OMRON HEM-FL31 Wide Range Fit Cuff

Instructions for Use

Product Symbols

Symbol Description
CE CE Marking
LOT LOT number
?️ Temperature limitation
? Humidity limitation
☁️ Atmospheric pressure limitation
i Identifier of cuffs compatible for the device
➡️ Cuff positioning indicator for the left arm
? Range pointer and brachial artery alignment position
ART. Artery mark
LATEX FREE Not made with natural rubber latex
? Range indicator of arm circumferences to help selection of the correct cuff size
REF Reference catalogue number
? Need for the user to consult the instruction manual
? Arm circumference
MD Medical device

Product production date is integrated in the Lot number, which is placed on the product and/or sales package: the first 4 digits mean year of production, the next 2 digits mean month of production and the last 2 digits mean day of production. Depending on the product, some of the above symbols may not be applicable on the product.

Manufacturer Information

Manufacturer: OMRON HEALTHCARE Co., Ltd., 53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN

EU-representative: OMRON HEALTHCARE EUROPE B.V., Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS, www.omron-healthcare.com

Asia Pacific HQ: OMRON HEALTHCARE SINGAPORE PTE LTD., 438A Alexandra Road, #05-05/08 Alexandra Technopark, Singapore 119967, www.omronhealthcare-ap.com

Production facility: OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD., Binh Duong Province, VIETNAM

This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co., Ltd., JAPAN.

About the HEM-FL31 Cuff

Thank you for purchasing the OMRON HEM-FL31. Arm circumference for this cuff is 22 to 42 cm. Follow this instruction manual and applicable OMRON blood pressure monitor manual thoroughly before use. Keep for future reference. For specific information about your own blood pressure, CONSULT YOUR PHYSICIAN.

Caution: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.

Instructions for Use

  1. Remove tight-fitting clothing or tight rolled up sleeve from your left upper arm. Do not place the arm cuff over thick clothes.
  2. Insert the air plug into the air jack securely.
  3. Apply the arm cuff to your left upper arm snugly. The bottom edge of the arm cuff should be 1 to 2 cm above the elbow. Air tube is centered on the middle of your inner arm.
  4. Close the fabric fastener FIRMLY.

Taking measurements on the right arm

The air tube will be at the side of your elbow. Be careful not to rest your arm on the air tube.

Note: The blood pressure can differ between the right arm and the left arm, and therefore also the measured blood pressure values can be different. OMRON recommends to always use the same arm for measurement. If the values between both arms differ substantially, please check with your physician which arm to use for your measurement.

Maintenance

Specifications

Specification Details
Product description Blood pressure monitor cuff
Model HEM-FL31
Arm circumference 22 to 42 cm
Cuff pressure range Pressure: 0 to 299 mmHg
Operating conditions +10 to +40°C, 15 to 90% RH (non-condensing), 700 to 1060 hPa
Storage/Transport conditions -20 to +60°C, 10 to 95% RH (non-condensing), 700 to 1060 hPa
Accuracy Pressure: ±3 mmHg, Pulse: ±5% of display reading
Durable period (Service life) 1 year

CE Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident that has occurred in relation to this device.

Made in Vietnam

All for Healthcare

Issue Date: 2019-10-03 1681977-2C

Models: HEM-FL31 Wide Range Fit Cuff, HEM-FL31, Wide Range Fit Cuff, Range Fit Cuff, Fit Cuff, Cuff

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