Synthes Colibri II User manual

Universal and powerful battery system for a variety of applications
Colibri II
Instructions for Use

Colibri II Instructions for Use DePuy Synthes 1
Table of Contents
Introduction General Information 3
Colibri II Handpiece 7
Use 9
Attachments General Information 14
Drill Attachments 16
Screw Attachments 17
Ream Attachments 18
Other Rotating Attachments 20
Saw Attachments 25
Other Attachments 29
Care and Maintenance General Information 30
Cleaning and Disinfection 31
• Preparation Prior to Reprocessing 31
• Manual Cleaning Instructions 32
• Automated Cleaning Instructions
with Manual Pre-cleaning 36
Maintenance and Lubrication 39
Function Control 43
Packaging, Sterilization and Storage 44
Repairs and Technical Service 46
Disposal 47
Troubleshooting 48

2 DePuy Synthes Colibri II Instructions for Use
Table of Contents
System Specifications 50
Electromagnetic Compatibility 56
Additional Information 60
Ordering Information 61

Colibri II Instructions for Use DePuy Synthes 3
Efciently working cutting tools are the basis for success-
ful surgery. Therefore, it is mandatory to check used cut-
ting tools after every use for wear and/ or damage and to
replace them if necessary. We recommend using new Syn-
thes cutting 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 “Surgical
Techniques”.
For important information regarding electromagnetic
compatibility (EMC), please refer to the chapter “Electro-
magnetic Compatibility” in this manual.
The tool is classied as type BF against electrical shock
and leakage current. The tool is suitable for use on pa-
tients in accordance with IEC 60601-1.
This system requires regular maintenance service, at least
once a year, in order to maintain its functionality. This
servicehas to be performed by the original manufacturer
or an authorized site.
The manufacturer assumes no responsibility for damage
resulting from neglected or unauthorized maintenance.
Unusual Transmissible Pathogens: Surgical patients iden-
tied as at risk for Creutzfeldt-Jakob disease (CJD) and
related infections should be treated with single-use in-
struments. Dispose of the instruments used or suspected
of use on a patient with CJD after surgery and/or follow
the current national recommendations.
Intended use
The Colibri II is designed for the use in traumatology and
orthopedic surgery of the skeleton, i.e. drilling, reaming
or cutting bone.
Safety instructions
The surgeon has to evaluate if the machine is suitable
for an application, based on power limitation of the
machine, attachment and cutting tool regarding bone
strength/anatomical situation as well as handling of the
machine, attachment and cutting tool regarding bone
size. In addition, the contraindications of the implant
have to be respected. Please refer to the corresponding
“Surgical Techniques” of the implant system used.
The Colibri II is only to be used for surgery 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,
nitrous oxide or a mixture consisting of ammable anes-
thetics and air.
To ensure the proper operation of the tool, only use Syn-
thes original accessories.
Before the rst and every subsequent use, power tools
and their accessories / attachments have to run through
the complete reprocessing procedure. Protective covers
and foils must be fully removed before sterilization.
For the tool to function properly, Synthes recommends
cleaning, disinfecting and servicing it after each use in ac-
cordance with the process recommended in the chapter
“Care and Maintenance”. Compliance with these speci-
cations can considerably extend the service life of the
tool. Only use Synthes oil (519.970) to lubricate the tool.
Introduction
General Information

4 DePuy Synthes Colibri II Instructions for Use
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 must only be operated with a fully
charged battery. To do this, ensure that the battery
is charged in good time. We recommend that the
battery is replaced into the charger immediately
after surgery.
• The aseptic transfer is detailed on page 9ff. Alter-
natively for the Li-Ion battery 532.103 follow the
guidelines provided in the STERRAD®/ V-PRO®
sterilization guide (DSEM/PWT/0591/0081).
No other sterilization methods are allowed.
• Additionally, the batteries must never be washed,
rinsed or dropped. This will destroy the battery
with possible secondary damage (explosion haz-
ard!). Only use original Synthes batteries. Further
information can be found on page 12ff.
• Should the machine drop on the oor and have
visible defects, do not use it anymore and send it to
the Synthes service center.
• If a product drops on the oor, fragments may split
off. This represents a danger for the patient and
user as:
– these fragments may be sharp.
–unsterile fragments may enter the sterile eld or
hit the patient.
• Should the system have corroded parts, do not use
it anymore and send it to the Synthes service center.
Accessories/Scope of delivery
The Colibri II consists of a handpiece, one or several bat-
tery casings and batteries and a range of attachments
and accessories designed for the system.
For the system to operate properly, only Synthes cutting
tools should be used.
Special auxiliaries such as cleaning brushes and Synthes
oil are available for cleaning and servicing the system.
No oils from other manufacturers must be used. Only
Synthes oil (519.970) must be used.
Lubricants with other compositions can cause jamming,
can have a toxic effect or can have a negative impact on
the sterilization results. Only lubricate the power tool
and the attachments when clean.
Synthes recommends the use of the specically designed
Synthes Vario Case (68.001.255) and of the specically
designed Washing Basket (68.001.610) to sterilize and
store the system.
The following components are essential to ensure proper
operation:
• Handpiece (532.101)
• Battery Casing (532.132)
• Battery (532.103)
• Sterile Cover (532.104)
• Universal Battery Charger II (05.001.204)
• At least one attachment of the system
Please refer to the end of these Instructions for Use for
an overview of the components of the system.
Locating of the instrument or fragments of
instruments
Synthes instruments are designed and manufactured
to perform within the scope of their intended use. How-
ever, if a Power Tool or accessory/attachment breaks
during use, a visual inspection or a medical imaging de-
vice (e. g. CT, Radiation Devices, etc.) can aid in locating
the fragments and/or components of the instrument.
Storage and transport
Please use the original packaging for dispatch and trans-
port. If this is no longer available, please contact the
Synthes ofce.
Warranty/Liability
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 excludes liability for damage resulting from
repairs or maintenance carried out by unauthorized sites.
The manufacturer assumes no responsibility for damage
resulting from neglected or unauthorized maintenance.
Introduction
General Information

Colibri II Instructions for Use DePuy Synthes 5
2
Do not reuse
Products intended for single use must not be
reused.
Reuse or reprocessing (e.g. cleaning and resteril-
ization) may compromise the structural integrity
of the device and/ or lead to device failure,
which may result in patient injury, illness or
death.
Furthermore, reuse or reprocessing of single use
devices may create a risk of contamination e.g.
due to the transmission of infectious material
from one patient to another. This could result in
the injury or death of the patient or user.
Synthes does not recommend reprocessing con-
taminated products. Any Synthes product that
has been contaminated by blood, tissue and/ or
bodily uids / matter should never be used again
and should be handled according to hospital
protocol.
Even though they may appear undamaged, the
products may have small defects and internal
stress patterns that may cause material fatigue.
Temperature
Relative humidity
Atmospheric pressure
S9 Duty cycle type according to IEC60034-1
IPX4 Ingress protection rating according to
IEC 60529
Explanation of the general symbols used
Caution
Read the provided Instructions for Use before
operating the device.
Consult the Instructions for Use before operat-
ing the device.
The device is classied as type BF against elec-
trical shock and leakage current. The device is
suitable for use on patients according to the
standards dened by IEC 60601-1
SM_109761
Do not immerse device in liquids.
10PB
Product is UL classied to the requirements
of both the United States and Canada
The device meets the requirements of directive
93/42/EEC for medical devices. It is authorized
by an independent notied body for which it
bears the CE symbol.
Li-Ion
This device contains Lithium-Ion batteries that
should be disposed of in an environmentally
friendly manner. The European Battery Directive
2006/66/EC applies to this device. See section
“Disposal” on page 47.
Cd MH
The European directive 2012/19/EC on waste
electrical and electronic equipment (WEEE)
applies to this device. This device contains ma-
terials that should be disposed of in accordance
with environment protection requirements.
Please observe national and local regulations.
See section “Disposal” on page 47.
Indicates Environment Friendly Use Period of
5years in China.
Indicates Environment Friendly Use Period of
10years in China.

6 DePuy Synthes Colibri II Instructions for Use
Manufacturer
Date of manufacture
Non sterile
Non sterile
Do not use if package is damaged.
Introduction
General Information

1
6
6 6
4
3
2
7
3
4
2
5
8
Colibri II Instructions for Use DePuy Synthes 7
Colibri II
Handpiece
1Attachment coupling
2Trigger for speed regulation
3Trigger for switching to reverse / oscillating drilling
4Mode selector switch OFF (lock), Oscillating Mode
(forward/oscillating), ON (forward, reverse)
5 Battery 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 pre-
vents the machine from being unintentionally started. To
lock and unlock the tool, turn the mode selector switch
4to the appropriate setting on the front plate of the
handpiece: OFF, or ON position.
Protective systems
The Colibri II is equipped with three protective systems:
• A thermal overload safety system that shuts off the
tool if it becomes too hot during use. After cooling,
the tool can be used again.
• An exhaustive discharge protection ensures that the
battery does not completely discharge. This protects
the battery and extends its life.
• An internal fuse in the battery that blows in case of
unintended short cut. This prevents excessive heat, re
or explosion. If this happens, the battery can not be
used anymore.
Speed and rotational direction control
Mode selector switch in the ON position
The bottom trigger 2gradually increases and decreases
the forward/reverse speed. When the bottom and top
triggers 2and 3are pressed at the same time, the tool
immediately switches to reverse. When the bottom trig-
ger 2is released, the tool immediately stops.

8 DePuy Synthes Colibri II Instructions for Use
Colibri II
Handpiece
Precautions:
• The information contained in this Information for
Use concerns the Colibri II system. For more infor-
mation on the Colibri articles, please refer to the
Colibri Instructions for Use (036.000.173).
• To prevent injury, the machine must be locked
(OFF position) with the mode selector switch 4
when coupling and removing attachments and
tools, and before laying it down (see page 7).
• Always check correct functioning before use on
patient.
• Always have a back-up system to prevent problems
in case of decient system.
• Always wear personal protective equipment (PPE)
including safety goggles when working with the
Colibri II system.
• When the tool is not in use during the surgery, set
the handpiece on its side to ensure that it does not
fall over due to instability. Only place the power
tool in an upright position on the sterile table to
insert / remove attachments and cutting tools.
• After inserting a cutting tool, always check that it
is properly engaged by pulling it.
Warning: Do not place the Colibri II on a magnetic
surface since the machine might start unintention-
ally.
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 oscil-
lating 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 battery pack (532.033 with battery casing 532.032)
can both be used with the new Colibri II handpiece
(532.101).
Existing Colibri handpiece is compatible with
Colibri II battery pack
The existing Colibri handpiece (532.001) can be used
with the new battery pack of the Colibri II (532.103 with
battery casing 532.132).
For additional information on the 12 VDC battery pack
(532.002, 532.003 or 532.004), please refer to
section “Additional Information” on page 60 of these
Instructions for Use.