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etectRx Patient Manual - DRAFT
Manual will be laid out using a publishing program, so please do not focus reviews on numbering /
indents / etc.
ID-Cap™ Medication Adherence Feedback System
Contents
1. Introduction.................................................................................................................................3
1.1. Conventions .................................................................................................................................. 3
2. etectRx Medication Adherence System Overview ..........................................................................3
2.1. Description .................................................................................................................................... 3
2.1.1. System Components: ......................................................................................................... 3
2.1.2. System Operation Overview .............................................................................................. 3
2.2. Intended Use ................................................................................................................................. 4
2.3. Indications for Use ........................................................................................................................ 4
2.3.1. Contraindications .............................................................................................................. 4
2.3.2. Compliant Use ................................................................................................................... 5
2.3.3. Precautions ........................................................................................................................ 5
2.4. System Components ..................................................................................................................... 5
2.5. Safety Instructions......................................................................................................................... 5
2.5.1. Electromagnetic Compatibility .......................................................................................... 5
2.5.2. Electrical Connection ......................................................................................................... 6
2.5.3. Charging ............................................................................................................................ 6
2.5.4. Environment ...................................................................................................................... 6
2.5.5. Malfunction ....................................................................................................................... 6
3. Instructions for Use - Patients Using App ......................................................................................6
3.1. Initial Setup ........................................................................................................................6
3.2. Ingesting an ID-Capsule .......................................................................................................8
3.3. End of Therapy / Reader Return ..........................................................................................9
4. Instructions for Use - Patients Not Using App ...............................................................................9
4.1. Initial Setup ........................................................................................................................9
4.2. Ingesting an ID-CAPSULE ................................................................................................... 10
4.3. Periodic Download ............................................................................................................ 10
4.4. End of Therapy / Reader Return ........................................................................................ 10
5. Cleaning the Reader ................................................................................................................... 11
6. System Maintenance .................................................................................................................. 11
7. Error Messages, Troubleshooting ................................................................................................ 11
7.1. App does not install .................................................................................................................... 11
NOTE: This is a word doc used to build content only. The User
USER MANUAL
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Table of Contents
Summary of Contents for etectRx ID-Cap
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Page 1: Table Of Contents
ID-Cap™ Medication Adherence Feedback System USER MANUAL Contents 1. Introduction..........................3 1.1. Conventions ..........................3 2. etectRx Medication Adherence System Overview ................3 2.1. Description ............................ 3 2.1.1. System Components: ......................3 2.1.2. System Operation Overview ....................3 2.2. Intended Use ..........................4 2.3. - Page 2 Patient Manual – DRAFT NOTE: This is a word doc used to build content only. The User Manual will be laid out using a publishing program, so please do not focus reviews on numbering / indents / etc. 7.2. App does not recognize Unique ID ....................11 7.3.
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Page 3: Introduction
/ etc. 1. Introduction This manual is your introduction to the etectRx ID-CAP System. You must read and fully understand this manual before using the system. Use this manual to initially set up the system, and keep it as a reference for day-to-day routines and as a guide to maintenance. If you have any difficulties in setting-up or using the etectRx ID-CAP, contact your dispensing pharmacy. -
Page 4: Intended Use
The ID-Cap System is intended to record time-stamped ingestions with the ingestible sensor, ID- Tag which transmits a signal to the ID-Cap Reader. When co-ingested with medication the tracking and trending of intake times may be used as an aid to measure adherence. The ID-Cap System enables unattended data collection For use with adult patients taking oral medications in an ambulatory or home-use environment. -
Page 5: Compliant Use
ATTENTION • Use of the ID-CAP System is reserved for users who have the ability to follow medication ingestion instructions while also interacting with the ID-CAP system. This system should not be prescribed to users who might not take their medication because of confusion with this system. -
Page 6: Electrical Connection
Designed to operate between 5 C and 40 2.5.5. Malfunction The ID-CAP System is designed to have very basic user interaction. Refer to Troubleshooting Section. If you continue to experience malfunction, contact your dispensing pharmacy. 3. Instructions for Use – Patients Using App These instructions apply to patients using the ETECTRX ADHERENCE APP with their phone. - Page 7 Prior to setting up the App, call the dispensing pharmacy to confirm receipt of the Reader and to obtain a unique ID# that is required to setup the App. Follow the phone operating instructions to download the etectRx App “ETECTRX ADHERENCE APP” to the phone, and then open the App.
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Page 8: Ingesting An Id-Capsule
Reader and App are not paired – reference Troubleshooting. Once you have verified the Reader is paired and has enough battery life to record the ingestion, place the Reader around your neck using the lanyard with the etectRx brand facing away from the body. -
Page 9: End Of Therapy / Reader Return
3.3. End of Therapy / Reader Return 4. Instructions for Use – Patients Not Using App These instructions apply to patients using the etectRx ID-CAP System but not using the optional App with their phone. Prior to First Use: 4.1. -
Page 10: Ingesting An Id-Capsule
30 minutes prior to the ingestion. Once you have verified the Reader has enough battery life to record the ingestion, place the Reader around your neck using the lanyard with the etectRx brand facing away from the body. ATTENTION DO NOT delay taking prescribed medication if the Reader is not charged or if you encounter any issue with the ID-CAP system. -
Page 11: Cleaning The Reader
• Close and re-open the App. • As the App will look for a specific Reader, ensure Reader # found in “etectRx Reader” under settings matches the Reader # on the back of the Reader. • If problems persist, call dispensing pharmacy. -
Page 12: App Loses Connection With Reader And Is Unable To Reconnect
Patient Manual – DRAFT NOTE: This is a word doc used to build content only. The User Manual will be laid out using a publishing program, so please do not focus reviews on numbering / indents / etc. Note that if Reader battery is fully charged it will not sync with the Charger Pad. If you are using the phone App, you can check battery level of Reader. - Page 13 The patient is the intended operator of the ID-Cap System. 9.2 Environmental Conditions of Use The ID-Cap System is intended for home use or use in a clinical setting. The ID-Cap System is intended for storage and operation in a room-temperature environment.
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Page 14: Regulatory Information
Manual will be laid out using a publishing program, so please do not focus reviews on numbering / indents / etc. The ID-Cap System has not been tested or approved for use in the presence of strong magnetic or electrical fields. DO NOT wear the ID-Cap Reader during magnetic resonance imaging (MRI), cautery, and external defibrillation procedures. - Page 15 This may impact the performance of the ID-Cap Reader or the other equipment. If adjacent or stacked use with other electromagnetic equipment is necessary, verify that the ID-Cap Reader operation is normal in the configuration in which it will be used.
- Page 16 Guidance and manufacturer’s declaration – electromagnetic immunity The ID-Cap Reader is intended for use in the electromagnetic environment specified below. The customer or the user of the ID-Cap Reader should assume that it is used in such an environment Immunity test...
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Page 17: Symbols Reference Guide
Patient Manual – DRAFT NOTE: This is a word doc used to build content only. The User Manual will be laid out using a publishing program, so please do not focus reviews on numbering / indents / etc. Rated maximum... -
Page 18: Legal Notices
Product Non-Sterile Shock Protection B or BF – IF NEEDED Single Use Only 12. Legal Notices 13. Declaration of Conformity etectRx, Inc. declares that the ID-Cap Reader is compliant with the following standards: • Electrical Safety AAMI/ANSI/ES 60601-1, 3 edition •...
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