Medela Invia Liberty User manual

NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Invia®Liberty™
EN Patient instructions for use
DE Gebrauchsanweisung für Patienten
FR Mode d’emploi pour le patient
ES Instrucciones de uso para el paciente
PT Instruções de utilização para pacientes
NL Gebruiksaanwijzing voor patiënten
SV Bruksanvisning för patienter
IT Istruzioni per l’uso per il paziente
FI Käyttöohjeet potilaalle
DA Brugsanvisning til patienter
NO Bruksanvisning for pasient

2
Assistance
Read the entire instruction manual before trying to operate
thedevice.
If you have any questions about your Invia Liberty Negative
Pressure Wound Therapy system, please contact your healthcare
provider/physician at the number below:
Keep this Patient instructions for use (IFU) booklet in an
easily accessible location.
HEALTHCARE PROVIDER/PHYSICIAN
CONTACT INFORMATION:

3
EN
Table of contents
Warnings, cautions and safety instructions ................................................ 4
General warnings................................................................................................................... 4
Purpose of the device ..................................................................................................... 6
Intended use.............................................................................................................................. 6
When to use the the device (Indications for use) .................................. 7
When not to use the device (Contraindications) ..................................... 7
Description of the device ............................................................................................. 8
Display ........................................................................................................................................... 9
Conditions that affect use ........................................................................................... 9
General safety at home .............................................................................................. 10
Sleeping .....................................................................................................................................11
Showering, bathing and washing .......................................................................11
When you leave the house ...................................................................................... 12
Set up instructions .......................................................................................................... 12
Set up carrying case ..................................................................................................... 14
Charge battery .................................................................................................................... 14
Change canister ................................................................................................................. 16
Connect/ disconnect Quick-connector .........................................................17
Notifications and troubleshooting ...................................................................... 19
Alarm table ............................................................................................................................. 20
Cleaning / Disinfection ................................................................................................... 24
Guarantee ................................................................................................................................ 24
Maintenance/ Safety-related check ................................................................. 24
Disposal ..................................................................................................................................... 24
Technical specifications .............................................................................................. 25
Signs and symbols .......................................................................................................... 26
Electromagnetic compatibility (EMC) .............................................................. 29

4
Warnings, cautions and
safety instructions
WARNING
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 avoid-
ed, could result in minor or moderate injury.
General warnings
WARNING
The individual responsible for operating this device on a daily
basis (patient, caregiver) must be able to read, understand and
follow directions provided in this IFU, on the pump display and
by the healthcare professional. The individual must be able to
hear and respond to auditory signals.
Only use the Invia Liberty NPWT system on the person for
whom it was ordered and only for its intended use.
Do not perform the therapy without first consulting with health-
care personnel and caregivers trained on the instructions for
use and the healthcare professional’s supervision.
No modification of this equipment is allowed.
WARNING
Visually check at the wound dressing and the Invia Liberty sys-
tem frequently.
If you see large amounts of blood in the dressing, tubing
or canister:
1 Turn off the pump by pressing and hold for 3 seconds.
2 Apply pressure to your wound.
3 Seek immediate Emergency Medical assistance.

5
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If you have difficulty breathing, seek immediate Emergency
Medical Assistance.
WARNING
Immediately contact your healthcare professional if you
experience the following symptoms:
– Significant vision or hearing loss
– Pain, soreness or redness around the wound
– Swelling, itching, or rash around the wound
– Fever
– Strong odor from the wound
– Thick green drainage or any unusual change in color
of drainage
– Nausea or vomiting or diarrhea
– Sore throat with swelling
– Dizziness or confusion
– Allergic reactions like redness, rash or hives, swelling
or severe itching
WARNING
Once the healthcare professional has set the pump pressure
and mode settings do not press any other button than the
on/ off button [ ], the standby button [ ] or the mute but-
ton [ ].
WARNING
The pump must be used 24 hours per day. Do not stop the
pump unless instructed by your healthcare professional or if
excessive bleeding occurs.
If the pump is stopped for more than 2 hours, the dressing
must be changed. Contact your healthcare professional to
request a dressing change.
WARNING
If the pump stops working and cannot be switched on, imme-
diately call your healthcare professional.

6
Purpose of the device
Your healthcare provider has prescribed Negative Pressure
Wound Therapy (NPWT) for you.
Negative Pressure Wound Therapy has been shown to help pro-
mote healing in several different kinds of wounds. Negative pres-
sure (suction) is delivered to a wound through a pump. The suc-
tion, or negative pressure, helps to remove fluid and close your
wound. Your healthcare professional will place a special dressing
on your wound and a tube will go from your wound to the canis-
ter on the pump. The pump is then turned on to the prescribed
pressure to remove the fluid from your wound. The fluid then
goes into the canister. The treatment will be on 24 hours a day.
Intended use
Intended user
The Invia Liberty NPWT system is intended to be used by
healthcare professionals or adequately trained lay users.
Healthcare professionals are responsible to train lay users
according to the patient instructions for use and explain all
related safety information.
Intended patient population
The Invia Liberty NPWT system is intended to be used on
patients only exhibiting conditions as described in the indica-
tions for use. The device has not been studied in pediatric
patients.
Intended environment
The Invia Liberty NPWT system is intended for use in acute,
extended and home care settings.

7
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When to use the device (Indications for use)
The Invia Liberty Negative Pressure Wound Therapy (NPWT)
system is indicated for patients who would benefit from a suction
device (NPWT) as it creates an environment that promotes wound
healing by secondary or tertiary (delayed primary) intention by pre-
paring the wound bed for closure, reducing edema, promoting gran-
ulation tissue formation and perfusion, and by removing exudate and
infectious material.
When used on closed surgical incisions, the Invia Liberty NPWT sys-
tem is also intended to manage the environment of surgical incisions
that continue to drain following sutured or stapled closure by main-
taining a closed environment and removing exudate via the applica-
tion of Negative Pressure Wound Therapy.
The Invia Liberty NPWT system is appropriate for the following indi-
cations:
– Acute or subacute wounds
– Chronic wounds
– Dehisced wounds
– Pressure ulcers
– Diabetic/Neuropathic ulcers
– Venous insufficiency ulcers
– Traumatic wounds
– Partial thickness burns
– Flaps and grafts
– Closed surgical incisions
When not to use the device (Contraindications)
The Invia Liberty NPWT system is contraindicated in
the presence of:
– Necrotic tissue with eschar
present
– Untreated osteomyelitis
– Non-enteric and unexplored
fistulas
– Malignancy in the wound
– Exposed vasculature
– Exposed nerves
– Exposed anastomotic site of
blood vessels or bypasses
– Exposed organs
If you have concerns, speak with your healthcare professional.

8
Description of the device
Check the delivery package of the Invia Liberty system
for completeness and general condition.
WARNING
Do not use any other accessories than the ones
described below.
Invia Liberty
pump with
instructions
for use
Invia Liberty canis-
ter 0.3 liter with
solidifier
Y-connector
Invia Liberty canis-
ter 0.8 liter with
solidifier
Charger
Holder with
standard rail
Carrying
case
Docking station
Invia Liberty tubing
set, single, sterile
Drain adapter*
Quick-connector
*Product not available in all countries

9
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Display
Buttons to operate the Invia Liberty pump
Conditions that affect use
CAUTION
The Invia Liberty pump must remain in an upright
position during use.
ON/ OFF
Mute
Do not press (only
for clinician)
Standby/ On

10
General safety at home
Please read and observe these warnings and safety instruc-
tions before operation. These instructions for use must be kept
with the device. Please note that these instructions for use are
a general guide for the use of the product. Medical situations
must be addressed by a physician.
CAUTIONS / WARNINGS
– Do not use extension cords with the Invia Liberty pump.
– Position the power cord so that it will not cause someone
to trip and fall.
– Never place the power supply cord around your neck.
– Keep the power supply cord away from hot surfaces.
– Do not unplug the power supply cord from the wall outlet
by pulling on the cord.
– Do not try to fix or repair the Invia Liberty pump. Contact
your healthcare professional if the pump is not working.
– Keep the Invia Liberty pump clean and dry.
– Never place the Invia Liberty pump in water or liquids.
– If the Invia Liberty pump gets wet, dry with a towel.
– Do not dry the Invia Liberty pump in a microwave.
– Keep the Invia Liberty pump away from children and pets.
– Supervision is necessary when the Invia Liberty pump is
used in the vicinity of children.
– Keep the Invia Liberty pump protected from direct sunlight.
– Explosion hazard – the Invia Liberty pump is not for use in
potentially explosive environments including oxygen enriched
environments and in areas of flammable anesthetics.
– Wireless communication equipment such as wireless home
network devices, mobile phones, cordless telephones and
their base stations, and walkie-talkies can interfere with the
Invia Liberty pump and should be kept at a minimum dis-
tance of 30 cm away from the Invia Liberty pump. This may
cause insufficient battery charging or may lead to an inter-

11
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nal fault. See the chapter Notifications and troubleshooting
for actions to take in the case of an internal fault.
– This product contains lithium-ion batteries which bear risk
of fire, explosion and burns. Do not disassemble, crash,
heat above 100°C, incinerate or dispose of in fire.
If you observe a change in the vacuum level or an error condi-
tion, move the Invia Liberty pump at least 30 cm from the
mobile phone when making or receiving calls. Turn the Invia
Liberty pump on and off again to reset it after an error
condition. Whenever possible, a safety distance of minimum
30cm between the Invia Liberty pump and a mobile phone is
recommended.
Sleeping
– Make sure the Invia Liberty pump tubing will not become kinked.
– Prevent the Invia Liberty pump from falling to the floor dur-
ing sleep.
– Always charge the Invia Liberty pump when going to bed.
Showering, bathing and washing
– Do not use the Invia Liberty pump while bathing or shower-
ing.
– The Invia Liberty pump can be disconnected from the
dressing for a short period of time (up to 20 minutes) in
order to change clothes or perform personal hygiene.
Discuss bathing plans with your healthcare professional.
– Prevent the Invia Liberty pump from getting wet.
– Do not put the Invia Liberty pump where it can fall into a
shower, sink or tub.
– Do not touch the Invia Liberty pump when it has fallen into
water. Unplug device immediately from electrical outlet
and disconnect the pump from the dressing.

12
Display view when the pump is runing.
Run/ Standby indicator is rotating [ ].
Switch Invia Liberty pump ON
by pressing [ ].
When you leave the house
– Check the battery status and recharge if necessary before
leaving the house.
– For your convenience, place the Invia Liberty pump into the
carrying case.
– Do not forget to take a spare canister and power supply with
you.
Set up instructions
WARNING
Check the Invia Liberty pump and dressing frequently to
make sure it is working. Visually check the wound dres-
sing, area around the wound and fluid in the canister for
signs of infection or other complications as provided by
your healthcare professional.
Turn ON

13
EN
Turn OFF
Switch Invia Liberty pump OFF by pressing
[ ] for 3 seconds. Press only once.
WARNING
Do not try to perform therapy without the supervision of
your healthcare professional.
WARNING
NPWT must run 24 hours a day. Do not stop the therapy
unless instructed by your healthcare professional or if
excessive bleeding occurs.
WARNING
The dressing should be changed and therapy restarted
by the healthcare professional if therapy is discontinued
for more than 2 hours.
WARNING
Invia Liberty pump does not detect blockage along tubing
connected to the drain adapter or connected to the cur-
ved arm of the Y-connector. Check dressing tubing con-
nected to the drain adapter or the curved arm of the
Y-connector frequently throughout the day to make sure
tubing is not kinked or blocked.
If blockage is identified along tubing connected to the drain
adapter or tubing connected to the curved arm of the
Y-connector, contact your healthcare professional.

14
Set up carrying case
The Invia Liberty pump is intended to be worn in a carrying
case during operation.
1Open the carrying case.
2Slide the Invia Liberty pump into the designated pocket.
3Close the velcro over the pump.
The shoulder strap can also be used as a belt strap.
To accomplish this, release the strap at the sides of the
carrying case and pull it through the two loops located on the
back of the carrying case.
Charge battery
When the battery is fully charged the battery run-time generally
exceeds 14 hours. If the Invia Liberty pump is running conti-
nuously due to an air leakage, the battery may need to be
recharged earlier.
Battery status symbols
full half full fully discharged (empty)

15
EN
If the battery becomes fully discharged (empty), please follow
the instructions below.
Open the electrical outlet port. Connect the Invia Liberty pump
to the supplied electrical plug from the power supply provided
with the pump. Plug the other end of the power supply into a
wall outlet. Moving bars on the battery display will indicate
charging is occurring.
The battery is fully charged after approximately 4 hours. Once
battery is fully charged and continues to be connected to the
power source will appear constantly on the display. After
charging is completed, unplug the power supply from the wall
and disconnect the Invia Liberty pump from the power supply.
Close the electrical outlet port by pressing the protection cover
down.
CAUTION
NPWT therapy must be continued while charging
the pump’s battery. Do not turn the pump off while char-
ging.
Always charge the battery overnight.
Electrical outlet port

16
Change canister
Change canister minimum once a week or when it appears full or
when the alarm sounds, in accordance with instructions on the
pump display.
1 Wash hands.
2 Press the "Standby" button [ > 3 seconds ]
and the pump motor will stop running.
3 Press release button at the top of the
pump and remove canister.
4 Seal used canister with a cap located on
the side of the canister.
5 Unpack new canister and remove the
safety sticker, position the feet at the bot-
tom of the canister into the grooves at the
base of the pump. Push the canister up
and click into the Invia Liberty pump.
CAUTION
Do not use an Invia Liberty canister if
the sterile packaging is damaged.

17
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6 Switch the Invia Liberty pump on by pres-
sing "On" [ ] to resume therapy and
slide the pump into the carrying case.
7 Discard the used canister according to instructions provided
by your healthcare professional.
Connect/disconnect Quick-connector
The Quick-connector can be disconnected for a short period of
time (up to 20 minutes) in order to change clothes or perform
personal hygiene. During this time the pump can be placed in
the "Standby" mode for a 5 minute interval, after which time
the "Standby mode" alarm will go off and can be muted for an
additional 5 minutes.
1 Wash hands.
2 Close the clamp on canister
tubing and close the clamp
on the dressing tubing.
➡
3 Press the "Standby" button [ > 3 seconds ]
and the pump motor will stop running.
4
➡ ➡
➡
➡
Disconnect the Quick-connector by pres-
sing under the sides of the connector.

18
5 ➡
➡
To reconnect the Quick-connector push
together the Quick-connector until you
hear the click.
click
6➡Open the clamp on canister tubing and
open the clamp on the dressing tubing.
7 Press "On" [ ] to resume therapy.

19
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Notications and troubleshooting
Do not panic if an acoustic signal sounds.
Follow the instructions below.
1 If the Invia Liberty pump is in the carrying case open the lid
of your carrying case.
2 Press [ ] to mute the acoustic signal for
60 seconds (can be pressed every time the
signal sounds.

20
Remarks / potential cause of fault
Warning
401
Recharge the battery either by placing the Invia Liberty pump in
thedocking station or plug in the charger to the electrical outlet port on
the pump.
Remaining time of battery is approximately 30 minutes.
405
If the pump is in Standby mode for more than 5 minutes, an alarm will go
off.
To continue therapy press “On” [ ]
406 Cool Invia Liberty pump down as per instructions on the display.
Alarm
301
Dressing:
– Check dressing for air leakage. Press firmly around the edges of
thedressing, around the drain tubing or on the Invia FitPad.
– May apply additional film dressing to seal the leaking area.
Connectors:
– Ensure that the tubing connected to the dressing is connected properly
to the canister tubing.
– Ensure that the canister tubing is inserted straight into the pump.
Canister:
– Ensure that the canister is properly inserted, release the canister
and reposition.
– Ensure that the orange O-ring/gasket, placed beside the canister tubing
on the pump is not missing. Additional O-ring is available viaMedela
representative.
302 Call your healthcare professional.
Alarm table