Mobilex 311815 Bed Lever User Manual

: June 8, 2024
: Mobilex

Mobilex 311815 Bed Lever

311815 Bed Lever

Introduction

Thank you for buying a high-quality Mobilex product. This user manual contains a description of the medical device and important guidance to ensure a correct and safe usage of the product. It is important prior to use to read this manual carefully. It is especially important to read the safety requirements and follow these.

We continuously develop our products and we reserve the right without further notice to change the specifications and functions of products.

Intended use

The Bed lever provides stable support to aid adult users (taller than 1.46m) transfer in and out of bed, moving from a lying to a sitting position as well as assist user repositioning.

Indications

The Bed lever provides stable support to aid adult users (taller than 1.46m) transfer in and out of bed, moving from a lying to a sitting position as well as assist user repositioning. Designed for use with solid base divan beds and framed beds with fixed slats. Suitable for all bed sizes from single to king- size, it can also be fitted to super king-size beds with additional straps (refer to Accessories & Spares Parts).

Contraindications

The Self-standing support rail is not suitable for patients who cannot maintain their body balance while sitting or standing. The freestanding and height-adjustable support must not be used if the user has perceptual problems.
Contraindications cannot be related to a specific clinical picture and depend on the individual assessment of the potential user’s state of health. The choice of the or thopaedic aid suitable for a particular clinical picture must always be made with the help of a specialist doctor or physiotherapist.

If you have any questions, please contact your dealer or Mobilex A/S.

Mobilex A/S
Grønlandsvej 5
DK-8660 Skanderborg
Denmark| Phone: +45 87 93 22 20
Telefax: +45 87 93 17 77
Email:[email protected]
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Safety requirements

Only use the product in flawless condition.
If defects or errors are detected you must immediately contact the dealer.
Be aware of the information on the product label.
Only use the product for the described purpose.
The device must only be used on stable surface.
To avoid possible entrapment, you must always position the product a minimum of 318mm from the headboard or footboard.
When adjusting the device the user must take care not to squeeze the fingers or other body parts.

Description

Product description

The Bed lever provides stable support to aid adult users transfer in and out of bed.

Parts supplied and mounting instructions

The Bed lever is delivered in a carton with the following contents:

Parts supplied:

✔ 2 E-clips
✔ The bed lever bottom
✔ Handle
✔ Bed straps
✔ This manual
Description

Assembly and installation of the bed lever:

Mounting on a spring mattress/divan bed

Note: We do not recommend fitting this product to a spring mattress unless an appropriate risk assessment has been carried out.

3.1a Remove the mattress and place the Bed Rail Board onto the divan base in the desired position. Ensure that the Hand Rail Guide is positioned downwards over the edge of the divan (see Diag.1).

3.1b Place the Hand Rail into the Hand Rail Guide. Please Note: the hand rail can be rotated so the angled part of the handle is facing tow ards or away from the user, depending on their needs. Secure in position with the two e-clips.
3.1c Position the Bed Rail such that the user can reach the handle from a relaxed lying position without having to stretch. For the safety of the user, this must be at least 318mm away from the headboard or footboard. (see Diag.2).

To secure the Bed Rail to the divan bed with the straps provided, as follows:
3.1d Take the first strap. Place the female buckle through one of the triangular slots near the Hand Rail and tie a secure knot. The buckle should hang down the side of the bed around 50-75mm (2-3 inches) (see Diag.3).
3.1e Feed the strap under the bed-rail board and up through the rear triangular slot , loop it round the end of the bed board and back through the slot (see Diag.3). The strap should be tight under the bed-rail board, and the bed-rail board should not slide on the strap. Diagram 2
3.1f Feed the strap over the top of the bed and back underneath the base (see Diag.3).
3.1g Once the strap is underneath the divan base, bring the male buckle up the side of the bed to meet the female buckle hanging down.
3.1h Clip the two ends of the strap together.
3.1i Pull down on the loose end of the strap to tighten. The Bed lever Base should be tight against the divan base. Tuck the loose end of the straps under the bed to prevent tripping.
3.1j Repeat for the second strap, fitting to the other side of the Bed lever Board. The Bed Rail should now be fully secured to the divan base ( see Diag.3). Diagram 3
3.1k Replace the mattress. Check the Bed Rail is stable and secure before use.

Assembly instructions – Slatted mattress with fixed slats:

3.2a Remove the mattress and place the Bed lever Board inside the wooden bed frame. Ensure that the Hand Rail Guide is positioned upwards (see Diag.4).
Description
3.2b Place the Hand Rail into the Hand Rail Guide. Please Note, the hand rail can be installed so the angled part of the handle is facing towards or away from the user, depending on their needs. Secure in position with the two e-clips (see Diag.4).

3.2c Position the Bed Rail such that the user can reach the handle from a relaxed lying position without having to stretch. For the safety of the user, this must be at least 318mm away from the headboard or footboard. Secure the Bed Rail to the bed with the straps provided:
3.2d Thread one end of the strap (with female buckle) from under the bed up around the bed slat, through the triangular slot on side of the Bed lever Board and back under the bed past the slat (see Diag.6).
3.2e Repeat step 3.2d using the other end of the strap (with male buckle) through the opposite triangular slot on other side of the Bed lever board (see Diag.6).
3.2f Pull both buckles so they meet in the middle on the underside of the bed and clip together (see Diag. 5). Pull the loose end of the strap to tighten. Tuck away any loose strap ends to prevent tripping.
3.2g Repeat the procedure for the second strap at the bottom of the Bed lever Board (see Diag.7).
3.2h Replace the mattress. Check the rail is stable and secure before use.
Description

Installation Instructions – Slatted Bed with loose slats:

For beds where the slats are not individually secured to the bed frame, do not use the fixing straps.
3.3a Assemble the Bed Rail as shown in Diagram 4 above.
3.3b To provide additional security, we recommend placing a non-slip mat between the Bed Rail and the slats (see back page for details).
3.3c Replace the mattress. Check
Description

Accessories

No accessories for this product.

For transport, the handle can be removed to reduce the size.

Technical Data:

Bed lever

| 311815
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Dimension (WxDxH) (mm)

|

335/625/547

Weight (Kg)|

3.30

Max. Load user (kg)

| 150
Max. Load (kg) (kg)|

100

Product label

The product label is located on main frame

Image of the product label shower stool 311815

| QR~code link to homepage
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| Manufacturer

Care & Maintenance

Normal dirt on metal and plastic parts can be removed with standard cleaning agents. Check the specific product information and use only commercial cleaning products which are suitable for cleaning and disinfection (no solvents or abrasives).Despite the solid construction and the use of resistant materials the product is subject to wear. It is therefore recommended to let check the product at regular intervals by a professional.

The device basically does not need maintenance. Despite the solid construction and the use of resistant materials the product is subject to wear. It is therefore recommended to check the product at regular intervals by a professional service. We recommend the following to be checked:

✔ Cleaning and disinfection of the product
✔ Frame/product should be checked if it has been bent, damaged, worn or corroded
✔ Wear parts are checked and replaced if necessary

Changing the Bedding

If required, the Hand Rail may be removed from the Bed Rail Base when changing the bedding. Simply remove the two e-clips and remove the Hand Rail. To replace, re-fit and replace the e-clips (see section 3.1b or 3.2b).

Recommended service life: Normally 10 years depending on use.

Storage

We recommend storage in a dry place.

Reuse

The product is suitable for reuse. Before reusing, where a new user is to take over the product, the product must be checked according to point 5.

Most common problems and solutions

Symptoms

| possible cause| what to do?
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The bed support is loose

| Tension straps are not tight enough|

Tighten the straps

Disposal of the product

The device cannot be deposited with normal garbage. It must be delivered to the public station for re-use.

Guarantee terms

Mobilex A/S offers 2 years of warranty for damages caused by errors in production or material errors. The warranty is not valid by not-intended repair or usage of the product. Parts subject to normal wear are not covered by the warranty, unless wear is caused by a manufacturing fault. If product changes are made without our written acceptance the CE-marking and product warranty will not be valid. In the event of product damages covered by this warranty, please notify your dealer or Mobilex A/S directly. The warranty does not cover transport costs and does not include compensation for personal injuries or non-use of the product during repair. The warranty does not cover damages due to the user manual not being followed.

Declaration of Conformity (CE)

Mobilex A/S, Grønlandsvej 5, DK-8660 Skanderbeg, Denmark, SRN: DK- MF-000021885

Hereby declare under our sole responsibility as a legal manufacturer that the product specified on the product list below, meet the essential health and safety requirements and is in conformance with the provisions of the Regulation (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices.

The product specified on the product list below is “technical aid for the disabled”, classified as Class I, medical device. The classification is based on the requirements of Rule 1 of annex VIII, of the Regulation (EU) 2017/745.

The CE marking has been affixed on the product according to Annex V of the Regulation (EU) 2017/745.

PRODUCT LIST

BED Lever:

REF / item no	311815
UDI-DI	5740001403893
BASIC-UDI-DI	57400014BEDLEVERCZ

ACCESSORIES LIST

Item nr.	Accessories item nr
311815	No

In case of unintended incidents or suspected faults, failures or defects of the product, the dealer or Mobilex A/S must be contacted

EU2017/745 for Medical Equipment

Harmonized norms used during conformity estimation:
PN-EN 12182:2012, EN581-2:2015, EN 1022:2005, PN-EN 60601-2-52: 2010, PN-EN ISO 14971:2012, PN-EN 1041:2009

homas Nygaard Christensen
Skanderborg, 18-05-2022
Signature

During the development of the Bed lever, the focus was placed on ergonomics to make it easier for user to stand up from the bed.
The handle can be easily turned
The width of the product can be easily asembled with clips and without tools. The pin of the clips is made of stainless steel
The welded aluminium construction provides a lightweight and stable frame for safe use.

311815 Bed Lever