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15. Electromagnetic compatibility information

15.1 FCC STATEMENT

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation.

FCC CAUTION
Changes or modifications not expressly approved by the party responsible for compliance could void the user's
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 and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. 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 to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.

Increase the separation between the equipment and receiver.

Connect the equipment into 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 transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the
FCC radio frequency (RF) Exposure Guidelines. This equipment has very low levels of RF energy that are deemed to
comply without testing of specific absorption ratio (SAR).

15.2

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.
Not use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
the FDTH3400 could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
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 FDTH3400, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.

Guidance and manufacturer´s declaration – electromagnetic emission

– for all EQUIPMENT AND SYSTEMS

Summary of Contents for FDTH3400

Page 1: ...escription Version V3 0 Revision date April 2021 The production date is shown on the outer package For American please refer to For European please refer to Before using your device please read these...

Page 2: ...raindications 7 6 Notes 8 7 Installation and use 10 8 Body Temperature 14 9 Troubleshooting instructions 15 10 Maintenance and maintenance 16 11 List of accessories 17 12 Final disposal 18 13 Informat...

Page 3: ...mperature of human body by collecting the change of the temperature and energy of human body heat source This product has 8 seconds rapid measurement mode and direct measurement mode so that you can e...

Page 4: ...7 2 Product structure and components The thermometer mainly consists of plastic shell thermistor PCBA buzzer chip LCD display and battery Main appearance structure diagram description Display Descript...

Page 5: ...Temperature 5 40 41 104 Relative humidity 15 95 RH No condensing Atmospheric pressure 70 kPa 106 kPa Transportation and storage Temperature 25 55 13 131 environment Relative humidity 15 95 RH No conde...

Page 6: ...ture and energy of Axillary Oral Rectal heat source 4 2 Expected patients and can be used for body temperature measurement in infants children and adults 4 3 Intended user Doctor nurse or regular user...

Page 7: ...7 27 5 Contraindications 5 1 Do not use local lesions such as inflammation trauma and postoperative 5 2 It is forbidden for those who are allergic to stainless steel and ABS plastic...

Page 8: ...ts may cause temperature fluctuations after intense exercise crying eating etc It is recommended to keep quiet for 30 minutes before measurement 6 When measuring please keep the subject quiet and stea...

Page 9: ...ions to avoid use problems or measurement deviations 7 Do not put in direct sunlight high temperature and humidity dust near the fire vulnerable to vibration shock place custody 8 The thermometer is n...

Page 10: ...installing pay attention to the positive and negative polarity 5 Reinstall the battery cover as is and use a Phillips screwdriver to turn clockwise to tighten the fixing screws 7 2 Measurement process...

Page 11: ...t result with prompt sound Axillary Raise your arm Place the probe tip under the armpit parallel to the arm pressing the arm against the body Make sure the metal probe of the thermometer is completely...

Page 12: ...ed the following tips may appear in the thermometer 7 4 Power off function If the thermometer does not perform any operation within 30 seconds or press power key again it will enter the shutdown state...

Page 13: ...ter immediately enters the state to be measured 7 6 Low Voltage Prompt Function 1 The thermometer automatically detects the battery voltage every time it is turned on When the battery voltage is insuf...

Page 14: ...emperature will also change at different times The following are the reference values for the definition of fever in various parts of the human body Data sources ISO 80601 2 56 2017 AMD 1 2018 for inf...

Page 15: ...rs on the screen and flashes Too low battery voltage Causing failure to boot Please replace the new battery and restart Battery icon appears on the screen Battery power is running out Please replace t...

Page 16: ...isplay and other parts are damaged please contact the after sales service 4 Do not put in direct sunlight high temperature and humidity dust near the fire vulnerable to vibration shock place custody 5...

Page 17: ...onents 1 pcs FDTH3400 host 1 pcs CR1632 batteries Placed inside the mainframe 1 pcs User Manual The technical data should be combined with the user manual In addition to specifying the use of CR1632 b...

Page 18: ...ehold garbage but bring it to a collection point for the recycling of electronic equipment Waste Electrical and Electronic Equipment can have potentially harmful effects on the environment Incorrect d...

Page 19: ...19 27 13 Information on critical parts Name Model Supplier Thermistor XWTH002 A041 IC XWIC036 A102 Thermometer casing ABS D004...

Page 20: ...tion see Instructions for use Caution Consult accompanying documents Type BF applied parts Batch code Serial number Manufacturer information IP code of the device this device s grade of against ingres...

Page 21: ...separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV tec...

Page 22: ...the FDTH3400 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 k...

Page 23: ...part of the FDTH3400 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF...

Page 24: ...cation in which the FDTH3400 is used exceeds the applicable RF compliance level above the FDTH3400 should be observed to verify normal operation If abnormal performance is observed additional measures...

Page 25: ...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 highe...

Page 26: ...requirements for basic safety and essential performance Collateral Standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 10...

Page 27: ...ed by improper usage of the device and not following the instructions on the user manual Please contact after sales service and support and enclose your product purchase receipt while claiming for war...

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