etectRx ID-Cap User manual

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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

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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

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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.

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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, 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.
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.

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•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 ID-
CAP 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.

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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.

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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
•Wireless Charging Pad
•Quick Start Guide
•Instruction Manual
3.1.1. Charger Setup
Note that the Reader in the box only has a partial charge to allow for initial setup, and should
be charged before taking any ID-Capsule ingestions.
Connect the AC Adapter, the USB Charger Cable, and the Wireless Charging Pad as shown in
Figure TBD. Plug the AC Adapter into a 110V wall outlet. A blue indicator light on the charging
pad will briefly flash when it is plugged in and ready for the Reader to be placed.
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 steady orange while charging and still below enough battery for use, and
steady green while charging and ready to be used. Once fully charged the Reader LED will blink
green.
The Reader will automatically stop charging once the battery is fully charged.
3.1.3. App Setup
Use of the optional App requires a compatible iPhone or Android phone to pair with the Reader
(iPhone v### or later or Android v### or later).
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.
Follow guidance within the App for setup of any preferences and interactions.

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Ensure App remains open at phone at all times to ensure communications received from
Reader.
3.1.4. Reader Pairing
Turn the Reader on by pressing the power button for 2 seconds until the Reader LED emits a
blinking Blue light. See figure TBD.
Ensure the Reader and Phone are within 10ft of each other.
Open “Settings” on the phone and ensure Bluetooth is turned on. NOTE: Bluetooth must be
enabled on the phone for proper communications with the etectRx Reader. etectRx
recommends leaving Bluetooth enabled for the duration of device use.
Close “Settings” on the phone, and open or re-open the eTectRx Adherence App. The phone
will automatically pair with the Reader, and then will require entry of code “032669” to
complete pairing. The LED on the Reader will blink Green once successfully paired.
3.2. Ingesting an ID-Capsule
Before ingesting each ID-Capsule:
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 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.
ATTENTION
DO NOT delay taking prescribed medication if the Reader is not charged or if you encounter any
issue with the ID-CAP system.
When ingesting each ID-Capsule:
Proceed to swallow an ID-CAPSULE at the same time as your prescribed medication. After
swallowing ID-Capsule, continue wearing the Reader around your neck while going about normal
daily activities.
After Ingesting each ID-Capsule:
Within 30 minutes, the Reader will detect the swallowed ID-Capsule and notify by a blinking white
LED light on the Reader which displays for TBD minutes and a message of “ingestion detected” on
the App.
If the confirmation of ingestion is not observed, use the App to self-report an ingestion.

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WARNING
DO NOT take an additional ingestion if the first one was not reported.
Remove Reader and Charge
Once the ingestion has been detected or 30minutes after ingestion, take off the Reader and place
back on the charger to ensure readiness for the next use.
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. 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.
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
•Wireless Charging Pad
•Quick Start Guide
•Instruction Manual
4.1.1. Charger Setup
Note that the Reader in the box only has a partial charge to allow for initial setup, and should
be charged before taking any ID-Capsule ingestions.
Connect the AC Adapter, the USB Charger Cable, and the Wireless Charging Pad as shown in
Figure TBD. Plug the AC Adapter into a 110V wall outlet. A blue indicator light on the charging
pad will briefly flash when it is plugged in and ready for the Reader to be placed.
4.1.2. Reader Charging
Attach the Lanyard to the Reader as shown in Figure TBD.

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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 steady orange while charging and still below enough battery for use, and
steady green while charging and ready to be used. Once fully charged the Reader LED will blink
green.
The Reader will automatically stop charging once the battery is fully charged.
4.2. Ingesting an ID-CAPSULE
Before ingesting each ID-Capsule:
Remove Reader from the Wireless Charging Pad and check for the blinking Blue 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.
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.
When ingesting each ID-Capsule:
Proceed to swallow an ID-CAPSULE at the same time as your prescribed medication. After
swallowing ID-Capsule, continue wearing the Reader around your neck while going about normal
daily activities.
After Ingesting each ID-Capsule:
Within 30 minutes, the Reader will detect the swallowed ID-Capsule and notify by a blinking white
LED light on the Reader which displays for TBD minutes.
WARNING
DO NOT take an additional ingestion if the first one was not reported.
Remove Reader and Charge
Once the ingestion has been detected or 30minutes after ingestion, take off the Reader and place
back on the charger until the next use.
4.3. Periodic Download
Coordinate with the dispensing pharmacy to bring the Reader in to them for data download.
4.4. End of Therapy / Reader Return

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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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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. If Reader is not charging while
on Charger Pad first ensure charger is plugged in, then adjust Reader position on pad until
pad blue light comes on. If problems persist, call dispensing pharmacy.
7.6. App loses connection with Reader and is unable to reconnect
•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).
•Go to settings on phone, access BT, and forget device. Ensure BT is on.
•Shutdown and then restart App.
•If still not successful, restart 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-Capsule if the Reader displays an Orange light. Charge your Reader per
the instructions until a Green Light is observed. If the light is still Orange after 30 minutes,
the Reader can be restarted by holding the power button down for TBD seconds to turn off
and then holding the power button down for 2 seconds to turn back on. If the light is still
Orange after 8 hours of charging and the reboot does not address, call your dispensing
pharmacy.
7.10. Reader Error ###
TBD
7.11. App Error ###
TBD
7.12. Other Messages
8. Warranty, Useful Life, and Shelf-Life
This product has a shelf life of 18 months from date of manufacture and a service life of 12
months from patient initial use.
9. Technical Information

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9.1 Device Classification
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a
physician.
The ID-Cap System is categorized as a Class II medical device by the United States Food
and Drug Administration and identified as an ingestible event marker under 21 CFR
880.6305. An ingestible event marker is a prescription device used to record time-
stamped, patient-logged ingestion events. The ingestible component links wirelessly
through radio frequency communication to an external recorder which records the date
and time of ingestion.
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.
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% - 85%
700 – 1060 hPa
ID-Capsules
Condition
Temperature
Humidity
Storage
Transport
9.3 Protection Against Ingress of Solids and Liquids
The ID-Cap Reader has an Ingress Protection rating of IP53. This means that the enclosure
is protected from limited dust ingress, and it has been rated for protection from water
spray less than 60 degrees from vertical. For continued safety, should the enclosure
become damaged, do not use the ID-Cap Reader and contact the manufacturer.
9.4 Avoiding Unsafe Use Conditions
The ID-Cap System is not used for the diagnosis or treatment of any medical conditions.

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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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communications. However, there is no guarantee that interference will not occur in a
particular installation.
If this equipment does cause harmful interference to radio or television reception (which
can be determined by turning the equipment on and off), the user is encouraged to try to
correct the interference by using one or more of the following measures:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and the receiver.
•Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.
Caution: Changes or modifications not expressly approved by etectRx could void your
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 requirements in
EN60601-1-2 Class B for Electromagnetic Compatibility (EMC). Medical Electrical
Equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in this User Manual. Portable and
mobile RF communications equipment can affect Medical Electrical Equipment. The ID-
Cap Reader should not be used adjacent to or stacked with other electromagnetic
equipment. 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.
Information on the Radio Subsystem

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The ID-Cap Reader incorporates a Bluetooth™ radio subsystem which is compliant with
the Bluetooth standard. The following information is provided to satisfy the requirements
of EN/IEC 60601-1-2:
The Bluetooth radio transmits and receives on __ frequency bands which are equally
spaced at __ MHz intervals between ___ MHz and ___ MHz.
The effective receive bandwidth is ____ MHz.
The transmit modulation is frequency-hopping using GTSK (Gaussian Frequency Shift
Keying) with a bandwidth-bit period product BT-0.5. The Modulation index is between
0.28 and 0.35.
The effective radiated power is -15dBm (P=0.032mW).
Tables to be completed:
Guidance and manufacturer's declaration - electromagnetic emissions
The ID-Cap Reader is 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 user of the ID-Cap Reader should assume that it is used in such an
environment
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Recommended separation distances between portable and mobile RF
communications equipment and the ID-Cap Reader
The ID-Cap Reader is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the ID-Cap
Reader can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters)
and the ID-Cap Reader as recommended below, according to the maximum output
power of the communications equipment.

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17
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
150 kHz 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 Instructions for Use
Not made with Natural Rubber Latex
Independent Lab Tested (Put Lab’s Symbol)
Expiry Date

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Storage Temp
Do not use if packaging damaged
Product Non-Sterile
Shock Protection B or BF – IF NEEDED
Single 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 Information
etectRx, Inc.
107 SW 140th Terrace, Suite 1, Newberry, FL 32669
Ph: [phone]
www.etectrx.com