LENIRE Tinnitus User manual

IFU-0026 V2.0
Neuromod Devices Ltd., Rainsford St., Dublin, D08 R2YP, Ireland.
www.neuromoddevices.com
DE
FR
IT
NL
Lenire-Tinnitus-Behandlungsystem. Benutzerhandbuch
Manuel de l’utilisateur Système de traitement des acouphènes
Lenire Manuale d’uso Lenire Tinnitus Treatment System
Lenire Tinnitus Behandelingssysteem. Gebruikershandleiding
Lenire Tinnitus Treatment System. User Manual

IFU-0026 Lenire User Manual Version 2.0
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English page 2
Deutsch Seite 28
Français page 54
Italiano pagina 80
Nederlands bladzijde 106
Using this manual
This manual is supplied with the Lenire device to provide you with information on the
product, treatment regime and instructions for its safe and eective use. You should read
and understand these instructions before use.
Verwendung dieses Handbuchs
Diese Anleitung ist im Lieferumfang des Lenire-Systems enthalten. Sie enthält Informationen zu
dem Produkt und zur Behandlung sowie Anweisungen zur sicheren und eektiven Handhabung.
Diese Anweisungen sollten vor Gebrauch gelesen werden.
Utilisation de ce manuel
Le présent manuel contient des informations sur le dispositif Lenire avec lequel il est fourni,
sur le programme de traitement et sur l’utilisation sûre et ecace du produit. Assurez-vous
de lire et de comprendre ce mode d’emploi avant d’utiliser votre produit.
Utilizzo del presente manuale
Il presente manuale viene fornito insieme al dispositivo Lenire e contiene informazioni circa
il prodotto e il regime di trattamento nonché istruzioni per un utilizzo sicuro ed ecace.
Siprega di leggere e comprendere le presenti istruzioni prima dell’uso.
Deze handleiding gebruiken
Deze handleiding wordt bij het Lenire-apparaat meegeleverd om u te voorzien van
informatie over het product, de behandeling en instructies voor een veilig en eectief
gebruik. U moet deze instructies lezen en begrijpen vóór gebruik.

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Table of Contents
Using this Manual 1
Section A - General Information 3
Chapter 1 - Introduction 3
Chapter 2 - Intended Use 3
Chapter 3 - Contraindications 3
Chapter 4 - Risks Associated with Use 3
Chapter 5 - General Warnings 4
Chapter 6 - Product and Package Labelling 5
Section B - Using Lenire 7
Chapter 7 - Product Components & Accessories 7
Chapter 8 - Controls and Indicators 8
Chapter 9 - Controller port 11
Chapter 10 - Charging the Controller and Headphones 11
Chapter 11 - Device Setup 13
Chapter 12 - Tonguetip Setup 14
Chapter 13 - Starting and Controlling a Treatment Session 15
Chapter 14 - Treatment Guidelines 17
Section C - Care, Storage Maintenance and Disposal 18
Chapter 15 - Cleaning 18
Chapter 16 - Storage and Transport 19
Chapter 17 - Maintenance 20
Chapter 18 - Disposal 20
Section D - Troubleshooting 21
Chapter 19 - Frequently Asked Questions 21
Chapter 20 - Bluetooth Pairing / Un-Pairing 23
Chapter 21 - Servicing 24
Chapter 22 - Device Errors 24
Section E - Technical Information 25
Chapter 23 - Environmental Operating Conditions 25
Chapter 24 - Radio Frequency (RF) Specifications 25
Chapter 25 - Guidance and Declaration for Electromagnetic Compatibility 25
Chapter 26 - Materials in Direct Contact with Human Tissue 26
Chapter 27 - Declaration of Conformity Radio Equipment Directive 2014/53/EU 26
Section F - Customer Support Contact Details 27
ENGLISH

IFU-0026 Lenire User Manual Version 2.0
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Section A
General Information
This section outlines the general information relating to the Lenire device,
including important safety information.
Chapter 1 - Introduction
Lenire® is a medical device intended to reduce the symptoms of tinnitus. It comprises a handheld
Controller and a Tonguetip® which, delivers gentle, electrical stimulation to the tongue, and
is used in conjunction with wireless Headphones that deliver audio stimulation. A Charger is
included that can be used to charge both the Controller and the Headphones.
The audio and tongue stimulation are congured and calibrated to your individual characteristics
during the initial tting procedure by a trained clinician.
Chapter 2 - Intended Use
The Lenire device is intended to be used by tinnitus suerers of at least 18 years of age to
alleviate the symptoms of chronic, subjective tinnitus. It should be used for 30 to 60 minutes
per day, every day, for at least 10 weeks, after which you may experience sustained alleviation
of your tinnitus symptoms.
The Lenire device can be used in the home environment after consultation and tting
by a suitably qualied clinician.
Lenire is intended for prescription use only. Use by a person for whom the device has not
been congured may cause discomfort, or temporary exacerbation of tinnitus loudness.
Chapter 3 - Contraindications
• You have a pacemaker, debrillator or any other active implantable device,
unless directed by a doctor.
• You are pregnant, unless directed by a doctor.
• You suer from epilepsy or any other condition that may result in loss of consciousness.
• You suer from any condition that causes impaired sensitivity of the tongue.
• You have lesions, sores, or inammation of the oral cavity, unless directed by a doctor.
• You are suering from any intermittent or chronic neuralgia in the head and neck area.
Chapter 4 - Risks Associated with Use
Potential risks associated with use of the Lenire device include
Caution! – Do not use the device if:
Contact between the Tonguetip and dental retainers or metal fillings may
cause temporary discomfort.

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Chapter 5 - General Warnings
There is a possibility that some people may experience a mild allergic
reaction to the materials in the device.
You may experience a mild numbing sensation or a discomfort on the
tongue during treatment. If this occurs, reduce the tongue stimulation.
If the symptoms persist, contact your clinician.
Use of the treatment may result in mild fluctuations in tinnitus symptoms,
such as tinnitus loudness.
Headaches may accompany use of the treatment device.
Do not use the Tonguetip when going to sleep or under the influence
of alcohol or other substances that cause drowsiness.
Keep the Tonguetip and Charger out of the reach of children, to avoid
possible choking and strangulation hazards.
To avoid the risk of cross-contamination, the Tonguetip should not be
shared with any other person, as it is a single-patient, multi-use device.
Do not use the Tonguetip if you have lesions, sores, or inflammation of the
oral cavity. Discontinue use of the device until symptoms have resolved.
Do not leave the device in the sun, near an open fire or on a radiator.
The use of rechargeable Lithium Ion batteries is very common and they
are generally considered safe to use. With any energy storage device, they
carry safety risks including overheating. Only use the Charger provided
with your device and always follow the instructions in this manual when
charging your Lenire device.
To avoid the risk of a burn do not puncture, crack or crush the Controller.
Do not attempt to replace the Lithium Ion battery in your Lenire device.
Do not use in conjunction with a hearing aid.

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Chapter 6 - Product and Package Labelling
The label on the Controller, the Tonguetip plug, Carry Case and the product packaging provide
important information. The meanings of the associated symbols are described below, and in the
context of the relevant sections throughout this User Manual.
Use-by date (year and month). This is the date after which the device should
no longer be used.
Do not use if the packaging is damaged or previously opened.
Consult the User Manual.
This symbol indicates the need for the user to consult the User Manual
for warnings and precautions associated with this medical device.
Manufacturer’s details (name and address) and date of manufacture
(year and month).
The device’s Serial Number, Model Number and Lot Number appears next to
these symbols. You will need these numbers if you call Customer Support for
assistance. See Section F for the manufacturer’s contact details.
Ingress Protection (IP) Rating: IP ratings describe how eectively an enclosure
is sealed.
IP22 rated equipment is protected from objects greater than 12mm in
diameter being inserted e.g. ngers, and against small amounts of vertically
dripping water.
Non-ionizing radiation.
This symbol appears next to the model number of the Charger which should
be used to charge the Controller.
This symbol signies that the device should not be disposed of as domestic
waste. This ensures compliance with the Battery Directive 2006/66/EC.
The logo for this product range (Lenire).

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This symbol (direct current) identies a charging port.
This symbol represents the Tonguetip.
The USB (Universal Serial Bus) symbol – this is the connection that is used
by the clinician when they congure your device.
This symbol indicates that the Tonguetip provides a high degree of protection
against electric shock (Type BF Applied Part).
Storage and transport temperature limits. The lower limit is indicated near the
lower horizontal line and the upper limit is indicated near the upper line.
Storage and transport humidity limits. The lower limit is indicated near the
lower horizontal line and the upper limit is indicated near the upper line.
Keep dry.
Fragile, handle with care.
This symbol, the CE Mark, signies compliance with applicable EU Directives.
The number (2797) is the Notied Body number for the British Standards
Institute (BSI), who approved Lenire for CE Marking.

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Controller
The Controller (Model Number CR-201) is used to
“control” the treatment session i.e. you can start, pause
and resume the treatment session, adjust the volume of
the sound, adjust the level of the tongue stimulation, and
turn the device on or o.
Tonguetip The Tonguetip (Model Number TP-101) is a device which
provides gentle, electrical stimulation to the tongue.
Charger
The Charger (XP Power model VEP08US05-XE0767
or ACM06US05W-XZ1663A) is used to charge the
Controller.
Carry Case
The Carry Case (Model Number CE-401) is a portable
case which can be used to store the Controller and
Tonguetip in-between uses.
7.1 - Headphones
Lenire must be used in conjunction with a set of Bluetooth Headphones. For best performance,
it is essential that you use the Headphones provided by your clinician at the time of purchase.
For more information and specific instructions on the Headphones supplied with your
Lenire Device, please visit www.lenire.com/product-support and download the Lenire
Headphone Handbook. A printed version can be requested by contacting Customer
Support (see Section F for details).
The Lenire device box also contains a Quick Start Guide which outlines
the basic steps needed to commence a treatment session.
Lenire is designed to work only with the Headphones listed
in the Lenire Headphone Handbook which can be found at
www.lenire.com/product-support.
Chapter 7 - Product Components & Accessories
In the Lenire device box, you will nd:
Section B
Using Lenire
This section describes the components, controls and indicators of Lenire
and outlines the steps required to prepare for and commence treatment.

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7.2 - Batteries
The Controller is powered by a 3.7V Lithium Ion battery. The battery is charged using the
supplied Charger. The Controller battery is pre-tted and is not intended to be replaced.
See Chapter 10 for instructions on charging the Controller and Headphones.
If there are any diculties charging the Controller or the Headphones, see the section on
Troubleshooting (see Section D) or contact Customer Support (see Section F).
Chapter 8 - Controls and Indicators
8.1 - Treatment Controls
There are three control buttons on the front of the Controller:
1. Power Button
Hold this button for 2 seconds to switch the device on.
Hold this button for 2 seconds to switch the device o.
2. Play Button
Press this button to start or resume the treatment session.
3. Pause Button
Press this button to pause the treatment session.
Play Button Power Button Pause Button
8.2 - Indicators
The status of the device is indicated by several lights surrounding the buttons on the top
of the Controller.
Battery Indicator
Headphone Indicator
Tonguetip Indicator
Treatment Indicator

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Battery Indicator
Green The battery power is ok.
Orange The battery has less than 1 hour of power remaining. Please charge
the device before next use (see Chapter 10).
Red The battery is exhausted. The device will shut o automatically. Please
charge the device before next use (see Chapter 10).
Orange (Pulsing) The Charger is connected and the battery is charging.
Green (Pulsing) The Charger is connected and the battery is fully charged.
Headphones Indicator
Blue (Pulsing) The Controller is trying to establish a wireless connection to the
Headphones.
Green The Controller is connected wirelessly to the Headphones.
Blue
(Pulsing Rapidly)
The Controller is attempting to pair with the Headphones, see Chapter 20
for details.
Orange
(Pulsing Rapidly) The Controller is not congured for the connected Headphones.
Tonguetip Indicator
Blue (Pulsing) There is no Tonguetip connected.
Green (Pulsing) The Tonguetip is connected but it is not in contact with the tongue.
Green The Tonguetip is connected and it is in contact with the tongue.
Orange or Orange
(Pulsing)
The Tonguetip has less than 10 hours of use remaining before expiry.
Please purchase a new Tonguetip to avoid disruption to your treatment
regime.
Red The Tonguetip has expired. Please purchase a new Tonguetip to continue
treatment.
Treatment Indicator
White (Pulsing) The treatment session is paused.
White (Animated) The treatment session is active – the white light rotates around the
buttons.
Green (Pulsing) The treatment session has completed.
When the device is powered o, none of the lights will be illuminated.

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8.3 - Headphones Volume and Tonguetip Stimulation Controls
Headphones Volume Control
The Headphones volume can be adjusted to
a comfortable level by pressing the buttons
indicated below. Please see Chapter 13.3 for
guidelines on setting the volume level.
Indication of default (optimum) Tonguetip
stimulation intensity
Indication of default (optimum)
Headphones volume level
Indication of maximum Tonguetip
stimulation intensity
Indication of maximum
Headphones volume level
Indication of minimum Tonguetip
stimulation intensity
Indication of minimum
Headphones volume level
Tonguetip Stimulation Control
The Tonguetip stimulation intensity can be
adjusted to a comfortable level by pressing the
buttons indicated below. Please see Chapter
13.3 for guidelines on setting the stimulation
intensity.

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The Headphones volume and Tonguetip stimulation are calibrated to the
optimum levels during device fitting by the clinician. For further details,
please see Chapter 13.3.
Controller port
This symbol (direct current) identies a charging port.
This symbol represents the Tonguetip.
The USB symbol – this is the connection that is used by the clinician when
they congure your device.
This symbol indicates that the Tonguetip provides a high degree of protection
against electric shock.
The Tonguetip and the supplied Charger are the only equipment that should
ever be plugged into the Controller port.
Chapter 10 - Charging the Controller and Headphones
Before Lenire is used for the rst time, it is recommended that the Controller and the
Headphones be fully charged.
Only use the supplied Charger with the Lenire device.
To avoid the risk of electric shock, do not connect or disconnect the
Charger from the mains if it, or your hands, are wet.
Chapter 9 - Controller port
The Controller port is used to connect the Tonguetip
and the Charger to the Controller. For safety, the
Tonguetip and the Charger cannot be connected to
the Controller at the same time.
The following symbols are adjacent to the
Controller port:

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While charging, the Battery Indicator will pulse orange. Once the battery is fully charged, the
Battery Indicator will pulse green.
10.2 - Charging the Headphones
For details on your specic Headphones, please see the Lenire Headphone Handbook
at www.lenire.com/product-support.
An empty battery should take no more than 3 hours to fully recharge, and
a full charge should allow the Lenire device to be used for at least 8 hours.
Once the battery is fully charged, the Charger should be disconnected
to help conserve the life of the battery in the Controller.
10.1 - Charging the Controller
To charge the Controller:
• Plug the cable end of the supplied Charger into
the Controller port of the Controller.
• Plug the Charger into a mains electrical socket.
The supplied Charger may be used to charge both the Controller and the
Headphones.

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Chapter 11 - Device Setup
To commence a treatment session, the Lenire device should be set up as follows:
11.1 - Controller and Headphones Setup
The Headphones should be worn so they cover both ears and should be adjusted to maximise
comfort before commencing the treatment session.
It is essential that the left and right earphones cover the left and right ears,
respectively. This is because the device calibration is unique to each ear – it
is based on your audiogram. Failure to put on the Headphones correctly
could result in excessive loudness in one ear, which could cause discomfort,
or incorrect loudness that may reduce the eectiveness of the treatment.
The Headphones supplied to you at the time of purchase will include
markings to distinguish the left and right earcups. For details on your specific
Headphones, please see the Lenire Headphones Handbook which can be
found at www.lenire.com/product-support.
The above instruction assumes that the Headphones are already ‘paired’ with
the Controller. This should be the case in most situations, as the clinician will
have paired the Headphones during the device fitting. If they are not paired,
or if you are having diculty connecting to the Headphones, then you should
follow the instructions in Chapter 20.
During treatment, the Controller can be kept adjacent to you, e.g. in a pocket
or a bag, or in another dry location that is close by, e.g. on a bedside table.
11.2 - Connecting the Headphones with the Controller
The Controller connects to the Headphones wirelessly via Bluetooth by following these steps:
• Turn on the Controller, by pressing the Power Button for two seconds. The Controller will
attempt to connect to the Headphones during which time the Headphones Indicator will
pulse blue.
• Turn the Headphones on (see Lenire Headphone Handbook at www.lenire.com/product-
support for headphone specic details).
• Once the connection to the Headphones has been established, the Headphones Indicator
on the Controller will illuminate green.

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If the packaging is damaged, the Tonguetip should not be used and it should
be returned to the point of sale.
Before connecting and using the Tonguetip for the first time, it should be
cleaned as per the instructions in Chapter 15.
Chapter 12 - Tonguetip Setup
The Tonguetip is supplied within a protective pouch (made of clear lm, designed to be peeled
open in the area closest to the V shaped seal).
The Tonguetip must be connected to the
Controller by plugging it into the Controller port,
such that the label side of the plug faces away
when viewed from the front of the Controller. Tonguetip Plug
Once connected, the Tonguetip Indicator should change from pulsing blue to pulsing green.
The Tonguetip should be placed in your mouth, just behind your upper front teeth (on the top
of the tongue towards the front of the mouth) with the electrodes facing down.
As you close your mouth, the electrodes should make contact with the tip of your tongue and
rest there comfortably.
Once adequate contact is made with the tongue, the Tonguetip Indicator should stop pulsing
(it should illuminate green without pulsing).
For maximum comfort, the mouth and jaw should remain closed but relaxed for the duration
of the treatment session.
To avoid the risk of electrical shock or burns, do not connect the Controller or
Tonguetip to any equipment other than those specified in this User Manual.
The Tonguetip model TP-101 is designed to function for 360 treatment
sessions (180 hours) before expiring. Indications of imminent expiry and
actual expiry are outlined in Chapter 8.2.

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Chapter 13 - Starting and Controlling a Treatment Session
13.1 - Starting a Treatment Session
As soon as the Headphones and the Tonguetip are connected, which will be indicated by the
Headphones Indicator and the Tonguetip Indicator illuminating green, you are ready to start
a treatment session.
Headphone Indicator
Battery Indicator
Tonguetip Indicator
Treatment Indicator
Pause Button
Play Button
Once you are in a comfortable position, press the Play Button to commence the treatment.
The Treatment Indicator (white) will rotate around the display.
A single treatment session lasts approximately 30 minutes from the time the Play Button
is pressed.
Towards the end of the treatment session, the sound will gradually fade out over a period
of 2 minutes to a lower volume level.
It is essential that you continue to listen to the sound during the fade out
period, i.e. until the treatment session is complete.
Once the treatment session is complete, the Treatment Indicator will pulse green.
The Controller will power o automatically after 20 minutes of being idle (no
treatment session in progress).

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The duration of treatment during a session will remain at 30 active minutes
of stimulation. For example, if the treatment is paused for 5 minutes, the total
duration of the session would be 35 minutes.
13.2 - Pausing and Resuming a Treatment Session
It is recommended to complete each treatment in a single, continuous 30-minute session
to maximise the eectiveness of the treatment.
However, the treatment session can be paused at any time by pressing the Pause Button.
The Treatment Indicator will pulse white instead of rotating around the display.
The treatment session will automatically pause if the Tonguetip loses contact with the tongue
for more than 30 seconds.
To resume treatment, press the Play Button while also ensuring that the Tonguetip is in contact
with the tongue.
If you do pause a treatment session, it is recommended that you resume again within 5 minutes.
It is also recommended that you do not pause the treatment more than once within a single
treatment session in order to maximise the eectiveness of the treatment.
13.3 - Adjusting the Stimulation Levels
13.3.1 - Tonguetip Stimulation Level Control
It is recommended to leave the tongue stimulation level set to the default level unless either:
• There is a strong sensation from the Tonguetip that causes discomfort. In this case the tongue
stimulation level can be adjusted downwards to a comfortable level.
• There is a weaker tongue sensation than was perceived during the initial training you received
as part of the device tting. In this case the tongue stimulation level may be adjusted upwards.
The tongue stimulation is calibrated to your sensation thresholds during
device fitting by the clinician. The treatment stimulation is then set to be
sucient for optimum eectiveness and may not be perceptible. If the
stimulation level is set to the default level (i.e. the level that the device defaults
to at the start of each treatment session), then the stimulation is functioning
properly as long as the Tonguetip Indicator is illuminated green (i.e. when it is
not pulsing).

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The Headphones volume levels are calibrated to your hearing thresholds
for optimum eectiveness.
Depending on your audiological profile, you may perceive the sound
levels to be soft. It is important that you seek a quiet environment for
your treatment sessions.
If volume control buttons are present on your Headphones, they should not
be used to adjust the volume. Please only use the volume control buttons on
the Controller.
Depending on your hearing profile, the range over which you can increase
the Headphones volume level may be limited. This is to ensure that the
volume levels remain within safe limits, so as not to cause hearing damage.
13.3.2 - Headphones Volume Control
The Headphones volume level should be left at the default level unless either:
• The treatment environment is noisy, in which case the volume level can be increased.
• The volume is so high that it causes any discomfort, or prevents you from relaxing,
in which case the volume level can be decreased.
Chapter 14 - Treatment Guidelines
The following guidelines should be followed to maximise the eectiveness of the treatment
programme:
• While the treatment is intended for use between 30 to 60 minutes per day, it is
recommended that you try to complete at least a full 30 minutes at each daily treatment.
• Try to keep the tongue stimulation level and the Headphones volume level at the default
settings, as these are the optimum levels calibrated to your individual characteristics.
• Try to complete each treatment session in a place that is quiet, relaxing and comfortable.
Focusing your attention away from distractions such as the TV may improve the
eectiveness of the treatment.
• Try to keep a routine for the treatment sessions, where the treatment is delivered
at the same time(s) each day.
• It is not unusual for tinnitus symptoms to disimprove or uctuate. It is recommended that you
continue treatment even during periods where the symptoms disimprove, for the 10 weeks
minimum recommended treatment duration. However, if there is a signicant disimprovement
in your symptoms it is recommended to seek advice from your clinician.
Do not use whilst showering, in rain, or in a moist atmosphere such as a steam
bath or sauna. Do not use whilst applying items such as, perfume, cosmetics,
after-shave, hairspray or suntan lotion.

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Section C
Care, Storage,
Maintenance and Disposal
This section details the correct procedures for cleaning, storage, maintenance
and disposal of the Lenire device.
Chapter 15 - Cleaning
It is advisable to clean the Controller, the Headphones, the Carry Case and the Tonguetip
after prolonged disuse or storage, or after exposure to conditions that could aect their hygiene.
• The Tonguetip should be rinsed thoroughly with water or distilled water.
• You may use the Tonguetip immediately after rinsing.
• If you do not intend to use the Tonguetip immediately after cleaning, place on a clean, dry
surface and allow it to air-dry.
• In addition, the Tonguetip may be cleaned by gently rubbing the Tonguetip surfaces, including
the electrodes and the plug using 70% IPA (Isopropyl alcohol) wipes.
Notes: 70% IPA wipes are available over the counter in pharmacies.
15.1 - Instructions for Cleaning of the Controller, the Headphones and the Carry Case
Before cleaning the Controller or Headphones, ensure that they are switched
o and not connected to the Charger.
Before cleaning the Tonguetip ensure that it is disconnected from the
Controller.
Do not expose the plug end of the Tonguetip to liquids.
After cleaning the Tonguetip with IPA, place on a clean, dry surface
to allow to air-dry for at least one minute before use.
Do not use any cleaning agent other than IPA or water.
• The exterior surfaces of the Controller, the Headphones and Carry Case should be cleaned
using a soft cloth to remove debris.
15.2 - Instructions for Cleaning of the Tonguetip

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Attempting to clean the device using a method other than that described
here can damage the device and voids the warranty.
Do not scrub or wipe the surfaces forcefully.
Do not immerse the Controller, the Charger or the Tonguetip plug in water.
To avoid damaging the devices do not force dry, for example by using
a hairdryer, or leaving on top of a heater.
Chapter 16 - Storage and Transport
It is recommended to store the Controller and the Tonguetip in the Carry Case (model CE-401)
supplied as it has been specially designed to protect them during storage and transport. It can
also help maintain the cleanliness of the Tonguetip in-between uses.
It is not necessary to disconnect the Tonguetip plug from the Controller port before placing them
into the Carry Case. For ease of storage, it is possible to leave the Tonguetip cable outside the
case, whereby the cable enters and exits the case through the holes as indicated in this image:
The Controller and the Tonguetip should be stored in a location that is not
too hot, nor too cold (between -20 and 45 degrees Celsius), and that is not
excessively humid (relative humidity less than 85%).
The Controller has a shelf life of two years, meaning that it should be used for
the first time within two years of it being manufactured, otherwise the battery
life may deteriorate.
The environmental limits and precautions pertaining to storage and transport of the device
are illustrated on the packaging labels, next to these symbols:
Storage and transport temperature limits. The lower limit is -20°C, as indicated
near the lower horizontal line and the upper limit, 45°C, as indicated near the
upper line.