NOVACARE Smartline plus 5 User Manual

Anti-decubitus alternating pressure system
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User Manual
Smartline plus 5
Anti-Decubitus Alternating Pressure System
Product name
Item no.
Smartline plus 5
996600 UK/
996600

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Summary of Contents for NOVACARE Smartline plus 5

  • Page 1 User Manual Smartline plus 5 Anti-Decubitus Alternating Pressure System Smartline plus 5 Product name 996600 UK/ Item no. 996600...
  • Page 2: Table Of Contents

    Thank you for purchasing the novacare Smartline plus 5, a system for the ® treatment and prevention of pressure ulcers up to grade 3 according to EUPAP. A Smart decision. Please read the following operating instructions carefully and read the safety notices before using the system.
  • Page 3: The System / Scope Of Use

    1. The system / scope of use The novacare Smartline plus 5 is an overlay system that is placed onto a ® standard mattress and is designed for use in home care, care home and hospital environments. The system consists of a control unit with a membrane pump and a mattress replacement with 17 nylon/TPU (Thermoplastic polyurethane) air cells arranged horizontally.
  • Page 4: Area Of Application

    3. Area of application The novacare Smartline plus 5 is suitable for use with decubitus ulcers ® of grade I - III (according to Seiler) or category I – III (according to EPUAP/ NPUAP). In the case of a higher risk or decubitus grade, use an appropriate system from the novacare range.
  • Page 5: Safety / Preparing The System For Use

    Ensure that the connection hose is located at the foot end of the bed and does not become kinked. Attach the novacare Basic overlay to the patients mattress using the straps provided at the head and foot end. This prevents the overlay from movement.
  • Page 6: Alternative Positioning Of The Control Unit

    8. Alternative positioning of the control unit The control unit of the novacare Smartline plus 5 should be hung onto the ® foot end of the bed. Alternatively, if space is an issue, the unit can also be hung on the lower of the two bedside rails. Please check that the tubing leading to the pump doesn´t get kinked.
  • Page 7: Static Mode

    You should carry out the Practical Test here, too (see section 14). 12. Alarm function The novacare Smartline plus 5 is equipped with an alarm system. Low ® pressure is indicated visually and audibly. Any power failure or interruption in the power supply is indicated by an acoustic signal and the „Power LED“...
  • Page 8: Practical Test

    16. CPR valve The novacare ® Smartline plus 5 is equipped with a CPR emergency tab pull system. It allows deflation within seconds, for example, to carry out resuscitation. Quick deflation is achieved by pulling on the red tab marked “CPR”...
  • Page 9: Safety Notices

    Medical Devices Operator Ordinance must be observed. • Only allow repairs to be carried out by the manufacturer or an authorised dealer. • The novacare plus 5 is a mattress overlay system. Always place the ® overlay onto the hospital bed mattress.
  • Page 10: System Failure / Notes For The User

    5 °C to + 40 °C Relative humidity: 30 % to 75 % at 30 °C – non-condensing Air pressure: 700 to 1,060 hPa Transport Do not drop the compressor or damage the housing during dismantling or transport. Avoid using any damaged compressors. www.novacare.de...
  • Page 11: Technical Data

    48 % Polyurethane 52 % Polyester 21. Maintenance / inspection The novacare Smartline plus 5 is considered to be a medical device according ® to Directive 93/42/EEC and the German Medical Devices Act (MPG). These statutory regulations should be observed during use.
  • Page 12: Hygiene

    Test according to EN 62353 • Safety inspection Maintenance and inspections undertaken by the service department of novacare gmbh are recorded and documented. The year of manufacture is determined by the first two didgets of the serial number. 22. Hygiene For application at domestic location:...
  • Page 13: Preparation By Qualified Personnel

    23. Preparation by qualified personnel All service work, repairs and inspections must be carried out by trained and qualified personnel. The wrap-around protective cover of the novacare Smartline plus 5 can be ® cleaned in a machine using a chemical/thermal process up to 95º C. For the cells, we recommend wiping with a disinfectant.
  • Page 14: Toxicological Safety And Biocompatibility (Fulfilment Of Standards)

    Electrical devices from novacare gmbh are registered (see symbol) WEEE – Reg. No. DE – 89 403 200 The batteries contained in the system from novacare gmbh are registered (see symbol) GRS contract number 109101377 Ni-MH battery...
  • Page 15: Explanation Of Symbols

    Caution! The device and battery must not be disposed of as house-hold waste! (see operating instructions) Application part Type BF - protection against electric shock (see technical data) Matress cover: Manufacturer novacare gmbh, 67098 Bad Dürkheim, ® Germany (see label) Maximum washing temperature 95 °C...
  • Page 16: Emc

    The Smartline plus 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the the Smartline plus 5 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance...
  • Page 17 Guidance & Declaration — Electromagnetic immunity The Smartline plus 5 is intended for use in the electromagnetic environment as specified below. The customer or the user of the Smartline plus 5 should assure that It is used in such an environment.
  • Page 18 The Smartline plus 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the model Smartline plus 5 should assure that it is used in such an environment. Immunity test IEC 60601 test...
  • Page 19 If the measured field strength in the location in which the Smartline plus 5 are used exceeds the applicable RF compliance level above, the Smartline plus 5 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the the Smartline plus 5.
  • Page 20 RF communications equipment and the Smartline plus 5 The Smartline plus 5 is intended for use in electromagnetic environment in which radiated RF disturbances is controlled. The customer or the user of the Smartline plus 5 help prevent electromagnetic interference...
  • Page 21: Warranty

    • We will not be liable for damage or faults arising from fair wear and tear or during transportation. • Replacement of wear parts is not included in the guarantee. • The guarantee on batteries is six months. www.novacare.de...
  • Page 22: General Information

    30. General information The novacare Smartline plus 5 is a medical aid. It is supplied by novacare ® ® gmbh primarily to medical specialists (medical nursing staff, medical stockists, operators, medical institutions, social institutions, etc.) and to professional users. Specialists and professional users include persons who by virtue of their...
  • Page 23: Notes

    33. Notes www.novacare.de...
  • Page 24 These operating instructions are protected by copyright. Any reproduction or duplication, incorporation in online services and the internet, as well as saving or copying on data storage media such as CD ROM, DVD, etc. is prohibited and requires the explicit written consent of novacare gmbh.

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