Blatchford AK30M1 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
� 30 mm Tube Clamp Adapter
with Female Pyramid
Instructions for Use
AK30M1
EN 2
SL 11
BG 20
HR 29
SK 38
HU 47
EL 56
LV 65
LT 74
ET 83

2
Contents EN
Contents.................................................................................................................................................................2
1 Description and Intended Purpose ...................................................................................................................3
2 Safety Information....................................................................................................................................................4
3 Construction ...............................................................................................................................................................5
4 Function........................................................................................................................................................................5
5 Maintenance...............................................................................................................................................................6
6 Limitations on Use....................................................................................................................................................7
7 Fitting Advice..............................................................................................................................................................8
8 Technical Data ............................................................................................................................................................9
9 Ordering Information ..............................................................................................................................................9
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1 Description and Intended Purpose
These Instructions for Use are intended for the practitioner and user, unless otherwise stated.
The term device is used throughout to refer to the �30mm Tube Clamp Adapter with Female
Pyramid.
Please read and ensure you understand these instructions, in particular all safety information and
maintenance instructions.
Application
This device is to be used exclusively for lower limb prosthetic ttings, intended for a single user.
The device is used to connect a �30mm tube securely to a Blatchford male pyramid, and allows
for angular and rotational adjustment.
Features
• Lightweight, strong, titanium construction
Activity Level
This device is suitable for Activity Levels 1-4 (weight limits apply, see Technical Data). Of course
there are exceptions and in our recommendation we want to allow for unique, individual
circumstances and any such decision should be made with sound and thorough justication.
Activity Level 1
Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at xed
cadence. Typical of the limited and unlimited household ambulator.
Activity Level 2
Has the ability or potential for ambulation with the ability to traverse low-level environmental barriers
such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.
Activity Level 3
Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator
who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or
exercise activity that demands prosthetic utilization beyond simple locomotion.
Activity Level 4
Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting
high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or
athlete.
Contraindications
There are no known contraindications if used in accordance with these instructions.
Clinical Benets
• Allows connection from shin tube to other prosthetic componentry.
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2 Safety Information
Any changes in the performance or
function of the limb, e.g. excessive
play 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.
The device is designed for prolonged
submersion and suitable for immersion
in fresh water only. Ensure any use of
the device in water complies with the
conditions given in Limitations on Use.
This warning symbol highlights important safety information which must be
followed carefully.
The user must not adjust or tamper
with the setup of the device.
The user is advised to contact their
practitioner if their condition changes.
To reduce the risk of injury due
to failure or loosening of the bolt
connections, ensure the bolt threads
are cleaned thoroughly before each
installation.
Always apply the specied torque value
to the screws.
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3 Construction
Principal Parts
• Female Pyramid Titanium
• Clamp Screw Plated steel
• Clamp Screw Washer Plated steel
• Set Screws Plated steel (x4)
Component Identication
4 Function
This device provides angular and rotational adjustment for a customized limb alignment to suit
the amputee. When the set screws are tightened securely, using Loctite 243, this device oers a
secure way to connect a 30mm diameter tube to a male pyramid adapter.
Female Pyramid
Blatchford
Male Pyramid
Tube (Pylon)
30mm diameter
Clamp Screw
Clamp Screw Washer
Set Screws
4
15Nm
4
10Nm
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5 Maintenance
Visually check the device regularly.
Report any changes in performance of this device to the practitioner/service provider e.g.
unusual noises or signicant wear.
Inform the practitioner/service provider of any changes in body weight and/or activity level.
Cleaning
Use a damp cloth and mild soap to clean outside surfaces. DO NOT use aggressive cleansers.
The remaining instructions in this section are for practitioner use only.
This maintenance must be carried out only by competent personnel (practitioner or suitable
trained technician).
The following routine maintenance is to be carried out at least annually:
• Check for tube tightness. If loose, remove, clean and re-t.
• Check the set screws for tightness. If loose, remove and clean, then apply Loctite 243 and
tighten to the correct torque setting, see Construction section.
• Check for defects that could aect proper function.
Ensure the user has read and understood all safety and user-level maintenance information.
Advise the user that a regular visual check of the device is recommended and signs of wear that
may aect function should be reported to their service provider.
Advise the user to inform the practitioner/service provider of any changes in body weight and/or
activity level.
If this device is used for extreme activity, the maintenance level and interval should be reviewed
and if required advice and technical support sought to plan a new maintenance schedule
dependent upon the frequency and nature of the activity. This should be determined by a local
risk assessment carried out by a suitably qualied individual.
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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
This device is waterproof to a maximum depth of 1 meter. Thoroughly rinse with fresh water
after use in abrasive environments such as those that may contain sand or grit, for example, to
prevent wear or damage to moving parts. Thoroughly rinse with fresh water after use in salt or
chlorinated water.
Exclusively for use between -15°C and 50°C (5°F to 122°F).
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8
The instructions in this section are for practitioner use only.
Position as close as practical to the build line.
Symptom Solution
A recurring noise occurs at the device
interfaces.
Check security of all alignment screws and
tube clamp. Apply Loctite as required and
tighten to correct torque settings. Ensure
mating surfaces are clean and end of tube is
cut square.
The adapter moves out of position. User must not use the device until adjusted,
repaired or replaced.
Set Screws
Clamp Screw
4
15Nm
4
10Nm
7 Fitting Advice
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Device Part Number
�30mm Tube Clamp Adapter with Female Pyramid AK30M1
Storage and Handling
When storing for prolonged periods, ensure the product is free from moisture and
stored at room temperature.
Operating and
Storage Temperature Range:
-15°C to 50 °C
(5°F to 122 °F)
Component Weight: 92g (3 oz)
Activity Level: 1–4
Maximum User Weight: 145kg (320 lb)/1–4
150kg (330 lb)/1–3
Attachment Type: Proximal— female pyramid (Blatchford)
Distal—30mm diameter tube
Range of Adjustment: 360° axial rotation
±7° tilt from vertical
Length: 15mm (50 mm)
8 Technical Data
9 Ordering Information
Fitting Length
The device is of xed length.
15mm
35mm
�30mm
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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
This device is warranted for 24 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 is made from a recyclable material. Where possible, the components should be
recycled in accordance with local waste handling regulations.
Retaining the Packaging Label
The practitioner is advised to keep the packaging label as a record of the device supplied.
Single Patient – multiple use
Medical Device
Trademark Acknowledgements
Blatchford is a registered trademark of Blatchford Products Limited.
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK.
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Vsebina
Vsebina................................................................................................................................................................. 11
1 Opis in namen uporabe ...................................................................................................................................... 12
2 Varnostne informacije .......................................................................................................................................... 13
3 Konstrukcija.............................................................................................................................................................. 14
4 Delovanje.................................................................................................................................................................. 14
5 Vzdrževanje.............................................................................................................................................................. 15
6 Omejitve uporabe.................................................................................................................................................. 16
7 Nasvet za namestitev............................................................................................................................................ 17
8 Tehnični podatki..................................................................................................................................................... 18
9 Podatki za naročanje............................................................................................................................................. 18
SL

12 938252PK2/1-0121
1 Opis in namen uporabe
Ta navodila za uporabo so predvidena za zdravnika in uporabnika, razen če je navedeno drugače.
Izraz pripomoček se uporablja za cevno objemko za ženski piramidni adapter s premerom 30mm.
Preberite in poskrbite, da boste razumeli vsa navodila, predvsem vse varnostne informacije in
navodila za vzdrževanje.
Uporaba
Ta pripomoček je treba uporabljati izključno s protezami za spodnje okončine, predviden pa je
za enega uporabnika.
Pripomoček se uporablja za varno povezavo cevi premera 30mm z moškim piramidnim
adapterjem Blatchford in omogoča kotno ter rotacijsko prilagoditev.
Lastnosti
• Lahka, močna konstrukcija iz titana
Stopnja aktivnosti
Pripomoček je primeren za stopnje aktivnosti 1–4 (upoštevati je treba omejitve teže, glejte
Tehnični podatki). Seveda pa obstajajo izjeme, zato pri našem priporočilu dopuščamo možnost
edinstvenih, posameznih okoliščin, odločitev o tem pa je treba sprejeti na osnovi temeljite
presoje.
Stopnja aktivnosti 1
Ima sposobnost ali potencial uporabljati protezo za transferje oz. premikanje po ravnih površinah
z enakomernim korakom. Običajno omejeno in neomejeno pokretna oseba v gospodinjstvu in
domačem okolju.
Stopnja aktivnosti 2
Ima sposobnost ali potencial za premikanje s sposobnostjo premagovanja nizkih ovir, kot so robniki,
stopnice ali neravne površine. Običajno je to omejeno pokretna oseba v javnosti.
Stopnja aktivnosti 3
Ima sposobnost ali potencial za premikanje s spremenljivim korakom. Običajno pokretna oseba,
ki lahko premaga večino okoljskih ovir in morda opravlja poklicno, terapevtsko ali zično aktivnost,
ki zahteva uporabo proteze, ki presega zgolj preprosto gibanje.
Stopnja aktivnosti 4
Ima sposobnost ali potencial za hojo s protezo, ki presega osnovne sposobnosti hoje, in je izpostavljena
močnim udarcem, visokim obremenitvam ali visokim ravnem energije. Običajno za zahteve za protezo
otroka, aktivne odrasle osebe ali športnika.
Kontraindikacije
Pri uporabi pripomočka v skladu s temi navodili kontraindikacije niso znane.
Klinične prednosti
• Omogoča povezavo od cevi goleni do druge protetične komponente.

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2 Varnostne informacije
Morebitne spremembe v delovanju
okončine, kot je npr. prekomerna
zračnost ali neobičajni zvoki, je treba
nemudoma javiti ponudniku storitve.
Pri hoji po stopnicah navzdol in vedno,
ko je sicer mogoče, je treba uporabljati
držala.
Pripomoček je zasnovan za dolgotrajno
potopitev, in sicer samo v sladko
vodo. Preverite, ali so pri uporabi tega
pripomočka v vodi upoštevani pogoji,
navedeni v Omejitve uporabe.
Ta opozorilni simbol poudarja pomembne varnostne informacije, ki jih je
treba natančno upoštevati.
Uporabnik ne sme prilagajati ali
spreminjati nastavitve pripomočka.
Uporabniku je treba svetovati,
da se naj obrne na svojega zdravnika,
če se njegovo stanje spremeni.
Za zmanjšanje tveganja telesnih
poškodb zaradi odpovedi ali zrahljanja
vijačnih povezav je treba pred vsako
namestitvijo temeljito očistiti navoje
vijakov.
Vijake je treba vedno priviti z
navedenim zateznim momentom.

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3 Konstrukcija
Glavni deli
• Ženski piramidni adapter titan
• Prižemni vijak platirano jeklo
• Podložka za prižemni vijak platirano jeklo
• Nastavitveni vijaki platirano jeklo (4)
Identikacija komponente
4 Delovanje
Ta pripomoček omogoča kotno in rotacijsko prilagoditev za poravnavo okončine po
meri glede na potrebe uporabnika. Ko so nastavitveni vijaki čvrsto priviti in zavarovani
z Loctite243, pripomoček zagotavlja varen način za povezavo cevi premera 30mm na
moški piramidni adapter.
Ženski piramidni
adapter
Moški piramidni
adapter Blatchford
Cev (palica)
premer 30mm
Prižemni vijak
Podložka prižemnega
vijaka
Nastavitveni vijaki
4
15Nm
4
10Nm

15 938252PK2/1-0121
5 Vzdrževanje
Pripomoček je treba redno vizualno pregledovati.
Morebitne spremembe v delovanju pripomočka, kot so npr. neobičajni zvoki ali močna obraba,
je treba nemudoma javiti zdravniku/ponudniku storitve.
Zdravnika/ponudnika storitve obvestite o morebitnih spremembah v telesni teži in/ali stopnji
aktivnosti.
Čiščenje
Z vlažno krpo in blagim milom očistite zunanje površine. NE uporabljajte agresivnih čistil.
Preostala navodila v tem poglavju so samo za zdravnika.
To vzdrževanje lahko izvaja samo usposobljeno osebje (zdravnik ali ustrezno usposobljen
zdravstveni tehnik).
Rutinsko vzdrževanje v nadaljevanju je treba opraviti najmanj enkrat letno:
• Preverite čvrstost pritrditve cevi. Če je zrahljana, jo odstranite, očistite in znova namestite.
• Preverite čvrstost pritrditve nastavitvenih vijakov. Če so zrahljani, jih odstranite in očistite,
nanesite Loctite 243 in zategnite z navedenim zateznim momentom; glejte poglavje
Konstrukcija.
• Preverite, ali so prisotne poškodbe, ki bi lahko vplivale na pravilno delovanje.
Poskrbite, da bo uporabnik prebral in razumel vse varnostne informacije ter informacije
o vzdrževanju, ki ga mora opravljati uporabnik.
Uporabniku svetujte, naj redno vizualno pregleduje pripomoček in če opazi morebitno obrabo,
ki bi lahko vplivala na delovanje, naj o tem obvesti ponudnika storitve.
Uporabniku svetujte, da zdravnika/ponudnika storitve obvesti o morebitnih spremembah
v telesni teži in/ali stopnji aktivnosti.
Če se pripomoček uporablja za ekstremne aktivnosti, je treba preveriti raven in interval
vzdrževanja ter se po potrebi posvetovati s tehnično podporo glede novega vzdrževalnega
načrta na osnovi pogostosti in narave aktivnosti. To je treba določiti na osnovi lokalne ocene
tveganja, ki jo mora opraviti ustrezno usposobljen posameznik.

16 938252PK2/1-0121
Primerno za potopitev v tekočine
6 Omejitve uporabe
Predvidena uporabna doba
Na osnovi aktivnosti in uporabe je treba opraviti lokalno oceno tveganja.
Dviganje bremen
Glede na težo in aktivnost uporabnika veljajo navedene omejitve.
Pri prenašanju bremena mora uporabnik upoštevati lokalno oceno tveganja.
Okolje
Pripomoček je vodotesen do globine največ 1m. Po uporabi v abrazivnih okoljih, kot so tista,
ki vsebujejo pesek ali prod, je treba pripomoček temeljito sprati v sladki vodi, da preprečite
obrabo ali poškodbo premikajočih se delov. Pripomoček je prav tako treba temeljito sprati po
uporabi v slani ali klorirani vodi.
Izključno za uporabo pri temperaturi med –15°C in 50°C .

17 938252PK2/1-0121
Navodila v tem poglavju so namenjena samo zdravniku.
Namestite čim bliže liniji okončine.
Težava Rešitev
Ponavljajoč se zvok na stičiščih pripomočka. Preverite, ali so vsi poravnalni vijaki in cevne
objemke dobro pritrjeni. Po potrebi nanesite
Loctite in zategnite z ustreznim zateznim
momentom. Prepričajte se, da so stične
površine čiste in je konec cevi pravokotno
odrezan.
Adapter se premakne iz položaja. Uporabnik pripomočka ne sme uporabljati,
dokler mu ga ne prilagodijo, popravijo ali
zamenjajo.
Nastavitveni vijaki
Prižemni vijak
4
15Nm
4
10Nm
7 Nasvet za namestitev

18 938252PK2/1-0121
Pripomoček Številka dela
Adapter za 30-mm cevno objemko z ženskim piramidnim adapterjem AK30M1
Shranjevanje in uporaba
Pri daljšem shranjevanju poskrbite, da na pripomočku
ni vlage in ga hranite pri sobni temperaturi.
Temperaturno območje
za uporabo in hrambo: –15°C do 50°C
Teža komponente: 92g
Stopnja aktivnosti: 1–4
Največja teža uporabnika: 145kg/1–4
150kg/1–3
Vrsta pritrditve:
Proksimalno – ženski piramidni adapter
(Blatchford)
Distalno– cev s premerom 30mm
Območje prilagoditve: 360° aksialni zasuk
±7° nagib iz navpičnega položaja
Dolžina: 15mm (50mm)
8 Tehnični podatki
9 Podatki za naročanje
Namestitvena dolžina
Pripomoček ima ksno dolžino.
15mm
35mm
�30mm

19 938252PK2/1-0121
Odgovornost
Proizvajalec priporoča, da se pripomoček uporablja samo pri speciciranih pogojih in
v predvidene namene. Pripomoček je treba vzdrževati v skladu z navodili, priloženimi
pripomočku. Proizvajalec ne prevzema odgovornosti za morebitne neželene posledice,
nastale zaradi kakršnih koli kombinacij komponent, ki jih ni odobril.
SkladnostCE
Ta izdelek je v skladu z zahtevami evropske Uredbe EU 2017/745 o medicinskih pripomočkih.
Ta izdelek je klasiciran kot izdelek razredaI v skladu z merili za klasikacijo, navedenimi
v prilogiVIII Uredbe. ES-izjava o skladnosti je na voljo na naslednjem spletnem naslovu:
www.blatchford.co.uk
Združljivost
Kombiniranje z izdelki znamke Blatchford je odobreno na osnovi preizkusov v skladu
z ustreznimi standardi in uredbo o medicinskih pripomočkih, vključno s strukturnim testom,
dimenzijsko združljivostjo in nadzorovano učinkovitostjo med uporabo.
Pri kombinacijah z alternativnimi izdelki z oznakoCE je treba upoštevati dokumentirano
lokalno oceno tveganja, ki jo opravi zdravnik.
Garancija
Ta pripomoček ima 24-mesečno garancijo.
Uporabnik se mora zavedati, da zaradi sprememb ali prilagoditev, ki niso izrecno odobrene,
garancija, uporabne licence in izjeme morda ne bodo veljavne.
Za trenutno celotno garancijsko izjavo obiščite spletno stran podjetja Blatchford.
Prijava resnih nesreč
V malo verjetnem primeru resnih nesreč, nastalih v povezavi s tem pripomočkom, je treba
o dogodku obvestiti proizvajalca in pristojne oblasti v vaši državi.
Okoljski vidiki
Pripomoček je izdelan iz materialov, ki jih je mogoče reciklirati. Kjer je mogoče, je treba
komponente reciklirati v skladu z veljavnimi lokalnimi predpisi za obravnavo odpadkov.
Nalepka na embalaži
Zdravniku svetujemo, da nalepko na embalaži nameščenega pripomočka shrani za morebitno
uporabo v prihodnje.
Samo za enega bolnika –
za večkratno uporabo
Medicinski pripomoček
Izjave o blagovnih znamkah
Blatchford je registrirana blagovna znamka podjetja Blatchford Products Limited.
Uradni naslov proizvajalca
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, Združeno kraljestvo.

20 938252PK2/1-0121
Съдържание
Съдържание...................................................................................................................................................... 20
1 Описание и предназначение ......................................................................................................................... 21
2 Информация относно безопасността......................................................................................................... 22
3 Устройство............................................................................................................................................................... 23
4 Функция.................................................................................................................................................................... 23
5 Поддръжка.............................................................................................................................................................. 24
6 Ограничения в употребата.............................................................................................................................. 25
7 Съвети относно монтажа.................................................................................................................................. 26
8 Технически данни................................................................................................................................................. 27
9 Информация за поръчка................................................................................................................................... 27
BG