Feral inne MINILAB System Manual

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SYSTEM MANUAL 4.0

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Summary of Contents for Feral inne MINILAB

Page 1 SYSTEM MANUAL 4.0...
Page 4: Table Of Contents
→ About this document → Intended use → About inne → About the inne MINILAB → The science behind the inne MINILAB → When the inne MINILAB must no be used → Precautions THE INNE MINILAB Overview → Components of the reader box →...
Page 5 Interpret progesterone results Cycle → Start a new cycle → If you forget to start a new cycle → Past cycles Tracking cervical fluid → How to observe and classify your cervical fluid → Cervical fluid in the inne MINILAB...
Page 6: 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.
Page 7: Intended Use
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.
Page 8: About The Inne Minilab
ABOUT THE INNE MINILAB In order to use the inne MINILAB, you need to carry out a daily saliva collection using an inne STRIP, perform a measurement using the inne READER, and finally review the results and view your fertility status on your inne APP .
Page 9 inne STRIPS (Pack of 8) for collecting and inne APP for viewing your data measured analysing your saliva sample (one inne by the inne READER and your fertility STRIP per day) status Introduction...
Page 10: The Science Behind The Inne Minilab
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...
Page 11 MENSTRUAL PHASES PROGESTERONE LEVEL CHANCE OF PREGNANCY CERVICAL FLUIDS Introduction...
Page 12: When The Inne Minilab Must No Be Used
WHEN THE INNE MINILAB MUST NOT BE USED Before using the inne MINILAB for fertility monitoring, make sure none of the following statements applies: You are younger than 18 years of age Your menstrual cycles are shorter than 22 days or longer than 35 days...
Page 13: Precautions
PRECAUTIONS For in vitro diagnostic use Not for internal use For self-testing at home Keep out of the reach of children Read the SYSTEM MANUAL carefully before performing the test Do not use the inne STRIP after the expiration date printed on the pouch Do not use the inne STRIP if the pouch is punctured or damaged Use the inne STRIP immediately after removing it from the pouch Pay attention to collection time and procedure of activation of the inne STRIP...
Page 14: The Inne Minilab
2. The inne MINILAB - Overview COMPONENTS OF 'THE READER' BOX COMPONENTS OF 'THE STRIPS' BOX The inne READER box includes the following The inne STRIP box includes the following components. If something is missing, please contact components. If something is missing, please contact Feral GmbH .
Page 15: Additional Equipment Required
In order to install the inne APP and connect to the inne READER. → Apple iPhone (model 5s or later) Please download the free inne APP (latest → 2.4 GHz Wi-Fi (in order to perform software version) from the Apple App reader software updates) Store. The inne MINILAB...
Page 16: Component Names And Functions
2. The inne MINILAB - Component names and functions INNE READER The inne READER is designed with Wi-Fi more locations than at home. So we made sure the connectivity so it can integrate into a home inne READER is also a perfect travel companion by...
Page 17 READER button or insert an inne STRIP during this process. STRIP SLOT Slot for inne STRIP Insert the activated inne STRIP by placing the window side inside the STRIP SLOT (see image on p.54) until you feel it is firmly in place. The inne MINILAB...
Page 18 (above 10%) to measure an inne STRIP Yellow bliking Charging - battery level above 10% USB-C PORT Battery charging Connect a USB-C cable to this USB-C-port, and connect the other end of port the cable to the Adaptor or Computer. The inne MINILAB...
Page 19: Important Information About The Inne Reader
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. Inout 4.75 V 5.25 V max. → inne READER dimensions: Height: 67mm Width: 38mm Lenght: 68mm Weight: 86g The inne MINILAB...
Page 20: Inne Strip
The inne STRIP is designed for single-use only. Each inne STRIP is packaged in a pouch. To take out the inne STRIP, tear open the pouch by pinching and pulling firmly where indicated. COLLECTOR HANDLE WINDOW WINDOW-SIDE The inne MINILAB...
Page 21: Storage And Stability Of The Inne Strip
(Measure). STORAGE AND STABILITY OF THE INNE STRIP Store at 15°-30°C Keep away from direct sunlight, moisture and heat. Stable in the sealed pouch up to the CAUTION: DO NOT FREEZE expiration date printed on the pouch The inne MINILAB...
Page 22: Inne App
There’s an app update available Update to get the latest features and ﬁxes LAB → Follow the daily testing process → View progesterone reading and fertility status → Track cervical fluids → View the current cycle → Access past menstrual cycles The inne MINILAB...
Page 23 READER → Access information on how to use the → Set alarm and testing window inne MINILAB and FAQs → Access account details and legal → Contact the inne support team information The inne MINILAB...
Page 24: The Lab
THE DRAWER P.26 THE FERTILITY STATUS P.25 PROGESTERONE MEASUREMENT TAB P.58 CERVICAL FLUIDS TAB P.66 DAY VIEW SYMPTOMS AND EVENTS TAB P.70 SET GOAL There’s an app update available Update to get the latest features and ﬁxes The inne MINILAB...
Page 25 The longer the inne swiping on the 'cycle view'. MINILAB is used regularly, the shorter the fertile window can become. Access 'past cycles' by swiping all the way to the left on the 'cycle view'. The inne MINILAB...
Page 26: The Drawer
Access more information about the current Swipe up or down to see all information cycle by dragging the 'drawer' up. available in the 'drawer'. Drag the 'drawer' down to minimise it and see the extended 'graph' in the 'cycle view'. The inne MINILAB...
Page 27 INFORMATION ABOUT PROGESTERONE MEASUREMENTS INFORMATION ABOUT SYMPTOMS AND EVENTS RECOMMENDATIONS SET GOAL FOR YOUR GOAL Upcoming Events UPCOMING CYCLE EVENTS Ovulation New Cycle Period Phase There’s an app update available Update to get the latest features and ﬁxes The inne MINILAB...
Page 28: The Graph
The current day is automatically shown in the middle, providing context on the previous and upcoming cycle days. CYCLE DAYS PROGESTERONE LEVEL NO DATA FLUID PATTERN LOW CHANCE OF PREGNANCY SYMPTOMS AND EVENTS HIGH CHANCE OF PREGNANCY The inne MINILAB...
Page 29 Tracked stages of cervical fluids. See more on how to track cervical FLUID PATTERN fluids on p.66 period sticky creamy runny Summary of tracked symptoms and events. See more on how to log SYMPTOMS AND EVENTS symptoms and events on p.70. The inne MINILAB...
Page 30: Testing Window And Timer
APP showing how much time is left to perform the as 'important measurements' in the APP ② test. The timer can be started while the testing for the algorithm to be able to detect window is open. your ovulation. The inne MINILAB...
Page 31: Important Measurements
1h and 23min ② On days that are not important we show you when the next important measurement is. START COLLECTION TIMER PROGESTERONE MEASUREMENT No Measurement Needed Your next important measurement is on March 12th The inne MINILAB...
Page 32: General Principles Of The Test
CONTROL PROCEDURE luteal phase of the menstrual cycle. When a sustained The inne MINILAB does not require the user to do elevation in the salivary progesterone is measurable any additional controls or use calibrators to assure between the follicular and luteal phases for at least 3 the accuracy of the test.
Page 33: Biological Reference Range
1994 Feb 18;709:287-98. Review. No abstract available. 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 . The inne MINILAB...
Page 34: Performance Characteristics
2. The inne MINILAB - Performance characteristics DYNAMIC RANGE The range of the assay is 100.5 – 1450 pg/mL ANALYTICAL SPECIFICITY From the different substances evaluated for cross- reactivity and interference, Caffeine and Ethanol have been identified as possible interferents.
Page 36: Download The Inne App And Create An Inne Account
3. 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 on your iPhone. Follow the on-screen instructions to sign in with your existing inne account or create a new inne account.
Page 37 When launching the inne APP for the first time, it is possible to: ① Log in Click 'log in' to log in with your existing inne account ② Get started Click 'get started' and follow the on- screen instructions to create a new inne account.
Page 38: Pair And Link Your Inne Reader
PAIR AND LINK YOUR INNE READER In order to use the inne APP, the inne READER must be paired with an iPhone and linked with an inne account. The inne READER is designed for a single user's use and therefore can only be linked to one account at a time.
Page 39 Long press (3 seconds) the button on Once pairing is complete the inne READER the inne READER until the UI light starts will automatically be linked to the inne blinking blue. Tap 'connect reader' to account. establish a connection between the iPhone and the inne READER.
Page 40: Setup Wi-Fi
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 and notifications to your inne APP even when you are not in proximity to the device.
Page 41 The inne READER is searching for a Select the Wi-Fi you want the inne compatible Wi-Fi. READER to pair with and fill in the Wi-Fi IMPORTANT: The inne READER can only password. connect to secure Wi-Fi networks which work on 2.4 GHz (not to open hotspots) Setup...
Page 42 A Wi-Fi has been successfully set up for the inne READER. Setup...
Page 43 Setup...
Page 44: Add Wi-Fi
ADD WI-FI The inne READER can be setup with several Wi-Fi networks. To add an additional Wi-Fi, go to the 'settings' -> 'wi-fi'-> 'add wi-fi connection for reader'. ① Go to the ‘settings’ tab of the inne APP ② and click on ‘wi-fi’ Setup...
Page 45 3 SEC PRESS continue add wi-ﬁ connection for reader ③ ④ Tap ‘add wi-fi connection for reader Long press the button on your inne READER until ⑤ ⑥ the UI light is blinking yellow . Tap ‘continue' and follow the on-screen instructions. Setup...
Page 46: Set Up Your Daily Alarm Within The Testing Window
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.
Page 47 To set the daily alarm, go to the settings ① tab, turn on the daily notification ② select the preferred notification time Setup...
Page 48: Fertility Monitoring
4. Fertility monitoring - Daily progesterone test The inne MINILAB requires a daily saliva test to RULES understand the progesterone level in the body. In order to record accurate progesterone levels, it is In order to guarantee accurate results, the inne...
Page 49: Daily Alarm
DAILY ALARM FOUR STEPS OF THE DAILY PROGESTERONE TEST You will receive the daily alarm by the inne APP, In order to make it easy to remember the process of within the set 4-hour testing window when it is time daily testing, we have divided them into the following for the test.
Page 50: Collect
COLLECT In order to collect a saliva sample accurately with an inne STRIP, please follow these steps: Take a new inne STRIP Start the timer Make sure the pouch is intact before Use the timer in the inne APP to collect using the inne STRIP, then tear the pouch saliva for 30 seconds or more if needed.
Page 51 Collect saliva Check collected sample Place the collector in your mouth and move Make sure the collector pad is fully it freely over your tongue until the pad is soaked after taking it out of the mouth. fully soaked. CAUTION Make sure to not bite or suck CAUTION Make sure there is no blood the collector.
Page 52 ACTIVATE The inne STRIP must be activated after saliva collection in order to develop a test result. Start here Open Lid To open the lid locate the inne symbol on Grab the front of the lid to pull it open as the strip.
Page 53: Activate
Fold Activate Use the handle to fold in the collector as Close the lid again and press until it seen below: ’clicks', indicating that the inne STRIP is activated. CAUTION The inne STRIP needs to be inserted into the inne READER right after activation.
Page 54: Measure
MEASURE Insert the activated inne STRIP into the inne READER to start measurement of the collected sample. Start Reading Reading automatically starts when an inne STRIP is inserted into the inne READER as shown below TIP Make sure to insert the window CAUTION The inne STRIP needs to be side of the inne STRIP first as shown inserted into the inne READER right...
Page 55 Reading in progress Reading successful The white pulsating UI light indicates the When the measurement is done, the UI reading is in process. 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.
Page 56: Review
REVIEW Receive Results Review the results on home screen ① Launch the inne APP by clicking on the Today's progesterone reading shown on the graph. ② notification on your iPhone informing Explanation of today's progesterone measurement. ③ about a successful reading. Today's 'fertility status', taking today's reading into account.
Page 57: Discard Used Inne Strip
DISCARD USED INNE STRIP The inne STRIPS are made for single-use only. After the measurement has been done, the inne STRIP can be removed from the inne READER and discarded in the residual waste. Fertility mornitoring...
Page 58: Interpret Progesterone Results
4. Fertility monitoring - Interpret progesterone results ① The measurement results are charted in the graph on the `lab' tab showing the daily changes in progesterone levels throughout the cycle. ② The progesterone interpretation provides information about the progesterone trend and the occurrence of ovulation.
Page 59 The behavior of progesterone throughout the menstrual cycle is displayed below in a simplified graph. falling 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...
Page 60: Start A New Cycle
4. Fertility monitoring - Cycle 9 41 START A NEW CYCLE Set the start of a new cycle for each menstrual cycle. Do this on day 1, which is the first day of your period. The first day of your period is the first day of blood flow –...
Page 61 ② ④ Select ‘period’ in the fluid menu Confirm by tapping on ‘start new cycle’ ③ click 'save selection' Fertility mornitoring...
Page 62 Past Cycles You have a low chance of pregnancy today CERVICAL FLUIDS EDIT Period Be aware that bleeding can cover your cervical ﬂuid. SET GOAL There’s an app update available Update to get the latest features and ﬁxes A new cycle has been started. Fertility mornitoring...
Page 63: If You Forget To Start A New Cycle
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 your fertility calculation. Not tracking a new cycle will result in inaccurate fertility information.
Page 64: Past Cycles
You have a low chance of pregnancy today VIEW AND ADD PAST CYCLES ② Current and past cycles recorded with the inne MINILAB ③ Past cycles input by you, the user EDIT ④ Add missing cycle: Tap 'add a missing past cycle' ⑤...
Page 65 EDIT AND DELETE PAST CYCLES ⑥ → Change start date of past cycle: Tap 'edit period dates' to change past period dates within the calendar view. ⑦ → Delete cycle : Swipe the cycle to the left to see the option 'delete' as shown below.
Page 66: Tracking Cervical Fluid
4. Fertility monitoring - Tracking cervical fluids Tracking cervical fluids is an additional parameter for fertility monitoring with the inne MINILAB. Cervical fluids provide information about where you are at in your menstrual cycle and inform how long sperm will survive in your vagina.
Page 67: Cervical Fluid In The Inne Minilab
CERVICAL FLUID IN THE INNE MINILAB The inne MINILAB allows to track four different Additional to the cervical fluid visuals the inne APP cervical fluid states (dry, sticky, creamy and runny) uses icons to represent the fluid pattern in the graph.
Page 68 HOW TO TRACK CERVICAL FLUIDS IN THE INNE Once you have classified your cervical fluids you can track them on the 'cervical fluids tab' on the ‘lab’ screen of your inne APP. STEPS ① Tap on the ‘log fluids’ button ②...
Page 69 EDIT period There’s an app update available SET GOAL Update to get the latest features and ﬁxes Fertility mornitoring...
Page 70: Additional Features
4. Fertility monitoring - Additional features SYMPTOMS AND EVENTS With the inne APP, it is possible to track different symptoms and events which are relevant when monitoring fertility. There’s an app update available SET GOAL Update to get the latest features and ﬁxes Click on the ‘track symptoms &...
Page 71 events There’s an app update available SET GOAL Update to get the latest features and ﬁxes ③ Tap to select the symptoms or events to Selected items will appear on the day ② track and tap 'done'. view under the 'symptoms & events' tab Fertility mornitoring...
Page 72: Maintenance
5. Maintenance - Troubleshooting The troubleshooting guide in this chapter is I HAVE MISSED MY 4-HOUR TESTING WINDOW applicable to both the inne READER and the inne If you have missed taking your reading within APP. the 4-hour testing window, you cannot take a The described troubleshooting is only for problems measurement for that day.
Page 73: My Inne Reader Is Showing A Red Ui Light
MY INNE READER IS SHOWING A RED UI LIGHT STEPS: Repeat the test with a new inne STRIP to get the daily progesterone RED STATIC LIGHT reading. Follow the steps outlined in p.48 If the inne READER shows a solid red UI light, it means the device has encountered an error.
Page 74: My Readings Have Not Synchronised With My Inne App
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 iPhone.
Page 75: Inne Reader 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 AppStore. INNE READER SOFTWARE If a software update for the inne READER is available, it will be shown through a notification in the inne APP.
Page 76: General Information
5. Maintenance - General Information conditions. In the event that Feral decides to provide READER REPAIR a replacement, any replacement will not extend the Your inne READER contains no user-serviceable life of this warranty. parts. Don’t attempt to open or disassemble your...
Page 77: Regional Disposal And Recycling Information
IEC 61010-1:2010 accordance with local environmental laws and IEC 61010-1-2010/AMD1:2016 guidelines. IEC 61010-2-101:2018 ISO 18113-1:2009 © 2021 Feral GmbH. No part of this work may be ISO 18113-4:2009 reproduced, modified, distributed, or otherwise used ISO 18113-5:2009 without prior written permission. Maintenance...
Page 78: Legend
LEGEND MANUFACTURER DETAILS Designed and manufactured by Consult the SYSTEM MANUAL for Feral GmbH important information such as Skalitzerstrasse 85-86, TR B warnings and precautions 10997, Berlin GERMANY Do not use if package is damaged Batch code 0483 Do not reuse...
Page 79 Maintenance...

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