Dretec Pulse Oximeter OX-101 Blue

Coolbe: Este produto é um dispositivo médico que deve ser utilizado apenas como previsto e de acordo com as instruções de utilização. Este dispositivo não substitui o aconselhamento, diagnóstico ou tratamento médico profissional. Em caso de dúvida, consulte um profissional de saúde qualificado antes de o utilizar. O vendedor/distribuidor não é responsável por quaisquer danos resultantes de utilização incorreta, modificação não autorizada ou utilização para além das indicações especificadas.

-----

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