Medtronic CITVST0001S Technical Manual

Sensor Array

Multi-Electrode Mapping Vest

Technical Manual

Explanation of packaging and product symbols

Refer to the package label and product to see which symbols apply to this product.

Item Description

Warning

Precaution

Note

Consult instructions for use

Package contents

Product documentation

Re-order number

Lot number

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Date of manufacture

Manufacturer

Use by

Do not reuse

Keep away from sunlight

Keep dry

Fragile: handle with care

Storage temperature

Transit temperature

Humidity limitation

This way up

Do not use if package is damaged

Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.

Multi-Electrode Mapping Vest (Sensor Array)

Sensor Array size code

Sensor Array Front Left Panel

Sensor Array Front Right Panel

Sensor Array Back Panel

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Before use, refer to the documentation provided with the system.

General Description

The Sensor Array is a Multi-Electrode Mapping Vest composed of three panels and
contains a total of 252 electrodes. It is fitted on the patient and then connected to the
CardioInsight™ Cardiac Mapping System for signal acquisition via the mapping
amplifier.

Packaging Contents:

One of the following Sensor Array Sizes:

CITVST0001S (1)

CITVST0002M (2)

CITVST0003L (3)

CITVST0004XL (4)

Sensor Array Use

The Sensor Array is to be used only with the CardioInsight™ Cardiac Mapping System
to provide a means of acquiring electrocardiographic signals in order to process and
display virtual epicardial maps.

Indications for Use

The CardioInsight™ Cardiac Mapping System is intended for acquisition, analysis,
display and storage of cardiac electrophysiological data and maps for analysis by a
physician.

Contraindications

There are no known contraindications.

Sensor Array Sizing Chart

Use the sizing chart to select the correct Sensor Array size using the ratio of the
patient’s height and weight.

Ratio (cm/kg)x100 Ratio (in/lb)x100 Recommended size

>290 >50 1

250-290 46-50 2

190-250 34-45 3

<190 <34 4

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WARNINGS

DO NOT use the Sensor Array if the patient has sensitivity, open sores, or a
severe skin condition or disease of the thorax area.

DO NOT perform magnetic resonance (MR) imaging with the Sensor Array
on the patient. The Sensor Array may cause harm to the patient if used in
MR imaging. Remove Sensor Array prior to performing MR imaging studies.

Remove or peel back front Sensor Array panels prior to using an external
defibrillator on the patient.

PRECAUTIONS

The Sensor Array should only be connected to the CardioInsight™ Cardiac
Mapping System.

The Sensor Array is meant to be used only during computed tomography
(CT) imaging procedures that use legally marketed CT scanners.

The CardioInsight™ acquisition should be performed on the same day as the
completion of the CT scan. The Sensor Array should not be removed or
repositioned between the CT scan and the acquisition.

DO NOT expose the Sensor Array to organic solvents such as alcohol. If an
organic solvent is used on patient, allow to dry for at least one minute prior to
applying Sensor Array.

DO NOT expose the Sensor Array and electrical connectors to fluids or
solvents, except when following the cleaning instructions in the Operator’s
Manual.

Store Sensor Array flat (parallel to the floor) with the correct side facing up,
as labeled, according to the environmental storage conditions.

Store Sensor Array panels in their sealed protective pouches until use.

Inspect the packaging and Sensor Arrays prior to use.

DO NOT use Sensor Array if pouches are opened or damaged.

The Sensor Array is intended for single use ONLY. Reusing the Sensor Array
may result in poor system performance or transmission of infection.

Panels from different Sensor Array sizes should NEVER be mixed and
matched for use.

DO NOT cut or fold the circuitry on the Sensor Array.

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Environmental Conditions

Sensor Array Storage

Sensor Array Usage

Temperature +15°C to +30°C (+59°F to +86°F)

Temperature +15°C to +30°C (+59°F to +86°F)
Relative Humidity, non-condensing 20%-80%
Pressure >724 hPa

Instructions

CardioInsight™ Sensor Array is to be applied by trained
personnel only.

Follow the instructions below for skin preparation and Sensor Array placement and
refer to Appendix A as indicated below.

Skin Preparation

The patient will require skin preparation prior to Sensor Array placement. This includes
cleaning of the skin to reduce impedance and enhance signal quality. Cleaning of the

patient shall be done with a product containing the following properties

- Either a liquid or a wipe

- Non-abrasive

- Hypoallergenic

- Non-staining

- Non-alcoholic

Step 1. Ensure that the patient’s torso is completely shaved (refer to Appendix A,

step 1,2 for an illustration of the area to be shaved).

Step 2. Apply the cleaning solution to the patient’s torso according to the cleaning

product instructions (refer to Appendix A, step 1,2 for an illustration of the
area to be cleaned).

Sensor Array Placement

The Sensor Array must be applied after skin preparation.

Step 3. Have the patient carefully lie down on his or her back on a flat bed.
Step 4. Remove the plastic backing from the “Front Left” panel, and position the

medial edge of the panel such that it lines up with the patient’s sternum.
This panel should also be positioned on the torso so that the medial end of
the left clavicle is between sensors 65 and 66 (refer to Appendix A, step 4

:

).

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Step 5. Remove the plastic backing from the “Front Right” panel. Position the

Step 6. After placing both front panels, place three equally distributed strips of

Step 7. Have the patient carefully stand up, or sit up with his or her back straight if

Step 8. Remove the plastic backing from the “Back” panel and position the panel so

Step 9. Have the patient lie back down on the flat bed taking care that all four

Step 10.Place two strips of medical tape horizontally across the panels to secure the

Step 11.Place two strips of medical tape horizontally across the panels to secure the

Step 12.Place two perpendicular strips of medical tape across each shoulder to

medial edge of the “Front Right” panel along the medial edge of the “Front
Left” panel, staggered in such a manner that it fits like a “puzzle” with the
“Front Left” panel. The “Front Right” panel should be staggered slightly
higher than the “Front Left” panel (refer to Appendix A, step 5,6).

medical tape horizontally across the two panels along the sternum (refer to
Appendix A, step 5,6).

they are unable to stand, for placement of the “Back” panel.

that it is symmetrical on the patient’s back. This panel should also be
positioned on the back so that sensor 192 rests at the level where the neck
meets the shoulders. First, adhere the top center of the panel to the
patient’s back and continue down through the bottom. Next, adhere the left
and right sides of the “Back” panel to cover the left and right lateral sides of
the torso, respectively. Lastly, drape the shoulder straps on top of the
shoulders (refer to Appendix A, step 8).

Note: If the “Back” panel shoulder electrodes overlap with the “Front Left” panel
shoulder electrodes, give priority to adhering the “Front Left” panel electrodes onto
the skin.

Note: If the “Back” panel shoulder electrodes overlap with the “Front Right” panel
shoulder electrodes, give priority to adhering the “Front Right” panel electrodes
onto the skin.

Sensor Array cable connectors are accessible on either side of the patient.

lateral side of the “Front Left” panel with the “Back” panel (refer to Appendix
A, step 10,11).

lateral side of the “Front Right” panel with the “Back” panel (refer to
Appendix A, step 10,11).

secure the “Back” panel shoulder straps with the Front panels (refer to
Appendix A, step 12).

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Compatible Device Placement

The following steps are not required to operate the device but will allow for compatibility
with other equipment such as a patient return electrode, ECG electrodes, and
defibrillator patches.

Patient return electrode placement

When there is a need to use a patient return electrode, follow the manufacturer’s
instructions for placement. Within these guidelines, there is a preference for the patient
return electrode to be placed low on the back.

It is preferred not to have the ECG electrodes or defibrillator patches attached to the
patient during signal acquisition. Whenever possible, acquire the signals prior to ECG
electrode and defibrillator patch placement to optimize Sensor Array electrode contact
and minimize outside noise.

Defibrillator patch placement

Step 13.Gently peel back the nearest edge of the Sensor Array that corresponds to

Step 14.Return the peeled edge of the Sensor Array back to its previous location on

the defibrillator patch location. Apply the defibrillator patch and route the
DCC (direct current cardioversion) cables to the nearest edge of the Sensor
Array. Refer to Figure 1 for suggested defibrillator patch placement.

the patient’s torso.

Figure 1: Defibrillator patch placement

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ECG electrode placement

Step 15.Identify locations between the Sensor Array electrodes for the desired ECG

Step 16.Gently peel the nearest edge of the Sensor Array off of the patient’s skin

Step 17.Return the peeled edge of the Sensor Array back to its previous location on

Step 18.Connect the ECG cables to the electrode snaps.

electrodes.

and apply the ECG electrodes. Avoid placing the ECG electrodes directly
beneath Sensor Array electrodes and circuitry.

the patient’s torso. Cut holes in the spandex just large enough for
connecting ECG cables to the electrode snaps, making sure to avoid cutting
the Sensor Array circuitry.

Disposal

Dispose of the Sensor Array and its residual elements or waste items according to
institution’s biohazard requirements.

For additional education and materials for Sensor Array sizing and placement, please
contact your local Medtronic Representative.

Medtronic Limited Warranty

For Sensor Array warranty information, see the accompanying limited warranty
document.

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,

Appendix A: Steps

6
5

4

1, 2

66

65

12

65

10, 11

192

8

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Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.cardioinsight.com

© 2016 Medtronic
M967769A001 1A
2016-08-31

*M967769A001*