Caradyne Criterion 60 User manual

Criterion 60

Pressure/Oxygen

Monitor

User’s Manual

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
8-100333-00 Rev. B

iii

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

iv

8-100333-00 Rev. B

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 intra­hospital transport use only.

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B 1

Power

Oxyge

supply

Criterion 60
Pressure/

n Monitor

Pressure

Oxygen
sensor cable

Oxygen
sensor tee

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.

Criterion 60 Pressure/Oxygen Monitor User's Manual

2

8-100333-00 Rev. B

Labels

y

Rear panel label

Manufactured b
Caradyne
Parkmore Business Centre
Parkmore West, Galway, Ireland
Tel: + 353 (0) 91 709010
Fax: + 353 (0)91 758929

2055 Executive Dri ve
Indianapol is, IN 46241, USA
Tel: [phone]
Fax: [phone]

Email : i nfo@cara dyne.c om www.cara dyne.c om

NOTE: The symbol “P” on the back panel label shows the
pressure tubing connection, and the symbol “O

” shows the

2

oxygen sensor connection.

Battery compartment label

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B 3

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

Criterion 60 Pressure/Oxygen Monitor User's Manual

4

8-100333-00 Rev. B

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
8-100333-00 Rev. B 5

Criterion 60 Pressure/

(

Oxygen Monitor

back panel)

Oxygen sensor
(4-pin) connector

Pressure
(luer)

Oxyge
n

Oxygen
sensor

From positive
pressure

22F/22F
straight
connector (use

Pressure

Tee for
pressure

Figure 3. Connecting the Criterion 60 to the patient

system

Criterion 60 Pressure/Oxygen Monitor User's Manual

6

8-100333-00 Rev. B

Figure 4. Connecting the Criterion 60 to a face mask

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B 7

Figure 5. Connecting the Criterion 60 to a tee or wye and

ET tube

Criterion 60 Pressure/Oxygen Monitor User's Manual

8

8-100333-00 Rev. B

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

9 (ACCEPT) key Saves a new setting or proceeds to

8 (CLEAR) key Cancels a change that has not yet

Soft keys Select a setting or option displayed

soft key The Menu soft key, which selects the

(ALARM)
indicator

(SILENCE) key Silences the audible portion of an

(RESET) key Resets audible and visual alarm

Scroll up and down to adjust values of
selected setting.

next calibration step.

been accepted.

below each key.

pressure or oxygen screen for display.
Flashes when an active alarm has not
yet been reset (whether or not alarm
silence is in effect).

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.

indicators, cancels alarm silence, and
clears peak pressure displays on the
screen (measurement and bar graph).

Criterion 60 Pressure/Oxygen Monitor User's Manual
8-100333-00 Rev. B 9