MACS ® Mask CPAP System

MACS®
Mask CPAP System
Operators Manual
20101
CD–M–005 Rev E
Released 23 March 2015
The MACS CPAP delivery system is under US patent
protection as part of the pNeuton® Ventilator
(Patent # 6,591,835)
pNeuton and MACS are Registered Trademarks of the
Airon Corporation
Copyright © 2014 by Airon Corporation
Manufactured by:
Airon® Corporation
751 North Drive
Unit 6
Melbourne, Florida 32934
USA
Tel: 888-448-1238 (toll free USA &
Canada)
+1-321-821-9433
Fax: +1-321-821-9443
www.AironUSA.com
Emergo Europe
EC REP
Molenstraat 15
2513 BH The Hague
The Netherlands
Table of Contents
Section 1. General Description ............................ 1-1
Indications for Use .......................................... 1-1
Contraindications ............................................ 1-2
Section 2. Warnings, Cautions, Notes .................
Warnings .........................................................
Cautions ..........................................................
Notes ..............................................................
Medical Symbol Key ……………………………
2-1
2-1
2-3
2-3
2-5
Section 3. Controls and Patient Safety Systems ..
Front Panel ......................................................
Rear Panel .......................................................
Internal Patient Safety Systems .......................
3-1
3-1
3-3
3-4
Section 4. Operating Instructions ......................... 4-1
Device Set-up ..............................................
4-1
Operational Verification .................................... 4-1
Patient Set-up…….............................................. 4-3
Oxygen Control ............................................... 4-3
Hypobaric Operation ......................................... 4-3
Section 5. Patient Circuit ......................................
Adult / Pediatric Circuit ....................................
Patient Connection ...................................…...
Single-Use Medical Devices/Accessories ……
5-1
5-1
5-2
5-3
Section 6. Accessories ……………………………. 6-1
Section 7. Theory of Operation .............................
Pneumatic System Diagram ............................
Pneumatic System Description .........................
CPAP Demand Flow Breathing System ...........
Oxygen Delivery System ..................................
MACS CPAP System
7-1
7-1
7-2
7-2
7-3
I
Section 8. Troubleshooting ……………………….. 8-1
Section 9. Cleaning and Maintenance .................
Cleaning the Device ..................................…..
Cleaning / Disinfecting the Patient Circuit .......
Routine Maintenance ......................................
Factory Preventative Maintenance....................
9-1
9-1
9-1
9-1
9-1
Section 10. Specifications ..................................... 10-1
General Description ......................................…. 10-1
System Performance ........……………..........…. 10-1
Environmental and Physical Characteristics .... 10-2
Power Sources ................................................. 10-2
Section 11. Limited Warranty ................................. 11-1
Section 12. Index ................................................... 12-1
MACS CPAP System
II
MACS Mask CPAP System
Section 1: General Description
MACS is a small, lightweight Continuous Positive Airway
Pressure (CPAP) system designed for use on
spontaneously breathing patients who require oxygen
assistance. The patient is allowed to breath
spontaneously with minimal work of breathing. The CPAP
system provides expiratory positive pressure delivered
non-invasively via face mask or invasively via ET tube.
The delivered oxygen is adjustable between 65 and 100
percent, with oxygen as the driving source gas.
MACS is an all pneumatic device. Electrical power is not
required for operation. MACS has been specifically
designed for patient support by trained Emergency Medical
Professionals, Respiratory Therapists, nurses and
physicians, both in the prehospital and hospital
environment. It may also be used at the accident scene,
during intra and inter-hospital transport, in aircraft, on
ambulances, and in emergency rooms.
Indications for Use
The MACS CPAP System is intended for spontaneously
breathing patients requiring up to 140 L/min oxygen at
65% or 100% concentrations.
The device is suitable for use in:
Pre-hospital transport applications including accident
scene, emergency rescue vehicles
• Hospital ICU transport applications including
emergency, surgery, post-anesthesia / recovery
• Air transport via helicopter or fixed wing
•
MACS CPAP System
1-1
Contraindications
The following conditions contraindicate the use of the
MACS CPAP System:
• Patients undergoing procedures with flammable
anesthetic gasses
• Patients requiring ventilatory support with mechanical
respiratory rate and tidal volume
MACS CPAP System
1-2
Section 2: Warnings, Cautions, Notes
The MACS Mask CPAP System is intended for use by
properly trained personnel under the direct supervision of a
licensed medical Physician or Practitioner only. Personnel
must become thoroughly familiar with this Operators
Manual prior to using the MACS Mask CPAP System on a
patient.
As used in this manual, the following terms mean:
Warning: Indicates the possibility for injury to the
patient or the operator
Caution: Indicates the possibility of damage to the
device
Note:
Places emphasis on an operating
characteristic
Warnings
This manual serves as a reference. The instructions in this
manual are not intended to supercede the physician’s
instructions regarding the use of the MACS Mask CPAP
System.
The operator should read and understand this entire
manual before using the MACS system. Incorrect
operation can be hazardous.
DO NOT use the MACS system in conjunction with
flammable anesthetics or in the presence of open flame.
Ensure the device and all accessories are free from oil or
grease.
MACS uses air entrained from the atmosphere. Do not
use in contaminated (hazardous, explosive) atmospheres.
Only compressed oxygen may be used.
MACS CPAP System
2-1
DO NOT use conductive (anti-static) patient breathing
circuits. The only approved patient circuit for use with
MACS CPAP are the Airon® circuits listed in Section 5 of
this manual. Any other patient circuit should NOT be used
and may lead to patient harm. The patient and equipment
should be constantly monitored.
The Airon patient circuit is a single use, disposable
device. Cleaning, reprocessing and / or reuse of this
device is not recommended. Reprocessing may cause a
change in ventilation characteristics. The circuit and all
components are sold clean and non-sterile.
The Operational Verification tests as described in this
manual (Section 4) must be performed prior to connecting
a patient to the device. If the device fails any of the tests it
must be removed from clinical use. DO NOT return the
unit to clinical use until all repairs has been completed by
an Airon approved repair facility and all operational
verification tests are acceptable.
The MACS CPAP System does not have a patient
disconnect alarm. If the patient becomes disconnected
from the device there will be no audible or visual alarm to
indicate this condition. Always observe the patient while
providing CPAP support.
MACS CPAP System
2-2
Cautions
Insure that clean, dry medical grade compressed air is
used at all times. Compressed air that is contaminated
with water or other material will damage the internal
components of the ventilator.
DO NOT attempt to service the unit. Service may
only be performed by Airon® Corporation authorized
engineers. The Preventative Maintenance program
requires a general service and calibration every two years.
Only original manufacturer parts and accessories should
be used, and only factory trained personnel may perform
Preventative Maintenance.
Any attempts to modify the hardware of this device without
the express written approval of Airon Corporation will void
all warranties and liabilities.
Do not immerse the MACS CPAP System or allow any
liquid to enter the case or the inlet filter. Clean as directed
in Section 9, Cleaning and Maintenance.
Notes
In the USA, the MACS CPAP system is a restricted
medical device intended for use by qualified medical
personnel under the direction of a physician.
The CPAP system will operate normally at altitudes
up to 15,000 feet. Changes in altitude will not affect
pressure provided to the patient.
MACS CPAP System
2-3
Special note on the presence of latex: The components,
devices, accessories, and packaging that make up the
MACS CPAP System do not contain any dry natural rubber
or natural rubber latex, which may cause allergic reactions.
Special note on the presence of di (2-ethylhexyl) phthalate
(DEHP): The components, devices, accessories, and
packaging that make up the MACS CPAP System do not
contain any phthalates which are classified as
carcinogenic, mutagenic or toxic to reproduction, of
category 1 or 2, in accordance with Annex I to Directive
67/548/EEC.
Additional Warnings, Cautions, and Notes are located
throughout this manual.
MACS CPAP System
2-4
Airon’s Medical Symbol Key
Consult Instructions of Use
CE Marked
Authorized Representative in European
Community
Model (Part) Number
Lot Number
Do Not Reuse
MRI Conditional (3 T)
Manufacturer
Manufactured Date
Use By Date
Keep Dry
Temperature limitation - upper and
lower temperature limits
MACS CPAP System
2-5
MACS CPAP System
2-6
Section 3: Controls and Patient Safety Systems
Front Panel
Pressure gauge, patient
circuit pressure
CPAP control, calibrated,
range 0 to 20 cm H2O
MACS CPAP System
3-1
Oxygen control, select
either 100% or 65%
Patient Circuit connection,
see section 5 for a complete
description of the patient
circuit and its attachment to
the front panel
Expiratory Valve connection
MACS CPAP System
3-2
Rear Panel
Driving Gas Input (oxygen),
DISS connection, requires
55 + 15 psi (380 + 100
kPa), (40 liter/minute
minimum)
Ambient Air Inlet filter
MACS CPAP System
3-3
Internal Patient Safety Systems
The MACS CPAP System has the following internal safety
systems. These systems help ensure patient safety in the
event of device malfunction.
High Pressure Release
There is an internal safety pressure release valve included
in the MACS CPAP System. This valve will automatically
limit circuit pressure to approximately 42 cm H2O.
Anti-Suffocation System
An internal safety system will allow the patient to breathe
on his or her own in the event of device malfunction. At
approximately 2 cm H2O negative pressure an internal
valve will open allowing unimpeded ambient air to enter
the patient circuit for the patient. This system is always
available to the patient, irrespective of control settings.
Note: Always use an external oxygen monitor to ensure
the desired oxygen percentage is delivered to the patient.
MACS CPAP System
3-4
Section 4: Operating Instructions
Device Set-up
The following equipment is needed:
1. MACS CPAP Device with breathing circuit
(See Section 5)
2. High pressure oxygen hose with pressure
regulated oxygen supply
3. Test lung, (1 Liter rigid wall, Airon Part #21002)
When ready:
1. Attach breathing circuit to device following
instructions in the Operators Manual.
2. Attach the test lung to the patient side of the
breathing circuit.
3. With the device set up as described above,
adjust the controls as follows:
a. Oxygen % to 65%
b. CPAP to 10 cm H2O.
4. Attach Oxygen Input (Driving Gas) on rear
panel of the device to a high pressure oxygen
source and turn on the oxygen.
NOTE: The unit will begin operation at the above
settings when the oxygen is turned on.
Operational Verification
Verification Step
Expand the test lung at a
rate of approximately 10
breaths per minute to
simulate spontaneous
breathing. Ensure that the
pressure gauge returns to
10 ± 2 cm H2O after each
breath.
MACS CPAP System
Acceptable
Range
10 ± 2 cm
H2O
Result
Pass / Fail
4-1
Switch the oxygen toggle
to 100%. Expand the test
lung at a rate of
approximately 10 breaths
per minute and ensure the
pressure gauge returns to
10 ± 2 cm H2O after each
breath.
Turn the CPAP knob to the
off position. Ensure the
pressure gauge points
inside the off range and
flow stops.
10 ± 2 cm
H2O
Pass / Fail
Off
Pass / Fail
When the device has passed the Operational Verification
procedure it is ready for clinical use. If the device fails to
pass any of the following tests do not apply it to patients.
Call your local distributor or Airon Corporation Customer
Support at 888-448-1238. Do not attempt to service the
unit.
CAUTION: Do not disassemble the MACS CPAP
System. No internal user replaceable parts. All service
must be performed by Airon Corporation or an approved
service technician. Opening the device will negate the
warranty. User will be responsible for all repair costs to
service the unit.
MACS CPAP System
4-2
Patient Set-up
1. Set up the MACS CPAP System according to the
set-up instructions above.
2. Attach the patient circuit with face mask to the
device.
3. Set the % Oxygen control to the desired FIO2.
4. Adjust the CPAP control to the desired level. There
is no adjustment for spontaneous breath trigger
sensitivity as this is automatically set by the device.
5. Inform the patient of what you will be doing and
apply the face mask.
6. Monitor the pressure gauge to ensure proper
delivery of CPAP. Pressure should not vary more
than 3 to 4 cm H2O per breath, depending on
patient effort.
7. Observe and monitor the patient and the device per
your institution's standards. If using a portable
oxygen gas supply, monitor the supply level to
ensure there is sufficient gas to power the device.
Never leave the patient unattended.
Oxygen Control
The Oxygen control sets the level of oxygen delivered to
the patient. The device uses an internal venturi system
which provides the 65% oxygen concentration. See
Section 7 for a complete description of the Oxygen
Delivery System. It is recommended that an external
oxygen analyzer always be used to verify oxygen delivery.
Hypobaric Operation
The device will operate normally at altitudes up to 15,000
feet. Changes in altitude will not affect pressure delivery to
the patient. Always monitor the patient carefully using a
cardiac monitor.
MACS CPAP System
4-3
MACS CPAP System
4-4
Section 5: Patient Circuit
Adult / Pediatric Circuit
Large adult mask
Headstrap
The patient circuit designed for use with the MACS CPAP
System is part number 58011; 6 ft. disposable patient
circuit with disposable face mask (size Large) and
headstrap. The compression volume is 1 ml per cm H2O.
Additionally, a full range of compatible patient circuits is
available to meet your needs. Other patient circuits may
become available in the future. All acceptable circuits will
have part numbers from 58001 to 58999.
Part
Number
58001
58006
58011
58021
58051
Description
6 ft. (1.8 m) disposable, box of 15
6 ft. (1.8 m) disposable, with expiratory filter,
box of 15
6 ft. (1.8 m) disposable, with large adult mask
and head strap, box of 10
6 ft. (1.8 m) disposable, with expiratory filter,
large adult mask and head strap, box of 10
8 ft. (2.4 m) disposable, box of 15
WARNING: Patient circuits other than the Airon®
circuits listed above may alter the ventilator's CPAP / PEEP
characteristics and / or expiratory flow resistance. They
should NOT be used and may lead to patient harm.
MACS CPAP System
5-1
WARNING: Do not use air filters on the expiratory
port of the patient circuit except those provided by Airon
Corporation. Some filters may alter the ventilator's CPAP
characteristics and / or expiratory flow resistance. They
should NOT be used and may lead to patient harm.
CAUTION: The MACS requires the use of a nonvented full-face mask for proper CPAP operation.
Patient Connection
The patient circuit must be attached to MACS properly.
Incorrect attachment could result in failure to provide
adequate oxygen delivery.
The main breathing hose
(22mm) is connected to the
large connection port.
The small tubing (3mm)
connects the expiratory
valve to the small
connection port.
NOTE: The Airon patient circuit is a single use, disposable
device. Cleaning, reprocessing and / or reuse of this
device is not recommended. The circuit and all
components are sold clean and non-sterile.
MACS CPAP System
5-2
Single-Use only Medical Devices/Accessories
How do I know if a device is Single-Use?
This symbol will be identified on the packaging and
User’s Manual of the device.
What does Single-Use mean?
Do not reuse. A single-use device is used on an individual
patient during a procedure, such as transport ventilation,
and then discarded. It is not intended to be reprocessed
and used again, even on the same patient.
What is the concern with reused device labeled SingleUse?
The use of reprocessed devices may present serious
incidents relating to the health and safety of patients and
healthcare professionals. Reuse can be unsafe because of
risk of:
•
•
•
•
Cross-infection – inability to clean and
decontaminate due to design, device components
are not manufactured for disassembly and
reassembly
Endotoxin reaction – excessive bacterial breakdown
products, which cannot be adequately removed by
cleaning
Patient injury – device failure from reprocessing or
reuse because of fatigue or material alteration
Chemical burns or sensitization – residues from
chemical decontamination agents on materials that
can absorb chemicals
NOTE: If you reuse a single-use device you may be
legally liable for the safe performance of the device.
MACS CPAP System
5-3
MACS CPAP System
5-4
Section 6: Accessories
Using the MACS CPAP System should be convenient and
user-friendly for healthcare providers and patients.
Accessories for the device add serviceability in clinical
situations and allow the device to be adaptable to the
environment of use.
Adult/pediatric patient circuit
- Disposable, single patient use.
- 6 foot (1.8m) and 8 foot (2.4m)
length
Adult/pediatric CPAP Masks Disposable, single patient use.
Adult Small
Adult Medium
Adult Large
Bacterial/Viral Filter
Disposable, single patient use.
Approved for use in-line and on
expiratory valve.
Safe-T-Vent Nebulizer
Designed to nebulize
medications for inhalation in
conjunction with the pNeuton
Ventilator/MACS CPAP System
and other positive pressure
breathing devices. This unique
nebulizer system includes a
spring-loaded seal that allows
the nebulizer to be removed
while maintaining positive
pressure.
Test Lung
A rigid wall Test Lung is ideal to
test device performance and
create spontaneous breaths.
MACS CPAP System
6-1
Travel Bag
The Travel Bag holds the
MACS securely and safely for
transport. The clear front panel,
held closed with Velcro, can be
opened to make control
adjustments and then closed for
operation. The bag has side
pouches for circuits and
accessories, a bright yellow
reflective stripe, hand carry
strap and a shoulder strap.
Protective Boot with
Shoulder Strap
The Protective Boot wraps
around MACS to protect it from
accidental falls. MACS can be
operated while in the boot. A
shoulder strap makes it very
easy to carry. The Pole Mount
and Bed Rail Mount brackets
can be used with the Protective
Boot.
Bracket, Pole Mount
The Pole Mounting Bracket
allows the MACS to be firmly
attached to a vertical pole, such
as an IV pole. Poles up to 1.25”
(3 cm) can be accommodated.
MACS slide in and out of the
bracket, which allows portable
use.
MACS CPAP System
6-2
Bracket, Bed Rail Mount The
Bed Rail Mounting Bracket
allows the MACS to be firmly
attached to a horizontal tube,
such as a bed rail. Tubes up to
1.25” (3 cm) can be
accommodated. MACS slide in
and out of the bracket, which
allows portable use.
Oxygen Regulator
MRI compatible high pressure
oxygen regulator for D / E size
oxygen tanks.
High Pressure Oxygen Hose DISS Female both ends, MRI
compatible. (Note: ISO color
hose available)
Oxygen Cylinder
E Size
MRI compatible
D Size
400 liter cylinder with toggle
valve
Reusable Patient Circuit
- Adult/pediatric patient circuit,
autoclavable
- 1.8 meters (6 ft)
Available for International
Customers Only.
MACS CPAP System
6-3
MACS CPAP System
6-4
Section 7: Theory of Operation
MACS is a pneumatic device that provides Continuous
Positive Airway Pressure (CPAP). It provides up to 20 cm
H2O at up to 140 L/min flow for a spontaneously breathing
patient. This section describes how the device operates.
Further information on the device's theory of operation,
including circuit diagrams, parts lists, and calibration
instructions is available from Airon Corporation to properly
trained service personnel.
Pneumatic System Diagram
MACS CPAP System
7-1
Pneumatic System Description
The major components of the pneumatic system and the
control of gas flow through the device are as follows:
1. High pressure gas (oxygen) enters the device and
is filtered (5 micron) and reduced to a lower
working pressure (35 psi - 240 kPa).
2. The adjustable CPAP control system directs a
pressure signal to the expiratory valve to generate
CPAP and provides variable flow through the gas
delivery venturi on demand for spontaneous
breaths.
3. The oxygen control is used to increase the
delivered oxygen level from 65% to 100%. When
turned on, oxygen is fed into the gas delivery
venturi system.
CPAP Demand Flow Breathing System
The device’s internal CPAP demand flow system provides
gas for spontaneous breathing at adjustable CPAP
pressures up to 20 cm H2O. This system has several key
features:
1. When turned on, the system supplies a continuous
flow of gas at approximately 10 L/min. This flow of
gas helps to establish the desired CPAP level by
balancing flow with the pressure generated on the
expiratory valve by the CPAP system.
2. The continuous flow of gas also establishes the
flow sensitivity to spontaneous breathing efforts. If
the patient's inspiratory flow demand exceeds the
continuous flow of gas, additional flow will be added
to meet patient demand. There is no sensitivity
adjustment to this system. The CPAP system will
automatically meet the needs of the patient, with
flows up to 140 L/min, by attempting to maintain the
MACS CPAP System
7-2
balance between flow and pressure at the
expiratory valve.
3. The CPAP control is calibrated to the dynamics of
Airon Corporation disposable patient circuit (part
numbers 58001 through 58999). Using this circuit
will ensure proper operation and the full 0 to 20 cm
H2O CPAP range.
Using other patient circuits may affect operation and
alter the device’s CPAP characteristics and full CPAP range.
Oxygen Delivery System
With the device driven by 100% oxygen as the source gas,
MACS can be set to deliver 65% or 100% oxygen.
Oxygen Delivery
The FIO2 of this system is set by the % Oxygen control.
When set for 65%, the actual oxygen percentage and
baseline flow is related to the level of CPAP in use. When
set for up to 10 cm H2O CPAP, the system will provide a
FIO2 of approximately 0.65. As the CPAP level increases
to 20 cm H2O, the FIO2 can be expected to increase to as
high as 0.75 + 0.10. This is due to a drop off in efficiency
(stalling) of the CPAP venturi system at higher CPAP
levels. Whether set for 65% or 100%, extremely high
inspiratory flow demand may decrease the desired FIO2.
It is recommended that an external oxygen monitor be
used at all times to measure and display the delivered
oxygen concentration.
Factors Effecting the Operating Time of Oxygen Tanks
There are several factors that affect the length of time the
device will operate from a tank of oxygen. MACS uses
very little gas for its own operation (less than 20 ml/min)
and is not a major factor in oxygen tank consumption. The
MACS CPAP System
7-3
major factors are:
• Volume of oxygen in the tank
• Patient's tidal volume and rate (minute volume)
• Position of the % Oxygen control
• Level of CPAP in use
Setting the % Oxygen control to 65% will decrease the
amount of oxygen used from the tank, nearly doubling the
time an oxygen tank lasts.
When CPAP is turned on, MACS uses approximately 5
L/min oxygen from the tank to provide the 10 L/min
baseline flow of the system. In addition, if the % Oxygen
control is set for 100%, 7 L/min more is used. The
patient's own spontaneous tidal volume and rate will use
additional oxygen from the tank, based upon the tidal
volume of those breaths. Below are approximate operating
times based on different combinations of patient tidal
volume and rate, known as minute volume.
Approximate operating time
using a full "D" size cylinder (400 liters)
at 10 cm H20 CPAP
Minute Volume
5 L/min
10 L/min
15 L/min
100% Oxygen
44 min
29 min
22 min
65% Oxygen
65 min
45 min
35 min
Approximate operating time
using a full "E" size cylinder (660 liters)
at 10 cm H20 CPAP
Minute Volume
5 L/min
10 L/min
15 L/min
MACS CPAP System
100% Oxygen
65 min
43 min
32 min
65% Oxygen
100 min
67 min
50 min
7-4
Section 8: Troubleshooting
This troubleshooting guide lists common problems that
may be encountered and possible solutions. If none of the
corrective actions seem to work, contact Airon Corporation
or your distributor.
Indication
Meaning
Device does not
operate – no gas
flow
Missing or
insufficient driving
gas supply
Patient circuit
disconnection
Internal Malfunction
Device seems to
“want” to operate,
but little gas flow is
available
Expiratory Valve
drive line
disconnected
Expiratory Valve is
malfunctioning
Insufficient driving
gas supply
Internal Malfunction
Device appears to
be stuck with high
flow
CPAP may be
turned on high
Internal Malfunction
Can’t get the
CPAP desired
Expiratory Valve
malfunctioning
Using a circuit not
recommended by
Airon
Internal malfunction
MACS CPAP System
Corrective Action
Check gas source,
55 psi (380 kPa) at
40 L/min is required
Reconnect patient
circuit
Send device for
service
Ensure tubing is
properly connected
Replace Patient
Circuit
Check gas source,
55 psi (380 kPa) at
40 L/min is required
Send device for
service
Check CPAP control
Send device for
service
Replace patient
circuit with Airon part
number 58011
Replace patient
circuit with Airon part
number 58011
Send device for
service
8-1
Indication
Meaning
Excessive
“chattering” of
CPAP system
Device using too
much gas
Leak at gas source
Internal leaks
Oxygen
concentration too
low
Source gas not
100% oxygen
High patient
spontaneous
ventilation
Internal malfunction
MACS CPAP System
Corrective Action
Occurs when using
some test lungs but
will not when
connected to a
patient. If problem
persists, send device
for service
Check hoses and
tank regulator for
leaks
Send device for
service
Ensure source gas is
100% oxygen
Decrease
spontaneous
ventilation
Send device for
service
8-2
Section 9: Cleaning and Maintenance
Cleaning the Device
•
•
•
Use only mild detergent or disinfectant and water with
a soft cloth.
Do not immerse the device in water.
Do not attempt to sterilize the device with autoclave or
ethylene oxide. Severe damage to the device may
occur.
Cleaning / Disinfecting the Patient Circuit
The recommended Airon patient circuit is a disposable,
single use device, Airon part number 58001 through
58999. This circuit must not be cleaned, disinfected or
reused.
See Single-Use only Medical Device information, page 5-3.
Routine Maintenance
Airon Corporation recommends that an Operational
Verification Test (see Section 4) be performed with initial
installation and prior to use on each patient. Institution’s
standards may require additional biomedical surveillance.
No additional routine maintenance is required.
Factory Preventative Maintenance
•
A Preventative Maintenance service is required every 2
years to ensure continuous safety and reliability of the
device.
MACS CPAP System
9-1
•
•
•
Device service includes:
o Replacement of internal and external filters
o Replacement of internal materials subject to wear
o Reconditioning of the enclosure
o Complete calibration
This service must only be performed by Airon
Corporation or an Airon approved service technician.
Failure to perform this service may result in
malfunctioning of the device.
MACS CPAP System
9-2
Section 10: Specifications
General Description
•
•
•
Pneumatically operated device provides CPAP using a
demand flow system
Equipment not suitable for use in the presence of
flammable anesthetics
Rated for continuous operation
System Performance
•
•
Controls
o CPAP
o % Oxygen
0 to 20 cm H2O
100% or 65%
Operating Ranges
o Internal P Limit
42 cm H2O
•
Accuracy of Controls
o CPAP + 5%
o FIO2 + 10%
•
Precision - breath to breath repeatability of controls
o CPAP + 2 cm H2O
o FIO2 + 5%
•
Specificity - effect of one control on another
o CPAP + 5%
o FIO2 + 5%
•
Internal Compliance
MACS CPAP System
0.1 ml/cm H2O
10 - 1
•
Device Resistance to Flow
Inspiratory, 60 L/min: less than 2 cm H2O
Expiratory, 50 L/min: less than 2 cm H2O
o
o
Environmental and Physical Characteristics
•
•
•
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Hypobaric (high altitude) compatible up to 15,000 feet
(4,600 meters)
Weight: 3.0 pounds (1.35 kg)
Size: 6.7”H x 3.7”W x 8.2”D (17.0 cm x 9.4 cm x 20.8 cm)
Storage Temperature Range: -46 to 71 °C (-51 to 160
°F), 15 to 95 percent humidity, noncondensing
Operating Temperature Range: -26 to 60 °C (-15 to 140
°F), 15 to 95 percent humidity, noncondensing
Power Sources
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Driving gas requirement
o 55 psi + 15 psi (380 kPa + 100 kPa)
o 100% oxygen. Do not use the device with other
types of gases.
o The gas supply must be capable of delivering at
least 40 liters per minute at 55 psi. If input pressure
drops less than 40 psi due to insufficient gas flow,
the device will begin to malfunction.
NOTE: Baseline oxygen consumption at 10 cm H2O CPAP;
65% Oxygen: 5 L/min
100% Oxygen: 12 L/min
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Section 11: Limited Warranty
AIRON CORPORATION, through its Official Distributor,
warrants this product to be free from defects in
construction, material and workmanship for a period of
twelve (12) months from the date of original delivery to
buyer when operated properly under conditions of normal
use for which the product is intended. This twelve (12)
month warranty does not extend to expendable items such
as membranes, hoses, patient circuits and filters which are
warranted to be free of defects only at time of original
delivery.
The official AIRON CORPORATION Distributor will, at its
option, either repair or replace any defective product, as
above defined, which is reported to that AIRON
CORPORATION Distributor within 72 hours of occurrence
during the warranty period. If so instructed by the
Distributor, such defective products must be returned to
the official AIRON CORPORATION Distributor in the
original container with freight charges prepaid. In any
case, AIRON CORPORATION shall be responsible for
repairs to, or replacement of, such defective product only.
LIMITATIONS ON AND DISCLAIMER OF WARRANTIES:
AIRON CORPORATION shall be relieved of any liability
under this warranty: if the product is not used in
accordance with manufacturer's instructions; if attachment
or incorporation of any device is made to this product
without written approval; if use is made in any manner
other than intended by the manufacturer; if regular periodic
maintenance and service is not performed; if repairs are
made by other than authorized AIRON CORPORATION
service personnel; if the product has been subject to
abuse, misuse, negligence or accident. Any product that
has been mechanically or electronically altered without
MACS CPAP System
11 - 1
specific written authorization from AIRON CORPORATION
is also excluded from this warranty.
The warranty described in this Agreement is in lieu of all
other warranties. THE PARTIES AGREE THAT THE
IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE AND ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, ARE
EXCLUDED FROM THIS AGREEMENT.
Except as stated above, AIRON CORPORATION SHALL
NOT BE LIABLE FOR ANY DAMAGES, CLAIMS OR
LIABILITIES INCLUDING, BUT NOT LIMITED TO,
PERSONAL BODILY INJURY, OR INCIDENTAL,
CONSEQUENTIAL, OR SPECIAL DAMAGES.
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11 - 2
Section 12: Index
A
Accessories 6-1
Airway Connection Port 3-2
Altitude Operation 4-3
C
Cautions 2-3
Circuit, Patient Breathing
Cleaning 9-1
Configuration 5-1
Connecting 5-2
Cleaning 9-1
Contraindications 1-2
Controls
% Oxygen 3-2
CPAP 3-1
CPAP
Control 3-1
Functional Operation 7-2
E
Expiratory Valve
Connection 5-2
Relationship to CPAP System 7-2
F
Front Panel 3-1
H
Hypobaric Operation 4-3
I
Indications For Use 1-1
Internal Patient Safety Systems 3-4
M
Maintenance - Device Service 9-1
Medical Symbol Key 2-5
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12 - 1
N
Notes 2-3
O
Operational Verification 4-1
Oxygen
% Oxygen Control 3-2
Driving Gas Inlet 3-3
Driving Supply Requirements 10-2
Operational Characteristics 7-3
Oxygen Control, Set-up 4-3
P
Patient Circuit
Cleaning 9-1
Configuration 5-1
Connecting 5-2
Performance Verification 4-1
CPAP
Control 3-1
Functional Operation 7-2
Trigger Sensitivity 7-2
Pneumatic System 7-1
Power Requirements - Driving Gas Supply 10-2
Pressure - CPAP Control 3-1
Pressure Gauge 3-1
Principles of Operation
CPAP Demand Flow Breathing System 7-2
Oxygen Delivery System 7-3
Pneumatic System Diagram 7-1
Pneumatic System Description 7-2
R
Rear Panel 3-3
S
Safety Systems 3-4
Sensitivity 7-2
Set-up 4-1
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12 - 2
Service, Ventilator 9-1
Specifications
Environmental and Physical Characteristics 10-2
General Description 10-1
Power Sources 10-2
Ventilator System Performance 10-1
Spontaneous Breaths
FIO2 7-3
Peak Flow 7-2
T
Theory of Operation
CPAP Demand Flow Breathing System 7-2
Oxygen Delivery System 7-3
Pneumatic System Diagram 7-1
Pneumatic System Description 7-2
Troubleshooting 8-1
V
Verification, Operating 4-1
W
Warnings 2-1
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