Medela Vario 18 Instruction 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 Vario 18 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 Vario 18 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 Vario 18 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 Vario 18 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 Vario 18 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 highquality 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 nasopharyngeal, tracheal, surgical, gastrointestinal in either
«constant» or «intermittent» mode.
Intended user
The Vario 18 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
12 V DC
connector
socket
(AC / DC
version only)
Exhaust
Front of the pump
Vario 18 AC Vario 18 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 Vario 18 for
completeness and general condition.
Set up instructions
Accessories
Please ask your healthcare provider / physician in case
of missing parts or for additional accessories.
1 x Vario 18 suction pump
1 x Instructions for use
5 x Disposable filters
1 x Silicone Tubing with 2 coupling
pieces
11
EN
Preparation for use
Checks before use
– Check the Vario 18 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 Vario 18 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 Vario 18 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 Vario 18 jar adapter (blue
piece) to the pump’s jar holder.
3. a) Prepare the 1.5 l 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 Vario 18 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 12 V DC
connection cable to the socket on
the side of the pump and connect
it to the 12 V DC power source
(cigarette lighter in the car).
or
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 «troubleshooting».
Check maximal vacuum for functional check
2. Press and turn the vacuum regulator
to the right to set maximum vacuum.
1. Switch on the Vario 18. The pump will
start running.
Specifications:
+ 2000 m – 59 kPa
+ 1000 m – 66 kPa
+ 500 m – 70 kPa
+ 0 m – 75 kPa
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 Vario 18. See chapter
«cleaning guidelines».
2.If the pump is
connected to a
fixed mains
socket:
Disconnect the mains plug from the
fixed mains socket.
If the pump is
connected to a
12 V DC power
source:
Disconnect the 12 V DC plug from the
12 V DC power source.
or
Placing out of operation after use
1. Switch the off switch of the Vario 18
to position «0».
21
EN
Filter test
4. a) Read the vacuum.
b) Replace the filter if the vacuum
exceeds 10 kPa.
1. Remove tubing from filter.
3. Switch on the Vario 18. The pump will
start running.
2. Select maximum vacuum.
22
Changing reusable jar
3. a) Prepare new jar and unpack it.
b) Attach new jar to the Vario 18.
c) Reconnect vacuum tubing and
new patient tubing firmly.
1. a) Switch the Vario 18 off.
b) Remove patient and vacuum
tubings from the lid.
2. Remove full jar from the Vario 18.
23
EN
4.Empty jar and dispose of patient tubing according to
the instructions from your healthcare provider.
5.Switch on the Vario 18. The pump will start running.
6.Set vacuum according to the instructions from your
physician. See chapter «changing vacuum level».
24
4.Dispose of the liner and patient tubing according to
the instructions from your healthcare provider.
Changing disposable liner
1. a) Remove patient tubing with
colored angle piece from lid.
b) Plug patient port.
2. Switch the Vario 18 off.
Reduce vacuum to minimum by
pressing and turning the vacuum
regulator to the left.
WARNINGS
Do not reuse disposable liners.
1.5 l
3. Remove full liner from the jar.
25
EN
5.Prepare new liner, unpack it and insert it in the jar.
Press down lid.
7. Switch on the Vario 18. The pump will start running.
8.Set vacuum according to the instructions from your
physician. See chapter «changing vacuum level».
6. Connect new patient tubing firmly.
26
Troubleshooting
Check if:
– the Vario 18 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)
Motor not running
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 floater on the reusable lid moves freely up / down.
– the suction jar / lid has 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 «filter test».
Suction of pump too low
27
EN
The rechargeable battery is
fully charged.
No LED lit
– The rechargeable battery is
being charged.
– The pump is connected to the
mains.
LED lit up
The rechargeable battery is soon
empty.
LED blinks slowly
The rechargeable battery is
defective.
LED blinks rapidly
AC / DC version only:
– if an overflow into the device has occurred
– 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.
If the fault cannot be rectified, please contact your
healthcare provider.
CAUTIONS
Do not try to fix or repair the Vario 18 pump.
Contact your healthcare provider immediately if:
28
Battery data and test
(AC / DC version only)
Duration of pumping
If the battery is fully charged, the operating time is about
30 minutes.
The Vario 18 is a mains- and battery powered suction
pump. One full battery charge (Vario 18 AC / DC version)
would last you a total of 30 minutes continuous running
time. Then the battery must be recharged.
If you are not using your Vario 18 AC / DC version or storing for a longer period of time (> 2 months), recharge the
battery every 60 – 90 days.
Battery low
Only recharge the battery when the LED indicator blinks
slowly and you hear the acoustic signal (beep - beep beep). You have 10 minutes of suctioning time left.
Battery empty
As soon as the rechargeable battery is empty, the pump
comes to a stop. The rechargeable battery must be
recharged.
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.
29
EN
Charging time
Charged up to 100 % in approx. 5 hours.
Make sure that the rechargeable battery is fully charged.1.
Pull out the mains plug from the fixed wall outlet.2.
Testing the rechargeable battery
4. Switch on the Vario 18. The pump
will start running.
3. Press vacuum regulator and turn it to
the right to select maximum vacuum.
5.Measure the time until the pump comes to a stop.
The battery is ok, when pump runs for more than
30 minutes.
If the values are not reached, repeat test or calibrate
the battery (see next page).
30
Battery calibration
Storage of the rechargeable battery
In order to keep the self-discharge at a minimum, store
the Vario 18 and the replacement rechargeable batteries
at temperatures below 25 °C (77 °F). Repeat the calibrating process every 60 – 90 days.
Pull out the mains plug from the fixed wall outlet.2.
Plug the mains cable into the wall outlet.
The rechargeable battery is being charged.
5.
Wait until the charging indicator LED goes out.6.
Let the pump run until the rechargeable battery is
empty and the pump comes to a stop.
4.
Repeat steps 1 to 6. The Vario 18 AC / DC is then ready
to use.
7.
Make sure that the battery is fully charged.1.
Calibrating NiMH rechargeable battery
3. Switch on the Vario 18. The pump will
start running.
CAUTIONS
Calibrate rechargeable batteries before the first use,
or after a storage period > 2 months. If the calibration process fails, return to your healthcare provider
to have battery replaced.
(AC / DC version only)
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