Pic Solution ThermoDiary EAR Instructions For Use Manual

ThermoDiary EAR
EN
Infrared ear thermometer
INSTRUCTIONS FOR USE
PLEASE READ THESE INSTRUCTIONS CAREFULLY BEFORE USE AND
KEEP THEM FOR FUTURE REFERENCE.
Dear Customer, thank you for choosing our product!
All PiC Solution thermometers are produced using the most advanced technology and undergo stringent
quality control checks, in accordance with EU legislation, to guarantee the utmost quality and precision. Do
not use this device for Live & Dead decision or Safety related applications. In case of doubts or increased
body temperature, consult a physician.
Probe cap
Measure
button
LCD
Fever
Indicator
ON/MEM
Intended Use: The infrared ear thermometer measures the infrared heat generated by the eardrum and
surrounding tissue to reflect patient's body temperature
Intended operator: At least 11 years old (5 years intensive reading experience), no maximum.
HOW TO TAKE A TEMPERATURE
Switching on the appliance and taking readings
1. Press "ON/MEM" button (see figure 1), the thermometer is ready for use after the icon stop flashing and
two short beep sound.
2. Taking Ear Temperature:
2.1 Gently move the ear back slightly to straighten the ear canal and very
carefully insert the probe into the canal. Aim towards the timpani membrane
to get the most accurate reading (fig. 2).
• For children under two years of age, gently pull the ear backwards.
• For children over two years of age and adults, gently pull the ear upwards
and backwards.
2.2 Press and hold the "MEASURE" button until you hear a beep sound. Remove
the probe from ear and read the temperature measurement on display.
2.3 For Next Measurement: After two short beeps are heard, the icon stops
flashing to be ready for next measurement.
PRECAUTIONS
• The thermometer tends to compensate ear temperature readings according to the room temperatures.
To get the most accurate reading the thermometer must stay in the room where it will be used, at stable
ambient temperature, for at least 15 minutes before operating. The person whose temperature will be
taken should also be in the same room for at least 5 minutes before taking the reading. Whilst taking the
temperature, make sure that the patient and thermometer are not exposed to direct heat, sunlight or air
conditioning.
• Before taking the reading, check that the ear canal is clean and accessible; do not clean the ear just before
using the probe as the use of hot or cold water will affect the reading.
• Do not take a person's temperature for at least thirty minutes after physical effort, a bath or after a meal.
• Always make sure the probe is clean and without damage.
REMARKS:
1. It is recommended that you measure 3 times with the same ear. If the 3 measurements are different, select
the highest temperature.
2. Before the measurement, please stay in a stable environment for 5mins and avoid the exercise, bath for
30mins.
3. To avoid the risk of cross contamination, please clean the probe according to "Care and cleaning" section
after each use.
4. The different temperature varies in healthy persons: between different parts of the body can be between
0.2~1°C
5. The "Clinical Bias" is -0.5~ -0.7°C.
6. The "Limits of Agreement" is 1.02.
7. The "Repeatability" is 0.19°C.
WARNING: Choking from swallowing small parts and batteries by children or pets is possible, please
keep small parts and batteries at places where children and pets can't reach.
PAIRING UP THE THERMOMETER WITH YOUR SMARTPHONE
1. Download the free app PIC HEALTH STATION from the Google Play and AppStore.
2. Turn on PIC HEALTH STATION app on your smartphone. Bluetooth® version v. 4.0 will be automatically
turned on.
3. Make sure the thermometer is powered on.
4. Search the thermometer with PIC HEALTH STATION and pair the thermometer with your smartphone.
5. During the pairing, only the smartphone to be connected with the thermometer shall run PIC HEALTH
STATION. If you meet problem in pairing please check that no other smartphone are running PIC HEALTH
STATION, or reboot your smartphone.
Please take note that the thermometer sends temperature data only when it is connected with your
smartphone.
Every temperature reading will be transfer to your mobile device automatically.
AFTER MEASUREMENT
1. Power off: Device will automatically shut off if left idle for more than 1 minute to extend battery life.
2. Clean the probe after each use to ensure an accurate reading and avoid cross contamination. (See the
section of Cleaning and Storage for details.)
3. Remember to put on the Probe Cap when not in use.
FUNCTIONS
Fever Indication
If the thermometer detects a body temperature ≥ 37.5°C (99.5°F), there will be "Red" light signal. At the
same time, a long beep sound followed by three short beep sounds to warn the user for potential fever; if
temperature < 37.5°C, there will be "Green" light signal.
WARNING: Red light - suggest continually monitoring the body temperature. If in doubt about the
person's condition, seek medical assistance.
MEMORY
There are total 25 sets memories for body temperature.
When power on, press the "ON/MEM" button to see the temperature stored with
Please take note that data stored in the memory of the thermometer are not sent to the app.
°C / °F SWITCH
In "Power off" mode. Press and hold the "MEASURE" button, then immediately press and release the "ON/MEM"
button. After 3 seconds, icon "°C" will be switched to icon "°F". (You may use the same way to switch back to "°C")
MUTE MODE
The device setting with buzzer is on, you can set buzzer on/off under Mute mode.
P 281 C
Probe lens
Probe
Battery cover
Figure 1
0-2 years +2 years
icon.
When power on, press and hold the "ON/MEM" button for 3 seconds. The icon will flash on the LCD screen
and then release the "ON/MEM" button to set MUTE. Thus you will not hear beep sounds. You can also use
the same process to turn off the Mute function.
NOTE: If keep pressing "ON/MEN" button for 5 seconds after icon flashing, the device will be power off
WITHOUT setting Mute.
Bluetooth®
The temperature data is automatically synced to the device via Bluetooth® v. 4.0
SPECIFICATIONS
• Comply with ASTM E1965-98, EN ISO 80601-2-56, IEC/EN60601-1-2(EMC), IEC/EN60601-1(Safety) standards,
ISO10993, RoHS
• Temperature measurement range: 34~42.2°C (93.2~108°F)
• Operating range: 10~40°C (50~104°F), 15%~85% RH
• Storage/ Transportation environment: Stored at room temperature between -20~+50°C, RH ≤ 85%
• Atmospheric pressure: 800~1013 hPa
• Accuracy: ±0.2°C (0.4°F) within 35~42°C (95~107.6°F), ±0.3°C (0.5°F) for other range.
• Battery: One lithium cell battery (CR2032 *1pcs)
• Enclosure Rating: IP54
• IP54 degree:
Protected against splashing water and dust-protected.
• Dimensions: 143.16 x 39.91 x 55.86 mm
• Weight: 75.7 grams including battery
• Battery life: Around 2,000 continuous readings.
• Expected Service Life: 4 years
• BT module: nRF51822
• Frequency: 2,402 - 2,480 GHz
• Output power range:
≤4 dBm
• Bluetooth® & Fever indication & memory and °C/°F switch function.
• This thermometer converts the ear temperature to display its "oral equivalent. " (according to the result of
the clinical evaluation to get the offset value).
WARNING:
• The device should not submerge into any liquids and expose it to direct moisture.
• There is no gender and age limitation for using infrared thermometer.
• This is not an AP or APG product and is therefore not suitable for use in the presence of mixes of flammable
or explosive anaesthetic gases, air, oxygen or nitrous oxide..
CARE AND CLEANING
WARNING: The probe is the most delicate part of the thermometer. Use with care when
cleaning the lens to avoid damage.
1. After the measurement, please use the cotton swab with the Alcohol (70% concentration)
to clean the lens(on the inside of the probe).
2. Allow the probe to fully dry for at least 1 minute.
3. Storage temperature range: It should be stored at room temperature between -20~ +50°C, RH ≤ 85%
4. Keep the unit dry and away from any liquids and direct sunlight.
5. The Probe should not be submerged into liquids.
*Note: Please check the device if damaged once it falls. If you can't make sure of it, please
send the complete device to the nearest retailer for recalibration.
WARNING: Holding the thermometer too long may cause a higher ambient temperature reading of
the probe. This could make the body temperature measurement lower than usual.
CHANGING THE BATTERY
• Battery replacement
• This device is supplied with one lithium cell (CR2032x1).
1. Please pick the rubber gasket on the battery cover by using small, pointed screwdriver with the "X" shaped.
2. Loosen the screw on the battery cover.
3. Use thumb to push battery cover out.
4. Hold the device and use the screwdriver to flip out the battery.
5. Replace new battery under the metal hook on the left side and press the right side of the battery down
until you hear a "click" sound.
6. Replace the battery cover and fasten the screw, and stuff the screw hole with the rubber gasket.
WARNING: The positive (+) side up and the negative (-) side pointed down.
TROUBLE SHOOTING
Error Message Problem
Error 5~9, the system is not functioning properly.
Measurement before device stabilization.
The ambient temperature is not within the
range between 10oC and 40oC (50oF ~104oF).
Temperature taken is higher than +42.2oC
(108°F)
Temperature taken is lower than +34oC
(93.2°F)
Device cannot be powered on to the ready stage.
SYMBOLS KEY
The CE mark and Notified Body Regi-
stration Numbers, the requirement of
Annex II from Medical Device Directi-
0120
ve 93/42/EEC are met.
(93/42/EEC)
Authorized representative in the European
community
Manufacturer
Battery Recycling
Classification of enclosure protection against
ingress of water and particulate matter.
Follow instructions for use
Instructions for use
Batch number or Lot Number
1
Solution
Unload the battery, wait for 1 minute and
repower it. If the message reappears, contact
the retailer for service.
Wait until all the icons stops flashing.
Allow the thermometer to rest in a room for
at least 15 minutes at room temperature:
10oC and 40oC (50oF ~104oF).
Spend 5 minutes at room temperature and avoid
physical exercise and bathing for 30 minutes; then
make sure that the probe lens is clean before ta-
king the temperature again.. If a malfunction still
exists, please contact the nearest retailer.
Change with a new battery.
Indicates this device is subject to the Waste
Electrical and Electronic Equipment Directi-
ve 2012/19/EU in the European Union. To
protect the environment, dispose of useless
device at appropriate collection sites accor-
ding to national or local regulations.
Caution
BF type applied part
Paper Recycling
The Bluetooth® combination mark,
Bluetooth® version v. 4.0
Product catalogue reference code or
catalog number
Stand-by
Compliance to RED directive
2014/53/EU
(2014/53/EU)
2