AKS S4 Instructions For Use Manual
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AKS S4 Instructions For Use Manual

AKS S4 Instructions For Use Manual

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aks-S4
Instructions for use
Translation of the original instructions for use

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  • Page 1 Instructions for use Translation of the original instructions for use...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS 1 Introduction ____________________________________________________________ 4 _____________________________________________ 6 Explanation of the symbols used 2 Intended use ____________________________________________________________ 7 _______________________________________________________ 7 Intended purpose _____________________________________________________________ 7 Indication ________________________________________________________ 7 Contraindication ____________________________________________________________ 7 Side effects 3 Safety instructions _______________________________________________________ 8 __________________________________________ 8...
  • Page 3 18 Declaration of conformity ________________________________________________ 49 19 Maintenance ___________________________________________________________ 50 ___________________________________________ 50 19.1 General maintenance instructions ___________________________________________ 52 19.2 Removing/replacing the batteries ________________________________ 53 19.3 Maintenance schedule: Inspection by the operator ___________________________________ 59 19.4 Maintenance schedule: Inspection by the user...

  • 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 The aks-S4 homecare bed (in the following also referred to as the product) meet the requirements of modern homecare bed. Using the product means a better quality of life for the patient and makes work easier for the user. Thanks to its homely wood trim, the homecare bed is easy to integrate into an existing living ambience.

  • Page 6: Explanation Of The Symbols Used

    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

    Intended use The products are Class I active medical devices according to Regulation (EU) 2017/745, Annex VIII. The have been tested for application environments 3 and 4 of the standard EN 60601-2-52, and are therefore suitable both for long-term care in a medical sector (e.g. old people's homes and care homes, rehabilitation facilities, geriatric facilities) and for domestic care.

  • Page 8: Safety Instructions

    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 9 Qualified electricians as defined in the German accident prevention regulations DGUV Specification 3; persons who, through their specialist training, skills and knowledge as well as through knowledge of the valid regulations, are capable of performing the assigned work and assessing potential hazards.

  • Page 10: General Safety Instructions

    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 11 For patients with a height of 185 cm or more, we recommend using a bed extension (see the chapter on assembly, section Accessories – Bed extension: Assembly). Use only original aks accessories/spare parts in order to avoid danger (see the chapter on Accessories/combinations).

  • Page 12: Safety Instructions For The Operator

    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 13 Inform the user that, in addition to the periodic checking by suitable qualified personnel, the user themselves must check that the product and its accessories are in a safe state before each use (see chapter on Maintenance, section Maintenance schedule: Inspection by the user).

  • Page 14: Safety Instructions For The User

    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

    Scope of delivery The product has already been inspected at the factory to ensure completeness and freedom from defects. Nevertheless, check the product 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 Fig. 4.01 – Foot support (FA) Fig. 4.02 – Head support (KA) version with sprung slats version with sprung slats Fig. 4.03 – Scissor lift (SH) Fig. 4.04 – Mirror panels (SP) Fig. 4.05 – Wood side bars (HSG) Fig.
  • Page 17 Fig. 4.07 – Uplifter with handle and safety strap Fig. 4.08 – Controller, mains adapter (SMPS), manual control unit including lock key Fig. 4.09 – Instructions for use, Fig. 4.10 – Allen bolt Allen key and transport lock Page 17...

  • Page 18: Product Overview

    Back part Thigh and lower leg part Back part drive with controller Mirror panel Mains adapter Scissor lift Manual control unit including lock key Castor with locking device Scissor lift drive Fig. 5.01 – Product overview of aks-S4 Page 18...

  • Page 19: Assembly

    Assembly Assemble and dismantle the product according to the specifications in these instructions for use. Observe the safety instructions and use protective materials placed on the ground (e.g. cardboard/ packaging material) to prevent damage to the flooring. In addition to the supplied 6 mm Allen key, Assemble and dismantle the product according to the specifications in these instructions for use.

  • Page 20: Assembling The Homecare Bed

    Assembling the homecare bed If you have established that the delivery is complete based on the chapter Scope of delivery and that the delivery is undamaged, proceed as follows to set up the product: 1. Place the scissor lift with the castors on the floor and brake the castors (see chapter on Operation, section Castors) (Fig.
  • Page 21 7. Place the foot support with the extension tubes at the front on the castors on the scissor arm. Move the foot support forwards and at the same time thread the C-rails on the castors carefully (Fig. 6.1.04). 8. When both C-rails are on the castors, push the foot support until the cross member (see arrow) comes into contact with the scissor lift drive.
  • Page 22 13. Now assemble the controller as described in the chapter on Assembly, section Assembling the controller. 14. Insert a mirror panel in the longitudinal tubes at the foot end of the bed surface (Fig. 6.1.08). Attach the mirror panel with two Allen bolts.

  • Page 23: Assembling The Controller

    Assembling the controller 1. Take the controller from the cardboard box (Fig. 6.2.01) and push it onto the back part drive. Secure the controller against slipping away using the fixing screw (Fig. 6.2.02). Fixing screw Fig. 6.2.01 – Controller, manual control unit, Fig.
  • Page 24 1 2 2 3 3 4 4 Fig. 6.2.04 – Controller Fig. 6.2.05 – Controller with motor power cables 4. Plug in the drives as shown in Fig. 6.2.05. S = connection for power cable (with screws) H = connection for manual control unit...

  • Page 25: Assembling The Uplifter And Grab Handle

    Assembling the uplifter and grab handle The uplifter should be mounted on the side of the homecare bed that the patient uses to get in and out of bed. 1. For easier assembly of the uplifter, lower the homecare bed.

  • Page 26: Commissioning

    Commissioning 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 27: Operation

    Operation The products (incl. accessories) have been developed for use with a suitable mattress. Before and, if applicable, during each use of the product, note the following information: Inspect the product at regular intervals (see the section Maintenance schedule: Inspection by the user in the maintenance chapter).

  • Page 28: Castors

    The product can generally be used on tiles, carpets, laminate flooring and linoleum without any problem, though care should be taken to ensure that any damage that does occur is noticed at an early stage. aks GmbH accepts no liability for damage arising from everyday use on floors.

  • Page 29: Side Bars

    When using the side bars, there is an increased risk of crushing and shearing! Take top side of the mattress is at least 220 mm. If it is less than 220 mm, use the aks side bar care when lowering the side bars that no extremities (e.g. fingers, hands) are height extender.
  • Page 30 Ensure that the side bar height from the top side of the mattress is at least 220 mm. If it is less than 220 mm, use the aks side bar height extender.

  • Page 31: Uplifter

    Uplifter The uplifter with grab handle and strap (Fig. 8.3.01) is a useful aid which helps patients move in the homecare bed by themselves and encourages mobility. The standard position of the grab handle is above the centre of the homecare bed. It can be swivelled from the centre of the bed to the edge of the bed for safe access when getting into or out of the bed.

  • Page 32: Bed Surface

    Bed surface The homecare bed’s bed surface is electrically adjustable. It consists of several elements, which are shown in Fig. 8.4.01. When using alternating-pressure systems, observe the manufacturer’s specifications, as positioning the bed surface at an angle may impair the alternating-pressure system’s performance.
  • Page 33 1. Move the thigh part completely up. In doing so, the lower leg part moves with it. 2. Now move the thigh part down again. Each of the four ratchet adjuster positions are moved to successively. Reaching each individual stage can be recognised by an audible click. Stop the thigh part at the required stage.

  • Page 34: Manual Control Unit

    Manual control unit In order to execute the electrically powered functions, press the corresponding function button on the manual control unit until the desired position is reached (Fig. 8.5.01). Note that only one function button may ever be used at any one time. Otherwise the electrical system can shut down and/or be damaged due to overload.

  • Page 35: Lock Function

    Lock function The manual control unit is equipped with a lock function. This allows the user to disable the manual control unit’s functions using the corresponding key. There are many situations in which it is prudent to lock the manual control unit, for example: •...

  • Page 36: Emergency Lowering

    Emergency lowering Lowering using the battery (electric) Restoring the In the event of a power failure, you can lower the adjustment drives to their lowest position once. This is made possible using the 9-V block battery in the controller. However, the energy is only sufficient to lower the bed once.

  • Page 37: Mains Adapter

    Restoring the homecare bed to its original condition (requires one user) Never restore the homecare bed to its original condition while there is a patient in it. 4. Lift the back part. 5. Swivel the drive up and fully align the hole on the drive with that in the retaining plate. Fasten the drive to the retaining plate by inserting the tube clip.

  • Page 38: Patient Transport

    Patient transport The product is suitable for transporting patients. Before transport, make sure that the product has been set to its lowest position and that the bed surface is horizontal. The bed surface elements, such as the back part, thigh part and lower leg part, must have been lowered. Pull up the side bars until they audibly engage.

  • Page 39: Accessories/Combinations

    The following table summarises the accessories that have been checked and approved by aks GmbH for safe use of the aks homecare beds described in these instructions for use.
  • Page 40 We reserve the right to make changes and amendments. As a result, the specifications for REF may vary. Latest REF available on request. Combination The product can be combined with other aks products. These include our anti-decubitus alternating pressure systems and our patient hoists. Combinations that have not been approved by aks GmbH can cause hazards.

  • Page 41: Troubleshooting

    11 Troubleshooting Not all malfunctions are caused by product faults. The following table provides assistance for troubleshooting. If you are unable to rectify the malfunction using the information in this table, please contact your authorised dealer. Repairs to and measurements of the electrical components may only be performed by suitably qualified personnel (see chapter on Maintenance).

  • Page 42: Cleaning/Disinfecting

    12 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 43: General Cleaning And Disinfecting Instructions

    Failure to observe the safety instructions can result in significant damage to the product, and may have further aftereffects. 12.1 General cleaning and disinfecting instructions The product is suitable for reuse (see the chapter on Reuse). The product is manufactured subject to the highest quality standards.

  • Page 44: Cleaning By The User/Operator

    E.g. in accordance with the requirements of the Robert Koch Institute (RKI) the Verbund für Angewandte The following disinfectants and disinfection methods have been tested and approved by aks GmbH. Hygiene e. V. or another disinfectant that has been validated by the operator/treatment personnel.

  • Page 45: Storage

    13 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 46: Reuse

    (see chapter on Maintenance), they can also be used for longer. The fact that aks GmbH specifies an expected service life/useful life for the products does not represent an additional guarantee. Note that additional specifications regarding service life/useful life may apply to individual components (e.g.

  • Page 47: Disposal

    13  August 2005, the owner is legally obligated not to hand over electrical components to municipal collecting points but to send them directly to the manufacturer for disposal. The general terms and conditions of aks GmbH apply to these returns. Page 47...
  • Page 48 The end user is legally obligated to return discharged batteries. They can be submitted free-of-charge to a municipal collection point or returned to aks GmbH for proper disposal. The general terms and conditions of aks GmbH apply to these returns.

  • Page 49: Warranty

    Before using the product on parquet/natural wood floors, check whether the floor sealant is suitable for preventing the castors from causing damage (e.g. discolouration). Aks GmbH accepts no liability for damage arising from everyday use on floors (see chapter on operation, section Castors).

  • Page 50: Maintenance

    (see chapter on assembly, Section Assembling the uplifter and grab handle). Only original aks spare parts and aks accessory parts that are approved for this product may be used (see chapter on Accessories/combinations). Otherwise, any warranty claims and product liability are excluded.
  • Page 51 The latest versions of EN 62353 and the maintenance schedule must be used as test specifications for the products (incl. accessories) described in these instructions for use, and this must be properly documented. Perform all tests under normal indoor ambient conditions (humidity and temperature). Perform the tests in the specified order (visual inspection first, then functional check).

  • Page 52: Removing/Replacing The Batteries

    19.2 Removing/replacing the batteries If the product has been lowered by means of emergency lowering or using the battery instead of mains voltage, the 9-V block battery must be replaced. The original 9-V block battery must only be replaced with an equivalent alkaline manganese battery TYPE 6LR61.

  • Page 53: Maintenance Schedule: Inspection By The Operator

    Last inspected on: ______________ by: __________________________ Inspection prior to initial commissioning conducted on: by: __________________________ ______________ Data for the aks homecare bed Date of manufacture (MM/JJJJ) _____/__________ __________________________ Inventory number: ______________________ UDI-DI of the aks homecare bed Wooden homecare bed included wood side bar (HSG), packaged...
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  • Page 58  YES  NO Remark: Test date Company Inspector Signature Data for the aks homecare bed and the aks accessories Next maintenance/ Product Model Date of manufacture inspection Homecare bed Uplifter Grab handle with strap...

  • Page 59: Maintenance Schedule: Inspection By The User

    The following maintenance schedule provides help for this inspection: Inspection of the aks homecare bed/lifting homecare bed frame – check points Product and accessories show no obvious signs of damage or wear (e.g.
  • Page 60 Appendix – Leakage current test To conduct a leakage current measurement using the adapter, proceed as follows: • First, check the adapter for any obvious signs of damage on its enclosure/power cable/plug/ socket. Assess whether the adapter is still fully functional from an electrical perspective.

  • Page 61: Product Labelling

    20 Product labelling Fig. 20.01 – Single view of the Fig. 20.02 – Single view of the foot support uplifter Fig. 20.03 – Single view of the scissor lift Page 61...
  • Page 62 Product labelling Item Rating plate (technical) Position: - Foot support (inside) See also chapter on Technical data Rating plate (organisational) Position: - Foot support (inside) See also chapter on Technical data Date of manufacture Position: - Head and foot support...

  • Page 63: Warning Sign

    Item Product labelling Warning sign - Individual part weighs more than 20 kg Explanation of the symbols CE-Marking – this product satisfi es the applicable requirements of the Regulation (EU) 2017/745 on Medical Devices (MDR) and other legal requirements of the European Union regarding affi xing the relevant marking.
  • Page 64 Explanation of the symbols EN ISO 15223-1 Observe instructions for use Attention Manufacturer Date of manufacture Article number Serial number Air pressure, limit Humidity, limit Temperature, limit Keep dry/store in a dry place Protect against heat/sunlight Fragile, handle with care...
  • Page 65 ISO 15223-1 Protection type of the enclosure acc. to EN 60529 First digit: Level of protection against contact and foreign objects IPXX Second digit: Level of protection against water IPX4 4 – Protection against splash water on all sides IPX5 5 –...

  • Page 66: Technical Data

    21 Technical data General information on the products active class I medical device Classifi cation according to Regulation (EU) 2017/745, Annex VIII Basic UDI DI 425181871773011H2 Safe working load (incl. patient, mattress, accessories) [kg] Max. patient weight [kg] Operating force for the manual control unit [N] <...
  • Page 67 Electrical data limoss GmbH & Co. KG Input 100 to 240 V (AC); 50/60 Hz; 2.1 A bis 0.9 A SMPS Output 35 V (DC); 2 A Protection class Protection type IPX4 On-time Max. 10% or 2 minutes continuous operation Switch-on cycle Switch-off...
  • Page 68 Notes: Page 68...
  • Page 69 Notes: Page 69...
  • Page 70 Notes: Page 70...
  • Page 71 Enter the data for your product here: Type:  aks-L4  aks-L5  aks-D4 low entry  aks-B4 compact  aks-S4  aks-SB L  aks-SB XL  aks-SB XXL  aks-B4 L  aks-B4 XL  aks-B4 XXL Bed surface: ...
  • Page 72 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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