Synthes Colibri II User manual

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
0123
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
1Attachment coupling
2Trigger for speed regulation
3Trigger for switching to reverse/oscillating drilling
4Mode selector switch
5Battery pack (battery casing with inserted battery)
6Release buttons for attachment
7Release buttons for battery casing
8Knob 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 4to 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 2gradually controls the forward speed
(up to approx. 1440 rpm with the AO/ASIF quick coupling).
When the bottom and top triggers 2and 3are pressed at
the same time, the tool immediately switches to reverse.
When the bottom trigger 2is 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 2and 3are pressed at
the same time, the tool immediately switches to oscillating
rotation. When the top trigger 3is 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 4when 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