AKS saniflow IV Instructions For Use Manual
AKS saniflow IV Instructions For Use Manual

AKS saniflow IV Instructions For Use Manual

Anti-decubitus alternating pressure system

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

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Summary of Contents for AKS saniflow IV

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

    saniflow® IV TABLE OF CONTENTS 1 Introduction ____________________________________________________________ 4 _____________________________________________ 6 Explanation of the symbols used 2 Intended use ____________________________________________________________ 7 _______________________________________________________ 7 Intended purpose _____________________________________________________________ 7 Indication ________________________________________________________ 8 Contraindication ____________________________________________________________ 8 Side effects 3 Safety instructions _______________________________________________________ 9 __________________________________________ 9 Explanation of the groups referred to ________________________________________________ 11...
  • Page 3 saniflow® IV 19 Maintenance ___________________________________________________________ 43 ___________________________________________ 43 19.1 General maintenance instructions ________________________________ 45 19.2 Maintenance schedule: Inspection by the operator ___________________________________ 49 19.3 Maintenance schedule: Inspection by the user 20 Product labelling _______________________________________________________ 50 ___________________________________________________ 53 20.1 Quick reference guide 21 Technical data __________________________________________________________ 54 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® IV The saniflow® IV anti-decubitus alternating pressure systems (also referred to in the following as the product) are available in different sizes and each consist of a pump unit and an alternating pressure mattress. They have been developed for decubitus prophylaxis and therapy. Among other things, the products feature the following: •...
  • Page 6: Explanation Of The Symbols Used

    saniflow® IV 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® IV 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® IV 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® IV 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® IV 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® IV 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® IV 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® IV 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® IV 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® IV Product overview Retaining Control bracket panel Case Pressure setting diagram Mains power switch Power supply line Mains plug Fig. 5.01 – Front view of pump unit Mounting feet (rear side) Quick reference guide Rating plate Air filter Rubber strips Fuses Mounting feet...
  • Page 18 saniflow® IV Mattress top side Mattress cover with zip Cells Compartment for mattress underlay End plugs for Supply hoses fast deflation with connector Fig. 5.03 – Top side of alternating pressure mattress Mattress rear side Packaging straps Fastening straps Fig. 5.04 – Underside of alternating pressure mattress Page 18...
  • Page 19: Functional Description

    saniflow® IV Functional description Fig. 5.1.01 – saniflow® IV pump unit control panel Explanation of the display elements and controls of the pump unit Element Pictogram Function Cycle time This is where you set the suitable cycle time for the patient. Pressure You set the optimum pressure for the patient here.
  • Page 20 saniflow® IV The product consists of a pump unit and an air-filled alternating pressure mattress that are connected to each other by two supply hoses. The pump unit contains an electrically operated pump, a synchronised air distributor and an electronic pressure sensor, which function together as a microprocessor-controlled control unit.
  • Page 21: Commissioning

    saniflow® IV 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 saniflow® IV Fasten the alternating pressure mattress by tensioning the four fastening straps on the underside of the alternating pressure mattress (Fig.  5.04) under the corners of the reclining surface of the bed. In the case of beds with an adjustable reclining surface, all movement functions of the bed must be able to be performed without damaging the alternating pressure mattress.
  • Page 23 saniflow® IV Fig. 6.03 – Connection socket Fig. 6.04 – Connector plug 13. Check whether the supply and distribution hoses of the alternating pressure mattress are completely closed by the end plugs. The end plugs are located on the right-hand side (from the point of view of the person lying in bed) at the head end of the alternating pressure mattress (Fig. 5.03).
  • Page 24: First Time Use

    saniflow® IV 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 25: Normal Operation

    saniflow® IV Normal operation Before operation, ensure that the alternating pressure mattress is securely attached by the fastening straps to the reclining surface of the bed and that the supply hoses are not kinked, pinched or twisted. While using the product, check the support pressure between the patient and the alternating pressure mattress regularly by applying the hand test (Fig.
  • Page 26 saniflow® IV Now check the set pressure using the hand test. Slide your flat hand between the buttocks of the patient and the deflated cell of the alternating pressure mattress. For optimum positioning, there must be a distance of approximately 3-4 cm between the buttocks and the deflated cell (Fig.
  • Page 27: Cycle Time

    saniflow® IV Cycle time The product provides the option of changing the cycle time for the alternating pressure intervals. You can set a cycle time in 4 stages of 10, 15, 20 or 25 minutes on the pump unit. To adjust the setting, press the cycle time button (Fig. 5.1.01) one or more times.
  • Page 28: Power Failure

    saniflow® IV Power failure In the event of power failure, there is the risk of rapid pressure loss in the alternating pressure mattress. Proceed as follows in order to prevent this: Disconnect the supply hose connectors from the pump unit by pressing the releasable lock (Fig. 8.5.01).
  • Page 29: Patient Transport

    saniflow® IV Patient transport The power supply line and the supply hoses must not be driven over. Note the information in the instructions for use for the care bed in question. If the patient is transported on the alternating pressure mattress in a reclining position, the interruption to the power supply can cause rapid pressure loss in the alternating pressure mattress.
  • Page 30: Leak Alarm

    saniflow® IV Leak alarm The product is equipped with an alarm function to prevent the patient developing bedsores in the case of pressure loss (e.g. due to leaks). If there is a pressure loss in the system, the red “low pressure” LED lights up.
  • Page 31: Fast Deflation

    saniflow® IV Fast deflation In an emergency, the alternating pressure mattress can be quickly deflated as follows: Disconnect the connectors for the supply hoses from the pump unit by pressing the releasable lock (Fig. 8.8.01). Remove both end plugs on the supply and distributor hoses (Fig. 8.8.02 and Fig. 8.8.03).
  • Page 32: Troubleshooting

    saniflow® IV 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 33: Accessories/Combinations

    10 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 34: Cleaning/Disinfecting

    saniflow® IV 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 35: General Cleaning And Disinfecting Instructions

    saniflow® IV 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. This is the only way to guarantee that the product is safe and effective for its intended purpose.
  • Page 36: Cleaning By The User/Operator

    saniflow® IV 11.2 Cleaning by the user/operator The pump unit, the alternating pressure mattress together with the mattress cover, and the mattress underlay together with the cover can be cleaned by hand with a mild, alcohol-free cleaning agent and a cloth. In addition, the mattress cover of the alternating pressure mattress and the cover of the mattress underlay can be washed in a washing machine using normal household laundry detergents.
  • Page 37: Disinfection By The User

    saniflow® IV 11.3 Disinfection by the user Please note: it is important to clean the product thoroughly prior to disinfection! To disinfect the pump unit and alternating pressure mattress by hand, use wipe disinfection. For regular disinfection by the user, domestic disinfectants can be used. The pump unit and the alternating pressure mattress together with the mattress cover can be disinfected using a mild antiseptic solution and a wipe disinfection method.
  • Page 38: 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 39: Shutdown

    saniflow® IV 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 40: Reuse

    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. Page 40...
  • Page 41: 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. Page 41...
  • Page 42: 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 43: 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 44 saniflow® IV 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 45 saniflow® IV 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 46 saniflow® IV The following maintenance schedule provides help for this inspection: Item Inspection of the 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 (see chapter Accessories/combinations) Secure positioning of the pump unit Secure positioning of the alternating pressure mattress...
  • Page 47 saniflow® IV Visual inspection of the alternating pressure mattress No unauthorised modifications or improper handling No contamination Mattress cover present and undamaged Mattress cover is positioned with the “foot symbol” imprint on the foot side of the alternating pressure mattress (see chapter on Product labelling) “saniflow”...
  • Page 48 Alternating pressure  90 x 200 cm mattress  100 x 200 cm  90 x 220 cm  100 x 220 cm We recommend the certified treatment unit at aks pura GmbH for the periodic monitoring, cleaning and disinfection of the products. Page 48...
  • Page 49 saniflow® IV 19.3 Maintenance schedule: Inspection by the user In addition to the periodic checking by suitable qualified personnel, the user must check that the product (incl. accessories) is in a safe state before each use. Do not use the product/accessories if you are concerned about the safety of using them.
  • Page 50: Product Labelling

    saniflow® IV 20 Product labelling Product labelling Rating plate Pump unit Sticker (rear of case) see chapter on Technical data Marking X Y Y M M X X X X X YY – year of manufacture MM – month of manufacture Marking Cover of alternating pressure mattress Label (inside, foot end)
  • Page 51 saniflow® IV 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 52 saniflow® IV 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 53 saniflow® IV Explanation of the care symbols EN ISO 3758 Coloured wash (normal washing cycle) Washing temperature 60 °C, normal process Do not bleach Use bleach-free detergents Do not dry in a tumble dryer Do not iron Do not dry clean Protection type of the enclosure acc.
  • Page 54: Technical Data

    saniflow® IV 21 Technical data General information on the product Classification active class I medical device according to Regulation (EU) 2017/745, Appendix VIII Basic UDI DI 425181871222411DP 40 to 130 Permitted patient weight [kg] Ambient temperature 10 to 40 [°C] 0 to 40 Transport/storage Climate conditions...
  • Page 55 saniflow® IV Enter the data for your product here: Type:  saniflow® II  saniflow® II S  saniflow® III  saniflow® IV (01)042518187__ __ __ __ __ __________________________________________ Pump unit __________________________________________ Alternating pressure mattress SIZE [cm]  90 x 200 ...
  • Page 56 Reprints whether in whole or in part are only allowed with prior permission by the publisher. 12/01/2022 All rights reserved, particularly the right to make technical amendments. Printing errors excepted. 17B15061_05...

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