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Coloplast Conveen - User Manual

Coloplast Conveen
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Leg bag
Strap
Instructions for use
23322986 Version 1
The Coloplast logo is a registered trademark of Coloplast A/S. All rights
reserved.© 2020-02-17
Intended purpose
The urine bag is intended to passively collect urine.
Indications
Urine bags are indicated for patients su󰀨ering from urinary incontinence
and/or retention of any aetiology.
Warnings
Re-use of the single use product is not recommended cross contamination
may occur.
Reprocessing, washing, disinfection and/or (re)sterilisation may
compromise product characteristics, causing additional risk of physical harm
or infection to the user.
This leg bag is intended to be used while out of bed and moving about.
Change to a bedside drainage bag with higher capacity while in bed and
during sleep. Alternatively, leave your leg bag in place and attach a bedside
drainage bag to expand the capacity of the overall urine collection system.
This product contains phthalates and should neither be used by children
nor by pregnant or nursing women without consulting a health care
professional.
Information
The bag is designed for single use.
The product has a capacity of 600/800 mL.
The printed volume indicator is only an indicative volumetric measurement
scale.
The straps can be washed at temperature of 40℃/104℉ or lower.
The products are intended to be stored in the box until removed for use, as
the box protects the products and the label on the box contains important
information like batch code, use-by date and a unique barcode.
The device does not have to be removed before an MR scan as it is MR
safe.
How to use
Preparation
Application
Removal
Disconnect the bag from the urisheath or catheter.
Unfasten the straps and remove the bag from your leg.
The leg bag has an inlet tube which may
be pre-attached to the bag or may be sep-
arate from the bag. The length of the tube
determines where the bag can be placed
on the leg.
If the tube does not have a pre-attached
inlet connector or if the tube itself is not
pre-attached to the bag you can shorten
the tube to your preferred length. Simply
cut the tube with scissors.
When cutting a corrugated tube, leave as
much of the straight section as possible in
place. This will ensure a secure connec-
tion between tube and connector when
mounting the connector.
Attach the connector to the tube by push-
ing the thin end of the connector into the
tube as far as possible.
Make sure the outlet tap is closed.
Attach the straps to the bag. Fit the bag
to your leg. Any surplus strap may be
trimmed o󰀨.
Conveen siliconized strap
Use the longer strap at the top of the bag.
If tting the bag to the calf, wrap the top
strap in a gure-of-eight behind and over
the knee.
If the connector has a protective cap,
remove it.
Attach the connector to the urisheath or
catheter.
The urinary collection system is now
functional.
We recommend emptying the bag when
it is a little over half full to ensure optimal
drainage.
Coloplast accepts no liability for any injury or loss that may arise
if this product is used in a manner contrary to Coloplast's current
recommendations.
Maximum number of allowable reuses
Straps should be replaced when the elasticity weakens.
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Summary

Product Usage Instructions

Preparation for Use

Prepare the leg bag and tube by attaching the connector.

Application and Securing

Fit the leg bag to the leg using straps and connect to catheter.

Removal Procedure

Disconnect the bag from the catheter and remove from leg.

Product Purpose and Indications

Intended Purpose

The urine bag is intended to passively collect urine.

Indications for Use

For patients with urinary incontinence or retention.

Important Warnings and Information

Safety Warnings

Single use, avoid reprocessing, phthalate concerns, special populations.

Usage Guidance

Use out of bed; consider bedside bag for sleep; strap washing.

Product Details

Capacity, volume indicator, single use design, MR safe.

Disposal and Incident Reporting

Disposal Instructions

Change bag per guidelines, empty before discarding, do not flush.

Strap Reuse

Straps may be reused as elasticity permits.

Reporting Incidents

Report serious incidents to manufacturer and national authority.

Explanation of Symbols

Regulatory and Identification Symbols

MD, CE, REF, LOT, UDI, GTIN, Manufacturer, Dates.

Usage and Handling Symbols

Consult IFU, Do not re-use, Non-sterile, Keep away from sunlight, Recyclable packaging.

Overview

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.

Function Description

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.

Usage Features

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.

Maintenance Features

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.

Coloplast Conveen Specifications

General IconGeneral
CategoryPersonal Care Products
MaterialLatex or Silicone (depending on the specific product)
BrandColoplast
RangeConveen
Adhesive TypeHydrocolloid
Color OptionsTransparent
UsageSingle-use
Available SizesVarious sizes available

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