Famidoc FDTH3400 Product Instructions

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Product instructions

FDTH3400

PN:6004213F001-03A

Description 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 instructions and warnings completely.

FCC ID :PONFDTHB34

1 / 27

Table of Contents

Need help?

Do you have a question about the FDTH3400 and is the answer not in the manual?

Questions and answers

Summary of Contents for Famidoc FDTH3400

Page 1 Product instructions FDTH3400 PN:6004213F001-03A Description 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 instructions and warnings completely.
Page 2: Table Of Contents
CONTENT 1. Product Description ............................3 2. Product structure and components ......................4 3. Product specifications ...........................5 4. Intended use and scope of application ......................6 5. Contraindications ............................7 6. Notes ................................8 7. Installation and use .............................10 8. Body Temperature ............................14 9.
Page 3: Product Description
This product has 8 seconds rapid measurement mode and direct measurement mode, so that you can easily and quickly know the health status of yourself and your family anytime and anywhere. Product name:Digital Clinical Thermometer Product model: FDTH3400 3 / 27...
Page 4: Product Structure And Components
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 Description: 4 / 27...
Page 5: Product Specifications
3. Product specifications Product name Digital Clinical Thermometer Product model FDTH3400 Power supply voltage d.c. 3.0V, one CR1632 battery Measurement type Adjusted mode / Direct mode Measuring part Axillary / Oral / Rectal Reference site Oral cavity Measuring range 32.00℃ ~ 42.90℃ (89.60℉~109.22℉) ±0.10℃: between 35.00℃~42.00℃...
Page 6: Intended Use And Scope Of Application
4. Intended use and scope of application 4.1 This product is used to measure the temperature of human body by collecting the change of the temperature 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 ：...
Page 7: Contraindications
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. 7 / 27...
Page 8: Notes
6. Notes 6.1 Measurement 1. This product is only for monitoring and self-testing body temperature, can not be used for disease diagnosis, patients only through the results of self-judgment and treatment is very dangerous, so please follow the guidance of the doctor. 2.
Page 9 6.2 About Products 1.Except for measurement of Axillary, oral and rectal temperature, don ’ t use this product for other purposes. 2.Please do not force collision, fall, stampede or shake this product, may cause product failure or cause measurement deviation. 3.
Page 10: Installation And Use
7. Installation and use 7.1 Installation of batteries 1.This product uses One CR1632 button battery and has been built into the thermometer body when it leaves the factory.(Note: The built-in battery in the thermometer is a trial battery. This battery may not provide the same life as the new battery.) 2.To replace the battery, turn the phillips screwdriver counterclockwise to remove the screw on the battery cover.
Page 11 • Raise your arm,Place the probe tip under the armpit parallel to the arm, pressing the arm against the body. Axillary • Make sure the metal probe of the thermometer is completely wrapped around the armpit. • Place the thermometer in one of the two locations under the tongue, to the left or right of the root of the tongue.
Page 12 Up to 5 minutes 5. Remove the battery of the thermometer and power it on again each time. The Adjusted mode is entered by default for the next measurement. 7.2.2 The mode switch 1. In the off state, press and hold “power key”for 5 seconds and release it, then it will automatically enter the measurement state different from that used last time.
Page 13 7.5 Temperature unit setting function 1. When the thermometer is off, hold down“power key” and do not release it. The product will start. Wait for 5 seconds after the screen turns off, and then enter the temperature unit setting interface. 2.Hold down the“power key”...
Page 14: Body Temperature
8. Body Temperature The normal body temperature of people is a range value, the normal body temperature of different people will be different, and the personal body temperature 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 information only.
Page 15: Troubleshooting Instructions
9. Troubleshooting instructions Fault Description Possible causes Solution Please replace the new Battery runs out battery and re-open Please install the battery The screen does not react when the power is correctly according to the Battery installation error on or Equipped with batteries. positive and negative pole mark in the battery bin.
Page 16: Maintenance And Maintenance
10. Maintenance and maintenance 1. Please use a soft, dry cloth to gently wipe the dirt on the mainframe. If the surface is more serious dirty, you can dip some alcohol to wipe.Cleaning is recommended every 1 month. Caution: Do not wash with water or use cleaners, diluents or volatile oils containing abrasives. 2.
Page 17: List Of Accessories
11. List of accessories Use only original accessories to check whether the received accessories are complete. Quantity Components 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.
Page 18: Final Disposal
12. Final disposal At the end of the product lifecycle, do not throw this product into the normal household 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 disposal can cause harmful toxins to build up in the air, water and soil and can be harmful to human health.
Page 19: Information On Critical Parts
13. Information on critical parts Name Model Supplier Thermistor XWTH002 A041 XWIC036 A102 Thermometer casing D004 19 / 27...
Page 20: Explanation Of Standardized Symbol
14. Explanation of standardized symbol Complies with the European Medical Device Belgium NV Directive (93/42/ EEC), Notified Body is SGS Authorized representative in the European Community. Attention: 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 ingress of solid foreign objects .
Page 21: Electromagnetic Compatibility Information
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.
Page 22 Guidance and manufacturer´s declaration – electromagnetic emission The FDTH3400 is intended for use in the electromagnetic environment specified below. The customer or the user of FDTH3400 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The FDTH3400 uses RF energy only for its internal function.
Page 23 EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING Guidance and manufacturer´s declaration – electromagnetic immunity The FDTH3400 is intended for use in the electromagnetic environment specified below. The customer or the user of the FDTH3400 should assure that it is used in such an environment.
Page 24 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 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 may be necessary,such as such as reorienting or relocating the FDTH3400.
Page 25 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (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.
Page 26: Standard List
16. Standard List FDTH3400 complies with the following standards Medical electrical equipment Part 1: General requirements for basic safety and essential IEC 60601-1 performance Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential IEC 60601-1-2 performance - Collateral standard: Electromagnetic compatibility - Requirements and tests Medical electrical equipment –...
Page 27: Warranty
Please contact after-sales service and support and enclose your product purchase receipt while claiming for warranty services. Location of purchase: Contact number: Date of purchase: Famidoc Technology Co., Ltd. Add.: No. 212 Yilong Road, Hexi Industrial Zone,Jinxia, Changan Town, Dongguan 523853, Guangdong Province, P.R. China. Tel.: +86-769-89272488 Fax: +86-769-89272498 Website: www.famidoc.com...