BIO-MED DEVICES TV-100 User manual

Bio-Med Devices Inc.
TV-100 Operator's Manual
Catalog Number: 5501
Revision: 041122
61 Soundview Road, Guilford, CT 06437
Telephone: [phone]
Fax: [phone]
Website: www.biomeddevices.com

Table of Contents
About this Manual ........................................................................................................................................ 7
I. Scope...................................................................................................................................................... 7
II. Indications for Use / Intended Use ....................................................................................................... 7
CONTRAINDICATIONS ........................................................................................................................... 7
III. Organization of this Manual................................................................................................................. 7
About this Manual................................................................................................................................. 7
Chapter 1: Installation........................................................................................................................... 7
Chapter 2: Principles of Operation ....................................................................................................... 8
Chapter 3: User Interface...................................................................................................................... 8
Chapter 4: Performance Checkout Procedures .................................................................................... 8
Chapter 5: Alarm Handling.................................................................................................................... 8
Chapter 6: Troubleshooting .................................................................................................................. 8
Chapter 7: Specifications ...................................................................................................................... 8
IV. Symbols................................................................................................................................................ 9
V. Abbreviations......................................................................................................................................12
VI. Safety Statement ...............................................................................................................................14
VII. Warnings, Cautions, and Notices...................................................................................................... 15
Document Conventions for Warnings, Cautions, and Notices ...........................................................15
WARNINGS .......................................................................................................................................... 15
CAUTIONS ........................................................................................................................................... 19
NOTICES ..............................................................................................................................................20
VIII. Contact Information ........................................................................................................................ 22
IX. Recommended Maintenance Schedule .............................................................................................23
Chapter 1: Installation.................................................................................................................................24
1.1 Unpacking ......................................................................................................................................... 24
1.2 Accessories........................................................................................................................................ 24
1.3 Cleaning and Sterilization .................................................................................................................25
1.3.1 LCD Touchscreen Keypad ........................................................................................................... 25
1.3.2 Patient Circuit.............................................................................................................................25
1.4 Batteries............................................................................................................................................26
1.4.1 Battery Overview .......................................................................................................................26
1.4.2 Battery Installation and Initial Charge .......................................................................................28
1.5 Patient Circuit Connection ................................................................................................................29

Table of Contents
1.6 USB Dock / Software Update Connection......................................................................................... 30
1.7 Training Recommendations ..............................................................................................................30
Chapter 2: Principles of Operation ............................................................................................................. 31
2.1 General Overview ............................................................................................................................. 31
2.2 Phases of Breath ...............................................................................................................................32
2.2.1 Inspiration .................................................................................................................................. 32
2.2.2 Expiration ................................................................................................................................... 32
2.3 Breath Types ..................................................................................................................................... 33
2.3.1 Assisted Breath ..........................................................................................................................33
2.3.2 Mandatory Breath...................................................................................................................... 33
2.3.3 Manual Breath ...........................................................................................................................33
2.3.4 Sigh Breath ................................................................................................................................. 33
2.3.5 Spontaneous Breath................................................................................................................... 34
2.4 Ventilation Controls .......................................................................................................................... 34
2.4.1 Volume Control .......................................................................................................................... 34
2.4.2 Pressure Control......................................................................................................................... 35
2.4.3 Pressure Support........................................................................................................................ 37
2.5 Ventilation Modes.............................................................................................................................37
2.5.1 A/C Mode (Assist/Control).........................................................................................................37
2.5.2 CPAP Mode (Continuous Positive Airway Pressure).................................................................. 37
2.5.3 NIV Mode (Non-invasive Ventilation) ........................................................................................38
2.5.4 SIMV Mode (Synchronized Intermittent Mandatory Ventilation) ............................................. 39
2.5.5 PRVC-AC Mode (Pressure Regulated Volume Control – Assist Control).................................... 40
2.5.6 nCPAP/HFNC (High Flow Nasal Cannula) Mode......................................................................... 41
2.5.7 Apnea Detection ........................................................................................................................ 41
2.5.8 Standby Mode............................................................................................................................ 42
2.6 Oxygen Delivery ................................................................................................................................
42
2.6.1 Oxygen Controls......................................................................................................................... 42
2.6.2 Oxygen Source ...........................................................................................................................42
2.6.3 Oxygen .......................................................................................................................................43
Chapter 3: User Interface............................................................................................................................ 44
3.1 Physical Interface ..............................................................................................................................44
3.1.1 Case Overview............................................................................................................................ 44

Table of Contents
3.2 Graphical User Interface (GUI).......................................................................................................... 46
3.2.1 Startup........................................................................................................................................ 46
3.2.2 Setup Assistant........................................................................................................................... 49
3.2.3 Popup Menus ............................................................................................................................. 51
3.2.4 Status Bar ................................................................................................................................... 55
3.2.5 Main Page .................................................................................................................................. 58
3.2.6 Parameters................................................................................................................................. 60
3.2.7 Alarms Page................................................................................................................................64
3.2.8 Monitoring Page.........................................................................................................................67
3.2.9 Lung Mechanics Page................................................................................................................. 68
3.2.10 Graphs Page .............................................................................................................................69
3.2.11 Tools Page ................................................................................................................................71
Chapter 4: Performance Checkout Procedures .......................................................................................... 73
4.1 General Overview ............................................................................................................................. 73
4.2 Touchscreen Calibration ................................................................................................................... 73
4.3 Oxygen Calibration............................................................................................................................ 74
4.4 Leak Test ...........................................................................................................................................75
4.5 Compliance Measurement................................................................................................................ 76
4.6 Audio & Alarm Test ........................................................................................................................... 78
4.7 Resistance Measurement ................................................................................................................. 78
Chapter 5: Alarm Handling.......................................................................................................................... 80
5.1 General Overview ............................................................................................................................. 80
5.2 High Priority Alarms ..........................................................................................................................80
5.3 Medium Priority Alarms....................................................................................................................81
5.4 Alarm Silence and Alarm Inhibition .................................................................................................. 81
5.4.1 Alarm Silence ............................................................................................................................. 81
5.4.2 Alarm Inhibition .........................................................................................................................
81
5.5 Displaying Alarms.............................................................................................................................. 82
5.5.1 Patient Parameter Alarms.......................................................................................................... 82
5.5.2 Alarms Tab .................................................................................................................................82
5.5.3 Warning Popup .......................................................................................................................... 82
5.6 Alarm Parameter Ranges and Alarm Limits ...................................................................................... 85
5.7 Default Alarm Values ........................................................................................................................ 86

Table of Contents
Chapter 6: Troubleshooting ........................................................................................................................89
Chapter 7: Specifications ............................................................................................................................90
7.1 Specifications ....................................................................................................................................90
7.1.1 Default Parameter Values..........................................................................................................91
7.2 Operating and Storage / Shipping Environment............................................................................... 95
7.3 Electrical Specifications.....................................................................................................................95
7.4 Physical and Material Characteristics ............................................................................................... 95
7.5 Pneumatic Characteristics.................................................................................................................96
7.6 EN 60601-1 Safety Ratings ................................................................................................................97
7.7 AC Adapters and Inverters ................................................................................................................97
7.7.1 Land Operation ..........................................................................................................................98
7.7.2 Air Operation – Fixed or Rotary Wing Aircraft...........................................................................98
7.7.3 Inverter Operation .....................................................................................................................98
7.8 EMC Compatibility ............................................................................................................................ 99
7.8.1 Additional Guidance and Manufacturer’s Declaration – Electromagnetic Emissions/Immunity
............................................................................................................................................................ 99
7.9 Device Lifetime & End-of-Life Disposal...........................................................................................102
7.9.1 Disassembly Hazards (for service or EOL device disposal)....................................................... 103
Addendum A ............................................................................................................................................. 104
Additional Information per IEC 60601-1 & 60601-1-8 Standards......................................................... 104

Bio-Med Devices, Inc. Page 7
About this Manual
I. Scope
This manual describes the features and operation of Bio-Med Devices Inc. TV-100 ventilator. To help
ensure patient safety and proper performance of the TV-100, read and familiarize yourself with this
manual before operating the TV-100.
II. Indications for Use / Intended Use
The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous
ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both
invasive and non-invasive ventilation modes. The TV-100 is a transportable device, but can also be used
in a fixed or permanently-installed installation. The TV-100 is intended for use in hospital including intra-
hospital transport, pre-hospital, and air transport settings.The TV-100 is intended for use in ground /
road ambulances and in air ambulances (both helicopters and fixed-wing aircraft).
CONTRAINDICATIONS
There are no direct contraindications for mechanical ventilation as it is a life-saving measure in a
critically ill patient, and all patients should be offered the opportunity to benefit from this if needed. The
only absolute contraindication for mechanical ventilation is if it is against the patient's stated wishes for
artificial life-sustaining measures. The only relative contraindication is if non-invasive ventilation is
available and its use is expected to resolve the need for mechanical ventilation. This should be started
first as it has fewer complications than mechanical ventilation.1
III. Organization of this Manual
About this Manual
This section provides introductory information about the TV-100. This section includes scope, intended
use, symbols, abbreviations, and safety information.
Chapter 1: Installation
This section provides information on unpacking, installing, and connecting the TV-100 ventilator;
provides a list of the accessories included with the TV-100; provides information on the TV-100; and
provides cleaning and sterilization information.
1. Ventilator Management, Andres L. Mora Carpio; Jorge I. Mora. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK448186

About this Manual
Bio-Med Devices, Inc. Page 8
Chapter 2: Principles of Operation
This section provides a detailed description of the TV-100 principles of operation.
Chapter 3: User Interface
This section provides a detailed description of the TV-100 user interface.
Chapter 4: Performance Checkout Procedures
This section provides procedures to set up and test the TV-100 prior to patient use.
Chapter 5: Alarm Handling
This section provides a detailed description of how to recognize and respond to TV-100 alarm
conditions.
Chapter 6: Troubleshooting
This section provides a top level troubleshooting guide for the TV-100.
Chapter 7: Specifications
This section provides TV-100 product specifications. This section also provides information on operating
environment, physical and pneumatic characteristics of the unit, AC adapters and inverters, and EMC
compatibility.

About this Manual
Bio-Med Devices, Inc. Page 9
IV. Symbols
Symbol
Description
Alarm Silence
Type BF Equipment
Manufacturer
Date of Manufacture
MR Unsafe
Direct Current
Warning
Caution
Notice
Consult Accompanying Documents
Follow Instructions for Use
Power On / Off
Must be disposed of in accordance with WEEE Directive. At the unit’s “end of life”, it
may be returned to the manufacturer for proper reclamation.

About this Manual
Bio-Med Devices, Inc. Page 10
Symbol
Description
Rx Only
Caution: Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner
EC Representative
Patient Output Connector
Flow Sensor Connector
Exhalation Valve Connector
Airway Pressure Connector
O2Connector
Do Not Obstruct
Product should be kept dry
The CE mark displayed on this product signifies that this device is in compliance with
the European Medical Devices Regulation (2017/745). As a prerequisite for the CE
mark, Bio-Med Devices operates under an ISO 13485 compliant quality system
(covering the design and manufacture of medical devices). The four-digit code
underlying the CE mark (2797) pertains to Bio-Med's Notified Body, the British
Standards Institute, whose function is to investigate and attest to the validity of CE-
mark claims.
Humidity Limitation

About this Manual
Bio-Med Devices, Inc. Page 11
Symbol
Description
Temperature Limit
Country of Origin & Manufacture
Medical Device
Unique Device Identifier
Contains Hazardous Substances (see Section 7.4 Physical and Material
Characteristics)

About this Manual
Bio-Med Devices, Inc. Page 12
V. Abbreviations
Abbreviation
Definition
A/C
assist/control
AC
alternating current
Ah
amp-hour
BPH
breaths per hour
BPM
breaths per minute
C
degrees Celsius
CCW
counter-clockwise
cm
centimeter
cmH2O
centimeters of water pressure
CPAP
continuous positive airway pressure
CW
clockwise
DARV
diaphragm actuated relief valve
dB
decibel
DC
direct current
E-Time, E, or EXP
expiratory time
ESD
electrostatic discharge
ESDS
electrostatic discharge sensitivity
Exh
exhalation
F
degrees Fahrenheit
Hz
hertz (cycles per second)
I:E Ratio
inspiratory to expiratory ratio
I-Time, I, or INSP
inspiratory time
kg
kilogram
kPa
kilopascal
L
liter
lbs
pounds
LCD
liquid crystal display

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Bio-Med Devices, Inc. Page 13
Abbreviation
Definition
LED
light emitting diode
LPM
liters per minute
mA
milliamp
mL
milliliter
mm
millimeter
MRI
magnetic resonance imaging
ms
millisecond
mV
millivolt
MV
minute volume
MVe
exhaled minute volume
N/A
not applicable
Paw
pressure at the patient connector (airway pressure)
PCB
printed circuit board
PEEP
positive end expiratory pressure
PIP
peak inspiratory pressure
P/N
part number
PSI
pounds per square inch
SIMV
synchronized intermittent mandatory ventilation
Sec
second
SN
serial number
Te
expiratory time
Ti
inspiratory time
UI
user interface
VA
volt amp
VAC
volt alternating current
VDC
volt direct current
VER
software version
VT
tidal volume
VTe
exhaled tidal volume
W
watt

About this Manual
Bio-Med Devices, Inc. Page 14
VI. Safety Statement
Bio-Med Devices, Inc. TV-100 ventilator performs in conformity with the specifications and descriptions
contained in this manual, when operated in accordance with the information provided herein.
It is your responsibility to read and familiarize yourself with this manual before operating Bio-Med
Devices, Inc. TV-100 ventilator. The TV-100 should only be used by qualified medical personnel.
Attempting to use the TV-100 without a comprehensive understanding of its operation may result in
patient injury.
Upon receipt of the TV-100, and periodically thereafter, complete the procedures detailed in Chapter 4:
Ventilator Performance Checkout Procedures. While it is not necessary to perform a leak test,
compliance test, or oxygen calibration prior to every use when using a Bio-Med Devices, Inc. circuit, the
leak test can be performed if the user wants to verify the integrity of the circuit. If the TV-100 fails
during a checkout procedure remove the TV-100 from use, contact Bio-Med Devices, Inc., and return the
unit to be serviced by a qualified technician.

About this Manual
Bio-Med Devices, Inc. Page 15
VII. Warnings, Cautions, and Notices
Document Conventions for Warnings, Cautions, and Notices
Warnings, cautions, and notices are presented in this manual in a format dissimilar to their surrounding
text in order to clearly delineate the important information provided by these messages. An example of
each message is presented below:
WARNING: When the ventilator is connected to a patient, qualified medical personnel should
be present at all times, or within hearing range of the ventilator alarm system.
CAUTION: Touchscreen control buttons should be pressed by hand only. Care should be
taken not to allow buttons to be contacted by sharp objects, as damage may result.
NOTICE: The batteries should be replaced at least every 2 years. Only use batteries supplied
by Bio-Med Devices, Inc. part number PRT5567.
WARNINGS
•When the ventilator is connected to a patient, qualified medical personnel should be present at all
times, or within hearing range of the ventilator alarm system. Failure to be in close proximity to
the ventilator can contribute to a patient death or serious injury.
•In case of ventilator failure, the lack of immediate access to appropriate alternative means of
ventilation can result in patient death. In transport / EMS situations, the alternative life supporting
method would usually be a manual resuscitator bag. For longer periods of usage time, e.g. in case
of ventilator failure in a hospital setting, another ventilator should be used to replace the original
ventilator.
•Only qualified medical personnel should operate the TV-100.
•The operating instructions provided in this manual are not intended as recommended clinical
protocols.
•Do not attempt to ventilate a patient until thoroughly familiar with the operating instructions.
•Always test the TV-100 prior to use. Ventilate a test lung to verify proper operation prior to
connecting the TV-100 to a patient.
•If the TV-100 fails a checkout procedure discontinue use, Bio-Med Devices, Inc. technical support
should be contacted, and the TV-100 should be serviced by a qualified technician.
•If a ventilator malfunction should occur, Bio-Med Devices, Inc. technical support should be
contacted, the TV-100 should be removed from use and serviced prior to use on another patient.
•Only qualified, trained, service technicians should attempt repairs and service when necessary.
Serious personal injury and/or equipment damage can result if repairs are performed by
unqualified personnel.
•If a system error persists after cycling power remove the TV-100 from use and contact Bio-Med
Devices, Inc. technical support.

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Bio-Med Devices, Inc. Page 16
•Do not connect the TV-100 to a patient or ventilate a patient if there is any connection made to
the USB dock. Do not make any connection to the USB dock while ventilating a patient.
•If the TV-100 is connected to a PC via the USB dock, starting TV-100 Utility while the TV-100 is
powered on will turn off TV-100 power.
•Whenever an alarm condition exists it should be rectified immediately. Do not allow ventilation
for an extended length of time with an alarm condition.
•Alarm limits set by alarm auto set may need to be adjusted manually. Verify that clinically
appropriate alarm limits are set prior to connecting the TV-100 to a patient.
•VTe and MVe alarm limits are not set in alarm auto set functionality. Verify that clinically
appropriate VTe and MVe alarm limits are set prior to connecting the TV-100 to a patient.
•It is imperative to verify that clinically appropriate alarm limits are fully operational following
connection of the ventilator to a patient.
•The patient should not be left unattended after the alarm silence key is pressed as this will be
followed by a period when the audible alarms are deactivated.
•The alarm port on the TV-100 should never be obstructed.
•In the event of an AC power failure, the TV-100 will automatically switch to battery operation and
sound an alarm. The audible alarm may be silenced by pressing the alarm silence button, which
will be flashing. On fully charged batteries, there will be approximately 7 hours of battery powered
operation. No further lost external power alarm will sound until the low battery alarm. The low
battery alarm may be temporarily silenced by pressing the alarm silence button. It is imperative to
restore external power at this time to assure continued safe operation of the ventilator.
•Rapid blinking of the battery charge indicator LED indicates a problem charging; Bio-Med Devices,
Inc. technical support should be contacted.
•It is extremely important that the pressure trigger control be carefully adjusted to assure proper
operation in the SIMV and CPAP modes.
•In CPAP mode manual breaths will be delivered according to the set value of the backup breath. It
is important that the backup ventilation parameters be carefully adjusted to assure proper
operation of the manual breath feature.
•Under certain conditions in SIMV, with PEEP, even though the low peak pressure alarm is set
correctly for assisted breaths there may be no low peak pressure alarm following a patient
disconnect until the next delivered assisted breath. This period can be up to one minute. As an
added precaution, set the low PEEP/CPAP and low exhaled tidal volume alarms so that they are
appropriately operative.
•Always be certain that the maximum pressure limit is set correctly and is operative even when
volume limiting to prevent possible inadvertent administration of high pressure. Increased
pressure can be caused by blockage, changes in patient compliance or resistance, or system
malfunction.
•In standby mode if the control pressure is set to a value greater than the peak pressure high alarm
limit, then the TV-100 will set the high alarm limit 1 cmH2O above the control pressure value.
•If the pressure at the patient connector exceeds the peak pressure high alarm limit, then the TV-
100 will initiate pressure cycle to the set PEEP.

About this Manual
Bio-Med Devices, Inc. Page 17
•Operation of the TV-100 in a contaminated environment can be hazardous to the patient.
•A patient filter should always be used in the patient breathing circuit to prevent cross
contamination.
•Do not re-use disposable breathing circuits. Re-use of disposable (single-use) breathing circuits can
result in contamination (patient infection) or circuit degradation (circuit can fall apart, develop
holes, or exhibit polymer decay).
•Extreme care should be taken to assure that the patient circuit components are connected
correctly. Improper connection can cause ventilator malfunction.
•The exhaled volume of the patient can differ from the measured exhaled volume due to leaks
around the mask, or any other leaks in the breathing circuit.
•If CO2monitoring equipment is used with the ventilator for the measurement of expiratory carbon
dioxide concentration, e.g., in the expiratory limb or at the patient connection port, it should be
used in accordance with the standard BS EN ISO 80601-2-55 before being put into service.
•Do not apply tension to the flow sensor tubing. The flow sensor should not be in the patient circuit
when not connected to the ventilator.
•Do not operate the TV-100 without batteries since it will fail to operate if the external power
supply is disconnected.
•The TV-100 battery will require increased time to charge if the battery is depleted to less than 1%
of charge capacity.
•The battery will not charge above 54 degrees Celsius (131 degrees Fahrenheit).
•Extended exposure to temperatures above 45 degrees Celsius can degrade battery performance
and life.
•Breathing through the negative pressure relief valve requires greatly increased work of breathing
and only air is provided. A situation in which the patient is breathing through this valve should be
rectified immediately in order to prevent possible adverse effects to the patient.
•The TV-100 shall not be covered or positioned in such a way that the operation or performance of
the TV-100 is adversely affected. Do not position the TV-100 in such a way that there is a risk of
overheating. Do not block the gas intake port or emergency intake port.
•If the gas supply fails or there is a total electrical power failure, the patient may breathe
atmospheric gas through the emergency intake port. This is, however, only a temporary
emergency measure, which requires elevated inspiratory effort and it should be corrected
immediately.
•Adding attachments or other components or sub assemblies to the ventilator breathing system
can change the pressure gradient across the ventilator breathing system, and such changes to the
ventilator breathing system can adversely affect the ventilator performance.
•Do not add any attachments or accessories to the ventilator that contravene the instructions for
use of the ventilator or accessory, as the ventilator might not function correctly, leading to the risk
of patient death or serious deterioration of health.
•Nebulization or humidification can increase the resistance of breathing system filters, and the
operator needs to monitor the breathing system filter frequently for increased resistance and
blockage.

About this Manual
Bio-Med Devices, Inc. Page 18
•When using nebulization or humidification, breathing system filters and heat-and-moisture
exchangers can require more frequent replacement to prevent increased resistance and blockage.
•The accuracy of the ventilator can be affected by the gas added by use of a nebulizer.
•The TV-100 should be used while it is in an upright position.
•Do not continue to use a ventilator which has been seriously impacted or abused.
•To avoid risk of electrical shock when using the TV-100 with AC power connected, this equipment
must only be connected to a supply mains with protective earth.
•Because this is a CE marked device, the TV-100 must never be modified without prior expressed
written consent from Bio-Med Devices, Inc.
•If using this ventilator in conjunction with a humidifier, a temperature monitor with alarm must be
used if such a monitor is not a part of the base humidifier unit.
•Outside of the recommended pressure range for oxygen input of 40-90 PSI, the delivered oxygen
concentration to the patient cannot be guaranteed to remain in specification, in which case an
output delivered-oxygen limit alarm would sound. However, the dedicated alarm for low oxygen
input pressure does not activate until the input pressure falls to 29 PSI, to forestall recurring
nuisance alarms when hospital oxygen supplies are overtaxed facility-wide (e.g., in pandemic
situations). Thus when the input pressure falls outside the range 29-90 PSI, the TV-100 will display
an O2Pressure Inlet Out of Range alarm condition. The alarm condition should be corrected as
quickly as possible.
•For units with the low pressure oxygen concentrator available as the oxygen source (not available
in all regions), the required input pressure range includes 1-32 PSI. When the pressure falls
outside that range, the TV-100 will display an O2Pressure Inlet Out of Range alarm condition. The
alarm condition should be corrected as quickly as possible.
•This device is MR unsafe and not to be used in an MRI environment.
•Do not use in a hyperbaric chamber. Such use might impair ventilator function, possibly causing
patient death or serious injury.
•The ventilator shall not be used with inlet gases, which are not specified for use (e.g. helium or
mixtures with helium). Such use might cause the ventilator to not function correctly, leading to
the risk of patient death or serious deterioration of health.
•The initial charge of the TV-100 battery will be 30% or less of the rated capacity in accordance
with IATA transport safety guidelines. The battery should be charged fully prior to operating the
TV-100 ventilator.
•Volume-limited ventilators should not be used on unattended patients.
•Avoid exposure to known sources of EMI (electromagnetic interference) with medical devices such
as magnetic resonance imaging MRI systems, diathermy, lithotripsy, electrocautery, RFID (Radio
Frequency Identification), and electromagnetic security systems such as metal detectors. Note
that the presence of RFID devices may not be obvious.
•If the ventilator is dropped, it should be examined by qualified personnel for both external and
internal damage. A complete checkout should be performed before returning the ventilator to
service.

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Bio-Med Devices, Inc. Page 19
•It is the responsibility of the responsible user organization to ensure that the oxygen source is
compatible with the rated range of pressure, flowrate and oxygen concentration as marked on the
ventilator and indicated in the instructions for use, as this can affect the performance of the
ventilator that can consequently result in patient death or serious deterioration of health.
•Do not use this ventilator in explosive environments. Such use might cause an explosion.
•Do not attempt to service or perform maintenance (except swapping a single battery) while the
ventilator is in use.
CAUTIONS
•Only replace the battery pack with Bio-Med Devices, Inc. part number PRT5567. Do not substitute.
•The battery pack thermal fuse goes open circuit and non-resettable (rendering the battery non-
functional) if the cell case temperature reaches 93 degrees Celsius (200 degrees Fahrenheit).
•When using an AC power source, only the power supply provided with the TV-100 is approved for
use with this ventilator. Any other power supply may cause damage and/or unreliable operation.
•Any more comprehensive DC power supply than that which is supplied must be short circuit
protected and must comply with all of the specifications as listed in Chapter 7: Specifications.
•When it is necessary to operate the TV-100 from an AC inverter, only inverters in compliance with
NEMA standards should be used.
•Touchscreen control buttons should be pressed by hand only. Care should be taken not to allow
buttons to be contacted by sharp objects, as damage may result.
•Do not place liquids on or near the TV-100. Liquid entering the unit can cause severe damage and
malfunction.
•Do not position the equipment in such a way as to make it difficult to operate the disconnect
device (applies to either end of power cord: the wall plug or the connector to the AC adapter).
•Antistatic or electrically conductive hoses or tubing should not be used with the TV-100.
•Under no circumstances should the TV-100 unit be gas sterilized, steam autoclaved, or submerged
in liquid. The components of the unit are incompatible with these sterilization methods and
severe damage can result.
•Moisture or dirt can affect the operation of the TV-100. Any input oxygen supply source must
always be clean and dry; the oxygen should be “medical oxygen” per FDA terminology, that is, at
least 99.0% pure. The oxygen also must contain < 37.5 milligrams of water per cubic meter of gas
(mg/m3) or < 50 ppm H2O.
•When using a low pressure oxygen source option, the maximum attainable FiO2will be limited by
the oxygen flow limits, the oxygen purity, and the MVE.
•When utilizing an oxygen concentrator, the oxygen concentration may not be constant due to
limitations in flow, pressure, purity and concentration of the supplied oxygen. The inspired
oxygen concentration will vary, depending on the pressures, volumes, flows and circuit leak.
•Portable and mobile RF communications equipment can affect medical electronic equipment.

About this Manual
Bio-Med Devices, Inc. Page 20
NOTICES
•In nCPAP/HFNC or HFNC mode on, pressure trigger and pressure support are inoperative.
Additionally, peak pressure and PEEP read continuous pressure during CPAP mode.
•The maximum pressure should always be set higher than PEEP in order to achieve the PEEP
setting.
•It is recommended that an external filter be used at all times in order to provide greater
protection to the internal components of the TV-100.
•If a patient filter is not used there is a possibility of contamination with bodily fluids or expired
gases during normal or single fault condition to the following components in the gas pathway:
pressure relief valve assembly, oxygen sensor, mass flow sensor, main proportional valve,
compressor assembly, and input manifold.
•If the ventilator is contaminated internally due to use without a patient filter, do not attempt to
clean the internal components of the device. Instead, return the ventilator to the factory for
evaluation.
•When using a patient filter connect it directly to the patient connector then connect the patient
circuit.
•Due to the fact that O2sensors sometimes change output over time once exposed to atmosphere,
a calibration should be performed periodically (once a month) in order to assure optimal accuracy.
When the sensor is consumed and does not calibrate properly, it should be discarded and a new
sensor installed and calibrated.
•The batteries should be replaced at least every 2 years. Only use batteries supplied by Bio-Med
Devices, Inc., part number PRT5567.
•The TV-100 is capable of approximately 7 hours of operation with fully charged batteries under
typical patient parameters.
•When running with two batteries installed, approximately 20 minutes of operation will remain
after the second low battery alarm (charge below 10%) assuming properly maintained batteries in
good condition.
•Prior to disposal of any component, with particular attention to the batteries and PCB, check with
your local controlling authority for disposal regulations.
•Only you may make a claim against the carrier for damage occurring in shipment. Notify the
carrier if any damage is observed.
•Non Bio-Med Devices, Inc. brand circuit compliance data is unknown, and volume compensation
will be unavailable until the circuit compliance is measured.
•The TV-100 is equipped with automatic barometric pressure compensation for measured exhaled
tidal volume.
•TV-100 components in contact with respiratory gases are shipped from the manufacturer clean,
but not sterilized.
•Some portion of any oxygen supplied to the oxygen high pressure gas inlet is used as “fresh gas”
(i.e. patient gas, gas supplied to the ventilator breathing system) if the delivered oxygen
percentage is set above 21%.