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
