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 person 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 highquality 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�

1 x Instructions for use

1 x Power adapter

1 x Disposable fingertip tubing

1 x 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 12 V DC connection cable to the socket on the side of the pump and connect it to the 12 V 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�

21

EN

Placing out of operation after use

3� Clean and desinfect the Clario Toni�

See chapter "Cleaning guidelines"�

2� If the pump is

connected to a fixed mains socket:

Disconnect the mains plug from the fixed mains socket�

If the pump is connected to a 12 V DC power source:

Disconnect the 12 V DC plug from the 12 V DC power source�

or

1� Press the On / off button to switch off

the pump�

22

Emptying the canister

Safety related tip

On a daily basis or latest when the fluid level reaches 550 ml and the floater stops suction into the canister the canister should be emptied�

4�

Empty canister and dispose of fingertip tubing in accor-

dance with local guidelines and inhouse guidelines�

6� Switch on the pump and set the vacuum as

prescribed by a physician�

1� Press the On / off button to switch off

the pump�

2� a) Disconnect the disposable finger-

tip tubing from the suction port�

b) Remove canister from the pump�

5� a) Attach a clean canister�

b) Attach a new disposable fingertip tubing to the suction port�

3� For transportation always seal the

canister with the plugs�

23

EN

Replacing the valve discs

Attach the SafetyChamber to the pump as described in chapter "Preparation for use"�

5�

1� Remove the canister�

2� a) Turn SafetyChamber 45 ° to the

left�

b) Remove SafetyChamber by pulling

it off the pump�

3� Open the SafetyChamber�

Replace defective valve discs� Make sure that the new valve discs are attached correctly�

4�

24

Replacing the rechargeable battery

WARNINGS

Before replacing the rechargeable battery, switch off the Clario Toni and pull the mains plug from Clario Toni out of the fixed mains socket�

Calibrate and test the rechargeable battery (see chapters Battery data and test/Battery calibration)�

7�

1� Open the lid of the battery

compartment on the bottom of the Clario Toni�

5� Reattach the battery cable by

plugging in the plug�

6� Close the lid of the battery compartment� Make sure

that the lid is closed well and that the battery cable is not clamped or pinched�

2� Detach the battery cable by

pulling the plug�

3� Remove the old rechargeable battery� 4� Insert the new rechargeable battery�

25

EN

Battery data and test

Duration of pumping

If the battery is fully charged, the operating time at maximum vacuum is approximately > 50 minutes�

Charging time (charged up to 100 %) Approx� 5 hours

Battery status

CAUTIONS

Only charge the rechargeable battery when the charging indicator blinks slowly�

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

26

Pull out the mains plug from the fixed mains socket�2�

Testing the rechargeable battery

5� Measure the time until the pump comes to a stop�

The battery is ok, when the running time is

> 50 minutes� If the running time is < 50 minutes,

repeat test or calibrate the battery (see next page)�

4� Switch on the Clario Toni�

The pump will start running�

3� Set vacuum regulator to position

"max�"�

Make sure that the rechargeable battery is fully

charged�

1�

27

EN

Battery calibration

CAUTIONS

Calibrate the rechargeable battery before first use and after storage duration > 2 months� Replace battery if the calibration is not successful�

Calibrating NiMH rechargeable battery

Pull out the mains plug from the fixed mains socket�2�

Connect the Clario Toni to a fixed mains socket� The rechargeable battery is being charged�

5�

Wait until the charging indicator goes out�6� Repeat step 1 to 6� The Clario Toni AC / DC is then

ready to use�

7�

Let the pump run until the rechargeable battery is empty and the pump comes to a stop�

4�

3� Switch on the Clario Toni�

The pump will start running�

Make sure that the rechargeable battery is fully charged�1�

Storage of the rechargeable battery

In order to keep the self-discharge at a minimum, store the Clario Toni and the removed replacement rechargeable batteries at temperatures below 25 °C (77 °F)� Repeat the calibration process every 60–90 days�

28

Troubleshooting

If the motor is not running

Check if: – the Clario Toni is switched on� – the mains voltage is correct and if the mains plug is

inserted correctly into the wall socket� – the internal battery is charged (only under battery

operation)�

If the pump does not suction strongly enough

Check if: – the vacuum regulator is set to the correct and

prescribed suction level� – the tubings are not defective or broken� If necessary,

replace� – all plug-in connections are tight� – the suction canister / lid have no cracks, brittle areas,

discolouration� If necessary, replace� – the seal of the valve discs inside the SafetyChamber

is tight� – the membrane is clean and has no tears�

If the pump is too loud

Check the position and seal of the valve discs inside the SafetyChamber� If necessary reposition according to chapter "Replacing the valve discs"�

29

EN

Running time from battery insufficient

Calibrate the rechargeable battery (see chapter "Battery calibration")�

CAUTIONS

If the fault cannot be rectified, please contact your healthcare provider�

The rechargeable battery is fully charged�

No LED lit

– The rechargeable battery is being

charged�

– The pump is connected to the

mains�

LED lit up

The rechargeable battery is soon empty� The battery power is sufficient for about 10 minutes of pumping�

LED blinks slowly

The rechargeable battery is defective, please contact your healthcare provider�

LED blinks rapidly

30

Cleaning guidelines

General notes

– Follow the cleaning instructions given by your

healthcare provider� – Wear protective gloves for cleaning / disinfection� – Dispose of fluids such as blood and secretions and

the parts contaminated with them according to your

healthcare provider’s instructions�

Water

Use only the purest quality of water for cleaning� Water hardness is a serious consideration since deposits left on medical products may not be properly decontaminated� Use deionised water in order to reduce this problem�

Disposable products

These are single use products not intended to be

reused� Reuse could cause loss of mechanical, chemical and / or biological characteristics� Reuse could cause cross contamination�

Disassembly

Separate all individual parts before cleaning and disinfecting�

WARNINGS

Before cleaning the device, pull the mains plug out of the wall socket�

Medela Clario toni User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual