OMRON HEM-FL31 Intelli Wrap Cuff
User Manual and Specifications
Introduction
Thank you for purchasing the OMRON HEM-FL31 cuff, manufactured by OMRON. This cuff is designed for arm circumferences of 22–42 cm. Please refer to the user manual supplied with your blood pressure monitor for detailed operation.
Please read this user manual carefully for your safety. Keep it for future reference. Consult your doctor for specific blood pressure values.
Safety Information
⚠️ Attention! Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury or damage to equipment or other property.
- This OMRON cuff can be used with various OMRON blood pressure monitors.
- Refer to the cuff label near the air socket for information on which OMRON blood pressure monitors it is compatible with.
- Ensure you know which air plug to connect to your blood pressure monitor. Using the wrong plug may cause air leaks and inaccurate readings.
- Do not wash the cuff and avoid exposing it to moisture.
Instructions for Use
For the Left Arm
Remove tight-fitting clothing or roll up the sleeve of your left arm above the elbow. Do not place the cuff over thick clothing.
- Securely insert the air plug into the air socket until you hear a click.
Note: The air plug shown on the left should be inserted into the air socket until it clicks. - Place the cuff on the upper part of your left arm. The lower edge of the cuff should be 1–2 cm above the elbow. Position the cuff with the air tube pointing towards your palm.
- Secure the cuff using the hook-and-loop fastener.
For the Right Arm
Position the air tube on the side of your elbow. Be careful not to pinch the air tube with your arm.
Note: Blood pressure may differ between the right and left arms, so the readings may also differ. OMRON recommends measuring on the same arm each time. If there is a significant difference in readings between arms, consult your doctor about which arm to use for measurement.
Maintenance
- Clean the cuff using a soft, dry cloth or a soft cloth dampened with mild soap.
- Do not use gasoline or solvents to clean the cuff.
- Do not store the cuff in locations exposed to high temperatures, humidity, direct sunlight, dust, or corrosive vapors.
- Do not bend the air tube sharply.
Technical Specifications
| Appliance Name | OMRON blood pressure monitor cuff |
|---|---|
| Model | HEM-FL31 |
| Arm Circumference | 22–42 cm |
| Cuff Dimensions | Not more than 585 x 160 mm (unfolded) |
| Cuff Air Pressure Range | 0–299 mmHg |
| Accuracy | ±3 mmHg |
| Classification | Class I |
| Operating Conditions | Temperature: +10 to +40°C (50 to 104°F) Relative Humidity: 15–90% (non-condensing) Pressure: 700–1060 hPa |
| Storage/Transport Conditions | Temperature: -20 to +60°C (-4 to 140°F) Relative Humidity: 10–95% (non-condensing) Pressure: 700–1060 hPa |
| Weight | Not more than 179 g |
| Package Contents | Cuff, user manual, air plugs |
| Service Life, Warranty | 1 year |
Symbol Explanations
| CE | CE Marking |
| UKCA | UKCA Marking (UK Conformity Assessed) |
| [Lot Number] | LOT Number |
| [Unique Device Identifier] | UDI |
| [Medical Device] | MD |
| ?️ | Temperature Limitation |
| ? | Relative Humidity Limitation |
| ☁️ | Atmospheric Pressure Limitation |
| [Compatible Cuff Identifier] | Identifier for cuffs compatible with this device |
| [Cuff Position Indicator] | INDEX: Cuff position indicator for the left arm |
| [Artery Position Indicator] | ART. : Indicator of range and position of the brachial artery |
| [Latex Free] | LATEX FREE: Manufactured without natural rubber latex |
| [Reference Number] | REF: See catalog number |
| Easy Cuff | Easy Cuff |
| Intelli Wrap Cuff | Intelli Wrap Cuff |
| Comfort Cuff | Comfort Cuff |
| [OMRON Healthcare Technology, Japan] | TECHNOLOGY BY OMRON HEALTHCARE IN JAPAN: Technology owned by OMRON Healthcare (Japan) |
| [Date of Manufacture] | Date of Manufacture |
| ℹ️ | Refer to the user manual |
| [Arm Circumference] | Arm circumference |
Note on Date of Release: The date of release is indicated in the lot number on the product and/or packaging: the first 4 digits represent the year of manufacture, the next 2 digits represent the month of manufacture, and the last 2 digits represent the day of manufacture.
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, NETHERLANDS
www.omron-healthcare.com
EU Importer
OMRON DALIAN Co., Ltd.
No.3 Song Jiang Road, Economic and Technical Development Zone, Dalian 116600 Liaoning, People's Republic of China
Subsidiaries
Importer in Great Britain and responsible person:
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UNITED KINGDOM
www.omron-healthcare.com/distributors
Other Subsidiaries:
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH / OMRON SANTÉ FRANCE SAS
www.omron-healthcare.com/distributors
Made in China
