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ImpediMed SFB7 Operating Document

Concordia university
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Use and Cleaning of ImpediMed SFB7
Revision History
Version
Reason for Revision
01
New POD

Summary

The content of this PERFORM Operating Document (POD) provides guidelines for the
safe use and cleaning of the ImpediMed SFB7 as identified in the equipment inventory at
the PERFORM Center, Concordia University.
PC-POD-CP-010-v01
PERFORM Operating Document
PC-POD-CP-010-v01
Printed copies are not controlled.
PC-POD-CP-010-v01
Date
November 26, 2015
Page 1 of 14

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Summary of Contents for ImpediMed SFB7

  • Page 1: Summary

    November 26, 2015 Summary The content of this PERFORM Operating Document (POD) provides guidelines for the safe use and cleaning of the ImpediMed SFB7 as identified in the equipment inventory at the PERFORM Center, Concordia University. PC-POD-CP-010-v01 Printed copies are not controlled.

  • Page 2: Table Of Contents

    PC-POD-CP-010-v01 Table of Contents SUMMARY ------------------------------------------------------------------------------ 1 DEFINITION OF TERMS ------------------------------------------------------- 3 RELEVANT DOCUMENTS ---------------------------------------------------- 3 INTRODUCTION --------------------------------------------------------------- 3 -------------------------------------------------------------------------------------- 3 ACKGROUND ---------------------------------------------------------------------------------------------- 4 URPOSE ------------------------------------------------------------------------------------------------ 4 COPE -------------------------------------------------------------------------------------- 4 ESPONSIBILITY DEVICE COMPONENTS ------------------------------------------------------- 4 DEVICE CALIBRATION -------------------------------------------------------- 5 MODES & PREDETERMINED MEASUREMENT SETTINGS ------------- 6 BIS M -------------------------------------------------------------------------------------------- 6 SFBI M...

  • Page 3: Definition Of Terms

    3.1 Background Body composition can be assessed using various techniques from field to more clinical tests. The ImpediMed SFB7 is a portable battery powered device that offers a rapid, reliable, non-invasive, and cost effective means of measuring body composition (i.e. fat- PC-POD-CP-010-v01 Printed copies are not controlled.

  • Page 4: Purpose

    The objectives of the current POD are to 1) outline the procedure for using ImpediMed SFB7; 2) provide a set of standard practices for safe operation and a training guide for new users of the systems at the PERFORM Centre, Concordia University; and 3) outline the procedure of cleaning/disinfecting of auxiliary items used for this device.

  • Page 5: Device Calibration

    Battery Status Indicator 5.2 Turn device on by pressing the On/Off button on the front panel of the unit. After a couple of seconds the device will display the ImpediMed logo and will go to the main menu. 5.3 Connect each colored lead to corresponding color on back of device. Make sure the arrow on lead is in line with notch on device.

  • Page 6: Modes & Predetermined Measurement Settings

    5.11 Disconnect the leads from test cell and replace the alligator clips. NOTE: Failing to adhere to the above conditions may affect your results. 6 Modes & Predetermined Measurement Settings The ImpediMed SFB7 offers two modes of functions: bioimpedance spectroscopy (BIS), and selected frequencies (SFBI). 6.1 BIS Mode This mode measures BI paramaters over a frequency range of 4-1000 kHz with 256 data points defining the BIS mode as a true BI spectroscopy.

  • Page 7: Sfbi Mode

    PC-POD-CP-010-v01 In addition the characteristic frequency for the subject is determined as well as total cell membrance capacitance. These estimates are then used in algorithms to give body water and fat-free mass. 6.2 SFBI Mode This mode measures BI parameters over a frequency range of 4-1000 kHz. There are 8 selectable frequencies of which 5 are fixed and 3 are user definable.

  • Page 8: Preliminary Instructions

    PC-POD-CP-010-v01 • Undergoing external defibrillation • Pregnant 8 Preliminary Instructions 8.1 Participant should respect the following instructions in order to minimize changes in the body’s hydration status (as this can over or underestimate values): 8.1.1 Excessive exercise should be avoided 2 hours prior to measurement to avoid changes in vascular perfusion, temperature, cutaneous blood flow, vasodilation, and fluid losses.
  • Page 9 PC-POD-CP-010-v01 NOTE: Measurements can be done on either the right or left side, but do not mix sides. Consistent measurement practices and electrode placement are important to obtain accurate results. 5 cm 10.7 Clean the sites with an alcohol swab. 10.8 Allow sites to dry for 30 seconds before placing electrodes.

  • Page 10: Data Retrieval

    PC-POD-CP-010-v01 10.15 Predetermined measurement settings (e.g. number of measures to be taken and at what interval) are set to the following, but can be modified at this stage: Measurement: interval Interval(s): 10 Number: 3 10.16 Click “Measure”. 10.17 Click “Start”. Once measurements are completed (based on predetermined settings) the device will say “Ready”...
  • Page 11 2. Attach the RED Ethernet crossover cable from your device to your PC. 3. Turn on your PC and once the PC is booted turn on your Imp SFB7 device. 4. Your PC will now detect the new network connection and you are ready to upload files from the SFB7 to your software or computer.

  • Page 12: Safety And Cleaning

    12.1.5 The ImpediMed SFB7 should be unplugged from the recharging unit before use to avoid possible noise contamination of the measurement. 12.1.6 The ImpediMed SFB7 has yet to be clinically validated for use on pregnant patients. 12.1.7 Only use ImpediMed electrodes.

  • Page 13: Care And Maintenance

    PC-POD-CP-010-v01 12.2 Care and Maintenance 12.2.1 Care of the product: 12.2.1.1 When in use always keep the SFB7 in the carry case. 12.2.1.2 Clean the SFB7 with a dry, clean cloth only. 12.2.1.3 Avoid exposure to water, impact and excessive heat or direct exposure to sunlight.

  • Page 14: Troubleshooting

    12.2.4.1 Always use the stylus pen provided to operate the touch screen. Use the rubber end of the stylus pen to operate Imp SFB7 touch screen. 12.2.4.2 If necessary clean the touch screen with a soft damp cloth, and do not use any liquids directly.

  • Page 15: Appendix I: Pod Training Record Form

    PC-POD-CP-010-v01 APPENDIX I POD Training Record Form PC-POD-CP-001-v01 Printed copies are not controlled. APPENDIX I...
  • Page 16 PC-POD-CP-010-v01 POD Title Use and Cleaning of ImpediMed SFB7 SOP Code Ownership Document type Area SOP Number Version Training Record Full Name Institution Contact (email or phone number) Signature Sign here Date...

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