QOCA Disposable BLE Thermometer User Manual CIH418-01 Ver.
TABLE OF CONTENTS Safety Notes ......................................................... 3 Product Overview ................................................ 7 Indication for Use ........................................................ 7 Package Contents ....................................................... 8 Components ................................................................ 9 Sensor .................................................................... 9 Product Requirements .......................
Additional Information ....................................... 19 LED Indicators ........................................................... 19 Sensor Status Indicator ...... 錯誤! 尚未定義書籤。 Cleaning ..................................................................... 19 Patch Information ....................... 錯誤! 尚未定義書籤。 Specifications ............................................................ 20 Troubleshooting ........................................................ 22 Gateway mode information .........
SAFETY NOTES • • • • • • • Please read through this user guide carefully before using QOCA DISPOSABLE BLE THERMOMETER. The QOCA DISPOSABLE BLE THERMOMETER is to be used for clinical assessment and personal reference only. The QOCA DISPOSABLE BLE THERMOMETER consists entirely of sophisticated medical electrical parts. Maintenance can only be carried out by professional technicians. Unauthorized disassembly of the device by the user is not allowed.
• • • • • • Avoid using devices that can affect the accuracy of the readings when the QOCA DISPOSABLE BLE THERMOMETER is taking measurements. Avoid using other electronic devices when the QOCA DISPOSABLE BLE THERMOMETER is taking measurements. If using another other electronic device is necessary, please check to ensure the thermometer is continuing to take measurements normally. Do not use the QOCA DISPOSABLE BLE THERMOMETER near open flames or in excessive heat.
• • • • • • The QOCA DISPOSABLE BLE THERMOMETER can only take measurements while the subject is at rest (e.g., while sitting or lying down) or engaging in ordinary activity. Any activities not permitted by the attending physician may affect the accuracy of the measurements. Do not expose QOCA DISPOSABLE BLE THERMOMETER to extreme temperatures, extremely moist environments, dust, or direct sunlight. Do not clean the QOCA DISPOSABLE BLE THERMOMETER with corrosive or abrasive cleaning agents.
• • • • • • People with sensitive skin or with known skin conditions should use the QOCA DISPOSABLE BLE THERMOMETER with caution. If irritation such as redness, severe itching or allergic symptoms (i.e. hives) develop, instruct patients to remove the QOCA DISPOSABLE BLE THERMOMETER immediately and have them contact their physician. Do not use QOCA DISPOSABLE BLE THERMOMETER on patients with known skin allergies or family history of skin allergies.
PRODUCT OVERVIEW Indication for Use QOCA DISPOSABLE BLE THERMOMETER detects body temperature continuously. Attached to a unique tape and sensor user can easily monitor their body temperature in daily life at home or at hospital. QOCA DISPOSABLE BLE THERMOMETER can be measured and transferred body temperature via BLE up to 14 days. And those body temperature data can be forwarded to the cloud server by mobile phone or gateway for further data analysis.
Package Contents After purchasing the QOCA DISPOSABLE BLE THERMOMETER , please check the product package to ensure that the following items are included: Q-temp-w1 product package Q-temp-w1 Sensor x 1 MH8418-01 User Manual x 1 8 Adhesive x 1
Components Sensor Front 1 2 1 2 Power Button LED (see LED Indicators for more information) NOTE: Electrode button connector will support plug in/off test under 1000 times.
Back 1 1 Temperature Sensor Contact Point MH8418-01 10
Product Requirements In order to properly use the QOCA DISPOSABLE BLE THERMOMETER the following items are required: For Body Patch: • The Sensor with adhesive • A Bluetooth-enabled Android Smartphone* (with Android version 8.x or above and a display resolution of 1920x1080 or 2560x1440) • The Q-temp APP * * Items not included in the product package.
BEFORE YOU START Before you start using the QOCA DISPOSABLE BLE THERMOMETER you must: 1. 2. Install the Q-temp APP on your Android smartphone Enable Bluetooth on your smartphone Installing the App To install the app, search for and download “Q-temp APP” on Google Play Store. NOTE: In order to install the Q-temp APP your smartphone will need at least 5MB of storage capacity available. Enabling Bluetooth To enable Bluetooth, enter the Settings menu on your smartphone and enable Bluetooth.
GETTING STARTED Once you have completed the steps described in Before You Start, you can begin using the QOCA DISPOSABLE BLE THERMOMETER by following these steps: 1. 2. Pair your smartphone to the sensor via Bluetooth Wear the QOCA DISPOSABLE BLE THERMOMETER Pairing 1. 2. 3. When enter the APP, it would show the nearby BLE devices. Please select the name “MH8XXXXXXXXX” . It takes a few seconds to do the pairing. Please wait for a while.
Wearing the QOCA Disposable BLE Thermometer The following steps describe the body patch wearing process: A. Preparing the Skin Step 1: Remove all hair over armpit area by shaving close to the skin. Do not merely clip hair. The prepared area should extend 2 inches past where the sensor will be placed. Step 2: Skin should be scrubbed well enough to be slightly reddened. Allow the skin to dry for 1 minute prior to applying. B.
Step 4: Adhere the QOCA disposable BLE thermometer under armpit as shown below figure. Step 5: Hand pressure on the body patch (especially on the connect point) for at least 30 seconds. Step 6: Do not exercise or take shower after adhesive sensor on the body for at least 2 hours.
IMPORTANT: Able to engage in daily activities, do not do strenuous exercise, or swimming. IMPORTANT: The Patch needs 24 hours to fully stick to your skin, we recommend showering briefly with your back to the water, and avoid any activities that cause sweating during this period. Skin exfoliation will help the contact of patch. IMPORTANT: If the skin at the contact point develops a rash, blisters, reddening, or other irritation, please contact a medical professional or physician.
THE Q-TEMP APP Main Screen Once you have successfully launched and worn the QOCA Disposable BLE Thermometer, the Q-temp APP’s BLE device list will display on your mobile phone. Select the device’s name “MH8Demo” for BLE connection. 1.
Take a Measurement When the BLE is connected, it would take measurement automatically. And the temperature value will show on the middle of screen. 1. Temperature Value 2.
ADDITIONAL INFORMATION LED Indicators The following tables describe the indicators on both the sensor and charger: Event Power on Action Press power button Low N/A battery Behavior The LED flashing green until it’s connected or auto power off. Battery LED flashing orange light. Cleaning The appropriate cleaning methods: Item Sensor MH8418-01 Cleaning Method Wipe with a dry cloth when it’s dirty. And clean it every day if it is frequently used.
Specifications Model Q-temp-w1 Temperature range 77 – 113℉ (25 – 45℃) Reading resolution (1) Accuracy 35.5 – 42℃ +/-0.1℃ (+/-0.18℉) Battery 25 – 35.5℃ & 42 – 45℃ +/-0.2℃ (+/-0.36℉) Measured location Armpit Connectivity BLE 5.0 (measured range: open space 5 m) Transmission Frequency Temperature sensing default at every 30 seconds.
IP Rating IP34 Button One power button Indicator One LED 1. Flash green light while power on 2. Flash red light while low battery 3. LED turn off while BLE connected 4. Automatic turn off while temperature lower 30℃ for 5 mins Weight 5.8g Dimension (mm) L x WxH 39.3 x 29.2 x 4.
Troubleshooting 1) Cannot pair the QOCA DISPOSABLE BLE THERMOMETER with the Q-temp APP. Refer to the notes listed in Pairing. Gateway mode information When using QOCA DISPOSABLE BLE THERMOMETER, the data needs to be transmitted to many different servers at the same time. The Gateway part is not included in the package. You must use compatible gateway device for the QOCA disposable BLE thermometer to work properly.
Customer Support For additional technical information, contact Quanta Customer Support Department. Quanta Computer Inc.(QCI) Address: No. 188, Wenhua 2nd Rd., Guishan Dist., Taoyuan City 333, Taiwan TEL: +886-3-327-2345 FAX: +886-3-318-4207 Email: MedicalService@quantatw.
Federal Communications Commission (FCC) Statement The FCC ID is HFSMH8 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules.
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.
Regulatory Marks The QOCA DISPOSABLE BLE THERMOMETER conforms to the following regulatory requirements. Administrative Regulations on Low Power Radio Waves Radiated Devices (930322) Article 12 Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to an approved low power radiofrequency devices.
CE Mark: Indicates that the body sensor has been certified and conforms to EC Directive 93/42/EEC on medical devices. Type applied part Indicates that the body sensor is classified as electrical or electronic equipment requiring proper disposal (WEEE Directive) Indicates the manufacturer's catalogue number Attention: Catalogue number may also be referred to as the reference number or reorder number. Indicates the manufacture's serial number.
Indicates the manufacturer's name and address To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself Indicates the need for the user to consult the instructions for use. Protected against solid objects down to 12mm.
Supplier’s Declaration The QOCA DISPOSABLE BLE THERMOMETER conforms to the international EN 60601-1 and EN 60601-1-2 standards for electromagnetic compatibility with medical electrical devices and systems. Manufacturer’s declaration-electromagnetic emissions The Q-temp-w1 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-temp-w1 should assure that it is used in such an environment.
RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations Class B Class A Compliance /flicker emissions IEC 61000-3-3 The Q-temp-w1 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Manufacturer’s declaration-electromagnetic immunity The Q-temp-w1 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-temp-w1 should assure that it is used in such an environment.
IEC 610004-4 Surge IEC 610004-5 Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 610004-11 + 1kV for input/ output lines + 0.5kV, +1kV line(s) to line(s) + 0.5kV, +1kV,+ 2kV line(s) to earth Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles Not applicable home healthcare environment. + 0.5kV, +1kV line(s) to line(s) Not applicable Mains power quality should be that of a typical home healthcare environment.
Power 30 A/m frequency(5 50 Hz or 60 0, 60 Hz) Hz magnetic field 30 A/m 50 Hz IEC 610004-8 The Q-temp-w1 power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
Manufacturer’s declaration-electromagnetic immunity The Q-temp-w1 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-temp-w1 should assure that it is used in such and environment.
radio bands between 80 % AM at 1 kHz applicable to the frequency of the transmitter.
recommended separation distance in metres (m). Interference may occur in the vicinity of equipment marked with the following symbol: NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
The Q-temp-w1 is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the Q-temp-w1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Q-temp-w1 as recommended below, according to the maximum output power of the communications equipment.
power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
interference in nearby electronic equipment. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations /flicker emissions IEC 61000-3-3 MH8418-01 The Q-temp-w1 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
