BESTMED DMT-4318 Instant Flexible Digital Thermometer Owner’s Manual

BESTMED DMT-4318 Instant Flexible Digital Thermometer Owner’s Manual

Warning :

• Read instructions thoroughly before using digital thermometer.
• Choking Hazard: Thermometer cap and battery may be fatal if swallowed.
• Do not allow children to use this device without parental supervision.The Patient is an intended operator.
• Do not use thermometer in ear. Designed use is for oral, rectal, and armpit (axilla) readings only.
• Do not place thermometer battery near extreme heat as it may explode.
• Remove battery from the device when not in operation for a long time.
• The use of temperature readings for self-diagnosis is dangerous. Consult your doctor for the interpretation of results. Self-diagnosis may lead to the worsening of existing disease conditions.
• Do not attempt measurements when the thermometer is wet as inaccurate readings may result.
• Do not bite the thermometer. Doing so may lead to breakage and/or injury.
• Do not attempt to disassemble or repair the thermometer. Doing so may result in inaccurate readings.
• After each use, disinfect the thermometer especially in case the device is used by more than one person.
• Do not force the thermometer into the rectum. Stop insertion and abort the measurement when pain is present. Failure to do so may lead to injury.
• Do not use thermometer orally after being used rectally.
• For children who are two years old or younger, please do not use the devices orally.
• If the unit has been stored at temperatures over 41℉～104℉(5℃～40℃), leave it in 41℉～104℉ (5℃～40℃) ambient temperature for about 15 minutes before using it.

Indications For Use

The digital thermometers are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 years old with adult supervision.

PLEASE READ CAREFULLY BEFORE USING

This digital thermometer provides a quick and highly accurate reading of an individual’s body temperature. To better understand its functions and to provide years of dependable results, please read all instructions first.
This appliance conforms to the following standards:
ASTM E1112 Standard Specification for Electronic Thermometer 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, 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 and complies with the requirements of IEC 60601-1-2(EMC), AAMI/ANSI ES60601-1(Safety) standards. And the manufacturer is ISO 13485 certified.

CONTENTS

• 1 Thermometer,
• 1 Owner’s Manual,
• 1 Storage Case

PRODUCT ILLUSTRATION

PRECAUTION

The performance of the device may be degraded should one or more of the following occur:

• Operation outside the manufacturer’s s tated te mperature and humidity range.
• Storage outside the manufacturer’s s tated te mperature and humidity range.
• Mechanical shock (for example, drop test) or degraded sensor.
• Patient temperature is below ambient temperature.
  *Portable and mobile RF communications can affect the device. The device needs special pre-cautions regarding EMC according to the EMC information provided in the accompany documents.

*Do not use the devices in the MR environment.

SYMBOL EXPLANATION

| Direct Current| | Batch Code
---|---|---|---
| Type BF Applied Part| | Manufacturer
| Consult Accompanying Documents| | Storage and Transportation

Temperature Limit:-4℉～131℉ (-20℃~55℃)

SPECIFICATIONS

Type:

| l Thermometer (Not Predictive)
---|---

Measure Range:

| 90.0℉-109.9℉(32.0℃－42.9℃) (℃ /℉chosen by manufacturer )
Accuracy:|

±0.2℉(±0.1℃) during 95.9℉~107.6℉(35.5℃~42.0℃) at 64.4℉~82.4℉(18℃~28℃ ) ambient operating range ±0.4℉(±0.2℃) for other measuring and ambient operating range

Operating mode:

| Direct Mode
Display:|

Liquid crystal display, 3 1/2 digits

Memory:

| For storing the last measured value
Battery:|

One 1.5 V DC. button battery (size LR41or SR41, UCC 392)

Battery life:

| Approx. 200hours of continuous operation or 1 year with 3 measurements per day
Dimension:|

13.9cm x 2.2cm x 1.3cm (L x W x H)

Weight:

| Approx. 11 grams including battery
Expected service life:|

Three years

Ambient operating range:

| Temperature: 41℉～104℉(5℃～40℃) Relative humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa
Storage and transportation condition:|

Temperature:-4℉～131℉ (-20℃~55℃) Relative humidity: 15%~95%RH Atmospheric Pressure : 700hPa ~ 1060hPa

Ingress Protection Rating:

| IP 27
Classification:|

Type BF

℉/℃ SWITCHABLE

Temperature readings are available in the Fahrenheit or Celsius scale (℉/℃; located in the upper right corner of LCD.) With the unit off, press and hold the On/Off Button for approximately 2 seconds to change the current setting.

DIRECTIONS

1. Press the On/Off Button next to LCD display. A tone will sound as the screen shows , followed by last recorded temperature. After showing the self-test temperature, the thermometer is now in the testing mode.

2. Position thermometer in desired location (mouth, rectum, or armpit.)

   • Oral Use: Place thermometer under tongue as indicated by“√” position shown in Figure 2. Close your mouth and breathe evenly through the nose to prevent the measurement from being influenced by inhaled/exhaled air.
   • Rectal Use: Lubricate silver probe tip with petroleum jelly for easy insertion. Gently insert sensor approximately 1cm (less than 1/2 “) into rectum.
   • Armpit Use: Wipe armpit dry. Place probe in armpit and keep arm pressed firmly at side.
     From a medical viewpoint, this method will always provide inaccurate readings, and should not be used if precise measurements are required.

3. The degree sign flashes throughout the testing process. When flashing stops an alarm will beep for approximately 10 seconds. The measured reading will appear on the LCD simultaneously. The minimum measurement time until the signaling tone (beep) must be maintained without exception. The measurement continues even after the buzzer notification. So that in order to achieve better body temperature measurement result, recommend to keep the probe in mouth and rectum about 2 minutes, or in armpit about 5 minutes regardless of the beep sound and at least 30 seconds measurement interval should be maintained.
   Note: Normally the buzzes are“Bi-Bi-Bi- B i-”; A larm beeps more rapidly when temperature reaches 100℉ (37.8℃) or higher ,and the buzzes are“ Bi-Bi- Bi—– Bi-Bi-Bi——- Bi-Bi-Bi

4. To prolong battery life, press the On/Off Button to turn unit off after testing is complete. If no action is taken, the unit will automatically shut off after around10 minutes.

TROUBLESHOOTING

| Temperature   taken   is lower than 90.0°F(32.0°C)| Turn off, wait one minute and take a new temperature via close contact and sufficient rest.
| Temperature    taken    is higher than 109.9°F(42.9°C)| Turn off, wait one minute and take a new temperature via close contact and sufficient rest.
| The system is not functioning properly.| Unload the battery, wait for 1 minute and repower it. If the message reappears, contact the retailer for service.
| Dead battery: Battery icon is flashing, can’t be measurable.| Replace the battery.

BATTERY REPLACEMENT

1. Replace battery when“ ”appears in the lower right corner of LCD display.

2. Pull battery cover off as shown in Figure 3.

3. Gently pull out plastic circuit board with battery chamber approximately 1 cm (slightly less than1/2″.) (See Figure 4)
   

4. Use pointed object such as a pen to remove old battery. Discard battery lawfully. Replace with new 1.5V DC button type LR41 or SR41,UCC392, or equivalent. Be sure battery is installed with “+” polarity facing up. (See Figure 5)
   
   

5. Slide battery chamber back into place and attach cover.

CLEANING AND DISINFECTION

1. Immerse the thermometer probe in distilled water for at least 1 minute;

2. Using a clean, soft cloth to wipe the thermometer down to remove any residue;

3. Repeat step 1 and 2 for three times until no soil is seen with visual inspection after cleaning;

4. For thoroughly clean and disinfection, please use method A or B：
   Method A(High level disinfection): immerse the thermometer probe in 0.55% OPA(O-Phthaldehyde), such as CIDEX OPA, for at least 12 minutes under temperature at 20℃;
   Method B(Low level disinfection): Using a clean soft cloth dipped in 70% medical alcohol,wipe the probe 3 times,at least one minute for each time.

5. Repeat step 1 to 3 to remove OPA residuals;
   Note1: Rectal use is not recommended for home use as OPA will not be readily available outside of a hospital.
   If rectal measurement is necessary, we strongly recommend high level disinfection.
   Note2: Please operate according to the manual of OPA for reference.
   To prevent damage to the thermometer please note and observe the following:

   • Do not use benzene, paint thinner, gasoline or other strong solvents to clean the thermometer.
   • Do not attempt to disinfect the sensing probe (tip) of the thermometer by immersing in alcohol, OPA or in hot water (water over 122℉(50℃) for long time.
   • Do not use ultrasonic washing to clean the thermometer.

CALIBRATION

The thermometer is initially calibrated at the time of manufacture. If the thermometer is used according to the use instruction, periodic readjustment is not required. However, we recommend checking calibration every two years or whenever clinical accuracy of the thermometer is in question. Turn on the thermometer and insert into the water bath and then check the laboratory accuracy. Please send the complete device to the dealers or manufacturer. ASTM laboratory accuracy requirements in the display range of 98.6 to 102.2 °F (37.0 to 39.0 °C) for electronic thermometers is ±0.2°F(±0.1°C).
The above recommendations do not supersede the legal requirements. The user must always comply with legal requirements for the control of the measurement, functionality, and accuracy of the device which are required by the scope of relevant laws, directives or ordinances where the device is used.

FCC INFORMATION

Caution: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user authority to operate the equipment.
*Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the distance between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

LIMITED WARRANTY

The thermometer is guaranteed for one year from the date of purchase. If the thermometer does not function properly due to defective components or poor workmanship, we will repair or replace it free of charge. All components are covered by this warranty excluding the battery. The warranty does not cover damages to your thermometer due to improper handling. To obtain warranty service, an original or copy of the sales receipt from the original retailer is required.

Disposal of this product and used batteries should be carried out in accordance with the national regulations for the disposal of electronic products.
JOYTECH HEALTHCARE CO.LTD.
No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city, 311100 Zhejiang,China

Document No. :JDMT-2104-002
Article No.: 001
Version: A
Date of Issue: 2020.01

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