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.