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Micro Diary

Operating Manual

Inc.
www.medicaldevicedepot.com
1-877-646-3300

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Summary of Contents for CareFusion Micro Diary

  • Page 1: Operating Manual

    Micro Diary Operating Manual Inc. www.medicaldevicedepot.com 1-877-646-3300...
  • Page 2: Table Of Contents

    CONTENTS INTRODUCTION ............3 INDICATIONS FOR USE..........5 TARGET POPULATION ..........5 ENVIRONMENT OF USE ..........5 ENVIROMENT CONDITION OF USE ......6 CONTRAINDICATION, WARNINGS AND CAUTIONS..6 ............. 6 ONTRAINDICATIONS : ..............7 AUTION PACKAGE CONTENTS ........... 8 CONFIGURATION ............
  • Page 3 CONSUMABLES & SUPPORTING PRODUCTS ....24 SPECIFICATION OF THE MICRO DIARY ....... 25 SYMBOLS ..............26 CUSTOMER CONTACT INFORMATION ....... 27 UK C ........... 27 USTOMERS ONLY ........27 NTERNATIONAL CUSTOMERS ONLY...
  • Page 4: Introduction

    FEV1, PEF, FVC or FEV6, and symptom scores in epidemiological studies and drug trials. The Micro Diary connects to a PC for configuration and uploading of stored data using the Micro Diary System Windows™ based software. This software allows the unit...
  • Page 5 The recorded tests can be uploaded to a computer for future analysis or printing, via a USB interface. The spirometer uses the CareFusion Digital Volume Transducer, an extremely stable form of volume transducer, which measures expired air directly at B.T.P.S...
  • Page 6: Indications For Use

    Indications for Use The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6, and PEF. The device also records the test data for later review and has the ability to transfer these records to a compatible computer.
  • Page 7: Enviroment Condition Of Use

    Environment Please observe the following precautions: • Avoid exposing the Micro Diary to direct sunlight. • Avoid operating the spirometer in dusty conditions or near to heating appliances or radiators • Do not keep the spirometer in a damp or expose it to extreme temperatures •...
  • Page 8: Caution

    Caution: CAUTION: Read the manual before use WARNING: The instrument is not suitable for use in the presence of explosive or flammable gases, flammable anaesthetic mixtures or in oxygen rich environments. CAUTION: Mouthpieces are single patient use. If used on more than one patient there is a risk of cross- infection.
  • Page 9: Package Contents

    Package Contents The Micro Diary is packaged in a convenient carrying case and comes complete with the following items (Fig.1): Micro Diary microcomputer unit. CareFusion Digital Volume Transducer. Lithium coin cell, CR2450 USB cable Scroll up Delete Enter Scroll down...
  • Page 10: Configuration

    ‘del’. The Micro Diary is now ready to perform the defined sequence of questions when the unit is turned on. The subject is instructed to complete the sequence of questions and spirometry tests.
  • Page 11 off after several minutes. Data collected on a partially completed sequence will not be stored and the subject must turn the unit on again and complete the whole sequence before the results are stored. If an alarm is set then the unit will turn on automatically at the required time, sound an audible alarm, and display: The subject should then press ‘enter’...
  • Page 12: Operation

    Operation Spirometry Recording When taking a spirometry measurement the following will be displayed: The subject should then perform a spirometry manoeuvre using a clean mouthpiece connected to the transducer. After completion the display will show the results together with a spirometry manoeuvre quality check:...
  • Page 13 The results and quality checks displayed to the user may be configured with the PC software. The software may also be configured to automatically reject any manoeuvre that fails any of the quality checks. The unit will ‘beep’ once at the end of the manoeuvre or three times if an alarm has been set and the result is below the acceptable level.
  • Page 14 FEV1 and FVC but display no results if a blind study is to be undertaken. In this case the Micro Diary will move on to the next question or spirometry test immediately after the test is performed...
  • Page 15: Symptom Score Entry

    which case the alarm will sound and the display will flash the reading that triggered the alarm. Symptom Score entry Numerical data and responses to questions may be entered in five different ways. Question with Numeric Answer: The question is displayed at the top of the screen and the default response is shown flashing below.
  • Page 16 The display shows the question number with the default response (set by the PC software) to one decimal place. The subject adjusts the response, as described above, and then presses ‘enter’. Note that it is not possible to enter the default value whist the display is flashing. Pressing the ‘up’...
  • Page 17 the default response flashes until the ‘up’ or ‘down’ arrow keys are first used. Question with Long Written Answer:...
  • Page 18 When the answers are too long to fit on one line, paged responses may be used. Using the ‘up’ and ‘down’ keys will scroll between the programmed responses. Pressing the ‘enter’ key will select the required response. Question with Analogue Scale Response: Question requiring an answer on an analogue display can also be displayed.
  • Page 19: Menu Options

    Menu Options To obtain the options menu hold down the ‘enter’ key, turn the unit on, and when the sounder is heard release the ‘enter’ key. Use the up and down arrow keys to select the required option and then press enter. Select option 9, Exit, when you have finished using the options.
  • Page 20: Pc Connection

    1 PC Connection When this option is used connect the Diary unit to a PC running the software supplied to a USB port using the cable supplied. The Diary is then controlled by the PC in order to upload saved data or to reprogram the unit. 2 Message Log The feature is not used in the Diary system.
  • Page 21: Calibration Check

    Use this option to perform a calibration check. A calibration syringe will be required. 8 Telephone Log This function is not used in the Micro Diary. Maintenance Battery Management The Diary is powered by a 3 Volt Lithium coin cell accessed via a slide cover on the rear of the instrument.
  • Page 22: Battery Replacement

    Press until clicked into place Slide the battery cover back into place. Calibration Check The Micro Diary is calibrated to read in litres at body temperature, barometric pressure saturated with water vapour (BTPS). The calibration should remain stable indefinitely, unless the transducer is physically damaged, and the unit should not require re-calibration.
  • Page 23: Cleaning The Transducer

    ‘enter’ key pressed and select ‘Calibration Check’ from the menu options, see section Menu Options Connect a 3L syringe to the Micro Diary with the minimum of adapters and the syringe volume should be injected into the transducer evenly, without pausing.
  • Page 24: Servicing

    Information section for more details. Trouble Shooting Information Should you encounter problems operating your spirometer, please consult the table below: Problem Possible Solution Cause Micro Diary cannot Batteries are Change the be switched on flat batteries Every time you The internal...
  • Page 25: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) Changes or modifications to the Micro Diary spirometer that are not expressly approved by Carefusion can cause EMC issues with this or other equipment. The device is designed and tested to comply with applicable regulation regarding EMC and needs to be installed and put into...
  • Page 26: Specification Of The Micro Diary

    Specification of the Micro Diary Measurements: Forced Vital Capacity (FVC) or Forced Expired Volume in 6 seconds (FEV6) Forced Expired Volume in 1 second (FEV1) Peak Expiratory Flow rate (PEF) Accuracy: Meets the accuracy requirements of the ATS/ERS Standardisation of Lung...
  • Page 27: Symbols

    Symbols Type B device In accordance with Directive 93/42/EEC 0086 Disposal in compliance with WEEE Consult the instructions for use Date of manufacture Manufacturer Serial Number (Rx only) : Federal U.S. law restricts this device to sale by or on the order of a physician Inc.

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