OMRON Intelli Wrap Cuff HEM-FL31
Brand: OMRON
Model: HEM-FL31
Product Overview
Thank you for purchasing the OMRON HEM-FL31 cuff. The arm circumference for this cuff is 22 to 42 cm. Refer to the original user manual of your blood pressure monitor.
Caution: Indicates a potentially hazardous situation which, if not avoided, could result in minor to 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. The cuff only works with OMRON blood pressure monitors compatible with HEM-FL31, as indicated on the cuff label next to the air hose connector.
- Check your current product to determine which plug to use. Using the incorrect plug can result in air leakage and inaccurate readings.
- Do not wash the cuff and do not get it wet.
Instructions for Use
Step 1: Connecting the Air Hose
Firmly insert the air hose plug into the air hose connector until you hear a click sound [Click sound].
Step 2: Placing the Cuff on the Arm
Remove tight-fitting clothing or a tightly rolled-up sleeve from your left upper arm. Do not place the arm cuff over thick clothing.
Place the arm cuff around your left upper arm.
The lower edge of the arm cuff should be 1 to 2 cm above the elbow. The cuff should be placed around the upper arm with the air hose pointing towards your hand.
Step 3: Securing the Cuff
Secure the cuff firmly with the Velcro fastener.
Performing Measurements on the Right Arm
The air hose should be located next to your elbow. Ensure that you do not rest your arm on the hose.
Note: Blood pressure in your left arm may differ from that in your right arm, leading to different measured blood pressure values. OMRON recommends using the same arm for blood pressure measurements. If blood pressure differs significantly between arms, consult your doctor about which arm to use for measurements.
Maintenance
- Use a soft, dry cloth, or a soft, damp cloth with mild soap for cleaning the arm cuff.
- Do not use gasoline, thinners, or similar solvents to clean the cuff.
- Do not expose the arm cuff to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors.
- Do not bend or kink the air hose excessively.
Specifications
| Product Description | OMRON cuff for blood pressure monitor |
|---|---|
| Model | HEM-FL31 |
| Arm Circumference | 22 to 42 cm |
| Cuff Dimensions | Not more than 585 x 160 mm (unfolded) |
| Cuff Pressure Range | Pressure: 0 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, user manual, air hose plugs |
| Service Life (Lifespan), Warranty | 1 year |
Description of Symbols
| CE marking | CE marking |
| UKCA marking | UKCA marking |
| LOT | Lot Number |
| UDI | Unique Device Identification |
| MD | Medical Device |
| [Temperature Limitation] | Temperature Limitation |
| [Humidity Limitation] | Humidity Limitation |
| [Air Pressure Limitation] | Air Pressure Limitation |
| [Identification of cuffs compatible with the device] | Identification of cuffs compatible with the device |
| [Indicator for cuff positioning on the left arm] | Indicator for cuff positioning on the left arm |
| [Artery symbol] | Artery symbol |
| LATEX FREE | Contains no natural rubber latex |
| [Arm circumference range indicator to help select the correct cuff size] | Arm circumference range indicator to help select the correct cuff size |
| [Reference number catalog] | Reference number catalog |
| Easy cuff | Easy cuff |
| Intelli Wrap cuff | Intelli Wrap cuff |
| Comfort cuff | Comfort cuff |
| [Technology by OMRON Healthcare in Japan] | Technology by OMRON Healthcare in Japan |
| [Production Date] | Production Date |
| [User needs to consult the instructions for use] | User needs to consult the instructions for use |
| Arm Circumference | Arm Circumference |
The production date of the product is integrated into the batch number applied to the product and/or packaging: the first 4 digits indicate the year of production, the next 2 digits the month of production, and the last 2 digits the day of production.
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
UK Importer: OMRON HEALTHCARE UK LTD., Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK, www.omron-healthcare.com/distributors
Other Distributors: OMRON MEDI ZINTECHNIK HANDELSGESELLSCHAFT mbH / OMRON SANTÉ FRANCE SAS, www.omron-healthcare.com/distributors
Made in China
Incident Reporting
Report any serious incidents that occur with this device to the manufacturer and the competent authority of the Member State in which you are established.
