Condor RO.2127 Guide
Instructions for Care and Use
Extension System (ES) | Tibial System
444.GA.EAS.EN
Last updated on 23.08.22
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
2
Content
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 .................................................................................................. 5
2. Basic requirements .............................................................................................................. 6
2.1 Intended use ............................................................................................................. 6
2.2 Device Description ....................................................................................................... 6
3. Storage .......................................................................................................................... 7
4. Operation ....................................................................................................................... 7
4.1 Connecting the extension system to the operating table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.2 Removing and attaching segmental plates ................................................................................ 8
4.3 Attaching and removing the countertraction post ......................................................................... 8
4.4 Attaching and removing leg plates ........................................................................................ 9
4.5 Attaching and adjusting the leg plate support on the ES .................................................................. 12
4.6 Attaching a traction device to the leg plate ................................................................. . ............. 13
4.7 Working with distance adapter for traction device ........................................................................ 14
4.8 Working with the extension system ...................................................................................... 15
4.9 Addition: Side rail adaptation ES for vertical drape support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5. ES accessories: Tibial System ................................................................................................... 17
6. Cleaning and disinfection ...................................................................................................... 20
7. Inspections and maintenance ...................................................................................................21
8. Repairs
......................................................................................................................... 21
9. Replacement parts ............................................................................................................. 21
10. Disposal ..................................................................................................................... 22
11. Technical specifications ....................................................................................................... 22
11.1 Working load and weight .............................................................................................. 22
11.2 Example of a nameplate ............................................................................................... 22
11.3 Classification .......................................................................................................... 22
11.4 Applied standards ..................................................................................................... 22
11.5 Certificates ............................................................................................................. 22
12. Copyright ..................................................................................................................... 22
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
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1. Introduction
1.1 About this manual
These instructions for use include all relevant information for
the use of the extension system (ES) including the accessories.
This section contains information about the structure of the
user manual as well as explanations of the signs and symbols
used.
This user manual contains instructions regarding the use of
the extension system. In the following, it will also be called ES.
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 modifi-cations. Thus, changes or improvements are
possible at any time without previous notification. If you have
any questions, please contact us.
Any person using the ES must read the user manual and
observe the instructions.
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
ma-nual to indicate especially important information.
Attention!
This symbol is used with safety instructions indi-
cating a risk of damage to the device or other
property.
a
Danger!
This symbol indicates safety instructions warning of
risks to personal health and safety. It indicates imminent
danger of death or serious injury.
g
Caution!
This symbol indicates potentially dangerous situa-
tions involving a risk of light injury.
v
This symbol indicates additional useful information
• 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.
h
1.3 General safety instructions
The extension system 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 ES only when in proper working condition, within the
scope of the intended use, in consideration of safety and poten-
tial hazards and in compliance with this user manual. Immedia-
tely repair any defects that could possibly affect 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 modify the device without the manufacturer‘s approval.
Spare parts must comply with the requirements stipulated by
the manufacturer. Original spare parts always comply with these
requirements.
Observe the specified inspection intervals. Ensure safe and
environmentally friendly disposal of replaced parts.
Intended use also includes compliance with this
manual as well as inspection and maintenance
conditions. Before every use, make sure that the
entire system is stable and safely supported.
h
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
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Summary of the safety instructions
g
g
a
Attention !
During height adjustment or lateral movements,
the RotexTable® and the leg plate may collide and
damage the device. In this case, swivel the leg plate
of the healthy leg outward in order to ensure suffi-
cient freedom of movement for the RotexTable®.
a
Attention!
If the stability of the ES and operating table combi-
nation is low, please always use the leg plate support
for the ES to prevent the operating table including
the ES from tipping over!
Pay attention to instructions on the use of the
support in the delivery documents.“
Danger !
If RF current flows unintentionally in activated RF
surgery devices, there is a risk of burns for pati-
ents. Patients must therefore have no contact with
electrically conductive pads and metal parts of the
extension system. Always place an insulated,
water-proof foil between pads and patient.
Danger !
The ES can come loose if the cross strut is not
properly attached to the operating table. Always
verify that the ES is firmly attached to the operating
table.
Danger !
The leg plate or the RotexTable® may become deta-
ched from the ES if the connecting pins are not
completely latched in. Always verify that the leg
plate or the RotexTable® is firmly attached to the ES.
g
a
Attention!
In some cases, the leg plates may need to be folded
away.
a
a
Attention!
When adjusting the height of the operating table
again, the height of the support must also be read-
justed. For this purpose, the star grip should be
opened before moving the operating table and then
fixed again at the appropriate height.
Attention!
The support must be adjusted again and positioned
vertically if the operating table is moved longitudi-
nally. Check the stability of the system again!
g
g
Danger!
If the operating table is moved down without first
releasing the height adjustment of the support,
damage may occur to the support, the ES and/or
the operating table.
Danger!
If the operating table is moved upwards without
adjusting the height of the support, the operating
table may tip over. Therefore, adjust the height of
the support each time you adjust the height of the
table.
v
Caution !
Even though the hand wheel of the traction device
runs very smoothly, injuries to the patient through
excessive extension are still possible. Proceed very
carefully during extension.
v
Caution !
Extension shoes that have not been properly
secured can get loose, and the patient could be
injured. Verify the firm attachment of the extension
shoe on the traction device.
a
Attention!
When using the ES, make sure that nothing is under
the system. Otherwise, when lowering the opera-
ting table, damage to the ES and/or operating table
may occur.
g
v
Caution !
Please make sure that both leg plates are selected
on the operating table control and that they are
only moved on both sides. There is a risk of the ES
conncting plate breaking if it is moved on one side
only!
Danger !
After the operation, make sure that the patient is
centrally positioned on the operating table before
transporting him out of the operating room! There
is a risk of tipping!
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
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Summary of the safety instructions
a
Attention !
When using an ES on a longitudinally adjustable
bed surface, the ES may press against the centre
column of the operating table and damage the
device. Avoid longitudinal movement, in particular
when the ES slants down. Always ensure sufficient
space for the longitudinally adjustable bed surface.
Danger !
The maximum permitted weight for side rail
adaptation for a drape holder is 5 kg! Also observe
the maximum permitted total weight for the ES
and the operating table. Make sure that the
complete system is stable!
g
v
Caution!
The hand wheel of the tension device [8] can be
moved very easily. Extend the device with care.
a
a
a
Attention !
Abrasive detergents may damage surfaces. Do not
use abrasives for cleaning.
Attention !
Skin disinfectants may cause discolourations in the
pads. Immediately remove skin disinfectants from
the pad to avoid discolourations.
Attention !
Alcoholic detergents damage the faux leather
(hardening and tearing). Do not use these agents
for cleaning or disinfection.
a
a
Attention !
Pointed or sharp objects may damage the pads. Be
careful with pointed or sharp objects.
Attention !
Damaged pads may soak up moisture. Always
replace damaged pads immediately.
vCaution !
Disinfectants containing alcohol can cause inflam-
mable gas mixtures. Do not use alcoholic disinfec-
tants.
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
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1.4 Graphical symbols used
Table 1 Graphical symbols used
The following graphical symbols are used in accordance with
DIN ISO 15223-1.
Graphical symbol Identification
Identification in agreement
with ISO 15223-1 standard.
Symbol for “product number“
Identification in agreement
with ISO 15223-1 standard.
Symbol for “serial number“
Identification in agreement
with ISO 15223-1 standard.
Symbol for “name and
address of the manufacturer“
Identification in agreement
with ISO 15223-1 standard.
Symbol for „date of
manufacture“
Identification in agreement
with ISO 15223-1 standard.
Symbol for “observe
instructions for use“
Identification in agreement
with ISO 15223-1 standard.
Symbol for “temperature
range“
Identification in agreement
with ISO 15223-1 standard.
Symbol for “relative humidity“
Graphical symbol Identification
Identification in agreement
with ISO 15223-1 standard.
Symbol for “air pressure“
Identification in agreement
with ISO 15223-1 standard.
Symbol for “product not
sterile“
Identification in agreement
with ISO 15223-1 standard.
Labelling of medical devices.
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® Extension System (ES) – Edition 2022-08-23 EN
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2 Basic requirements
2.1 Intended use
The extension system (ES) is an accessory for a medical device.
It is intended for human medical applications exclusively and
must only be used in conjunction with an operating table. It is
optimised for application in combination with the RotexTable by
Condor®.
The ES is used to position the hip and lower extremities of pati-
ents during operations on the hip, thigh, lower spine, as well as
during induction and emergence. It is equipped with leg plates
and enables countering during extension and traction. If the safe
load capacity of the operating table permits this, the ES may be
used for patients weighing up to 225 kg. If the load capacity of
the operating table including manufacturer-supplied extensions
of the bed surface is lower, then this lower safe load capacity of
the operating table applies. Ensure the stable positioning of the
system when it is bearing the entire work load before each use.
During use, the ES is connected to a specific operating table.
For adaptation to a specific operating table, the model of the
operating table has to be indicated in the order. The operating
table and ES may only be used by persons who have familiarised
themselves with the product by reading this manual. The ES 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 noncompliance 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 ES may only be used in complete accordance
with the user manual.
No liability shall be assumed for potential product damage or
personal injury due to non-approved accessories or contradic-
ting intended use, non-compliance with maximum limits or
requirements regarding function checks and visual inspections.
2.2 Device Description
Cross strut, adapted to operating
table (illustrated here with
connecting pin)
Segmental plate,
right, carbon
(enables optimal
access to the hip)
Countertraction post with fitted pad
Segmental plate, left, carbon
Pad for leg plate, right
side
Rotary pick-up
Connecting
plate
Star grip
Traction device
Hand wheel
Leg plate, left with
traction device
Supports with star
grip for the traction
device
Tension bolt for extending
the extension bar
Leg plate support
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
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4. Operation
4.1 Connecting the extension system to the operating table
The ES can be attached to operating tables of various manufactu-
rers. The cross strut of the ES is adapted to specific models of an
operating table manufacturer. The model of the operating table
needs to be indicated in the order.
The ES is attached to the seat part of the operating table unless
another option has been expressly approved.
Attachment to the operating table should be according to the
specifications of the manufacturer of the operating table. For
further details please consult the operating instructions of the
operating table.
• Always verify that the extension system is firmly attached to
the operating table.
The stability of the operating table, RotexTable® and extension
system depends on various factors:
– Structure and weight of the operating table
– Position of the rollers on the operating table trolley
– Position of the longitudinal adjustment of the bed surface (if
available)
Always make sure that the system of operating table, Rotex-
Table®, ES and patient is stable before use.
The connecting plate is shown here with connecting
pins without pad
Connecting pins for attaching the
extension system to an operating
table
Danger !
The extension system can come loose if the cross
strut is not properly attached to the operating table.
Always verify that the extension system is firmly
attached to the operating table.
g
Danger !
If RF current flows unintentionally in activated RF
surgery devices, there is a risk of burns for pati-
ents. Patients must therefore have no contact with
electrically conductive pads and metal parts of the
extension system. Always place an insulted, water-
proof foil between pads and patient.
Danger !
The combination of operating table with extension
system can tip over if the stability is insufficient.
Make the system as stable as possible. Check that
the entire system is standing firmly.
g
g
3. Storage
In its original packaging, the extension system may be exposed
to the following ambient conditions for a period of 15 weeks:
Ambient temperature
-5°C
+50°C
Relative humidity
10%
95%
Pressure
500 hPa
1060 hPa
a
Attention!
If the stability of the ES and operating table combi-
nation is low, please always use the leg plate support
for the ES to prevent the operating table including
the ES from tipping over!
Pay attention to instructions on the use of the
support in the delivery documents.“
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
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4.2 Removing and attaching segmental plates
The connecting plate of the extension system has removable
segmental plates to enable optimal access to the patient‘s hip
joints.
•In order to remove the segmental plate, pull the release
button outwards and swing the segmental plate down.
•Lift the segmental plate all the way up from its mount.
•To attach the segmental plate, insert it into its mount and
swing it upwards until the lock latches in.
• Check the segmental plate for secure fit.
Illustration without pad
Release button for the
segmental plate
4.3 Attaching and removing the countertraction post
The extension system enables countering during extension and
traction. A countertraction post with fitted pad is needed for that.
•Insert the countertraction post along with its pad into the
rectangular mount of the ES so that it latches in.
• Check the countertraction post for firm seat.
•In order to remove the countertraction post, pull the knob
and lift it out upwards.
Illustration without pad
Knob for releasing the
countertraction post
Rectangular mount for
countertraction post
Instructions for Care and Use Condor® Extension System (ES) – Edition 2022-08-23 EN
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4.4 Attaching and removing leg plates
The connecting plate of the extension system has at its narrow
end two connection openings where leg plates or the Rotex-
Table® can be attached.
The methods for connecting a leg plate or a RotexTable® to the ES
are identical. Only the leg plate is shown here.
Illustration without pad and with
the segmental plates removed
Connecting pin of the leg plate for
attaching to the connecting plate
Star grip
Latching bar (not visible in the
X-ray image)
Connecting plate Connection openings for
leg plate or RotexTable®
Knobs for releasing the connecting
pins in the connection openings
g
Danger !
The leg plate or the RotexTable® may become deta-
ched from the extension system if the connecting
pins are not completely latched in. Always verify that
the leg plate or the RotexTable® is firmly attached to
the connecting plate of the extension system.
•Push the connecting pin into the mount on the ES until it
latches in audibly.
•Verify that the leg plate or the RotexTable® is firmly latched
to the connecting plate of the ES.
•To prevent the operating table from tipping, we recommend
attaching a support to the leg plate after it has been atta-
ched. For more information, see chapter 4.5.
•To remove the leg plate or RotexTable®, release the connec-
ting pin in the connection opening. Pull the knob down to
do so.
• Remove the leg plate or the RotexTable®.
This manual suits for next models
1
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