etectRx ID-Cap User Manual Download Page 14 | Manualshive

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etectRx ID-Cap User Manual Download Page 14

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.

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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. Damage to the Reader or
an unexpected magnetic attraction may result. Please inform your healthcare
professional that the ID-Cap Reader must be removed prior to engaging in one of these
procedures.

WARNING

: No modification of the ID-Cap Reader is allowed. DO NOT tamper with or

open the ID-Capsule. Modifying the ID-Cap Reader or the ID-Capsule may cause a safety
hazard for the user.

10.

Regulatory Information

CISPR Interference Statement

Medical Electric Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this section of
the manual. Portable and mobile RF communications equipment can affect Medical
Electrical Equipment. The ID-Cap Reader may be interfered with by other equipment,
even if that equipment complies with CISPR emission requirements.

FCC Interference Statement

This device complies with part 15 of the FCC and Canadian Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may cause
undesired operation.

Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils
radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes : (1)
l’appareil ne doit pas produire de brouillage; (2) l’utilisateur de l’appareil doit accepter
tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en
compromettre le fonctionnement.

This equipment has been tested and found to comply within the limits of a Class B digital
device pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio

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Summary of Contents for ID-Cap

Page 1: ...ons 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...

Page 2: ...er 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 R...

Page 3: ... 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 cont...

Page 4: ...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 ID Tag which transmits a signal to the ID Cap Reader When co ing...

Page 5: ...or 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 sens...

Page 6: ... 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 5o C a...

Page 7: ...aced 3 1 2 Reader Charging Attach the Lanyard to the Reader as shown in Figure TBD Note that the Reader LED blinks green whenever it is paired and ready to use blinks a green orange pattern when the battery is low and blinks orange when the battery is too low to be used See Figure TBD To charge the Reader place the Reader on the Wireless Charger Pad as seen in Figure TBD The Reader LED will show s...

Page 8: ...e Remove Reader from the Wireless Charging Pad and check for the blinking Green light signifying the Reader is ready to detect an ingestion If the Reader shows an Orange light the battery is too low and should be charged for 30 minutes prior to the ingestion If the Reader shows a blinking Blue light the Reader and App are not paired reference Troubleshooting Once you have verified the Reader is pa...

Page 9: ... 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 Read this manual and the pharmacy prescription instructions before using this product The Reader box should contain the following components see picture TBD please contact your dispensing pharmacy if any item is missing Reader Lanyard AC Adapter USB Charging Cable Wirele...

Page 10: ...ight the battery is too low and should be charged for 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 sy...

Page 11: ...7 1 App does not install Attempt to download App again If problems persist call your pharmacy 7 2 App does not recognize Unique ID Call your dispensing pharmacy as they can generate a new Unique ID if needed 7 3 Unable to pair Reader with Phone If you encounter issues in pairing the Reader with the App follow the following steps Confirm BT on phone is on Ensure Reader and Phone are within 10 feet ...

Page 12: ...art phone and Reader then start App If still unsuccessful call dispensing pharmacy 7 7 Ingestion was not detected If using the App follow instructions to add an ingestion manually If not using the App do nothing If issue persists call your dispensing pharmacy 7 8 Ingestion detected when ID Capsule was not taken Call your dispensing pharmacy 7 9 Reader light remains Orange Do NOT ingest an ID Capsu...

Page 13: ... 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 ID Cap Reader Condition Temperature Humidity Pressure Altitude Operating 20 C 28 C 15 93 700 1060 hPa Storage 15 C 30 C 15 93 700 1060 hPa Transport 2 C 38 C 15 8...

Page 14: ...ns equipment can affect Medical Electrical Equipment The ID Cap Reader may be interfered with by other equipment even if that equipment complies with CISPR emission requirements FCC Interference Statement This device complies with part 15 of the FCC and Canadian Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept...

Page 15: ...ur authority to operate the equipment This Class B digital apparatus meets all requirements of the Canadian Interference Causing Equipment Regulations Cet appareil numérique de la classe B respecte toutes les exigences du Règlement sur le matériel brouilleur du Canada FCC Identifier FCC ID Electromagnetic Compatibility EMC The ID Cap Reader has been evaluated and deemed compliant with the requirem...

Page 16: ... intended for use in the electromagnetic environment specified below The customer or the user of ID Cap Reader should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance 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...

Page 17: ...Hz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 P d 2 3 P 11 Symbols Reference Guide Manufacturer Date of Manufacture Serial Number Class II Equipment Keep Dry Caution Federal law USA restricts this device to sale by or on the order of a physician Separate Waste Collection for Waste of Electrical and Electronic Equipment WEE Model Number Batch Code the Manufacturer s Code Refer to ...

Page 18: ...gle Use Only TBD TBD 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 3rd edition Home Use Safety AAMI IEC 60601 1 11 2015 EMC EMI AAMI IEC 60601 1 2 4th edition 2014 RFID Testing AIM 7351731 Wireless Coexistence ANSI C63 27 2017 Battery IEC 62133 2017 14 Manufacturer Contact I...

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