ZOLL CMCT Monitoring System User manual

CMCT Monitoring System
Rx Only
Instructions for Use

CMCT Monitoring System
Instructions for Use
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For assistance with the µCor 3.0 System, please contact ZOLL at:
121 Gamma Drive
Pitts urgh, PA 15238 USA
Phone toll free (USA) 1.888.592.3798
Copyright Notice
2016, ZOLL Medical Corporation. All rights reserved
Trademarks
ZOLL is a trademark or registered trademark of ZOLL Medical Corporation in the United States.
Disclaimer
Information, operation, specifications, and product appearance may change without notice.
Symbols Glossary
The symbols glossary is located in Section 9 of this Instructions for Use
User Guide RA-72-002-034-ENG
Version 1 ∙ March 2017
PLEASE READ THIS ENTIRE INSTRUCTIONS FOR USE
BEFORE OPERATING THE CMCT SYSTEM

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TABLE OF CONTENTS
Part I: General Information ....................................................................................................5
1 Introduction .............................................................................................................. 6
2 Conditions for Use ........................................................... Error! Bookmark not defined.
2.1 Intended Use and Indications for Use ...................................................................... 6
2.2 Contraindications ....................................................... Error! Bookmark not defined.
3 General Warnings and Precautions .................................. Error! Bookmark not defined.
3.1 Warnings .................................................................... Error! Bookmark not defined.
3.2 Precautions ................................................................ Error! Bookmark not defined.
4 Detailed Descripton of the CMCT System ................................................................... 7
4.1 System Components................................................................................................ 8
4.2 How CMCT System works ........................................................................................ 9
4.3 Prescription Duration and Measurement Scheduling ............................................... 9
4.4 Patch ..................................................................................................................... 10
4.5 Sensor ................................................................................................................... 10
4.6 Charger ................................................................................................................. 11
4.7 Data transmission device (Gateway) ...................................................................... 12
4.8 Server ................................................................................................................... 12
4.9 Device (sensor + Patch) Placement Location .......................................................... 12
5 Directions for Use .................................................................................................... 13
5.1 Getting started ...................................................................................................... 13
5.1.1 Locate the components of the CMCT System: .................................................. 13
5.1.2 Connect the Charger ............................................ Error! Bookmark not defined.
5.1.3 Confirm that the Sensor is ready for use .............. Error! Bookmark not defined.
5.1.4 Confirm that the Gate ay is ready for use ...................................................... 13
5.2 Connecting the Sensor to the Patch ....................................................................... 14
5.3 Preparing the Skin ................................................................................................. 14
5.4 Applying the Device ............................................................................................... 15
5.4.1 Side Location .................................................................................................. 15
5.4.2 Front Location ................................................................................................ 17
5.5 How to USe the Gateway....................................................................................... 18
5.6 Replacing the Patch ............................................................................................... 18
5.7 Recharging the Sensor ........................................................................................... 19
5.8 Sensor and light Indicator statuses ........................................................................ 19
6 Trou leShooting ...................................................................................................... 20
7 Cleaning and Return of System ................................................................................ 20
8 Maintenance ........................................................................................................... 21
9 Sym ols Glossary .................................................................................................... 21
Part II: Technical Specifications ............................................................................................ 23
10 Technical Specifications ........................................................................................... 24
10.1 Accuracies ............................................................................................................. 24
10.2 Electrical (Power) Requirements ........................................................................... 25

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10.3 Wireless Transmission Specifications ..................................................................... 25
10.4 Sensor Dimensions ................................................................................................ 26
10.5 Environmental & Other Specifications ................................................................... 27
11 Compliances ............................................................................................................ 28
11.1 Electrical Safety ..................................................................................................... 28
11.2 Electromagnetic compatibility (EMC) ..................................................................... 28

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Part I:
General
Information

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1INTRODUCTION
The CMCT System is a wearable, wireless system that is used to aid clinicians in the
diagnosis and identification of various clinical conditions, events and/or trends. It consists
of the CMCT wearable Sensor and Patch, a portable data transmission device (Gateway),
and a Charger. The Sensor unit continuously records and transmits ECG data to the data
transmission device, and from there to the ZOLL monitoring center. Other physiological
parameters such as thoracic impedance, heart rate, respiration rate, activity and posture
are recorded periodically and are also transmitted, via the data transmission device to the
monitoring center. Certified technicians at the ZOLL Monitoring Center review received
data and prepare clinical reports to the prescribing physician. The CMCT System is designed
for use in outpatient clinic and home settings for up to 30 days.
2INDICATIONS FOR USE
The CMCT System is intended to continuously record, store, and transmit ECG, Heart Rate,
Activity, and Posture to medical professionals. The CMCT System also periodically records,
stores, and transmits Respiration Rate and Thoracic Impedance to medical professionals.
The CMCT System is indicated for patients ho are 21 years of age or older:
i. Who require monitoring for the detection of non-lethal cardiac arrhythmias, such
as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial
flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction
disorders
ii. ith fluid-management problems;
iii. taking diuretic medication;
iv. living ith heart failure;
v. living ith end-stage renal disease;
vi. recovering from a coronary artery disease-related event; and/or suffering from
recurrent dehydration.

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3WARNINGS AND PRECATIONS
•Do not use the CMCT System if you:
-Have allergies or skin sensitivities to electrode hydrogel and/or acrylic based
adhesives.
-Are pregnant (the CMCT System has not been tested on pregnant women).
-Have skin breakdown in areas where device (Patch + Sensor) placement is required.
•The CMCT System is not intended to be an alarm or to alert patients or physicians, and
will not summon emergency response in the event help is needed
•The CMCT System is not intended to replace direct communication with healthcare
providers.
•Data provided by the system should be used by physicians along with all other clinical
findings and exams to come to a diagnosis.
•Patients should talk to their healthcare provider immediately if there are any concerns
or if their condition changes.
•Remove the device (Patch + Sensor) from your body prior to an MRI scan, or any
emergency medical procedure. The CMCT System is not compatible for use with MRI
machines.
•If you have an implanted pacemaker or defibrillator, do not place the Sensor directly
on top of the implanted device. Consult with your physician about the correct
placement of the device for you.
•Sensor and Data Transmission Device must be turned OFF prior to boarding an
airplane. Remove Sensor from Patch and call ZOLL for further instructions.
•Do not wear the Patch for more than 5 days. Replace the Patch every 3 days, or more
frequently when needed. The Patch is designed for a maximum of 5 days use only.
•No creams of lotions should be applied to the skin immediately prior to the
application of the Patch.
•Do not re-use the Patch. Once the Patch is peeled off or removed, discard
immediately. The Patch is designed for single use. Re-using the Patch may result in
poor adhesion to the body and may affect measurements.
•Remove the device (Patch +Sensor) if any pain or discomfort occurs. If skin irritation,
discomfort, redness, itching or rash persists after the device is removed, a topical,

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anti-inflammatory cream may be applied (in consultation with your health care
provider).
•Do not submerge the Sensor in water by swimming or sitting in a tub. The Sensor is
water-resistant, but not waterproof. Wearing the Sensor while showering is okay.
•Keep the Charger and Data Transmission Device away from water.
•The power adapter connector should not be touched or manipulated when the Power
Adapter is connected to the supply mains.
•Do not change, modify, or disassemble any parts or components of the CMCT System.
The system contains no user-serviceable components. Any changes, modification, or
servicing of the CMCT System will only be performed by ZOLL.
•Connect the Charger to the AC adapter that is provided with the system in the original
packaging. Using any other AC adapter may damage the Charger and may have
electric hazards.
•Place the Sensor in the Charger when not in use.
•When using the µCor 3.0 System, use only cables and accessories provided by ZOLL.
Using non-approved cables and accessories may affect the EMC performance
•Do not stack the µCor 3.0 system with other devices or equipment.
•Discontinue use and contact ZOLL if the CMCT System shows signs of damage or is not
working correctly.
•Keep the CMCT System out of reach of children.
4DETAILED DESCRIPTON OF THE CMCT SYSTEM
4.1 SYSTEM COMPONENTS
The CMCT System consists of the following components:
•Patch
•Sensor
•Charger
•Data transmission device (Gateway)
•Server
Each component will be further described within this Section.

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4.2 HOW CMCT SYSTEM WORKS
Once activated, the wearable Sensor automatically acquires ECG, thoracic impedance,
Heart Rate, Respiration Rate, Activity, and Posture measurements. Patients can also
activate a patient trigger when they experience symptoms by double tapping the Sensor
when it is on the body. Data are automatically transmitted from the Sensor to the Data
transmission device, and from there to the Server for analysis. Certified technicians at
the Monitoring Center review the data generated by the Server and prepare reports
according to the pre-defined criteria as requested by the prescribing physician. Data
provided in the report will aid the prescribing physicians in the diagnosis and
identification of various clinical conditions, events and/or trends. The CMCT System is
designed for use in outpatient clinic and home settings.
4.3 PRESCRIPTION DURATION AND MEASUREMENT SCHEDULING
The CMCT System is intended for up to 30 days of monitoring.
During the prescription period, the Sensor will automatically acquire your clinical
measurements. As described previously, data acquired by the body-worn Sensor will be
transmitted wirelessly to the data transmission device, which will then be forwarded to
the remote Server for data analysis, and subsequently to the Monitoring Center for
review and report generation. See Figure 1 for a graphical illustration of the data
transmission.
Figure 1: Data transmission of the CMCT System

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4.4 PATCH
The Patch (as shown in Figure 2) consists of a plastic frame intended for housing the
Sensor, and two ECG electrodes on each side of
the frame. It is applied to your body.
The Patch is a single-use disposable item. As
described in the General Warnings and
Precaution Section, it should not be worn for
more than 3 days. At the end of 3 days, it should
be replaced with a new Patch.
4.5 SENSOR
The Sensor (as shown in Figure 3) is a battery powered unit that acquires your
measurements. The Sensor connects to the Patch via the snap-in clip and positioning
tabs. Through the adhesive backing on the Patch, the device becomes wearable.
The Sensor is not disposable and needs to be returned to ZOLL upon the completion of
the prescription.
As shown in Figure 3, a light indicator is located close to the center and serves to
communicate the Sensor’s status at different points of use. Note that the light indicator
is visible only when lit.
Figure 2: Patch
Snap-in Clip for
Patch attachment
Light Indicator
Positioning tabs for
Patch attachment

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Figure 3: Sensor
4.6 CHARGER
A dedicated Charger (as shown in Figure 4) is
supplied with the CMCT System for recharging the
Sensor and the Data Transmission Device. A blue
light appears when the Charger is connected to an
AC outlet.
Figure
4
: Charger

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4.7 DATA TRANSMISSION DEVICE (GATEWAY)
A Data Transmission Device or Gateway is responsible for
sending data from the Sensor to the Server for data
analysis. When the screen display is on, the gateway
battery status is visible on the screen. Once the battery
status is under a certain level, a short beeping sound will
be made every few minutes until the battery is depleted
or the Gateway is placed in the Charger. Make sure you
charge the gateway daily.
4.8 SERVER
The Server refers to the hardware and the processing software and resides in a remote
cyber-secure location. The software analyzes the data recevied from the Sensor via the
Gateway and processes the data into clinical values for presentation to your healthcare
provider after review by certified technicians at the Monitoring Center.
4.9 DEVICE (SENSOR + PATCH) PLACEMENT LOCATION
There are two locations for device (Sensor + Patch) placement: (1) below left armpit
(side location); and (2) upper left chest (front location). See Figure 6.
Figure 6: Device (Sensor + Patch) placement location
Figure 5: Gateway
Display/ Power
on/off button
Front
S
ide

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5DIRECTIONS FOR USE
5.1 GETTING STARTED
5.1.1 LOCATE THE COMPONENTS OF THE CMCT SYSTEM:
1. Patch in Envelope
2. Sensor
3. Charger
4. Gateway
5. Power Cord (or AC Adapter)
6. Preparation Wipes
See Figure 7.
5.1.2 CHARGING THE SENSOR – FIRST USE AND EVERY 3 DAYS
IMPORTANT: Set up Charger in bedroom or room where you sleep. This allows device to send
data to ZOLL at least once a day.
1. Connect the Charger to a power outlet in your
edroom. A Blue light on the Charger means the
Charger has power.
1. Place the Sensor on the Charger. Wait for a solid green
light to appear on the Sensor, this means it is fully
charged and ready for use. Once removed from the
Charger, the green light will disappear.
2. The Sensor, typically, takes about one hour to charge.
See Figure 8.
Figure 8: Charging the
Sensor

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5.1.3 CHARGING THE GATEWAY – FIRST USE AND EVERY DAY
1. Place the Gateway on the Charger in its designated area.
2. The Gateway screen should light up and display it is being
charged. Once removed from the Charger, the Gateway
screen will display battery status in percent.
3. The Gateway, typically, takes about three hours to charge.
See Figure 9.
5.2 PREPARING THE SKIN
IMPORTANT: This step ensures good adhesion to skin.
1. Remove your bra/ undershirt.
2. If hair is present, trim hair at the Patch location indicated by your physician. See images
below.
3. Use provided Prep Wipes to clean area where Patch will be applied and allow skin to
dry.
Figure 9: Charging the
Gateway
Figure 10: Trimming area

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5.3 CONNECTING THE SENSOR TO THE PATCH
1. Remove the Sensor from the Charger.
2. Hold the Patch so that the word “ZOLL” on the Patch
is right-side up.
3. Place the lower tabs of the Sensor on the lower part
of the Patch frame.
4. Press the rest of the Sensor onto the Patch until you
hear a snap. The Sensor should be firmly attached to
the Patch.
See Figure 11.
5.4 APPLYING THE DEVICE
The device can be applied to either of the two locations detailed below. Once you wear the
device in one location, you will continue to wear the device at the same location for the entire
duration of your prescription.
5.4.1 LEFT-SIDE LOCATION
1. Stand in front of a mirror.
2. Remove both parts of the Patch liner.
3. Turn the Patch so that the word “ZOLL” on the Patch is at the top.
4. Raise the left arm to shoulder height.
5. If needed, slightly move the breast aside when applying the Patch.
6. Place the Patch below the left arm pit with the nipple aligned anywhere between the
top and middle of the Sensor. See Figure 12.
7. Ensure the Patch is completely adhered to the skin.
Figure 11: Sensor Patch
attachment

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8. Stay still and wait for a green light to appear on the Sensor, which signals it is ready to
monitor (refer to Section 6 Trouble Shooting if a blinking amber light appears instead).
Note that the green light will last for several seconds, after which the light indicator will
remain off. Figure 13 illustrates examples of incorrect device placements for the side
locations.
Figure 63: Side location incorrect placement
Figure
5
2: De
vice (Sensor + Patch) applied to left
-
side location
Left side
Left side

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5.4.2 CHEST LOCATION
1. Stand in front of a mirror.
2. Remove both parts of the Patch liner.
3. Position the Patch on the upper left chest, just below the collarbone, and angle the
device towards the nipple. The arrow on the Patch should point up (↑). See Figure 14.
4. Ensure the Patch is completely adhered to the skin.
5. Stay still and wait for a green light to appear on the Sensor, which signals it is ready to
monitor (refer to Section 6 Troubleshooting if a blinking amber light appears instead).
Note that the green light will last for several seconds, after which the light indicator will
remain off.
6. Figure 15 illustrates examples of incorrect device placements for the front location.
Figure 8: Chest location incorrect placement
Figure
7
4: Device (Sensor + Patch) applied to front

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5.5 HOW TO USE THE GATEWAY
1. Make sure to keep the Gateway not more that 10 meters
away from the body at all times to allow proper
communication with the Sensor.
•During the day, carry the Gateway with you
2. At night, keep the Gateway on a nightstand close to you
while you sleep
3. The Gateway may be turned ON and OFF manually by
pressing and holding the Power button for several
seconds.
•When boarding an airplane, make sure to turn the Gateway OFF to prevent
interference with aircraft systems.
•Otherwise, please keep the Gateway ON at all times to allow proper
communication with the Sensor.
4. Charge the Gateway daily, (for example, every night while you sleep)
•The Gateway takes about 3 hours to fully charge
•With an adequate charge, the Gateway can be used for up to 18 hours before
needing to be recharged.
See Figure 16.
5.6 REPLACING THE PATCH
5.6.1 REMOVE THE SENSOR FROM THE PATCH
1. Press the blue upper snap-in clip.
2. Tilt and remove the Sensor from the Patch while pressing the clip.
3. Place the Sensor in the Charger. Whenever the Sensor is not on the body, it should be
kept in the Charger.
5.6.2 REMOVE THE PATCH FROM THE BODY
1. Hold the skin with one hand while using the other to gently peel-off the Patch. You may
use a wet cloth to assist you in the process
F
igure
9
6: Gateway Charging

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2. Discard the Patch immediately. Do not reuse.
If required, replace the Patch with a new one according to the instructions in Sections 6.2 to 6.4.
The Patch should be replaced at least once every five days. Make sure to place the new Patch
on the same spot (or as closely as possible to the location) of the previous Patch).
5.7 RECHARGING THE SENSOR
1. The Sensor should be charged every three days, or
with every replacement of the Patch, the sooner of
the two.
2. Place the Sensor in the Charger. See Figure 17.
The color of the light indicator on the Sensor will
be amber when being charged. It will turn green
when the Sensor is fully charged and ready to go.
5.8 SENSOR AND LIGHT INDICATOR STATUSES
The following is a summary of the light indicator statuses of the Sensor:
Sensor Position Light Color Meaning
Sensor in Charger Solid green Battery is fully charged and is ready for use.
The solid green light will continue until the
Sensor is removed from the Charger.
Solid amber Battery is not full and is being charged. The
light will change to green once battery is
charged and Sensor is ready for use.
Sensor on the body Solid green Sensor is ready for monitoring. This solid
green light will last for several seconds, after
which it will disappear.
Blinking
amber
Sensor error. Call ZOLL customer service at
1.888.592.3798.
Figure
10
7: Sensor
Charging

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6TROUBLESHOOTING
The following table lists the recommended actions for potential issues with the CMCT
System. Please call ZOLL at [phone] if you need assistance with any of these
instructions .
Signs Possi le Causes Actions
Sensor light indicator
is not on while sitting
in the Charger for
charging.
The Sensor does not sit
properly in the Charger.
Remove the Sensor from the Charger and
reinsert back to the Charger.
The Charger is not connected
to the power outlet.
Plug in the Charger to the power outlet using
the power cable provided in the CMCT
packaging. When properly connected, the
light indicator on the Charger should be on
and is green.
Sensor light turns
blinking amber after
being applied on the
patient’s body.
Sensor Error. Contact ZOLL customer service
at
1.888.592.3798.
Charger light indicator
is not on.
The Charger is not connected
to the power outlet.
Plug in the Charger to the power outlet using
the power cable provided in the CMCT
packaging. When properly connected, the
light indicator on the Charger should be on
and is green.
The Gateway screen
does not indicate the
Gateway is being
charged while sitting
in the Charger for
charging.
The Gateway does not sit
properly in the Charger.
Remove the Gateway from the Charger and
reinsert back to the Charger.
7CLEANING AND RETURN OF SYSTEM
Users are not required to clean the CMCT System. When the monitoring period is over, use
the box provided in the original packaging to return the CMCT System (Sensor, Charger,
Gateway, power cable, and any unused Patches) to ZOLL.