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
Product Name
Pulse Oximeter OX-101
Warnings
- 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
- Do not use this product near electromagnetically affected devices (electrical appliances such as mobile phones, televisions, and wireless devices, or medical devices such as electric scalpels and defibrillators).
- Do not use in areas controlled by radiation equipment or MRI (magnetic resonance imaging) devices. (This may cause malfunction, damage, or failure.)
*Pacemaker users should consult their physician before using a pulse oximeter.
- This device does not have an alarm function, so do not use it when an alarm is necessary.
Target Users
- Do not use on infants and young children.
- Do not wear it for long periods of time or use it continuously.
・Do not wear on fingers with scars or other injuries.
Product Specifications
[Measurement Range]
SpO2: 35% - 99%
Pulse: 30 bpm - 250 bpm
[Measurement Accuracy]
SpO2: 70% - 99%: ±2% (no specifications for values below 70%)
Pulse: 30 bpm - 100 bpm ±2 bpm, 100 bpm - 250 bpm ±2%
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 and pulse rate.
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 any malfunction is detected in the device, discontinue use immediately.
② If you notice any abnormalities in your body or the device, discontinue use immediately.
③ Do not use simultaneously with medical devices such as electric scalpels.
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 wearing nail polish or hand cream
- When the device is not worn properly on the finger
- During 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 dampened with rubbing alcohol.
② To clean, wipe with a soft cloth dampened with water or mild detergent, then wipe with a dry cloth.
Maintenance and Inspection Matters
① If you notice a malfunction or abnormality in this product, contact us.
② When using this product after it has not been used for a while, please make sure 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 open the product.
Name of Manufacturer/Distributor
Manufacturer/Distributor: Doretec Co., Ltd.
Address: 2-3-9 Koshigaya Ryutsu Danchi, Saitama Prefecture
Manufacturer: Contec Medical Systems 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 10:00-12:00, 13:00-16:00, excluding public holidays and company-designated holidays)
Purpose of Use or Effects/Indications
Measure and display transcutaneous arterial blood oxygen saturation.
Medical Device Classification: Special Maintenance-Restricted Medical Device/Specially Controlled Medical Device
Medical Device Certification Number: 227AKBZX00100000
