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Concordia HIC-4000I Instructions For Use And Cleaning

Impedance cardiograph
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PERFORM Operating Document
Use and Cleaning of HIC-4000I Impedance Cardiograph
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 HIC-4000I Impedance Cardiograph as identified as
equipment inventory at the PERFORM Centre, Concordia University.
PC-POD-CP-006-v01
PC-POD-CP-006-v01
Printed copies are not controlled.
PC-POD-CP-006-v01
Date
August/19/2015
Page 1 of 35

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Summary of Contents for Concordia HIC-4000I

  • Page 1: Summary

    August/19/2015 Summary The content of this PERFORM Operating Document (POD) provides guidelines for the safe use and cleaning of the HIC-4000I Impedance Cardiograph as identified as equipment inventory at the PERFORM Centre, Concordia University. PC-POD-CP-006-v01 Printed copies are not controlled.

  • Page 2: Table Of Contents

    PC-POD-CP-006-v01 Table of Contents SUMMARY ------------------------------------------------------------------------------- 1 1. DEFINITION OF TERMS ---------------------------------------------------------- 3 2. RELEVANT DOCUMENTS ------------------------------------------------------- 3 3. INTRODUCTION ------------------------------------------------------------------ 3 3.1 B --------------------------------------------------------------------------------------------- 3 ACKGROUND 3.2 P ---------------------------------------------------------------------------------------------------- 4 URPOSE 3.3 S ------------------------------------------------------------------------------------------------------- 4 COPE 3.4 R --------------------------------------------------------------------------------------------- 4 ESPONSIBILITY 4.

  • Page 3: Definition Of Terms

    2. Relevant Documents This POD is governed by the following Concordia University policies, SOPs, and PODs:  PC-POD-GA-001 “PERFORM Centre Booking System for Facilities and Equipment”.

  • Page 4: Purpose

    The objectives of the current POD are to 1) outline the procedure of using the HIC- 4000I Impedance Cardiograph; 2) provide a set of standard practices for safe operation and training guide for new users of the system at the PERFORM Centre, Concordia University; and 3) outline the procedure for cleaning/disinfecting.

  • Page 5: Acronyms

    PC-POD-CP-006-v01 5. Acronyms 5.1 Hardware  HR = Heart Rate  dZ/dt = Rate of Change of Impedance  PEP = Pre-Ejection Period  RSP = Respiration  SIM= Simulation Mode  * = Wildcard  INT = Initialization Control ...

  • Page 6: Software

    Ohms in the software. 6. Hardware and Software Setup 6.1 Plug in main cable for HIC-4000I - Impedance Cardiograph to power source. Connect other end of cable to “Connect MED POWER” located on the lower right corner of the rear panel.
  • Page 7 6.6 Connect the USB cable attached to the “RS-232” input on the left side of the rear panel of the SunTech Tango+ to SPIRO 1 or SPIRO 2 laptop. 6.7 Connect the USB cable attached to the rear panel of the HIC-4000I Impedance Cardiograph labeled “USB” to the laptop.

  • Page 8: Test Setup

    PC-POD-CP-006-v01 7. Test Setup 7.1 ECG Setup 7.1.1 OPTION 1 - Attachment of Band Impedance Electrodes NOTE: Manufacturer recommends the use of band electrodes in ICG applications for research purposes when the best signal quality and parameter accuracy is desired. 7.1.1.1 Using the electrode tape measure the quantity required by placing it around the upper limit of the participant’s neck, leaving an extra 3-4 inches at each end of the electrode tape and cut accordingly.
  • Page 9 PC-POD-CP-006-v01 7.1.1.5 Stick the band electrode around the participant at the first attachment location, as shown below, making sure that the folded back ends of the tape are joined on the anterior surface of the participant. NOTE: Use enough tension so that the band sticks, but not too much to the point that it wrinkles or twists.
  • Page 10 PC-POD-CP-006-v01 7.1.1.11 Fold-back the ends of the tape so that the sticky part is not exposed. 7.1.1.12 Stick the band electrode tape around the participant’s neck so that the mark is aligned with the upper edge of the conductive part of the electrode tape.
  • Page 11 PC-POD-CP-006-v01 7.1.2 OPTION 2 - Attachment of 4-Lead ECG Electrode Configuration NOTE: Manufacturer recommends the use of band electrodes in ICG applications for research purposes when the best signal quality and parameter accuracy is desired. 7.1.2.1 Wearing gloves, shave hair from electrode sites, if necessary. Locate electrode sites as shown.

  • Page 12: Sun Tech  T

    PC-POD-CP-006-v01 7.1.3.2 Cleanse area with alcohol swab. 7.1.3.3 Using abrasive ECG prep tape, lightly scratch an “X” pattern into the skin, taking care to avoid excess abrading. 7.1.3.4 Dry the skin vigorously with a gauze pad. 7.1.3.5 Place electrodes on the skin. 7.1.3.6 Press the contour of electrode.
  • Page 13 PC-POD-CP-006-v01 7.2.5 Slide the sanitary sleeve and cuff sleeve up the participant’s left arm, ensuring the ARTERY marker points down the arm and is over the participants brachial artery. As well, ensure the lower border of the cuff is placed 3-5 cm above the antecubital fossa.

  • Page 14: Etup

    PC-POD-CP-006-v01 7.2.7 If not already done, attach cable to cuff. 7.2.8 Use the Velcro strap to secure the cable to the individual’s wrist. 7.2.9 Ask participant to sit down. Wait 5 minutes. 7.2.10 Ensure a stable heart rate is displayed on the monitor. NOTE: A stable heart rate must be displayed on the monitor for Tango+ to be able to obtain an accurate reading.

  • Page 15: Calibration

    PC-POD-CP-006-v01 NOTE: Make sure to click on the file ending in “.ifo” and not “(T#)”, since “(T#)” represents files with existing data. 7.3.2.5 Click “Open”. 7.3.2.6 In the “Program Help Advisory!” window, click “OK”. 7.3.2.7 Click “Save”. 7.3.2.8 The “Patient (Subject) Information Form” window will appear. In the top half of the window update information, if necessary.
  • Page 16 PC-POD-CP-006-v01 On the ICG machine, press the “CAL” key on the keypad. Wait two or three cycles of the dZ/Dt calibration signal (a square wave) to appear then click the “CALIBRATE” button. Click “OK” on the calibration screen to save and exit the calibration screen. PC-POD-CP-006-v01 Printed copies are not controlled.
  • Page 17 PC-POD-CP-006-v01 If calibration is successful, window will show statement “COP-WIN Calibration Complete” as shown below. If calibration is unsuccessful, click “REDO”. 8.10 Click “OK”. 8.11 The “Calibration Information” window will appear. PC-POD-CP-006-v01 Printed copies are not controlled. Page 17 of 35...

  • Page 18: Data Acquisition

    PC-POD-CP-006-v01 8.12 Click “OK”. 8.13 On ICG machine, press “OP” key to switch back to operate mode, which allows data to be collected. Data Acquisition Opening Acquisition Window 9.1.1 From the main menu select “Acquisition” then “Data Acquisition and Setup”. This window will allow for operational parameters to be specified.
  • Page 19 PC-POD-CP-006-v01 9.2.2 Change the “Ensemble Average DURATION” accordingly to make sure that it is at least one second less than the Inter-Sample Interval Time. For example, if you want the total duration of your test to be 30 seconds, yet would like to acquire data for 20 seconds then have a 10 second break of no data acquisition, then type 30 in the red box and 20 in the “Ensemble Time (sec)”...
  • Page 20 PC-POD-CP-006-v01 When this option is selected and the “OK” button is pressed, a screen will appear allowing for the selection of a specific ID Code. NOTE: If there are any parameters left to change in the prior screen, do so prior to clicking “OK”...
  • Page 21 PC-POD-CP-006-v01 9.2.7 RRI options are used to calculate heart rate variability by measuring the distances between the R peaks in the QRS complex. Under “RRI Data Acquisition” (RRI = R-R Interval) select “RRI Not Active” to disable RRI data acquisition OR select “Continuous RRI Mode” to enable RRI data acquisition during pre-selected time intervals OR select “With Each EA Sample using HRV frequency…”.
  • Page 22 PC-POD-CP-006-v01 9.2.10 Select “Yes” to set the time limit for RRI data acquisition as equal to the time limit specified for Continuous EA (Ensemble Averaged) acquisition Mode earlier. Select “Cancel” to make no change to the current settings. Select “No” and another Dialogue Box will appear. 9.2.11 Enter a time limit in minutes in the blank area.
  • Page 23 PC-POD-CP-006-v01 NOTE: The minimum time is 128 seconds and the maximum possible time is 1024 seconds. 9.2.13 Under BP Control make sure “SunTech Tango” appears. 9.2.14 Select “Auto Start/Stop Continuous Mode” when it is important that EA data samples be acquired at preset intervals over a finite length of time. 9.2.15 Select “BP Result Initiates Block or One-Shot Mode”...

  • Page 24: Ollect Data Continuously

    PC-POD-CP-006-v01 9.2.18 Check the “Automatically save EA Data to Disk” to have acquired data saved. 9.2.19 Check the “Use PEP value from PEP Detector (B-wave cursor placement)” to be able to compute systolic time interval values. 9.2.20 Click to store and retain the options selected. These will be retained through all subsequent executions of the software until changed by the user.
  • Page 25 PC-POD-CP-006-v01 9.3.4 If you want to set it to a pre-determine time interval, under the “Total Run Time For Continuous/ Non-Stop EA Acquisition Mode” select “Limit to” and choose the total time under “Hours” and “Minutes”. 9.3.4.1 The “Continuous Time Intervals” mode offer a Block Mode option that permits the user to acquire and label data samples with an ID Code.
  • Page 26 PC-POD-CP-006-v01 9.3.5 Under “Input-Digital-Filter-Setting”, select filter. 9.3.6 RRI options are used to calculate heart rate variability by measuring the distances between the R peaks in the QRS complex. Under “RRI Data Acquisition” (RRI = R-R Interval) select “RRI Not Active” to disable RRI data acquisition OR select “Continuous RRI Mode”...
  • Page 27 PC-POD-CP-006-v01 9.3.9 Select “Yes” to set the time limit for RRI data acquisition as equal to the time limit specified for Continuous EA acquisition Mode earlier. Select “Cancel” to make no change to the current settings. Select “No” and another Dialogue Box will appear.
  • Page 28 PC-POD-CP-006-v01 NOTE: The minimum time is 128 seconds and the maximum possible time is 1024 seconds.  9.3.12 Under BP Control make sure “SunTech Tango” appears. 9.3.13 Select “Auto Start/Stop Continuous Mode” when it is important that EA data samples be acquired at preset intervals over a finite length of time. 9.3.14 Select “BP Result Initiates Block or One-Shot Mode”...
  • Page 29 PC-POD-CP-006-v01 NOTE: When acquiring cardiac output data, bear in mind that the BP values are only retrieved from the BP frame at the very end of the EA period. 9.3.17 Check the “Automatically save EA Data to Disk” to have acquired data saved. 9.3.18 Check the “Use PEP value from PEP Detector (B-wave cursor placement)”...
  • Page 30 PC-POD-CP-006-v01 Note that the latter option can only be selected if the inter-sample interval time is > 1.2 minutes. 9.4.5 If the “Continuous RRI Mode” is selected and the “No Limit” button appears, acquisition will be continuous from the time the user starts data acquisition, until the user stops the acquisition.
  • Page 31 PC-POD-CP-006-v01 9.4.8 Enter a time limit in minutes in the blank area. 9.4.9 Select “OK”. 9.4.9.1 If “With Each EA Sample using HRV frequency…” is selected, set the number of seconds to be used for the RRI sample by using the spin control.
  • Page 32 PC-POD-CP-006-v01 9.4.12 Select “BP Result Initiates Block or One-Shot Mode” to be able to control output data acquisition through the BP monitor’s interval times and/or clicking the “READ” BP control button. 9.4.13 Select “Manual Mode” in order to collect COP/HRV data and BP data that is independent of each other.

  • Page 33: Cquisition Window

    PC-POD-CP-006-v01 Data Acquisition Window 9.5.1 The options in the “Acquisition Setup Window” need to be verified before the software allows access to the “Data Acquisition Window”. 9.5.2 Verify that the mode of acquisition under Acquire Mode is correct. This option allows the changing the mode of data acquisition without having to go back to the Acquisition set-up window.

  • Page 34: Cquisition Window With Rri Data

    PC-POD-CP-006-v01 Data Acquisition Window with RRI Data 9.6.1 Controls The RRI Mode Control Frame displays the current RRI Mode, Session Time, and Event Control. NOTE: FOR RRI DATA ACQUISITION, THERE MUST BE AN ECG SIGNAL PRESENT. 9.6.1.1 RRI Mode Control  Displays the current RRI mode and mode status. This control allows the user to activate and deactivate the RRI mode.

  • Page 35: Reporting

    PC-POD-CP-006-v01 10. Reporting 10.1 To create a report click on “Reports”  select option desired from drop down menu. 10.2 Should “Select Parameters for Printing” be selected, a wide range of parameters could be selected for printing. 11. Cleaning/Disinfecting 11.1 Clean blood pressure cuff according to POD entitled “Use and Cleaning Procedures for Manual and Automatic Aneroid Sphygmomanometers”.

  • Page 36: Appendix I: Pod Training Record Form

    PC-POD-CP-006-v01 APPENDIX I POD Training Record Form PC-POD-CP-006-v01 Printed copies are not controlled. APPENDIX I...
  • Page 37 PC-POD-CP-006-v01 POD Title Use and Cleaning of HIC4000I Impedance Cardiograph SOP Code Document Ownership Area SOP Number Version type Training Record Full Name Institution Contact (email or phone number) Signature Sign here Date...

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