Medela Invia Ease User manual

Invia®Ease
Negative Pressure Wound Therapy system
EN Clinician Instructions for Use

For Clinician Use Only
Please read all instructions before using this product.
Keep these instructions for future reference.
– Misuse or failure to follow the instructions in this manual may result in serious or fatal injury
to the patient.
– Clinician Instructions for Use are intended for healthcare professionals only.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
Medela Customer Service phone: [phone]

EN
Table of contents
1 Introduction ........................................................................................................................... 4
2 Intended use.......................................................................................................................... 4
3 Indications for use................................................................................................................. 5
4 Contraindications.................................................................................................................. 5
5 Safety information ................................................................................................................ 6
6 Invia Ease NPWT system and accessories........................................................................ 11
7 Initial pump setup: first time the pump is turned on........................................................ 18
8 Operating instructions........................................................................................................ 20
9 Access the Clinician menu.................................................................................................. 33
10 Change therapy settings .................................................................................................... 34
11 Change pump settings ....................................................................................................... 35
12 View therapy history........................................................................................................... 38
13 End therapy ......................................................................................................................... 39
14 Alarms and troubleshooting.............................................................................................. 40
15 Accessories setup ................................................................................................................ 44
16 Safety-related checks.......................................................................................................... 49
17 Maintenance and service................................................................................................... 49
18 Sterility requirements.......................................................................................................... 49
19 Cleaning, disinfection and storage ................................................................................... 50
20 Disposal ............................................................................................................................... 51
21 International Regulations................................................................................................... 52
22 Technical specifications ...................................................................................................... 57
23 Material ............................................................................................................................... 58
24 Warranty ............................................................................................................................. 58
25 Service life............................................................................................................................ 58
26 Meaning of symbols ........................................................................................................... 59
27 Ordering information......................................................................................................... 62

4 | Introduction/Intended use
1 Introduction
The Invia Ease NPWT system is designed to provide Negative Pressure Wound Therapy
(NPWT), to help promote wound healing. The Invia Ease system includes the Invia Ease
pump, an Invia Ease canister and tubing in a range of sizes (300ml, 500ml and 1000ml) and
an Invia Ease charger.
Invia Ease NPWT system is intended to be used in conjunction with the Invia dressings only.
2 Intended use
2.1 Intended user
– The Invia Ease NPWT system is intended to be used by clinicians or by adequately trained
lay users (patients or caregivers).
– Medical situations must be addressed by a physician. Therapy changes should only be
done as prescribed by a physician.
– To ensure safe use of the Invia Ease NPWT system, clinicians are responsible to train lay
users (patients and caregivers) according to the Patient Instructions for Use and explain
all related safety information.
2.2 Intended patient population
– The Invia Ease NPWT system is intended to be used only on patients exhibiting conditions
as described in the Indications for Use.
– Appropriate patient selection according to Indications for Use is important to prevent
complications and help ensure the efficacy and successful treatment with NPWT.
– The Invia Ease NPWT system has not been studied on pediatric patients.
– The lay user (patient or caregiver) must have the visual and hearing acuity to appropriately:
– respond to notifications displayed by the pump
– understand directions from a clinician
– follow the instructions provided in the Patient Instructions for Use
2.3 Intended use environment
The Invia Ease NPWT system is intended for use in acute, extended and home care settings.

EN
Indications for use/Contraindications | 5
The Invia Ease 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 preparing the wound bed for closure, reducing
edema, promoting granulation tissue formation and perfusion, and by removing exudates
and infectious material.
When used on closed surgical incisions, the Invia Ease NPWT system is also intended to
manage the environment of surgical incisions that continue to drain following sutured or
stapled closure by maintaining a closed environment and removing exudate via the
application of Negative Pressure Wound Therapy.
The Invia Ease 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
3 Indications for use
The Invia Ease NPWT system is contraindicated in the presence of:
– Necrotic tissue with eschar present
– Untreated osteomyelitis
– Non-enteric and unexplored fistulas
– Malignancy in the wound (with exception of palliative care to enhance quality of life)
– Exposed vasculature
– Exposed nerves
– Exposed anastomotic site of blood vessels or bypasses
– Exposed organs
4 Contraindications

6 | Safety information
5 Safety information
WARNING
Indicates a potentially hazardous situation that, if not avoided, could result in death
or serious injury.
CAUTION
Indicates a potentially hazardous situation that, if not avoided, could result in minor
or moderate injury.
NOTICE
Can lead to material damage (not related to personal injury).
INFORMATION
Useful or important information that is not related to safety.
i
1. Therapy interruption: The recommended application of the therapy with Invia Ease
NPWT system is 24 hours without interruption. If therapy is interrupted for more than
2 consecutive hours (120 minutes), the dressing should be changed and therapy
restarted by a clinician in order to avoid the risk of infection or sepsis.
2. Bleeding: Patient with an increased risk of bleeding complications must be closely
monitored and should be treated in the appropriate care settings (e.g. hospital).
If sudden or increased bleeding is observed, immediately stop the use of the pump,
apply pressure on wound dressing and seek immediate Emergency Medical Attention.
Patients with an increased risk for bleeding include:
– Patients who have been administered anticoagulants or platelet aggregation
inhibitors
– Patients with inadequate wound hemostasis
– Patients who are more likely to experience vascular anastomosis
– Patients with friable vessels, infected blood vessels or organs in or around the wound
as a result of but not limited to suturing of the blood vessels or organs, infection,
trauma, radiation.
3. Canister size: Do NOT use the 1000ml canister on patients with an increased risk of
bleeding complications or patients, who should not be permitted to lose a large
amount of fluid. Assess patient’s physical condition and wound type prior to choosing
the canister. The 1000ml canister is recommended for acute care (hospital) setting only.
4. Patient monitoring:
– A patient undergoing NPWT therapy requires frequent supervision. Signs of possible
infection or any complication must be addressed immediately.
5.1. WARNING
When using electrical products, especially when children are present, basic safety
precautions must always be followed.

EN
Safety information | 7
– Small adults and elderly patients as well as patients with highly exudating wounds
should be closely monitored for fluid loss and dehydration. When needed, fluid
output in the canister and tubing should be compensated accordingly to avoid excess
fluid loss and dehydration.
– Monitor the patient status and patient comfort level, the exudate collected in the
canister, the wound, and the surrounding skin frequently to ensure efficient and safe
treatment as well as patient comfort. Non-observance can cause pain, injury or lead
to considerable danger to the patient
– Y-Connector: The use of NPWT with single-lumen drain or with the curved arm
of the Invia Y-Connector may increase the risk of exudate accumulation, infection,
maceration, or loss of NPWT while blockage occurs in the vacuum system.
These conditions may only be detected by frequent monitoring and may require
more frequent dressing changes.
5. Wound assessment: Observe wound/periwound tissue and exudate for signs of
infection or other complications. Most common signs of infection include redness,
tenderness, swelling, pain, itching, increased warmth in the wound area, strong odor
or purulent discharge. Additional symptoms to be noted in patient include nausea,
vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the
mucous membranes, disorientation, high fever (>102°F, >38.8°C), refractory hypo-
tension, orthostatic hypotension, or erythroedema (a sunburn like rash).
More serious complications include infection gangrene, toxic or septic shock.
If more serious complications of infection occur, discontinue therapy and consult a
physician immediately.
6. Osteomyelitis: Do NOT use Invia Ease NPWT system on wounds with untreated
osteomyelitis. In the presence of osteomyelitis, thoroughly debride all necrotic or
infected bone tissue and start systemic antibiotic therapy prior to initiating NPWT.
7. Autonomic hyperreflexia/spinal cord injury: Special care is required when NPWT is
used near vagus nerve (bradycardia) or on patients with a history of spinal cord injury
(stimulation of sympathetic nervous system). Should a patient with a spinal cord injury
experience autonomic hyperreflexia in response to stimulation of the sympathetic
nervous system (characterized by a sudden elevation in blood pressure and one of the
following signs/symptoms: bradycardia, headache, flushing, and/or profuse sweating
above the lesion level), discontinue treatment with the Invia Ease NPWT system and
consult a physician immediately.
8. Defibrillation: In the event that defibrillation is required, clamp the tubings and
disconnect the Invia Ease pump from the wound dressing before the patient is
defibrillated.
9. Hyperbaric Oxygen Therapy (HBOT): Do not take the pump into the hyperbaric
oxygen chamber (HBO). When going into the hyperbaric oxygen chamber, clamp the
canister tubing and disconnect the Invia Ease pump prior to patient entering the
hyperbaric oxygen chamber. Note: Do not clamp the dressing tubing and protect the
end of the dressing tubing at the Quick-Connector.
10.Magnetic Resonance Imaging (MRI): The Invia Ease pump is Magnetic Resonance
unsafe. Do not take the Invia Ease pump into MRI environment. When going into MR
environment, clamp the canister tubing and disconnect the Invia Ease pump prior to
patient entering the MR environment. Note: Do not clamp the dressing tubing and
protect the end of the dressing tubing at the Quick-Connector.
11. Risk of fire, electric shock, or serious burns:
– Due to the fire hazard the Invia Ease pump is not for use in potentially explosive
environments including oxygen enriched environments and in areas of flammable
anesthetics.
– Only use the charger that comes with the pump. An inadequate power source may
result in a fire hazard, electric shock or malfunction of the pump.

8 | Safety information
– Prior to charging, always inspect the charger and the cord for damage. If damage
is found, immediately disconnect the charger and call the Medela Customer Service
or the system provider.
– Never operate the pump if it is not working properly, if it has been damaged
or dropped into water.
– Do not take the pump into a bathtub or shower.
– Never place or drop the pump into water or other liquids.
– If the pump has been exposed to water or other liquids, do not touch it. Disconnect
the pump from electrical outlet port, turn the pump off and contact the manufacturer.
– This pump contains lithium-ion batteries, which bears risk of fire, explosion and
burns.
– Do not disassemble, crash, or heat the Invia Ease pump above 212°F (100 °C ),
do not incinerate or dispose of in fire.
12. System modification: Do not modify the Invia Ease pump or any of the system
components without authorization from the manufacturer.
13. Magnet: The Invia Ease pump contains a magnet, which may interfere with other
medical devices. Keep a distance of 00xx between the pump and other medical
devices
14. Sterile products: Do not use the sterile products if the sterile packaging is damaged,
was opened prior to use or has expired.
15. Dressing application:
– For detailed dressing application information, indications, contraindications,
warnings and precautions consult the appropriate Invia dressing Instructions for Use.
– Wound dressing to be applied and changed by clinicians only.
– Perform a thorough wound cleansing per physician’s orders or facility protocol prior
to performing a dressing application.
– Always count the number of dressing filler pieces used in the wound and document
that number on the Transparent Film and in the patient’s chart. Make sure all pieces
are removed when a dressing is changed.
– Document the dressing change date on the Transparent Film and in the patient’s
chart.
– Sharp edges/bone fragments must be eliminated from the wound area or covered
to prevent puncturing blood vessels or organs.
– Do not place dressing filler into blind and/or unexplored tunnels.
– Do not force dressing fillers into any area of the wound, as this may damage tissue,
alter the delivery of negative pressure, or hinder exudate and dressing filler removal.
– Do not place the dressing filler directly on exposed blood vessels, organs, nerves,
tendons, bones or ligaments. When using the Invia Ease NPWT system in close
proximity to these structures, a protective barrier such as a non-adherent wound
contact layer must be used.
– Avoid circumferential dressing application.
– Consider the use of a protective barrier on skin that may come in contact with the
tubing, especially in patients with fragile skin.
– When treating infected wounds or wounds more susceptible to tissue in-growth into
wound filler material, more frequent dressing changes or a non-adherent wound
contact layer may be needed. The frequency of dressing changes should be based
on an evaluation of the wound characteristics rather than standard recommendations.
– For closed surgical incision the recommended pressure level is –125mmHg at
constant mode.

EN
Safety information | 9
1. Incorrect use of the Invia Ease NPWT system may cause pain or injury to the patient.
2. Routinely check that therapy is running and that the negative pressure level and therapy
mode are at the prescribed setting.
3. The patient should be monitored regularly according to the physician instructions and
facility guidelines. Monitor patient comfort, signs of wound infection, integrity of the
dressing, volume of fluid in the canister and therapy compliance.
4. Wounds that involve a fistula may require special care.
5. Excessive negative pressure, a too tight adhesive film dressing, or an infection of the
wound may cause pain to the patient. In each case, the dressing must be removed and
the wound assessed.
6. Constant versus intermittent pressure: use continuous pressure over unstable structures
(such as unstable chest wall or non-intact fascia) in order to help minimize movement
and stabilize the wound bed. Continuous pressure is also recommended for patients
with increased risk of bleeding, flaps and grafts, highly exudating wounds and when
used on closed surgical incisions.
7. Infection control: To reduce the risk of cross contamination, apply universal precautions
for infection control per institutional protocol. Use gloves and other protective equip-
ment if exposure to body fluids is likely.
8. Protect the canister tubing from coming in direct contact with the wound area.
5.2 CAUTION

10 | Safety information
1. Only use products specified in these Instructions for Use.
2. Do not modify the Invia Ease pump or any of the system components without authoriza-
tion from the manufacturer.
3. The Invia Ease pump is verified within the scope of conformity evaluation and is only to be
used with products included in the Invia Ease NPWT system and distributed by Medela.
Medela can only guarantee the effective performance of the system with these products.
4. Before you plug in the Invia Ease pump, please check that your local power supply is the
same as the voltage given on the specification type plate located at the base of the pump.
5. 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 Ease pump and should be kept at a minimum distance of 1 foot (30cm) away
from the Invia Ease pump.
6. Supervision is necessary when the Invia Ease pump is used in the vicinity of children.
7. Do not use the Invia Ease pump if:
– The power cord or charger are damaged
– The pump is damaged
– The pump is not functioning properly
– The pump has apparent safety defects
8. Do not use the Invia Ease products if they are damaged.
9. Never pull the plug out of the main socket by pulling on the connecting cord.
10.Keep the Invia Ease pump and the associated products away from hot surfaces.
11. Never place the Invia Ease pump or charger in water or other liquids and keep the
charger connector away from moisture or immersion in water.
12.The Invia Ease pump must not be used for suctioning explosive, easily flammable or
corrosive liquids.
5.3 Safety measures
5.4 Physician’s orders
A physician must assess each wound when applying this therapy and determine
an appropriate negative pressure setting according to the wound characteristics.
Changes to the therapy should only be done as prescribed by a physician.

EN
Invia Ease NPWT system and accessories | 11
6 Invia Ease NPWT system and accessories
Carrying case
Y-Connector with
Quick-Connector
Charger
Handle
IV pole/bed holder
Canister and tubing 300 ml, 500ml and 1000ml
with Quick-Connector
Pump
For ordering information refer to chapter 26.

12 | Invia Ease NPWT system and accessories
6.1 Invia Ease pump
Mute button
Touch screen
On/Off button
Light indicator
Charging port
Therapy mode Default setting Pressure range
Constant –125 mmHg –40 to –200mmHg
Intermittent –125mmHg for 5min /
–40 mmHg for 2 min
High values: –40 to –200mmHg
Low values: 0 to –175 mmHg
6.2 Light indicator status
Green Therapy is running
Yellow – Therapy is paused
– Alarm state
i
For instructions, refer to chapter “Alarms and troubleshooting”
on page 41.
The Invia Ease pump is a reusable suction pump that provides adjustable negative pressure,
constant and intermittent therapy modes, and an electronic measuring and monitoring
system. The Invia Ease pump is compact, portable and includes a long-lasting rechargeable
battery. The light indicator conveniently shows the therapy status and is easily visible from
a distance. The user-friendly touch screen guides the user through troubleshooting steps to
help resolve audio and visual alarms as well as provides instructions on how to change a
canister and to detach the patient from the pump. The complete history file can be accessed
via the touch screen throughout the therapy. The pump dynamically regulates the air flushing
cycles to help prevent clogging of the tubing.

EN
Invia Ease NPWT system and accessories | 13
Main screen
Open instructions
Battery status
Air leak indicator:
Low/Medium/High
Therapy running status:
moving waves
Therapy setting
Clinician menu
Exit Clinician menu
Change therapy and pump
settings
End current therapy
View therapy history
Pause screen Pause therapy timer
Log dressing change
Therapy restarts running/Return to Main screen
Access Clinician menuAccess Clinician menu
Motor stops running/Therapy is paused
6.3 Touch screen navigation

14 | Invia Ease NPWT system and accessories
– Canister release button disconnects the canister from the pump with one touch
– Control lumen (smaller tubing) regulates the pressure between the pump and the wound site
– Removal lumen (larger tubing) removes the fluid from the wound into the canister
– Graduation scale shows the amount of fluid in the canister
– Clamp closes the tubing to prevent fluid from spilling out
– Quick-Connector securely attaches canister tubing to the dressing tubing
– Overflow protection/carbon bacteria filter automatically clogs when it comes in contact
with fluids to prevent any fluids from entering the pump
– Solidifier is activated when exposed to fluids
6.4 Invia Ease canister and tubing
Canister release button
Overflow protection/Carbon bacteria filter
Removal lumen
Control lumen
Graduation scale
Quick-Connector
to dressing tubing
Clamp
Canister release button
NOTICE
Select the appropriate canister size depending on the wound type.
Canister sizes: 300ml, 500ml and 1000ml
Tubing length: 1.5m
Tubing inner diameter: 2.0mm/3.0mm

EN
Invia Ease NPWT system and accessories | 15
•Only use the charger that comes with the pump. An inadequate power source may result
in a fire hazard, electric shock or malfunction of the pump.
•Prior to connecting the charger, always inspect the charger and the cord for damage.
If damage is found, immediately disconnect the charger and call the Medela Customer
Service or the system provider.
WARNING
6.5 Invia Ease charger
The pump operates when the pump battery is sufficiently
charged or when the pump is connected to an electrical
outlet port via the charger provided with the pump.

16 | Invia Ease NPWT system and accessories
6.6 Accessories
Invia Y-Connector with Quick-Connector
Invia Y-Connector with Quick-Connector is intended to
connect two dressing tubings to a single Invia Ease pump.
Invia Ease carrying case
The carrying case is designed to more conveniently carry
around a pump, which does not include a handle. The
carrying case is compatible with the 300ml and 500ml
canisters and includes a removable shoulder strap for
easier transport. Canister exchange and battery charging
can be done while the pump is in the carrying case. The
outer pocket of the carrying case should be used to store
the quick reference card.
Invia Ease handle
The Invia Ease pump is designed with an option to attach
a handle to the pump to more conveniently carry around
the pump. The handle should be affixed to the pump via
two screws, which are supplied with the handle.
Invia Ease IV pole/bed holder
The IV pole/bed holder is designed to be used with the
Invia Ease pumps, which include a handle. The IV pole/bed
holder allows for easy attachment and removal of the
pump to the IV pole or the bed board.
NOTICE
For warnings and cautions of the Invia Y-Connector
with Quick-Connector consult the Invia Y-Connector
with Quick-Connector Instructions for Use.
NOTICE
The carrying case is for a single patient use only.

EN
Invia Ease NPWT system and accessories | 17
Pump feet
Handle attachment covers
Filter gasket with orange O-ring
6.7 Spare parts
For ordering information refer to chapter 26.

18 | Initial pump setup: first time the pump is turned on
7 Initial pump setup:
first time the pump is turned on
To carry out the initial pump setup:
Never operate the pump if it is not working properly, if it has been damaged or dropped
into water. If damage is found, immediately disconnect the charger and call the Medela
Customer Service or the system provider.
WARNING
Turn on the pump by pressing the “On/Off” button
The light indicator will illuminate yellow and the start-up
screen will appear.
Click to begin the initial setup.
NOTICE
Medela recommends to fully charge the pump battery before its first use.
INFORMATION
For instructions, refer to chapter “Battery status and charging” on page 20.
i

EN
Initial pump setup: first time the pump is turned on | 19
Select the preferred language from the list.
Click to continue.
Program the date and time:
– Choose between / or format
– To set date (day, month, year) and time (hours, minutes)
press or
Click to continue.
The Invia Ease pump setup is now complete.
To proceed either:
Turn pump off
Turn the pump off by clicking
Start therapy
Start a new therapy by clicking
Select the method to access the Clinician menu. This prevents patients from changing any
settings. Choose between a Disclaimer or a Code.
Click to continue.
Disclaimer
Access the clinician menu with a
swipe.
Code
Access the Clinician Menu by entering a code:
– The default code is programmed as 1111.
– To set an additional code refer to chapter “Pump
settings/Clinician menu access” on page 36.
OR

20 | Operating instructions
8 Operating instructions
Never operate the pump if it is not working properly, if it has been damaged or dropped
into water. If damage is found, contact the Medela Customer Service or the system
provider.
WARNING
The Invia Ease NPWT system is intended to be used by clinicians or by adequately trained
lay users (patients or caregivers).
8.1 Pump positioning
•This product contains lithium-ion batteries, which bear risk of fire, explosion and burns.
•Only use the charger that comes with the pump. An inadequate power source may result
in a fire hazard, electric shock or malfunction of the pump.
•Prior to charging, always inspect the charger and the cord for damage. If damage is
found, immediately disconnect the charger and call the Medela Customer Service or
the system provider.
WARNING
8.2 Battery status and charging
NOTICE
•Medela recommends continuous charging while the pump is running overnight to ensure a
full charge.
•If the pump is not being used, the battery must be charged approximately once every
6 months to ensure optimum function.
✓
– The Invia Ease pump should remain in an upright position or can be placed on its front or
its back during use.
– If the Invia Ease pump is placed in an inappropriate position (upside-down or on its side),
it will lead to the “Pump in the wrong position” alarm.
– If the canister filter becomes clogged because the pump is in an inappropriate position
for too long, it will lead to the “Canister full” alarm. The canister must then be replaced.
iFor troubleshooting instructions refer to chapter “Alarms and troubleshooting/Pump in
the wrong position” on page
42.
iFor troubleshooting instructions refer to chapter “Alarms and troubleshooting/Canister
full” on page
44.