Medacta AMIS SHOE User manual

Ref: 75.09.100 rev. 01–M09.06.001 Rev.3
Strada Regina
CH - 6874 Castel San Pietro - Switzerland
Phone [phone] - Fax [phone]
[e-mail] –www.medacta.com
Ref:99.15.0315rev. 04
Manufactured by:
Medacta International SA
CH-6874 Castel San Pietro - Switzerland
AMIS SHOE
CAUTION
For a U.S. specific package insert, please go to www.medacta.com or call toll free 800-901-7836.
SYMBOLS / SIMBOLI / PICTOGRAMMES / PIKTOGRAMME / PICTOGRAMAS / PICTOGRAMAS / PICTOGRAMMES /
ΕΙΚΟΝΟΣΎΜΒΟΛΑ
Consult instructions for use / Consultare le istruzioni di utilizzo / Gebruiksaanwijzing / Bitte lesen Sie die Gebrauchsanweisung / Consulte las Instrucciones
antes de su uso / Consulte as instrucções de uso / Consultez les instructions d’utilisation / Οδηγίες χρήσης
Store in a dry place / Conservare in luogo asciutto / Droog bewaren / Trocken aufbewahren / Conservar en lugar seco / Conserv ar em local seco / Conserver au
sec / Φυλάσσετε σε ξηρό χώρο
Lot number / Numero di lotto / Nummer van de partij / Waren-Lot-Nummer / Número de lote / Número de lote / Numéro de lot / Αριθμός παρτίδας
Reference number / Riferimento commerciale / Handelsreferentie / Referenznummer / Numero de Referencia / Referência comercial / Référence commerciale
/ Νούμερο παραπομπής
Manufacturer / Produttore / Fabrikant / Hersteller / Fabricante / Fabricante / Fabricant / Κατασκευαστής

Ref: 75.09.100 rev. 01–M09.06.001 Rev.3
Index
ENGLISH: AMIS SHOE - INSTRUCTIONS FOR USE............................................................................................................... 3

ENGLISH
English –3DMETAL TIBIA CONES ANDFEMORAL CONES - INSTRUCTIONS FOR USE - Ref: 75.09.100 rev. 01–M09.06.001 Rev.3 3
ENGLISH: AMIS SHOE - INSTRUCTIONS FOR USE
1. GENERAL
Before any THA surgery, the surgeon must be familiar with the AMIS operative technique.
2. AMIS SHOE INTENDED USE
The AMIS shoe is a reusable device that must be used only with the AMIS mobile leg positioner for a stable patient
positioning during Hip Arthroscopic procedures. All structures of the AMIS shoe (reference 01.15.10.0315) shown
below, are part of quoted reference.
3. AMIS SHOE DESCRIPTION
NOTE: The decision of when to use the small foot adaptor is up to the surgeon. While doing it, please consider the
dimensions of the small foot adaptor:
I. 76 mm in the calf area
II. 78mm in the heel area
III. 83 mm in the foot area, near the toes
Padded foot holder
Tibial strap
Fixation buckles
Foot strap
Black plunger
Small foot adaptor

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English –3DMETAL TIBIA CONES ANDFEMORAL CONES - INSTRUCTIONS FOR USE - Ref: 75.09.100 rev. 01–M09.06.001 Rev.3 4
4. WARNINGS AND PRECAUTIONS
The success of the operation depends on compliance with the operative technique supplied, and the proper use of
the instrumentation supplied.
For THA procedures, please refer to the dedicated AMIS surgical technique.
When preparing the Patient’s foot it’s important not to overtighten the fixation buckle fo the AMIS shoe to avoid
excessive pressure on the patient’s foot (see AMIS SHOE ASSEMBLY paragraph).
5. SURGICAL TECHNIQUE
For THA procedures, the surgeon should be fully familiar with the AMIS surgical technique. Please refer to the AMIS
surgical Technique for supplementary information.
6. INSTRUCTIONS FOR USE
AMIS SHOE ASSEMBLY
STEP 0
Bolster the foot appropriately before
placing it into the AMIS shoe (the image
on the right is an example of how to
bolster the foot).
OPTION FOR SMALL FOOT: ASSEMBLY
WITH ADAPTOR
When the Small foot adaptor is deemed
necessary, simply insert it into the AMIS
shoe (2) and proceed as described in STEPS
1- 4.
1
2

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English –3DMETAL TIBIA CONES ANDFEMORAL CONES - INSTRUCTIONS FOR USE - Ref: 75.09.100 rev. 01–M09.06.001 Rev.3 5
CAUTION:
Correctly position the Small Foot Adaptor by
placing the part with a small foot printed on
it, internally and externally(3) (4), in contact
with the patient’s sole of the foot.
Additionally, check that the longer part of the
Small Foot Adaptor is facing upwards (2) .
STEP 1
Insert the bolstered foot into the AMIS shoe.
The patients heel needs to be in contact with
the AMIS shoe.
Fix-it by fastening the Fixation buckle:
Introduce the strap into the buckle(6)(7).
Repeat the procedure for both the Fixation
buckles (8).
To tighten it, pull the buckle as shown in
picture (9). The padded foot holder should be
centered in order to apply an equal pressure
all over the foot. If necessary adjust it with
the Fixation buckles on both sides (10).
WARNING: do not overtighten the fixation
buckle to avoid excessive pressure on the
patient’s foot.
4
3
10
0
8
7
5
9
6

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English –3DMETAL TIBIA CONES ANDFEMORAL CONES - INSTRUCTIONS FOR USE - Ref: 75.09.100 rev. 01–M09.06.001 Rev.3 6
STEP 2
At this time, the Foot strap can be
tightened, as shown in pictures
(11)(1)(13)(14).
Note: the stability of the foot is not
influenced by this strap. Do not
overtighten it.
STEP 3
At this time, the Tibial strap can be
tightened, as shown in pictures
(15)(16)(17).
11
12
13
14
16
17
15

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English –3DMETAL TIBIA CONES ANDFEMORAL CONES - INSTRUCTIONS FOR USE - Ref: 75.09.100 rev. 01–M09.06.001 Rev.3 7
Note: the stability of the foot is not
influenced by this strap. Do not
overtighten it.
At this time check that the foot is stable
but without excessive pressure applied on
it. A finger should easily pass between the
foot and the shoe at malleolus level (18).
To reach the perfect stability
apply/release the pressure through the
Fixation buckles.
The foot is now fixed to the AMIS shoe.
STEP 4
Slide the shoe onto the traction arm of the
AMIS Mobile Leg Positioner (20) and lock
the system with the black plunger21).
To check the stability of the foot inside the
AMIS shoe, apply some traction with the
AMIS Mobile Leg Positioner and check
that the heel does not move.
19
18
20
21
23

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English –3DMETAL TIBIA CONES ANDFEMORAL CONES - INSTRUCTIONS FOR USE - Ref: 75.09.100 rev. 01–M09.06.001 Rev.3 8
7. AMIS SHOE DISASSEMBLY AND CLEANING
When the surgery is finished, the AMIS shoe must be disassembled from the AMIS Mobile Leg Positioner BEFORE
disassembling the Leg Positioner from the operating table (24) (25). Simply Unlock the black plunger and remove the
AMIS shoe from the traction arm of the AMIS leg. Positioner.
STEP 1
Remove the Tibial and the Foot
straps as shown in the pictures
(26) (27) (28) (29) (30).
24
25
26
27
29
2
8
28

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English –3DMETAL TIBIA CONES ANDFEMORAL CONES - INSTRUCTIONS FOR USE - Ref: 75.09.100 rev. 01–M09.06.001 Rev.3 9
Step 2
Release the Fixation buckle by
pressing on its overhang, as
shown in the picture (31) (32).
8. STORAGE
After removing the AMIS shoe from the patient’s foot, store it with the Small Foot adaptor to avoid losing it (33).
Follow the general rules for cleaning operating tables.
NOTE: Do not autoclave the AMIS shoe (Ref. 01.15.10.0315).
Last update: January 2020
32
31
33
30

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