Clario Operating Instructions April 2011

VIII

‹ Click ›

‹ Click ›

EN

Instructions for use

2

DE

Gebrauchsanweisung

10

FR

Mode d’emploi

18

IT

Istruzioni per l’uso

26

NL

Gebruiksaanwijzing

34

SV

Bruksanvisning

42

FI

Käyttöohjeet

50

NO

Bruksanvisining

58

ES

Instrucciones de uso

66

PT

Manual de instruções

72

Caution: Federal law restricts this device to sale by or on the order of a health professional.

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Congratulations

The Medela Clario is a high quality suction pump for use on order of a health professional/ physician only. This product provides you with a unique threefold hygienic design and optimal protection from an overflow. It is operated by a membrane system with an electric and maintenance-free motor. Using the 3 vacuum settings, the suction strength can be adjusted to the required level.

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Use in accordance with the instructions

Use only according to the instructions from your doctor and after getting instructions from trained medical specialists. Indications

The Clario is intended for use in the medical field for suctioning secretions, body liquids and foreign objects in the nasal, pharyngeal and tracheal areas. This suction pump is suitable for use at home, in the hospital, in the car (AC/DC version) or outdoors (AC/DC version).

Contraindications

The device is not suitable for use for prolonged suctioning.

lll Important safeguards Correct and safe operation only with Medela accessories Read all safety instructions before use. For patients for whom a breakdown of the device can lead to a critical situation (e.g. patients with acute dyspnoea or severe catarrhal congestion), a replacement device must always be available. • Before you plug in the device, please check that your local power supply is the same as the voltage given on the specification plate. • In each of the following cases, the device must not be used and it must be repaired by Customer Services: - If the power cable or the plug are damaged. - If the device is not functioning perfectly. - If the device is damaged. - If the device indicates clear safety defects. • The pump must stand upright during use. • The device must not be used for suctioning explosive, easily flammable or corrosive liquids. • The connecting tubing supplied with the device must never come into direct contact with the suction area. • Keep the power cord away from hot surfaces. • The plug and the ON/OFF switch must not come into contact with moisture.

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• Separation from the mains is only assured through the disconnection of the plug and socket connection. • Never pull the plug out of the mains socket by pulling on the connecting cable! • Never use the device at high room temperatures, while bathing or showering, if you are very tired or in an environment where there is a risk of explosion. • Never leave the device unattended when it is switched on. • The Medela Clario is a medical device that requires special safety measures in regard to EMC and must be installed and put into operation in accordance with the attached EMC information. • Never place the device in water or other liquids. These Instructions for Use must be kept for later reference.

lV Guarantee 2 years for the unit from date of delivery, battery: 6 months. The manufacturer is not liable for any damage or consequential damage caused by incorrect operation, inappropriate usage as well as use by unauthorized persons.

EN

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V

Operating elements

Vacuum regulator

On/Off switch

only for AC/DC-versions:

LED-warning light For battery charge

Other elements (see inside of cover): a

Motor unit

h

Floater

b

Membrane

i

Pug for closing lid

c

Handle

j

Suction port

d

SafetyChamber

k

Disposable connection tubing with fingertip control

e

Vacuum regulator

l

Rechargeable battery

f

Valve discs

m

Power cord

g

Canister

Vl Spare parts/Accessories Correct and safe operation only with Medela accessories Contained in the delivery package j

074.0003

Disposable connection tubing with fingertip control

Optional accessories – not contained in the delivery package

☛ 074.0007 074.0017

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Carrying bag Car connection cable for 12 V DC

Vll AC/DC versions Indicators

visual

during battery operation

does not light up blinks slowly

Rechargeable battery soon empty (~10 mins. pumping duration)

During mains operation EEP!

lights up

Rechargeable battery is being charged

B P! E BE P! E BE

LED display

does not light up P!

blinks rapidlyBEEEEP! B P! E BE

Rechargeable battery is fully charged / empty

Rechargeable battery is fully charged Rechargeable battery is defective. Replace with a new one.

Performance of rechargeable battery Duration of pumping at max. vacuum at min./med. vacuum

> 50 mins. < 50 mins.

Charging time (charged up to 100%)

~ 5 hrs.

Rechargeable battery 1. 2. 3. 4. 5.

Disconnect the mains cable Select maximum vacuum Switch on the Clario Measure the running time Compare the running time

ok?

> 50 mins.

OK, if the above value is reached

not OK • Calibrating the rechargeable battery • Repeat this process

If the calibration was not successful,

replace battery

NiMH rechargeable battery

Before first use Calibrating the rechargeable battery A Completely discharge the rechargeable battery after storage • Disconnect the mains cable duration > 2 months • Switch on the Clario and allow to run until it comes to a standstill B Charge the Clario • Plug in the mains cable – the rechargeable battery is being charged • Wait until the charging indicator goes out

Repeat this process once The Clario is then ready for use

Operation with ☛ Only charge the rechargeable battery when the charging indicator rechargeable battery blinks slowly Storage

In order to keep the self-discharge at a minimum, store the Clario and the replacement rechargeable batteries at temperatures below 25°C (77°F). When storing the Clario over a longer period of time, we recommend to store device and battery separately. EN

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Vlll Application after assembly (see front flap) Wear gloves for all operations. Use only after getting instructions from trained medical specialists. 1. Check general condition of the device • Membrane (has no tears and is clean)? • Floater attached and OK? • Canister and lid - cracks, brittle areas, discolorations? If necessary, replace • Valve discs in SafetyChamber? Tight seal? • Check markings at canister and lid. 2. Test function

AC/DC

• AC/DC versions: before first use, calibrate the battery (see chapter VII) • AC versions: plug in a. Switch the device on

AC

b. Set maximum vacuum

c. Attach fingertip tubing and plug fingertip port

d. Place fingertip into water and check suction or use the optional vacuum gauge

ok?

not OK, see Chapter X

OK 3. Use • Attach catheter prescribed by physician • Adjust the vacuum for use according to instructions from a specialist • Do not let the skin cling! Release vacuum (see picture) • Automatic stop at max. fluid level of 550 ml • Empty canister regularly 6

EN

lX Cleaning After each use:

Canister

• • • • •

Tubings/ Catheter

• Remove and dispose of according to local regulations.

Remove Secure connectors before transport Empty Disassemble parts Clean in dishwasher, boiling water or disinfecting solution.

Clean SafetyChamber after an overflow or when the device has not been used over an extended amount of time. Safety Chamber

• Remove and disassemble • Clean in dishwasher, boiling water or disinfecting solution.

If necessary: Housing/ Membrane

• Unplug and switch off the device before cleaning • Clean the device with a damp cloth and with non-aggressive cleaning material.

EN

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X

Troubleshooting

The device does not contain any parts which may be repaired by the user! Motor not running

Check • Is there mains/battery power present? • Is the device switched on?

Insufficient vacuum

Check • Check general condition of the device according to VIII, 1 • The setting of the vacuum regulator • The condition of the tubings • Tight seal of valve disks inside safetyChamber • Membrane is clean and has no tears • If canister, lid and seals have tears, brittle areas or blockages

Running time from battery insufficient

Calibrating the rechargeable battery => Chapter VII

Too loud

Check position and seal of valve disks inside SafetyChamber

If the fault cannot be corrected, contact your service center

Xl Replacing the rechargeable battery Disconnect the pump from the mains supply 1) open lid 2) Replace the rechargeable battery (use only Medela battery) 3) Plug in battery 4) Close lid Corresponding illustrations are to be found on the back flap

Xll Routine check The Clario Home Care Pump requires no maintenance, but please perform the functional tests before each use. There are no parts in the Clario motor-unit that can be repaired by the user.

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XlII Disposal The Clario is made from various metals and plastics. Before disposal, the device is to be rendered unusable and it must be disposed of in accordance with the local regulations. With the AC/DC versions, the electronic components and the rechargeable batteries must be disposed of separately, in accordance with the local regulations.

XIV Parts list Article numbers a1

Motor unit AC-version

200.0334

a2

Motor unit AC/DC-version

200.0335

d

SafetyChamber

074.0002

e

Vacuum regulator

810.0627

f

Valve discs

074.0008

g

Canister set

074.0001

h

Floater

074.0010

i

Plug for closing lid

810.0639

k

Disposable connection tubingwith fingertip control

074.0003

l

Rechargeable battery

074.0005

m1

Power cord (EURO)

014.0006

m2

Power adapter

014.0004

m3

Power cord (USA)

014.0009

m4

Power cord (GB)

014.0007

m5

Power cord (AUS/NZ)

014.0008

The company reserves the right to change technical specifications without prior notice. Product may vary from picture.

EN

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Notes

82

Notes

83

Notes

84

Technical specifications – Technische Daten – Données techniques – Dati tecnici – Technische gegevens – Tekniska data – Tekniset tiedot – Tekniske data – Datos técnicos – Características técnicas

min. vacuum med. vacuum - 131 mmHg - 266 mmHg - 18 kPa - 36 kPa Tolerance ± 15 %

low flow

max. vacuum - 595 mmHg - 80 kPa - 15 %

15l/min.

Measured at 0m, atmospheric pressure: 1013.25 hPa Please note: vacuum levels may vary depending on location (meters above sea level, atmospheric pressure and temperature). See chart on front flap.

AC

Gemessen bei 0m, atmosphärischer Druck: 1013.25 hPa Bemerkung: Vakuumwerte können abweichen, je nach Ort (Meter über Meereshöhe, atmosphärischer Druck und Temperatur). Siehe Tabelle in vorderer Klappe.

100 – 240 V

50 – 60 Hz

12 V = < 2A

Mesurée à 0m, pression atmosphérique: 1013.25 hPa Veuillez noter que les niveaux de vide peuvent varier en fonction de l’emplacement (nombre de mètres au-dessus du niveau de la mer, pression atmosphérique et température). Voir le graphique situé sur le dépliant de couverture.

NiMH

8 mm 6 mm

Misurazione effettuata a 0 m, pressione atmosferica: 1013.25 hPa Nota bene: i livelli di vuoto possono variare in funzione dell’ubicazione (metri sul livello del mare, pressione atmosferica e temperatura). Vedere l’etichetta sul portello frontale.

150 cm

PVC

HxBxT 223 x 255 x 95 mm

Gemeten op 0 m, luchtdruk: 1013,25 hPa Let op: vacuümwaarden kunnen uiteenlopen afhankelijk van de plaats (hoogte boven zeeniveau, luchtdruk en temperatuur). Zie diagram op voorflap. AC 1.7 kg AC/DC 2.0 kg

Mätt vid 0 m, atmosfäriskt tryck: 1013.25 hPa Observera: Vakuumnivåer kan variera beroende på platsen för mätningen (meter över havsnivå, atmosfäriskt tryck och temperatur). Se listan på det främre locket.

kg

Ilmanpaine (mittasuure 0m): 1013.25 hPa Huom: Tyhjiötaso saattaa vaihdella sijainnista riippuen (korkeus meren pinnasta, ilmanpaine ja lämpötila). Katso laitteen etuosan läpässä olevaa taulukkoa. Målt ved 0m, atmosfæretrykk: 1013.25 hPa Vennligst merk: Vakuumnivåer kan variere avhengig av sted (høyde over havet, atmosfæretrykk og temperatur). Se tabell på fliken foran. Presión atmosférica medida a 0 m: 1013,25 hPa Tome nota, por favor: los niveles de vacío pueden variar en función del lugar (altitud sobre el nivel del mar, presión atmosférica y temperatura). Consulte el diagrama en la tapa delantera. Medido em 0m, pressão atmosférica: 1013.25 hPa Tome nota por favor: Os níveis de vácuo podem variar em função do local (metros acima do nível do mar, pressão atmosférica e temperatura). Veja a tabela na orla frontal. 75

30

+40 +10 °C

Operation Betrieb Fonctionnement Funzionamento Werking

Drift Käyttö Drift Funcionamiento Funcionamento

Operation Betrieb Fonctionnement Funzionamento Werking

Drift Käyttö Drift Funcionamiento Funcionamento

Type BF SS

A

CL

106

70

kPa

95

20

+50 -20 °C

Operation Betrieb Fonctionnement Funzionamento Werking

Drift Käyttö Drift Funcionamiento Funcionamento

Transport/Storage Transport/Lagerung Transport/Stockage Trasporto/Conservazione Transport/Opslag

Transport/Lagring Kuljetus/Varastointi Transport/Lagring Transporte/lmacenamiento Transporte/Armazenagem

Transport/Storage Transport/Lagerung Transport/Stockage Trasporto/Conservazione Transport/Opslag

Transport/Lagring Kuljetus/Varastointi Transport/Lagring Transporte/lmacenamiento Transporte/Armazenagem

ISO 9001 ISO 13485 CE (93/42/EEC), IIa

Check Kontrollieren Contrôler Controllare Controleren Kontrollera Tarkista Kontroller Controlar Controlar

Recharge immediately Sofort aufladen Recharger immédiatement Ricaricare immediatamente Direct opladen Ladda batteriet omgående Lataa välittömästi Må lades umiddelbart Recargue immediatamente Recarregue imediatamente

Charging Am laden Charger Ricarica Opladen Ladda Latauksessa Lader Cargado A carregar

Direct current Gleichstrom Courant continu Corrente continua Gelijkstroom Likström Tasavirta Likestrøm Corriente continua Corrente contínua

Alternating current Wechselstrom Courant alternatif Corrente alternata Wisselstroom Växelström Vaihtovirta Vekselstrøm Corriente alterna Corrente alternada

Important Wichtig Important Importante Belangrijk Viktigt Tärkeää Viktig Importante Importante

Disposable article – do not reuse Einweg-Artikel – nicht wiederverwendbar Article à usage unique – ne pas réutiliser Articolo monouso – non riutilizzare Wegwerpartikel – niet opnieuw bruikbaar Engångsartikel – får ej återanvändas Kertakäyttöartikkeli – ei uudelleen käytettävä Engangsprodukt – ikke bruk på nytt Artículo desechable – no reutilizar Artigos descarataveis – não reutilizar

Rechargeable battery Akku Batterie Batteria Accu Batteriet Akun Batteri Batería Acumulador

Please see accompanying papers Begleitpapiere beachten Lire les documents joints à l'appareil Attenersi alla documentazione Bijgevoegde documenten in acht nemen Se bilagor Katso mukana seuraava dokumentaatio Se følgebrev Aténgase a la documentación adjunta Verifique os documentos de transporte

Must not be disposed of together with household refuse Darf nicht zusammen mit Hausmüll entsorgt werden Ne doit pas être éliminé avec les ordures ménagères Non deve essere smaltito con i rifiuti domestici Mag niet samen met huisvuil weggegooid worden Får ej slängas tillsammans med vanliga hushållssopor Rintapumppua ei pidä panna talousjätteisiin Skal ikke kastes i husholdningsavfall No eliminar junto con la basura doméstica Não pode ser eliminado juntamente com o lixo doméstico

Medela recommendation Medela Empfehlung Recommandation Medela Raccomandazione Medela Aanbeveling van Medela Medelas rekommendation Medela-suositus Medela anbefaling Recomendación de Medela Recomendação da Medela

Type BF

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h

k

e

g

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a

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International Sales Medela AG, Medical Technology Lättichstrasse 4b 6341 Baar Switzerland Phone +41 (0)41 769 51 51 Fax +41 (0)41 769 51 00 [email protected] www.medela.com

Canada Medela Inc. 4160 Sladeview Crescent Unit # 8 Mississauga, Ontario Canada, L5L 0A1 Phone +1 905 608 7272 Fax +1 905 608 8720 [email protected] www.medela.ca China Medela (Beijing) Medical Technology Co., Ltd. Unit M, 4F, No 1068 Wuzhong Road, Minhang District Shanghai 201103 China Phone +86 21 62368102 Fax +86 21 62368103 [email protected] www.medela.cn France Medela France Sarl 14, rue de la Butte Cordière 91154 Etampes cedex France Phone +33 (0)1 69 16 10 30 Fax +33 (0)1 69 16 10 32 [email protected] www.medela.fr Germany Medela Medizintechnik GmbH & Co. Handels KG Postfach 1148 85378 Eching Germany Phone +49 (0)89 31 97 59-0 Fax +49 (0)89 31 97 59 99 [email protected] www.medela.de

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©Medela AG/177.1405/04.11/H

Australia Medela Pty Ltd, Medical Technology 3 Arco Lane, Heatherton Vic 3202 Australia Phone +61 (0) 3 9552 8600 Fax +61 (0) 3 9552 8699 [email protected] www.medela.com.au