OMRON HEM-FL31 Blood Pressure Monitor Cuff Instruction Manual

June 14, 2024
Omron

OMRON HEM-FL31 Blood Pressure Monitor Cuff

OMRON HEM-FL31 Blood Pressure Monitor Cuff

Thank you!

Thank you for purchasing the OMRON cuff HEM-FL31. Arm circumference for this cuff is 22 to 42 cm. Please refer to the original instruction manual of your Blood Pressure Monitor.
Please follow this instruction manual thoroughly for your safety.
Please 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.

  • 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 , as noted on cuff sticker next to the air jack.
  • Check your present product as to which plug you must use. Using the wrong plug may cause air leakage and incorrect readings.
  • Do not wash the cuff or make it wet.

Instructions for use

Remove tight-fitting clothing or tight rolled up sleeve from your left upper arm.
Do not place the arm cuff over thick clothes.

  1. Insert the air plug into the air jack securely.
    Note: If you are using the air plug as the image shown on the left, make sure inserting it into the air jack until it clicks.
    Instructions for use

  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 elbow. Cuff should be positioned on the upper arm with the air tube pointing towards your hand.

  1. Secure closed with the fabric fastener.

Maintenance

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.

  • Use a soft and dry cloth, or a soft and moistened cloth and neutral soap to clean on the arm cuff.
  • Do not use petrol, thinners of similar solvents to clean the arm cuff.
  • Do not store the arm cuff to extreme

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.

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

Specifications:

Product description OMRON Blood Pressure Monitor Cuff
Model HEM-FL31
Arm circumference 22 to 42 cm
Cuff dimensions Not more than 585 x 160 mm (unfolded)
Cuff pressure range Pressure: O to 299 mmHg
Accuracy Pressure: ± 3 mmHg
Classification Class I
Operating conditions +10 to +40°C (50 to 104°F)

15 to 90% RH (non-condensing)
700 to 1060 hPa
Storage/Transport conditions| -20 to +60°C (-4 to 140°F)
10 to 95% RH (non-condensing)
700 to 1060 hPa
Weight| Not more than 179 g
Package contents| Cuff, instruction manual, air plugs
Durable period (Service life), Warranty| 1 year

Symbols description

| CE Marking
---|---
| UKCA Marking
| LOT number
| Unique device identifier
| Medical device
| Temperature limitation
| Humidity limitation
| Atmospheric pressure limitation
| Identifier of cuffs compatible for the device
| Cuff positioning indicator for the left arm
---|---
| Range pointer and brachia! artery alignment position
| Artery mark
| Not made with natural rubber latex
| Range indicator of arm circumferences to help selection of the correct cuff size
| Reference catalogue number
| Easy Cuff
| lntelli Wrap Cuff
**| Comfort Cuff
| Technology by OMRON Healthcare in Japan
| Date of manufacture
| Need for the user to consult the instruction manual
| Arm circumference
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.
Manufacturer| OMRON HEALTCEAR 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
Importer in EU
Production facility| OMRON DALIAN Co., Ltd.
No.3 Song Ji ang Road,
Economic and Technical Development Zone,
Dalian 116600 Liaoning, P.R. China
Subsidiaries| importer in the United Kingdom and UK responsible person| OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Millon Keynes,
MK15 ODG, UK
www.omron-healthcare.com/distributors
OMRON MEDI ZJNTECHNIK / OMRON SANTE FRANCE SAS
**www.omron-healltlcare.com/distributors

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