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Qufora® IrriSedo Irrigation System
Using the Qufora® IrriSedo Irrigation
System makes it possible to perform
rectal irrigation.
Please read both pages of this instruction
before using the Qufora® IrriSedo
Irrigation System.
Application
The Qufora® IrriSedo Irrigation System
is used to prevent chronic faecal in-
continence and/or constipation or for
those who spend a long time on bowel
management. It should be used regularly -
usually daily or every other day to provide
the best effect.
Before starting rectal irrigation
Use only after assessment, approval
and full instruction by a doctor/health
care professional who is specialised in
this procedure. A digital rectal exam-
ination is mandatory prior to your first
irrigation. You should be supervised by
an experienced healthcare professional
during your first irrigation.
Indications for using rectal irrigation
Individuals with the following condition
and symptoms may benefit:
• Neurogenic bowel dysfunction, e.g.
spinal cord injury, spina bifida and
multiple sclerosis.
• Chronic constipation.
• Chronic faecal incontinence.
Within these groups some individuals
may require support of a healthcare
professional to perform the procedure.
Irrigation should not be used under
the following circumstances (absolute
contraindications):
• Known anal or colorectal stenosis.
• Colorectal cancer pre-surgical removal.
• Acute inflammatory bowel disease.
• Acute diverticulitis.
• Within 3 months of anal or colorectal
surgery.
• Within 4 weeks of endoscopic
polypectomy.
• Iscaemic colitis.
Since the list is not exhaustive a doctor/
healthcare professional should always
consider individual patient factors as
well.
Use rectal irrigation only after careful
discussion with a relevant medical prac-
titioner under the following circum-
stances (relative contraindications):
How to use the system
The system comprises:
(Fig. 1) Water bag that holds up to 1.5 litres with a tube fitted with a valve
(Fig. 2) Valve
(Fig. 3) Pump and control unit
(Fig. 4) Velcro strap
(Fig. 5) Double lumen tube
(Fig. 6) Coated rectal catheter with a silicone balloon
(Fig. 7) Control unit
The numbers on the control unit indicate the following functions:
Position 1 - Fills the tubes with water/dries the system after use.
Position 2 - Fills the balloon with water to retain the balloon in the rectum.
Position 3 - Water runs through the catheter into the rectum.
Position 4 - Water evacuates the balloon to allow the catheter to be
removed from the rectum.
Between the numbered positions, 4 "stop positions" are indicated by white dots.
Use irrigation only after assessment and approval by a qualified health care professional.
To use the system, please follow the instructions:
1
Fill the water bag (Fig. 8) with warm (36 – 38 °C) tap water (only fill the bag up to the amount of water you
need for your irrigation) and fit the lid. Place the water bag no higher than 50 cm above the toilet seat. The
length of the tube from water bag to the valve is 50 cm. Connect the water bag to the pump and regulator.
2
Push the catheter onto one end of the double lumen tube (Fig. 9) and fit the other end of the tube to the
control unit. Use the Velcro strap to attach the control unit to the thigh. Turn the control unit to position 1.
3
Hold the pump with the control unit pointing upwards and open the valve (Fig. 10). Compress the pump
slowly to fill the pump and tubes with water (Fig. 11) until water runs out of the catheter. Turn the control
unit to position 2, ready to fill the balloon. Dip the catheter in water to activate the lubrication
4
Seated on the toilet, carefully insert the catheter into the rectum (Fig. 12).
5
The balloon is filled by compressing the pump completely. If the catheter needs to be further secured,
compress the pump again.
6
Turn the control unit to position 3. Water can now be pumped into the rectum (Fig. 13). Allow approximately
300 to 500 ml (less for children as specified by the healthcare professional) to enter the rectum and set the
control unit between position 3 and 4. The amount of water can be monitored on the bag scale. Use max. 1000
ml. per irrigation. If any discomfort is felt, do not instil more water into the bowel.
7
When the water has been instilled in the bowel, turn the control unit to position 4.
The water from the balloon will flow into the rectum and the catheter can be removed.
8
Water and faecal matter will flow into the toilet.
9
The procedure can be repeated by repeating step 4 – 8.
10
After irrigation wash the outside of the water bag, the control unit and double lumen tube with mild soap.
Disassemble the double lumen tube from the regulator. Empty the water bag and hang the double lumen tube
and control unit individually to dry with the control unit in position 1 and the lid off the water bag.
11
Do not re-use the balloon catheter. It should be disposed of by putting it into a disposal bag before putting it in
the household waste. Do not flush down the toilet. Wash your hands to complete the procedure.
To gain faecal continence or to resolve constipation, irrigation should be used routinely daily or every other day.
• Pregnancy or planned pregnancy or
breast feeding.
• Children under 3 years of age, consid-
ering the size and shape of the device
delivering the water. For child irriga-
tion the approval of a qualified medical
practioner specialised in paediatric
care is required.
• Inflammatory bowel disease (e.g.
Crohn's disease or ulcerative colitis).
• Active perianal sepsis (fistula or abscess).
• Rectal or colonic surgery within the
past 6 months.
• Diarrhoea of unknown aetiology.
• Faecal impaction/rectal constipation.
• Severe autonomic dysreflexia.
• Severe diverticulosis or diverticular
abscess.
• Abdominal or pelvic radiotherapy.
• Known diverticular disease.
• Long term steroid therapy.
• Anti-coagulant therapy.
• Low blood sodium.
• Pelvic malignancy.
• Colonic biopsy within the past 3
months.
• Use of rectal medications for other dis-
eases which may be diluted by irrigation.
• Congestive cardiac failure.
Warning
Perforation of the bowel wall is ex-
tremely rare. However, it is a serious and
potentially lethal complication of rectal
irrigation. Should this occur, immediate
medical attention is required.
Seek medical attention if the follow-
ing is experienced during or after
rectal irrigation:
• Sustained or severe bleeding from
the rectum.
• Sustained or severe abdominal or
back pain, with or without fever.
If the single use items of the product
are reused, there is a risk of unwanted
effects that can influence the function
of the product and the health of the pa-
tient, the caregivers and third persons.
Please observe
Rectal irrigation can be associated with
passing sensations of bowel discomfort,
nausea, shivering, fatigue, sweating,
headache and light passing bleeding
from the rectum.
By following the recommended water
volumes and water temperatures the
bowel electrolyte balance is unlikely to
be affected.
Recommended usage time
(when used routinely every other day)
The balloon catheter is a single use item.
The water bag can be used up to 1 month.
The pump and control unit can be used
up to 6 months.
Should discolouration develop on
any part of the system within the
recommended usage time, the part
should be replaced.
Liability
MBH-International 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 MBH-International A/S.
Handling and storage
Qufora® IrriSedo Irrigation System should
be stored at temperatures between 0
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.
Further information about this product
can be found on www.qufora.com.
Distributor United Kingdom
MacGregor Healthcare Ltd
Unit 2A, Euro House
Satellite Park, Macmerry
East Lothian
EH33 1RW
Distributor Ireland
Uniphar Medical,
4045 Kingswood Road,
Citywest Business Park,
Co. Dublin
D24 VO6K
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