Berrcom ET-005 Forehead And Ear Thermometer User Manual

User Manual
EAR THERMOMETER
Model: ET005

NOTE:
You must read this instruction manual thoroughly before use and follow all instructions. Keep the instructions for later use. You must check the device functions according to this instruction manual before use each time and only use this device if it is in proper working condition.
THE MANUFACTURER RESERVES THE RIGHT TO ALTER THE SPECIFICATIONS OF THE PRODUCT WITHOUT PRIOR NOTIFICATION.

Features

1. Special design to take the Human Body Temperature from forehead and eardrum.
2. Audible alert if temperature is more than 37.4℃.
3. LED digital display screen with white color.
4. Temperature unit can be displayed in either Celsius or Fahrenheit.
5. Automatic power-off (<30 secs) to conserve energy.

Indication for Use

The Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact measurement method for forehead measurement, the recommended measurement distance is 0cm to 3cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.

Warnings and Precautions

• Keep the product out of reach of children and newborns. Avoid small parts falling off and being swallowed.
• Never use the thermometer for purposes other than those it has been intended for. Please follow the general safety precautions when using on children.
• Keep the thermometer away from direct exposure to the sun and keep it in a dust- free, dry area well-ventilated place at a temperature between 10°C (50°F)~40°C (104°F). Do not use the thermometer in high humidity environments. (>85% RH)
• When the thermometer is removed from a low-temperature storage environment of -20℃ (-4℉) or a high-temperature storage environment of 55℃(131℉), it needs to be recovered at room temperature for 4 hours before normal measurement.
• Do not use the thermometer if there are signs of damage on the measuring sensor or on the instrument itself. If damaged, do not attempt to repair the instrument! Please contact dealer.
• Never immerse the thermometer into water or other liquids (not waterproof). For cleaning and disinfecting please follow the instructions in the “Cleaning and Disinfection” section.
• This thermometer consists of high-quality precision parts. Do not drop the instrument. Protect it from severe impact and shock. Do not twist the instrument or the measuring sensor.
• Please consult your doctor 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.
• Clean the thermometer probe after each use.
• Do not use the thermometer for continuous temperature monitoring purposes.
• Do not take a measurement while or immediately after nursing a baby.
• Patients should not drink, eat or be physically active before/while taking the measurement.
• Avoid using it with cell phones, electrocautery and MRI equipment, etc.
• Do not use the thermometer if the ear is infected with otitis or suppuration.
• The thermometer shall not be serviced or maintained while in use with a patient.
• The patient is an intended operator. The patient can use and maintain the device and its accessories according to this manual.
• The thermometer and accessories are to be disposed of according to local regulations after their service lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal.
• No modification of this thermometer is allowed.
• The thermometer is not suitability for use in an OXYGEN RICH ENVIRONMENT.
• This device may be used for professional purposes or for personal home use.
• Do not expose this thermometer to electric shocks.
• The protective glass over the lens is the most fragile part of the thermometer. Do not touch the glass of the infrared lens with your fingers.
• The readings of the left and right ears may be different. It is recommended that the temperature of the same ear be collected when observing the changes of body temperature.
• When the ears are covered hot due to sleeping on the side, wearing headphones or hearing aids, long hair coverage, etc., the temperature of the ear canal will be temporarily higher than the true temperature. Please wait for 30 minutes to measure again.
• The device requires no calibration. If need, refer to chapter 10.
• Manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instruction to assist to SERVICE PERSONNEL in parts repair.
• Remove batteries if equipment is not likely to be used for some time.
• Before and after each use, the thermometer should be cleaned according to the requirement of this manual to avoid possible bacterial infections.
• Do not put this product in the place with direct sunlight, high temperature, high humidity, excessive dust, or the place where it may contact with corrosive gas or liquid, and do not use this product in the above environment.
• The device should no longer be reused when it reaches the expected service life (5 years, from the date of production) of the device. See chapter 14. to dispose the device.
• Batteries may do harm to environment, please dispose according to local law.
• Do not throw away randomly after replace the attached accessories or scrapped bodies, it should be treated according to local government environmental protection requirements to avoid environmental pollution.
• Electrical components and batteries have heavy metal or chemicals which may do harm to environment, please follow the local law and regulation on its disposal.
• You contact Berrcom ( “manufacture” ) or your dealer on the following issues: If an error occurs or if ear thermometer is damaged. DO NOT attempt to repair ear thermometer yourself, as this will void the warranty. Only have repairs carried out by authorized service partners.

The MANUFACTURER will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist SERVICE PERSONNEL to repair those parts of ME EQUIPMENT that are designated by the MANUFACTURER as repairable by SERVICE PERSONNEL.
If you need assistance in setting up, using, or maintaining the ear thermometer.
If you have unexpected operation or events to report.

Operating Principle

Ear temperature: Ear tympanic blood vessel connects with the hypothalamus, which is the temperature control center in human cerebral; therefore, by means of testing the ear tympanic temperature, it can figure out the accurate body temperature of human being. The thermometer is such a product to detect body temperature of human being by means of temperature taking on ear tympanic through infrared sensor.

Forehead Temperature: The infrared sensor receives the heat energy generated by artery blood, the device figures out the precise body temperature of human being.

Basic Instrument

Product description

1. LED
2. ON/Scan Button
3. Front shell
4. Infrared sensor
5. Probe cover
6. Battery cover
7. Back shell

LED display screen

Packaging items:
Thermometer 1pc
User manual 1pc

Explanation of Symbols

| Trade mark
| Indicates the need for the user to consult the instructions for use for crucial cautionary information such as warnings and precautions that can not, for a variety of reasons, be presented on the medical device itself.
| Please read the instructions carefully.
| Applied part, Type BF
| Direct current
IP22| Degree of protection against harmful ingress of water and particulate matter
2 Protected and against solid foreign objects of 12.5mm Φ and greater
2 Protection against vertically falling water drops when ENCLOSURE titled up to 15°
| DISPOSAL: Do not dispose of this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
| Manufacturer
| Serial number
| Date of manufacture
| Model number
| Made in China
| Symbol of European Authorized Representative, expressly indicate the name and address of European Authorized Representative after the symbol.
| Medical device

Changing the Battery

Slide the battery cover off along the marked direction. Put two AAA batteries correctly into the compartment. Remove the batteries if the thermometer will not be used for more than two months.
If the” ” displays on the screen, which means the low battery, you must replace the batteries.

How to Take A Temperature

1. . Power on
   Press the “ ” button, one second after the screen panel in full display, it will enter the standby mode with the sign “ ” (ear temperature mode, without transparent cover) or “ ” (forehead temperature mode, fitted with transparent cover).
   Then press the “ ” button again, you will get the measuring result in 3 second. But if there is no more operation, it will turn off in 30 seconds automatically.

2. Ear temperature measurement
   Take the transparent cover off, and then the screen will show up with the sign of ear “ “, which is for the ear temperature mode. Pull the ear edge, insert the probe into ear canal, point to the eardrum.
   Press the “ ” button, you will get the measuring result in 3 second, then the thermometer will beep to indicate that the measurement has been completed. The temperature reading will be displayed on the screen.

• Make sure the probe aims at the eardrum when insert it into the ear canal; otherwise, the result will inaccurate. (See below figures)	Ear Thermometer measures the infrared heat generated by the eardrum and surrounding tissues.

  | When measuring ear temperature, if the ear canal is seriously bended or something exists in the ear, the measuring results will be affected.
  | Please take hold of the ear to keep the ear canal smooth and be at the same level with the infrared sensor. Make sure to clean the ear canal before measuring.

Approach for straight the ear canal:

|
---|---
Newbom under 12 months: pull in outward rear direction| Child above 12 months and the adult: pull in outward upper direction

Note: A 10-second interval is allowed between two measurements.

3. Forehead Temperature measurement
   Put the transparent cover on the top then the screen will show up with a sign of forehead like “ “, which means forehead temperature mode. Press the “ ” button, you will get the measuring result in 3 second, then the thermometer will beep to indicate that the measurement has been completed. The temperature reading will be displayed on the screen.

• Make sure the probe is aim to the central forehead with ideal distance 0~3cm during testing. (See below figure) Forehead Temperature
  Note: A 10-second interval is allowed between two measurements.

  4. Choosing the unit
     Open the battery cover, use the toggle switch to change the °C/°F.

  5. Mute and unmute the thermometer
     When the thermometer is off, long press the “ ” button until the “OFF” is displayed on the screen to turn off the sound, and the sound icon on the screen disappears. Long press the “ ” button in the shutdown state until the “ON” and the sound icon are displayed on the screen or power off again, and the sound can be turned on.

  6. Power off
     The device turn off automatically after 30 seconds of inactivity.

  7. Read your temperature
     T indicates a temperature reading. In forehead or ear temperature mode.
     ● If T＜32°C, the device will display “——-℃”, and beeping for one time.
     ● If 32°C≦T＜37.4°C, the LED displays the reading, and beeping for one time.
     ● If 37.4°C≦T≦43°C, the thermometer will display the reading with 5 times short beeps warning that you may have a high temperature.
     ● If T＞43°C, display “——℃”, and beeping for one time.

Technical Specifications

32.0°C ~ 43.0°C (89.6°F ~ 109.4°F)
Accuracy| 32.0°C~ 34.9°C(89.6°F~94.8°F): ±0.3°C(±0.5°F)
35.0°C~ 42.0°C(95°F~107.6°F):  ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F ): ±0.3°C(±0.5°F)
Clinical repeatability| ≤ ±0.2°C/0.4°F
Batteries| DC 3V (2pcs AAA batteries)
Measurement time| Approx. 3 seconds
Display mode| LED screen
Display resolution| 0.1°C (0.1°F)
Automatic power-off| Approx. 30 seconds
Audible Alert| Yes
Use of Probe Covers| No
Unit size| Approx. 144×34×43.5mm (L x W x H)
Unit weight (include battery)| Approx. 80g
Expected Service Life| 5 year
Applied part| Sensor; Type BF
IP Class| IP22
Normal using condition| Ambient temperature: 10°C~40°C (50°F~104°F)
Relative humidity: ≤85%RH, noncondensing Pressure altitude: 700hPa~1060hPa
Storage and shipping condition| Ambient temperature: -20°C~55°C(-4°F ~ 131°F) Relative humidity: ≤95%RH, noncondensing
Pressure altitude: 700hPa to 1060hPa
Essential Performance| 1. In normal using condition 10°C~40°C (50°F~104°F), LABORATORY ACCURACY meet:
32.0°C~ 34.9°C(89.6°F~94.8°F) :   ±0.3°C(±0.6°F)
35.0°C~ 42.0°C(95°F~107.6°F):     ±0.2°C(±0.4°F)
42.1°C~ 43.0°C(107.8°F~109.4°F ):   ±0.3°C(±0.6°F)
2. OUTPUT TEMPERATURE
Displays “—— ℃” when measuring temperature above 43.0°C (109.4°F) and lower than 32.0°C (89.6°F).

Maintenance of the Product

Cleaning and Disinfection
The thermometer is a multi-patient reusable device, and the cleaning and disinfection instructions were validated. Please follow the instructions to clean/disinfect your thermometer prior to use.
Cleaning:

1. Use a cotton swab moistened with hot water or neutral detergent to throughout clean the casing of thermometer and measuring probe to remove stain or oil.
2. Inspect the thermometer visually after the cleaning process, ensure there is no soil or stain is seen. If the device is determined not to be visually clean at the end of the cleaning step, you should either repeat the relevant previous cleaning steps or safely dispose of the device so that a visibly soiled device is not used again.

Disinfection:

1. Disinfect the thermometer casing and the probe for 30 seconds with a cotton swab or non-dust cloth dipped in 75% ethanol.
2. Repeat the above steps at least 3 times, then wipe surface and probe dry with a clean cloth, and wait about 1 minute for drying after disinfection process.

Note:

• Ensure that no liquid enters the interior of the thermometer.
• Never use abrasive cleaning agents, thinners, or benzene for cleaning, and never immerse the thermometer in water or other cleaning liquids.
• Take care not to scratch the surface of the probe lens and the display.
• If the visual inspection identifies unacceptable deterioration such as corrosion, discoloration, pitting, cracked, the device should not be further used and should be discarded.
• If the thermometer has been used in patients, please visually inspect the thermometer to determine if there is stain or oil on the casing or probe after each use, and follow the instruction of cleaning and disinfection to cleaning your thermometer.

Care and Maintenance

• Please clean the thermometer regularly, usually once a month.
• If the probe tip is damaged, please contact the maintenance center.
• If necessary, you can clean it properly according to the actual dirt of the product; if you do not use this product for a long time (more than 2 months), install the forehead cap and replace all the batteries take out.
• Store ear thermometer in a dry location free from dust and contamination and away from direct sunlight.
• Do not use other batteries than mentioned batteries, do not use rechargeable batteries, do not throw in fire.
• Do not expose the thermometer to sunlight or water.
• Do not use the thermometer rudely. Dropping, crashing and severe shock will damage the product

Calibration:
This thermometer is calibrated at the time of manufactured, If the thermometer is used according to the instruction, periodic recalibration is not required. If at any time you question the accuracy of the measurement, please contact the retailer immediately.
Don’t attempt to modify or reassemble the thermometer.
The calibration operation of this product must have corresponding calibration equipment, otherwise it cannot calibrate by itself.

Troubleshooting

If you have problems while using your thermometer, please refer to this guide to help resolve the problem. If the problem persists, please contact our customer service.

batteries
Put batteries into the wrong polarity location| Keep the polarity correct with indicated on battery box
Measurements in lower| The wrong method of measuring| Measuring according to the correct manual instructions
| Dirt the ear canal or on the sensor| Measuring after cleaning away the dirt

EMC Declaration

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare and clinic environments.
Warning：Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
Warning：Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ear thermometer. Otherwise, degradation of the performance of this equipment could result.

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
   Portable and mobile RF communication equipment may affect the performance of the ear thermometer, avoiding strong electromagnetic interference when used, such as near mobile phones, microwave ovens, etc.

2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity

Guidance and manufacturer’s declaration- electromagnetic emissions and Immunity
Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11| Group 1
RF emissions CISPR 11| Class B
Harmonic emissions IEC 61000-3-2| Not application
Voltage fluctuations/flicker emissions IEC 61000-3-3| Not application

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2 Test level| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15
kV air
Electrical fast transient/burst
IEC 61000-4-4| Not application| Not application
Surge
IEC 61000-4-5| Not application| Not application
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| Not application| Not application
Power frequency magnetic field
IEC 61000-4-8| 30 A/m
50Hz/60Hz| 30 A/m
50Hz/60Hz
Conduced RF IEC61000-4-6| Not application| Not application
Radiated RF IEC61000-4-3| 10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz| 10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
NOTE UT is the a.c. mians voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF IEC61000-4-3 (Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication is equipment)| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Modulation| Distance (m)| IMMUNITY TESTLEVE L (V/M)
385| 380-390| TETRA 400| Pulse modulation 18 Hz FM| 1.8| 0.3| 27
450| 430-470| GMRS 460
FRS 460| ±5 kHz Deviation
1 kHz sine| 2| 0.3| 28
710| 704-787| LTE Band 13,17| Pulse modulation
217 Hz| 0.2| 0.3| 9
745
780
810| 800-960| GSM800/900,
TETRA800,
CDMA850,
LTE Band 5| Pulse modulation
18 Hz| 2| 0.3| 28
870
930
1720| 1700-1990| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,3,4,25;UMTS| Pulse modulation
217 Hz| 2| 0.3| 28
1845
1970
2450| 2400-2570| Bluetooth, WLAN, 802.11 b/g/n, RFID2450, LTE Band 7| Pulse modulation
217 Hz| 2| 0.3| 28
5240| 5100-5800| WLAN 802.11 a/n| Pulse modulation
217 Hz| 0.2| 0.3| 9
5500
5785

Warranty/service

In accordance with our policy of continual product
improvement, we reserve the right to make technical and optical changes without notice.
Warranty and repair terms
Warranty: 18 months.
Please contact your dealer or the service centre in case of a claim under the warranty. If you have to return the unit, please enclose a copy of your receipt and state what the defect is.
The following warranty terms apply:

1. The warranty period for BERRCOM products is 18 months from date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.

2. Defects in material or workmanship will be removed free of charge within the warranty period.

3. Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.

4. The following is excluded under the warranty:
   a. All damage which has arisen due to improper treatment, e.g. nonobservance of the user instructions.
   b. All damage which is due to repairs or tampering by the customer or unauthorised third parties.
   c. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.
   d. Accessories which are subject to normal wear and tear.

5. Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim.

• GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD EXPRESSLY DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
• UNDER ON CIRCUMSTANCES SHALL BERRCOM HAVE ANY OBLIGATION OR LIABILITY FOR ANY LOSS OF PROFIT OR FOR ANY CONSEQUENTIAL, INCIDENTAL INDIRECT, SPECIAL, PUNITIVE, OR CONTINGENT DAMAGES WHATSOEVER WITH RESPECT TO CLAIMS MADE BY ANY CUSTOMER, CONSUMER OR OTHER USER OF BERRCOM PRODUCTS.
• IN THE EVENT THAT ANY APPLICABLE LAWS IMPOSE WARRANTIES, CONDITIONS, OR OBLIGATIONS THAT CANNOT BE EXCLUDED OR MODIFIED, THIS PARAGRAPH SHALL APPLY TO THE GREATEST EXTENT ALLOWED BY SUCH LAWS.

Disposal

It is required that you should not dispose of WEEE as unsorted municipal waste and collect such WEEE separately.
In accordance with Directive 2012/19/EU and national disposal regulations regarding old electrical and electronic devices, please be advised that such items must be disposed of in a special way within the European Union (EU). These regulations require the environmentally friendly recycling/disposal of old electrical and electronic devices. Such items must not be disposed of as domestic refuse. This has been expressed using the icon of the “crossed out trash can”.
**** The ear thermometer (Model: ET005) contains batteries and recyclable electronic waste. To protect the environment, do not dispose of it in household waste as unsorted municipal waste, but collect separately and take it to an appropriate local collection center.
The ear thermometer (Model: ET005) is classified as small equipment (5th category) according to ANNEX IV of Directive 2012/19/EU.
Before disposing of your ear thermometer (Model: ET005), please take away the batteries from ear thermometer (Model: ET005) and dispose of the batteries and ear thermometer (Model: ET005) separately.
You can take away the batteries as follows:
＞＞Battery remove diagram

1. Open the lid on the back of the device
2. Remove the batteries.

Batteries represent a hazard to health and the environment! Never open, damage, or swallow batteries or allow them to pollute the environment. They may contain toxic, ecologically hazardous heavy metals. The removed batteries shall be disposed of at the point of sale or in the corresponding containers provided at collection points by local public waste authorities and treated according to 2006/66/EC.
The batteries and recyclable electronic waste shall be disposed of in a separate waste container.
Packaging materials must be disposed of according to local regulations. Consult the authorized collection points for more information.
In Germany
For the recyclable electronic waste disposal, you can search the authorized collection points at the following website: https://www.ear-system.de/ear- verzeichnis/sammel-und-ruecknahmestellen
For batteries, you can search the authorized collection points at the following website: https://www.ear-system.de/ear- verzeichnis/battghersteller#no-back
Search method: using your postcode or the name of the city and state where you live to find collection points near you.
Other countries
For country-specific information on disposal, contact your local dealers or importer.
**** Address: No.38 Huanzhen Xi Road, Dagang Town, Nansha, 511470 Guangzhou, PEOPLE’S
REPUBLIC OF CHINA
Tel: +86 (20) 34938449
Fax: +86 (20) 34936960

Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany

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