Blatchford Navigator User manual

Instructions for Use
Instructions d’utilisation
Gebrauchsanweisung
Istruzioni per l’uso
Instrucciones de uso
Gebruiksaanwijzing
Instrukcje użytkowania
Instruções de utilização
Návod k použití
PK1
EN 2
FR 16
DE 30
IT 44
ES 58
NL 72
PL 86
PT 100
CS 114
Navigator
Instructions for Use
NAV22LWW–NAV30RBB
NAV22LWWD–NAV30RBBD

2
Contents.................................................................................................................................................................2
1 Description and Intended Purpose ....................................................................................................................3
1.1 Ankle Ball and Snubber Selection ................................................................................................................4
2 Safety Information....................................................................................................................................................5
3 Construction ...............................................................................................................................................................6
4 Function........................................................................................................................................................................7
5 Maintenance ...............................................................................................................................................................7
6 Limitations on Use....................................................................................................................................................8
7 Alignment ....................................................................................................................................................................9
7.1 Additional Components ...................................................................................................................................9
7.2 Static Alignment..................................................................................................................................................9
7.3 Dynamic Alignment ...........................................................................................................................................9
8 Fitting Advice........................................................................................................................................................... 10
9 Assembly Instructions .......................................................................................................................................... 10
9.1 Changing the Ankle Ball ................................................................................................................................ 10
9.2 Changing the Snubber................................................................................................................................... 11
9.3 Assembling and Finishing the Foot Shell................................................................................................ 12
10 Technical Data ......................................................................................................................................................... 13
11 Ordering Information ........................................................................................................................................... 14
Contents
938247PK1/1-0421
EN

3
1 Description and Intended Purpose
These instructions are for the practitioner and user unless otherwise stated.
The term device is used throughout these instructions for use to refer to Navigator.
Please read and ensure you understand all instructions for use, in particular all safety information
and maintenance instructions.
Application
This device is an ankle-foot unit that is for use as a component of a lower limb prosthesis.
This device comprises an integrated multi-axial ankle and a resilient keel which oer the user
enhanced ground compliance.
This device is for a single user.
Features
• Multi-axial ankle with resilient keel
• Short, energy-ecient, rollover shape keel optimized for K2 gait
• Integrated ankle joint
• Choice of ankle stiness
• Sandal toe foot shell
Activity Level
This device is recommended for Activity Level 1–3 users (weight restrictions apply, see Technical
Data section). As an exception to our recommendation, Activity Level 4* users may only use this
device based upon the outcome of a prosthetic assessment.
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.
*Maximum user weight: 100kg (220 lb).
Contraindications
This device is not suitable for use in competitive sports events.
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4
1.1 Ankle Ball and Snubber Selection
The ankle ball and the snubber are color-coded to indicate their hardness.
Use the table to choose an ankle ball and snubber combination that suits the weight and Activity
Level of the user. The letter on the left refers to the ankle ball. For example, WO refers to a white
ankle ball and an orange snubber.
• White (W) = Soft
• Orange (O) = Medium
• Blue (B) = Hard
Notes:
i) Bilateral users might need stier snubbers than unilateral users.
ii) Transfemoral users might need softer ankle balls than transtibial users.
Location of color codes Weight Activity Level
kg lb 1 2 3
44–52 100–115 WW WW WW
53–59 116–130 WW WW WO
60–68 131–150 WW WO OO
69–77 151–170 WO OO OB
78–88 171–195 OO OB BB
89–100 196–220 OB BB BB
101–125 221–275 BB BB BB
Clinical Benets
• Optimized keel allows for more consistent rollover radius of curvature.
• Rollover shape falls within the most energy ecient range for most people.
• Greater stability for low mobility users when moving through stance phase compared to
single axis feet and solid-ankle-cushioned-heel feet.
• Improved inter-limb symmetry of stance phase timing, compared to rigid ankles.
• Reduced sound limb loading, compared to rigid ankles.
For bilateral users, the clinical benets of this device compared to rigid ankle devices include:
• No loss of stability during standing.
• Easier to walk on uneven ground, on slopes and to walk longer distances.
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5
2 Safety Information
This warning symbol highlights important safety information which must be
followed carefully.
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.
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.
Assembly, maintenance and repair of
the device must only be carried out by a
suitably qualied clinician.
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. Ensure any use of the
device complies with the conditions
given in Limitations on Use.
Ensure only suitably retrotted vehicles
are used when driving. All persons are
required to observe their respective
driving laws when operating motor
vehicles.
To minimize the risk of slipping and
tripping, appropriate footwear that ts
securely onto the foot shell must be
used at all times.
Avoid exposure to extreme heat and/
or cold.
The user must not adjust or tamper
with the setup of the device.
The user should contact their clinician if
their condition changes.
Be aware of nger trap hazard at all
times.
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6
Principal Parts
• Dome (aluminum alloy)
• Snubber (rubber)
• Top Housing (aluminum alloy)
• Ankle Ball and Pyramid (aluminum alloy/rubber/stainless steel/titanium)
• Keel (ber-reinforced polymer)
• M6x27 Socket Cap Screw (plated carbon steel)
• Glide Sock (UHM PE)
• Foot Shell (polyurethane)
3 Construction
Component Identication
Dome
Snubber
Top Housing
M6x27 Socket Cap
Screw
Glide Sock
Foot Shell
Ankle Ball and
Pyramid
Keel
5
10Nm
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7
Visually check the device regularly.
Report any changes in performance of this device to the practitioner/service provider e.g.
unusual noises, increased stiness or restricted/excessive rotation, signicant wear or excessive
discoloration from long term exposure to UV.
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 the foot shell and glide sock for damage or wear, and replace if necessary;
• Check the ankle ball and the snubber for damage or wear, and replace if necessary;
• Make sure the socket cap screws are tight. If they are loose, tighten them to the correct
torque setting (see Construction section);
• Re-lubricate the snubber.
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 any changes in
performance and signs of wear that may aect function should be reported to their service
provider (e.g. signicant wear or excessive discoloration from long term exposure to UV).
Advise the user to report to the practitioner any changes in body weight or activity level.
5 Maintenance
4 Function
This device is an ankle-foot unit that comprises both an integrated ankle and a resilient keel
inside a sandal-toe foot shell. The ankle center is positioned anatomically to promote a natural
gait from heel strike to toe-o. The plantar exion and dorsiexion resistances can be adjusted by
changing the ankle ball and the snubber to suit the weight and the Activity Level of the user.
938247PK1/1-0421

8
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
Avoid exposing the device to corrosive elements such as water, acids and other liquids. Avoid
abrasive environments such as those containing sand, as these may promote premature wear.
Exclusively for use between -15 °Cand 50 °C
(5 °F and 122°F).
6 Limitations on Use
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9
½½
½½
Accommodate the heel height of the
user’s footwear
*
7 Alignment
Load
Line
7.1 Additional Components
Follow the alignment instructions that are
supplied with any additional components.
7.2 Static Alignment
Sagittal Plane
With the exion accommodated, the load line
should pass through the center of the socket
and through the center of the pyramid.
Make sure that, when the user is standing, the
heel and the toe are evenly loaded and the
foot is in full contact with the oor.
7.3 Dynamic Alignment
Coronal Plane
Minimize M–L thrust by adjusting the relative
positions of the socket and the foot.
Sagittal Plane
Make sure that the user transitions smoothly
from heel strike to toe-o.
*
Trochanter
Approx. ⁄ ⁄
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10
Symptoms Remedy
• Sinking at heel strike
• Foot slap
a) Conrm A–P alignment and heel height
accommodation.
b) Fit a harder ankle ball.
• Rapid transition from heel strike through
stance phase
• Diculty controlling heel action (e.g. the
foot jars into mid-stance)
• Foot feels too rigid
a) Conrm A–P alignment and heel height
accommodation.
b) Fit a softer ankle ball.
• Drop-o
• Feels like walking downhill
a) Conrm A–P alignment and heel height
accommodation.
b) Fit a harder snubber.
• Feels like walking uphill a) Conrm A–P alignment and heel height
accommodation.
b) Fit a softer snubber.
8 Fitting Advice
9 Assembly Instructions
The main function of the ankle ball is to provide plantar exion resistance. Harder ankle balls
provide more resistance and softer ankle balls provide less resistance.
The main function of the snubber is to provide dorsiexion resistance. Harder snubbers provide
more resistance and softer snubbers provide less resistance.
1. To release ankle ball, remove keel and ankle
assembly from foot shell and remove four
M6x27 socket cap screws (see Fig. 3).
2. Clean the replacement ankle ball (Fig. 1) and
the keel pocket with acetone or a similar
solvent.
3. Align the ats of the male pyramid along the
axis of the keel and rest the ankle ball in the
keel pocket.
4. Insert the alignment screw into the ankle ball
through the hole in the bottom of the keel.
5
9.1 Changing the Ankle Ball
Be aware of nger trap hazard at all times.
Use appropriate health and safety equipment at all times including extraction facilities.
Please contact your supplier if it is not possible to achieve a smooth gait after following the
advice above.
Ankle Ball
Alignment Screw
1
938247PK1/1-0421

11
243
Loctite
9.2 Changing the Snubber
5. Clean inside of the top housing with acetone
or a similar solvent.
6. Place the top housing over the ankle ball.
Note… Make sure the opening of the top housing
faces posteriorly.
7. Insert four socket cap screws fully into the four
holes in the bottom of the keel, then apply
Loctite 243 to the screw threads where they
expose above the keel.
8. Apply pressure to the top housing while
maintaining pyramid alignment. Then, engage
the socket cap screws into the housing.
9. Turn each screw, in sequence, ½to 1 turn at a
time until the top housing comes into contact
with keel.
Note… Make sure that the alignment screw stays in
place while you tighten the socket cap screws.
10.Torque tighten the socket cap screws to 10Nm
and remove the alignment screw.
1. Lubricate the snubber with a suitable rubber
lubricant.
2. Press the cone tool onto the housing.
3. Place the dome over the ankle stem.
Note… Make sure the‘A’ on top of the dome faces
anteriorly.
Top Housing
Socket Cap Screw (x4)
1
2
3
45
10Nm
Cone tool
940083
e.g.
928107
2
3
1
938247PK1/1-0421

1. Place the keel inside the glide sock and slide
them both into the foot shell.
Note… Make sure that the heel of the keel is fully
engaged in the location feature in the heel of the
foot shell.
Location
Feature
1
Note… After assembling to the limb, make sure that
the glide sock is not trapped under the dome.
2. Pull the glide sock under slight tension.
3. Use a cable tie to secure the glide sock to the
pylon just above the adapter.
2
4. Remove the end of the cable tie, then fold the
glide sock over.
3
5. Abrade the top surface of the foot shell.
6. Bond a 12mm pelite interface to the foot shell
and shape as appropriate. Use Evostik 528
(926213) or an equivalent.
7. Bond a foam cosmesis to the top surface of the
pelite interface and shape as appropriate. Use
Thixox (926204), Evostik 528 (926213) or an
equivalent.
4
12
9.3 Assembling and Finishing the Foot Shell
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13
Fitting Length
10 Technical Data
Operating and Storage Temperature Range: -15°C to 50 °C
(5 °Fto122 °F)
Component Weight (size 26): 565g (20 oz)
Activity Level: 1–3
Maximum User Weight: 125kg (275 lb)
Proximal Alignment Attachment: Male pyramid (Blatchford)
Range of Adjustment ±7° angular
Build Height: 95mm
Heel Height: 10mm
95mm
10mm
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14
Foot Shells (Add a D for dark tone)
Size
(cm)
Left Part
Number
Right Part
Number
22 539020 539021
23 539022 539023
24 539024 539025
25 539026 539027
26 539028 539029
27 539030 539031
28 539032 539033
29 539034 539035
30 539036 539037
Snubbers
Type Part Number
White 60° 405605
Orange 70° 405606
Blue 80° 405607
Tools for Assembly
Part Part Number
Alignment Screw 910414
Cone Tool 940083
Cable Tie 929029
11 Ordering Information
Ankle and Keel Assemblies (USA only)
Size Type Part
Number
Small White 60° 409156
Medium White 60° 409157
Large White 60° 409158
Extra Large White 60° 409159
Small Orange 70° 409256
Medium Orange 70° 409257
Large Orange 70° 409258
Extra Large Orange 70° 409259
Small Blue 80° 409356
Medium Blue 80° 409357
Large Blue 80° 409358
Extra Large Blue 80° 409359
Glide Sock 405815
Ankle Ball and Pyramids
Type Part Number
White 60° 409456
Orange 70° 409556
Blue 80° 409656
Order Example
Available from size 22 to size 30:
NAV22LWW to NAVR30RBB
NAV22LWWD to NAV30RBBD
*(Add ‘D’ for a dark tone foot shell)
NAV 25 L W W D
Size Side
(L/R)
Ankle
Ball
(W/O/B)
Snubber
(W/O/B)
*Dark
Tone
e.g. NAV25LOB, NAV29RWW, NAV26RBBD
938247PK1/1-0421

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 foot shell is warranted for 12 months, andthe glide
sock is warranted for 3 months. The user should be aware that changes or modications not
expressly approved could void the warranty, operating licenses and exemptions. See 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
Where possible the components should be recycled in accordance with 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
15
Trademark Acknowledgements
Navigator and Blatchford are registered trademarks of Blatchford Products Limited.
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK
938247PK1/1-0421

Table des matières........................................................................................................................................... 16
1 Description et objectif visé................................................................................................................................. 17
1.1 Choix de la sphère de cheville et de l’amortisseur .............................................................................. 18
2 Informations de sécurité...................................................................................................................................... 19
3 Construction ............................................................................................................................................................ 20
4 Fonction..................................................................................................................................................................... 21
5 Entretien.................................................................................................................................................................... 21
6 Limites d’utilisation ............................................................................................................................................... 22
7 Alignement............................................................................................................................................................... 23
7.1 Composants supplémentaires .................................................................................................................... 23
7.2 Alignement statique ....................................................................................................................................... 23
7.3 Alignement dynamique................................................................................................................................. 23
8 Conseils de pose..................................................................................................................................................... 24
9 Instructions de montage..................................................................................................................................... 24
9.1 Changer la sphère de cheville ..................................................................................................................... 24
9.2 Changer l’amortisseur .................................................................................................................................... 25
9.3 Assemblage et nition de l’enveloppe de pied..................................................................................... 26
10 Données techniques............................................................................................................................................. 27
11 Pour commander.................................................................................................................................................... 28
Table des matières FR
16 938247PK1/1-0421

1 Description et objectif visé
Ces instructions sont destinées au praticien et à l’utilisateur, sauf indication contraire.
Le terme dispositif est utilisé dans ce manuel pour se référer au dispositif Navigator.
Veuillez lire et vous assurer que vous comprenez toutes les instructions d’utilisation,
en particulier les informations de sécurité et les instructions relatives à l’entretien.
Application
Ce dispositif est un ensemble pied-cheville destiné à être utilisé comme composant d’une
prothèse de membre inférieur.
Ce dispositif comprend une cheville multiaxiale intégrée et une âme résiliente qui orent
à l’utilisateur une meilleure adaptabilité au sol.
Ce dispositif est destiné à un utilisateur unique.
Caractéristiques
• Cheville multiaxiale avec âme résiliente
• Âme courte, à haut rendement énergétique avec forme de déroulement optimisée pour
le cycle de marche des K2.
• Articulation de cheville intégrée
• Choix de la rigidité de la cheville
• Enveloppe de pied avec orteil séparé
Niveau d’activité
Ce dispositif est recommandé aux utilisateurs ayant un niveau d’activité1 à 3 (des limites de
poids s’appliquent, voir la section Données techniques). Contrairement à notre recommandation,
les utilisateurs de niveau d’activité4* ne peuvent utiliser ce dispositif qu’en fonction des résultats
d’une évaluation prothétique.
Activité de niveau 1
A la possibilité ou le potentiel d’utiliser une prothèse pour les transferts ou déplacements sur des
surfaces planes à une cadence xe. Caractéristiques du patient domestique limité et illimité.
Activité de niveau 2
A une capacité ou un potentiel de déambulation avec possibilité de gérer des obstacles
environnementaux bas tels que les trottoirs, les escaliers ou les surfaces inégales. Caractéristique
du patient limité en extérieur.
Activité de niveau 3
A une capacité ou un potentiel de déplacement à cadence variable. Typique du patient en extérieur
qui a la capacité de franchir la plupart des barrières environnementales et peut avoir une activité
professionnelle, thérapeutique ou physique qui exige l’utilisation de prothèses au-delà de la simple
locomotion.
Activité de niveau 4
A une capacité ou un potentiel de déplacement prothétique qui dépasse les capacités de déplacement
de base, présentant des niveaux d'impact, de contrainte ou d’énergie élevés. Typique des exigences
prothétiques de l’enfant, de l’adulte actif ou du sportif.
*Poids maximum de l’utilisateur: 100kg
Contre-indications
Ce dispositif ne convient pas à une utilisation dans le cadre de compétitions sportives.
17 938247PK1/1-0421

1.1 Choix de la sphère de cheville et de l’amortisseur
La sphère de cheville et l’amortisseur possèdent des codes de couleur qui indique leur fermeté.
Utilisez le tableau pour choisir une combinaison de sphère de cheville et d’amortisseur adaptée
au poids et au niveau d’activité de l’utilisateur. La lettre de gauche correspond à la sphère de
cheville. Par exemple, WO fait référence à une sphère de cheville blanche et à un amortisseur
orange.
• Blanc (W) = Souple
• Orange (O) = Moyen
• Bleu (B) = Dur
Remarques:
i) Les utilisateurs bilatéraux peuvent avoir besoin d’amortisseurs plus fermes que les utilisateurs
unilatéraux.
ii) Les utilisateurs transfémoraux peuvent avoir besoin de sphères de cheville plus souples que
les utilisateurs transtibiaux.
Emplacement des codes de couleur Poids Niveau d’activité
kg lb 1 2 3
44–52 100–115 WW WW WW
53–59 116–130 WW WW WO
60–68 131–150 WW WO OO
69–77 151–170 WO OO OB
78–88 171–195 OO OB BB
89–100 196–220 OB BB BB
101–125 221–275 BB BB BB
Avantages cliniques
• L’âme optimisée permet d’obtenir un rayon de déroulement de la courbe plus régulier.
• La forme de déroulement se situe dans la gamme énergétique la plus ecace pour la
plupart des gens.
• Plus grande stabilité pour les utilisateurs à faible mobilité lors de la phase d’appui par
rapport aux pieds à axe unique et aux pieds à talon rembourré et à cheville solide.
• Meilleure symétrie entre les membres dans la synchronisation de la phase d’appui,
par rapport aux chevilles rigides.
• Réduction de la charge sur le membre sain, par rapport aux chevilles rigides.
Les avantages cliniques de ce dispositif par rapport aux chevilles rigides pour les utilisateurs
bilatéraux sont les suivants:
• Aucune perte de stabilité en position debout.
• La marche est plus facile sur les sols irréguliers, en pentes et sur les longues distances.
18 938247PK1/1-0421

2 Informations de sécurité
Ce symbole d’avertissement met en évidence des informations de sécurité
importantes qui doivent être scrupuleusement respectées.
Tout changement dans la performance
ou la fonction du membre,
par exemple un mouvement restreint,
un mouvement irrégulier ou des bruits
inhabituels, doit être immédiatement
signalé à votre prestataire de services.
Servez-vous toujours d’une rampe pour
descendre les escaliers et à tout autre
moment si possible.
Le dispositif n’est pas adapté aux sports
extrêmes, à la course à pied ou à vélo,
aux sports de glace et de neige,
aux pentes et aux marches extrêmes.
Toutes les activités de ce type sont
menées aux risques et périls des
utilisateurs. Le cyclisme de loisir est
acceptable.
Seul un clinicien dûment qualié peut
procéder au montage, à l’entretien et
à la réparation du dispositif.
Le dispositif n’est pas destiné à être
utilisé en immersion dans l’eau ou
comme prothèse de douche. Si le
membre entre en contact avec de l’eau,
essuyez-le immédiatement. Veiller à ce
que toute utilisation du dispositif soit
conforme aux conditions énoncées au
paragraphe Limites d’utilisation.
Veillez à ce que seuls les véhicules
adaptés soient utilisés pour la conduite.
Toutes les personnes sont tenues de
respecter leurs lois respectives en
matière de conduite de véhicules
motorisés.
Des chaussures appropriées, bien
adaptées à l’enveloppe du pied, doivent
être utilisées à tout moment an de
réduire au minimum le risque de glisser
et de trébucher.
Évitez l’exposition à la chaleur et/ou au
froid extrêmes.
L’utilisateur ne doit pas régler ou
modier la conguration du dispositif.
Le patient doit contacter son praticien
si son état vient à changer.
Tenez compte du risque de pincement
des doigts.
19 938247PK1/1-0421

Composants principaux
• Dôme (alliage d’aluminium)
• Amortisseur (caoutchouc)
• Boîtier supérieur (alliage d’aluminium)
• Sphère de cheville et pyramide (alliage d’aluminium/caoutchouc/acier inoxydable/titane)
• Âme (polymère renforcé de bres)
• Vis letée d’emboîtureM6x27 (acier carbone nickelé)
• Chaussette de protection (UHMPE)
• Enveloppe de pied (polyuréthane)
3 Construction
Identication des composants
Dôme
Amortisseur
Boîtier supérieur
Vis letée d’emboîture
M6x27
Chaussette de protection
Enveloppe de pied
Sphère de cheville
et pyramide
Âme
5
10Nm
20 938247PK1/1-0421