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

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:
2

Table of contents
EN Instructions for use 2
ES Instrucciones de uso 30
FR Mode d’emploi 58
Warnings, cautions and safety instructions .......................................................... 4
General warnings............................................................................................................................. 4
Purpose of the device................................................................................................................. 6
Intended use......................................................................................................................................... 6
When to use 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
3
EN

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 avoided,
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 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 the Invia Liberty system
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.
4

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 button [ ].
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 by a healthcare professional. Contact your healthcare
professional to request a dressing change.
WARNING
If the pump stops working and cannot be switched on, immedi-
ately call your healthcare professional.
CAUTION U.S. Federal law restricts this device for sale or rental
by or on the order of a physician.
5
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 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 canister
on the pump. The pump is then turned on to the prescribed pres-
sure 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 health-
care professionals or adequately trained lay users.
Healthcare professionals are responsible to train lay users accord-
ing 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 indications 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.
6

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 (Negative Pressure Wound Therapy) as when used on
open wounds 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
granulation tissue formation and perfusion, and by removing exu-
date and infectious material.
When used on closed surgical incisions, the Invia Liberty NPWT
system is also intended to manage the environment of surgical
incisions that continue to drain following sutured or stapled clo-
sure by maintaining a closed environment and removing exudate
via the application of Negative Pressure Wound Therapy.
The Invia Liberty NPWT system is appropriate for use for the
following indications:
– 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.
7
EN

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
8

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
9
EN

General safety at home
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 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 distance
of 1 foot (30cm) away from the Invia Liberty pump. This may
cause insufficient battery charging or may lead to an internal
10

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 (212°F), incinerate or dispose of in fire.
If you observe a change in the vacuum level or an error condition,
move the Invia Liberty pump at least 1 foot (30cm) 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 1 foot (30cm)
between the Invia Liberty pump and a mobile phone is recom-
mended.
Sleeping
– Make sure the Invia Liberty pump tubing will not become kinked.
– Prevent the Invia Liberty pump from falling to the floor during
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 showering.
– The Invia Liberty pump can be disconnected from the dress-
ing 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.
11
EN

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 dressing,
area around the wound and fluid in the canister for signs of
infection or other complications as provided by your health-
care professional.
Turn ON
12

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 exces-
sive 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 curved
arm of the Y-connector. Check dressing tubing connected to
the drain adapter or the curved arm of the Y-connector fre-
quently throughout the day to make sure tubing is not
kinked or blocked.
If blockage is identified along tubing connected to the drain adap-
ter or tubing connected to the curved arm of the Y-connector,
contact your healthcare professional.
13
EN

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 continuo-
usly due to an air leakage, the battery may need to be recharged
earlier.
Battery status symbols
full half full fully discharged (empty)
14

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 out-
let. 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 charging.
Always charge the battery overnight.
Electrical outlet port
15
EN

Change canister
Change canister minimum once a week, 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.
16

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 per-
sonal 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 additi-
onal 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.
17
EN

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.
18

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.
19
EN

Alarm table
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.
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