Coolbe: This product is a medical device which must be used only as intended and in accordance with the instructions for use.
This device is not a substitute for professional medical advice, diagnosis, or treatment. Consult a qualified healthcare professional before use if in doubt. The seller/distributor is not liable for any damages arising from misuse, unauthorized modification, or use beyond stated indications.
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[Please read the instruction manual carefully]
[Generic Name]
Pulse Oximeter
[Brand Name]
Pulse Oximeter OX-104
[Contraindications]
Intended Use (Patients)
- This product is intended for patients weighing 15 kg or more. Do not use on infants or young children under this age.
- If you are using a pacemaker, consult your doctor before using a pulse oximeter.
Concomitant Medical Devices
- Do not use in areas controlled by radiation 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.
[Warnings]
- Do not use inside or in conjunction with hyperbaric oxygen equipment. (This may cause malfunction, damage, or failure.)
- Do not use in the presence of flammable substances (anesthetic gases, high-concentration oxygen, gasoline, etc.) or flammable vapors. (This may cause a fire.)
[Product Specifications]
[Measurement Range]
SpO2: 70-99%
Pulse: 30-250 bpm
PI: 0.3-20.0%
[Measurement Accuracy]
SpO2: 70-99%: ±2% (No regulation 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%
[Usage Precautions]
(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 clean.
(2) Precautions During Use
1. If a malfunction is detected in the device, discontinue use immediately.
2. If you experience any abnormalities with 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 nail polish or hand cream is applied
- When the device is not worn correctly on the finger
- When there is vigorous movement
6. Do not pull on the device by the strap.
(3) Precautions After Use
1. After use, wipe the finger holder with a cloth soaked in rubbing alcohol.
2. When cleaning, wipe with a soft cloth dampened with water or mild detergent, then dry with a dry cloth.
[Maintenance and Inspection Information]
(1) If you notice any malfunctions or abnormalities with this product, contact the appropriate contact information.
(2) When using this product after it has not been used for a while, verify that it is operating normally and safely before using it again.
(3) To clean the main unit, soak a cloth in water or lukewarm water and wipe it with a well-wrung cloth.
(4) When cleaning, be careful not to scratch the sensor. Do not force the product open.
[Name and Address of Manufacturer and Distributor]
Manufacturer: Doretec Co., Ltd.
Address: 2-3-9 Ryutsu Danchi, Koshigaya City, Saitama Prefecture
Manufacturer: Shenzhen Yimi Life Technology Co., Ltd.
Country: People's Republic of China
Distributor:
Doretec Co., Ltd. Customer Service Center
2-3-9 Ryutsu Danchi, Koshigaya City, Saitama Prefecture, 343-0824
Tel: 0120-875-019 (Mon-Fri 9:00-12:00, 13:00-17:00, excluding public holidays and company-designated holidays)
[Purpose of Use]
Measure and display transcutaneous arterial oxygen saturation.
Medical Device Classification: Special Maintenance-Restricted Medical Device/Specially Designated Medical Device
Medical Device Certification Number: 305AKBZX00017000
