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.
- Use only the approved Blood Pressure Monitor for this cuff.
- Use the same arm cuff as indicated by the air jack. Do not use other types of arm cuffs.
- Do not wash the cuff or make it wet.
Instructions for Use
- Remove tight-fitting clothing or tight rolled-up sleeves from your left upper arm. Do not place the arm cuff over thick clothes.
- Insert the air plug into the air jack securely.
- 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.
- 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
- Use a soft, moistened cloth and neutral soap to clean the arm cuff.
- Do not use petrol, thinners, or similar solvents to clean the arm cuff.
- Do not store the arm cuff in extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors.
- Do not forcibly bend the arm cuff or the air tube excessively.
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, CuffRelated Documents
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