AKS saniflow p Instructions For Use Manual
AKS saniflow p Instructions For Use Manual

AKS saniflow p Instructions For Use Manual

Anti-decubitus alternating pressure system

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saniflow® p
Anti-decubitus alternating pressure system
Instructions for use
Translation of the original instructions for use

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  • Page 1 saniflow® p Anti-decubitus alternating pressure system Instructions for use Translation of the original instructions for use...
  • Page 2: Table Of Contents

    4 Scope of delivery _______________________________________________________ 16 5 Product overview _______________________________________________________ 17 ___________________________________________________ 19 Functional description 6 Commissioning _________________________________________________________ 21 _____________________________ 22 Fitting the aks-inkocover stretch cover to the product 7 First time use ___________________________________________________________ 23 8 Operation/use __________________________________________________________ 23 ______________________________________________________ 24 Normal operation ____________________________________________________________ 25...
  • Page 3 saniflow® p 19 Maintenance ___________________________________________________________ 36 ___________________________________________ 36 19.1 General maintenance instructions ________________________________ 38 19.2 Maintenance schedule: Inspection by the operator ___________________________________ 41 19.3 Maintenance schedule: Inspection by the user 20 Product labelling _______________________________________________________ 42 ___________________________________________________ 45 20.1 Quick reference guide 21 Technical data __________________________________________________________ 46 Version history Version...
  • 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 saniflow® p The saniflow® p anti-decubitus alternating pressure system (also referred to in the following as the product/products) consists of a pump unit and an alternating pressure mattress. It has been developed for decubitus prophylaxis. Among other things, the product features the following: •...
  • Page 6: Explanation Of The Symbols Used

    saniflow® p 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). Warning of dangerous electrical voltage Indicates safety instructions that must be observed in order to avoid danger through electrical voltage that may result in serious or fatal injury.
  • Page 7: Intended Use

    saniflow® p Intended use The products are active Class I medical devices according to Regulation (EU) 2017/745, Appendix VIII. The products are suitable for domestic use as well as for use in inpatient facilities. The products are intended for use by a trained caregiver (user). The products are only suitable for use in dry, indoor areas.
  • Page 8: Contraindication

    saniflow® p 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. Potential further contraindications include, for example, acute multiple traumas, unstable bone fractures, unstable spinal injuries or other spinal diseases.
  • Page 9: Safety Instructions

    saniflow® p 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 saniflow® p Electrically instructed persons are persons who have been instructed and, if necessary, trained by a qualified electrician regarding their assigned tasks and the possible hazards in the event of improper behaviour, as well as regarding the necessary safety equipment and safety measures. 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.
  • Page 11: General Safety Instructions

    saniflow® p 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). Do not leave children unsupervised in the vicinity of the product. The anti-decubitus alternating pressure system is not a toy.
  • Page 13: Safety Instructions For The Operator

    If you experience any serious incidents involving the product (incl. accessories), please contact aks GmbH and the relevant national authorities without delay. Safety instructions for the operator Prior to initial use and every reuse, train the user on the product itself (incl. ...
  • Page 14 saniflow® p Only allow suitable qualified personnel to perform the commissioning, maintenance, treatment (cleaning/disinfecting) and repair of the product (incl. accessories). Make sure that the user is physically and mentally able to perform the following activities in relation to the medical devices (incl.  accessories) described in these instructions for use: •...
  • Page 15: Safety Instructions For The User

    saniflow® p When using the product, comply with all the provisions of the EU Medical Devices Adaptation Act (MPEUAnpG), and in particular the Medical Devices Implementation Act (MPDG) contained in Article 1, and all additionally applicable legal regulations as well as with the applicable work health and safety regulations, accident prevention regulations and the general provisions concerning the handling of technical devices.
  • Page 16: Scope Of Delivery

    saniflow® p 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: Product Overview

    saniflow® p Product overview Retaining bracket Pressure regulator Mains power switch Case Mains plug Power supply line Fig. 5.01 - Side view of saniflow® p pump unit Quick reference guide Connecting piece Rating plate Rubber feet Fig. 5.02 - Rear view of saniflow® p pump unit Seite 17...
  • Page 18 saniflow® p Separated flow air® micro perforations Supply hoses Fold-over ends (head end) air chambers (cells) Fold-over ends (foot end) Fig. 5.03 - Small-cell alternating pressure mattress, top side Seite 18...
  • Page 19: Functional Description

    saniflow® p Functional description Fig. 5.1.01 – Control panel for saniflow® p pump unit Explanation of the controls for the pump unit Element Function Pressure regulator You set the optimum pressure for the patient here. You switch the device on and off here. If the pump unit is switched on, the green Mains power switch operation indicator lamp in the mains power switch lights up.
  • Page 20 The product is protected from soiling by a liquid-impermeable aks-inkocover stretch cover. The aks-inkocover stretch cover is available as an optional accessory (see chapter on Accessories/ combinations). It has an elastic strap all around its edge and it is stretched over the mattress. In the event of soiling, it can be removed and washed in a washing machine using normal household washing agents (see chapter on Cleaning/disinfecting).
  • Page 21: Commissioning

    saniflow® p Commissioning The product (incl. accessories) was developed for use on a care bed or a “standard bed”. Do not use a damaged or heavily worn product. Inspect the relevant product (incl.  accessories) before and during set-up for damage and defects. The power supply line, the pump unit case as well as the connections and the alternating pressure mattress must not be damaged.
  • Page 22: Fitting The Aks-Inkocover Stretch Cover To The Product

    Next, place a separate mattress cover on the alternating pressure mattress, e.g. aks-inkocover stretch cover (see chapter on Fitting the aks-inkocover stretch cover to the product) and fit a bed sheet over the mattress cover. Make sure that the sheet is fitted without creases.
  • Page 23: First Time Use

    saniflow® p 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: Normal Operation

    Fit a separate cover such as the aks-inkocover stretch cover to the alternating pressure mattress. Unfolding of the alternating pressure mattress must not be obstructed. Next, fi t a thin bed sheet over the alternating pressure mattress or over the aks-inkocover stretch cover. Make sure that the sheet is fi tted without creases.
  • Page 25: Cycle Time

    saniflow® p Cycle time The product’s cycle time is six minutes. Using the control unit of the pump unit, both air chamber circuits of the alternating pressure mattress are inflated and deflated intermittently in a cycle of six minutes. Power failure In the event of power failure, there is the risk of rapid pressure loss in the alternating pressure mattress.
  • Page 26: Troubleshooting

    saniflow® p Troubleshooting Not all malfunctions are caused by product faults. The following table provides assistance for troubleshooting in case of malfunctions. 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)! Other persons (e.g.
  • Page 27: Accessories/Combinations

    Latest available on request. Combination The product can be combined with other aks GmbH products. These include the aks-inkocover stretch cover, for example. As a mattress overlay system, the product may only be used in combination with a standard foam mattress or with a mattress underlay (minimum height 10 cm).
  • Page 28: Cleaning/Disinfecting

    saniflow® p 11 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 micro-organisms (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 29: General Cleaning And Disinfecting Instructions

    saniflow® p 11.1 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.
  • Page 30: Cleaning By The User/Operator

    The pump unit and the alternating pressure mattress together with the aks-inkocover stretch cover can be cleaned by hand with a mild, alcohol-free cleaning agent and a cloth. In addition, the aks-inkocover stretch cover for the alternating pressure mattress can be washed in a washing machine using normal household washing agents.
  • Page 31: 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 32: Shutdown

    saniflow® p 12 Shutdown If the products described in these instructions for use will no longer be used and should be shut down, proceed as follows: The patient must no longer be lying on the alternating pressure mattress when removing it from service.
  • Page 33: Reuse

    Cleaning/disinfecting, they can also be used for longer. for longer. The fact that aks GmbH specifies an expected service life/useful life for the products The fact that aks GmbH specifies an expected service life/useful life for the products does not represent an additional guarantee.
  • Page 34: Disposal

    13 August 2005, the owner is legally obligated not to hand over electrical components to municipal collecting Fig. 16.01 – WEEE marking points but to send them directly to the manufacturer for disposal. The general terms and conditions of aks GmbH apply to these returns. Seite 34...
  • Page 35: Warranty

    (e.g. attachments) without Non-observance of the instructions for use, improper use, improperly carried out the permission of aks GmbH render the warranty and general product liability void. maintenance work, and technical modifications and additions (e.g. attachments) without the permission of aks GmbH render the warranty and general product liability void.
  • Page 36: General Maintenance Instructions

    Maintenance may only be carried out when the anti-decubitus alternating pressure mattress is unoccupied. 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. You must not make any technical modifications and additions without permission from aks GmbH.
  • Page 37 saniflow® p 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. 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.
  • Page 38 saniflow® p 19.2 Maintenance schedule: Inspection by the operator Perform maintenance of the product (incl. accessories) at least once a year , before every reuse, 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 39 The following table provides help for this inspection: Item Inspection of the aks anti-decubitus alternating pressure system – inspection points* Check of the basic requirements Appropriate and safe use (see chapter Intended use, section Intended purpose) Permissible combination of pump unit and alternating pressure mattress...
  • Page 40 Product Model Date of manufacture inspection Pump unit sanifl ow® p Alternating pressure 90 x 192 cm mattress We recommend the certifi ed treatment unit at aks pura GmbH for the periodic monitoring, cleaning and disinfection of the products. Seite 40...
  • Page 41 No soiling is used. immediately. aks-inkocover stretch cover: Elastic strap suffi ciently elastic and tight Pump unit incl. power supply cable – shows no obvious damage or wear The following maintenance schedule provides help for this inspection: Pump unit –...
  • Page 42: Product Labelling

    X Y Y M M X X X X X YY – year of manufacture MM – month of manufacture Rating plate aks-inkocover stretch cover Label (inside) Explanation of the care symbols EN ISO 3758 Hot wash (normal washing cycle) Washing temperature 95 °C, normal process...
  • Page 43 saniflow® p 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. WEEE marking (the device must not be disposed of with domestic waste) Dimensions of the product Medical device as per Regulation (EU) 2017/745 on medical devices class I...
  • Page 44 saniflow® p Explanation of the symbols EN ISO 15223-1 ulation Protect against heat/sunlight of the Fragile, handle with care Explanation of the symbols IEC 60417 For indoor use only Protection class II against electric shock VIII Application part type BF umeric on the Device fuse...
  • Page 45 Rating plate aks-inkocover stretch cover saniflow® p Label (inside) Explanation of the care symbols EN ISO 3758 Explanation of the care symbols EN ISO 3758 Hot wash (normal washing cycle) Coloured wash (normal washing cycle) Washing temperature 95 °C, normal process Washing temperature 60 °C, normal process...
  • Page 46: Technical Data

    2.3 Number of cells Material Air fi lling time approx. 15 minutes aks-inkocover stretch cover (optional) 100% polyester with polyurethane membrane Material Weight: 100 g/m All specifi cations regarding dimensions and weights are approximate specifi cations. The sizes of the mattresses are aff ected by manufacturing tolerances; this means that deviations in the stated dimensions of up to 2 cm are possible.
  • Page 47 Enter the data for your product here: Type: sanifl ow® p Mattress protection:   aks-inkocover ______________ (01)042518187 __ __ __ __ __ __________________________________________ Pump unit __________________________________________ Small-cell alternating pressure mattress SIZE [cm] 90 x 192 Year ____________ Month ____________...
  • Page 48 Reprints whether in whole or in part are only allowed with prior permission by the publisher. 19/01/2022 All rights reserved, particularly the right to make technical amendments. Printing errors excepted. 17B15320_01...

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