Allied EPV100 User manual
EPV100 Portable Ventilator
Battery Powered Ventilator
With Oxygen Source Required
St. Louis, MO 63110
Phone 314-771-2400
Patent Pending
S168-556-001 Rev. C
Section
Description
Page
1
Product Description
3
2
Product Intended Use
3
3
Explanation of Warnings
3
4
Explanation of Abbreviations
3
5
Specifications
4
6
Features
5
7
Operating the Ventilator
6 - 8
8
Alarms
9
9
Battery Replacement
10
10
Cleaning
10-11
11
Maintenance and Schedule
11-12
12
Check-out procedure
13
13
Accessories
14
14
Warranty
14
15
Oxygen Cylinder Depletion Times
15 - 16
16
Symbols
16
17
Applicable Standards
17
18
Approximate settings based on height
18 - 19
19
Attaching EPV100 to equipment
20
Table of Contents:
Models: EPV100
2
Tv
Tidal Volume
BPM
Breaths per Minute
It
Inspiratory Time
Psi
Pounds per Square Inch
cm H2O
Centimeters of Water
kpa
kilopascal
ml
Milliliters
LPM
Liters per minute
mm
Millimeters
LED
Light emitting diode
CPR
Cardio Pulmonary Resuscitation
HPA
High pressure alarm
RH
Relative Humidity
1 Product Description:
The EPV100 is an internal battery powered, electronically controlled, portable ventilator
that requires a 50 psi oxygen source. The EPV100 has selectable Tidal Volume, BPM
and Inspiratory Times, based on the intended Patients’ respiratory requirements.
2 Product Intended Use:
The EPV100 is intended to be used as an electronically controlled gas powered
emergency ventilator, which is designed to provide emergency respiratory support by
means of a face mask or tube inserted into the patient’s airway. The ventilator is
intended for use on patients weighing greater than 20kg (44 lbs). This ventilator is
intended to be used in the environments associated with emergency medical services
(EMS), inter-hospital transport and hospital facility usage. The ventilator is intended to
be used in temperatures of -9 to 50°C (15 to 122°F) and 5% - 95% relative humidity,
non condensing.
Biocompatibility testing has proven this unit safe for periods up to 14 days of continuous
use. Results beyond this length of time are not known.
CAUTION: Federal law restricts this device to sale by or on the order of a
physician.
CAUTION: The EPV100 should not be used on children with a weight of 20 kg
(44 lbs) or less.
3 Explanation of Warnings:
Warning: Potential injury to the patient or operator exists.
Caution: Potential damage to the ventilator, breathing circuit or other equipment may
result.
Warnings and cautions should be read and understood before operating the ventilator.
4 Explanation of Abbreviations:
3
5 Specifications:
A. Gas Supply Pressure: 280 kPa (40.6psi) to 600 kPa (87 psi) Oxygen DISS
B. Breaths per Minute (BPM): Accuracy: ±10%
BPM Range: 1 sec Inspiratory Time = 8 to 30
BPM Range: 2 sec Inspiratory Time = 8 to 20
C. Tidal Volume (Tv): Accuracy: ±10% with 100% Oxygen
Tidal Volume Range 1 Second Inspiratory Time = 200ml to 600ml
Tidal Volume Range 2 Second Inspiratory Time = 400ml to 1200ml
D. Inspiratory Time (It): Accuracy: ±10%
1 second or 2 second selection
E. Safety Pressure Relief: Fixed at a maximum of 60 cm H2O.
F. Low Source Gas Alarm: Activates at 275 to 241kPa (40 to 35 psi) source
pressure.
G. High Airway Pressure Alarm Electronic: Activates at 45 cm H2O
Alarm Sound Level is greater than 58 decibels
H. Breath Delivery Alarm: Activates if the Airway pressure does not go above 9
cm H2O during a span of 15 seconds.
I. Battery Life: Greater than 48 hours at room temperature (10 BPM & 2 sec It)
J. Oxygen Inlet Filter: 65 Micron sintered bronze.
K. Leakage: The unit shall be designed so that pressurized oxygen is not allowed
to leak through any seals or fittings.
L. Gauge: 0-99 cm H2O accuracy ± 5% or 1 cm H2O whichever is greater
M. Inspiratory and Expiratory Resistance: 5 cm H2O (.5kPa) maximum
N. Inadvertent PEEP: < 2 cm H2O
O. Inadvertent Continuing Expiratory Pressure: < 2 cm H2O
P. Dead Space: < 5.5% of minimum tidal volume
Q. Weight: 1.4 kg (3.1 lbs.) with batteries
R. Size: 3.5 x 7.0 x 9.3 (88.9 x 177.8 x 236.2 mm)
S. Operating Conditions: -9 to 50°C (15 to 122°F) 5% - 95% RH non condensing
T. Storage Conditions: -40 to 60°C (-40 to 140°F) 5% - 95% RH non condensing
U. Shipping Conditions: -40 to 60°C (-40 to 140°F) 5% - 95% RH non condensing
Latex Free: This product does not contain latex.
4
Item #
Description
Item #
Description
1
Tidal Volume Control
8 Anti-Suffocation Valve
2
Inspiratory Time Control
9 Patient Circuit Connection
3
BPM Control
10
High Airway Pressure Alarm
4
Oxygen Inlet
11
Low Source Gas Alarm
5
Airway Pressure Display
12
Low Battery Alarm
6
Power On/Off Switch
13
Breath Delivery Alarm if
Flashing
7
Battery Compartment
14
BPM Display
3 52
12
11
10
13 641798
14
6 Features:
5
Warning: This device should only be operated by qualified personnel
under approved medical direction.
Warning: Use only as directed. Improper usage or unauthorized
modification of this product may result in user or patient injury.
Warning: Unit is not MRI compatible.
Warning: Not for use in Toxic Environment or in the presence of
flammable anesthetics.
Warning: Proper tidal volumes may not be provided with a gas source
not meeting the specified requirements on page 4.
Warning: This device operates with medical gases under pressure,
including oxygen. Do not use this device while smoking or near open
flames. Do not use on this device or operate near flammable materials.
Caution: In order to provide optimal performance, check all gas
supplies to assure only clean, dry gas is used, free of contaminants
and/or liquids.
7 Operating the Ventilator:
Connecting to an Oxygen Source:
Located on the right side of the ventilator and marked with text is a diameter index
safety system (DISS) fitting. Connect a 50 psi oxygen source with a minimum of 40
LPM flow capacity to this fitting. The unit comes with a single use supply hose made of
PVC. A rubber reusable hose may be purchased and is recommended. See
accessories.
The gas source may also be a high flow air/oxygen blend meeting the flow and pressure
requirements.
Select the proper inspiratory time:
Press the ON/OFF button to activate the unit. The EPV100 has the options of a 2
second inspiratory time (this is used on adults with tidal volume requirements of more
than 600ml) and a 1 second inspiratory time (this is used on children or adults). Push
the appropriate Inspiratory time button and a green LED will show the selected
Inspiratory time
Select the desired Breaths per Minute, BPM:
The EPV100 has a BPM range of 8 to 20 with a 2 second inspiratory time and a BPM
range of 8 to 30 with a 1 second inspiratory time. Use the up and down arrows above
or below the text “BPM” to set the desired BPM. The BPM setting will be displayed in
the window above the selection arrows.
The American Heart Association Guidelines 2005 recommend a BPM rate of 8 to 12 for
an adult and 12 to 20 for a child. These are recommendations and you should always
follow your physicians or medical directors’ instructions.
Select the desired Tidal volume, Tv:
Turn the tidal volume knob to desired tidal volume. The flow to the patient is different
for each tidal volume.
6
Tidal Volume Setting
Approximate Flow (LPM)
It = 1 second
It = 2 second
200
400
12
240
480
14.4
280
560
16.8
320
640
19.2
360
720
21.6
400
800
24
440
880
26.4
480
960
28.8
520
1040
31.2
560
1120
33.6
600
1200
36
Warning: Preset tidal volumes may not be delivered when the
maximum pressure limit is reached. Inspiratory times will remain
constant, however no additional tidal volume will be delivered after the
pressure limit is reached.
Verify the Pressure Relief Setting:
This unit has a factory set pressure relief setting of less than 60cm H2O. The 60
cmH2O setting is a maximum regardless of vent settings. The pressure relief setting
will vary slightly with tidal volume setting. Lower tidal volumes will have a slightly lower
pressure relief point. Always verify the relief pressure after the vent settings have been
selected. To check the actual relief pressure, block the end of the ventilator breathing
circuit and observe the reading on the airway pressure gauge. This will be the
maximum airway pressure. You should hear an audible alarm and see a flashing light
as this maximum pressure is reached.
Connecting the patient breathing circuit:
Located on the left side of the unit is a 22mm connection for a patient breathing circuit.
The patient breathing circuit has been design to fit with an oxygen mask (22mm outside
diameter) or endotracheal tube (15mm inside diameter). Install the corrugated tubing
over the connector so that it is on securely. Follow the established guidelines for
maintaining the patient’s airway.
Verify the patient is receiving good ventilation:
Once the patient is connected to the ventilator the patient should be observed to make
sure they have adequate chest rise and fall. The chest rise should be even and should
return to a normal position. If the patient does not have adequate chest rise check the
tidal volume setting, patient connections and examine the patient for a possible
obstruction of the airway or other injury. The patient should be monitored to make sure
they are receiving proper ventilation.
7
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