medela Invia Liberty Negative Pressure Wound Therapy NPWT System Instructions

medela Invia Liberty Negative Pressure Wound Therapy NPWT System

Specifications

• Product Name: Invia Liberty Negative Pressure Wound Therapy System
• Intended Users: Healthcare professionals or adequately trained lay users
• Intended Environment: Acute, extended, and home care settings
• Compatibility: For use with Invia Liberty system accessories only

Product information

The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is designed for wound management and healing. It is intended for use by healthcare professionals or trained lay users in various care settings.

Usage Instructions

Device setup

Check the delivery package for all components listed below:

• Quick connector
• Y connector
• Drain adapter
• Invia Liberty tubing set, single, sterile
• Carrying case
• Invia Liberty canister 0.3 liters with solidifier
• Invia Liberty pump with instructions for use
• Holder with standard rail Charger
• Invia Liberty canister 0.8 liters with solidifier

Intended Use

• The device is to be used on patients as described in the indications for use. It is important to follow the instructions provided by healthcare professionals and ensure proper training for lay users.

When to Use the Device (Indications for Use)

• The Invia Liberty NPWT system is suitable for various wound conditions. Consult with your healthcare professional to determine if it is appropriate for your situation.

When Not to Use the Device (Contraindications)

• Avoid using the device in the presence of fistulas or if you have concerns, consult with your healthcare professional.

Safety Instructions

Follow these general warnings for the safe operation of the system:

• Visually check wound dressing and system components regularly.
• If excessive bleeding occurs, seek immediate medical assistance.
• Avoid pressing buttons other than on/off, standby, or mute after settings are configured.
• The pump should run continuously unless advised otherwise by a healthcare professional.
• If the pump malfunctions, contact your healthcare provider immediately.

Frequently Asked Questions (FAQ)

Q: Can the Invia Liberty NPWT system be used on pediatric patients?

• A: The device has not been studied in pediatric patients and is intended for adult use only.

Q: What should I do if the pump stops working?

• A: If the pump cannot be switched on, contact your healthcare professional immediately for assistance.

Q: How often should the dressing be changed?

• A: If the pump is stopped for more than 2 hours, contact your healthcare provider to request a dressing change.

Assistance

• Read the entire instruction manual before trying to operate the device.
• If you have any questions about your Invia Liberty Negative Pressure Wound Therapy system, please contact your healthcare provider/physician at the number below:

HEALTHCARE PROVIDER/PHYSICIAN CONTACT INFORMATION:

• Keep this Patient Instructions for Use (IFU) booklet in an easily accessible location.

Warnings, cautions, and safety instructions

WARNING

• 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.

General warnings

WARNING

• The individual responsible for operating this device daily (patient, caregiver) must be able to read, understand, and follow directions provided in this IFU, on the pump display and by the healthcare professional.
• The individual must be able to hear and respond to auditory signals.
• Only use the Invia Liberty NPWT system on the person for whom it was ordered and only for its intended use.
• Do not perform the therapy without first consulting with healthcare personnel and caregivers trained on the instructions for use and the healthcare professional’s supervision.
• No modification of this equipment is allowed.

WARNING

• Visually check the wound dressing and the Invia Liberty system frequently.
• If you see large amounts of blood in the dressing, tubing or canister:

1. Turn off the pump by pressing and hold for 3 seconds.
2. Apply pressure to your wound.
3. Seek immediate Emergency Medical assistance.

• If you have difficulty breathing, seek immediate Emergency Medical Assistance.

WARNING

• Immediately contact your healthcare professional if you experience the following symptoms.
• Significant vision or hearing loss
• Pain, soreness, or redness around the wound
• Swelling, itching, or rash around the wound
• Fever
• Strong odor from the wound
• Thick green drainage or any unusual change in the color of drainage
• Nausea vomiting or diarrhea
• Sore throat with swelling
• Dizziness or confusion
• Allergic reactions like redness, rash or hives, swelling, or severe itching

WARNING

• Once the healthcare professional has set the pump pressure and mode settings do not press any other button than the on / off button [ ], the standby button [ ], or the mute button [ ].

WARNING

• The pump must be used 24 hours per day. Do not stop the pump unless instructed by your healthcare professional or if excessive bleeding occurs.
• If the pump is stopped for more than 2 hours, the dressing must be changed. Contact your healthcare professional to request a dressing change.

WARNING

• If the pump stops working and cannot be switched on, immediately call your healthcare professional.

Purpose of the device

• Your healthcare provider has prescribed Negative Pressure Wound Therapy ( NPWT ) for you.
• Negative Pressure Wound Therapy has been shown to help promote healing in several different kinds of wounds. Negative pressure (suction) is delivered to a wound through a pump. The section, or negative pressure, helps to remove fluid and close your wound. Your healthcare professional will place a special dressing on your wound and a tube will go from your wound to the canister on the pump. The pump is then turned on to the prescribed pressure to remove the fluid from your wound. The fluid then goes into the canister. The treatment will be on 24 hours a day.

Intended use

Intended user

• The Invia Liberty NPWT system is intended to be used by healthcare professionals or adequately trained lay users. Healthcare professionals are responsible for training lay users according to the patient instructions for use and explaining all related safety information.

Intended patient population

• The Invia Liberty NPWT system is intended to be used on patients only exhibiting conditions as described in the indication for use. The device has not been studied in pediatric patients.

Intended environment

• The Invia Liberty NPWT system is intended for use in acute, extended, and home care settings.

When to use the device (Indications for use)

• The Invia Liberty Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as 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 exudate and infectious material.
• When used on closed surgical incisions, the Invia Liberty NPWT sys-tem 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 Liberty NPWT system is appropriate 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

When not to use the device (Contraindications)

• The Invia Liberty NPWT system is contraindicated in the presence of.
• Necrotic tissue with eschar present
• Untreated osteomyelitis
• Non-enteric and unexplored fistulas
• Malignancy in the wound
• Exposed vasculature
• Exposed nerves
• Exposed anastomotic site of blood vessels or bypasses
• Exposed organs
• If you have concerns, speak with your healthcare professional.

Description of the device

• Check the delivery package of the Invia Liberty system for completeness and general condition.

WARNING

• Do not use any other accessories than the ones described below.

Display

• Buttons to operate the Invia Liberty pump

Conditions that affect the use

CAUTION

• The Invia Liberty pump must remain in an upright position during use.

General safety at home

• Please read and observe these warnings and safety instructions before operation.
• These instructions for use must be kept with the device.
• Please note that these instructions for use are a general guide for the use of the product.
• Medical situations must be addressed by a physician.

CAUTIONS / WARNINGS

• Do not use extension cords with the Invia Liberty pump.
• Position the power cord so that it will not cause someone to trip and fall.
• Never place the power supply cord around your neck.
• Keep the power supply cord away from hot surfaces.
• Do not unplug the power supply cord from the wall outlet by pulling on the cord.
• Do not try to fix or repair the Invia Liberty pump. Contact your healthcare professional if the pump is not working.
• Keep the Invia Liberty pump clean and dry.
• Never place the Invia Liberty pump in water or liquids.
• If the Invia Liberty pump gets wet, dry it with a towel.
• Do not dry the Invia Liberty pump in a microwave.
• Keep the Invia Liberty pump away from children and pets.
• Supervision is necessary when the Invia Liberty pump is used in the vicinity of children.
• Keep the Invia Liberty pump protected from direct sunlight.
• Explosion hazard – the Invia Liberty pump is not for use in potentially explosive environments including oxygen-enriched environments and in areas of flammable anesthetics.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless telephones, base stations, and walkie-talkies can interfere with the Invia Liberty pump and should be kept at a minimum distance of 30 cm away from the Invia Liberty pump. This may cause insufficient battery charging or may lead to an internal fault. See the chapter Notifications and Troubleshooting for actions to take in the case of an internal fault.
• This product contains lithium-ion batteries which bear the risk of fire, explosion, and burns. Do not disassemble, crush, heat above 100°C, incinerate, or dispose of in a fire.
• If you observe a change in the vacuum level or an error condition, move the Invia Liberty pump at least 30 cm from the mobile phone when making or receiving calls. Turn the Invia Liberty pump on and off again to reset it after an error
  condition. Whenever possible, a safety distance of a minimum of 30 cm between the Invia Liberty pump and a mobile phone is recommended.

Sleeping

• Make sure the Invia Liberty pump tubing will not become kinked.
• Prevent the Invia Liberty pump from falling to the floor during sleep.
• Always charge the Invia Liberty pump when going to bed.

Showering, bathing, and washing

• Do not use the Invia Liberty pump while bathing or showering.
• The Invia Liberty pump can be disconnected from the dressing for a short time ( up to 20 minutes ) to change clothes or perform personal hygiene. Discuss bathing plans with your healthcare professional.
• Prevent the Invia Liberty pump from getting wet.
• Do not put the Invia Liberty pump where it can fall into a shower, sink, or tub.
• Do not touch the Invia Liberty pump when it has fallen into the water. Unplug the device immediately from the electrical outlet and disconnect the pump from the dressing.

When you leave the house

• Check the battery status and recharge if necessary before leaving the house.
• For your convenience, place the Invia Liberty pump into the carrying case.
• Do not forget to take a spare canister and power supply with you.

Set up instructions

WARNING

• Check the Invia Liberty pump and dressing frequently to make sure it is working.
• Visually check the wound dressings, the area around the wound, and the fluid in the canister for signs of infection or other complications as provided by your healthcare professional.

Turn ON

• Switch the Invia Liberty pump ON by pressing [ ].
• Display view when the pump is running. Run / Standby indicator is rotating [ ].

WARNING

• Do not try to perform therapy without the supervision of your healthcare professional.

WARNING

• NPWT must run 24 hours a day. Do not stop the therapy unless instructed by your healthcare professional or if excessive bleeding occurs.

WARNING

• The dressing should be changed and therapy restarted by the healthcare professional if therapy is discontinued for more than 2 hours.

WARNING

• Invia Liberty pump does not detect blockage along tubing connected to the drain adapter or connected to the curved arm of the Y-connector. Check dressing tubing is con-nected to the drain adapter or the curved arm of the
• Y-connector frequently throughout the day to make sure tubing is not kinked or blocked.
• If the blockage is identified along the tubing connected to the drain adapter or tubing connected to the curved arm of the Y-connector, contact your healthcare professional.

Turn OFF

• Switch the Invia Liberty pump OFF by pressing [ ] for 3 seconds. Press only once.

Set up carrying case

• The Invia Liberty pump is intended to be worn in a carrying case during operation.

1. Open the carrying case.
2. Slide the Invia Liberty pump into the designated pocket.
3. Close the velcro over the pump.

• The shoulder strap can also be used as a belt strap.
• To accomplish this, release the strap at the sides of the carrying case and pull it through the two loops located on the back of the carrying case.

Charge battery

• When the battery is fully charged the battery run-time generally exceeds 14 hours. If the Invia Liberty pump is running conti-nuously due to an air leakage, the battery may need to be recharged earlier.

Battery status symbols

• If the battery becomes fully discharged (empty), please follow the instructions below.
• Open the electrical outlet port. Connect the Invia Liberty pump to the supplied electrical plug from the power supply provided with the pump.
• Plug the other end of the power supply into a wall outlet.
• Moving bars on the battery display will indicate charging is occurring.
• The battery is fully charged after approximately 4 hours. Once the battery is fully charged and continues to be connected to the power source will appear constantly on the display.
• After charging is completed, unplug the power supply from the wall and disconnect the Invia Liberty pump from the power supply. Close the electrical outlet port by pressing the protection cover down.

CAUTION

• NPWT therapy must be continued while charging the pump’s battery. Do not turn the pump off while charging.
• Always charge the battery overnight.

Change canister

Change the canister minimum once a week or when it appears full or when the alarm sounds, under instructions on the pump display.

1. Wash hands.
2. Press the “Standby” button [ > 3 seconds ] and the pump motor will stop running.
3. Press the release button at the top of the pump and remove the canister.
4. Seal used canister with a cap located on the side of the canister.
5. Unpack the new canister and remove the safety sticker, position the feet at the bottom of the canister into the grooves at the base of the pump. Push the canister up and click into the Invia Liberty pump.
   • CAUTION Do not use an Invia Liberty canister if the sterile packaging is damaged.
6. Switch the Invia Liberty pump on by pressing “On” [ ] to resume therapy and slide the pump into the carrying case.
7. Discard the used canister according to the instructions provided by your healthcare professional.

Connect/disconnect Quick-connector

• The Quick-connector can be disconnected for a short time (up to 20 minutes) to change clothes or perform personal hygiene.
• During this time the pump can be placed in the “Standby” mode for a 5-minute interval, after which time the “Standby mode” alarm will go off and can be muted for an additional 5 minutes.

1. Wash hands.
2. Close the clamp on the canister tubing and close the clamp on the dressing tubing.
3. Press the “Standby” button [ > 3 seconds ] and the pump motor will stop running.
4. Disconnect the Quick-connector by pressing under the sides of the connector.
5. To reconnect the Quick-connector push together the Quick-connector until you hear the click.
6. Open the clamp on the canister tubing and open the clamp on the dressing tubing.
7. Press “On” [ ] to resume therapy.

Notifications and troubleshooting

• Do not panic if an acoustic signal sounds.
• Follow the instructions below.

1. If the Invia Liberty pump is in the carrying case open the lid of your carrying case.
2. Press [ ] to mute the acoustic signal for 60 seconds (can be pressed every time the signal sounds.

Alarm table

Remarks / potential cause of fault

Recharge the battery either by placing the Invia Liberty pump in the docking station or plug in the charger to the electrical outlet port on the pump.

The remaining time of the battery is approximately 30 minutes.

If the pump is in Standby mode for more than 5 minutes, an alarm will go off.

To continue therapy press “On” [ ]

Cool Invia Liberty pumps down as per instructions on the display.
Dressing:

–   Check dressing for air leakage. Press firmly around the edges of

the dressing, around the drain tubing, or on the Invia FitPad.

–   May apply additional film dressing to seal the leaking area.

Connectors:

–   Ensure that the tubing connected to the dressing is connected properly to the canister tubing.

–   Ensure that the canister tubing is inserted straight into the pump.

Canister:

–   Ensure that the canister is properly inserted, release the canister, and reposition it.

–   Ensure that the orange O-ring / gasket, placed beside the canister tubing on the pump is not missing. Additional O-ring is available via Medela representative.

Call your healthcare professional.

CAUTION

If you are unable to identify any symbol or do not understand the alarm on the display, contact your healthcare professional.

Remarks / potential cause of fault

Recharge the battery either by placing the Invia Liberty pump in the docking station or plugging in the charger to the electrical outlet port on the pump.

The remaining time of the battery is approximately 15 minutes.

Change the canister, see chapter “Change canister”.
Canister:     – Release the canister and reposition it.

Tubing:       – Ensure that the tubing is not twisted, kinked, or clamped.

Change canister, see chapter “Change canister”.
Restart the pump. If the internal fault remains, turn it off by pressing [ > 3 seconds ] and contact your healthcare professional.

WARNING

• If the pump fails or cannot be switched on call your healthcare professional immediately.

Cleaning / Disinfection

• The Invia Liberty pump can be wiped with a damp cloth using a mild household cleaner.

Guarantee

• The warranty period is for 2 years after the 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.

Maintenance / Safety-related check

• Service work may only be carried out by authorized personnel. A safety-related check is confined to visual inspection of the housing and charger for damage and must be performed before each use.
• If the Invia Liberty pump has not been in use, the battery must be charged approximately once every 6 months to ensure optimum function.

Disposal

• Ask your healthcare professional how to dispose of used dres-sings, canisters, and tubing.

Technical specifications

Accessories storage conditions

• Accessories must remain in the packaging and stored at a temperature range of – 20° Celsius and + 50° Celsius.

Operation environmental conditions

• The Invia Liberty pump and accessories must be operated within a temperature range of + 5° Celsius and + 40° Celsius. Do not operate the products in extreme cold or heat. Avoid high relative humidity ( 15 – 93 % is permissible ).

CAUTION

• Do not operate the Invia Liberty pump above 3000 meters above sea level.

Protection Class IP33

• The Invia Liberty pump is protected against ingress of solids larger than 2.5 millimeters and dripping water.

Signs and symbols

Electromagnetic compatibility (EMC)

• Invia Liberty is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and IEC 60601-1-2:2014 4th Edition according to clauses 7 and 8.9.

WARNING

• The Invia Liberty pump should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Invia Liberty pump should be observed to verify normal operation in the configuration in which it will be used.

WARNING

• Do not use other accessories than those specified or sold by the manufacturer as replacement parts for internal components as it may result in increased emissions or decreased immunity of the Invia Liberty pump.

WARNING EMC

• HF (high-frequency) surgical equipment, radio networks, or the like can influence the operation of the device and may not be operated in combination with the Invia Liberty pump.

Medela AG

• Lättichstrasse 4b
• 6340 Baar, Switzerland
• www.medela.com

Germany

• Medela Medizintechnik
• GmbH & Co. Handels KG Georg-Kollmannsberger-Str. 85386 Eching
• Germany
• Phone +49 89 31 97 59-0
• Fax +49 89 31 97 59 99 info@medela.de

United Kingdom

• Medela UK Ltd.
• Huntsman Drive Northbank Industrial Park Irlam, Manchester M44 5EG United Kingdom
• Phone +44 161 776 0400 Fax +44 161 776 0444 info@medela.co.uk
• If you need assistance contact © Medela AG/201.0397/2022-12/D

References

• Breastfeeding & Pumping

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