1A200-HD GERY
Instruction Manual
GERY
1A200-HD
1A200-HD GERY
 | GERY – 1A200-HD Instructions for use for Prosthetists/Orthotists Please read before using or working on the device | 1A20099 2021-04 |
Pass on § 3, 7, 8 and 9 of these instructions to the Patient
COMPONENTS INCLUDED
| Designation | Ref. | Included/Sold separately |
| Foot shell | 1A200-xx | Included |
| Malleolar clip | 1D101 | Included |
DESCRIPTION, PROPERTIES, AND MECHANISM OF ACTION
A. Description
A prosthetic foot designed to allow older adult patients to perform their everyday activities, consisting of:
- A core and foot shell that cannot be disassembled
- A malleolar clip
The hole in the lower face of the foot is used to identify the location of the gap between the big toe and the other toes so that a separation can be made if required to allow sandal-type footwear to be worn. To make the cut, use a band saw to saw through to the hole and open up the cut as required.
B. Properties
| Weight (Size 25) | 395 g | |
| Side | Right or Left | |
| Size | 22 to 25 | 26 to 29 |
| Malleolar clip | 1D101-2225 | 1D101-2629 |
| Maximum patient weight (Including carried load) | 150 kg | |
INTENDED USERS/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists/orthotics) who then instruct the patient in how to use it. The prescription is drawn up by a doctor. The doctor works with a prosthetist/orthotist to assess whether the patient is suited to using the device.
This device should be used on ONE PATIENT ONLY. It must not be reused on other patients.
This device is exclusively intended to be used as orthopedic equipment for a below-knee or above-knee amputee whose activity level is low (1) to medium (2).
Maximum weight (including carried load): 150 kg Designed to accommodate a heel height of 0 to 20 mm.CAUTION: the GERY foot is not suitable for bilateral use by double amputees
CLINICAL BENEFITS
The device provides optimal comfort for below-knee and above-knee amputees when they perform their everyday activities.
ACCESSORIES AND COMPATIBILITIES
The foot incorporates a male pyramid link that allows it to be used with female pyramid connectors (refer to our catalog). The heel height can be adjusted from 0 to 20 mm.
ASSEMBLY AND FITTING TO THE PATIENT
A. Assembly and Aligning
Assemble in the normal way, checking that the load line passes 5 to 15 mm in front of the axis of the pyramid and provides a stable upright position for the patient.
The dynamic alignment is performed in accordance with good professional practices.
B. Finishing
Comply with traditional good professional practices in terms of fitting the malleolar clip to cosmetic elements.
DETECTING ANY MALFUNCTIONING
If you notice that the device is behaving abnormally or if its characteristics feel different, or if it has been badly knocked, consult your prosthetist/orthotist.
WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS A. Warnings
Using the foot in a way that goes against the advice given by your prosthetist/orthotist may damage or degrade the foot’s components (e.g. carrying heavy loads, excessive stresses, use after its service life has expired, etc.) The device is only resistant to fresh water and too bad weather conditions and requires compliance with the care instructions specified in §9.A.
B. ContraindicationsThis foot is not intended to be used for activities associated with a risk of significant impact or excessive loading. This foot is not resistant to salt water or chlorinated water.
C. Side effects There are no side effects directly associated with the device. Any serious incident that occurs which relates to the device must be reported to the manufacturer and to the competent authority of the member state in which the incident occurred.
MAINTENANCE, STORAGE, DISPOSAL, AND SERVICE LIFE
A. Maintenance/cleaning
Clean the foot shell with a damp cloth or sponge. All work on the foot should be performed by the prosthetist/orthotist; no other operations, such as lubrication, work on the fastenings or other work, need to be performed. After being used in freshwater or in bad weather conditions
- Rinse the foot with clean water
- Dry thoroughly The malleolar clip may need to be replaced (in the event of wear, loss, etc.)
B. Storage
Service and storage temperature: -20°C to +60°C Relative humidity of the air: no restrictions
C. Disposal
The various components of the foot are considered as special waste: stainless steel, thermoplastic (polyamide, polyethylene), and polyurethane. They must be treated in accordance with current, applicable legislation.
D. Service life
It is advisable to arrange for a prosthetist/orthotist to check the product once a year.
DESCRIPTION OF THE SYMBOLS
| Manufacturer |  |
| Identified risk | |
| CE marking and year of first declaration of conformity | |
REGULATORY INFORMATION
This product is a CE-marked medical device that is certified as conforming with regulation (EU) 2017/745
NAME AND ADDRESS OF MANUFACTURER
PROTEOR SAS
6 rue de la Redoute 21850 Saint-Apollinaire France
Tel.: +33 3 80 78 42 42
Fax: +33 3 80 78 42 15
[email protected]
www.proteor.com
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