OMRON Intelli Wrap Cuff HEM-FL31
OMRON Blood Pressure Monitor Cuff
Instructions for Use
Please follow this instruction manual thoroughly for your safety. 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.
Step 1: Prepare the Arm
Remove tight-fitting clothing or tight rolled up sleeve from your left upper arm. Do not place the arm cuff over thick clothes.
Step 2: Insert Air Plug
Insert the air plug into the air jack securely. [Click sound] If you are using the air plug as shown in the image, make sure inserting it into the air jack until it clicks.
Step 3: Apply the Cuff
Apply the arm cuff to your left upper arm. The bottom edge of the 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.
Step 4: Secure the Cuff
Secure closed with the fabric fastener.
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.
Maintenance
- Use a soft and dry cloth, or a soft and moistened cloth and neutral soap to clean the arm cuff.
- Do not use petrol, thinners of similar solvents to clean the arm cuff.
- Do not store the arm cuff to extreme temperatures, humidity, direct sunlight, dust or corrosive vapours.
- Do not bend or crease the air tube excessively.
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: 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, instruction manual, air plugs |
| Durable period (Service life), Warranty | 1 year |
Symbols Description
| CE Marking | CE |
| UKCA Marking | UKCA |
| LOT number | LOT |
| Unique device identifier | UDI |
| Medical device | MD |
| Temperature limitation | ?️ |
| Humidity limitation | ? |
| Atmospheric pressure limitation | ☁️ |
| Identifier of cuffs compatible for the device | ? |
| Cuff positioning indicator for the left arm | [Indicator for left arm cuff positioning] |
| Range pointer and brachial artery alignment position | [Range pointer and artery alignment] |
| Artery mark | [Artery mark] |
| Not made with natural rubber latex | ?? (Latex Free) |
| Range indicator of arm circumferences to help selection of the correct cuff size | [Range indicator] |
| Reference catalogue number | ?️ (REF) |
| 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] |
| Date of manufacture | [Date of manufacture] |
| Need for the user to consult the instruction manual | ⓘ |
| Arm circumference | [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 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., Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK, www.omron-healthcare.com/distributors
- OMRON MEDI ZINTECHNIK HANDELSGESELLSCHAFT mbH / OMRON SANTÉ FRANCE SAS, www.omron-healthcare.com/distributors
Made in China
