etac BM40499 Moloift RgoSling Ampu HighBack Instruction Manual

etac BM40499 Moloift RgoSling Ampu HighBack

Specifications

• Product Name: Molift RgoSling Shooter
• Back Type: HighBack, MediumBack
• Model Number: BM40499
• Revision: 6.0
• Website: www.etac.com

Product Information

The Molift RgoSling Ampu is designed to assist users with amputations in various lifting situations. It comes in two back types, HighBack and MediumBack, providing support and comfort during transfers.

Usage Instructions

Handling

• Ensure the sling is properly positioned under the user before lifting. Check all connections and adjust as necessary for a secure fit.

Sitting Application

• Gently guide the user into a seated position while supporting their back with the sling. Make sure the leg supports are in the correct position for stability.

Sitting Removal

• To remove the sling while the user is seated, carefully unhook the connections and assist the user in standing up before fully removing the sling.

Lying Application

• When assisting a user to lie down, position the sling under them and ensure proper alignment before lowering them onto the surface.

Lying Removal

• To remove the sling while the user is lying down, gently detach the connections and guide the user to a seated position before fully removing the sling.

FAQ

Q: Where can I find the latest version of the user manual?

A: The latest versions of all user manuals can be accessed and read on the website in PDF format.

Q: Is the user manual available in Braille?

A: The user manual is not available in Braille, but it can be read using screen reader software for users with visual impairments.

• 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 section.
• Consult instructions The latest version of all user manuals can be downloaded as a “pdf-file” from the web page.
• Themanuals 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.

Symbols

• Refer to the user manual
• CE marked
• Medical device
• Serial number
• Manufacturer
• Catalogue number
• UKCA marked
• Date of manufacture. YYYY-MM-DD (year/month/date)
• This Way Up, this side is outside
• Maximum user weight
• Ready for use
• Incorrect use
• Examine, Check
• Pause
• Recyclable
• Fold out
• Washing
• Tumble drying
• Do not dry-clean
• Do not bleach
• Keep away from sunlight
• Do not iron
• Keep dry
• Type BF applied part

OVERVIEW

1. Product label
2. Periodic inspection
3. User name
4. QR-code
5. (01) EAN-code, (11) date,
6. Size label
7. Upper strap
8. Lower strap
9. Padding
10. Guide handle
11. Waist belt
12. Leg support
13. Application pocket
14. Loop connection
15. Head support
16. Safety loop for leg strap

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.

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 concerning the device should be reported to your district- attorney/representative and the national competent authority within your region promptly.
• The distributor/representative will forward the informa-tion to the manufacturer.

Pre-sales information

• Please visit www.etac.com.

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.

Device description

• Etac supplies a wide selection of slings for different types of transfers. The Molift RgoSling series is designed 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 Ampu supports the entire core and is available with either a medium back or a high back with head support.
• The sling can be used for hoisting to and from a sitting and/or a lying position. The HighBack model is suitable for users with reduced head and/or core stability.
• The sling is primarily designed for a 4-point sling bar, but it also works with a 2-point sling bar.
• The narrow split-leg support opening makes it suitable for users with amputated limbs, poor muscle tone, or users at risk of slipping out of a sling with a standard split-leg support opening.

Benefits

• The sling is padded to distribute the weight, which provides comfortable support for the user through the entire transfer.
• The sliding loops in the upper straps allow an even weight distribution during the transfer.
• The sling has a waist belt with non-slip lining inside, which helps keep it in place.
• Using the sling provides a high level of safety and security for the user.
• Application pockets on the back and the leg supports facilitate application and guide handles help with lowering the user into an optimal sitting position.

Materials

• Fabric: Polyester
• Padding: Polyethylene

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 with a need to be lifted.

Intended environment

• For indoor use in acute care, long-term care, and home care.

Indications

• For users who need 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

• Users with reduced head stability should not use the sling with medium back.

Precautions

• Make sure the sling fits the user and the sling bar.

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 warning symbols are given in the context relevant to the actual handling and/or operating situation – the given instruction must be 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 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 hoist-ed.
• Never attach the guide handles to the sling bar hooks.
• 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.
• Decide on whether one or more carers are required.
• Plan the transfer to ensure that it is performed as safely and smoothly as possible.
• Remember to work ergonomically according to local 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 recommended 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.
• 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 requirements may be affected.
• The person/company responsible for the combination of the devices must ensure that the applicable requirements are fulfilled.
• If the safe working load (SWL) differs between hoist, sling bar, and sling, the lowest load should always be used.

Troubleshooting

There is more than 10 cm between the left and right side padding of the waist belt.| Try a larger size.
The waist belt is too loose after tightening it.| Try a smaller size.
The user’s head comes too close to the sling bar.| Try another loop connection to extend the distance to the sling bar. Otherwise, try a larger size.

The straps are not loaded at the same time.

| Make sure the straps are attached symmetrically. Make sure the center of the sling is at the midline of the user.
The user’s buttocks slide down the opening of the sling.| Make sure the sling is positioned low enough on the user’s back when applying it. Otherwise, try a smaller size.

Make sure the leg supports are placed overlapped under the user and that one leg support passes through the safety strap on the other leg support.

Make sure the user is not wearing slippery clothes.

(Only highback slings)

The sling does not reach the top of the user’s head.

| Make sure the sling is not placed lower than the coccyx. Otherwise, try a larger size.

• 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 under 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 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.

Cleaning

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 64 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

1. Place the leg supports overlapped under both thighs. If applicable, place the leg support under the amputated leg first.
2. Pull the outer lower strap through the safety loop for the leg strap.
3. Never hoist the user higher than necessary.
4. Be careful when transferring, the user may swing and hit surrounding objects.
5. Remove the sling gently to ensure the user does not fall out of the chair.
6. Remove the sling gently to ensure the user does not roll out of the bed.

Information

1. Use the application pocket to slide the sling down behind the user’s back until it reaches the seat.
2. Make sure the straps are fastened symmetrically on the left and right sides.
3. Before performing the transfer – make sure that:
   • The waist belt is locked and tightened.
   • Leg supports are placed under the thighs without creases.
   • One leg support passes through the safety strap on the other leg support, when applied overlapped.
   • Lower straps are symmetrically applied.
4. Perform a safety stop when the straps are stretched and tense. Check that all straps are correctly and symmetrically attached.
5. Lower the user to a sitting position using either method A, B, or C.
6. The sling can be folded at the edge of the padding.
7. Place the sling at the level of the user’s coccyx. The label should be centered on the midline of the user.
8. If possible, raise the backrest closer to a sitting position before hoisting from a lying position.

Combination list 2-point sling bar

Combination list 4-point sling bar

Sling measurements MediumBack

Sling measurements HighBack

Size guide

• Etac Ltd.
• Unit 60, Hartlebury Trading Estate,
• Hartlebury, Kidderminster,
• Worcestershire, DY10 4JB
• +44 121 561 2222
• Sodimed SA
• Ch. Praz-Devant 12
• CH-1032 Romanel-sur-Lausanne
• +41 58 911 06 06
• Etac A/S
• Parallel 3
• DK-8751 Gedved
• +45 796 858 33
• patienthandling@etac.com
• www.etac.com

Documents / Resources

| etac BM40499 Moloift RgoSling Ampu HighBack [pdf] Instruction Manual
BM40499, BM40499 Moloift RgoSling Ampu HighBack, Moloift RgoSling Ampu HighBack, RgoSling Ampu HighBack, Ampu HighBack, HighBack
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References

• Etac - A world-leading developer of assistive devices

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