OMRON Intelli Wrap Cuff

Introduction

Thank you for purchasing the OMRON HEM-FL31 cuff. This cuff is suitable for arm circumferences between 22 and 42 cm. Refer to the original blood pressure monitor manual. Follow this manual carefully for your safety. Keep for future reference. For specific information about your own blood pressure, CONSULT YOUR PHYSICIAN.

⚠️ Attention: 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 device or other equipment.

This OMRON cuff can be connected to various OMRON blood pressure monitors. It only works with OMRON monitors compatible with HEM-FL31, as indicated on the cuff label next to the air jack. Check your cuff for the correct jack to use. Using the wrong jack may cause an air leak and incorrect measurement.

Do not wash or wet the cuff.

Instructions for Use

Preparation: Remove tight clothing from your left arm and roll up sleeves. Do not place the cuff over thick clothing.

1. Insert the air plug firmly into the air jack.

   Note: If using the air plug as shown in the left image, ensure it is inserted into the air jack until it clicks [click sound].

2. Place the cuff on the upper arm. The lower edge of the cuff should be placed 1-2 cm above the elbow. Position the cuff on the upper arm with the air tube pointing towards your hand.
3. Securely fasten the fabric band of the cuff.

Measurement Guidance

Right Arm Measurements

The air tube should be on the side of your elbow. Ensure your arm is not resting on the air tube.

Remark: Blood pressure may differ between the right and left arm, and measured blood pressure values may consequently also differ. OMRON recommends always using the same arm for measurement. If the values measured on both arms are too different, consult a physician to determine which arm to use for measurement.

Maintenance and Care

• Clean the cuff using a soft, dry cloth, or a soft, damp cloth with mild soap.
• Do not use gasoline, thinner, or other solvents to clean the cuff.
• Do not store the cuff in locations subjected to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors.
• Do not excessively bend or twist the air tube.

Specifications

Description of Symbols

• [CE Mark]
• [UKCA Mark]
• [LOT Number]
• [UDI] (Unique Device Identifier)
• [Medical Device]
• [Temperature Limitation]
• [Humidity Limitation]
• [Atmospheric Pressure Limitation]
• [Compatible Cuff Identifier]
• INDEX: Cuff positioning indicator for left arm.
• ART.: Artery mark and alignment pointer on the brachial artery.
• LATEX FREE: Does not contain natural rubber latex.
• [Cuff Size Indicator]: Cuff circumference range indicator for selecting the appropriate cuff size.
• REF: Reference number.
• [Comfort Cuff]
• [Intelli Wrap Cuff]
• [Comfort Cuff] [Technology by OMRON Healthcare in Japan]
• [Date of Manufacture]: The production date is integrated into the lot number on the product and/or sales packaging: the first 4 digits indicate the year of production, the next 2 the month of production, and the last 2 the day of production.
• [Consult Manual] (i symbol)
• [Recycling Symbol]: CARTON + PAPER TO SORT

Manufacturer and Compliance

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. Visit: www.omron-healthcare.com

Production facility: OMRON DALIAN Co., Ltd., No.3 Song Jiang Road, Economic and Technical Development Zone, Dalian 116600 Liaoning, P.R. China.

Made in China.

Subsidiaries/Importers include: OMRON HEALTHCARE UK LTD., OMRON MEDI ZINTECHNIK HANDELSGESELLSCHAFT mbH / OMRON SANTÉ FRANCE SAS. Visit: www.omron-healthcare.com/distributors

This product OMRON is compliant with the rigorous quality system requirements of OMRON HEALTHCARE Co., Ltd., JAPAN.

Report any serious incident to the manufacturer and competent authorities.