Liberate Medical VentFree User manual

Document #:
MAN-006
Version
01
Document Title:
VentFree User’s Manual EUA
Approval Date:
28-Apr-2020
Effective Date:
28-Apr-2020
CHANGE SUMMARY
Rev # Date Description CO#
00 21-Apr-2020
EUA requirements
CO-2020-348
01 28-Apr-2020
Liberate Medical Electrodes
CO-2020-382

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Respiratory Muscle Stimulator
User Manual
VentFree has not been FDA cleared or approved.
VentFree has been authorized by FDA under an Emergency Use
Authorization (EUA).
VentFree is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency use
under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.

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1 Product Description 6
1.1 Principles of Operation 6
1.2 VentFree Features 7
1.3 VentFree Indications for Use 8
1.4 VentFree Contraindications 9
1.5 VentFree Warnings 9
1.6 VentFree Dangers 11
1.7 Cautions 11
1.8 Electrode Cautions 13
1.9 Flow Sensor Cautions 13
1.10 Stimulator Adverse Effects 14
1.11 Glossary of Symbols 15
2VentFree Directions for Use 17
2.1 Getting Started 17
2.2 External Power 17
2.3 Electrode Setup 18
2.4 Electrode Cautions 21
2.5 Electrode Warnings 22
2.6 Re-Application and Storage of Electrodes 23
2.7 User Interface 24
2.8 Connections 25
2.9 Connecting the System 26
3Setting up the System 30
3.1 Stimulation Levels 36
3.2 Begin treatment 37
3.3 Treatment Pause 38

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3.4 Treatment Discontinuation 38
3.5 Power Removal and Device Disconnection 39
3.6 MAIN MENU 40
3.6.1 Brightness 40
3.6.2 Key Volume 41
3.6.3 Session Length 41
3.6.4 Date/time menu 42
3.6.5 Stim Settings 42
3.6.6 About 42
4Error Messages and Troubleshooting 43
5Technical Data 44
5.1 Power Source 44
5.1.1 Battery 44
5.1.2 AC/DC Converter (Power Supply) 44
5.2 Standard Measurement Conditions 45
5.3 Outputs 45
5.4 Typical Waveforms 46
5.5 Treatment Duration 47
5.6 Output Signal Indication 47
5.7 Physical Characteristics 47
5.8 Accessories 47
5.8.1 Electrodes 48
5.8.2 Flow Sensor 49
5.8.3External AC/DC Converter 50
5.9 Environmental Conditions 50
5.10 EN 60601-1 Classification 50
5.11 Electromagnetic Compatibility (EMC) Tables 51
6Disinfection and Cleaning 55
6.1 Agents 55
6.2 VentFree and AC/DC Converter Cleaning and Disinfection Methods 55

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6.3 Electrodes Cleaning and Disinfection Methods 57
6.4 Cleaning and Disinfection of the Flow Sensor 59
7Battery Replacement 62
7.1 Battery Disposal 68
8Calibration and Maintenance 68
8.1 Repairable Parts 68
8.2 Equipment Disposal 68
9Manufacturer Information 68

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1 Product Description
Figure 1: VentFree
VentFree is an electrotherapy device that monitors the patient’s breathing activity using an airflow
sensor, and during the expiratory phase of breathing, applies transcutaneous neuromuscular
electrical stimulation (NMES) to the abdominal wall muscles over two stimulation channels.
Figure 2 Illustration of the VentFree muscle stimulator setup
1.1 Principles of Operation
NMES elicits muscle contractions through the delivery of small electrical pulses to the motor nerve
endings that supply a muscle. When NMES is applied to the abdominal wall muscles in synchrony

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with exhalation, the effect on ventilation is similar to a physiological contraction of the abdominal
wall muscles. An important advantage of using NMES in critically ill respiratory patients is that it
can be used to recruit the abdominal wall muscles inthe absence of patients’ voluntary or automatic
recruitment of those muscles.
1.2 VentFree Features
•Does not depend on patient participation.
•Non-invasive NMES.
•Stimulator protected against defibrillation potentials.
•Audible and visual notifications when the electrodes are not connected or if the flow
sensor is not functional.
•Simple user interface for navigating menus and manipulating settings.
•Real time graphical display of patient’s respiration.
•Two independent digital intensity controls.
•Timed therapy sessions with customizable length.
•Manual control of stimulation.
•Touch Screen operation of non-critical functions.
•Illuminated backlight display.
•Easy to clean surface.
•End of treatment review that displays the session length, starting intensity, average
intensity, and disposables information.
•Displayed battery charge level.
•Powered from rechargeable smart battery source that indicates if the remaining
charge will suffice for at least one treatment.
•Consumables tagged to ensure they are not used for more than the prescribed number
of times or used past their expiration date.
•High Impedance monitor
•Charged balance stimulation
•Current Control stimulation
•Maximum Conformance voltage monitoring
•Battery status indicator
•Battery health monitoring
•Easy to Pause Treatment button

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1.3 VentFree Indications for Use
The VentFree muscle stimulator applies transcutaneous neuromuscular electrical stimulation to
the abdominal wall muscles during the expiratory phase of breathing in conjunction with a
mechanical ventilator.
The VentFree muscle stimulator is for treatment of patients on mechanical ventilation adults
who require mechanical ventilation, including patients with COVID-19, over the duration of the
emergency use authorization. The VentFree muscle stimulator may prevent or retard disuse
atrophy of the abdominal wall muscles and reduce the number of days of ventilator support in
adults who require mechanical ventilation.
The VentFree muscle stimulator is intended to be used by healthcare professions in a healthcare
facility. It is recommended to be used for two 30 minute sessions per day (one in the morning
and one in the afternoon / evening), five days per week, for six weeks or until successful
weaning, whichever occurs sooner.
VentFree has not been FDA cleared or approved.
VentFree has been authorized by FDA under an Emergency Use
Authorization (EUA).
VentFree is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency use
under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.

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1.4 VentFree Contraindications
VentFree should NOT be used for the following situations or patients with:
●Do not use with demand type implanted pacemaker or defibrillator.
●Do not use electrical stimulation over pregnant uterus.
●Do not use on a patient with recent abdominal surgery with open abdominal wounds.
●Do not use on open or damaged skin.
●Do not use on patients under 18 years of age.
1.5 VentFree Warnings
Regional Use – ALWAYS use the AC/DC converter with the corresponding regional AC Inlet
plug .
Use Setting- This device should only be used in a hospital ICU setting.
Cleaning -Clean device with disinfectant wipe between uses (after use-before storage and
before use). Only use approved chemicals for cleaning/disinfection (refer to Section 6).
Patient Supervision - Clinicians should regularly monitor patient for adequate stimulation level
throughout the treatment.
Multiple Patient Use -If the device is used on more than one patient, the operator should follow
facility infection control procedures.
Prescription and Use – This device should only be prescribed and operated by a clinician that is
familiar with the precautionary measures and operational functions associated with the unit.
Electrode Placement- Electrodes should only be placed on the abdomen in compliance with the
directions for use (refer to Section 2)
Cutting Electrodes - Electrodes should not be cut other than as indicated by the dotted lines in
the back of the electrodes.
Reposition of Electrodes- Electrodes should not be repositioned during treatment sessions.
Throat Stimulation – Severe spasm of the laryngeal and pharyngeal muscles may occur when
the electrodes are placed across the throat or mouth. This may be strong enough to close off the
airway or cause breathing difficulty.
Transthoracic Stimulation – Do not apply electrical stimulation transthoracically (through the
chest area) in that the introduction of electrical current into the heart may cause cardiac
arrhythmias.
Other Electrode Placement -Stimulation should not be applied across or through the head,
directly on the eyes, covering the mouth, on the front of the neck(especially the carotid sinus), or
placed on the chest, upper back or crossing over the heart.
Electrical Shock – To prevent electrical shock, disconnect the unit from the power source and
remove the battery before attempting any maintenance procedures.
Accessories – Use only accessories that are specifically designed for this device. Do not use this
device with accessories manufactured by companies other than Liberate Medical. Liberate
Medical, LLC is not responsible for any consequence resulting from using products
manufactured by other companies. The use of accessories, transducers, or cables other than those
specified by the manufacturer, may result in increased emissions or decreased immunity of the
VentFree muscle stimulator.

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Defibrillation Signals – In certain circumstances, there can be risk of burns under the electrode
sites during the defibrillation.
Safety – The safety and efficacy of the VentFree system depends on the proper use and handling
of the device and accessories. If used improperly, VentFree has a potentially hazardous electrical
output. It must be used only as prescribed.
Electrode Safety-Electrode burns may result from misuse. Electrodes should be securely
adhered to the patient to prevent disconnection. Check accessories regularly as they may show
signs of wear over time and replace if needed.
Electrode Uses- Electrodes should not be shared between patients but may be reused on the
same patient.
Flow Sensor – The Flow Sensor should not be shared between patients but may be reused on the
same patient.
Mechanical Ventilation- VentFree should not be used as a replacement for a mechanical
ventilator.
Intended Use – VentFree should not be used as a replacement of any medical treatment not
specified in VentFree’s Intended Use.
Mechanical Damage (Casing/LCD) – Do not disconnect VentFree from power if casing or
LCD display becomes compromised.
Mechanical Damage (Electrode leads) –Do not touch device electronics or electrode leads if
casing or insulation becomes compromised.
Mechanical Damage (AC/DC converter) – Do not use VentFree if external AC/DC converter
enclosure is damaged.
Battery Safety – Care should be taken if signs of hazardous gaseous or liquid chemicals are
leaking from the battery.
Environment –Do not use device outside of specified environmental conditions.
Repair –Only authorized personnel can open / repair the device.
Modifications – Modifications to the VentFree device or its AC/DC converter are prohibited.
Skin Infection –Care should be taken when using electrodes on patients with skin infections
and the clinician should determine when to change the electrodes.
Network / Data Couplings – USB / DATA Ports in the connector panel of VentFree are for
Factory Use ONLY or as authorized by Liberate Medical, LLC. Any other use is strictly
prohibited.
Proximity to other Equipment –Use of this equipment adjacent to or stacked with other
equipment such as RFID equipment , Diathermy, Electrocautery and Electrosurgical Equipment
or others should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify that they are
operating normally.
Surgery – Discontinue the use of VentFree if high-frequency surgical equipment are to be used
during a stimulation session.
Diathermy treatment - Discontinue the use of VentFree if Diathermy treatment is to be
conducted during a stimulation session.
Electrocautery treatment - Discontinue the use of VentFree if Electrocautery treatment is to be
conducted during a stimulation session.

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Neurally Adjusted Ventilatory Assist (NAVA) Ventilation - Do not use device if in conjunction with
NAVA ventilation mode
1.6 VentFree Dangers
Dangerous voltage – Stimulus delivered by VentFree, in certain configurations, may deliver a
voltage of up to 100 Volts per pulse.
Biohazardous materials – Handle, clean and dispose of components and accessories that
have encountered bodily fluids according to National, Local and Facility rules, regulations
and procedures.
Stimulus delivered by the VentFree waveforms of this device, in certain configurations, will
deliver a charge of 25 micro coulombs (µC) or greater per pulse and may be sufficient to cause
electrocution. Electrical current of this magnitude must not flow through the thorax because it may
cause a cardiac arrhythmia.
Handle, clean and dispose of components and accessories that have come in contact with bodily
fluids according to National, Local and Facility rules, regulations and procedures.
1.7 Cautions
Uncomfortable Stimulation – If the stimulation levels are uncomfortable for the patient, reduce
the intensity level. Contact the prescribing physician if the problem persists.
Gastric Residual – Closely monitor any patient with suspected gastric residual.
Skin Reactions – On rare occasions, therapy can result in transient skin reactions such as rash,
inflammation, irritation, or burns. These skin reactions may be the result of individual sensitivity
to the condition of the skin at the onset of treatment, reaction to the materials in the electrodes, or
a poor connection between the electrodes and the patient’s skin. If a visible skin reaction does
occur, discontinue the treatment and consult the prescribing physician.
Skin & Vascular Problems – Do not use this device over swollen, inflamed or infected areas, or
skin eruptions.
MRI Scans – Do not allow patient to wear electrodes during Magnetic Resonance Imaging
(MRI) scans as this may result in the metal overheating causing skin burns around the patch.
Feeding Tube –Do not use device if patient is being fed through a feeding tube.
Tripping – Care should be used to avoid tripping on lead wires.
High Frequency Surgical Devices – Simultaneous connection of a patient to a high frequency
surgical device may result in burns at the site of the electrodes and possible damage to the device.

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Damage from Liquids – Do not immerse the device in water or other liquids. Water or liquids
could cause malfunction of internal components of the system, causing a risk of injury to the
patient.
Proper Electrode Size –Output current density is related to electrode size. Improper application
may result in patient injury. If any question arises as to the proper electrode size, consult a licensed
practitioner prior to therapy session.
Sedated Patients – Clinician’s discretion should be used when setting stimulation levels on
sedated patients or on skin areas with reduced sensation.
Colostomy – Patients with a colostomy should be closely monitored while using VentFree.
Heart Problems –Use caution for patients with suspected or diagnosed heart problems.
Epilepsy –Use caution for patients with suspected or diagnosed epilepsy when using this device.
Hemorrhages –Use caution when there is a tendency to hemorrhage such as following acute
trauma or fracture.
Post-Surgical Use – Use caution following recent abdominal surgical procedures when muscle
contraction may disrupt the healing process.
Sensory Loss –Use caution where sensory nerve damage is present, causing a loss of normal skin
sensation.
Unequal Electrode Size –Use caution and follow clinician instructions when using different size
electrodes together. Improper use can cause skin irritation or increased stimulation intensity under
the smaller electrode.
Keep Out of Reach of Children –Keep this device out of the reach of children.
Leads and Electrodes –Use the device with only the leads and electrodes provided for use by the
manufacturer. The safety of other products has not been established and their use could result in
injury to the patient. Use only the electrode placements and stimulation settings prescribed by your
practitioner.
Monitoring Equipment –Electronic monitoring equipment (such as ECG and ECG alarms) may
not operate properly when electrical stimulation is in use.
Flammable – Do not use the device in an environment where flammable or explosive fumes may
exist.
External Use –This device is for external use only.
Sharp Objects – Do not use sharp objects such as a pencil point or ballpoint pen to operate the
buttons on the control panel or the touch screen.
Cables and Connectors – Inspect cables and connectors before each use.
Drugs –Treatment outcome may be influenced by the patient’s use of certain drugs.
Negative Reaction to Stimulation – Patients who react negatively to the stimulation sensation
after an adequate trial period or who find stimulation intolerable should not undergo further
treatment.
Operation Conditions – This unit should be operated in temperatures between 41 °F and 95 °F
(5 °C and 35 °C), atmospheric pressure between 70 kPa to 106 kPa (10.2 psia to 15.4 psia) and
relative humidity between 10% and 95%.
Transportation & Storage Conditions – This unit should be transported and stored in
temperatures between 41 °F and 95 °F (5°C and 35°C) and relative humidity between 10% and
95%.

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Heat and Cold Products –The use of heat or cold producing devices such as electric heating
blankets, heating pads or ice packs may impair performance of the electrode or alter the patient’s
circulation/sensitivity and increase the risk of injury to the patient.
Body Mass Index (BMI)- VentFree may not be effective on patients with a BMI over 35.
External AC/DC Converter –Use only the VentFree external AC/DC converter approved by
Liberate Medical, LLC.
Gastric and Bladder Pacemaker- Use precaution when using VentFree on patients with a gastric
or bladder pacemaker.
PPE – Operators should follow facility’s IC procedures on PPE when handling patients.
EKG -Precaution shall be used when using VentFree on patients with an EKG machine.
Shaving – Medical staff should use care when shaving patients.
Device Transport – The VentFree device is installed with a lithium ion battery. Lithium Ion
batteries cannot be shipped by Air.
EMC Information -Medical Electrical Equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in this
manual.
1.8 Electrode Cautions
●DO NOT place electrodes on broken skin. If skin irritation develops, discontinue use and
consult prescribing physician
●Replace electrodes when they do not adhere or become uncomfortable.
●For single patient use only. However, the electrodes may be repositioned several times on
the same patient.
●Stimulation should not be applied transcerebrally or over the anterior neck region.
●Electrodes should ONLY be placed as described in the directions for use.
●Keep electrodes separated during treatment.
●DO NOT remove electrode by pulling on the lead wire.
●DO NOT modify electrodes other than as indicated in the instructions for use.. Using
stimulation electrodes that are too small or incorrectly applied could result in discomfort
or skin burns.
●DO NOT remove more than one electrode at a time.
●There should be no stimulation present during disconnection.
●DO NOT touch adhesive when handling electrodes.
●Electrode leads should be disinfected in between uses and prior to storage.
●Replace electrode leads if they are not fully intact.
●Replace electrodes if the gel appears dry.
1.9 Flow Sensor Cautions
●Each Flow Sensor is for single patient use only.
●Flow Sensors should be high-level disinfected prior to each use.

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●If the Flow Sensor becomes dirty, it can be washed with soap and water and then
properly disinfected unless the facility’s IC procedures indicate that the disposable be
discarded.
●Do not alter the Flow Sensor tubing.
●Follow Instructions for use provided with the Flow Sensor.
1.10 Stimulator Adverse Effects
•Skin irritation, muscle soreness and increase work of breathing, electric shock, and burns
beneath the electrodes are potential adverse reactions.

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1.11 Glossary of Symbols
Symbol
Description
Indicates European Community technical conformity and the Notified Body number
Indicates the medical device Authorized Representative in the European Community.
Refer to Instructions or User’s Manual to signify that instructions for use must be read.
Dangerous voltage – Stimulus delivered by VentFree, in certain configurations, may deliver a
voltage of up to 100 Volts per pulse.
Indicates the need for the user to consult the User’s Manual for important cautionary information
such as warnings and precautions that cannot, for a variety of reasons, be presented on VentFree
itself.
Biohazardous materials – Handle, clean and dispose of components and accessories that have
encountered bodily fluids according to National, Local and Facility rules, regulations and
procedures.
Recycle: Electronic Equipment. Do not throw in trash.
Keep Dry. Indicates that VentFree needs to be protected from moisture.
Indicates the range of humidity that VentFree can be safely exposed to.
Indicates the range of temperature that VentFree can be safely exposed to.
Indicates the range of atmospheric pressure that VentFree can be safely exposed to.
Fragile, handle with care. Indicates that VentFree can be broken or damaged if not handled
carefully.
This side up. Indicates the side of the packaging that shall be face upward to prevent damage to
the equipment.
Indicates that VentFree or its accessories should not be used if the package is damaged.
VentFree requires a prescription to be used.

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Indicates VentFree Manufacturer.
Indicates manufacturing date.
Indicates UDI (Unique Device Identifier).
Indicates manufacturing serial number.
Indicates the catalog number for VentFree and its accessories.
Indicates the identification number of manufacturing batch or lot.
Indicates the expiration or use by date of the accessories.
Indicates that VentFree or its accessories have not been subject to a sterilization process.
IP22
Indicates the degree of protection provided by the enclosure. VentFree is protected against solid
foreign objects of 12.5mm or greater (similar to fingers) and against the effects of vertically
dripping water when the enclosure is tilted at an angle of 15° from its normal position. A total of
four positions are tested within two axes.
Indicates that the electrodes and leads are Defibrillation Proof type BF applied parts.
Keep away from magnetic resonance imaging (MRI) equipment.

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2VentFree Directions for Use
2.1 Getting Started
Figure 3 shows:
●VentFree device
●External AC/DC converter
●Stimulation electrodes
●Flow Sensor
Figure 3: VentFree Components
2.2 External Power
VentFree can be battery operated or connected to an external source of power (as shown in
Figure 3). When connected to the external AC/DC converter, the battery will also be charged.
Do not use VentFree if external AC/DC converter enclosure is
damaged.
VentFree Device
Electrodes
Flow Sensor
Power Supply

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ONLY use an AC/DC converter with VentFree that is approved by
Liberate Medical, LLC.
Ensure that the location of VentFree when connected to the
AC/DC converter prevents tripping with the AC/DC converter cable and accidental
disconnections of the AC/DC converter from the Mains or from VentFree.
Ensure that the location of the Mains outlet where the AC/DC
converter will be connected to allow the converter to be readily available at all times while
connected to VentFree.
ALWAYS use the AC/DC converter with the corresponding
regional AC Inlet plug.
2.3 Electrode Setup
1. The unit must be turned off and electrodes disconnected from VentFree before and after
each treatment or as directed by prescribing physician.

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2. Clean electrode application area with soap and water or as directed by prescribing
physician. Rinse and dry. Electrodes should only be applied to intact, clean skin (e.g., not
over open wounds, lesions, infected, or inflamed areas). It is recommended that patients
with excessive body hair be shaved prior to applying electrodes.
3. Remove electrode from liner by grasping the edge of the electrode and peeling it off the
liner. Retain liner for storage.
4. The stimulation electrodes should be positioned over the posterolateral side of the
abdominal wall, so that the transverse abdominal, internal oblique, and external oblique
muscles will be stimulated. The placement of the stimulation electrodes is illustrated in
Figure 4. This configuration has been demonstrated to be the most effective method of
generating abdominal muscle contraction compared with alternative configurations.
There are two channels of stimulation with each channel comprising of two electrodes. The
blue electrodes should be placed on the proper right side of the abdomen and the gray
electrodes should be placed on the proper left side of the abdomen. Each channel of
stimulation includes an anterior ( “2” and “3” in Figure 4) and a lateral electrode ( “1” and
“4” in Figure 4). The anterior electrodes should be on the anterior superior iliac spine and
angled obliquely along the costal margin and toward the xiphoid process. The lateral
electrodes should be placed on the intersection between the posterior midaxillary line and
the iliac crest and angled toward the midaxillary line. The electrodes should bilaterally
symmetrical. Small adaptations of the electrode configuration can be made based on
individual anatomical differences.
CAUTION: Electrodes are single patient use ONLY
CAUTION: Electrodes MUST NOT be placed over broken skin
5. Attach lead wire to unit and begin treatment.
6. Following treatment, turn the unit off.
7. Remove electrode from skin by peeling electrode edge.
8. Return electrode to liner.
9. Disinfect the top of the electrode pads with disinfectant wipe.
10. Place the liner with electrode in the storage bag.

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Figure 4. Optimal Electrode Placement