ottobock 17KL19 Duchenne Bow Kit Instruction Manual
- June 3, 2024
- ottobock
Table of Contents
ottobock 17KL19 Duchenne Bow Kit
Foreword
Date of last update: 2021-07-14
- Please read this document carefully before using the product and observe the safety notices.
- Instruct the user in the safe use of the product.
- Please contact the manufacturer if you have questions about the product or in case of problems.
- Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
- Please keep this document for your records.
These instructions for use provide you with important information on the use of the 17KL19=2 Duchenne bow kit and 17KL19=3, 17KL19=5 Chailey bow kits.
Product description
Available sizes
To ensure proper product function, only use the product with the components specified in this section.
Article number| Size| Can be combined
with
---|---|---
17KL19=2| 13 mm
16 mm
20 mm
| 17KL40=13,
17KL40=13-A
17KL40=16,
17KL40=16-A
17KL40=20,
17KL40=20-A
17KL19=3| 16 mm| 17KL6=16-A
17KL6=16-CS
Article number| Size| Can be combined
with
---|---|---
17KL19=5| 13 mm| 17KL6=13-A
17KL6=13-CS
Components/design
*17KL19 (see Fig. 1, see Fig. 2)**
Item| Quantity| Designation| Service sets
1| 1| Washer| 17KL19=2
17KL19=3
17KL19=5
2| 1| Bow
3| 1| Bearing bushing
4| 1| Red washer
5| 1| Joint screw
Intended use
Indications for use
The product is intended exclusively for orthotic fittings of the lower limbs. Only use the product in pairs.
Indications
- Partial or total paralysis of the leg muscles.
- Orthopaedic diseases of the lower limbs Indications must be determined by the physician.
Restrictions for use
The product is not suited for use with heavy stress, such as sports,
gardening or lifting/carrying heavy items, which result in greater physical
exertion.
Lifetime
The product is designed for a lifetime of 3 years when used as intended and
assembled professionally.
Qualification
Patients may be fitted with the product only by trained qualified personnel.
The qualified personnel must be familiar with the handling of the various
techniques, materials, machines and tools.
Safety
Explanation of warning symbols
- Warning regarding possible risks of accident or injury.
- Warning regarding possible technical damage.
Safety instructions
- Only use the product for the defined area of application.
- If the product has been exposed to extreme strain (e.g. due to falling), take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.)
CAUTION
- Use the product on only one patient.
- Observe the maintenance recommendations.
NOTICE
- Do not carry out any heat treatment on aluminium at temperatures above 150 °C.
- Do not carry out any heat treatment on steel or stainless steel at temperatures above 300 °C.
- Do not carry out any heat treatment on titanium.
- Prior to thermal treatment, remove all temperature-critical components (such as plastic parts).
NOTICE
- Avoid storage in condensing ambient humidity.
- Avoid contact with abrasive substances (e.g. sand, dust).
- Do not expose the product to temperatures below -10 °C (14 °F) or above +60 °C (140 °F) (e.g. sauna, excessive sunlight, drying on a radiator).
Preparing the product for use
Incorrect alignment, assembly or adjustment
Risk of injury due to change in or loss of functionality
- Assembly, adjustment and maintenance operations may only be completed by qualified personnel.
- Observe the alignment, assembly and adjustment instructions.
Protect the product against environmental influences
- The steel that is used can rust. Apply a cover or paint to the product for extra protection before handing it over to the patient.
Locking mechanism
- Do not adjust the locking mechanism or the orthotic joint. Bending bars
- Align the bars with the bending irons without exposing the joint heads to any bending load.
Installing mounting materials
- Install the mounting materials.
INFORMATION: Make sure that the mounting materials do not obstruct the locking mechanism.
Assembling the kit
- Place the red washer on the bearing bushing.
- Guide the joint screw through the bearing bushing.
- Guide the joint screw with the bearing bushing through the bow and the washer and attach it to the orthotic joint.
- Bend the bows.
- Connect the bows to each other, ensuring that the two orthotic joints are aligned parallel to one another.
- Check the locking function and adjust if necessary.
Final assembly of orthosis joint
- Use the 633F7 special lubricant to grease the metal.
- Clean the threads of the screw connections using a degreasing cleaner and secure them with Loctite 241.
INFORMATION
Delivery of finished orthosis to the patient
Prior to delivery of the orthosis to the patient, the fit, support and all
functions must be tested.
Pay attention to the parallel alignment of the orthosis joints.
Check the locking mechanism and instruct the patient in handling the lock and
the product.
Patient information
Inform the patient:
Verify lock functionality
- Before standing up, check that both locks are engaged. Carry out a function test.
- Inspect the orthosis for damage daily, paying special attention to the locks and bars. Contact the qualified personnel promptly if changes are noted.
Cleaning
Promptly clean the product after contact with water containing salt, chlorine or soap, or if it gets dirty.
- Rinse the product with clear fresh water.
- Dry the product with a cloth or allow it to air dry. Avoid exposure to direct heat (e. g. from an oven or radiator).
Maintenance
The product may be exposed to increased loads by the patient.
- Shorten the maintenance intervals according to the expected loads. The manufacturer requires an inspection of the product every 6 months to verify functionality and check for wear at a minimum. A service kit can be ordered for product maintenance. Spare parts are listed in the section “Components/design”. Only use 633F7 special lubricant. Before handing the orthosis over to the patient, secure all screw connections with Loctite 241. If you have any doubts, please contact the manufacturer.
Disposal
Dispose of the product in accordance with national regulations.
Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
Liability
The manufacturer will only assume liability if the product is used in
accordance with the descriptions and instructions provided in this document.
The manufacturer will not assume liability for damage caused by disregarding
the information in this document, particularly due to improper use or
unauthorised modification of the product.
CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical
devices. The CE declaration of conformity can be downloaded from the
manufacturer’s website.
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>