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aks-microplot plus
Anti-decubitus pressure-reducing support mattress
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:
2022-02-11
Version
01
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Table of Contents
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Summary of Contents for AKS Microplot Plus
- Page 1 Anti-decubitus pressure-reducing support mattress 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: 2022-02-11 of equipment and accessories for patient positioning and patient transport”...
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Page 2: Table Of Contents
6 Commissioning _________________________________________________________ 18 ________________________________ 20 Fitting the inkoair® mattress cover to the product _____________________________ 21 Fitting the aks-inkocover stretch cover to the product 7 First time use ___________________________________________________________ 22 8 Use ___________________________________________________________________ 22 9 Accessories/combinations _______________________________________________ 23 10 Cleaning/disinfecting ___________________________________________________ 24 ___________________________________ 24 10.1... - Page 3 Version history Version Date Change 2022-02-11 Adaptations to Regulation (EU) 2017/745 Page 3...
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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-microplot plus foam cube mattresses available in different sizes (hereinafter also referred to as the products) have been developed for decubitus prophylaxis and therapy. Among other things, they feature the following properties: • Favourable microclimate regulation thanks to cube-shaped reclining surface •...
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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 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 products are only suitable for use in dry, indoor areas. -
Page 8: Contraindication
Contraindication In combination with a care bed (EN 60601-2-52), the products are only suitable for adult patients with a body weight of at least 40 kg, a height of at least 146 cm, and a body mass index (BMI) equal to or higher than 17. -
Page 9: Safety Instructions
Safety instructions The safety instructions apply to all and any persons who perform work in any way with or on the product. 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 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.
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Page 11: General Safety Instructions
Match the functional characteristics of the aks foam mattress to the specific disabilities and functional limitations of the respective patient. Potential contraindications must be observed here. - Page 12 For hygiene reasons, always use the product 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.
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Page 13: 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 14: Safety Instructions For The User
If relatives take over responsibility for the patient’s care, check that these relatives are in a position to consult a health care professional when in doubt. Explain to the users when they should ask a health care professional for advice, e.g.: •... -
Page 15: Scope Of Delivery
• Depending on the order, alternatively: 1 x inkoair® mattress cover (fitted on the mattress) 1 x aks-inkocover stretch cover (included separately) Fig. 4.01 - Delivered rolled up • 1 x instructions for use The product is 16 cm high and can be delivered in the following variants/dimensions:... -
Page 16: Product Overview
Product overview inkoair® mattress cover Reclining with zip surface with cube structure Foam tub with edge zone Fig. 5.01 - aks-microplot plus with inkoair® mattress cover aks-inkocover Reclining stretch cover surface with cube structure Foam tub with edge zone Fig. 5.02 - aks-microplot plus with aks-inkocover stretch cover... - Page 17 The product is protected from soiling by the liquid-impermeable inkoair® or aks-inkocover protective mattress covers. The inkoair® mattress cover is closed with a zip, while the aks-inkocover stretch cover has an elastic strap all around its edge and it is stretched over the mattress. In the event of soiling, they can be removed and washed in a washing machine using normal household washing agents (see chapter on Cleaning/disinfecting).
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Page 18: Commissioning
Make sure that the “aks” imprint and the foot symbol are upright on the inkoair® mattress cover. The “aks” imprint should be positioned at the head of the bed and the foot symbol should be positioned at the foot (Fig. 6.01). - Page 19 Fit the aks-inkocover stretch cover onto the product (see Commissioning chapter, section Fitting the aks-inkocover stretch cover to the product). Head (aks) Foot (foot symbol) Fig. 6.01 - Mattress with inkoair® mattress cover Secure the product on the support surface of your bed to prevent it from slipping. In order to do so, wedge the pressure-reducing support mattress between the mattress holders or in the frame construction.
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Page 20: Fitting The Inkoair® Mattress Cover To The Product
Fitting the inkoair® mattress cover to the product The product is delivered fitted with a cover. However, it may be necessary to remove and then re-fit the cover for cleaning (see chapter Cleaning/disinfecting). To fit the cover, proceed as follows: •... -
Page 21: Fitting The Aks-Inkocover Stretch Cover To The Product
Remove the aks-inkocover stretch cover from the packaging. Take care not to damage the stretch cover. • Fit the aks-inkocover stretch cover over the mattress, taking care to prevent any creases. Make sure that the corners of the foam core are fitted into the corners of the stretch cover. •... -
Page 22: First Time Use
Match the functional characteristics of the aks foam mattress to the specific disabilities and functional limitations of the respective patient. If a patient has restless legs syndrome, for example, we recommend positioning them so that their heels are not in contact with the mattress. -
Page 23: Accessories/Combinations
Accessories/combinations Only original aks accessory/spare parts may be used as accessories/spare parts because only these have been tested by aks GmbH and thus guarantee faultless and safe function. Accessories/spare parts that have not been approved by aks GmbH can cause hazards. -
Page 24: Cleaning/Disinfecting
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 25: Cleaning By The User/Operator
10.2 Cleaning by the user/operator The inkoair® mattress cover or aks-inkocover stretch cover can be cleaned by hand with a mild, alcohol-free cleaning agent and a cloth. Alternatively, the inkoair® mattress cover or aks-inkocover stretch cover can be washed in a washing machine using normal household washing agents. -
Page 26: Disinfection By The User
The aks-inkocover stretch cover is a cover that is pulled over the mattress and held in place by a bordered elastic strap; the underside is only partially enclosed. The sides are protected against liquids running down. -
Page 27: Approved Disinfectants And Disinfection Methods
(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 Manufacturer of... -
Page 28: Storage
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 29: Service Life
If the products are treated properly and handled carefully, and they are cleaned/ disinfected as described in the chapter on Cleaning/disinfecting, 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. 14 Disposal The products described in these instructions for use are made of plastic and, in some cases, metal (zip of the mattress cover). -
Page 30: Warranty
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 31: Maintenance
Maintenance may only be carried out when the mattress is unoccupied. 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 32: Maintenance Schedule: Inspection By The Operator
17.2 Maintenance schedule: Inspection by the operator Service the product at regular intervals , every time it is returned to use after storage and after every repair. Article 7 of the MPBetreibV specifies the following: “Maintenance measures refer to inspections and maintenance tasks that are necessary in order to continuously ensure safe and proper operation of medical devices. - Page 33 Mattress cover: “Top/head” label on the front side present and legible (see chapter on Product labelling) Stretch cover: Elastic strap sufficiently elastic and tight Overall assessment: Anti-decubitus foam mattress aks anti-decubitus foam mattress and accessories are in order: YES NO Remark:...
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Page 34: Maintenance Schedule: Inspection By The User
17.3 Maintenance schedule: Inspection by the user In addition to the periodic inspections by suitable qualified personnel, the user must check at regular intervals that the product is in a safe state. Do not use the product if you are concerned about the safety of using it. -
Page 35: Product Labelling
18 Product labelling Product labelling Rating plate Mattress imprint (on side) Bottom marking Mattress imprint (bottom) Rating plate Mattress cover label (inside) Top/head marking Mattress cover label (outside) Rating plate Stretch cover label (inside) Page 35... - Page 36 Explanation of the symbols CE marking – this product satisfies the applicable requirements of the Regulation (EU) 2017/745 on Medical Devices (MDR) and other legal requirements of the European Union regarding affixing the relevant marking. Dimensions of the product...
- Page 37 Explanation of the symbols IEC 60417 Stacking limit by quantity Explanation of the symbols EN 60601-2-52 Min. patient body weight = 40 kg Min. patient height= 146 cm Min. patient BMI = 17 Body mass index (BMI) is a measurement of a person’s outline based on their...
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Page 38: Technical Data
19 Technical data General information on the product Classification Class I medical device according to Regulation (EU) 2017/745, Appendix VIII Basic UDI DI 425181871240112DJ Permitted patient weight [kg] 40 to 120 Ambient temperature [°C] Use 10 to 50... - Page 39 Enter the data for your product here: Type: aks-maxiplot aks-microplot plus aks-varioplus aks-duoplot aks-duoplot RV aks-duoplot plus aks-duoplot plus RV aks-memoplot aks-memoplot RV aks-theraplot aks-viscoplot aks-HD85 L ...
- Page 40 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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