VENTILATOR ICU Ririn Dwi Lestari

BLOCK DIAGRAM
SCHEMATIC CIRCUIT
SCHEMATIC CIRCUIT
A. Gas-mixture and gas-metering
assembly
B. Inspiratory unit
C. Expiratory unit
D. Expiratory flow sensor
E. Barometric pressure sensor
F. Pressure measurement
assembly
G. Calibration assembly
H. Oxygen sensor
I. Medication nebulizer assembly
BASIC COMPONENTS OF
VENTILATOR ICU
1. The Power Source. The power source consists of the energy used to keep the machine functioning and the
gas flowing to the patient. Ventilators are powered by electricity flowing from a wall outlet and a series of
backup batteries. The gas flowing to the patient is, of course, oxygen, so they can breathe.
2. The Controls. Like any machine, there are controls that the doctor or nurse uses to operate the machine.
Ventilators have many controls that do different functions. They have gas blenders, gas accumulators, flow
regulators, humidifiers, and pressure regulators. All perform a specific function that is vital for the patient’s
wellbeing. Flow and pressure regulators keep the flow of the gasses consistent and constant so that the doctor
can set the rate and pressure of the gas and the machine will maintain it.
3. The Monitors. The monitors sense and present the characteristics of the gas delivery, so the doctor can
assess the performance of the machine. The doctor can look at the monitors to ensure that the settings are being
maintained and the patient is doing okay. The main thing they watch is the flow of the gasses that keep the
patient alive.
4. Safety Features. The safety features on a ventilator are there so that, in the event of a catastrophic accident,
the patient will stay alive. There are alarms to warn the attending staff if the machine loses power or the
pressure level drops. The features usually include emergency backups in the event of power loss.
COMPONENTS LIST
PRICE OF THE COMPONENTS
 Support arm = 740,000-2,200,000 IDR
 Humidifier 25,000,000 IDR
 Blenders = 5,000,000-7,000,000 IDR
 Pressure regulator = 7,000,000-10,000,000 IDR
 Flow regulator = 8,500,000 IDR
 Monitor = 9,000,000-10,000,000 IDR
 MODEL IN MARKET
1. S1100A ICU Ventilator – Superstar
USD 7,900-10,000 IPPV,
Ventilation modes: A/C, PCV, SIMV, SPONT/CPAP,
PSV,SIGH,MANU
The AC power failure alarm Power failure or no connection
Internal battery backup low voltage ≤11.3±0.3V
Ventilator parameter ranges alarm
Tidal volume(Vt) 0 ～ 2000mL No tidal volume No tidal volume within 6s
Frequency (Freq) 1bpm ～ 100 bpm High Minute Volume alarm 5L/min-99L/min
Oxygen concentration 21%-100% LowMinute Volume alarm 1L/min-30L/min
I/E High Airway pressure alarm 20cmH2O-100cmH2O
4:1 ～ 1:8
Low Airway pressure alarm 0cmH2O-20cmH2O
PEEP 0cmH2O ～ 40 cmH2O High oxygen concentration alarm 19%-100%
Pressure Limit 20 cmH2O ～ 100 cmH2O Low oxygen concentration alarm 18%-99%
Monitored Parameters Continuous pressure alarm (PEEP+1.5cmH2O) over 16s
Frequency (Freq) 0 /min ～ 100 /min Suffocation warning 5-60s
Tidal volume(Vt) 0 mL ～ 2500 mL Fan error Show on screen
Oxygen concentration Oxygen deficit Show on screen
15 % ～ 100 %
The maximum limited pressure ＜ 12.5 kPa
Oscillographs display:
P-T(pressure – time) Working conditions
F-T(flow – time) Gas source O2,AIR
P-V loop (pressure – volume loop) Pressure 280kPa-600kPa
Size Voltage -220V±22V
Power frequency 50Hz±1Hz
1st Wooden case packing size （ main engine ）： L560*W 560*H 605mm , GW ： 35KG ;
Input power 900VA(with air compressor)
NW ： 17KG 250VA(without air compressor)
2nd Wooden case packing size （ air compressor ）： L670*W700*H 1160 mm , GW ： 79KG ;
NW ： 46.2KG
Alarm and protection
2. Meditec England ICU Ventilator, Meditec 1700
14,000-18,000 USD
3. Aeonmed Ventilator VG70
11,000-16,000 USD
 STANDARD TESTING
Different models of ventilators use different procedures to verify their performance, but most ventilator
testing includes leak checking, high- and low-pressure accuracy, volume delivery, air and oxygen flow
accuracy, and alarm checks.

Battery test/power loss alarm. With the unit turned on, momentarily disconnect and then reconnect the power source
while the ventilator is not in use on a patient. The machine's battery backup and its disconnection alarms should function
appropriately.
Lamp test. Test lamps according to the manufacturer's procedures.
Audible and visual alarms. Disconnect the oxygen supply hose and, separately, the air supply hose (if used). Appropriate
alarm(s) should result. Reconnect the hoses. Using a test lung, check for the appropriate activation of all audible and visual
alarms. Specifically, momentarily disconnect the circuit to test the low pressure, low exhaled volume, and apnea alarms.
Occlude the circuit to test the high pressure alarm. Or, as an alternative to these steps, momentarily change the alarm setting
parameter to trigger the alarm under test (e.g., FiO2 alarm). The inverse inspiratory:expiratory (I:E) ratio alarm can be
verified by momentarily adjusting peak flow to create an inverse-ratio condition.
Proximal airway pressure gauge and positive end- expiratory pressure (PEEP) control. Set the PEEP level required for
the patient. The manometer reading should cycle and return to the appropriate baseline (±1 cm H2O) at the end of each
breath delivered to the test lung. Check the manometer zero (±1 cm H2O) by momentarily disconnecting the pressure line or
inspiratory limb of the circuit.
 STANDARD TESTING
Leak tests. Perform either or both of these tests as the machine allows:
--Occlude the patient connection, set the pressure limit and tidal volume to their maximum levels and the
peak flow and rate to their minimum levels, and initiate a breath. The manometer should reach the set
maximum level, and the high pressure alarm should activate.
--Set the inspiratory pause to ³ 2 sec, if possible, and set the PEEP level to 0. When the ventilator cycles,
observe the pressure during the pause (i.e., the plateau pressure); the amount of drift should not exceed ±10%
of the plateau pressure.
Modes. Set the mode to be used for the patient. Using a test lung, verify proper operation for that mode as the
ventilator cycles.
Ventilator rate (and rate display). Count the number of breaths delivered during a convenient interval,
timed using a clock or watch with a second hand. The measured rate should be within ±1 breath per minute of
the rate setting (and of the rate display, if so equipped).
 STANDARD TESTING
Volume (and volume display)—tidal volume, sigh volume,* and minute volume. Use an external device such as a
Wright respirometer or equivalent to independently measure exhaled volume. Connect a test lung to the circuit, cycle
the machine, and compare the measured exhaled tidal volume and minute volume to their respective settings.
Manually trigger a sigh breath, if possible, and compare the measured value to the setting. All measurements should
be within ±5% of the settings (and displays, if so equipped).
Sensitivity. Put the ventilator into an assist mode. Squeeze and release the test lung; an inspiration should result when the
airway pressure drops to the intended sensitivity level.
Oxygen calibration. Expose the oxygen monitor (or analyzer) used with the ventilator to room air and to wall oxygen
(100%), and calibrate it. Final readings should be within ±2%. Set the oxygen concentration to be delivered by the ventilator.
Verify this concentration (±2% FiO2) using the oxygen monitor (or analyzer).
Nebulizer (if present).* Turn the ventilator's nebulizer on, and verify that flow is produced at the nebulizer output port
during each inspiratory cycle.
Filters. Ensure that a high-efficiency particulate-air (HEPA) filter is present on the main inspiratory line.
Remote alarm operation (if present).* Set up a convenient alarm condition (e.g., power loss, high pressure), and verify
that appropriate alarm notification occurs at the remote location.
TOOLS FOR TESTING
- Ventilator Tester
Ex: Certifier® Flow Analyzer Plus 4080 Ventilator Test System
APPLICATIONS:
1. Ventilator testing
2. Anesthesia gas delivery machine testing
3. Insufflator testing
4. Oxygen concentrator testing
TO GET FDA CERTIFICATE
FDA Approval of Medical Devices
FDA places medical devices into one of three risk-based categories: Class I, Class II, and Class
III. Class III devices are the highest-risk devices and the only devices that require FDA
premarket approval. Manufacturers of Class III devices must demonstrate to FDA that the device
provides reasonable assurance of safety and effectiveness.
Class I and II devices do not require FDA approval. These devices, unless exempt under the
FD&C Act, must submit premarket notification (510(k)) to FDA instead. The purpose of a
510(k) is to demonstrate to FDA that the device is substantially equivalent (as safe and effective)
to an already legally marketed device. If FDA determines that the device is indeed substantially
equivalent to a legally marketed device, the agency clears the product for marketing rather than
approving it.
Device establishments must  register with FDA and list their devices, but neither registration nor
listing indicates FDA approval of the establishment or its devices.
TO GET FDA CERTIFICATE
Appendix A. Criteria for Safety, Performance and Labeling
Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
To be added to Appendix B, ventilators, ventilator tubing connectors, and ventilator
accessories must be determined to meet the applicable criteria for safety, performance
and labeling set forth below. FDA will add a ventilator, ventilator tubing connector, or
ventilator accessory to the list of authorized products in 0 upon submission of a
request from the sponsor as described in Section II and after confirmation that the
applicable safety, performance and labeling criteria have been met, and pursuant to
the Conditions of Authorization in this EUA.