Medela Vario User manual

SUCTION PUMP
Vario
Vario18 AC/DC
EN Instructions for use
DE Gebrauchsanweisung
FR Mode d’emploi
IT Istruzioni per l’uso
NL Gebruiksaanwijzing
SV Bruksanvisning
FI Käyttöohjeet
NO Bruksanvisning
ES Instrucciones de uso
PT Instruções de utilização

2 | Table of contents
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

EN
Table of contents | 3
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

4 | Congratulations
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.

EN
Warnings and safety instructions | 5
1 Warnings and safety instructions
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.
Indicates a potentially hazardous situation which, if not avoided, could result in death or
serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in minor or
moderate injury.
Indicating useful information about the safe use of the device.
WARNINGS
CAUTIONS
Safety related tip

6 | Warnings and safety instructions
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 considerable danger of the patient.
Monitor the Vario frequently for operating 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.

EN
Warnings and safety instructions | 7
– 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.

8 | Power supply and battery operation | Description
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.
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 com-
bines 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.
Battery low (only AC/DC versions)
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 10minutes (20minutes 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.

EN
Description | 9
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.

10 | Overview
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 -10kPa for example always
refers to a pressure range in kPa below atmospheric ambient pressure (according to
EN ISO 10079:1999).
Versions of the pump
Suction port
Jar adaptors
Handle
Tubing holder
12VDC
connector socket
(AC/DC versions only)
Exhaust
Front 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

EN
Overview | 11
Off: pump is switched off
On: pump is running
On/off switch not c/i
versions
Off: pump is switched off
Constant:
pump is running in constant mode
On/off switch c/i versions
Bottom of device
During battery operation an acoustic signal (beep - beep -
beep) indicates that the rechargeable battery is soon
discharged.
Acoustic indicator
Vacuum regulator
Vacuum gauge
Rechargeable battery indicator
(only AC/DC versions)
Operating elements and
battery status
not lit Battery is fully charged
blinks slowly Battery is soon empty
blinks rapidly Battery is defective
lit up – Battery is being charged
– Pump is connected to the
mains
Fuse
Specification plate
Intermittent:
pump is running in intermittent mode
Vario 8 c/i AC/DC
Vario 18 c/i AC/DC

12 | Installation
Check initial delivery
5 Installation
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.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 026.XXXX
Instructions for use
177.26 0 4
5x Disposable overflow protection / bacteria filter with Medela
connections
077.0 571
Silicone Tubing ø7x12mm, 25cm with 2 coupling pieces
077.0 9 31

EN
Preparation for use | 13
6 Preparation for use
Checks before use
– 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.
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).
6.1
Attach all necessary accessories according to your needs.
See the system overview for more details.
2.
Assembly of the
basic configuration
1. 1.1 Attach the overflow
protection bacteria filter to
the Vario with the arrow
pointing in the flow
direction.
6.2

14 | Preparation for use
Assembly of
the REUSABLE
collection system
1. If you use a DISPOSABLE collection system proceed
with step 6.4.
3. 3.1 Attach the lid to the jar.
3.2 Lock with the two lid
clamps.
3.2 3.2
3.1
2. 2.1 Attach mechanical
overflow protection to lid.
2.2 Pull gently downwards
to make sure it is
open/ deactivated.
2.1
2.2
positions for jars:
4. 4.1 Attach the jar to the Vario.
4.2 Connect tubing to the
filter.
4.3 Connect tubing to the lid
of the jar (marked with
«vacuum»).
4.1
4.2
4.3
5. 5.1 Connect patient tubing to
the lid of the jar (marked
with «patient»).
6.3

EN
Preparation for use | 15
Assembly of
the DISPOSABLE
collection system
1. If you use a REUSABLE collection system proceed with
step 6.3.
positions for jars:
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).
3. 3.1 Choose the 1.5l size
(yellow code) for the Vario.
3.2 Prepare and insert corre-
sponding 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. 4.1 Attach the jar to the Vario.
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
4.2 4.3
2. 2.1 Attach the Vario jar
adapter to the Vario.
6.4

16 | Operating instructions
7 Operating instructions
Connect Vario to
mains power
Check the pump before use following the instruction in
chapter 6.1.
1.
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.
Check maximal
vacuum for
functional check
1. 1.1 Switch on the Vario. The
pump will start running.
Caution: c/i versions
must be switched on in
«constant» mode.
2. 2.1 Press and turn the
vacuum regulator to the
right to set maximum
vacuum.
2. All versions: if the pump
is connected to a fixed
mains socket:
Plug in the mains plug of the
power cord to a fixed mains
socket.
AC/DC versions: if the
pump is operated with a
12VDC power source:
Connect the optional 12VDC
connection cable to the
socket on the side of the
pump and connect it to the
12VDC power source.
AC/DC versions: if the
pump is operated with the
rechargeable battery:
No connection to a power
source is needed. Make
sure that the battery was
charged for five hours.
or
or
or
CAUTIONS
The Vario is to be set up in such a way, that a separation from the mains supply can be
easily managed.
7.1
7.2

EN
Operating instructions | 17
+ 2000m – 7.0kPa – 43kPa – 59kPa
+ 1000m – 7.9kPa – 48kPa – 66kPa
+ 500m – 8.5kPa – 51kPa – 70kPa
0m – 9.0kPa – 55kPa – 75kPa
Altitude
above
sea level:
(Tolerance +/- 10%)
Specifications:
Vario 8 / Vario 8 c/i
Max. Vacuum:
low vacuum
Vario 18
Max. Vacuum:
high vacuum
Vario 18 c/i
Max. Vacuum:
medium vacuum
3. Clean and desinfect the Vario. See chapter 18.
Placing out of
operation after use
1. 1.1 Switch the on/off switch
of the Vario to position
«0» (c/i-versions: «Off»).
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 12VDC power source: Disconnect the 12VDC plug from the 12VDC
power source.
or
or
Changing vacuum
level
1. 1.1 Clamp patient tubing
1.2 Push and turn vacuum
regulator to select the cor-
rect vacuum according to
the particular application.
1.3 Check vacuum gauge for
setting.
7.3
7.4

18 | Changing reusable jar
8 Changing reusable jar
4. Empty jar and dispose of patient tubing in accordance with
local guidelines and inhouse guidelines.
3. 3.1 Prepare new jar and
unpack it.
3.2 Secure new jar to the
Vario
3.3 Reconnect vacuum tubing
and new patient tubing
firmly.
or
1. 1.1 Switch the on/off switch
of the Vario to position «0»
(c/i-versions: «Off»).
1.2 Remove patient and
vacuum tubings from the
lid.
2. 2.1 Remove full jar from the
Vario.
5. Switch on the Vario. The pump will start running.
6. Set vacuum according to the particular application.
See chapter 7.3.

EN
Changing disposable liner | 19
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.
9 Changing disposable liner
1. 1.1 Remove patient tubing
with colored angle piece
from lid.
1.2 Plug patient port.
2. 2.1 Switch the on/off switch
of the Vario to position «0»
(c/i-versions: «Off»).
Reduce vacuum to
minimum by pressing
and turning vacuum
regulator to the left.
or
7. Switch on the Vario. The pump will start running.
8. Set vacuum according to the particular application.
See chapter 7.3.
1.5 l
6. 6.1 Connect new patient
tubing firmly.
3. 3.1 Remove full liner from the
jar.
WARNINGS
Disposable liners are not intended to be reprocessed. Reprocessing could cause loss
of mechanical, chemical and/or biological characteristics.

20 | Troubleshooting
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
chapter 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 version only)
The rechargeable battery is fully charged.
LED lit up (AC/DC version only)
– The rechargeable battery is being charged.
– The pump is connected to the mains.
LED blinks slowly (AC/DC version only)
The rechargeable battery is soon empty.
LED blinks rapidly (AC/DC version only)
The rechargeable battery is defective. For replacing the defective battery see chapter 14.