dretec OX-101 Pulse Oximeter, Blue

[Please refer to the instruction manual.]

[General Name] Pulse Oximeter

[Product Name] Pulse Oximeter OX-101

[Warning] * Do not use in or in conjunction with a hyperbaric oxygen chamber. (This may cause malfunction, damage, or failure.) * Do not use in areas with flammable materials (anesthetic gas, high-concentration oxygen, gasoline, etc.) or flammable vapors. (This may cause a fire.)

[Contraindications/Prohibitions] * Do not use this product near equipment affected by electromagnetic fields (electrical appliances such as mobile phones, televisions, and wireless devices, or medical devices such as electrosurgical units and defibrillators). * Do not use in areas controlled by radiation equipment or MRI (Magnetic Resonance Imaging) systems. (This may cause malfunction, damage, or failure.) * If you have a pacemaker, please consult your doctor before using a pulse oximeter. * This device does not have an alarm function; do not use it if an alarm is required.

Target Users * Do not use on infants. * Do not wear or use continuously for extended periods.

* Do not attach to fingers with wounds or other injuries.

[Product Specifications, etc.] [Measurement Range] SpO2: 35%~99% Pulse Rate: 30bpm~250bpm [Measurement Accuracy] SpO2: 70%~99%: ±2% (No specification below 70%) Pulse Rate: 30bpm~100bpm±2bpm, 100bpm~250bpm±2%

[Precautions for Use] 1) Usage Conditions and Basic Precautions ① Follow the instructions in the user manual before use. ② Do not use for purposes other than measuring blood oxygen saturation and pulse rate. ③ Do not repair or modify. ④ Do not use on anything other than fingers. ⑤ Ensure the finger to which the device is attached is clean. (2) Precautions During Use ① If a malfunction is detected in the device, immediately stop using it. ② If you feel any abnormality in your body or the device, immediately stop using it. ③ Do not use simultaneously with medical devices such as electrosurgical units.

④ Do not move your fingers or body during measurement. ⑤ Measurement may not be accurate in the following cases: • When there is a large amount of abnormal hemoglobin (such as carbon monoxide hemoglobin) • When a dye (such as methylene blue) is present in the blood • When blood circulation at the measurement site is insufficient • When this product is attached to the same arm as the blood pressure monitor • When ambient light such as lighting, fluorescent lights, or direct sunlight is too strong • When you are wearing nail polish or hand cream • When this product is not properly attached to your finger • When there is vigorous body movement ⑥ Do not pull this product by the strap. (3) Precautions after use ① After use, wipe the finger holder with a cloth dampened with disinfectant alcohol. ② When cleaning, wipe with a soft cloth dampened with water or a neutral detergent, then wipe with a dry cloth.

【Maintenance and Inspection Matters】 ① If you notice any malfunction or abnormality in this product, please contact us. ② When using this product after a period of disuse, please ensure that it is functioning correctly and safely before use.

③ To clean the main unit, wipe it with a cloth dampened with water or lukewarm water and wrung out thoroughly.

④ When cleaning, be careful not to scratch the sensor. Do not force the product open.

[Name of Manufacturer and Distributor] Distributor: DRETEC Corporation Address: 2-3-9 Koshigaya Ryutsu Danchi, Saitama Prefecture Manufacturer: Contec Medical Systems Co., Ltd. Country: People's Republic of China Distributor: DRETEC Corporation Customer Service Center 2-3-9 Ryutsu Danchi, Koshigaya City, Saitama Prefecture 343-0824 Phone: 0120-875-019 (Monday-Friday 10:00-12:00, 13:00-16:00, excluding national holidays and company-designated holidays)

[Intended Use or Effect/Efficacy] To measure and display transcutaneous oxygen saturation of arterial blood. Medical Device Classification: Specified Maintenance and Management Medical Device / Specified Controlled Medical Device Medical Device Certification Number: 227AKBZX00100000