Innovo iF100A Non-contact Digital Infrared Forehead Thermometer User Manual
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iF100A
Non-contact Digital
Infrared Forehead
Thermometer
User Manual Ver 1.0
Copyright © Innovo Medical
2014-2019. All rights reserved.
Innovo Medical owns and reserves all of the rights comprised in the copyright of this document. No part of this document may be changed, excerpted, copied, reproduced, or imitated in any form or by any means without prior written consent of Innovo Medical.
All statements, information, and recommendations in this document are provided "AS IS" without warranties, guarantees or representations of any kind, either expressed or implied. The information in this document is subject to change without notice. Innovo Medical reserves the right of final interpretation of this document.
Version 1.0
Issuing Date: December 2019
To download the latest manual for the thermometer, simply scan the QR code below or visit https://innovo-medical.com/products/innovo-i
F100A-thermometer
Contact Us
Questions or Comments?
Call: 858-888-9781
Email: [email protected]
Visit: www.innovo-medical.com
Introduction
Thank you for purchasing the Innovo iF100A
Non-contact Digital Infrared Forehead
Thermometer. The iF100A Forehead
Thermometer has passed numerous rigorous clinical tests and has proven to be safe, reliable and accurate when used in accordance with the operation manual.
The iF100A Forehead Thermometer has been specifically designed to measure body temperature from the forehead. The non-contact method of measurement is safe, hygienic and suitable for use by people of all ages. It can also be used to provide an estimation of room temperature and surface temperature of an object, such as a milk bottle.
Before using the thermometer, please read this User Manual carefully and follow the instructions stated herein. Please check and inspect the package contents. If any component is damaged or missing, or if you have any concerns, please contact [email protected]
or call 858-888-9781 for assistance.
Keep this User Manual in a safe place for future reference.
Contents
Features of the iF100A Forehead
..................................... 1
........................................ 3
.............................. 6
Measuring Forehead Temperature
..................................... 11
Temperature Taking Tips for Accurate
................................... 15
.................................. 16
........................... 17
Warranty and After-Sale Service
........................................... 25
EMC Information - Guidance and
Manufacturer’s Declaration .............. 26
1.Standard Packing List
iF100A Forehead Thermometer…..1 PC
AAA Batteries (preinstalled) .
...
.
.
.
. 2 PC S
User M anual…………………………1 PC
Quick Start Guide…………………...1 PC
2.Features of the iF100A Forehead
Thermometer
The iF100A Forehead Thermometer measures body temperature without making contact with the body. It detects the natural infrared heat emitted from the skin surface of the forehead and displays the corresponding oral equivalent temperature reading obtained via clinical trials within 1 second.
When set to Object Measurement mode, the thermometer can also detect natural infrared heat emitted by an object or infrared heat present in an environment to provide an estimation of the surface temperature of the object or room temperature respectively.
Convenient and easy to use
Easy mode of operation – take measurement with the press of a button
Easily switch reading between Fahrenheit and Celsius
Can be used anytime – even when your child is asleep
Obtain reading faster than an oral thermometer and more comfortable than a rectal thermometer
Ergonomic design
Visual and audible alarm for fever detection
Accurate and quick
Utilize the latest infrared technology – accurate, precise and instant readings
Auto distance technology ensures correct measurement distance from the forehead
Blue tracking light provides visual aid of the measurement site
1
Safe and hygienic
Non-contact measurement method prevents cross-contamination
Unlike traditional thermometers, there is no glass or mercury that could pose as a potential health hazard. The thermometer is made up of ABS plastic, an infrared sensor, an infrared temperature measuring element, a microcomputer controlled circuit and an LED display.
BPA and latex free
Memory recall
Has a Memory Mode that automatically stores up to 30 readings
Conveniently tracks changes in temperature by recalling stored data
Convenient fever warning
When the temperature registers
99.5°F/37.5°C and above, the thermometer will warn user of a possible fever with 10 short beeps and a color coded ring that glows red.
(For normal body temperature, the signal is a long beep with a color coded ring that glows blue.)
Intended use
The iF100A Forehead Thermometer is a non-contact infrared thermometer intended to measure body temperature via the forehead.
It may be used by medical professionals or by consumers in a home environment.
Operating principle
The infrared temperature sensor detects infrared energy emitted from the forehead. A built-in lens focuses the collected energy, which is then converted into a temperature reading by the thermopiles and measurement circuits.
2
3.Important Warnings and Safety
Precautions
Warning
This product is not intended to substitute advice from a physician, pharmacist, or other licensed health-care professional. You should not use this product for self-diagnosis or for treating a health problem. Seek advice from your health-care provider immediately if you suspect that you or your child is not feeling well, has a fever, appears distressed or has a medical condition.
Do not use the thermometer for purposes not specified in this User Manual. Follow the instructions stated herein and operate the thermometer carefully as directed.
Do not use the thermometer if any part, especially the sensor, shows any sign of damage. Please contact manufacturer if it is within the warranty period.
Do not attempt to repair, modify or disassemble the thermometer. This voids the warranty.
The thermometer is not designed for use on newborns. Please consult a doctor before using the thermometer on a newborn.
The device is not a continuous monitoring device.
The thermometer is not a toy. Please keep out of children’s reach. Some parts are small enough to be swallowed.
Do not use the thermometer in the vicinity of strong electromagnetic fields such as mobile telephones or radio installations.
Keep a minimum distance of 3.3 meters from such devices when using the thermometer.
Please dispose the used thermometer and batteries in accordance with local regulation and requirement.
3
Caution
Do not use the thermometer under an ambient temperature higher than 40.0°C
(104.0°F) or lower than 15.0°C (59.0°F) while in Forehead mode. These are beyond the operating temperature range of the thermometer.
The thermometer is not waterproof. Do not immerse in water or other solutions. For cleaning and disinfecting, please follow instructions in the ‘Care and Cleaning’ section.
The thermometer is assembled precisely in order to perform properly. Do not drop the thermometer or touch the sensor with a hard object. The thermometer is not designed to withstand intense impact or vibration.
Please remove the batteries if the thermometer is not used for an extended period of time, e.g. more than 1 month.
4.Note on Body Temperature
Normal body temperature is a range. It varies from person to person and can fluctuate throughout the day.
Body temperature also varies by sites.
Therefore, the iF100A Forehead
Thermometer should not be used to obtain body temperature from other parts of the body.
Normal body temperature fluctuates throughout the day and is affected by external factors. The body temperature of an individual is the lowest between 2:00 a.m. and 4:00 a.m. and the highest between 2:00 p.m. and 8:00 p.m. An individual's body temperature typically changes by less than 1°C (1.8 °F) each day.
4
To determine if an individual is experiencing an elevated body temperature or has a fever, it is therefore critical to know, as a reference point, the individual’s normal body temperature range when he/she is well.
5.Elements of the Thermometer
Measuring unit
(1) Unit button (Celsius/Fahrenheit)
(2) Mode button (Forehead/Object measurement mode)
(3) LED display
(4) Power/Measure button (with color coded ring)
(5) Memory button
(6) Sound button (On/Off)
(7) Blue tracking light
(8) Sensor lens
(9) Battery cover
5
Button and its function
Button
Power/Measure button
Unit button
Measurement mode button
Function
Press once to power on or to take measurement.
Press for about 3-4 seconds to power off.
To switch unit of measurement between
Celsius and Fahrenheit.
To switch between
Forehead and Object measurement mode.
Memory button To enter Memory mode.
Sound button To turn sound on and off.
Screen display and symbol designation
6.Battery Installation
1. Open the battery cover.
2. Install two AAA batteries into the battery compartment according to the stated polarities.
3. Close the battery cover until it snaps back in place.
6
Note:
Prior to using the thermometer for the first time, pull the plastic tab, if any, off the battery compartment.
Batteries should be installed according to the stated polarities. Otherwise, the thermometer bracket may be damaged.
Replace the batteries when the low battery icon ( ) flashes on the LED display. When battery is completely exhausted, the battery icon appears for 10 seconds, after which device switches off automatically.
Please remove the batteries if the thermometer is not used for an extended period of time, e.g. more than 1 month.
Warning
Do not charge the included batteries because it may cause leakage, fire disaster or even explosion.
Do not throw batteries into fire because it can cause an explosion.
Dispose of batteries in accordance with local laws and regulations.
7.Measuring Forehead Temperature
Step 1: Power on
Press the Power/Measure button to turn the thermometer on.
7
Backlight comes on, color coded ring glows blue-to-red and the warm up sequence starts.
Step 2: Ready to measure
The Forehead measurement mode ( ) is selected by default. If not selected, press the
Mode button ( ) to switch between
Forehead and Object measurement mode.
The selected unit (°F or °C) blinks. Press the
Unit button ( and Fahrenheit.
) to switch between Celsius
The auto distance indicator ( ) directs user to position the thermometer closer to the forehead. Distance should be within 2” (5cm).
Note: You can press the Sound button ( ) at any time to turn sound on and off.
Step 3: Position
Point thermometer at the center of the forehead, just above the eyebrow. Bring thermometer closer towards the forehead until
“good” registers on the screen and auto distance indicator ( ) disappears. This means distance is appropriate (within 2” or
5cm). You will hear a beep and the blue tracking light will activate.
8
Note: If forehead area is covered with hair, sweat or dirt, please clean the area to improve reading accuracy.
Note: Make sure the thermometer is pointing at the forehead at right angle. Otherwise,
“good” may not register on the screen even if the thermometer is within appropriate distance.
Adjust the angle and repeat Step 3 above.
Step 4: Taking temperature
Press the Power/Measure button once.
Reading will be displayed in about 1 second.
Note: You can press the Unit button ( to switch the result between Celsius and
Fahrenheit.
)
Normal temperatures
93.2°F to 99.3°F /
34.0°C to 37.4°C
Long beep
Color coded ring glows blue for 3 seconds
Fever may be present*
99.5°F to 109.4°F /
37.5°C to 43.0°C
10 short beeps
Color coded ring glows red for 3 seconds
9
Out of measurement range
Higher than 109.4°F /
43.0°C
3 short beeps
Color coded ring glows red for 1 second
Out of measurement range
Lower than 93.2°F /
34.0°C
3 short beeps
Color coded ring glows red for 1 second
* Note: Temperature 99.5°F/37.5°C and above indicates that fever may be present. Please consult with your doctor if you are not sure.
Step 5: Getting ready for next measurement
Previous reading will continue to show on the screen. To enter “Ready to measure” mode, press the Power/Measure button once after color coded ring stops to glow blue or red (i.e. after 3 seconds from last reading). Screen will show “- - - -” with auto distance indicator
( ) on and blinking unit (°F or °C).
Repeat Step 3 and Step 4 to continue with measurement.
10
If Power/Measure button is pressed while color coded ring still glows blue or red (i.e. within 3 seconds from last reading), the screen will show “hold” as the thermometer is not ready for measurement. Please wait until screen returns to show previous reading.
Press the Power/Measure button again. The screen now should show “- - - -” with auto distance indicator ( ) on and blinking unit (°F or °C). Repeat Step 3 and Step 4 to continue with measurement.
Step 6: Power off
Press the Power/Measure button for about
3-4 seconds at any time to power off the device.
Device will also power off automatically in 30 seconds if no activity is detected.
8.Measuring Object Surface
Temperature
Step 1: Power on
Press the Power/Measure button to turn the thermometer on.
Backlight comes on, color coded ring glows blue-to-red and the warm up sequence starts.
11
Step 2: Ready to measure
The Forehead measurement mode ( ) is selected by default. Press the Mode button
( ) to switch between Forehead and
Object measurement mode. Object mode icon
( ) should show on the screen.
The selected unit (°F or °C) blinks. Press the
Unit button ( and Fahrenheit.
) to switch between Celsius
Note: You can press the Sound button ( ) at any time to turn sound on and off.
Step 3: Position and take temperature
Point thermometer at the object (for example: milk bottle) within 2” or 5cm distance away from the surface.
Press the Power/Measure button once. Blue tracking light activates and reading will be displayed in about 1 second.
Note: You can press the Unit button ( to switch the result between Celsius and
Fahrenheit.
)
12
Within measurement range
32.2°F to 211.8°F /
0.1°C to 99.9°C
Long beep
Color coded ring glows blue for 3 seconds
Out of measurement range
Higher than 211.8°F /
99.9°C
3 short beeps
Color coded ring glows red for 1 second
Out of measurement range
Lower than 32.2°F /
0.1°C
3 short beeps
Color coded ring glows red for 1 second
Note:
To measure ambient temperature, press the Power/Measure button once without pointing at any object.
The Object measurement mode provides approximation of surface temperature of an object or ambient temperature. Please allow ±2.0°F (±1.0°C) margin of error.
Infrared radiation is affected by the material, surface color and texture of an object.
Do not use the iF100A Forehead
Thermometer if the absolute surface temperature of an object is required.
13
Step 4: Getting ready for next measurement
Previous reading will continue to show on the screen. To enter “Ready to measure” mode, press the Power/Measure button once after color coded ring stops to glow blue (i.e. after 3 seconds from last reading). Screen will show
“- - - -” and blinking unit (°F or °C). Repeat
Step 3 to continue with measurement.
If Power/Measure button is pressed while color coded ring still glows blue (i.e. within 3 seconds from last reading), the screen will show “hold” as the thermometer is not ready for measurement. Please wait until screen returns to show previous reading. Press the
Power/Measure button again. The screen now should show “- - - -” and blinking unit (°F or °C). Repeat Step 3 to continue with measurement.
Step 5: Power off
Press the Power/Measure button for about
3-4 seconds at any time to power off the device.
Device will also power off automatically in 30 seconds if no activity is detected.
14
9.Temperature Taking Tips for
Accurate Measurement
1. Always start with a clean thermometer to maintain measurement accuracy and hygiene. Pay extra attention to the sensor lens as any obstruction, such as dust or grease on the lens will prevent an accurate measurement.
2. If the sensor lens is dirty, please clean before use (Refer to Care and Cleaning section). A clean sensor lens should be reflective and gleaming. If it looks dull and lackluster, then it is dirty and requires cleaning.
3. Make sure both user and thermometer have remained at a constant ambient temperature for at least 30 minutes. Recent exposure of the thermometer to hot or cold temperatures will affect the reading.
4. Please use the thermometer indoor or in an environment where there is no strong air draft, such as from a fan, air conditioning or heater.
5. Before measuring forehead temperature, remove anything that may interfere with infra-red detection such as hair, sweat, or makeup/oil.
6. Do not move when taking temperature.
7. Do not hold the thermometer for a long time as it is highly sensitive to ambient temperature and heat.
Note: As with any thermometer, proper technique is critical to obtain accurate measurements. Failure to follow instructions will result in inaccurate readings.
15
10.Memory Mode
Accessing recorded data
When device is off, press the Memory button
( ) to enter Memory mode. Screen shows
“- - - -” and Memory icon “M”.
Press the Memory button again. Screen shows “1”, then the newest recorded reading.
Press the Memory button again. Screen shows “2”, then the next recorded reading.
Repeat the steps above to access more recorded data.
Note:
You can enter Memory mode from “Ready to measure” mode by pressing the
Memory button.
A total of 30 readings can be recorded.
When memory is full, the oldest data will be
overwritten as new data is recorded.
“1” corresponds to the newest data and
“ 30 ” to the oldest data.
16
Exiting memory mode
To exit and power off, press the
Power/Measure button for about 3-4 seconds.
To enter measurement mode from memory mode, press the Power/Measure button once.
If no button is pressed within 30 seconds, device will power off automatically.
Deleting recorded data
In Memory mode, press the Memory button
( ) for about 4-5 seconds until screen shows “Clr”. Press the Memory button again to confirm the deletion. “Clr” flashes three times and data is deleted. Screen shows
“- - - -”.
Note:
To cancel data deletion after screen shows
“Clr”, press the Power/Measure button once to return to Memory mode.
After screen shows “Clr” and no button is pressed within 5 seconds, device will return to Memory mode. No data is deleted.
11.Care and Cleaning
To clean the sensor lens, gently swab the surface with a cotton swab slightly moistened with rubbing alcohol (70%
Isopropyl). Do not exert too much pressure or use hard object to clean as it may damage the delicate sensor lens.
17
Place the thermometer in a well ventilated area and wait for the alcohol to evaporate completely before using the thermometer.
This may take about 5-10 minutes. Any residual alcohol will prevent accurate readings.
To clean the thermometer, wipe with a soft cloth slightly moistened with water or rubbing alcohol. Allow to air dry in a well ventilated area or gently wipe dry with a piece of tissue.
Caution
The thermometer sensor is extremely sensitive. The sensor lens has to be absolutely clean and free of obstruction to ensure accurate readings.
Always check the sensor before use. The lens should be reflective and gleaming. If it looks dull and lackluster, please clean the lens before use.
Do not use abrasive, acidic or alkaline cleaners.
Do not immerse in water or cleaning solution.
Do not expose the thermometer to extreme temperatures, humidity, dust or direct sunlight.
Do not drop the thermometer and avoid strong vibrations.
18
12.Errors and Troubleshooting
Error Message Possible cause and solution
Possible cause:
In Forehead measurement mode, the auto distance sensor is blocked.
Auto distance sensor blocked
(Forehead mode only)
Distance error
(Forehead mode only)
Solution:
Do not touch the thermometer probe, especially the bottom area where the auto distance sensor is embedded.
Possible cause:
In Forehead measurement mode, the Power/Measure button is pressed when distance between the thermometer and forehead is not within 2” or 5cm (when
“ ” is not displayed on screen).
3 short beeps
Color coded ring glows red for 1 second
Solution:
Position thermometer within
2” or 5cm from the forehead.
When distance is appropriate, “ ” registers on the screen. You will also hear a beep and the blue tracking light will activate. Press the
Power/Measure button to take a reading.
Possible cause:
Battery life is less than 20%.
However, the device can still work until battery is completely exhausted.
Low battery
Low battery icon flashes on the screen
Solution:
Replace the batteries. Refer to Section 6 on ‘Battery
Installation’.
19
Possible cause:
Battery is completely exhausted.
Solution:
Replace the batteries. Refer to Section 6 on ‘Battery
Installation’.
Dead battery
Low battery icon is displayed on screen for 10 seconds, then device powers off automatically.
Out of operating temperature range
3 short beeps
Color coded ring glows red for 3 seconds, then device powers off automatically in
10 seconds.
Possible cause:
Ambient temperature is too high (more than 104.0°F/
40.0°C).
Solution:
Thermometer should be used in an environment where ambient temperature is between 59.0°F to
104.0°F /15.0°C to 40.0°C
(for Forehead mode);
41.0°F to 104.0°F /5.0°C to
40.0°C (for Object mode).
Out of operating temperature range
3 short beeps
Possible cause:
Ambient temperature is too low (less than 59.0°F/
15.0°C for Forehead mode;
41.0°F/ 5.0°C for Object mode).
Solution:
Thermometer should be used in an environment where ambient temperature is between 59.0°F to
20
Color coded ring glows red for 3 seconds, then device powers off automatically in
10 seconds.
104.0°F /15.0°C to 40.0°C
(for Forehead mode);
41.0°F to 104.0°F /5.0°C to
40.0°C (for Object mode).
Troubleshooting
Problem Possible
Cause
The thermometer fails to power on.
The temperature reading is lower than typical body temperature range.
The battery is exhausted.
Polarities of the batteries are reversed.
The thermometer is faulty.
The sensor lens is dirty or there is an obstruction on the sensor lens.
The thermometer is used within
30 minutes after being taken from a
Solution
Replace with new batteries of the same model or specifications.
Ensure that the batteries are correctly installed according to the polarity symbols in the battery compartment.
If the warranty period has not expired, contact the manufacturer.
Clean the sensor lens.
Refer to
Section 11 on
‘Care and
Cleaning’. A clean sensor lens should be reflective and gleaming.
Wait 30 minutes or more for thermometer to adjust to room
21
The temperature reading is higher than typical body temperature range, in the absence of a fever.
cold environment.
The thermometer is used in an overly bright-lit environment.
The thermometer is used within
30 minutes after being taken from a hot environment.
The thermometer infrared sensor is faulty. temperature before taking measurement again.
Choose a moderately lit environment to use the thermometer.
Wait 30 minutes or more for thermometer to adjust to room temperature before taking measurement again.
If the warranty period has not expired, contact the manufacturer.
Attention:
● Electromagnetic interference: iF100A
Forehead Thermometer contains sensitive electronic components. You should not use the thermometer in an area with electromagnetic interference (e.g. near mobile phones or microwaves).
● Please dispose of the used thermometer and batteries in accordance with local regulation requirements.
● Please remove the batteries if the thermometer is not used for an extended period of time, e.g. more than 1 month.
22
13.Technical Specifications
Item Specification
Product name and model
Applicable regulations and laws
Innovo iF100A Non-contact
Digital Infrared Forehead
Thermometer
ASTM E1965; IEC 60601-1;
IEC 60601-1-2 (EMC);
ISO80601-2-56; IEC
60601-1-11
Temperature units
°F/°C, adjustable
Measure- ment temperature range
Forehead measurement mode:
93.2
F-109.4
F
(34.0°C-43.0°C)
Object measurement mode:
32.2
F-211.8
F
(0.1°C-99.9°C)
Forehead mode:
±0.4
F within 95.0
F-107.6
F/
±0.2°C within 35.0
C-42.0°C
Measure- ment
Accuracy
(Laboratory)
±0.5
F within 93.2
F-94.8
F and 107.8
F-109.4
F/
±0.3°C within 34.0
C-34.9°C and 42.1
C-43.0°C
Object mode:
±2.0
F within 32.2
F-211.8
F/
±1.0°C within 0.1
C-99.9°C
Display resolution
Measure time
0.1°F/0.1°C
About 1 second
Latency time About 3 seconds
Measuring distance
Memory storage
½” to 2” (1 to 5cm)
Display type White LED
Automatic shutdown function
In 10 seconds when error message or flat battery icon appears.
In 30 seconds when no button is pressed.
30 sets of measurement data
23
Low battery indicator
When voltage is below
2.6V+0.1V/-0.05V, low battery icon ( ) flashes. Device will still work.
When voltage is below
2.5V+0.04V/-0.1V, low battery icon ( ) appears for 10 seconds, then device powers off automatically. Device will not work.
Operating voltage
Battery
2.6 ~ 3.3V
Battery life
Dimension
(LxWxH)
2x AAA size 1.5V
At least 500 measurements after two years storage.
5.7” x 1.5” x 1.8” (145.5mm x
39.0mm x 45.0mm)
Weight 3.3oz (94g) with batteries
IP Class IP22
Operating conditions
Storage and shipping conditions
Temperature: 59°F~104°F
(15°C~40°C) for Forehead mode; 41°F~104°F (5°C~40°C) for Object mode
Humidity: 15%~95% RH, non-condensed
Atmospheric pressure:
86kPa-106kPa
Temperature: -4°F~+122°F
(-20°C~+50°C)
Humidity: 15%~95% RH, non-condensed
Atmospheric pressure:
50kPa-106kPa
Store in well ventilated area.
Avoid severe shock, vibration and water during transportation
The infrared thermometer has been tested and conforms to the standard ASTM
E1965-98. ASTM laboratory accuracy requirements in the display range of 98°F to102°F (37°C-39°C) for skin IR thermometers is ±0.5°F (±0.3°C). Note that for mercury-in-glass and electronic thermometers,
24
the requirement per ASTM Standards
E667-86 and E1112-86 is ±0.2°F (±0.1°C).
Attention:
● Type of protection against electric shock:
Internally Powered Equipment
● Degree of protection against electric shock:
Type BF applied part
● Degree of protection against ingress of water: IP22
14.Warranty and After-Sale Service
For inquiries, please email [email protected]
The device is covered by a 1-year warranty, effective from the date of purchase. Please go to www.innovo-medical.com to register your purchase.
Batteries, packaging, and any damage caused by improper use are not covered under warranty.
15.Symbols
Symbol Description
The product is a Type BF device.
Follow Instructions for Use.
This document provides important product operation and safety information regarding this thermometer.
Please read this document thoroughly before using the device and keep for future reference.
Manufacturer information, including its name and address.
25
Symbol Description
Warning
A personal injury or device damage may result if the device is not used correctly.
Caution
IP22
Inaccurate reading or device damage may result if the device is not used correctly.
Protected against solid foreign objects of 12.5mm diameter and greater. Protected against vertically falling water drops when the device is tilted up to
15°.
Low battery symbol
Device sound on/off
Measurement unit (Switch between Celsius and
Fahrenheit)
Measurement mode (Switch between Forehead ( ) and
Object ( mode)
) measurement
Memory mode
16.
EMC Information - Guidance and
Manufacturer’s Declaration
● Electromagnetic compatibility: This device fulfills the stipulations of the standard IEC
60601-1-2 (EMC).
● Portable and mobile RF communications equipment can affect the device.
● Note: Do not use this device in the presence of electromagnetic or other interference outside the normal range specified in IEC60601-1-2.
26
Guidance and manufacturer’s declaration
– Electromagnetic emission
The model iF100A is intended for use in the electromagnetic environment specified below.
The customer or the user of the model iF100A should ensure that it is used in such an environment.
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The model iF100A uses
RF energy only for its internal function.
Therefore, its
RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The model iF100A is suitable for use in all establishments, in-
RF emissions
CISPR 11
Class B cluding domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
27
Harmonic emissions
IEC
61000-3-2
Voltage fluctuations
/ flicker emissions
IEC
61000-3-3
N/A
N/A
Guidance and manufacturer’s declaration
– Electromagnetic immunity
The model iF100A is intended for use in the electromagnetic environment specified below.
The customer or the user of the model iF100A should assure that it is used in such an environment.
Immunity test
IEC
60601 test level
Compliance level
Electro- magnetic environment- guidance
Electrostatic discharge
(ESD)
IEC
61000-4-
2
Electrical fast transient
/burst
±8 kV contact
±15 kV air
±2 kV for power supply lines and
±8 kV con- tact
±15 kV air
N/A
Floors should be wood, concrete or cera- mic tile. If floors are covered with synthetic material, the relative humidity should be at least
30%.
Mains power quality should
28
IEC
61000-4-
4
Surge
IEC
61000-4-
5 patient coupled lines
±1 kV line(s) and neutral
Voltage dips, short interrup
-tions and voltage variations on power supply input lines
IEC
61000-4-
11
<5 % U
T
(>95% dip in
U
T
) for
0,5 cycle
40 % U
T
(60% dip in
U
T
) for
5 cycles
70 % U
T
(30 % dip in
U
T
) for
25 cycles
<5 % U
T
(>95 % dip in U
T
) for
5s
N/A
N/A be that of a typical commer- cial or hospital environment.
Mains power quality should be that of a typical commer- cial or hospital environment.
Mains power quality should occurs, the current of the model iF100A may drop off from normal level. It may be be that of a typical commer- cial or hospital environment. If dips or interruptions of main power
29
Power frequency
(50/60
Hz) magnetic field
IEC
61000-4-
8
3 A/m 3 A/m necessary to use uninter- ruptible power supply or a battery.
Power frequency magnetic fields should be at levels character
-ristic of a typical location in a typical commercial or hospital environment.
NOTE U
T is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration
– Electromagnetic immunity
The model iF100A is intended for use in the electromagnetic environment specified below.
The customer or the user of the model iF100A should ensure that it is used in such an environment.
Immunity test
IEC
6060
1 test level
Compliance level
Electromagne
-tic environment
-guidance
Con- ducted
RF IEC
61000-
4-6
3
Vrms
150 kHz to 80
N/A Portable and mobile RF communications equipment should be
30
Radia- ted RF
IEC
61000-
4-3
MHz
3
V/m
80
MHz to 2.5
GHz
3 V/m used no closer to any part of the model iF100A, including cables, than the recommen- ded separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommen- ded separation distance where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
b
Field strengths from fixed RF transmitters, as determined
31
by an
Electromagnetic site survey,a should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 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. 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 model iF100A is used exceeds the applicable
RF compliance level above, the model iF100A should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the model iF100A. b. Over the frequency range 150 kHz to 80
MHz, field strengths should be less than 3
V/m.
32
Recommended separation distances between portable and mobile RF communications equipment and the model iF100A
The model iF100A is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model iF100A can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model iF100A as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter
W
Separation distance according to frequency of transmitter
80 MHz to
800 MHz m
800 MHz to
2,5 GHz
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
33
Manufactured for:
Innovo Medical
10101 Stafford Centre Drive Ste B
Stafford, TX 77477
Phone: +1-858-888-9781 [email protected] www.innovo-medical.com
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