WhisperFlow
CPAP System - Variable & Fixed
®
User’s Manual
8-100335-00 Rev E
Copyright © 2008 Respironics, Inc. and its affiliates.
All rights reserved.
This work is protected under Title 17 of the United States copyright code and is
the sole property of Respironics. No part of this document may be copied or
otherwise reproduced, or stored in any electronic information retrieval system,
except as specifically permitted under United States copyright law, without the
prior written consent of Respironics.
Respironics Novametrix, LLC
5 Technology Drive
Wallingford, CT 06492
USA
USA and Canada: 1-800-345-6443 or 724-387-4000
Europe, Africa, Middle East: +33-1-47-52-30-00
Asia Pacific: +852-3194-2280
Authorized Representative:
Respironics Deutschland
Gewerbestrasse 17
D 82211 Herrsching Deutschland
+49 8 15 29 30 60
Made in USA
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Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
How it works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Setting up the WhisperFlow System . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Notes to Figures 2 through 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Operating the WhisperFlow System . . . . . . . . . . . . . . . . . . . . . . . . . 10
Monitoring the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Customer Service and Product Support . . . . . . . . . . . . . . . . . . . . . . 16
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Year of manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Parts list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
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Introduction
The WhisperFlow 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 System is intended for use on spontaneously breathing patients.
The variable generator WhisperFlow System allows you to vary fractional inspired
oxygen (FIO
delivers FIO
) from 28% to 100%. The fixed generator WhisperFlow System
2
from 28% to 33%, depending on the flow and PEEP valve used.
2
Figure 1. WhisperFlow CPAP System: variable and fixed generators
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The WhisperFlow 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 CPAP System is a precision venturi device that uses an oxygen
supply in conjunction with entrained air to generate an output flow. The
WhisperFlow System uses a 60 psi (412 kPa) oxygen supply, and can generate
flows over 150 L/min. down to 28% fractional inspired oxygen (FIO
WhisperFlow CPAP valves, which are placed within the circuit, are used to
maintain preset positive pressure at flow rates from 10 to 150 L/min.
). The
2
Setting up the WhisperFlow System
WARNING: Do not use the WhisperFlow System without an oxygen analyzer to
alert you to a loss of oxygen wall pressure or other system faults.
WARNING: Always ensure that the PEEP valve is correctly connected to the
patient circuit, and that the exhaust port of the PEEP valve is not attached to
the circuit.
WARNING: The ON/OFF knob controls a continuous valve. Be sure to turn the
knob FULLY counterclockwise, one half turn, for the fully ON position.
WARNING: Place a pressure gauge or pressure monitor in-line, between the
generator outlet and the patient interface by use of an in-line tee. Alternatively,
pressure can be monitored by attaching pressure monitoring tubing to the
mask port.
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CAUTION: To avoid damage to the WhisperFlow System by entraining particles
into the device, always install a filter on the fresh gas intake port.
CAUTION: The WhisperFlow System, as with similar systems from other manufacturers, does not include a non-rebreathing valve for use with tracheal tubes.
If the oxygen supply fails while the patient’s tracheal tube is connected to the
system, the patient will rebreathe the gas in the supply tubing and may be
asphyxiated.
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 PEEP valve. (See the parts list for a complete list of available PEEP
valve sizes and part numbers.)
3. Assemble the circuit according to Figures 2 through 6, depending on the
mask, oxygen analyzer, pressure gauge or monitor, and humidifier you are
using. As you assemble the circuit, please note:
• Use a pressure relief valve to protect the patient's lungs from trauma in the
event that the PEEP valve becomes occluded. Select a PEEP valve at least
5 cmH
• To ensure accurate measurement of the FIO
O higher than the expiratory PEEP valve.
2
2
delivered to the patient, use
an inline oxygen analyzer upstream of the patient connection and
humidification device (if used).
• To assist in detecting adequate flow from the generator, place a pressure
gauge, 0-30cmH
O, or pressure monitor, in-line between the generator
2
outlet and the patient interface, or attach a pressure monitor line to the
patient mask. Should the registered pressure decrease significantly during
patient inhalation, then the flow to the patient needs to be increased.
WhisperFlow® CPAP System User’s Manual
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• The WhisperFlow System can deliver a minimum FIO2 of 28-29% to the
patient. However, the longer the tube lengths used, the higher the
minimum FIO
. (Longer tubing increases the resistance of the patient
2
circuit, allowing the generator to entrain less air.)
• The WhisperFlow System's location upstream of the patient and the high
flows it produces make contamination and resulting cross-infection highly
unlikely. However, if cross contamination is a concern, attach a 22-mm
OD/ID filter to the output port of the generator.
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Figure 2. Dual-port mask, oxygen probe with integrated tee piece
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Figure 3. Dual-port mask, 15-mm oxygen probe
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Figure 4. ET tube connection, 15-mm oxygen probe
CAUTION: The WhisperFlow System, as with similar systems from other manufacturers, does not include a non-rebreathing valve for use with tracheal tubes.
If the oxygen supply fails while the patient’s tracheal tube is connected to the
system, the patient will rebreathe the gas in the supply tubing and may be
asphyxiated.
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Figure 5. ET tube connection, oxygen probe with integrated tee piece
CAUTION: The WhisperFlow System, as with similar systems from other manufacturers, does not include a non-rebreathing valve for use with tracheal tubes.
If the oxygen supply fails while the patient’s tracheal tube is connected to the
system, the patient will rebreathe the gas in the supply tubing and may be
asphyxiated.
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8 8-100335-00 Rev E
Notes to Figures 2 through 5
The notes below apply to Figures 2 through 5 above:
• Figures 2 through 5 show how to assemble the WhisperFlow system and
WhisperFlow accessories. The WhisperFlow unit should only be used with
the accessories supplied by the manufacturer, Respironics, or its
authorized agent. In particular, the face mask has an integral one-way
valve, which prevents exhalation into the delivery tubing in the event of no
fresh gas flow. When used with a tee-piece however, exhalation into the
delivery tubing will result in CO
• If the fresh gas flow fails, the one-way valve will minimize the risk of
asphyxia when there is no oxygen pressure. However, if there is no fresh
gas flow, the patient will have to inhale at ambient pressure, though will
still continue to exhale at the PEEP pressure (see Table 1); this will result
in an increased work of breathing and may not be well tolerated by some
patients. Therefore, when there is no oxygen flow from the WhisperFlow
System, the mask should not be worn, and nor should the device be
connected to a tracheal tube.
• External monitoring should be used to ensure that the WhisperFlow
generator setting is suitable for the patient. An in-line pressure gauge or
pressure monitor will show a constant pressure approximately the same as
the PEEP valve specification. If the delivered flow is too low, the pressure
exhibited will indicate a significant drop when the patient inhales. This
inadequate flow can be corrected by increasing the flow from the
WhisperFlow generator.
• The oxygen monitor with alarms is used in setting and monitoring the FIO
delivered by the unit. It may alert the user to the loss of oxygen flow if the
patient continues to draw fresh gas without oxygen through the air inlet of
the WhisperFlow generator.
• The safety PEEP valve is placed in the circuit line in the event that the
PEEP valve attached to the face mask or endotracheal tube becomes
occluded. Thus any excess circuit pressure above the prescribed PEEP
pressure will be relieved.
rebreathing, and may result in asphyxia.
2
2
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Figure 6. Installing a humidifier
Operating the WhisperFlow System
1. Turn all control valves off by turning fully clockwise (finger-tight only).
2. Connect the oxygen supply, then listen for leaks:
• Variable generator: Connect directly to the oxygen supply or connect an
oxygen hose between the WhisperFlow System oxygen fitting and the
oxygen supply.
• Fixed generator: Connect directly to flowmeter capable of delivering at
least 13 L/min. at 60 psi (412 kPa).
WARNING: Do not connect any gas supply other than oxygen to the WhisperFlow System.
WhisperFlow® CPAP System User’s Manual
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NOTE: The WhisperFlow should not be connected directly to oxygen tanks with
pressures over 230 bar (3336 PSI). Frost may form on the regulator and the
device when FIO
settings are higher than 30%.
2
3. Turn the ON/OFF valve fully on (one-half turn). Turn the flow adjustment valve
fully on and check that the output flow from the patient outlet varies
accordingly.
WARNING: The ON/OFF knob controls a continuous valve. Be sure to turn the
knob fully counterclockwise, one half-turn, for the full ON position
4. For higher concentrations (variable generator only), turn the oxygen adjustment
valve counter-clockwise until the oxygen analyzer displays the appropriate FIO
for 30 seconds.
5. Leave the oxygen and flow controls as you have just set them, then turn the
ON/OFF valve fully off (clockwise). Attach the circuit to the patient, and then
turn the ON/OFF valve fully on (counter-clockwise).
6. Watch the PEEP 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. Monitor the FIO
decreases, the FIO
2
as you reduce the circuit flow: as the circuit flow
2
rises slightly. You can reduce the FIO2 by closing the
oxygen adjustment valve.
2
7. Monitor the in-line pressure gauge or monitor. If the pressure drops
significantly then the flow is inadequate.
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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 PEEP valve during inspiration (which means
that the generator is supplying adequate flow to meet patient demand).
• Monitor the in-line pressure gauge or monitor during inspiration. If the
pressure drops significantly, then the flow is inadequate.
• Monitor the patient's arterial blood oxygen saturation (SaO
).
2
• Monitor the patient for signs of dehydration and discomfort in the upper
airways.
• Monitor the patient’s delivered FIO
.
2
Maintenance
Under normal conditions, the WhisperFlow System does not require any special
maintenance or sterilization. However, the WhisperFlow System generator 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 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 System's minimum FIO
annually:
2
1. Variable generator only: set the flow adjustment to its maximum, and the
oxygen adjustment valve to its minimum.
2. Attach a 10-cmH
3. Ensure that the FIO
12 8-100335-00 Rev E
O PEEP valve to the generator using a patient circuit.
2
at a circuit pressure of 10 cmH2O does not exceed 30%.
2
WhisperFlow® CPAP System User’s Manual
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)
• For flow requirements see Figure 10.
NOTE: The WhisperFlow should not be connected directly to oxygen tanks with
pressures over 230 bar (3336 PSI). Frost may form on the regulator and the
device when FIO
settings are higher than 30%.
2
Flow O2
160
155
150
145
140
135
Flow (L/min)
130
125
120
5 7.5 10 12.5 15 17.5 20
Pressure (cmH2O)(hPa)
32
31.5
31
30.5
30
29.5
29
28.5
28
% O2
Figure 7. Maximum flow and minimum oxygen versus pressure
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36
35
% Oxygen
34
33
32
31
30
29
28
27
26
40 60 80 100 120
Flow (L/min)
2.5
5
7.5
10
15
Figure 8. Minimum oxygen achievable at different flow settings for different PEEP values
2
1.8
1.6
1.4
1.2
1
0.8
0.6
Pressure (cmH2O)
0.4
0.2
0
40 60 80 100 120
Flow (L/min)
Figure 9. Circuit pressure loss per meter of tubing
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160
)
140
120
100
80
60
40
20
Supply Oxygen Consumption (L/min
0
30 50 70 100
Patient Oxygen %
40 L/min
60 L/min
80 L/min
100 L/min
120 L/min
140 L/min
Figure 10. Oxygen supply consumption at several flow and oxygen settings
Inspiratory Flow
(L/min.)
Approximate Pressure Drop
(cmH
O)
2
20 -1.0
40 -2.7
60 -3.9
80 -4.9
100 -5.1
Table 1: Pressure required to breathe through a system comprising a face mask,
1.8m tubing, and a CPAP generator in the instance where oxygen supply is lost.
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Accessories
The following accessories are compatible with the WhisperFlow CPAP System:
• Mounting pole: Any pole with a clamp range of 10 to 40 mm.
• 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 System. Some WhisperFlow procedure packs include a
connector for attaching the oxygen monitors using a silicone tee or 15-mm
probe.
Please contact your local dealer before using other accessories with the
WhisperFlow System.
Customer Service and Product Support
Full service and repair is available from the manufacturer.
USA and Canada
Phone 1-800-345-6443 or 724-387-4000
Customer Service Fax 1-800-886-0245
Product Support Fax 1-724-387-5236
International Customer Service Phone 724-387-4000
International Customer Support Fax 724-387-5012
Europe/Africa/Middle East +33-1-47-52-30-00
Asia Pacific +852-3194-2280
service@respironics.com
clinical@respironics.com
www.respironics.com
WhisperFlow® CPAP System User’s Manual
16 8-100335-00 Rev E
Manufacturer
Respironics Novametrix, LLC.
5 Technology Drive
Wallingford, CT 06492
USA
USA 800-345-6443 or 724-387-4000
Europe/Africa/Middle East +33-1-47-52-30-00
Asia Pacific +852-3194-2280
www.respironics.com
service@respironics.com
clinical@respironics.com
Approvals
The WhisperFlow System complies with the requirements of directive
93/42/EEC concerning medical devices and therefore bears the CE mark.
Authorized Representative:
Respironics Deutschland
Gewerbestrasse 17
82211 Herrsching
Deutschland
Telephone: +49 8-152930640
Year of manufacture
The fifth and sixth digits of the serial number indicate the WhisperFlow System's
year of manufacture.
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Parts list
Description Part number
WhisperFlow CPAP System, variable generator (where x
8-20860x-00
indicates the gas fitting, hose, and country). Contact
your local dealer for further details.
WhisperFlow CPAP System, fixed generator 8-208530-00
CPAP valve, 2.5 cmH
CPAP valve, 5 cmH
CPAP valve, 7.5 cmH
CPAP valve, 10 cmH
CPAP valve, 12.5 cmH
CPAP valve, 15 cmH
CPAP valve, 20 cmH
O 8-208503-00
2
O 8-208505-00
2
O 8-208507-00
2
O 8-208510-00
2
O 8-208512-00
2
O 8-208515-00
2
O 8-208520-00
2
Filter, 22 mm 8-208570-00
Tee piece, safety valve, 22M/22F/22F ports 8-202502-00
Tee piece, oxygen analyzer, 22M/22M/(22M/15F) ports 8-202503-00
Connector, 22M/22F with Pressure Port 8-100327-00
Connector, 22F/22F ports 8-201009-00
Connector, 22M/22M ports 8-201007-00
Mask, dual-port, large 8-209000-00
Mask, dual-port, medium 8-209001-00
Mask, dual-port, small 8-209002-00
Head strap, four-point, latex 8-209102-00
Head strap, four-point, nonlatex 8-209103-00
WhisperFlow Mounting Kit 8-100068-00
Several CPAP procedure packs are available: please contact your local
dealer for further details.
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Notes:
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