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 (IFU) booklet in an
easily accessible location.
HEALTHCARE PROVIDER/PHYSICIAN
CONTACT INFORMATION:
3
EN
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
4
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
5
EN
– 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, immediately call your healthcare professional.
CAUTION: U.S. Federal law restricts this device for sale or rental
by or on the order of a physician.
6
Purpose of the device
Your healthcare provider has prescribed Negative Pressure
Wound Therapy ( NPW T ) 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.
7
EN
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.
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 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
Drain adapter
Quick- connector
9
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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