Condor MedTec RotexShoe RO.0162.2018 Guide

Instructions for Care and Use
of Traction boot
RO.0162.2018 | RO.0082.2019 | RO.0074.2018 | RO.0081.2019
RO.0073.2018 | RO.0110.2020 I RO.0110.2020 S
444.GA.RS.EN
Last updated on 13.07.22

Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 11
Contents
I List of gures 2
II List of tables 2
1. Introduction..................................................................................................................... 3
1.1 About this manual........................................................................................................ 3
1.2 Symbols used in the text.................................................................................................. 3
1.3 General safety instructions................................................................................................ 3
1.4 Graphical symbols used .................................................................................................. 7
2. Basic requirements. ............................................................................................................. 8
2.1 Intended use ............................................................................................................. 8
2.2 Interfaces ................................................................................................................ 8
2.3 Variants .................................................................................................................. 8
2.4 Device description ....................................................................................................... 9
3. Storage.........................................................................................................................10
4. Operation ......................................................................................................................10
4.1 General information ....................................................................................................10
4.2 Positioning with disposable inlay incl. mounting brackets ................................................................12
4.3 Fastening and positioning the traction boot at extension device ..........................................................16
4.4 Removing traction boot .................................................................................................16
5. Hygiene ........................................................................................................................17
5.1 Safety information.......................................................................................................17
5.2 Cleaning ................................................................................................................18
5.3 Disinfection .............................................................................................................18
6. Service and Maintenance ......................................................................................................19
6.1 Spare parts..............................................................................................................19
6.2 Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.3 Inspection and Maintenance.............................................................................................19
6.4 Maintenance ............................................................................................................20
6.5 Repairs..................................................................................................................20
7. Disposal ........................................................................................................................21
8. Technical specications ........................................................................................................21
8.1 Working load and weight ................................................................................................21
8.2 Example of a nameplate .................................................................................................21
8.3 Classication ............................................................................................................21
8.4 Standards used..........................................................................................................21
8.5 Certicates..............................................................................................................21
9.Copyrights ......................................................................................................................21

Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 2
I List of figures
Illustration 1 Wing screw ........................................................................................................... 8
Illustration 2 Quick-release fastener ................................................................................................ 8
Illustration 3 round Interface. ..................................................................................................... 8
Illustration 4 Device description I .................................................................................................... 9
Illustration 5 Device description II for single-use components ........................................................................ 9
Illustration 6 Lay the padding in the shell ........................................................................................... 12
Illustration 7 Shell with padding ................................................................................................... 12
Illustration 8 Traction boot with foot ............................................................................................... 12
Illustration 9 Traction boot with foot and padding . ............................................................................... 12
Illustration 10 Traction boot with padding and mounting bracket............ ....................................................... 13
Illustration 11 Mounting bracket xated on shin-bone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Illustration 12 Padding for ankle .................................................................................................... 13
Illustration 13 Mounting bracket xations ........................................................................................... 13
Illustration 14 Fixated mounting bracket............................................................................................ 13
Illustration 15 Double padding at the shin-bone.................................................................................... 14
Illustration 16 Inserting mounting brackets in buckles............................................................................... 14
Illustration 17 Fixating the mounting brackets by pressing.......................................................................... 14
Illustration 18 Detailed image of quick-release lever................................................................................. 15
Illustration 19 Re-tigthening the mounting brackets................................................................................ 15
Illustration 20 Releasing the buckle to open the mounting bracket.................................................................. 15
Illustration 21 Example of sticker................................................................................................... 15
Illustration 22 Details of the interface with wing screw.............................................................................. 15
Illustration 23 Details of the interface with quick-release fastener.................................................................... 16
Illustration 24 Details of the attachable guide block ................................................................................. 16
Illustration 25 Traction boot with round interface . . . . . . ............................................................................. 16
Illustration 26 Buckle............................................................................................................... 19
Illustration 27 Padding set ......................................................................................................... 19
Illustration 28 Padding set S . ....................................................................................................... 19
II List of tables
Table 1 Graphical symbols used .................................................................................................... 7
Table 2 Storage ................................................................................................................... 10
Table 3 Spare Parts ................................................................................................................ 19
Table 4 Accessories................................................................................................................ 19
Table 5 Sample maintenance plann ................................................................................................ 20
Table 6 Working load and weight .................................................................................................. 21

Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 3
1 Introduction
1.1 About this manual
These instructions for use encompass all the information relevant
to use of the traction boot traction boots with the item numbers
listed above including its accessories.
This section contains information about the structure of the user
manual as well as explanations of the signs and symbols used.
These instructions for use contain instructions on handling the
traction boot with regard to operation, hygiene, service, main-
tenance, and disposal.
This user manual may contain inaccuracies or printing errors. The
information provided here is updated periodically and changes
are incorporated in later issues in the course of product modi-
cations. Thus, changes or improvements are possible at any time
without previous notication.
Should you have further questions, please contact Condor®
directly.
These instructions for use are to be read and used by all persons
who use or operate the traction boot.
In addition to the instructions in this manual and any binding
regulations for the prevention of accidents in the country and at
the location of use, observe accepted rules for safe and professi-
onal work.
1.2 Symbols used in the text
The following signal words and/or symbols are used in this
manual to indicate especially important information.
Danger!
This symbol indicates safety instructions warning
of risks to personal health and safety. It indicates
imminent danger of death or serious injury.
Caution!
This symbol indicates potentially dangerous
situations involving a risk of light injury.
Attention!
This symbol is used with safety instructions indica-
ting a risk of damage to the device or other property.
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This symbol indicates additional useful informa-
tion.
• A dot in front of the text means:
This task is mandatory.
Indented text describes the result of your action.
– A dash in front of the text means:
This is part of a list.
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1.3 General safety instructions
The traction boot is constructed according to the state of the art
and complies with accepted safety rules. However, its use may
present risks to the patient or third parties or risk of damage to
the device or other property.
Use the traction boot only when in proper working condition,
within the scope of the intended use, in consideration of safety
and potential hazards and in compliance with this user manual.
Immediately repair any defects that could possibly aect safety.
Always keep this manual readily accessible at the location of use.
In addition to this manual, observe all applicable laws and other
regulations on accident prevention and environmental protec-
tion.
Do not make any changes, extensions, or conversions to the trac-
tion boot without the manufacturer‘s permission. Spare parts
must comply with the requirements stipulated by the manu-
facturer. Original spare parts always comply with these require-
ments.
Ensure safe and environmentally-friendly disposal of operating
and auxiliary materials, as well as replacement parts!

Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 4
Summary of the safety instructions
Danger!
Continuous traction and pressure may cause
damage to tissue. Regularly check the position and
relieve the leg.
Danger!
Danger of infection! Dirt particles can become en-
capsulated and this can lead to the product not
reaching the necessary level of germ reduction af-
ter disinfection. The product must be thoroughly
cleaned of soiling and encapsulated dirt particles
before disinfection.
Danger!
A foot that is not xed correctly can loosen from the
extension device. Always ensure that the traction
boot is xed securely to the extension device.
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Danger!
The traction boot is designed for a maximum
traction of 80 kg. Traction that exceeds this does not
correspond to the manufacturer‘s recommendations. Danger!
Dispose of all single-use components after use.
Reusing articles that are intended for single use
deviates from the manufacturer‘s specication.
Danger!
If the transport, positioning, and cleaning and
disinfection information is not observed, material
breakage may occur. Always comply with these
instructions for use.
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Danger!
Insucient padding can lead to the shoe t beco-
ming less secure. Check the padding and increase
if required by additional padding with cotton wool. Danger!
Danger of infection!The product can be contaminated.
Always wear gloves during cleaning / disinfection.
Danger!
Danger due to incorrect handling of cleaning and
disinfection agents! Always observe the cleaning
and disinfection agent Manufacturer‘s specication
on use, as well as the hospital‘s currently applicable
hygiene rules.
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Danger!
A padding tongue that is not turned over can be the
cause of Insucient padding. Ensure that the foot
is t securely in the traction boot. For this, turn the
padding tongue over and lay it in doubled.
Danger!
Danger of explosion! Agents containing alcohol
form ammable mixtures that could lead to explosi-
ons in the case of high-frequency applications. Do
not use agents containing alcohol in the case of
high-frequency applications.
Danger!
Multiple use of the mounting brackets can lead to
instability. A suciently secure t cannot be guaran-
teed in the case of multiple use.
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Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 5
Summary of the safety instructions
Caution!
Worn mounting brackets or buckles can loosen un-
intentionally and cause injuries. Check that the trac-
tion boot is xed securely. Only use traction boots
with new components. Document the single use.
Caution!
Improper cleaning and disinfection may lead to
damage!
Caution!
Damage due to improper cleaning and disinfection!
Always perform visual and functional checks after
cleaning and disinfection.
Caution!
Only use components that are specied for single
use on one patient.
Caution!
Damage due to improper cleaning! Residues from
physiological salt solutions (e.g. sodium chloride)
attack the product‘s surfaces. Remove residues of
physiological salt solutions with a cloth that has
been dampened in clear water. Afterwards dry the
product with a dry lint-free cloth.
Caution!
Positional damage may occur due to high traction
and pressure forces when used for a longer duration.
Regularly check the position in the foot area in order
to prevent positional damage.
Caution!
Damage due to improper cleaning! Do not splash
cleaning agent directly into joints or cracks and do
not use a high-pressure cleaner!
Caution!
When removing the patient from the traction
boot, ensure that the leg returns securely to its
original position. Carry out this procedure in a team
if possible.
Caution!
Damage due to improper cleaning and disinfection!
Only use as much cleaning and disinfection agent
as necessary.
Caution!
Damage due to long exposure times! If the
prescribed exposure time of the disinfection agent
is exceeded, the surfaces may be damaged. Obser-
ve the exposure time prescribed by the disinfection
agent manufacturer.
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Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 6
Summary of the safety instructions
Attention!
User‘s duty of documentation. Use the documenta-
tion code and labels supplied with the product as
proof of single use.
Attention!
Pay attention to the patient‘s position each time the
extension table is adjusted, and check this! Avoid
unintended tensile loads and rotation of the legs.
Attention!
Reduce all changes of position during the operation.
Attention!
Check all components for proper function before
every use. If certain parts display wear, they must
be re-ordered. Returning a shoe may also prove
necessary. Always carry out visual inspections!
Attention!
The entire patient weight should not exceed a
maximum of 250 kg. Use the specication of the
respective extension device / operating table to
determine this. If the specication are under 250 kg,
then this weight must not be exceeded.
Attention!
Use the given table and regularly perform inspec-
tions on the product. Document this procedure.
Expand the table according to your needs!
Attention!
Document instruction in the medical product
according to medical products law.
Attention!
Always follow the handling guidelines in
these instructions for use.
Attention!
The traction boot (RO.0162.2018, RO.0074.2018,
RO.0073.2018) are suitable from shoe size 37 to 45
according to experience. Please note that the entire
anatomy must be taken into account when
selecting the shoe (e.g. calf circumference, foot
width).
Attention!
Experience has shown that the traction boot in size
S (RO.0081.2019, RO.0082.2019) are suitable for shoe
sizes 32 to 37. Please note that the entire anatomy
must be taken into account when selecting the shoe
(e.g. calf circumference, foot width).
Attention!
The manufacturer is freed from all legal
responsibility in the case of unintended use, or use
that deviates from these instructions.
Attention!
Make sure the locking bolts, clamping screws, and
other locking options between traction boot and
extension device, are xed securely.
Attention!
Only use all-purpose cleaning agents that are slight-
ly alkaline (soap solution) and contain surfactants
and phosphates as cleaning-active components. In
the case of extremely soiled surfaces, use concen-
trated all-purpose cleaners.
Attention!
All serious incidents which occur in conjunction
with the product must be reported to the manu-
facturer and to the responsible authority in the
member state in which the user is located.
Attention!
If the surfaces of the product are strongly soiled,
we recommend cleaning the product additionally
before disinfection.
Attention!
Do not use cleaning tools that can scratch (e.g. steel
wool). This could damage the surfaces.
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Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 7
1.4 Graphical symbols used
The following graphical symbols are used in accordance with
DINISO 15223-1.
Table 1 Graphical symbols used
Graphical symbol Identication
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘product number’
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘serial number’
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘name and address
of the manufacturer’
Identication in agreement
with ISO 15223-1 standard.
Symbol for„date of
manufacture“
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘observe
instructions for use’
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘protect against
sunlight’
Identication in agreement
with ISO 15223-1 standard.
Identication of packaging
material.
Symbol for‘protect against
wetness’
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘temperature
range’
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘relative humidity’
Graphical symbol Identication
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘air pressure’
Symbol for‘latexfrei’
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘do not re-use’
Identication in agreement
with ISO 15223-1 standard.
Symbol for‘product not
sterile’
Identification in agreement
with ISO 15223-1 standard.
Symbol for „Medical Device“
Identification in agreement
with ISO 15223-1 standard,
displays a carrier that
contains information on a
unique product identifier
(UDI).
Symbol for„Unique Device
Identifier“.
Labelling of products
developed and marketed in
accordance with relevant
European legal provisions.
Marking shows the
authorized representative in
Switzerland.

Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 8
Interface with quick-release fastener
Article number: RO.0074.2018
Article number: RO.0081.2019
Article number: RO.0073.2018
RO.0110.2020
Illustration 2 Quick-release fastener
Round interface
Article number:
Article number: RO.0110.2020 S
Illustration 3 round interface
2.3 Variants
The following variants of the traction boot can be obtained:
2. Basic requirements
2.1 Intended use
The traction boot is used for patient positioning during
operations on the lower extremities.
The traction boot is used to fixate the foot and the shank
during medical procedures within the scope of hip
arthroplasty, hip arthroscopy and trauma surgery on the
thigh, hip and pelvis. The traction boot is used before, during,
and after, an operation, examination, or treatment.
The traction boot is only used in the non-sterile area. The
entire shoe does not come into contact with injured tissue or
with open wounds.
The traction boot is intended for human medical
applications exclusively. It is an accessory for a medical device
and must only be used in conjunction with an operating table
and an extension system.
The traction boot may only be used by medical personnel
who have familiarised themselves with the product through
the inst-ructions for use. It may only be used in complete
accordance with the user manual. We will not accept liability for
property damage or personal injuries caused by third-party
accessories or noncom-pliance with the intended use.
The specified application is the intended use. This use is
made fully apparent to the owner or user from the labelling
and the user manual. The traction boot may only be used in
complete accordance with the user manual.
We cannot undertake any liability for damage to persons or
the product that has been caused by external accessories or
subse-quent deviation from the intended purpose,
exceeding max. load, re-use of single use materials, or non-
observance of functi-onal and visual checks.
2.2 Interfaces
Interface with wing screwArticle number: RO.0162.2018
Article number: RO.0082.2019
Illustration 1 Wing screw
REF Designation
With wing screw interface:
RO.0162.2018 Traction boot RotexShoe with slide rail
connection
RO.0082.2019 Traction boot RotexShoe, Small
with slide rail connection
With Quick-release fastener
RO.0074.2018 Traction boot RotexShoe with quick
release for RotexTable® and ES
RO.0081.2019 Traction boot RotexShoe, Small
with quick release for RotexTable® and ES
With attachable guide clamp:
(see chapter 4.3 and illustration 24)
RO.0073.2018 Traction boot RotexShoe® for
minimal-invasive surgery
With round interface
RO.0110.2020 Traction boot RotexShoe with round
interface
RO.0110.2020 S Traction boot RotexShoe, size S with
round interface

Instructions for Care and Use Condor® Traction boot – Edition 2022-07-13 EN 9
2.4 Device description
Illustration 4 Device description I
shell
padding
buckles
mounting bracket 1
mounting bracket 2
Illustration 5 Device description II for single-use components
padding tongue
padding for
sole
padding for
ankle
mounting
bracket 1
mounting
bracket 2