B. Braun Flexima 3S Be 1 User manual

Flexima® / Softima®3S Be 1

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Flexima® / Softima® 3S Be 1
≤ 40mm≤ 30mm ø 65mmø 55mm
2
1
936616, 936646936516, 936536, 936541
A
2mm MIN
BCED
F G H I J
K1 K2 L M N

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Flexima® / Softima® 3S Be 1
O P RS1
Q
S2 T V1 V2
X Y
W
U

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What Be 1 is and what it is used for
Capsule Be 1: compact 2-Piece closed and folded pouch
with an integrated lter with active and passive degassing
possibilities. The aim of this product, while being safe of
use, is to give back to colostomate patients the possibility
to control the continence of their stoma for both gas
and stools evacuation while improving their body image,
comfort and self-esteem.
The 2-piece collection system for colostomates is made
up of:
- Flexima®/ Softima® 3S Be 1 base plate with an adhesive
surface (composed mainly of hydrocolloids) and a ring for
coupling with the pouch;
- Be 1 capsule ostomy device with integrated lter and
closed pouch folded inside
- Flexima® / Softima® 3S closed pouch.
Degassing button
Folded pouch Base plate
Capsule cover
Filter
Flexima® / Softima® 3S Be 1 may be used concomitantly
with B.Braun stoma care accessories.
EN Instructions for Use
Indications – Contraindications
- Indications / Patient population:
The product is indicated for collection and containment
of stools by patients with colostomy. The product is
not intended to be used on a skin or mucus membrane
presenting a pathological change or change following
disease or a wound.
The capsule is indicated for colostomates adults or children
above four years who have had their stoma for more than
1 month and whose stools are hard to soft in consistency.
Bristol’s
scale
Type 1
Type 5Type 4
Type 2
Type 6
Type 3
Type 7
Clinical benets & performances: Ostomy appliances
compensate for the loss of faecal continence.
- Contraindications:
• Be 1 capsules are not intended for use with convex
supports (References: 937xxx) or supports with acrylic
reinforcement (References: 938xxx).
•Not intended for use until the abdomen and peristomal
skin are completely healed after bowel surgery.
•Not intended for use by individuals with a colostomy
protruding more than 10mm from the skin, as measured
when lying down.
•Not recommended for use by colostomates with liquid
stools.

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EN Instructions for Use
•Not for use on a stoma with a diameter of 40 mm or
more.
Warnings:
Choice of the capsule and supports depending on the size
of the stoma:
Stoma diameter Be 1 capsule Base Plate
1Inferior to 30mm Ø 55 mm 9365xx
2Inferior to 40mm Ø 65 mm 9366xx
• Monitor your stoma and peristomal skin regularly. If you
notice any changes, discontinue usage of the device and
consult a healthcare professional.
• In case you encounter gastrointestinal symptoms,
discontinue usage of the device. If these symptoms
persist, consult a healthcare professional.
• In case the pouch opens unintentionally, do not try
to fold it back, use the device with the pouch in open
position or use a new capsule cap.
• Using a tight belt or garment over the device might
impair the self-deployment of the collection bag.
Residual risks or side eects:
•Feeling of temporary discomfort disappearing with the
cap removal and deployment of the bag
•Local skin irritation
•Stool leakages
•Unpleasant smells and odours
1Preparing the skin
Wash your hands before starting the procedure.
Gently clean the peristomal area with lukewarm water (C).
Avoid ether, alcohol or any other topical product which
could interfere with base plate adhesion. Carefully dab dry
the skin with soft and non-shedding cloths.
2Preparing the base plate
Cut the central opening of the hydrocolloid adhesive to
the size of your stoma (A) possibly with the help of the
Stoma Guide. Do not cut beyond the maximum possible
diameter and make sure that there is always a 2 to 3 mm
margin around your stoma in order not to strangle or hurt
the stomal mucosa (B).
3Applying the base plate
Peel o the release (D). Apply the base plate around your
stoma in a way such that the 3 security knobs are located
at the top (E). In order to improve the adhesion, place
hands over the base plate to warm it up.
4Applying the capsule or the pouch
For Capsule
•Make sure the capsule cap is closed, if you are not sure
apply pressure with your ngers around the capsule cap
to close it.
•Hold the capsule by the side edges (the guiding tab
should point downwards).
•Insert the guiding tab which is situated at the bottom of
the capsule cap into one of the slots at the bottom of the
base plate coupling ring, depending on how you want
to orient the capsule cap (F). The safety button must be
placed opposite the upper tab (G) to have the capsule cap
well centered on the base plate. Starting at the bottom
of the coupling rings, interlock them by pressing them
together, progressing from bottom to top (H) over the
entire circumference. You can place your thumbs under
the base plate ring to achieve a better grip and so avoid