Dretec Pulse Oximeter OX-101 Blue

Joom: מוצר זה הוא מכשיר רפואי שיש להשתמש בו רק כמתוכנן ובהתאם להוראות השימוש. מכשיר זה אינו מהווה תחליף לייעוץ רפואי מקצועי, אבחון או טיפול. יש להיתייעץ עם גורם רפואי מוסמך לפני השימוש במקרה של ספק. המוכר/מפיץ אינו אחראי לכל נזק הנובע משימוש לרעה, שינוי לא מורשה או שימוש מעבר לאינדיקציות המוצהרות.

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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