Lindhe Xtend AB
Olofsdalsvägen 40 A, 302 41 Halmstad, Sweden
[email protected]
Phone: +46 (0)35 262 92 00
www.lindhextend.com
SIZE AND WEIGHT GUIDE
The maximum weight for Xtend Connect is 330 lbs/150 kg.
The max weight is limited to 220 lbs / 100 kg for patients who do high-intensive sports activities.
Always check that the patient’s weight is correct. The maximum weight may never be exceeded.
INTENDED USE:
XTEND CONNECT is a prosthetic component intended for use by above-knee or lower leg amputees who want to
remove or change prosthetic parts.
XTEND CONNECT is designed to be fitted between two prosthetic parts in a prosthetic leg and designed to fit
standard connections according to common industry practice.
PATIENT INDICATIONS
The PATIENT is physically disabled and the disability can vary from amputation of a lower limb to hip amputation.
Double amputees can also use the product.
More specifically, the product is suitable for the following types of applications:
Patients who want to switch between different prosthetic feet depending on the type of activity.
For example, a sports foot and everyday foot.
Above-knee amputees who want to switch between different prosthetic knees depending on the activity.
For example, a waterproof prosthetic and everyday knee.
Patients who want to switch between indoor and outdoor prosthetics.
Patients who find changing or taking off their shoes difficult and time-consuming.
Patients who wear tight pants and find it difficult to put them on over rigid prosthetic feet.
Patients who find it difficult to get in and out of cramped vehicles and need to remove parts of their prosthesis
to sit comfortably during the journey.
CONTRAINDICATIONS
The product is unsuitable for the following types of applications:
Patients who weigh over 330 lbs/150 kg cannot use Xtend Connect.
The permitted maximum weight is 330 lbs/150 kg.
Patients with a diagnosis of dementia, e.g. Alzheimer’s, should not use Xtend Connect.
Patients who lift heavy weights and weigh around 330 lbs/150 kg should not use Xtend Connect.
The permitted max. weight incl. external load is 330 lbs/150 kg.
The product is not suitable for patients who do extreme sports.
The product is not suitable for patients exceeding 220 lbs / 100 kg who do high-intensive sports activities.
XTEND
®
CONNECT AND ITS DIFFERENT COMPONENTS
Xtend Connect consists of two components:
Quick fit unit – can be opened and closed with the aid of a locking wheel and a safety push-button
Base unit – fits into the quick fit unit.
A) Locking wheel
B) Safety push-button
C) Base unit
D) Quick fit unit
Closed and locked position.
Open and divided position.
B
A
A
C
D
D
C
Item number
Description
The parts are sold separately.
Quick fit units
A100-Q30-150
Xtend Connect quick fit unit with tube clamp for 30 mm tube
A100-Q4-150
Xtend Connect quick fit unit with 4-hole adapter
A100-QF-150
Xtend Connect quick fit unit with female pyramid adapter
A100-QP-150
Xtend Connect Quick fit unit with M36 Prong adapter
Base units
A100-BF-150
Xtend Connect base unit with female pyramid adapter
A100-BM-150
Xtend Connect base unit with male pyramid adapter
GENERAL INSTRUCTIONS:
Review the care, safety and patient instructions with the patient at the time of fitting the product. The patient
must be given the special folder for patient guidance.
Get the patient to practice connecting and removing Xtend Connect several times until he/she has mastered
the process. This is extremely important to ensure that product satisfaction is high.
It is VERY IMPORTANT that the patient is seated while removing and connecting Xtend Connect. The patient
may NEVER stand while connecting and removing Xtend Connect.
Under no circumstances may the patient walk on Xtend Connect if it is not correctly locked. This can cause the
patient to fall and get injured.
Only authorized prosthetist may test the product on patients.
Xtend Connect can be fitted on a number of different connecting parts and in a number of different configura-
tions. Consider carefully how it will be used before ordering.
Before ordering components, it is important to have analyzed whether the patient is suited to using this type
of quick fit connector and if he/she is able to follow the instructions.
Before mounting the Xtend Connect on the patient, assure that the joining components fits well to the inter-
faces of the Xtend Connect. Test-lock the complete unit mounted on the prosthetic leg before fitting it to the
patient. Only external components using industry standard may be used.
All adverse events that occurs and are related to this product should be reported to the manufacturer and the
local authority in the country of occurred event.
After finished life cycle, the product shall be disposed in metal recycling.
INSTALLATION
Only trained personnel such as an prosthetist may install, carry out maintenance on and fit the product on pa-
tients/users.
Xtend Connect can be fitted with the quick fit unit facing upwards and the base unit facing downwards, as well as
vice versa. It is the connecting components in the prosthetic leg that determine which is most suitable.
Remember that right-handed people will want the locking wheel on their right and left-handers vice versa.
WHAT YOU NEED FOR INSTALLATION
Torque wrench 4 mm Allen key
Thread locker e.g. Loctite 243
Thread locker e.g. Loctite 275
INSTALLATION OF TUBE COUPLING
Tightening torque
Thread locker
Clamp screw
7 Nm
E.g. Loctite 243
Make sure the tube goes all the way into Xtend Connect. Xtend Connect is
designed to fit flush with the tube. For this reason, it may sometimes be
necessary to grind the tube so the parts fit. When the tube is all the way in and
everything is stable, tighten the clamp screw with the torque wrench.
When everything has been installed, use Loctite to lock the screw. This must be
done before the patient leaves the clinic.
INSTALLATION OF 4 HOLE ADAPTER
Tightening torque
Thread locker
Adjusting screws
–
E.g. Loctite 243
Tighten all the four screws. When the installation is ready, use Loctite to secure
all four screws. This must be done before the patient leaves the workshop.
It is possible to order different length of the screws from Lindhe Xtend if this
should be required.
INSTALLATION OF FEMALE PYRAMID
Tightening torque
Thread locker
Adjusting screws
15 Nm
E.g. Loctite 243
Tighten the adjustment screws using the torque wrench once you have tested
the product on the patient.
When everything has been installed, use Loctite to lock each screw one at a time.
This must be done before the patient leaves the clinic.
Lindhe Xtend Inc.
The Nexus Stuart, 850 NW Federal Highway,
Suite 208 & 209, Stuart, FL 34994, USA
E-mail: [email protected]
Phone: 888-454-7054
Instructions For Use, IFU
Prosthetists
Xtend
®
Connect A100
Document ID:
IFUUS-
A100-150_r
ev03 2021-11-01
