OMRON Intelli Wrap™ Cuff HEM-FL31 Type B

Instruction for Use

Symbols Description

[Artery Mark][Temperature Limitation]
LATEX FREE[Humidity Limitation]
[Cuff Compatibility Identifier][Atmospheric Pressure Limitation]
Arm CircumferenceLOT number
CE Marking[Reference Catalogue Number]
[Consult Instruction Manual]Medical Device [MD]

Product production date is integrated in the Lot number: first 4 digits = year, next 2 digits = month, last 2 digits = day of production.

Note: Some symbols may not be applicable depending on the product.

Manufacturer and Representatives

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

Made in Vietnam

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.
  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.
  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.

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.

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

Product descriptionUpper Arm Blood Pressure Monitor Cuff
Product nameIntelli Wrap™ Cuff
ModelHEM-FL31 Type B (REF HEM-FL31-BAP)
Arm circumference22 to 42 cm
DimensionsApprox. 145 mm × 532 mm (air tube: 750 mm)
Operating conditions+10 °C to +40 °C / 15 to 90% RH (non-condensing) / 800 to 1060 hPa
Storage/ Transport conditions-20 °C to +60 °C / 10 to 90% RH (non-condensing)
Durable period (Service life)5 years

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

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