Coolbe: Questo prodotto è un dispositivo medico che va utilizzato solo seguendo le istruzioni e nel rispetto delle indicazioni per l'utilizzo.
Questo dispositivo non è un sostitutivo di pareri, diagnosi o trattamenti medici professionali. Consultare un professionista sanitario qualificato prima dell'utilizzo in caso di dubbi. Il venditore/distributore non è responsabile per eventuali danni derivanti da un uso improprio, modifiche non autorizzate o l'utilizzo al di fuori delle indicazioni fornite.
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Please be sure to read the instruction manual.
Generic Name
Pulse Oximeter
Brand Name
Pulse Oximeter OX-104
Contraindications/Prohibitions
Intended Use (Patients)
- This product is intended for use with patients weighing 15 kg or more. Do not use on infants or young children under this age.
- Pacemaker users should consult a 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 Rate: 30-250 bpm
PI: 0.3-20.0%
[Measurement Accuracy]
SpO2: 70-99%: ±2% (No regulation for values below 70%)
Pulse Rate: 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 instructions in this 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.
2When cleaning, wipe with a soft cloth soaked in water or neutral detergent, then wipe with a dry cloth.
Maintenance and Inspection Information
(1) If you notice a malfunction or abnormality with this product, contact the appropriate person.
(2) When using this product after it has not been used for a while, make sure it is operating normally and safely before using it again.
(3) To clean the main unit, soak it 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/Distributor
Manufacturer/Distributor: 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
To measure and display transcutaneous arterial oxygen saturation.
Medical Device Classification: Special Maintenance-Restricted Medical Device/Specially Controlled Medical Device
Medical Device Certification Number: 305AKBZX00017000
