Description
The Lepucare LOX100A Fingertip Pulse Oximeter is a small, easy-to-use Class IIa medical device that allows for fully automated measurements. Thanks to its compact and lightweight design, it ensures fast, quick, and reliable measurement of Oxygen Saturation (SpO2), Heart Rate (PR), and Perfusion Index (PI), providing preliminary information on vital parameters related to respiratory and cardiac function. The Lepucare LOX100A Fingertip Pulse Oximeter can be widely used at home or in hospitals and by all types of individuals, such as children, adults, and the elderly, as well as athletes and sports enthusiasts. Its very light weight of 60 g (including batteries) allows it to be carried anywhere, in a bag or backpack when exercising. The device features a color OLED display for easy parameter reading and a low battery indicator. Its automatic shutdown function after 8 seconds of finger removal ensures low power consumption, with a battery life of 25 hours.
ACCURATE AND RELIABLE MEASUREMENT: The Lepucare LOX100A Fingertip Pulse Oximeter can accurately measure oxygen saturation (SpO2), heart rate (PR), and perfusion index (PI) in just a few seconds with a very high accuracy of ±2%.
GUARANTEED PRODUCT QUALITY: The Lepucare LOX100A Pulse Oximeter is a CE certified Class IIa medical device compliant with EN ISO 13485:2016 standards and the electromagnetic compatibility requirements for electromedical products or systems established in IEC 60601-1-2.
COMPACT AND EASY TO USE: Thanks to its very light weight of only 60 g (including batteries), the Lepucare LOX100A Pulse Oximeter can be easily carried in a pocket, bag, or backpack. For an accurate measurement, simply insert your finger fully into the device and wait a few seconds.
LOW POWER CONSUMPTION: The battery life is 25 hours with two 1.5 V AAA alkaline batteries. After 8 seconds of finger removal, the device will automatically turn off.
WIDE APPLICATION: The Lepucare LOX100A Pulse Oximeter is intended for home or hospital use for non-invasive measurement of oxygen saturation, heart rate, and perfusion index. The device can be used by both children and adults.

Technical Characteristics

Oxygen Saturation	-Measurement range: 70-99% -Accuracy: 80-99%±2%; 70-79%±3% -Resolution: 1%
Heart Rate	-Measurement range: 30-240 bpm -Accuracy: 30-240 bpm, ±2 bpm or ±2% (whichever is greater) -Resolution: 1 bpm
Measurement range for blood perfusion index	0.3-20%
LED probe wavelength	RED 660±3 nm IR 905±10 nm
Radiation Power	RED 2 mW IR 2 mW
Battery Model	2 AA batteries
Power Consumption	<30 mA
Battery Life	Continuous use for 25 hours with 2 1.5 V AAA alkaline batteries
Operating Temperature	5-40°C
Storage Temperature	-20-55°C
Relative Humidity	≤80%: no condensation in working conditions ≤93%: no condensation in working conditions
Operating Atmospheric Pressure	86-106 kPa
Storage Atmospheric Pressure	70-106 kPa
Response Time	<20 seconds
Anti-shock protection category	Internal power supply
Anti-shock protection measure	BF type applied part
Waterproof rating	IP22
Net weight	approx. 60 g (including batteries)
Dimensions	69x35x29 mm (LxWxH)
Operating Mode	Non-continuous operation
Data Averaging	-SpO2: average of the subsequent 5 detected pulses, with subsequent exponential smoothing; -Heart rate: average within 8 seconds
Update Time	-SpO2: update per second, update period is less than 20 seconds; -Heart rate: update per second, update period is less than 12 seconds.

Instructions for Use
· Battery Installation
1) Open the battery compartment.
2) Insert 2 AAA type batteries into the battery compartment, ensuring they are positioned correctly.
3) Close the battery compartment.
If the batteries are installed incorrectly, the device may be damaged. Always remove batteries during prolonged periods of disuse.
· Operating Instructions
1) After installing the batteries, open the oximeter.
2) Fully insert your finger.
3) Press the power button to turn on the oximeter.
4) Ensure minimal finger and body movement during measurement.
5) Read the measurement from the device screen.
6) The LOX100 has 4 different user screen options. Once the measurement displayed on the screen is stable, pressing the power button will change the screen display.
7) Once the patient's finger is removed from the device, the screen will display the message "Finger removed." After 8 seconds, the device will automatically turn off.
8) When the battery is low, the screen will display the corresponding symbol. The device will automatically turn off after 8 seconds.
· Settings
While in the "Finger removed" non-measurement state, pressing and holding the power button allows the user to access the menu settings.
Once in the settings menu, short presses of the power button will scroll through the menu options. Long presses will allow the user to adjust the parameters for that setting. To exit the settings menu, select "Exit," then press and hold the power button. The device will automatically exit the settings menu after 30 seconds of user inactivity. During measurement, if the SpO2 and PR values exceed their set limits, the device will periodically emit beeps and the numeric value will flash to alert the user. Pressing and holding the power button will deactivate the alert for approximately 100 seconds before it is re-enabled.
· Lanyard Installation
1) Pass the thinner end of the lanyard through the designated slot on the device.
2) Then pass the thicker end of the lanyard through the thinner loop of the lanyard and pull tightly.
Due to the presence of small parts, always keep the device out of reach of children. Never leave the device dangling from the lanyard in a position accessible to children.

Warnings
Read the User Manual carefully before use. The product cannot be used for continuous measurements. Electrosurgical devices and defibrillators can impair the use of this device. The product should not be used in combination with MRI or CT equipment. Do not squeeze, crush, or apply excessive pressure to the silicone pad during use. The product should not be used in flammable or explosive environments. The product plays a supportive role in patient analysis. Definitive diagnosis must be based on clinical manifestations and symptoms. In case of long-term use, the analysis site can be changed periodically. Skin integrity and the patient's circulatory conditions must be checked every 2 hours to make adjustments accordingly. Disinfection by autoclave, vinyl oxide, or immersion of the sensor in a disinfectant solution will damage the device and cause inaccurate readings. The device specified in this manual, along with its accessories and batteries, must comply with local laws and regulations. The device complies with the electromagnetic compatibility requirements for electromedical products or systems established in IEC 60601-1-2. Radio transmission equipment or other electromagnetic interference can impair the performance of this device. Portable radio communication equipment can impair the performance of this device. The device should not be used near other radio equipment or placed on top of any other equipment. The use of this device is not recommended during patient transport, such as in ambulances or other vehicles. Do not disassemble or attempt to repair this device without prior authorization. The materials that will come into contact with the patient are composed of silicone gel pads compliant with ISO 10993. When in contact with the patient, the temperature must not exceed 40°C. The maximum recommended application time must not exceed 2 hours.
The device is not intended for patients weighing less than 20 kg, pregnant or breastfeeding women. Battery disposal must be carried out in accordance with local authority regulations. Never throw batteries into flames. This device does not have audible alerts. The device is ready for its intended use when the ambient temperature reaches 40°C. The time required to reach ambient temperature from the minimum/maximum storage temperature is approximately 15±5 minutes.

Format
Pack containing:
-1 LOX100A pulse oximeter;
-1 lanyard;
-2 AAA batteries;
-1 user manual;
-1 qualified certificate.