Concordia HIC-4000I User manual

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PERFORM Operating Document
Use and Cleaning of HIC-4000I Impedance Cardiograph
PC-POD-CP-006-v01
Revision History
Version Reason for Revision Date
01 New POD 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.

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Table of Contents
SUMMARY -------------------------------------------------------------------------------1
1. DEFINITION OF TERMS----------------------------------------------------------3
2. RELEVANT DOCUMENTS -------------------------------------------------------3
3. INTRODUCTION ------------------------------------------------------------------3
3.1 BACKGROUND --------------------------------------------------------------------------------------------- 3
3.2 PURPOSE ---------------------------------------------------------------------------------------------------- 4
3.3 SCOPE ------------------------------------------------------------------------------------------------------- 4
3.4 RESPONSIBILITY--------------------------------------------------------------------------------------------- 4
4. MAIN COMPONENTS ------------------------------------------------------------4
5. ACRONYMS-------------------------------------------------------------------------5
5.1 HARDWARE------------------------------------------------------------------------------------------------- 5
5.2 SOFTWARE -------------------------------------------------------------------------------------------------- 6
6. HARDWARE AND SOFTWARE SETUP ---------------------------------------6
7. TEST SETUP -------------------------------------------------------------------------8
7.1ECG SETUP ------------------------------------------------------------------------------------------- 8
7.2SUNTECHTANGO+BLOOD PRESSURE SETUP -------------------------------------------------12
7.3SOFTWARE SETUP -----------------------------------------------------------------------------------14
8.CALIBRATION ------------------------------------------------------------------ 15
9.DATA ACQUISITION --------------------------------------------------------- 18
9.1OPENING ACQUISITION WINDOW---------------------------------------------------------------18
9.2OPTION 1–COLLECT DATA INTERMITTENTLY USING INTER-SAMPLE PAUSES -------------18
9.3OPTION 2–COLLECT DATA CONTINUOUSLY ------------------------------------------------24
9.4OPTION 3–COLLECT A SINGLE SAMPLE AT A TIME -------------------------------------------29
9.5DATA ACQUISITION WINDOW -------------------------------------------------------------------33
9.6DATA ACQUISITION WINDOW WITH RRI DATA ----------------------------------------------34
10.REPORTING --------------------------------------------------------------------- 35
11.CLEANING/DISINFECTING-------------------------------------------------- 35
APPENDIX I: POD TRAINING RECORD FORM

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7. Definition of Terms
PERFORM operating
document (POD)
Operating documents that are specific to an instrument or
technique that require approval by area managers.
Standard Operating
Procedure (SOP)
SOP’s at PERFORM are any operating document that require
a full review process and approval by the SD.
User Person using space or equipment at the PERFORM Centre
that has received adequate technical and safety training.
Supervisors
Knowledgeable person regarding all or an aspect of a project
or program and is familiar with PERFORM’s best practices,
that is responsible for ensuring that users conduct their
activities in a safe manner and within scope of the project
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”.
PC-SOP-GA-002 “Handling of Biological Materials at PERFORM”.
PC-SOP-GA-007 “General Access to PERFORM Centre”.
PC-SOP-GA-009 “Emergency Response Procedures at the PERFORM Centre”.
PC-SOP-GA-011 “Guidelines for Management of Incidental Findings at
PERFORM”.
PC-SOP-CP-001 “Cardio-Pulmonary Suite – Access, Use, Safety, and Training of
Personnel”.
PC-POD-CP-002 “Use and Cleaning Procedures for Manual and Automatic
Aneroid Sphygmomanometers”.
3. Introduction
3.1 Background
The HIC-4000I Impedance Cardiograph is a noninvasive instrument for detecting and
monitoring bioelectric impedance cardiography (ICG) signals from human subjects. It is a
standalone system, which acquires, displays, and produces ICG analog signals. This
system is primarily intended for ICG applications involving the assessment of heart rate,
stroke volume, cardiac output, basal thoracic impedance (Zo), rate of change of
impedance (dZ/dt), pre-ejection period (PEP), delta-Z (dZ), heart sounds, and

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respiratory rate (R). A separate unit (SunTech Tango+™) is used in conjunction with
the HIC-4000I Impedance Cardiograph to measure blood pressure.
3.2 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.
3.3 Scope
This POD applies to all users and supervisors using the HIC-4000I Impedance
Cardiograph at the PERFORM Centre, Concordia University. Any other document
other than this POD is out of scope for this operating procedure.
3.4 Responsibility
It is the responsibility of all users and supervisors to ensure that this POD is followed.
4. Main Components
1. HIC-4000I - Impedance Cardiograph System
2. DB-9 connector (black cable) – Four miniature coaxial cables with a 9-pin
male connector at the instrument end, and four small alligator clips at
participant end. Each cable is numbered 1 through 4.
3. External ECG electrode cable assembly (blue cable) – Separate external 3-
electrode ECG cable with 5-pin circular connector.
4. SunTechTango+ - Automatic blood pressure system.
4
1
2
3

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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
SL = Signal Levels
OFF = Off Button
L40 = Low-Pass 40Hz Filter
N60 = 60Hz Notch Filter
N50 = 50 Hz Notch Filter
OP = Operate Mode
BL = Baseline
CAL= Calibrate
dZ = Change in Basal Thoracic Impedance.
PWR = Power on when light on.
RESP GAIN = Adjust level of Respiration Signal between 0 and max.
RESP IN = Inlet for Respiration Transducer.
HS GAIN = Adjust level of the Heart Sound (HS) signal between 0 and max.
HS MIC = Inlet for Heart Sounds (HS) Microphone.
ECG GAIN = Adjust level of the Electrocardiogram signal (ECG) signal between
0 and max.
INT = “Internal” ECG collected through Impedance Cables.
EXT = “External” ECG collected through separate ECG Cables.
ECG-IN = Inlet for the External ECG electrode cable assembly.
Z-IN = Inlet for the DB-9 connector.

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FRONT
5.2 Software
CI (Cardiac Index) = CO/ BSA (L/min/m
2
)
SI (Stroke Index) = SV/BSA (ml/beat/m
2
)
VI (Velocity Index) = dZ/dt (peak)/ Avg. Zo * 1000 (Value/1000sec)
TFC (Total Fluid Content) = 1000/ Avg. Zo (Value/ K Ohm)
Zo = Basal Thoracic Impedance. This is the base impedance of the thorax,
displayed in 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.

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BACK
6.2 Plug in main cable for SunTechTango+ to power source and connect other
end of the cable to the input located on the lower left corner of the rear panel.
6.3 If using electrode tape to measure impedance, connect the DB-9 connector to
the electrode input connector labeled Z-IN. Secure the plug by tightening the
two screws on either side.
6.4 If using spot electrodes to measure impendence, connect the 3-electrode ECG
cable to the electrode input connector labeled ECG-IN.
6.5 Connect appropriately sized blood pressure cuff to the end of the grey cable
making sure that both the bladder and the artery are connected.
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.
6.8 Power on laptop SPIRO 1 or SPIRO 2.
6.9 Turn the HIC-4000I Impedance Cardiograph power on by pressing on the
“POWER” button.

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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.
7.1.1.2 Place the tape on a flat surface with the metallic/colored part facing
upward. Strip off the electrode tape insulation backing.
NOTE: You can tape the ends to the table to prevent the tape from twisting.
7.1.1.3 Apply conductive electrode gel to the metallic/colored surface on the
sticky side of the tape leaving 3-4 inches at each end not coated.
7.1.1.4 Fold-back the ends of the tape so that the sticky part is not exposed.

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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.
7.1.1.6 Measure at least 3cm from the lower edge of the conductive part of
electrode band #1 (metallic/colored band) and mark the location.
7.1.1.7 Using the electrode tape, measure the quantity required by placing the
upper edge of the conductive part of the electrode tape on the mark,
leaving an extra 3-4 inches at each end of the electrode tape and cut
accordingly.
7.1.1.8 Place the tape on a flat surface with the metallic/colored part facing
upward.
7.1.1.9 Strip off the electrode tape insulation backing.
7.1.1.10 Apply conductive electrode gel to the metallic/colored surface on
the sticky side of the tape leaving 3-4 inches at each end not coated.

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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. Make sure that the folded back ends of the tape are
joined on the anterior surface of the participant.
7.1.1.13 Place electrode band #3 directly under the breast line (under
xyphoid process) following the same procedure as described above.
NOTE: For female participants, make sure that the electrode band is not in contact
with the participant’s bra.
7.1.1.14 Measure at least 3cm from lower edge of the conductive part of
electrode band #3 (metallic band) and mark the location.
7.1.1.15 Place electrode band #4 so that the mark is aligned with the
upper edge of the conductive part of the electrode tape following the
same procedure as described above.
7.1.1.16 Measure the distance in cm between the lower edge of the
conductive portion of band #2 and the upper edge of the conductive
portion of band #3 in both the anterior and posterior of the participant
and take note for future use.
7.1.1.17 Connect the appropriately numbered electrode clip of the DB-9
connector to both folded ends of the folded back ends of the electrode
band.
7.1.1.18 Once placed, tape the alligator clip down to secure, if needed.

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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. Place #1 electrode on C4, #2 electrode 4cm
above clavicle, #3 electrode on sternum, #4 electrode on T9.
7.1.2.2 Cleanse area with alcohol swab.
7.1.2.3 Using abrasive ECG prep tape, lightly scratch an “X” pattern into the
skin, taking care to avoid excess abrading.
7.1.2.4 Dry the skin vigorously with a gauze pad.
7.1.2.5 Place electrodes on the skin.
7.1.2.6 Press the contour of electrode. Avoid pressing the center of the gel
area.
7.1.2.7 Attach alligator clips of DB-9 connector to the electrodes at the
appropriate locations.
7.1.3 OPTION 3 - Attachment of 3-Lead ECG Electrode Configuration
7.1.3.1 Wearing gloves shave hair from electrode sites, if necessary. Locate
electrode sites as shown. The black (+) electrode should be located on
the subject’s left side, just below the 5
th
rib, the white (-) electrode near
the subject’s right shoulder just below the collar bone and the red
(common) reference electrode near the subject’s left shoulder just
below the collar bone.

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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. Avoid pressing the center of the gel
area.
7.1.3.7 Attach alligator clips of External ECG electrode cable assembly to the
electrodes at the appropriate locations.
7.2 SunTech

Tango+ Blood Pressure Setup
7.2.1 Explain measurement procedure to participant. Instruct participant to relax arm
and to not talk during measurements.
7.2.2 Choose the appropriate cuff size.
7.2.2.1 Without using the sleeve of the cuff, wrap the cuff around the
participant’s upper arm. Make sure the arm circumference falls within the
cuff’s RANGE arrow (located on the inside if the cuff). If it does not, use
a different cuff size. Remove cuff.
7.2.3 Verify that the microphone and bladder are in the cuff. If not, insert microphone
and/or bladder into cuff.
7.2.4 Palpate brachial artery between the bicep and triceps.

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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.
7.2.6 Wrap the cuff around the arm and secure using Velcro.
Artery Marke
r
3-5 cm

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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.
7.3 Software Setup
7.3.1 Creating a New Participant
7.3.1.1 Click on “COPWINHRV” on desktop to open software.
7.3.1.2 Select “File”, “New Patient”, “New Patient - First Data” to create a new
participant file.
7.3.1.3 Select the desired project folder in the dialog box.
7.3.1.4 Enter participant’s ID and date in “File Name:” box and click “Save”.
NOTE: It is recommended that a project folder be created for each participant.
7.3.1.5 Select “Yes” in the “Patient Folder Creation Option!” window.
7.3.1.6 Enter subject’s general information in the top half of the “Patient
Information Form” window.
NOTE: “Birth Date” is written as month, day, and year (e.g., Sept 16 1983).
7.3.1.7 In the bottom half of the window, more specifically, in the “Posture” box,
select “#1” and assign a posture label (e.g., seated, standing, or reclining).
In the red boxes below, enter the electrode distance in centimeters
previously noted. Repeat for posture “#2” and “#3”, if multiple postures
are desired.
7.3.1.8 Click “Save Changes”.
7.3.2 Open an Existing Participant
7.3.2.1 Click on “COPWINHRV” on desktop to open software.
7.3.2.2 Select “File”, “New Patient”, “Previous Patient- New data” to open an
existing participant.
7.3.2.3 Select the desired project folder in the dialog box.
7.3.2.4 Select the patient folder which had previously been created for the
participant.

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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.
7.3.2.9 In the bottom half of the window, more specifically, in the “Posture” box,
select “#1” and assign a posture label (e.g., seated, standing, or reclining).
In the red boxes below, enter the electrode distance in centimeters
previously noted.
7.3.2.10 Click “Save Changes”.
8. Calibration
8.1 In the main menu, select “Calibration”.
8.2 Click on “Calibrate COP_WIN System”.
8.3 The “System Calibration” window will open.
8.4 On the ICG machine, press the “BL” key on the keypad.
8.5 In the software, click the “BASELINES” button in the “System Calibration”
window.

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8.6 On the ICG machine, press the “CAL” key on the keypad.
8.7 Wait two or three cycles of the dZ/Dt calibration signal (a square wave) to
appear then click the “CALIBRATE” button.
8.8 Click “OK” on the calibration screen to save and exit the calibration screen.

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8.9 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.

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8.12 Click “OK”.
8.13 On ICG machine, press “OP” key to switch back to operate mode, which allows
data to be collected.
9. Data Acquisition
9.1 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.
9.1.2 Under “Acquisition Mode” select the desired mode of data acquisition.
Options are the following:
9.2 OPTION 1 – Collect data intermittently using inter-sample pauses
9.2.1 For acquisition of impedance data intermittently at preset time intervals select
“Continuous Time Intervals (Auto)” under Acquisition Mode. Enter the
desired “Inter-Sample Interval Time” in either minutes (blue) or seconds (red).

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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)”
box as shown.
9.2.3 Click the “Apply” button that appears.
9.2.4 If you like to manually start and stop data acquisition, under the “Total Run
Time For Continuous/ Non-Stop EA Acquisition Mode” select “No limit”.
9.2.5 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”.
9.2.5.1 The “Continuous Time Intervals” mode offer a Block Mode option that
permits the user to acquire and label data samples with an ID Code. To
turn this option on, select “Limit to”, then check “BLOCK MODE”
under “Block Run Time For Continuous/ Non-Stop EA Acquisition
Mode”.

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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” as data acquisition will begin as soon as “OK” is selected.
9.2.5.2 Under the “Ensemble Average MODE” select the mode by which data is
to be collected. “Cardiac Cycles” mode is recommended when using
blocks.
9.2.6 Under “Input-Digital-Filter-Setting”, select filter.