Page 1 PATIENT GUIDE How to use and care for your Jewel...
Page 3 PATCH WEARABLE CARDIOVERTER DEFIBRILLATOR (P-WCD) PATiENT NAME: PHYSiCiAN NAME: EMERGENCY CONTACT: DEFiBRiLLATOR UNiT SERiAL NUMBER(S): CUSTOMER SERViCE 1-800-985-5702 customerservice@elementsci.com ELEMENT SCiENCE, iNC. 301 Chesapeake Dr. Redwood City, CA 94063 www.elementscience.com/manuals...
Page 4: Table Of Contents
1.1 iNTRODUCTiON TO THE JEWEL ................2 About the Jewel ............................2 About this Patient Guide .......................... 3 Who Should Use the Jewel? ........................4 Who Should Not Use the Jewel? ......................4 Considerations for PrescriberS ........................ 4 Safety information ........................... 5 Warnings ..............................6 Cautions ..............................
Page 5 3.2 JEWEL PREPARATiON ................... 61 Preparing to Assemble The Jewel ......................62 Loading The Jewel into The Placement Accessory ................68 3.3 APPLiCATiON PREPARATiON ................73 Putting on the Placement Accessory ..................... 74 Aligning the Lower Belt .......................... 76 Aligning the Upper Placement Accessory....................80 3.4 APPLiCATiON ......................
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Page 9: About The Jewel
ABOUT THE JEWEL®...
Page 10: Introduction To The Jewel
The electrical shock passes between the Upper and Lower Patches, through your chest, and restores your heart’s electrical activity back to normal. The Jewel alarms before an electrical shock is given so that you can cancel the electrical shock if you are conscious.
Page 11: About This Patient Guide
This section also introduces you to the components of the Jewel and Placement Accessory as well as the contents of each box. The Jewel Mobile App is also covered in this section. 2. Daily Use tells you about daily living with the Jewel and what activities you should and should not do.
Page 12: Who Should Use The Jewel
WHO SHOULD USE THE JEWEL? iNDiCATiONS FOR USE The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Page 13: Safety Information
SAFETY INFORMATION Read and understand the warnings, cautions, and symbols before using the Jewel. This information will help you safely operate the Jewel. TERMS USED WARNING: A situation which, if not avoided, could result in death or serious injury. CAUTION:...
Page 14: Warnings
•Do NOT put anything between the Jewel and the skin. Placing anything between the Jewel and the skin could result in an electrical shock not given when needed or in an ineffective electrical shock.
Page 15: Cautions
30cm (12 inches) to any part of the Jewel, including cables. •AVOiD use of the Jewel adjacent to or stacked with other equipment. This may result in improper operation. if such use is necessary, observe the equipment to verify normal operation.
Page 16 Jewel. This may result in increased electromagnetic emissions , decreased electromagnetic immunity and/or improper operation. •Do NOT tamper, alter, drop, or abuse any part of the Jewel system. There are no user- serviceable components in the Jewel. Altering the Jewel could create an electrical safety hazard and damage or break the device.
Page 17: Important Considerations For Patients
Jewel or the Patch Unit. •ALWAYS turn on the Jewel before applying it. Do NOT apply the Jewel if the lights, speaker, or vibration motor are not working. When turning on the device, the patient should feel the device vibrate, see a green light, and hear “Jewel is in Application Mode.
Page 18: Electromagnetic Interference
Many common devices, including motors and electronic equipment, may produce electromagnetic interference that can affect the operation of the Jewel. The Jewel has been tested with a number of common sources of such electromagnetic interference, including cellular telephones, airport security systems, and anti-theft detection systems.
Page 19: Where Should You Use The Jewel
WHERE SHOULD YOU USE THE JEWEL? iNTENDED OPERATOR, USE, AND LOCATiONS The Jewel is intended for use by patients prescribed the Jewel by a physician. An Element Science representative fits and trains the patient on proper use and care of the Jewel.
Page 20 ABOUT THE JEWEL...
Page 21: Symbols Glossary
SYMBOLS GLOSSARY This section defines the symbols used on the Jewel labels and packaging. Symbol Standard/ Standard/Reference Title Symbol Explanatory Text Reference Title iSO 15223-1, Ref. Medical devices – Manufac- indicates the medical 5.1.1 Symbols to be used turer device manufacturer...
Page 22 Medical devices – Keep dry indicates a medical 5.3.4 Symbols to be used device that needs to with medical device be protected from labels, labelling, and moisture information to be supplied iSO 7000-0626 Graphical symbols for use on equipment ABOUT THE JEWEL...
Page 23 Symbol Standard/ Standard/Reference Title Symbol Explanatory Text Reference Title iSO 15223-1, Ref. Medical devices – Tempera- indicates the 5.3.7 Symbols to be used ture limit temperature limits with medical device to which the medical labels, labelling, and device can be safely information to be exposed supplied...
Page 24 Table D.2, Symbol equipment — Part 1: instruction General requirements manual/ instructions for use for basic safety and booklet essential performance iSO 7010-M002 Graphical symbols — Safety colours and safety signs — Registered safety signs ABOUT THE JEWEL...
Page 25 Symbol Standard/ Standard/Reference Title Symbol Explanatory Text Reference Title iEC 60601-1, Ref. Medical electrical Degree of Manufacturer- Table D.3, Symbol equipment — Part 1: ingress determined degree General requirements Protection of particle and water for basic safety and Provided by ingress protection, essential performance Enclosure...
Page 26 (Classified in (OSHA), Hazard vapor of the following; Accordance with Communication flammables, self Appendix B.6) Standard (HCS), reactives, pyrophorics, Appendix C – Allocation self-heating, emits of Label Elements, flammable gas, organic Section C.4.19 peroxides. “Flammable Liquids” ABOUT THE JEWEL...
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Page 28: Getting To Know Your Jewel
The Jewel consists of a single-use Patch Unit (which includes the Upper Patch, Connection Cable, and Lower Patch) as well as a reusable Defibrillator Unit. The Jewel is designed to be placed and worn beneath all clothing, including undergarments.
Page 29 1 module 2 module 3 module 4 DEFiBRiLLATOR UNiT THE JEWEL OUTER SiDE UPPER PATCH LOWER PATCH buttons defibrillator unit foam border tab 4 tab 1 foam border status light tab 2 + 3 connection cable THE JEWEL SKiN SiDE...
Page 30: Connection Cable
The two buttons located on the first module of the Defibrillator Unit are used to turn the Jewel on, cancel an electrical shock, check the status of the Jewel and put the Jewel into Removal Mode. To cancel an electrical shock, press and release both buttons.
Page 31: Status Lights
Jewel is turned on and the Placement Accessory is in the correct location. Each tab is meant to be pulled in a specific direction to help apply the Jewel correctly to your body. For more information, see Chapter 3: Application.
Page 32: The Placement Accessory
Placement Accessory becomes bent or twisted, it may lead to incorrect alignment and placement of the Jewel in the wrong location. Call Customer Service (1-800-985-5702) if you feel your Placement Accessory may have become warped or damaged.
Page 33: Placement Accessory Components
PLACEMENT ACCESSORY COMPONENTS PLACEMENT ACCESSORY OUTER SiDE Upper Patch shoulder strap placement pad red alignment lines buckles PLACEMENT ACCESSORY SKiN SiDE Upper Patch placement pad shoulder strap adhesive sheets buckles foam ring Lower Patch slot CHAPTER 1...
Page 34: Starter Kit Box Contents
STARTER KIT BOX CONTENTS • Jewel Patient Guide • Replacement Adhesive Sheets PATIENT GUIDE How to use and care for your Jewel • Electric Hair Trimmer Jewel Patient • Placement Accessory Guide Replacement Adhesive Sheets Electric Hair Trimmer Placement Accessory...
Page 35: Patch Kit Box Contents
PATCH KIT BOX CONTENTS • Removal Kit • Skin Prep Kit • Patch Unit 4 adhesive 3 foam 1 dish remover tools packets Removal Kit 2 Coloplast 2 sponges soap packets Skin Prep Kit Skin Prep Mitt Patch Unit pouch Patch Unit CHAPTER 1...
Page 36: Defibrillator Unit Box Contents
DEFIBRILLATOR UNIT BOX CONTENTS • Patient Card • Jewel Overview • Defibrillator Unit PATIENT CARD Patient Card JEWEL OVERVIEW Refer to Patient Guide for full instructions Jewel Overview Defibrillator Unit ABOUT THE JEWEL...
Page 37: Returns
RETURNS Keep your Patch Unit boxes, Defibrillator Unit box and Starter Kit box in order to ship back to Element Science. See Chapter 6: Returning Your Jewel and Accessories. PATCH UNiT You cannot recycle or dispose of Patch Units. After use, you should return Patch Units to Element Science.
Page 38: About The Jewel App
After you undergo your training session and apply your first Jewel, Element Science will send you an e-mail with step by step instructions on how to set up the Jewel App including creating a secure password and downloading the App. Once you have created a new password please write it and your username in the space provided below.
Page 39 Jewel on your iPhone. • Stay within 50 feet of your iPhone. if the Jewel you are wearing goes out of range of your iPhone, it will become disconnected and the Status Screen will be unable to update.
Page 40 • Element Science will never request your Jewel Mobile App password. if you suspect your password has been stolen, immediately change your password by clicking on “Forgot Password?” on your Jewel Mobile App Login and follow the steps to reset your password or contact Customer Service at 1-800-985-5702 to reset your password.
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Page 42 THE JEWEL MOBiLE APP SECTiONS: STATUS AND HELP The Status Section The Help Section provides basic shows the current information about state of the Jewel the Jewel, daily use, you are wearing. application instructions, removal instructions, contact information, and troubleshooting.
Page 43 • if you receive an electrical shock, the Mobile App will transmit the treatment data to your physician. The Mobile App will only transmit data when you have an internet connection. • The Jewel Mobile App will provide a “Call 911” button. If pressed, 911 is dialed. You will still need to initiate the call.
Page 44: Pairing The Jewel
Jewel and the Mobile App for the first time. Pairing is not possible if the Jewel has not been applied to your body. You do not have to manually pair each time you replace a Patch Unit. Once the Jewel is paired with your phone, there is no need to pair again unless you need to replace your Defibrillator Unit.
Page 45 “Jewel is in Pairing Mode. Pairing Jewel now.” Press and hold the top button on the Jewel for The App should display 5 seconds until you hear “Jewel is in Pairing Mode. an ‘Attempting to Pair’ Pairing Jewel now.”...
Page 46: Mobile App Troubleshooting
5. if the issue persists, contact Customer Service: 1-800-985-5702 iF YOU ARE PAiRiNG A REPLACEMENT DEFiBRiLLATOR UNiT: 1. Go to your Bluetooth settings and find the Jewel within the list of ‘My Devices’. Tap the information icon next to the Jewel and select ‘Forget This Device’.
Page 47 Mobile App settings. Make sure your phone is no more than 5 feet away from the Jewel. 2. if the Jewel and Mobile App do not reconnect after completing the previous step, try restarting the Mobile App and turning Bluetooth off and then back on in your phone settings.
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Page 51: Daily Use & Faq
DAILY USE & FAQ...
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Page 53: Living With Your Jewel
LIVING WITH YOUR JEWEL DO’S AND DON’TS 30°C 50°C 86°F 122°F 15 °C 10°C 50°F 59 °F WATER RESISTANT TO CLEAN: STORE DEVICE OPERATE DEVICE ONLY SHOWERING GENTLY WIPE BETWEEN BETWEEN 10 °C (50 °F) ALLOWED WITH DRY CLOTH 15 °C (59 °F) AND 50 °C (122 °F)
Page 54: Frequently Asked Questions
Can I swim wearing my Jewel? No. The Jewel cannot be submerged in water or any liquid. Do not swim, take a bath, or sit in a hot tub while wearing the Jewel. Submerging the Jewel may damage or break the device.
Page 55 Jewel. The Jewel will automatically continue monitoring your heart. (See Chapter 4: Notifications for details.) • in Application Mode, the Jewel will automatically turn off after 2 hours if it detects it has not been applied to your body. (See Chapter 3: Application for details.)
Page 56 Can I use lotion or ointment under or around the patches? No. Keep the patch area clear of lotions and ointments. Lotions or ointments around the patch may reduce the ability of the Jewel to stick to your skin and result in needing to replace the Patch Unit early.
Page 57 Is it OK if the patches are peeling on the edges? The patch edges might start to peel off the skin as you wear your Jewel. This is expected. The Jewel will tell you when it needs to be replaced. Removal of the Jewel prior to replacement alerts is not recommended.
Page 58: Electrical Shocks
Jewel. Move away from motors and any electronic equipment. Keep the Jewel on, it is still monitoring your heart unless you hear an alert otherwise. See Chapter 4: Notifications for details on Siren Alarms.
Page 59 Do not put the Placement Accessory in an automatic washer or dryer. How should I clean the Jewel? if the Jewel becomes dirty, clean it using a dry cloth. Do not use harsh chemicals or cleaners. CHAPTER 2...
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Page 63: Applying Your Jewel
APPLYING YOUR JEWEL...
Page 64: Skin Preparation
Preparing Skin with Skin Prep Mitts on the next pages. TiPS FOR THiS SECTiON: Read over all instructions before applying your Jewel. Use a mirror for hard to see areas. Ask someone to assist you for hard to reach areas. SUPPLiES NEEDED: •...
Page 65 (front of Lower Patch area) C. LEFT TORSO SiDE/BACK (back of Lower Patch area) Wipe away trimmed hair. Do not discard trimmer: You will use it again prior to each Jewel application. Refer to trimmer instructions for cleaning and storage. CHAPTER 3...
Page 66: Preparing Skin With Skin Prep Mitts
Skin Prep Kit NOTE: Do not use the Patch Kit if the seal is broken on the Patch Kit box. Use a sealed Patch Kit and contact Customer Service right away for replacements. Patch Kit timer (not provided) APPLYiNG YOUR JEWEL...
Page 67 Do NOT wear a bra that cannot be unclasped. Your bra will become trapped under the Jewel when applied. A bra is not required to be worn for skin prep or your Jewel application. Remove two skin prep mitt packets from the box.
Page 68 B. LEFT TORSO FRONT (front of Lower Patch area) 30 sec. front C. LEFT TORSO SiDE/BACK (back of Lower Patch area) 30 sec. back Skin preparation is complete when • hair is trimmed • skin is clean and dry APPLYiNG YOUR JEWEL...
Page 69: Jewel Preparation
IMPORTANT CONSIDERATION •ALWAYS turn on the Jewel before applying it. Do NOT apply the Jewel if the lights, speaker, or vibration motor are not working. When turning on the device, the patient should feel the device vibrate, see a green light, and hear “Jewel is in Application Mode.
Page 70: Preparing To Assemble The Jewel
PREPARING TO ASSEMBLE THE JEWEL Confirm Use by date on outside of Patch Kit box before opening. Apply the Jewel on or before the Use by date. Open Patch Kit box and remove the sealed pouch. Look for the tear lines on the pouch and open the pouch.
Page 71 Open the patch tray using the opening tabs with both hands. ATTENTION: Leave the Patch Unit in the Tray when assembling the Jewel. Position the Defibrillator Unit so that buttons are on the right side. CAUTION: Do NOT assemble or...
Page 72 DEVICE Gently lower the Defibrillator Unit making sure the connectors on the patch are guided into the slots. Press down on module 4 with the palm of your hand until you hear a click. module 4 module APPLYiNG YOUR JEWEL...
Page 73 Press down on each module individually to confirm they are properly engaged. Turn on the Jewel by pressing and holding both buttons simultaneously until you feel the Jewel vibrate. ATTENTION: Make sure Jewel has been turned on before proceeding to next page.
Page 74 Check the Jewel status and “Jewel is in Application proceed to loading the Jewel into Mode. Apply Jewel now using Placement Accessory. Placement Accessory.” if you see a red flashing light, follow below instruction. JEWEL OK Proceed with your Jewel application.
Page 75: Replace Device
“Patches no longer working. electrical shock. Press on (first Replace patches immediately.” or last) module of device.” DISCONNECTED REPLACE DEVICE Do not apply the Jewel. Make sure the Defibrillator Unit is properly connected to the Patch Unit. CHAPTER 3...
Page 76: Loading The Jewel Into The Placement Accessory
LOADING THE JEWEL INTO THE PLACEMENT ACCESSORY These steps cover loading the Jewel into the Placement Accessory. The Placement Accessory is required to apply the Jewel in the correct location on your body. SUPPLiES NEEDED: - The Jewel and the Placement Accessory...
Page 77 THE JEWEL (OUTER SiDE) COMPONENTS TO KNOW: buttons UPPER PATCH tab 4 tab 1 LOWER PATCH THE JEWEL (SKiN SiDE) COMPONENTS TO KNOW: tab 4 tab 1 LOWER PATCH UPPER PATCH Make sure you have turned the Jewel on BEFORE loading into the Placement Accessory.
Page 78 Hold the Lower Patch button side down. Place the Lower Patch into the slot. Press the Lower Patch into the slot until the patch is flush with the foam. press down Check that the cable is resting in the cable slot. APPLYiNG YOUR JEWEL...
Page 79 Touch orange center of Upper Placement Accessory Pad to check that it is sticky. if it is not sticky, remove one adhesive sheet to reveal a new one. if there are no more adhesive sheets, replace with the provided extra adhesive sheets.
Page 80 Press the Upper Patch in place. The Jewel loading is complete. APPLYiNG YOUR JEWEL...
Page 81: Application Preparation
APPLICATION PREPARATION PLACEMENT ACCESSORY COMPONENTS TO KNOW: Upper Patch pad left shoulder strap Lower Patch pad plastic backing Make sure the plastic backings have not been crumpled and are intact before putting on the Placement Accessory. CHAPTER 3...
Page 82: Putting On The Placement Accessory
PUTTING ON THE PLACEMENT ACCESSORY These steps cover putting the Placement Accessory on your body. Follow these steps carefully to prevent damaging the Jewel. Lean forward. mirror Pull shoulder strap onto left shoulder. Position Upper Patch Placement Accessory onto your right chest area.
Page 83 Hold both ends of the buckles. Align the buckles to the centerline of your body. Fasten buckles. buckle at centerline mirror Check again that the buckles are in line with centerline of your body. Check that the belt is not twisted in the back.
Page 84: Aligning The Lower Belt
Use a mirror to see red lines while aligning the belt. WARNING: ALWAYS ensure the Jewel is in the correct location on the body. Always use the Placement Accessory while applying the Jewel. Do NOT skip alignment steps or adjust the settings of the Placement Accessory, which could result in the Jewel being applied in the wrong location.
Page 85 mirror Align belt so that: A. Red lines on belt are level and under chest/ breasts. B. Red buckles are on centerline of body. do NOT pull tab 2 or 3 C. Check that the belt is level in front and back. continue CHAPTER 3...
Page 86 Pull bra band at least 1 inch above belt. side ATTENTION: The foam ring of the lower patch slot must lay flat on skin and not span any skin folds. Pull clothing at least 1 inch below belt. APPLYiNG YOUR JEWEL...
Page 87 MEN: ATTENTION: Do not leave any clothing or chest tissue under the belt. Anything under the belt will stick to the device. This may result in discomfort and early device replacement. No clothing or breast tissue under the belt Lift any chest tissue from under belt. ATTENTION: The foam ring of the lower patch slot must...
Page 88: Aligning The Upper Placement Accessory
Follow these steps so that nothing is stuck under the Upper Patch when applied. TiPS FOR THiS SECTiON: Use a mirror while aligning the Upper Placement Accessory. mirror Remove jewelry from under the Upper Placement Accessory. Women: Remove bra from under the Upper Placement Accessory. APPLYiNG YOUR JEWEL...
Page 89 do NOT pull tab 1 Align Upper Placement Accessory so that: A. Horizontal edge is on top of collar bone B. Shoulder strap lays flat on left shoulder. C. Rivet is on or to the right of the center of the chest. Placement Accessory Alignment complete.
Page 90: Application
PULLING TAB 1 Gently rest hand on upper pad with left palm. Grip tab 1 with right hand. DO NOT pull tab 1 straight down or forward away from the body. (This may result in a poor device application.) APPLYiNG YOUR JEWEL...
Page 91 Keep pad in place with left palm. Pull tab 1 straight to the side away from your body in a continuous motion until the plastic backing pulls free. Discard tab 1. Press down on circle with both hands for 30 seconds to adhere patch to body.
Page 92: Pulling Tab 2
Keep left arm straight down. Do NOT apply pressure on the belt with your left arm. Do NOT pull tab 2 with your left hand, straight down or forward away from body. (This may result in a poor device application.) APPLYiNG YOUR JEWEL...
Page 93 Swing arm across the body in a slow continuous motion until the plastic backing pulls completely free. Discard tab 2. Press down for 30 seconds on circle (front left) to adhere patch to body. 30 sec. continue CHAPTER 3...
Page 94: Pulling Tab 3
PULLING TAB 3 Grip tab 3 with left hand. Do NOT pull tab 3 straight down or forward. (This may result in a poor device application.) APPLYiNG YOUR JEWEL...
Page 95 Swing arm back in a continuous motion until plastic backing pulls completely free. Discard tab 3. Press down for 30 seconds on circle (back left) to adhere patch to body. 30 sec. hand or inner arm. continue CHAPTER 3...
Page 96: Pulling Tab 4
Pull tab 4 across the body in a continuous motion until the plastic backing pulls free. Discard tab 4. When the Jewel recognizes it is on your body and is preparing to monitor your heart signals, it should beep and give you a solid green light.
Page 97 Press down on Upper Patch with both hands for 30 seconds to 30 sec. adhere patch to body. Smooth down patch fabric and white border for 30 seconds. 30 sec. Remove white foam border on edge of Upper Patch Press down on Defibrillator Unit for 30 seconds to adhere patch to body.
Page 98 Placement Accessory is not aligned correctly, the Jewel may be applied in the wrong location. Applying the Jewel in the wrong location could result in an electrical shock not given when needed or in an ineffective shock possibly resulting in serious injury or death.
Page 99 More than an inch of the Upper Patch Status light on Upper Patch is over is over your shoulder. your centerline. if the Jewel has been applied in an incorrect location you need to remove it and reapply the Jewel with a new Patch Unit.
Page 100 Complete a Status Check to confirm that the Jewel is monitoring: Press both buttons and release after you feel a click. Solid green light “Jewel is active.” If you do NOT hear “Jewel is active” then see Chapter 7: Troubleshooting. APPLYiNG YOUR JEWEL...
Page 101 The Mobile App and Jewel will automatically reconnect. To remove your Jewel, see Chapter 5: Removal To repackage and return your used Patch Unit and Defibrillator Unit, see Chapter 6: Returns. Do not discard the Patch Kit box,...
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Page 105: Notifications
NOTIFICATIONS RESPONDING TO ALERTS AND ALARMS...
Page 106: What Are The Jewel Notifications
WHAT ARE THE JEWEL NOTIFICATIONS? HOW THE JEWEL COMMUNICATES The Jewel communicates to you through tones, voice prompts, lights, and vibrations. Use this section to know what each alert and alarm means and how to respond. SYMBOL GUiDE: Tones Voice Prompts...
Page 107: Status Check
STATUS CHECK Status check helps you understand the current state of the Jewel. if a voice alert has been delivered, a status check will repeat the last voice alert. TO COMPLETE A STATUS CHECK: Press both buttons and release after you feel a click.
Page 108: Weekly Jewel Notifications
Jewel This beep is heart rhythms. correctly. Press each applied. Call has been the start of a 2 if the Jewel continues to module to make Customer Service applied yet. minute warming play the Application Mode sure the Defibrillator...
Page 109 Patches must be replaced within patches may be replaced within three hours. This The Jewel will not be able to losing skin contact 24 hours. This alert repeats detect specific life-threatening and need to be alert repeats every hour.
Page 110 Removal Mode Remove Patch Unit Confirmed from Device Finish removing the Jewel The Jewel will The Jewel is now in from your body. prompt you again to Removal Mode and press and hold both cannot give you an After the Jewel has been buttons for at least 5 electrical shock.
Page 111: Siren Alarm Overview
24 seconds. WARNING: You should immediately press both buttons to respond to this alarm. No one else should press the buttons for you. if you do not press both buttons, the Jewel will deliver an electrical shock. Start of alarm Electrical shock given Press both buttons to cancel electrical shock.
Page 112 If you keep getting the siren alarm but feel fine, there is something in the environment that may be affecting the Jewel. Continue to cancel the electrical shock by pressing both buttons and change your location.
Page 113 YOU ARE UNCONSCiOUS: Electrical shock was given. You are experiencing specific life- threatening heart rhythms and You should keep wearing the Jewel will receive an electrical shock. and seek emergency care. Bystanders should NOT touch you or the Jewel.
Page 114: Emergency Services Required Alarm
EMERGENCY SERVICES REQUIRED ALARM This alarm may occur when the Jewel detects specific life-threatening heart rhythms that it cannot treat OR after the Jewel has delivered all available electrical shocks. THiS ALARM iNCLUDES THE FOLLOWiNG: Red Flashing Light Loud Siren “...
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Page 116: Alerts And Alarms Index
ALERTS AND ALARMS INDEX This index lists all of the possible voice prompts you might receive while using the Jewel. You may feel a vibration during some of these notifications. flashing green light AFTER TURNiNG ON THE JEWEL: If you hear:...
Page 117 “Replace patches soon.” This is a Replacement Alert. The Replace patches within Jewel may detect the battery has a 24 hours. This alarm repeats every maximum of 24 hours remaining or 6 hours and cannot be...
Page 118 To start Removal Mode immediately. press and hold both buttons.” The Jewel will not be able to detect the specific life-threatening This alarm repeats every heart rhythms or deliver an 20 minutes and cannot electrical shock if needed.
Page 119 See Chapter 5: Removal The Jewel may not be able to detect the specific life-threatening heart rhythms or deliver an electrical shock if needed. “Device is disconnected The first module of the Defibrillator...
Page 120 “Removal Mode not You have not confirmed that you Press and hold both buttons confirmed, to confirm would like to put the Jewel in to confirm that you would Removal Mode press and Removal Mode. like to put the Jewel into hold both buttons.”...
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Page 124 REMOViNG YOUR JEWEL...
Page 125: Removing And Disassembling Your Jewel
REMOVING & DISASSEMBLING YOUR JEWEL CHAPTER 5...
Page 126: Removal Mode
Jewel. You will press and hold both buttons two times to initiate and confirm Removal Mode. The Jewel is NOT monitoring for specific life-threatening heart rhythms in Removal Mode. Remove the Jewel immediately and apply a new Patch Unit.
Page 127 Press and hold both buttons longer if you did not hear the words above. The Jewel is in Removal Mode for 30 minutes. Continue to next page for removal instructions. if Removal Mode is not confirmed within 1 minute you will hear: “Removal Mode not confirmed.”...
Page 128: Removing The Jewel
These steps cover removing the Jewel. TiPS FOR THiS SECTiON: Read over all instructions before removing your Jewel. ONLY use the materials provided for removal. Use a mirror for hard to see areas. Ask someone to assist you for hard to reach areas.
Page 129 ATTENTION: Do NOT remove patches without adhesive remover. if you do not use adhesive remover, it may cause injury to your skin. Remove dish from box. Open two adhesive remover packets. Pour adhesive remover into dish. Dip foam tool into adhesive remover. Repeat as needed.
Page 130 Rub wet foam tool on crease between skin and patch. Repeat step 4 until the Upper Patch is fully detached from the skin. Allow Upper Patch to hang when fully removed. The Jewel may now say “Replace patches immediately.” REMOViNG YOUR JEWEL...
Page 131 LOWER PATCH REMOVAL: Remove top section of Lower Patch before moving to bottom section. remove top first bottom Use adhesive remover and foam tool. Do NOT rip patch off your skin. Rub wet foam tool on one spot for 30 seconds to lift an edge. 30 sec.
Page 132 Repeat step 8 to remove the bottom section. support with hand Place the Jewel onto two discard sheets and set aside. ATTENTION: When the Defibrillator Unit is not on your body, hold it with both hands and keep it as flat as possible.
Page 133 REMOViNG LEFTOVER ADHESiVE: Feel for sticky spots of adhesive in the following areas: A. Right chest (upper patch area) B. Left torso front (front of lower patch area) C. Left torso side/back (back of lower patch area) Rub wet foam tool in a circular motion on skin to remove sticky spots of adhesive.
Page 134: Washing, Rinsing, And Drying Your Skin
WASHING, RINSING, AND DRYING YOUR SKIN These steps include washing, rinsing, and drying the skin. Follow these steps so that your next Jewel is applied to clean skin. SUPPLiES NEEDED: 2 soap packets 2 sponges clean and dry towel water...
Page 135 WASHiNG SKiN Open sponge packet. Wet sponge with water. Open soap packet. Apply soap to sponge. Clean skin with soapy sponge in the following areas: A. Right chest (Upper Patch area) B. Left torso front (front of Lower Patch area) C.
Page 136 A. Right chest (Upper Patch area) B. Left torso front (front of Lower Patch area) C. Left torso side/back (back of Lower Patch area) Dry skin areas A, B, and C with a clean, dry towel. REMOViNG YOUR JEWEL...
Page 137 Check that skin is dry and no soap or sticky spots can be seen or felt. Continue to instructions in the next section to disassemble your Defibrillator Unit from the used Patch Unit. continue CHAPTER 5...
Page 138: Disassemble Your Jewel
Patch Unit. Accumulation of lint or dust within the electrical connections of the Defibrillator Unit can affect the performance of the device. Place the Jewel in front of you with the cable on the left hand side and battery on the right before you start disassembling.
Page 139 Push each yellow trigger down until you hear a click. (The trigger should stay in place once pushed down.) Push down the L shaped lever to unlock battery latch. (The lever should stay in place once pushed down.) Hold Battery Unit down with one hand.
Page 140 DO NOT TWIST DO NOT FOLD DEVICE DEVICE To apply the Jewel with a new Patch Unit, see Chapter 3: Application. To return the used Patch Unit or Defibrillator Unit to Element Science, see Chapter 6: Returns. REMOViNG YOUR JEWEL...
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Page 144 RETURNiNG YOUR JEWEL...
Page 145: Returning Your Jewel
RETURNING YOUR JEWEL AND ACCESSORIES CHAPTER 6...
Page 146: Returning Used Patches
(NOTE: The shipper box can fit two used Patch Kit boxes.) Seal the box closed. Use the return label enclosed and and apply to the box for shipping. The Patch Unit is ready to be shipped back to Element Science. RETURNiNG YOUR JEWEL...
Page 147: Returning Defibrillator Unit
RETURNING DEFIBRILLATOR UNIT Note: It is important that the Defibrillator Unit is shipped back to Element Science for processing and proper recycling at the end of your prescription or if the Defibrillator Unit is disabled and needs to be replaced. Retrieve the saved Defibrillator Unit box from the Starter Kit and place the Defibrillator Unit in the box.
Page 148: Returning Accessories At End Of Prescription
Placement Accessory stays in place during shipping. Apply the return label on the top of the box and use tape to seal the box for shipping. The Placement Accessory is ready to be shipped back to Element Science. RETURNiNG YOUR JEWEL...
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Page 152 144 | TROUBLESHOOTiNG...
Page 153: Troubleshooting
TROUBLE SHOOTING CHAPTER 7 | 145...
Page 154: Troubleshooting
Defibrillator Unit. After making sure the Defibrillator Unit and Patch Unit are assembled, turn on the Jewel again. if you see a red light again do not apply the Jewel. Call Customer Service (1-800-985-5702) immediately to order a replacement Defibrillator Unit.
Page 155 Press and release both buttons to perform a status check. You should see a solid green light and hear the Jewel say “Jewel is active.” if you see a solid green light and hear a beep, the Jewel is preparing to monitor. Wait a few minutes and then perform another status check.
Page 156: While Wearing The Jewel
Make sure the Jewel is turned on: press and hold both buttons for 10 seconds. • if the Jewel says "Jewel is in Application Mode", it should then say "Jewel is Active" once it recognizes it has been applied. Once the Jewel said “Jewel is Active”, the Jewel is now monitoring your heart and no further action is required.
Page 157 If the Jewel were to detect a specific life-threatening heart rhythm, you would not hear a siren alarm but the red lights would flash and the Jewel would vibrate. If you were to see red lights and feel vibrations, you should press both buttons to cancel the electrical shock until you can replace your Defibrillator Unit.
Page 158: Skin
If you have gotten this alarm but feel fine, there is something in the environment that may have affected the Jewel. To stop the alarm, put the Jewel into Removal mode and replace the Patch Unit immediately. See removal instructions in Chapter 5: Removal.
Page 159: Removal
I took off the Jewel and now it keeps saying “Patches no longer working. Replace patches immediately”. if you hear this prompt it means that Jewel was removed prior to initiating Removal Mode and it has detected it is off your body. To turn off the voice prompt immediately, initiate Removal Mode (See Chapter 5: Removal).
Page 160: If Your Weight Changes: Checking The Fit Of The Placement Accessory
These steps cover making sure the Placement Accessory fits on your body correctly if you have lost or gained weight. Proper Placement Accessory fit is required to apply the Jewel in the correct location. Put on Placement Accessory and align belt so that: A.
Page 161 Do NOT adjust the settings of your Placement Accessory. Changing the settings of your Placement Accessory could result in the Jewel being applied in the wrong location. Applying the Jewel in the wrong location could result in an electrical shock not given when needed or in an ineffective shock possibly resulting in serious injury or death.
Page 162 Electrical connection 8, 20, 63, 122, 123 Alerts and Alarms 108 Electrical Shock Given 105, 109, Jewel App 30, 31, 34, 35, 36 Aligning the lower belt 76 Jewel Notifications 9, 98, 100 Application Mode 47, 48, 61, Electric hair trimmer 26, 56...
Page 163 Safety information 3 tab 4 21, 69, 71, 88 Press both buttons 6, 7, 22, 35, SCA 2, 50 The Jewel App 30, 34, 35, 36 92, 99, 103, 104 Seek emergency care 35, 50, Timer 58 Pulling Tab 1 82...
Page 164: Customer Service
CUSTOMER SERVICE 1-800-985-5702 customerservice@elementsci.com Part #320-00049 Rev C 2025-03...

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