Synthes TRS User manual

Instructions for Use
Trauma Recon System (TRS).
Battery-driven Power System designed
for traumatology and arthroplasty.

Table of Contents
Introduction
TRS Battery Modular
General Information 3
– Intended use 3
– Safety instructions 3
– Accessories/scope of delivery 4
– Storage and transport 4
– Warranty 4
General Information on Power Tools 5
– Handpiece (05.001.201/05.001.240) 5
– Lid (05.001.231/05.001.241) 5
– Power module (05.001.202) 5
Starting the System 6
– Inserting the power module 6
– Removing the power module 8
– Available battery capacity 9
– Power module overheat protection 9
– Energy saving function 9
– Charging and storing the power module 10
– State of charge and service indicator 11
of the power module
– Cleaning, care and maintenance 12
Power Tool 13
– Handpiece (05.001.201) 13
– Lid (05.001.231) 13
– Power module (05.001.202) 14
Functions of the Lid for TRS Battery Modular 15
– Mode switch 15
Attachments for TRS Battery Modular 17
– Important notes 17
– Color marking on the attachments 17
– Mounting the attachments 18
– Changing cutting tools on attachments 18
– Switching the mode 18
– Removing the attachments 19
– Rotating attachments 20
– Quick Couplings for cutting tools 22
from other manufacturers
– Saw attachments 24
– Radiolucent Drive 29
– Torque limiters 31

Trauma Recon System Instructions for Use Synthes 1
TRS Recon Sagittal Saw
Care and Maintenance
Power Tool 32
– Handpiece (05.001.240) 32
– Lid (05.001.241) 32
– Power module (05.001.202) 33
Functions of the Lid for TRS Recon Sagittal Saw 34
– Mode switch 34
Working with the TRS Recon Sagittal Saw 35
– Starting the TRS Recon Sagittal Saw 35
– Positioning the saw head 35
– Changing the saw blades 36
– Working with the TRS Recon Sagittal Saw 36
– Instructions for handling saw blades 36
General Information 37
– Unusual Transmissible Pathogens 37
– Important 37
Preparation prior to Cleaning 38
– Disassemble 38
Manual Cleaning Instruction 39
– Remove debris 39
– Spray with solution 39
– Rinse with tap water 39
– Clean with detergent 40
– Rinse with tap water 40
– Visually inspect device 40
– Finale rinse with de-ionized/purified water 41
– Dry 41
Mechanical /Automated Cleaning Instruction 42
with Manual Pre-cleaning
– Remove debris 42
– Spray with solution 42
– Clean with detergent 43
– Rinse with tap water 43
– Visually inspect device 43
– Load washing basket 44
– Automated cleaning cycle parameters 44
– Inspect device 44
Lubrication 45
– The following individual parts must be lubricated 45

2 Synthes Trauma Recon System Instructions for Use
Table of Contents
Care and Maintenance
Troubleshooting
Technical Data
Explanation of Symbols Used 65
Ordering Information 66
Packaging, Sterilization and Storage 46
– Packaging 46
– Sterilization 46
– Storage 46
Repairs and Technical Service 47
Disposal 48
Handpiece and Lid 49
Power Module 52
Attachments and Cutting Tools 53
Duty Cycle 55
Machine Specifications 56
– TRS Battery Modular 56
– TRS Recon Sagittal Saw 56
– Battery 56
Environmental Conditions 57
Applicable Standards 58
Electromagnetic Compatibility Accompanying 61
documents in accordance with EN/IEC 60601-1-2,
clause 5.2.2

Trauma Recon System Instructions for Use Synthes 3
Introduction
Intended use
The Trauma Recon System (TRS) is a battery-driven power
tool system intended for use during general orthopedic
procedures to drill, saw and ream hard tissue or bone and
soft tissue.
Safety instructions
The Trauma Recon System is only to be used for patient
treatment after careful consultation of the instructions for
use. It is recommended that an alternative system is available
to use during application, as technical problems can never be
completely ruled out.
The Trauma Recon System is designed for use by physicians
and trained medical personnel.
DO NOT use any component if damage is apparent.
DO NOT use this equipment in presence of oxygen, nitrous
oxide or a mixture consisting of flammable anesthetic and air.
To ensure proper operation of the tool, use only Synthes
original accessories.
Before first and every use, power tools and their accessories/
attachments except the Power Module 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 that it
is cleaned and serviced 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
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 Trauma Recon System 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 proper operation of the tool, Synthes recommends
annual maintenance by a Synthes service center. The manu-
facturer shall assume no responsibility for damage resulting
from improper operation or unauthorized maintenance of
the tool.
Caution
– 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 the
LOCK positon .
– The tool may only be operated with a fully charged power
module. To do this, ensure that the power module is
charged in good time. We recommend that the power
module is replaced into the charger immediately after sur-
gery.
– The power module may never be sterilized, washed,
rinsed or dropped. This would destroy the power module
with possible secondary damage.
General Information

Introduction
Accessories/scope of delivery
The Trauma Recon System consists of two handpieces with
corresponding lids, one or several power modules (battery,
motor and electronics) and a range of attachments designed
for the TRS Battery Modular.
To charge the power module, please only use the correspon-
ding Synthes Universal Battery Charger II (05.001.204).
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 may be used. Only Synthes oil may
be used.
Synthes recommends the use of the specifically designed
washing basket (68.001.606 with lid 68.001.602) to wash,
sterilize and store the system.
The following components are essential to ensure proper
operation:
Main system components TRS Battery TRS Recon
Modular Sagittal Saw
Battery Handpiece 05.001.201 05.001.240
Lid for Battery Handpiece 05.001.231 05.001.241
Power Module 05.001.202 05.001.202
Sterile Cover 05.001.203 05.001.203
Universal Battery Charger II 05.001.204 05.001.204
Attachment option Yes No
Please refer to the end of these instructions for use for an
overview of components for 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.
The same environmental conditions apply for transport as for
storage, see page 57.
Warranty
The warranty for the tools and accessories does not cover
damage of any kind resulting from improper use, damaged
seal and improper storage and transport. The manufacturer
does not accept liability for damage resulting from repairs
or maintenance carried out by unauthorized sites.
4 Synthes Trauma Recon System Instructions for Use

2
3
1
4
45
1
2
3
66
6
6
45
1
2
3
Handpiece (05.001.201/05.001.240)
1Trigger(s)
2Lid
3Mode switch (integrated onto lid)
General Information on Power Tools
Power module (05.001.202)
1Information button (when pressed, the charge status
display and/or service indicator illuminate for a few
seconds)
2Charge status display
3Service indicator (when LED illuminates the power module
must immediately be sent to the nearest Synthes service
center)
4Lever to remove the power module from the handpiece
Trauma Recon System Instructions for Use Synthes 5
Lid (05.001.231/05.001.241)
4UNLOCK position
5LOCK position
6Mode(s) for dedicated applications

Fig. 6
Fig. 3 Fig. 4
Fig. 2Fig. 1
Introduction
Inserting the power module
To ensure sterility, the power module is inserted into the ster-
ile housing of the handpiece by two people, one of whom is
wearing sterile garments:
1. The person wearing the sterile garments holds the open,
sterile handpiece with the open side up (Fig. 1).
2. The person wearing the sterile garments places the sterile
cover on the handpiece (Fig. 2) and checks if it is seated
correctly. The sterile cover ensures that the unsterile
power module does not contact the outside of the sterile
handpiece.
3. The person not wearing sterile garments carefully guides
the unsterile power module through the sterile cover into
the handpiece (Fig. 3). Press firmly onto the power mod-
ule to ensure that it is correctly seated in the handpiece
(Fig. 4). During insertion ensure that the power module is
properly aligned and that the person not wearing sterile
garments does not touch the outside of the sterile hand-
piece.
4. The person not wearing sterile garments grasps the
flanges on the sterile cover and removes it from the hand-
piece (Fig. 5).
5. The person wearing the sterile garments places the sterile
lid on the handpiece (Fig. 6). It is essential to ensure that
the sterile lid does not touch the unsterile power module.
Ensure the correct alignment of the markings on the
outside of the handpiece and the lid (Fig.1 on the next
page). Twist the lid clockwise to lock the handpiece (Fig. 2
on the next page) and check if the lid is seated correctly
by gently pulling on it. Secure by turning the mode switch
to LOCK (Fig. 3 on the next page).
6. The desired mode can now be selected. Please find
detailed information about the different modes in the
chapters “TRS Battery Modular” and “TRS Recon Sagittal
Saw”.
Starting the System
Fig. 5
6 Synthes Trauma Recon System Instructions for Use

Fig. 1
Fig. 2
Fig. 3
Caution
– The lid has to be properly attached to the handpiece.
Therefore, step 5 on the previous page has to be carefully
followed.
– The tool should only be operated with a fully charged
power module. We recommend that the power module is
replaced into the charger immediately after surgery.
– If in doubt press the information button before using the
power module to check the state of charge.
– To ensure aseptic conditions the power module must not
be removed from the handpiece until the end of surgery.
The power module has enough battery capacity for the
entire surgery.
– Sterilize the sterile cover after each use to ensure aseptic
conditions when inserting the unsterile power module
into the sterile handpiece.
How to proceed if the power module is exposed to a
light mechanical shock:
1. Check the power module for signs of mechanical damage,
tears, etc. Damaged power modules must not be used
and have to be sent to be repaired.
2. Press the information button briefly to check the state of
charge and the service indicator. If the service indicator il-
luminates the power module may not be used and has to
be sent in to be repaired.
3. Press the information button for approximately 7 seconds
until the motor starts and the power module performs a
self-test. If this is completed and the service indicator does
not illuminates, the power module can be used.
If the power module does not function properly after the
self-test has been carried out, it needs to be sent in to be
repaired.
Trauma Recon System Instructions for Use Synthes 7

8 Synthes Trauma Recon System Instructions for Use
Removing the power module
Simultaneously press the safety button of the mode switch
and turn to UNLOCK (Fig. 1). Turn the lid counterclock-
wise to open the handpiece and remove the lid. Then pull
the power module using the lever (Fig. 2). Finally insert the
power module back into the battery charger.
Caution: The power tool has to be kept upright (Fig. 2) so
that the Power Module does not drop to the floor.
Fig. 1
Fig. 2
Introduction

Trauma Recon System Instructions for Use Synthes 9
Available battery capacity
A fully charged power module has sufficient capacity to carry
out long and complex surgeries without needing recharging.
The state of charge of the power module can be checked be-
fore inserting or after removing the power module from the
handpiece
Caution
– The tool may only be operated with a fully charged power
module. To do this, ensure that the power module is
charged in good time. We recommend to replace the
power module into the charger immediately after surgery.
– If in doubt press the information button before using the
power module to check the state of charge.
– Do not use a faulty power module (service indicator illumi-
nates). It should be sent in to the nearest Synthes service
center for servicing.
– To ensure aseptic conditions, the power module must not
be removed from the handpiece until the end of surgery.
Power module overheat protection
Generally, medical power tools can heat up if in constant use.
The “cool down” times should be observed, cf. chapter
“Duty Cycle” on page 55 to prevent from exceeding the ac-
ceptable surface temperature of the tool.
A safety system prevents defects of the battery and the mo-
tor by thermal overload:
– If the battery or the motor become too hot during use,
initially the power is automatically cut and the speed is re-
duced. Although it is still possible to work with the tool, it
is not recommended.
– In a second step, the tool automatically switches off and
cannot be operated until the battery and the motor have
cooled down.
Energy saving function
If the tool with inserted power module is not used for ap-
proximately two hours the power module switches itself off
automatically. It is only possible to continue working if the
mode switch is first set to the LOCK position and then
back to the desired mode (DRILL/REAM, SAW, OSC DRILL).

10 Synthes Trauma Recon System Instructions for Use
Charging and storing the power module
The power module contains the motor, the battery and the
electronics and should therefore be handled with care.
To ensure that the tool operates properly, please observe the
following points:
Charging
– Fully charge the power module before use.
– Charge the power module within an ambient temperature
range of 10°C to 40°C.
Storage
– Never expose the power module to temperatures over
55°C for a maximum of 72 hours.
– The battery cells of the power module do not discharge if
not used. Before using the power module it is important
to check if it is fully charged by pressing the information
button and reading the state of charge LED.
For further information on the battery charger please consult
the relevant instructions for use or your local Synthes office.
Caution
Do not
– wash
– rinse
– sterilize
– drop or
– apply force to the power module (Fig. 1).
This would destroy it with possible secondary damage.
– Only use the Synthes Universal Battery Charger II
(05.001.204) to charge the power module. The use of
other power sources can damage the power module.
– Do not use faulty power modules. These should be sent to
your local Synthes service center.
– Only use the power module in the designated handpiece.
– The power module may only be opened by the original
manufacturer or an authorized Synthes office. Unautho-
rized opening voids the warranty.
Fig. 1
Introduction

Trauma Recon System Instructions for Use Synthes 11
Fig. 1
Fig. 2
State of charge and service indicator
of the power module
The power module has an information button. After briefly
pressing the information button, the LED of either the state
of charge or the service indicator illuminates for approxi-
mately 5 seconds.
If the service indicator or none of the LEDs illuminates, the
power module needs to be sent in for repair.
State of charge
Service-LED
State of charge (Fig. 1):
All four LEDs illuminate:
The power module is fully charged.
Three or fewer LEDs illuminate:
The power module is not fully charged. The state of charge
may suffice, depending on the state of charge and the
surgery. It is, however, recommended that the power module
is fully charged.
Bottom LED flashes:
The power module is fully discharged.
Service indicator (Fig. 2):
The LED lights red:
The power module is faulty. It is blocked for further use and
has to be sent to be repaired.
Caution
– The service indicator does not illuminate constantly. It only
illuminates if the information button is pressed first and
maintenance is required. The indicator lamp goes out
after a few seconds to save the battery.
– If the service indicator does not illuminate this does not
necessarily mean that the power module is fully func-
tional.

12 Synthes Trauma Recon System Instructions for Use
What to do if the power module is exposed to a light
mechanical shock:
1. Check the power module for signs of mechanical damage,
tears, cracks, etc. Damaged power modules must not be
used and have to be sent to the Synthes service center to
be repaired.
2. Press the information button briefly to check the state of
charge and the service indicator. If the service indicator
illuminates the power module may not be used and has to
be sent to be repaired.
3. Press the information button for approximately 7 seconds
until the motor starts and the power module performs
a self-test. If this is completed and the service indicator
does not illuminate, the power module can be used.
If the power module does not function properly after the
self-test has been carried out, it needs to be sent in to be
repaired.
Displays when the power module is in the battery charger
The state of charge display (or service indicator if faulty) also
illuminates if the power module is in a charging bay of the
switched on battery charger. In this case, the LEDs illuminate
constantly.
For further information on the battery charger please consult
the relevant instructions for use or your local Synthes office.
Cleaning, care and maintenance
The tool and all accessories should be cleaned immediately
after use. Detailed cleaning instructions can be found from
page 37 forward.
Introduction

1
3
2
4
5
15
6
7
2
34
Trauma Recon System Instructions for Use Synthes 13
TRS Battery Modular
Handpiece (05.001.201)
1Release sleeve for attachment
2Trigger for speed regulation
3Trigger for switching to reverse (DRILL/REAM mode)
or to oscillating drilling (OSC DRILL mode);
the trigger has no function in the SAW mode.
4Lid
5Mode switch (integrated onto lid)
Lid (05.001.231)
1Mode switch
2Safety button for mode switch (prevents inadvertent open-
ing of the lid; only press to set to UNLOCK )
3UNLOCK position
4LOCK position
5DRILL/REAM position
6SAW position
7OSC DRILL position
Power Tool
Fig. 1
Fig. 2

2
3
1
4
14 Synthes Trauma Recon System Instructions for Use
Power module (05.001.202)
1Information button (when pressed, the charge status
display and/or service indicator illuminates for a few sec-
onds)
2Charge status display
3Service indicator (when LED illuminates the power module
immediately must be sent to the nearest Synthes service
center)
4Lever to remove the power module from the handpiece
TRS Battery Modular

3
4
5
12
Trauma Recon System Instructions for Use Synthes 15
Functions of the Lid for
TRS Battery Modular
Mode switch
The mode switch on the lid for TRS Battery Modular
(05.001.231) can be set to 5 different positions.
1UNLOCK position
2LOCK position
3DRILL/REAM position
4SAW position
5OSC DRILL position
The lid for TRS Battery Modular (05.001.231) only fits onto
the TRS Battery Modular handpiece (05.001.201).
UNLOCK position :
In this position, the lid can be attached and removed. In all
other positions the lid is secured so that it cannot inadver-
tently disengage during surgery.
To position the mode switch to UNLOCK , press the safety
button on mode switch (see Fig. 2 on page 13) at the same
time. This prevents inadvertent switching the mode switch to
UNLOCK and opening of the handpiece. It is not neces-
sary to press the safety button to turn the mode switch to
any other position.
LOCK position :
In this position, the tool is secured and cannot operate.
Caution
– To avoid injuries, the mode switch has to be in LOCK posi-
tion when inserting/removing attachments or cutting
tools and when placing the tool down.
– When preparing the tool for surgery, once the power
module has been inserted the lid should be attached and
tightened and then the mode switch should be set to
LOCK . This prevents the handpiece being opened inad-
vertently.
– 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.
– While switching from LOCK to one of the other posi-
tions (DRILL/REAM, SAW, OSC DRILL), a trigger delay of
1–2 seconds will occur for reasons of safety.

16 Synthes Trauma Recon System Instructions for Use
DRILL/REAM, SAW and OSC DRILL positions
Before working on the patient, ensure that the correct mode
has been selected, e.g. by operating the tool in the air.
DRILL/REAM mode
This mode is suitable for all rotating attachments:
– Drill attachments (blue color marking and DRILL)
– Ream attachments (red color marking and REAM)
– Screw attachment (red color marking and SCREW)
– DHS/DCS quick coupling
– Kirschner wire attachment
– Torque limiter
– Adapter for radiolucent drive
The attachments are described in detail from page 20
forward.
The rotating attachments are most effective in the
DRILL/REAM mode. They are much slower and less efficient
in the SAW mode. When using rotating attachments in SAW
mode, no reverse mode is available.
Working in DRILL/REAM mode:
The bottom trigger gradually controls the forward speed. If
the top trigger is also pressed the tool immediately switches
to reverse. When the bottom trigger is released, the tool
immediately stops.
SAW mode
This mode is designed for saw attachments and the recipro-
cating saw attachment.
The attachments are described in detail from page 24
forward.
Working in SAW mode:
The bottom trigger gradually controls the speed. The top
trigger has no function in SAW mode, i.e. there is no effect
if the top trigger is pressed. When the bottom trigger is
released, the tool immediately stops.
OSC DRILL mode
The oscillating drilling movement in oscillating mode pre-
vents tissue and nerves from wrapping around the drill. This
can considerably improve the operating results.
This mode is therefore suitable for drill attachments
(05.001.205, 05.001.206, 05.001.208, 05.001.217,
05.001.219 and 05.001.221). An oscillating insertion of
Kirschner wires is also possible with the Kirschner wire
attachment (05.001.212).
Working in OSC DRILL mode:
Pressing the bottom trigger by itself causes the tool to rotate
clockwise as usual. Simultaneously pressing the top and
bottom triggers causes the tool to immediately switch to os-
cillating mode. The clamped cutting tool oscillates clockwise/
counterclockwise. The speed can be changed by means of
the bottom trigger. After the top trigger is released, the tool
returns to normal clockwise rotation.
Caution
– Use all saw attachments only in SAW mode. Using the in-
correct mode will effect performance and wear.
– When using rotating attachments in SAW mode, no
reverse mode is available.
– You can only switch to reverse by turning the mode
switch to “DRILL/REAM” position.
– The maximum cutting speed of an attachment is less
in OSC DRILL mode than in DRILL/REAM mode.
– Only use oscillation mode with the above mentioned
attachments.
– While switching from LOCK to one of the modes a trig-
ger delay of 1–2 seconds will occur for reasons of safety.
– To avoid injuries, the mode switch has to be in LOCK posi-
tion when inserting / removing attachments or cutting
tools and when placing the tool down.
TRS Battery Modular

Trauma Recon System Instructions for Use Synthes 17
Fig. 1: Chuck with drilling speed (text DRILL and blue color marking)
Fig. 2: Chuck with reaming speed (text REAM and red color marking)
Attachments for TRS Battery Modular
Color marking on the attachments
Some rotating attachments are available in two speeds:
Drilling and reaming speed. The attachments are marked
accordingly (Fig. 1 and 2):
– Drill attachments (approximately 1450 rpm idle speed):
blue color marking and DRILL
– Ream attachments (approximately 330 rpm idle speed):
red color marking and REAM
The screw attachment is specially coded so that it can easily
be recognized:
– Screw attachment (approximately 330 rpm idle speed):
red color marking and SCREW.
Important notes
The following applies to all attachments:
Caution
– Always secure (LOCK ) the tool when connecting/dis-
connecting attachments and cutting tools.
– After inserting a cutting tool, always check that it is
properly seated by pulling it.
– Only use original Synthes attachments and cutting tools.
– Damage that arises from using attachments and cutting
tools by other manufacturers is not covered by the
warranty.
– The use of irrigation fluid is recommended to cool the
cutting tools and prevent heat necrosis.
– Check the cutting tools for wear and/or damage after
each use, and replace if necessary. Synthes recommends
that cutting tools are only used once.
– Always use the attachments in the correct mode (DRILL/
REAM, SAW, OSC DRILL). Use all saw attachments only in
SAW mode. Using the incorrect mode will effect perform-
ance and wear.
– When using rotating attachments in SAW mode, no
reverse mode is available.

18 Synthes Trauma Recon System Instructions for Use
Mounting the attachments
The attachments can be connected in 8 different positions
(45° increments). To mount, turn the release sleeve for the
attachments clockwise (see arrow on the release sleeve) until
it engages (Fig. 1), so that it jumps forwards slightly. The
yellow marking on the sleeve is then visible.
Insert the attachment in the selected position into the release
sleeve from the front and press it lightly against the hand-
piece (Fig. 2). The attachment automatically engages. If the
release sleeve inadvertently automatically closes before the
attachment has engaged, it is also possible to couple the at-
tachment by pushing and turning the attachment clockwise
against the sleeve (Fig. 3). Once it is connected check if the
attachment is seated correctly by gently pulling on it.
Reset the mode switch to the desired mode (DRILL/REAM,
SAW, OSC DRILL). The tool is ready to use. Before working
on the patient again, ensure that the correct mode has been
selected, e.g. by operating the device in the air.
Changing cutting tools on attachments
See detailed explanations about each attachment from
page 20 forward.
Switching the mode
Stop the tool (release the bottom trigger) and remove from
the patient. Then turn the mode switch to the desired posi-
tion. Before working on the patient again, ensure that the
correct mode has been selected, e.g. by operating the device
in the air.
Caution: Do not operate the mode switch when the device
is running.
Fig. 1
Fig. 2
Fig. 3
TRS Battery Modular