OMRON HEM-FL31 Wide Range Fit Cuff

Instructions for Use

About the OMRON HEM-FL31 Cuff

Thank you for purchasing the OMRON HEM-FL31. This cuff is designed for arm circumferences from 22 to 42 cm. Please follow these instructions and your OMRON blood pressure monitor manual thoroughly before use. Keep this manual for future reference. For specific information about your 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 sleeves 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. The air tube should be centered on the middle of your inner arm.
  4. Close the fabric fastener FIRMLY.

Taking Measurements on the Right Arm

When 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: Blood pressure can differ between the right and left arm, leading to different measured values. OMRON recommends always using the same arm for measurement. If values differ substantially between arms, consult your physician to determine which arm to use for measurements.

Maintenance

Specifications

Product description Blood pressure monitor cuff
Model HEM-FL31
Arm circumference 22 to 42 cm
Cuff pressure range 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

Symbols Description

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

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 and Contact 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. Made in Vietnam.

Regulatory Information

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.

Issue Date: 2019-10-03

Document Number: 1681977-2C

All for Healthcare

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

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