iuvas sippa home User manual

1 Important notes
Read through the whole of this instruction manual. Keep
this document for future reference. If these instructions
are not properly followed, the possibility of injuries or dam-
age to the product cannot be ruled out.
1.1 Information about these instructions for
use
The contents of these instructions for use are intended
for healthcare professionals and home users. Healthcare
professionals are persons conversant with the hygiene re-
quirements in clinics and medical practices and also include
specialist dealers, pharmacists, medical assistants, speech
therapists, doctors, nurses, carers, etc.
1.2 Explanation of symbols
The product/packing carries the following symbols:
Follow the instructions for use.
This symbol indicates the manufacturer of
the medical product.
The product meets the fundamental re-
quirements according to the provisions of
the European Medical Products Regula-
tions 2017/745 EU.
This symbol indicates the date of manu-
facture of the medical product.
This symbol indicates the date beyond
which the medical product should no lon-
ger be used.
The medical product should not be used if
the packaging is damaged.
The medical product must not be filled
with liquids hotter than 100°C.
1.3 Information on safety guidance
Safety-related information or warnings are identified as
follows in this instruction manual:
The heading NOTE identifies general precau-
tions that should be followed when handling
the product in order to prevent product
damage or faults.
The heading CAUTION identifies hazards
which could potentially result in injuries or im-
pairment of use if precautions are not taken.
1.4 General safety guidance
If the sippa home drinking aid is used without
the pad and retaining ring components, it is
not being used as intended.
All individual components must be cleaned
daily. To do so, follow the instructions given in
Section 4, Cleaning and disinfection.
Make sure that all individual components are
always adequately dried after cleaning and
disinfection.
Healthcare professionals must observe the
general rules for hospital hygiene and infec-
tion prevention.
Status of information: 03/12/19
All rights reserved.
Subject to technical and layout
amendments and printing errors.
Illustrations may not be identical to product supplied.
EN Instructions for Use
iuvas medical GmbH
Martin-Luther-Str. 2
81539 München
Germany
Made in Germany

2 Product description
2.1 Specications supplied
The specifications vary according to the set supplied. The
specifications of your set are shown in the table below.
Article number Components included
4260551630309 Cup, retaining ring, pad, lid
4260551630316 Cup, retaining ring, pad, lid, handle,
valve
4260551630408
4260551630903
Pad
4260551630507 Handle, valve
4260551630606 Cup
4260551630705 Lid
4260551631108 Handle
4260551631207 Valve
4260551631009 Retaining ring
The specifications supplied also include an instruction
manual.
Please immediately check that the product supplied is com-
plete and undamaged on delivery. If the item is damaged
or incomplete, please immediately inform the dealer from
whom you have purchased the sippa home.
2.2 Intended purpose
The medical product sippa home is intended as a drink-
ing aid for persons who have dysphagia and/or a risk of
pulmonary aspiration. Because the liquid level remains con-
stant, users can drink with their head tilted forwards and
their chin lowered towards their chest. Having your head in
that position makes drinking safer and reduces the risk of
pulmonary aspiration.
The sippa home can be used for persons with difficulty
swallowing, dysphagia, drinking difficulties and/or restricted
mobility of the head, neck or arms.
3 Use
Using the sippa home with the pad increases safety during
the process of drinking. With the aid of the patented sip-
pa-mechanism, the user’s head position does not need to
be altered while drinking.
Risk of damage:
Note the sensitivity of the pad.
Do not use any sharp objects when assem-
bling or using the product.
Risk of damage:
Stirring with an object may damage the pad.
Please stir the drink in a different receptacle.
iuvas medical GmbH accepts no liability for
damage arising form the use of the sippa
home with accessories made by other manu-
facturers.
Small parts contained may pose a risk of
choking if swallowed. Keep small parts out of
the reach of children.
3.1 Assembling the sippa home drinking aid
There are various versions of the sippa home
drinking aid that can be used.
Risk of contamination:
Make sure you observe the rules of hygiene
when assembling and using the product.
Risk of damage:
Always check all individual parts before use.
Replace any parts that are broken, misshapen
or show significant discoloration. Parts that
have passed their use-by date must not be
used. Damaged individual parts and incorrect
assembly may impair function and, therefore,
use of the product.
Place the pad in the cup, screw the retaining ring securely
in place with a twist.

Handles can be attached to the sides of the cup as
required. Simultaneously, slide the tab at the top and the
button at the bottom into the fixings provided until they
snap into place.
3.2 Filling the sippa home drinking aid with pad
Risk of incorrect use:
When using the sippa home with the pad,
note that the retaining ring must be securely
in place when filling.
To fit the valve, turn the lid over and insert the valve into
the recess provided.
Press firmly until the retaining tabs snap into place on thePress firmly until the retaining tabs snap into place on the
right and left with a click.right and left with a click.
Fit the lid on the cup.
If the sippa home is used without the pad, the retaining
ring is not required.
Take off the lid.
Pour the liquid onto the pad and the pad will expand ac-
cordingly. You can check on the expansion through the side
viewing windows in the cup.
3.2.1 Filling the sippa home drinking aid without pad
Take off the lid.
If a means of preventing spillage is required, the lid must be
fitted.
Pour liquid into the cup.
Risk of overfilling:
When first using the pad, fill the sippa home
very slowly with tap water in order to pre-ex-
pand the diaphragm. Then empty the sippa
home again. After that, you can fill the sippa
home normally.
If using different liquids one after the other, rinse out the
pad under running water after each use. Remove excess
water through the spout and fill the sippa home as de-
scribed.

3.3 Drinking
General note:
The sippa home enables safe ingestion of
fluids because of the chin-down position
required. That compensatory method is
employed to prevent and reduce pulmonary
aspiration. However, the method does not
offer hundred-percent protection against
pulmonary aspiration. Therefore, you should
pay close attention to any signs of pulmonary
aspiration.
Risk with hot drinks:
Because of the air cushion between the
diaphragm and the inside wall of the cup, it
is possible for the actual temperature of the
liquid to be misjudged.
General note:
The valve prevents the liquid running out if
the cup tips over. Furthermore, the valve pre-
vents the fluid from coming out if the user’s
head is tilted too far.
Risk of damage:
Do not use a straw as an additional aid.
Inserting a straw may result in damage to the
diaphragm.
Drinking with pad:
oAll individual parts must be firmly attached.
oAdopt an upright and stable sitting position.
oMove your chin towards your chest.
oDrink the liquid in that position. You do not need to
change the position of your head.
oYou can use the sippa home with or without the lid.
The same applies to the valve.
4 Preparation
4.1 General details
Risk of contamination:
Preparation of the sippa home must be per-
formed using suitable validated methods such
that the success of the method is verifiable
and the safety and health of the user is not
endangered.
Pay attention to the manufacturer’s instruc-
tions regarding cleaning agents and disinfec-
tants. The instructions for preparation meet
the requirements of ISO 17664: 2018-04.
The effectiveness of the preparation method
has been validated by an independent labo-
ratory that is certified to ISO 17025.
4.2 Limits of preparation
Risk of damage:
Do not expose the sippa home to tempera-
tures higher than 100°C.
Drinking method 1
(With lid)
Drinking method 2
(Without lid)
4.3 Preparations for cleaning
oRemove the lid from the cup.
oIf the valve is fitted in the lid, remove it. To do this,
bend the retaining tabs outwards.
oRelease the retaining ring with a twist.
oRemove the pad from the cup.
oIf the handles are fitted, remove them.
4.4 Cleaning and disinfection
When choosing cleaning agents and disinfec-
tants, pay attention to compatibility with the
material used as otherwise the possibility of
damage to the sippa home cannot be ruled
out.
4.4.1 Machine preparation
Equipment:
oStandard dishwasher with 70°C programme
oCleaning agent comparable with validated method (see
Validation)
For instructions on reprocessing in professional applicati-
ons, please contact: [e-mail]
Carrying out machine preparation:
oPlace product components in the dishwasher in a way
that they can be optimally cleaned.
oPosition the pad firmly and securely in a basket where
it is protected against sharp objects.
oSelect a suitable washing programme and cleaning
agent.

Validation:
The process is validated if using the following:
oBosch brand dishwasher SPS24CW00E, Program
Intensive 70°
oSomat classic dishwashing tabs
Visual inspection:
Always check product components for damage after clean-
ing/disinfection and replace where necessary.
Replacing the pad after 10 days is recommended.
4.5 Storage
Risk of damage:
Keep all parts of the product in a dry and
dust-free location where they are protected
against contamination.
5 Miscellaneous
5.1 Technical data
Material Components
Polypropylen Lid, retaining ring,
handles
Silicone Pad
PBT Pad
SMMA Cup, valve
Stainless Steel Valve
5.2 Disposal
The sippa home components and accessories can be
disposed ofas normal household waste provided the local
regulations in the country of use do not specify otherwise.
5.3 Contact
For information of any kind about the product,
if any faults occur or if you have any questions
about handling the product, please contact
the iuvas Service Centre:
Tel: [phone]
E-mail: [e-mail]