HUMAN CARE 25130C Back Belt E-Clip User Manual

HUMAN CARE 25130C Back Belt E-Clip

User manual

Important!
You must read the user manual for your device prior to usage. Keep this booklet and information handy for future use.

Symbols

WARNING symbol indicates a potentially hazardous situation which, if not avoided, could result in serious injury to the user or damage to property and/or the device itself.

INFORMATION symbol indicates recommendations and information for proper, trouble-free usage.

WEIGHT CAPACITY symbol indicates maximum user weight for the product. Do not exceed this weight in any circumstance.

CE MARKING symbol indicates product meets requirements of EU Directive 93/42/EEC (MDD) and/or EU Regulation 2017/745 (MDR).

RECYCLE according to local regulations.

MEDICAL DEVICE symbol indicates  that the product is a medical device according to the definition of medical device in EU Directive 93/42/ EEC (MDD) and/or EU Regulation 2017/745 (MDR).

READ INSTRUCTIONS and ensure you fully understand them before using this product.

Product modification is not permitted.
Before use, always check that the product is not damaged or worn.

Human Care’s products are continuously being developed and updated to provide our customers with the highest quality. We reserve the right to make design changes without prior notice.
Always make sure that you have the most recent version of the manual which is available for downloading from our website at www.humancaregroup.com.
Contact your local distributor if you have any questions about the product and its use.

Notice to user/patient in case of serious incident

Any serious incident that has occurred in relation to the product, should be reported to thelocal contact, who reports to the manufacturer, and the competent authority of the country in which the user/patient is established.

Safety instructions

Lifting and transferring a client always involves risks. It is therefore important that you carefully read the user manual for both the lift and the sling. Make sure that the lift you are using is suitable for the intended use. As a caregiver, you are responsible for the client’s safety and you need to know whether the client is able to handle the lifting process. The sling must meet the client’s needs. If you are in any doubt, we recommend that you contact the distributer.

• Visually inspect the sling each time before use.
• Check that the correct sling is used for the client. The model, size and material must be appropriate to the client’s needs.
• Plan the transfer and lifting process so that it can be carried out as safely as possible.
• Before actually lifting the client, check that the sling is correctly attached to the spreader bar at the time when the clips are under tension.
• It is important that the clips are correctly attached: Apply the clip through the large hole (photo 1) and then pull it to the small hole. The dark grey parts automatically secure the clip attachment (photos 2 and 3). You can hear an audible click when the clip is secured.
• Check that the client is safely seated in the sling before you start lifting.
• Check that the lift is balanced while moving and raising/lowering the client.
• Never leave a client unattended while in the lift.
• Our slings are designed and tested for indoor use by one client at a time and can only be used for lifting one person. The lift is not a swing.
• The sling must not come into contact with sharp objects.

General description/Intended use

Back Belt E-clip

The Back Belt E-clip, 25130 (loops)/25130C (clips) is used in combination with a stand-up lift to allow clients to safely stand up or sit down from, for example, a toilet, bed or chair/ wheelchair in the most comfortable manner. This belt supports the central part of the back and has a soft padding for optimal comfort. The Back Belt is recommended for patients with poor stability or who have difficulty getting up. The sling is made of polyester and is suitable for users weighing up to 250 kg. The client must be able to stand on his/her feet.

Technical specifications

It is very important to use the correct size of sling for the client. So that our sizes can be identified, we use color codes for quick recognition. The color code can be found on the tag next to the sling’s label. This tag can also be used to store/hang up the sling.

Item| Part No.:| Size| Colour code| A (cm/ inch)| B (cm/ inch)| C (cm/ inch)| *Weight Capaci- ty (kg/lbs)| Weight Capaci- ty (kg/lbs)**
---|---|---|---|---|---|---|---|---
Back Belt E-clips| 25130C-S| Small| Red| 69/27,2| 27/10,6| 33/13| 30-60/66-132| 250/551
Back Belt E-clips| 25130C-M| Medium| Yellow| 83/32,7| 30/11,8| 39/15,4| 55-90/121-198| 250/551
Back Belt E-clips| 25130C-L| Large| Green| 92/36,2| 34/13,4| 44/17,3| 85-120/187-265| 250/551
Back Belt E-clips| 25130C-XL| Extra large| Blue| 103/40,6| 39/15,4| 50/19,7| 110-150/243-331| 250/551

*the safe working loads are guidelines only and are not a substitute for individual tests. Differences may occur, tolerances ± 1 cm.

In compliance with / Standards / CE

Human Care is an ISO 13485:2016 Swedish certified medical device company . The Quality Management System is in compliance with US 21 CFR part 820. The sling has been tested in accordance with ISO 10535.
The sling has a CE marking in accordance withthe Medical Device Directive 93/42/EEC and/or Medical Device Regulation (EU) 2017/745). The CE mark label is at the sling mark label.

Product label

The label on the sling shows the following information:

1. Human Care company logo

2. This way up arrow and marking the centre line of the sling

3. CE and MD marking

4. Product name and size

5. Picture showing the sling in use

6. Part number

7. Safe Working Load

8. “This side facing out” – outside of the sling, not in touch with the client

9. Manufacturer

10. Date and country of production

11. Instruction labels
    a. Do not use fabric softener
    b. Visual inspection
    c. Latex Free
    d. Read the manual before use

12. Serial number

13. Washing instructions
    a. Machine Wash Temperature
    b. Do Not Bleach
    c. Tumble Dry, Low Heat
    d. Do Not Dry Clean
    e. Never Iron

14. Owner name. (For example, write the client’s name or another unique identifier)

15. Indicate bi-annual inspection

16. UDI: (01) EAN/GS1/GTIN (11) manu – facturing date (21) serial number

17. Unique Product Code

Attachment options

Slings with 4 safety clips can only be used with a 4-point spreader bar with snap hooks.

Our slings are designed in the knowledge that people are all different, with a variety of requirements, needs and wishes with regard to lifting.
The mechanism and design of a sling must be such that it prevents human mistakes as much as possible. With this in mind, the universal safety clip has been developed. It is shown that many of the accidents that involve lifts are caused by incorrect attachment of the sling to the hanger/spreader bar or lift arm. The safety clip is an important addition because it greatly reduces the likelihood of errors.
The clip is placed around the snap hooks of the hanger/spreader bar and closes with an audible ‘click’. It is a signal to the caregiver that the clipis securely attached and cannot unexpectedly become loose. The clip has a built- in lock to prevent this from happening. Releasing the clip can be done very easily with one hand. The safety clip is universal and can be used on all types of lifts fitted with mushroom shaped hooks with a diameter ranging between 6.8 and 8.2 mm.

Compatibility

Human Care Group slings are suitable for all Human Care lifts and hanger/spreader bars. The products can also be used with products from other suppliers, which are equipped with the same fastening method for attaching slings to a hanger/spreader bar and lift. Due to the wide range of products available worldwide, Human Care cannot be held responsible for any mistakes/defects that may result from incorrect use or use of different combinations of slings, hanger/spreader bars and lifts from other suppliers. The use of a combined system is at the adviser’s own risk and liability.
In order to protect the safety of the client and caregiver, Human Care recommends the following minimum instructions are followed:

1. When using slings with lifts and hanger/ spreader bars made by manufacturers other than Human Care, the combined system must be designed with the same sling connection method for the hanger/spreader bar of mobile lifts and ceiling lifts, i.e. strap loop slings are used with a strap loop style hanger/spreader bar, clip slings are used with a clip style hanger/spreader bar.
2. The relevant patient lifts and slings must be CE marked in accordance with the Medical Devices Directive, MDD 93/42/EEC and MDR 2017/745 and comply with the standard requirements for patient lifts as set out in EN ISO 10535.
3. The caregiver must follow the instructions and recommendations set out in the manufacturer’s manuals with regard to the use, care, client, caregiver, cleaning and servicing of slings and lifts.
4. Different products on the assembled lift system: i.e. lift, sling, hanger/spreader bar, scales, and other accessories, may have a different maximum safe working load. The lowest maximum working load of all the individual products and the system will always apply for the whole system. Always check the labels on all individual products in the system.
5. Individual risk assessment, including practical testing of the system and validation of the specific combination used, is required to confirm that the size of the sling is correct for its intended use and compatible with the width and design of the hanger/spreader bar. The combined system must be documented by the competent prescriber.

If you have any questions, please contact your local Human Care office or distributor.

Attaching a sling

Attaching the sling to a spreader bar from a sitting position

1. Stand beside or behind the client and position the sling so that the center of the sling is aligned with the client’s back. Pay attention to the marking on the sling, the arrow indicates the middle, top and outside of the sling. The anti-slip material on the inside must be directed towards the client’s back. Place the strap at the lower back and bring the attachment loops to the front underneath the arms.
   

2. Fasten the buckle of the waist belt.
   

3. Move the lift close to the user. Check that the client is sitting safely.
   Lower the lift arm using the hand control to a position where it does not touch the client but it is possible to attach the loops or safety clips to the hanger/spreader bar without having to use physical force. The client places his/her feet on the footplate.
   The height-adjustable under leg supports must be positioned approximately 2 cm below the client’s kneecap. Attach the sling symmetrically to the connection points of the lift arm by means of the loops or safety clips. Carefully check each of the attachments.
   

4. Using the hand control, raise the lift arm until there is some tension in the sling but do not start lifting the client yet. Check the connections again and also the positionof the client’s feet on the footplate. Lift the client up until he/she has reached the desired standing position.
   

Removing the sling

When the transfer process has been completed, the client is returned to the chair or wheelchair. When the client is seated safely and the feet have been removed from the footplate, the Back Belt can be disconnected from the lift arm. The stand-up lift is then moved away. Thesling is removed by unclipping the buckle of the waist belt and removing the sling from behind the client’s back.

Troubleshooting

• The sling is too large.
• The lifting sling is not entirely suitable – the clips must be load-bear- ing at the same time.

The client is not in balance when he/she is being lifted.|

• The instructions in the individual logbook have not been followed or a new assessment/adjustment must be carried out.

The sling is too small.|

• This can be very uncomfortable for the client. The sling could cut into the client’s skin and/or his/her back may not be supported sufficiently.

Note: It is important that the correct sling is used for each client and that individual tests are carried out to ensure that the sling meets the client’s needs and the transfer situation.

Maintenance instructions

Wear and tear

Check the sling for any signs of wear and tear. It is important to check the fabric, outer edges, seams and E-clips before use. Damaged lifting equipment must not be used.

Cleaning

Human Care slings are intended for individual  use. In order to prevent infections or transmission of bacteria, it is important to clean the slings properly. All lifting slings should bemachine washed and dried as soon as possible. Slings must always be cleaned after being exposed to moisture.

See the washing instructions on the sling’s label

Periodic service

A periodic service must be carried out at least every six months. See Human Care’s periodic service checklist.

Product lifetime

The product´s expected lifetime 3 years or 150-180 times washing, if the product is used as intended and maintained according to the manufacturer´s instructions, depending on the intensity of use and maximum load applied during use. If the product label is no longer legible, the product should be discarded.

Warranty and support

If you need information or support, please contact your Human Care office, www.humancaregroup.com, or distributor.

Recycling

Once the product has reached the end of its life, it should be disposed according to your country’s rules, especially for the separate collection of electrical and electronic products. Correct disposal helps prevent negative consequences for the environment and human health.

Overview of care for sling materials| Polyester/ Soft air mesh| Polyester Net| Trevira| Polyester/Polyester Net| Polyester/Cotton| Ventilating polyester| Cotton| Polyester Tricot| Coated nylon
---|---|---|---|---|---|---|---|---|---
| Maximum washing machine temperature 60°C (140°F) (sling with reinforcement)| ●| ●| | | | | | | ●
| Maximum washing machine temperature 75°C (167°F)| ●| ●| ●| ●| ●| | ●| ●|
| Tumble drye, low temperature, maximum temperature 30°C- 54°C (86°F- 130°F)| | | | | | | | | ●
| Tumble drye, low temperature, maximum temperature 60°C (140°F)| ●| ●| ●| ●| ●| | ●| ●|
| Do not tumble dry| | | | | | ●| ●| ●|
| Do not iron| ●| ●| ●| ●| ●| ●| ●| ●| ●
| Do not dry clean| ●| ●| ●| | ●| ●| ●| ●| ●
| Do not use bleach| ●| ●| ●| ●| ●| ●| ●| ●| ●
| Do not use fabric softener| ●| ●| ●| ●| ●| ●| ●| ●| ●
| Do not wash| | | | | | ●| | |
| Discard after use| | | | | | ●| | |
| Disinfection allowed (see list of permitted disinfectants)| ●| ●| ●| ●| ●| | ●| ●| ●

Disinfection procedure

Human Care slings are intended to be used by one client at a time. In order to prevent possible transmission of infectious diseases, it is important to clean the sling if it has become dirty or if it is used by another client.

sterilization
Thermal disinfection: wash at 65°C (149°F) for at least 10 minutes1.| Iodine- based disinfectants
Thermal disinfection: Wash at 71°C (160°F) for at least 3 minutes1.| Ethylene Oxide ‘Gas’ sterilization
Note: Add 8 minutes to both options of thermal disinfection to ensure that heat has penetrated the fabric. Finish with a rinse cycle.1|

1 Ref: HSG (95) 18: Hospital Laundry Arrangements for Used and Infected Linen, Department of Health, NHS (National Health Service, England)

HUMAN CARE SWEDEN (HQ)
Årstaängsvägen 21B
117 43 Stockholm
Phone: +46 8 665 35 00
Fax: +46 8 665 35 10
Email: info.se@humancaregroup.com
HUMAN CARE CANADA
10-155 Colonnade Road
Ottawa, ON K2E 7K1
Phone: +1 613 723 6734
Fax: +1 613 723 1058
Email: info.ca@humancaregroup.com
HUMAN CARE UNITED STATES
8006 Cameron Street, Suite K
Austin, TX 78754 USA
Phone: +1 512 476 7199
Fax: +1 512 476 7190
Email: info.us@humancaregroup.com
HUMAN CARE NEDERLAND
Elspeterweg 124
8076 PA Vierhouten
Phone: +31 577 412 171
Fax: +31 577 412 170
Email: info.nl@humancaregroup.com

www.humancaregroup.com

References

• comhumancaregroup.com
• Safe Patient Handling Products and Walking Aids - Human Care

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