Medela Vario User manual

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Vario

SUCTION PUMP

Instructions for use Gebrauchsanweisung

Mode d’emploi

Istruzioni per l’uso

Gebruiksaanwijzing Bruksanvisning

Käyttöohjeet

Bruksanvisning

Instrucciones de uso

Instruções de utilização

Vario 18 AC / DC

Page 2

Table of contents

Congratulations ........................................................................................................................... 4

1 Warnings and safety instructions ...................................................................................... 5

Safety instructions .................................................................................................................. 7

2 Power supply and battery operation .................................................................................. 8

Battery low (only AC / DC versions) ......................................................................................... 8

Battery empty (only AC / DC versions) .................................................................................... 8

3 Description ............................................................................................................................ 8

Introduction ............................................................................................................................8

Intended use ........................................................................................................................... 8

Indications .............................................................................................................................. 9

Contraindications ....................................................................................................................9

Intended user.......................................................................................................................... 9

Intended Patient Population ................................................................................................... 9

Important note ........................................................................................................................ 9

4 Overview ............................................................................................................................. 10

Definition of vacuum ............................................................................................................. 10

Versions of the pump ........................................................................................................... 10

Front of the pump ................................................................................................................. 10

Bottom of device ...................................................................................................................11

Operating elements and battery status ................................................................................. 11

Acoustic indicator ..................................................................................................................11

On/off switch not c/i versions ................................................................................................11

On/off switch c/i versions ......................................................................................................11

5 Installation ........................................................................................................................... 12

Check initial delivery ..............................................................................................................12

6 Preparation for use ............................................................................................................ 13

Checks before use ................................................................................................................13

Assembly of the basic configuration ......................................................................................13

Assembly of the REUSABLE collection system .....................................................................14

Assembly of the DISPOSABLE collection system .................................................................15

7 Operating instructions ....................................................................................................... 16

Connect Vario to mains power ............................................................................................. 16

Check maximal vacuum for functional check ....................................................................... 16

Changing vacuum level..........................................................................................................17

Placing out of operation after use..........................................................................................17

8 Changing reusable jar ........................................................................................................ 18

9 Changing disposable liner ................................................................................................. 19

2 | Table of contents

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10 Troubleshooting.................................................................................................................. 20

Motor not running ................................................................................................................. 20

Insufficient vacuum............................................................................................................... 20

No LED lit (AC / DC version only)........................................................................................... 20

LED lit up (AC / DC version only) ........................................................................................... 20

LED blinks slowly (AC / DC version only) ............................................................................... 20

LED blinks rapidly (AC / DC version only) .............................................................................. 20

11 Replacing defective fuse ................................................................................................... 21

12 Setting interval times ......................................................................................................... 22

13 Replacing the QuatroFlex .................................................................................................. 23

14 Replacing the rechargeable battery................................................................................. 24

15 Battery data and test ......................................................................................................... 25

Duration of pumping ..............................................................................................................25

Charging time (charged up to 100 %) ....................................................................................25

Testing the rechargeable battery ...........................................................................................25

16 Battery calibration ............................................................................................................. 26

Calibrating NiMH rechargeable battery .................................................................................26

Storage of the rechargeable battery ......................................................................................26

17 Filter test ............................................................................................................................. 27

18 Cleaning guidelines ............................................................................................................ 28

General notes ........................................................................................................................28

Medela recommended surface cleaning agents for pump housing ......................................28

Water .....................................................................................................................................28

Cleaning / disinfection machines ...........................................................................................28

Disposable products .............................................................................................................28

19 Accessories overview ........................................................................................................ 30

20 Accessories legend............................................................................................................ 31

21 Technical specifications .................................................................................................... 33

22 Signs and symbols ............................................................................................................. 34

23 Warranty and servicing ..................................................................................................... 36

Warranty ............................................................................................................................... 36

Servicing / routine check ....................................................................................................... 36

24 Disposal ............................................................................................................................. 36

25 Technical documentation .................................................................................................. 37

Technical documentation / EMC ...................................................................................... 366

Table of contents | 3

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Congratulations

By choosing the Vario, you have acquired a high-quality suction pump which is adaptable to your needs. The QuatroFlex suction aggregate is the innovative continuation of the proven Medela piston / cylinder system. As all Medela suction pumps, this pump provides reliable and simple suction. Its simple handling and cleaning as well as the safety features are additional advantages you receive. A comprehensive range of accessories makes the Vario ideally suited to a wide range of medical applications and can be used for continuous operation. Contact us – we will be pleased to advise you.

4 | Congratulations

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1 Warnings and safety instructions

WARNINGS

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTIONS

Indicates a potentially hazardous situation which, if not avoided, could result in minor or moderate injury.

Safety related tip

Indicating useful information about the safe use of the device.

The Vario is approved exclusively for the use as described in these instructions for use. Medela can only guarantee the safe functioning of the system when the Vario is used in combination with the original Medela accessories (collection system, tubings, filters etc. – see chapters 19 / 20).

Please read and observe these warning and safety instructions before operation. These 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.

Medela considers herself only responsible for the effect on BASIC SAFETY, reliability and performance of the Vario if it is used in accordance with the instructions for use.

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.

Subject to change.

Warnings and safety instructions | 5

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WARNINGS

– For use only by medically trained persons who have been adequately trained in suction

procedures and in the use of aspirators.

– 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.

– Gastric suction: When the device is used for gastric suction, the patient’s condition and

correct functioning of the pump (on the basis of acoustic and visual signs) must be checked at least once every four hours.

–

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. A sterile suction catheter must always be used (risk of infection). – Before cleaning the device, pull the plug out of the fixed mains socket. – No modification of this equipment is allowed. – Do not connect this device to a passive drainage tube. – Consult the indications for use and consider risk factors and contraindications before

using the Vario. Failure to read and follow all instructions in this manual prior to use

may result in serious or fatal injury of the patient. – The Vario pump may shortly shut down with electrostatic discharge (ESD) events at the

DC port of 15kV.

CAUTIONS

– Incorrect use can cause pain and injury to the patient. – Do not use sterile accessories when the sterile packaging is damaged. – Wireless communications equipment such as wireless home network devices, mobile

phones, cordless telephones and their base stations, walki-talkie can affect the Vario

and should be kept at least a distance 1ft (30 cm) away from the equipment. – Portable and mobile RF communications equipment can affect medical devices. – The patient should be monitored regularly according to the physicians instructions and

facility guidelines. Objective indications or signs of a possible infection or complication

must be met immediately (e.g. fever, pain, redness, increased warmth, swelling or

purulent discharge). Non-observance can lead to con si de rable danger of the patient.

Monitor the Vario frequently for opera ting status.

Safety related tip

– The Vario suction pump is Magnetic Resonance (MR) unsafe. Do not take the pump

into the MR environment. –

For safety tests, it is assumed that the device is serviced and repaired throughout its

service life in accordance with the service manual. Because the Vario is a device of safe-

ty class lI (EN IEC 60601-1, A1, A2:1995), the safety tests are confined to visual inspec-

tion of the housing and power cord. This test must be carried out before each use. – Testing the patient leakage current: Please see service manual for details. – The protection of the Vario against the effects of the discharge of a cardiac defibrillator

is dependent upon the use of appropriate cables.

6 | Warnings and safety instructions

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– Separation from the mains is only assured through the disconnection of the mains plug and

the fixed mains socket.

– Before you plug in the device, please check that your local power supply is the same as the

voltage given on the specification plate.

Safety instructions

– The Medela Vario is a medical device that requires special safety measures in regard to EMC.

It must be installed and put into operation in accordance with the attached EMC information.

– In the case of overflow, inform the internal technical service immediately and perform the tasks

in the service manual.

– In each of the following cases, the device must not be used and it must be repaired by

Customer Services: – if the power cord or the plug are damaged – if the device is not functioning perfectly – if the device is damaged – if the device shows clear safety defects. – Keep the power supply cord away from hot surfaces. – The mains plug and the on / off switch must not come into contact with 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 place the power supply cord around your neck. – 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 place the device in water or other liquids. – When using single use, sterile products, please note that they are not intended to be

reprocessed. Reprocessing could cause loss of mechanical, chemical and / or biological

characteristics. Reuse could cause cross contamination. – Contact your local Medela customer service representative for assistance with product

operations. – Do not place a 2 l suction jar in the lateral adaptor. – The overflow protection / bacteria filter protects the pump against overflow. Caution: Suctioning

is interrupted when the filter is wet / moist or clogged. Test the filter before each use and

during use periodically (see chapter 17).

These instructions for use must be kept for later reference.

Warnings and safety instructions | 7

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2 Power supply and battery operation

The Vario is a mains-powered suction pump. Before you plug in the device, please check that your local power supply is the same as the voltage given on the specification plate. If the Vario AC / DC versions are running continuously, a maximum of 30 minutes of battery time is expected before it is necessare to recharge. If the Vario AC / DC version is not in use, the battery must be calibrated every 60–90 days.

Battery low (o nly AC / DC ver sions) During battery operation a slow blinking of the LED indicator and an acoustic signal (beep - beep

- beep) indicates, that the rechargeable battery is soon discharged. The function of the Vario is maintained for 10 minutes (20 minutes Vario low vacuum versions), but the battery must be recharged as soon as possible.

Battery empty (only AC / DC versions) As soon as the rechargeable battery is empty, the pump comes to a stop. The proper function of the pump is no longer maintained. The rechargeable battery must be recharged.

3 Description

Introduction

The Vario is a high-quality suction pump. It is powered by the well-proven QuatroFlex system and guarantees maximum suction performance for many suctioning needs. It ideally combines easy handling and cleaning with safety features to ensure optimal operation. You can choose from a comprehensive range of accessories from Medela to configure the pump to many medical applications. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.

Intended use

The Vario 8 / 18 / ci suction pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient’s airway or respiratory support system, either during surgery or at the patient’s bedside. Generally the Vario 8 / 18 / ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal suctioning either in «constant» or «intermittent» mode. Please make sure you have a correct Vario version for the required application.

8 | Power supply and battery operation | Description

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Contraindications

None known.

Intended user

The Vario should only be operated by properly trained staff. These persons must not be hard of hearing or deaf and must have adequate visual faculty. The training has to be refreshed at least once a year.

Intended Patient Population

The Vario is intended to be used on patients only exhibiting conditions as described in the indications for use.

Important note

Compliance with proper surgical procedures and techniques is the responsibility of the physician. Each physician must evaluate the appropriateness of the treatment based on his own knowledge and experience.

Description | 9

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4 Overview

Definition of vacuum

By the application of medical aspiration devices, vacuum is normally given as the difference (in absolute figures) between absolute pressure and atmospheric pressure or as negative values in Kilopascal (kPa). In this document, the indication of -10 kPa for example always refers to a pressure range in kPa below atmospheric ambient pressure (according to EN ISO 10079:1999).

Versions of the pump

Vario 8 AC Vario 8 AC / DC Vario 8 c/i AC / DC

Vario 18 AC Vario 18 AC / DC Vario 18 c/i AC / DC

Front of the pump

10 | Overview

Suction port

Jar adaptors

Handle

Tubing holder

12 V DC

connector socket

(AC / DC ve rsions on ly)

Exhaust

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Bottom of device

Operating elements and battery status

Specification plate

Fuse

Vacuum gauge

Vacuum regulator

Rechargeable battery indicator (only AC / DC ver sions)

not lit Battery is fully charged

lit up – Battery is being charged

– Pump is connected to the

mains

blinks slowly Battery is soon empty

blinks rapidly Battery is defective

Acoustic indicator

On/off switch not c/i versions

On/off switch c/i versions

During battery operation an acoustic signal (beep - beep beep) indicates that the rechargeable battery is soon discharged.

On: pump is running Off: pump is switched off

Constant: pump is running in constant mode

Off: pump is switched off Intermittent:

pump is running in intermittent mode

Overview | 11

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5 Installation

Check initial delivery

Check the delivery package of the Vario for completeness and general condition.

Vario portable version

Vario 8 AC 026.XXXX Vario 8 AC / DC 026.XX XX Vario 8 c/i AC / DC 026.XXXX Vario 18 AC 026.XXXX Vario 18 AC / DC 026.XX XX Vario 18 c/i AC / DC 026.XXXX

Silicone Tubing ø 7 x 12 mm, 25 cm with 2 coupling pieces

077. 0 931

5 x Disposable overflow protection / bacteria filter with Medela connections

077. 0 571

12 | Installation

Instructions for use

17 7. 26 04

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6 Preparation for use

WARNINGS

For use only by medically trained persons who have been adequately trained in suction procedures and in the use of aspirators.

CAUTIONS

– The Vario 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, disinfected and / or sterilized

according to the Medela cleaning guide (product code 200.2391).

Checks before use

6.1

– Check the Vario system before use for damage of the power cord or plug,

obvious device damage or safety defects and proper functioning of the device. – Check for completeness and general condition of the Vario delivery package. – Only for AC / DC versions: make sure that the rechargeable battery is calibrated

according to chapter 16. – Check all accessories prior to use: – suction jars, lids and liners for cracks, brittle and flawed spots. Replace if

necessary. – Tubing for cracks, brittle areas and that connectors are firmly attached.

Replace if necessary. – As an additional safety test, evacuate the system (including jars) to maximum

vacuum several times before actual use.

Assembly of the

6.2

basic configuration

1. 1.1 Attach the overflow

Attach all necessary accessories according to your needs.

2. See the system overview for more details.

protection bacteria filter to the Vario with the arrow pointing in the flow direction.

Preparation for use | 13

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Assembly of

6.3

the REUSABLE collection system

positions for jars:

1. If you use a DISPOSABLE collection system proceed

with step 6.4.

2. 2.1 Attach mechanical

2.1

2.2

overflow protection to lid.

2.2 Pull gently downwards to make sure it is open / de activated.

3. 3.1 Attach the lid to the jar.

3.2 3.2

4. 4.1 Attach the jar to the Vario.

4.2

4.3

5. 5.1 Connect patient tubing to

4.1

3.1

3.2 Lock with the two lid clamps.

4.2 Connect tubing to the filter.

4.3 Connect tubing to the lid of the jar (marked with «vacuum»).

the lid of the jar (marked with «patient»).

14 | Preparation for use

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Assembly of

6.4

the DISPOSABLE collection system

positions for jars:

1. If you use a REUSABLE collection system proceed with

step 6.3.

2. 2.1 Attach the Vario jar

3. 3.1 Choose the 1.5 l size

4. 4.1 Attach the jar to the Vario.

4.2

4.3

adapter to the Vario.

(yellow code) for the Vario.

3.2 Prepare and insert corresponding liner size (yellow) according to instructions delivered with liners. The disposable liner has an integrated overflow protection filter. No action is necessary to activate it.

4.2 Connect tubing to the filter.

4.3 Connect tubing to the jar. The tubing connector is on top of the jar.

4.1

5. 5.1 Connect patient tubing to the lid of the liner using either the coloured angle piece or the patient port directly (depending on tubing size).

Preparation for use | 15

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7 Operating instructions

CAUTIONS

The Vario is to be set up in such a way, that a separation from the mains supply can be easily managed.

Connect Vario to

7.1

mains power

Check maximal

7.2

vacuum for functional check

Check the pump before use following the instruction in

1. cha pter 6 .1.

2. All versions: if the pump

is connected to a fixed mains socket:

AC / DC versions: if the pump is operated with a 12 V DC power s ource:

AC / DC versions: if the pump is operated with the rechargeable battery:

1. 1.1 Switch on the Vario. The

2. 2.1 Press and turn the

Plug in the mains plug of the power cord to a fixed mains socket.

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 so urce.

No connection to a power source is needed. Make sure that the battery was charged for five hours.

pump will start running. Caution: c / i vers ions must be switched on in «constant» mode.

vacuum regulator to the right to set maximum vacuum.

16 | Operating instructions

3. 3.1 Seal the end of the patient

tubing with your thumb.

3.2 Compare the maximum vacuum according to the specification. See chapter 10 if the maximum vacuum is not reached.

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Specifications:

Altitude above sea level:

+ 2000 m – 7.0 kPa – 43 kPa – 5 9 kPa

+ 1000 m – 7.9 kPa – 4 8 kPa – 66 kPa + 500 m – 8.5 kPa – 51 kPa – 70 kPa 0 m – 9.0 k Pa – 55 kPa – 75 kPa

(Tolerance +/- 10 %)

Vario 8 / Vario 8 c/i Max. Vacuum: low vacuum

Vario 18 c/i Max. Vacuum: medium vacuum

Vari o 18 Max. Vacuum: high vacuum

Changing vacuum

7.3

level

Placing out of

7.4

operation after use

1. 1.1 Clamp patient tubing

1.2 Push and turn vacuum regulator to select the correct vacuum according to the particular application.

1.3 Check vacuum gauge for setting.

1. 1.1 Switch the on / off switch

2. If the pump is connected

to a fixed mains socket:

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

3. Clean and desinfect the Vario. See chapter 18.

of the Vario to position «0» (c/i - ve rsions: «Of f»).

Disconnect the mains plug from the fixed mains socket.

Disco nnect the 12 V DC plug from the 12 V DC power source.

Operating instructions | 17

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8 Changing reusable jar

1. 1.1 Switch the on / off switch

2. 2.1 Remove full jar from the

3. 3.1 Prepare new jar and

4. Empty jar and dispose of patient tubing in accordance with local guidelines and inhouse guidelines.

5. Switch on the Vario. The pump will start running.

of the Vario to position «0» (c/i - versi ons: «O ff»).

1.2 Remove patient and vacuum tubings from the lid.

Vario.

unpack it.

3.2 Secure new jar to the Vario

3.3 Reconnect vacuum tubing and new patient tubing firmly.

18 | Changing reusable jar

6. Set vacuum according to the particular application. See chapter 7.3.

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9 Changing disposable liner

WARNINGS

Disposable liners are not intended to be reprocessed. Reprocessing could cause loss of mechanical, chemical and / or biological characteristics.

1.5 l

1. 1.1 Remove patient tubing

2. 2.1 Switch the on / off switch

3. 3.1 Remove full liner from the

4. Dispose of the liner and patient tubing in accordance with local guidelines and inhouse guidelines.

5. Prepare new liner, unpack it and insert it in the jar. Press down lid.

with colored angle piece from lid.

1.2 Plug patient port.

of the Vario to position «0» (c/i - versi ons: «O ff»). Reduce vacuum to minimum by pressing and turning vacuum regulator to the left.

ja r.

6. 6.1 Connect new patient

7. Switch on the Vario. The pump will start running.

8. Set vacuum according to the particular application. See chapter 7.3.

tubing firmly.

Changing disposable liner | 19

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10 Troubleshooting

Motor not running

Check if: – the Vario is switched on. – the mains voltage is correct and if the mains plug is inserted correctly into the fixed mains

socket. – the internal battery is charged (only AC / DC version under battery operation) – the fuse on the bottom of the Vario is not defective. For replacing the defective fuse see

cha p ter 11.

Insufficient vacuum

Check if: – the vacuum regulator is set correctly. – the tubings are not defective or broken. If necessary, replace. – all plug-in connections are tight. – the overflow protection is deactivated / open. If the overflow protection is activated, deactivate

as shown under 6.3a/2.2. – the suction jar / lid have no cracks, brittle areas, discolouration. Replace if necessary. – the disposable system has no cracks, brittle areas, discolouration. Replace if necessary. – filter is not clogged. To test if the filter is clogged see chapter 17. – the QuatroFlex is defective. To replace the QuatroFlex see chapter 13.

No LED lit (AC / DC vers ion on ly) The rechargeable battery is fully charged.

LED lit up ( AC / DC versi on onl y) – The rechargeable battery is being charged.

– The pump is connected to the mains.

LED blinks slowly ( AC / DC versi on onl y) The rechargeable battery is soon empty.

LED blinks rapidly (AC / DC versi on onl y) The rechargeable battery is defective. For replacing the defective battery see chapter 14.

20 | Troubleshooting

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11 Replacing defective fuse

WARNINGS

Before replacing the fuse, pull the mains plug from Vario out of the fixed mains socket.

Disconnect the Vario from the mains.1.

2. 2.1 Open (turn left) the fuse

3. Replace the defective fuse(s). Make sure that the technical specification are corresponding.

AC-versions: T 0.8 A L, 5 x 20 , 230 –240 V

T 1.25 AL , 6.3 x 2 0, 120 V

AC / DC-versi ons: T 1.0 AL , 5 x 20, 100 –240 V

4. 4.1 Close (push back and turn

Reconnect the Vario to the mains again.5.

Switch on the Vario again.6.

holder on the bottom of the Vario.

right) the fuse holder.

Replacing defective fuse | 21

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12 Setting interval times

(c / i ver sions o nly)

WARNINGS

Before setting the interval times, switch off the Vario and pull the mains plug from Vario out of the fixed mains socket.

1. 1.1 Unscrew the 4 screws on

2. 2.1 Determine the location of

Reattach the back cover to the Vario and tighten the 4 screws.

Plug the Vario to a fixed mains socket and test the correct

4. functioning of the Vario (see chapter 7).

the back of the Vario.

1.2 Open the Vario by removing the back cover.

the red jumper.

2.2 Place the red jumper according to the desired interval:

On-time Off-time 8 sec. 4 sec. 16 sec. 8 sec. 32 sec. 16 sec.

22 | Setting interval times

Page 23

13 Replacing the QuatroFlex

WARNINGS

Before replacing the QuatroFlex, switch off the Vario and pull the mains plug from Vario out of the fixed mains socket.

1. 1.1 Unscrew the 4 screws on

2. 2.1 Remove the 3 marked

3. 3.1 Turn the QuatroFlex 45 °

Clean inside of the Vario.4.

5. 5.1 Insert new QuatroFlex.

the back of the Vario.

1.2 Open the Vario by removing the back cover.

tubings from the QuatroFlex.

to the left.

3.2 Pull out the QuatroFlex and remove it from the Vario.

5.2 Turn it 45 ° to the right.

5.3 Reattach the 3 tubings to the QuatroFlex.

Reattach the back cover to the Vario and tighten the 4 screws.

Plug the Vario to a fixed mains socket and test the correct

7. functioning of the Vario (see chapter 7).

Replacing the QuatroFlex | 23

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14 Replacing the rechargeable battery

(AC / DC ve rsions on ly)

WARNINGS

Before replacing the rechargeable battery, switch off the Vario and pull the mains plug from Vario out of the fixed mains socket.

1. 1.1 Unscrew the 4 screws on

2. 2.1 Detach the battery cable

3. 3.1 Remove the old

3.1

3.2

4. 4.1 Reattach the battery cable.

the back of the Vario.

1.2 Open the Vario by removing the back cover.

by pulling the plug.

rechargeable battery.

3.2 Insert the new rechargeable battery.

24 | Replacing the rechargeable battery

Reattach the back cover to the Vario and tighten the 4 screws.

Plug the Vario to a fixed mains socket and calibrate the rechargeable battery (see chapter 16).

Page 25

15 Battery data and test

(AC / DC ve rsions on ly)

CAUTIONS

Only charge the rechargeable battery when the acoustic signal sounds and the charging indicator blinks slowly. The rechargeable battery is charged during mains operation.

Duration of pumping

If the battery is fully charged, the operating time is about: – low vacuum versions: approx. 120 minutes – high and medium vacuum versions: approx. 30 minutes.

Charging time (charged up to 100 %) – low vacuum versions: approx. 5 hours – high and medium vacuum versions: approx. 5 hours.

Testing the rechargeable battery

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

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

3. 3.1 Press vacuum regulator

4. 4.1 Switch on the Vario. The

5. Measure the time until the pump comes to a stop. The battery is ok, when the following values are reached: – low vacuum versions: > 120 min. – high and medium vacuum versions: > 30 min.

If the values are not reached, repeat test or calibrate the battery (see next page).

and turn it to the right to select maximum vacuum.

pump will start running. Caution: c / i vers ions must be switched on in «constant» mode.

Battery data and test | 25

Page 26

16 Battery calibration

(AC / DC ve rsions on ly)

CAUTIONS

Calibrate rechargeable batteries before the first use, or after a storage period > 2 months. Replace the battery if the calibration process fails.

Calibrating NiMH rechargeable battery

Storage of the rechargeable battery

Make sure that the battery is fully charged.1.

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

3. 3.1 Switch on the Vario. The

Let the pump run until the rechargeable battery is empty

4. and the pump comes to a stop.

Plug the mains cable into a fixed socket. The rechargeable

5. battery is beeing charged.

Wait until the charging indicator goes out.6.

Repeat step 1 to 6. The Vario AC / DC is then ready to use.7.

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

pump will start running. Caution: c / i vers ions must be switched on in «constant» mode.

26 | Battery calibration

Page 27

17 Filter test

1. 1.1 Remove tubing from filter.

2. 2.1 Select maximum vacuum.

3. 3.1 Switch on the Vario. The

4. 4.1 Read the vacuum.

pump will start running. Caution: c / i vers ions must be switched on in «constant» mode.

4.2 Replace the filter if the vacuum exceeds the values given in the following table:

Vario 8 / Vario 8 c/i – 3 kPa low vacuum

Vario 18 – 10 kPa high vacuum

Vario 18 c / i – 10 kPa medium vacuum

Filter test | 27

Page 28

18 Cleaning guidelines

WARNINGS

After each use, the parts that had been in contact with the aspirated secretions are to be cleaned, disinfected, sterilised or disposed of according to the table on the next page.

Before cleaning the device, pull the mains plug out of the fixed mains socket.

General notes

– These are general recommendations only that may be adjusted individually, based on the

hospital’s specific directives and cleaning practices and policies. – Detailed information according to Medela cleaning instructions (product code 200.2391). – Wear protective gloves for cleaning / disinfection. – Dispose of fluids such as blood and secretions and the parts contaminated with them in

accordance with internal hospital guidelines.

Medela recommended surface cleaning agents for pump housing

– CaviWipes, Metrex Research, www.metrex.com – Mikrozid AF Wipes, Schülke & Mayr, www.schuelkemayr.com

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. The final rinse water is bacterial free and contains no endotoxins.

Cleaning / disinfection machines

Can be used to desinfect parts from the table on the next page. A hot water rinse (maximum temperature 100 °C) may provide a medium-to high level of disinfection. Every section of the constituent parts must be accessible in order to ensure efficient cleaning. We recommend using a cleaning / disinfecting machine that has been approved by the Robert Koch- Institute and complies with ISO 15883. Recommended temperature for noncritical medical devices (i.e. those that only come into contact with uninjured skin) is 90 °C for 1 minute. The time is increased to 5 minutes for all medical devices that are considered to be critical.

Disposable products

These are single use products not intended to be reprocessed. Reprocessing could cause loss of mechanical, chemical and / or biological characteristics. Reuse could cause cross contamination.

28 | Cleaning guidelines

Page 29

PSU* jars, lids

PC** jars

Silicone

tubing

Pump housing

Mains cable

x x x x x

x x x

x x

x x x x

x x

x x x x

Legend:

* Polysulfone ** Polycarbonate

Plastic

accessories

1. Disassembly

Separate all individual parts before cleaning, disinfecting and sterilising.

2. Cleaning

Clean components in hot water (60–70 °C) containing a detergent with a pH range between 6.0 and 8.0 only, in order to avoid damaging the instruments and containment devices. Enzymatic detergents help with the removal of organic matter, such as blood. Detergents should be used according to their manufacturer’s recommended concentration levels. Some alkaline detergents have been formulated to be safe for reprocessing medical devices. The manufacturers of these detergents should provide information about specific materials that may be damaged by their detergents. Soak all parts thoroughly with warm, soapy water or in enzymatic detergent for 1–5 minutes.

1. Remove visible dirt with a cleaning tool – general purpose cleaning brushes, such as pipe cleaners or non-abrasive lint cloths. Brushes and pipe cleaners should fit snugly but still be able to be moved around easily within the area to be cleaned. Rinse thoroughly in clear water. Allow to dry

2. Check the instruments for visible dirt and repeat these steps if necessary.

3. Cleaning

Wipe with detergent mentioned above. Use clean cloth to dry.

4. Disinfect

Soak at room temperature for 30 minutes in a disinfection / cleaning solution (A). After the reaction time, use water to rinse the solution residue from the individual parts and rinse the tubing. Rinse for at least 2 minutes with the cleaning solution (B).

(A) fluid aldehyde-free disinfection solution with cleaning effect for use as a soaking bath, bactericide, fungicide, limited virucide, with good material compatibility for stainless steel, non-ferrous material and plastics including silicone, slightly alkalic. e.g. 2 % neodisher® Septo MEDsolution

(B) Fluid, pH-neutral, enzymatic cleaning solution for the treatment of instruments by machine or manually with very good material compatibility for stainless steel, non-ferrous material and plastics including silicone.

or use cleaning / desinfecting machine. or use your dishwasher at home.

5. Sterilise

Remove any chemical disinfectant residue before autoclaving. Do not stack during autoclaving. In the autoclave at 134 °C for 10 minutes. The sterilisation device must comply to ISO 17665:2003. The following procedures are acceptable: In the autoclave with saturated steam at 132 °C, with triple pre-evacuation, sterilisation time of 6 minutes, or at 135–137 °C in an porous load vacuum autoclave for 3–3.5 minutes

6. Storing components

After disinfection / sterilising, store the components in sterile foil until required for use.

Cleaning guidelines | 29

Page 30

19 Accessories overview

WARNINGS

Vario was verified in combination with the accessories listed below. For a correct and safe operation use Vario with these accessories only. Further information is supplied on the instruction sheet of the individual accessory.

Patient tubings / tubing connectors

with funnel connectors:

07 7.1020

07 7.1017

077.0952 180 cm

077.0191 300 cm

without coup ling pieces, 7 x 12 mm

Liners Reusable lids

077.0083/84 07 7.04 4 0 077.0420/30

PC jars

07 7.0 0 8 2

07 7.01 0 5

Reusable jars

077.012 5: 0.25 l

077.0155: 0.5 l

077.0110: 1 l

Connectors and Tubings (max. length 60 cm)

07 7.101 9 07 7.1 018 07 7.101 5 /16

Filters

07 7.0 0 9 2 077.057707 7.0 571

with 1 coupling piece, 7 x 12 mm

077.0900: 25 m

077.0901: 1 m

077.0902: 2 m

077.0905: 5 m

Fingertip tubing

07 7.0 9 51

with 2 coupling pieces, 7 x 12 mm

Reusable sets

with 2 coupling pieces, 7 x 12 mm

077.0921: 0.3 m

077.0922: 0.6 m

077.0931: 0.25 m, 1 coupling piece 90 °

077.0912: 0.6 m

077.0913: 1 m

077.0921: 0.3 m

077.0922: 0.6 m

077.0931: 0.25 m

077.0715: 1 l

* *

Drainage valve

07 7.1022

Additional accessories

07 7.0 8 23 077.0821 07 7.0 8 31 077.083207 7.0 8 25

30 | Accessories overview

Specimen cups

07 7.0 5 6 2 / 6 4 07 7.0 0 9 4

Foot control

077.0731

Vario 8 AC 026.X XX X Vario 8 AC / DC 026.XX XX Vario 8 c/i AC / DC 026.XXXX Vario 18 AC 026. XX XX Vario 18 AC / DC 026.X XX X Vario 18 c/i AC / DC 026.X XX X

Page 31

Safety related tip If the pump is used together with non-Medela applied parts, they must: – have CE mark and (if necessary) local registration – be able to be attached to Medela accessories safely without impacting the

performance of the pump. Note: when combining Medela parts and non-Medela parts, you take over the responsibility of the entire system.

20 Accessories legend

026.XXXX Vario 8 AC

026.XXXX Vario 8 AC / DC

026.XXXX Vario 8 c/i AC / DC

026.XXXX Vario 18 AC

026.XXXX Vario 18 AC / DC

026.XXXX Vario 18 c/i AC / DC

Filters

Reusable jars

Drainage valve

Liners

Reusable sets

PC jars

07 7. 0 0 9 2 Disposab le overf low protec tion / bacteria / o dour filter

with Medela connections

07 7. 0 5 71 Disposable overflow protection/bacteria filter with

Medela connections

077.0577 Disposable overflow protection/bacteria filter with Medela and conical connections

07 7. 011 0 Suction jar, polysulfone, 1 l 07 7. 01 2 5 Suction jar, polysulfone, 0.25 l 07 7. 01 5 5 Suction jar, polysulfone, 0.5 l

07 7.10 2 2 Drainage valve (for vacuum ports of reusable jars)

07 7. 0 0 8 3 Disposable suction liner 1.5 l 07 7. 0 0 8 4 Disposable suction liner 1.5 l with solidifier

077.0715 Reusable 1 l set with PSU suction jar

07 7. 0 0 8 2 Suction jar PC, 1.5 l 07 7. 01 0 5 Vario jar adapter

Accessories overview | Accessories legend | 31

Page 32

Specimen cups

07 7. 0 0 9 4 Specimen cup for disposable system. Can be

attached to lid of liner (patient port) of Disposable Collection System

07 7. 0 5 6 2 Disposable specimen cup, Ø 6–10 mm 07 7. 0 5 6 4 Disposable specimen cup, Ø 10–14 mm. Attach to lid

of Reusable Collection System (patient port)

Reusable lids

Patient tubings / tubing connectors

07 7. 0 4 4 0 Small lid with conical patient connection, Ø 6–10 mm

and overflow protection device

07 7. 0 4 2 0 Large lid with conical patient connection Ø 6–10 mm

and overflow protection device

077.0430 Large lid with conical patient connection Ø 10–14 mm and overflow protection device

07 7. 0 9 0 2 Silicone tubing Ø 7 x 12 mm, w/o coupling pieces, 2 m 07 7. 0 912 Silicone tubing Ø 7 x 12 mm with 1 coupling piece, 60 cm 07 7. 0 9 0 0 Silicone tubing Ø 7 x 12 mm, w/o coupling pieces, 25 m 07 7. 0 9 0 1 Silicone tubing Ø 7 x 12 mm, w/o coupling pieces 1 m 07 7. 0 9 0 5 Silicone tubing Ø 7 x 12 mm, w/o coupling pieces, 5 m 07 7. 0 913 Silicone tubing Ø 7 x 12 mm with 1 coupling piece, 100 cm 07 7. 0 9 51 Disposable (PVC) tubing, 180 cm, with fingertip, sterile

(applied part)

077.0952 Disposable tubing with funnel connector

(non-sterile), 180 cm

077.0191 Disposable tubing with funnel connector

(non-sterile), 300 cm 07 7.10 17 Double conical coupling piece. For connecting

2 tubings to each other

07 7.10 2 0 Y-Piece. For connecting 3 tubings to each other 07 7. 0 9 2 1 Silicone tubing Ø 7 x 12 mm with 2 coupling pieces, 30 cm 07 7. 0 9 2 2 Silicone tubing Ø 7 x 12 mm with 2 coupling pieces, 60 cm

077.0931 Silicone tubing Ø 7 x 12 mm, 25 cm, with 1 coupling piece

and 1 coupling piece 90 °

07 7.10 15 Angle piece Ø 6–10 mm 07 7.10 16 Angle piece Ø 10–14 mm. Attaches to lid of Reusable

Collection System (patient port) 07 7.10 18 Coupling piece. Used to connect tubing to vacuum port

of pump

07 7.10 1 9 Coupling piece 90 °. Used to connect tubing to vacuum port of pump

Additional accessories

Foot control

32 | Accessories legend

07 7. 0 8 2 1 Rail holder 07 7. 0 8 2 3 Universal holder 07 7. 0 8 2 5 Rail holder

077.0831 Carrying bag

07 7. 0 8 3 2 Car connection cable for 12 V DC

077.0731 Foot vacuum regulator

Page 33

21 Technicalspecications

CLASS

Vario 8 / Vario 8 c/i: low va cuum, - 9 kPa / - 6 8 mmHg ( Tolerance: +/- 10 %) Vario 18 c/i: mediu m vacuum , - 55 kPa / - 413 mmHg (Toler ance: +/- 10 %) Vario 18: high vacu um, - 75 kPa / - 563 mmH g (Tolera nce: - 10 %)

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

Vario 8: 8 l/mi n. (+/- 10 %) Vario 18: 18 l/min. (+/- 10 %)

AC 3.5 kg AC / DC 4.2 kg Without jar

230–240 V, 50 Hz, 90 VA 230–240 V, 60 Hz, 90 VA 120 V, 60 Hz, 70 VA

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

h x w x d 380 x 170 x 285 mm

+50

0 °C

-25 °C

+25

Transport / Storage Rechargeable battery

+5 °C

+40

Transport / Storage Conditions

106

kPa

Operating Conditions

106

kPa

100 –24 0 V 50 / 60 Hz 80 VA

IP21

Technical specifications | 33

Page 34

22 Signs and symbols

CLASS

This symbol indicates the compliance with the essential requirements of the Council Directive 93/42/ EEC of 14 June 1993 concerning medical devices.

This symbol indicates the compliance with additional USA and Canada safety requirements for medical electrical equipment.

This symbol indicates the legal specifications of the pump.

This symbol indicates to follow instructions for use.

This symbol indicates to consult instructions for use.

This symbol indicates a CAUTION or WARNING associated with the device.

This symbol indicates safety related tip.

This symbol indicates the class of the pump.

This symbol indicates a class Il device.

This Symbol indicates the protection against ingress of solid foreign objects and against harmful effects due to the ingress of water.

This symbol indicates a type CF applied part.

This symbol indicates

MR UNSAFE.

This symbol indicates that interferences may occur in the vicinity of equipment marked with this symbol.

This symbol indicates the manufacturer.

This symbol indicates the date of manufacture (four digits for the year and two digits for the month).

This symbol indicates that the device should not be used after the end of the year and month shown.

This symbol indicates a single use device. Do not reuse the device.

This symbol indicates manufacturer’s catalogue number.

This symbol indicates manufacturer’s serial number.

This symbol indicates manufacturer’s batch code.

This symbol indicates the device is sterilized using ethylene oxide.

This symbol indicates the temperature limitation for operation, transport and storage.

This symbol indicates the humidity limitation for operation, transport and storage.

34 | Signs and symbols

Page 35

This symbol indicates the atmospheric pressure limitation for operation, transport and storage.

This symbol indicates do not use the device if package is damaged.

This symbol indicates the number of items n that the content is sufficient for.

This symbol indicates do not dispose the device together with unsorted municipal waste (for EU only).

This symbol indicates that the material is part of a recovery/ recycling process.

This symbol indicates a carton package.

This symbol indicates to keep the device dry.

This symbol indicates the maximum vacuum level of the pump.

This symbol indicates the flow levels of the pump.

This symbol indicates the electrical specifications of the pump.

This symbol indicates alternating current.

This symbol indicates direct current.

This symbol indicates the weight of the

pump.

This Symbol indicates a Prescription Device. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. (for US only).

This symbol indicates

pcs

number of items.

This symbol indicates the fuse

This symbol indicates to keep the device away from sunlight.

This symbol indicates to handle the fragile device with care.

This symbol indicates the dimensions (h x w x d) of the pump.

Signs and symbols | 35

Page 36

23 Warranty and servicing

Warranty

Medela AG warrants the device will be free from defects in materials and workmanship for a period of 2 years (6 month for the rechargeable battery and the QuatroFlex) from the date of delivery. Faulty material will be replaced free of charge during this period if not resulting from abuse or misapplication. This will not apply to parts subject to wear and tear in use. To ensure compliance with this warranty as well as optimum service from Medela products, we recommend the exclusive use of Medela accessories with our appliances. In no event shall Medela AG be liable for claims which exceed the scope of warranty described including liability for consequential damages, etc. The right to the replacement of faulty parts will not be recognized by Medela if any work has been carried out on the pump by unauthorized persons. This warranty is subject to the appliance being returned to a Medela service centre.

Servicing / routine check

Routine checks and service work are only to be carried out by positions authorised by Medela. The routine check is to be carried out 1 x per year (see service manual). The Medela service manual is available upon request.

24 Disposal

The Vario comprises metals and plastics and should be disposed of in accordance with the European directives 2011 / 65 / EU and 2012 / 19 / EU. Additional, local guidelines must also be observed. With the AC / DC versions, the electronic components and the rechargeable battery must be disposed of separately, in accordance with the local regulations. Please take care that you dispose the Vario and its accessories in accordance with your local disposal guidelines.

User information for the disposal of electrical and electronic equipment

This symbol means that the electrical and electronic equipment must not be disposed as normal household refuse. A correct disposal of this device protects and prevents

possible damage to the environment or human health. For more information about the disposal contact the manufacturer, your local caregiver or healthcare provider. This symbol is only valid in the European Union. Please respect the relevant state laws and rules in your country for the disposal of electrical and electronic equipment.

36 | Warranty and servicing | Disposal

Page 37

25 Technical documentation

WARNINGS

Do not use other accessories than those specified or sold by the manufacturer as replacement parts for internal components as it may result in increased emissions or decreased immunity of the Vario pump. HF (high-frequency) surgical equipment, radio networks or the like can influence the operation of the device and may not be operated in combination with the system.

EMC

Vario 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. Vario is suitable for use in home and clinical environments. Vario is a medical device that requires special safety precautions and must be installed and placed in operation in accordance with the attached EMC information.

Technical documentation | 37