Warnings And Precautions - Optimum Medical ugo sheath Bedienungsanleitung

Ugo Sheath
GBR
PRODUCT REF / CONTENTS
PRODUCT
CODE LENGTH DIAMETER QUANTITY
NAME
3100 Ugo Sheath Standard 25mm 28 units - 4 boxes of 7 Ugo Sheaths
3101 Ugo Sheath Standard 28mm 28 units - 4 boxes of 7 Ugo Sheaths
3102 Ugo Sheath Standard 30mm 28 units - 4 boxes of 7 Ugo Sheaths
28 units - 4 boxes of 7 Ugo Sheaths
3103 Ugo Sheath Standard 32mm
3104 Ugo Sheath Standard 36mm 28 units - 4 boxes of 7 Ugo Sheaths
3105 Ugo Sheath Standard 40mm 28 units - 4 boxes of 7 Ugo Sheaths
3106 Ugo Sheath Pop-On 25mm 28 units - 4 boxes of 7 Ugo Sheaths
3107 Ugo Sheath Pop-On 28mm 28 units - 4 boxes of 7 Ugo Sheaths
28 units - 4 boxes of 7 Ugo Sheaths
3108 Ugo Sheath Pop-On 30mm
3109 Ugo Sheath Pop-On 32mm 28 units - 4 boxes of 7 Ugo Sheaths
3110 Ugo Sheath Pop-On 36mm 28 units - 4 boxes of 7 Ugo Sheaths
3111 Ugo Sheath Pop-On 40mm 28 units - 4 boxes of 7 Ugo Sheaths
This is a product information leaflet for the user.
The Ugo Sheath has been recommended/prescribed for you by a Healthcare Professional. Do not share it with
anyone else.
Read all of the product information leaflet prior to use and retain for your information.
If you are unsure about how to use this product, or whether it is suitable for you, please seek medical advice.
PRODUCT DESCRIPTION | The Ugo Sheath is a self-adhesive soft silicone penile sheath. It is used for the
management of male urinary incontinence, by external application of the sheath over the penis. It is then
connected to a urine drainage bag with a universal connector to drain away urine.
COMPOSITION | Silicone sheath, Acrylic adhesive
INTENDED PURPOSE | The Ugo Sheath is a medical device indicated for the non-invasive management and
containment of male urinary incontinence.
INTENDED USER | The intended users of the Ugo Sheath are men who require a non-invasive urinary
containment device (who have been assessed as suitable by a Healthcare Professional). It is applied by the user,
their carers and/or Healthcare Professionals.
CONTRAINDICATIONS | Do not use the Ugo Sheath unless you have been assessed as suitable by a Healthcare
Professional and it has been recommended for you.
The Ugo Sheath is contraindicated:
• In patients with urinary retention;
• On penile skin which is broken, inflamed or swollen;
• In patients who are sensitive or allergic to any of the device materials;
• On a retracted penis where there is no accessible penile length to fit the sheath.

WARNINGS AND PRECAUTIONS

• It is recommended that the Ugo Sheath is used in line with healthcare policies and procedures
following a patient assessment by a Healthcare Professional.
• Ensure that the Ugo Sheath is suitable for the intended use and compatible with other medical devices
to be used in conjunction with it.
• Only use the Ugo Sheath if you (or your carer) are willing to use it and are able to care for it and you
can remember to do so.
• The Ugo Sheath measuring guide should only be used when measuring for the Ugo Sheath.
It is not suitable for use with any other sheath.
• It is important that your urine drainage bag is secured or supported with appropriate devices
to prevent pulling on your sheath.
• It is important to check your Ugo Sheath is not twisted prior to attaching to your urine drainage bag
• Regularly check that your Ugo Sheath and all urine draining tubing are free from obstruction
• Do not modify or adapt the Ugo Sheath to fit.
• Do not use barrier creams and moisturisers including moisturising soaps or shower gels, wet wipes,
• Do not use on skin which is broken or inflamed.
• Do not shave the pubic area as it may cause skin irritation.
• Do not use the Ugo Sheath if it is damaged or soiled.
• Do not use if the packaging is damaged or unintentionally opened prior to use.
Each inner box contains:
• Keep out of reach of children.
28 Sheaths -
• The Ugo Sheath is not made of natural rubber latex.
4 boxes of 7 Ugo Sheaths
This is a single-use device. Re-use of this device may result in patient infection / cross-contamination.
28 disposable hair guards.
Re/sterilisation, reprocessing, cleaning and disinfection may also compromise the product characteristics,
1 reusable travel pouch.
resulting in trauma or infection to the patient.
UNDESIRABLE SIDE EFFECTS | There may be an increased risk of complications from using the Ugo Sheath if you
have decreased sensation, if you have not been assessed by a Healthcare Professional and you are not suitable to
use the Ugo Sheath (see contraindications), or you have not been measured and fitted correctly.
Remove the Ugo Sheath and seek help immediately from a Healthcare Professional if you experience any of the
following:
• Swelling, inflammation or discomfort of the penis;
• Lesions or broken skin on the penis;
• Compression or discolouration of the penis;
• Feeling unwell, high temperature, nausea/vomiting;
• Feeling of any pain or discomfort;
• Urine not draining into the urine drainage bag;
• Urine leaking from the sheath or sheath falling off;
• Cloudy or foul-smelling urine;
• Blood seen in urine;
• Changes to urine colour and volume.
In rare cases local irritation or hypersensitivity may occur. Symptoms of irritation or hypersensitivity include
redness, itchiness, or blistering. If this occurs, stop using the Ugo Sheath and consult your Healthcare
Professional.
Any serious incident or malfunction that has occurred in relation to the Ugo Sheath should be reported to the
manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.
HOW TO USE | Consult your Healthcare Professional for advice before using the Ugo Sheath.
Always wash and dry your hands before and after handling your Ugo Sheath. If someone else is handling your
Ugo Sheath, they must wash and dry their hands and apply a clean pair of gloves on every occasion to avoid
cross infection.
Selecting the correct size of your Ugo Sheath:
It is important to measure for the correct size. If the Ugo Sheath is too tight it can restrict circulation and if too
loose will not give an adequate seal. Measure the penis when seated in a chair or on the edge of a bed.
Warning! Only use the Ugo Sheath measuring guide to measure for a Ugo Sheath.
Sheath length: If the penis length is 5cm or less in the seated position, select a pop-on length sheath.
Sheath diameter: Using the Ugo Sheath measuring guide, measure the penis where its diameter is widest and
select the correct size. When sizing for a sheath take into consideration natural changes in penis size.
If you measure between sizes, try both sizes for best fit.
(see how to use) and the urine drainage bag connector is not pushed too far into the sheath.
and urine is draining freely.
baby wipes or talcum powder prior to, or while using the Ugo Sheath, as they may affect the adhesion
of the sheath.