ZOLL Arrhythmia Management System User manual

ZOLL Arrhythmia
Management System
Paent Instrucon Manual
Rx Only
20B0087 Rev J

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Table of Contents
Contact ZOLL ........................................................................................................................................................................................ 1
Welcome to the ZOLL Arrhythmia Management System ....................................................................................................................... 2
Indicaons for Use................................................................................................................................................................................ 3
Warnings .............................................................................................................................................................................................. 4
Precauons ....................................................................................................................................................................................... 4-5
Important Informaon ......................................................................................................................................................................... 6
Part 1: Meet the Arrhythmia Management System............................................................................................................................ 7-8
The Arrhythmia Management System Components ................................................................................................................. 7
How the Arrhythmia Management System Works.................................................................................................................... 8
Part 2: Geng Started ..................................................................................................................................................................... 9-19
Before You Begin...................................................................................................................................................................... 9
Charge the Sensor..............................................................................................................................................................10-11
Sensor While in Charger: Understanding the Lights................................................................................................................ 12
Solid Orange, Solid Green, No Light ........................................................................................................................... 12
Charge the Gateway............................................................................................................................................................... 13
Understanding the Gateway Interface.................................................................................................................................... 15
Prepare Your Skin: Every Time You Apply a Patch ................................................................................................................... 16
Connect Sensor to Patch ........................................................................................................................................................ 17
Peel O Patch Liner — 2 Pieces .............................................................................................................................................. 18
Sensor + Patch Body Placement ............................................................................................................................................. 19
Part 3: Important Instrucon..........................................................................................................................................................20-26
Replace Patch on Your Body...............................................................................................................................................20-21
How to Use Gateway ............................................................................................................................................................. 22
Gateway Interface: Understanding the Baery Status for Sensor and Gateway ...................................................................... 23
Green, Orange, Red, and Charging Icon ..................................................................................................................... 23
How to Record a Symptom & Acvity Level: From Gateway ................................................................................................... 24
How to Record a Symptom & Acvity Level: From Sensor ..................................................................................................25-26
Part 4: Troubleshoong ...................................................................................................................................................................... 27
Part 5: Maintenance and Cleaning ...................................................................................................................................................... 28
Part 6: Symbols Glossary ................................................................................................................................................................29-31
Part 7: Compliances............................................................................................................................................................................ 32

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Page 1
Disclaimer: Informaon, operaon, specicaons, and product appearance may change without
noce.
Trademarks: ZOLL is a trademark and/or registered trademark of ZOLL Medical Corporaon in the
United States and other countries.
Copyright Noce: © 2022 ZOLL Medical Corporaon. All rights reserved.
Patents: Patent: www.zoll.com/patents
Symbols Glossary: The symbols glossary is located in Part 6 of this manual.
If you have any quesons, contact ZOLL
24 hours a day, 7 days a week:
Toll free (USA) 1.888.592.3798
121 Gamma Drive ● Pisburgh, PA 15238 USA

ZOLL Arrhythmia Management System
Page 2
Welcome to the ZOLL Arrhythmia Management System
The ZOLL Arrhythmia Management System (AMS) is a wearable medical device that is intended to
connuously transmit, store, and record your medical data to healthcare professionals.
Once placed on your body and acvated, the wearable Sensor automacally acquires your body’s heart
rhythm (ECG), Heart Rate, Respiraon Rate, Acvity, and Posture measurements. You can acvate a
paent trigger when experiencing symptoms by double tapping the Sensor when it is on your body or by
pressing the record event buon on the Gateway interface.
Your data are automacally transmied from the Sensor to the Gateway, and from there to ZOLL for
analysis by cered technicians. The cered technicians also prepare reports according to the dened
criteria as requested by your prescribing physician. Data provided in the report aids your prescribing
physician in the diagnosis and idencaon of various clinical condions, events and/or trends.
AMS is intended for use in an outpaent clinic and home sengs.
Contact ZOLL at 1.888.592.3798 if you have any quesons.

Page 3
ZOLL Arrhythmia Management System
AMS is intended for use in clinic and home sengs. AMS is indicated for paents who are
21 years of age or older who require monitoring for the detecon of non-lethal cardiac
arrhythmias, such as, but not limited to, atrial brillaon, atrial uer, ventricular ectopy, and
bradyarrhythmias.
Indicaons for Use
The ZOLL Arrhythmia Management System (AMS) is intended to connuously record, store, and
transmit ECG, Heart Rate, Respiraon Rate, Acvity, and Posture. The data provided will aid
medical professionals as they diagnose and idenfy various clinical condions, events, and/or
trends.

Warnings and Precauons
Page 4
Warnings
• Do not use AMS if you have allergies or skin sensivies to electrode hydrogel and/or acrylic based
adhesives. Irritaon such as redness or itching may develop.
• Do not use AMS if you have skin breakdown in areas where device (Patch + Sensor) placement is
required, as this can cause further injury to your skin.
Precauons
• If you are pregnant, consult with your prescribing physician before using the device.
• Remove the device (Patch + Sensor) from your body prior to a magnec resonance imaging
(MRI) scan. AMS is MRI unsafe.
• Remove the device (Patch + Sensor) if any pain or discomfort occurs. If skin irritaon, discomfort,
redness, itching, or rash persists aer the device is removed, contact your physician.
... Precauons connued on next page →

Page 5
Warnings and Precauons
Precauons (connued)
• If you have an implanted pacemaker or debrillator, do not place the Sensor directly on top of the
implanted device. This may cause the Sensor to malfuncon.
• Do not submerge the Sensor in water by swimming or bathing in a tub. It is okay to wear the Sensor
while showering. The Sensor is water-resistant, but not waterproof. If wet, dry the Sensor before
placing it into the Charger.
• Keep the Charger and Gateway away from water. Water entering the Charger or Gateway may
damage the device and/or cause the Charger or Gateway to malfuncon.
• Connect the Charger to the Power Cord that is provided with the system. Using any other power cord
may damage the Charger or result in electrical hazard.
• When using AMS, use only cables and accessories provided by ZOLL. Using non-approved cables or
accessories may aect device performance.
• Do not change, modify, or disassemble any parts or components of AMS. This may cause AMS to
malfuncon. The system contains no user-serviceable components. Any changes, modicaon, or
servicing of AMS will only be performed by ZOLL.

Page 6
Important Informaon
• When traveling by aircra, paents should remove the Sensor from the Patch and turn o the Gateway
while on the plane to prevent interference with aircra systems.
• Do not place AMS on top of, below, or in close proximity to other electronic devices because it could result
in improper operaon.
• AMS is not intended to be an alarm or to alert paents or physicians, and will not summon emergency
response in the event help is needed.
• AMS is not intended to replace direct communicaon with healthcare professionals.
• Data provided by the system may be used by healthcare professionals along with all other clinical ndings
and exams to come to a diagnosis.
• Paents should talk to their prescribing physician immediately if there are any concerns or if their condion
changes.
• Do not apply creams or loons to the skin immediately prior to the applicaon of the Patch. This may result
in poor adhesion to the body or may aect measurements.
• Place the Sensor in the Charger when not in use. Doing so will ensure the Sensor is fully charged upon next
use.
• Disconnue use and contact ZOLL if AMS shows signs of damage or is not working properly.
• Keep AMS out of reach of children.

Page 7
Part 1: Meet the Arrhythmia Management System
The Arrhythmia Management System Components
Patch Sensor Charger Gateway Power Cord
• Patch ─ Disposable, adhesive patch that is applied to your body. It contains a plasc frame that houses the
Sensor, and two ECG electrodes on each side of the frame. Patch should not be worn for more than 7 days.
• Sensor ─ Battery powered device that acquires your clinical measurements. Sensor connects to Patch via the
snap-in clip and positioning tabs.
• Charger ─ Recharges the Sensor and the Gateway.
• Gateway ─ Sends your data from the Sensor to the server for data analysis.
• Power Cord ─ Plugs into a standard power outlet to provide power to the Charger.

Page 8
Part 1: Meet the Arrhythmia Management System
3-4
Data Transmission of AMS
How the Arrhythmia Management System Works
1
2
During your prescripon period, the Sensor automacally acquires your clinical measurements.
Your data, acquired by the wearable Sensor, are transmied via Bluetooth® to the Gateway.
From the Gateway, your data are then forwarded to the remote server for analysis where your data are
viewed by ZOLL. You do not need to congure the system for Bluetooth®, Wi-Fi® or cellular connection.
ZOLL does this for you.
ZOLL provides your data report to your prescribing physician.
ZOLL Arrhythmia Management System

Page 9
Part 2: Geng Started
Before You Begin
This secon helps you set up and start wearing AMS.
1 6
1. Gather all AMS components.
2. Make sure none of the components have been damaged during shipping. If a component is
damaged, call ZOLL.
3. Follow Part 2: Geng Started steps ─ in this guide.

Page 10
Part 2: Geng Started
Charge the Sensor:
IMPORTANT: Set up Charger in your bedroom or where you sleep.
2. Connect Charger to a
power outlet in your
bedroom. A blue light
shows when Charger has
power.
3. Tilt lower part of Sensor
with the tabs on the
boom into Charger. Snap
the Sensor clip into place.
Sensor light is orange
while it charges.
1. Connect Power Cord to
Charger.
Charger
Light
Tabs
Connect
... step 4. connued on next page →
1
Snap-in
Clip
First Use and Every 5 Days

Page 11
Part 2: Geng Started
Charging the Sensor
Charge the Sensor: First Use and Every 5 Days
Sensor
Light
Charger
Light
(connued)
Sensor charges in about one hour.
4. Sensor is fully charged when the orange
light changes to green .
1
Note:
• Make sure the Sensor is dry before
placing into the Charger.
• Place the Sensor in Charger when
not on your body. This ensures the
Sensor is fully charged upon next
use.

Page 12
Part 2: Geng Started
Sensor While in Charger: Understanding the Lights
Solid Orange
Sensor is charging and is
not full.
Sensor takes about
1 hour to fully charge.
Solid Green
Sensor is fully charged
and ready for use.
No Light
When Sensor is out of the
Charger, the light turns o.
See Part 4: Troubleshoong if
there is no light when placed in the
Charger.

Page 13
Part 2: Geng Started
• Charge the Gateway nightly in the Charger. Leave the Gateway on the Charger every night
when you sleep. Gateway power can last up to 18 hours before needing to be recharged.
• Once the baery charge is under 20%, a short beeping sound is made every 20 minutes unl
the baery is depleted or the Gateway is placed in the Charger.
• The Gateway takes about three hours to fully charge.
Charge the Gateway: First Use and Every Day
2

Page 14
Part 2: Geng Started
Charge the Gateway: First Use and Every Day
2
1. If the Gateway has a belt clip, remove the belt clip before placing the Gateway in the Charger.
=
2. Place Gateway on Charger.
3. The Gateway screen should light up and display a baery status icon with the
percent charge.
4. When the Gateway is fully charged , remove it from the Charger. If
desired, place the belt clip back on the Gateway.
100%
(connued)

Page 15
Part 2: Geng Started
Understanding the Gateway Interface
Record Event
Pending Recordings
3
100%
100%
Gateway
Sensor
9:41 AM
Pending Recordings Buon
Record Event Buon
This buon only appears if there are
paent acvated recordings that have
not been sent to ZOLL.
See page 26.
Sensor Baery Status
Gateway Baery Status
Number of Pending
Recordings
See page 23.
See page 23.
See page 26.
See page 24.

Page 16
Part 2: Geng Started
Prepare Your Skin: Every Time You Apply a Patch
3
IMPORTANT: This step ensures good adhesion to your skin.
Target
Area Preparaon
Wipe
3. Use provided Preparaon Wipe to scrub area
where Patch is to be applied.
4. Repeat step 3 with a second Preparaon Wipe.
Allow your skin to dry.
1. Remove all clothing and undergarments from
your upper body.
2. Trim hair (if any) in Target Area where Patch is
to be placed.