Blatchford Linx User manual

User Guide
Brukerhåndbok
Руководство пользователя
用户指南
 
Linx
User Guide
LINX22L1S—LINX30R8S
LINX22L1SD—LINX30R8SD
PK3
EN 2
NO 16
RU 30
ZH 44
AR 58

2
Contents
Contents.................................................................................................................................................................2
Warnings ................................................................................................................................................................3
1 Description and Intended Purpose ....................................................................................................................4
2 Safety Information....................................................................................................................................................5
3 Construction ...............................................................................................................................................................6
4 Key Points.....................................................................................................................................................................7
5 Transport and Storage.............................................................................................................................................7
6 Battery Charging .......................................................................................................................................................8
6.1 Magnetic Charger Connection.................................................................................................................... 10
6.2 Battery Status .................................................................................................................................................... 10
7 User Modes............................................................................................................................................................... 11
7.1 Flexion Lock Mode........................................................................................................................................... 11
7.2 Cycling Mode..................................................................................................................................................... 12
7.3 Training Mode ................................................................................................................................................... 12
938354V2APK3/1-0321
EN

3
Low Temperature Operation
Warnings
The device contains Li-Ion type rechargeable batteries. Please read and comply with the safety
information, see Section 2 and Section 6. Failure to do so may cause the battery to become hot,
explode, or ignite and cause serious injury.
Battery On/O Switch
IMPORTANT: Battery Charging
To charge the device ensure that the On/O Switch is in the ON
position. When the device is charging the Battery Charger LED will
be ashing green.
The battery should only be charged within the temperature range
10˚C to 40˚C (50˚F to 104˚F).
IMPORTANT: If the limb is subjected to temperatures lower than -10°C (14°F) it must be returned
to be inspected for possible damage to the battery pack.
Following extended periods of inactivity at temperatures below 0°C (32°F) the limb may swing
less freely. In such an eventuality, it is recommended to exercise caution while descending stairs
and avoid descending stairs leg-over-leg using the knee yield until you feel the swing returns to
normal.
Battery Safety
The term device is used throughout this manual to refer to Linx.
Regular cleaning of the magnetic charging surfaces is required to ensure no liquids,
contamination or debris prevents correct connection. (See Section 4 for cleaning advice).
Magnetic Connector Cleaning
Package Contents:
1. Linx limb
2. Detachable Cosmetic Cover
3. User Guide
4. Cable bag and accessories
i) Battery charger
ii) Battery charger AC power socket outlet adapter(s)
938354V2APK3/1-0321

4
1 Description and Intended Purpose
This document describes the V2 version of the Linx limb.
These instructions are for the user. Please keep these instructions.
Make sure that you understand all instructions for use, drawing particular attention to all
maintenance and safety information sections.
Application
The device is to be used exclusively as part of a lower limb prosthesis.
Intended for single user.
The device is a fully integrated, microprocessor-controlled knee and foot system. It provides
simultaneous control over both foot and knee, co-ordinating their responses for a variety of
terrains and situations in one complete biomimetic limb. Individual adjustments can be made for
slopes and stairs, and there is a standing mode which locks the device to assist when standing.
Features
• All the functions of a microprocessor control in both knee and hydraulic ankle
• Centralised control of knee and foot to give the user a better co-ordinated response for
standing, level walk, ramp ascent and descent
• Proven to reduce stress at the socket interface
• An easy access single charging and point
• Longer battery life, 3 days average use from the internal rechargeable Li-ion battery pack
• 3 user modes
• Activity monitoring of dierent activities
The enhanced stability system oers:
• Standing Mode, control of knee exion and ankle for standing
• Controlled ramp descent with Braking eect of knee and ankle
• Enhanced ramp ascent with optimized assistive eect of knee and ankle
• Active control of heel rise during walking
• Dynamic stair descent with an easy start of knee exion
coupled with increasing support to gently lower the user during exion
• Supportive resistance to exion as soon as the knee stops exing
• Increased supportive resistance to exion to prevent ‘stumbles’associated with instability at
heel strike.
938354V2APK3/1-0321

5
2 Safety Information
Any changes in the performance or
function of the limb e.g. restricted
movement, non-smooth motion or
unusual noises should be immediately
reported to your service provider.
Always use a hand rail when descending
stairs and at any other time if available.
Any excessive changes in heel height
after programming will adversely aect
limb function and should be immediately
reported to your service provider for
reprogramming and calibration.
After continuous use the ankle and knee
casing may become hot to the touch.
Avoid strong magnetic elds, sources
of electrical interference, atmospheres
containing liquids and/or powders.
Do not place near any heat source. Do not
leave in direct sunshine or inside a car in
hot weather.
The device is not intended for use
when immersed in water or as a shower
prosthesis. If the limb comes into contact
with water wipe dry immediately.
Before connecting the battery charger
to the device, ensure that the magnetic
mating surfaces of the charging connector
and charging terminal are clean, dry
and free of any debris or conductive
materials that could prevent correct
charging operation. (See further warnings
in Section 6.1 and cleaning advice in
Section4).
Never connect the charger to the device
while still wearing the limb.
The device is not suitable for extreme
sports, running or cycle racing, ice and
snow sports, extreme slopes and steps.
Any such activities undertaken are done
so completely at the users’ own risk.
Recreational cycling is acceptable.
Be aware of nger trap hazard at all times.
Contact your service provider for advice if
the device is to be used with a pacemaker
or any other electronic medical device.
Assembly, programming, maintenance
and repair of the device must only be
carried out by a suitably qualied clinician
that has attended an approved training
course.
The user must not adjust or tamper with
the setup of the device.
The user should be advised to contact
their clinician if their condition changes.
The device detects standing and walking
on inclines, declines and walking
at various speeds. Non-identied
movements may cause unexpected
behaviour.
Only charge the batteries in the device
using the charger supplied with the
product. Do not use this charger for
charging anything else.
Ensure only suitably retrotted vehicles
are used when driving. All persons are
required to observe their respective
driving laws when operating motor
vehicles.
Make sure that no liquids enter the device
during donning or normal use.
The charging connector and terminal are
sources of strong magnetic elds. Always
keep a safe distance (at least 10 cm)
between these magnets and all objects
that can be damaged or aected by
magnetism (such as watches, pacemakers,
credit cards, or any magnetically stored
media).
To minimise the risk of slipping and
tripping, appropriate footwear that ts
securely onto the footshell must be used
at all times.
The caution symbol highlights safety information which must be followed
carefully.
938354V2APK3/1-0321

6
Knee
Module
Pylon
Ankle
Module
3 Construction
Principal Parts
• Knee Module including pyramid (aluminium/St. Stl./titanium, carbon)
• Ankle Module (aluminium/St. Stl.)
• Pylon (aluminium)
• Heel & Toe Springs (e-Carbon)
• Spring Attachment Screws (titanium/St.Stl.)
• Glide Sock (UHM PE)
• Foot Shell, cables and exi-boards (polymers and PU)
• Batteries (lithium ion)
Toe Spring
Washer
Toe Spring
Screw
Heel
Spring
Heel spring
Screws
Toe
Spring
Battery On/O
Switch
[+], [-]
Buttons
and LED
Magnetic
Charging
Terminal
Extension
Cable
Glide
Sock
Foot
Shell
938354V2APK3/1-0321

7
High exion resistance settings may induce some noise during stairs descent, this will not aect
function.
Any changes in performance of this device must be reported to the clinician.
Changes in performance may include:
• Increase or decrease in knee and/or ankle stiness
• Instability
• Knee starting to extend too aggressively
• Reduced ankle/knee support (free movement)
• Any unusual noise
• Any unrecognized beeps or warning lights
The practitioner must also be informed of the following:
• Any changes in body weight and/or activity level
• Signicant wear or excessive discoloration from long term exposure to UV
Cleaning:
Use a damp cloth and mild soap to clean outside surfaces, DO NOT use aggressive cleansers. Ensure
water/liquids do not enter the charging socket. Thoroughly dry before use.
To clean the magnetic mating surfaces of the charging connector and charging terminal use a
clean and dry cotton swab or a soft bristle brush. Make sure that no cotton bres or bristles are
left on the surfaces.
Never apply water or any other cleaning liquid to the magnetic mating surfaces.
Environment:
Avoid exposing the device to corrosive elements such as water, acids and other liquids. Also
avoid abrasive environments such as those containing sand for example as these may promote
premature wear.
Keep magnetic or electrically conductive materials away from the magnetic mating surfaces of
the charging connector and charging terminal.
Exclusively for use between -10˚C and 50˚C (14˚F to
122˚F).
4 Key Points
5 Transport and Storage
The device must not be used with large variations in heel height.
Do not attempt stairs descent leg-over-leg on this device unless you have been
trained for stairs descent.
1. Ensure that the device is in a straight (fully extended) position when not in use.
2. If the limb is to be stored upright then it must be secured to prevent it falling over or exing.
3. If the device is shipped either on its own or built into a limb it should be maintained in an
extended position and packaged in a suitable box to allow this.
4. If a unit is to be returned, contact Blatchford prior to sending if any obvious physical damage
has occurred to the battery pack.
5. For transport purposes the unit must be switched o, and packed securely so that
a) it cannot be inadvertently switched on and become operative while in transit;
b) the unit is thoroughly protected from damage in transit.
938354V2APK3/1-0321

8
6 Battery Charging
Please familiarize yourself with the charging information in this section.
The batteries are not eld replaceable and will be replaced as necessary when
serviced.
If the device is subjected to temperatures lower than -10 °C ( 14°F) it must be returned
to be inspected for possible damage to the battery pack.
WARNING: The device contains Li-ion type rechargeable batteries. Please read and
comply with the safety information. Failure to do so may cause the battery to become
hot, explode, or ignite and cause serious injury.
Magnetic
Charging
Terminal
Battery
On/O
Switch
[+],[-] Buttons
and LED
1. The battery should only be charged in temperatures between 10˚C to 40˚C (50˚F to
104˚F).
2. Only charge the batteries in the device using the charger supplied with the product.
Do not use this charger for charging any other device.
3. The battery charger can be used with an electrical outlet that is rated
between 100V and 240V AC, 50/60Hz.
4. Never connect the charger to the device whilst still wearing the limb.
5. During charging no power is delivered to the device’s control system.
6. The knee module may become warm during charging but should never be too hot
to touch. There should be no unusual smell, if there is immediately switch OFF [O]
the battery, unplug the charger from the electrical supply and contact your service
provider.
7. Do not ret the device until the charger has been disconnected and the device has
completed the full start-up procedure.
8. Always recharge the device before use if it has not been used for an extended period
of time.
938354V2APK3/1-0321

9
Note… Do not move
or don the limb while
reset is processing
otherwise this will
prolong the reset
time.
Battery
Charger
LED
Battery
Charger
6Battery Charging (continued)
Battery Charger LED Charging State
Yellow Standby
Green > fast ashing Fast charging
Green > slow ashing Close to full charge
Green Maintain (trickle charge)
Yellow > fast ashing Error (Ensure Battery Switch is
ON [I])
Device
LED
*You can enable or disable the
audible reset conrmation by
pressing and holding the [+]
and[-] buttons simultaneously
for 2 seconds. The change
will be conrmed by 2 short
beeps.
Note… If the charger LED is yellow and the Limb is
making a clicking noise check that the Battery switch is in
the ON [I]position.
Fully charge the battery before rst use.
We recommend that the device should be fully charged
every night. It should take 8 hours to charge fully (from fully
discharged). We also recommend battery charging whenever
convenient.
Step-by-Step Guide:
1. Lay the limb on a at surface.
2. Ensure the mating surfaces of the magnetic charging
connector and terminal are clean (see Section 4).
3. Magnetically join the charging connector to the charging
terminal at the posterior of the knee and check alignment is
correct (see Section 6.1).
4. Switch the Battery On/O switch to ON [I].
5. Check the Battery Charger LED is ashing green to conrm
the battery is charging.
6. Refer to table below to ensure Limb is charging.
7. Disconnect from the charger when charged suciently and
ret terminal cover.
8. Wait for 30 seconds while observing the device LED
changing color as indicated:
Device
LED
Red Blue Red Green O
9. After a successful reset sequence, 2 short beeps will be
heard (if this alert is not disabled; see* below).
10.If reset sequence is unsuccessful or the LED remains Red,
switch the battery OFF [O] then ON [I] and repeat from
step8.
Magnetic
Connector
Device
938354V2APK3/1-0321

10
When fully charged the device’s battery is intended to provide up to 3 days of normal use
(conditional on the type of use). We recommend that the knee be fully charged every night.
Switching o the device when not in use will also prolong the period of use
Note… The device will take 30 seconds to reset after it is switched back ON [I] ; refer to Section 6
Battery Charging (continued) for the reset sequence.
Battery Charge Indicator
LED Beeps Battery Condition
Green 3 ashes -- fully charged
Green 2 ashes -- good
Green 1 ash -- ok
Yellow slow ash 8 x Short beeps low charge
Red slow ash 5 x Long beeps no charge
Device
LED
6.1 Magnetic Charger Connection
The charging connector can be connected to the device through the charging terminal located
at the posterior of the knee.
The connector and the terminal magnetically lock together and correctly self-align on
connection (Figure 1).
Please check for any misalignment between mating surfaces as
this may result in no charging. This can happen especially when
the charging setup puts strain on the charging cable (Figure 3).
Before charging ensure charging surfaces are clean, dry and free
of any debris.
Do not allow any ferrous material to attach itself to the charging
surfaces.
Keep the magnetic surfaces away from materials that may be
adversely aected by their proximity to strong magnetic elds
(e.g. watches, pacemakers, bank cards or magnetically stored
media).
Prevent build up of debris on the charging surfaces as this may
prevent charging or damage the charger. Disconnect the charger
from the mains socket and remove any debris before reconnecting
the charger to the device.
1.
2.
3.
Note… The connector and the terminal are not polarized so
orientation is not critical (Figure 2).
6.2 Battery Status
To check the battery condition press and hold the [-] button on the knee, one short beep will be
heard and the LED will indicate the battery condition.
Device
938354V2APK3/1-0321

11
7 User Modes
The device has 3 user modes. Please note that these modes are only available if they have been
enabled by your practitioner.
WARNING: Care must be taken to only use those modes as instructed by your
practitioner.
1. Flexion Lock Mode
Sets the limit of exion to a predetermined angle set by the practitioner.
The maximum lock angle is 45 degrees from fully extended.
2. Cycling Mode (Free swing)
Releases stance resistance, the device will then swing freely.
WARNING: In Cycling Mode there is no stance control active, this mode must be de-
activated before resuming walking to avoid falling and possible injury.
3. Training Mode
In this mode, the device has a predened xed pneumatic resistance setting, set by the
practitioner, which does not adapt to changes in walking speed. Also, Standing Mode is not
available or operational in Training Mode.
WARNING: In Training Mode, the device has a predened xed pneumatic resistance
setting which does not adapt to changes in walking speed. Also, Standing Mode is not
active in Training Mode.
7.1 Flexion Lock Mode
To activate/de-activate Flexion Lock Mode use the[-] button on the device, as follows:
To activate Flexion Lock Mode:
• Fully extend the knee.
• Press the[-] button 3 times (each time pressing until the device responds with a single short
beep).
• 3 medium beeps then sound to conrm that Flexion Lock is ON.
To de-activate Flexion Lock Mode:
• Press and hold the [-] button
• 2 long beeps then sound to conrm that Flexion Lock is OFF and normal operation has
resumed.
• WARNING: After exiting Flexion Lock Mode, always test/conrm that the device is
operating normally again before walking.
938354V2APK3/1-0321

12
7.2 Cycling Mode
WARNING: In cycling (free swing) mode there is NO stance resistance.
To activate/de-activate Cycling Mode use the[-] button on the device, as follows:
To activate Cycling Mode:
• Sit on bicycle before activating Cycling Mode as once activated there is no support for
walking.
• Press the[-] button 4 times (each time pressing until the device responds with a single short
beep).
• 4 medium beeps then sound to conrm that Cycling Mode is ON.
To de-activate Cycling Mode:
• Press and hold the [-] button.
• 2 long beeps then sound to conrm that Cycling Mode is OFF and normal operation has
resumed.
WARNING: After exiting Cycling Mode, always test/conrm that the device is operating
normally again before walking.
7.3 Training Mode
WARNING: In Training Mode, the device has a predened xed pneumatic resistance
setting which does not adapt to changes in walking speed. Also, Standing Mode is not
active in Training mode.
To activate/de-activate Training Mode use the [-] button on the device, as follows:
To switch ON Training Mode:
• Press the [-] button 5 times (each time pressing until the device responds with a single short
beep).
• 5 medium beeps then sound to conrm that Training Mode is ON.
To switch OFF Training Mode:
• Press and hold the [-] button.
• 2 long beeps then sound to conrm that Training Mode is OFF and normal operation has
resumed.
WARNING: After exiting Training Mode, always test/conrm that the device is operating
normally again before walking.
938354V2APK3/1-0321

13 938354V2APK3/1-0321
FCC Compliance Statement
This device complies with part 15 of the FCC Rules.
Operation is subject to the following three conditions:-
1. This device may not cause harmful interference.
2. This device must accept any interference received, Including interference that may cause undesired
operation.
Note… Contains pre-approved Bluetooth® module: FCC ID: PVH0946 IC: 5325A-0946
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment o and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Any changes or modications not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in
conjunction with any other antenna or transmitter.
Responsible party: Blatchford Inc.
1031 Byers Road, Miamisburg, OH 45342
800-548-3534 (toll free) | 937-291-3636
[email protected]om
RSS Compliance Statement
This device complies with RSS 210 of Industry Canada.
Operation is subject to the following two conditions:
1. this device may not cause interference, and
2. this device must accept any interference, including interference that may cause undesired operation of
this device.
L’utilisation de ce dispositif est autorisée seulement aux conditions suivantes:
1. il ne doit pas produire d’interference et
2. l’utilisateur du dispositif doit étre prêt à accepter toute interference radioélectrique reçu, même si celle-
ci est susceptible de compromettre le fonctionnement du dispositif.
Caution: Exposure to Radio Frequency Radiation.
The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not
emit RF eld in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable
from Health Canada’s website Blatchford Inc. 1031 Byers Road, Miamisburg, OH 45342.
800-548-3534 (toll free) | 937-291-3636 [email protected]

14
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
Warranty
This device is warranted for 36 months, the foot shell for 12 months, and the glide sock for 3
months.
Extended warranties of an additional 12, 24, or 36 months are available.
A service between 30 and 36 months is required for all extended warranties.
For the maximum 36-month extended warranty, a second service must be carried out between
54 and 60 months.
We reserve the right to void extended warranties if the device is not serviced at the required
intervals.
The user should be aware that changes or modications not expressly approved could void the
warranty, operating licenses and exemptions.
The above may vary by market; consult your local representative for details.
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.
Single Patient – multiple use
Medical Device
938354V2APK3/1-0321

15
Environmental Aspects
This symbol indicates that the product contains electrical/electronic components
and/or batteries that should not be disposed of in general waste or be incinerated at
the end of the product’s life.
At the end of the product’s life, all electrical/electronic components and/or batteries
should be recycled or disposed of in accordance with the current regulations for the
handling of WEEE (Waste Electrical and Electronic Equipment), or equivalent local
regulations. The remainder of the product should also be recycled where possible in accordance
with local waste recycling regulations.
To help prevent potential harm to the environment or to human health from uncontrolled waste
disposal, Blatchford oers a take-back service. Please contact Customer Services for details.
Trademark Acknowledgements
Linx and Blatchford are registered trademarks of Blatchford Products Limited.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG Inc., and any use of
such marks by Blatchford is under License. Other trademarks and trade names are those of their respective
owners.
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK.
938354V2APK3/1-0321

16
Innhold................................................................................................................................................................. 16
Advarsler ............................................................................................................................................................. 17
1 Beskrivelse og tiltenkt formål ............................................................................................................................ 18
2 Sikkerhetsinformasjon.......................................................................................................................................... 19
3 Konstruksjon............................................................................................................................................................ 20
4 Nøkkelpunkter......................................................................................................................................................... 21
5 Transport og oppbevaring.................................................................................................................................. 21
6 Batterilading............................................................................................................................................................. 22
6.1 Magnetisk laderforbindelse ......................................................................................................................... 24
6.2 Batteristatus....................................................................................................................................................... 24
7 Brukermoduser ....................................................................................................................................................... 25
7.1 Fleksjonslåsmodus........................................................................................................................................... 25
7.2 Sykkelmodus...................................................................................................................................................... 26
7.3 Opptreningsmodus......................................................................................................................................... 26
Innhold
938354V2APK3/1-0321
NO

17
Drift i lav temperatur
Advarsler
Ordet enhet brukes i denne håndboken for å referere til Linx
Enheten inneholder oppladbare litiumion-batterier. Les og følg sikkerhetsinformasjonen i
avsnitt 2 og avsnitt 6. Hvis ikke kan batteriene bli varme, eksplodere eller antenne og forårsake
alvorlig personskade.
Av/på-batteribryter
VIKTIG: Batterilading
For å lade enheten må du se til at av/på-bryteren er i PÅ [I]-posisjonen.
Hvis enheten lader, vil LED-lampen på batteriladeren blinke grønt.
Batteriet skal bare lades innenfor temperaturområdet 10˚C til 40˚C.
VIKTIG:
Hvis protesen utsettes for temperaturer under -10°C, må den returneres for en inspeksjon av
mulig skade på batteripakken.
Etter lengre perioder uten aktivitet ved temperaturer under 0°C kan det hende at protesen ikke
svinger like fritt. I så fall bør brukeren være forsiktig når han/hun går ned trapper, og unngå å gå
ned ben-over-ben ved hjelp av knestøtten, til brukeren føler at den svinger normalt.
Batterisikkerhet
Pakkens innhold:
1. Linx-protese
2. Avtagbart pyntedeksel
3. Brukerhåndbok
4. Kabelpose og tilbehør
i) Batterilader
ii) Vekselstrømadapter(e) for batterilader
Regelmessig rengjøring av de magnetiske ladeoveratene er nødvendig for å sikre at væsker,
kontaminering eller smuss ikke forhindrer riktig tilkobling. (Se avsnitt 4 for rengjøringsråd.)
Rengjøring av magnetisk kontakt
938354V2APK3/1-0321

18
1 Beskrivelse og tiltenkt formål
Dette dokumentet beskriver V2-versjonen av Linx-lemmet.
Disse instruksjonene er for brukeren. Oppbevar disse instruksjonene.
Forsikre deg om at du forstår alle bruksanvisningene, og spesielt avsnittene om vedlikehold
og sikkerhetsinformasjon.
Anvendelse
Enheten skal utelukkende brukes som en del av en protese for nedre ekstremiteter.
Beregnet for én enkelt bruker.
Enheten er et helintegrert, mikroprosessor-styrt kne- og fotsystem. Den gir kontroll over fot og
kne samtidig og koordinerer responsene i en rekke ulike terrenger og situasjoner i ett komplett
biomimetisk lem. Individuelle justeringer kan gjøres for bakker og trapper, og det nnes et
ståmodus som låser enheten for å hjelpe pasienten å stå.
Funksjoner
• Alle funksjonene til en mikroprosessor, i både kne og hydraulisk ankel
• Sentralisert kontroll av kne og fot gir brukeren en bedre koordinert reaksjon for stående
stilling, gange på at mark samt gange opp og ned en rampe.
• Mindre slitasje på kontaktaten
• Ett lett tilgjengelig ladepunkt
• Lengre batterilevetid, tredagers gjennomsnittlig bruk fra den interne, oppladbare
litiumion-batteripakken
• Tre brukermoduser
• Overvåking av ulike aktiviteter
Det forbedrede stabilitetssystemet tilbyr:
• Ståmodus, kontroll av kneeksjon og ankel for å stå
• Kontrollert gange ned rampe med bremsevirkning for kne og ankel
• Forbedret gange opp rampe med optimert hjelpeeekt for kne og ankel
• Aktiv styring av hælstigning under gange
• Dynamisk gange ned trapp gjennom enkel start av kneeksjon kombinert med økende
støtte som bremser brukeren forsiktig ved eksjon
• Støttende motstand mot bøyning så snart kneet slutter å bøyes
• Økt støttende motstand mot bøyning for å forhindre snubling forbundet med ustabilitet
ved hælkontakt.
938354V2APK3/1-0321

19
2 Sikkerhetsinformasjon
Forsiktighetssymbolet uthever sikkerhetsinformasjon som må følges nøye.
Enhver endring i ytelsen eller funksjonen
til protesen, f.eks. begrenset bevegelse,
ujevn bevegelse eller uvanlige lyder,
skal øyeblikkelig rapporteres til
tjenesteleverandøren din.
Bruk alltid gelenderet når du går ned
trapper, hvis tilgjengelig.
Alle store endringer i hælhøyde
etter programmering vil påvirke
protesefunksjonen negativt og må
umiddelbart rapporteres til sertisert
helsepersonell for omprogrammering
og kalibrering.
Etter kontinuerlig bruk kan ankel- og
knepakningen bli varme å ta på.
Unngå sterke magnetfelt, kilder til
elektrisk interferens samt væske- og/
eller pulverfylte atmosfærer.
Må ikke plasseres i nærheten av en
varmekilde. Ikke la ligge i direkte sollys
eller i en bil i varmt vær.
Enheten skal ikke brukes under vann
eller som en dusjprotese. Hvis protesen
kommer i kontakt med vann, må den
tørkes av umiddelbart.
Før du kobler batteriladeren til
enheten, må du påse at de magnetiske
paringsatene på ladekontakten og
ladeterminalen er rene, tørre og frie
for smuss eller ledende materialer
som kan forhindre riktig lading. (Se
ytterligere advarsler i avsnitt 6.1 og råd
for rengjøring i avsnitt 4).
Laderen må aldri kobles til enheten
mens du fortsatt har den på deg.
Koble aldri laderen til enheten mens du
fortsatt har på deg enheten.
Enheten er ikke egnet for ekstremsport,
kappløping eller -sykling, is- og
snøsport eller ekstreme bakker og
berg. Alle slike aktiviteter utføres på
brukerens egen risiko. Fritidssykling er
akseptabelt.
Vær til enhver tid oppmerksom på
ngerklemfaren.
Kontakt helsepersonell for råd hvis
enheten skal brukes med en pacemaker
eller annen elektromedisinsk enhet.
Montering, programmering,
vedlikehold og reparasjon av enheten
må kun utføres av helsepersonell som
har deltatt i et godkjent treningskurs.
Brukeren må ikke justere eller tukle
med enhetensoppsettet.
Brukeren bes kontakte sertisert
helsepersonell hvis tilstanden endres.
Enheten kan registrere at du står og
går i oppoverbakke eller nedoverbakke
og at du går i forskjellige hastigheter.
Uidentiserte bevegelser kan forårsake
uventet atferd.
Enheten kan registrere at du står og
går i ulike hastigheter. Uidentiserte
bevegelser kan forårsake uventet
atferd.
Batteriene i enheten skal bare lades
med laderen som følger med produktet.
Ikke bruk laderen til å lade noe annet
utstyr.
Kjør bare biler som er riktig utstyrt for
formålet. Følg alltid trakkreglene.
Påse at det ikke kommer væske inn i
protesen under påsetting eller normal
bruk.
Ladekontakten og -terminalen er
kilder til sterke magnetfelt. Du må
alltid holde trygg avstand (minst
10 cm) mellom disse magnetene og
alle objekter som kan skades eller
påvirkes av magnetisme (slik som
klokker, pacemakere, kredittkort eller
magnetisk lagrede medier).
For å minimere risikoen for å skli og
snuble må egnet fottøy som sitter godt
over fotskallet, brukes til enhver tid.
938354V2APK3/1-0321

20
Kne-
modul
Mast
Ankel-
modul
3 Konstruksjon
Hoveddeler
• Knemodul med pyramide (aluminium / rustfritt stål / titan, karbon)
• Ankelmodul (aluminium/ rustfritt stål)
• Mast (aluminium)
• Hæl- og tåærer (e-Carbon)
• Fjærskruer (titan / rustfritt stål)
• Glidesokk (UHM PE)
• Fotkosmetikk, kabler og eksibord (polymerer og PU)
• Batterier (litiumion)
Tåærskive
Tåærskrue
Hælær Hælærskruer
Tåær
Av/på-batteri-
bryter
[+]-,
[-]-knapper
og LED
Magnetisk
ladeterminal
Skjøte-
kabel
Glidesokk
Fotkosmetikk
938354V2APK3/1-0321