AKS -D4 90 Instructions For Use Manual
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AKS -D4 90 Instructions For Use Manual

AKS -D4 90 Instructions For Use Manual

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aks-D4 90 / aks-D4 100
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"
With optional
foot-end lowering
Date:
2022-12-12
Version
02

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Summary of Contents for AKS aks-D4 90

  • Page 1 90 / aks-D4 100 Instructions for use Translation of the original instructions for use With optional foot-end lowering DIN EN ISO 13485 “Certified quality management system for the development, production and distribution Date: 2022-12-12 of equipment and accessories for patient positioning and patient transport”...

  • Page 2: Table Of Contents

    90 / aks-D4 100 TABLE OF CONTENTS 1 Introduction ____________________________________________________________ 4 _____________________________________________ 7 Explanation of the symbols used 2 Intended use ____________________________________________________________ 8 _______________________________________________________ 8 Intended purpose _____________________________________________________________ 8 Indication ________________________________________________________ 8 Contraindication ____________________________________________________________ 8 Side effects 3 Safety instructions _______________________________________________________ 9...
  • Page 3 90 / aks-D4 100 14 Reuse _________________________________________________________________ 53 15 Service life _____________________________________________________________ 53 16 Disposal _______________________________________________________________ 54 17 Warranty ______________________________________________________________ 56 18 Declaration of conformity ________________________________________________ 56 19 Maintenance ___________________________________________________________ 57 ___________________________________________ 57 19.1 General maintenance instructions ___________________________________________ 59 19.2...

  • 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 90 / aks-D4 100 The aks-D4 90 / aks-D4 100 homecare bed (also referred to in the following as the product/products) meets the requirements of modern homecare beds. Thanks to its homely wood trim, the homecare bed is easy to integrate into an existing living ambience.
  • Page 6 90 / aks-D4 100 The different versions These instructions for use describe the available functions/equipment. Depending on the version, your homecare bed may not possess some of these functions (e.g. foot-end lowering). This product is available with the following bed surface variants: •...

  • Page 7: Explanation Of The Symbols Used

    90 / aks-D4 100 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 8: Intended Use

    90 / aks-D4 100 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 9: Safety Instructions

    90 / aks-D4 100 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.
  • Page 10 90 / aks-D4 100 Qualified electricians as defined in the German accident prevention regulations DGUV Specification  3 are 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 11: General Safety Instructions

    90 / aks-D4 100 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 90 / aks-D4 100 Use only original aks accessories/spare parts in order to avoid danger (see the chapter For patients with a height of 185  cm or more, we recommend using a bed extension on Accessories/combinations). (see the chapter on assembly, section Accessories – Bed extension: Assembly).

  • Page 13: Safety Instructions For The Operator

    90 / aks-D4 100 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 90 / aks-D4 100 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 15: Safety Instructions For The User

    90 / aks-D4 100 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 16: Scope Of Delivery

    90 / aks-D4 100 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 17 90 / aks-D4 100 The product is available in the following optional variants: Variants aks-D4 90 aks-D4 100 3554111 3558111 3554110 3558110 3554115 3558115 3554114 3558114 3554141 3558141 3554140 3558140 3554145 3558145 3554144 3558144 3554011 3558011 3554010 3558010 3554054...
  • Page 18 90 / aks-D4 100 Delivery on transport aid • 2 x stand parts (Fig. 4.02) • 1 x head support (Fig. 4.03) • 1 x foot support (Fig. 4.03) • 4 x wood side bar slats (Fig. 4.04) •...

  • Page 19: Foot Support

    Fig. 4.03 – Bed surface halves with metal mesh Fig. 4.04 – Wood side bar slats Fig. 4.05 – Uplifter with grab handle and strap Fig. 4.06 – Contents of the aks bag Fig. 4.07 – Side bar slider Page 19...

  • Page 20: Product Overview

    Drive unit on stand part Castor with Thigh and lower individual arrester leg part with drive Fig. 5.01 – aks-D4 with metal mesh bed surface and wood side bars Figure shows contoured European plug Page 20...

  • Page 21: Assembly

    90 / aks-D4 100 Assembly Assemble and dismantle the product according to the specifications in these instructions for use. 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/ Observe the safety instructions and use protective materials placed on the ground (e.g.

  • Page 22: Assembling The Homecare Bed

    90 / aks-D4 100 6.1 Assembling the homecare bed If you have established that the delivery is complete based on the chapter on the scope of delivery and that the delivery is undamaged, proceed as follows to set up the product.

  • Page 23: Assembling The Controller (Standard)

    90 / aks-D4 100 6.2 Assembling the controller (standard) For homecare beds with the optional foot-end lowering, assemble the controller as detailed under item 6.3. 1. Take the controller from the cardboard box (Fig.  6.2.01) and push it onto the back part drive.
  • Page 24 90 / aks-D4 100 d under t drive. 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. screw S = connection for power cable (with screws)

  • Page 25: Assembling The Controller (Optional Foot-End Lowering)

    90 / aks-D4 100 6.3 Assembling the controller (optional foot-end lowering) 1. Take the controller and holder from the cardboard box (Fig. 6.3.01). 2. Fit the holder to the controller (Fig. 6.3.02). Fig. 6.3.01 – Controller, manual control unit, mains Fig.
  • Page 26 90 / aks-D4 100 Connector cover strip Fig. 6.3.05 – Controller Fig. 6.3.06 – Controller with connector cover strip = H = connection for manual control unit = 1 = connection for back part drive = 2 = connection for thigh part drive...

  • Page 27: Assembling The Side Bars

    90 / aks-D4 100 6.4 Assembling the side bars 1. Before you start assembling the side bars, connect the homecare bed to the mains supply and move the reclining surface to Rounded edge, a height of approx. 60 cm. 2. To assemble the wood side bar slats, place two side bar slats flat and parallel on the floor.

  • Page 28: Assembling The Uplifter And Grab Handle

    90 / aks-D4 100 6.5 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 29: Accessories - Bed Extension: Assembly

    90 / aks-D4 100 6.6 Accessories – Bed extension: Assembly The bed extension enables you to extend the length of the bed surface from 200 cm to 220 cm. This ensures that tall patients can also enjoy the comfort they are used to when lying down.
  • Page 30 90 / aks-D4 100 6. Undo the two flat-head screws at the foot end that connect the bed surface frame to the stand part (Fig. 6.6.03). 7. Disconnect the foot end of the bed surface from the stand part, and slowly and gently lower the bed surface to the ground.

  • Page 31: Commissioning

    90 / aks-D4 100 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 32: Operation

    90 / aks-D4 100 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 33: Side Bars

    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 34 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. The side bars only provide protection against accidentally falling out if they are raised on both sides (head and foot end) and if the bed surface elements such as back, thigh and lower leg part are in the horizontal position.

  • Page 35: Uplifter

    90 / aks-D4 100 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.

  • Page 36: Bed Surface

    90 / aks-D4 100 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 37 90 / aks-D4 100 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.

  • Page 38: Manual Control Unit

    90 / aks-D4 100 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 39 90 / aks-D4 100 Adjustment of the back part Adjustment of the thigh part Bed surface adjustment Adjustment of the foot-end lowering (optional) Fig. 8.5.01 – Manual control Fig. 8.5.02 – Manual control unit unit with foot-end lowering Pressing the button tilts the homecare bed to the lowered foot-end position.

  • Page 40: Lock Function

    90 / aks-D4 100 Lock function The manual control unit is equipped with a lock function. This enables the user to disable the functions of the manual control unit using the corresponding key. There are many situations in which it is prudent to lock the manual control unit, for example: •...

  • Page 41: Emergency Lowering

    90 / aks-D4 100 Lock function for foot-end lowering (optional) On the back of the manual control unit is a second rotary switch (Fig. 8.6.04); this can be used to lock the foot-end lowering function separately (Fig. 8.6.05). Unlocked...
  • Page 42 90 / aks-D4 100 Emergency lowering of the back part (manual) If the back part has to be lowered in less than 30 seconds (e.g. to perform CPR), lower the back part manually. Always enlist the help of another person for manual emergency lowering! Uncontrolled falling of the back part can severely injure both user and patient! The emergency lowering must only be performed by trained users.

  • Page 43: Mains Adapter

    90 / aks-D4 100 Mains adapter The product is supplied with low voltage via the external mains adapter. The operational state is indicated by a green LED as soon as the mains adapter is plugged into a mains socket (Fig. 8.8.01).

  • Page 44: Patient Transport

    90 / aks-D4 100 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.

  • Page 45: 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 46 90 / aks-D4 100 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. Non-original side bars/height extenders can cause hazards.

  • Page 47: Troubleshooting

    90 / aks-D4 100 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.

  • Page 48: Cleaning/Disinfecting

    90 / aks-D4 100 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 49: General Cleaning And Disinfecting Instructions

    90 / aks-D4 100 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. The following manufacturer information on cleaning/disinfecting must always be observed to ensure that the characteristics stated by the manufacturer do not change. This is the only way to guarantee that the product is safe and effective for its intended purpose.

  • Page 50: Cleaning By The User/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. Wipe disinfection Effectiveness* Manufacturer of disinfectant...

  • Page 51: Storage

    90 / aks-D4 100 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.

  • Page 52: Storage On The Transport Aid

    90 / aks-D4 100 13.2 Storage on the transport aid To save space during storage, the homecare bed can be stored on the transport aid. To do so, the homecare bed must be dismantled by reversing the steps described in the chapter on Assembly.

  • Page 53: 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 54: 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 54...
  • Page 55 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 56: 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 57: 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 58 90 / aks-D4 100 In Germany, the EU Medical Devices Adaptation Act (MPEUAnpG) applies, including the Medical Devices Implementation Act (MPDG) and the Medical Devices Operator Ordinance (MPBetreibV). The corresponding national laws, regulations and requirements are applicable in other countries.

  • Page 59: Removing/Replacing The Batteries

    90 / aks-D4 100 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 60: Maintenance Schedule: Inspection By The Operator

    90 / aks-D4 100 19.3 Maintenance schedule: Inspection by the operator Perform maintenance of the product (incl.  accessories) at least once a year, before every reuse, and Perform maintenance of the product (incl.  accessories) at least once a year, before every reuse, and after every repair.
  • Page 61 Sprung slats 04251818704758 04251818704918 aks-D4 100   knee bend Metal mesh 04251818704741 04251818704895   aks-D4 90 / aks-D4 100 Sprung slats 04251818704772 04251818704970 aks-D4 100   FTL* + knee bend Metal mesh 04251818704765 04251818704963   UDI-DI for the aks homecare bed...
  • Page 62 90 / aks-D4 100 The following tables provides help for this inspection: Item Inspection of the aks homecare bed – check points* Check of the basic requirements Appropriate and safe use (no collision points or objects above or under the bed)
  • Page 63 90 / aks-D4 100 Visual inspection of the electrical parts The product must be disconnected from the mains supply. Product-specific drive components present, no systems comprising a mixture of different brands (see Technical Data chapter) Power cable and mains adapter (SMPS) undamaged...
  • Page 64 Overall assessment of the aks homecare bed aks homecare bed and accessories are in order:  YES  NO Remark: Test date Company Inspector Signature Data for the aks homecare bed and the aks accessories Date of Next maintenance/ Product Model manufacture inspection Homecare bed Uplifter...

  • Page 65: Maintenance Schedule: Inspection By The User

    The following maintenance schedule provides help for this inspection: Regularly and at short intervals, check the product (incl. accessories) for obvious damage Inspection of the aks homecare bed/lifting homecare bed frame – check points If any checks indicate defects/damage (e.g. damaged insulation), immediately disconnect or wear on its mechanical and electrical components (e.g.
  • Page 66 90 / aks-D4 100 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 67: Product Labelling

    90 / aks-D4 100 20 Product labelling Seite 1 von 1 1300686~0.SLDASM 06.07.2022 Fig. 20.01 – Uplifter Fig. 20.02 – Foot support Page 67...
  • Page 68 90 / aks-D4 100 Item Product labelling 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:...
  • Page 69 90 / aks-D4 100 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 70 90 / aks-D4 100 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...
  • Page 71 90 / aks-D4 100 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 72: Technical Data

    90 / aks-D4 100 21 Technical data General information on the product active class I medical device according to Regulation (EU) Classifi cation 2017/745, Appendix VIII Basic UDI DI 425181871770112GL Safe working load (incl. patient, mattress, accessories) [kg] Max. patient weight [kg] Operating force for the manual control unit [N] <...
  • Page 73 90 / aks-D4 100 Additional information on the product - Steel (powder-coated or galvanised) - Commercially available plastics (POM, ABS, PP, PVC, PA6.6) - Rubber Materials used - Wood (varnished or covered in decorative fi lm) - MDF boards covered in decorative fi lm...
  • Page 74 90 / aks-D4 100 Notes: Page 74...
  • Page 75 90 / aks-D4 100 Enter the data for your product here: Type:  aks-D4 90  aks-D4 100 Bed surface:  Sprung slats  Metal mesh Version:  Knee bend  Foot-end lowering (01)042518187 __ __ __ __ __...
  • Page 76 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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