling, and rotate the attachment into the desired position (Fig. 1). Caution – To prevent injury, always grip the saw attachment with the inserted saw blade from the direction of the machine.
Using the Colibri Positioning the saw blades The saw blades can be adjusted in the desired position vertically and horizontally at an angle of 45º (See the prior sections: “Positioning the saw attachment“ and “Exchanging saw blades“). 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; this will delay the cutting process, and the saw teeth will catch in the bone.
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).
Using the Colibri Mini Quick Coupling (532.011) J-Latch Coupling (532.012) (Speed: 0–3200 rpm) The Mini Quick Coupling and the J-Latch Coupling are compatible with all protection sleeves for the MicroDrive plus (512.101) and Mini Air Drill (512.100) systems by Synthes. AO/ASIF Quick Coupling (532.013) (Speed: 0–920 rpm) For tools with an AO/ASIF coupling shaft Quick Coupling for DHS/DCS® Triple Reamers (532.
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)* (Speed: 0–320 rpm) The Quick Couplings for Medullary Reaming enable flexible shafts with the appropriate coupling geometry to be coupled. Reverse, which can damage the flexible shafts, is prevented by a special mechanical system. * For these attachments, the 14.4 VDC Colibri battery (532.
Using the Colibri Radiolucent Drive (511.300) (Speed: 0–920 rpm) The Radiolucent Drive can be used with the Compact Air Drive II in combination with the AO/ASIF Quick Coupling (511.750). Coupling the Radiolucent Drive to the power tool Connect the AO/ASIF Quick Coupling to the Colibri and the adapter to the Quick Coupling. Position the Radiolucent Drive as far as it will go over the Quick Coupling and the adapter, and rotate it into the desired working position. Support the drive with your free hand.
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.
Using the Colibri Torque Limiter 1.5 Nm (511.773), Torque Limiter 0.8 Nm (511.776), and Torque Limiter 0.4 Nm (511.777) Coupling the Torque Limiter to the power tool Torque Limiters are connected to the Colibri using the AO/ASIF Quick Coupling (532.013). 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 Regular care and maintenance according to the following instructions (fulfilling DIN EN ISO 17664) can substantially increase the reliability and life of the system components. Synthes recommends annual servicing and inspection by the original manufacturer or its exclusive sales outlets. The manufacturer assumes no warranty for damages arising from improper use or unauthorized servicing.
Care and Maintenance Preparation for Cleaning and Disinfection In the operating room Remove surface soiling with a disposable cloth or paper towel. Storage and transport No special requirements. Reprocess an instrument directly after it is used so that blood does not dry on it. Preparation for cleaning – Reprocessing must be carried out immediately after each use. – Before disinfection and cleaning, all attachments and instruments must be removed from the machine.
Cleaning and Disinfection Manual cleaning and disinfection 1. Wipe or spray the outside of the unit, battery housing and accessories with disinfectant and let the disinfectant work according to the instructions of the disinfectant’s manufacturer. 2. Remove all residues from the disinfected machine and accessories under running water using a soft brush or cloth. 3. Clean cannulations of the power tool and attachments with the provided cleaning brush. Fig.
Care and Maintenance Automated cleaning and disinfection (Validated with Miele G 7735 CD, program: Vario TD; detergents: Deconex 23 Neutrazym) 1. Manually clean critical sites such as cannulations, unlocking sleeves and other difficult-to-access locations. 2. Place all articles in the washing tray in a way that an effective washing/disinfection can be performed. Ensure that the water can flow off any surface.
Lubrication The power tool and attachments should be regularly lubricated to ensure a long service life. It is recommended to oil the accessible moving parts of the unit, battery casing and attachments with 2–3 drops of Synthes special oil (519.970) and distribute the oil by moving the components. Wipe off excess oil with a cloth. Fig. 1 2 2 2 The poster „Care and Maintenance“ (Art. 038.000.017), has clear pictures showing which items need lubrication.
Care and Maintenance Lubricating the attachments Jacobs Chuck (532.014/532.016) Lubricating jaws and toothed rim. Open and close the drill chuck several times. Quick Coupling for Kirschner Wires (532.022) Lubricating tension lever and clamping mechanism. Hold the Quick Coupling up and add two drops of oil into the attachement hole and on the holder of the lever (Fig. 2). Move the tension lever several times. Mini Quick Coupling (532.011), J-Latch Coupling (532.012), AO/ASIF Quick Coupling (532.
Inspection and Sterilization Inspection and function test – Visually inspect for damage and wear. – Check the handpiece controls for smooth operation and function. – Check the coupling and unlocking sleeves of the handpiece and attachments for smooth operation, and check for function together with instruments such as cutting tools. Packaging – We recommend the Synthes Vario Case (689.040) or sterilizing trays in combination with double-layer sterile paper. – Sterile containers can also be used.
Troubleshooting Problem Possible causes Remedy Tool does not start. 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. Safety system is activated. Turn the mode selector switch to ”ON“ or ”OSC“. No contact between the tool and battery pack. Reinsert the battery pack or replace it. Tool does not have enough power. Battery is dead.
Problem Possible causes Remedy It is difficult to close the battery casing. The battery casing seal has become brittle from repeated cleaning. Lubricate the seal as described on page 25. The battery casing knob is difficult to turn. The locking mechanism needs to be lubricated. Lubricate the locking mechanism as described on page 25. The knob mechanism needs to be lubricated. Lubricate the knob as described on page 25. The triggers are difficult to move. The trigger shafts need to be lubricated.
Ordering Information Drive unit 532.001 Saw blades (for 532.021) Colibri Art. No. non-sterile Art. No sterile Usable Width length (mm) (mm) Cut thickness (mm) Charger, Battery and Accessories for Battery 532.041 532.041S 15 mm 6 mm 0.4 mm 532.002 Battery Casing for Nos. 532.001 and 532.010, Standard 532.042 532.042S 15 mm 10 mm 0.4 mm 532.003 Battery for Colibri, 12 V, Standard 532.043 532.043S 15 mm 16 mm 0.4 mm 532.032 Battery Casing for 14.4 V battery, for Colibri 532.
036.000.