AKS standard Instructions For Use Manual
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AKS standard Instructions For Use Manual

AKS standard Instructions For Use Manual

Hoist sling
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aks hoist sling
aks standard sling
aks bath sling
Instructions for use
Translation of the original instructions for use
DIN EN ISO 13485
"Certified quality management system for the development, production and distribution
of equipment and accessories for patient positioning and patient transport"
Date:
2021-04-01
Version
01

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Summary of Contents for AKS standard

  • Page 1 Instructions for use Translation of the original instructions for use DIN EN ISO 13485 “Certified quality management system for the development, production and distribution Date: 2021-04-01 of equipment and accessories for patient positioning and patient transport”...

  • Page 2: Table Of Contents

    Size selection ____________________________________________ 19 Transport position for the patient ___________________________________________________________ 21 Sling loops ________________________________________ 22 Spreader bars of the aks patient hoists 7 First time use ___________________________________________________________ 23 8 Use ___________________________________________________________________ 23 ______________________________________________________ 23 Instructions for use _______________________________________________ 25 Lifting from a sitting position...
  • Page 3 Standard sling/Bath sling 17 Maintenance ___________________________________________________________ 37 ___________________________________________ 37 17.1 General maintenance instructions ________________________________ 38 17.2 Maintenance schedule: Inspection by the operator ___________________________________ 41 17.3 Maintenance schedule: Inspection by the user 18 Product labelling _______________________________________________________ 42 19 Technical data __________________________________________________________ 45...

  • Page 4: Introduction

    If you have any difficulty reading these instructions for use (e.g. due to the font size), you can always download the current version of these instructions for use as a PDF document from the aks website Open the PDF document and adjust the display on your screen according to your needs.
  • Page 5 Standard sling/Bath sling The aks standard sling and the aks bath sling (referred to hereinafter as the hoist sling(s) / product(s) are flexible body support systems and are high-quality hoist slings for basic care that are easy to use. The two hoist slings support the user when lifting and moving (transferring, relocating) a patient using a patient hoist.

  • Page 6: Explanation Of The Symbols Used

    Standard sling/Bath sling Explanation of the symbols used For ease of reading, these instructions for use employ the following symbols to indicate important information: Warning of danger Indicates safety instructions that must be observed under all circumstances in order to avoid an immediate danger to life and limb (risk of serious or fatal injury).

  • Page 7: Intended Use

    The products are Class I medical devices according to Regulation (EU) 2017/745, Annex VIII. The products are suitable for domestic use as well as for use in inpatient facilities. The standard variant is only intended for use in dry areas. The bath variant is made of fast-drying material and is specifically designed for use in wet areas.

  • Page 8: Contraindication

    (head hanging down). If the patient is not stable in the neck and shoulder area, use the optional extra aks head support (see chapter on Accessories/combinations) to support the neck and shoulder area.

  • Page 9: Safety Instructions

    Standard sling/Bath sling Safety instructions The safety instructions apply to all and any persons who perform work in any way with or on the product (incl. accessories). Where a specific group is addressed, this does not exclude any other persons. Read and observe the safety instructions. The safety instructions comprise text or a combination of a symbol with text.
  • Page 10 Standard sling/Bath sling In the context of these instructions for use, the word user refers to the person who uses (operates) the medical device (incl. accessories) on the patient. The user will be taught the skills and knowledge required to do this by means of proper training in the use of the product provided by the operator, in accordance with these instructions for use.

  • Page 11: General Safety Instructions

    Standard sling/Bath sling General safety instructions Training is required in the proper handling of the product (incl. accessories). The  training must be documented in an appropriate form. The training must be conducted on the product itself in accordance with the instructions for use, and must observe all the contents of said instructions for use.
  • Page 12 For hygiene reasons, always use the product (incl. accessories) for the same patient. Use only original aks accessories/spare parts in order to avoid danger (see the chapter on Accessories/combinations). If the mattress is not used for an extended period, observe the requirements for storage in the chapter Storage.

  • Page 13: Safety Instructions For The Operator

    Standard sling/Bath sling Safety instructions for the operator Prior to initial use and every reuse, train the user on the product itself (incl. accessories) on the basis of the instructions for use, explain the safety instructions, test the effectiveness of the training, and properly document said training. Make the user aware of the hazards that may arise in case of unintended use of the product (incl.

  • Page 14: Safety Instructions For The User

    Standard sling/Bath sling Safety instructions for the user Arrange for the operator (e.g. your responsible medical supply store/authorised dealer) to train you in the safe handling of the product (incl. accessories) using the product itself, in accordance with the instructions for use.

  • Page 15: Scope Of Delivery

    Standard sling/Bath sling Scope of delivery The products have already been inspected at the factory to ensure completeness and freedom from defects. Nevertheless, check the products immediately after receipt for possible transport damage. After removing all individual parts, check the completeness of the scope of delivery using the delivery note.

  • Page 16: Product Overview

    (inner side) Lower edge Leg support Coloured leg loops 4 suspension positions Fig. 5.01 – Outer side of aks standard sling (aks bath sling) Hoist sling sizes (dimensions in cm) aks standard sling aks bath sling SIZE All specifications regarding dimensions and weights are approximate specifications. The sizes of the hoist slings are affected by manufacturing tolerances;...
  • Page 17 The aks standard sling is only intended for use in dry areas. The aks bath sling has a similar pattern to the aks standard sling. Due to the water-permeable and fast-drying mesh structure of the material, it is particularly suitable for use in wet areas.

  • Page 18: Preparation

    To help with the selection of the size of the hoist sling, you can use Figure 5.01 in conjunction with the details in the hoist sling size table. Your authorised dealer and aks GmbH are available to provide additional information. They help you to take account of the patient’s individual requirements and characteristics when it comes to type and size selection.

  • Page 19: Transport Position For The Patient

    Standard sling/Bath sling Transport position for the patient Correct position when transporting with an aks patient hoist 1. The patient is sitting upright and is leaning back slightly in a relaxed position. 2. Appropriate headroom from the spreader bar is observed.
  • Page 20 Standard sling/Bath sling Transferring a patient in an incorrect position is associated with an increased risk. Failure to observe this requirement may cause the patient to fall, and thus result in severe or even fatal injury to the patient. The individual loops are given different colour-coded suspension positions to achieve the correct sitting position (see chapter on Preparation, section Sling loops).

  • Page 21: Sling Loops

    Standard sling/Bath sling Sling loops The loops of the hoist sling can be suspended in various positions in order to obtain the correct position for the patient. Note the colour coding on the loops and always suspend sling loop pairs that have the same colour in the same suspension position (Fig.

  • Page 22: Spreader Bars Of The Aks Patient Hoists

    Standard sling/Bath sling Spreader bars of the aks patient hoists The products are suitable for use in combination with a spreader bar with a 4-point attachment (see chapter Technical data). The loop pairs are to be positioned in the hooks in accordance with the following figures.

  • Page 23: First Time Use

    Standard sling/Bath sling First time use Before using the product for the first time and every time it is reused, check that the product (incl.  accessories) is in safe condition based on the maintenance information in the chapter on Maintenance. Before the product (incl.  accessories) is reused, always clean and disinfect it in accordance with the instructions given in the chapter on Cleaning/disinfecting.
  • Page 24 Standard sling/Bath sling Ensure that the sling loops do not catch in the castors of the hoist/wheelchair. Before each lifting/uprighting process, check that all the loops on the spreader bar/lifting arm are suspended properly and not twisted when the hoist sling is pulled taut.

  • Page 25: Lifting From A Sitting Position

    Cross the leg loops and attach them to the hooks on the spreader bar (Fig. 8.2.03), as described in the chapter on Preparation, section Spreader bars of the aks patient hoists. Make sure that they are both in the same attached position. You can identify this by the colour coding on the loops (see chapter on Preparation, section Sling loops).
  • Page 26 To lower the patient into a sitting position after the lifting procedure/transfer, follow these instructions in reverse order. Please note that the instructions to be observed when lifting apply here too. The aks patient hoist remains unbraked even when setting down the patient and while the wheelchair is braked.

  • Page 27: Lifting From A Lying Position

    Cross the leg loops and attach them to the hooks on the spreader bar (Fig. 8.3.03), as described in the chapter on Preparation, section Spreader bars of the aks patient hoists. Make sure that they are both in the same attached position. You can identify this by the colour coding on the loops (see chapter on Preparation, section Sling loops).
  • Page 28 10. Suspend the shoulder loops from the hooks on the spreader bar (Fig. 8.3.03), as described in the chapter on Preparation, section Spreader bars of the aks patient hoists. Ensure the suspension positions are identical here too, which you can identify by the colour coding on the loops (see chapter on Preparation, section Sling loops).

  • Page 29: Accessories/Combinations

    The following tables list the combinations of the aks hoist slings described in these instructions for use that have been checked and approved by aks GmbH for safe use.
  • Page 30 Standard sling/Bath sling Compatibility Our hoist slings for lifting hoists can be used with all aks hoists and with a number of hoists from other manufacturers. Please note our declaration of compatibility for hoist slings. This can be found on our website: www.aks.de On request, additional combination variants that have been approved by aks GmbH are possible.

  • Page 31: Cleaning/Disinfecting

    Standard sling/Bath sling 10 Cleaning/disinfecting Cleaning: Achieving a state of cleanliness (visible). Removal of contamination to the extent required for the intended purpose of the product. Disinfection: Reducing the number of or destroying microorganisms (not visible). Procedure designed to reduce the number of viable micro-organisms to a pre-defined acceptable level appropriate to the intended purpose of the product.

  • Page 32: Cleaning By The User/Operator

    Standard sling/Bath sling If possible, use • Environmentally and dermatologically tested cleaning agents • Alcohol-free and chlorine-free disinfectants and methods from the Robert-Koch Institut (RKI) list or the disinfectants list of the Verbund für Angewandte Hygiene e.V. (VAH) Observe the instructions and safety precautions from the manufacturers of the cleaning and disinfectant materials.

  • Page 33: Disinfection By The Operator

    (dosage) and exposure time. Always use cold water (max. 30°C) when diluting disinfectants. The following disinfectants and disinfection methods have been tested and approved by aks GmbH. Mechanised disinfection Manufacturer of cleaning...

  • Page 34: Storage

    Standard sling/Bath sling 11 Storage The storage location should be as cool and dry as possible and not exceed normal room temperature. The climatic conditions are described in the chapter on Technical data and must be complied with. Ensure damage and continual strain are ruled out during the storage period.

  • Page 35: Service Life

    The fact that aks GmbH specifies an expected service life/useful life for the products does not represent an additional guarantee. While new and unpacked, and if stored according to chapter Storage, the product has a storage life of up to five years.

  • Page 36: Disposal

    Non-observance of the instructions for use, improper use, improperly carried out maintenance work, and technical modifications and additions (e.g. attachments) without the permission of aks GmbH render the warranty and general product liability void. We reserve the right to make technical changes for the purpose of improvement. For the product designation and information for clear identification (e.g.

  • Page 37: Maintenance

    Do not carry out any repairs or modifications on the products. Exception: Replacing, among others, reinforcing elements, push-fit fastening, seat swing. Only original aks spare parts and aks accessory parts that are approved for these products may be used (see chapter on Accessories/combinations). Otherwise, any warranty claims and product liability are excluded.

  • Page 38: Maintenance Schedule: Inspection By The Operator

    8-point sling with head support attachment attachment for bathing  aks universal comfort  aks universal mesh sling  aks universal Flex sling  goliath® sling sling  aks standaid sling with  aks calf sling  aks standaid sling with ...
  • Page 39 Standard sling/Bath sling The following maintenance schedule provides help for this inspection: Inspection of the aks hoist sling – check points* Rating plate present, attached and legible (see chapter on Product labelling) Patches present, attached and legible (see chapter on Product labelling)
  • Page 40 Hoist sling Accessories We recommend the certified treatment unit at aks pura GmbH for the periodic monitoring, cleaning and disinfection of the products. Reference to EN ISO 10535: It takes approx. two (2) minutes to perform one (1) lifting cycle; this can vary according to the hoist/drive manufacturer.

  • Page 41: Maintenance Schedule: Inspection By The User

    Contact your authorised dealer immediately. The following maintenance schedule provides help for this inspection: Inspection of the aks hoist sling – check points No damage to textiles (e.g. torn, cut, punctured, blistered, scorch marks) No damage to straps or sling loops (e.g.

  • Page 42: Product Labelling

    Standard sling/Bath sling 18 Product labelling Product labelling Rating plate Front/rear Patch beside the rating plate Front/rear Page 42...
  • Page 43 Only use in combination with: aks standard spreader bar Only use in combination with: aks tandem spreader bar or goliath® comfort spreader bar Use only in combination with: aks horizontal transport spreader bar with 8-point attachment Only use in combination with:...
  • Page 44 Standard sling/Bath sling Explanation of the symbols EN ISO 15223-1 of the Observe instructions for use legal rking. Attention Manufacturer Date of manufacture MDR), Production batch number, batch Article number Serial number Explanation of the care symbols EN ISO 3758 Coloured wash (normal washing cycle) Washing temperature 60 °C, normal process...

  • Page 45: Technical Data

    Class I medical device according to Regulation (EU) 2017/745, Appendix VIII 250 kg Maximum load [kg] Holder 4-point attachment Spreader bar or other spreader bars approved by aks GmbH Posture of the patient during transfer / change in position Ambient temperature [°C] 5-40 Transport/...
  • Page 46 Standard sling/Bath sling Notes: Page 46...
  • Page 47  aks hygiene sling  aks comfort hygiene sling  aks hygiene sling with back reinforcement  aks standard sling with  aks bath sling with  aks bath sling with back reinforcement and back reinforcement and Flex head support...
  • Page 48 Aktuelle Krankenpflege Systeme GmbH Antwerpener Straße 6 D-53842 Troisdorf  +49 2241 9474-0 +49 2241 9474-88  aks@aks.de   www.aks.de Reprints whether in whole or in part are only allowed with prior permission by the publisher. All rights reserved, particularly the right to make technical amendments. Printing errors excepted.

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