OMRON Intelli Wrap™ Cuff HEM-FL31 Type B

Symbols Description

The 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.

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.

Manufacturer Information

Important Safety Information

Warning

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

• To help avoid strangulation, keep the air tube away from infants, toddlers and children.
• Keep components out of the reach of infants, toddlers or children. This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers and children.

Caution

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

• This OMRON arm cuff can be connected to various OMRON Blood Pressure Monitors. This cuff only works with OMRON Blood Pressure Monitors compatible with HEM-FL31 Type B, as noted on cuff sticker next to the air jack.
• Remove tight-fitting and thick clothing from your arm while taking a measurement.
• ONLY use the arm cuff on persons whose arm circumference is within the specified range of the cuff.
• DO NOT crease the arm cuff or the air tube excessively.
• DO NOT fold or kink the air tube while taking a measurement. This may cause an injury by interrupting blood flow.
• To unplug the air plug, pull on the plastic air plug at the base of the tube, not the tube itself.

Instructions for Use

1. Plug the arm cuff into your monitor by inserting the air plug into the air jack securely until it clicks. [Click Sound Indicator]
2. Apply the arm cuff to your left upper arm. The bottom edge of the arm cuff should be 1 to 2 cm above the inside elbow. The air tube is on the inside of your arm and aligned with your middle finger. [Diagram showing cuff placement on left arm]
3. Make sure that the air tube is positioned on the inside of your arm and wrap the cuff securely so it can not move around your arm. [Diagram showing cuff wrapping]

Taking measurements on the right arm

The air tube should run along the side of your elbow, along the bottom of your arm. Be careful not to rest your arm on the air tube. [Diagram showing cuff placement on right arm]

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

Maintenance

• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean the arm cuff and then wipe it with a dry cloth.
• Do not wash or immerse the arm cuff in water.
• Do not use gasoline, thinners or similar solvents to clean the arm cuff.
• Do not store the arm cuff in locations exposed to extreme temperatures, humidity, direct sunlight, dust or corrosive vapors such as bleach.

Specifications

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