Hetaida HTD8823US - User Manual

Technical File
File No.
ZHTF-CE-01-015
Rev. No.
A.1
Non Contact Infrared Body
Thermometer
Instructions for use
Rev. Date
2020-6-8
Page
1 / 18
HeTaiDa
Non Contact Infrared Body
Thermometer
User Manual
Model: HTD8823US
Software version: V10

Summary

Foreword

Safety Information

General Safety Precautions

Provides essential safety guidelines, warnings, and precautions for operating the thermometer correctly and safely.

Overview

Indication for Use

Specifies the intended use of the HTD8823US thermometer for measuring body temperature.

Device Principle and Controls

Explains the working principle and details the controls, indicators, and symbols of the infrared thermometer.

Equipment Symbols and Applications

Equipment Symbols and Markings

Illustrates and explains the meaning of key symbols and markings used on the thermometer and its packaging.

Technical Specifications

Device Specifications and Requirements

Details key technical parameters including measurement unit, accuracy, operating conditions, power, and dimensions.

Equipment Classification and Standards

Safety Standards and Certifications

Lists the safety standards and certifications the thermometer complies with, such as IEC and ANSI.

Performance Indicators

Presents calculated performance indicators like clinical bias and repeatability based on ISO 80601-2-56 standards.

ME Equipment Safety Classification

Details the safety classification of the medical equipment regarding electric shock, applied parts, and ingress protection.

Operation Guide

Battery Installation

Step-by-step instructions for correctly installing new batteries into the thermometer.

Starting and Measuring

Covers turning on the device, self-test, memory display, and taking measurements in Forehead and Scan modes.

Unit Setting and Fever Indication

Explains how to set the unit and interpret the fever indications based on backlight colors.

Troubleshooting

Error Messages and Solutions

Provides solutions for common error messages like 'Hi', 'Lo', and 'Err' displayed by the thermometer.

Battery Management

Battery Replacement Procedure

Detailed steps for safely removing and replacing the batteries in the thermometer.

Battery Handling Warnings

Important warnings regarding battery handling, charging, disposal, and usage.

Cleaning, Care, and Storage

Cleaning Instructions

Instructions for cleaning the thermometer using isopropyl alcohol wipes and maintaining its parts.

Storage Guidelines

Recommendations for storing the thermometer to protect it from dust, moisture, and extreme environments.

Disposal Information

Proper Disposal Procedures

Guidance on the environmentally friendly disposal of used batteries and the appliance at the end of its life.

Warranty and Support

Warranty Coverage and Exclusions

Details items and conditions that are not covered by the product's warranty.

Obtaining Warranty Service

Explains the process for obtaining warranty service, including required documentation.

Important Notes and Calibration

Provides important notes on contacting service, calibration, and intended operator roles.

Electromagnetic Compatibility (EMC)

EMC Emission Guidance

Details EMC precautions, installation requirements, and manufacturer declarations regarding electromagnetic emissions.

EMC Immunity Guidance

Provides guidance on electromagnetic immunity, detailing test levels and recommended environments for the thermometer.

Recommended RF Separation Distances

Calculates recommended separation distances for RF communication equipment based on transmitter power and frequency.

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Maintenance Features

The HeTaiDa Non Contact Infrared Body Thermometer, model HTD8823US, is an electronic clinical thermometer designed for measuring human body temperature from the forehead in people of all ages for home use. It is a hand-held, reusable, battery-operated device that utilizes infrared sensor technology. The IR sensor outputs different signals based on object and ambient temperatures, which the ASIC converts into a digital value for display on the LCD. This device is intended for multiple use and has a service life of 5 years.

Function Description:

The thermometer operates in two modes: Forehead mode and Forehead Scan mode.

• Forehead Mode: To use, press the On/Scan button to power on the device. Align the thermometer with the middle of the forehead (between the eyebrows, above) at a vertical distance of 1-5cm (0.4-2in). Press the On/Scan button again; a position lamp will indicate the measurement site with a light spot on the forehead. The temperature will display immediately, typically within 2 seconds.
• Forehead Scan Mode: Gently position the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline. Press and hold the On/Scan button. Lightly slide the thermometer across the forehead, keeping the sensor flat and in contact with the skin, until the hairline is reached. Release the On/Scan button and remove the thermometer from the head. The temperature will then display on the screen. This process takes 3-10 seconds.

The device provides a three-color backlight (Color Alarm) to indicate temperature ranges:

• No backlight for temperatures between 34.0°C - 35.7°C (93.2°F - 96.3°F).
• Green for normal temperature: 35.8°C - 37.4°C (96.2°F - 99.4°F).
• Yellow for slight fever: 37.5°C - 38.5°C (99.5°F - 101.3°F).
• Orange for high fever: 38.6°C - 43.0°C (101.4°F - 109.4°F).

The thermometer also features an automatic power-off function after ≤18 seconds of inactivity to conserve battery life. It stores one memory reading.

Important Technical Specifications:

• Measurement Unit: °C/°F (HTD8823US)
• Operating Mode: Adjusted mode (Body mode)
• Reference Body Site: Oral
• Rated Output Range: 34.0°C ~ 43.0°C (93.2°F - 109.4°F)
• Range: 34.0°C ~ 43.0°C (93.2°F - 109.4°F)
• Accuracy (Body mode):
  • 34.0°C ~ 34.9°C: ± 0.3°C (93.2°F - 94.8°F: ± 0.5°F)
  • 35.0°C ~ 42.0°C: ± 0.2°C (95.0°F - 107.6°F: ± 0.4°F)
  • 42.1°C ~ 43.0°C: ± 0.3°C (107.8°F - 109.4°F: ± 0.5°F)
• Display Resolution: 0.1°C / 0.1°F
• Auto Power Off Time: ≤18s
• Measuring Time: Forehead mode: ≤ 2s; Forehead scan mode: 3 ~ 10s
• Measuring Distance: 1 CM - 5CM (0.4 in - 2in)
• Memories: 1
• Batteries: 1.5V (AAA) Alkaline battery X2 (IEC Type LR03)
• Adaptable Range: 2.6V~3.6V
• Operating Temperature: 5°C ~ 40°C (41°F ~ 104°F)
• Relative Humidity (Operating): ≤ 85% (non-condensing)
• Atmospheric Pressure (Operating): 70 KPa - 106 KPa
• Storage Temperature: -20°C ~ 55°C (-4°F - 131°F)
• Relative Humidity (Storage): ≤ 95% (non-condensing)
• Atmospheric Pressure (Storage): 70 KPa - 106 KPa
• Weight (without batteries): 47g
• Size: L: 122mm X W: 30mm X H: 43mm
• Protection against harmful ingress of water or particulate matter: IP22 (Protected against solid foreign objects of ≥ 12.5 mm and greater, and protected against vertically falling water drops when enclosure is tilted up to 15°).
• Safety Standards: ANSI AAMI ES60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2: 2015, ISO 15223-1:2016, ASTM E1965-98 (2016), IEC 60601-1-11:2015.
• Notified Body Number: CE 0598

Usage Features:

• Ease of Use: Simple one-button operation for power on and scanning.
• Quick Measurement: Fast temperature readings, especially in forehead mode (≤ 2 seconds).
• Visual Feedback: The three-color backlight provides immediate visual indication of temperature status (normal, slight fever, high fever).
• Memory Function: Stores the last measurement value for easy recall.
• Unit Setting: Allows switching between Celsius (°C) and Fahrenheit (°F) units.
• Environmental Considerations: The device is designed to operate in a stable environment. It is recommended to allow the thermometer to acclimate to room temperature (5°C to 40°C) for 30 minutes if moved from a significantly different temperature environment. Avoid strong electrostatic or magnetic fields.
• Troubleshooting Guidance: The manual provides clear solutions for common issues such as out-of-range temperatures, incorrect measuring distance, and battery problems.

Maintenance Features:

• Battery Installation: Requires two AAA size alkaline batteries. Instructions are provided for proper installation and replacement. It is crucial to use recommended batteries and not mix old and new ones. Remove batteries if the thermometer will not be used for a long period.
• Cleaning: The lens of the infrared sensor is delicate and must be protected from dirt and damage. The thermometer can be cleaned with 70% isopropyl alcohol wipes after each use. Rubbing the device (including markings, probe, shell, and LCD) with 70% isopropyl alcohol for 15 seconds is recommended. The sensor should be gently wiped for 3 seconds with a cotton swab wetted with 70% isopropyl alcohol if dirty.
• Storage: Store the device in a dry room, protected from extreme moisture, heat, lint, dust, and direct sunlight. Do not place heavy objects on the storage case. Maintain storage within the specified temperature (-20°C to 55°C) and humidity (≤ 95% non-condensing) ranges.
• Disposal: Used batteries and the appliance itself should not be disposed of in household waste. They should be taken to special local collection points for environment-friendly disposal, adhering to local regulations.
• Calibration: Calibration is needed to ensure proper function every two years or after device impact.
• Warranty: The device comes with a one-year warranty from the date of original purchase. The warranty does not cover damage from misconnection, accidents, unauthorized modifications, or issues with batteries and packaging. For warranty service, proof of purchase with the dealer's stamp is required.

Hetaida HTD8823US Specifications

General

Brand	Hetaida
Model	HTD8823US
Category	Thermometer
Language	English