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Feral inne MINILAB System Manual Download Page 77

Maintenance

77

REGIONAL DISPOSAL 
AND RECYCLING INFORMATION

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.
© 2021 Feral GmbH. No part of this work may be 
reproduced, modified, distributed, or otherwise used 
without prior written permission.

REGULATORY COMPLIANCE INFORMATION

This system was developed in compliance with the 
following standards:

ISO 13485:2016

IVD Directive 98/79/EC (IVDD)

ISO 14971:2007

IEC 62366-1:2015

IEC 62304:2006+A1:2015

IEC 61010-1:2010

IEC 61010-1-2010/AMD1:2016

IEC 61010-2-101:2018

ISO 18113-1:2009

ISO 18113-4:2009

ISO 18113-5:2009

Summary of Contents for inne MINILAB

Page 1: ...SYSTEM MANUAL 4 0 ...

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Page 4: ...nal equipment required Component names and functions inne READER Important information about the inne READER inne STRIP Storage and stability of the inne STRIP inne APP The Lab Resources Settings The Lab in detail Fertility Status The Drawer The Graph Testing Window and Timer Important measurements General principles of the test Test procedure Control procedure Biological reference range 6 7 7 8 1...

Page 5: ...etails Bibliographical Reference Performance characteristics Dynamic range Analytical specificity Reproducibility SET UP PROCESS Download the inne APP and create an inne account Pair and link your inne READER Set up Wi Fi Add Wi Fi Set up your daily alarm within the testing window FERTILITY MONITORING Daily progesterone test Rules Daily alarm Collect Activate Measure Review Discard used inne STRIP...

Page 6: ... 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 ...

Page 7: ... 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 ...

Page 8: ...tus on your 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 ind...

Page 9: ...9 inne STRIPS Pack of 8 for collecting and analysing your saliva sample one inne STRIP per day Introduction inne APP for viewing your data measured by the inne READER and your fertility status ...

Page 10: ...we recommend observing cervical fluid as a secondary sign of fertility The primary function of the cervical fluid is to support and transport sperm as you approach ovulation Around ovulation the cervix will release large amounts of runny and stretchy fluid that assists sperm to fertilize the egg Once ovulation has taken place your fluids will reduce in quantity until the next cycle begins More inf...

Page 11: ...MENSTRUAL PHASES PROGESTERONE LEVEL CHANCE OF PREGNANCY CERVICAL FLUIDS Introduction 11 ...

Page 12: ...enstrual cycle this would be mentioned in the patient information leaflet of the treatment You suffer from polycystic ovarian syndrome or endometriosis You must avoid pregnancy at all costs You are currently or have recently been pregnant until after the third consecutive period even if the pregnancy was not carried to term You are breastfeeding or have recently breastfed You have had or have meno...

Page 13: ...om the pouch Pay attention to collection time and procedure of activation of the inne STRIP The inne STRIP cannot be used if blood is detected on the inne STRIP as it interferes with the result The inne STRIP is for single use only and cannot be reused The inne STRIPs can only be read by the inne READER The inne reader does only work with original inne STRIPs Test results may vary for different in...

Page 14: ...e following components If something is missing please contact Feral GmbH inne READER Charge Kit SYSTEM MANUAL Quick Guide COMPONENTS OF THE STRIPS BOX The inne STRIP box includes the following components If something is missing please contact Feral GmbH 8x inne STRIP in single pouches How to use instructions ...

Page 15: ...or later 2 4 GHz Wi Fi in order to perform reader software updates Please download the free inne APP latest software version from the Apple App Store ADDITIONAL EQUIPMENT REQUIRED In order to install the inne APP and connect to the inne READER ...

Page 16: ...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 ...

Page 17: ...luetooth connected The inne READER has established a Bluetooth connection to the inne APP Setup mode searching for connection The inne READER is trying to establish a connection to the inne APP Setup mode connected The inne READER has established a connection to the inne APP To exit from this mode wait until the light has turned off Setup mode inne READER software update in progress Do not press t...

Page 18: ...ging battery level critically low below 10 wait until battery light turns yellow above 10 to measure an inne STRIP Setup mode start the following actions from the inne APP unlink the inne READER from the inne account by following the on screen instructions in the inne APP update the inne READER software by following the on screen instructions in the inne APP Reset inne READER will revert to factor...

Page 19: ...indoor use only 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 Inout 4 75 V 5 25 V max 4w inne READER dimensions Height 67mm Width 38mm Lenght 68mm Weight 86g ...

Page 20: ... 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 LID WINDOW WINDOW SIDE ...

Page 21: ...of the inne STRIP marks the side which goes into the inne READER Open the lid before folding in the collector and close it back afterwards to activate the inne STRIP See more details in p 53 Activate Make sure the inne STRIP window is clean and is never covered by anything Only insert activated inne STRIP inside the inne READER S ee more details on p 54 Measure Collector Handle Lid Window Window s...

Page 22: ... and fixes 14 4 The inne MINILAB 22 INNE APP The inne APP is structured in three main tabs lab resources and settings LAB Follow the daily testing process View progesterone reading and fertility status Track cervical fluids View the current cycle Access past menstrual cycles ...

Page 23: ...ional content about fertility monitoring Access information on how to use the inne MINILAB and FAQs Contact the inne support team SETTINGS Information and maintenance of your inne READER Set alarm and testing window Access account details and legal information ...

Page 24: ...e latest features and fixes 14 4 PROGESTERONE MEASUREMENT TAB P 58 The inne MINILAB 24 THE LAB TAB IN DETAIL DAY VIEW CYCLE DAY AND DATE THE FERTILITY STATUS P 25 CERVICAL FLUIDS TAB P 66 SYMPTOMS AND EVENTS TAB P 70 THE DRAWER P 26 THE GRAPH P 28 CYCLE VIEW ...

Page 25: ... for today you have a low chance of pregnancy for 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 Access past cycles by swiping all the way to the left on the cycle view Access past and future days of the cycle by swiping o...

Page 26: ...DRAWER Drag the drawer down to minimise it and see the extended graph in the cycle view Access more information about the current cycle by dragging the drawer up Swipe up or down to see all information available in the drawer ...

Page 27: ...here s an app update available Update to get the latest features and fixes The inne MINILAB 27 INFORMATION ABOUT PROGESTERONE MEASUREMENTS TODAYS FERTILITY STATUS INFORMATION ABOUT TRACKED FLUIDS INFORMATION ABOUT SYMPTOMS AND EVENTS RECOMMENDATIONS FOR YOUR GOAL UPCOMING CYCLE EVENTS ...

Page 28: ... 18 17 16 15 The inne MINILAB 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 FLUID PATTERN SYMPTOMS AND EVENTS NO DATA LOW CHANCE OF PREGNANCY HIGH CHANCE OF PREGNANCY ...

Page 29: ...on is displayed once it has been confirmed based on the progesterone trend Predicted ovulation is displayed based on data from your previous cycles Tracked stages of cervical fluids See more on how to track cervical fluids on p 66 Summary of tracked symptoms and events See more on how to log symptoms and events on p 70 CYCLE DAYS CONFIRMED OVULATION PREDICTED OVULATION PROGESTERONE LEVEL FLUID PAT...

Page 30: ...ogesterone test should be done during the same 4 hour testing window which can be set between 5 00 am 2 00 pm see more information on page 46 The window will be displayed while open and until a successful reading has been done The timer can be used to ensure that the saliva sample is collected for 30 seconds see page 50 WARNING measurements taken outside the 4 hour window are not recorded by the i...

Page 31: ...surement is on March 12th PROGESTERONE MEASUREMENT The inne MINILAB 31 On days that are not important we show you when the next important measurement is On Important Days we will show you why we need a measurement on that day IMPORTANT MEASUREMENTS The inne app displays important measurements as an orange symbol on the progesterone measurement tab on days where they are essential to help pinpoint ...

Page 32: ...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 46 Upon sample collection and strip activation the saliva fluid migrates through the capillary bed and initiates the reaction The test result is displayed by a T...

Page 33: ...estigating 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...

Page 34: ...rence 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 48 mitigates the possible interference of caffeine and ethanol REPRODUCIBILITY The variability between production lots is estimated above 20 so it is important to use inne STRIPS from the same lot througho...

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Page 36: ... App Store on your iPhone Follow the on screen instructions to sign in with your existing inne account or create a new inne account The inne APP on the Apple App Store TIP Open the Camera app on your iPhone 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 ...

Page 37: ...en instructions to create a new inne account For the account creation you need to enter the following information and set a password First and last name E mail Date of birth Click log in to log in with your existing inne account When launching the inne APP for the first time it is possible to ...

Page 38: ...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 After setting up an account the inne APP will automatically lead to the following steps ...

Page 39: ...e inne READER will automatically be linked to the inne account Long press 3 seconds the button on the inne READER until the UI light starts blinking blue Tap connect reader to establish a connection between the iPhone and the inne READER ...

Page 40: ...low the inne READER to send readings and notifications 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 We recommend to set up the Wi Fi during the set up process of your inne READER Setup a Wi Fi connection for the inne READER after successfully pairing it with the inne account Tap set up Wi Fi to start ...

Page 41: ...searching for a compatible Wi Fi IMPORTANT The inne READER can only connect to secure Wi Fi networks which work on 2 4 GHz not to open hotspots Select the Wi Fi you want the inne READER to pair with and fill in the Wi Fi password ...

Page 42: ...Setup 42 A Wi Fi has been successfully set up for the inne READER ...

Page 43: ...Setup 43 ...

Page 44: ...Setup 44 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 Go to the settings tab of the inne APP and click on wi fi ...

Page 45: ...wi fi connection for reader 3 SEC PRESS Setup 45 Tap add wi fi connection for reader Long press the button on your inne READER until the UI light is blinking yellow Tap continue and follow the on screen instructions ...

Page 46: ...ful reading which is made within the testing window More information about daily use of the testing window can be found on page 30 For ease of use we recommend using the daily alarm as a reminder The daily alarm and the testing window are set up during the sign up process In addition the daily alarm can be modified in the settings tab WARNING measurements taken outside the 4 hour window are not re...

Page 47: ...11 10 9 8 7 6 5 Setup 47 To set the daily alarm go to the settings tab turn on the daily notification and select the preferred notification time ...

Page 48: ... 4 hour testing window every day 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 rin...

Page 49: ...w when it is time for the test Click on the alarm to launch the inne APP on the iPhone FOUR STEPS OF THE DAILY PROGESTERONE TEST In order to make it easy to remember the process of daily testing we have divided them into the following consecutive steps Each step will be explained in detail COLLECT ACTIVATE MEASURE REVIEW ...

Page 50: ...while the testing window is open Start the timer Use the timer in the inne APP to collect saliva for 30 seconds or more if needed COLLECT In order to collect a saliva sample accurately with an inne STRIP please follow these steps CAUTION If the pouch is damaged this inne STRIP cannot be used Please take another one Take a new inne STRIP Make sure the pouch is intact before using the inne STRIP the...

Page 51: ...ctor pad Check collected sample Make sure the collector pad is fully soaked after taking it out of the mouth CAUTION Make sure to not bite or suck the collector Collect saliva Place the collector in your mouth and move it freely over your tongue until the pad is fully soaked ...

Page 52: ...aliva collection in order to develop a test result Open Lid Grab the front of the lid to pull it open as shown below Start here To open the lid locate the inne symbol on the strip CAUTION Make sure not to touch the collector pad with your fingers during the activation process ...

Page 53: ...ne STRIP needs to be inserted into the inne READER right after activation See p 54 Activate Close the lid again and press until it clicks indicating that the inne STRIP is activated Fold Use the handle to fold in the collector as seen below ...

Page 54: ...to insert the window side of the inne STRIP first as shown and check that nothing is covering the strip window CAUTION The inne STRIP needs to be inserted into the inne READER right after it has been activated to ensure accurate results Start Reading Reading automatically starts when an inne STRIP is inserted into the inne READER as shown below ...

Page 55: ...e inne STRIP out of the inne READER while the measurement is in progress 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 Reading in progress The white pulsating UI light indicates the reading is in process ...

Page 56: ...ing 56 REVIEW Review the results on home screen Today s progesterone reading shown on the graph Explanation of today s progesterone measurement Today s fertility status taking today s reading into account Receive Results Launch the inne APP by clicking on the notification on your iPhone informing about a successful reading ...

Page 57: ...ty mornitoring 57 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 ...

Page 58: ...lts are charted in the graph on the lab tab 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 4 Fertility monitoring Interpret progesterone results ...

Page 59: ... graph Low Rising High Falling Progesterone level is low in the follicular phase and stays low until ovulation occurs Progesterone rise can be seen right after ovulation and when entering the luteal phase Progesterone level is high during the luteal phase Ovulation has taken place Progesterone level decreases as the cycle ends ...

Page 60: ...d fixes 4 9 41 Fertility mornitoring 60 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 spotting should not be logged as period Click on log fluids on the day the cycle has started 4 Fertility monitoring Cycle ...

Page 61: ...Fertility mornitoring 61 Select period in the fluid menu and click save selection Confirm by tapping on start new cycle ...

Page 62: ...our cervical fluid CERVICAL FLUIDS EDIT You have a low chance of pregnancy today SET GOAL There s an app update available Update to get the latest features and fixes 1 2 3 4 3 4 Past Cycles Fertility mornitoring 62 A new cycle has been started ...

Page 63: ...ws you to select and confirm the start date of a new cycle STEPS Set the correct start date Click start new cycle to confirm 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: ...cles which have been manually put in and the ones which are recorded while using the inne MINILAB GO TO YOUR CYCLES Scroll to the left of your current cycle on the graph and tap on past cycles OR tap the calendar to view and add past cycles VIEW AND ADD PAST CYCLES Current and past cycles recorded with the inne MINILAB Past cycles input by you the user Add missing cycle Tap add a missing past cycl...

Page 65: ...AY 16 DELETE Fertility mornitoring 65 EDIT AND DELETE PAST CYCLES Change start date of past cycle Tap edit period dates to change past period dates within the calendar view Delete cycle Swipe the cycle to the left to see the option delete as shown below When pressing delete the cycle will be removed and the days of this cycle will be added to the previous cycle Your measurements will not be lost ...

Page 66: ...long sperm will survive in your vagina HOW TO OBSERVE AND CLASSIFY CERVICAL FLUIDS The inne APP contains instructions on three different methods on how to observe and classify cervical fluids 1 The toilet paper method 2 The insertion method 3 The touch method Read these instructions in the inne APP by going to the resources tab fertility monitoring and open tracking fluids 4 Fertility monitoring T...

Page 67: ... four different cervical fluid states dry sticky creamy and runny spotting period bleeding and abnormal fluid DRY ABNORMAL STICKY SPOTTING CREAMY PERIOD RUNNY Additional to the cervical fluid visuals the inne APP uses icons to represent the fluid pattern in the graph icons as in the cycle view ...

Page 68: ...ssified your cervical fluids you can track them on the cervical fluids tab on the lab screen of your inne APP STEPS Tap on the log fluids button Select the cervical fluid you have observed TIP The short description underneath the fluid visual will help you to make sure you are selecting the right one Tap save selection The cervical fluid will be shown on the day view under the fluids tab ...

Page 69: ...period 4 EDIT SET GOAL There s an app update available Update to get the latest features and fixes 4 Fertility mornitoring 69 ...

Page 70: ...nd fixes 1 2 4 Fertility mornitoring 70 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 Click on the track symptoms events button on the day view ...

Page 71: ... app update available Update to get the latest features and fixes 1 2 4 Fertility mornitoring 71 Tap to select the symptoms or events to track and tap done Selected items will appear on the day view under the symptoms events tab ...

Page 72: ...edure to be performed by you the user 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 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 I HAVE FORGOTTEN TO ACTIVATE THE INNE STRIP BEFORE STARTING A READING If...

Page 73: ... BATTERY LIGHT Battery level is too low to take a measurement STEPS Connect the inne READER to a charger and wait till the battery light changes from red to yellow Then take a new inne STRIP and repeat the progesterone measurement YELLOW GREEN BATTERY LIGHT Battery level is sufficient to do a reading Problem with the collected sample or the inne STRIP STEPS Repeat the test with a new inne STRIP to...

Page 74: ...ke sure the iPhone is within reach that Bluetooth connection is enabled and the inne APP is launched when pressing the button on the inne READER The inne READER sends the results automatically via Wi Fi or 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 memo...

Page 75: ...READER go to the settings tab and tap on about the reader What is needed to update the inne READER software The inne APP on your iPhone with connection to the internet The inne READER with connection to an active Wi FI The inne READER sufficiently charged or connected to a charging point To update the inne READER software when an update is available click on update and follow the on screen instruc...

Page 76: ...o high temperatures or liquids Disassembling your inne READER may damage it or cause injury to you 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 Gmb...

Page 77: ...ironmental laws and guidelines 2021 Feral GmbH No part of this work may be reproduced modified distributed or otherwise used without prior written permission REGULATORY COMPLIANCE INFORMATION This system was developed in compliance with the following standards ISO 13485 2016 IVD Directive 98 79 EC IVDD ISO 14971 2007 IEC 62366 1 2015 IEC 62304 2006 A1 2015 IEC 61010 1 2010 IEC 61010 1 2010 AMD1 20...

Page 78: ...arnings and precautions Do not use if package is damaged Do not reuse Temperature limit to which the inne STRIP can be safely exposed In vitro diagnostic Medical device MANUFACTURER DETAILS Designed and manufactured by Feral GmbH Skalitzerstrasse 85 86 TR B 10997 Berlin GERMANY Batch code ...

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