Blatchford KX06 User manual

KX06
Instructions for Use
KX06V2
Instructions for Use
Brugsanvisning
Bruksanvisning
Käyttöohjeet
Bruksanvisning
Инструкция протезиста
使用说明
PK3
EN 2
DA 19
NO 36
FI 53
SV 70
RU 87
ZH 104

2
Contents.................................................................................................................................................................2
Package Contents ...............................................................................................................................................2
1 Description and Intended Purpose ...................................................................................................................3
2 Safety Information....................................................................................................................................................4
3 Construction ...............................................................................................................................................................5
4 Function........................................................................................................................................................................6
5 Maintenance ...............................................................................................................................................................6
6 Limitations on Use....................................................................................................................................................7
7 Bench Alignment.......................................................................................................................................................8
8 Static Alignment........................................................................................................................................................9
8.1 Check Anterior-Posterior Alignment............................................................................................................9
8.2 Adjusting Yield/Stance Resistance................................................................................................................9
9 Dynamic Alignment: Swing Resistance.......................................................................................................... 10
9.1 Flexion Resistance............................................................................................................................................ 10
9.2 Extension Resistance ...................................................................................................................................... 11
9.3 Stirrup Function and Features..................................................................................................................... 11
9.4 Static Alignment Check ................................................................................................................................. 12
9.5 Dynamic Alignment Adjustment Flow Diagram................................................................................... 13
10 Fitting Advice........................................................................................................................................................... 14
11 Socket Attachment................................................................................................................................................ 14
12 Fitting the Cosmetic Cover ................................................................................................................................. 15
13 Knee Pad Removal/Replacement..................................................................................................................... 15
14 Fitting T-Slot Style Adapters............................................................................................................................... 16
15 Technical Data ......................................................................................................................................................... 16
16 Ordering Information ........................................................................................................................................... 17
Contents
Package Contents
1. KX06V2 Knee prosthesis
2. Cosmetic cover
3. Clinician’s manual
4. User guide
5. Parts bag with:
i) 5 x M4 x 12mm low prole hex socket cap head screws
ii) 5 x Cover xing spacers
iii) Hex key, 2.5mm
938409PK3/1-0121
EN

3
1 Description and Intended Purpose
These instructions are for the practitioner.
The term device is used throughout these instructions for use to refer to KX06V2.
Application
This device is a knee unit that is for use exclusively as a component of a lower limb prosthesis.
This device is a polycentric knee unit that uses both a 4-bar mechanism and a hydraulic cylinder
to control the phases of the gait cycle. It provides swing and stance control for active hip
disarticulation, transfemoral and knee disarticulation users.
The geometry of the device provides increased toe clearance during swing phase. The build
height is short and upon sitting minimizes protrusion of the prosthetic knee beyond the contra-
lateral limb. This combination of features reduces asymmetry for users with longer residual limbs.
This device is manufactured from water resistant materials and is designed to accommodate
limited exposure to such environments.
Features
• Adjustable stance support
• Adjustable swing (exion and extension) resistances
• Reduced build height*
• Increased toe clearance during swing phase*
• Reduced protrusion during sitting*
• Flexion Lock mode
• Cycling mode
*Compared to a single axis knee unit.
Clinical Benets
• Improved ground clearance reducing trips and falls risk
• Geometry increases knee stability during stance phase
Activity Level
This device is for Activity Level 3 and 4 users.
Contraindications
This device might not be suitable for Activity Level 1–2 users or for use in competitive sports
events. These types of users might be better served by a specially designed prosthesis that is
optimized for their needs.
This device is not suitable for users with:
• Residual muscular weakness, contractures that cannot be correctly accommodated, or
proprioceptive dysfunction including poor balance
• Contralateral joint instabilities or pathology
• Complicated conditions involving multiple disabilities
This device is for a single user.
Users must be given gait training before using this device.
Make sure that the user has understood all instructions for use, drawing particular attention to all
maintenance and safety information sections.
938409PK3/1-0121

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2 Safety Information
1. Be aware of nger trap hazard at all times.
2. Any changes in the performance or function of the limb e.g. instability, double-
action, restricted movement, non-smooth motion or unusual noises should be
immediately reported to your service provider.
3. Always use a hand rail when descending stairs and at any other time if available.
4. Any excessive changes in heel height after nalization of alignment may adversely
aect limb function.
5. After continuous use the cylinder can become hot.
6. The device is not designed for prolonged submersion. Ensure any use of the device
in water complies with the conditions given in "Limitations on Use" (see Section 6).
7. After any period of immersion in water, rinse the device with fresh clean water and
then thoroughly dry before reuse.
8. Ensure only suitably retrotted vehicles are used when driving. All persons are
required to observe their respective driving laws when operating motor vehicles.
9. Care should be taken when carrying heavy loads as this may adversely aect the
stability of the device.
10. The user should be advised to contact their practitioner if their condition changes.
11. Avoid exposure to extreme heat and/or cold.
12. Assembly, maintenance and repair of the device must only be carried out by a
suitably qualied clinician.
Note… The device is supplied with the cosmetic cover detached. Although the device can be
congured with the cosmetic cover attached, the adjustment cap is more accessible with the cover
detached. Therefore it is easier to rst align and congure the device for the user (see Sections 7 to
10) while the cosmetic cover is o (taking care to avoid nger trap hazards), then, when conguration
is completed, immediately attach the cosmetic cover (see Section 12) to help protect against nger
trap hazards in use.
This warning symbol highlights important safety information which must be
followed carefully.
938409PK3/1-0121

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3 Construction
Principal Parts
Cosmesis
The following standard Blatchford continuous
polyester foam cosmesis may be used with
this device:
561021 - Fairing Unshaped Long
Rear View
Knee Control Detail
Component Identication
Knee Pad
Chassis
Posterior Pivot
Chassis
Carrier
Carrier
Anterior Pivot
Male Pyramid
Spacer
(x4)
M4 Hex Screw
(x4)
Knee Control
Yield Adjuster
Stirrup
Cosmetic
Cover
Latch
Adjustment Cap
Trunnion
Link Arms
M3 Hex Screw
(x2) Chassis
Anterior Pivot
Carrier
Posterior Pivot
Avoid over-tightening the cover screws
• Frame Aluminium alloy, brass, stainless steel, titanium, steel
• Knee control Various materials, principally aluminium alloy, stainless steel, acetal
homopolymer, nitrile butadiene rubber (NBR), hydraulic uid
• Knee pad Polyurethane
• Cosmetic cover Thermoplastic elastomer
938409PK3/1-0121

6
4 Function
The knee is a polycentric design comprising pivots connecting a chassis to a carrier via four
link arms. A hydraulic knee control sits within this frame assembly, tted between the chassis
posterior pivot (rear proximal axis) and the carrier anterior pivot (distal axis).
The device provides increased toe clearance during swing phase as a result of ease of initiation
of free swing and mechanical advantage of the geometry compared to a single axis device, and
short protrusion when sitting.
The device has dual stance control, combining the geometric stability of the polycentric knee
linkage with an adjustable hydraulic yielding support activated from knee extension prior to heel
strike and released by a hyper-extension moment at any time, usually occurring after mid-stance.
The device provides an adjustable hydraulic swing phase control to accommodate variable
cadence.
5 Maintenance
An annual visual inspection is recommended. Check for visual defects that may aect proper
function.
Maintenance must be carried out by competent personnel.
Do not carry out maintenance on this device yourself. Instead, return it to a Blatchford center for
maintenance. If the device is still under warranty, we will loan you another knee unit while we
carry out maintenance.
The user should be advised:
Any changes in performance of this device must be reported to the practitioner.
Changes in performance may include:
• Increase or decrease in knee stiness
• Instability
• Reduced knee support (free movement)
• Any unusual noise*
* Due to the nature of the hydraulics there may be some slight air noise from the cylinder during the
rst few steps. This is not detrimental to the function of the unit and should dissipate quickly.
If symptoms persist, please consult your practitioner.
Storage and Handling
When storing for prolonged periods place the device vertically with trunnion uppermost.
Alternatively and in addition, air management may be assisted by cycling the knee control
several times with the stance resistance switched o (refer to Section 9.3).
Use product packaging supplied.
Cleaning
Use a damp cloth and mild soap to clean the outside surfaces.
DO NOT use aggressive cleansers.
938409PK3/1-0121

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6 Limitations on Use
Intended Life
A local risk assessment should be carried out based upon activity and usage.
Lifting Loads
User weight and activity is governed by the stated limits.
Load carrying by the user should be based on a local risk assessment.
Environment
The device is suitable for submersion in fresh water only.
Knee must be locked while submerged, then rinsed and thoroughly dried.
Light surface corrosion aects neither the function nor the security of this device.
However, if it is heavily corroded, stop using and contact your practitioner.
Avoid exposing the device to abrasive or corrosive environments, such as those containing sand,
salt or chemically treated water e.g. swimming pools. After any exposure to such environments
rinse the device in fresh water and dry thoroughly.
Exclusively for use between -10°C and 50°C (-14°F and
122°F).
It is recommended that only Blatchford products be
used in conjunction with the device.
938409PK3/1-0121

8
7 Bench Alignment
Build Line
Trochanter
ref: 10 mm
(refer to tting instructions
supplied with the foot)
Users be aware of potential nger trap hazard.
Additional Components
Follow the alignment instructions that are
supplied with any additional components.
Load line 0 to 5mm
posterior
Allow for the user’s
footwear
938409PK3/1-0121

9
1
2
3
4
5
6
789
+
-
1
2
3
4
5
6
789
8 Static Alignment
To achieve optimal function from the Blatchford hydraulic knee control the knee must be aligned
geometrically stable.
Check exion is fully accommodated when worn by user.
Stance Resistance (Yield)
Do not turn the yield adjustment screw
counterclockwise beyond 180° position as
this will cause the control unit to operate
inconsistently (may or may not release from
stance.)
8.1 Check Anterior-Posterior Alignment
1) Ensure stirrup is down.
2) Stand with feet side by
side holding onto rails.
3) Load prosthesis.
1) Check exion is fully
accommodated.
2) Conrm bench
alignment, see
Section 7.
3) Slide socket
anteriorly to make
knee just stable.
Knee stable during
weight bearing:
OR
1) Proceed to adjusting
yield/stance resistance,
see Section 8.2.
Knee unstable during
weight bearing:
8.2 Adjusting Yield/Stance Resistance
Stirrup
Yield
Adjuster
2
9 = Maximum
Stance Resistance
1 = Minimum Stance
Resistance
2mm
Hex Key
Having rst checked A-P alignment
as above (initial adjustment
position is factory set):
1) Ensure stirrup in down position.
2) Standing with feet side by side
try to sit (do not hyperextend
limb).
If excessive resistance, reduce
resistance by turning the yield
adjustment screw with the hex
key counterclockwise until correct
resistance is felt to sitting naturally.
1.
2.
938409PK3/1-0121

10
1) Initial adjustments are factory set
(Extension 2, Flexion 4).
2) Observe the user walking.
3) If there is excessive heel rise: Increase exion
resistance.
4) If there is insucient heel rise: Decrease
exion resistance.
9 Dynamic Alignment: Swing Resistance
Indicator
Ring
Decrease
resistance
Adjustment
Cap Increase
resistance
Flexion
Scale
Extension
Scale
Indicator
Mark
Raise latch to allow
adjustment cap to turn.
Lower latch to lock
adjustment cap.
Latch
Warning! If adjusting the exion resistance
has no eect on heel rise, check stirrup is in
down position and ensure that the user is
initiating exion whilst still loading the toe.
Note that a hyperextension moment is
needed about the knee to initiate exion.
9.1 Flexion Resistance
Hydraulic-Knee-
Control Adjuster
(940091)
Note… If you cannot turn the adjustment cap with
your ngers, use a hydraulic-knee-control adjuster
(940091).
Take care not to force the adjuster ring and
overcome the adjustment stops; this could
cause loss of function.
Note… The same adjustment cap is used to adjust
both exion resistance and extension resistance.
The exion scale on the adjustment cap is
numbered from left to right 1 (minimum) to
10 (maximum). Directly below the exion
adjustment cap is an indicator mark.
Turning the cap
counterclockwise
reduces exion
resistance until
the minimum
resistance is
reached where
“1”on the exion
scale is over the
indicator mark.
Turning the cap clockwise increases the
resistance to a maximum setting at“10”.
To adjust exion resistance:
1) Raise the latch.
2) Turn the adjustment cap to the required
exion setting.
3) Lower the latch to lock the cap and prevent
accidental adjustment.
Maximum
Flexion (10)
Indicator Mark
Minimum
Flexion (1)
3.
938409PK3/1-0121

11
1) Flex knee slightly without
overriding stance resistance.
2) Lift stirrup.
3) The knee is now locked
against exion but will extend.
4) Lower stirrup to resume
normal operation.
1) Load toe of prosthesis.
2) While toe is loaded, lift
stirrup up.
3) Stance now o but knee
may be unstable.
4) Lower stirrup to resume
normal operation.
Note… If there is any doubt over the position of
the indicator ring in relation to the settings, its
position can be reset by turning the adjustment
cap to maximum exion, then maximum
extension prior to making any adjustments.
1) Observe the user
walking.
2) If there is excessive
terminal impact on
knee extension:
increase resistance.
3) If the knee does not
extend satisfactorily:
decrease resistance.
Note… As a ‘rule of thumb’exion resistance
should be greater than extension resistance.
How to switch o stance resistance
(for cycling etc.)
How to lock knee against exion
(for prolonged standing etc.)
9.2 Extension Resistance
9.3 Stirrup Function and Features
Make a note of the exion setting before starting to
adjust the extension resistance.
To increase extension resistance:
1) Raise the latch and turn the adjustment cap in the
clockwise direction
until it reaches 10 on
the exion scale.
2) Continue turning
the cap clockwise
to engage and
turn the indicator
ring clockwise; this
moves the indicator
mark from right
to left (clockwise),
increasing extension resistance from 1 to 10 on the
extension scale.
To reduce extension resistance:
3) Raise the latch and turn the adjustment cap
anticlockwise to minimum on the exion scale
then continue turning until the desired extension
resistance is reached on the extension scale.
When the correct extension resistance setting is
achieved, turn the adjustment cap back to the
previously noted exion resistance setting, taking care
not to re-engage and turn the indicator ring again.
Lower the latch to lock the cap and prevent accidental
adjustment.
Maximum
Extension (10)
Indicator Mark
Minimum
Extension (1)
4.
After completing all exion and extension
resistance adjustments, ret the cosmetic cover
if previously removed (see Section 12).
938409PK3/1-0121

12
9.4 Static Alignment Check
Note: Initial stability adjustment is
factory set.
Align as recommended, (Section 7),
accommodate exion etc.
With user standing ensure stirrup is in
down position.
Instruct user to extend limb and gently
lift prosthesis from oor...
...then load limb again.
Is the knee stable?
Check A-P alignment (Section 8.1,
box 1). Socket may be positioned too
posteriorly. Realign anteriorly.
Check socket exion. Does this
accommodate user’s exion? Change
exion to suit user before continuing.
Instruct user to sit using stance
resistance (Section 8.2, box 2).
Does knee oer sucient support
to sit?
Is resistance OK, excessive or
insucient for user?
Increase resistance by turning stance/
yield adjustment screw clockwise until
correct.
Check A-P alignment.
Yes
No
Yes
OK
Proceed to Dynamic Adjustment.
(Section 9.5)
Reduce by turning stance/yield
adjustment screw counterclockwise
until correct.
No
Excessive resistance
Increase by turning stance/yield
adjustment screw clockwise until
correct.
Insucient resistance
938409PK3/1-0121

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9.5 Dynamic Alignment Adjustment Flow Diagram
Begin with initial adjustments as
factory set: Extension 2, Flexion 4.
Ensure stirrup is down.
Observe user walking.
Does limb release
from stance?
Yes
No
Yes
No
No
Is heel rise
satisfactory?
Is extension
satisfactory?
Finish
Adjust exion
resistance
(Section 9.1)
Adjust extension
resistance
(Section 9.2)
Does user initiate
exion with limb
loaded?
Provide
instruction on
doing so.
Gait training may
be required.
No
Yes
Does foot
have very soft
dorsiexion
resistance?
Conrm alignment of limb as per Static
Alignment Check (Section 9.4), then retry
Dynamic Alignment.
If function is still unsatisfactory, contact
your sales representative.
Note... A hyperextension moment is
required to initiate a swing phase.
Stien/adjust
dorsiexion
resistance. Yes
No
Yes
938409PK3/1-0121

14
10 Fitting Advice
Problem Solution
The user’s sitting movement is too slow. Decrease the stance support (see Section 8.2).
The user’s sitting movement is too fast. Increase the stance support (see Section 8.2).
The device does not release from stance.
1. Make sure that the user loads the toe of the foot
unit while initiating swing and that the device
reaches full extension.
2. Make sure that the ankle-foot unit’s dorsiexion
resistance is not too low.
3. Re-check alignment. Socket may be too
posteriorly aligned causing the knee to ex/yield
at heel strike).
The heel rise is too high during swing. Increase the exion resistance (see Section 9.1).
The heel rise is too low during swing. Decrease the exion resistance (see Section 9.1).
The user is experiencing terminal
impact. Increase the extension resistance (see Section 9.2).
The device does not fully extend during
swing. Decrease the extension resistance (see Section 9.2).
11 Socket Attachment
Ensure socket does not contact the knee control or posterior link arms when fully exed.
The socket may contact the carrier only.
Carrier
Socket
938409PK3/1-0121

15
12 Fitting the Cosmetic Cover
The cover and mounting screws are supplied detached allowing easy access to the alignment
controls.
Always t the cosmetic cover after all alignment adjustments have been made to help
prevent nger trap hazards.
1. Fit the cosmetic cover to the device at the chassis anterior pivots and carrier anterior pivots
using the 4 x M4 hex screws and 4 x spacers supplied (see gure below).
2. Tighten the screws using the 2.5mm hex key supplied. Avoid over-tightening the screws.
Knee Pad Removal
1. Using the hex key supplied, unscrew,
remove and set aside the two lateral M3
hex screws that retain the knee pad.
2. Slide the knee pad horizontally o the
chassis.
Knee Pad Replacement
1. Slide the replacement knee pad
horizontally onto the chassis until the
lateral knee pad and chassis screw holes
align (see gure opposite).
2. Using the hex key supplied, fasten the
knee in place with the two M3 hex screws.
Avoid over-tightening the screws. Knee Pad Replacement
13 Knee Pad Removal/Replacement
2.5
Fitting Cosmetic Cover
Knee Pad
239561
M3 Hex Screw
(x2)
910408
Chassis
Anterior Pivot
Carrier
Anterior Pivot
Spacer
236122
(x4)
M4 Hex Screw
913216
(x4)
Cosmetic
Cover
236121
Avoid over-tightening the
cover screws
Avoid over-tightening the
knee pad screws
938409PK3/1-0121

16
30mm
220mm
Operating and Storage Temperature Range: -10˚C to 50 ˚C
(14˚F to 122 ˚F)
Component Weight: 1.34kg (2 lb 15 oz)
Activity Level: 3–4
Maximum User Weight: Level 3: 150kg (330lb)
Level 4: 145kg (320lb)
Maximum Flexion Angle: 160°
Proximal Alignment Attachment: 4–bolt interface
T–slot interface
Distal Alignment Attachment: Blatchford male pyramid
Build Height (see Diagram): 220mm (8.7 inches)
14 Fitting T-Slot Style Adapters
If tting a T-slot style adapter:
1. Remove knee pad as described in
Section13.
2. Unscrew two M3 x 8 hex socket set screws
(see gure right) until the T-Slot opening is
unobstructed.
3. Slide adapter into T-slot.
4. Screw in the two M3 x 8 screws until tight
against the chassis to prevent the adapter
from sliding out of the T-slot.
Do not overtighten screws.
5. Ret knee pad as described in Section 13.
1.5
M3 x 8mm
Hex Screws
(x2)
910394
T-Slot
Opening
Chassis
15 Technical Data
Avoid over-tightening the screws
after tting T-slot adapter
Unscrewing T-Slot Screws Before Fitting Adapter
938409PK3/1-0121

17
16 Ordering Information
Description Part Number
Device
KX06V2 KX06V2
Spare Parts
Knee pad kit (includes knee pad, 2.5mm hex key and 2 x M3 x 10mm hex
socket cap head screws) 239561
Knee pad screw (M3 x10mm hex socket cap head screw) 910408
Cover replacement kit (includes cosmetic cover, 2.5mm hex key, 5 x M4 x
12mm low prole hex socket cap head screws and 5 x cover xing spacers) 239661
Spacer and screws kit for cosmetic cover (includes 4 x M4 x 12mm low prole
hex socket cap head screws and 4 x cover xing spacers) 239761
Cover screw: M4 x 12 mm low prole hex socket cap head screw 913216
Cover spacer 236122
Hydraulic-knee-control adjuster 940091
Liability
The manufacturer recommends using the device only under the specied conditions and for
the intended purposes. The device must be maintained according to the instructions for use
supplied with the device. The manufacturer is not liable for any adverse outcome caused by any
component combinations that were not authorized by them.
CE Conformity
This product meets the requirements of the European Regulation EU 2017/745 for medical
devices. This product has been classied as a class I device according to the classication rules
outlined in Annex VIII of the regulation. The EU declaration of conformity certicate is available at
the following internet address: www.blatchford.co.uk
Compatibility
Combination with Blatchford branded products is approved based on testing in accordance
with relevant standards and the MDR including structural test, dimensional compatibility and
monitored eld performance.
Combination with alternative CE marked products must be carried out in view of a documented
local risk assessment carried out by a Practitioner.
Single Patient – multiple use
Medical Device
938409PK3/1-0121

18
Trademark Acknowledgements
KX06 and Blatchford are registered trademarks of Blatchford Products Limited.
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK.
Warranty
This device is warranted for 36 months.
The user should be aware that changes or modications not expressly approved could void the
warranty, operating licenses and exemptions.
See the Blatchford website for the current full warranty statement.
Reporting of Serious Incidents
In the unlikely event of a serious incident occurring in relation to this device it should be
reported to the manufacturer and your national competent authority.
Environmental Aspects
This product contains hydraulic oil, mixed metals and plastics. It should be recycled where
possible in accordance with local waste recycling regulations.
Retaining the Packaging Label
You are advised to keep the packaging label as a record of the device supplied.
938409PK3/1-0121

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Indhold
Pakkens indhold
1. KX06V2 knæprotese
2. Kosmetisk dæksel
3. Lægens håndbog
4. Brugervejledning
5. Pose med dele:
i) 5 x M4 x 12mm lavprol sekskantede hylsterhovedskruer
ii) 5 x afstandsstykker til påsætning af dæksel
iii) Unbrakonøgle, 2,5mm
Indhold................................................................................................................................................................. 19
Pakkens indhold ............................................................................................................................................... 19
1 Beskrivelse og tilsigtet formål .......................................................................................................................... 20
2 Sikkerhedsinformation......................................................................................................................................... 21
3 Konstruktion ............................................................................................................................................................ 22
4 Funktion..................................................................................................................................................................... 23
5 Vedligeholdelse ...................................................................................................................................................... 23
6 Begrænsninger i forbindelse med brugen.................................................................................................... 24
7 Bænkjustering ......................................................................................................................................................... 25
8 Statisk tilpasning .................................................................................................................................................... 26
8.1 Kontrollér anterior-posterior justering..................................................................................................... 26
8.2 Justere støtte/stillingsmodstand................................................................................................................ 26
9 Dynamisk justering: Svingmodstand.............................................................................................................. 27
9.1 Fleksionsmodstand ......................................................................................................................................... 27
9.2 Ekstensionsmodstand .................................................................................................................................... 28
9.3 Stigbøjlefunktioner ......................................................................................................................................... 28
9.4 Kontrol af statisk justering ........................................................................................................................... 29
9.5 Flowdiagram over dynamisk justering..................................................................................................... 30
10 Rådgivning vedrørende tilpasning.................................................................................................................. 31
11 Påsætning af hylster.............................................................................................................................................. 31
12 Montering af kosmetisk dæksel........................................................................................................................ 32
13 Aftagning/udskiftning af knæpude ................................................................................................................ 32
14 Tilpasning af T-rilleadaptere............................................................................................................................... 33
15 Tekniske data ........................................................................................................................................................... 33
16 Bestillingsoplysninger.......................................................................................................................................... 34
938409PK3/1-0121
DA

20
1 Beskrivelse og tilsigtet formål
Denne brugsanvisning er til lægen.
Udtrykket anordning anvendes i hele brugsanvisningen og henviser til KX06V2.
Anvendelse
Denne anordning er en knæenhed, som udelukkende må anvendes som en del af en
bensprotese.
Denne anordning er en polycentrisk knæenhed, som både benytter en mekanisme med
4 stænger og en hydraulisk cylinder til kontrol af faserne i gangcyklussen. Den giver sving- og
stillingskontrol for aktive brugere med disartikulation i hofte eller knæ, samt for transfemorale
brugere.
Anordningens geometri sørger for øget tåafsæt under svingfasen. Byggehøjden er kort,
og sørger for minimal fremspring af proteseknæet udover den kontralaterale stump. Denne
kombination af funktioner reducerer asymmetri for brugere med en lang stump.
Denne anordning er fremstillet af vandresistente materialer og er designet til at tåle begrænset
eksponering for sådanne miljøer.
Funktioner
• Justerbar støtte i standfasen
• Justerbar modstand i svingfasen (eksion og ekstension)
• Reduceret byggehøjde*
• Øget tåafsæt under svingfasen*
• Reduceret fremspring i siddende stilling*
• Låst modus under eksion
• Cyklusmodus
*Sammenlignet med en knæenhed med enkelt akse.
Kliniske fordele
• Forbedret afsæt fra underlaget, hvilket mindsker risikoen for at snuble og falde
• Geometrien øger knæprotesens stabilitet under standfasen
Aktivitetsniveau
Denne anordning er beregnet til brugere med aktivitetsniveau 3 og 4.
Kontraindikationer
Denne anordning er muligvis ikke egnet til personer med aktivitetsniveau 1-2, eller som dyrker
konkurrencesport Denne type brugere vil være bedre tjent med en specialfremstillet protese,
som er optimeret til vedkommendes behov.
Denne anordning er ikke egnet til brugere med:
• Residual muskelsvaghed, kontrakturer, som ikke kan lægges ordentligt til rette eller
proprioceptiv dysfunktion, herunder dårlig balance
• Kontralateral ledinstabilitet eller patologi
• Komplicerede sygdomme der involverer ere handicap
Denne anordning er beregnet til en enkelt bruger.
Brugere skal modtage gangtræning, før de bruger denne anordning.
Sørg for, at brugeren har forstået hele brugsanvisningen, og gør især opmærksom på alle afsnit
om vedligeholdelse og sikkerhed.
938409PK3/1-0121