TABLE OF CONTENTS
I. General Cautions and Warnings
II. Introduction
III. MediResp IV Portable Emergency Ventilator
IV. Setup Instructions
1. Charging your Battery
2. Initial Settings
3. New Patient Setup
4. Patient Setup Circuit
5. Applying Your Mask
V. Operating Instructions
1. Mode and Breath Characterization
a. Constant Mandatory Ventilation (CMV) Mode
2.
b. Assist Mode
c. Manual Mode
d. Cardiopulmonary Resuscitation (CPR) Mode
Utilizing Your Pulse Oximeter-SpO2 Sensor
VI. Maintenance
VII.
Storage
VIII. Trouble Shooting
IX. Summary
X. References
I.GENERAL CAUTIONS & WARNINGS
II. INTRODUCTION
The Mediresp IV Portable Emergency Ventilator (PEV) was designed to aid
Emergency Medical Technicians (EMT) in an emergency medical setting. The PEV
operates under four basic ventilation modes to aid adults, pediatric and
infants based on their respiratory requirements. Ventilator operation
achieves a wide-range of respiratory support by integrating a pressure-sensing
technology for to minimize respiratory stress during patient care.
This document is intended for use by EMT’s, medical device developers,
biomedical engineers, trained professionals in the medical field and anyone
who wishes to understand the operation of the Mediresp IV PEV.
III. MEDIRESP IV PORTABLE
EMERGENCY VENTILATOR
The Mediresp IV Portable Emergency Ventilator includes a Breath Delivery
Unit (BDU) which controls the ventilation and a graphic user interface (GUI)
that displays patient ventilation response. The PEV operates under volumecontrolled airflow to administer the appropriate ventilation to the patient.
The device also is pressure limiting; to restrict the pressure received by the
patient. Breath characteristic will be given using the controls for volume
flow rate (10-70 L/min), Frequency (4-15 Breath/min) and Maximum Pressure
(0.15-1.0 psi). Each breath can be pressure or flow-triggered according to
user’s initial settings.
Touchscreen LCD displays initial user settings, set breath
characteristics and patient’s response to care. The integrated LCD is
utilized to allow the user to observe patient care and assess the condition of
respiratory support. The display will also feature alerts during medical care
to alert user to error in operation or need for alternate ventilation
support.
FIGURE 1- MediResp IV PEV. This figure denotes location of all components used on front interface.
IV. SETUP INSTRUCTIONS
In this section we will be explaining charging your PEV, Initial Settings and the
initial arrangement prior to medical care of patient.
1. Charging Your Battery
Plug AC Adapter into AC plug outlet (shown in Figure 2). The three pronged plug is
enclosed a receptacle to prevent from hazards due to contact and provide ease while
plugging and un-plugging. The power cable will plug into the PEV using the power port
(shown in Figure 3). Ensure that all plugs are fully inserted into ports. Lack of a
complete connection will not charge the Tinergy Lithium-Ion 14.8V Battery enclosed in
the PEV.
FIGURE 2- Three Prong Plug Receptacle to 15 Amp Outlet
FIGURE 3- Plug power chord to the side panel receptacle of PEV to charge internal battery
When the charging circuit is complete, a message will illuminate on the
display to show that the battery is charging. If, by case, you remove the
ventilator from a power connection for an extended period of use, an alert
will alarm and display LOW BATTERY on the screen. This commands the user to
quickly connect the ventilator to a power source in order to recharge the
battery for future use. If the ventilator has been charging for over five
hours and the LOW BATTERY is still showing, call the 800-number to notify the
technician, as the battery will require servicing.
WARNING:
To avoid electric shock, make sure power is grounded before connecting to the
ventilator.
2. Initial Settings
First powering your ventilator is important to recognize the initial settings for
safe operation. For setup, a message box will appear as shown below in Figure 4:
--SHOW SCREEN w/ labels—
*Update when screen is functioning*
FIGURE 4- Ventilator Initial Setup Display
Select ‘NEW PATIENT’ if you create a new ventilator setup for a patient.
If not, Select ‘CURRENT PATIENT’ to continue setup for the same patient the
ventilator has been operating on.
WARNING:
It is important to correctly supply the ventilator with the correct initial settings
for patient safety. Dictating initial settings to the ventilator is for memory
tracking purposes. The system will restart memory if a ‘NEW PATIENT’ command is
sent. Further, it will continue monitoring memory if ‘CURRENT PATIENT’ is sent.
3. New Patient Setup
(Fill In this part once programming is complete)
4. Patient Circuit Setup
Following Initial Setup, the patient and mask can be added to the system for
ventilation support.
Connect the mask tubing to the Mask Port shown in below in figure 5.
FIGURE 5- Mask Tubing should be inserted directly into Mask Port (See Fig. 1 for location).
CAUTION:
If Tube Fitting is not properly installed, the patient circuit will not
function. Be sure to press the entire tube fitting into the mask port for a
secure fit. This connection must be maintained while the ventilator is in
use. A clamp can be used to avoid tube removal during use.
Connect the open end of mask tubing to the remaining open mask port on the MedRes Full Vented
Mask, as shown below in Figure 6. This will complete the patient circuit for safe and efficient
ventilator performance.
FIGURE 6- Patient Circuit Assembly to connect Mask to Ventilator
5. Applying your Mask
The mask is designed to fit over the entire nasal and oral area on the pateint’s
face.
Place the mask into position completely covering mouth and nasal passages.
Secure supporting blue straps around head. Figure 7 shows the approriate
application of the mask on the head.
FIGURE 7- Correct Mask Application on Patient
WARNING:
The mask should only be operated for patients under respiratory distress. It should
NEVER be placed on a patient or removed from a patient without qualified supervision.
Do not use if there is damage to mask or tubing.
Do not use mask or tubing if the device is not turned on. When in use vented portion
of the mask are open and free to expel exhausted air during breath delivery process.
Only use ventilator in an area with proper ventilation. The ventilator will utilize
ambient conditions to supply the patient with the necessary respiratory support.
Now your device is setup and ready for Operational Use!
CAUTION:
Be aware that the ventilator is designed for automatic medical attention, but should
only be used by qualified supervision or under the direct hands of medical personel.
V.OPERATIONAL INSTRUCTIONS
1. Mode and Breath Characterization
One of the first steps to operating the MediResp IV Portable Emergency Ventilator is
understand the mode operation of the device. On the front panel the mode switch will
dictate which operating function the ventilator will be utilizing for patient
respiratory support. Although each mode has fundamental operating platforms, each
mode is designed to assist the patient specific to the respiratory support needed.
Below is a discusion of each mode operation in detail.
FIGURE 8- Mode Control Dial - Determines System Operating Mode (See Fig. 1 for location)
CAUTION:
In every system operating mode a Positive End-Expiratory Pressure (PEEP) flow will be
administered to the patient during the exhalation period. This is a minimum pressure
limit established by the MediResp IV PEV to avoid ventilator-induced lung damage in
expanding and contracting alveoli in the lungs. This minimal applied pressure must be
at least 5 cm of H20 (.07 psi).
a. Constant Mandatory Ventilation (CMV) Mode
Turn Mode Dial to CMV
Adjust Volume Flow Rate Control Knob, Frequency of Breath Control Knob and
Maximum Pressure Control Knob
CAUTION:
The ventilator is set to a constant Inhale-to-Exhale ratio of 1:2. The ventilator will
apply breath for one-third of set time, then allow the patient to exhale for two-thirds
of the remaining time before administering another breath.
Constant Mandatory Ventilation Mode operates as an automatic mode. CMV mode does not
recognize a patient’s own inspiration, but will constantly provide a breath to the
patient based on time settings. A mechanical breath is administered to the patient
based on the volume and pressure control knob settings on the front panel (See Fig. 1
for location). Figure 9 below shows an example breath under CMV mode.
FIGURE 9 - Constant Mandatory Breath Mode Example Breath Pattern. Ti is the inspiration period where the
full breath volume is given administered to the patient. Te is the exhalation period where the air is
exhausted from the patient’s lungs. “1/RR” specifies the time setting for one breath cycle.
This mode is volume controlled and pressure monitored. A full volume will be
administered during each breath period. If the pressure seen at the lungs
reaches the pressure limit, the flow will pause until pressure is relieved.
If the LOW PRESSURE alarm sounds during use, check all fittings at mask and
ventilator to ensure a closed circuit to the patient. If all fittings and
mask are correct according to the procedure outlined in section 5, then push
the Reset button, to reset the system operation. If alarm still sounds, call
the 800-number to notify the technician, as the ventilator will require
servicing. Utilize the hand pump included outlined in section (******) for
remaining respiratory support to the patient.
WARNING:
Do not use CMV mode if patient is capable of self-inspiration.
Do not use device in ambient conditions which are not suit for inhalation
purposes.
Failure or absence of monitoring patient during ventilation use may result in
serious injury or death.
b. Assist Mode
Turn Mode Dial to Assist
Adjust Volume Flow Rate Control Knob, Frequency of Breath Control Knob and Maximum Pressure
Control Knob
CAUTION:
The ventilator is set to a constant Inhale-to-Exhale ratio of 1:2. The ventilator will
apply breath for one-third of set time, then allow the patient to exhale for two-thirds
of the remaining time before administering another breath.
Assist mode functions as an aid to a patient which is capable of selfinspiration, but requires assistance to either regularly take a breath or
struggles to inhale enough air per breath. This mode also functions in a timed
manner as described in the CMV mode section above, however the ventilator will
now incorporate a trigger detection zone. A trigger zone occurs only during a
patient’s exhalation period; this detection looks for a pressure spike as the
patient initiates their own breath. Once this is sensed, the ventilator will
begin administering a full breath to the patient.
If the patient inpiration is not attempted during the trigger zone, the system
will administer a breath according to the volume and pressure control knob
settings (See Fig. 1 for location).
CAUTION:
The ventilator will always apply a breath according to the control settings in a
set prescribed time only if no breath is sensed from the patient. This is for the
optimum safety and efficacy of respiratory support to the patient.
Figure 10 below shows an example breath under Assist mode.
FIGURE 10- Assist Mode Example Breath Pattern. Ti is the inspiration period where the full breath volume is
given administered to the patient. Te is the exhalation period where the air is exhausted from the
patient’s lungs. “1/RR” specifies the time setting for one breath cycle.
CAUTION:
Assist mode allows patient to breathe more frequently than the controls dictate.
In this mode they are able to breathe according to their own respiration pace.
This is shown below in Figure 11.
FIGURE 11- Patient breath pattern in Assist mode. Given breaths can be administered more rapidly as
needed by the patient. This is seen when inspiration occurs in the trigger for a breath cycle.
WARNING:
Do not use device in ambient conditions which are not suit for inhalation
purposes.
Failure or absence of monitoring patient during ventilation use may result in
serious injury or death.
c. Manual Mode
Turn Mode Dial to Manual
Adjust Volume Flow Rate Control Knob, Frequency of Breath Control Knob and
Maximum Pressure Control Knob
Manual Trigger Button (See Figure 1 for location) will illuminate.
Push Manual trigger button to administer breath to patient.
CAUTION:
The ventilator is set to a constant Inhale-to-Exhale ratio of 1:2. The ventilator
will apply breath for one-third of set time, then allow the patient to exhale for
two-thirds of the remaining time before administering another breath.
The Manual trigger button must be engaged by the user to send a breath
to the patient. A larger trigger zone is designed into this mode operation.
The trigger zone will begin after a full breath is administered and span the
entire exhalation period. The system waits for the manual trigger button to be
pushed for another breath to be administered. This requires breath frequency
to be established by the trained attending user for the patient.
If the manual trigger button is not pushed in the allotted trigger zone
timing, the system will administer a breath according to the volume and
pressure control knob settings (See Fig. 1 for location).
CAUTION:
The ventilator will always apply a breath according to the control settings in
a set prescribed time only if a breath is not sent to the patient. This is for
the optimum safety and efficacy of respiratory support to the patient.
Figure 12, below,
is an example of a breathing pattern in manual mode.
FIGURE 12- Manual Mode Example Breath Pattern. Ti is the inspiration period where the full breath volume
is given administered to the patient. Te is the exhalation period where the air is exhausted from the
patient’s lungs. “1/RR” specifies the time setting for one breath cycle.
CAUTION:
Manual mode is different than the other MediResp IV PEV ventilation modes
because it will allow the attending user to hyperventilate the patient.
Breaths can be administered one after another to hyperventilate the patient,
but can never exceed the max pressure limit given by the controls. This is
shown below in Figure 13.
FIGURE 13- Patient breathing pattern in Manual mode. The patient is hyperventilated to reach miximum
pressure limit as specified by pressure control knobs (See Figure 1 for location). Given breaths can be
administered more rapidly as needed by the patient. This is seen when the trigger button is pushed in
the trigger zone for a breath cycle.
WARNING:
Do not use Manual Mode if operated by an untrained attendant.
Do not use device in ambient conditions which are not suit for inhalation
purposes.
Failure or absence of monitoring patient during ventilation use may result in
serious injury or death.
d. Cardiopulmonary Resuscitation (CPR) Mode
Turn Mode Dial to CPR
Adjust Volume Flow Rate Control Knob, Frequency of Breath Control Knob
and Maximum Pressure Control Knob
Wait for Ventilator to administer first Breath and kneel down by patient’s
chest.
Place one the heel of one hand on chestbone (sternum), pointer finger
perpindicular to the legs. Place other hand on directly on top of the first
hand. Shift weight such that attendant’s shoulders are directly over
patient’s chest. Keep fingers away from the chest wall, it may be more
beneficial to interlock fingers.
Push straight down (approximately 2 inches) on Patient’s chest. Keep arms
locked during compressions. Push down hard and fast and then relieve applied
pressure. Repeating compression process 30 times.
Relieve all chest pressure for another breath to be administered to the
Patient by the ventilator.
Repeat previous 2 steps until one of the following...
(1)Additional medical attention has arrived and is being implemented on
patient
(2)Medical personel has relieved user from resuscitation
responsisbilities.
CAUTION:
The MediResp IV has been designed to allow the user to apply 30 fast
compressions to the patient following an administered breath. The Mediresp IV
will count the number of compressions seen by the patient on the LCD Display,
to ensure operating breath delivery unit (BDU) and user are working in
sequence with one another.
CAUTION:
Technique for applying CPR compressions are critical to the patient safety and
effectiveness of the ventilation assistance. Please note Figure 14a below for
appropriate technique to perform compressions to patient’s chest.
CAUTION:
For infants and younger, two fingers should be placed on the sternum to
complete compressions. DO NOT place the heel of your hands. This is for
safety of the infant, as too much force may be harmful to their fragile rib
cage. This technique is also depicts in Figure 14b.
FIGURE 14- Chest Compression Technique- (a) Depicts appropriate compression technique for an adult
while (b) Depicts appropriate compression technique for an infant or younger
Figure 15 below represents a normal patient breathing pattern when using CPR mode
FIGURE 15- CPR Mode Example Breath Pattern. 30 Compressions will be seen by ventilator until a full
breath is provided.
In the instance that a compression is not seen by the ventilator for over 3
seconds, or the attending user has left the patient, the system will
administer a back up breath will be administered. A full breath will given
according to the volume and pressure control knob settings (See Fig. 1 for
location) to the patient.
CAUTION:
The ventilator will always apply a breath according to the control settings in
an instance when compressions are not being applied to the patient. This is
for the optimum safety and efficacy of respiratory support to the patient.
WARNING:
Do not use CPR Mode if operated by an untrained attendant.
Abdominal Thrusts may cause injury.
Do not use device in ambient conditions which are not suit for inhalation
purposes.
Failure or absence of monitoring patient during ventilation use may result in
serious injury or death.
2. Utilizing your Pulse Oximeter (SpO2 Sensor)
The Pulse Oximeter is a optional feature to the Mediresp IV Portable Emergency
Ventilator. A pulse oximeter is a medical device which measures the amount of
oxygen saturation (SpO2) in your blood based on non-invasive techniques. This
requires use of a medical connector which is applied to the pointer finger of
the pateint. The device contains medical-oriented boards to sense signals and
coorelate this to an approximate blood saturation level.
This device is critical in monitoring the amount of oxygen effectively
entering the blood from the mechanical ventilation. The device will reflect
oxygen levels present at any point during respiratory support. Essentially it
is another feedback measure utilized by the attending user, to understand
adjustments which need to be made to optimize respiratory support.
Connect USB cable to the SpO2 Connector (See Figure 1 for location).
Place the clasp firmly on end of finger.
Wait. Do not move as signals are being processed.
Refer to LCD Display Screen (See Figure 4 for location) to read Oxygen
Saturation Measurement.
FIGURE 16- Pulse Oximeter Cable USB Cable attachment to MediResp IV Portable emergency Ventilator
FIGURE 17- Correct Pulse Oximeter Application to Finger