Medela Clario toni User manual

SUCTION PUMP
EN Patient Instructions for use
DE Gebrauchsanweisung für Patienten
FR Mode d’emploi
IT Istruzioni per l’uso per i pazienti
NL Gebruiksaanwijzing voor patiënten
SV Patientbruksanvisning
FI Käyttöohjeet potilaalle
NO Pasientbruksanvisning
ES Instrucciones de uso para el paciente
PT Instruções de utilização para o paciente

2
Assistance
Read the entire instruction manual before trying to
operate the device.
If you have any questions about your Clario Toni suction
pump, please contact your healthcare provider/
physician at the number below:
Keep this Patient Instructions for use booklet in an
easily accessible location.
HEALTHCARE PROVIDER/PHYSICIAN CONTACT
INFORMATION:

3
EN
Table of contents
Warnings and safety instructions�����������������������������������������������������������������������������������4
Description of the device���������������������������������������������������������������������������������������������������������������9
Set up instructions�������������������������������������������������������������������������������������������������������������������������������� 13
Preparation for use��������������������������������������������������������������������������������������������������������������������������������14
Operating instructions��������������������������������������������������������������������������������������������������������������������� 18
Emptying the canister���������������������������������������������������������������������������������������������������������������������22
Replacing the valve discs��������������������������������������������������������������������������������������������������������23
Replacing the rechargeable battery��������������������������������������������������������������������� 24
Battery data and test����������������������������������������������������������������������������������������������������������������������� 25
Battery calibration����������������������������������������������������������������������������������������������������������������������������������� 27
Troubleshooting������������������������������������������������������������������������������������������������������������������������������������������ 28
Cleaning guidelines������������������������������������������������������������������������������������������������������������������������������30
Signs and symbols�������������������������������������������������������������������������������������������������������������������������������32
Warranty and servicing�����������������������������������������������������������������������������������������������������������������34
Disposal���������������������������������������������������������������������������������������������������������������������������������������������������������������������35
Technical specifications���������������������������������������������������������������������������������������������������������������36

4
Warnings and safety instructions
The Clario Toni is approved exclusively for the use as
described in these Patient Instructions for use� Medela
can only warranty the safe functioning of the system
when the Clario Toni is used in combination with the
original Medela accessories�
Please read and observe these warning and safety
instructions before operation. These Patient
Instructions for use must be kept with the device for
later reference.
Please note that these instructions for use are a general
guide for the use of the product� Medical matters must
be addressed by a physician�
WARNINGS
The individual responsible for operating this device
on a daily basis (patient, caregiver) must be able
to read, understand and follow directions provided
in this instructions for use and by the healthcare
professional� The individual must be able to hear
and respond to auditory signal�
Only use the Clario Toni suction pump on the per-
son for whom it was ordered and only for its
intended use�
Do not perform the therapy without your healthcare
provider’s supervision�

5
EN
– If you are dependent on the device for airway suction-
ing and a breakdown can lead to a critical situation,
you must have a replacement device at hand�
– The connecting tubing delivered with the device
must always be connected to a sterile catheter as
prescribed by your physician�
– Do not modify the equipment�
– Clario Toni is EMC-tested in conformity with the
requirements of IEC 60601-1-2:2007 and IEC 60601-
1-2:2014 4th Edition according to clause 7 and 8�9�
Clario Toni is suitable for use in home and clinical
environments�
– Wireless communications equipment such as wireless
home network devices, mobile phones, cordless tele-
phones and their base stations, walkie-talkies can
affect the Clario Toni and should be kept at least a
distance 1ft (30 cm) away from the equipment�

6
General safety at home
– Clario Toni should not be used adjacent to or stacked
with other equipment� If adjacent or stacked use is
necessary, Clario Toni should be observed to verify
normal operation in the configuration in which it will
be used�
– Keep the power supply cord away from hot surfaces�
– Keep the mains plug and the on/off switch away
from moisture�
– Never pull the mains plug out of the fixed mains
socket by pulling on the power supply cord!
– Never leave the device unattended when it is
switched on�
– The pump must stand upright during use�
– Never use the device at high room temperatures,
while bathing or showering or if you are very tired�
– Do not use extension cords with Clario Toni pump�
– Keep the power supply cord where you will not fall or
trip over it�
– Never place the power supply cord around your neck�
– Keep the Clario Toni pump clean and dry�
– Never place the pump in water or liquids�

7
EN
– If the pump gets wet, rub with dry towel� Do not dry
in a microwave�
– Keep the pump away from children and pets�
– Keep the pump protected from direct sunlight�
– Prevent the pump from falling to the floor during sleep�
– Do not touch the pump when it has fallen into water�
Unplug device immediately from electrical outlet�
– The power supply may be damaged through electro-
static discharge (ESD) events at the DC port of 15 kV�

8
When you leave the house
– Make sure the LED indicator is not blinking when you
leave the house�
– For your convenience put the pump into the optional
carrying bag and store the tubing safely in the tubing
bag�
– Don’t forget to take a spare jar/tubing and the power
supply with you�
These instructions for use must be kept for later reference�

9
EN
Description of the device
Introduction
Your physician has prescribed the Clario Toni for airway
suctioning� This suction pump from Medela is a high-
quality suction pump that combines easy handling and
cleaning with safety features to ensure optimal operation�
Intended use
The Clario Toni suction pumps are indicated for
aspiration and removal of secretions, bodily fluids and
foreign objects from a patient’s airway or respiratory
support system in the nasal, pharyngeal and tracheal
areas of pediatric and adult patients� The suction
pump is suitable for use at home, in the hospital, in the
car or outdoors�
Indications
The Clario Toni suction pump is indicated to clear
the airways either through the nose, mouth or
tracheostomy tube�
Contraindications
The device is not suitable for use for prolonged
suctioning�

10
Intended user
The Clario Toni should only be operated by properly
instructed users�
Expected service life
The expected service life of the device is seven years�
CAUTION: U�S� Federal law restricts this device to sale
by or on the order of a physician�
Subject to change�

11
EN
Versions of the pump
Front of the pump
Clario Toni AC/DC
Handle
On/off button
SafetyChamber
Motor unit
Mains socket
Specification plate
Battery compartment
Canister
Power cord
Plugs for
closing
Floater
Suction port
LED
Vacuum regulator

12
Position of the membrane
Valve discs in the SafetyChamber
Operating elements and battery status
Vacuum regulator
not lit Battery is fully charged
lit up
blinks slowly Battery is soon empty
blinks rapidly Battery is defective
– Battery is being charged
– Pump is plugged in
Membrane
Rechargeable battery LED
On/off button

13
EN
Check initial delivery
Check the delivery package of the Clario Toni for
completeness and general condition�
Set up instructions
Accessories
Please ask your healthcare provider/ physician in case
of missing parts or for additional accessories�
1x Instructions for use
1x Power adapter
1x Disposable fingertip tubing
1x Clario Toni suction pump
WARNING
The connecting tubing supplied with the device
must never come into direct contact with the suction
area� A sterile suction catheter must always be used
(risk of infection)�

14
Preparation for use
Checks before use
– Check the Clario Toni system before use for dam-
age of the power cord or plug, obvious device
damage or safety defects and proper functioning
of the device.
– Make sure that the rechargeable battery
is calibrated according to chapter "Battery
calibration".
– Check all accessories prior to use:
– Canister and lid for cracks, brittle and flawed
spots. Replace if necessary.
– Tubing for cracks, brittle areas and that connec-
tors are firmly attached. Replace if necessary.
WARNINGS
For use only by persons who have been adequately
trained in the use of suction pumps for airway
suctioning by their healthcare provider/physician�
CAUTIONS
– The Clario Toni must remain in an upright position
during use�
– Sterile accessories must be checked on the
integrity of the packaging before use�
– Non sterile and reusable accessories must be
cleaned and disinfected before use�

15
EN
Assembly of the canister
1� Attach the floater to the canister�
2� Attach the lid to the canister� Mind
the markings on the front of the
canister and the lid�

16
Make sure that both valves (silicone
discs) are attached to the
SafetyChamber�
2�
Assembly of the SafetyChamber
1� Open the lid of the SafetyChamber�
3� Make sure that the lid of the
SafetyChamber is closed well�
4� a) Hold the SafetyChamber and tilt
45° to the left to attach it to the
motor unit�
b) Turn the SafetyChamber to an
upright position until you hear a
click�

17
EN
CAUTION
Do not use tubing or other sterile accessories if the
sterile packaging is damaged� Do not reuse single
use or sterile products�
Attaching the canister to the pump
1� Attach the canister to the pump�
Press firmly�
2� Attach the disposable fingertip
tubing to the suction port�

18
Operating instructions
CAUTIONS
The Clario Toni is to be set up in such a way, that
a separation from the mains supply can be easily
managed� Calibrate the rechargeable battery
before the first use�
Connect Clario Toni to mains power
Check the pump before use following the instruction in
chapter "Preparation for use"�
1�
2� All versions: Plug in the mains plug of the power
cord to a fixed mains socket�
If the pump is
operated using
the optional
car connection
cable:
Connect the optional 12V DC
connection cable to the socket on
the side of the pump and connect
it to the 12V DC power source
(cigarette lighter in the car)�
or
If the pump is
operated with
the recharge-
able battery:
No connection to a power source is
needed� Make sure that the battery
was charged for five hours�
or

19
EN
Functional check with water
1� Press the On/off button to switch
on the pump�
2� Set vacuum regulator to position
"max�"�
3� a) Attach the fingertip tubing�
b) Plug fingertip port�
4� Place fingertip into water and check
if there is suction�
If there is suction, proceed with step 6� If not, see
chapter "Troubleshooting"�
5�
6� Use catheter and vacuum setting as prescribed by a
physician�

20
WARNING
For use only by medically trained persons who have
been adequately trained in suction procedures and in
the use of aspirators� Wear gloves for all operations�
Changing vacuum level
1� Set vacuum regulator to the
necessary position�
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