Caradyne Criterion 60 User manual

Criterion 60
Pressure/Oxygen
Monitor
User’s Manual

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B iii
Table of contents
Table of contents _________________________________iii
Introduction _____________________________________ 1
Labels________________________________________ 3
Connecting the Criterion 60 to power _________________ 4
Connecting the Criterion 60 to the patient system________ 5
The Criterion 60 front panel _________________________ 9
Functional test __________________________________ 11
Normal operation ________________________________ 12
Pressure bar graph ____________________________ 13
Oxygen concentration measurement _______________ 14
Language selection ____________________________ 15
Illegal key press _______________________________ 15
AC power loss ________________________________ 15
Criterion 60 Alarms ______________________________ 16
When an alarm is active_________________________ 19
Adjusting alarm settings _________________________ 20
Alarm silence _________________________________ 20
Alarm presilence ______________________________ 20
Maintenance ___________________________________ 21
Calibration procedures __________________________ 22
Zero calibration: pressure (non-technical user) ____ 23
Gain calibration: pressure (qualified technician only) 24
21% calibration: oxygen (non-technical user)______ 28
Gain calibration: oxygen (non-technical user)______ 29
Battery pack recharge (non-technical user) _______ 31
Battery pack replacement (qualified technician only) 32
Specifications___________________________________ 33
Service _______________________________________ 35
Warranty ______________________________________ 35
Approvals______________________________________ 35
Parts list_________________________________________
_______________________________________ 37
Appendix: Effect of humidity on oxygen measurements __ 38

Criterion 60 Pressure/Oxygen Monitor User's Manual
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iv
Figures
Figure 1. Criterion 60 Pressure/Oxygen Monitor __________2
Figure 2. Connecting the Criterion 60 to AC (wall) power ___ 4
Figure 3. Connecting the Criterion 60 to the patient system _ 6
Figure 4. Connecting the Criterion 60 to a face mask ______ 7
Figure 5. Connecting the Criterion 60
to a tee or wye and ET tube ______________________8
Figure 6. Criterion 60 front panel _____________________10
Figure 7. Pressure monitoring screen _________________ 12
Figure 8. Oxygen monitoring screen __________________ 13
Figure 9. Entering service mode _____________________22
Figure 10. Calibration kit and setup ___________________25
Figure 11. Pressurizing the system ___________________26
Figure 12. Replacing the battery pack _________________ 32
Figure 13. Saturated water vapor pressure (SVP)
of gas (100% RH) versus temperature _____________38
Tables
Table 1. Criterion 60 front panel ______________________9
Table 2. Criterion 60 alarms ________________________ 16
Table 3. Selectable alarm limits______________________18

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B 1
Introduction
The Criterion 60 Pressure/Oxygen Monitor (Figure 1) monitors
patient airway pressure and oxygen concentration throughout
the breathing cycle. The monitor uses solid-state pressure
transducers to measure circuit and atmospheric pressures,
and a galvanic oxygen sensor to measure the partial pressure
of oxygen. The oxygen sensor samples gas directly without
diverting it from the circuit. The monitor uses the atmospheric
pressure and partial pressure of oxygen measurements to
derive oxygen concentration.
The Criterion 60 is intended for use with devices that are not
capable of monitoring pressure or oxygen concentration (for
example, a resuscitation bag or basic ventilator) or as an
independent backup for devices that do measure pressure or
oxygen.
The Criterion 60 alarms when the airway pressure or oxygen
concentration falls outside of the user-selected high and low
alarm limits, and displays real-time airway pressure and
oxygen concentration.
The Criterion 60 also includes alarm delay (for pressure
alarms), alarm silence, and alarm presilence features. Battery
backup provides up to 24 hours of backup power in case of
AC power failure or when AC power is not available.
NOTE: The Criterion 60 is designed for stationary and intra-
hospital transport use only.

Criterion 60 Pressure/Oxygen Monitor User's Manual
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2
Figure 1. Criterion 60 Pressure/Oxygen Monitor
WARNINGS:
•To avoid the risk of fire, do not use this device near
flammable anesthetics.
•Federal law (U.S.) restricts the sale of this device to, or by
the order of, a physician.
•Do not use this device to monitor pressures when patient
respiratory rate exceeds 60 breaths per minute.
•This device is not suitable for use in a MRI environment.
Power
supply
Criterion 60
Pressure/
O
x
yge
n M
o
ni
to
r
Oxygen
sensor tee
Oxygen
sensor cable
Pressure

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B 3
Labels
Rear panel label
Manufactured b
y
Caradyne
Parkmore Business Centre
Parkmore West, Galway, Ireland
Tel: + 353 (0)91 709010
Fax: + 353 (0)91 758929
2055 Executive Drive
Indianapolis, IN 46241, USA
Tel: [phone]
Fax: [phone]
Emai l: i [e-mail] www.caradyne. com
NOTE: The symbol “P” on the back panel label shows the
pressure tubing connection, and the symbol “O2” shows the
oxygen sensor connection.
Battery compartment label

Criterion 60 Pressure/Oxygen Monitor User's Manual
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4
Connecting the Criterion 60 to power
The Criterion 60 comes with a power supply that accepts
mains power (120 or 230 V AC, depending on model/country)
and provides a 12 V DC output. Figure 1 shows how the
Criterion 60 connects to AC (wall) power. The ON/OFF switch
turns monitoring on and off (when the monitor is connected to
AC power, the battery can recharge whether the ON/OFF
switch is ON or OFF).
WARNINGS
•To avoid personal injury or equipment damage, keep the
power supply cable out of the way of users.
•Use the Criterion 60 Monitor only with Caradyne power
supply and battery pack.
Figure 2. Connecting the Criterion 60 to AC (wall) power

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Connecting the Criterion 60 to the patient system
The Criterion 60 monitors pressure and oxygen:
•The monitor measures pressure using disposable
pressure tubing that includes a hydrophobic filter. The
filter protects the monitor from moisture, and reduces the
risk of cross contamination.
•The monitor measures oxygen concentration using a
reusable oxygen sensor. The sensor is designed for use
with the Criterion 60 Pressure/Oxygen Monitor only.
The pressure tubing is typically connected close to the patient
airway, while the oxygen sensor is placed in the inspiratory
limb upstream of the humidifier. Figure 3, Figure 4, and Figure
5 show how the Criterion 60 can connect to a patient system.
WARNING:
Do not disassemble the oxygen sensor as it contains harmful
caustic substances.
CAUTIONS
The sensor will not operate in 100% condensing humidity as the
condensing water will block the O2 supply to the sensor. (It will
work in 100% non-condensing O2).
The sensor should not be handled unnecessarily during
calibration or use. Body heat can cause disproportional
changes in the sensor compared to the gas, which may produce
errors in the readings.
To avoid monitor damage due to condensation, position the
pressure sensor at least 25 cm (10 in.) lower than the monitor.

Criterion 60 Pressure/Oxygen Monitor User's Manual
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Figure 3. Connecting the Criterion 60 to the patient
system
Oxygen
sensor
Pressure
Tee for
pressure
t
From positive
pressure
di
Oxyge
n
Criterion 60 Pressure/
Oxygen Monitor
(
back
p
anel
)
Pressure
(luer)
Oxygen sensor
(4-pin) connector
22F/22F
straight
connector (use
if i d)

Criterion 60 Pressure/Oxygen Monitor User's Manual
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Figure 4. Connecting the Criterion 60 to a face mask

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B
8
Figure 5. Connecting the Criterion 60 to a tee or wye and
ET tube

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The Criterion 60 front panel
The Criterion 60 front panel (Figure 6) includes the elements
summarized in Table 1.
Table 1. Criterion 60 front panel
∆and ∇keys Scroll up and down to adjust values of
selected setting.
9(ACCEPT) key Saves a new setting or proceeds to
next calibration step.
8(CLEAR) key Cancels a change that has not yet
been accepted.
Soft keys Select a setting or option displayed
below each key.
soft key The Menu soft key, which selects the
pressure or oxygen screen for display.
(ALARM)
indicator
Flashes when an active alarm has not
yet been reset (whether or not alarm
silence is in effect).
(SILENCE) key Silences the audible portion of an
alarm for two minutes following the
most recent key press. The SILENCE
key LED lights when the silence is
active and the monitoring screen
shows alarm silence time remaining.
Also used for alarm presilence feature,
which provides two minutes of silence
from the most recent key press if
pressed before an alarm becomes
active.
(RESET) key Resets audible and visual alarm
indicators, cancels alarm silence, and
clears peak pressure displays on the
screen (measurement and bar graph).

Criterion 60 Pressure/Oxygen Monitor User's Manual
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Table 1. Criterion 60 front panel
Screen Shows screen test and introductory
messages, normal monitoring
information (alarm settings, oxygen
concentration, peak pressure
measurement, and bar graph), and
calibration prompts.
Figure 6. Criterion 60 front panel
∆and ∇
k
ACCEPT key
CLEAR key
SILENCE key
RESET key
ALARM
indicato
Screen
Soft keys
Menu soft key

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Functional test
Before using the Criterion 60 Pressure/Oxygen Monitor, follow
these steps to verify that the monitor is functioning properly:
1. Connect AC power and turn the monitor on, then check
that the monitor screen turns on each of the screen
characters, one block at a time.
2. Once the introductory screen appears, check that the
power source indicator displays “AC” to indicate AC
power operation.
3. Disconnect the power supply and verify that the screen
displays "Bty" to indicate battery operation. Verify that
alarm sounds. Reconnect AC power and press RESET.
4. When no pressure is connected to the monitor's luer
connector, the monitor should display a Ppk of 0 cmH2O
and a single line at the zero position on the bar graph.
5. Set the low pressure alarm to 10 cmH2O (see Adjusting
alarm settings in this manual) and verify that the low
pressure alarm activates.
6. When exposed to room air, the monitor should display an
O2% of 21% ±1%.
7. Set the high O2% alarm to 19% oxygen and verify that the
high O2% alarm activates.

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Normal operation
When you turn on the Criterion 60 Pressure/Oxygen Monitor,
the monitor screen turns on each screen character, and then
displays introductory screen information:
Criterion 60
Pressure/O2 Monitor
Rev. x.x
The Criterion 60 then displays the pressure monitoring screen
(Figure 7). Press the menu key to select the pressure
monitoring or oxygen monitoring (Figure 8) screen.
Figure 7. Pressure monitoring screen
Menu key
(press to
select oxygen
)
High pressure alarm soft
key (current setting: 20
Bar graph shows real-time
pressure and peak
Peak pressure
measurement (peak
pressure since last
Bar graph peak
pressure
indicator
Alarm delay soft key
(current setting: 5
d)
Low pressure alarm soft
key (current setting: 5
cmH
O)
Alarm silence: LED
on
key lights and
screen shows

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Figure 8. Oxygen monitoring screen
Pressure bar graph
The pressure monitoring and oxygen monitoring screens
display a bar graph that shows real-time patient airway
pressures from -10 to 39.5 cmH2O. If the measured pressure
is below -10 cmH2O or above 39.5 cmH2O, a star (*) is
displayed at that end of the bar graph.
A vertical line ( | ) indicates the peak pressure since the most
recent RESET key press. The pressure monitoring screen
displays the peak pressure measurement (Ppk) from 0 to 99.5
cmH2O (for pressures above 99.5 cmH2O, the monitor
displays ">99.5 cmH2O"). Pressing RESET clears the Ppk
display and the peak pressure indicator on the bar graph.
Power source indicator
AC = AC power operation
Bty = Battery power
operation
(Battery icon fills to show
hll)
Bar graph shows real-
time pressure and peak
Oxygen concentration
measurement (30.0%)
- - - = Sensor
disconnected, and
“Connect O2 Sensor”
lthb h
Bar graph peak
pressure
indicator
Menu key (oxygen
screen currently
ltd)
High O2 alarm soft
key (current setting:
Unused
Low O2alarm soft
key (current setting:
18%)

Criterion 60 Pressure/Oxygen Monitor User's Manual
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Oxygen concentration measurement
•If the monitor detects an out of calibration condition during
normal operation, this message replaces the pressure bar
graph:
Calibrate O2 sensor
•If the monitor measures an oxygen concentration of less
than 10% (indicating a sensor disconnect or sensor fault),
it displays this message:
O2%= - - -
and the message Connect O2 Sensor replaces the bar
graph. Reconnecting the oxygen sensor resumes the
oxygen display, and the Calibrate O2 sensor message
replaces the pressure bar graph. Press the RESET key to
clear the alarm. The Calibrate O2 sensor message
remains until the monitor is powered off then on.
•If the monitor is powered up with no oxygen sensor
connected, the monitor does not alarm and the oxygen
monitoring screen displays this message:
O2%= - - -
and the message Connect O2 Sensor replaces the bar
graph. Reconnecting the oxygen sensor resumes the
oxygen display, and the Calibrate O2 sensor message
replaces the pressure bar graph. The Calibrate O2 sensor
message remains until the monitor is powered off then on.

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Language selection
Follow these steps to select the language for the Criterion 60:
1. Turn the monitor on.
2. At the introductory screen, press the RESET key to display
the language menu. The monitor displays this message:
Language: English
↑↓ to change
ACCEPT to save
3. Press the ∆and ∇keys to select the language.
4. Press ACCEPT to restart the monitor in the selected
language.
Illegal key press
The Criterion 60 sounds an illegal key press tone (a single
beep) if you attempt to select an out of range setting or press
the same key twice.
AC power loss
The Criterion 60 alarms if AC power is lost. You can press the
RESET key to clear an AC power loss alarm. The screen
shows whether AC or battery is powering the monitor. During
battery operation, the monitor conserves power by turning off
the screen backlight when no key has been pressed for 30
seconds or more. Pressing any key turns the backlight on
again.

Criterion 60 Pressure/Oxygen Monitor User's Manual
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16
Criterion 60 Alarms
Table 2 summarizes the possible Criterion 60 alarms.
Table 2. Criterion 60 alarms
If you see and hear
this: It means: Do this:
Flashing ALARM
indicator, flashing
high pressure alarm
symbol, audible
alarm.
High pressure alarm:
airway pressure rose
above the set high
pressure limit.
Check patient.
Check patient
system for kinks or
occlusions. Consider
appropriate settings
for high pressure
alarm and ventilation
device.
Flashing ALARM
indicator, flashing
low pressure alarm
symbol, audible
alarm.
Low pressure alarm:
airway pressure fell
below the set low
limit.
Check patient.
Check patient
system for
disconnect. Consider
appropriate settings
for low pressure
alarm and ventilation
device.
Flashing ALARM
indicator, flashing
high oxygen alarm
symbol, audible
alarm.
High oxygen alarm:
oxygen
concentration rose to
the set high limit.
Check patient.
Check all gas
sources. Consider
appropriate settings
for high oxygen
alarm and ventilation
device.
Flashing ALARM
indicator, flashing
low oxygen alarm
symbol, audible
alarm.
Low oxygen alarm:
oxygen
concentration fell to
the set low limit.
Check patient.
Check all gas
sources. Consider
appropriate settings
for low oxygen alarm
and ventilation
device.