FCC ID: 2ATCR608283 The Invia Ease pump is a suction pump designed to help promote wound healing through Negative Pressure Wound Therapy.

 

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: 1-800-435-8316

Table of contents

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2

Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3

4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Invia Ease NPWT system and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

6

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

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 (300 ml, 500 ml and 1000 ml) 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

– Medical situations must be addressed by a physician. Therapy changes should only be

lay users (patients or caregivers).

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.

4 | Introduction/Intended use

3 Indications for use

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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

4 Contraindications

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

Indications for use/Contraindications | 5

5 Safety information

Indicates a potentially hazardous situation that, if not avoided, could result in death

or serious injury.

Indicates a potentially hazardous situation that, if not avoided, could result in minor

or moderate injury.

WARNING

CAUTION

NOTICE

Can lead to material damage (not related to personal injury).

i

INFORMATION

Useful or important information that is not related to safety.

When using electrical products, especially when children are present, basic safety

precautions must always be followed.

WARNING

5.1.

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 1000 ml 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 1000 ml 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.

6 | Safety information

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– 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.

Safety information | 7

 – 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 00 xx 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 –125 mmHg at

constant mode.

8 | Safety information

 CAUTION

5.2

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

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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.

Safety information | 9

5.3 Safety measures

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 (30 cm) 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.

5.4 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.

10 | Safety information

6 Invia Ease NPWT system and accessories

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For ordering information refer to chapter 26.

Canister and tubing 300 ml, 500 ml and 1000 ml

with Quick-Connector

Handle

IV pole/bed holder

Pump

Charger

Y-Connector with

Quick-Connector

Carrying case

Invia Ease NPWT system and accessories | 11

6.1 Invia Ease pump

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.

Therapy mode

Default setting

Pressure range

Constant

–125 mmHg

–40 to –200 mmHg

Intermittent

–125 mmHg for 5 min /

–40 mmHg for 2 min

High values: –40 to –200 mmHg

Low values: 0 to –175 mmHg

Touch screen

Mute button

On/Off button

Light indicator

Charging port

6.2 Light indicator status

Therapy is running

Green

Yellow

– Therapy is paused

– Alarm state

i For instructions, refer to chapter “Alarms and troubleshooting”

on page 41.

12 | Invia Ease NPWT system and accessories

6.3 Touch screen navigation

Main screen

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Motor stops running / Therapy is paused

Pause screen

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Clinician menu

Therapy setting

Battery status

Air leak indicator:

Low/Medium/High

Therapy running status:

moving waves

Pause therapy timer

Open instructions

Log dressing change

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Exit Clinician menu

View therapy history

Change therapy and pump

settings

End current therapy

Invia Ease NPWT system and accessories | 13

6.4 Invia Ease canister and tubing

NOTICE

Select the appropriate canister size depending on the wound type.

Canister sizes:

Tubing length:

Tubing inner diameter:

300 ml, 500 ml and 1000 ml

1.5 m

2.0 mm/3.0 mm

Canister release button

Control lumen

Removal lumen

Graduation scale

Clamp

Quick-Connector

to dressing tubing

Canister release button

Overflow protection/Carbon bacteria filter

– 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

14 | Invia Ease NPWT system and accessories

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6.5 Invia Ease charger

WARNING

• 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.

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.

Invia Ease NPWT system and accessories | 15

6.6 Accessories

Invia Y-Connector with Quick-Connector

Invia Ease carrying case

Invia Ease handle

NOTICE

For warnings and cautions of the Invia Y-Connector

with Quick-Connector consult the Invia Y-Connector

with Quick-Connector Instructions for Use.

Invia Y-Connector with Quick-Connector is intended to

connect two dressing tubings to a single Invia Ease pump.

NOTICE

The carrying case is for a single patient use only.

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 300 ml and 500 ml

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.

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.

16 | Invia Ease NPWT system and accessories

6.7 Spare parts

For ordering information refer to chapter 26.

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Filter gasket with orange O-ring

Handle attachment covers

Pump feet

Invia Ease NPWT system and accessories | 17

7 Initial pump setup:

first time the pump is turned on

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

NOTICE

Medela recommends to fully charge the pump battery before its first use.

i

INFORMATION

For instructions, refer to chapter “Battery status and charging” on page 20.

To carry out the initial pump setup:

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.

18 | Initial pump setup: first time the pump is turned on

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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.

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

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

Initial pump setup: first time the pump is turned on | 19

8 Operating instructions

WARNING

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.

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

its back during use.

– The Invia Ease pump should remain in an upright position or can be placed on its front or

– 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.

i

For troubleshooting instructions refer to chapter “Alarms and troubleshooting/Pump in

the wrong position” on page 42.

– 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/Canister

full” on page 44.

✓

8.2 Battery status and charging

WARNING

• 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.

NOTICE

full charge.

• Medela recommends continuous charging while the pump is running overnight to ensure a

• If the pump is not being used, the battery must be charged approximately once every

6 months to ensure optimum function.

20 | Operating instructions

The battery level (as a percentage of fully charged) and the battery symbol are displayed

at the top of the touch screen:

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Battery status/battery level and

symbol

Additional battery symbols/status

Battery is charging

Battery fault

Charging is not possible at this time

To charge the pump battery:

1. Connect the charger to the charging port.

The LED light on the charger will illuminate white when

the charger is correctly connected to the pump’s charging

port.

2. Plug the charger into an electrical outlet port.

Operating instructions | 21

When the pump begins to charge:

Therapy is running

– The touch screen lights up and the battery symbol

indicates that the pump is charging.

– If there is no user interaction after 1 minute, the touch

screen will enter sleep mode.

Pump is turned off

– The touch screen will display that the pump is charging.

– If there is no user interaction after 1 minute, the touch

screen will enter sleep mode.

– The pump is fully charged after approximately 4 hours.

– A fully charged pump should work for at least 20 hours. If there is an air-leak in the system,

the pump motor may need to work harder to maintain the target level of negative pressure.

Under these circumstances, the pump may need to be recharged more frequently.

– When the battery charge drops to 20%, an acoustic alarm will sound and the “Battery low”

alarm will appear on the touch screen. This alerts the user to recharge the battery.

i

For troubleshooting instructions refer to chapter “Alarms and troubleshooting/Battery

low” on page 42.

– When the battery charge drops below 5%, an acoustic alarm will sound, the “Battery

empty” alarm will appear on the touch screen and therapy will be automatically paused.

i For troubleshooting instructions refer to chapter “Alarms and troubleshooting/Battery

empty” on page 43.

22 | Operating instructions

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8.3 Attach canister to the pump

WARNING

NOTICE

Sterile products: Do not use the sterile products if the sterile packaging is damaged,

was opened prior to use or has expired.

• Wear gloves for all operations and apply universal precautions.

• Canisters are designed for single patient use only and cannot be reused.

1. Select the appropriate canister size depending

on the wound type (300 ml, 500 ml, 1000 ml).

2. Unpack a new sterile canister.

3. Slip the pegs at the bottom of the canister to secure

into the slots at the base of the pump.

click

place.

4. Push the canister towards the pump until it clicks into

Operating instructions | 23

8.4 Connect canister tubing to dressing tubing

1. Align both parts of the Quick-Connector and push

the Quick-Connector together until you hear a click.

click

8.5 Turn pump ON

1. Turn on the pump by pressing the “On/Off” button

2. The light indicator will illuminate yellow and the start-up

screen will appear.

24 | Operating instructions

8.6 Start new therapy

NOTICE

• New therapy should only be started by a clinician.

• The default therapy setting of the Invia Ease pump is –125 mmHg in constant mode.

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i For instructions, refer to chapter “Turn pump ON” on page 24.

1. Turn the pump ON.

2. To start new therapy:

In default settings

Click

Change settings first

Click

i

For instructions on how to change therapy settings

refer to chapter “Change therapy settings” on page 34.

For instructions on how to change pump settings refer

to chapter “Change pump settings” on page 35.

Click

3. The light indicator will illuminate green when therapy is running and the target level

of negative pressure is reached.

8.7 Activate the display during running therapy

Touch anywhere on the touch screen to activate the display.

The touch screen will automatically activate in the event of an alarm.

8.8 Dim the display/sleep mode during therapy

The touch screen will dim and go into sleep mode 1 minute after the last user interaction.

Operating instructions | 25

8.9 Pause therapy

WARNING

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.

The pump may be paused for a variety of reasons including:

– To change the wound dressing. For detailed information regarding dressing applications,

consult the appropriate Invia dressing Instructions for Use.

– To change the cannister.

– To temporarily detach the patient from the pump.

The pump allows the therapy to be paused for up to 30 minutes. After therapy has been

paused for 30 minutes, the “Pause reminder” alarm will appear on the touch screen.

i

For troubleshooting instructions refer to chapter “Alarms and troubleshooting/Pause

reminder” on page 43.

To pause therapy:

Click and hold for 3 seconds.

Pause screen will appear, the pump motor will stop working and the light indicator will switch

from green to yellow.

Pause screen

Access Clinician menu

Pause therapy timer

Open instructions

Log dressing change

Restart therapy

26 | Operating instructions

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8.10 Change a canister

WARNING

Sterile products: Do not use the sterile products if the sterile packaging is damaged,

was opened prior to use or has expired.

NOTICE

• To change a canister, therapy must be paused.

• Canisters are designed for single patient use only and cannot be reused.

• Change the canister a minimum of once a week or when:

– The canister appears full

– “Canister full” alarm appears on the touch screen

1. Click and hold for 3 seconds on the Main screen.

i For instructions to change the canister click on the Pause screen

i To exit the instructions at any time, click

2. Position the clamps next to the Quick-Connector and

close clamps on the canister tubing and the dressing

tubing.

3. Disconnect the canister tubing from the dressing tubing

by pressing the sides of the Quick-Connector.

Prevent the end of the dressing tubing from becoming

contaminated.

Operating instructions | 27

4. Press the canister release button on top of the canister

to release and remove the used canister.

5. Unpack a new sterile canister and attach it to the pump.

i

For instructions, refer to chapter “Attach canister to the pump” on page 23.

6. Connect canister tubing to the dressing tubing.

i

For instructions, refer to chapter “Connect canister tubing to dressing tubing” on page 24.

7. Open the clamp on the dressing tubing and make sure

the canister tubing is unclamped.

8. To resume the therapy click on the Pause screen.

The pump motor will start to work, the Main screen will appear and the light indicator

should switch from yellow to green when the target level of negative pressure is reached.

9. Discard the used canister in accordance with local environmental guidelines.

For instructions, refer to chapter “Disposal” on page 50.

28 | Operating instructions

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8.11 Detach the pump from the patient

NOTICE

To detach the pump from the patient, therapy must be paused.

1. Click and hold for 3 seconds on the Main screen.

For instructions to detach from the pump click on the Pause screen

i

i

To exit the instructions at any time, click

2. Position the clamps next to the Quick-Connector and

close clamps on the canister tubing and the dressing

tubing.

3. Disconnect the canister tubing from the dressing tubing

by pressing the sides of the Quick-Connector. Prevent

the end of the dressing tubing from becoming contami-

nated.

4. The patient can perform the activity while being disconnected from the pump, such as

taking a shower.

5. When the activity is completed, re-connect the canister tubing to the dressing tubing.

i

For instructions, refer to chapter “Connect canister tubing to dressing tubing” on page 24.

Operating instructions | 29

6. Open the clamps on the dressing tubing and

the canister tubing.

7. To resume the therapy click on the Pause screen.

The pump motor will start to work, the Main screen will appear and the light indicator

should switch from yellow to green when the target level of negative pressure is reached.

8.12 Change a dressing

NOTICE

To change a dressing, therapy must be paused.

i

For detailed information regarding dressing applications, consult the appropriate Invia

dressing Instructions for Use.

1. Click and hold for 3 seconds.

2. Log the dressing change by moving the toggle bar from

left to right.

When the DRESSING CHANGE toggle is activated:

– The “Pause reminder” alarm is suspended

– The pump will provide an acoustic sound every 15 min

– A dressing change is logged in the pump’s History

3. Perform the dressing change according to the facility guidelines.

4. To resume the therapy click on the Pause screen.

The pump motor will start to work, the Main screen will appear and the light indicator

should switch from yellow to green when the target level of negative pressure is reached.

30 | Operating instructions

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8.13 Turn the pump off to temporarily interrupt therapy

WARNING

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.

For instructions on how to end therapy refer to chapter “End therapy” on page 40.

i

To turn the pump off either:

OR

1. Press the “On/Off” button

1. Press and hold the “On/Off” button

for 3 seconds

2. Click

Operating instructions | 31

8.14 Resume existing therapy (after the pump was turned off)

1. Press the “On/Off” button to turn the pump on.

i

i

2. Click to resume existing therapy.

To start new therapy click

For instructions, refer to chapter “Start new therapy”

on page 25.

NOTICE

New therapy should only be started by a clinician.

32 | Operating instructions

9 Access the Clinician menu

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NOTICE

the Clinician menu.

• The Clinician menu should be used by clinicians only.

• The pump automatically switches to the Main screen 1 minute after the last interaction in

The Clinician menu can be accessed during running therapy or while therapy is paused.

From the Clinician menu it is possible to:

– Change therapy settings

– Change pump settings

– Check the history and log file of the existing therapy

– End therapy

To access the Clinician menu:

1. Select at the top of the Main

screen.

2. Acknowledge that you are a clinician:

Disclaimer

Read the disclaimer and swipe right to unlock.

Code

Enter the code (default code 1111 or a pre-set personal

code).

3. To exit the Clinician menu click

Access the Clinician menu | 33

10 Change therapy settings

NOTICE

• Changes to therapy settings should only be made as prescribed by a physician.

• The default therapy setting of the Invia Ease pump is –125 mmHg in constant mode.

1. Access the Clinician menu.

For instructions, refer to chapter “Access the Clinician menu” on page 33.

i

2. Click

3. Select between or

therapy modes.

4. Select the field that needs to be changed and then

use or to adjust:

– Pressure between –40 and –200 mmHg in increments

– Time between 2 and 60 minutes (in the intermittent

of 5 mmHg

mode only)

5. Click to save the new therapy settings.

If the new therapy settings are not saved, the pump will

revert to the previous therapy settings.

6. Click to return to the Clinician menu.

34 | Change therapy settings

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11 Change pump settings

The following settings can be changed from the pump settings menu:

– Date and time

– Clinician access

– Alarm volume

– Vacuum intensity

– Language

– Bluetooth on/off

– Reset factory settings

1. Access the Clinician menu.

For instructions, refer to chapter “Access the Clinician menu” on page 33.

i

2. Click

3. Click

4. Select the field that needs to be changed

per instructions on the following pages.

5. Click to return to the Clinician menu.

Change pump settings | 35

11.1 Date and time

1. Choose between / or format.

2. Click or to set date (day, month, year) and time (hours, minutes).

3. Click to return to the pump settings menu.

11.2 Clinician menu access

1. Choose between a disclaimer or a code.

Disclaimer

Access the clinician menu with a swipe.

Code

Access the Clinician menu with a default code 1111

or set an additional code.

To set an additional code:

– Check the box “Set additional code”

– Enter a four digit code

– Click to return to the pump settings menu.

To change an additional code:

– Click and enter a new four digit code.

– Click to return to the pump settings menu.

36 | Change pump settings

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Select the sound of the acoustic alarm. The sound always starts low and continues to get

louder until it reaches its maximum volume. The default alarm volume setting is Medium.

Select the speed at which the negative pressure is applied and the dressing compresses. The

Low vacuum intensity requires the longest time to apply the target negative pressure while

the High vacuum intensity is the quickest to apply the target negative pressure at the

dressing. The default vacuum intensity setting is Medium.

11.3 Alarm volume

11.3 Vacuum intensity

11.5 Language

1. Select the language from the list.

2. Click to return to the pump settings menu.

11.6 Bluetooth

– Bluetooth functionality is presently inactive regardless of Bluetooth setting (On or Off).

– Default setting of the Invia Ease pump is Bluetooth Off.

– Bluetooth interface is used by the Medela service centers only.

11.7 Factory settings reset

The Invia Ease pump can be reset to the default factory settings:

– Therapy setting is constant mode in –125 mmHg

– Language is English

– Clinician access is Disclaimer

– Alarm volume is medium

– Vacuum intensity is medium

– Unit pressure is mmHg

– Bluetooth is Off

Change pump settings | 37

12 View therapy history

1. Access the Clinician menu.

For instructions, refer to chapter “Access the Clinician menu” on page 33.

i

2. Click

3. To check the detailed therapy events , click

History screen

Exit history screen

Therapy start date

Therapy ID number

Number of dressing changes

performed during therapy

Indicates an alarm on the therapy

graph

Number of canisters used during

therapy

Check detailed therapy events

Therapy run rate

Therapy duration

Therapy graph showing dates,

pressure setting(s), alarm(s) and

pause(s)

4. Scroll down to view the log file. To filter the events

recorded in the log file, click to select the respective

fields

and scroll down to view the full list. Filterable events

include alarms, dressing changes, canister changes and

therapy pauses.

5. Click to return to the Clinician menu.

38 | View therapy history

13 End therapy

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NOTICE

• The therapy history of the current therapy will be erased once therapy is ended

and the pump is turned off.

• Therapy should only be ended by a clinician.

i

If you wish to temporarily interrupt therapy, please refer to chapter “Turn pump off

to temporarily interrupt therapy” on page 31.

To end existing therapy either:

1. Access the Clinician menu.

i

For instructions, refer to chapter

“Access the Clinician menu” on page 33.

OR

1. Press the “On/Off” button

2. Click and hold

for 3 seconds.

3. Acknowledge you are a clinician

via a disclaimer or a code to confirm

the end of therapy.

2. Click and hold

for 3 seconds.

3. Therapy history of the current therapy will

be shown on the touch screen.

4. To see the detailed log file, click

5. To turn the pump off, click

End therapy | 39

14 Alarms and troubleshooting

WARNING

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.

When the pump detects a fault, an acoustic alarm sounds, troubleshooting instructions

appear on the touch screen and the light indicator illuminates yellow. The pump differentiates

between “Low Priority” and “Medium Priority” alarms (IEC 60601-1:2005, 3rd edition and

IEC 60601-1-8:2006):

“Low priority” alarms:

– Battery low

– Temperature high

– No canister detected

– Pump in wrong position

“Medium priority” alarms:

– Pause reminder

– Battery empty

– Internal temperature exceeded

– High leakage

– Blockage

– Canister full

– Defective charger

– Pump error

To resolve an alarm:

1. Press the Mute button to silence the alarm.

The mute symbol will appear on the screen to

indicate that the pump has been silenced. The acoustic

alarm will resume in 5 minutes if the problem has not

been resolved.

2. Follow the instruction shown on the touch screen or refer to the chapter “Alarm table”

on page 42.

3. If the problem cannot be resolved, turn the pump off and contact the Medela Customer

Service or the system provider for further instructions. For instructions, to turn the pump off

refer to chapter “Turn pump Off to temporarily interrupt therapy” on page 31.

40 | Alarms and troubleshooting

Alarm table

“Low priority” alarms:

– Therapy continues to run

– Status indicator illuminates yellow

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NOTICE

”Low Priority” alarms that are not resolved will lead to “Medium Priority” alarms.

To close the instructions after acknowledging the alarm and to return to the Main screen

click

Alarm type

Potential cause

Notes

Battery low

• Battery charge has

fallen to 20 %

• Alarm will repeat if

the battery charge

drops to 15 % and

subsequently to 10 %

Troubleshooting

instructions

Charge the pump

battery

i

For instructions,

refer to chapter

“Battery status

and charging” on

page 20.

Temperature high

The pump is next to a

heat source or is under

a cover

Remove the pump

from the heat source

or uncover the pump

If battery charge

drops to 5 %, it will

lead to the “Battery

empty” alarm and

therapy will be auto-

matically paused.

The pump is at risk

of overheating. If the

pump is not cooled, it

will lead to “Tempera-

ture exceeded” alarm

and therapy will be

automatically paused.

If a canister is missing

or is not correctly

attached, it will lead to

“High leakage” alarm.

No canister detected

The pump does not

detect a canister

• Attach a canister to

the pump

• Release and

reposition

the canister if

needed

Pump in wrong

position

The pump is positio-

ned on its side or is

upside down

Place the pump

in the upright position

If the pump is in a

wrong position for too

long, it could lead to

“Canister full” alarm.

Alarms and troubleshooting | 41

“Medium priority” alarms:

– Therapy may automatically pause

– Status indicator illuminates yellow and flashes

Alarm type

Potential cause

Notes

Pause reminder

The therapy has been

paused for 30 minutes

or longer

Troubleshooting

instructions

• To resume

the therapy click

• To remain in the

pause therapy

mode, click

After 90 minutes in the

pause therapy mode,

the “Pause reminder”

alarm will display an

additional warning

regarding dressing

change

Battery empty

Battery charge is 5 %

or below

Internal temperature

exceeded

The pump

has overheated

• Remove the pump

• Therapy is automati-

from the heat source

or uncover the pump

cally paused.

• To acknowledge

Charge the pump

battery

i

For instructions,

refer to chapter

“Battery status

and charging”

on page 20.

Therapy is automati-

cally paused. Resume

the therapy once the

pump is charging by

clicking

• Wait a minimum of

30 minutes for the

pump to cool down

the instructions and

switch to the Pause

screen click

• Resume the therapy

after the pump is

cooled off by

clicking

Blockage

• Tubing may be

• Clamp may be

twisted

closed

• Check the tubing

to make sure it is not

twisted

• Make sure that both

clamps are open

If the tubing is blocked

or the blockage

cannot be identified,

the canister and/or

the dressing should be

changed.

42 | Alarms and troubleshooting

Alarm type

Potential cause

Troubleshooting

instructions

Notes

High Leakage

The pump detects an

air leak in the system

and cannot maintain

the target level of

negative pressure

N

E

• If the leakage is not

resolved in the first

five minutes, the

pump will switch

into pause therapy

mode.

• Inspect the dressing

for an air leak

• Press firmly around

the edges of the

dressing and around

the Invia FitPad

• Apply additional film

around the dressing

if needed to seal the

leak

• Check that the

Quick-Connector is

securely attached

• Check that canister

is fully connected to

the pump

• Release and

reposition

the canister if

needed

• Ensure that the two

filter gasket orange

O-rings on the canis-

ter side of the pump

are not missing

Filter gasket with orange O-ring

Change the canister

For instructions,

i

refer to chapter

“Change a

canister” on

page 27.

• If the therapy has

been automatically

paused, click

to check if the

leakage has been

resolved or continue

to look for the leak

by following the

troubleshooting

instructions.

• If an air leak cannot

be identified or re-

solved, the dressing

should be changed.

If the pump is not

positioned upright,

it may cause the

canister filter to clog.

• Unplug the charger

immediately

• Inspect the charger

for damage

• Replace the charger

If the charger is not

unplugged imme-

diately, it may cause

damage to the pump.

• Click

to turn the pump off

• Press the “On/Off”

button on the

side of the pump to

restart the pump

If the problem cannot

be resolved, turn the

pump off and contact

the Medela Customer

Service or the system

provider for further

instructions.

Alarms and troubleshooting | 43

Canister full

• Canister is full

• Canister filter is

clogged

Defective charger

The charger may be

damaged

Pump error

The pump has an

internal error

15 Accessories setup

15.1 Invia Ease carrying case

To place the pump inside the carrying case:

1. Open the Velcro on the top of the carrying case.

2. Slide the pump with canister attached into

the designated slot.

3. Close the Velcro over the pump and over the canister.

Make sure that the canister tubing is not kinked and

the status indicator is visible.

4. Secure additional tubing with a Velcro on the side

of the pump.

44 | Accessories setup

To exchange a canister from the carrying case:

1. Detach the handle strap on the side of the canister.

N

E

2. Open the Velcro over the canister.

3. Unzip the carrying case from the canister side.

4. Change the canister.

i

For instructions, refer to chapter “Change a canister”

on page 27.

5. Zip up the carrying case from the canister side.

Accessories setup | 45

6. Close the Velcro over the canister.

7. Re-attach the handle strap on the side of the canister.

46 | Accessories setup

15.2 Invia Ease handle

To affix the carrying handle to the pump:

1. Remove the two hole covers from the back of the pump.

N

E

2. Align the two handle parts and fixate the screws inside

the two holes.

3. Cover the screws with the two hole covers from the

pump.

Accessories setup | 47

15.3 Invia Ease IV pole/bed holder

To attach the IV pole/bed holder to an IV pole or a bed board (up to 50 mm):

1. Turn the knob left to open the IV pole/bed holder.

2. Position the open holder in the center of the IV pole

or over the bed board.

3. Turn the knob to the right to firmly secure the holder

onto the IV pole or the bed board.

To mount the Invia Ease pump onto the IV pole/bed holder:

1. Hold the pump by the handle and position the base of

the handle over the IV pole/bed holder.

2. Slide the pump down along the handle until the IV pole/

bed holder is secured to the pump handle.

To remove the Invia Ease pump from the IV pole or the bed board:

1. Hold the pump by the handle and lift the pump up to release it from the IV pole/bed

holder.

48 | Accessories setup

16 Safety-related checks

N

E

– The Invia Ease pump is a device in protection class II (EN IEC 60601-1), the safety-related

checks are confined to visual inspection of the housing and charger for damage.

This check must be performed prior to each use.

– If any damage or safety defects are observed, contact the Medela Customer Service

or the system provider.

– Devices of protection class II do not have a protective earth conductor therefore there

is no need to check the earth leakage current.

– The Invia Ease pump enclosure is made entirely of insulated material. Tests of the enclosure

leakage current using common measuring instruments will therefore not reveal measurable

values.

– Even when suctioning a conductive fluid until the overflow protection device activates,

measurements of the patient leakage current using common measuring instruments will

not reveal measurable values.

– The Invia Ease pump does not have patient circuits or functional earth connections.

17 Maintenance and service

– The Invia Ease pump and charger should be maintained and repaired throughout

its service life in compliance with the Medela service procedures.

– Service work may only be carried out by Medela’s authorized personnel.

– To request maintenance service contact the Medela Customer Service.

18 Sterility requirements

WARNING

Sterile products: Do not use the sterile products if the sterile packaging is damaged,

was opened prior to use or has expired.

Invia Ease pump, charger, handle, IV pole/bed holder and carrying case cannot

be sterilized.

The following products are sterile and single use only:

Invia Ease canister and tubing

These are single use products that should be disposed of after use.

Do not reuse.

If reused, the performance of the product may deteriorate, cross-contamination may occur.

Safety-related checks/Maintenance and service/Sterility requirements | 49

19 Cleaning, disinfection and storage

Reusable devices and components from Medela are delivered non-sterile and are intended

for reuse. Prior to use, clean and reprocess the product by following the procedure in

the Cleaning and Disinfection instructions below.

Materials and equipments:

– Personal Protective Equipment (PPE: disposable gloves, proper protective gear)

– Lint free nonwoven wipes

– Clean water (<104 °F, <40 °C)

– Common household cleaner

• Never use steel brushes or steel wool for cleaning.

• Invia Ease pump and accessories (charger, handle and IV pole fixation) should be cleaned

and disinfected after every use.

• Never place or drop the pump into water or other liquids.

• Before cleaning/disinfecting the pump or the charger, disconnect the charger from

the electrical outlet port.

NOTICE

WARNING

19.1 Cleaning

– The Invia Ease pump and the accessories (charger, handle, IV pole fixation and carrying

case) can be wiped with a damp cloth using a common household cleaner throughout

the therapy.

– The carrying case can be washed in the washing machine if needed.

19.2 Disinfection

The Invia Ease pump and the accessories (charger, handle and IV pole fixation) should

be disinfected after every therapy with a disinfectant containing alcohol to avoid

cross-contamination.

NOTICE

• Do not spray disinfectants directly into openings as this may harm electronic components.

• Immersion disinfection, thermal disinfection and ultrasound cleaning are not permitted.

50 | Cleaning, disinfection and storage

N

E

To disinfect the Invia Ease pump and the accessories (charger, handle and IV pole

fixation):

1. Wear suitable protection (clothing, gloves, face mask and goggles) according to the facility

guidelines.

2. Apply the disinfectant agent in accordance with instructions from the manufacturer.

Pay particular attention to the edges, narrow corners, and bottom side.

3. Leave the disinfection agent on for the time recommended by the manufacturer.

4. Thoroughly clean the surface, all edges, housing niches, corners, and bottom side.

5. Wipe dry or air dry according to the instructions from the manufacturer.

6. If needed, repeat step 2–5.

7. Dispose contaminated material in accordance with local environmental guidelines.

For detailed cleaning instructions contact the Medela Customer Service.

19.3 Drying

After the manual disinfection, store the product on a clean dry cloth and let it dry.

Alternatively, follow the instructions provided by the disinfectant manufacturer.

19.4 Inspection

After reprocessing according to the steps described above, the device and its components

must be inspected for signs of degradation that may limit the useful life and/or performance

of the device, such as the following: visible corrosion, mechanical wear, abrasion, damage,

or deformation. Furthermore, check if the silicone O-ring is still in place (if applicable).

Discard the device if any signs of degradation are evident.

19.5 Storage

Store the product dry and dust-free.

20 Disposal

NOTICE

environmental guidelines.

• Invia Ease products should be handled and disposed of in accordance with the local

• The Invia Ease pump or the accessories must not be disposed of with the household refuse.

– The Invia Ease pump is made from various metal and plastic parts, which should be

disposed of in accordance with the local environmental guidelines.

– Before disposal of the pump, the rechargeable battery and electronics must be removed.

For instructions, contact the Medela Customer Service.

Cleaning, disinfection and storage/Disposal | 51

21 International regulations

21.1 Electromagnetic compatibility (EMC)

The Invia Ease pump is intended to be used in the professional healthcare facility environment

and home healthcare environment and is EMC tested in conformity with the requirements of

the standard IEC 60601-1-2:2014 4th Edition according to clause 7 and 8.9.

The pump needs special precautions regarding EMC and needs to be installed and put into

service according to the EMC information provided in these instructions for use. Portable and

mobile RF communications can affect the pump.

NOTICE

This equipment has been tested and found to comply with the limits for a Class B digital

device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reason-

able protection against harmful interference in a residential installation. This equipment

generates, uses and can radiate radio frequency energy and, if not installed and used in

accordance with the instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation.

If this equipment does cause harmful interference to radio or television reception, which can

be determined by turning the equipment off and on, the user is encouraged to try to correct

the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the distance between the equipment and receiver.

• Connect the equipment to an outlet on a circuit different from that to which the receiver

is connected.

• Consult the dealer or an experienced radio/TV technician for help.

WARNING

To prevent malfunction resulting from electromagnetic interference:

• The Invia Ease pump should not be used adjacent to or stacked with other equipment.

If adjacent or stacked use is necessary, the Invia Ease pump should be observed to verify

normal operation in the configuration in which it will be used.

• Wireless communications equipment such as wireless home network devices, mobile

phones, cordless telephones and their base stations, walkie-talkies, RFID can affect

the Invia Ease pump and should be kept at a distance of at least 30 cm away from the

device.

• Use of accessories or cables other than those provided by the manufacturer of this device

could result in increased electromagnetic emissions or decreased electromagnetic

immunity of this equipment and result in improper operation.

52 | International regulations

N

E

Guidance and manufacturer’s declaration – electromagnetic emissions

This Invia Ease pump is intended for use in the electromagnetic environment specified below.

The customer or the user of the Invia Ease pump should assure that it is used in such an

environment.

Emission tests

Compliance

Electromagnetic environment – guidance

RF Emissions

CISPR 11

RF emissions

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Group 1

Class B

Not

applicable

Not

applicable

The Invia Ease pump uses RF energy only for

its internal function. Therefore, its RF emissions

are very low and are not likely to cause any

interference in nearby electronic equipment.

The Invia Ease pump is suitable for use in all

establishments, including domestic establishments

and those directly connected to the public low-

voltage power supply network that supplies

buildings used for domestic purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test

Compliance level

IEC 60601

test level

Electrostatic

discharge ( ESD )

IEC 61000-4-2

± 8 kV

contact discharge

± 8 kV

contact discharge

± 15 kV

air discharge

± 15 kV

air discharge

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV

for power supply

lines

± 2 kV

for power supply

lines

Surge

IEC 61000-4-5

± 0,5 kV, ± 1 kV

Line-to-line

± 0,5 kV, ± 1 kV

Line-to-line

Electromagnetic

environment

– guidance

Floors should be wood,

concrete or ceramic tile.

If floors are covered with

synthetic material,

the relative humidity

should be at least 5 %.

Mains power quality

should be that of a typical

commercial or hospital

environment.

Mains power quality

should be that of a typical

commercial or hospital

environment.

International regulations | 53

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

0 % UT for 0.5 cycle

at 0°, 45°, 90°, 135°,

180°, 225°, 270°,

and 315°

0 % UT for 0.5 cycle

at 0°, 45°, 90°, 135°,

180°, 225°, 270°,

and 315°

0 % UT for 1 cycle

at 0°

0 % UT for 1 cycle

at 0°

70 % UT

for 25 cycles at

50 Hz at 0°

for 30 cycles at

60 Hz at 0°

0 % UT

for 250 cycles at

50 Hz at 0°

for 300 cycles at

60 Hz at 0°

70 % UT

for 25 cycles at

50 Hz at 0°

for 30 cycles at

60 Hz at 0°

0 % UT

for 250 cycles at

50 Hz at 0°

for 300 cycles at

60 Hz at 0°

Power frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

30 A/m

30 A/m

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Mains power quality

should be that of a

typical commercial or

hospital environment. If

the user of the Invia Ease

pump requires continued

operation during power

mains interruptions, it

is recommended that

the Invia Ease pump

be powered from an

uninterruptible power

supply or a battery.

It may be necessary

to position the Invia

Ease pump further

from sources of power

frequency magnetic fields

or to install magnetic

shielding. The power

frequency magnetic field

should be measured in

the intended installation

location to assure that it is

sufficiently low.

54 | International regulations

Guidance and manufacturer’s declaration – electromagnetic immunity

This Invia Ease pump is intended for use in the electromagnetic environment specified below.

The customer or the user of the Invia Ease pump should assure that it is used in such an

environment.

Immunity test

IEC 60601

test level

Compliance

level

Electromagnetic environment –

guidance

N

E

Conducted RF

IEC 61000-

4-6

3 Vrms

150 kHz to

80 MHz

outside ISM band

3 Vrms

6 Vrms

d = 2.0√P

6 Vrms

150 kHz to

80 MHz

in ISM and

amateur radio

bands

Radiated RF

IEC 61000-

4-3

10 V/m

80 MHz to

2.5 GHz

10 V/m

Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2 These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reflection from structures, objects and people.

Except as indicated in the table on the

next page, portable and mobile RF

communications equipment should be

used no closer to any part of the Invia

Ease pump, including cables, than the

recommended separation distance

calculated from the equation applicable

to the frequency of the transmitter.

Recommend separation distance

d = 1.2√P

d = 0.35√P 80 MHz to 800 MHz

d = 0.7√P 800 MHz to 2.5 GHz

Where P is the maximum output power

rating of the transmitter in watts (W)

according to the transmitter manufacturer

and d is the recommended separation

distance in metres (m).

Field strengths from fixed RF transmitters,

as determined by an electromagnetic

site survey,a should be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of

equipment marked with the following

symbol.

International regulations | 55

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot

be predicted theoretically with accuracy. To assess the electromagnetic environment due to

fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field

strength in the location in which the Invia Ease pump is used exceeds the applicable RF compliance

level above, the Invia Ease pump should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as re-orienting or relocating

the Invia Ease pump.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Table of frequencies of portable and mobile transmitters for which the recommended

separation distance is 30 cm (12 inches):

Band (MHz)

Service

380–390

TETRA 400

430–470

GMRS 460, FRS 460

704–787

LTE Band 13, 17

800–960

GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5

1 700–1 990

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

2 400–2 570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

5 100–5 800

WLAN 802.11 a/n

WARNING

Portable RF communications equipment (including peripherals such as antenna cables and

external antennas) should be used no closer than 30 cm (12 inches) to any part of the Invia

Ease pump including cables specified by the manufacturer. Otherwise, degradation of the

performance of this equipment could result.

21.2 Radio transmission

FCC (USA) statement

Changes or modifications not expressly approved by the party responsible for compliance

could void the user’s authority to operate the equipment. This device complies with Part 15

of the FCC Rules. Operation is subject to the following two conditions:

(1)

(2) this device must accept any interference received, including interference that may cause

this device may not cause harmful interference, and

undesired operation.

56 | International regulations

22 Technical specifications

N

E

vacuum range

–40 to –200 mmHg

–5 to –27 kPa

low flow

5 l/min.

without canister

1.1 kg

2.4 lbs

H x W x D

125 x 175 x 90 mm

4.92 x 6.89 x 3.54 inch

max. noise level

35 dBA

(250 ml/min; 125 mmHg)

alarm noise level

62/68/74 dBA

Switching adapter AC

Model: MSA-C2500IS12.0-30C-ZZ

IEC:

Input:

Output: 12 VDC, 2.5 A

60601-1

100–240 VAC, max 0.8 A, 50/60 Hz

Transport/Storage Conditions

Operating Conditions

ISO 13485

Technical specifications | 57

23 Material

Item description

Raw material description

Raw material information

Invia Ease pump (base unit)

Pump housing (upper and lower

part) is made of ABS material.

The silicone seal in between is

made of silicone material.

Housing: ABS

Housing seal: MQ Elastosil

Invia Ease charger

Charger housing is made of PC

material, plug is made of ABS.

PC and ABS material, heat

resistant

Invia Ease canister and tubing

300 ml, 500 ml, 1000 ml

Invia Ease carrying case

Invia Ease handle

Invia Ease IV pole/bed holder

The canister is made of

polypropylene material, the

tube is made of silicone and the

Quick-Connector is made of

ABS material.

Body of carrying case is made

of microfiber material.

Handle is made of PA with 30 %

glass fiber, seal between pump

and handle is made of silicone

material.

Plastic parts are made of PA

with 30 % glass fiber, silicone

pads are made of silicone

material, and metal parts are

stainless steel and aluminum.

Canister: PP

Tubing: MVQ, silicone

Quick-Connector: ABS

Polyester microfibre with

thermoplastic elastomer

backing

Plastic parts: PA

Pad: silicone

Metal parts: aluminium and

inox material

24 Warranty

Warranty period is for 2 years after date of delivery. The manufacturer is not liable for any

damage or consequential damage caused by incorrect operation, inappropriate usage as

well as use by unauthorized persons.

The service life of the device is five years; the internal batteries life included.

25 Service life

58 | Material/Warranty/Service life

26 Meaning of symbols

The following tables explain the meaning of the symbols found on the product parts

and its packaging.

N

E

Symbols used in these instructions

General safety alert symbol, points to information related to safety. 1

Symbols on the motor unit

Indicates the part number

of the device. 7

MD

This symbol indicates the

item is a medical device. X

Defines a relative humidity

range (e.g. for operation,

transport or storage). 3

Read and follow the

instructions for use. 12

Indicates the serial number

of the device. 8

Defines a temperature

range (e.g. for operation,

transport or storage). 2

Identifies the manufactur-

er. 5

This symbol indicates a

Prescription Device U.S.

Federal law restricts

this device to sale by or on

the order of a physician

(for US only). X

Contains fragile goods.

Handle with care. 14

Keep away from rain. Keep

in dry conditions. 16

Keep away from sunlight. 15

Indicates the compliance

with the requirements of

the Federal Communica-

tions Commission. 13

XXX

#

XXX

Indicates that the package

is capable of being

recycled. 17

Indicates the compliance

with additional USA and

Canada safety

requirements for medical

electrical equipment. 11

XXX

Indicates that this device

contains Bluetooth wireless

technology. (Trademarks

of Bluetooth Special

Interest Group (SIG))

Indicates compliance with

international requirements

for protection from electric

shock (Type BF applied

parts). 9

Do not dispose of electric/

electronic devices together

with unsorted municipal

waste (dispose of the

device in accordance with

local regulations). 10*

Indicates the location of

the On/Off button. 4

Indicates the location of

the mute button. 4?

Meaning of symbols | 59

Symbols on the power adapter

Indicates the compliance

with additional USA and

Canada safety

requirements for medical

electrical equipment. 11

The CE mark indicates

conformity with the

European low voltage and

electromagnetic

compatibility directive.*

Indicates alternating

current. 17

Do not dispose of electric/

electronic devices together

with unsorted municipal

waste (dispose of the

device in accordance with

local regulations). 10*

Identifies the manufactur-

er. 5

Indicates the part number

of the device. 7

Indicates the date of

manufacturing. 6

This symbol indicates

manufacturer’s batch

code. X

Symbols on the canister/tubing

Indicates the part number

of the device. 7

x

10

Indicates the quantity (x) of

individual devices in

pack. X

300 ml

Quick reference of the

canister size.

MD

This symbol indicates the

item is a medical device. X

This symbol indicates

manufacturer’s batch

code. X

This symbol indicates that

the device should not be

used after the date

shown. X

This symbol indicates a

single use device. Do not

reuse the device. X

This symbol indicates the

device is sterilized using

ethylene oxide. X

C onne

k

c

t

o

r

Quic

S

ecure H o l d

XXX

CC

XXX

This symbol indicates a

Prescription Device U.S.

Federal law restricts

this device to sale by or on

the order of a physician

(for US only). X

Identifies the manufactur-

er. 5

Contains fragile goods.

Handle with care. 14

Keep away from rain. Keep

in dry conditions. 16

Keep away from sunlight. 15 XXX

Indicates that the package

is capable of being

recycled. 17

Single sterile barrier

system with protective

packaging inside. X

Single sterile barrier

system. X

60 | Meaning of symbols

Symbols on the handle and IV pole/bed holder

N

E

Indicates the part number

of the device. 7

Indicates the date of

manufacturing. 6

Identifies the manufactur-

er. 5

Indicates that the package

is capable of being

recycled. 17

Contains fragile goods.

Handle with care. 14

Keep away from rain. Keep

in dry conditions. 16

This symbol indicates a

carton package. X

References

1 IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential

performance, Table D.2 Symbol 2 General Warning sign

2 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.3.7 Temperature Limit/ISO 7000-0632,

Graphical symbols for use on equipment, Temperature Limit

3 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.3.8 Humidity Limit/ISO 7000-2620,

Graphical symbols for use on equipment, Humidity Limit

4 IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential

performance, Table D.1 Symbol 29 Stand-by

5 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.1.1 Manufacturer

6 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.1.3 Manufacturing Date/ISO 7000-2497,

Graphical symbols for use on equipment, Date of manufacture

7 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.1.6 Article number/ISO 7000- 2493,

Graphical symbols for use on equipment, Catalogue number

8 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.1.7 Serial number/ISO 7000-2498,

Graphical symbols for use on equipment, Serial number

9 IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential

performance, Table D.1 Symbol 20 Type BF applied parts

10 EN 50419, Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of Directive

2002/96/EC (WEEE).

11 TÜV (Technical Inspection Association) mark indicates that the product is manufactured in compliance

with UL safety requirements for USA and Canada (USA: UL60950-1, CAN: CSA C22.2 NO. 60950-1).

12 IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential

performance, Table D.2 Symbol 10 Refer to instruction manual/booklet

13 Code of Federal Regulations, Title 47, Part 15b/15 c

14 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.3.1, Fragile, handle with care/ISO 7000-0621,

Graphical symbols for use on equipment, Fragile, handle with care

15 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.3.2 Keep away from sunlight/ISO 7000-0624,

Graphical symbols for use on equipment, Keep away from sunlight

16 ISO 15223-1, Medical devices – Symbols to be used with medical device labels, labelling and information

to be supplied, Part 1: General requirements, Clause 5.3.4, Keep away from rain/ISO 7000-0626,

Graphical symbols for use on equipment, Keep away from rain

17 ISO 7000-1135, Graphical symbols for use on equipment, General symbol for recovery/recyclable

* These symbols are not applicable for the US, Canada, Mexico market.

Meaning of symbols | 61

27 Ordering information

Product

Invia Ease NPWT system (pump and charger)

Invia Ease canister and tubing 300 ml (5pcs)

Invia Ease canister and tubing 500 ml (5 pcs)

Invia Ease canister and tubing 1000 ml (3 pcs)

Invia Ease carrying case

Invia Ease handle

Invia Ease IV pole/bed fixation

Invia Ease charger US

Filter gasket with orange O-ring

Pump feet

Handle attachment covers

REF number

101037357

101037361

101037362

101037363

101037360

101037364

101041744

101041939

62 | Ordering information

N

E

Medela AG

Lättichstrasse 4b

6340 Baar, Switzerland

www.medela.com

USA

Medela LLC

1101 Corporate Drive

McHenry, IL 60050

USA

Phone +1 877 735 1626

Fax

+1 815 307 8942

info-healthcare@medela.com

www.medelahealthcare.us

Medela Customer Service phone: 1-800-435-8316

A

-

6

0

-

1

2

0

2

/

9

1

4

3

4

0

1

0

1

/

G

A

a

e

d

e

M

©

l



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

m: dela 5 bhp Federal Communications Commission PNUlistelera-lilelelelate| Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Syelarcvivlas Werner Schnenberger Team Leader HW/SW IW Kre(=1 EW ANG) To whom it may concern:

We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf in all matters cil aTo CoM Tevellter-li(e late iets equipment authorization FCC ID: 2ATCR608283 including the signing of all documents related to these matters. Any and all acts carried out by Eurofi as acts of our own. ns Product Service GmbH on our behalf shall have the same effect We also hereby certify that no party to this application is subj ect to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Medela AG Lattichstrasse 4b 6341 Baar Switzerland Phone +41 (0)41 5625151 Fax +41 (0)41 562 54 00 info@medela.ch www.medela.com 4/30/2021