Page 1 Jewel Patch Wearable ® Cardioverter Defibrillator (P-WCD) INSTRUCTIONS FOR USE Element Science, Inc 301 Chesapeake Dr Redwood City, CA 94063 Federal law restricts this device to sale by or on the order of a physician.
Page 2 IMPORTANT INFORMATION Trademarks Element Science and Jewel are trademarks or registered trademarks of Element Science, Inc. Publication Date: 2025-03 REF: 320-00050 REV B ©2025 Element Science, Inc. All Rights Reserved.
Page 3: Table Of Contents
Intended Operator, Use, and Location ...................... 4 Safety Information ............................. 4 2. SAFETY AND EFFICACY DATA ......................7 Clinical Studies ............................7 2.1.1 The Jewel IDE Study ........................... 7 Jewel EP Lab Study ..........................10 3. DEVICE DESCRIPTION ......................... 11 Defibrillator Unit ............................13 3.2.
Page 4: Introduction
Therapy Report will be available for review at that time. 1.1 Indications for Use The Jewel P-WCD is indicated for adult patients 18 years of age and older who are at risk for Sudden Cardiac Arrest, and either are not candidates for or refuse an Implantable Defibrillator.
Page 5: Intended Operator, Use, And Location
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. The patient will be the primary operator of the Jewel.
Page 6 After returning to Monitor Mode, if similar alarms resume, the device can once again be placed into Removal Mode. Do NOT use the Jewel in the presence of flammable agents or in an oxygen enriched atmosphere. This could present an explosion and fire hazard.
Page 7 • Do NOT remove the Patch Unit plastic backings until ready to apply the Jewel. Dust and lint may impact the Patch Unit adhesive’s ability to stick to the body. Prolonged sunlight may degrade electrode signal quality and result in early Patch replacement.
Page 8: Safety And Efficacy Data
Pa+ents can contact Customer Service if they need assistance, have ques+ons, or require retraining for the • Jewel System use. Customer Service is available 24 hours a day, 7 days a week and can be reached by phone at 1-800-985-5702 and email at customerservice@elementsci.com.
Page 9 Primary Inappropriate shock rate of no more than 2.0 inappropriate shocks per 100 patient-months using a one-sided upper 98% confidence interval. Rate of subjects experiencing clinically significant cutaneous adverse device eﬀects (ADEs) of less than 15% using a one-sided, exact 98% upper confidence bound. Note: A cutaneous ADE was considered “clinically significant”...
Page 10 Characteristic Primary Analysis Population (N=290) Race, Black or African American (% of total) 67 (23.1%) Race, Asian (% of total) 4 (1.4%) Race, American Indian or Alaska Native (% of total) 0 (0.0%) Race, Native Hawaiian/Other Pacific Islander (% of total) 0 (0.0%) Race, Other (% of total) 8 (2.8%)
Page 11: Jewel Ep Lab Study
2.2 Jewel EP Lab Study The Jewel EP Lab Study was conducted in the European Union from 27 November 2018 to 7 October 2021. The Study was designed to demonstrate the safety and clinical eﬀectiveness of the Jewel EP Lab System, which is representative of the Jewel P-WCD, in terminating life-threatening VT or VF with a single transthoracic defibrillation shock.
Page 12: Device Description
The Jewel is designed to be applied directly to the patient’s skin on the upper right chest and lower left torso, beneath the patient’s clothing.
Page 13 Skin Facing Side The Jewel Defibrillator Unit and Patch Unit are designed to be worn by the patient continuously. Each Jewel Patch Unit may be worn and replaced on the 7th day of wear. If the Patch Unit is not replaced by the 8th day, the device will alert patient to replace the Patch Unit through audio alarms.
Page 14: Defibrillator Unit
The Defibrillator Unit contains the electronics that monitor the heart and provide an electrical shock if needed. The Defibrillator Unit has four interfaces to connect to the Patch Unit and must be properly connected to the Patch Unit for the Jewel to operate as intended. The Defibrillator Unit is intended to be reused throughout a prescription There are TWO BUTTONS on the Defibrillator Unit that are used to turn the Jewel on, cancel an electrical shock, check the status of the Jewel and put the Jewel into removal mode.
Page 15: Placement Accessory
• the Patch Unit to apply the Jewel to the body. 3.3 Placement Accessory The Placement Accessory is used to help the patient apply the Jewel correctly and in the correct location on the body. Outer Side Skin Facing Side Red Buckles and Red Alignment Lines help ensure the Placement Accessory is in the correct location before applying the Jewel.
Page 16: Application And Removal Accessories
For patients who are not using the App, an Element Science representative will need to extract the ECG data from the Jewel. Once the data is extracted from the Jewel, it can be transmitted to the Report Generator to develop a therapy report for the physician.
Page 17: Arrhythmia Detection
Patient Impedance Limits: The Jewel will not deliver an electrical shock to resistance loads less than 25 ohms or greater than 450 ohms. From impedances of 200 ohms to 450 ohms, if the Jewel detects fast VT or VF, the Jewel will deliver a shock to attempt to convert the rhythm since the patient is unlikely to have other lifesaving options available.
Page 18: Report Generator
App automatically. For patients who are not using the App, an Element Science representative will extract the ECG data from the Jewel when the Defibrillator Unit is made available. Once the data is extracted from the Jewel, it can be transmitted to the Report Generator to develop a therapy report for the physician.
Page 19: Patient Training
During the initial device placement and training session, Element Science certified personnel will train the patient on appropriate use of The Jewel and provide the Patient Guide. The Placement Accessory will be fitted for the patient during this visit. The Element Science Representative then will provide hands-on training for the patient, walking through application, removal, common alarms and other tasks performed during the Jewel prescription including operation and maintenance.
Page 20: Alerts And Notifications
A siren alarm plays when the Jewel detects ventricular tachycardia or ventricular fibrillation. The Jewel will cancel a shock if a non-shockable rhythm is detected, or if the shock is deferred. If the patient is conscious, they can defer the shock. To defer therapy, the patient can press both buttons on the Defibrillator Unit simultaneously.
Page 21: Device Status Notifications
(Patient should continue wearing the Jewel and seek emergency care) EMERGENCY SERVICES REQUIRED ALARM When the Jewel detects asystole OR after the Jewel has delivered all available electrical shocks, it will issue an emergency service required alarm. 6.2 Device Status Notifications This section describes the notifications the Jewel will use to let a patient know its status.
Page 22 Device has been applied successfully Solid green + tone No prompt; Jewel has been successfully applied but is and is warming up before becoming not yet active (the Jewel is warming up and will active become active in 2- minutes) Device is active...
Page 23: Technical Information
Lower Patch Battery: 3 Single-cell lithium-manganese dioxide CR123A primary batteries, 3VDC nominal • each, 1.5 Ah; total power approximately 9VDC and 4.5 Ah) Jewel Defibrillator Internal Battery: coin type lithium ion rechargeable battery 3.7V, 200 mAh • Device Notification Specifications •...
Page 24 7.1.2 DETECTION CRITERIA This section provides information regarding the Jewel’s algorithm's performance and test methods per 60601- 2-4. The Jewel employs a proprietary embedded algorithm to detect shockable arrhythmias, and uses several features extracted from sensed ECG to determine whether the ensuing rhythm is shockable or non-shockable.
Page 25 • For shocks 2-5 of a salvo, the Jewel is capable of delivering a shock within 35 seconds of the previous shock. Charge time: The Jewel requires 34 seconds or less to charge the capacitors with a newly replace battery •...
Page 26: Operating Environment
0 dBm. BLE is a secure, industry-standard wireless communication technology widely used in commercial and medical applications, and readily available in mobile devices. Quality of Service: In the event of an electrical shock, the Jewel device will queue the treatment data if it •...
Page 27: Transportation Environment
Degree of protection against harmful ingress: IP 24 protection against solid objects greater than • 12.5mm and splashing/spraying water. The Jewel can be worn in the shower including high flow shower heads up to 3.3 gallons per minute and soapy water conditions. Avoid prolonged direct pounding water on the device.
Page 28 Standard/Reference Standard/Reference Title ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization ISO 10993-12:2021 Biological evaluations of medical devices- Part 12: Sample Preparation and Reference Materials ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation IEC 60529:2013-08 (Edition 2.2) Degrees of Protection Provided by Enclosures (IP Codes) IEC 60601-1:2005 + AMD1:2012...
Page 29: Electromagnetic Compatibility (Emc) Testing
Standard/Reference Standard/Reference Title ISO 15223-1:2021 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements ISO 27185:2012/(R)2017 Cardiac Rhythm Management Devices – Symbols to be used with cardiac rhythm management device labels, and information to be supplied –...
Page 30: Iec 60601-1-2:2020 Emc Manufacturer's Declaration
7.4 IEC 60601-1-2:2020 EMC Manufacturer's Declaration Standard Description IEC 60601-1-2 IEC 60601-1-2 Compliance Level Test Level EMISSIONS CISPR 11 Radiated RF Class B Group 1 tested at both min and Class B Group 1 tested at both min and Emissions max line voltage max line voltage IMMUNITY...
Page 31: Rfid Immunity Standard Aim 7351731 Manufacturer's Declaration
7.5 RFID Immunity Standard AIM 7351731 Manufacturer's Declaration Standard Description AIM 7351731 Compliance Level AIM 7351731 Test Level IMMUNITY ISO 14223 Magnetic Field Immunity 134.2 kHz@65A/m 134.2 kHz@65A/m IEC 14443-3 (Type A) Magnetic Field Immunity 13.56 MHz@7.5A/m 13.56 MHz@7.5A/m IEC 14443-4 (Type B) Magnetic Field Immunity 13.56 MHz@7.5A/m 13.56 MHz@7.5A/m...
Page 32 Table 7.6b: Nominal second through fifth shock waveform parameters Nominal Second-Fifth Shock Waveform (162J) parameters for patient loads of 25, 50, 100, 150, and 200 ohms. Patient Resistance (Ω) Phase I Duration (ms) Phase 2 Duration (ms) Peak Current (A) 52.9 28.6 13.5...
Page 33: Symbols Glossary
8. SYMBOLS GLOSSARY This section defines the symbols used on the Jewel labels and packaging. Symbol Standard/Reference Standard/Reference Title Symbol Title Explanatory Text Medical devices – Symbols to be used with medical device ISO 15223-1, Ref. 5.1.1 labels, labelling, and...
Page 34 Symbol Standard/Reference Standard/Reference Title Symbol Title Explanatory Text Medical devices – Symbols to Indicates that a medical Do not use if be used with medical device device that should not be package is ISO 15223-1, Ref. 5.2.8 labels, labelling, and used if the package has been damaged and damaged or opened and that...
Page 35 Symbol Standard/Reference Standard/Reference Title Symbol Title Explanatory Text Medical devices – Symbols to Consult be used with medical device instructions for ISO 15223-1, Ref. 5.4.3 Indicates the need for the labels, labelling, and use or consult user to consult the information to be supplied electronic instructions for use...
Page 36 Symbol Standard/Reference Standard/Reference Title Symbol Title Explanatory Text Manufacturer-determined Medical electrical equipment degree of particle and water IEC 60601-1, Ref. Table — Part 1: General ingress protection, where... D.3, Symbol 2 requirements for basic safety and essential performance N1= degree of protection from particulates (scale of 0- Degree of Ingress 6);...
Page 37 Symbol Standard/Reference Standard/Reference Title Symbol Title Explanatory Text Occupational Safety and Indicates the possible 29 CFR 1910.1200, Health Standards (OSHA), presence of the following; Section C.4.19 Hazard Communication Flammable liquid flammables, self reactives, (Classified in Standard (HCS), Appendix C – and vapor pyrophorics, self-heating, Accordance with...
Page 38 APPENDIX A This appendix contains instructions from Chapters 3 through 5 from the Jewel Patient Guide. For full instructions, see the Jewel Patient Guide.
Page 41 APPLYING YOUR JEWEL...
Page 42: 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 43 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. 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 44 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 45 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 46 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 47 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 48 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 49 NOT touch the battery electrical connections or place anything in the recessed areas on the Patch Unit or Defibrillator Unit. This may result in skin injury or damage or break the device. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 50 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 51 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. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 52 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 53: Replace Device
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. 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 54 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 55 4 tab 1 LOWER PATCH UPPER PATCH Make sure you have turned the Jewel on BEFORE loading into the Placement Accessory. Set the unbuckled Placement Accessory on a flat surface. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 56 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 57 • Patch matches the shape of the Upper Placement Accessory pad. tab 1 ( tab 1 will hang off right side of pad and tab 4 hang off left side of pad) tab 4 continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 58 Press the Upper Patch in place. The Jewel loading is complete. APPLYING YOUR JEWEL...
Page 59 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. 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 60 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 61 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. 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 62 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 63 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 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 64 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 65 Lift any chest tissue from under belt. 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. 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 66 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 67 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. 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 68 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 69 Discard tab 1. Press down on circle with both hands for 30 seconds to adhere patch to body. 30 sec. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 70 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 71 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 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 72 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 73 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 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 74 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 75 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. continue 30 sec. 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 76 If the 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 77 The Jewel needs to be replaced with a new Patch Unit even if you hear “Jewel is active.” See Chapter 5: Removal. INCORRECT: None of the Lower Patch plastic housings are under your arm. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 78 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 79 Store boxes in a cool, dry location. The contents of the Patch Kit box will be used to remove and return the used Patch Unit. DEFIBRILLATOR UNIT BOX PATCH KIT BOX 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
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Page 83 NOTIFICATIONS RESPONDING TO ALERTS AND ALARMS...
Page 84 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 85: 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 86 Jewel This beep is heart rhythms. correctly. Press each Customer Service has been the start of a 2 If the Jewel continues to module to make immediately applied yet. minute warming play the Application Mode sure the Defibrillator...
Page 87 6 hours. electrical shock if needed. This your skin. alert repeats every 20 minutes. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 88 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 89 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 90 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 91 You should keep wearing the Jewel will receive an electrical shock. and seek emergency care. Bystanders should NOT touch you or the Jewel. flashing yellow “Electrical shock given. Seek emergency care.” 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 92 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 94 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 95 “Electrical shock given. You should keep wearing shock. An electrical shock was Seek emergency care.” the Jewel and seek given because the Jewel detected emergency care. you had specific life-threatening heart rhythms. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 96 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 97 Jewel longer working. Replace detected you had specific patches immediately.” life-threatening heart rhythms. The Jewel will not be able to detect or deliver any more additional electrical shocks if needed. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 98 “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 102 REMOVING YOUR JEWEL...
Page 103 REMOVING & DISASSEMBLING YOUR JEWEL 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 104 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 105 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 106: Supplies Needed
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 107 Pour adhesive remover into dish. Dip foam tool into adhesive remover. Repeat as needed. UPPER PATCH REMOVAL: Rub wet foam tool on one spot for 30 seconds to lift an edge. 30 sec. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 108 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 109 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. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 110 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 111 Rub wet foam tool in a circular motion on skin to remove sticky spots of adhesive. Inspect skin again for remaining sticky spots of adhesive. Repeat cleaning until these areas are no longer sticky. continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 112 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 113 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. Left torso side/back (back of Lower Patch area) continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 114 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 115 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 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 116 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 117 Hold Battery Unit down with one hand. Using the other hand, insert fingers under Module 4 of the Defibrillator Unit. Lift Module 4 directly upwards to disassemble. Module 4 Battery Unit continue 320-00050 Rev B Jewel P-WCD eIFU Appendix A...
Page 118 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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