Colibri ll

Instructions

for Use

Colibri II. Universal battery power tool

system for use in traumatology, hand

and foot surgery.

Colibri II Gebrauchsanweisung Synthes 1

Introduction

Colibri II

Attachments

Care and Maintenance

General Information 3

Handpiece 6

Use 8

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 33

with Manual Pre-cleaning

Lubrication 36

Function Control 40

Packaging, Sterilization and Storage 41

Repairs and Technical Service 43

Disposal 44

Contents

2 Synthes Colibri II Gebrauchsanweisung

Contents

Troubleshooting 45

System Specifications 47

Electromagnetic Compatibility

Ordering Information 55

Accompanying Documents 51

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.

Colibri II Gebrauchsanweisung Synthes 3

Intended use

The Colibri II is a battery-driven power tool for use in trauma-

tology 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. It is recom-

mended that an alternative system is available to use during

application, as technical problems can never be completely

ruled out.

The Colibri II is designed for use by physicians and trained

medical personnel.

DO NOT use any component if damage is apparent.

DO NOT use any component if the packaging is damaged.

DO NOT use this equipment in the presence of oxygen, ni-

trous oxide or a mixture consisting of flammable anesthetics

and air.

To ensure the proper operation of the tool, only use Synthes

original accessories.

Before the first and every subsequent use, power tools and

their accessories/attachments have to run through the com-

plete reprocessing procedure. Protective covers and foils

must be fully removed before sterilization.

For the tool to function properly, Synthes recommends clean-

ing and servicing it after each use in accordance with the

process recommended in the chapter “Care and Mainte-

nance”. Compliance with these specifications can consider-

ably extend the service life of the tool. Only use Synthes oil

(519.970) to lubricate the tool.

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 cut-

ting tools for every surgery. Cutting tools must be cooled

with irrigation liquid to prevent heat necrosis.

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”.

For important information regarding electromagnetic com-

patibility (EMC), please refer to the chapter “Electromagnetic

Compatibility” in this manual.

The tool is classified as type BF against electrical shock and

leakage current. The tool is suitable for use on patients in ac-

cordance with IEC 60601-1.

To ensure the proper operation of the tool, Synthes recom-

mends annual maintenance by a Synthes service center. The

manufacturer shall assume no responsibility for damage re-

sulting from improper operation, neglected or unauthorized

maintenance of 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 bat-

tery. 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 de-

fects, do not use it anymore and send it to the Synthes

service center.

Introduction

General Information

4 Synthes Colibri II Gebrauchsanweisung

Accessories/scope of delivery

The Colibri II consists of a handpiece, one or several battery

casings and batteries and a range of attachments and acces-

sories 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.

Lubricants with other compositions can cause jamming, can

have a toxic effect or can have a negative impact on the ster-

ilization results. Only lubricate the power tool and the at-

tachments 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 op-

eration:

– 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.

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.

Introduction

General Information

Colibri II Gebrauchsanweisung Synthes 5

Explanation of the general symbols used

Caution

Read the provided Instructions for Use before operat-

ing 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 speci-

fied temperature range.

Colibri II

With regard to electrical shock, fire, mechanical haz-

ards, only in accordance with UL 60601-1 and

CAN/CSA C22.2 No. 601.1

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.

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.

Precaution: Risk of fire, explosion and burns. Do not disas-

semble, crush, heat above 100 °C or incinerate the battery

cells.

10PB

01 23

Li-Ion

Do not reuse

Products intended for single use must not be reused.

Reuse or reprocessing (e.g. cleaning and resteriliza-

tion) 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 de-

vices may create a risk of contamination e.g. due to

the transmission of infectious material from one pa-

tient to another. This could result in the injury or

death of the patient or user.

Synthes does not recommend reprocessing contami-

nated 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 prod-

ucts may have small defects and internal stress pat-

terns that may cause material fatigue.

2

1

6

6 6

4

3

2

7

3

4

2

5

8

6 Synthes Colibri II Instructions for Use

1 Attachment coupling

2 Trigger for speed regulation

3 Trigger for switching to reverse/oscillating drilling

4 Mode selector switch

5 Battery pack (battery casing with inserted battery)

6 Release buttons for attachment

7 Release buttons for battery casing

8 Knob for the battery casing cover

Safety system

The Colibri II is equipped with a safety system that prevents

the machine from being unintentionally started. To lock and

unlock the tool, turn the mode selector switch 4 to the ap-

propriate 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 bat-

tery does not completely discharge. This protects the bat-

tery and extends its life.

– An internal fuse in the battery that blows in case of unin-

tended short cut. This prevents excessive heat, fire or ex-

plosion. If this happens, the battery can not be used any-

more.

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.

Colibri II

Handpiece

Colibri II Gebrauchsanweisung Synthes 7

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 14.4 VDC bat-

tery 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 con-

cerns 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 at-

tachments 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 indi-

vidual 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) includ-

ing safety goggles when working with the Colibri II system.

8 Synthes Colibri II Instructions for Use

Figure 4Figure 3

Before initial use, brand-new tools and accessories must un-

dergo 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 cas-

ing by two people, one of whom is wearing sterile garments:

1. The person with the sterile garments holds the sterile bat-

tery 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 out-

ward.

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 unster-

ile battery does not contact the outside of the sterile cas-

ing.

Colibri II

Use

Figure 1 Figure 2

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 per-

son 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 bat-

tery 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.

Colibri II Gebrauchsanweisung Synthes 9

Figure 7 Figure 8

Figure 5 Figure 6

10 Synthes Colibri II Instructions for Use

Colibri II

Use

Figure 9

Figure 10

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 chang-

ing 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 11 Figure 12

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 cor-

rectly 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.

Colibri II Gebrauchsanweisung Synthes 11

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 Uni-

versal 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 ma-

terials 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 In-

structions for Use of the Synthes Universal Battery

Charger II (036.000.500).

12 Synthes Colibri II Instructions for 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 clock-

wise 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.

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 13 Figure 14

Colibri II

Use

Colibri II Gebrauchsanweisung Synthes 13

Figure 1

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 cou-

pling.

Precautions:

– To prevent injury, the power tool must be switched off

with the safety system (see page 6) during each manipula-

tion.

– 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 war-

ranty.

– Never use an attachment in reverse mode with an old flex-

ible 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).

Attachments

General Information

14 Synthes Colibri II Instructions for Use

Article

Number

Product Speed Color

coding

Drill

Attachments

05.001.250 AO/ASIF Quick Coupling 1440 rpm Blue

05.001.252

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

1440 rpm 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 AO/ASIF Quick Coupling for Medullary Reaming 384 rpm Red

532.018 Hudson Quick Coupling for Medullary Reaming 384 rpm Red

532.019 Trinkle Quick Coupling for Medullary Reaming 384 rpm Red

532.020 Trinkle Quick Coupling, modified, for Medullary Reaming 384 rpm Red

532.015 Quick Coupling for DHS/DCS triple reamers 384 rpm Red

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

⭋ 7.3 mm, with reverse motion

384 rpm Red

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

⭋ 7.3 mm, without reverse motion

384 rpm Red

Other

Rotating

Attachments

532.011 Mini Quick Coupling 3840 rpm None

532.012 J-Latch Coupling 3840 rpm None

532.022 Quick Coupling for Kirschner Wires 960 rpm None

05.001.187 Burr Attachment 16000 rpm None

511.300 Radiolucent Drive 3840 rpm None

Saw

Attachments

532.021 Oscillating Saw Attachment 19200 rpm None

532.023 Oscillating Saw Attachment II (Crescentic Technique) 19200 rpm None

532.026 Large Oscillating Saw Attachment 19200 rpm None

Other

Attachments

511.773 Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling – None

511.776 Torque Limiter, 0.8 Nm, with AO/ASIF Quick Coupling – None

511.777 Torque Limiter, 0.4 Nm, with AO/ASIF Quick Coupling – 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

General Information

Colibri II Gebrauchsanweisung Synthes 15

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 op-

erate 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.

16 Synthes Colibri II Instructions for Use

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 apply-

ing 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. 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

Screw Attachments

Colibri II Gebrauchsanweisung Synthes 17

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 pre-

vented 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.

Removing cutting tools

Push the unlocking ring on the attachment backward and re-

move the tool.

Precautions:

– Do not use “Quick Couplings for Medullary Reaming” for

acetabular reaming. They may only be used for medullary

reaming.

– Check the cutting tool for wear and/or damage after each

use and replace if necessary.

Quick Coupling for DHS/DCS Triple Reamers (532.015)

For DHS/DCS Triple Reamers; can also be used to open the

medullary cavity with most of the Synthes nailing systems.

Mounting and removing the tools

To connect the tool, push the coupling sleeve forward and

then introduce the tool while turning slightly. To disconnect,

push the coupling sleeve of the attachment forward and re-

move the tool.

18 Synthes Colibri II Gebrauchsanweisung

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.

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.

– 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

Ream Attachments

J

L

K

Colibri II Gebrauchsanweisung Synthes 19

Attachments

Other Rotating Attachments

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.

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.

(511.300)(532.031)(05.001.250)

20 Synthes Colibri II Instructions for Use

Attachments

Other Rotating Attachments

Radiolucent Drive (511.300)

The Radiolucent Drive can be used with the Colibri II in com-

bination 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. Sup-

port 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.

Colibri II Gebrauchsanweisung Synthes 21

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 lock-

ing hole can now be drilled directly.

22 Synthes Colibri II Instructions for Use

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 Syn-

thes representative will be glad to provide you with addi-

tional information on which drill bits can be used.

– Handle the Radiolucent Drive with great care. Do not al-

low 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 correc-

tions:

– 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.

M

Colibri II Gebrauchsanweisung Synthes 23

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 cor-

rectly 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 oper-

ation. 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 in-

tended 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.

ON

24 Synthes Colibri II Instructions for Use

Attachments

Saw Attachments

Precaution: Even if lines and measurements are indicated on

the saws, these articles should not be used as measuring in-

struments.

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 slid-

ing sleeve N toward the saw blade coupling and rotate the

attachment into the desired position (Fig. 1).

Precaution: To prevent injury, always grip the saw attach-

ment 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 counterclock-

wise.

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 posi-

tions 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.

Precaution: Saw blades labeled “Single Use” should not be

used repeatedly because of cleaning problems.

Figure 2

Figure 1

Figure 3

Colibri II Gebrauchsanweisung Synthes 25

Figure 4

Positioning the saw blade

The saw blade can be adjusted in the desired position verti-

cally and horizontally at an angle of 45º (see the earlier sec-

tions “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

70 mm

26 Synthes Colibri II Instructions for Use

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 hand-

piece in the ON mode. Never use the attachments in oscil-

lating drilling mode ( ).

– The appropriate surgical technique (036.000.907) should

be observed to ensure the safe and successful application

of the Crescentic Technique.

Colibri II Gebrauchsanweisung Synthes 27

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 attach-

ment is set to the unlock position . Insert the saw attach-

ment in any position into the attachment coupling of the

handpiece until it locks into place. To prevent vibrations dur-

ing 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 push-

ing both release buttons on the handpiece.

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 screw-

driver (e.g. 314.115).

Check that the saw blade is correctly in place and properly

tightened.

28 Synthes Colibri II Instructions for Use

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.

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 be-

fore 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.

Attachments

Other Attachments

Colibri II Gebrauchsanweisung Synthes 29

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 mainte-

nance 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.

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 re-

quire 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 mate-

rial 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 compati-

bility, 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 tem-

perature and time are not specified, follow Synthes’ rec-

ommendations. 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 in-

structions.

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.

Important:

– The clinical processing instructions provided have been

validated by Synthes for preparing a non-sterile Synthes

medical device; these instructions are provided in accor-

dance with ISO 17664:2004 and ANSI/AAMI ST81:2004.

– Consult the national regulations and guidelines for addi-

tional information. In addition, compliance with internal

hospital policies and the procedures and recommenda-

tions 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 pro-

cessing unit. Any deviation by the processor from the in-

structions provided should be properly evaluated for effec-

tiveness and potential adverse consequences.

Care and Maintenance

General Information

30 Synthes Colibri II Instructions for Use

Figure 1

Figure 2

Figure 3

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!

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.

Care and Maintenance

Preparation Prior to Cleaning

Colibri II Gebrauchsanweisung Synthes 31

Care and Maintenance

Manual Cleaning Instruction

3. Spray and wipe. Spray and wipe the device using a neu-

tral 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 deter-

gent 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 de-

bris.

Follow the enzymatic cleaner or detergent manufacturer’s

instructions for use for correct temperature, water quality

and concentration/dilution.

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 attach-

ments, 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.

32 Synthes Colibri II Instructions for Use

5. Rinse with tap water. Rinse the device thoroughly using

cool to lukewarm running water for a minimum of 2 min-

utes. 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 run-

ning water.

6. Visually inspect device. Inspect the cannulations, cou-

pling 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 com-

pressed air.

Care and Maintenance

Manual Cleaning Instruction

Colibri II Gebrauchsanweisung Synthes 33

Care and Maintenance

Mechanical/Automated Cleaning

Instruction with Manual Pre-cleaning

3. Spray and wipe. Spray and wipe the device using a neu-

tral 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.

Important:

– Manual pre-cleaning prior to mechanical/automated

cleaning/disinfection is important to ensure that cannula-

tions and other difficult to access areas are clean.

– Alternative cleaning/disinfection procedures other than in

the procedure described below (including manual pre-

cleaning) 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 attach-

ments, 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.

34 Synthes Colibri II Instructions for Use

Care and Maintenance

Mechanical/Automated Cleaning Instruction

with Manual Pre-cleaning

5. Rinse with tap water. Rinse the device thoroughly using

cool to lukewarm running water for a minimum of 2 min-

utes. 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 run-

ning water.

6. Visually inspect device. Inspect the cannulations, cou-

pling 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 wash-

ing basket.

4. Clean with detergent. Clean the device manually under

running warm water using an enzymatic cleaner or deter-

gent 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 de-

bris.

Follow the enzymatic cleaner or detergent manufacturer’s

instructions for use for correct temperature, water quality

and concentration/dilution.

Colibri II Gebrauchsanweisung Synthes 35

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 man-

ual 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 regu-

larly sent to be serviced (at least once per year).

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

8. Automated cleaning cycle parameters

Note: The washer/disinfector should fulfill the require-

ments as specified in ISO 15883.

1

36 Synthes Colibri II Instructions for Use

The power tool and attachments should be regularly lubri-

cated to ensure a long service life and smooth operation. It is

recommended that the accessible moving parts of the hand-

piece, 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 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 sev-

eral times.

– Lubricate the attachment coupling.

Figure 1

Figure 2

Care and Maintenance

Lubrication

1

Colibri II Gebrauchsanweisung Synthes 37

Figure 3

Figure 4

Lubricating the battery casing (Fig. 3 and 4)

– Place oil on the seal of the cover and then evenly distrib-

ute the oil on the seal.

– Lubricate the lock, hinge and knob, then actuate it several

times.

1

38 Synthes Colibri II Instructions for Use

Care and Maintenance

Lubrication

Figure 6

Figure 5

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.

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 at-

tachment 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

Colibri II Gebrauchsanweisung Synthes 39

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 re-

quire 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.

40 Synthes Colibri II Instructions for Use

– Visually inspect for damage and wear.

– Check the handpiece controls for smooth operation and

function.

– Check the coupling sleeves of the handpiece and attach-

ments for smooth operation and check for function to-

gether with instruments such as cutting tools.

– Check instruments for correct adjustment and functioning

prior to every use.

Care and Maintenance

Function Control

Colibri II Gebrauchsanweisung Synthes 41

Care and Maintenance

Packaging, Sterilization and Storage

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, de-

vice 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 steriliza-

tion are not recommended.

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 stan-

dards). Synthes’ recommendations for packed devices and

cases are as follows.

Cycle type Sterilization

exposure time

Sterilization

exposure temperature

Drying time

Saturated steam-forced air

removal (pre-vacuum,

minimum 3 pulses)

Minimum 4 minutes Minimum 132 °C 20 – 60 minutes

Maximum 138 °C

Minimum 3 minutes Minimum 134 °C 20 – 60 minutes

Maximum 138 °C

42 Synthes Colibri II Instructions for Use

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

Packaging, Sterilization and Storage

Colibri II Instructions for Use Synthes 43

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”).

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 at-

tachments to be regularly (once a year) serviced by the origi-

nal manufacturer or an authorized site.

Precaution: The manufacturer assumes no responsibility for

damage resulting from neglected or unauthorized mainte-

nance.

44 Synthes Colibri II Instructions for Use

In most cases, faulty tools can be repaired (refer to the previ-

ous section “Repairs and Technical Service”).

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 in-

fection 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.

Li-Ion

Care and Maintenance

Disposal

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. Charge the battery or replace it with a

charged battery.

Machine stops suddenly. The machine has overheated (over -

heating protection is activated).

Wait until the machine has cooled down.

Battery is dead. Charge the battery or replace it with a

charged battery.

Attachments cannot be coupled to the

unit.

The attachment coupling is blocked

by deposits.

Remove solid objects with a pair of

tweezers.

Precaution: When removing objects,

turn the mode selector switch to OFF.

Tool (saw blade, drill, burr etc.) can not

be coupled or only with difficulty.

Shaft geometry of the attachment or

tool is damaged.

Replace the attachment or tool or send it

to your Synthes service office.

Oscillating saw attachment vibrates too

much.

The saw blade locking mechanism is

not tight.

Tighten the locking knob of the saw

blade coupling.

The mode selector switch is set to .

Turn the mode selector switch to ON.

The Kirschner wire is inserted in the

handpiece and cannot be moved

forward.

The Kirschner wire was inserted from

the rear.

Lock the machine by turning the mode

selector switch to OFF. Remove the at-

tachment, hold the drive shaft opening

down and shake out the Kirschner wire.

Bone and tool heat up during surgery. Cutting edges of the tool are blunt. Replace the tool.

Colibri II Instructions for Use Synthes 45

Troubleshooting

46 Synthes Colibri II Instructions for Use

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. The trigger shafts need to be lubricated.

Lubricate the trigger shafts as described

on page 36.

It is difficult to couple the battery casing

to the machine.

The battery casing release buttons

need to be lubricated.

Lubricate the battery casing release but-

tons as described on page 36.

Colibri II is used with the EPD console

and handpiece does not start up.

Console is not switched on or not

connected.

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.

Troubleshooting

Colibri II Instructions for Use Synthes 47

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.

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)

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

Transportation

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

Relative humidity: 10 – 90 %

Atmospheric pressure: 500 – 1060 hPa

System Specifications

48 Synthes Colibri II Instructions for Use

System Specifications

Duty Cycle:

Intermittent operation

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 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

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 overheat-

ing and possibly harming the patient or user. The user is re-

sponsible 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.

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 devel-

opment in the handpiece and the attachments.

– The Colibri II must not be stored or operated in an explo-

sive atmosphere.

Colibri II Instructions for Use Synthes 49

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 Attachment Tool Sound Pressure

Level (LpA) in

[dB(A)]

Sound Power

Level (LwA) in

[dB(A)]

Max. daily

exposure time

without hearing

protection

Colibri II

(532.101)

– – 63 – > 8 h

AO/ASIF Quick

Coupling (05.001.250)

– 64 – > 8 h

Oscillating Saw

Attachment (532.021)

Saw blade

(532.045)

73 – > 8 h

Saw blade

(532.067)

85 94 8 h

Oscillating Saw

Attachment (532.023)

Saw blade

(03.000.313)

84 92 > 8 h

Saw blade

(03.000.316)

85 94 8 h

Large Oscillating Saw

Attachment (532.026)

Saw blade

(03.000.394)

83 92 > 8 h

Saw blade

(03.000.396)

85 96 8 h

50 Synthes Colibri II Instructions for Use

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 Attachment Tool Declaration [m/s

2

] Max. daily

exposure

Colibri II

(532.101)

– – < 2.5 No limitation

AO/ASIF Quick Coupling

(05.001.250)

– < 2.5 No limitation

Oscillating Saw

Attachment (532.021)

Saw blade

(532.045)

vertical: < 2.5

horizontal: < 2.5

No limitation

Saw blade

(532.067)

vertical: 3.73

horizontal: 6.58

No limitation

4 h 35 min

Oscillating Saw

Attachment (532.023)

Saw blade

(03.000.313)

< 2.5 No limitation

Saw blade

(03.000.316)

6.2 5 h 12 min

Large Oscillating Saw

Attachment (532.026)

Saw blade

(03.000.394)

14.02 1h 1 min

Saw blade

(03.000.396)

18.44 35 min

System Specifications

Colibri II Instructions for Use Synthes 51

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.

Emission test Compliance Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1 The Synthes Colibri II system uses RF energy only

for its internal function. Therefore, its RF emis-

sions are very low and are not likely to cause any

interference in nearby electronic equipment.

RF emissions

CISPR 11

Class B The Synthes Colibri II system is suitable for use in

all establishments, including domestic establish-

ments and those directly connected to the public

low-voltage power supply network that supplies

buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage ﬂuctuations/

ﬂicker emissions

IEC 61000-3-3

Not applicable

Electromagnetic Compatibility

Accompanying Documents According to

IEC 60601-1-2, 2007, Clause 6

52 Synthes Colibri II Instructions for Use

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.

Immunity test

standard

IEC 60601

test level

Compliance

level

Electromagnetic environment – guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile.

If the ﬂoors are covered with synthetic material,

the relative humidity should be at least 30 %.

Electrical fast

transient/burst

IEC 61000-4-4

±2 kV for power

supply lines

Not applicable 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 % UT

(0.5 cycle)

40 % U

T

(5 cycles)

70 % U

T

(25 cycles)

< 5 % U

T for 5 s

Nicht anwendbar Mains power quality should be that of a typical

commercial or hospital environment.

Note: UT is the AC mains voltage prior to the application of the test level.

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.

Colibri II Instructions for Use Synthes 53

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 environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Synthes Colibri II system, in-

cluding cables, than the recommended separation distance calculated from the equation applicable to the frequency of the

transmitter.

Immunity test

standard

IEC 60601

test level

Compliance

level

Recommended

separation distance

a

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

Not applicable

d = 0.35

公僓

P

150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 800 MHz

E1 = 10 V/m

(measured 20 V/m)

80 MHz to 800 MHz

d = 0.35

公僓

P

80 MHz to 800 MHz

Radiated RF

IEC 61000-4-3

3 V/m

800 MHz to 2.5 GHz

E2 = 10 V/m

(measured 20 V/m)

80 MHz to 800 MHz

d = 0.35

公僓

P

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.

54 Synthes Colibri II Instructions for Use

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

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

d = 0.35

公僓

P

80 MHz to 800 MHz

d = 0.35

公僓

P

800 MHz to 2.5 GHz

d = 0.35

公僓

P

0.01 4 cm 4 cm 4 cm

0.1 11 cm 11 cm 44 cm

1 35 cm 35 cm 1.4 m

10 1.11 m 1.11 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.

Electromagnetic Compatibility

Accompanying Documents

According to IEC 60601-1-2, 2007, Clause 6

Colibri II Instructions for Use Synthes 55

Consoles

05.001.002 Basic Console for Electric Pen Drive and Small Electric Drive

05.001.108 Light Adapter, for Colibri (II)

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 Oil Dispenser with Synthes Special Oil, 50 ml

532.024 Cleaning Brush for Oscillating Saw Attachment II (532.023)

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

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

Drive unit

532.101 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

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

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

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

with reverse motion

05.001.255 Chuck (Reaming Speed), with Key, clamping range up to ⭋ 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 Radiolucent Drive

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

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

511.777 Torque Limiter, 0.4 Nm, with AO/ASIF Quick Coupling

Ordering Information

56 Synthes Colibri II Instructions for Use

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.

Ordering Information

01 23

All technique guides are available as PDF files at

www.synthes.com/lit

Ö036.001.387öAAoä

036.001.387 SE_476817 AA 07/2012 60087351 40100081 © Synthes, Inc. or its affiliates Subject to modifications Synthes and Vario Case are trademarks of Synthes, Inc. or its affiliates