EPV200 Portable Ventilator: Battery Powered Ventilator With Oxygen Source Required
EPV200 Portable Ventilator: Battery Powered Ventilator With Oxygen Source Required
EPV200 Portable Ventilator: Battery Powered Ventilator With Oxygen Source Required
Patent Pending
S168-570-001 REV. A
Biocompatibility testing has proven this ventilator to be safe for periods up to 14 days of
continuous use. Results beyond this length of time are not known.
3 Explanation of Warnings
A. Gas Supply Pressure: 280 kPa (40.6 psi) to 600 kPa (87 psi) oxygen DISS
B. Breaths Per Minute (BPM): Accuracy: ±10%
BPM Range: 1 second inspiratory time = 0 and 5 to 30
BPM Range: 2 second inspiratory time = 0 and 5 to 20
C. Tidal Volume (Tv): Accuracy: ±10% with 100% oxygen
Tidal volume range 1 second inspiratory time = 200 ml to 600 ml
Tidal volume range 2 second inspiratory time = 400 ml to 1200 ml
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 241 kPa (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, or if a spontaneous breath is
detected.
I. Battery Life: Greater than 48 hours at room temperature (10 BPM and
2 seconds 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
V. Breathing mode: Assist Control with ≤2 cm H2O required to trigger a
spontaneous breath.
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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. Physician or medical
director instructions should always be followed.
The airway pressure gauge should be observed to make sure the patient is receiving
adequate positive pressure ventilation. If the gauge reading is low during the delivery of
a breath and the chest rise is also low, check the tidal volume setting and patient
connections and examine the patient for a possible obstruction of the airway or other
injury. The gauge reading should also be observed to make sure it is not too high.
Common numbers used in practice are a maximum of 20 cm H2O for an unprotected
airway and 30 cm H2O for a protected airway. Higher pressures may be required based
on the patient’s condition. Physician instructions should always be followed. A high
reading with a pressure limit alarm may indicate a blocked airway or a stiff lung. If you
are using a PEEP valve with the ventilator circuit, the PEEP pressure will not be
displayed on the gauge (Airway Pressure Display).
This ventilator contains several alarms: high airway pressure, low source gas, low
battery, and breath delivery failure.
The high airway pressure alarm is an audible alarm with a red LED that is actuated
when the airway pressure during inspiration reaches 45 cm H2O. The safety pressure
relief will actuate at pressures between the alarm setting and 60 cm H2O.
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.
This alarm is automatically cleared when 25 seconds pass without a high airway
pressure being detected.
The low source gas alarm is an audible alarm with a red LED that activates when the
source gas pressure drops below 40 to 35 psi. This is an indication that the unit will
stop functioning soon and that the unit may not be delivering proper tidal volumes.
Warning: Preset tidal volumes may not be delivered when the low
source gas pressure is reached.
This alarm clears when proper source gas pressure is restored for 15 seconds.
The low battery alarm is a red LED that indicates the battery is running low. The unit
will operate for approximately 2 hours after the alarm first turns on. The batteries
should be replaced when the low battery alarm turns on.
Warning: The displays on the unit will stay on after the unit has
stopped delivering breaths. Batteries should be replaced when a low
battery condition is encountered.
This alarm clears when the batteries have proper battery voltage.
The breath delivery alarm is a flashing red LED. This alarm uses the same light as the
high airway pressure alarm. The breath delivery failure alarm will sound when the
airway pressure does not reach 9 cm H2O in 15 seconds or when a spontaneous breath
is detected. This alarm may indicate that the patient has become disconnected from the
unit or the unit has stopped delivering breaths. This alarm clears when airway pressure
exceeds 9 cm H2O.
Silence Button – When an alarm occurs, the user may press the button for the
currently selected inspiratory time for 3 seconds to silence the alarm. This will turn off
the buzzer for 110 seconds as long as there are no other alarms. Pressing this button
will not clear the alarm LEDs.
Loosen
screws on
battery
door in
4 places
Turn the unit on and verify that the displays turn on. Connect a 50 psi oxygen source to
the unit and verify that the unit does deliver breaths. The breath delivery alarm will
sound if the unit is not connected to a test lung. This is normal and not a concern. The
ventilator is now ready for use. Always turn the ventilator off when not in use to
preserve battery life. The ventilator does not turn off automatically.
Warning: Do not recharge alkaline batteries.
10 Cleaning
The EPV200 should be cleaned after each use. To clean the EPV200, keep the gas
supply hose on the unit to prevent contamination of the oxygen circuit.
Warning: Cleaning procedures should be performed in an environment
free of oil and petroleum based products.
The EPV200 has been designed to be water resistant, but the unit cannot be
submerged or sprayed down for cleaning.
Wipe the unit with a damp rag containing a mild detergent to remove any residue from
the surface. Once the residue has been removed, the unit may be wiped with isopropyl
alcohol or a cold disinfecting solution to kill bacteria. The unit should then be wiped with
water to remove any film left by the cold disinfecting solution. Make sure the unit is dry
before putting the unit away.
The EPV200 should be checked annually to insure proper function. Batteries should be
replaced if they are beyond the expiration date on the battery. Replace with D size
alkaline batteries.
Year 1:
Perform Yearly Verification of function and Calibration procedure. Check battery
expiration date; replace batteries as necessary.
Year 2:
Perform Yearly Verification of function and Calibration procedure. Check battery
expiration date; replace batteries as necessary. Replace disposable O2 inlet hose with 6
foot oxygen hose (see Accessories on page 14).
Replace main valve with piston, o-ring, and spring for units manufactured before April
2009. The manufacturing date is coded into the serial number for each unit. The first
four digits identify the year of manufacture, and the next two digits identify the month of
manufacture. Example: the serial number 20090403001 was manufactured in the year
2009 and in the month of April. All repairs should be performed by Allied Healthcare
Products trained and certified technicians.
Year 3:
Perform Yearly Verification of function and Calibration procedure. Check battery
expiration date; replace batteries as necessary.
Year 4:
Perform Yearly Verification of function and Calibration procedure. Check battery
expiration date; replace batteries as necessary.
Year 5:
Perform Yearly Verification of function and Calibration procedure. Check battery
expiration date; replace batteries as necessary.
The unit has a life expectancy of 5 years based on normal usage and proper
maintenance. A comprehensive rebuild will be necessary at this time, and should be
performed by Allied Healthcare Products trained and certified technicians.
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Equipment Required
Certified gas flow analyzer, capable of measuring BPM, inspiratory time and
tidal volume
Regulated 50 psi oxygen source
New batteries
36 inches of 22 mm corrugated tubing or the allied patient circuit provided.
Procedure
Connect the 50 psi oxygen source to the oxygen inlet connector.
Connect the 22 mm corrugated tubing to the patient circuit connection valve, and
the other end to the gas analyzer.
Turn the tidal volume, inspiratory time and BPM to the values indicated in the
table below. Monitor the values to evaluate acceptability of the unit.
To test pressure relief, turn tidal volume to 640 ml, block the patient end of the
22 mm corrugated tubing or patient circuit while monitoring the airway
pressure display. The airway pressure should not exceed 60 cm H2O. The
High Airway Pressure alarm should sound and a red LED should be activated.
To test the breath delivery failure alarm, remove all obstructions from the patient
circuit connection valve and allow the ventilator to cycle. The breath delivery
alarm should sound, and a red LED should be flashing.
To test the low source gas alarm, reduce the inlet pressure source to below
35 psi. The low source gas alarm should sound and a red LED should be
flashing.
Should the unit fail any of these tests, contact the Allied Healthcare Products, Inc.,
Technical Support Center in St. Louis: 314-771-2400 or 800-411-5136.
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The unit should be checked for proper operation before each use. This can be done
after cleaning to prepare the unit for the next use.
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*When using a PEEP valve, the airway pressure display will not show the PEEP
pressure.
14 Warranty
Allied shall in no event be liable for any consequential damages, nor for loss,
damages or expenses directly or indirectly arising from the use of this product.
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These times are approximate and assume full cylinder capacity. Always monitor the
cylinder pressure and low pressure alarm to make sure you do not run out of oxygen.
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16 Symbols
On/Off
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This equipment has been tested and found to comply with the EMC limits for the Medical Device
Directive 93/42/ECN (EN 55011 and EN 60601-1-2). These limits are designed to provide
reasonable protection against harmful interference in a typical medical installation. There is no
guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference with other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
Reorient or relocate the receiving device
Increase the separation between the equipment
Connect the equipment into an outlet on a circuit different from that which the
other device(s) is connected.
Consult the manufacturer or field service technician for help
The EPV200 is intended to provide emergency respiratory support for children and adults. The
product is intended to meet the following safety and performance standards:
The above listing of standards is not intended to be a complete listing of standards reviewed and
tested during the development of this product. It also may not reflect latest versions, as
standards change. Allied Healthcare Products, Inc. regularly reviews the standards and updates
the products to ensure compliance as necessary.
For the latest revision of the instruction manual, please refer to the company website at
www.alliedhpi.com
This manual is also available in other languages. Please call 314-771-2400 for more
information on obtaining this manual in other languages.
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Using two hook and loop straps, the EPV200 can be attached to hospital or other equipment as
shown. (See Accessories on page 14.)
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