JOYTECH DET-1025b Infrared Ear Thermometer Owner’s Manual
- June 13, 2024
- Joytech
Table of Contents
Owner’s Manual
Infrared Ear Thermometer
**Model DET-1025b
**
Introduction
Please read all instructions carefully and thoroughly before using this
product.
The DET-1025b thermometer is specifically designed for safe use in the
eardrum. The Infrared Ear Thermometer is a device capable of measuring
people’s body temperature by detecting the intensity of infrared light emitted
from the ear canal of human. It converts he measured heat into a temperature
reading displayed on the LCD.
When properly used, it will quickly assess your temperature in an accurate
manner.
Indications for Use:The infrared ear thermometer is intended for the
intermittent measurement of human body temperature.The device can be reused by
people of all ages for home use and clinical use.
Intended use:The infrared ear thermometer is used to measure body temperature.
This appliance conforms to the following standards:
ASTM E1965-98 Standard Specification for Infrared Thermometers 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.
Warning
-
This thermometer is intended for home use only.
It’s not meant to replace a visit to the doctor. Please consult with doctor if you have health concerns. -
There is no gender or age limitation for using infrared ear thermometer.
-
To avoid inaccurate readings, always attach a new, clean probe cover for each temperature reading.
-
Do not expose the thermometer to temperature extremes (below -25℃/-13℉ or over 55℃/131℉) nor excessive humidity (>95%RH).
-
This thermometer must only be used with this brand thermometer probe covers.
-
Keep the battery away from children.
-
Remove battery from the device when not in operation for a long time.
-
Do not put the thermometer in direct sunlight or with cotton wool, otherwise the accuracy will be affected.
-
Portable and mobile RF communications can affect the devise.
The device needs special precaution regarding EMC according to the EMC information provided in the accompany documents. 10. ME equipment should not be cleaned and disinfected while in use. -
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
-
The probe of the ME equipment shall not be serviced or maintained while in use with a patient.
Product Description
1. Probe Cover | 6. Battery Cover |
---|---|
2. Probe | 7. Dust Cover |
3. Test Button | 8. Nightlight |
4. Memory Button | 9. LCD |
5. Setting Button |
LCD Display Introduction
Basic Functions
Ear Temperature Mode| The thermometer has been designed for practical use.
It’s not meant to replace a visit to the doctor. Please also remember to
compare the measurement result to your regular body temperature.
→Please see the Illustration For Use section to learn how to measure the body
temperature.
---|---
Probe cover detection and eject function| The thermometer has been designed
for use with or without probe
cover. Users can press the eject button to remove the probe cover.
Object Temperature Mode| The object mode shows the actual, unadjusted surface
temperatures, which is different from the body temperature. It can help you to
monitor if the object temperature is suitable for the baby or patient, for
example the baby’s milk.
-. Please see the Illustration For Use section to learn how to measure the object emperature.
Beep Hint| When the testing is done, it will sound one short beep.
Memory Mode| The machine can store up to 30 sets of measurements. Each memory
also records the measurement results mode. When the data exceeds 30 sets, the
coverage starts from the earliest data.
°C/ °F Switch| Please see the Illustration For Use section to learn how to
change between Celsius and Fahrenheit.
Sound Switch| You can use the Setting Button to choose whether to turn on or
off the sound.
Bluetooth sign| If the APP is successfully connected to the machine,the
Bluetooth sign will always be on, otherwise it will keep flashing.
Nightlight| After the thermometer is turned on, the nightlight automatically
lights up, which is convenient for lighting at night. The nightlight is
automatically turned off during measurement and after the thermometer is
turned off.
Ear Thermometer Advantages
Infrared Ear Thermometer measures core body temperature, which is the
temperature of a body’s vital organs. (See Figure 1) Ear temperatures
accurately reflect core body temperatures since the eardrum is in the cranial
cavity and is not affected by the environment. The eardrum shares blood supply
with the hypothalamus (part of the brain.) Therefore, body temperature changes
are reflected sooner in the ear than they are in other parts of the body.
Clinical studies have shown that the ear is an excellent site for temperature
measurement because temperatures taken in the ear , reflect the body s core
temperature. Body temperature is regulated by the hypothalamus, which shares
the same blood supply as the
tympanic membrane. Changes in core body temperature are usually seen sooner at
the tympanic membrane than at other sites, such as the rectum, mouth or under
the arm.
Advantages of taking temperatures at the ear versus other sites:
- Axillary temperature readings only reflect skin temperature which may not indicate the internal body temperature.
- Rectal temperatures often lag significantly behind internal body temperature changes, especially at times of rapidly changing temperatures.
- Oral temperatures are often influenced by eating, drinking, thermometer placement, breathing through the mouth, or the inability of the person to close their mouth completely.
Body Temperature
The temperature of a healthy person is affected by various factors: the
person’s individual metabolism, their age(body temperature is higher in babies
and toddlers and decreases with age. Greater temperature fluctuations occur
faster and more often in children, e.g. due to growth spurts), their clothing,
the ambient temperature, the time of day(body temperature is lower in the
morning and increases throughout the day towards evening), the preceding
physical and, to a lesser extent, mental activity.
It is suggested that users develop the habit of daily measurement, and use
this product to establish a private normal temperature range for themselves
and their families as a reference for measurement.
Illustration For Use
To measure ear temperature:
-
To achieve accurate readings, if a probe cover is needed ,make sure a new, clean probe cover is in place before each measurement.
Place a new probe cover on the probe firmly; making sure the probe and the inner portion of the probe cover fit snugly. -
Press the Test Button, the display is activated to show all segments. After self-checking Figure 2 appears on the display screen with beeps, so you can start a new measurement. If error messages appears, it means the thermometer is not ready for measurement. Remarks:
a. Probe cover sign stand for taking the ear temperature with probe cover now and vice versa.
b. To avoid the risk of cross contamination, it is recommended that you always measure the ear temperature with probe cover. -
Insert the probe along the ear canal as deep as possible into the ear as depicted in Figure 3. Then press the Test Button once to start the measurement. A short beep will sound approximately 1 second after the Test Button is activated. This signals the end of the process as results are displayed on the LCD screen.
-
The thermometer is ready for testing again once an ear mark displays on the LCD. A waiting period of 20 seconds between testing is recommended to avoid excessive cooling of the skin.
-
The thermometer will shut off automatically after 15 seconds of inactivity.
-
How to turn on or off sound:
You can press Setting Button to turn on or off sound. -
How to change the ear mode and object mode:
You can press and hold Setting Button to switch the mode between ear mode and object mode. -
How to change the Fahrenheit and Celsius:
You can press and hold Memory Button to select the unit you want. -
To measure object temperature:
1. First eject the probe cover.
2. Aim the thermometer at the center of the object you want to measure with a distance of 1 to 2 cm.
3. Press the Test Button to turn on the thermometer, press and hold Setting Button to switch to object mode. You can take the object temperature after hearing two beep sounds.(see figure 4)
Remarks:
This mode shows the actual, unadjusted surface temperatures, which is different from the body temperature. -
After measurement:
1. Power off:
Device will automatically shut off if left idle for more than 15 seconds to extend battery life.
2. Clean the probe after each use to ensure an accurate reading and avoid cross contamination.
(See the section of Care and Cleaning for details.)
● BackLight:
In Ear mode:
1. The display will be lighted GREEN for 3 seconds with a happy face ?when the unit is ready for measurement and a measurement is completed with a reading less than 37.3 (99.1 ).
2. The display will be lighted YELLOW for 3 seconds with a happy face? when a measurement is completed with a reading less than 37.8℃(100.0 ).
3. The display will be lighted RED for 3 seconds with a bad face? when a measurement is completed with a reading equal to or higher than 37.8℃(100.0 ).
In Object mode:
The display will only be lighted WHITE for 3 seconds when the unit is ready for measurement and a measurement is completed. -
Bluetooth requirements
The thermometer requires a bluetooth device with:
. Bluetooth 5.0 or later
. Android 6.0 or later
. IOS 10.0 or later
And works with:
. iphone , iPod, iPad
. Android Phones and Tablets -
Using for the first time
1. Download the “JoyHealth” App from Website or APP Store (Such as Apple Store).
2.Open the App on your phone or tablet. If requested, you should enable Bluetooth on your device. You can enable Bluetooth under the Settings menu on your smart phone or tablet.
3. Create a new user login, or login with your existing user name and password.
4. Selection device “Thermometer”. -
Match your thermometer with a Smart Device
1. If this is your first time using it, bind first.Open “SETTING” menu,choose“Bind and unbind device” and select the appropriate model.
The date and time on your thermometer will automatically be updated when it’s connected with your phone.
2. Confirm that your thermometer is connected successfully.
When your thermometer is connected successfully to your smart phone, the “ ” symbol stop flashing and keep showing. -
Transfer your readings
1. As soon as your measurement is finished, open the app on your smart phone to transfer the readings.
Note : On the matched smart phone, Bluetooth must be enabled.
2. You can view your temperature readings in the app.
Temperature Taking Hints
-
The right ear reading may differ from the reading taken at the left ear. Therefore, always take the temperature in the same ear.
-
The ear must be free from obstructions or excess earwax buildup to take an accurate reading.
-
External factors may influence ear temperatures such as:
● lying on one ear or the other
● their ears covered
● exposed to very hot or very cold temperatures
● recently swimming or bathing
In these cases, remove the individual from the situation and wait 20 minutes prior to taking a temperature. -
For persons wearing hearing aids or ear plugs, remove the device and wait 20 minutes prior to taking a temperature.
-
When using the thermometer on infants under age 1, pull the ear up making sure the sensor faces the eardrum. (See Figure 5)
-
When using the thermometer on individuals over the age of 1, pull the ear back making sure the sensor faces the eardrum. (See Figure 6)
-
Do not touch the probe window. A cotton swab and rubbing alcohol may be used to clean the sensor window.
-
If the thermometer is stored in a significantly different environment than testing location, place it in the testing location for approximately 30 minutes prior to use.
-
It is not intended for use in the oxygen rich environment and presence of flammable anesthetic mixture with air, oxygen or nitrous oxide.
-
The Applied part is the probe.
-
The patient is an intended operator.
Memory Mode
- The Memory Mode can be accessed either in ear mode or object mode:
When the thermometer has been turned on and followed by Figure 2/4 or finished testing, press the Memory Button.
The letter M will appear in the upper left corner of the display. (See Figure
-
The thermometer will automatically memorize the last 30 temperature readings.
Each time the Each memory also records the Button measurement mode icon.
Memory is pressed, the screen displays past readings that correspond with a number 1-30. The number 1 reflects the most recent reading, while the number 30 reveals the oldest reading stored in memory.(See Figure 8) -
In the memory mode, mark or mark will not change.
The user can press the Test Button to take new measurements.
Care And Cleaning
-
Probe covers are intended for single use only!
Absent, damaged, perforated, or soiled probe covers can lead to inaccurate temperature readings. -
The probe window must be kept clean, dry, and undamaged at all times to ensure accurate readings. The accuracy of temperature readings can be affected by damage to the probe window, or the presence of dirt and ear wax on the probe window.
-
Fingerprints, earwax, dust and other soiling compounds reduce transparency of the window and result in lower temperature readings. If the thermometer is accidentally placed in the ear without a probe cover installed, the window must be cleaned immediately.
-
The probe window is the most delicate part of the thermometer.
To safely clean the window, gently wipe its surface with a cotton swab slightly moistened with isopropyl alcohol and immediately wipe dry with a clean cotton swab. After cleaning, allow at least
5 minutes drying time before taking temperatures.
Note : Do not use any chemical other than isopropyl alcohol to clean the probe window. -
Use a soft, dry cloth to clean the thermometer display and exterior.
-
Do not put the thermometer into water directly.
-
Store the thermometer and probe cover in a dry location, free from dust and contamination and away from direct sunlight.
-
Periodic cleaning and disinfection of the device following use to prevent patient cross infection.
-Use a soft cloth slightly moistened with a 75% isopropyl alcohol solution to disinfect the thermometer and probe. Do not use abrasive cleaners. -
Ensure that children do not use the instrument unsupervised; some parts are small enough to be swallowed.
-
Do not remove or modify the equipment without permission.
-
Put the thermometer back to the original packaging after using.
Battery Replacement
- Replace battery when ” appears in the upper right corner ” “of LCD display. (See Figure 9)
- Slide battery cover down as shown in Figure 10.
- Remove battery and install 1 new AAA alkaline battery as shown in Figure 11 .
- Slide battery cover back on.
Specifications
Measuring range| Ear mode: 32.0t-43.0t(89.67-109.47) Object mode: Or-
100t(327-2127)
---|---
Measuring site| Ear canal(Ear Mode)
Reference body site| Oral (This thermometer converts the ear temperature to
display its “oral equivalent.”)
Operation mode| Ear mode(Adjust mode)
Laboratory accuracy| Ear mode:
±0.2t (0.47) during 35.5t-42.0t (95.97-107.67)
at 15t-35t (59.07-95.07) operating temperature range ±0.3-C (0.57) for other
measuring and operating temperature range
Object mode: ± 4% or ±2t(47) whichever is greater
Display resolution| 0.1t or 0.17
Measure time| Approximately one second
Operating temperature range:| I Ot-40t(507-1047), I S%-85%RH, non-condensing
Atmospheric Pressure : 70kPa – 106kPa
Storage and transport temperature range| -25r- 55r (-137-1317), 15%-95%Ril,
non-condensing Atmospheric Pressure : 70kPa – 106kPa
Clinical accuracy
1-5 years old:| 0-1 year old:
Clinical bias: -0.07t (-0.137) ; Clinical repeatability: 0.10t (0.187) ;
Limits of agreement:0.55C (0.997)
Clinical bias: 0. 20t (0. 367) : Clinical repeatability: 0.12t (0.227) ;
Limits of agreement:0.80t (1.447) Over 5 years old:
Clinical bias: 0. 113t (0. 327) ; Clinical repeatability: 0.10-C (0.187) ;
Limits of agreement:0.60t (1.087)
Shock| withstands drop of 3 feet
Dimension| 150.2•77.425.5mm
Weight| Approx.79grams(with batteries)
Battery| DC1.5V(1 X AAA battery)
Battery life| Approx. 3000 readings
Applied part| Probe
Expected service life/ Shelf life| Three years
Ingress protecting rating| 1P22
Accessories| Battery,probe cover
Contraindications| None
Bluctooth technical parameters| Modulation mode: GFSK
Frequency range: 2400-2483.5MHz Bandwidth occupied: ;52MHz Transmit power:
4.5.20db
Troubleshooting
Error message | Problem | Solution |
---|---|---|
Measurement before thermometer is ready | Take a measurement |
T
until ..42 or *appears on the display.
| The ambient temperature is not within the range between 10°C and 40°C
(50°F-104°F).| Place the thermometer in a room for at least 30 minutes at room
temperature between 10°C and 40°C
(50°F —104°F )
| The thermometer is placed incorrectly or unsteady.| Read Illustration For
Use thoroughly and
U
take a new temperature measurement.
| The thermometer showing a rapid ambient temperature change| Allow the
thermometer to rest in a room for at least 30 minutes at room temperature:
between 10°C and 40°C
(50°F —104°F )
| The thermometer is not functioning properly.| Unload the battery, wait for 1
minute and repower it. If the message reappears. contact the retailer for
service.
| In object temperature mode, measurement with probe cover.| Remove probe
cover in object temperature mode.
---|---|---
| In Ear mode: Temperature taken is higher than 43.0 °C (109.4°F).
In Object mode: Temperature taken is higher than 100 °C (212°F).| Read
Temperature Taking Hints Thoroughly, then check the integrity of the probe
cover and take a new temperature measurement.
| In Ear mode: Temperature taken is lower than 32.0 °C (89.6°F).
In Object mode: Temperature taken is lower than 0 °C
(32°F).| Read Temperature
Taking Hints thoroughly , then make sure the probe cover and lens filter are
clean, then take a new temperature measurement.
| The thermometer works properly.| Use the thermometer normally
| When battery outline flashes, it indicates that the power is low, but you
can continue to measure.| The thermometer will take a proper measurement but
batteries must be replaced soon.
| The thermometer could not work due to low battery.| Replace a new alkaline
battery size AAA.
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 recommends checking calibration
every two years or whenever clinical accuracy of the thermometer is in
question. Please send the complete device to the dealers or manufacturer.
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 ordinanceswhere the device is used.
A clinical summary and procedures for checking calibration are available upon
request.(Turn on the thermometer and press the button to enter memory mode.
And press and hold Memory button long time until entering into calibrate mode,
software version will be displayed.)
Symbol Explanation
| Caution
---|---
| Direct Current
| Batch Code
| Storage and Transportation Temperature Limit: -13T-131°F(-25t-55°C)
| TYPE BF APPLIED PART
| Refer to instruction manual/booklet
| Generalaymbol for recovery/ recyclable
****| Disposal of this product and used batteries should be carried out in
accordance with the national regulations for the disposal of electronic
products.
| Atmospheric pressure limitation
| Storage and Transportation Humidity limitation: 15%-95%RH
| Manufacturing Date
| Manufacturer
IP22| The first num.2:Protected against solid foreign objects of 12,5 mm 0 and
greater.
The second num.2:Protection against vertically falling water drops when
ENCLOSUREtilted up to 15° .
Service
The thermometer has a limited one year warranty. Do not attempt to disassemble
or repair the thermometer by yourself. Should service be required during or
after the warranty period you must contact the manufacturer. Repackage the
thermometer carefully in
its original packaging or securely pack to avoid damage during shipping.
Include the original sales slip indicating the date of purchase, a note
describing the problem, and your return address.
Send the thermometer prepaid and insured.
The lay operator or lay responsible organization should contact the
manufacturer or the manufacturer’s representative:
- for assistance, if needed, in setting up, using or maintaining the thermometer; or
- to report unexpected operation or events.
Warranty
Thermometer is warranted by manufacture to be free from defects in material and workmanship under normal use and service for a period of one year from the date of delivery to the first user who purchases the instrument. This warranty does not cover batteries, damage to the probe window, or damage to the instrument caused by misuse, negligence or accident, and extends to only to the first purchaser of the product. Additionally this warranty becomes void, if the thermometer is operated with anything other than this brand hermometer probe covers.
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.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
- This device may not cause harmful interference, and
- this device must accept any interference received, including interference that may cause undesired operation.
The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction.
Electromagnetic Compatibility Information
The device satisfies the EMC requirements of the international standard IEC
60601-1-2.The requirements are satisfied under the conditions described in the
table below. The device is an electrical medical product and is subject to
special precautionary measures
with regard to EMC which must be published in the instructions for use.
Portable and mobile HF communications equipment can affect the device. Use of
the unit in conjunction with non-approved accessories can affect the device
negatively and alter the
electromagnetic compatibility. The device should not be used directly adjacent
to or between other electrical equipment.
Table 1
Guidance and manufacturer’s declaration — electromagnetic emission
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in
such an environment.
Emissions test| Compliance
Conducted emission
CISPR II| Not applicable
Radiated emission
CISPR I I| Group I Class B
I Iarmonic emissions
IEC 61000-3-2| Not applicable
Voltage fluctuations /
flicker emissions
IEC 61000-3-3| Not applicable
Table2
Guidance and manufacturer’s declaration — electromagnetic immunity
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should
assure that it is used in such an environment.
Immunity test| IEC 60601
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
Electrostatic
transient / burst
IEC 61000-4-4| *2 kV for power
supply lines
100 kHz repetition frequency
- I kV for input/output
lines| N/A
Surge
IEC 610004-5| * 0.5 kV, ± I kV differential
mode
line-line| N/A
Voltage dips, short
interruptions and
voltage variation..
on power supply
input lines
IEC 610004.11| 0 % UT
(100 %dip in UT )
for 0.5 cycle at 0°. 45°. 90°. 135°,180°, 225°, 270°, and 315°
0 % UT
(100 %dip in UT) for I cycle at 0°
70 % UT
(30 %dip in UT )
for 25/30 cycles at 0°
0 % UT
(100 %dip in UT)
for 250/300 cycle at 0°| N/A
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8| 30 Alm, 50/60Hz| 30 A/m, 50/60Hz
Proximity magnetic fields| IEC 61000-4-39| See Table 3
NOTE: UT is the a. c. mains voltage prior to application of the test level.
Table3
Test specifications for ENCLOSURE PORT IMMUNITY to proximity magnetic fields
Test frequency| Modulation| IMMUNITY TEST LEVEL lAhn)
30 kHz a)| CW| 8
134.2 kHz| Pulse modulation b)
2.1 kHz| 65 c)
13.56 MHz| Pulse modulation b)
50 kHz| 7.5 c)
a)This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use
in the HOME HEALTHCARE ENVIRONMENT.
b)The carrier shall be modulated using a 50% duty cycle square wave signal.
c)Lin . belbre modulation is applied.
Table4
Guidance and manufacturer’s declaration — electromagnetic immunity
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in
such an environment.
Immunity test| IEC 60601 test
level| Compliance
level
Conducted RF
IEC 610004-6
Radiated RF
IEC 610004-3| 3 Vrms
150 kHz to 80 MHz
6 Vrms 150 kHz to
80 MHz outside
ISM bandsa
10 V/m
80 MHz to 2.7 GH/| N/A
10 V III
NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These
guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a The ISM(industrial, scientific and medical) bands between 0,15 MHz and 80
MHz are 6,765 MHzto6,795 MHz;13,553 MHz to 13,567 MHZ;26,957 MHz to 27,283
MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and
80 MHz are 1,8 MHz to 2,0 MHz,3,5 MHz to 4,0 MHz,5,3 MHz to 5,4 MHz,7 MHz to
7,3 MHz,10,1 MHz to 10,15 MHz,14 MHz to 14,2 MHz,18,07 MHz to 18,17
MHz,21,0MHz to 21,4MHz,24,89 MHz to 24,99 MHz,28,0 MHz to 29,7 MHz and 50,0
MHz to 54,0 MHZ.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz
and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the
likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this
reason, an additional factor of 10/3 has been incorporated into the formulae
used in calculating the recommended separation distance for transmitters in
these frequency ranges.
c Field strengths from fixed transmitters, such as base stations for
radio(cellular/ cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the device is used exceeds
the applicable RF compliance level above, the device should be observed to
verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the device.
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
Recommended separation distances between RF wireless communications equipment|
|
---|---|---
The device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
device can help prevent electromagnetic interference by maintaining a minimum
distance between RF wireless communications equipment and the device as
recommended below, according to the maximum output power of the communications
equipment.
Frequency
MHz| Maximum
Power
W| Distance| 1EC 60601
Test Level| | Compliance
Level
385| 2.| 0.3| 27| | 27
450| 2| 0.3| 28| | 28
710| | | | |
745| 0.2| 0.3| 9| | 9
780| | | | |
810| | | | |
870| 2| 0.3| 28| | 2s
930| | | | |
1720| | | | |
1845| 2| 0.3| 28| | 28
1970| | | | |
2450| 2| 0.3| 28| | 28
5240| | | | |
5500| 0.2| 0.3| 9| | 9
5785| | | | |
Note 1: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
WARNINGS!
-
This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone, transceiver or radio control products. If you have to do so, the device should be observed to verify normal operation.
-
The use of accessories and power cord other than those specified, with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system.
-
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.
-
Use of accessories, transducers and cables other than those specifi 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.
-
Portable RF communications equipment (including peripherals su as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device,including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
-
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.
-
The Operator should not use the system and should inform the customer service, if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES.
-
PRECAUTION : The performance of the device may be degraded should one or more of the following occur:
– Operation outside the manufacturer’s stated temperature and humidity range.
– Storage outside the manufacturer’s stated temperature and humidity range.
– Mechanical shock (for example, drop test) or degraded sensor.
– Patient temperature is below ambient temperature.
JOYTECH Healthcare Co., Ltd.
No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou , Zhejiang 311100 China
Telephone: +86-571-81957767
Fax: +86-571-81957750
Made in China
Document No.: JDET-2904-005
Article No.: 002
Version: Z
Date of Issue: XXXX.XX
Documents / Resources
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JOYTECH DET-1025b Infrared Ear
Thermometer
[pdf] Owner's Manual
DET-1025b, DET-1025b Infrared Ear Thermometer, Infrared Ear Thermometer, Ear
Thermometer, Thermometer
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Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>