Dretec OX-400 Pulse Oximeter, Gray

Please be sure to read the instruction manual.

Generic Name Pulse Oximeter

Product Name Pulse Oximeter OX-400

Warning - Do not use inside or in conjunction with a hyperbaric oxygen device. (This may cause malfunction, damage, or failure.) - Do not use in the presence of flammable substances (anesthetic gas, high-concentration oxygen, gasoline, etc.) or flammable vapors. (This may cause a fire.)

Contraindications/Prohibitions Intended Use (Patients) - This device is intended for patients weighing 15 kg or more. Do not use on infants or young children under this age. - If you use a pacemaker, consult your doctor before using a pulse oximeter. Concomitant Medical Devices - Do not use in areas controlled by radiation equipment or MRI (magnetic resonance imaging) equipment. (This may cause malfunction, damage, or failure.) How to Use - Do not wear the device for long periods of time or continuously. - Do not wear on injured fingers.

Product Specifications [Measurement Range] SpO2: 70-99% Pulse: 30-250 bpm PI: 0.3-20.0% [Measurement Accuracy] SpO2: 70-99%: ±2% (no specification for values below 70%) Pulse: 30-100 bpm: ±2 bpm, 100-250 bpm: ±2% PI: 0.3-1.0%: ±0.2%, 1.1-20.0%: ±2.0%

Precautions for Use (1) Conditions of Use and Basic Precautions ① Read the instruction manual before use. ② Do not use for purposes other than measuring blood oxygen saturation, pulse rate, and perfusion index. ③ Do not repair or modify. ④ Do not use on anything other than your fingers. ⑤ Keep the finger where the device is attached clean. (2) Precautions during Use ① If a malfunction is detected, discontinue use immediately. ② If you experience any abnormalities in your body or the device, discontinue use immediately. ③ Do not use simultaneously with medical devices such as electrosurgical units. ④ Do not move your finger or body during measurement. ⑤ Measurement may not be accurate in the following cases:

- When there is a high amount of abnormal hemoglobin (such as carboxyhemoglobin) - When pigments (such as methylene blue) are present in the blood - When blood circulation at the measurement site is insufficient - When the device is worn on the same arm as the blood pressure monitor - When ambient light, such as lighting, fluorescent light, or direct sunlight, is too strong - When you have nail polish or hand cream on your nails - When the device is not worn properly on your finger - When there is vigorous body movement ⑥ Do not pull the device by the strap. (3) Precautions after Use ① After use, wipe the finger holder with a cloth soaked in rubbing alcohol. ② To clean, wipe with a soft cloth soaked in water or mild detergent, then wipe with a dry cloth.

Maintenance and Inspection Information (1) If you notice any malfunctions or abnormalities with this product, please contact us. (2) When using this product after a period of inactivity, please confirm that it is operating normally and safely before use.

Name of Manufacturer and Distributor Manufacturer: Doretec Co., Ltd. Manufacturer: Shenzhen Yimi Life Technology Co., Ltd. Country of Manufacturer: People's Republic of China Contact Information Doretec Co., Ltd. Customer Service Center 2-3-9 Ryutsu Danchi, Koshigaya City, Saitama Prefecture, 343-0824 Tel: 0120-875-019 (Monday-Friday 9:00-12:00, 13:00-17:00, excluding public holidays and company-designated holidays)

Purpose of Use To measure and display transcutaneous arterial oxygen saturation. Medical Device Classification: Special Maintenance-Restricted Medical Device/Special Controlled Medical Device Medical Device Certification Number: 305AKBZX00055000