Synthes Colibri II Instructions For Use Manual

Instructions for Use

Colibri II. Universal battery power tool system for use in traumatology, hand and foot surgery.

Contents

Introduction

Colibri II

Attachments

Care and Maintenance

General Information 3

Handpiece 6

Use 8


Drill Attachments 15

Screw Attachments

Ream Attachments

16

17

Other Rotating Attachments

Saw Attachments

Other Attachments

19

24

28


Preparation Prior to Cleaning 30

Manual Cleaning Instruction 31

Mechanical/Automated Cleaning Instruction 33 with Manual Pre-cleaning

Lubrication 36

Function Control 40

Packaging, Sterilization and Storage 41

Repairs and Technical Service 43

Disposal 44

Colibri II Gebrauchsanweisung Synthes 1

Contents

Troubleshooting 45

System Specifications 47

Electromagnetic Compatibility Accompanying Documents 51

Ordering Information 55

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.

2 Synthes Colibri II Gebrauchsanweisung

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.

Efficiently working cutting tools are the basis for successful surgery. Therefore, it is mandatory to check used cutting tools after every use for wear and/or damage and to replace them if necessary. We recommend using new Synthes cutting tools for every surgery. Cutting tools must be cooled with irrigation liquid to prevent heat necrosis.

Safety instructions

The Colibri II is only to be used for patient treatment after careful consultation of the instructions for use. It is recommended that an alternative system is available to use during application, as technical problems can never be completely ruled out.

The user of the product is responsible for proper use of the equipment during surgery.

If the Colibri II is used in conjunction with an implant system, make sure to consult the corresponding “Technique Guide”.

The Colibri II is designed for use by physicians and trained medical personnel.

DO NOT use any component if damage is apparent.

For important information regarding electromagnetic compatibility (EMC), please refer to the chapter “Electromagnetic

Compatibility” in this manual.

DO NOT use any component if the packaging is damaged.

DO NOT use this equipment in the presence of oxygen, nitrous oxide or a mixture consisting of flammable anesthetics and air.

To ensure the proper operation of the tool, only use Synthes original accessories.

The tool is classified as type BF against electrical shock and leakage current. The tool is suitable for use on patients in accordance with IEC 60601-1.

To ensure the proper operation of the tool, Synthes recommends annual maintenance by a Synthes service center. The manufacturer shall assume no responsibility for damage resulting from improper operation, neglected or unauthorized maintenance of the tool.

Before the first and every subsequent use, power tools and their accessories/attachments have to run through the complete reprocessing procedure. Protective covers and foils must be fully removed before sterilization.

For the tool to function properly, Synthes recommends cleaning and servicing it after each use in accordance with the process recommended in the chapter “Care and Maintenance”. Compliance with these specifications can considerably extend the service life of the tool. Only use Synthes oil

(519.970) to lubricate the tool.

Precautions:

– To avoid injuries, the locking mechanism of the tool has to be activated before every manipulation and before placing the tool back down, i.e. the mode switch has to be in OFF position.

– The tool may only be operated with a fully charged battery. To do this, ensure that the battery is charged in good time. We recommend that the battery is replaced into the charger immediately after surgery.

– The batteries may never be sterilized. This would destroy the battery with possible secondary damage.

– Should the machine drop on the floor and have visible defects, do not use it anymore and send it to the Synthes service center.


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.

Warranty

The warranty for the tools and accessories does not cover damage of any kind resulting from improper use, damaged seals or improper storage and transport. The manufacturer does not accept liability for damage resulting from repairs or maintenance carried out by unauthorized sites.

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.

Lubricants with other compositions can cause jamming, can have a toxic effect or can have a negative impact on the sterilization results. Only lubricate the power tool and the attachments when clean.

Synthes recommends the use of the specifically designed

Synthes Vario Case (68.001.255) and of the specifically

designed Washing Basket (68.001.610) to sterilize and store the system.

The following components are essential to ensure proper operation:

– Handpiece (532.101)

– Battery Casing (532.132)

– Battery (532.103)

– Sterile Cover (532.104)

– Universal Battery Charger II (05.001.204)

– At least one attachment of the system

Please refer to the end of these Instructions for Use for an overview of the components of the system.

Storage and transport

Please use the original packaging for dispatch and transport.

If this is no longer available, please contact the Synthes office.


Explanation of the general symbols used

Caution

Read the provided Instructions for Use before operating the device.

Consult the Instructions for Use before operating the device.

The device is classified as type BF against electrical shock and leakage current. The device is suitable for use on patients according to the standards defined by

CSA 601.1, IEC 60601-1 and UL 60601-1.

Do not immerse device in liquids.

The marked device shall only be used within a specified temperature range.

10PB

Colibri II

With regard to electrical shock, fire, mechanical hazards, only in accordance with UL 60601-1 and

CAN/CSA C22.2 No. 601.1

0123

The device meets the requirements of directive

93/42/EEC for medical devices. It is authorized by an independent notified body for which it bears the CE symbol.

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. See section “Disposal” on page 44.

2 Do not reuse

Products intended for single use must not be reused.

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.

Furthermore, reuse or reprocessing of single use devices may create a risk of contamination e.g. due to the transmission of infectious material from one patient to another. This could result in the injury or death of the patient or user.

Synthes does not recommend reprocessing contaminated products. Any Synthes product that has been contaminated by blood, tissue and/or bodily fluids/matter should never be used again and should be handled according to hospital protocol.

Even though they may appear undamaged, the products may have small defects and internal stress patterns that may cause material fatigue.

Precaution: Risk of fire, explosion and burns. Do not disassemble, crush, heat above 100 °C or incinerate the battery cells.


Colibri II

Handpiece

1 Attachment coupling

2 Trigger for speed regulation

3

6

7

8

Trigger for switching to reverse/oscillating drilling

4 Mode selector switch

5 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 II is equipped with a safety system that prevents the machine from being unintentionally started. To lock and unlock the tool, turn the mode selector switch 4 to the appropriate setting on the front plate of the handpiece: OFF, or ON position.

Protective systems

The Colibri II is equipped with three protective systems:

– A thermal overload safety system that shuts off the tool if it becomes too hot during use. After cooling, the tool can be used again.

– An exhaustive discharge protection ensures that the battery does not completely discharge. This protects the battery and extends its life.

– An internal fuse in the battery that blows in case of unintended short cut. This prevents excessive heat, fire or explosion. If this happens, the battery can not be used anymore.

8

7

5

6

1

4

3

2

Speed and rotational direction control

Mode selector switch in the ON position

The bottom trigger 2 gradually controls the forward speed

(up to approx. 1440 rpm with the AO/ASIF quick coupling).

When the bottom and top triggers 2 and 3 are pressed at the same time, the tool immediately switches to reverse.

When the bottom trigger 2 is released, the tool immediately stops.

6

4

3

2

6 Synthes Colibri II Instructions for Use

6

Mode selector switch in the oscillating drilling position

( )

When the bottom and top triggers the same time, the tool immediately switches to oscillating rotation. When the top trigger to normal forward rotation.

3

2 and 3 are pressed at is released, the tool returns

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 14.4 VDC battery pack (532.033 with battery casing 532.032) can both be used with the new Colibri II handpiece (532.101).

Existing Colibri handpiece is compatible with Colibri II battery pack

The existing Colibri handpiece (532.001) can be used with the new battery pack of the Colibri II (532.103 with battery casing 532.132).

Important:

– The information contained in this Information for Use concerns the Colibri II system. For more information on the

Colibri articles, please refer to the Colibri Instructions for

Use (036.000.173).

– To prevent injury, the machine must be locked with the mode selector switch 4 when coupling and removing attachments and tools, and before laying it down (see page 6).

– Always check correct functioning before use on patient.

– Always have a back-up system to prevent problems in case of deficient system.

– Never place the Colibri II on a magnetic surface since the machine might start unintentionally.

– Always check its functioning before use.

– Pay particular attention to all the instructions in the individual sections that are identified with “Precaution”.

– Components that are no longer useful must be disposed of in accordance with the local and national regulations.

– Always wear personal protective equipment (PPE) including safety goggles when working with the Colibri II system.


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. If the casing is not opened, the same person presses the central button to unlock (Fig. 1), turns the lid sideways (90°) as indicated by the arrow (Fig.2) and pulls to open (Fig. 3). Leave the locking mechanism swung outward.

2. The person wearing the sterile garments 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.

Figure 1

Figure 3

Figure 2

Figure 4


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. 8).

5. The person wearing the sterile garments closes the casing cover from the outside without contacting the battery or the inside of the casing. After having closed the casing cover, turn the lid sideways (90°) until it clicks.

Figure 5 Figure 6

Figure 7 Figure 8


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.

– 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. 9 and 10) so that the locking mechanism properly engages. Always control that the cover is totally closed before using the system.

– Sterilize the sterile cover after each use to ensure aseptic conditions when inserting the unsterile battery into the sterile battery casing.

Figure 9

Figure 10

Inserting the battery pack into the power tool

Guide the battery pack (battery casing with inserted battery) from below into the shaft of the handpiece (Fig. 11). The shape of the battery casing prevents the battery from being inserted incorrectly. Check if the battery pack is seated correctly by gently pulling on it.

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.

Figure 11 Figure 12


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.

– 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 Synthes

Universal Battery Charger II (05.001.204). This will avoid it from discharging, and the battery will be fully charged and ready to use.

– Never load the batteries in another charger than the Universal Battery Charger II (05.001.204).

– The charging station should always be turned on when a battery is in the charging base. This ensures availability and prevents discharge.

Use

– Only insert the battery pack directly before using the

Colibri II. This saves battery energy and prevents having the need to change it during surgery.

– Only use batteries for the indicated purpose.

– Do not transport or store the batteries together with materials that conduct electricity and can cause a short-circuit.

This can damage the battery and generate heat which can cause burns.

– Never open the battery (532.103).

– Never expose batteries to temperatures above 60 °C.

– Do not apply force to the batteries and do not let them fall.

– Never use damaged batteries; they can damage the power tool.

– Follow the additional information in the chapter “Care and Maintenance“ starting on page 29 as well as the Instructions for Use of the Synthes Universal Battery

Charger II (036.000.500).


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). The adapter can be inserted into the Colibri II handpiece and removed like a battery pack (see Fig. 13 and 14). Also follow the Electric Pen Drive’s Instructions for

Use (036.000.800).

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. Simultaneously pressing the top and bottom triggers causes the tool to immediately switch to oscillating mode. The clamped tool oscillates clockwise/anticlockwise.

The speed can be changed by means of the bottom trigger.

After the top trigger is released, the tool returns to normal clockwise rotation.

Figure 13

Precautions:

– Oscillating mode may only be used with the following

attachments:

– AO/ASIF Quick Coupling (532.013, 05.001.250)

– Chuck (05.001.252, 05.001.253)

– Quick Coupling for Kirschner Wires (532.022)

– Do not use the oscillating mode with the oscillating saw attachments!

– You can only switch to reverse by turning the mode

selector switch to ON position.

– The maximum cutting speed of a cutting tool is slightly less in oscillation mode than in normal mode.

Figure 14


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).

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 6 (see figure on page 6) simultaneously and remove the attachment from the coupling.

Precautions:

– To prevent injury, the power tool must be switched off with the safety system (see page 6) during each manipulation.

– Only use original attachments and tools from Synthes.

Damage that arises from using attachments and tools made by other manufacturers is not covered by the warranty.

– Never use an attachment in reverse mode with an old flexible shaft as this could cause serious injury to the patient.

For this application, we recommend to use exclusively the attachment without possible reverse motion (05.001.255).

Figure 1


Attachments

General Information

Article

Number

Product

Drill

Attachments

05.001.250

AO/ASIF Quick Coupling

05.001.252

Chuck (Drilling Speed), with Key, clamping range up to ⭋ 4.0 mm

05.001.253


Speed

1440 rpm

1440 rpm

1440 rpm

384 rpm Screw

Attachments

05.001.251

Screw Attachment with AO/ASIF Quick Coupling

Ream

Attachments

532.017

532.018

532.019

532.020

532.015

AO/ASIF Quick Coupling for Medullary Reaming

Hudson Quick Coupling for Medullary Reaming

Trinkle Quick Coupling for Medullary Reaming

Trinkle Quick Coupling, modified, for Medullary Reaming

Quick Coupling for DHS/DCS triple reamers

05.001.254

Chuck (Reaming Speed), with Key, clamping range up to

⭋ 7.3 mm, with reverse motion

05.001.255


⭋ 7.3 mm, without reverse motion

Other

Rotating

Attachments

532.011

532.012

Mini Quick Coupling

J-Latch Coupling

532.022

Quick Coupling for Kirschner Wires

05.001.187

Burr Attachment

511.300

Radiolucent Drive

384 rpm

384 rpm

384 rpm

384 rpm

384 rpm

384 rpm

384 rpm

3840 rpm

3840 rpm

960 rpm

16000 rpm

3840 rpm

Saw

Attachments

Other

Attachments

532.021

532.023

532.026

511.773

511.776

511.777

Oscillating Saw Attachment

Oscillating Saw Attachment II (Crescentic Technique)

Large Oscillating Saw Attachment

Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling

Torque Limiter, 0.8 Nm, with AO/ASIF Quick Coupling


19200 rpm

19200 rpm

19200 rpm

–

–

–

Red

Red

Red

Red

Red

Red

Red

Color coding

Blue

Blue

Blue

Red

None

None

None

None

None

None

None

None

None

None

None

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.


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.

Article number Clamping range Spare key Comments

05.001.252 0 – 4.0 mm 310.932 For drilling

05.001.253 0 – 7.3 mm 510.191 For drilling

Inserting cutting tools

Open the jaws of the 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. Tighten the drill chuck with the key. Make sure that the teeth of the key engage correctly in the toothed rim of the chuck.

Removing cutting tools

Open the Chuck with the key and remove the tool.

Precautions:

– Do not use the Colibri II for acetabular reaming.

– Check the cutting tool for wear and/or damage after each use and replace if necessary.

– To ensure good fixation of the tools, make sure the toothed rims on the drill chuck and key are not worn.


Attachments

Screw Attachments

Screw Attachment, with AO/ASIF Quick Coupling

(05.001.251)


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.


Precautions:

– Care should be taken when inserting screws with the drive unit.

– Never fully insert screws with the drive unit. The last turns or locking should always be done manually.

– Always use an appropriate torque limiting attachment when putting locking screws into a locking plate.

– Theoretically, it is also possible to use the AO/ASIF Quick

Coupling (05.001.250) to insert screws. However, the

Screw Attachment (05.001.251) has a lower speed and a higher torque and is therefore more suitable. Screws with a large diameter may not be able to be inserted with the

AO/ASIF Quick Coupling as the torque may not suffice.

– The attachment is also suitable for application at a lower rpm and/or higher torque.


Attachments

Ream Attachments

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.

Reverse motion, which can damage the flexible shafts, is prevented by a special mechanical system.

Inserting cutting tools into the coupling

Maneuver the unlocking ring on the attachment backward and insert the tool (such as a drill bit) while rotating it slightly until it locks into place. Release the ring. Check if the tool is seated correctly in the coupling by gently pulling on it.


Push the unlocking ring on the attachment backward and remove the tool.

Precautions:

– Do not use “Quick Couplings for Medullary Reaming” for acetabular reaming. They may only be used for medullary reaming.


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.


To connect the tool, push the coupling sleeve forward and then introduce the tool while turning slightly. To disconnect, push the coupling sleeve of the attachment forward and remove the tool.


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. 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. Tighten the drill chuck with the key. Make sure that the teeth of the key engage correctly in the toothed rim of the chuck.


Open the chuck with the key and remove the tool.

Precautions:

– Do not use the Colibri II for acetabular reaming.


– To ensure good fixation of the tools, make sure the toothed rims on the drill chuck and key are not worn.

– Use the Chuck with Reverse motion (05.001.254) only with tools that are approved for such use. Otherwise, the tool may break with subsequent damage.


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.


To connect the tool, pull the coupling sleeve back and then introduce the tool while rotating slightly.


Quick Coupling for Kirschner Wires (532.022)

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 K . Slightly press the adjusting sleeve axially against the handpiece and rotate the sleeve.

2. Apply a slight amount of pressure to insert the Kirschner

Wire from the front or back into the cannulation J . The wire is held automatically.

3. Adjust the working length by pulling on the wire.

4. To affix the wire, pull the tension lever L against the tool with your little finger and ring finger. Only pull the tension lever against the tool as much as necessary. The clamping force can be varied by pulling and releasing the clamping lever.

5. Insert the wire into the bone. Apply the clamping force as long as the wire is advanced.

6. To adjust the grip on the wire, reduce the clamping force and move the tool to the desired length. Reclamp the wire by pulling on the tension lever.

K

L

J


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. 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.

Inserting the drill bit

Pull the ring on the attachment forward and position the drill bit inside the coupling as far as it can go while rotating it slightly. Engage the ring on the attachment back in order to fix the drill. Check if the drill bit is seated correctly by gently pulling on it.

Removing the drill bit

Follow the same procedure in reverse order.

(05.001.250) (532.031) (511.300)


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.

Swing the drive up and center it precisely so that the drill bit appears as a round point and the locking hole is visible around it. The target ring also assists the centering. The locking hole can now be drilled directly.


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.

– 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.

– To protect the gears, the Radiolucent Drive is equipped with a slip clutch that disengages in case of an overload and emits an audible rattling noise.

– The following procedures can cause an overload:

– Correcting the drilling angle when the cutting edges of the drill bit are completely in the bone.

– Hitting the nail with the drill bit.

– Drilling can continue after making the following corrections:

– Correcting the drilling angle: Remove the drill bit until the flutes are visible and then restart the drilling.

– Hitting a nail: Remove the drill bit until the flutes are visible and re-aim the drill bit or exchange the drill bit if necessary.


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.

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. Insert the new tool as far as possible, turn it slightly until it locks in place and then turn the release sleeve for burrs into the LOCK position until it engages. The burr is correctly clamped when the marking M or L 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 the burr

Precautions:

– Burrs must be cooled with irrigation liquid to prevent heat necrosis.

– The attachments may only be used with the burrs intended for this purpose or one size above (attachment is size M, please therefore only use burrs of size M or L).

– Synthes recommends wearing protective goggles when working with burrs.

M


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).

Figure 1

Precaution: To prevent injury, always grip the saw attachment with the inserted saw blade from the direction of the machine.

Changing the saw blade (Fig. 2)

1. Lock the machine.

2. Pull the locking knob O down and turn it counterclockwise.

3. Lift and remove the saw blade.

4. Use a slight amount of pressure to insert the new saw blade and turn it to the desired position. The desired positions can be offset from each other at 45º angles.

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.

6. Unlock the power tool.

Figure 2

Precaution: Saw blades labeled “Single Use” should not be used repeatedly because of cleaning problems.

N

Figure 3

O


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. Optimal saw performance is achieved by moving the power tool slightly back and forth in the plane of the saw blade so that the blade oscillates beyond the bone on both sides. Very precise cuts can be made when the saw blade is guided steadily. Imprecise cuts arise due to used blades, excess pressure or jamming the saw blade.

Instructions for handling the saw blades

Synthes recommends using a new blade for each operation to ensure that the saw blade is optimally sharpened and clean. The following risks are associated with used blades:

– Necrosis caused by excessive heat build-up

– Infection caused by residue

– Extended cutting time due to poor saw performance

Figure 4


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).

Inserting the saw blade

Pull the saw blade coupling toward the handpiece and insert the saw blade while rotating it slightly until it locks into the saw attachment coupling. Release the saw blade coupling and check that the saw blade is correctly fixed by gently pulling on the saw blade.

Removing the saw blade

Pull the saw blade coupling towards the handpiece to release the saw blade.

Precautions:

– The saw attachments may only be used with the handpiece in the ON mode. Never use the attachments in oscillating drilling mode ( ).

– The appropriate surgical technique (036.000.907) should be observed to ensure the safe and successful application of the Crescentic Technique.

70 mm


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 (532.027) that was delivered with the attachment or use a T15 StarDrive screwdriver (e.g. 314.115).

Check that the saw blade is correctly in place and properly tightened.

Mounting the saw attachment

Make sure that the mode switch of the handpiece is in the

OFF position and that the locking sleeve on the saw attachment is set to the unlock position . 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 increase the sawing capacity, additional manual tightening of the attachment onto the handpiece is required. Turn the locking sleeve into the lock direction until you feel that the coupling pins engage into the handpiece

(approx. half a revolution).

Precautions:

– Set the mode switch of the Colibri II to the ON position.

Never operate the Large Oscillating Saw attachment in the oscillating drilling mode ( ).

– Avoid applying high pressure onto the saw blade.

Removing the saw attachment

Turn the locking sleeve to the unlock position before pushing both release buttons on the handpiece.


Attachments

Other Attachments

Torque Limiter 1.5 Nm (511.773)



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.

Using the Torque Limiter

Pick up a screw from the corresponding LCP system (Locking

Compression Plate) with the screwdriver shaft and insert it in the desired plate hole. To insert the screw, start the power tool slowly, increase the speed and then reduce it again before the screw is fully tightened. The torque is automatically limited to 1.5, 0.8 or 0.4 Nm. When this limit is reached, you will hear a distinct clicking. Stop the tool immediately and pull the tool away from the screw.

Follow the surgical technique of the respective LCP system.

Precaution: The Torque Limiter must be annually serviced and recalibrated by Synthes. Note the information on the test certificate in the packaging. The user is responsible for following the calibration schedule.


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.

Unusual Transmissible Pathogens

Surgical patients identified as at risk for Creutzfeldt-Jakob disease (CJD) and related infections should be treated with single-use instruments. Dispose of the instruments used or suspected of use on a patient with CJD after surgery and/or follow the current national recommendations.

Gentle care and maintenance with proper lubrication 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 manu facturer assumes no warranty for damages arising from improper use, neglected or unauthorized servicing.

For more information about Care and Maintenance, please refer to the Colibri II Care and Maintenance Poster

(036.001.383).

Precautions:

– Reprocessing must be performed immediately after each use.

– Cannulations, unlocking sleeves and other narrow sites require special attention during cleaning.

– Cleaners with pH 7 – 9.5 are recommended. The use of cleaners with higher pH values can – depending on the cleaner – cause the dissolution of the surface of aluminum and its alloys, plastics or compound materials and they should only be used considering the data regarding material compatibility according to its data sheet. At pH values higher than 11, the surfaces of stainless steel can also be affected. For detailed information about material compatibility, see “Material Compatibility of Synthes Instruments in Clinical Processing“ at www.synthes.com/reprocessing.

– Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for the correct dilution concentration, temperature, exposure time and water quality. If the temperature and time are not specified, follow Synthes’ recommendations. Devices should be cleaned in a fresh, newly-made solution.

– Detergents used on the products will be in contact with the following materials: stainless steel, aluminum, plastic and rubber seals.

– Synthes recommends using new sterile cutting tools for each operation. Refer to “Clinical Processing of Cutting

Tools” (036.000.499) for detailed clinical processing instructions.

Important:

– The clinical processing instructions provided have been validated by Synthes for preparing a non-sterile Synthes medical device; these instructions are provided in accordance with ISO 17664:2004 and ANSI/AAMI ST81:2004.

– Consult the national regulations and guidelines for additional information. In addition, compliance with internal hospital policies and the procedures and recommendations of manufacturers of detergents, disinfectants and any clinical processing equipment is additionally required.

– It remains the responsibility of the processor to ensure that the processing performed achieves the desired result using the appropriate properly installed, maintained and validated 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 consequences.



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.

Battery poles must not contact water or solvents: danger of short circuiting!

Figure 1

Return batteries to charger (05.001.204) after each use

(Fig. 3).

Never immerse the handpiece, lid or attachments in aqueous solutions or in an ultrasonic bath as this could decrease the service life of the system.

Handpieces and attachments may be processed using a) manual cleaning and/or b) automated cleaning with manual pre-cleaning.

Note: Clean all movable parts in opened position.

Figure 2

Figure 3



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. Manipulate all moving parts such as the triggers, sleeves and switches under running tap water to loosen and remove gross debris.

3. Spray and wipe. Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes.

Follow the enzymatic detergent manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and concentration/dilution.

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.

Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct temperature, water quality and concentration/dilution.



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. Final rinse with de-ionized/purified water.

Final rinse with de-ionized or purified water for a minimum of

2 minutes.

8. Dry.

Dry device using a soft lint-free cloth or clean compressed air.



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. 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. Manipulate all moving parts such as the triggers, sleeves and switches under running tap water to loosen and remove gross debris.

3. Spray and wipe. Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes.

Follow the enzymatic detergent manufacturer’s directions for correct temperature, water quality (i.e. pH, hardness) and concentration/dilution.



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.

Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for correct temperature, water quality and concentration/dilution.

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. Load washing basket.

Place devices in the specially

designed tray for machine washing supplied by Synthes

(68.001.610). Ensure that all cannulations (handpiece and attachments), if applicable, are positioned vertically, i.e. in an upright position as shown.

Note: Specific lid (68.001.602) is available for the washing basket.


8. Automated cleaning cycle parameters

Note: The washer/disinfector should fulfill the requirements as specified in ISO 15883.

Step Duration Cleaning instructions

(minimum)

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.

Remove all the devices from the washing basket. Inspect the cannulations, coupling sleeves, etc. for visible soil. If necessary, repeat the manual pre-clean/automated cleaning cycle. Confirm that all parts are completely dry.

Mechanical cleaning/disinfection is an additional stress for power equipment, especially for seals and bearings.

Therefore, systems must be properly lubricated and regularly sent to be serviced (at least once per year).



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.

1

For detailed information, please refer to the Colibri II Care and Maintenance Poster (036.001.383).

1

Lubricating the handpiece (Fig. 1 and 2)

– Lubricate the trigger shafts and then press the triggers several times.

– Lubricate the attachment release buttons and then press the buttons several times.

– Lubricate the battery casing release buttons from both the outside and inside (see Fig. 2) and then press the buttons several times.

– Lubricate the mode selector switch and then move it several times.

– Lubricate the attachment coupling.

Figure 1

1

1

1

1

Figure 2

1


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.

1

Figure 3

1

1

1

Figure 4



Lubrication

Attachments

All moving parts of all the attachments. Exception: the

Radio lucent 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.

Quick Coupling for Kirschner Wires (532.022)

Lubricate the tension lever and clamping mechanism.

Hold the Quick Coupling up and add one drop of oil into the attachment hole and on the holder of the lever (Fig. 5).

Move the tension lever several times.

Mini Quick Coupling (532.011)

J-Latch Coupling (532.012)

AO/ASIF Quick Coupling (05.001.250/05.001.251)

Quick Coupling for DHS/DCS Triple Reamers (532.015)

Quick Coupling for Medullary Reaming

(532.017/532.018/532.019/532.020)

Lubricate the unlocking ring. Move it back and forth several times.

Figure 5

1

Oscillating Saw Attachment (532.021)

Lubricate the locking mechanism and the saw blade coupling.

Open and close the locking mechanism several times.

Oscillating Saw Attachment II (532.023)

Lubricate the unlocking sleeve, the tool holder and the attachment coupling. Move it back and forth several times.

Large Oscillating Saw Attachment (532.026)

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

Figure 6

1

1

1


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.

– Only lubricate the power tool and attachments when clean.



Function Control

– Visually inspect for damage and wear.

– Check the handpiece controls for smooth operation and function.

– Check the coupling sleeves of the handpiece and attachments for smooth operation and check for function together with instruments such as cutting tools.

– Check instruments for correct adjustment and functioning prior to every use.



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.

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).

Synthes Colibri II system may be resterilized using validated steam sterilization methods (ISO 17665 or national standards). Synthes’ recommendations for packed devices and cases are as follows.

Cycle type

Saturated steam-forced air removal (pre-vacuum,

minimum 3 pulses)

Sterilization exposure time

Minimum 4 minutes

Minimum 3 minutes

Sterilization exposure temperature

Minimum 132 °C

Maximum 138 °C

Minimum 134 °C

Maximum 138 °C

Drying times generally range from 20 to 60 minutes due to differences in packaging materials (Sterile Barrier System, e.g., wraps or reusable rigid container systems), steam quality, device materials, total mass, sterilizer performance and varying cool down time.

Precautions:

– The following maximum values may not be exceeded:

138 °C over a maximum of 18 minutes. Higher values can damage the sterilized products.

– Do not accelerate the cooling process.

– Hot air, ethylene oxide, plasma and formaldehyde sterilization are not recommended.

Drying time

20 – 60 minutes

20 – 60 minutes



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.



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”).

Other than the above-mentioned care and maintenance, no further maintenance work may be carried out independently or by third parties.

Synthes recommends the device and accessories such as attachments to be regularly (once a year) serviced by the original manufacturer or an authorized site.

Precaution: The manufacturer assumes no responsibility for damage resulting from neglected or unauthorized maintenance.

Colibri II Instructions for Use Synthes 43


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.

– Risk of fire, explosion and burns. Do not disassemble, crush, heat above 100 °C or incinerate the battery cells.

Please send tools 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 respective directive. The tool may not be disposed of with household waste.


Troubleshooting

Problem

Handpiece does not start up.

Possible causes

Battery is dead.

Solution

Charge the battery or replace it with a charged battery.

Let the tool cool to room temperature.

The tool was not cooled off after

sterilization.

Mode selector switch is on OFF.

Turn the mode selector switch to ON or

.

Reinsert the battery pack or replace it.

No contact between the handpiece and the battery pack.

Battery is dead.

Handpiece does not have enough power.

Machine stops suddenly.


Wait until the machine has cooled down.

The machine has overheated (over heating protection is activated).

Battery is dead.

Attachments cannot be coupled to the unit.

The attachment coupling is blocked by deposits.

Tool (saw blade, drill, burr etc.) can not be coupled or only with difficulty.

Shaft geometry of the attachment or tool is damaged.

Oscillating saw attachment vibrates too much.

The saw blade locking mechanism is not tight.

The Kirschner wire is inserted in the handpiece and cannot be moved

forward.

The mode selector switch is set to .

The Kirschner wire was inserted from the rear.

Bone and tool heat up during surgery.

Cutting edges of the tool are blunt.


Remove solid objects with a pair of tweezers.

Precaution: When removing objects, turn the mode selector switch to OFF.

Replace the attachment or tool or send it to your Synthes service office.

Tighten the locking knob of the saw blade coupling.

Turn the mode selector switch to ON.

Lock the machine by turning the mode selector switch to OFF. Remove the attachment, hold the drive shaft opening down and shake out the Kirschner wire.

Replace the tool.


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.

It is difficult to couple the battery casing to the machine.

Colibri II is used with the EPD console and handpiece does not start up.

The trigger shafts need to be lubricated. Lubricate the trigger shafts as described on page 36.

The battery casing release buttons need to be lubricated.

Console is not switched on or not

connected.

Lubricate the battery casing release buttons as described on page 36.

Connect console and/or switch it on.

Handpiece is not connected to console.

Connect handpiece to console.

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.


System Specifications

The device meets the following standards

EN 60601-1 / IEC 60601-1 /

EN 60601-1-2 / IEC 61000-6-1 /

IEC 61000-6-2 / IEC 61000-6-3

IEC 61000-6-4

Medical electrical devices

UL 60601-1

Only in conformance with EN 60601-1 and UL 60601-1 and

CAN/CSA C22.2 No. 601.1 in reference to electrical shock, fire, casualty.

Environmental conditions

Operation Storage

Temperature: 10 – 40 °C 10 – 40 °C

Relative humidity: 10 – 90 % 10 – 90 %

Atmospheric pressure: 500 – 1060 hPa 500 – 1060 hPa

Altitude: max. 5000 m max. 5000 m

Technical Data

Colibri II: 532.101

Continuously adjustable speed: 0 – 3500 rpm

Weight (w. battery): 918 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)

Transportation

Temperature: –29 – 60 °C for max. 72 h

Relative humidity: 10 – 90 %

Atmospheric pressure: 500 – 1060 hPa

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.


System Specifications

Duty Cycle:

Intermittent operation

X s on

Y s 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 30 sec 60 sec 5

532.023 15 sec 60 sec 4

532.026 30 sec 60 sec 4

Other attachments 60 sec 60 sec 7

Precautions:

– Carefully observe the above recommended duty cycles.

– Always use new cutting tools to prevent the heating up of the system due to reduced cutting performance.

– Careful maintenance of the system will reduce heat development in the handpiece and the attachments.

– The Colibri II must not be stored or operated in an explosive atmosphere.

Generally, electrical systems can heat up if in constant use.

For this reason, the handpiece and the attachment should be allowed to cool for at least 60 seconds (Y s off

) following the time of constant use (X s on

). After a certain amount of cycles

(defined in the above table under “Cycles”), the handpiece and attachment should be allowed to cool for 30 minutes. If this is observed, the system will be prevented from overheating and possibly harming the patient or user. The user is responsible for the application and for turning off the system as prescribed. If longer periods of constant use are required, an additional handpiece and/or attachment should be used.

These recommendations for times of use for the attachments of the Colibri II have been determined under average load with an ambient air temperature of 20 °C (68 °F). Depending on the cutting tool used and on the load applied, the heat generation of the handpiece, attachment and/or cutting tool can vary. Always control the temperature of the system to prevent overheating and possibly harming the patient or user.


Declaration of the emission sound pressure level and the power level according to the EU guideline 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.

Handpiece

Colibri II

(532.101)

Attachment Tool

– –

AO/ASIF Quick

Coupling (05.001.250)

–

Oscillating Saw

Attachment (532.021)

Saw blade

(532.045)

Saw blade

(532.067)

73

85

Oscillating Saw


Saw blade

(03.000.313)

84

Saw blade

(03.000.316)

85

Large Oscillating Saw


Saw blade

(03.000.394)

83

Saw blade

(03.000.396)

85

63

64

Sound Pressure

Level (LpA) in

[dB(A)]

Sound Power

Level (LwA) in

[dB(A)]

–

–

Max. daily exposure time without hearing protection

> 8 h

> 8 h

–

94

92

94

92

96

> 8 h

8 h

> 8 h

8 h

> 8 h

8 h


System Specifications

Declaration of vibration emission according to the EU guideline 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

Colibri II

(532.101)

Attachment

– –

AO/ASIF Quick Coupling

(05.001.250)

–

Oscillating Saw


Saw blade

(532.045)

Saw blade

(532.067)

Oscillating Saw


Tool

Saw blade

(03.000.313)

Declaration [m/s 2 ] Max. daily exposure

< 2.5

< 2.5

vertical: < 2.5

horizontal: < 2.5

vertical: 3.73

horizontal: 6.58

< 2.5

Saw blade

(03.000.316)

6.2

No limitation

No limitation

No limitation

No limitation

No limitation

4 h 35 min

No limitation

5 h 12 min

Large Oscillating Saw


Saw blade

(03.000.394)

14.02

Saw blade

(03.000.396)

18.44

1h 1 min

35 min


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 environment – guidance Emission test

RF emissions

CISPR 11

Compliance

Group 1 The Synthes Colibri II system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Class B

Not applicable

The Synthes Colibri II system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

Not applicable


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



Immunity test standard

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power

supply lines

Not applicable

Floors should be wood, concrete or ceramic tile.

If the floors are covered with synthetic material, the relative humidity should be at least 30 %.

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

±1 kV line to line

±2 kV line to earth

Not applicable Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interrup tions and voltage variations on power supply lines

IEC 61000-4-11

< 5 % U

T

(0.5 cycle)

40 % U

T

(5 cycles)

70 % U

T

(25 cycles)

< 5 % U

T for 5 s

Nicht anwendbar

Note: U

T is the AC mains voltage prior to the application of the test level.

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 100 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a

typical commercial or hospital environment.


Table 3: Immunity (not life-supporting devices)

Guidance and manufacturer’s declaration – electromagnetic immunity



Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Synthes Colibri II system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Immunity test standard

Conducted RF

IEC 61000-4-6

IEC 60601 test level

3 Vrms

150 kHz to 80 MHz

Compliance level

Not applicable

Recommended separation distance a d = 0.35

公僓

150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

3 V/m E1 = 10 V/m

(measured 20 V/m)

80 MHz to 800 MHz d = 0.35

公僓

80 MHz to 800 MHz 80 MHz to 800 MHz d = 0.35

公僓

Radiated RF

IEC 61000-4-3

3 V/m E2 = 10 V/m

(measured 20 V/m)

80 MHz to 800 MHz 800 MHz to 2.5 GHz 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters as determined by an electromagnetic site survey, b should be less than the compliance level in each frequency range.

c

Interference may occur in the vicinity of equipment marked with the following symbol:

Notes:

– At 80 MHz and 800 MHz, the higher frequency range applies.

– These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Possible shorter distances of outside ISM bands are not considered to have a better applicability of this table.

b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Synthes Colibri II system is used exceeds the applicable 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 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.


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. The customer or user of the Synthes Colibri II system can help prevent electromagnetic interference 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 of the communication equipment.

Rated maximum output power of transmitter

W

1

10

0.01

0.1

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz d = 0.35 P

4 cm

80 MHz to 800 MHz d = 0.35

4 cm

P

800 MHz to 2.5 GHz d = 0.35 P

4 cm

11 cm 11 cm 44 cm

35 cm

1.11 m

35 cm

1.11 m

1.4 m

4.4 m

100 3.5 m 3.5 m 14 m

For transmitters rated at a maximum output 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 rating of the transmitter in watts (W) according to the transmitter manufacturer.

Notes:

– At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

– These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

– An additional factor of 10/3 is used in calculating the recommended separation distance to decrease the likelihood that

mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.


Ordering Information

Drive unit

532.101

Colibri II

Consoles

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

532.103

532.104

Battery Casing for Nos. 532.101 and 532.110,

with Locking for Lid

Battery for Nos. 532.101 and 532.110

Sterile Cover for Nos. 532.101 and 532.110

05.001.204

Universal Battery Charger II

Attachments

532.011

Mini Quick Coupling,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.012

J-Latch Coupling,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

05.001.250

AO/ASIF Quick Coupling,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

05.001.251

Screw Attachment with AO/ASIF Quick Coupling,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

05.001.252


05.001.253


05.001.254

Chuck (Reaming Speed), with Key, clamping range up to ⭋ 7.3 mm,

with reverse motion

05.001.255


⭋

7.3 mm,

without reverse motion

532.015

Quick Coupling for DHS/DCS triple reamers,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.017

AO/ASIF Quick Coupling for Medullary Reaming,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.018

Hudson Quick Coupling for Medullary Reaming,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.019

Trinkle Quick Coupling,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.020

Trinkle Quick Coupling, modified,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.022

Quick Coupling for Kirschner Wires

⭋

0.6 to 3.2 mm,

for Nos. 532.001, 532.010, 532.101 and 532.110

05.001.187

Burr Attachment,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.021

Oscillating Saw Attachment,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.023

Oscillating Saw Attachment II (Crescentic Technique),

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.026

Large Oscillating Saw Attachment,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

532.031

Adapter for Radiolucent Drive,

for Nos. 532.001, 532.010, 532.101, 532.110 and 05.001.175

511.300

511.773

Radiolucent Drive

Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling

511.776

511.777



Accessories

68.001.255

Vario Case, size 1/1, for Colibri II and Small Battery Drive II,

without Lid, without Contents

689.507

Lid (stainless steel), size 1/1, for Vario Case

68.001.253

Vario Case for attachments for Colibri (II), Small Battery Drive (II)

and Small Electric Drive

519.400

Cleaning Brush for Compact Air Drive, Power Drive, Colibri (II)

and Small Electric Drive

68.001.610

Washing Basket, size 1/1, for Colibri (II) and Small Battery Drive (II)

68.001.602

Lid for Washing Basket, size 1/1

519.970

532.024

310.932

510.191

Oil Dispenser with Synthes Special Oil, 50 ml

Cleaning Brush for Oscillating Saw Attachment II (532.023)

Spare Key for Drill Chuck, clamping range up to ⭋ 4.0 mm

Spare Key for Drill Chuck, clamping range up to ⭋ 7.3 mm


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.


All technique guides are available as PDF files at www.synthes.com/lit

Ö036.001.387öAAoä

0123

Synthes Colibri II Instructions For Use Manual

Instructions for Use

Colibri II. Universal battery power tool system for use in traumatology, hand and foot surgery.

Contents

Introduction

General Information

Colibri II

Handpiece

Use

Attachments

General Information

Drill Attachments

Screw Attachments

Ream Attachments

Other Rotating Attachments

Saw Attachments

Other Attachments

Care and Maintenance

General Information

Preparation Prior to Cleaning

Manual Cleaning Instruction

Mechanical/Automated Cleaning

Instruction with Manual Pre-cleaning

Lubrication

Function Control

Packaging, Sterilization and Storage

Repairs and Technical Service

Disposal

Troubleshooting

System Specifications

Electromagnetic Compatibility

Accompanying Documents According to

IEC 60601-1-2, 2007, Clause 6

Ordering Information

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