BIO-MED DEVICES TV-100 Operator's Manual
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BIO-MED DEVICES TV-100 Operator's Manual

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Bio-Med Devices Inc.
TV-100 Operator's Manual
Catalog Number: 5501
Revision: 041122
61 Soundview Road, Guilford, CT 06437
Telephone: 800-224-6633
Fax: 203-458-0440
Website: www.biomeddevices.com

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  • Page 1 Bio-Med Devices Inc. TV-100 Operator's Manual Catalog Number: 5501 Revision: 041122 61 Soundview Road, Guilford, CT 06437 Telephone: 800-224-6633 Fax: 203-458-0440 Website: www.biomeddevices.com...

  • Page 3: Table Of Contents

    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 ........................
  • Page 4 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 .............................
  • Page 5 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 .........................
  • Page 6 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.........................

  • Page 7: About This Manual

    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.

  • Page 8: Chapter 2: Principles Of Operation

    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.

  • Page 9: Symbols

    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. Bio-Med Devices, Inc. Page 9...
  • Page 10 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...
  • Page 11 About this Manual Symbol Description Temperature Limit Country of Origin & Manufacture Medical Device Unique Device Identifier Contains Hazardous Substances (see Section 7.4 Physical and Material Characteristics) Bio-Med Devices, Inc. Page 11...

  • Page 12: Abbreviations

    E-Time, E, or EXP expiratory time electrostatic discharge ESDS electrostatic discharge sensitivity exhalation degrees Fahrenheit hertz (cycles per second) I:E Ratio inspiratory to expiratory ratio I-Time, I, or INSP inspiratory time kilogram kilopascal liter pounds liquid crystal display Bio-Med Devices, Inc. Page 12...
  • Page 13 SIMV synchronized intermittent mandatory ventilation second serial number expiratory time inspiratory time user interface volt amp volt alternating current volt direct current software version tidal volume exhaled tidal volume watt Bio-Med Devices, Inc. Page 13...

  • Page 14: Safety Statement

    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.

  • Page 15: Warnings, Cautions, And Notices

    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. •...
  • Page 16 About this Manual • 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 •...
  • Page 17 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.
  • Page 18 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 •...

  • Page 19: Cautions

    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. •...

  • Page 20: Notices

    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.
  • Page 21 Exposure to sunlight should not have any appreciable effect on the ventilator. When using the ventilator for extended periods of time in a high dust environment the external • filter should be changed more frequently. Bio-Med Devices, Inc. Page 21...

  • Page 22: Contact Information

    1911JA Uitgeest The Netherlands Telephone: +31 251 316358 Service If service is required in the USA, the TV-100 must be properly packed and shipped pre-paid, directly or through your dealer, to the address below. Bio-Med Devices, Inc. 61 Soundview Road...

  • Page 23: Recommended Maintenance Schedule

    About this Manual IX. Recommended Maintenance Schedule Periodic preventative maintenance should be performed to insure continued proper operation of the TV-100 Ventilator. The frequency of preventative maintenance is determined by many factors, some of which are: • Frequency & length of use •...

  • Page 24: Chapter 1: Installation

    Notify the carrier if any damage to the product is observed. 1.2 Accessories The following is a list of basic accessories which can be used in conjunction with the TV-100 ventilator. Based on the options ordered, some of these will be included in the TV-100 shipping carton. Optional TV-100 accessories may be found on our website at www.biomeddevices.com, or by contacting Bio-Med...

  • Page 25: Cleaning And Sterilization

    1.3.1 LCD Touchscreen Keypad The touchscreen of the TV-100 is made of transparent plastic and may be damaged by chemical solvents and abrasive cleaners. Great care should be taken not to touch it with sharp objects, since it may be punctured, which could damage the touchscreen.

  • Page 26: Batteries

    TV-100 batteries run in parallel. This allows the user to swap out one of the batteries and still safely operate the TV-100 on battery power when the TV-100 is not connected to external power.
  • Page 27 WARNING: Extended exposure to temperatures above 45 degrees Celsius can degrade battery performance and life. WARNING: 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.

  • Page 28: Battery Installation And Initial Charge

    1.1 below). 3. Repeat the above steps to install second battery. 4. Place the TV-100 within reach of a power outlet. Lock the AC adapter into AC adapter mount on the TV-100. 5. Plug the AC adapter into the TV-100 external power connector. The plug is keyed and the alignment notch on both connectors must be aligned before engaging (See Figure 1.2 below).

  • Page 29: Patient Circuit Connection

    Chapter 1: Installation 1.5 Patient Circuit Connection The patient circuit is made up of external components that route gas from the TV-100 to the patient. The breathing circuit will differ depending on the patient. Bio-Med Devices, Inc. adult disposable breathing circuit (BMD P/N 80011) is illustrated below.

  • Page 30: Usb Dock / Software Update Connection

    Bio-Med Devices also recommends further video training, available at www.biomeddevices.com. Training should be refreshed annually at a minimum, if the medical professional is not a regular user of the TV-100 ventilator.

  • Page 31: Chapter 2: Principles Of Operation

    The TV-100 is easy to mount in an ambulance or to a transport incubator, and it is easy to transport via its built in handle and mounting bracket. The TV-100 features an internal compressor which allows the TV-100 to operate without the need for external pressurized air supply;...

  • Page 32: Phases Of Breath

    2.2 Phases of Breath 2.2.1 Inspiration Inspiration is the phase of a breath where air is flowing into the patient’s lungs. The TV-100 supplies this flow during normal ventilator operation. The flow waveform depends on the breath type and the control method (i.e., volume control, pressure control).

  • Page 33: Breath Types

    These limits may result in the TV-100 delivering a sigh breath with less than a 30 percent increase in volume. When using pressure control, a sigh breath will deliver an additional 10 cmH O pressure above the peak pressure of the previous breath.

  • Page 34: Spontaneous Breath

    1.5 seconds or longer). In the Peds/Adult CPAP Mode the maximum allowable inspiratory time is 3.0 seconds. During the expiratory phase, the TV-100 permits the patient to exhale freely above the set baseline pressure level. Expiration lasts until the patient triggers another breath, or the TV-100 triggers a breath according to the set rate.

  • Page 35: Pressure Control

    I-Time. The TV-100 delivers flow as needed to maintain the set pressure for the duration of the inspiratory phase. The set pressure will be referenced to PEEP. Figure 2.2 below illustrates a TV-100 pressure control waveform, as well as patient triggered breaths.
  • Page 36 10,000 rpm as the baseline in this particular case. Subtracting 10,000 rpm from the maximum motor speed of 32,000 rpm and dividing by 8 gives 2,750 rpm for every incremental change in the I-Rise time setting. In summary for this example, the TV-100 would operate as follows:...

  • Page 37: Pressure Support

    PEEP. The TV-100 then delivers flow in a decelerating pattern to maintain the set pressure support level for the duration of the inspiratory phase. Inspiration will be terminated when 2 times the set Inspiratory time has been reached or if the patient begins to exhale prior to the above criteria being met, pressure will rise above the pressure support level and the TV-100 will pressure cycle.

  • Page 38: Niv Mode (Non-Invasive Ventilation)

    Pressure support breaths are triggered by the flow sensor; or if there is no flow sensor present, via the airway pressure line. If the TV-100 determines the patient has not initiated a breath within the apnea delay time interval, the TV-100 will begin apnea ventilation and the apnea alarm will actuate.

  • Page 39: Simv Mode (Synchronized Intermittent Mandatory Ventilation)

    TV-100 will not deliver a controlled breath. If a rate is set in NIV Mode, because you are expecting the patient to have a spontaneous respiratory effort, the rate should be set to a level lower than the actual patient’s rate.

  • Page 40: Prvc-Ac Mode (Pressure Regulated Volume Control - Assist Control)

    Controlled breaths are triggered based on the set ventilation rate. If flow cycle is turned on, the TV-100 will cycle the breath based on a flow cycle threshold; otherwise, the TV-100 will cycle on the set I-time.

  • Page 41: Ncpap/Hfnc (High Flow Nasal Cannula) Mode

    Some inherently provide a leak allowing for constant flow, others do not. To ensure a proper delivery of the set oxygen level, the TV-100 will open the exhalation valve on the patient circuit every five seconds. This ensures the oxygen level will not increase substantially beyond the set point in cases when there is no flow due to the absence of any leak.

  • Page 42: Standby Mode

    If the selected oxygen source is High Pressure, the connected oxygen source must be medical grade oxygen at a pressure of 29 to 90 PSI. Prior to initiating ventilation, the TV-100 measures the pressure at the oxygen input connector on the right side of the unit.

  • Page 43: Oxygen

    If the selected oxygen source is Concentrator for units with the low pressure oxygen concentrator available (not available in all regions), the required input pressure range includes 1 to 32 PSI. When the pressure falls outside that range, the TV-100 will display an O Pressure Inlet Out of Range alarm condition.

  • Page 44: Chapter 3: User Interface

    Chapter 3: User Interface 3.1 Physical Interface 3.1.1 Case Overview Figure 3.1: TV-100 Case Left & Front View Bio-Med Devices, Inc. Page 44...
  • Page 45 Figure 3.2: TV-100 Case Right & Back View WARNING: 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.

  • Page 46: Graphical User Interface (Gui)

    The TV-100 uses a simple color code, so that you can tell from a glance what information is being displayed. The TV-100 displays teal colored numbers when the number is set by the user, white colored numbers when the number is measured by the TV-100, and orange colored numbers when the numbers are alarm values set by the user.
  • Page 47 Pressing the Circuit type button will load the select circuit popup. This popup allows you to select circuit type. The TV-100 stores compliance data for Bio-Med Devices, Inc. brand circuits in memory. This selection includes both disposable and reusable circuit types, as well as types for neonate, pediatric and adult patients.
  • Page 48 TV-100 will display the advanced setup page (basic setup is inaccessible for these patient types). If you select adult patient type, the TV-100 will give you the choice to select either basic setup or advanced setup.

  • Page 49: Setup Assistant

    If the patient type is neonate or pediatric only advanced setup will be available, and the TV-100 will open the advanced setup page automatically. If the patient type is adult the user can select either the Basic Setup button or the Advanced Setup button.
  • Page 50 After setting a parameter the next parameter will be displayed to the right of the previously set parameter. The TV-100 will display an animated arrow to point the user to the next parameter to be set. The user can accept the displayed parameter value by pressing the NEXT button.

  • Page 51: Popup Menus

    TV-100. The TV-100 will display the shutdown popup when the user presses and holds the power button for two (2) seconds. If the user presses the Power off button the TV-100 will power off. If the user presses the Cancel button the TV-100 will close the shutdown popup and return to normal operation.
  • Page 52 If you press the set value, low alarm limit, or high alarm limit the TV-100 will highlight the box surrounding that value and make the set value adjustable.
  • Page 53 The numeric key pad is used for entering numeric values, increasing or decreasing values, as well as turning values on and off. The TV-100 will automatically apply decimal places to applicable values as you type them into the key pad.
  • Page 54 Cancel button the TV-100 will close the numeric parameter popup, cancelling any changes you have made. When you press the OK button the TV-100 will check the entered values, then the TV- 100 will apply those values and close the numeric parameter popup. When you press the OK button and the entered value is above or below its applicable range the TV-100 will display “Out of range”.

  • Page 55: Status Bar

    When the TV-100 is in standby mode, the status bar will display the message: Standby Mode. Standby Mode is displayed in large text with a flashing yellow background. Standby Mode replaces the Manual breath, inspiratory hold (Insp.
  • Page 56 The ventilation mode and delivered breath displays indicate the current ventilation mode, as well as the type of breath the TV-100 is delivering to the patient. There will be no delivered breath display when the TV-100 is not delivering a breath.
  • Page 57 When the TV-100 detects a battery is not present that bar icon will be black with a red X symbol. When the TV-100 detects a battery is charging the numeral below the bar icon will toggle from the numeral to a lightning bolt icon.

  • Page 58: Main Page

    Chapter 3: User Interface 3.2.5 Main Page Figure 3.17: Main Page The main page displays various TV-100 ventilator parameters. The main page allows the user to easily start or stop ventilation. The main page contains the following: 3.2.5.1 Pressure Bar Graph This vertical bar graph is displayed on the left of the screen and displays airway pressure.
  • Page 59 3.2.5.3.1 Page Layout Popup Figure 3.18: Page Layout Popup When you press the Page Layout button the TV-100 will display the popup above. You can choose between three different pairs of parameters to display on the main page. These pairs are: Flow &...

  • Page 60: Parameters

    Sensor”. If a flow sensor is connected this field will display the name and type of flow sensor connected. 3.2.6.3 I:E Ratio Display The I:E ratio display is located at the top of the page to the right of the flow sensor display. This field will display the I:E ratio. Bio-Med Devices, Inc. Page 60...
  • Page 61 Ventilation Controls, and Chapter 2.5 Ventilation Modes. When you press the Ok button the TV-100 will set the selected mode and close the selection popup. If you press the Cancel button the TV-100 will disregard the mode change and close the selection popup.
  • Page 62 Figure 3.22: New Mode Verification Parameters Page If you adjust mode during ventilation the mode selection popup will close and the TV-100 will load the new mode verification parameters page. The parameters page will display the available parameters for the newly selected mode. The TV-100 will continue to ventilate while the user adjusts parameters for the newly selected mode.
  • Page 63 29 PSI and less than 90 PSI for high pressure oxygen source; or greater than or equal to 1 PSI and less than 32 PSI for concentrator oxygen source. Flow Trigger: available only if the TV-100 detects a flow sensor, not available in nCPAP/HFNC •...

  • Page 64: Alarms Page

    Apnea delay time is adjusted on the alarms page. To adjust apnea delay time press the Apnea delay time button. The TV-100 will load a numeric value popup where you can make adjustments to apnea delay time and confirm these changes. For more information on apnea functionality refer to Chapter 2 Section 2.5.7 Apnea Detection.
  • Page 65 If you press the Alarm auto set button the TV-100 will load the alarm auto set popup. Figure 3.25: Alarm Auto Set Popup When you press the Set button, the TV-100 will begin to set the alarms. The TV-100 will take five sample breaths then calculate the necessary values to balance alarm limits.
  • Page 66 The Clear all button will clear the list of events. The Close button will close the event log page and the TV-100 will reload the alarms page. Turning the TV-100 power off will clear the event log. 3.2.7.3 Alarms Page during Patient Parameter Alarm When an alarm condition occurs, the TV-100 will initiate an audible and visual indication of the alarm.

  • Page 67: Monitoring Page

    PEEP/CPAP/EPAP, Exhaled tidal volume (VTe), I-Time, Mean pressure, Oxygen, and I: E Ratio. These parameter displays include the measured value, alarm limits if available, and the set value if available. If a parameter is in an alarm condition the exceeded alarm limit(s) will blink red. Bio-Med Devices, Inc. Page 67...

  • Page 68: Lung Mechanics Page

    Auto PEEP will display its measured numeric value only after the user performs an expiratory hold. After 10 seconds, the numeric value will be removed from the lung mechanics page and will be replaced with double dashes. Bio-Med Devices, Inc. Page 68...

  • Page 69: Graphs Page

    The volume waveform measures volume in milliliters (mL). The waveform is green. Volume range is 0 to 2500 mL. The scale ranges for the volume wave are: 0 to 2500, 0 to 1000, 0 to 500, 0 to 100, and 0 to 25. Bio-Med Devices, Inc. Page 69...
  • Page 70 Volume axis are adjustable from a maximum of 0 to 2500 mL to a minimum of 0 to 10 mL. The scale ranges for the Flow axis are adjustable from a maximum of -200 to 200 LPM to a minimum of -5 to 5 LPM. Bio-Med Devices, Inc. Page 70...

  • Page 71: Tools Page

    TV-100 is in standby mode. All alarm functionalities will be disabled when the tools menu page is active. In a column on the right side of the tools page the TV-100 displays a summary of product information. This information includes: the company logo, the device name "TV-100", software version, copyright date, serial number, hours used, and last service date.
  • Page 72 Chapter 3: User Interface 3.2.11.1 System Language Popup The system language popup is used to set the display language for the TV-100. The system language selection popup displays an option button for each language with the name of the language as the button label.

  • Page 73: Chapter 4: Performance Checkout Procedures

    To access the tools menu page press the Tools Menu button on the status bar. The tools page is accessible only when the TV-100 is in standby mode. All alarm functionalities will be disabled when the tools menu page is active.

  • Page 74: Oxygen Calibration

    TV-100 does not detect an oxygen source, the Start button will be disabled. As the TV-100 performs the calibration, a bar representing the calibration progress will fill as each step is successfully completed. If you cancel the calibration the TV-100 will reload the oxygen calibration popup.

  • Page 75: Leak Test

    If the detected flow is greater than the values above the leak test will fail. As the TV-100 performs the calibration, a bar representing the test progress fills as each step is successfully completed. If you cancel the test the TV-100 will reload the leak test popup.

  • Page 76: Compliance Measurement

    Chapter 4: Performance Checkout Procedures Figure 4.5: Leak Test When the test is complete, the TV-100 will reload the leak test popup and the test result will be displayed below the Leak Test button: “Passed” or “Failed”. If the leak test fails, check the patient circuit and all connections then restart the test procedure. If the leak test passes, the compliance measurement will become active and accessible from the tools page.
  • Page 77 Chapter 4: Performance Checkout Procedures Figure 4.6: Compliance Measurement Press the Calibrate button to begin the measurement. As the TV-100 performs the measurement, a bar representing the measurement progress fills as the measurement is successfully completed. If you cancel the measurement then the TV-100 will reload the compliance measurement popup.

  • Page 78: Audio & Alarm Test

    There is no cancel button for this test. If the TV-100 emits all 3 audible tones, then the test has passed. If the TV-100 does not emit 3 audible tones, then the test has failed. When the test is complete, the audio & alarm popup will close and the TV-100 will reload the tools page.
  • Page 79 If measuring a single limb circuit do not occlude the end of the circuit. If measuring a dual limb circuit connect the patient end of the circuit to the TV-100. Occlude the limb of the circuit that will not be measured.

  • Page 80: Chapter 5: Alarm Handling

    When an alarm condition occurs, the TV-100 will initiate an audible and visual indication of the alarm. The TV-100 will blink the alarm parameter that is out of limit on the alarms page, the physical alarm button will blink, and the TV-100 will sound an audible alarm. The clinician can switch to the Alarms page to view details of the alarm.

  • Page 81: Medium Priority Alarms

    TV-100. The alarm button is labeled in Chapter 3 Section 3.1.1 Case Overview. 5.4.1 Alarm Silence When you press the alarm button during an active alarm condition, the TV-100 will silence the alarm for 120 seconds. If you press the alarm button again during the 120 second period the TV-100 will cancel the alarm silence.

  • Page 82: Displaying Alarms

    Page for more information on how the TV-100 displays patient parameter alarms. 5.5.2 Alarms Tab Figure 5.1: Alarms Tab The TV-100 will blink the alarms tab red to indicate the alarm condition. The alarms tab will have the same flashing characteristics as those on the alarms page. 5.5.3 Warning Popup Figure 5.2: Warning Popup...
  • Page 83 These numeric settings include all settable parameters, all settable alarm values, and patient height. Apnea Detected (High priority alarm): Apnea detected is displayed when the TV-100 switches to backup mode. Bio-Med Devices, Inc.
  • Page 84 15 seconds or acknowledgement of the alarm condition, whichever comes first. To test this alarm is functional the user should connect a patient circuit with test lung to the TV-100, and then occlude the patient circuit exhalation valve.

  • Page 85: Alarm Parameter Ranges And Alarm Limits

    0 - 104 Mean High 1 - 80 1 - 105 18 - 100 18 - 100 High 19 - 105 19 - 105 1. Peak Pressure Low alarm defaults to off in nCPAP/HFNC mode Bio-Med Devices, Inc. Page 85...

  • Page 86: Default Alarm Values

    Measurement) Rate (BPM) Volume-AC Volume-SIMV PRVC-AC Pressure-AC Pressure-SIMV nCPAP/HFNC CPAP Volume- Backup CPAP Pressure- Backup Oxygen (%) Volume-AC Volume-SIMV PRVC-AC Pressure-AC Pressure-SIMV nCPAP/HFNC CPAP Volume- Backup CPAP Pressure- Backup PEEP/EPAP/CPAP Volume-AC (cmH Volume-SIMV PRVC-AC Pressure-AC Bio-Med Devices, Inc. Page 86...
  • Page 87 CPAP Pressure- Backup IPAP Volume-AC (cmH Volume-SIMV PRVC-AC Pressure-AC Pressure-SIMV nCPAP/HFNC CPAP Volume- Backup CPAP Pressure- Backup Vte (mL) Volume-AC Volume-SIMV PRVC-AC Pressure-AC Pressure-SIMV nCPAP/HFNC CPAP Volume- Backup CPAP Pressure- Backup Mve (L) Volume-AC Volume-SIMV Bio-Med Devices, Inc. Page 87...
  • Page 88 CPAP Volume- Backup CPAP Pressure- Backup Peak Pressure Volume-AC (cmH Volume-SIMV PRVC-AC Pressure-AC Pressure-SIMV nCPAP/HFNC CPAP Volume- Backup CPAP Pressure- Backup Mean Pressure Volume-AC (cmH Volume-SIMV PRVC-AC Pressure-AC Pressure-SIMV nCPAP/HFNC CPAP Volume- Backup CPAP Pressure- Backup Bio-Med Devices, Inc. Page 88...

  • Page 89: Chapter 6: Troubleshooting

    Software failure technical support Continuous audible tone Hardware failure Contact Bio-Med Devices, Inc. technical support Auto cycling of the TV-100 Pressure trigger or Flow trigger Increase pressure trigger parameters too low (sensitive) parameter Hardware failure Contact Bio-Med Devices, Inc.

  • Page 90: Chapter 7: Specifications

    3.0:1 – 1:99.0 3.0:1 – 1:99.0 Apnea Delay Time 5 – 60 seconds 5 – 60 seconds 1. All values are expressed under ATPD conditions (ambient temperature & pressure dry) 2. MVe accuracy ±20% in PRVC-AC mode Bio-Med Devices, Inc. Page 90...

  • Page 91: Default Parameter Values

    Volume-AC 4 cmH 5 cmH 5 cmH Volume-SIMV 4 cmH 5 cmH 5 cmH PRVC-AC 4 cmH 5 cmH 5 cmH Pressure-AC 4 cmH 5 cmH 5 cmH Pressure-SIMV 4 cmH 5 cmH 5 cmH Bio-Med Devices, Inc. Page 91...
  • Page 92 OFF (10 cmH OFF (10 cmH PRVC-AC Pressure-AC Pressure-SIMV OFF (10 cmH OFF (10 cmH OFF (10 cmH nCPAP/HFNC CPAP Vol-Backup OFF (10 cmH OFF (10 cmH CPAP Pres-Backup OFF (10 cmH OFF (10 cmH Bio-Med Devices, Inc. Page 92...
  • Page 93 OFF (2.0 lpm) OFF (2.0 lpm) CPAP Pres-Backup OFF (2.0 lpm) OFF (2.0 lpm) Flow Cycle Volume-AC Volume-SIMV OFF (5 lpm) OFF (5 lpm) OFF (5 lpm) PRVC-AC OFF (5 lpm) OFF (5 lpm) OFF (5 lpm) Bio-Med Devices, Inc. Page 93...
  • Page 94 25 cmH nCPAP/HFNC CPAP Vol-Backup CPAP Pres-Backup 20 cmH 25 cmH Backup Rate Volume-AC Volume-SIMV 30 BPM 15 BPM 12 BPM PRVC-AC Pressure-AC Pressure-SIMV 30 BPM 15 BPM 12 BPM 30 BPM 15 BPM 12 BPM Bio-Med Devices, Inc. Page 94...

  • Page 95: Operating And Storage / Shipping Environment

    12 – 30 VDC Input Voltage (AC) 100 – 240 VAC 7.4 Physical and Material Characteristics Parameter Measurement Height 12.8" (32.5 cm) Width 11.9" (30.2 cm) Depth 7.6" (19.3 cm) Weight 15.6 lbs (7.1 kg) Bio-Med Devices, Inc. Page 95...

  • Page 96: Pneumatic Characteristics

    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 O Pressure Inlet Out of Range alarm condition.

  • Page 97: 60601-1 Safety Ratings

    This section explains some of the requirements for connecting a Bio-Med Devices, Inc. TV-100 ventilator to an AC adapter. It is important that the correct AC adapter be used and if a TV-100 is to be used in a vehicle with an AC generating device (inverter), it must comply with certain requirements.

  • Page 98: Land Operation

    Chapter 7: Specifications 7.7.1 Land Operation When using an AC adapter to either run the TV-100 or to charge the batteries, only the AC adapter supplied by Bio-Med Devices, Inc. should be used. This AC adapter has been thoroughly tested for proper operation with the TV-100 to make sure that all standards are met.

  • Page 99: Emc Compatibility

    Bio-Med Devices’ part # 5502 external power supply/charger with 6' intrinsic output cable and 8' • IEC-320 input cable. Note: The TV-100 is compliant when run on its charged battery alone, but if it is run with the charger plugged in, the charger must be as specified above.
  • Page 100 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 TV-100, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 101 IEC 61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity The TV-100 is intended for use in the electromagnetic environment specified below. The customer or the user of the TV-100 should assure that it is used in such an environment. Immunity test...

  • Page 102: Device Lifetime & End-Of-Life Disposal

    The TV-100 is suitable for the electromagnetic environment of typical commercial or hospital settings. Radiated RF IEC 10 V/m 61000-4-3 The TV-100 was also tested for radiated immunity to RF wireless communication equipment at the test levels below. Frequency (Hz) Modulation Level V/m Pulse, 18 Hz, 50% DC FM, 1 kHz Sine, ±5 Hz Deviation...

  • Page 103: Disassembly Hazards (For Service Or Eol Device Disposal)

    To decommission the TV-100 Ventilator, the user may send it back to Bio-Med Devices for proper disposal and recycling of all applicable components. If this is not practical, the user may disassemble the device and recycle components using local recycling resources.

  • Page 104: Addendum A

    Device Shutdown Procedure: Press and hold down the power button until the unit displays the shutdown pop-up (2 seconds). Press the power off button to shut down the TV-100. Press the alarm button to silence the audible alarm. In the event of power interruption or loss user set alarm limits will not be lost.

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