Product fields

Field Name

Field content and typ

Explanation

Product Name

Name in free text, built up over the levels of the Classification Code (See field 3).

Unique name of the product type as described in this record.

Drawings

One or more drawings

The Nomenclature is using mainly drawings from AOPA

Record Identifier

Unique numerical code for a record

Not relevant for users of the Nomenclature; only relevant for communication and database management.

Classification

Classification code with corresponding name. The code consists out of 12 digits, structured as 6 levels by 2 digits per level, subdivided by dots, e.g. 12.34.56.78.90.12

Hierarchical classification of prostheses and orthoses, based on

• EN-ISO9999 for the three upper levels
• up to three additional levels as subdivision based on the function and intended use of the device, derived from ISO-standards or other relevant classifications.

Description

Free text

Description of the device, containing information on design. technical construction, different variations and materials.

Production

Table production type

Characterisation of the production of the device based on the EU-MDD manufacturer's responsibilities.

1. Prefabricated (ready to use or adjustable)

See under terms and definitions.

2. Custom made

See under: terms and definitions

Usage

Table usage

The duration/period of the use of the device by the user.

1. Permanently

No particular restriction on the period of use.

2. Temporary for treatment

Use over a restricted period to support healing or rehabilitation. There is no exact timeline, and this depends of the impairment, illness and healing process.

3. Permanently and temporary

Can be either for permanent or for temporary use

4. Other

Used for any period, e.g. as interim device until the definitive device is available.

Process steps and actions

Table process steps and actions

Listing of different steps and actions to be executed by the supplier for delivery and support of use. Is it a qualitative table which may be used as basis for quantification. See also Terms and definitions under Process steps and actions.

1. Intake and client/patient's problems in functioning

First contact with client to catch the needs including registration and collection of basic administrative data

2. Prosthetic/orthotic assessment of functioning

See Terms and definitions under Assessment, Orthotic assessment and Prosthetic assessment.

3. (Gait)analysis

Analysis of patient/client's activities able to execute without the device e.g. gait analysis

4. Selection of device from Nomenclature

The INTERBOR Nomenclature© includes all orthoses and prostheses. The selection of the device is according to the terminology of the INTERBOR Nomenclature©.

5. Conception/design of the entire device

Design and composition of the complete intended device. See also Terms and definitions under Orthosis Composition and Prosthesis definition.

6. Measurement and casting/scanning

See Terms and definitions under (Orthotic and Prosthetic) Casting and measurement.

7. Modification and tracing of cast/scan

See Terms and definitions under Tracing modification.

8. Selection of device from catalogue (prefab)

For prefabricated devices commercial catalogues can be consulted for selection and ordering of the device or components.

10. Bench assembly and alignment

See Terms and definitions under Bench assembly and alignment.

11. Fitting, static and dynamic alignment

See Terms and definitions under Alignment, Alignment of a skeletal segment, Alignment of the trunk, Bench assembly and Alignment.

12. Adjustments and functional additions

Devices need adjustments at workshop level to achieve correct functioning with the patient/client.

13. Finishing

See Terms and definitions under Finishing.

15. Check-out, delivery, user instruction (usage, warranty, maintenance)

Delivery of the product to the user including completion of (administrative) procedures to the medical team and the reimbursement procedure. See also Terms and definitions under Checkout.

16. Service and maintenance scheme

Regular service and maintenance as a straight-on consequence of the supply of the device. Includes regular maintenance to avoid unexpected repair and to increase the period of life of the device.

17. Evaluation of patient/client's device

Scheduled regular reviews and controls of the device, immediately connected to a changing disease or impairment. e.g. instability or progressing or decreasing illnesses, therapy or treatment. Excludes changes of the device as far as not regular adjustments for which the device is intended.

18. Prosthetic or orthotic assessment during use of device

Scheduled and unscheduled reviews and controls of the patient/client while using the device with assessment of the intended use of the device as formulated earlier.

19. Adjustments, functional updates

Following scheduled or unscheduled controls reviews and (items 17 and 18) adjustments or functional updates could be considered necessary, depending on the individual changes as well as the intended use of the device.

20. Unexpected repair and adjustments and modifications

Repair of the device after damage or lost of the function of it, due to an unexpected accident, insufficient maintenance or inadequate usage by the user.

22. Keeping in store raw material, components and prefab devices

Materials necessary for the production of (mainly) custom fabricated devices. Also in other types of production raw material can be used.

23. Product responsibility (custom made/prefab)

Prefabricated devices and custom made devices may have other responsibilities for the supplier.

25. Basic business obligations

E.g administration and bookkeeping, business recognition, necessary certification of company or staff.

26. Respecting privacy and patient's dignity and human rights

Approach and communicate clients considering international and national legislation on human rights, provision of health care and market client ship.

28. Maintaining a patient/client dossier

Make and maintain a paper or digital dossier of all activities regarding the patient/client, also considering international and national legislation.

29. Other duties

Other activities and duties as well as conditions and infrastructure necessary for the supplier of the device.

User characteristics (text)

Free text description based of the ICF codes used in 11.

Characteristics of the user.
Includes the indication for which the device is intended (only examples and non exhaustive). Also diseases and impairments are listed, as well relevant characteristics such as life style and general health status as far as relevant.

User characteristics (ICF codes)

Table of impairments of body functions and structures and restrictions of activities, extracted from ICF (only examples and non exhaustive). Based on:

• b-codes: impairments of body functions
• s-codes: impairments of body structures.

Characteristics of the user.
Includes the indication for which the device is intended in ICF-codes (examples and non exhaustive).
For full listing, see separate entry: user characteristics based on ICF.

Intended use device (text)

Free text description of the ICF codes used in 14.

The intended use of the device.
E.g. relief of impairment, supporting activities or enabling particular participation seen from the perspective of the user.
In case of lower limb prostheses, it is based on mobility profiles of types of lower limb prostheses (see separate table mobility levels of lower limb prostheses).

Intended use device (ICF codes)

Table of body functions and structures, activities and participation areas extracted from ICF (examples and non exhaustive) as well as clinical objectives for orthoses from ISO8551.
The field is a combination of the three sub fields:

1. body functions and structures from ICF (examples and non exhaustive). It contains:

• b-codes: relief of body functions;
• s-codes: relief of body structures;

2. clinical objectives of orthoses from ISO8551. It contains:

• 1a. to prevent deformities in alignment;
• 1b. to reduce deformities in alignment;
• 1c. to stabilise deformities;
• 2a. To limit range of motion of joint(s);
• 2b. To increase range of motion of joint(s);
• 3. To add to length of segment(s);
• 4. To improve shape of segment(s);
• 5a. To compensate for weak muscle activity;
• 5b. To control the effect of muscle hyperactivity;
• 6. To reduce or redistribute load on tissue;
• 7. To promote healing;
• 8. To provide effects like warmth and postural feed back.

3. activities and participation areas from ICF (examples and non exhaustive). It contains:

• d-codes: activities and participation areas.

Indicating the intended use of the device for the user from the perspective of the user in ICF- and ISO-codes.
For full listing, see separate entrance: intended use device based on ICF.

Related terms

Free text

Synonyms or similar devices as described in the record; also are sometimes national names of the device listed.

Comments

Free text

Any relevant comment.