molift BM41099 RgoSling Shadow User Manual

: July 22, 2024
: molift

Table of Contents

molift BM41099 RgoSling Shadow
General
Device description
Introduction
Safety information
Troubleshooting
Service, cleaning and maintenance
Handling
Information

molift BM41099 RgoSling Shadow

Specifications

Product Name: Molift RgoSling Shadow
Model Number: BM41099
Revision: 3.0
Website: www.etac.com

Product Information
The Molift RgoSling Shadow is a lifting sling designed to assist with sitting and lying applications for individuals who need support during transfers. It is suitable for use in various languages as indicated in the manual.

Usage Instructions

Handling:
Ensure the sling is correctly positioned under the individual before lifting. Follow the instructions provided for safe handling of the device.

Information
Refer to the combination list and size guide provided in the manual for detailed information on sling measurements and sizing for optimal use.

FAQ:
Q: Can the Molift RgoSling Shadow be used for all individuals?
A: The sling is designed to accommodate various individuals; however, it is essential to ensure proper sizing and use according to the guidelines for each individual’s safety.

Warning:
This symbol appears in the user manual along with a number referring to the instructions below. It draws attention to situations where the product or the user or carer’s safety may be in danger.

Information
This symbol appears in the user manual along with a number referring to supplementary information which can be found in the information
Consult instructions. The latest version of all user manuals can be downloaded as a “pdf file” from the web page. The manuals can be read with a “Read Out Loud” functionality in e.g Adobe Acrobat and /or printed in a larger size to accommodate persons with visual impairments. The user manual is not available in Braille.

Product label
Periodic inspection
User name
QR-code
(01) EAN-code, (11) date, (21) Serial number
Size label
Upper strap
Fixed loop connection
Lower strap
Loop connections
Leg support
Centre marking

General

Thank you for choosing an Etac device.
This manual must be read thoroughly before you start using the device as it contains important safety information and gives instructions on how to use the device correctly. Visit www.etac.com for all relevant product documentation, for example the user manual, periodic inspection document and recycling in- structions. You can select your language via the “International” and “Local websites” link.
You can also consult the QR code on the product label for further information and instructions.

Copyright
This document is the property of Etac A/S. The content shall not be modified in whole or part without prior approval of Etac A/S.

Disclaimer
Etac continuously makes improvements to our devices and information. We therefore reserve the right to modify our devices and instructions for use without prior notice. Consult www.etac.com to find the latest version of the documentation.

Declaration of Conformity
The device mentioned in this manual and the different models hereof comply with the Medical Device Regulation (EU) 2017/745.
The device is classified as a Class I medical device.

Product standards
The device has been tested and complies with the requirements applicable for this type of device in the below-mentioned standards:

ISO 10535:2021 Assistive products – Hoists for the transfer of persons – Requirements and test methods.

Notice
Any serious incident that has occurred in relation to the device should be reported to your distributor/representative and the national competent authority within your region in a timely manner. The distributor/representative will forward the informa-tion to the manufacturer.

Pre-sales information
Please visit www.etac.com

Device description

Etac supplies a wide selection of slings for different types of transfers. The Molift RgoSling series is de-signed to provide high comfort for users by evenly distributing weight and pressure. Molift RgoSlings are available in different sizes, models and materials. See www.etac.com for a complete overview of possible variants.
Molift RgoSling Shadow has a high back, head support and supports the entire core. This makes it suita-ble for users that require full body support and especially suitable for users in moulded seat units.
The sling is designed to remain under the user after the transfer and has no straps or seams on the surface.
The sling can be used for hoisting to and from a sitting and/or a lying position. The sling is designed to be combined with a 4-point sling bar, but it also works with a 2-point sling bar.
The sling has a standard split-leg support opening.

Benefits
The sling is made of net material which shapes itself to the body and allows moisture and heat to pass through.
The sliding loops in the upper straps allow an even weight distribution during the transfer.

Materials
Fabric: Polyester mesh

Introduction

The person referred to as “the user” is the person who is sitting in the product. “The carer” is the person who applies the product.

Intended purpose
The sling is an assistive device intended for alleviation of or compensation for a functional impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to/from a bed, the floor, a wheelchair, a chair, a toilet or similar, due to reduced mobility or physical strength.

Intended user
The device can be used for children, adults and elderly people when there is a need to leave the sling under the user.

Intended environment
For indoor use in acute care, long term care and home care.

Indications
For users who are in need of support to be lifted for a short time; e.g. people with limited ability to move and who require body support during transfers. Not an exhaustive list.
The user group for the device is based on individual health and mobility function, and not on a specific diagnosis or age.

Contraindications
There are no known contraindications.

Precautions
Make sure the sling fits the user and the sling bar. Not suitable to be left under users with signs of pressure injuries in the sling area.

Training requirements
Only carers who have read and understood the user manual are allowed to use the device.

Safety information

The safety of both user and carer must never be jeopardized – if you suspect that the device has a malfunction you must put it in quarantine marked “out of order” and call your local distributor/representative.

Safety signs, safety measures and warnings symbols are given in the context relevant for the actual handling and/or operating situation – it is mandatory the given instruction is followed to avoid dangerous/hazardous situations.
Signs, symbols and instructions placed on this device must never be covered or removed and must remain present and clearly legible throughout the entire lifetime of the device. Immediately replace or repair illegible or damaged signs, symbols, and instructions. Contact your distributor/representative for instructions.

Patient transfer
Transfer of a user will always pose a certain risk. Therefore, a risk assessment must always be carried out before the transfer is performed.

Never leave a user unattended when hoisted.
Molift slings shall only be used to hoist persons. Never use the sling to hoist objects of any kind.

Risk assessment

Do a risk assessment of the sling, the individual user and the intended transfer, and document your analysis. You as the carer are responsible for the safety of the user.
Make a decision on whether one or more carers are required.
Plan the transfer in advance to ensure that it is performed as safe and smooth as possible.
Remember to work ergonomically according to lo-cal recommendations.

Before using the sling, mark the date of first use on the periodic inspection label.

Slings
Always check – before each use:

that the user has the required ability for the sling.
that the model, size and fabric are suitable for the user and the transfer situation.
that the sling is suitable for the hoist and the sling bar.
that the sling does not have visible damage or frays to seams, fabric, straps and loops.
that the loop connections are correctly attached to the sling bar hooks before hoisting the user.
that the wheels on the wheelchair or bed are locked during the transfer. If using a mobile hoist the wheels on the hoist must not be locked.

If the inspection reveals any safety risks, the sling must immediately be taken out of service and be disposed of.
Never use a faulty or damaged sling as it can break and cause personal injury. Destroy and discard damaged and old slings.

Materials
All used materials that are to be in direct contact with skin are biologically assessed and evaluated according to relevant standards. However, users/carers who are allergic to any of the materials are recommend not to use the device.

Accessories
User manuals supplied with accessories must be read and understood before use. This includes any limitations in use and combinations. Information about accessories can be found on www.etac.com.

Combinations
This device can be combined with Molift sling bars and hoists. See the combination list on page 63.
Statement on sling and hoist compatibility for other manufacturers of hoists can be found on www.etac.com
When combining the device with other devices, the combination must not change the intended purpose of the devices or modify the devices in such a way that compliance with the applicable re-quirements may be affected. The person /compa-ny responsible for the combination of the devices must ensure that the applicable requirements are fulfilled.

If safe working load (SWL) differs between hoist, sling bar and sling, the lowest load should always be used.

Troubleshooting

Service, cleaning and maintenance

Maintenance and periodic inspections of the device are wholly the responsibility of the owner of the device. Failure to maintain a device in accordance with the instructions may compromise the safety of the user and/or carer and may affect the expected lifetime of the device.

Expected lifetime
The device has an expected lifetime of 1 to 5 years under normal use. The lifetime of the device may vary depending on usage frequency, loads and washing/drying frequency and conditions.
Washing and drying at high temperatures wear out the material faster.

Periodic inspection
Periodic inspection must be carried out at least every 6 months. More regular inspection may be required if the sling is used or washed heavily. See the periodic inspection label on the sling and the periodic inspection document at www.etac.com

Transportation, storage and disposal
Transportation and storage
When the device is not in use, it can be stored under the following conditions:

Technical data Size guide
Measurements in the table on page 63 should be used as a reference. The correct sling size depends on the user’s weight, function and body shape. Consult the size guide, and measure the user’s relevant measurements in a sitting position. Try the sling with the most correct measurements to make sure it fits.

Disposal
The device contains no hazardous substances that require special disposal. Dispose of the device according to the national provisions that apply.

Recycling
See the recycling instructions on www.etac.com, and follow the national provisions that apply.

Maximum user weight

Handling

Warnings

Be careful when transferring, the user may swing and hit surrounding objects.
Never hoist the user higher than necessary.
Remove the sling gently to ensure the user does not fall out of the chair.
Remove the sling gently to ensure the user does not roll out of the bed.

Information

Slide the sling down behind the user’s back until it reaches the seat.
Make sure the straps are fastened symmetrically on left and right side.
Before performing the transfer – make sure that:
- Sling is level with the coccyx.
- Leg supports are placed under the thighs without creases.
- Lower straps are crossed and symmetrically applied.
- If the user has been sitting or lying on the sling, check that the sling is still correctly positioned.
Perform a safety stop when the straps are stretched tense. Check that all straps are correctly and symmetrically attached.
Lower the user to sitting position using either method A or B.
Place the sling at the level of the user’s coccyx. The centre marking should follow the midline of the user.
If possible, raise the backrest closer to a sitting position before hoisting from a lying position