GERATHERM Spirostik Complete User Manual
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Spirostik Complete
User Manual
Version 1.2.2
th
Date 17
October, 2014

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Summary of Contents for GERATHERM Spirostik Complete

  • Page 1 Spirostik Complete User Manual Version 1.2.2 Date 17 October, 2014...
  • Page 2: Table Of Contents

    Warranty ................23 General Description ............23 Warranty exclusion ............. 23 Packing and shipping ............23 Technical Data ..............24 Technical Data Spirostik Complete (8 inch touch screen)... 24 Technical Data Spirostik Complete (10.4 inch touch screen) ..................... 25 SPIROSTIKCOMPLETE_MAN_ENG_V1.2.2_REV01.DOCX Page 2...
  • Page 3: Welcome To Blue Cherry

    Complete. We strongly recommend reading this manual carefully in order to avoid incorrect use or damage to the device. Geratherm Respiratory does not take responsibility for any direct or indirect damage to the Device, if it is not operated in accordance with this manual. Users must observe precautions, warnings and instructions.
  • Page 4: Spirostik Complete

    MVV or SPO2 very simple. The Spirostik Complete is designed to provide a portable diagnostic solution for the determination of lung disease. The system is designed for use within both the primary and secondary care environments, and may also be used in a research capacity.
  • Page 5: Scope Of Delivery

    Graphic data and the editing of curves retrospectively. The Spirostik complete has a fully integrated thermal printer, which can be used for the generation of printed reports. It is also possible to connect any USB windows compatible printer for the generation of larger and colour reports.
  • Page 6: Setup

    2.2.1 Connecting the Pressure Hose On the rear of the Spirostik Complete device are two connectors for the connection of the pressure tubes from the Handle. These connectors are colour coded to ensure correct connection of the two tubes.
  • Page 7: Paper Installation

    User Manual Spirostik Complete 2.2.2 Paper Installation At the rear of the device on the right side is the cover for the printer paper. The case top can be opened using the button on the right side. Place the Thermal paper roll into the tray ensuring about 1cm of paper hangs outside the cover.
  • Page 8: Switching On The Spirostik Complete

    It is possible to connect an Ambistik or Mouse or even other components to the Spirostik complete by using the USB Ports shown in the picture below: The Spirostik complete may only be operated by using the provided power supply.
  • Page 9: Boot Up And Control Of The Integrated Computer

    User Manual Spirostik Complete 2.2.4 Boot up and control of the integrated computer The integrated computer boots after pressing the button on the housing surface. After booting up, the following will be shown: By double-clicking the Blue Cherry Icon the software will start.
  • Page 10 User Manual Spirostik Complete Whenever text or other data has to be entered the following software keyboard will appear. The capital letters will be shown after clicking the shift button. By clicking the button on the left of the space bar the keyboard layout will change to the following: SPIROSTIKCOMPLETE_MAN_ENG_V1.2.2_REV01.DOCX...
  • Page 11: Security

    Geratherm Respiratory is responsible for the security and reliability of function of the Spirostik Complete, as such only authorised personnel should perform changes or repairs to the system. Please consult your Geratherm Respiratory specialist service centre for any repairs.
  • Page 12: Norms And Guidelines

    User Manual Spirostik Complete 2.3.1.1 Norms and Guidelines The Geratherm Respiratory products are manufactured in accordance with DIN EN ISO 13485. According to the European directive 93/42/EEC, Spirostik fulfils the requirements of annex II. In addition the following norms are fulfilled:...
  • Page 13: Secure Use Of The Spirostik Complete

    Spirostik Complete 2.3.2 Secure Use of the Spirostik Complete Spirostik complete is a desktop spirometry equipment. It is highly recommended that the user observes all warning notices in order to ensure a safe use of the device. The Spirostik complete should not be used in conjunction...
  • Page 14: Connecting The Pressure Tubes To The Handle

    User Manual Spirostik Complete Remove excess fluids using a dry cloth. For housing and PC use a surface wipe disinfection. Please see additional notes in section on disinfection. The device should not be exposed to water or operated in wet environments.
  • Page 15: Replace Handle

    You can buy this article at your local dealer. On the rear of the Spirostik Complete device are two connectors for the connection of the pressure tubes from the Handle. These connectors are colour coded to ensure correct connection of the two tubes.
  • Page 16: Connecting The Flow Sensor To The Handle

    User Manual Spirostik Complete 2.3.2.3 Connecting the flow sensor to the handle In order to ensure the safe function of the Spirostik, the flow sensor must be connected correctly to the handle. Please read the following procedure carefully. Place the flow sensor in the ‘mouth’ of the grab handle, ensure the...
  • Page 17: Removing The Flow Sensor From The Handle

    User Manual Spirostik Complete Examine that the flow sensor to ensure it is correctly engaged in the handle: 1: Upper section of the handle must be accurately between the two guidance ribs of the flow sensor. 2: The locating spigot must be located securely in the opening of the guidance rib on the patient side of the flow sensor.
  • Page 18 User Manual Spirostik Complete Take the handle in the left hand and tilt the mouthpiece side of the flow sensor downwards. Gently pushing the upper part of the handle with the thumb opens the ‘mouth’ of the handle, so that the flow sensor can fall out. This procedure can be done directly over the waste facility.
  • Page 19: Combination With Other Devices

    2.3.3 Combination with other devices Always ensure all connections and cables are connected properly when using the Spirostik complete together with other devices. All connected devices must comply with legal regulations and the total leakage current must not exceed the maximum allowed valued specified in the Norm DIN EN 60601-1.
  • Page 20 User Manual Spirostik Complete Situation Medical used room Non-medical used Possible solution room Within patient Out of area patient area resource A and B within patient area IEC 60601 IEC 60601 resource A and B for B: additional within patient area...
  • Page 21: Disposal

    2013. The identifier |8|102| is a product specific code. The remaining digits define the device number of the Spirostik. In this example number 1 REF: designates the part number for the Spirostik Complete 40 020. SPIROSTIKCOMPLETE_MAN_ENG_V1.2.2_REV01.DOCX Page 21...
  • Page 22: Used Symbols

    93/42 ECC for medical devices and fulfil the requirements of annex II 0494 of the directive Maintenance The Spirostik Complete has been designed to ensure it is a low maintenance device. Only minor maintenance is required to ensure trouble free operation. Interval Maintenance work After every patient resp.
  • Page 23: Warranty

    Geratherm Respiratory, and respectively equal to installation date if purchased from a sales partner. All service must be provided by Geratherm Respiratory or an authorized service partner of Geratherm Respiratory. Geratherm Respiratory will not accept warranty claims on any unauthorised repairs.
  • Page 24: Technical Data

    User Manual Spirostik Complete 4. Technical Data Technical Data Spirostik Complete (8 inch touch screen) Modifications are not permitted with this device Technical Data: Dimensions: 350mm x 330mm x 70mm (L x W x H) Weight: 2100g Electrical data: IP protection type:...
  • Page 25: Technical Data Spirostik Complete (10.4 Inch Touch Screen)

    User Manual Spirostik Complete Technical Data Spirostik Complete (10.4 inch touch screen) Modifications are not permitted with this device Technical Data: Dimensions: 350mm x 330mm x 70mm (L x W x H) Weight: 2250g Electrical data: IP protection type: IPX0 IEC 529...

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