Berrcom DT007 Digital Thermometer User Manual

Digital Thermometer
Use Manual

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NOTE: You must read this instruction manual completely before use and follow all instructions. Keep the instructions for later use. You must check the device functions according to this instruction manual prior to each use and only use this device if it is in proper working condition.

INTENDED USE/INDICATIONS FOR USE

Digital Thermometer is intended to measure the body temperature orally, rectally, or under the arm, in a clinical or household environment for people of all ages (infants, children, and adults).

WARNINGS AND PRECAUTIONS

• Only use this thermometer once you have read and understood the instruction for use.

• Only use this thermometer for the specific purpose described in the instruction manual. Any misuse will void the warranty.

• This thermometer may be used for professional purposes or for personal home use.

• Using this thermometer is no substitute for consulting a doctor. Do not self-diagnose or self-medicate on the basis of the measurements without consulting your doctor.
  In particular, do not start taking any new medication or change the type and/ or dosage of any existing medication without prior approval. Specially, do not take any new medication or change the type and/or dosage of any existing medication without consulting your doctor and obtaining your doctor’s approval.

• Children must not be allowed to use this thermometer unsupervised, please put the thermometer in an untouched place for children after use. Medical device is not toy.

• If this thermometer is stored in a location that is cooler or warmer than where it is being used, let it sit in the patient’s room for at least 15 minutes before taking the measurement.

• After physical activity, a bath or spending time outdoors, wait approx. 30 minutes before you take a measurement.

• To ensure an accurate measurement, this thermometer must only be used indoors when the ambient temperature range is between 5°C(41°F) and 40°C (104°F) .

• This thermometer must always be kept in a clean, dry area.

• Do not expose this thermometer to electric shocks.

• Do not expose this thermometer to extreme temperature conditions of greater than 55°C(131°F) or less than -20°C (-4°F) .

• Do not use this thermometer in relative humidity higher than 85%.

• Do not expose the thermometer to direct sunlight, extremely high or low temperatures, dirt or dust.

• The device is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide.

• Do not drop this thermometer.

• Do not excessively bend the thermometer. Do not bite the thermometer.

• For cleaning, follow the instructions in section IX CLEANING AND DISINFECTING.

• Do not use this thermometer if it is damaged.

• Do not leave this thermometer where children can get to them. It contains small parts, including: battery, battery cover and probe cover, which might be swallowed by children.

• Do not expose the thermometer to water or other liquid, as it may damage the thermometer.

• Failure to use a probe cover while measuring rectal temperature may lead to bacteria and viral infection.

• If an error occurs or if the device is damaged. DO NOT attempt to repair this device yourself, as this will void the warranty. Contact your dealer and only have repairs carried out by authorized service partners.

• Manufacturer will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist to SERVICE PERSONNEL in parts repair.

• Remove the batteries if you do not wish to use the unit for an extended period of time. Otherwise, there is a danger that the batteries may leak.

• Keep the thermometer away from electromagnetic fields produced by objects such as microwave ovens, arc welders or induction heaters.

• The performance of the device may be degraded if patient temperature is below ambient temperature.

• This thermometer conforms to all of the requirements established in ASTM E1112. Full responsibility for conformance of this thermometer to the specification is assumed by Berrcom.

HOW TO TAKE A TEMPERATURE

Measurement methods

1. Measuring the axillary temperature: Before measuring, the arm prolapses naturally and clamp for three minutes to make the axillary temperature stable, then put the probe in the axillary central and clamp for about 30s, until the “°C” or “°F” symbol on the panel stops flashing, it will send out ten times slower “BI” sound, continue measuring for about three minutes.
   When measure at oxter

• Attach to the middle of oxter. Boost up slightly, then clamp it. In clamp it. In order to full touch between thermometer and body, please hold the arm lightly.
  Do not remove immediately after the buzzer rang out , continue about 3 minutes.
  

  2. Measuring the oral temperature: Before measuring, lips close for about 1 minute to make the oral temperature stable, then place a disposable probe cover carefully over the tip, and then put the probe under tongue inside of the roots, attach to the  tongue and close the lips about 30s, until the “°C” or “°F” symbol on the panel stops flashing, it will send out ten times slower “BI” sound, it means oral temperature has been completed.
     When measure at oral

• Attach to the right/eft of tongue’s roof.
  * To coarctated the thermal of thermometer by tongue.

• Carry it by hand to avoid the movement of thermometer.

• Do no open your mouth during measurement.
  The following conditions cannot be accurately measured)

• Just finished exercising, took a shower, finished eating.
  Please rest for more than 30 minutes.

• Wrapped in a quilt for a long time, when there is sweat under the armpit.
  Dry the sweat under the armpits.
  * Active immediately after getting up
  Please measure before the activity, or rest for 30  Minutes after the activity.
  ※ Activity immediately after waking up, body temperature will rise.

  3. Measuring the rectal temperature: Commonly used for babies, young children, or when it is difficult to take an oral or underarm temperature.
     (a) Place a disposable probe cover carefully over the tip, lubricate the probe cover with a water-soluble jelly for easier insertion. Do not use a petroleum jelly. Read the label of the lubricant to be sure you are using the right kind. Replace the probe cover with a new one after each use.
     (b) Lay the patient on his/her side. If the patient is an infant, the proper position for a baby is to lay on its stomach with legs hanging down, either across your knees or at the edge of a bed or changing table. This positions the infant’s rectum for safe and easy insertion of the thermometer.
     (c) Gently insert the tip of the thermometer no more than 1.3cm into the rectum. If you detect resistance, stop. Hold the thermometer in place during measurement about 30s.
     (d) When the temperature is stable, beep signals will sound.

PRODUCT DESCRIPTION

TURNING ON AND SETTING THE THERMOMETER

1. Start the device
   Press the “ON/OFF” button to switch on the digital thermometer, First, the screen panel display sabout 2 seconds, then the screen panel displays the last measurement value for about 2 seconds, then displays “37.0°C(98.6°F)” for about 1 second, finally displays the current temperature and the symbol “°C(°F)” flashing, at this time, the measurement has already started.

2. Start the device & switch the temperature unit Press the “ON/OFF” button to switch on the digital thermometer, the screen panel display   sabout 2 seconds. Then the screen panel displays the last measurement value with the current temperature unit for about 2 seconds. If you want to switch the temperature unit between “°C” and “°F”, you can press the “ON/OFF” button to turn off the thermometer, and then press and hold the “ON/OFF” button, first the the screen panel display sabout 2 seconds, then displays “Lo” with the temperature unit, continue to press and hold the “ON/OFF” button, finally the temperature unit is switched. After switching the temperature unit, the screen panel displays the last measurement value for about 2 seconds, then displays “37.0°C(98.6°F)” for about 1 second and then displays the current temperature and the symbol “°C(°F)” flashing, at this time, the measurement has already started.

3. Measuring the body temperature Put the probe into the measuring site, the screen panel will display the temperature gradually rises. At the same time, “°C(°F)” symbol flashes that indicates measuring. About 30 seconds, the “°C(°F)” symbol will stop flashing and sound out beep prompt, at this moment the measurement is completed and has memorized the measurement, the result will display on the screen panel. (Note: In order to get a more accurate measurement of temperature, it is recommended to measure for 3 minutes after the “BI” sound.)

4. Measurement results display and beep prompt

• If the temperature is higher than 32.0°C, but less than 37.7°C, the screen panel will display the measurement value, then the buzzer will send out ten times slower “BI sound.
• If the temperature is higher than 37.7°C, but less than 42.9°C, the screen panel will display the measurement value, then the buzzer will send out ten times hasty three-short “BI BI BI” sound.
• If the temperature is less than 32°C, the screen panel will display “Lo” and the buzzer sends out ten times slower “BI” sound, When the temperature is higher than 42.9°C, the screen panel will display “Hi” and the buzzer sends out ten times hasty three-short “BI BI BI” sound. 5. Power off After measuring, press the “ON/OFF” button to turn off the power. If not, it will automatically turn off within 10 minutes.

BATTERIES

1. ChaNging the batteries
   If the battery power is low, the screen panel will display the battery symbol “ ” and flashing, to remind you replace the battery.
   To change the battery, open the battery cover, use a toothpick to pick out the semi-PCB then pick the battery out, after that replace a new battery. And ensure the new battery is positioned in the correct manner. Improperly installing the battery could cause damage to the device.
   Do NOT use rechargeable battery. Only use single-use battery.
   The recommended battery specification is as below: AG3 button cell: DC 1.5V.

2. Disposing of batteries
   To protect environment, dispose of empty battery at appropriate collection sites according to national or local regulations.

Notes on handling batteries

• Use identical or equivalent battery types only.
• Do not use rechargeable battery.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• If your skin or eyes come into contact with battery fluid, rinse the affected area with water and seek medical assistance.

Choking hazard!

• Small children may swallow and choke on battery.
  Store battery out of the reach of small children.

Risk of explosion!

• Do not throw battery into a fire.
• Do not disassemble, split or crush the battery.
•  Protect battery form excessive heat.

TECHNICAL SPECIFICATION

1. Normal using condition:
   Ambient temperature: 5°C ~ 40°C(41°F ~ 104°F)
   Relative humidity: <85%
   Pressure altitude: 700 hPa to 1060 hPa

2.  Storage and shipping condition
   Storage temperature: -20°C ~ 55°C (-4°F ~ 131°F)
   Storage humidity: <95%
   Pressure altitude: 700hPa ~ 1060hPa

3. Temperature display resolution: 0.1°C (0.1°F)

4. Power source: DC1.5V (1pc AG3 button cell)

5. Measuring time: 30 seconds

6. Measuring site: orally, rectally or under the arm

7.  Measuring range: 32.0°C ~ 42.9°C(89.6°F ~ 109.2°F)

8. Measuring accuracy:
   32.0°C ~ 35.9°C(89.6°F ~ 96.6°F) +0.2°C(+0.4°F)
   36.0°C ~ 39.0°C(96.8°F ~ 102.2°F) +0.1°C(+0.2°F)
   39.1°C ~ 42.9°C(102.4°F ~ 109.2°F) +0.2°C(+0.4°F)

9. Temperature unit: Centigrade(°C)/Fahrenheit(°F)

10. Automatic power-off: After the measurement is completed, it will automatically shut down within 10 minutes.

11. Shelf Life: 5 years

12. The device is a direct mode.

13. Dimension: approx. 128×18x10mm(L×W×H)

14. Weight: approx. 10.29g

CLEANING AND DISINFECTING

The enclosure only needs routine cleaning and disinfection, and period or times can be depended on user’s need.
It is recommended to clean and disinfect once a week.
It is recommended, the probe needs clean and disinfect before and after each use.
The method of cleaning and disinfecting the probe and enclosure are as follows:

1. Cleaning method: take a piece of nonwoven saturated with distilled water to clean the surface of the probe and enclosure back and forth, until there’s no visibly soil and contamination.
2. Disinfection method: After cleaning, take another piece of nonwoven saturated with 75% alcohol to swab on the surface of the probe and enclosure back and forth.

The nonwoven saturated with 75% alcohol should be remained on the device at least for 15s.
After cleaning and disinfection, the thermometer should be drying at the room temperature for 15s before use.

Note:
A. Never use aggressive cleaning agents, thinners, benzine or tough brushes.
B. Do not attempt to disinfect the sensing section of the thermometer by immersing in alcohol.
C. Never submerge this thermometer in water or any other liquid.

INCLUDED IN DELIVERY

Digital Thermometer: 1pc
AG3 button cell: 1pc
User manual: 2pcs

CLASSIFICATION

1. Protection against electric shock: Internally powered equipment;
2. Applied part type: Type BF applied part;
3. Protect against harmful ingress of water/matter: IP22;
4. EMC classification: Group | class B
5. Sterilization or disinfection: Disinfection;
6. Category AP / APG equipment: N/A;
7. Mode of operation: Continuous operation;

TROUBLESHOOTING

1. When message “E” can show on the screen. The NTC is failure, the DT007 cannot work.
2. When message “ ” can show on the screen, need to change the battery.
3. Should a problem occur with your device, please contact you retailer. Do not attempt to repair this device yourself.

SIGNS AND SYMBOLS

vertically falling water drops when enclosure tilted up to 15°
| DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
| Refer to instruction manual / booklet
| Batch code| | Date of manufacture
| Application part, Type BF| | Model number
| Direct current| | Medical device
****| Manufacturer| | Country of manufacture

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 equipment DT007, including cables specified by the manufacturer. 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 DT007, 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, t4 kV, t8 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 Alm 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 communications equipment)| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Modulation| Distance
(m)| IMMUNITY TEST LEVEL (V/m)
385| 380-390| TETRA 400| Pulse modulation 18 Hz| 2.| 0.3| 27
450| 430-470| GMRS 460,FRS 460| FM ±5 kHz
deviadon1 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| GSM 800/900, TETRA 800, CDMA 850, 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, RFID 2450, 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

**** Guangzhou Berrcom Medical Device Co., Ltd.
Address: No.38 Huanzhen Xi Road, Dagang Town, Nansha,
Guangzhou, Guangdong, CHINA 511470
Tel: +86(20)34938449
Email: service@berrcom.com

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