Related Manuals for ZOLL Arrhythmia Management System
Summary of Contents for ZOLL Arrhythmia Management System
- Page 1 ZOLL Arrhythmia Management System Patient Instruction Manual Rx Only 20B0087 Rev J...
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Page 3: Table Of Contents
Table of Contents Contact ZOLL ......................................1 Welcome to the ZOLL Arrhythmia Management System ........................2 Indications for Use ....................................3 Warnings ......................................4 Precautions ....................................... 4-5 Important Information ..................................6 Part 1: Meet the Arrhythmia Management System ..........................7-8 The Arrhythmia Management System Components ......................... - Page 4 This page intentionally left blank.
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Page 5: Contact Zoll
Disclaimer: Information, operation, specifications, and product appearance may change without notice. Trademarks: ZOLL is a trademark and/or registered trademark of ZOLL Medical Corporation in the United States and other countries. Copyright Notice: © 2022 ZOLL Medical Corporation. All rights reserved. -
Page 6: Welcome To The Zoll Arrhythmia Management System
Gateway interface. Your data are automatically transmitted from the Sensor to the Gateway, and from there to ZOLL for analysis by certified technicians. The certified technicians also prepare reports according to the defined criteria as requested by your prescribing physician. -
Page 7: Indications For Use
ZOLL Arrhythmia Management System Indications for Use The ZOLL Arrhythmia Management System (AMS) is intended to continuously record, store, and transmit ECG, Heart Rate, Respiration Rate, Activity, and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends. -
Page 8: Warnings
Warnings and Precautions Warnings • Do not use AMS if you have allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesives. Irritation 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. - Page 9 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 affect device performance. •...
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Page 10: Important Information
Place the Sensor in the Charger when not in use. Doing so will ensure the Sensor is fully charged upon next use. • Discontinue use and contact ZOLL if AMS shows signs of damage or is not working properly. • Keep AMS out of reach of children. -
Page 11: Part 1: Meet The Arrhythmia Management System
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 plastic 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. -
Page 12: How The Arrhythmia Management System Works
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 configure the system for Bluetooth®, Wi-Fi® or cellular connection. ZOLL does this for you. -
Page 13: Part 2: Getting Started
This section helps you set up and start wearing AMS. Gather all AMS components. Make sure none of the components have been damaged during shipping. If a component is damaged, call ZOLL. Follow Part 2: Getting Started steps ─ in this guide. -
Page 14: Charge The Sensor
Part 2: Getting Started Charge the Sensor: First Use and Every 5 Days IMPORTANT: Set up Charger in your bedroom or where you sleep. Snap-in Clip Charger Light Connect Tabs Tilt lower part of Sensor Connect Charger to a Connect Power Cord to with the tabs on the power outlet in your Charger. - Page 15 Part 2: Getting Started Charge the Sensor: First Use and Every 5 Days (continued) Sensor charges in about one hour. Sensor is fully charged when the orange light changes to green Charger Light Note: Sensor • Make sure the Sensor is dry before Light placing into the Charger.
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Page 16: Sensor While In Charger: Understanding The Lights
Part 2: Getting Started Sensor While in Charger: Understanding the Lights Solid Orange Solid Green No Light Sensor is charging and is Sensor is fully charged When Sensor is out of the not full. and ready for use. Charger, the light turns off. See Part 4: Troubleshooting if Sensor takes about there is no light when placed in the... -
Page 17: Charge The Gateway
Part 2: Getting Started Charge the Gateway: First Use and Every Day • 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. •... - Page 18 Part 2: Getting Started Charge the Gateway: First Use and Every Day (continued) If the Gateway has a belt clip, remove the belt clip before placing the Gateway in the Charger. Place Gateway on Charger. The Gateway screen should light up and display a battery status icon with the percent charge.
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Page 19: Understanding The Gateway Interface
Number of Pending Recordings Pending Recordings Button Pending Recordings See page 26. This button only appears if there are patient activated recordings that have not been sent to ZOLL. Record Event Button Record Event See page 26. See page 24. Page 15... -
Page 20: Prepare Your Skin: Every Time You Apply A Patch
Part 2: Getting Started Prepare Your Skin: Every Time You Apply a Patch IMPORTANT: This step ensures good adhesion to your skin. Target Area Preparation Wipe Remove all clothing and undergarments from Use provided Preparation Wipe to scrub area your upper body. where Patch is to be applied. -
Page 21: Connect Sensor To Patch
Part 2: Getting Started Connect Sensor to Patch Hold Sensor so the Hold Patch so that tabs are on the the ZOLL logo is at bottom. the top. Tabs Tilt and insert the lower part of Sensor Sensor should be... -
Page 22: Peel Off Patch Liner - 2 Pieces
Part 2: Getting Started Peel Off Patch Liner — 2 Pieces The liner on the back of the Patch is cut to create two separate pieces. Be careful to not touch the sticky adhesive. Peel off one liner piece. Peel off the second liner piece. Page 18... -
Page 23: Sensor + Patch Body Placement
Is the arrow pointing to 12 o’clock? If Yes, REMAIN STILL. A green light will temporarily appear on the Sensor within 30 - 60 seconds, indicating the Sensor is ready to monitor. If NO Green Light Call ZOLL at 1.888.592.3798. Page 19... -
Page 24: Part 3: Important Instruction
Part 3: Important Instruction Replace Patch on Your Body: Every 7 Days Hold a warm wet Press Sensor snap- washcloth against the in clip and remove Patch to get it wet for Sensor from Patch. approximately 2 minutes. This may Place Sensor in be done in the Charger. -
Page 25: Replace Patch On Your Body
Part 3: Important Instruction Replace Patch on Your Body: Every 7 Days (continued) Apply a new Patch as close Once Sensor is fully to the location of the charged connect Sensor to previous Patch as possible. new Patch. Follow Step 3: Prepare Your Discard Patch immediately. -
Page 26: How To Use Gateway
Part 3: Important Instruction How to Use Gateway To allow for proper communication and data transfer keep Gateway: • Turned ON* • In an area with cellular phone coverage • Within 30 feet of the Sensor Display/Power On/Off Button During the day, carry the At night, keep the Gateway in The Gateway may be turned ON Gateway with you. -
Page 27: Gateway Interface: Understanding The Battery Status For Sensor And Gateway
Part 3: Important Instruction Gateway Interface: Understanding the Battery Status for Sensor and Gateway 100% Green Orange Charging Icon Charging Icon Battery is charged. Battery is at 11% to Battery power is at 1% The Gateway or Sensor The number of green 25% power capacity. -
Page 28: How To Record A Symptom & Activity Level: From Gateway
Part 3: Important Instruction How to Record a Symptom & Activity Level: From Gateway When you experience a symptom, you can use the Gateway as follows to send information to your prescriber for review. Gateway is the preferred method for recording a symptomatic event. -
Page 29: How To Record A Symptom & Activity Level: From Sensor
Part 3: Important Instruction How to Record a Symptom & Activity Level: From Sensor Using the Gateway is the preferred method for recording a symptomatic event. However, you can also activate a recording by double tapping on Sensor when you experience a symptom. Beep Double tap Sensor with the palm of your hand. - Page 30 Select the Date and Time to record a Symptom Pending Recordings are and Activity Level. Pending Recordings automatically sent to ZOLL Note: To delete a Pending Recording select the within one hour. Your red trash can Record Event...
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Page 31: Part 4: Troubleshooting
Part 4: Troubleshooting Actions for Potential Issues The following table lists the recommended actions for potential issues with AMS. Call ZOLL if you need assistance with any of these instructions. POTENTIAL ISSUES POSSIBLE CAUSES ACTIONS Sensor light indicator is not on while... -
Page 32: Part 5: Maintenance And Cleaning
Part 5: Maintenance and Cleaning Maintenance and Cleaning You are not required to perform any maintenance or clean AMS. Page 28... -
Page 33: Part 6: Symbols Glossary
Part 6: Symbols Glossary Title and Designation # of the Symbol Title of Symbol Symbol Ref # Explanatory Text Standard Manufacturer 5.1.1 Device manufacturer and date when ANSI/AAMI/ISO 15223-1:2016, the device was made (when relevant). Medical devices – Symbols to be used with medical device Catalog number 5.1.6... - Page 34 Part 6: Symbols Glossary Title and Designation # of the Symbol Title of Symbol Symbol Ref # Explanatory Text Standard ANSI/AAMI/ISO 15223-1:2016, Non-sterile 5.2.7 The device is not sterile. Medical devices – Symbols to be used with medical device labels, labeling and information Humidity limitation 5.3.8 Humidity limitation.
- Page 35 Part 6: Symbols Glossary Title and Designation # of the Symbol Title of Symbol Symbol Ref # Explanatory Text Standard ANSI/AAMI ES60601-1:2005/ Direct current #5 (Table D.1) Direct current. (R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
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Page 36: Part 7: Compliances
Part 7: Compliances FCC Compliance Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. - Page 37 This page intentionally left blank.
- Page 38 121 Gamma Drive ● Pittsburgh, PA 15238 USA Rx Only Distributed by ZOLL Laboratory Services © 2022 ZOLL Medical Corporation. All rights reserved. ZOLL is a trademark and/or registered trademark of ZOLL Medical Corporation in the United States and other countries.