BRAUN IRT6515 ThermoScan 6 Ear Thermometer Owner’s Manual

ThermoScan® 6
Ear thermometer
Owner’s Manual

IRT6515
A004165R2
05JUL23

IRT6515 ThermoScan 6 Ear Thermometer

Product description

1. Hygienic lens filter (Box of 20)
2. Probe tip
3. Probe
4. ExacTemp® Stability Indicator
5. Hygienic lens filter ejector| 6. Display
7. Power button
8. Start button
9. Battery door
10. Protective case
---|---

The Braun ThermoScan Ear thermometer has been carefully developed for accurate, safe, and fast temperature measurements in the ear .
The shape of the thermometer probe prevents it from being inserted too far into the ear canal, which can hurt the eardrum .
However, as with any thermometer, proper technique is critical to obtaining accurate temperatures .
Therefore, read the instructions carefully and thoroughly .

Indications for Use / Intended Use

Braun Thermoscan® IRT6000 Series Infrared ear thermometers are indicated for the intermittent measurement of human body temperature by consumers of all ages in a home use environment .
The hygienic lens filter is used as a sanitary barrier between the thermometer and the ear canal .

Warnings and Precautions

The operating ambient temperature range for this thermometer is 50 – 104 °F (10 – 40 °C) .
DO NOT expose the thermometer to temperature extremes (below –13 °F / –25 °C or over 131 °F / 55 °C) or excessive humidity (15- 95 % RH) .
This thermometer must only be used with genuine Braun ThermoScan Hygienic lens filters (LF 40) .
To avoid inaccurate measurements ALWAYS use this thermometer with a new, clean hygienic lens filter attached . If the thermometer is accidentally used without a hygienic lens filter attached, clean the lens (see «Care and cleaning» section) . Keep hygienic 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 .
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 .
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 .
This thermometer is not intended to interpret hypothermic temperatures . If the device displays a temperature of 97 .5°F (36 .4°C) or less, and the individual is exhibiting atypical symptoms or behaviors, contact your doctor or health care professional .
DO NOT allow children under 12 years to take their temperature unattended .
DO NOT modify this equipment without authorization of the manufacturer .
People who are on antibiotics, analgesics, or antipyretics should not be assessed solely on temperature readings to determine the severity of their illness .
Temperature elevation may signal a serious illness, especially in neonates and infants, or in adults who are elderly, frail, or have a weakened immune system . Please seek professional advice immediately when there is a temperature elevation and if you are  taking temperature on:

• Neonates and infants under 3 months (Consult your physician immediately if the temperature exceeds 99 .4 °F or 37 .4 °C) .
• 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 ., paraplegia, quadriplegia, stroke, chronic illness, surgical recovery, nursing home patient, stroke, chronic illness, recovering from surgery) .
• A transplant recipient (e .g ., liver, heart, lung, kidney) .

This thermometer contains small parts that can be swallowed or produce a choking hazard to children Keep out of reach of children under 12 years .

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 . This is easily done using Braun ThermoScan . Practice taking temperatures on yourself and healthy family members to determine the normal temperature range .
Note: When consulting your physician, communicate that the ThermoScan temperature is a temperature measured in the ear and if possible, note the individual’s normal ThermoScan temperature range as additional reference .

Why measure in the ear?
The goal of thermometry is to measure core body temperature 1 , which is the temperature of the vital organs . Ear temperatures accurately reflect core body temperature, 2 since the eardrum shares blood supply with the temperature control center in the brain, 3 the hypothalamus . Therefore, changes in body temperature are reflected sooner in the ear than at other sites . Axillary temperatures measure skin temperature and may not be a reliable indicator of core body temperature . Oral temperatures are influenced by drinking, eating and mouth breathing . Rectal temperatures often lag behind changes in core body temperature and there is a risk of cross-contamination .

Color-coded fever guidance
Temperature guidance helps you to better understand the meaning of your child’s temperature with the color indicated on the display . The screen displays a green, yellow, or red backlight depending on the temperature reading .
It is important to note that a patient’s temperature may be impacted by age, gender, or medical condition, or by factors such as ambient temperature, time of day, medications taken or the temperature measurement site4 .

Note: Backlight is white with no fever indication when temperatures of 93 .2</ T</96 .3 are registered

1 Guyton A, Textbook of Medical Physiology, W .B . Saunders, Philadelphia, 1996, p 919 .
2 Guyton A, Textbook of Medical Physiology, W .B . Saunders, Philadelphia, 1996, pp 754-5 .
3 Netter F, Atlas of Human Anatomy, Novartis Medical Education, East Hanover, NJ, 1997, pp 63, 95 .
4 Herzog L, Phillips S . Addressing Concerns About Fever . Clinical Pediatrics . 2011; 50(#5): 383-390 .

How does Braun ThermoScan work?
The Braun ThermoScan measures the infrared heat generated by the eardrum and surrounding tissues . When placed in the ear, the Braun ThermoScan continuously monitors the infrared energy and the ExactTemp® Stability Indicator displays a reading only if the thermometer detects that an accurate and stable temperature measurement has been taken .

How to use your Braun ThermoScan

1. Remove the thermometer from the protective case.

2. Push the Power button .
   During an internal self-check, the display shows all segments .
   Then the last temperature taken will be displayed for 5 seconds .

3. The hygienic lens filter indicator will blink to signal one is needed .
   To achieve accurate measurements, make sure a new, clean hygienic lens filter is in place before each measurement .
   Attach a new hygienic lens filter by pushing the thermometer probe straight into the hygienic lens filter inside the box and then pulling out.
   Note: The Braun ThermoScan will not work unless a hygienic lens filter is attached.
   The thermometer is ready to take a temperature when the display looks like the following image:

4. Fully insert the IRT probe into the ear canal and point it towards the opposite temple . Make sure the IRT is pointed toward the ear drum and not the canal walls .
   Once positioned correctly, press and release the start button .

5. ExacTemp Stability Indicator light will pulse while temperature measurement is in progress . The light will remain solid for 3 seconds to indicate that a successful temperature reading has been achieved .
   NOTE: If the probe has been properly inserted into the ear canal during the measurement, a long beep will sound to signal the completed measurement .
   If the probe has NOT been constantly placed in a stable position in the ear canal, a sequence of short beeps will sound, the ExacTemp Stability Indicator light will go out and the display will show an error message (POS = position error) .
   See Errors and troubleshooting section for more information .

6. The confirmation beep indicates that an accurate temperature measurement has been taken . The result is shown on the display . Temperature reading displayed is an equivalent of oral temperature .
   To repeat Go to step 3 .

7. For the next measurement, press Eject   button to remove, and discard used hygienic lens filter, and put on a new, clean hygienic lens filter .
   The Braun ThermoScan Ear thermometer turns off  automatically after 60 seconds of inactivity . The thermometer can also be turned off by pressing the Power button .

The display will briefly flash OFF and it will go blank .

Temperature-taking hints

ALWAYS replace disposable hygienic lens filters to maintain accuracy and hygiene . A measurement taken in the right ear may differ from a 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:

Use the untreated ear if ear drops or other ear medications have been placed in the ear canal.
If an individual has been laying down on their side with an ear face down on a pillow, use the ear that has been facing upwards .

Last reading recall

1. The last temperature taken is stored in the memory and will be automatically displayed for 5 seconds when it is turned on again.

How to illuminate the display
The thermometer includes a convenient night light to illuminate the display in a dim environment .
The light will turn on when you press any button . It will stay on until the thermometer is inactive for up to 15 seconds even after temperature is taken.

How to change temperature between °C and °F
Your Braun ThermoScan is shipped with the Fahrenheit (°F) temperature scale activated . If you wish to switch to Celsius (°C) and/or back from Celsius to Fahrenheit, proceed as follows:

1. Make sure the thermometer is turned off .
2. Press and hold down the Power button After about 3 seconds the display will show this sequence: °F / SET / °C / SET .
3. Release the Power button when the desired temperature scale is shown.

There will be a short beep to confirm the new setting, then the thermometer is turned off automatically .

Care and cleaning

The probe tip is the most delicate part of the thermometer . It must be clean and intact to ensure accurate readings . If the thermometer is ever 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 . After the alcohol has completely dried out, you can put a new hygienic lens filter on and take a temperature measurement .
If the probe tip is damaged, please contact Consumer Relations .
Use a soft, dry cloth to clean the thermometer display and exterior . DO NOT use abrasive cleaners . NEVER submerge this thermometer in water or any other liquid . Store thermometer and hygienic lens filters in a dry location free from dust and contamination and away from direct sunlight .
Additional hygienic lens filters (LF 40) are available at most stores carrying Braun ThermoScan .

Replacing the batteries
The thermometer is supplied with two 1 .5 V type AA (LR 06) batteries .

1. Insert new batteries when the battery symbol appears on the display .
2. Open the battery compartment . Remove the batteries and replace with new batteries, making sure the poles are in the right direction.
3. Snap battery door into place .

Only discard empty batteries . To protect the environment, dispose of empty batteries at your retail store or at appropriate collection sites according to national or local regulations .
Do not mix alkaline, standard, or rechargeable batteries .

Calibration
The thermometer is initially calibrated at the time of manufacture . If this thermometer is used according to the use instructions, periodic re-adjustment is not required . If at any time you question the accuracy, please contact Consumer Relations .

Errors and troubleshooting

filter .
| The thermometer probe was not positioned securely in the ear .
An accurate measurement was not possible .| Check if the positioning of the probe is correct and remains stable .
Replace hygienic lens filter and reposition . Press Start button to begin a new measurement .
| 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 .
| Temperature taken is not within typical human temperature range (93 .2  – 108 °F or 34   –  42 .2 °C) .
HI = too high
LO = too low| Make sure the probe tip and lens are clean and a new, clean hygienic lens filter is attached . Make sure the thermometer is
properly inserted .
Then, take a new temperature .
| System error – self-check display flashes continuously and will not be followed by the ready beep and the ready symbol or screen is blank .
If error persists, If error persists, If error still persists,| Wait 1 minute until the thermometer turns off automatically, then turn on again .
. . . reset the thermometer by removing the batteries and putting them back in .
. . . replace the batteries with new batteries .
. . . please contact the Consumer Relations .
| Battery is low, but thermometer will still operate correctly .| Insert new batteries .
| Battery is too low to take correct temperature measurement .| Insert new batteries .

Product specifications

Clinical accuracy characteristics and calibration procedures are available upon request .
This thermometer is specified to operate at a pressure of 1 atmosphere or at altitudes with an atmospheric pressure up to 1 atmosphere . (700 – 1060 hPa) .

Subject to change without notice .
This appliance conforms to the following standards:
This infrared thermometer meets requirements established in ASTM Standard E 1965-98 as it pertains to infrared thermometers . Full responsibility for the conformance of this product to the standard is assumed by Kaz 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) .
EN 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 .
EN IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance .
EN ISO 14971: Medical devices – Application of risk management to medical devices .
EN ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process .
EN IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests .
EN ISO 15223-1: Medical devices . Symbols to be used with medical device labels, labeling and information to be supplied . General requirements .
EN 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 .
This product conforms to the provisions of the EC directive 93/42/EEC .

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC . For detailed description of EMC requirements please contact your authorized local Service Center (See guarantee card) .
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT .
Please do not dispose of the product in the household waste at the end of its useful life .
To protect the environment, dispose of empty batteries at appropriate collection sites according to national or local regulations .

Limited three year 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, Kaz 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 1-800-477-0457 or visit Braun Healthcare .com/contact-us 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 THERMOMETER HOUSING YOURSELF, DOING SO MAY VOID YOUR WARRANTY AND CAUSE DAMAGE TO THE PRODUCT OR PERSONAL INJURY.

Guidance and manufacturer’s declaration — electromagnetic immunity

The IRT6515 is intended for use in the electromagnetic environment specified below.
The customer or the user of the IRT6515 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| i 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM fields a)| IEC 61000-4-3| 10 V/m 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
d
magnetic fields d) e)| IEC 61000-4-8| 30 Alm g)
50 Hz or 60 Hz

a) The interface between the 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.
d) 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).
f) 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 IRT6515 is intended for use in the electromagnetic environment specified below The.customer or the
user of the IRT6515 should ensure that it is used in such an environment.
Emissions Test| Compliance| Electromagnetic environment —guidance
RF Emissions
CISPR 11| Group 1| The ME equipment uses RF energy only for its internal furction.
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.
Voltage fluctuations/
flicker emissions| Not
Applicable
Guidance and manufacturer’s declaration — RF wireless communication equipment immunity

Test
frequency
(MHz)| Band a)
(MHz)| Service a)| Modulation b)| Maximum
power
(W)| Distance
(m)| 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,
iDEN 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: 1-800-327-7226
Visit: BraunHealthcare.com/contact-us
www.braunhealthcare.com
Certain trademarks used under license from The Procter & Gamble Company or its affiliates .
ThermoScan® and ExacTemp® are trademarks owned by Helen of Troy Limited and/or its affiliates .

© 2023 All rights reserved .
Kaz USA, Inc ., a Helen of Troy Company 400 Donald Lynch Blvd ., Suite 300 Marlborough, MA 01752

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