Qufora IrriSedo MiniGo, Инструкция по эксплуатации

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Qufora IrriSedo MiniGo
Using the Qufora IrriSedo MiniGo
makes it possible to perform transanal/
rectal irrigation. Please read both
pages of this instructions for use
before using the Qufora IrriSedo
MiniGo.
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.
Please note:
Transanal/rectal irrigation is not
recommended for:
• Pregnancy or planned pregnancy or
breastfeeding
• Children under 3 years of age
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
irrigation
• Congestive cardiac failure
Warning
Seek medical attention if the
following is experienced during
or after transanal/rectal irrigation:
• Sustained or severe bleeding from
the rectum
• Sustained or severe abdominal or
back pain, with or without fever
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.
By using the water temperature
and volumes recommended by the
healthcare professional, the bowel
electrolyte balance is unlikely to be
affected.
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.
Handling and storage
Qufora IrriSedo MiniGo should be
stored at temperatures between 0° C
and 30° C.
Protect the product from direct
sunlight and do not expose to heavy
pressure.
The product should be kept out of
reach of children.
Please find further information about
this product on www.qufora.com.
*when used for irrigation every day.
Instructions for use
Note:
Please use Qufora IrriSedo MiniGo as advised by your healthcare professional.