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Prepare the leg bag and tube by attaching the connector.
Fit the leg bag to the leg using straps and connect to catheter.
Disconnect the bag from the catheter and remove from leg.
The urine bag is intended to passively collect urine.
For patients with urinary incontinence or retention.
Single use, avoid reprocessing, phthalate concerns, special populations.
Use out of bed; consider bedside bag for sleep; strap washing.
Capacity, volume indicator, single use design, MR safe.
Change bag per guidelines, empty before discarding, do not flush.
Straps may be reused as elasticity permits.
Report serious incidents to manufacturer and national authority.
MD, CE, REF, LOT, UDI, GTIN, Manufacturer, Dates.
Consult IFU, Do not re-use, Non-sterile, Keep away from sunlight, Recyclable packaging.
This document describes the Conveen® Contour Leg Bag and Strap, a medical device designed for the passive collection of urine. Coloplast, the manufacturer, emphasizes that the product should be used according to their recommendations to avoid injury or loss.
The Conveen® Contour Leg Bag is intended for patients experiencing urinary incontinence or retention due to various causes. Its primary function is to collect urine passively. The leg bag features an inlet tube, which may be pre-attached or separate, and its length can be adjusted to position the bag comfortably on the leg. The system includes straps to secure the bag to the leg. The printed volume indicator on the bag provides an indicative volumetric measurement scale.
Preparation: Before use, the inlet tube can be shortened to the user's preferred length using scissors. When cutting a corrugated tube, it's important to leave as much of the straight section as possible to ensure a secure connection with the connector. The connector is then attached to the tube by pushing its thin end into the tube as far as possible. It's crucial to ensure the outlet tap is closed before use.
Application: The straps are attached to the bag, and the bag is then fitted to the leg. Any surplus strap can be trimmed for comfort. For the Conveen siliconized strap, the longer strap should be used at the top of the bag. If fitting the bag to the calf, the top strap should be wrapped in a figure-of-eight behind and over the knee. If the connector has a protective cap, it should be removed. The connector is then attached to the urisheath or catheter, making the urinary collection system functional.
Optimal Drainage: It is recommended to empty the bag when it is a little over half full to ensure optimal drainage.
Removal: To remove the device, disconnect the bag from the urisheath or catheter, unfasten the straps, and remove the bag from the leg.
Specific Use Cases: This leg bag is designed for use while out of bed and during movement. For periods in bed or during sleep, it is recommended to switch to a bedside drainage bag with higher capacity. Alternatively, the leg bag can remain in place, and a bedside drainage bag can be attached to expand the overall urine collection system's capacity.
Reusability and Disposal: The leg bag itself is designed for single use. Re-use is not recommended due to the risk of cross-contamination, and reprocessing, washing, disinfection, or re-sterilization may compromise product characteristics, leading to physical harm or infection. The bag should be emptied before discarding and disposed of according to local guidelines, typically as normal household waste. It should not be flushed down the toilet.
Strap Maintenance: The straps, however, may be reused. They can be washed at a temperature of 40°C/104°F or lower. Straps should be replaced when their elasticity weakens.
Storage: Products are intended to be stored in their original box until removed for use. The box protects the products and contains important information such as batch code, use-by date, and a unique barcode.
MR Safety: The device does not need to be removed before an MR scan as it is MR safe.
Warnings: This product contains phthalates and should not be used by children or by pregnant or nursing women without consulting a healthcare professional.
Reporting Incidents: Any serious incident occurring during or as a result of the use of this device should be reported to the manufacturer and the relevant national authority.
| Category | Personal Care Products |
|---|---|
| Material | Latex or Silicone (depending on the specific product) |
| Brand | Coloplast |
| Range | Conveen |
| Adhesive Type | Hydrocolloid |
| Color Options | Transparent |
| Usage | Single-use |
| Available Sizes | Various sizes available |
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