Blatchford SMARTIP4B30 User manual

PK2
Instructions for Use
Navodila za uporabo
Инструкции за употреба
Upute za uporabu
Návod na použitie
Használati útmutató
Οδηγίες χρήσης
Lietošanas pamācība
Naudojimo instrukcija
Kasutusjuhend
SmartIP
Instructions for Use
SMARTIP4B30 SMARTIPSF30
SMARTIP4BPYR SMARTIPSFPYR
EN 2
SL 24
BG 46
HR 68
SK 90
HU 112
EL 134
LV 156
LT 178
ET 200

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Contents
Contents.................................................................................................................................................................2
1 Description and Intended Purpose ...................................................................................................................3
2 Safety Information....................................................................................................................................................4
3 Construction ...............................................................................................................................................................5
4 Function........................................................................................................................................................................6
5 Maintenance...............................................................................................................................................................6
6 Limitations on Use....................................................................................................................................................7
7 Static Alignment........................................................................................................................................................8
8 Limb Setup ..................................................................................................................................................................9
8.1 SmartIP Operation ..............................................................................................................................................9
8.2 Fine Tuning............................................................................................................................................................9
8.3 Cushion Valve Adjustment............................................................................................................................ 10
8.4 Using the Reset Switch................................................................................................................................... 11
9 Alignment Advice and Stability Adjustment................................................................................................ 12
10 Fitting Advice........................................................................................................................................................... 13
10.1 Changing Stanceex Rubbers..................................................................................................................... 13
10.2 Front Stop Adjustment - Adjustable Trunnion ...................................................................................... 14
10.3 Further Adjustments....................................................................................................................................... 15
11 Assembly Instructions .......................................................................................................................................... 16
11.1 Changing Front Stop Buer.......................................................................................................................... 16
11.2 Changing Shin Stops....................................................................................................................................... 16
11.3 Removing ESK+ Mechanism ........................................................................................................................ 17
11.4 Replacement of ESK+ Mechanism............................................................................................................. 18
12 Technical Data ......................................................................................................................................................... 19
13 Ordering Information ........................................................................................................................................... 20
938250PK2/1-0421
EN

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1 Description and Intended Purpose
These Instructions for Use are intended for use by the practitioner and user unless otherwise
stated.
The term device is used throughout these instructions for use to refer to SmartIP.
Please read and ensure you understand all instructions for use, in particular all safety information
and maintenance instructions.
Application
This device is to be used exclusively as part of a lower limb prosthesis.
Intended for a single user.
The device is a programmable microprocessor controlled knee with adjustable terminal impact,
extension damping and weight activated stance control.
Features
• Smart Programming for exion control
• Manually adjustable terminal impact and extension control
• Comfortable gait from very slow to fast walking speeds
• Smooth speed progression because of enhanced program
• Weight activated stance control
• Stanceex option improves comfort
• Battery life expectancy 9-12 months under normal usage
• 140° knee exion
• 4-Bolt option reduces build height
Activity Level
This device is recommended for users that have the potential to achieve Activity Level 2 or 3.
Some Activity Level 4 users may also benet from using the device (weight limits apply to all
activity levels, 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 2
Has the ability or potential for ambulation with the ability to traverse low-level environmental barries
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.
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Contraindications
This device may not be suitable for Activity Level 1.
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.
Clinical Benets
Microprocessor controlled swing device (IP) proven to:
• Increase stability and mobility on slopes and stairs, compared to non microprocessor-
controlled knees
• Reduce energy expenditure and cognitive demand, compared to non microprocessor-
controlled knees
• Make walking easier at dierent speeds, compared to non microprocessor-controlled knees
2 Safety Information
This warning symbol highlights important safety information which must be
followed carefully.
Beware of nger trap hazard all times.
Any changes in the performance or
function of the limb e.g. instability,
double-action, restricted movement,
non-smooth motion or unusual noises
should be immediately reported to your
service provider.
Always use a hand rail when descending
stairs and at any other time if available.
Any excessive changes in the heel
height after nalization of alignment
may adversely aect limb function.
Ensure only suitably retrotted vehicles
are used when driving. All persons are
required to observe their respective
driving laws when operating motor
vehicles.
Care should be taken when carrying
heavy loads as this may adversely aect
the stability of the device.
The user should be advised to contact
their practitioner if their condition
changes.
Avoid exposure to extreme heat and/
or cold.
Assembly, maintenance and repair of
the device must only be carried out by a
suitably qualied clinician.
The user must not adjust or tamper with
the setup of the device.
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.
Avoid strong magnetic elds, sources
of electrical interference, atmospheres
containing liquids and/or powders.
Contact your service provider for
advice if the device is to be used with
a pacemaker or any other electronic
medical device.
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3 Construction
4-Bolt Stanceex
Component Identication
Principal Parts
• Carrier Assembly Carbon bre composite & stainless steel
• Chassis Assembly Aluminium alloy, stainless steel, engineering thermoplastic,
bre reinforced (asbestos free) friction material.
• Distal Dome Aluminium alloy
• Distal Pyramid Titanium with stainless steel bolt
• Distal Tube Clamp Aluminium alloy
• Patella Engineering thermoplastic
• Stanceex Rubber Natural rubber
• Stanceex strap Kevlar
• SmartIP Unit Aluminium alloy, stainless steel, Titanium, engineering thermoplastic
Electronic components, batteries
Pyramid Tube Clamp
Carrier Assembly
Chassis Assembly
Distal Dome
Patella
Stanceex Rubber
Stanceex Strap
SmartIP Unit
Batteries
938250PK2/1-0421