OMRON Intelli Wrap Cuff
Model: HEM-FL31
Brand: OMRON
Introduction
Thank you for purchasing the OMRON HEM-FL31 Intelli Wrap Cuff. This cuff is designed for OMRON blood pressure monitors and has an arm circumference range of 22 to 42 cm. Please refer to your blood pressure monitor's original instruction manual for complete usage guidelines. Keep this manual for future reference.
Important: For specific information regarding your blood pressure, consult your physician.
Safety Information and Warnings
⚠️ Warning: Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury to the user or patient, or damage to the device or other property.
This cuff can be connected to many OMRON blood pressure monitors. Ensure compatibility with your specific OMRON monitor as indicated on the cuff label near the air hose connector. Using the wrong connector may cause air leaks and inaccurate readings.
Do not wash or wet the cuff.
Instructions for Use
Left Arm Measurement
Remove any tight clothing or tightly rolled-up sleeves from your left upper arm. Do not place the cuff over thick clothing.
- Insert the air hose plug firmly into the air hose socket.
- Place the cuff on your left upper arm.
Note: If using the air hose plug as shown in the illustration, ensure it is inserted into the air hose socket until you hear a click sound ?.
The bottom of the cuff should be approximately 1 to 2 cm above your elbow. Position the cuff on the upper arm with the air hose directed towards your hand.
Right Arm Measurement
The air hose will be on the side of your elbow. Avoid resting your arm on the air hose.
Note: Blood pressure can differ between the right and left arms. OMRON recommends using the same arm for measurements. If there is a significant difference in blood pressure readings between arms, consult your doctor to determine which arm to use for measurements.
Maintenance
- Clean the cuff using a soft, dry cloth, or a soft, damp cloth with mild soap.
- Do not use gasoline, thinners, or similar solvents to clean the cuff.
- Do not store the cuff in locations exposed to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors.
- Do not fold or sharply bend the air hose.
Specifications
| Feature | Details |
|---|---|
| Product Description | OMRON Blood Pressure Monitor Cuff |
| Model | HEM-FL31 |
| Arm Circumference | 22 to 42 cm |
| Cuff Dimensions | Not exceeding 585 x 160 mm (when unfolded) |
| Cuff Pressure Range | 0 to 299 mmHg |
| Cuff Accuracy | ±3 mmHg |
| Classification | Class 1 |
| Operating Conditions | +10°C to +40°C (50°F to 104°F), 15% to 90% RH (non-condensing), 700 hPa to 1060 hPa |
| Storage/Transport Conditions | -20°C to +60°C (-4°F to 140°F), 10% to 95% RH (non-condensing), 700 hPa to 1060 hPa |
| Weight | Not exceeding 179 g |
| Package Contents | Cuff, Instruction Manual, Air Hose Plugs |
| Warranty | One Year |
Symbols and Indicators
The following symbols and indicators are found on the product or packaging:
- CE Mark: Conformity with European Union regulations.
- UKCA Mark: Conformity with UK regulations.
- LOT: Batch Number / Lot Number.
- UDI: Unique Device Identification.
- MD: Medical Device.
- Temperature Range: ?️ (Indicates suitable temperature limits for operation/storage)
- Humidity Range: ? (Indicates suitable humidity limits for operation/storage)
- Pressure Range: ? (Indicates suitable atmospheric pressure limits for operation/storage)
- INDEX: ?️ (Indicator for left arm cuff position)
- ART: ? (Artery marking)
- LATEX FREE: ?? (Indicates the product is manufactured without natural rubber latex)
- REF: ? (Reference Number / Catalog Number)
- EASY: ✅ (Easy-wear cuff)
- INTELLI WRAP: ? (Smart cuff technology)
- COMFORT: ? (Comfortable cuff design)
- OMRON HEALTHCARE: (Technology by OMRON HEALTHCARE in Japan)
- Information Icon: ℹ️ (Refer to instruction manual)
Manufacturer and Distributor 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)
Production Facility: OMRON DALIAN Co., Ltd., No.3 Song Jiang Road, Economic and Technical Development Zone, Dalian 116600 Liaoning, P.R. China
Subsidiaries/Distributors: OMRON HEALTHCARE UK LTD., OMRON MEDI ZINTECHNIK HANDELSGESELLSCHAFT mbH / OMRON SANTÉ FRANCE SAS (www.omron-healthcare.com/distributors)
Made in China
Manufacturing Date: The production date is indicated in the lot number on the product label and/or sales packaging. The first 4 digits represent the year of production, the next 2 digits represent the month, and the last 2 digits represent the day.
