Medela Vario 18 User manual

SUCTION PUMP
Vario 18
EN Patient Instructions for use
DE Gebrauchsanweisung für Patienten
FR Mode d’emploi
IT Istruzioni per l’uso per i pazienti
NL Gebruiksaanwijzing voor patiënten
SV Patientbruksanvisning
FI Käyttöohjeet potilaalle
NO Pasientbruksanvisning
ES Instrucciones de uso para el paciente
PT Instruções de utilização para o paciente
Vario 18 AC / DC

2
Assistance
Read the entire instruction manual before trying to
operate the device.
If you have any questions about your Vario18 suction
pump, please contact your healthcare provider/
physician at the number below:
Keep this Patient Instructions for use booklet in an
easily accessible location.
HEALTHCARE PROVIDER/PHYSICIAN CONTACT
INFORMATION:

3
EN
Table of contents
Warnings and safety instructions ..................................4
Description of the device ...............................................7
Set up instructions.......................................................10
Preparation for use ...................................................... 11
Operating instructions..................................................17
Filter test......................................................................21
Changing reusable jar..................................................22
Changing disposable liner............................................24
Troubleshooting ..........................................................26
Battery data and test...................................................28
Battery calibration........................................................30
Cleaning guidelines......................................................31
Signs and symbols ......................................................33
Warranty and servicing................................................35
Disposal ......................................................................35
Technical specifications ...............................................36

4
Warnings and safety instructions
The Vario18 is approved exclusively for the use as
described in these Patient Instructions for use. Medela
can only guarantee the safe functioning of the system
when the Vario18 is used in combination with the
original Medela accessories.
Please read and observe these warning and safety
instructions before operation. These Patient
Instructions for use must be kept with the device
for later reference.
Please note that these instructions for use are a
general guide for the use of the product. Medical
matters must be addressed by a physician.
WARNINGS
The individual responsible for operating this device
on a daily basis (patient, caregiver) must be able
to read, understand and follow directions provided
in these instructions for use, and by the healthcare
professional. The individual must be able to hear
and respond to auditory signal.
Only use the Vario 18 on the person for whom it
was ordered and only for its intended use. Do not
perform the therapy without your healthcare
provider’s supervision.

5
EN
– If you are dependent on the device for airway
suctioning and a breakdown can lead to a critical
situation, you must have a replacement device at hand.
– The connecting tubing delivered with the device
must always be connected to a sterile catheter as
prescribed by your physician.
– Do not modify the equipment.
– 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.
– Wireless communications equipment such as wireless
home network devices, mobile phones, cordless tele-
phones and their base stations, walki-talkie can affect the
Vario 18 and should be kept at least a distance 1ft (30 cm)
away from the equipment.
General safety at home
– Vario 18 should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary,
Vario 18 should be observed to verify normal operation in
the configuration in which it will be used.
– Keep the power supply cord away from hot surfaces.
– Keep the mains plug and the on/off switch away from
moisture.
– Never pull the mains plug out of the fixed mains
socket by pulling on the power supply cord!
– Never leave the device unattended when it is switched on.
– The pump must stand upright during use.
– Never use the device at high room temperatures, while
bathing or showering or if you are very tired.

6
– Do not use extension cords with Vario18 pump. Keep the
power supply cord where your will not fall or trip over it.
– Never place the power supply cord around your neck.
– Keep the Vario18 pump clean and dry.
– Never place the pump in water or liquids.
– If the pump gets wet, rub with dry towel. Do not dry in a
microwave.
– Keep the pump away from children and pets.
– Keep the pump protected from direct sunlight.
– Prevent the pump from falling to the floor during sleep.
– Do not touch the pump when it has fallen into water.
Unplug device immediately from electrical outlet.
– The Vario 18 pump may shortly shut down with electro-
static discharge (ESD) events at the DC port of 15kV.
When you leave the house
– Make sure the LED indicator is not blinking when you
leave the house.
– For your convenience put the pump into the optional
carrying bag and store the tubing safely in the tubing bag.
– Don’t forget to take a spare jar/liner/tubing and the power
supply with you.
These instructions for use must be kept for later
reference.

7
EN
Description of the device
Introduction
Your physician has prescribed the Vario 18 for airway
suctioning. This suction pump from Medela is a high-
quality suction pump that combines easy handling and
cleaning with safety features to ensure optimal operation.
Intended use
The Medela 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 bed-side.
Generally the Medela Vario 8 /18 / ci is intended to be used
for a variety of suctioning procedures including naso-
pharyngeal, tracheal, surgical, gastrointestinal in either
«constant» or «intermittent» mode.
Intended user
The Vario18 should only be operated by properly trained
persons.
Expected service life
The expected service life of the device is seven years.
CAUTION: U.S. Federal law restricts this device to sale by
or on the order of a physician.
Subject to change.

8
Versions of the pump
Suction
port
Jar
adaptors
Handle
Tubing
holder
12VDC
connector
socket
(AC/DC
version only)
Exhaust
Front of the pump
Vario18 AC Vario18 AC/DC

9
EN
Off: pump is switched off
On: pump is running
On/off switch
Acoustic indicator
During battery operation an acoustic signal (beep - beep
- beep) indicates that the rechargeable battery is soon
discharged.
Operating elements and battery status
Vacuum regulator
Vacuum gauge
Only AC/DC version:
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

10
Check initial delivery
Check the delivery package of the Vario18 for
completeness and general condition.
Set up instructions
Accessories
Please ask your healthcare provider/physician in case
of missing parts or for additional accessories.
1x Vario18 suction pump
1x Instructions for use
5x Disposable filters
1x Silicone Tubing with 2 coupling
pieces

11
EN
Preparation for use
Checks before use
– Check the Vario18 pump before use for damage
of the power cord or plug, obvious device damage
or safety defects and proper functioning of the
device.
– Only for AC/DC versions: make sure that the
rechargeable battery is calibrated according to
chapter «battery calibration».
– 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 connec-
tors are firmly attached. Replace if necessary.
WARNINGS
For use only by persons who have been adequately
trained in the use of suction pumps for airway
suctioning by their healthcare provider/physician.
CAUTIONS
– The Vario18 must remain in an upright position
during use.
– Sterile accessories must be checked on the
integrity of the packaging before use.
– Non sterile and reusable accessories must be
cleaned and disinfected before use.

12
Attach all necessary accessories according to your
healthcare provider’s instructions.
2.
Basic assembly
1. Attach the filter to the Vario18 with
the arrow pointing towards the
pump. The filter must be exchanged
on a weekly basis.
WARNINGS
The filter protects the pump against overflow.
When the filter is wet/moist/clogged you will not be
able to suction. Test the filter before each use (see
chapter «filter test»).

13
EN
Reusable collection system
1. If you use a disposable collection system proceed
with chapter «disposable collection system».
3. a) Attach the lid to the jar.
b) Lock with the two lid clamps.
2. a) Attach floater to lid.
b) Make sure the floater moves up/
down freely.
4. a) Attach the jar to the pump.
b) Connect tubing to the filter.
c) Connect tubing to the lid of the jar.
The port is marked with «vacuum».

14
5. Connect patient tubing (the fingertip
tubing delivered with the pump) to
the lid of the jar. The port is marked
with «patient».
CAUTION
Do not use tubing or other sterile accessories if the
sterile packaging is damaged. Do not reuse single
use or sterile products.

15
EN
Disposable collection system (when using liners)
1. If you use a reusable collection system proceed
with chapter «reusable collection system».
2. a) Attach the Vario18 jar adapter (blue
piece) to the pump’s jar holder.
3. a) Prepare the 1.5l jar (yellow stripe).
b) Insert the liner with the yellow
plugs on top according to
instructions delivered with liners.
4. a) Attach the jar to the pump.
b) Connect tubing to the filter.
c) Connect tubing to the jar. The
tubing port is on top of the jar.

16
5. a) Take the coloured angle piece
from the lid of the liner and insert
into the port labeled «patient».
b) Connect patient tubing (the finger-
tip tubing delivered with the pump)
to the coloured angle piece.
CAUTION
Do not use tubing or other sterile accessories if the
sterile packaging is damaged. Do not reuse single
use or sterile products.

17
EN
Operating instructions
CAUTIONS
The Vario 18 is to be set up in such a way, that it
can easily be unplugged from the mains socket.
Connect Vario18 to mains power
Check the pump before use following the instruction in
chapter «preparation for use».
1.
2. All versions: Plug in the mains plug of the power
cord to a fixed mains socket.
AC/DC
version: (if the
pump is
operated using
the optional
car connection
cable)
Connect the optional 12V DC
connection cable to the socket on
the side of the pump and connect
it to the 12V DC power source
(cigarette lighter in the car).
or
AC/DC
version: (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

18
3. a) Seal the end of the patient tubing
with your thumb.
b) Compare the maximum vacuum
according to the specification.
If the maximum vacuum is not
reached, see chapter «trouble-
shooting».
Check maximal vacuum for functional check
2. Press and turn the vacuum regulator
to the right to set maximum vacuum.
1. Switch on the Vario18. The pump will
start running.
Specifications:
+ 2000m – 59kPa
+ 1000m – 66kPa
+ 500m – 70kPa
+ 0m – 75kPa
Altitude above
sea level:
(Tolerance +/- 10 %)
Max. Vacuum:

19
EN
Changing vacuum level
1. a) Clamp patient tubing
b) Push and turn vacuum regulator
to select the correct vacuum
according to the instructions
from your physician.
c) Check vacuum gauge for setting.
Use only vacuum level recommended by your healthcare
provider/physician.

20
3.Clean and desinfect the Vario18. See chapter
«cleaning guidelines».
2.If the pump is
connected to a
fixed mains
socket:
Disconnect the mains plug from the
fixed mains socket.
If the pump is
connected to a
12VDC power
source:
Disconnect the 12VDC plug from the
12VDC power source.
or
Placing out of operation after use
1. Switch the off switch of the Vario18
to position «0».