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