BRAUN IRT3515 ThermoScan 4 Ear Thermometer User Manual

IRT3515 Thermos can 4 Ear Thermometer
User Manual

Thermos can® 4 Ear thermometer
IRT3515
PN: A004474R1 12MAY22

IRT3515 Thermos can 4 Ear Thermometer

Product description

1. Protective cap
2. Hygienic lens filter
3. Probe
4. «start» button
5. Probe tip (lens)
6. Lens filter detector
7. Display
8. Battery door safety lock
9. Battery door (1X 3V type CR2032 battery)

Indications for Use / Intended Use
The Braun Thermos can® 4 Ear thermometer is intended for the intermittent measurement of human body temperature by consumers in a home-use environment .

Warnings and precautions
Keep out of reach of children under 12 years .
NEVER use the thermometer for purposes other than those for which it has been intended . Please follow the general safety precautions when using on children .
NEVER immerse the thermometer into water or other liquids (not waterproof) . For cleaning and disinfecting please follow the instructions in the “Care and cleaning” section .
DO NOT store this thermometer in temperature extremes below -13 °F or over 131 °F (below -25 °C or over 55 °C ) or in excessive humidity (above 95% non- condensing relative humidity) .
If thermometer is stored in a location that is cooler or warmer than where it will be used, allow it to acclimate to the room temperature for 10 minutes before taking a measurement .
DO NOT use the thermometer if there are signs of damage on the probe or on the thermometer itself . If damaged, DO NOT attempt to repair the product .
NEVER insert a sharp object into the probe area or any other open surface on the thermometer .
This thermometer consists of high-quality precision parts . DO NOT drop the instrument . Protect it from severe impact and shock .
This thermometer must only be used with genuine Braun
Thermos can® disposable lens filters (LF40/LF20) . Other lens filters can lead to inaccuracy .
DO NOT modify the equipment without the manufacturer’s authorization .
To avoid inaccurate measurements ALWAYS use this thermometer with a new, clean, disposable lens filter .
If the thermometer is accidentally used without a disposable lens filter, clean the lens after use (see “Care and cleaning”) .
Keep disposable lens filters out of reach of children .
This thermometer is intended for household use only .
Use of this thermometer is not intended as a substitute for consultation with your physician .
Temperature elevation may signal a serious illness, especially in neonates and infants, or in adults who are old, frail, or have a weakened immune system . Please seek  professional advice immediately when a temperature elevation occurs on persons that are:

• Neonates and infants under 3 months (Consult your physician immediately if the temperature exceeds 99 .4 °F [37 .4 °C])
• Individuals over 60 years of age (Fever may be blunted or absent in older individuals)
• Individuals having diabetes mellitus or a weakened immune system (e .g ., HIV positive, cancer chemotherapy, chronic immunosuppressant treatment, splenectomy)
• Individuals who are bedridden (e .g ., nursing home patient, stroke, chronic illness, paraplegia, quadriplegia, surgical recovery)
• A transplant recipient (e .g ., liver, heart, lung, kidney)

This thermometer is not intended for pre-term babies or small-for-gestational age newborn babies (birth to 4 weeks of age) . Pre-term is defined as babies born before  37 weeks of gestation .
Small-for-gestational-age is defined as a newborn baby, born at 37 weeks or later, with a weight below the 10th percentile for newborn babies of the same gestational age .
This thermometer is not intended to interpret hypothermic temperatures . If the device displays a temperature of 97 .5°F (36 .4°C) or less with an LED backlight color  of green or white, and the individual is exhibiting atypical symptoms or behaviors, contact your physician or health care professional .
DO NOT allow children to take their temperatures unattended .
Please consult your physician if you see symptoms such as unexplained irritability, vomiting, diarrhea, dehydration, changes in appetite or activity, seizure, muscle pain,  shivering, stiff neck, pain when urinating, etc. ., even in the absence of fever .
Even in the absence of fever, those who exhibit a normal temperature may still need to receive medical attention . People who are on antibiotics, analgesics, or  antipyretics should not be assessed solely on temperature readings to determine the severity of their illness .

Color-coded fever guidance
Color-coded fever guidance helps you to better understand the meaning of your child’s temperature with the color indicated on the display . The color-coded screen  displays GREEN for a normal temperature, YELLOW for a fever, and RED for a high fever .

Body temperature

Normal body temperature is a range . It varies by site of measurement, and it tends to decrease with age . It also varies from person to person and fluctuates throughout  the day . Therefore, it is important to determine normal temperature ranges .
How to use your Braun Thermos can®
Before taking the temperature, make sure the ear is free from obstructions or excess earwax .
DO NOT attempt to take the reading without a hygienic lens filter on – the measuring sensor must be kept protected and clean from earwax to give accurate readings .
Change the hygienic lens filter with each use to ensure hygiene, to keep child safe from cross-contamination and to ensure earwax residues on the hygienic lens filter do  not impact accuracy of the reading .

1. To turn the thermometer on, push the “start” button (4) as shown on page 3 .
   During an internal self-check, the display shows all segments .
   The reading shown on the screen is the last temperature taken .
   Flashing symbol of lens filter will appear if no lens filter is attached . Temperature can be taken only if lens filter is mounted on the probe .
   The thermometer is ready to use after two beeps and the non-flashing ear icon appears .

2. Fit the probe (3) snugly into the ear canal, then push the “start” button (4) .
   One beep signals normal temperature . Audio temperature indicator will trigger 2 consecutive beeps when the reading is equal or higher to 99 .5 °F (37 .5 °C) and 4  beeps if the reading is equal or higher to 101 .4 °F (38 .6 °C) . The result is shown on the display (7) .

3. Gently pull off the hygienic lens filter (2) . Do not use force in removing the hygienic lens filter .

4. Put on a new, clean, hygienic lens filter by snapping into position .

5. Place the protective cap on (1) .
   The Braun Thermos can® 4 Ear thermometer turns off automatically after 60 seconds of inactivity .
   The thermometer can be turned off by pressing and holding the start button for more than 5 seconds .

Hygienic lens filters (LF40/LF20)
Use a clean hygienic lens filter with each measurement:
1 . To ensure hygienic use
2 . To protect your child from cross-contamination
3 . To ensure earwax residues do not impact accuracy of the reading Earwax and dirt on the tip of the hygienic lens filter, even a microscopic layer, can create an  obstacle between the sensor and the infrared heat emitted by the ear and impact the accuracy of the measurement .

Temperature taking hints

• Replace the hygienic lens filter with every use to maintain hygiene and accuracy .

• A measurement taken in the right ear may differ from the measurement taken in the left ear . Therefore, always take the temperature in the same ear .

• The ear must be free from obstructions or excess earwax build-up to take an accurate reading .

• External factors may influence ear temperatures, including when an individual has:
  – been lying on one ear or the other
  – had their ears covered
  – been exposed to very hot or very cold temperatures
  – been recently swimming or bathing, or
  – been wearing hearing aids or headphones for an extended period of time
  In these cases, remove the individual from the situation and wait 20 minutes prior to taking a temperature .

• If ear drops or other ear medications have been placed in the ear canal of one ear, take the temperature in the untreated ear .

• Nursing mothers should not take a temperature measurement on themselves or have their temperature measured by another individual while or immediately after  nursing a baby, as nursing can affect body temperature .

Care and cleaning
The probe tip (5) is the most delicate part of the thermometer . It has to be clean and intact to ensure accurate readings .
If the thermometer is accidentally used without a hygienic lens filter, clean the probe tip as follows: Very gently wipe the surface with a cotton swab or soft cloth  moistened with alcohol .
DO NOT use cleaners other than alcohol on the probe tip . Use of other cleaners could damage the tip .

Once the alcohol has dried completely, a new hygienic lens filter can be put on and a temperature measurement taken . If the probe tip is damaged, please contact Consumer Relations .
Use a soft, dry cloth to clean the thermometer display and product exterior . DO NOT use abrasive cleaners . NEVER submerge this thermometer in water or any other liquid .
Store the thermometer and hygienic lens filters in a dry location free from dust and contamination and away from direct sunlight .
Additional hygienic lens filters (LF40 /LF20) are available at most stores selling the Braun Thermos can® 4 Ear thermometer .

Troubleshooting

filter.
| Measurement before device stabilization.| Wait until all the icons stop flashing.
| Ambient temperature is not within the allowed operating range ( 50–104 °F or 10–40 °C).| Allow the thermometer to remain for 30 minutes in a room where the temperature is between 50 and 104 °F or 10 and 40 °C.
| HI = too high LO = too low
Temperature taken is not within typical human temperature range (93.2–108 °For 34–42.2 °C ).| Make sure the probe tip and lens are clean and a new, clean, disposable lens filter is attached. Make sure the thermometer is properly inserted. Then, take a new temperature.
| System error.| Reset the thermometer by removing the battery and then replacing it again, wait 1 minute, then turn on again.
Please contact Consumer Relations (See Guarantee Card).
| Battery is low.| Insert new battery.
| Battery is too low. Device cannot be powered on to the  ready state.| Insert new battery.

Changing the temperature scale
Make sure the thermometer is turned off . Press and hold down the “start” button . Keep holding down the “start” button and after about 3 seconds the display will start  to cycle between temperature scales (°F or °C) .

Release the start button when the desired scale is shown . This will reset the thermometer to the new temperature scale .
Replacing the battery
The thermometer is supplied with one 3V Lithium cell battery (type CR2032) . Insert new battery when the low battery symbol appears on the display .
The battery door design is intended to prevent a small child from easily opening the battery door to address a possible choke hazard . Open the battery compartment by inserting a narrow pointed object such as a ball point pen or paperclip into the small hole above the battery door (8) . While pressing into the hole slowly slide back the  battery door with the other hand . To close battery door align the tabs along the side of the battery into the battery compartment and slowly slide back into position until the door clicks into its locked  position . Do not mix alkaline, standard, or rechargeable batteries .

Calibration
This product has been calibrated at the time of manufacture . If used according to the use instructions, periodic calibration is not required . If at any time you question  the accuracy of temperature measurements, please contact Consumer Relations .

3 Year Limited warranty
You should first read all Instructions before attempting to use this product.
A . This 3 year limited warranty applies to repair or replacement of product found to be defective in material or workmanship . This warranty does not apply to damage  resulting from commercial, abusive, unreasonable use or supplemental damage . Defects that are the result of normal wear and tear will not be considered manufacturing defects under this warranty . KAZ IS NOT LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY NATURE, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ON THIS PRODUCT IS LIMITED IN DURATION TO THE DURATION  OF THIS WARRANTY. Some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages or limitations on how long an  implied warranty lasts, so the above limitations or exclusions may not apply to you . This warranty gives you specific legal rights, and you also may have other rights  which vary from jurisdiction to jurisdiction . This warranty applies only to the original purchaser of this product from the original date of purchase .
B . At its option,  Katz will repair or replace this product if it is found to be defective in material or workmanship .
C . This warranty does not cover damage resulting from any unauthorized attempts to repair or from any use not in accordance with the instruction manual .
Call us toll-free at 1-800-327-7226 or
Email: ConsumerRelations@HelenofTroy.com
Please be sure to specify a model number .
NOTE: IF YOU EXPERIENCE A PROBLEM, PLEASE CONTACT CONSUMER RELATIONS FIRST OR SEE YOUR WARRANTY. DO NOT RETURN THE  PRODUCT TO THE ORIGINAL PLACE OF PURCHASE. DO NOT ATTEMPT TO OPEN THE DEVICE HOUSING YOURSELF, DOING SO MAY VOID YOUR  WARRANTY AND CAUSE DAMAGE TO THE PRODUCT OR PERSONAL INJURY. Model: IRT 3515

Displayed temperature range: 93 .2 °F – 108 °F (34 °C – 42 .2 °C)
Operating ambient temperature range: 50 °F – 104 °F (10 °C – 40 °C)
Storage temperature: -25°C – 55°C (-13°F – 131°F)
Display resolution: 0 .1°F or 0 .1°C
Accuracy for displayed temperature range: ±0 .4 °F (±0 .2 °C) in range 35 .5-42°C (95 .9-107 .6°F) ±0 .5 °F (±0 .3 °C) outside that temperature range Clinical accuracy characteristics and procedures are available upon request .
Measuring Site: Ear
Reference Site: Oral (estimated oral temperature is displayed)
Operating and storage Relative humidity: ≤ 95% non-condensing
Battery life: 3 years /1000 measurements
Service life: 5 years
Warranty: 3 years
If device is not used or stored within specified temperature and humidity ranges the technical accuracy cannot be ensured .
This infrared thermometer meets requirements established in ASTM Standard E 1965-98 (for the thermometer system [thermometer with lens filter]) . Full responsibility for the conformance of the product to the standard is assumed by Katz USA, Inc .
ASTM laboratory accuracy requirements in the display range of 37 to 39°C (98 to 102°F) for IR thermometers is ±0 .2°C (±0 .4°F), whereas for mercury-in- glass and  electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is ±0 .1°C (±0 .2°F) .
This thermometer is specified to operate at a pressure of 1 atmosphere or at altitudes with a pressure of up to 1 atmosphere .

Subject to change without notice .
This device conforms to the following standards:
ASTM E1965-98 – Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature .
ISO 80601-2-56 – Medical electrical equipment – Part 2-56:
Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement .
ANSI AAMI IEC 60601-1 – Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance .
IEC 60601-1-2 – Medical electrical equipment – Part1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests .
NOTE: DO NOT use this device in the presence of electromagnetic or other interference outside the normal range specified in IEC 60601-1-2 .
IEC 60601-1-11 – Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance —
Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment .
ISO 10993-1 – Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management process .
ISO 15223-1 – Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements .
Internally Powered Equipment
Continuous Operation
Not Protected against Ingress of Water .
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC . For detailed description of EMC requirements please contact Consumer Relations
Portable and mobile RF communications equipment can affect
MEDICAL ELECTRICAL EQUIPMENT .
This product contains batteries and recyclable electronic waste . To protect the environment, do not dispose of it in the household waste, but take it to appropriate local collection points .

Guidance and manufacturer’s declaration – electromagnetic immunity

The IRT3515 is intended for use in the electromagnetic environment specified below.
The customer or the user of the IRT3515 should ensure that it is used in such an environment.
Phenomenon| Basic EMC standard or test
method| IMMUNITY TEST LEVELS
HOME HEALTHCARE ENVIRONMENT
ELECTROSTATIC DISCHARGE| IEC 61000-4-2| ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields a)| IEC 61000-4-3| 10 Vim f)
80 MHz – 2.7 GHz b) 80 % AM at 1 kHz c)
Proximity fields from RF wireless
communications equipment| IEC 61000-4-3| See RF wireless communication equipment immunity table below
RATED power frequency magnetic fields d) a)| IEC 61000-4-8| 30 A/m g)
50 Hz or 60 Hz
a) The interface between he PATIENT physiological signal simulation, if used, and the ME EQUIPMENT Or ME SYSTEM shall be located  within 0,1 m of the vertical plane of the uniform field area in one orientation of the ME EQUIPMENT Or ME SYSTEM.
b) ME EQUIPMENT and ME SYSTEMS that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS. This test assesses the BASIC SAFETY and ESSENTIAL PERFORMANCE of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver might not achieve normal reception during the test.
c) Testing may be performed at other modulation frequencies identified by the RISK MANAGEMENT PROCESS.
41) Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry.
e)  During the test, the ME EQUIPMENT or ME SYSTEM may be powered at any NOMINAL input voltage, but with the same frequency as the test signal (see Table 1).
t) Before modulation is applied.
g)  This test level assumes a minimum distance between the ME EQUIPMENT or ME SYSTEM and sources of power frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the ME EQUIPMENT or ME SYSTEM will be used closer than 15 cm to sources of power frequency magnetic field, the IMMUNITY TEST LEVEL shall be adjusted as appropriate for the minimum expected distance.
Guidance and manufacturer’s declaration – electromagnetic emissions

The IRT3515 equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the IRT3515 should ensure that it is used in such an environment.
EmissionsTest| Compliance| Electromagnetic environment-guidance
RF Emissions
CISPR 11| Group 1| The ME equipment uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11| Class B| Complies
Harmonic emissions IEC 61000-3-2| Not Applicable| The ME equipment is solely battery powered. Not
Voltage fluctuations/flicker emissions| Applicable
Guidance and manufacturer’s declaration — RF wireless communication equipment immunity

Test
frequency
(MHz)| Band a)
(MHz)| Service a)| Modulation”)| Maximum
power (W)| Distancecm)| IMMUNITY
TEST LEVEL
(V/m)
385| 380 —390| TETRA 400| Pulse
modulation b)
18 Hz| 1,8| 0.3| 27
450| 430 — 470| GMRS 460,
FRS 460| FM C) + 5 kHz deviation
1 kHz sine| 2| 0,3| 28
710| 704 — 787| LTE Band 13,
17| Pulse
modulation b)
217 Hz| 0,2| 0,3| 9
745
780
810| 800 — 960| GSM 800/900. TETRA 800, ident 820. CDMA 850. LTE Band 5| Pulse
modulation b)
18 Hz| 2| 0,3| 28
870
930
1720| 1 700 —
1 990| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS| Pulse
modulation b)
217 Hz| 2| 0,3| 28
1845
1970
2450| 2 400 —
2 570| Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Pulse
modulation b)
217 Hz| 2| 0.3| 28
5240| 5 100 —
5 800| WLAN 802.11
a/n| Pulse
modulation b)
217 Hz| 0,2| 0,3| 9
5500
5785
a)For some services, only the uplink frequencies are included.
b)The carrier shall be modulated using a 50 % duty cycle square wave signal.
C) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

Contact Us
Questions or Comments?
Call us toll-free at: 1-800-327-7226
Or visit our website at: www.BraunHealthcare.com
Please specify the model number when contacting consumer relations .
ThermoScan® is a registered trademark of Helen of Troy Limited .
Certain trademarks used under license from
The Procter & Gamble Company or its affiliates .

© 2022 . All Rights Reserved .
Katz USA, Inc ., a Helen of Troy Company
400 Donald Lynch Blvd ., Suite 300, Marlborough, MA 01752
www.BraunHealthcare.com/us_en/patents
Made in China .

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