ZOLL Arrhythmia Management System, Instruction Manual

Page 1: ...ZOLL Arrhythmia Management System Patient Instruction Manual Rx Only 20B0087 Rev J ...

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Page 3: ...n 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 Off Patch Liner 2 Pieces 18 Sensor Patch Body Placement 19 Part 3 Important Instruction 20 26 Replace Patch on Your Body 20 21 How to Use Gateway 22 Gateway Interface Understanding the Battery Status for Sensor and Gateway 23 Green Orange Red ...

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Page 5: ...edical Corporation in the United States and other countries Copyright Notice 2022 ZOLL Medical Corporation 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 questions contact ZOLL 24 hours a day 7 days a week Toll free USA 1 888 592 3798 121 Gamma Drive Pittsburgh PA 15238 USA ...

Page 6: ...er when experiencing symptoms by double tapping the Sensor when it is on your body or by pressing the record event button on the 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 physici...

Page 7: ...diac arrhythmias such as but not limited to atrial fibrillation atrial flutter ventricular ectopy and bradyarrhythmias 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 event...

Page 8: ...cement is required as this can cause further injury to your skin Precautions If you are pregnant consult with your prescribing physician before using the device Remove the device Patch Sensor from your body prior to a magnetic resonance imaging MRI scan AMS is MRI unsafe Remove the device Patch Sensor if any pain or discomfort occurs If skin irritation discomfort redness itching or rash persists a...

Page 9: ...d Gateway away from water Water entering the Charger or Gateway may damage the device and or cause the Charger or Gateway to malfunction 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 af...

Page 10: ...ommunication with healthcare professionals Data provided by the system may be used by healthcare professionals along with all other clinical findings and exams to come to a diagnosis Patients should talk to their prescribing physician immediately if there are any concerns or if their condition changes Do not apply creams or lotions to the skin immediately prior to the application of the Patch This...

Page 11: ...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 ...

Page 12: ...surements Your data acquired by the wearable Sensor are transmitted 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 configure 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 Manag...

Page 13: ...gin This section 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 Getting Started steps in this guide ...

Page 14: ...r outlet in your bedroom A blue light shows when Charger has power 3 Tilt lower part of Sensor with the tabs on the bottom 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 continued on next page 1 Snap in Clip First Use and Every 5 Days ...

Page 15: ...or Light Charger Light continued 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 16: ...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 off See Part 4 Troubleshooting if there is no light when placed in the Charger ...

Page 17: ...u sleep Gateway power can last up to 18 hours before needing to be recharged Once the battery charge is under 20 a short beeping sound is made every 20 minutes until the battery 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 18: ...emove 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 battery 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 continued ...

Page 19: ... 100 Gateway Sensor 9 41 AM Pending Recordings Button Record Event Button This button only appears if there are patient activated recordings that have not been sent to ZOLL See page 26 Sensor Battery Status Gateway Battery Status Number of Pending Recordings See page 23 See page 23 See page 26 See page 24 ...

Page 20: ...hesion to your skin Target Area Preparation Wipe 3 Use provided Preparation Wipe to scrub area where Patch is to be applied 4 Repeat step 3 with a second Preparation 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 ...

Page 21: ...the tabs are on the bottom Tabs 2 Hold Patch so that the ZOLL logo is at the top 5 Sensor should be firmly attached to Patch 3 Tilt and insert the lower part of Sensor with the tabs into the bottom of Patch frame 4 Press Sensor onto Patch until you hear feel it snap in place ...

Page 22: ...ing Started Peel Off Patch Liner 2 Pieces 5 The liner on the back of the Patch is cut to create two separate pieces Be careful to not touch the sticky adhesive 1 Peel off one liner piece 2 Peel off the second liner piece ...

Page 23: ...atch on your upper left chest just below the collarbone see arrow on Patch pointing up in the image 4 Make sure Patch is smooth and flat on your skin 5 Is the arrow pointing to 12 o clock 6 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 24: ...e Sensor in Charger 3 Hold a warm wet washcloth against the Patch to get it wet for approximately 2 minutes This may be done in the shower 5 Slowly peel the remaining Patch while holding the skin against your body as tightly as possible 4 Slowly peel each corner of Patch toward the center until only the area under frame area outlined in red remains attached to your body ...

Page 25: ...ntinued 6 Discard Patch immediately Do not reuse 7 Apply a new Patch as close to the location of the previous Patch as possible Follow Step 3 Prepare Your Skin through Step 6 Sensor Patch Body Placement in Getting Started 8 Once Sensor is fully charged connect Sensor to new Patch ...

Page 26: ... in the Charger on a table close to you while you sleep During the day carry the Gateway with you The Gateway may be turned ON and OFF manually by pressing and holding the Power button for several seconds To allow for proper communication and data transfer keep Gateway Turned ON Within 30 feet of the Sensor Display Power On Off Button In an area with cellular phone coverage ...

Page 27: ...s charged The number of green bars represents the percent battery charge remaining from 26 to 100 Orange Battery is at 11 to 25 power capacity Red Battery power is at 1 to 10 capacity Place Sensor or Gateway immediately in Charger The Gateway or Sensor battery is charging in the Charger 100 25 10 10 Charging Icon Charging Icon ...

Page 28: ...September 29 at 05 38 PM How Did You Feel Save Vigorously Active Moderately Active Slighty Active Resting September 29 at 05 38 PM How Active Were You 1 Select Record Event 2 Select a symptom that describes how you feel 3 Select Next 4 Select your activity level 5 Select Save When you experience a symptom you can use the Gateway as follows to send information to your prescriber for review Gateway ...

Page 29: ...red method for recording a symptomatic event However you can also activate a recording by double tapping on Sensor when you experience a symptom 1 Remain still 2 Double tap Sensor with the palm of your hand 3 You will hear a beeping sound indicating that the trigger has been activated Beep step 4 continued on next page ...

Page 30: ...eway shows the number of your Pending Recordings in the orange circle Press the Pending Recordings button If you are near the Gateway and you do not record a symptom and activity level your Pending Recordings are automatically sent to ZOLL within one hour Your recordings will no longer be visible on the Pending Recordings list When you initiate a recording by double tapping the Sensor you can use ...

Page 31: ...ensor light is blinking orange after being applied on the body Sensor Error Call ZOLL at 1 888 592 3798 Charger blue light is not on Charger is not connected to a standard power outlet Plug Charger into a standard power outlet using the Power Cord provided in the AMS packaging When properly connected the light indicator on the Charger should be blue Gateway screen does not indicate Gateway is bein...

Page 32: ...Page 28 Part 5 Maintenance and Cleaning Maintenance and Cleaning You are not required to perform any maintenance or clean AMS ...

Page 33: ...he device was made when relevant Catalog number 5 1 6 Product catalog number Date of manufacture 5 1 3 Date when the device was made Batch code 5 1 5 Batch or lot number for device trace ability European representative 5 1 2 European representative Serial number 5 1 7 Serial number for device traceability Use by date 5 1 4 Date after which the device is not to be used Temperature limit 5 3 7 Stora...

Page 34: ...1 2009 R 2012 and A2 2010 R 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Refer to instruction manual booklet 10 Table D 2 See Instructions For Use Type BF applied part 19 Table D 1 Device intended to deliver electrophysiological signal to or from the patient Ingress protection 2 Table D 3 Indicates the Sensor is protected from light dust ...

Page 35: ...formance Direct current 5 Table D 1 Direct current Non ionizing radiation Emits non ionizing radiation Wireless connection Wireless connection ASTM F2503 13 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment Magnetic resonance MR unsafe Figure 9 Indicates the device may cause unacceptable risks to the patients medical staff or other perso...

Page 36: ...here is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures a Reorient or relocate the receiving antenna b Increase the separation betw...

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Page 38: ...on All rights reserved ZOLL is a trademark and or registered trademark of ZOLL Medical Corporation in the United States and other countries If you have any questions contact ZOLL 24 hours a day 7 days a week Toll free USA 1 888 592 3798 121 Gamma Drive Pittsburgh PA 15238 USA ...