Caradyne Whisperflow 2 User manual

Whisperflow 2

CPAP System

User’s Manual

Table of contents

Table of contents ........................................................ ii

Introduction .................................................................1

How it works ...............................................................2

Setting up the Whisperflow 2 System.........................2

Using Whisperflow 2 with Criterion 60........................7

Operating the Whisperflow 2 System .......................14

Monitoring the patient ...............................................15

Maintenance .............................................................15

Environmental specifications ....................................16

Accessories ..............................................................19

Service......................................................................19

Warranty ...................................................................19

Approvals..................................................................19

Manufacturer.............................................................20

Year of manufacture .................................................20

Introduction

The Whisperflow 2 CPAP System delivers continuous positive
airway pressure (CPAP) throughout the breathing cycle. It
provides CPAP at preset levels throughout inspiration and
exhalation, independent of the patient's flow rate. The
Whisperflow 2 is intended for use on spontaneously breathing
patients, and allows you to adjust FIO

The Whisperflow 2 controls are easy to use, and a swivel
elbow outlet port simplifies circuit configuration. An internal
safety valve eliminates the need for a separate pressure relief
valve and tee.
The Whisperflow 2 can be pole or bench mounted, and can
be attached to Caradyne’s Criterion monitors (Figure 1) to
create a system that delivers CPAP and measures applicable

from 28 to 100%.

2

Criterion 60

Whisperflow 2

parameters.

Figure 1. Whisperflow 2 CPAP System

with Criterion Monitor

Whisperflow 2 CPAP System User's Manual 1
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The Whisperflow 2 System may be contraindicated for
patients with any of these conditions:

• Fluid retention

• Pneumothorax

• Decreased cardiac output and gastric distention

• Severe facial injury (noninvasive use)

• Hypotension secondary to hypovolemia.

How it works

The Whisperflow 2 CPAP System is a precision venturi device
that uses an oxygen supply in conjunction with entrained air to
generate an output flow. The Whisperflow 2 System uses a 60
psi (412 kPa) oxygen supply, and can generate flows over
140 L/min with a minimum fractional inspired oxygen (FIO
28%. The Whisperflow 2 CPAP valves use constant force
springs to maintain the preset positive pressure at flow rates
from 10 to 140 L/min.

2

) of

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Setting up the Whisperflow 2 System

WARNING:

• Always use the Whisperflow 2 System with

an oxygen analyzer to alert you to a loss of
oxygen wall pressure or other system faults.
For complete control of the CPAP therapy,
Caradyne recommends using the Criterion
60 Pressure and Oxygen monitor.

• Always ensure that the CPAP valve is

correctly connected to the patient circuit,
and that the exhaust port of the CPAP valve
is not attached to the circuit.

• Use an in-line tee to insert a pressure gauge

or pressure monitor (such as the Criterion 40
or Criterion 60) between the output port of
the Whisperflow 2 and the patient interface.

• The Whisperflow 2 (as is typical of other

CPAP systems) does not include a non­rebreathing valve for use with tracheal tubes.
Oxygen supply failure during tracheal tube
connection can result in rebreathing and
asphyxiation.

CAUTION: To avoid damage to the Whisperflow 2
System by entraining particles into the device, always
install a filter (P/N 8-100471-00) on the fresh gas intake
port.

1. Select a sealing face mask or endotracheal (ET) tube as

the patient connection. Ensure that the mask fits
comfortably, seals the bridge of the nose, and fully covers
the nose and mouth.

2. Choose the CPAP valve (see the parts list for a complete

list of available CPAP valve sizes and part numbers).

Whisperflow 2 CPAP System User's Manual 3
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3. Assemble the circuit according to Figures 3 through 7,

depending on the mask, oxygen analyzer, and humidifier
used. As you assemble the circuit, please note:

• The Whisperflow 2 includes an internal safety valve
that automatically relieves pressure at approximately
28 cmH

O or above. To relieve pressure at lower

2

levels, use a separate pressure relief valve (use
safety valve tee, Caradyne part number 8-202502-00,
to insert a separate safety valve into the circuit).

• To ensure accurate measurement of the FIO

2

delivered to the patient, use an inline oxygen analyzer
upstream of the humidification device (if used).

• The Whisperflow 2 System can deliver a minimum

of 28-29% to the patient. However, the longer

FIO

2

the tube lengths used, the higher the minimum FIO
(longer tubing increases the resistance of the patient
circuit, allowing Whisperflow 2 to entrain less air).

• The Whisperflow 2 System's location upstream of the
patient and the high flows it produces make
contamination and cross-infection highly unlikely.
However, if cross contamination is a concern, attach
a 22-mm filter to the output port of the Whisperflow 2.

• Use the Whisperflow 2 with accessories supplied by
Caradyne, Ltd. or authorized representative.
Caradyne supplies face masks with an integral one­way valve that prevents exhalation into the supply gas
tubing in the event of supply gas failure. However,
when used with a tee piece, exhalation into the supply
tubing can result in rebreathing and asphyxia.

• Caradyne supplies face masks with an integral one-
way valve that minimizes the risk of asphyxia in case
of supply gas failure. However, a face mask with one­way valve results in an increased work of breathing in
the event of loss of oxygen that may not be well
tolerated by all patients. Do not use a mask or
tracheal tube connection when there is no oxygen
flow from the Whisperflow 2.

2

4 Whisperflow 2 CPAP System User's Manual
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• Use an external monitor (such as a Criterion monitor)
to ensure that the Whisperflow 2 is supplying
adequate flow to the patient. If flow is adequate, an
in-line pressure gauge or pressure monitor shows a
constant pressure approximately equal to the PEEP
valve specification. A significant (2 cmH

O or more)

2

pressure drop when the patient inhales indicates
inadequate flow: increase flow from the Whisperflow

2.

• Use an oxygen monitor with alarms (such as the
Criterion 60 Pressure and Oxygen monitor) to set and
monitor the FiO

delivered by the Whisperflow 2. An

2

oxygen monitor can signal loss of oxygen flow if the
patient continues to draw fresh gas without oxygen
through the air inlet of the Whisperflow 2.

• The Whisperflow 2 is shipped with covers for the
oxygen sensor and pressure ports. Keep these
covers in place whenever the ports are not in use.
Remove the oxygen sensor cover before installing a
Criterion 60 oxygen sensor. Remove the pressure
port cover when installing a pressure line to the
Whisperflow 2.

• When using the Whisperflow 2 pressure port, take
into consideration that the pressure reading includes
the pressure drop due to the resistance of the patient
circuit. For example, if the pressure at the patient’s
mask is 5 cmH
resistance of the circuit at the current flow is 2 cmH
then the monitor pressure reading is 7 cmH

0 and the pressure drop due to the

2

0.

2

0,

2

Because high pressure alarms are typically set 10
cmH

0 or more above peak inspiratory pressures, the

2

Whisperflow 2 pressure port is appropriate for use
where the pressure drop due to patient circuit
resistance is not significant. At very low patient
ventilation pressures when small variations in
pressure can be significant, measure pressure at the
patient connection to eliminate the effect of patient

Whisperflow 2 CPAP System User's Manual 5
8-100482-00 Rev. C

circuit resistance. Replace pressure tubing and filter
monthly during normal use.

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Using Whisperflow 2 with Criterion 60

The Whisperflow 2 System is designed to be compatible with
all Criterion monitors. Follow these steps to attach the
Whisperflow 2 to the Criterion 60 Pressure and Oxygen
Monitor (Figure 2):

1. Remove the rubber feet from the base of the Criterion 60.

2. Remove the rubber feet from the base of the Whisperflow

2.

3. If using the pole mounting kit (P/N 8-100315-00), connect
the mounting bracket to the Criterion 60 and Whisperflow
2 as described in the kit instructions.

4. Turn the Criterion 60 upside down, set the Whisperflow 2
on top of the Criterion 60, and align the mounting
locations.

5. Use the four M3 x 25 screws to connect the Criterion 60
and Whisperflow 2.

6. Replace the rubber feet to the base of the Whisperflow 2.

7. Once the Whisperflow 2 and Criterion 60 are attached,
connect the oxygen sensor and pressure line as shown in
Figures 3, 5, or 7.

Whisperflow 2 CPAP System User's Manual 7
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Figure 2. Attaching the Whisperflow 2 to the Criterion 60

8 Whisperflow 2 CPAP System User's Manual
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Figure 3. Whisperflow 2 and Criterion 60, dual-port mask

Whisperflow 2 CPAP System User's Manual 9
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Oxygen
sensor

Oxygen
analyzer

Whisperflow 2

Pressure
monitor

P

CPAP
valve

Figure 4. Whisperflow 2 and oxygen analyzer, dual-port

mask

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Pressure
line

Oxygen
sensor

CPAP valve

To ET tube

Figure 5. Whisperflow 2 and Criterion 60, ET tube

connection

Whisperflow 2 CPAP System User's Manual 11
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Oxygen
sensor

Oxygen
analyzer

CPAP
valve

P

Whisperflow 2

Figure 6. Whisperflow 2 and oxygen analyzer, ET tube

connection

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Humidifier
chamber

CPAP
valve

Figure 7. Installing a humidifier

Whisperflow 2 CPAP System User's Manual 13
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Operating the Whisperflow 2 System

1. Turn control valves off by turning fully clockwise (finger-

tight only).

2. Connect the oxygen hose to the port on the Whisperflow 2

back panel, then listen for leaks. (Connect directly to the
oxygen supply or connect an oxygen hose between the
oxygen inlet and the oxygen supply.)

WARNING: Do not connect any gas supply other than
oxygen to the Whisperflow 2 System.

3. Turn the ON/OFF knob on. Turn the flow adjustment valve

fully on and check that the output flow from the patient
outlet varies accordingly.

4. Turn the oxygen adjustment valve counter-clockwise until

the Criterion 60 or other oxygen analyzer displays the
appropriate FIO

5. Leave the oxygen and flow controls as you have just set

for 30 seconds.

2

them, then turn the ON/OFF knob off. Attach the circuit to
the patient, then turn the ON/OFF knob on.

6. Watch the CPAP valve to ensure that it remains open

during inspiration. Gradually reduce the circuit flow by
turning the flow adjustment valve down to point when you
can still feel a slight flow at the CPAP valve when the
patient inspires. If you are using a Criterion monitor,
watch the bar graph to verify sufficient flow.

7. Monitor the FIO

circuit flow decreases, the FIO
reduce the FIO

as you reduce the circuit flow: as the

2

by turning the oxygen adjustment

2

rises slightly. You can

2

clockwise.

14 Whisperflow 2 CPAP System User's Manual
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Monitoring the patient

During operation, be sure to check the following on regular
basis:

• Ensure that there are no leaks at the patient connection.

• Ensure that there is flow from the CPAP valve during

inspiration (which means that Whisperflow 2 is supplying
adequate flow to meet patient demand). If you are using
the Whisperflow 2 with a Criterion monitor, watch the
pressure bar graph: flow is adequate if pressure
fluctuations are minimal (± 2 cmH

O).

2

• Monitor the patient's arterial blood oxygen saturation

).

(SaO

2

• Monitor the patient for signs of dehydration and
discomfort in the upper airways.

• Use the Criterion 60 or other reliable oxygen analyzer to
monitor the FIO

delivered to the patient.

2

Maintenance

Under normal conditions, the Whisperflow 2 System does not
require any special maintenance or sterilization. However, the
Whisperflow 2 System can be gas-sterilized using ethylene
oxide (EtO). Following sterilization, open all the valves fully,
connect to an oxygen supply for five minutes, and verify
performance before reuse.

CAUTION: Do not autoclave or immerse the
Whisperflow 2 System or any of its components in any
solution. The circuit, including the inlet filter, is for
single patient use.

Follow these steps to test the Whisperflow 2 System's
minimum FIO

1. Set the flow adjustment to its maximum, and the oxygen

annually:

2

adjustment valve to its minimum.

2. Attach a 10-cmH

O CPAP valve to the Whisperflow 2

2

using a patient circuit.

3. Ensure that the FIO

at a circuit pressure of 10 cmH2O

2

does not exceed 30%.

Whisperflow 2 CPAP System User's Manual 15
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Environmental specifications

Temperature

Operating: 5 to 45 °C at 15 to 95% relative humidity
Storage: -40 to 60 °C at 95% relative humidity

Oxygen supply

40 to 80 psi (275 to 550 kPa)
See Figure 11 for flow requirements.

Performance

Figures 8 through 11 characterize Whisperflow 2
performance.

160

155

150

145

140

Flow (L/min)

135

130

125

120

5 7.5 10 12.5 15 17.5 20

Pre ssur e (cm H2 O)(h Pa)

Figure 8. Maximum flow and minimum oxygen

versus pressure

32

31.5

31

30.5

30

29.5

29

28.5

28

Flow
O2

% O2

16 Whisperflow 2 CPAP System User's Manual
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36

35

34

33

32

31

% Oxygen

30

29

28

27

26

40 60 80 100 120

Flo w (L/m iin)

Figure 9. Minimum oxygen achievable at different flow

settings

for different PEEP values

2

1.8

1.6

1.4

1.2

1

0.8

Pressure (cmH2O)(hPa)

0.6

0.4

0.2

0

40 60 80 100 120

Flo w (L /m in)

Figure 10. Circuit pressure loss per square meter of

tubing

2.5
5

7.5
10
15

Whisperflow 2 CPAP System User's Manual 17
8-100482-00 Rev. C

120

)

100

80

60

40

Supply Oxygen Consumption (L/min

20

PEEP

40 L/min
60 L/min
80 L/min
100 L/min
120 L/min
140 L/min

0

30 50 70 100

Patient Oxygen %

Figure 11. Oxygen supply consumption at several flow

and oxygen settings

18 Whisperflow 2 CPAP System User's Manual
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Accessories

The following accessories are compatible with the
Whisperflow 2 CPAP System:

• Humidifier: Fisher and Paykel MR730 and MR480. The
MR410 Humidifier can also be used when inspiratory flow
rates are set to less than 50 L/min.

• Oxygen monitor: You can use any in-line oxygen monitor
with the Whisperflow 2 System. Caradyne recommends
the Criterion 60 Pressure and Oxygen Monitor.

Please contact your local dealer before using other
accessories with the Whisperflow 2 System.

Service

Full service and repair is available from:

Caradyne
Parkmore Business Centre
Parkmore West
Galway, Ireland
Telephone: [phone]
Fax: [phone]

Or contact your local dealer.

Caradyne
2055 Executive Drive
Indianapolis, IN 46241
USA
Telephone: [phone]
Fax: [phone]

Warranty

The Whisperflow 2 System is warranted against defects in
material and workmanship for two years from the time of sale.

Approvals

The Whisperflow 2 System complies with the
requirements of directive 93/42/EEC concerning
medical devices and therefore bears the CE mark.

0050

Whisperflow 2 CPAP System User's Manual 19
8-100482-00 Rev. C

Manufacturer

Caradyne Ltd.
Parkmore Business Park,
Parkmore West
Galway, Ireland
Telephone: [phone]
Fax: [phone]

E-mail: [e-mail]
Internet: http://www.caradyne.com

Year of manufacture

The fifth and sixth digits of the serial number indicate the
Whisperflow 2 System's year of manufacture.

Parts list

Description Part number

Whisperflow 2 CPAP Systems

Whisperflow 2 CPAP System, Europe 8-100474-00
Whisperflow 2 CPAP System,

USA/Canada

CPAP valves, 22-mm connection

CPAP valve, 2.5 cmH2O 8-208503-00
CPAP valve, 5 cmH2O 8-208505-00
CPAP valve, 7.5 cmH2O 8-208507-00
CPAP valve, 10 cmH2O 8-208510-00
CPAP valve, 12.5 cmH2O 8-208512-00
CPAP valve, 15 cmH2O 8-208515-00
CPAP valve, 20 cmH2O 8-208520-00

CPAP valves, 30-mm connection

CPAP valve, 2.5 cmH2O 8-209503-00
CPAP valve, 5 cmH2O 8-209505-00
CPAP valve, 7.5 cmH2O 8-209507-00
CPAP valve, 10 cmH2O 8-209510-00

8-100475-00

20 Whisperflow 2 CPAP System User's Manual
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Description Part number

CPAP valve, 12.5 cmH2O 8-209512-00
CPAP valve, 15 cmH2O 8-209515-00
CPAP valve, 20 cmH2O 8-209520-00

CPAP masks, SealFlex

Mask, dual-port, large 8-209000-00
Mask, dual-port, medium 8-209001-00
Mask, dual-port, small 8-209002-00

CPAP masks, AirSeal

Mask, dual-port, large 4-005000-00
Mask, dual-port, medium 4-005001-00
Mask, dual-port, small 4-005002-00

CPAP masks, multi-strap

Mask, SealFlex multi-strap, 30-mm, large 4-005520-00
Mask, SealFlex multi-strap, 30-mm,

4-005521-00

medium
Mask, SealFlex multi-strap, 30-mm, small 4-005522-00
Mask, SealFlex multi-strap, 22-mm, large 4-005523-00
Mask, SealFlex multi-strap, 22-mm,

4-005524-00

medium
Mask, SealFlex multi-strap, 22-mm, small 4-005525-00

Filter, 22M/22F ports 8-208570-00
Filter, Whisperflow 2 8-100471-00
Connectors

Connector, 22F/22F ports 8-201009-00
Connector, 22M/22M ports 8-201007-00
Connector, 22F/30F ports 8-100264-00
Connector, 22M/30M ports 4-005053-00

Headstraps

Headstrap, multi-strap kit-cap-white, large 4-005572-00
Headstrap, multi-strap kit-cap-black, large 4-005573-00
Headstrap, multi-strap kit-cap-white,

4-005574-00

medium

Whisperflow 2 CPAP System User's Manual 21
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Description Part number

Headstrap, multi-strap kit-cap-black,

4-005575-00

medium
Headstrap, multi-strap kit ‘H’ white 4-005576-00
Headstrap, multi-strap kit ‘H’ white 4-005577-00
Head strap, four-point, latex 8-209102-00
Head strap, four-point, non-latex 8-209103-00

Whisperflow 2 CPAP System User’s Manual 8-100482-00
Pole mounting kit 8-100315-00
Patient monitors

Criterion 40 Pressure Monitor, UK/Ireland 8-100210-00
Criterion 40 Pressure Monitor, Europe 8-100324-00
Criterion 40 Pressure Monitor,

8-100325-00

USA/Canada
Criterion 60 Pressure/Oxygen Monitor,

8-100352-00

UK/Ireland
Criterion 60 Pressure/Oxygen Monitor,

8-100351-XX

Europe
Criterion 60 Pressure/Oxygen Monitor,

8-100353-00

USA/Canada

Caradyne continues to develop new accessories. Contact
your local dealer for an updated list.

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