Hormone Based Minilab
Product Information
Specifications
Product Name: inne MINILAB
Version: 7.3
Date: April 2nd, 2025
Description
The inne MINILAB is a fertility monitoring device that measures
progesterone in saliva throughout the menstrual cycle. It is
designed for self-testing by female laypersons at home.
About Inne
Inne’s mission is to help women understand their personal
fertility by combining science, technology, and design to provide
reliable information about the rhythms of their bodies and how they
influence fertility.
Product Usage Instructions
Setup
- Download the inne APP and create an account.
- Pair and link your inne READER to the app.
- Set up WI-FI connection.
- Choose your fertility monitoring goal.
Fertility Monitoring
Daily Progesterone Test
- Set up daily notification within the testing window.
- Follow the steps of the daily progesterone test: Collect
sample, Measure progesterone levels, Review results. - Understand fertility status, cycle, and implications for
getting pregnant.
Maintenance
- Ensure Cyber Security & Data Protection through secure
network usage. - Regularly update software & firmware for security
patches. - Maintain authorization & data privacy.
- Follow incident response and security monitoring
protocols.
Troubleshooting
- If you miss the 4-hour testing window, follow recommended
steps. - If the inne READER shows a red UI light, refer to
troubleshooting guidelines. - If readings do not synchronize with READER firmware,
troubleshoot the issue.
FAQ
What should I do if I forget to start a new cycle?
If you forget to start a new cycle, access the inne APP and
manually initiate a new cycle to continue monitoring your
fertility.
How do I contact Customer Care for assistance?
You can find customer care contact information in the manual
under “Customer Care and Contact Information” section. Reach out to
them for any product-related queries or issues.
Welcome to inne MINILAB.
System Manual 7.3
Table of contents
INTRODUCTION 6 About this document 7 Intended use 7 About inne
THE INNE MINILAB 8 Overview 8 About the inne MINILAB 10 When you have received your inne minilab
shipping box 10 Contents of the shipping box 10 Contents of the reader box 10 Contents of the strips pouch 11 Contents of the demo strips pouch 11 Additional equipment required 12 When the inne MINILAB must not be used –
Contraindications 13 Warnings and Precautions 16 Component names and functions 18 inne READER 19 Important information of the inne READER 20 inne Progesterone STRIP 20 Storage and stability of the inne
Progesterone STRIP
22 General principles of the test 22 Test procedure 22 Control procedure 22 Active Ingredients 23 Biological reference range 23 Bibliographical reference 24 Performance characteristics 24 Limit of detection 24 Dynamic range 24 Analytical specificity 24 Reproducibility 24 Repeatability 25 Clinical sensitivity & specificity 25 Bibliographical reference 26 Setup 26 Download the inne APP and create an
account 26 Pair and link your inne READER 26 Set up WI-FI 27 Choose your goal
FERTILITY MONITORING 28 Daily progesterone test 28 Rules 29 Set up your daily notification within the
testing window 29 Steps of the daily progesterone test 30 Collect 32 Measure 34 Review 34 Science behind the inne MINILAB 34 Review progesterone results 34 The fertility status 35 Understand your cycle 36 Getting pregnant 37 The behavior of progesterone
38 The graph in detail
40 Your cycles 40 Start a new cycle 40 If you forget to start a new cycle 41 View, edit and delete past cycles
MAINTENANCE 42 Cyber Security & Data Protection 42 Secure network usage 42 Software & firmware updates & security
patches 42 Authorization & data privacy 42 Incident response and security monitoring
44 Troubleshooting 44 I have missed my 4-hour testing window 44 My inne READER is showing a red UI light 45 My readings have not synchronised with
my inne APP 45 Data synchronisation 45 Software updates inne APP 45 Firmware updates inne READER 45 What is needed to update the inne
READER firmware
46 General information 46 Reader repair and cleaning 46 Warranty information 46 Customer care and contact information 46 Returns 47 Regional disposal and recycling information 47 Manufacturer details 47 Regulatory compliance information 47 Reporting 48 Legend
Introduction
ABOUT THIS DOCUMENT This SYSTEM MANUAL contains important information about how to use the inne MINILAB. Read it carefully prior to using the inne MINILAB for the first time and keep it for future reference. This manual describes the proper procedures for operation and maintenance. The inne MINILAB must not be used for any purpose other than that which is specified in this document.
Version: 7.3 Date: April 2nd, 2025
NOTE Always check the inne APP to access the latest version of this manual.
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Introduction
INTENDED USE The inne MINILAB is a fertility monitoring device
that measures progesterone in saliva throughout the menstrual cycle. It is designed for self-testing by female laypersons at home.
ABOUT INNE When we see the female reproductive system we see beauty and we see logic.
Our mission is to help women see the same and provide a way to get reliable information about their personal fertility. Our minilab combines science, technology and design to help women understand the rhythms of their bodies and how they influence fertility.
The rhythms of a woman’s body are controlled by hormones. These hormones, oestrogen and progesterone in particular, regulate the menstrual cycle and trigger ovulation. By measuring progesterone levels at different times in the cycle, the inne MINILAB is able to identify the days in which a woman has a high chance of getting pregnant and provide insights into her fertility.
Introduction
7
The inne MINILAB Overview
ABOUT THE INNE MINILAB In order to use the inne MINILAB, you need to carry out a daily saliva collection using an inne Progesterone STRIP, perform a measurement using the inne READER, and finally review the results and view your fertility status in the inne APP.
Our system’s algorithm calculates your fertility status by taking into account the progesterone concentration found in your saliva, the dates of your previous periods, the maximum lifespan of an unfertilised egg and the lifespan of sperm. The inne APP displays this fertility status by indicating whether you have a high or a low chance of pregnancy.
Since every woman’s cycle is individual and each cycle can vary, the inne MINILAB has to be used consistently in order to accurately predict and monitor your fertility.
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The inne MINILAB
inne Progesterone STRIP
inne READER
inne APP
The inne MINILAB
9
WHEN YOU HAVE RECEIVED YOUR inne MINILAB SHIPPING BOX Unpack the inne MINILAB and check for completeness according to the components listed on this spread. Inspect the package for damage from shipping.
Follow the set-up process steps described in the Quick Guide instructions included within the inne READER packaging (charging and pairing). Confirm the function of the inne READER through successful pairing with your smartphone device.
CONTENTS OF THE `SHIPPING’ BOX inne READER box inne Progesterone STRIP pouches (3X) inne Demo STRIP pouch (1X) SYSTEM MANUAL
System manual
CONTENTS OF `INNE READER’ BOX The inne READER box includes the following components. If something is missing, please contact Feral GmbH.
inne READER USB-C Cable Quick Guide
Quick guide
CONTENTS OF `INNE PROGESTERONE STRIP’ POUCH Each inne Progesterone STRIP pouch includes the following components. If something is missing, please contact Feral GmbH.
8x inne Progesterone STRIPs in a pouch
8x
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The inne MINILAB
CONTENTS OF `INNE DEMO STRIP’ POUCH Each inne Demo STRIP pouch includes the following components. If something is missing, please contact Feral GmbH.
2x inne Demo STRIPs in a pouch
2x
inne Demo STRIP
NOTE inne Demo STRIPs are non-functional strips for you to learn how to collect a saliva sample before using inne Progesterone STRIPs.
ADDITIONAL EQUIPMENT REQUIRED In order to install the inne APP and connect to the inne READER.
Apple iPhone (running IOS 13 or later) OR Android Devices (from version 7.0) 2.4 GHz Wi-Fi (in order to perform reader software updates) A Charging port with at least 0.5 A or 2.5W (5V)
Please download the free inne APP (latest software version) from Google Play or the Apple App Store.
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When the inne MINILAB must not be used Contraindications
Before using the inne MINILAB, make sure none of the following statements apply:
You are younger than 18 years of age
Your average menstrual cycles are shorter than 22 days or longer than 35 days
You are currently using or have used a hormonal treatment such as hormonal contraception (including progesterone-only, combined hormonal methods, or any other hormonal contraceptive program), fertility treatments or hormone replacement therapy. Since stopping the treatment, have not yet had 3 regular menstrual cycles.
You are currently using or have used a treatment which may affect their menstrual cycle (this would be mentioned in the patient information leaflet of the treatment). Since stopping the treatment, have not yet had 3 regular menstrual cycles.
You are pregnant or have recently been pregnant (including miscarriage or abortion), and have not yet had at least 3 regular cycles.
You are known to have polycystic ovarian syndrome or endometriosis.
Currently breastfeeding or have recently breastfed. After stopping breastfeeding, have not yet had 3 regular menstrual cycles.
Must avoid pregnancy at all costs.
Have or have had menopausal symptoms, including but not limited to hot flashes or night sweats.
You are menopausal or post-menopausal.
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The inne MINILAB
Warnings and Precautions
CAUTION Use of inne READER in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging electrostatic discharges that may cause erroneous results. CAUTION The inne MINILAB is designed for use in a HOME HEALTHCARE ENVIRONMENT. If it is suspected that performance is affected by electromagnetic interference, correct operation may be restored by increasing the distance between the inne READER and the source of the interference. CAUTION Ensure that saliva is only deposited into the collector to prevent invalidating the test. CAUTION Women to women differences and natural hormonal fluctuations during a cycle could influence the test and lead to false results of progesterone level and fertility detection. CAUTION only use inne Progesterone STRIPs from the same lot throughout a menstrual cycle. CAUTION Only use for self-testing at home. CAUTION Keep out of the reach of children. CAUTION Read SYSTEM MANUAL carefully before performing the test. CAUTION Use the inne Progesterone STRIP immediately after removing it from the pouch. CAUTION Pay attention to collection time and the flow indicator on the inne Progesterone STRIP. CAUTION Use the inne Progesterone STRIP only with the inne READER. CAUTION Use the inne READER only with original inne Progesterone STRIPs. CAUTION Use the test only for the purpose described in the SYSTEM MANUAL. CAUTION Store and use between 15°C-30°C. CAUTION Keep pouch closed and store in a dry place. Make sure to close the zipper after taking a strip out in order to protect the remaining strips. CAUTION Keep the inne READER dry. CAUTION The inne READER is for indoor use only. CAUTION Make sure the inne Progesterone STRIP read-out window is clean and is never covered by anything.
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CAUTION Make sure that the inne Progesterone STRIP barcode is never covered by dust, hair or saliva as it will not be scannable by the inne READER. CAUTION It is important to remember the day your period started and track it in the inne APP. The inne MINILAB takes the first day of your cycle into account for your fertility prediction. Not tracking a new cycle will result in inaccurate fertility information. CAUTION Keep the inne Progesterone STRIP horizontal after collection until the strip has been inserted into the reader. CAUTION If saliva is not starting to flow through the inne Progesterone STRIP within 30 seconds please refer to the help section in the inne APP. CAUTION The inne Progesterone STRIP needs to be inserted into the inne READER immediately after successful sample collection to ensure accurate results. CAUTION The inne READER shall remain still and upright on a flat surface until the measurement has ended. CAUTION – DISCARD USED INNE PROGESTERONE STRIP The inne Progesterone STRIPS are made for single-use only. After the measurement has ended, the inne Progesterone STRIP can be removed from the inne READER and should be discarded as residual waste. CAUTION Not synchronising the test results daily will prevent you from using the inne MINILAB for its intended use of fertility monitoring. CAUTION Do not use the inne READER in proximity to sources of strong electromagnetic radiation, as these may interfere with the proper operation. CAUTION Do not use if inne Progesterone STRIP is damaged. Please take another one. CAUTION Do not use inne Progesterone STRIP after the expiration date printed on the pouch. CAUTION Do not use the inne Progesterone STRIP with blood in saliva. CAUTION Do not take any decision of medical relevance without first consulting the appropriate healthcare professional. CAUTION Do not fill more saliva than the amount indicated below can lead to inaccurate results. If you collected too much saliva repeat the test with a new inne Progesterone STRIP. CAUTION Your inne READER contains no user-serviceable parts. There is danger of explosion if the battery is mishandled or incorrectly replaced. Do not attempt to open or disassemble your inne READER or remove, crush, or puncture the battery in your inne READER, expose it to high temperatures or liquids. Disassembling your inne READER may damage it or cause injury to you.
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The inne MINILAB
CAUTION Do not take the inne Progesterone STRIP out of the inne READER while the measurement is in progress. CAUTION Do not test if foreign substances have been in your mouth since 30 minutes prior to testing. Rinse your mouth thoroughly with water and wait 10 minutes before taking the test. CAUTION Do not collect samples when oral diseases, inflammation or lesions exist. CAUTION Please be aware of a general residual risk of potentially infectious materials from non-human origin that cannot be completely excluded by the excessive testing. CAUTION Failure to follow these cybersecurity recommendations may lead to data loss, unauthorized access, or improper device functionality. NOTE The inne MINILAB does not protect you from sexually transmitted infections. NOTE The inne MINILAB can help you achieve your pregnancy goal by providing you with personalized information about your most fertile days based on your progesterone levels and aided by our algorithm. However, there are many factors that can impact fertility, we cannot guarantee a positive pregnancy outcome. NOTE It can take healthy couples several months to achieve a pregnancy. You should consult with your doctor if you are younger than 35 years and have been trying to get pregnant for more than 12 months, if you are older than 35 years and have been trying to get pregnant for more than 6 months, or if you are more than 40 years old. NOTE If you taste blood in your mouth, you can rinse your mouth with clean water and wait for another 10 minutes before doing the test. NOTE It is especially important to always measure on days that are marked as `important measurements’ in the APP for the algorithm to detect your ovulation. NOTE The current day is automatically shown in the middle, providing context on the previous and upcoming cycle days. NOTE Always check the inne APP to access the latest version of this manual. NOTE Measurements taken outside the 4-hour window are not recorded by the inne APP. NOTE inne Demo STRIPs are non-functional strips for you to learn how to collect a saliva sample before using inne Progesterone STRIPs.
The inne MINILAB
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The inne MINILAB Component names and functions
INNE READER The inne READER is designed with Wi-Fi
connectivity so it can integrate into a home environment and connect seamlessly with the inne APP. But we know that life today takes place
in more locations than at home. So we made sure the inne READER is also a perfect travel
companion by giving it a compact form and the ability to connect via Bluetooth.
USB-C port Battery light UI light Strip slot
Button
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The inne MINILAB
UI LIGHT White breathing White solid Red solid Red blinking Green blinking Blue blinking
Blue solid Yellow blinking Yellow solid Yellow breathing
Reading in progress – do not take out the inne Progesterone STRIP!
Task completed successfully: Measurement, Pairing or Data upload.
Measurement error: the strip was taken out while analysing, the inne READER has encounterd an error while anaylsing or the battery is too low to start a measurement. See App for details.
Hardware error, contact inne support
Sending measurement data to inne APP, please wait
Setup mode, searching for available Bluetooth connection. The inne READER is not paired to an inne account
Setup mode, Bluetooth connected. The inne READER is not paired to an inne account. Follow the in-App instructions to pair the device.
Setup mode activated through long press: inne READER is trying to establish Bluetooth connection to inne APP.
Active Setup mode : The inne READER has established a connection to the inne APP. To exit from this mode, wait until the light has turned off.
Firmware update in progress, please wait
STRIP SLOT
Slot for inne Progesterone STRIP
After collection insert the inne Progesterone STRIP by placing the rounded side inside the STRIP SLOT (see image on p.32) until you feel it is firmly in place.
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BUTTON Short press 3-Second press long press
10-Second press
Wake up: inne READER attempts to send data to inne APP.
Setup mode: start the following actions from the inne APP. Pairing or unpairing the inne READER from the inne account by following the on-screen instructions in the inne APP. update the inne READER firmware by following the on-screen instructions in the inne APP. setup Wi-Fi network by following the on-screen instructions in the inne APP.
Reset: inne READER will restart firmware.
BATTERY LIFE Green solid Yellow solid Red solid
Red blinking Yellow blinking
On battery sufficiently charged.
On battery status low but sufficient for operation.
On battery status critically low, inne READER must be charged before an action.
Charging – please do not unplug. The READER can perform a measurement while charging.
Charging battery charging in progress. Level sufficient for operation.
USB-C PORT Battery charging port
Plug in the USB-C cable and connect to an adapter or computer.
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The inne MINILAB
IMPORTANT INFORMATION OF THE INNE READER
The equipment is supplied by protected and limited USB-C in compliance to IEC 61010-1
Limited-Energy- Circuit (LEC) or IEC 60950-1
Limited Power Supply (LPS)
Rated 3.5 V
4.4 V max.
Input 4.75 V
5.25 V max. 4W
Maximum altitude 3000 meters
inne READER dimensions:
Height: 67 mm
Width: 38 mm Length: 68 mm
Weight: 73 g
CAUTION Store and use between 15°C-30°C. CAUTION The inne READER is for indoor use only. CAUTION Keep the inne READER dry.
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INNE PROGESTERONE STRIP The inne Progesterone STRIP is designed for single-use only. The inne Progesterone STRIP comes in a pouch of 8 inne Progesterone STRIPS. Make sure to close the zipper after taking a strip out in order to protect the remaining strips.
Pouch
Collector
Flow Indicator 8x
Read-out Window Barcode Window
inne Progesterone STRIP
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The inne MINILAB
NAME Collector Flow Indicator Read-out Window
Barcode Window
DESCRIPTION
Saliva is deposited into the collector of the inne Progesterone STRIP.
INSTRUCTION See more details p.30 (Collect)
The flow indicator can be used to verify if saliva started moving through the inne Progesterone STRIP.
See more details p.31 (Collect)
The read-out window is used by the inne READER to analyse the progesterone level in your saliva and
verify the quality control inherent of the inne Progesterone STRIP.
Make sure the inne Progesterone STRIP read-out window is clean and is never covered by anything.
The barcode is used by the inne READER to identify the LOT to confirm that the same LOT of strips is used within each cycle for accurate results.
Make sure that the inne Progesterone STRIP barcode is never covered by dust, hair or saliva as it will not be scannable by the inne READER.
CAUTION Store and use between 15°C-30°C.
CAUTION Keep pouch closed and store in a dry place. Make sure to close the zipper after taking a strip out in order to protect the remaining strips.
CAUTION Do not use inne Progesterone STRIP after the expiration date printed on the pouch.
The inne MINILAB
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The inne MINILAB General principles of the test
The inne MINILAB is based on measuring progesterone in saliva samples with a competitive lateral flow assay (the inne Progesterone STRIP) which is further analysed by the inne READER. By
monitoring changes in the salivary levels of progesterone, the inne MINILAB identifies the days with a higher chance of pregnancy and the days with lower chance of pregnancy. The days with higher chance of pregnancy are around ovulation and take into account the lifespan of the egg and sperm. The rise of progesterone always occurs after
ovulation has happened and characterizes the
beginning of the luteal phase of the menstrual cycle. When a sustained elevation in the salivary progesterone is measurable between the follicular and luteal phases for at least 3 measurements, ovulation is confirmed, indicating the end of the fertile window and thus, the beginning of the non-fertile phase.
TEST PROCEDURE For the saliva sample collection, please refer to p.30. Upon sample collection, the saliva fluid migrates through the capillary bed and initiates the reaction. The test result is displayed by a Test Line and a Control Line. For a competitive assay, the Test Line (TL) will show as a full colored line when the progesterone in the saliva sample is below the limit of detection. A colored line for the Control Line (CL) will demonstrate the test’s validity.
CONTROL PROCEDURE The inne MINILAB does not require the user to do any additional controls or use calibrators to assure the accuracy of the test. Therefore no controls and calibrators are provided.
ACTIVE INGREDIENTS Each inne Progesterone STRIP contains 5.78 ng of anti-Progesterone antibody.
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The inne MINILAB
BIOLOGICAL REFERENCE RANGE Not applicable as no quantitative results are provided to the users.
BIBLIOGRAPHICAL REFERENCE Regulation of the human menstrual cycle. Chabbert Buffet N, Djakoure C, Maitre SC, Bouchard P.,Front Neuroendocrinol. 1998 Jul;19(3):151-86. Review.
The Effect of Steroid Hormones on Ovarian Follicle Development. Chou CH, Chen MJ.,Vitam Horm. 2018;107:155-175. doi: 10.1016/ bs.vh.2018.01.013. Epub 2018 Feb 9. Review.
Characteristics of salivary profiles of oestradiol and progesterone in premenopausal women. Chatterton RT Jr, Mateo ET, Hou N, Rademaker AW, Acharya S, Jordan VC, Morrow M.,J Endocrinol. 2005 Jul;186(1):77-84 .
Saliva as a medium for investigating intra- and
interindividual differences in sex hormone levels in premenopausal women. Gann PH, Giovanazzi S, Van Horn L, Branning A, Chatterton RT Jr.,Cancer Epidemiol Biomarkers Prev. 2001 Jan;10(1):59-64.
Salivary measurement of episodic progesterone release. O’Rourke MT, Ellison PT.,Am J Phys Anthropol. 1990 Mar;81(3):423-8.
Salivary steroids and natural variation in human ovarian function. Ellison PT.,Ann N Y Acad Sci. 1994 Feb 18;709:287-98. Review. No abstract available.
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The inne MINILAB Performance characteristics
LIMIT OF DETECTION The Limit of Detection (LoD) is the lowest amount of analyte that can be detected in a saliva sample. The estimated LoD is 92.2 pg/mL, determined consistent with the guidelines in CLSI document EP17 based on the proportions of false positives () less than 5% and false negatives (ß) less than 5%.
DYNAMIC RANGE The range of the assay is 92.2 1920 pg/mL.
ANALYTICAL SPECIFICITY From the different substances evaluated for crossreactivity and interference, Caffeine and Ethanol have been identified as possible interferents. Respecting the saliva collection guidelines as explained in the section Daily Progesterone Test in the SYSTEM MANUAL on p. 28, mitigates the possible interference of caffeine and ethanol.
REPEATABILITY
Four levels of progesterone saliva samples were analyzed in duplicate determinations twice a day. A total of 160 assays, 40 per sample concentration, over a period of 10 nonconsecutive days were run. Statistical analyses were performed to analyze repeatability, betweenrun, between-day components of variation as well as total variation to estimate within laboratory precision.
Repeatability is estimated to be below 9.18% CV, while total variation within laboratory precision is estimated to be below 13.62% CV.
REPRODUCIBILITY The variability between production lots is estimated above 20%, so it is important to use inne Progesterone STRIPs from the same lot throughout a menstrual cycle.
CAUTION only use inne Progesterone STRIPs from the same lot throughout a menstrual cycle.
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The inne MINILAB
CLINICAL SENSITIVITY & SPECIFICITY An at-home real-life context clinical evaluation was conducted comparing the ovulation confirmed by the inne MINILAB to the ovulation determination via commercial LH urinary tests.
Sixteen voluntary testers used the inne MINILAB and the LH test according to the respective instructions for use and recorded the results of the positive LH test via the inne APP. Thus, the data collected corresponds to a total of 68 menstrual cycles.
Each menstrual cycle was evaluated to determine the ability of the inne MINILAB to correctly identify the presence of the marker progesterone within the different phases of the menstrual cycle. The results were compared against the menstrual cycle phases classification according to the positive LH test results logged by the users in the inne APP. Clinical sensitivity and specificity have been calculated accordingly.
in 88.7% of the analyzed menstrual cycles.
Both clinical sensitivity and specificity are aligned with what previous studies have found for other fertility monitor systems based on a progesterone metabolite, pregnanediol 3-glucuronide (PDG).
BIBLIOGRAPHICAL REFERENCE Use of Urinary Pregnanediol 3-Glucuronide to Confirm Ovulation. Ecochard, R., R. Leiva, T. Bouchard, H. Boehringer, A. Direito, A. Mariani, and R. Fehring. Steroids 78, no. 10 (2013): 1035 40. https://doi.org/10.1016/j.steroids.2013.06.006.
This study has found a that the inne MINILAB detected a progesterone rise compatible with the ovulation in 92.4% of the cycles, with a Clinical Sensitivity of 91.5%, meaning that the inne MINILAB correctly identifies the luteal phase in 91.5% of the analyzed menstrual cycles, and a clinical specificity of 88.7%, meaning that the inne MINILAB correctly identifies the follicular phase
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The inne MINILAB Setup
DOWNLOAD THE INNE APP AND CREATE AN INNE ACCOUNT Prior to the first use, download and install the free inne APP from the Apple App Store or Google Play Store on your mobile device. Follow the on-screen instructions to sign in with your existing inne account or create a new inne account.
PAIR AND LINK YOUR INNE READER In order to use the inne APP, the inne READER must be paired with a smartphone and linked with
an inne account. The inne READER is designed for use by a single user and therefore can only be linked to one account at a time. After setting up an account, the inne APP will automatically lead through the pairing process.
SETUP WI-FI The inne READER can function with just a Bluetooth connection, but we highly recommend to set it up with your home Wi-Fi for more seamless and convenient use. The Wi-Fi communication will allow the inne READER to send readings to your inne APP even when you are not in proximity to the device. The inne READER also needs to be connected to a Wi-Fi to update its firmware.
TIP Open the Camera app on your smartphone and hold your device so that the QR code appears in the viewfinder in the Camera app. Tap the pop-up notification to download the inne APP.
We recommend to set up the Wi-Fi during the set up process of your inne READER. But you can
set up and manage different Wi-Fis from the inne APP Settings at any time.
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The inne MINILAB
CHOOSE YOUR GOAL You will be guided to select the goal for which you’d like to use the inne MINILAB:
1. Understand my cycle 2. Get pregnant
You can always easily change your goal in the profile section of your inne APP.
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Fertility Monitoring Daily progesterone test
The inne MINILAB requires a daily saliva test to understand the progesterone level in the body. In order to guarantee accurate results, the inne MINILAB only takes readings into account which are taken within your 4-hour testing window.
RULES In order to record accurate progesterone levels, it is important to ensure two key things:
Take the test inside your set daily 4-hour testing window.
No foreign substances have been in your mouth since 30 minutes prior to testing. OR Rinse your mouth thoroughly with water and wait 10 minutes before taking the test.
NOTE If you taste blood in your mouth, you can rinse your mouth with clean water and wait for another 10 minutes before doing the test.
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Fertility Monitoring
SET UP YOUR DAILY NOTIFICATION WITHIN THE
TESTING WINDOW To ensure accurate test results, the inne Progesterone STRIP should be used every day within the same 4-hour testing window which can be set between 5:00 am – 2:00 pm. The inne MINILAB will only take into account the first successful reading which is made within the testing window.
STEPS OF THE DAILY PROGESTERONE TEST In order to make it easy to remember the process of daily testing, we have divided it into three consecutive steps. Each step will be explained in detail in the next pages.
1
Collect
For ease of use, we recommend using the daily
2
notification as a reminder.
Measure
The daily notification and the testing window
3
Review
are set up during the sign-up process. Both can
be modified in the `settings’ tab.
NOTE It is especially important to always measure on days that are marked as `important measurements’ in the APP for the algorithm to detect your ovulation.
NOTE Measurements taken outside the 4-hour window are not recorded by the inne APP.
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1
Collect
How to collect a saliva sample for accurate results
TAKE A NEW INNE PROGESTERONE STRIP The inne Progesterone STRIPs come in a pouch with 8 single strips. Make sure to close the pouch after taking one out to protect the remaining ones.
COLLECT SALIVA Collect a pea-sized amount of saliva in your mouth and deposit it gently into the collector side marked with a droplet symbol.
CAUTION Ensure that saliva is only deposited into the collector to prevent invalidating the test.
CAUTION Keep the strip horizontal after collection until the strip has been inserted into the reader.
Collector
CAUTION Do not use if inne Progesterone STRIP is damaged. Please take another one.
Flow indicator Read-out window Barcode window
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2 Fertility Monitoring
WHAT IS THE RIGHT AMOUNT? When collecting a saliva sample, make sure to only fill the collector cavity of the strip up to the green line as shown below.
CAUTION Do not fill more saliva than the amount indicated below as it can lead to inaccurate results. If you collected too much saliva repeat the test with a new inne Progesterone STRIP.
CAUTION Do not use the inne Progesterone STRIP with blood in saliva.
OBSERVE THE FLOW INDICATOR The flow indicator temporarily turns light pink when saliva starts flowing through the strip.
Insert the strip into the reader immediately after successful collection as described on p.32.
CAUTION If saliva is not starting to flow through the inne Progesterone STRIP within 30 seconds please refer to the help section in the inne APP.
3
4
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2
Measure
Insert the inne Progesterone STRIP into the inne READER to start the measurement
START READING Reading automatically starts when an inne Progesterone STRIP is inserted into the inne READER with the rounded side first as shown below.
CAUTION The inne Progesterone STRIP needs to be inserted into the inne READER immediately after successful sample collection to ensure accurate results.
CAUTION The inne READER shall remain still and upright on a flat surface until the measurement has ended.
READING IN PROGRESS The white pulsating UI light indicates the reading is in progress.
CAUTION Do not take the inne Progesterone STRIP out of the inne READER while the measurement is in progress.
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Fertility Monitoring
READING SUCCESSFUL When the measurement is done, the UI light will turn solid white. The result is automatically sent to the inne APP. The inne READER will go to deep sleep, which is indicated by the UI light turning off.
TIP If you are connected via Bluetooth, make sure your phone is in the same room (10-meter reach) and has the inne APP running.
RECEIVE RESULTS You can review the results in the inne APP. See next page.
CAUTION – DISCARD USED INNE PROGESTERONE STRIP The inne Progesterone STRIPS are made for single-use only. After the measurement has ended, the inne Progesterone STRIP can be removed from the inne READER and should be discarded as residual waste.
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3
Review
Review your progesterone results in the inne App.
THE SCIENCE BEHIND THE INNE MINILAB The inne MINILAB enables women to understand their hormones, specifically progesterone. These hormones are secreted by the pituitary gland in the brain and ovaries. Progesterone influences many aspects of the body in a cyclic pattern. Along with informing the body about when to ovulate and when to menstruate these hormones also influence the cervical fluid pattern.
REVIEW PROGESTERONE RESULTS The measurement results are charted in the graph in the inne APP showing the daily changes in progesterone levels throughout the cycle. The progesterone interpretation provides information about the progesterone trend and the occurrence of ovulation. It is updated every time a new measurement comes in.
THE FERTLITY STATUS Based on the progesterone measurements, the inne APP identifies the fertile window and displays it as different fertility statuses such as:
You have a high chance of pregnancy today
You have a low chance of pregnancy today
In order for the algorithm to more precisely predict ovulation, it is important to be consistent with the progesterone measurements. The longer the inne MINILAB is used regularly, the shorter the fertile window can become.
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Fertility Monitoring
UNDERSTAND YOUR CYCLE If you are using the inne MINILAB for understanding your cycle, then you can use the results provided by the inne APP as information about your cycle and your fertile status.
You have a high chance of pregnancy today
A high chance of pregnancy result indicates that you are on your fertile window and, as such, would have higher chances of getting pregnant on that day.
You have a low chance of pregnancy today
A low chance of pregnancy indicates that you are either at the beginning of your cylce or pas ovulation, therefore, you would have lower chances of getting pregnant on that day.
NOTE The inne MINILAB does not protect you from sexually transmitted infections.
Fertility Monitoring
35
GETTING PREGNANT If you are using the inne MINILAB for trying to conceive, you should interpret the results provided by the inne APP as follows:
You have a small chance of getting pregnant
The inne APP will display progressively darker orange background bars on the days leading to your predicted ovulation to indicate the days with higher chances of getting pregnant
You have a low chance of pregnancy today
A small chance of pregnancy indicates that you are within a time span were sperm is able to survive until the onset of a predicted ovulation happening.
You have a high chance of getting pregnant
A high chance of pregnancy result indicates that you are on your fertile window and should try to have unprotected sexual intercourse on that day to increase the likelihood of conceiving in that cycle.
You have a very high chance of getting pregnant
A very high chance of pregnancy result indicates that you are in your fertile window and close to your predicted ovulation. You should try to have unprotected sexual intercourse on that day to increase the likelihood of conceiving in that cycle.
A low chance of pregnancy indicates that the likelihood of pregnancy on that day is low.
NOTE The inne MINILAB does not protect you from sexually transmitted infections.
If you suspect you might be pregnant, you should take a pregnancy test and consult with your doctor to get the most appropriate information about the next steps. The sooner you consult with your doctor, the better it is for your health.
NOTE The inne MINILAB can help you achieve your pregnancy goal by providing you with personalized information about your most fertile days based on your progesterone levels and aided by our algorithm. However, there are many factors that can impact fertility, we cannot guarantee a positive pregnancy outcome.
NOTE It can take healthy couples several months to achieve a pregnancy. You should consult with your doctor if you are younger than 35 years and have been trying to get pregnant for more than 12 months, if you are older than 35 years and have been trying to get pregnant for more than 6 months, or if you are more than 40 years old.
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Fertility Monitoring
THE BEHAVIOR OF PROGESTERONE
Low: Progesterone level is low in the follicular phase and stays low until ovulation occurs
Rising: Progesterone rise can be seen right after ovulation and when entering the luteal phase
High: Progesterone level is high during the luteal phase. Ovulation has taken place
Falling: Progesterone level decreases as the cycle ends
ovulation
progesterone
rising
high
falling
low chance of pregnancy
high chance of pregnancy
low chance of pregnancy
Fertility Monitoring
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Fertility Monitoring The graph in detail
15 16 17 18 19 20
Cycle days Progesterone level
Fluid pattern Symptoms and events
No data
Low chance of pregnancy
High chance of pregnancy
Cycle days Ovulation Progesterone level 38
The timeline of the graph is structured in cycle days.
20 the current day 19 past days 1 predicted start of a new cycle
21 future days
Predicted ovulation is displayed based on data from previous cycles. Ovulation is displayed once it has been confirmed based on the progesterone trend.
Displays the levels throughout the cycle. Rising progesterone is highlighted in orange color.
Fertility Monitoring
Past recorded period Progesterone level Confirmed ovulation Rising progesterone level Predicted start of new cycle
Tracked symptoms and events
Tracked fluid
pattern
NOTE The current day is automatically shown in the middle, providing context on the previous and upcoming cycle days.
Fluid pattern
Symptoms and events
You can track stages of
cervical fluids and period in
the inne APP.
period dry
sticky creamy runny
You can track multiple symptoms and events in the inne APP.
Fertility Monitoring
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Fertility Monitoring Your cycles
START A NEW CYCLE
Set the start of each menstrual cycle in your inne APP. Do this on cycle day 1, which is the first day of your period. The first day of your period is the first day of blood flow spotting should not be logged as period.
CAUTION It is important to remember the day your period started and track it in the inne APP. The inne MINILAB takes the first day of your cycle into account for your fertility prediction. Not tracking a new cycle will result in inaccurate fertility information.
You can start a new cycle by logging the fluid `period’ on the day the cycle begins. To do so, tap the fluid button on the APP’s home screen, select `period’ and save the change.
IF YOU FORGET TO START A NEW CYCLE A new cycle can be started anytime by logging `period’ as your current fluid. Select the day your
period started by scrolling through your cycle graph. Then tap the fluid button, select `period’ and save the change.
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Fertility Monitoring
VIEW, EDIT AND DELETE PAST CYCLES The section `Past Cycles’ in the inne APP gives an overview of previous cycles, their start date, duration, progesterone levels and detected ovulations. You can open `Past Cycles’ by tapping
the calendar symbol in the top right corner of the inne APP.
TIP You can view and edit all cycles in the `Past Cycles’ section in the inne APP.
The inne APP differentiates between cycles which have been added manually and those which were recorded while using the inne MINILAB.
Change the start date of a past cycle: Tap `edit period dates’, set the correct start date of your period within the calendar view and save the changes.
Delete a cycle: In the `Past Cycles’ overview, swipe the cycle to the left to see the option `delete’. When pressing `delete’ the cycle will be removed and the days will be added to the previous cycle. Your measurements will not be lost.
Fertility Monitoring
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Maintenance Cybersecurity & Data Protection
The inne MINILAB is designed with security in mind to protect user data and ensure safe operation. To maintain a secure system and prevent unauthorized access or potential cybersecurity risks, users must follow these guidelines:
SECURE NETWORK USAGE · The inne READER should always be connected
to a secure, password-protected Wi-Fi network. · Public or unsecured networks are not
supported.
SOFTWARE & FIRMWARE UPDATES & SECURITY PATCHES · Regular software & firmware updates are
required to maintain security and device functionality. · Updates will be made available through the inne APP and should be installed promptly when notified. If Wifi is connected, firmware updates will be conducted Over the Air (OTA) during the night.
AUTHORIZATION & DATA PRIVACY · User authorization is required before accessing
personal fertility data in the inne APP. · Personal data is encrypted and stored securely
according to GDPR and IVDR requirements.
INCIDENT RESPONSE & SECURITY MONITORING · If unauthorized access or a potential
cybersecurity threat is detected, please contact support immediately at support@inne.io. · Any security updates or vulnerabilities will be communicated via the inne APP and official website.
CAUTION Failure to follow these cybersecurity recommendations may lead to data loss, unauthorized access, or improper device functionality.
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Maintenance
Maintenance
43
Maintenance Troubleshooting
The troubleshooting guide in this chapter is applicable to both the inne READER and the inne APP.
The described troubleshooting is only for problems which can be solved by you, the user. If any other problems or defects occur with the inne READER, you should immediately contact customer care (see p.46) and ship the inne READER to the manufacturer for servicing.
There is no maintenance or service procedure to be performed by you, the user.
You can find the most up to date information in the inne Help Center.
I HAVE MISSED MY 4-HOUR TESTING WINDOW If you have missed taking your reading within the 4-hour testing window, you cannot take a measurement for that day.
MY INNE READER IS SHOWING A RED UI LIGHT If the inne READER shows a solid red UI light, it means the device has encountered an error. The error could either be a too low battery level or an error when analysing your saliva sample. In order to identify the error type please check the inne READER’s battery level. Press the button on the inne READER briefly and check the battery LED below the USB-C charging port. A red light indicates that the READER needs to be charged before performing the next measurement. If the inne READER shows you a blinking red light and goes off afterwards, it means that it has encountered a system error. Please
contact customer service by sending an email to support@inne.io
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Maintenance
MY READINGS HAVE NOT SYNCHRONISED WITH MY INNE APP If you have done your daily saliva test and the inne APP does not display your readings, short-press the inne READER button. If the inne READER shows a green UI light, it means that it has stored unsynchronised measurements due to a lack of connection to your inne APP.
DATA SYNCHRONISATION To transfer unsynchronised results make sure that the READER is within reach, that Bluetooth is enabled on your smartphone and that the inne APP is launched. Then, press the button on the inne READER briefly.
The inne READER sends the results automatically via Bluetooth to the inne APP. If results cannot be sent, the inne READER has the capacity to store the 10 most recent measurements.
When the inne READER has over 10 unsynchronised measurements in memory, it will overwrite the oldest with the latest one.
SOFTWARE UPDATES INNE APP Once a new update is available, it will be shown automatically upon launch of the inne APP. All updates are made available on the Apple App Store & Google Play.
FIRMWARE UPDATES INNE READER If a firmware update for the inne READER is available, it will be shown through a notification in the inne APP. You can also go to the `settings’ tab about the reader.
WHAT IS NEEDED TO UPDATE THE INNE READER FIRMWARE? The inne APP on your smartphone with connection to the internet The inne READER with connection to an active Wi-FI and sufficiently charged or connected to a charging point.
TIP With an established internet connection and a sufficient battery level the inne READER will automatically recieve and update the firmware overnight.
CAUTION Not synchronising the test results daily will prevent you from using the inne MINILAB for its intended use of fertility monitoring.
Maintenance
45
Maintenance General Information
READER REPAIR & CLEANING Your inne READER contains no user-serviceable parts. There is danger of explosion if the battery is mishandled or incorrectly replaced. Don’t attempt to open or disassemble your inne READER or remove, crush, or puncture the battery in your inne READER, expose it to high temperatures or liquids. Disassembling your inne READER may damage it or cause injury to you.
Cleaning of the inne READER is not recommended – if you want to clean the outer shell, you must use a dry cloth and no chemical detergents.
WARRANTY INFORMATION Feral GmbH warrants the inne READER, and only the inne READER, against defects in materials and workmanship under normal use for a period of three years from the date of purchase by the original purchaser. Defects discovered within the warranty period should be reported to Feral GmbH. Feral GmbH reserves the right to a period of investigation to establish the cause of the defect and may exercise its discretion in determining whether or not to replace free of charge. This warranty does not cover cosmetic
deterioration or damage caused by general wear and tear, physical or natural destruction, accident, misuse, neglect or other external causes. Any attempt to take the READER apart will invalidate this warranty. Any warranty claims must be supported with reasonable evidence, including proof of date of purchase, alongside these warranty conditions. In the event that Feral decides to provide a replacement, any replacement will not extend the life of this warranty.
CUSTOMER CARE If you have any questions or require assistance with your inne READER, inne Progesterone STRIP, inne APP, inne account, if you need support with your inne order, or if you want to share some feedback or complaints with us, please contact:
Via email: support@inne.io Via WhatsApp: +49 170 28 84 276 Via post: Feral GmbH, Skalitzer Straße 85-86,
TR B, 10997 Berlin, Germany
RETURN AUTHORISATION All returns must be preapproved by Feral GmbH before sending the device.
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Maintenance
REGIONAL DISPOSAL AND RECYCLING INFORMATION
REGULATORY COMPLIANCE INFORMATION This system was developed in compliance with the following standards:
The symbol above indicates that the inne READER and/or its battery should not be disposed of with household waste. When you decide to dispose of the inne READER and/ or its battery, do so in accordance with local environmental laws and guidelines.
The inne Progesterone STRIP pouches can be disposed in the recycling waste bin after removing the desiccant bags.
© 2024 Feral GmbH. No part of this work may be reproduced, modified, distributed, or otherwise used without prior written permission.
MANUFACTURER DETAILS
FERAL GmbH Skalitzer Straße 85-86, TR B 10997 Berlin GERMANY
IVD Directive 98/79/EC (IVDD) EN ISO 13485:2016 + AC:2018 + A11:2021 EN 13532:2002 EN 13612:2002 EN 13641:2002 EN ISO 14971:2019 + A11:2021 EN ISO 15223-1:2021 ISO 18113-1:2022-10 ISO 18113-4:2022-10 ISO 18113-5:2022-10 EN ISO 23640:2015 IEC 61010-1:2010 + COR:2011 + A1:2016, modified + A1:2016/COR1:2019 EN IEC 61010-2-101:2022 + A11:2022 EN IEC 61326-1:2021 EN IEC 61326-2-6:2021 IEC 62304:2006 + A1:2015 EN IEC 62311:2020 IEC 62366-1:2015 + COR1:2016 + A1:2020 ETSI EN 300 328 V2.2.2 ETSI EN 301 489-1 V2.2.3 ETSI EN 301 489-17 V3.2.4
REPORTING
Any serious incident occurring in relation to this
device should be reported to Feral GmbH and to
the competent authority of the EU Member State
in which the user is established.
WEEE-REG.-NR. DE40321321
Maintenance
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Legend
Consult the SYSTEM MANUAL for important information such as warnings and precautions
In vitro diagnostic Medical device (only for use outside of the body)
Batch code
Do not reuse
Keep dry Serial Number Manufacturer Date of manufacture
Do not use if package is damaged
Use-by date
Temperature limit for storage and usage of inne Progesterone STRIPs and inne READER
Temperature limit for transport of inne Progesterone STRIPs and inne READER
Indicates opening where to deposit a saliva sample in the inne Progesterone STRIP
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Maintenance
Documents / Resources
 |
inne Hormone Based Minilab [pdf] User Guide Hormone Based Minilab, Based Minilab, Minilab |