Medela Invia Motion 087.4000 User manual

EN Clinician Instructions for Use
ES Instrucciones para uso clínico
NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Invia®Motion™

3
EN
Table of Contents
Introduction ........................................................................................................................................................................................................................ 4
Overview .............................................................................................................................................................................................................................. 5
Intended Use .................................................................................................................................................................................................................... 7
Indications for Use ....................................................................................................................................................................................................... 7
Contraindications ......................................................................................................................................................................................................... 8
Warnings and Safety Instructions .................................................................................................................................................................. 9
Warnings ........................................................................................................................................................................................................................... 10
Cautions .............................................................................................................................................................................................................................11
Physicians Orders ......................................................................................................................................................................................................11
Wound Assessment ................................................................................................................................................................................................ 12
Dressing Technique ................................................................................................................................................................................................. 12
Initial Delivery ................................................................................................................................................................................................................ 13
Invia Motion Disposables ................................................................................................................................................................................... 14
Initial Set-up ................................................................................................................................................................................................................... 15
Charge Battery for the first time ................................................................................................................................................................... 15
Disconnect from Power Source ................................................................................................................................................................... 16
Functions .......................................................................................................................................................................................................................... 17
Preparation for Use .................................................................................................................................................................................................. 18
Operating Instructions ........................................................................................................................................................................................... 21
Power Supply and Battery Management .............................................................................................................................................23
Notifications and Troubleshooting ..............................................................................................................................................................25
Overview Notifications ..........................................................................................................................................................................................28
Cleaning and Sterilization ...................................................................................................................................................................................29
Disposal .............................................................................................................................................................................................................................30
Warranty and Maintenance .............................................................................................................................................................................. 31
Accessories ....................................................................................................................................................................................................................32
Technical Data .............................................................................................................................................................................................................33
Signs and Symbols .................................................................................................................................................................................................. 70
Technical Specifications ...................................................................................................................................................................................... 72
Federal law restricts this device to sale by or on the order of a physician.
EN Instructions for Use 3
ES Instrucciones de uso 35

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Introduction
The Invia Motion Negative Pressure Wound Therapy System, subsequently named "Invia Motion
NPWT System", is approved exclusively for the use described in these Instructions for Use.
Please read the information contained within these Instructions for Use before operation
of the Invia Motion NPWT System. These Instructions for Use must be kept with the device.
These Instructions for Use are a general guide for the use of the product. Medical situations
must be addressed by a physician.
Indications, Contraindications, Warnings, Cautions and other information to support the safe
use of the Invia Motion NPWT System are included on pages 7 –11 of these Instructions for
Use.
The Invia Motion NPWT Pump is a suction pump for Negative Pressure Wound Therapy that
provides treatment status through a display and acoustic signals. The Invia Motion NPWT Pump
is a single patient use pump which provides continuous or intermittent operation, multiple
negative pressure selection options and a lifetime of 60 days. The Invia Motion NPWT Pump is
portable and can be operated using a rechargeable battery. Acoustic and optical signals are
triggered for variances from the set values as well as for faults. The Invia Motion NPWT system
is intended for use in all healthcare settings, including home care, by healthcare personnel and
caregivers trained on the Instructions for Use. The patient or caregiver must have the visual and
hearing acuity necessary to appropriately respond to notifications with the sensory and cogni-
tive ability to understand directions from a healthcare professional pertaining to the proper use
of the pump.

5
EN
Overview
The Invia Motion NPWT System and the Invia Motion Carrying Case are for single patient
use only.
Buttons to Operate the Invia Motion NPWT Pump
Backlight
The backlight will be activated by pressing any button. The backlight will turn off after
10 seconds if no further interaction results.
Leakage Canister Full
Battery Status Info Used
Pump Time
Pump Is Running/
On-State In
Intermittent Mode
Off-State In
Intermittent
Mode
Display Information
Change Pressure
setting
Constant/
Intermittent Mode
On/Off
Mute Acoustic Signal/
Info Used Pump Time

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Notifications
Leakage
Canister full
Battery full
Battery charge condition
Battery low (symbol is blinking)
Battery empty
Battery charging (bars moving)
Information
Shows lifetime already used in days ( ) and hours ( )
Pump is running / On-state in intermittent mode
Off-state in intermittent mode
Constant mode
Intermittent mode
Negative pressure setting in mmHg
Symbols on Display

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EN
The portable Medela Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated
to create 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. It is intended for
use in hospitals, clinics, Long Term Care (LTC) and Home Care (HC) settings on adult patients with
chronic, acute, subacute, traumatic, dehisced wounds, partial-thickness burns, ulcers (such as
diabetic, neuropathic, pressure or venous insufficiency), flaps and grafts.
Indications for Use
The Invia Motion NPWT System is indicated for the use with the following types of wounds:
– Diabetic/Neuropathic ulcers
– Pressure or venous insufficiency ulcers
– Chronic wounds
– Traumatic wounds
– Acute or subacute wounds
– Dehisced wounds
– Partial thickness burns
– Flaps and Grafts
Intended User
The Invia Motion NPWT System is intended to be used by healthcare professionals or
adequately trained lay users.
Healthcare professionals are responsible to train lay users according to the Patients Instructions
for Use and explain all related safety information.
Intended Patient Population
The Invia Motion NPWT System is intended to be used on adult patients only exhibiting
conditions as described in the Indications for Use.
Intended Use

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Contraindications
The Invia Motion NPWT System is contraindicated in the presence of:
– Malignancy in the wound
– Untreated osteomyelitis
– Non-enteric and unexplored fistulas
– Necrotic tissue with eschar present
– Exposed vasculature
– Exposed nerves
– Exposed anastomotic site of blood vessels or bypasses
– Exposed organs

9
EN
Warnings and Safety Instructions
WARNINGS 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.
Safety Related Tip Indicating useful information about the safe use of
the device.
The Invia Motion Negative Pressure Wound Therapy System (subsequently named Invia Motion
NPWT System) is intended for use as described in these Instructions for Use.
Medela is only responsible for the effect on BASIC SAFETY, reliability and performance of the
Invia Motion NPWT System if it is used in accordance with the Instructions for Use.
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.

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WARNINGS
– Do not modify this equipment without authorization from the manufacturer.
– Consult the Indications For Use, Contraindications, Warnings and Cautions before
using the Invia Motion NPWT Pump as a negative pressure source with the Invia
Wound Dressing or Avance Dressing Kits. Failure to read and follow all instructions in
this manual prior to use may result in serious or fatal injury of the patient.
– Invia Wound Therapy Instructions advise 24 hours therapy without interruption.
If therapy is discontinued for more than 2 hours using foam or 24 hours using gauze,
the dressing should be replaced and therapy restarted by a healthcare professional.
– Unplug the pump before cleaning.
– Do not use accessories other than those specified or sold by the manufacturer as
replacement parts for internal components as it may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the Invia Motion
NPWT Pump.
– The Invia Motion NPWT System should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Invia Motion NPWT System
should be observed to verify normal operation in the configuration in which it will be
used.
– The Invia Motion NPWT Pump is intended for “Single Patient Use Only”. Reuse on
another patient might cause cross contamination.
– Patients must be closely monitored for bleeding. If sudden or increased bleeding is
observed, immediately stop use of the pump, apply pressure and seek immediate
emergency medical attention.
– Objective indications or signs of a possible infection or complication must be
addressed immediately (e.g. fever, pain, redness, increased warmth, swelling or
purulent discharge). Non-observance can lead to considerable danger to the patient.
– When using the Invia Motion NPWT System in close proximity to blood vessels,
organs, nerves, tendons or ligaments a protective barrier, such as a non-adherent
contact layer, must be used.
– Serious or fatal injury can result from bone fragments or sharp edges (e.g. staples or
hardware) that could puncture protective barriers, vessels or organs.
– Patients with spinal cord injuries (stimulation of sympathetic nervous system) who
experience Autonomic Hyperreflexia during therapy should have NPWT discontinued.
– In the event that defibrillation is required, disconnect the pump from the wound
dressing before the patient is defibrillated.
– Special care is advised for dressing placement and removal in order to avoid situations
such as unintentional gauze or foam retention.
– This device has not been studied in pediatric patients.
– Do not bring the device into the following areas: Positron Emission Tomography (PET)
or Hyperbaric Oxygen Chamber (HBO).
– The Invia Motion NPWT System is Magnetic Resonance (MR) Unsafe. Do not take the
Invia Motion NPWT System into the MR environment.
Warnings

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EN
CAUTIONS
– Incorrect use may cause pain and injury to the patient. Excessive negative pressure or
an infection of the wound may cause pain to the patient. In either case, the dressing
must be changed and the wound inspected in detail.
– The patient should be monitored regularly according to physician instructions and
facility guidelines to monitor patient comfort, therapy compliance and signs of wound
infection.
– Do not use an Invia Motion Canister/Tubing Set if the sterile packaging is damaged.
– The use of mobile telephones, local area networks (LAN) including wireless (WLAN),
walkie-talkies (two-way radios) and cordless telephones may affect the Invia Motion
NPWT Pump. A safe distance of 3.3 feet (1m) from the Invia Motion NPWT Pump to
the device is recommended.
– The Invia Motion NPWT Pump must remain in an upright (carrying case) or lying
(display side up) position during use.
The following statements describe medical conditions that may require special care for
the safe and effective use of the Invia Motion NPWT System.
– Patients at high risk for bleeding and hemorrhage, including patients experiencing
active bleeding or difficult wound hemostasis.
– Patients taking anticoagulants or platelet aggregation inhibitors.
– Patients with a history of vascular anastomosis or friable, irradiated, sutured or
infected blood vessels.
– Patients with infected wound or osteomyelitis.
– Wounds that involve an enteric fistula.
– Use near vagus nerve (bradycardia).
– Circumferential dressing application.
– The Negative Pressure Wound Therapy must be used 24 hours per day without
interruption. If the pump is stopped for more than the time frames shown below, the
dressing must be changed and therapy restarted.
Gauze dressing: Change dressing if the pump has stopped for more than 24 hours.
Foam dressing: Change dressing if the pump has stopped for more than 2 hours.
– Consider the patient's size and weight when prescribing this device.
– Consider mode of therapy – intermittent versus continuous.
Physicians Orders
A medical professional must assess each wound when applying this therapy and determining
negative pressure intensity according to the wound characteristics. Therapy or setting changes
may only be done under the order of a physician.
Cautions

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Wound Assessment
CAUTION
Patient Monitoring: The patient should be monitored regularly according to the
physician's instructions and facility guidelines to check for patient comfort, therapy
compliance and signs of infection.
WARNING
Objective indications or signs of a possible infection or complication must be addressed
immediately (e.g. fever, pain, redness, increased warmth, swelling or purulent discharge).
Non-observance can lead to considerable danger to the patient.
Observe the wound/periwound tissue and exudate for signs of infection or other complications.
The most common signs of infection include redness, tenderness, fever, swelling, itching,
increased warmth in the wound area, strong odor or purulent discharge. Additional symptoms
include nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the
mucous membranes, disorientation, high fever (>102° F, 38.8° C), refractory hypotension,
orthostatic hypotension, or erythroedema (a sunburn-like rash). More serious complications
of infection include pain, discomfort, fever, gangrene, toxic or septic shock. If more serious
complications of infection occur, discontinue therapy and consult a healthcare professional
immediately.
Dressing Technique
Consult the appropriate Invia Wound Dressing or Avance Dressing Kit Instructions for Use for
information regarding dressing applications. Perform a thorough wound cleansing per physician
orders prior to dressing applications.
Routine dressing changes should occur every 48 –72 hours. Dressing changes for infected
wounds should be considered more frequently.

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EN
Initial Delivery
Upon delivery, check the package containing the Invia Motion NPWT System for completeness and
general condition.
087.4000 Invia Motion Negative Pressure Wound Therapy System
200.4205 1 Invia Motion NPWT Pump
087.4001 1 Invia Motion Canister/Tubing Set 0.15 l (sterile, single use)
200.4212 1 Invia Motion Power Supply
087.4003 1 Invia Motion Carrying Case
200.4168 1 Invia Motion Negative Pressure Wound Therapy System Clinician
Instructions for Use
200.4169 1 Invia Motion Negative Pressure Wound Therapy System Patient
Instructions for Use
When first turned on, the Invia Motion pump needs to be attached to a wall outlet in order
to fully charge the battery.

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Invia Motion Disposables
Invia Motion Canister/Tubing Set 0.15l (150 ml), with Solidifier (Sterile, Single Use)
Capacity: 0.15 l (150 ml)
Material: Polypropylene, Silicon
Sterilization Method: Ethylene Oxide
Intended Use
The Medela Invia Motion Canister/Tubing Set 0.15 l (150 ml) is an accessory of the Medela Invia
Motion NPWT System and it is intended to collect removed wound exudate and infectious mate-
rial.
Overflow Protection/
Bacteria Filter
Solidifier
Fluid Chamber
Invia Motion Connector (Interface to
Wound Dressing Kit)

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EN
Initial Set-up
Attach the US Plug to the Invia Motion Power Supply
Charge Battery for the rst time
Plug the Invia Motion Power Supply into a wall outlet and open the small protective cover of the
pump for the Direct Current (DC) socket and attach the power supply. Moving bars on the battery
display will indicate charging is occurring. [ ].
Check the charging state of the battery periodically.
1. Battery empty 2. Battery is being charged 3. Battery is fully charged
(moving bars)

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Disconnect from Power Source
➔
➔
Disconnecting the Power Source
When the battery is fully charged (after approximately 4 hours) the following non-blinking symbol
will appear on the display . To disconnect the Invia Motion NPWT Pump from the
electrical source, hold the end of the plug and remove it from the pump.
Close the DC socket by pressing the small protective cover over the opening.

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EN
Pressure Regulation
The pressure is checked periodically by the Invia Motion NPWT Pump and maintained according
to the settings entered by a healthcare professional.
Canister Safety Chamber
CAUTION
The Invia Motion NPWT Pump must remain in an upright (carrying case) or lying
(display side up) position during use.
The Invia Motion NPWT Pump is protected against the penetration from solid/fluid substances
by a hydrophilic bacteria filter. If this filter fails, the Invia Motion NPWT Pump must be replaced.
In the event of inappropriate positioning of the pump, the special construction of the safety
chamber in the upper region of the canister protects the hydrophilic filter from premature
clogging to maintain the pressure.
If the canister is full and the Invia Motion NPWT Pump is placed in an inappropriate position,
fluids will flow into the safety chamber and clog up the hydrophilic overflow protection/bacteria
filter. In this situation, the pressure is interrupted and an acoustic information signal will sound.
The Invia Motion Canister/Tubing Set must be replaced.
O
O
P
P
Functions

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Preparation for Use
To be used by healthcare professionals or adequately trained caregivers only.
Checklist
Prior to using the Invia Motion NPWT System, it is important to check for the following:
– Completeness and general condition of the packaging
– Damage to the power cord and plug
– Damage to the pump
– Proper functioning of the device
– Battery status
1. Open sterile packaging.
CAUTION
Do not use the Invia Motion Canister/Tubing Set if
the sterile packaging is damaged.
2. Insert the Invia Motion Canister/Tubing Set into the Invia Motion
NPWT Pump connecting port.
3. Rotate the Canister/Tubing Set to the right to secure.
4. Connect the Invia Motion Tubing Connector to the wound drain
tubing or the tubing of the External Suction Interface (ESI).
For dressing applications, please refer to the Instructions for Use
provided with the Invia and Avance Dressing Kits.
minimum
maximum

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EN
Switch Invia Motion NPWT Pump On
1. Press [ ] to switch the Invia Motion NPWT Pump on.
2. When turned on for the first time, the Invia Motion NPWT Pump will start up in the default factory setting
(constant mode with pressure level of -125mmHg).
If the Invia Motion NPWT Pump is turned off, the setting will be as previously set when the pump is
turned back on.
Lifetime, Countdown and Safety Time
The Invia Motion NPWT Pump has a lifetime of 60 days. After one hour of use, the countdown of 60 days
is activated and will continue even when the pump is turned off. During the first hour of use, the Invia
Motion Pump can be turned on and off without starting the countdown.
After 60 days, a blinking symbol on the display [ ] will indicate the expiration of the Invia Motion NPWT
Pump.
The Invia Motion NPWT Pump provides an additional safety usage time of 72 hours. During this
time the device can be operated as usual. An acoustic signal will occur after 72 hours and the
negative pressure will be maintained for one hour. The acoustic signal cannot be muted and the
pump will shut down automatically after one hour unless it is turned off earlier. Once turned off, the
Invia Motion Pump cannot be turned on again and has to be disposed of according to local
regulations.
Change Pressure
Setting On/Off
Constant/
Intermittent Mode Mute Acoustic Signal/
Info Used Pump Time
Change Pressure
Setting On/Off
Constant/
Intermittent Mode Mute Acoustic Signal/
Info Used Pump Time
Change Pressure
Setting On/Off
Constant/
Intermittent Mode
Mute Acoustic Signal/
Info Used Pump Time

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Setup Carrying Case
The Invia Motion NPWT Pump is intended to be worn in a carrying case during operation. An Invia
Motion Carrying Case is provided with the Invia Motion NPWT Pump.
Attach shoulder/belt strap onto the carrying case as a first step.
1. Open the carrying case.
2. Slide the Invia Motion NPWT Pump into the designated upper pocket and close the Velcro strap.
3. Place the excess tubing into the designated lower pocket and close the Velcro strap.
4. Fold the pump and tubing sections of the carrying case together and align the inner Velcro tabs
to secure.
5. Secure the bag by closing the lid and fastening the button.
The carrying case strap can be worn over the shoulder or around the waist.
To wear over the shoulder, attach the strap clips to the carrying case. To wear as a belt, thread the
strap through the two loops located on the back of the case.
Shoulder strap Belt strap