Blatchford AqualimbTT 629705L-629716L User manual

EN 3
Instructions for Use
AqualimbTT
Instructions for Use
629705L-629716L

938255/7-0819

938255/7-0819
3
1 Description and Purpose
Application
These instructions are for the practitioner.
The term device is used throughout these
instructions for use to refer to AqualimbTT.
Make sure that the user understands all the
information in these instructions for use,
particularly the maintenance and safety
information.
This device is a shin-foot unit that is for use as
a component of a trans-tibial prosthesis.
This device comprises a foot shell with an
integrated shin for use in the shower.
Activity Level
This device is for Activity Level 1 and 2 users.
Activity Level 3 and 4 users may only use this
device if they limit their activities to Activity
Level 2.
Contra-indications
This device is for a single user.
This device is for barefoot use in the shower.
Principal parts:
• Cosmesis (PU foam)
• Foot Shell (PU foam)
• Shin (glass-ber-reinforced nylon)
• Alignment Kit (stainless steel/aluminum/
titanium/glass-ber-reinforced nylon)
Shin M5x50 Socket Cap Screw (x4)
Chassis
Clamp
Plate
Foot
Shell
Cosmesis
EN
2 Construction
Alignment
Kit
• Chassis (glass-ber-reinforced nylon)
• M5x50 Socket Cap Screw (stainless steel)
• Clamp Plates (stainless steel)

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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 up to a maximum depth of 1 meter.
To prevent damage or wear, thoroughly rinse this device with fresh water after use in the
following environments:
• Abrasive environments, such as those that contain sand or grit;
• Salt or chlorinated water.
Finish this device to prevent water ingress (see section 7.1). If water enters it, invert it to allow the
water to drain, then leave it to dry.
This device is buoyant. If the user intends to
submerge this device, remove the cosmesis with a
suitable cutting tool (see section 7.1, step 8a).
Take care on wet and slippery surfaces.
Exclusively for use between -15 ˚Cand 50˚C (5 ˚F and 122˚F).
We recommend using Blatchford products with this device.
Only competent personnel should carry out maintenance.
Carry out the following maintenance annually:
• Make sure that the socket cap screws are tight. If they are loose, tighten them to the correct
torque setting;
• Make sure that the anti-slip tread functions as intended, and replace if necessary.
Advise the user to report the following changes to the practitioner:
• Changes in body weight;
• Changes in the performance of the device, for example, unusual noises or play.
Cleaning
Use a damp cloth and a mild soap to clean outside surfaces. Do not use aggressive cleansers.
This device is a shin-foot unit that comprises a foot shell with an integrated shin. The shin can be
shortened to suit the user’s height. The sole of the foot features an anti-slip tread for grip on wet
surfaces.
3 Function
4 Maintenance
5 Limitations on Use

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Static alignment
Sagittal plane
*With the exion accommodated, the load
line should pass through the target shown in
the image, ±10mm A–P. The target intersects
the point where the anterior face of the shin
meets the keel.
Make sure that when the user is standing, the
heel and toe are evenly loaded and the foot is
in full contact with the oor.
Dynamic alignment
Coronal plane
Minimise 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.
Load
Line
6 Alignment
Approx. ⁄ ⁄
*

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35 Nm
*
*
2
34
5
45mm
45mm
7 Assembly
Ø25 mm
1
6
4
5Nm
Use the mark to check that the shin
is fully engaged in the chassis, then
torque-tighten each screw twice.
To check that
the shin is fully
engaged in the
chassis, mark
the shin with
the engagement
depth of the
chassis.

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8b
7
7.1 Assembly
Silicone Sealer
Go to Alignment
(see section 6), then
continue to step 8.
8a
If the user intends
to submerge this
device, remove
the cosmesis with
a suitable cutting
tool.
Note: This action is
irreversible.
50mm
If the user does not intend to submerge this device, nish it to prevent water ingress.
Waterproof Tape

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Fitting length
8 Technical Data
15mm
30mm
450 mm maximum
315 mm minimum
130 mm minimum if the shin is removed
(see section 7.1, step 8a)
Operating and Storage Temperature Range: -15 ˚C to 50 ˚C
(5 ˚F to122 ˚F)
Component Weight (size 26): 1.39kg (3lb)
Activity Level: 1–2
Maximum User Weight: 100kg (220lb)
Build Height: See the diagram below

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AqualimbTT
Size (cm) Part Number — Left Part Number — Right
22 629705L 629706L
23 629707L 629708L
24 629709L 629710L
25 629711L 629712L
26 629713L 629714L
27 629715L 629716L
9 Ordering Information
Replacement Parts
Part Part Number
Alignment Kit 169106
M5x50 Socket Cap Screw 910415

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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 damage caused by component combinations
that were not authorized by the manufacturer.
CE conformity
This product meets the requirements of 93/42/EEC guidelines for medical products. This
product has been classied as a Class I Product according to the classication criteria outlined in
Appendix IX of the guidelines. The Declaration of Conformity was therefore created by Blatchford
Products Limited with sole responsibility according to Appendix VII of the guidelines.
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
Blatchford website for the current full warranty statement.
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK.
Blatchford is a registered trademark of Blatchford Products Limited.