Medela Invia Liberty User manual

NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Invia
®
Liberty
™
EN Patient Instructions for use
ES Instrucciones de uso paciente
FR Mode d’emploi pour le patient

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 booklet in an
easily accessible location.
HEALTHCARE PROVIDER/PHYSICIAN
CONTACT INFORMATION:

3
EN
General Warnings.....................................................................................................................4
Purpose of the Device.......................................................................................................7
Intended Use ..................................................................................................................................7
When Not to Use Device (Contraindications)....................................8
Description of the Device..............................................................................................9
Display................................................................................................................................................. 10
Conditions that Affect Use...................................................................................... 10
General Safety at Home..............................................................................................11
Sleeping............................................................................................................................................. 12
Showering, Bathing and Washing................................................................. 13
When You Leave the House................................................................................. 13
Set Up Instructions............................................................................................................ 14
Set Up Carring Case....................................................................................................... 16
Charge Battery..........................................................................................................................17
Change Canister.................................................................................................................... 19
Notifications and Troubleshooting................................................................. 21
Alarm table....................................................................................................................................22
Cleaning/Disinfection.....................................................................................................26
Guarantee .......................................................................................................................................26
Maintenance/Safety related Check............................................................26
Disposal.............................................................................................................................................26
Technical Specifications.............................................................................................. 27
Signs and Symbols............................................................................................................28
Electromagnetic Emissions.....................................................................................86
Table of Contents
EN Instructions for Use 3
ES Instrucciones para uso 29
FR Mode d’emploi 58

4
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
healthcare 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 Invia Liberty
frequently.
If you see large amounts of blood in the dressing, tubing
or canister:
1Turn off the pump by pressing and hold for
3 seconds.
2Apply pressure to your wound.
3 Seek immediate Emergency Medical assistance.
General Warnings

5
EN
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, sore or red area around the wound
– Swelling, itching, or rash around the wound
– Fever
– Strong odor from the wound
– Thick green drainage or any 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 button [ ].

6
WARNING
The pump must be used 24 hours per day. Do not stop
the pump unless instructed by your healthcare profes-
sional or if excessive bleeding occurs.
If the pump is stopped for more than the time frames
shown below, the dressing must be changed. Contact
your healthcare professional to request a dressing
change.
Gauze dressings: Change dressing if the pump is
stopped more than 24 hours.
Foam dressings: Change dressing if the pump is
stopped more than 2 hours.
WARNING
If the pump stops working and cannot be switched on,
immediately call your healthcare professional.

7
EN
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 promote healing in several different kinds of
wounds. Negative pressure (suction) is delivered to a
wound through a pump. The suction, or negative pres-
sure, 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
canister 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 treat-
ment will be applied 24 hours a day.
Intended Use
The Medela®INVIA Liberty Wound Therapy is indicated
to help promote wound healing, through means in-
cluding drainage and removal of infectious material or
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intermittent negative pressures, particularly for patients
with chronic, acute, traumatic, subacute and dehisced
wounds, partial-thickness burns, ulcers (such as diabetic
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8
When Not to Use Device (Contraindications)
Contraindicated for patients with:
– Malignancy of the wound
– Untreated osteomyelitis
– Unmanaged malnutrition
– Non-enteric fistula
– Unexplored fistula
– Necrotic tissue with eschar present
– Do not place Invia Wound Therapy dressing over
exposed blood vessels or organs
– Do not place directly over anastomoses or sutured
vessels
If you have concerns, speak with your healthcare
professional.

9
EN
Description of the Device
Check the delivery package of the Invia Liberty NPWT
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
canister 0.3 liter
with solidifier
Y-connector
Invia Liberty
canister 0.8 liter
with solidifier
Charger
Holder with
standard rail
Carrying
Case
Docking station
Invia Liberty tubing
set, single, sterile

10
Buttons to Operate the Invia Liberty
Display
Conditions that Affect Use
ON/OFF
Mute
Do Not Press
(only for clinician)
Standby
CAUTION
The Invia Liberty must remain in an upright position
during use.

11
EN
Please read and observe these warnings and safety
instructions 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.
– Position the power cord so that it will not cause some-
one to trip and fall.
– Never place the power supply cord around your neck.
– Keep 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. Contact
your healthcare professional if the pump is not
working.
– Keep the Invia Liberty clean and dry.
– Never place the Invia Liberty in water or liquids.
– If the Invia Liberty gets wet, dry with a towel.
– Do not dry the Invia Liberty in a microwave.
– Keep the Invia Liberty away from children and pets.
– Supervision is necessary when the Avance wound-
pump is used in the vicinity of children.
– Keep the Invia Liberty protected from direct sunlight.
General Safety at Home

12
Sleeping
– Make sure the Invia Liberty tubing will not become kinked.
– Prevent the Invia Liberty from falling to the floor during
sleep.
– Always charge the Invia Liberty when going to bed.
– The use of mobile telephones, local area networks
(LAN) including wireless (WLAN), walkie-talkies (two-
way radios) telephone sets can affect the Invia Liberty.
This may cause insufficient battery charging or may
lead to an internal fault. See the chapter Notifications
and Trouble-shooting for actions to take in the case of
an internal fault. Certain mobile phones may interfere
with the Invia Liberty NPWT system when receiving
and making calls close to the pump. Prior to using a
mobile phone near the Invia Liberty NPWT system,
check that it continues to function while making or
receiving a call.
If you observe a change in the vacuum level or an
error condition, move the Invia Liberty NPWT system
at least 1meter (3.3 feet) from the mobile phone when
making or receiving calls. Turn the Invia Liberty NPWT
system on and off again to reset it after an error
condition. Whenever possible, a safety distance of
min. 3.3 feet (1meter) between the Invia Liberty and a
mobile phone is recommended.

13
EN
– Do not use the Invia Liberty while bathing or showering.
– 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 from getting wet.
– Do not put the Invia Liberty where it can fall into a
shower, sink or tub.
– Do not touch the Invia Liberty when it has fallen into
water. Unplug device immediately from electrical outlet
and disconnect the pump from the dressing.
When You Leave the House
– Check the battery status and recharge if necessary
before leaving the house.
– For your convenience, place the Invia Liberty into the
carrying case.
– Don’t forget to take a spare Canister and power sup-
ply with you.
Showering, Bathing and Washing

14
WARNING
Check the Invia Liberty frequently to make sure it is
working. Visually check the wound dressing, area
around the wound and fluid in the canister for signs
of infection or other complications as provided by
your healthcare professional.
Turn ON
Switch Invia Liberty Pump ON by pressing [ ].
WARNING
Do not try to perform therapy without the super-
vision of your healthcare professional.
Display view when the pump is run-
ing. Run/ Standby indicator is rotating
[ ].
Set Up Instructions

15
EN
WARNING
NPWT must run 24 hours a day. Do not stop the
therapy unless instructed by your healthcare profes-
sional 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 two (2) hours when using foam.
-More than 24 hours when using gauze.
Turn OFF
Switch Invia Liberty Pump OFF by pressing [ ] for
3 seconds. Press only once.

16
The Invia Liberty is intended to worn in a carrying case
during operation.
1Open the carrying case.
2Slide the Invia Liberty into the designated pocket.
3Close the velcro of 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 case.
Set Up Carrying Case

17
EN
Charge Battery
When the battery is fully charged it should last appro-
ximately 10 hours. If the Invia Liberty is running continu-
ously due to an air leakage, the battery may need to be
recharged earlier (after approximately 4 hours).
Battery Status Symbols
full half full empty
If the battery becomes empty, please follow the instruc-
tions below.
Open the electrical outlet port. Connect the Invia Liberty
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 dis-
play will indicate charging is occurring.

18
The battery will be fully charged after approximately 4
hours. Once charged will appear constantly on the
display. After charging is completed, unplug the power
supply from the wall and disconnect the Invia Liberty
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
charging.
Always charge the battery over night.
Electrical outlet port

19
EN
Change Canister when it appears full or when the alarm
sounds, in accordance with instructions on the pump
display.
1. Wash hands.
5. Seal used canister with cap.
4. Press release button at top of pump
and remove canister.
3. Press the Standby button [ > 3 seconds ]
and the pump motor will stop running.
2. Clamp double lumen tubing.
Change Canister

20
8. Discard the used canister according to instructions
provided by your healthcare professional.
7. Switch the Invia Liberty on by
pressing [ ] and slide the pump
into the carrying case.
6. Unpack new canister, position the
feet at the bottom 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.