Nabtesco N-D231 Instruction Manual

Dual Connector N-D231
Instruction Manual
1. Information
This product must be assembled by a certified prosthetist. 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.
2. Purpose of use and product overview
This product is a connector for adjusting the prosthesis length and rotation angle
of trans-femoral prosthesis, hip disarticulation prosthesis and trans-tibial
prosthesis. It is for everyday life and can be used multiple times by one user.
The connection with other prosthetic limb parts is a combination with a male
pyramid on the upper side and lower side. You can adjust the angle of the sagittal
plane and frontal plane of the prosthesis.
3. Product Specifications
・Maximum body weight: 100 kg (ISO10328-P5-100kg)
・K Level (MOB): K1 Level (MOB1) ~ K3 Level (MOB3)
・Expected lifetime: 3 years
 Applicable environmental conditions
・Storage temperature range: -20°C to +60°C (-4°F to +140°F)
・Operating temperature range: -10°C to +40°C
・Chemicals/liquids: Water or liquid (salt water ,sweat, urine) splash
 Prohibited environmental conditions
・Usage environment: Underwater (in liquid)
・Chemicals/liquids: Hydrochloric acid, sulfuric acid
4. Safety
Explanation of warning symbols
Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided,
could result in minor or moderate injury.
Indicates actions that you must not do when handling the product.
Strictly observe the following instructions to use the product safely.
● Tighten each of the set screws with the designated torque.
＊ If the torque used to tighten the screws is less than the
designated amount, the set screws could become loose and
fall out during use.
● Adjust the alignment according to the instructions of the
connected device.
● DO NOT use for a person who weighs over 100 kg (220 lb).
● DO NOT modify the products such as changing the
maximum length (75 mm).
＊Failure to observe the prohibitions could result in damage to
the products and user injury.
● Do not leave or use the product in an environment not
applicable.
● If there is any abnormality such as damage, abnormal noise,
or backlash, discontinue use and take appropriate measures.
(Contact the manufacturer or specialist workshop)
● Do not use the product beyond its useful lifetime.
5. How to use
The length of this connector is adjustable in the range from 60 mm to 75 mm. The
rotational direction can be adjusted as well.
(It changes length 0.5 mm by 90°rotation.)
After adjusting the angle of alignment, tighten the pyramid set screws.
After adjusting the connector length and rotation angle, tighten the hexagon socket
head bolt.
81-SS00024_EN (Ver. 2)
Date of issue: 2022-03-18
Language: English 5.1. How to fix the rotation angle fixing screw and the female pyramid fixing screw
5.2. Cleaning
5.3. Maintenance
5.4. Disposal
6. Warranty
7. Technical data
Manufacturer
Authorized representative for EU countries
Apply an appropriate amount of adhesive (LOCTITE 243 equivalent) to the threads
and tighten with the specified torque.
(1) M5 Hexagon socket head bolt: 1 piece
Tightening torque: 9±0.3 N･m (92±3 kgf･cm)
(2) M8 Set screw: 8 pieces
Tightening torque: 10±0.5 N･m (102±5 kgf･cm)
＊Connector limitation bolt (on inside) must not be removed.
2
1
● Tighten each of the set screws or hexagon socket head bolt
with the designated torque by a torque wrench.
＊ If the torque used to tighten the screws is less than the
designated amount, the set screws could become loose and
fall out during use.
＊If the torque used to tighten the screws is more than the
designated amount, which could break the connector during
use.
● Apply the adhesive (equivalent to LOCTITE 243) on the
thread part for anti-loosening of each screw, and tighten by
a specified torque.
＊Without using adhesive, the set screws could become loose
and fall out during use.
If necessary, wipe the surface with a soft cloth moistened with fresh water.
For safety, carry out regular inspections once a year for loose screws or abnormalities.
This product is made of titanium alloy and stainless alloy. Observe the information
provided by the responsible authorities in your country regarding disposal procedures.
● The warranty for this dual connector is valid for a period of one year from the date
of purchase.
● Note that if the connector is broken or damaged due to improper use the warranty
may become void even if it happens during the warranty period.
● Please note that we cannot guarantee if the product is malfunction or damaged due
to use outside the range shown in this manual.
● Weight: 170 g
● Overall height: 60 - 75 mm
● Adjustment range: 15 mm
This device complies with the European Medical Device Regulation (EU) 2017/745.
Nabtesco Corporation
Accessibility Innovations Company
Assistive Products Department
35, Uozakihama-machi, Higashinada-ku Kobe 658-0024, Japan
Phone: +81-78-413-2724 Fax: +81-78-413-2725
URL: https://welfare.nabtesco.com
PROTEOR SAS
6 rue de la Redoute
21850 Saint-Apollinaire, France
Phone: +33 3 80 78 42 42 Fax: +33 3 80 78 42 15
cs@proteor.com
75
60