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
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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:
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General warnings............................................................................................................................. 4
Purpose of the device................................................................................................................. 6
Intended use......................................................................................................................................... 6
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
Battery status.................................................................................................................................... 14
Charge battery................................................................................................................................. 15
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
Technical documentation...................................................................................................... 28
Electromagnetic compatibility (EMC)......................................................................... 81
Table of contents
EN Instructions for use 2
ES Instrucciones de uso 29
FR Mode d’emploi 56
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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.
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
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– 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 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 2 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, immedia-
tely call your healthcare professional.
CAUTION: U.S. Federal law restricts this device for sale or rental
by or on the order of a physician.
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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 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 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
The Medela Invia Liberty Negative Pressure Wound Therapy
system is indicated to help promote wound healing, through
means including drainage and removal of infectious material or
other fluids, under the influence of continuous and/or intermittent
negative pressures, particularly for patients with chronic, acute,
traumatic, subacute and dehisced wounds, partial thickness
burns, ulcers (such as diabetic or pressure), flaps and grafts.
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When not to use the 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.
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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
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EN
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
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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.
– The use of mobile telephones, local area networks (LAN)
including wireless (WLAN), walkie-talkies (two-way radios) and
cordless telephone sets can affect the Invia Liberty pump.
This may cause insufficient battery charging or may lead to an
internal fault. See the chapter Notifications and roubleshooting
for actions to take in the case of an internal fault. Certain
mobile phones may interfere with the Invia Liberty pump when
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receiving and making calls close to the pump. Prior to using
a mobile phone near the Invia Liberty pump, check that it con-
tinues 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 pump at least 1 meter (3.3 feet) 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 meter
(3.3 feet) 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 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 dres-
sing 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.
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Display view when the pump is runing.
Run/Standby indicator is rotating [ ].
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
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.
WARNING
Do not try to perform therapy without the supervision of
your healthcare professional.
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EN
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
frequently 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.
Turn OFF
Switch Invia Liberty pump OFF by pressing
[ ] for 3 seconds. Press only once.
WARNING
NPWT must run 24 hours a day. Do not stop the therapy
unless instructed by your healthcare professional or if
excessive bleeding occurs.
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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.
Battery status
When the battery is fully charged it should last approximately
10 hours. If the Invia Liberty pump is running continuously due
to an air leakage, the battery may need to be recharged earlier
(after approximately 4 hours).
Battery status symbols
full half full fully discharged (empty)
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Charge battery
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
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Change canister
Change canister when it appears full or when the alarm sounds,
in accordance with instructions on the pump display.
1 Wash hands.
2 Clamp the canister tubing.
3 Press the “Standby” button [ > 3 seconds ]
and the pump motor will stop running.
4 Press release button at the top of the
pump and remove canister.
5 Seal used canister with a cap located on
the side of the canister.
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.
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7 Switch the Invia Liberty pump on by
pressing [ ] and slide the pump into the
carrying case.
8 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.
1 Wash hands.
2 Clamp the canister tubing and 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.
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5 ➡
➡
To reconnect the Quick-connector push
together the Quick-connector until you
hear the click.
click
6 Press “On” [ ] to resume therapy.
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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.
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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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