etectRx ID-Cap Скачать руководство пользователя страница 11 | Manualshive

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etectRx ID-Cap Скачать руководство пользователя страница 11

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.

11

Once your prescription has completed, call the dispensing pharmacy to initiate a return of the
Reader.

5.

Cleaning the Reader

The Reader should be cleaned periodically as needed.  To clean the Reader, DO NOT put under
water.  Use a clean cloth dampened with water and household soap or mild detergent to wipe
the case.  Immediately dry off with a clean, dry cloth.

6.

System Maintenance

The Reader contains no user-serviceable parts. For any issues encountered, please contact the
manufacturer.

To order replacements for any parts of the system (Reader Device, Lanyard, Wireless Charger
Pad, USB Charging Cable, AC Adapter, Instruction Manual, or Quick Start Guide), please contact
the dispensing pharmacy

.

7.

Error Messages, Troubleshooting

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 of each other.

•

Ensure Reader is turned on (Flashing Blue or Flashing Green light).

•

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.

7.4.

Unable to power-on charger

Note that the charger indicator will very briefly flash blue when initially plugged in, but will
remain off until a Reader needing a charge is placed on the pad. If a fully charged Reader is
placed on the Charger Pad, no indicator will be observed.

If the Charger Pad does not appear to be on, check all connections. If problems persist,
plug into a different wall outlet.

7.5.

Unable to charge Reader

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Содержание ID-Cap

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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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