Qufora IrriSedo MiniGo Gebrauchsanweisung Seite 4

EN
Instructions for use
Indications for using transanal/rectal irrigation
The Qufora IrriSedo MiniGo is intended for adults and
children 3 years and above to help manage faecal
incontinence and/or constipation conditions.
For example:
• Passive faecal incontinence
• Post defaecation seepage
• Rectocele
• Incomplete evacuation
• Evacuation difficulties
• Low anterior resection syndrome
Within these groups some individuals may require the
support of a carer to perform the procedure.
For the best results Qufora IrriSedo MiniGo should be
used daily or as advised by your healthcare professional.
Before starting transanal/rectal irrigation
Use only after assessment and training from a qualified
healthcare professional. A digital rectal examination is
mandatory prior to your first irrigation. You should be
supervised by an experienced healthcare professional
during your first irrigation.
Transanal/rectal irrigation should not be used
under the following circumstances (absolute
contraindications):
• Known anal or colorectal stenosis
• Colorectal cancer/pelvic malignancy pre surgical
removal
• Acute inflammatory bowel disease
• Acute diverticulitis
• Within 3 months of anal or colorectal surgery
• Within 4 weeks of endoscopic polypectomy
• Ischaemic colitis
Since the list is not exhaustive a healthcare professional
should always consider individual patient factors as well.
Use transanal/rectal irrigation only after careful
discussion with relevant medical practitioner under the
following circumstances (relative contraindications):
• Inflammatory bowel disease (e.g. Crohn's disease
or ulcerative colitis)
• Active perianal sepsis (fistula or abscess, third or
fourth degree haemorrhoids)
• Previous rectal or colonic surgery
• Diarrhoea of unknown aetiology
• Faecal impaction/rectal constipation
• Severe autonomic dysreflexia
• Severe diverticulosis or diverticular abscess
• Abdominal or pelvic irradiation
• Long term steroid therapy
• Anti-coagulant therapy
• Low blood sodium
• Previous severe pelvic surgery
• Colonic biopsy within the past 3 months
• Use of rectal medications for other diseases which
may be diluted by
• Congestive cardiac failure
• Pregnancy or planned pregnancy or breastfeeding
• Children under 3 years of age
Warning
Seek medical attention if the following is experienced
during or after transanal/rectal irrigation:
•
•
Perforation of the bowel wall is extremely rare. However
it is a serious and potentially fatal complication of
transanal/rectal irrigation. Should this occur, immediate
medical attention is required.
Please observe
Transanal/rectal irrigation can be associated with
passing sensations of bowel discomfort, nausea,
shivering, fatigue, sweating, headache and light bleeding
from the rectum.
Please contact your healthcare professional for further
advice.
Recommended usage time
The soft pump can be used 30 times (equal to 1 month
usage time*).
Should discolouration develop within the recommended
usage time, the soft pump should be replaced.
The cone is for single-use only
If the cone is reused, there is a risk of adverse effects
to the product and the health of the patient, carers and
third persons.
Liability
Qufora A/S accepts no liability for any injury or other
loss that may arise if this product is used in any way
contrary to the recommendations of Qufora A/S.
If any serious incident has occurred you should contact
your healthcare professional who will liaise with Qufora
A/S and the competent authority.
Please find further information about this product on
www.qufora.com.
*when used for irrigation every day.
irrigation
Sustained or severe bleeding from the rectum
Sustained or severe abdominal or back pain, with
or without fever
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