Blatchford SMARTIP4B30 User manual

PK2
Instructions for Use
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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

2
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

3
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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4
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.
938250PK2/1-0421

5
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

6
4 Function
The device is a uniaxial design comprising a knee pivot connecting a chassis to a carrier. A weight
activated stabilizing knee mechanism is housed within the chassis. The stabilizing mechanism
has a resilient action which provides limited stance exion under load to absorb shock loads at
heel strike.
The Stanceex knee chassis has a pivotally connected top plate which is resiliently supported
by a rubber block, this provides an increased stance exion action under load to further absorb
shock loads at heel strike.
A knee control cylinder sits within this frame assembly, tted between the chassis posterior pivot
and the carrier distal pivot.
The SmartIP control cylinder uses a sensors to monitor walking speed and automatically adjusts
exion resistance accordingly. Extension control is via xed adjustment of a terminal impact
damper.
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, restricted/excessive rotation 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).
To maintain optimum performance, an annual inspection for unacceptable noise, play and
stability is recommended. More frequent inspections may be required depending on factors such
as the activity of the user, frequency of usage and the stability setting of the knee.
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 of this device must be reported to the practitioner. Changes in performance may
include: increase or decrease in knee stiness, instability, reduced knee support (free movement),
any unusual noise.
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.
5 Maintenance
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7
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
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.
Exclusively for use between -10 ˚C to 50 ˚C
(14˚F to 122˚F)
938250PK2/1-0421

8
7 Static Alignment
Fully extend limb to access the adjuster.
Rotate the SPRING STACK ADJUSTER to achieve
the required stability for the individual amputee.
Note: Audible clicks should be heard upon
adjustment, and the adjuster is self locking.
Tighten the SPRING STACK to reduce stability.
Release the SPRING STACK to increase stability -
See above.
If required, the adjuster may be reset to the
factory setting. This can be achieved by reducing
stability by six audible clicks from the maximum
stability setting.
Build Line
The instructions in this section are for practitioner use only.
1. Complete static alignment as per
diagram below. ESK+ function must be conrmed by
wearer before walking on the limb.
(See Alignment Advice and Stability
Adjustment)
Spring Stack Adjuster
Underside View of Chassis
Decrease
Stability
Increase
Stability
Trochanter
Knee Pivot
Ankle Centre
2. Walking Trials.
938250PK2/1-0421

HOLD
Fully
ƒ»•ƒfl¥
e›ƒ»?•–?¤·ƒ¢•ƒ·?•'¢fl?SO°
Save & Exit
x2
SO° +
S?¶ƒ⁄¶
vary speedgradually for approx. 200 steps
refrain from sitting during programming
x2x2
Q?¶ƒ⁄¶
x2
vary speed gradually for approx. 200 steps
refrain from sitting during programming
vary speed gradually for approx. 200 steps
refrain from sitting during programming
x3
Q?¶ƒ⁄¶
x2
Q?¶ƒ⁄¶
x3
x2
x1
x2
x2
HOLD
Fully
ƒ»•ƒfl¥
e›ƒ»?•–?¤·ƒ¢•ƒ·?•'¢fl?SO°
Save & Exit
x2
SO° +
S?¶ƒ⁄¶
vary speedgradually for approx. 200 steps
refrain from sitting during programming
x2x2
Q?¶ƒ⁄¶
x2
vary speed gradually for approx. 200 steps
refrain from sitting during programming
vary speed gradually for approx. 200 steps
refrain from sitting during programming
x3
Q?¶ƒ⁄¶
x2
Q?¶ƒ⁄¶
x3
x2
x1
x2
x2
9
8 Limb Setup
8.1 SmartIP Operation
8.2 Fine Tuning
The instructions in this section are for both practitioner and user.
Adjust for static alignment as shown in the ESK+ tting instructions supplied with the module.
Cushion Valve adjustment - If after programming for the rst time, the user experiences too much
or too little damping at the end of the swing, the cushion valve may be adjusted. (See Cushion
Valve Adjustment) Fine Tuning MUST always follow any cushion valve adjustment. (See Fine
Tuning)
The instructions in this section are for practitioner use only.
Initial Set Up (First Time Use)
Calibrate Limb to User
& Enter Program Mode
Programming
START
UNTIL
STOP
SAVE
& EXIT
START
2 sec
4 sec
2 sec
4 sec
Fully
Extend Fully Flex Fully Extend Fully Flex Fully Extend Fully Flex Fully Extend
HOLD
Vary speed gradually for aprox. 200 steps
Refrain from sitting during programming
Maximum 6 seconds
Approx. 12 m (40’) required
HOLD
Flex more
than 40º Fully Extend
HOLD
Fully
Extend Fully Flex Fully Extend Fully Flex Fully Extend
Vary speed gradually for aprox. 200 steps
Refrain from sitting during programming Flex more
than 40º Fully Extend
Maximum 6 seconds
SAVE
& EXIT HOLD
938250PK2/1-0421

10
The instructions in this section are for practitioner use only.
Adjust the Cushion Valve prior to commencement of programming.
For increased damping of terminal impact, rotate the valve clockwise (2.5 A/F Wrench Key).
Adjust the cushion resistance whilst the amputee is walking slowly.
At this speed the damping level should be set
to the highest resistance that still permits the
knee to extend fully and remain extended during
the entire stance phase. This should result in the
elimination of terminal impact at higher speeds.
Fine tune settings as the trial progresses, always
conrming that the limb fully extends during slow
walking.
Note… Typical increments are 1/4 turn until valve
has eect thereafter smaller increments should be
used to optimize terminal impact.
8.3 Cushion Valve Adjustment
938250PK2/1-0421
2.5
Cushion Valve Adjustment
ROTATE VALVE
CLOCKWISE TO
REDUCE
TERMINAL IMPACT

Should unit require return to Blatchford, please remove and dispose of the batteries.
(Disposal as per local waste handling regulations).
11
8.4 Using the Reset Switch
The instructions in this section are for practitioner use only.
Initial Set Up, Calibration and Programming
• Selects factory default program settings
• Enters calibration mode followed by programming mode.
1. Press reset button, conrmed by 1 beep.
2. Within 2 seconds press reset button again, conrmed by 2 beeps.
3. Within 2 seconds press reset button again, conrmed by 3 beeps.
Fine Tuning
• Enters program mode starting with current program settings
1. Press reset button, conrmed by 1 beep.
2. Within 2 seconds press reset button again, conrmed by 2 beeps.
Basic Reset
• Reverts to users programmed settings in normal operation mode.
1. Press reset button, conrmed by 1 beep.
Note… A basic reset should always be carried out after tting batteries.
When would you carry out any of the above resets?
• No response from the limb when trying any of the knee activation sequences
• Limb mode unknown
• After changing or reconnecting batteries (Basic Reset)
938250PK2/1-0421
Reset
Switch
Location

No
No
12
*Note:
Initial coarse
adjustments may
be carried out in
increments of 2
or more clicks,
followed by ne
adjustment of
a single click as
required
Start
Align as recommended
(Shin Vertical, load line
through knee centre)
With user standing and
limb loaded
With 100% weight on limb,
can the user ex the knee?
Note...Wearer standing
in parallel bars , gently
holding rails.
Increase
dorsiexion
resistance.
Is the
Stanceex
rubber too
soft?
Is the knee tted with a
Stanceex rubber?
Check level of stability
is sucient for amputee
needs and adjust
accordingly**
**Note,
There may
be a need to
compromise
between
maximum
walking speed
and level of
stability
Adjustment complete
If reducing the sensitivity
fails to have any eect
other than reducing the
stability, check that the
front stop is properly
adjusted
i.e. contacting the chassis
when loaded. Failure to
do so can result in the
brake operating when
hyper- extended
Does the foot have a low
dorsiexion resistance?
Ask user to walk
SLOWLY
Ask user to walk
at NORMAL speed
Does the knee release
smoothly at toe o?
Ask user to walk
FAST
Does the knee release
smoothly at toe o?
unable
to walk
fast
Does the knee release
smoothly at toe o?
9 Alignment Advice and Stability Adjustment
Yes No
Yes
Yes
No
No
No
Yes
Yes
Yes
Yes
No
The instructions in this section are for practitioner use only.
Increase stability*
underside view of chassis
underside view of chassis
Reduce stability*
Replace
Stanceex
rubber
938250PK2/1-0421

13
10 Fitting Advice
Pivot
06
White
35˚
2316
Orange
07
45˚
08
Pink
25˚
09
Blue
70˚
10.1 Changing Stanceex Rubbers
Static Knee Flexion Following Heel Strike
The instructions in this section are for practitioner use only.


Stanceex Rubbers
0-8 mm
+8 mm
13 mm
(Fitted as
standard)
938250PK2/1-0421

14
10.2 Front Stop Adjustment - Adjustable Trunnion
Fully tighten front stop.
Loosen trunnion
clamp screw. Turn
piston rod to
reveal thread and
apply Loctite 222.
Reassemble and
screw piston rod
fully home. The
chassis should
now be slightly
exed.
Apply a light extension load to the knee and
gradually unscrew the piston rod (lengthening
the cylinder) until the chassis edge is parallel with
the top of the shin.
Note… The stop pads mounted in the
chassis and side plate are required to
support ML loading. Simultaneous full
contact between the stops and the shin
is NOT required.
Front Stop Adjustment - Non-Adjustable Intelligent Prosthesis
(As tted to older SmartIP models.)
No adjustment is necessary when using these cylinders. They require the front stop to be fully
tightened as shown in Stage 1.
The instructions in this section are for practitioner use only.
Withdraw trunnion damp screw and
apply LOCTITE 222 to thread, re-
assemble and tighten.
*UNDER NO CIRCUMSTANCES MUST
THE PISTON ROD WITNESS LINE BE
VISIBLE BELOW THE TRUNNION.
1
3 4
2
938250PK2/1-0421

15
Symptom Solution
Knee does not stabilise
Increase sensitivity of ESK+
Shift socket anteriorly
Replace stabilizing mechanism if trailing edge of
brake is damaged
Check Stanceex rubber and replace if necessary
(See minimum thickness in compression in Knee
Flexion Following Heel Strike section)
Knee does not release
Decrease sensitivity of ESK+
Check correct adjustment of piston rod length
Shift socket posteriorly
Heel rise too high during swing See control cylinder IFU
Heel rise too low during swing See control cylinder IFU
User experiences terminal impact See control cylinder IFU
Device does not fully extend during swing See control cylinder IFU
If after following these instructions you still have problems with the function please contact the
sales team in your area for advice.
10.3 Further Adjustments
The instructions in this section are for practitioner use only.
938250PK2/1-0421

11 Assembly Instructions
11.1 Changing Front Stop Buer
16
When tting a new front stop, always re-adjust, and if applicable check length of cylinder if tted
with an adjustable trunnion. (See Front Stop Adjustment - Adjustable Trunnion.)
The instructions in this section are for practitioner use only.
424
Remove shin stops and remainder of
adhesive. Clean and lightly abrade mating
surfaces.
Shin Stops
Apply Loctite 424 on mating surfaces. Press
shin stops into place.
Mating Surfaces
11.2 Changing Shin Stops
12
12
938250PK2/1-0421

11.3 Removing ESK+ Mechanism
17
2
8
Underside view
of chassis
Oscillate
during removal
Clean bore with suitable solvent
Remove all preload and
record number of clicks
The instructions in this section are for practitioner use only.
Brake band material may be wiped clean with paper, do not use
solvents.
13
54 6
7
938250PK2/1-0421

11.4 Replacement of ESK+ Mechanism
18
54
Oer up side plate to align slot in spindle (2) with dowel (1)
but do not t at this stage.
Screw spindle to chassis.
ORIENTATION IS IMPORTANT!
Assemble at sides and lettering (RH,
LH) facing inwards.
Oscillate during
assembly
Re-apply preload
with recorded
number of clicks.
Underside
view of
chassis.
The instructions in this section are for practitioner use only.
2
1
3
6 7 8
938250PK2/1-0421

19
12 Technical Data
Build Height
Operating and Storage
Temperature Range:
-10°C to 50 °C
(14°F to 122 °F)
Component Weight:
4-Bolt
Single Bolt Stanceex
1.15 kg (2 lb 8.6 oz)
1.27kg (2 lb 13 oz)
Activity Level: 2-3 (4)
Maximum User Weight:
Activity Levels 2-3
Activity Level 4
125kg (275lb)
100kg (220lb 7.4ozs)
Proximal Attachment: 4-Bolt
or Single bolt Stanceex
(Blatchford)
Distal Alignment Attachment: 30 mm Tube Clamp
or Male Pyramid
(Blatchford)
Build Height: (See diagrams below.)
36 mm
223 mm
36 mm
262 mm
34 mm
4-Bolt
30 mm Distal Tube ClampDistal Pyramid
938250PK2/1-0421

20
13 Ordering Information
45 mm
223 mm
45 mm
262 mm
34 mm
Stanceex
30 mm Distal Tube Clamp Distal Pyramid
4-bolt
Adapter
Stanceex SMARTIP SF 30
SmartIP
Knee Stanceex
Distal Tube Clamp
30 mm
SMARTIP SF PYR
SmartIP
Knee Stanceex Distal Pyramid
SMARTIP 4B 30
SmartIP
Knee
4-bolt
Adapter
Distal Tube Clamp
30 mm
SMARTIP 4B PYR
SmartIP
Knee
4-bolt
Adapter
Distal
Pyramid
30 mm Distal Tube ClampDistal Pyramid
Item Part. No.
Stanceex Knee Assembly 239149
ESK Mechanism Alignment Pin 234914
Front Stop Pad 234903
ESK+ Stabilizing Mechanism Kit 239949
Shin Stop 233810
Replacement Parts
Item Part. No.
25˚ Pink (Soft) 231608
35˚ White 231606
45˚ Orange (Fitted as Standard) 231607
70˚ Blue (Hard) 231609
Stanceex Rubber
938250PK2/1-0421