etectRx BRCM1078 Patient Manual Content with Regulatory Information

etectRx 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.

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. 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

7.2. App does not recognize Unique ID .............................................................................................. 11

7.3. Unable to pair Reader with Phone .............................................................................................. 11

7.4. Unable to power-on charger ....................................................................................................... 11

7.5. Unable to charge Reader............................................................................................................. 11

7.6. App loses connection with Reader and is unable to reconnect .................................................. 12

7.7. Ingestion was not detected ......................................................................................................... 12

7.8. Ingestion detected when ID-Capsule was not taken ................................................................... 12

7.9. Reader light remains Orange ...................................................................................................... 12

7.10. Reader Error ### ....................................................................................................................... 12

7.11. App Error ### ............................................................................................................................ 12

7.12. Other Messages ........................................................................................................................ 12

8. Warranty, Useful Life, and Shelf Life ............................................................................................ 12

9. Technical Information ................................................................................................................. 12

10. Regulatory Information .............................................................................................................. 14

11. Symbols Reference Guide ........................................................................................................... 17

12. Legal Notices.............................................................................................................................. 18

13. Declaration of Conformity .......................................................................................................... 18

14. Manufacturer Contact Information ............................................................................................. 18

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.

1.1. Conventions

To avoid physical and material damage, this document identifies safety instructions into 2 danger levels:

ATTENTION

Hazardous situation which can cause material

damage or lead to minor or moderate injury

WARNING

Hazardous situation which can cause a serious

or fatal injury

2. etectRx Medication Adherence System Overview

2.1. Description

ID-Cap System is an ingestible event monitoring system which can provide near real-time confirmation of an ingestible event and act as an aid to measuring medication adherence and compliance. It utilizes a proprietary in vivo communications technology to emit a very low power digital message from within the patient each time a sensor is ingested.

2.1.1. System Components:

The components of the system include the following which are explained in greater detail in section 2.4.

• ID-Capsule, a capsule which contains the ingestible sensor, the ID-Tag;

• ID-Tag, ingestible sensor which transmits signal and is excreted

• ID-Cap Reader, a wearable Reader, which receives the signal from the ID-Tag, verifies the

message as being a valid ingestion event, and forwards the message using Bluetooth LE protocol;

• Optional Display System, includes an App which archives messages received from ID-Cap

Reader

2.1.2. System Operation Overview

The ID-Capsule is a standard medication capsule that contains an ID-Tag ingestible sensor. As the capsule dissolves in a patient’s stomach, the ID-Tag will power up when in contact with stomach fluid. It then emits a very low power digital radio frequency (RF) message to the patient-worn ID-Cap Reader to indicate an ingestion event has occurred. The ID-Tag subsequently passes through the patient’s GI tract and exits the body intact.

The ID-Cap Reader receives the ingestion signal from the tag, stores the message, and communicates to the patient that the ingestion was detected both via the ID-Cap Reader and the optional phone app. No protected health information (PHI) data is transmitted between the ID-Tag and Reader.

When an ingestion event message is received, the Reader can either securely store the ingestion event for post-event download, or dynamically transmit the ingestion event using a secure, HIPAA-compatible data protocol over BLE to a smartphone, tablet or PC running the etectRx mobile application (App). The Reader also provides device status messages to the App to allow for management of the Reader and system. The App collects the ingestion event and device status messages and forwards them via the mobile network to the etectRx database. The App contains a log of time-stamped ingestion event messages, device status messages, and system management information. The captured events may be used to generate reminder, confirmation or information messages to the subject.

2.2. Intended Use

The intended use of the etectRx ID-CAP System is to measure adherence with medication regimens for prescribed oral medications in ambulatory, unattended clinical and research applications in the home and clinical settings.

2.3. Indications for Use

The ID-Cap System is intended to record time-stamped ingestions with the ingestible sensor, IDTag 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.

2.3.1. Contraindications

• Not for use while on an aircraft or other areas where RF communications are

restricted.

• Not for use with patients who may have a significant medical condition which may

affect capsule passage through the gastrointestinal tract (including, but not limited to, Crohn’s disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis).

• Not for use with patients who may have a swallowing disorder (dysphagia).

• Not for use with patients who have a cardiac pacemaker or other implanted electro-

medical device.

• Not for use with patients subjected to strong electromagnetic fields i.e., MRI.

• Not for use with children under the age of TBD.

• Not for use with patients who are pregnant.

• Not for use with patients who have a hypersensitivity to gelatin, Kapton,

magnesium, or silver chloride.

• Not for use with colorblind patients.

2.3.2. Compliant Use

WARNING

• Federal law (USA) restricts this device to sale or use by, or on the order of a physician.

• A healthcare professional should evaluate each patient to ensure that the decision to use

the etectRx ID-CAP System on that particular patient is appropriate.

• Use the ID-Cap System as directed by your healthcare provider.

2.3.3. Precautions

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.

• Caregivers should use appropriate judgement when considering the use of the etectRx ID-

CAP System on patients at risk of harming themselves or others. The equipment, including the Reader, lanyard, AC Adapter, USB Charging Cable, and Wireless Charging Pad may create a hazard for at-risk patients and their caregivers.

• If the Reader or any of the Charging Components becomes damaged during normal use,

discontinue use of the product and contact your pharmacy for a replacement.

2.4. System Components

The components of the system include the following (Reference Figure TBD):

• ID-Capsule, a capsule which contains the ingestible sensor, the ID-Tag: Product Code TBD;

• ID-Tag, ingestible sensor which transmits signal and is excreted;

• ID-Cap Reader, a wearable Reader, which receives the signal from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the message using Bluetooth LE protocol: Product Code TBD, Software Version TBD;

• Optional Display System, includes an App which archives messages received from ID-Cap Reader

2.5. Safety Instructions

2.5.1. Electromagnetic Compatibility

The etectRx ID-CAP System is compliant with electromagnetic compatibility standards IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

There are no known significant risks of reciprocal interference posed by the etectRx IDCAP System. When using the ID-CAP System near other medical electrical equipment, consult the manufacturer’s instructions for Electromagnetic Compatibility of all devices to ensure potential electromagnetic or other interference is avoided or minimized.

WARNING

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Reader, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

2.5.2. Electrical Connection

ATTENTION

Use of USB Charging Cable without the Charging Plug decreases charging speed

2.5.3. Charging

WARNING

Use supplied charger or the functionality of the Reader may be affected

2.5.4. Environment

WARNING

Contains no user-serviceable parts – do not attempt to open Reader case or injury may result.

ATTENTION

Do not submerge Reader in water. Designed to operate between 5oC and 40oC.

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.

Prior to First Use:

3.1. Initial Setup

When the Reader box is opened, ensure the prescription on the side of the box identifies the correct patient. Save this box to store the system when not in use and to return the system at end of therapy.

+ 12 hidden pages

etectRx BRCM1078 Patient Manual Content with Regulatory Information

Specifications and Main Features

Frequently Asked Questions

User Manual