English - Manfred Sauer IQ-Cath IQ2604 Serie Notice D'utilisation

English

Hydrophilic Single-use catheter for ISC (Intermittent self-catheterisation)
Ready for use
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The catheter with 2 functional zones (rounded tip and guiding zone)
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Urine collection bag
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Total length: ca. 430 mm, Length without funnel: ca. 400 mm
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4 Größen: CH 12, CH 14, CH 16, CH 18
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Group of Users: IQ26x4.xx – Men
Intended use:
The IQ-Cath is a single use product designed for temporary drainage of urine from the
urinary bladder in a person with bladder voiding dysfunction for therapeutic or diagnostic
purposes. It is suitable for intermittent self-catheterisation (ISC) or carer-assisted clean
intermittent catheterisation (CIC).
Indication:
The indication for ISC or CIC is made following relevant diagnostic tests and is dependent
on the individual's situation.
The IQ-Cath is suitable for catheterisation in the following situations: bladder voiding dys-
function of various origins (e.g. neurogenic), underactive detrusor or acontractile detrusor,
chronic urinary retention, abnormal micturition (straining) with or without residual urine.
Contraindication:
The IQ-Cath may be unsuitable in the following cases, and a health care professional must
be consulted before use: injury of the urethra, bleeding of the urethra, acute inflammation
of the urethra or prostate, obstructions (e.g. tumours) in the urethra, at the sphincter or at
the prostate blocking passage.
Instructions for use:
The first use should be supervised by a professional.
If liquid has already leaked from the saline sachet into the packaging, the catheter may
no longer be used.
Risks and Cautions:
The use of catheters (especially improper use) may cause irritation/infection of the urinary
tract. You must seek medical attention if this occurs.
Improper use may cause residual urine to remain in the bladder. This catheter is intended for
single use only. The risk of infection increases if the catheter is reused or reprocessed. Do
not use without activating with sterile saline solution 0.9% first. Tap water affects catheter
sterility and thus poses an increased infection risk. Do not use if the sterile packaging
or the catheter is damaged as there is a risk of infection. We recommend an operating
temperature range of 15-25°C.
Any serious adverse event occurring during use of IQ-Cath must be reported to the manufacturer and the competent
authority of the user's country of residence.
MANFRED SAUER GmbH does not accept responsibility for damages or injuries that may result from improper hand-
ling contrary to these instructions for use or from neglecting the hygiene guidelines.
Article number
Serial number
Store in a dry place
Do not resterilise
Quantity
Keep away from sunlight
Sterilised with ethylene oxide
Batch number
Observe instructions for use
CE marked
medical device
4
IQ 2604.xx
Use by (year-month-day)
Not for reuse
Pharmaceutical central no.
Drug Tariff
List of products and services
Do not use if package is damaged
Date of manufacture
Manufacturer
Swiss authorised representative
Importer
IQ 2614.xx
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