Blatchford Silcare Walk SWTTCP22 User manual

Instructions for Use
Navodila za uporabo
Инструкции за употреба
Upute za uporabu
Návod na použitie
Használati útmutató
Οδηγίες χρήσης
Lietošanas pamācība
Naudojimo instrukcija
Kasutusjuhend
PK2
EN 2
SL 12
BG 22
HR 32
SK 42
HU 52
EL 62
LV 72
LT 82
ET 92
Instructions for Use
Silcare Walk Cushion Liner
Silcare Walk Locking Liner
SWTTCP22–SWTTCP40
SWTTLP22–SWTTLP40

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Contents
Contents.................................................................................................................................................................2
1 Description and Intended Purpose ....................................................................................................................3
2 Safety Information....................................................................................................................................................4
3 Construction ...............................................................................................................................................................5
4 Function........................................................................................................................................................................5
5 Maintenance...............................................................................................................................................................5
5.1 Cleaning the Device...........................................................................................................................................6
5.2 Cleaning the Residual Limb.............................................................................................................................6
6 Limitations on Use....................................................................................................................................................6
7 Choosing the Correct Size......................................................................................................................................7
8 Trimming the Device................................................................................................................................................7
9 Donning the Device .................................................................................................................................................8
10 Fitting Advice..............................................................................................................................................................8
11 Technical Data ............................................................................................................................................................9
12 Ordering Information ........................................................................................................................................... 10
EN

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1 Description and Intended Purpose
These instructions are for use by the practitioner.
Please read these instructions carefully before tting the device.
The term device is used throughout these instructions for use to refer to both Silcare Walk
Cushion and Locking Liner unless otherwise stated.
Ensure that the user understands all instructions for use, drawing particular attention to the
maintenance and safety information.
Application
This device is an interface component for use only as part of a lower limb prosthesis.
Intended for single user.
The device provides a cushioned socket interface and is manufactured from biocompatible
materials. Please read these instructions carefully before tting the device.
To optimise comfort ensure that the user is instructed in the correct way to handle and don/do
the device. Also ensure that they are made aware of how to maintain the device and to keep it
clean for maintaining hygiene as set out in these instructions.
Activity Level
The device is best suited for low to moderate activity users. If used on more active users device
life may be compromised.
Contraindications
• Conical residual limbs:
• This device may not be optimally contoured to t conical residual limbs.
• Users with poor hand or cognitive function might nds donning and cleaning dicult.
• Poor hygiene.
• Users whose suspension sleeve causes a bulk around their knee may be better suited with
alternative type liner.
• Short residual limbs where the integral matrix ends at (or above) the patella tendon or
bula head.
Clinical Benets
• Provides cushioning for the residual limb in the socket.
• Distributes in-socket pressure more evenly, compared other materials and alternative
cushioning solutions.
• The locking liner provides a means of suspension.

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2 Safety Information
The user should be advised to contact
their practitioner if their condition
changes.
Any deterioration in residuum condition
or any change in sensation should be
reported to the practitioner.
Make sure that any damaged skin or
open wounds are properly and suitably
dressed to prevent direct contact with
the device.
Wearers with sensitive skin, diabetics
and vascular cases should be extra
vigilant and may need to apply
lubricant to sensitive areas. We
recommend a routine visual check and
if required the user should consult their
medical practitioner.
For other medical conditions the
user should follow the advice and
recommendation of a physician or
amedical practitioner regarding
skincare.
Do not use alcohol sprays, household
cleaners, or abrasives. These cleaning
materials could damage the device and
irritate skin.
Do not pull or stretch the device.
Fingernails, sharp jewelry, and the
locking pin can tear the device.
If the device is torn, stop using
it and contact a Blatchford sales
representative.
Sockets with sharp proximal edges can
damage the device.
Take care when handling the device
to avoid possible contamination with
materials such as breglass which
will stick to the device and cause
skinirritation.
When donning a sock, clothing and
the prosthetic limb, be aware that the
device can build up a static charge.
To avoid danger of suocation, keep the
device away from babies and children.
Keep the device away from direct
heatsources.
Do not overtighten the locking pin.
This warning symbol highlights important safety information.

938459PK2/1-0121
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• Fabric (polyamide and lycra)
• Main Body (silicone)
• Distal Cap (silicone)
• Umbrella (nylon)
Main Body Distal cap
Cushion Liner
Locking Liner
Principal Parts
Umbrella
Cushion
The device, when used with an air-tight suspension sleeve, provides control, secure connection
and cushioning between the limb and the socket.
Locking
The device provides the same function without requiring an air-tight suspension sleeve.
Advise users to report the following to their practitioner:
• Tears in the fabric or the silicone
• Tissue damage on the residual limb
• Changes in either body weight or activity level
• Deterioration/changes to the residual limb
• Changes in the performance of the device
3 Construction
4 Function
5 Maintenance

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5.1 Cleaning the Device
Wash the inside of the device daily to avoid any build up of bacteria.
Take care handling the device when it is inside out to avoid picking up dust, grit and
other contamination which could cause irritation to the skin.
Dry thoroughly before use.
Do not tumble dry.
Washing by Hand:
1. Invert the device so that its silicone side points externally.
2. Clean the silicone and the distal cap with a solution of water and unperfumed, pH balanced
soap.
3. Invert the device so that its silicone side points internally.
4. Rinse the device with clean water to remove all residues.
5. Either pat dry the device with a lint-free cloth, or leave it to air dry. Take care when drying
and handling the device.
Note… Always dry the device with the silicone side of the device pointing internally. Otherwise, the
device can stretch and become distorted.
Machine Wash:
Suitable for machine washing at 30°C.
Do not invert the device for machine washing.
5.2 Cleaning the Residual Limb
Inspect residual limb before and after prosthetic limb use or at least daily.
Any deterioration in residuum condition should be reported to the practitioner.
1. Clean the skin daily with an unperfumed, pH balanced soap.
2. Rinse the skin with clean water to remove all residues.
3. Apply lotion to dry skin, as recommended by a practitioner.
Make sure that any damaged skin or open wound is properly and suitably dressed to
prevent direct contact with the device.
6 Limitations on Use
Intended life
A local risk assessment should be carried out based upon activity and usage.
Environment
Avoid exposing the device to corrosive elements such as acids, industrial detergents, bleach or
chlorine. The use of creams or lotions with this device should be used with caution as these can
cause the device to soften and stretch or distort.
Keep away from sharp objects (such as jewellery,
ngernails).
Exclusively for use between -15˚C and 50 ˚C (5˚F to
122˚F).

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7 Choosing the Correct Size
Circumference
Measured (cm) 20-23.5 23.6-25 25.1-26.5 26.6-28 28.1-30 30.1-32 32.1-34 34.1-36 36.1-40 -40.1-42
Available Sizes 22 23.5 25 26.5 28 30 32 34 36 38 40
Cushion üü ü üüüüüü-ü
Locking üü ü üüüüüü-ü
Where possible try to avoid abrupt changes of contour and sharp edges which could
cause tears in the silicone and fabric.
It is important that the correct size is specied to ensure
proper t and comfort in use.
1. Measure the circumference of the residual limb
4cm up from its distal end.
2. If the circumference of the residual limb matches
one of the sizes in the table, choose the next size
down.
3. If the circumference of the residual limb is between
one of the sizes in the table, choose the smaller size.
4cm
8 Trimming the Device
The device may be trimmed to suit as required but never below the socket trim line.
We recommend using a rotating disc cutter to achieve a bevelled edge.
Trim the proximal edge of the device to suit the shape of the user’s socket.
If necessary, trim the proximal edge of the device in a wave pattern to reduce shear stress.

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Do NOT pull or stretch the device.
1. Invert the device so that its silicone side
points externally.
2. Align the locking pin with the long axis of
the residual limb. (Locking liner only.)
3. Roll the device on the residual limb while
releasing any trapped air.
Care must be taken during donning/dong not to damage the device with ngernails,
sharp jewelry or the locking pin.
4. Do the device, and wait until normal sensation returns.
5. Don the device again.
6. If the user feels numbness, tingling or any unusual sensation again, stop using
thedevice.
After donning the device, allow the user to wear it
for 10 minutes. If the user feels numbness, tingling
or any unusual sensation within 10 minutes, do the
following:
9 Donning the Device
10 Fitting Advice
The pin should be secured by applying
Loctite243 to the threads of the locking pin.
Torque the locking pin to 3Nm, or tighten it
with your ngers by either 1/8 to 1/4 of a turn.
Cushion
The device must be worn in conjunction with an
air-tight sleeve.
Locking
When using a locking liner the integrated matrix
should nish just below bula head/patella
tendon level.
The locking pin must always follow the long axis
of the residual limb. (See diagrams.)
Locking Pin
Shoulder

938459PK2/1-0121
435mm
3.7mm 7mm
2.9mm 14.6mm
3.7mm 7mm
2.9mm 14.6mm
9
11 Technical Data
Principal Materials polyamide, lycra, silicone, nylon
Shore Hardness 30-35 shore 00
Component Weight (size 28) 695g (1lb 8oz)
Activity Level Low to Moderate
Size Range
(see Choosing the Correct Size section)
22-40cm
Length
(See diagram below)
435mm
Internal Length
(See diagram below)
420mm
Matrix Length (Locking Type Only) Approx. 10cm
Operating and
Storage Temperature Range
-15˚C to 50˚C (5 ˚F to 122˚F)
Distal End Attachment
(Locking Type Only)
M10
Requires Locking Pin With a Shoulder*
Locking Pin Shoulder Diameter 13.5-19mm
435mm
Cushion Liner
Locking Liner
Dimensions *Locking Pin Not Supplied

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12 Ordering Information
Order Example:
Available from size 22 to size 40*:
SWTTCP22 to SWTTCP40
SWTTLP22 to SWTTLP40
S W TT C P 26
Silcare Walk Trans
Tibial
C - Cushion
L - Locking Parallel Size* 26.5
*SWTTCP23 is for size 23.5. SWTTCP26 is for size 26.5.

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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.
Warranty
The device is warranted for 6 months from original date of purchase unless otherwise stated. See
Blatchford catalogue for details.
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 is fabricated from silicone rubber and fabric that cannot be easily recycled: please
dispose of it responsibly as general waste, as per local waste handling regulations.
Retaining the Packaging Label
You are advised to keep the packaging label as a record of the device supplied.
Medical Device Single Patient – multiple use
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK.
Trademark Acknowledgements
Blatchford is a registered trademark of Blatchford Products Limited.

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Vsebina
Vsebina................................................................................................................................................................. 12
1 Opis in namen uporabe....................................................................................................................................... 13
2 Varnostne informacije .......................................................................................................................................... 14
3 Konstrukcija.............................................................................................................................................................. 15
4 Delovanje.................................................................................................................................................................. 15
5 Vzdrževanje.............................................................................................................................................................. 15
5.1 Čiščenje pripomočka ...................................................................................................................................... 16
5.2 Čiščenje krna okončine.................................................................................................................................. 16
6 Omejitve uporabe.................................................................................................................................................. 16
7 Izbira pravilne velikosti......................................................................................................................................... 17
8 Obrezovanje pripomočka ................................................................................................................................... 17
9 Nameščanje pripomočka .................................................................................................................................... 18
10 Nasvet za namestitev............................................................................................................................................ 18
11 Tehnični podatki..................................................................................................................................................... 19
12 Podatki za naročanje............................................................................................................................................. 20
SL

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1 Opis in namen uporabe
Ta navodila so predvidena za zdravnika.
Pred nameščanjem pripomočka pozorno preberite ta navodila.
Izraz pripomoček se v teh navodilih za uporabo uporablja tako za oblazinjeni vložek kot
tudizazaporni vložek Silcare Walk, razen če je navedeno drugače.
Preverite, ali je uporabnik razumel vsa navodila za uporabo, pri čemer ga še posebej
opozoritenainformacije o vzdrževanju in varnosti.
Uporaba
Pripomoček je vmesniška komponenta, predvidena izključno kot del proteze za
spodnjeokončine.
Predviden je za enega uporabnika.
Pripomoček je oblazinjen vmesnik ležišča in je izdelan iz biološko združljivih materialov.
Prednameščanjem pripomočka pozorno preberite ta navodila.
Da bo udobje optimalno, je treba uporabnika seznaniti s pravilnim ravnanjem ter nameščanjem/
snemanjem pripomočka. Uporabnika je treba seznaniti tudi s pravilno nego in čiščenjem
pripomočka, da zagotovite ustrezno higieno, kot je določeno v teh navodilih.
Stopnja aktivnosti
Pripomoček je najbolj primeren za uporabnike z nizko do zmerno stopnjo aktivnosti.
Čepripomoček uporablja več aktivnih uporabnikov, to slabo vpliva na pripomoček.
Kontraindikacije
• Stožčasti krni:
• Ta pripomoček se morda ne bo optimalno prilegal stožčastim krnom.
• Uporabniki z oslabljeno funkcijo rok ali kognitivno funkcijo lahko imajo težave pri
nameščanju in čiščenju.
• Slaba higiena.
• Za uporabnike, katerih ovoj vzmetenja se nagrbanči okrog njihovega kolena in ga
odebeli,je morda primernejša druga vrsta vložka.
• Kratki krni okončin, kjer se integralna matrika konča pri (ali nad) kiti pogačice ali
glavipiščali.
Klinične prednosti
• Deluje kot blažilnik za krn v ležišču.
• Enakomerneje razporedi pritisk v ležišču v primerjavi z drugimi materiali in
rešitvamiblaženja.
• Zaporni vložek deluje vzmetno.

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2 Varnostne informacije
Uporabniku je treba svetovati, dase
naj obrne na svojega zdravnika,
česenjegovo stanje spremeni.
Vsako poslabšanja v stanju krna ali
morebitne spremembe v občutku
jetreba sporočiti zdravniku.
Poskrbite, da bo morebitna
poškodovana koža ali odprta rana
ustrezno povita, da preprečite
neposreden stik s pripomočkom.
Uporabniki z občutljivo kožo, sladkorni
bolniki ali osebe z žilnim obolenjem
morajo biti še posebej previdni in si
morajo občutljiva območja po potrebi
mazati. Priporočamo redni kontrolni
pregled in po potrebi posvetovanje
zzdravnikom.
Za druga zdravstvena stanja mora
uporabnik glede nege kože upoštevati
nasvete in priporočila zdravnika ali
zdravstvenega tehnika.
Ne uporabljajte alkohola, razpršil,
gospodinjskih čistil ali abrazivnih
sredstev. Ti čistilni materiali bi lahko
poškodovali pripomoček in dražili kožo.
Ne vlecite ali raztezajte pripomočka.
Nohti, oster nakit in zaporni zatič
lahko pretrgajo pripomoček. Če se
pripomoček pretrga, ga prenehajte
uporabljati in stopite v stik s prodajnim
zastopnikom za Blatchford.
Ležišča z ostrimi proksimalnimi robovi
lahko poškodujejo pripomoček.
Pri ravnanju s pripomočkom bodite
previdni, da preprečite morebitno
kontaminacijo zaradi materialov, kot
so steklena vlakna, ki se prilepijo na
pripomoček in dražijo kožo.
Pri obuvanju nogavic, oblačenju in
nameščanju proteze pazite, ker se lahko
pripomoček statično naelektri.
Da preprečite nevarnost zadušitve,
pripomoček hranite izven dosega
dojenčkov in otrok.
Pripomočka ne hraniti v bližini
neposrednih virov toplote.
Varovalnega zatiča ne zategnite
premočno.
Ta opozorilni simbol označuje pomembne varnostne informacije.

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• Tkanina (poliamid in lycra)
• Glavno ogrodje (silikon)
• Distalna kapica (silikon)
• Priključni nastavek (najlon)
Glavno
ogrodje Distalna kapica
Oblazinjeni vložek
Zaporni vložek
Glavni deli
Priključni nastavek
Blazina
Pripomoček v povezavi z ovojem vzmetenja, ki ne prepušča zraka, zagotavlja nadzor, varno
povezavo in oblazinjen vmesnik med krnom ter ležiščem.
Zapora
Pripomoček zagotavlja enako funkcijo tudi brez ovoja vzmetenja, ki ne prepušča zraka.
Uporabniki naj svojemu zdravniku sporočijo naslednje:
• raztrganine v tkanini ali silikonu,
• poškodbe tkiva na krnu okončine,
• spremembe v telesni teži ali stopnji aktivnosti,
• poslabšanje/spremembe na krnu okončine,
• spremembe v delovanju pripomočka.
3 Konstrukcija
4 Delovanje
5 Vzdrževanje

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5.1 Čiščenje pripomočka
Notranjost pripomočka je treba prati dnevno, da se ne namnožijo bakterije.
Kadar je pripomoček obrnjen navzven, pazite, da se nanj ne sprimejo prah, opilki in
druge nečistoče, ki lahko dražijo kožo.
Pred uporabo temeljito posušite.
Ne sušite v sušilniku.
Ročno pranje:
1. Pripomoček obrnite tako, da bo silikonska stran na zunanji strani.
2. Silikon in distalno kapico očistite z raztopino vode in mila brez dišav ter nevtralnim pH.
3. Pripomoček obrnite tako, da bo silikonska stran na notranji strani.
4. Pripomoček sperite s čisto vodo, da odstranite vse ostanke čistila.
5. Pripomoček lahko obrišete s krpo, ki ne pušča vlaken, ali pa ga pustite na zraku, da se
posuši. Pri sušenju in ravnanju s pripomočkom bodite previdni.
Opomba… Pripomoček vedno sušite tako, da je silikonska stran pripomočka na notranji strani.
Sicerse lahko pripomoček raztegne in deformira.
Strojno pranje:
Primerno za strojno pranje pri 30°C.
Pri strojnem pranju pripomočka ne obračajte.
5.2 Čiščenje krna okončine
Pred uporabo proteze in po njej ali vsaj enkrat dnevno je treba pregledati krn okončine.
Vsako poslabšanja v stanju krna okončine je treba sporočiti zdravniku.
1. Kožo dnevno čistite z milom brez dišav in nevtralnim pH.
2. Kože sperite s čisto vodo, da odstranite vse ostanke čistila.
3. Na suho kožo nanesite losjon, kot to priporoča zdravnik.
Prepričajte se, da je morebitna poškodovana koža ali odprta rana ustrezno povita,
dapreprečite neposreden stik s pripomočkom.
6 Omejitve uporabe
Predvidena uporabna doba
Na osnovi aktivnosti in uporabe je treba opraviti lokalno oceno tveganja.
Okolje
Pripomočka ne izpostavljajte korozivnim elementom, kot so kisline, industrijski detergenti, belilo
ali klor. Pri uporabi krem ali losjonov s tem pripomočkom je treba paziti, ker ga lahko zmehčajo in
raztegnejo ali deformirajo.
Pripomočka ne približujte ostrim predmetom (kot so
nakit, nohti).
Samo za uporabo med –15in 50˚C. Primerno za uporabo
med prhanjem

938459PK2/1-0121
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7 Izbira pravilne velikosti
Izmerjeni
obseg (cm) 20–23,5 23,6–25 25,1–26,5 26,6–28 28,1–30 30,1–32 32,1–34 34,1–36 36,1–40 40,1–42
Razpoložljive
velikosti 22 23,5 25 26,5 28 30 32 34 36 38 40
Blazina üü ü üüüüüü ü
Zapora üü ü üüüüüü ü
Kjer je mogoče, se poskusite izogniti nenadnim spremembam obrisa in ostrih robov,
kibi lahko raztrgale silikon in tkanino.
Pomembno je določiti pravilno velikost, kar zagotavlja
pravilno prileganje in udobje pri uporabi.
1. Izmerite obseg krna okončine, in sicer 4cm nad
njegovim distalnim koncem.
2. Če se obseg krna ujema z eno od velikosti v tabeli,
izberite eno velikost manjšo.
3. Če je obseg krna med dvema velikostma v tabeli,
izberite manjšo velikost. 4cm
8 Obrezovanje pripomočka
Pripomoček je mogoče obrezati po meri, vendar nikoli pod linijo ležišča.
Priporočamo, da uporabite rotacijski rezalnik, da robovi ne bodo ostri.
Obrežite proksimalni rob pripomočka, da se bo prilegal obliki uporabnikovega ležišča.
Po potrebi obrežite proksimalni rob pripomočka v valovitem vzorcu, da zmanjšate
možnostraztrganin.

938459PK2/1-0121
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NE vlecite ali raztezajte pripomočka.
1. Pripomoček obrnite tako, da bo silikonska
stran na zunanji strani.
2. Poravnajte varovalni zatič z dolgo osjo krna.
(Samo zaporni vložek.)
3. Pripomoček s svaljkanjem poveznite čez
krnokončine in hkrati sprostite morebitni
ujeti zrak.
Pri nameščanju/snemanju pripomočka je treba paziti, da ga ne poškodujete z nohti,
ostrim nakitom ali varovalnim zatičem.
4. Snemite pripomoček in počakajte, da se povrne normalen občutek.
5. Znova nadenite pripomoček.
6. Če uporabnik zopet zazna odrevenelost, mravljince ali kakršen koli neobičajen občutek,
prenehajte uporabljati pripomoček.
Po namestitvi pripomočka namenite uporabniku
10minut, da se ga navadi. Če uporabnik v 10minutah
zazna odrevenelost, mravljince ali kakršen koli
neobičajen občutek, upoštevajte naslednji postopek:
9 Nameščanje pripomočka
10 Nasvet za namestitev
Zatič je treba ksirati, tako da na njegove navoje
nanesete lepilo Loctite243. Privijte varovalni zatič
do navora 3Nm ali s prsti za1/8 oz. 1/4obrata.
Blazina
Pripomoček je treba uporabljati z ovojem, ki ne
prepušča zraka.
Zapora
Pri uporabi zapornega vložka se mora
integriranamatrika zaključiti tik pod nivojem
glave piščali/kite pogačice.
Varovalni zatič mora vedno slediti dolgi osi krna
okončine. (Glejte diagrame.)
Rob varovalnega
zatiča

938459PK2/1-0121
435mm
3,7mm 7mm
2,9mm 14,6mm
3,7mm 7mm
2,9mm 14,6mm
19
11 Tehnični podatki
Glavni materiali poliamid, lycra, silikon, najlon
Trdota po lestvici Shore 30-35 shore 00
Teža komponent (velikost28) 695g
Stopnja aktivnosti Nizka do zmerna
Razpon velikosti
(Glejte poglavje Izbira pravilne velikosti)
22–40cm
Dolžina
(glejte spodnji diagram)
435mm
Notranja dolžina
(glejte spodnji diagram)
420mm
Dolžina matrike (samo pri zaporni vrsti) pribl. 10cm
Temperaturno območje
za uporabo in hrambo
–15do 50˚C
Priključek na distalnem koncu
(samo pri varovalnem tipu)
M10
Potreben je varovalni zatič z robom*
Premer roba varovalnega zatiča 13,5–19mm
435mm
Oblazinjeni vložek
Zaporni vložek
Mere *Varovalni zatič ni priložen

938459PK2/1-0121
20
12 Podatki za naročanje
Primer naročila:
Na voljo od velikosti22 do40*:
SWTTCP22 do SWTTCP40
SWTTLP22 do SWTTLP40
S W TT C P 26
Silcare Walk Trans-
tibialno
C – oblazinjeni
L – zaporni Vzporedno Velikost* 26,5
*SWTTCP23 je za velikost 23,5. SWTTCP26 je za velikost 26,5.