BiPAP Focus Operators Manual (ENG) - 1027404 K

Noninvasive Ventilator System
Operator’s Manual
1027404 Rev K
Copyright © 2007 – 2014 Respironics California, Inc.
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.
Manufactured for:
Respironics California, Inc.
2271 Cosmos Court
Carlsbad, California 92011
USA
Made in USA
Authorized Representative:
Respironics Deutschland GmbH
Gewerbestrasse 17
D-82211 Herrsching
Germany
+49-8-15-29-30-60
Philips Healthcare Australia

65 Epping Road
North Ryde NSW 2113
Australia
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Table of Contents
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About BiPAP Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Patient Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Lifting the BiPAP Focus Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Mounting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Connecting to Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Connecting to an External Device . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Installing Air Inlet Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Language Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Connecting the Patient Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Connecting the Pressure Tube and Filter . . . . . . . . . . . . . . . . . . . . 20
Connecting Supplemental Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Pre-Operational Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
System Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Continuous Positive Airway Pressure (CPAP) Mode . . . . . . . . . . . 28
Spontaneous/Timed (S/T) Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Auto-Trak™ Sensitivity Function . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Leak Estimation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
System Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
The BiPAP Focus Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Screen Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Changing Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
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Changing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
CPAP Mode Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
S/T Mode Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Alarm Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Options Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Battery Back-up Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Battery Operating Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Battery Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Alarm Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Alarm Silence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Alarm Pre-silence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Alarm Message Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Alarm Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Care and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Storing the BiPAP Focus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Cleaning the Reusable Air Inlet Filter . . . . . . . . . . . . . . . . . . . . . . . . . 60
Replacing the Air Inlet Filter(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Testing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Default Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Settings: CPAP Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Settings: S/T Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Measured Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Alarm Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
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Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Patient Circuit Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Pressure Drop Versus Flow for Patient Circuits . . . . . . . . . . . . . . . 74
Maximum Pressure Drop for Disconnect . . . . . . . . . . . . . . . . . . . . . . 75
Triggers and Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Supplemental Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Environmental. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Bacteria Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Date of Manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Pneumatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
International Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
IEC 601-1 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Electromagnetic Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
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vi BiPAP® Focus™ Noninvasive Ventilator System

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System Description
Chapter 1: System Description
About BiPAP Focus

The BiPAP Focus Ventilator System provides noninvasive breathing
support for adult patients weighing 30 kg (66 lbs.) or greater.
The BiPAP Focus System offers two ventilation modes:
• Continuous positive airway pressure (CPAP), which provides a
single level of positive pressure to the patient.
• Spontaneous/Timed (S/T), which provides two levels of positive
pressure (one during inspiration and one during exhalation), and
delivers timed breaths if the patient does not initiate a breath.
The BiPAP Focus System alarms annunciate when high or low pressure
regulation, apnea, patient disconnect, low power, or loss of mains power
conditions occur. The system displays a real-time estimated delivered
pressure bar graph.
An Apnea Rate (#Apnea) Alarm is provided to alert the caregiver to
repeated periods of short apneas of 10 seconds or more. The caregiver
can set the value for how many apnea periods (10 seconds or more) can
occur within an hour before alarming. The total number of Apnea periods
(10 seconds or more) for the previous hour is displayed as part of the
patient data. Because the previous hours data is displayed, the number of
apnea periods for the first hour is an estimate only.
The BiPAP Focus System includes Alarm Silence and Alarm Pre-silence
features. Battery backup provides a minimum of 45 minutes of backup
power at default settings in case AC power is not available (for example,
during transport within the hospital).
The BiPAP Focus System features Digital Auto-Trak™, which allows it to
recognize and compensate for unintentional leaks and promote
synchrony by adjusting its trigger and cycle algorithms to maintain
optimum performance.
Intended Use
The BiPAP Focus Ventilator is a noninvasive, pressure support ventilator
used to augment the breathing of patients suffering from acute or chronic
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System Description
respiratory insufficiency or to maintain airway patency and provide

ventilatory support to patients who experience obstructive sleep apnea. It
is not intended to provide the total ventilatory requirements of the patient.
Intended population: Adults > 30 kg
Environments of use: Hospital, subacute and intrahospital transport under
qualified clinician direction and supervision
Contraindications
The BiPAP Focus System is contraindicated for patients with any of the
following conditions:
• Lack of spontaneous respiratory drive
• Inability to maintain a patent airway or adequately clear secretions
• At risk for aspiration of gastric contents
• Acute sinusitis or otitis media
• Hypotension
Patient Precautions
Advise the patient to immediately report any unusual chest discomfort,
shortness of breath, or severe headache.
If skin irritation or breakdown develops from the use of the mask, refer to
the mask instructions for appropriate action.
Potential side effects of noninvasive positive pressure therapy include:
ear discomfort, conjunctivitis, skin abrasions due to noninvasive
interfaces, gastric distention (aerophagia).
Restrictions
Federal law (U.S.) restricts this device to sale by or on the order of a
physician.
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Warnings
Chapter 2: Warnings
WARNING: To avoid the risk of fire, use this device in well-ventilated

areas away from flammable anesthetics. Do not use in a hyperbaric
chamber or other similarly oxygen-enriched environments.
WARNING: When using the BiPAP Focus System, an alternative

means of ventilation should always be available.
WARNING: To reduce the risk of electric shock, ensure that the AC

power cord is undamaged and always disconnect the device from
AC power before opening the enclosure. To ensure that AC power is
disconnected, always disconnect the mains supply at the wall
outlet.
WARNING: The BiPAP Focus System should not be used adjacent to

or stacked with other equipment. If adjacent use is necessary, the
BiPAP Focus System should be observed to verify stable orientation
and normal operation.
WARNING: To minimize the risk of overheating the device, do not

operate adjacent to heaters or other heat sources.
WARNING: The patient should be disconnected if operating in any

mode other than Normal operating mode.
WARNING: Failure to enter Standby mode before switching the ON/

OFF switch on the back of the unit to the OFF position (O) will cause
the unit to alarm for two minutes indicating the unit was not
powered off correctly. This is a safety feature. If it occurs, turn the
unit back ON ( | ) in Normal mode and then shut it down correctly.
WARNING: Medical electrical equipment requires special

precautions regarding electromagnetic compatibility (EMC) and
must be installed and put into service according to the EMC
information provided in this user manual.
WARNING: All components of the breathing circuit are intended for

single patient use only: do not attempt to sterilize or reuse. Follow
all applicable federal and local regulations for disposal or recycling.

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Warnings
WARNING: Do not use antistatic or electrically conductive tubing.
WARNING: This device is not for use with intubated patients.
WARNING: Do not use this device close to MRI or high-frequency

devices, such as electro surgery or diathermy equipment.
WARNING: Do not use this device with anesthetic gases.
WARNING: Do not use flammable disinfectants on or near this

device.
WARNING: Before using the BiPAP Focus System on a patient,

allow the device to acclimate to conditions of use following
transport or storage.
WARNING: Do not use the system if the screen is unreadable. If this

occurs turn the ON/OFF switch to the OFF position (O).
WARNING: Service on this device should only be performed by

qualified service technicians. See the BiPAP Focus System Service
Manual for equipment repair information.
WARNING: Do not make any unauthorized changes to the ventilator.
WARNING: Use only Respironics recommended batteries.
WARNING: Keep any sources of ignition as far as possible from the

device when using oxygen-enriched gas.
WARNING: Use the BiPAP Focus System with Respironics-

approved patient interfaces and circuits only, to assure accuracy of
patient data and correct alarm performance. To avoid the risk of
increased mask pressure during exhalation, do not use any
component or accessory other than those listed in this manual.
WARNING: Do not cover or block the exhalation port on the Vision

circuit, to assure accuracy of patient data and correct alarm
performance.
WARNING: Use of the bacteria filter at the outlet port of the machine
is mandatory. The displayed pressure compensates for the pressure

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Warnings
drop due to the BiPAP Vision single patient use circuit and the
bacteria filter (see “Accessories” on page 87 for ordering
information).
WARNING: Check that the orientation of the oxygen safety valve is

correct.
WARNING: Connect oxygen only on order of a physician.
WARNING: When connecting oxygen to the circuit, use an in-line

safety valve and do not allow oxygen to be entrained through the air
inlet.
WARNING: Observe the patient and monitor continuously using

pulse oximetry and arterial blood gas measurements as needed
during oxygen administration.
WARNING: Inspired oxygen concentration can vary according to

settings, patient breathing patterns, and leak rate.
WARNING: To avoid oxygen accumulation in the ventilator, put it

into Normal operating mode before turning the oxygen ON, and turn
oxygen OFF before putting it into Standby or turning the unit OFF.
WARNING: Do not use a Heat and Moisture Exchanger (HME) with

the BiPAP Focus due to high resistance to flow.
WARNING: The BiPAP Focus System can deliver pressures up to 30

cmH2O. In the unlikely event of certain fault conditions a maximum
static pressure of 42 cmH2O is possible.
WARNING: It is important to inspect and replace the air inlet filters at

the recommended intervals to avoid introducing foreign matter into
the system
WARNING: The BiPAP Focus System is shipped with the battery

disconnected. The battery must be connected before the BiPAP
Focus System will operate.
WARNING: To avoid the risk of fire, use only Respironics-approved

batteries. All battery connections are keyed to ensure proper
connection.

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Warnings
WARNING: When running on battery, the high flows that occur

during a patient disconnect will cause the battery to deplete in as
little as 2 minutes. Connect AC power immediately if the Battery
Depleted Alarm sounds to avoid total loss of power.
WARNING: To avoid the risk of electrical shock, do not touch the

communication ports on the ventilator and the patient
simultaneously.
WARNING: Do not perform the Preoperational Check with a patient

attached.
WARNING: To avoid the risk of electrical shock, this equipment

must only be connected to AC mains with protective earth.
WARNING: The AC power mains outlet used for the ventilator shall
be easily accessible by the operator. This is to provide the ability to
disconnect the BiPAP Focus system from electrical mains if this
should be necessary.
WARNING: The DC power supply provided with the BiPAP Focus

system is part of the equipment. Use only the DC power supply
approved for use with the BiPAP Focus system. Failure to use the
approved DC power supply can result in improper operation or
failure of the BiPAP Focus system.
WARNING: Do not remove the power cord retaining clip from the
device.
WARNING: If placing the BiPAP Focus System on a flat surface or

the stand, ensure that the surface is stable.
WARNING: To prevent possible patient injury, verify that the battery

is fully charged before putting a patient on the ventilator and before
unplugging the ventilator for transport or other purposes. The
battery is fully charged when the BATTERY CHARGING light is off
while the ventilator is connected to AC power.
WARNING: Do not use the BiPAP Focus for physical support.
WARNING: Stow the machine, patient circuits, power cords and

accessories safely when not in use.

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Warnings
WARNING: When using oxygen bleed-in, verify that the orientation

of the oxygen safety valve is correct before use.
WARNING: (Chapter 7, Care and Maintenance) Maintenance and

service work not listed in this chapter shall only be done by a
qualified service technician. Only a qualified service technician can
assure that the BiPAP Focus system is properly serviced for safe
operation.
WARNING: Do not connect any device other than remote alarm

cables if the unit is on a patient. Only use cables recommended by
Respironics.
WARNING: This product consists of devices that may contain

mercury, which must be recycled or disposed of in accordance with
local, state, or federal laws. (Within this system, the backlight lamps
in the monitor display contain mercury.)

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Warnings

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Setup
Chapter 3: Setup
When unpacking the BiPAP Focus System, ensure that all parts listed on
the packing list are included in the shipment. Inspect all parts for damage
before use, and immediately report any discrepancies to your Respironics
representative.
System Components
The BiPAP Focus System includes the ventilator, a DC power supply with
mains (AC) power cord, and a reusable inlet filter.
Setup
WARNING:
• Set up the device so that cables and hose do not pose a

tripping hazard. Do not use the device for physical support if
moving a person.
• Use proper technique for lifting the device.
• Use Respironics-approved patient circuits and interfaces only.
• Lift the unit as shown in Figure 1. Do not lift the unit by the
inlet filter at the rear of the unit or by the front panel.

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Setup
Lifting the BiPAP Focus Unit

CAUTION: Lift the unit as shown in Figure 1. Do not lift the unit by
the inlet filter at the rear of the unit or by the front panel.
Figure 1: Lifting the BiPAP Focus Unit

After removing all packaging materials, remove the protective plastic
cover from the display, and wipe the exterior of the BiPAP Focus clean
with a damp cloth and mild detergent solution before the first use (see
“Care and Maintenance” on page 57). Also clean the ventilator exterior
between each patient use and as needed.
The BiPAP® Focus™ Ventilator is shipped with the battery disconnected.
The battery must be connected before the BiPAP Focus Ventilator will
operate. Connecting the battery is a routine action, therefore a qualified
service technician is not required. Follow these simple steps to connect
the battery:
1. Ensure that the ON/OFF switch is in the OFF position (O) and
that the power cord is disconnected.

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Setup
2. Turn the unit over, remove the two battery compartment cover
screws, and battery cover as shown in Figure 2.
Battery compartment cover
Figure 2: Remove the battery compartment cover.

3. Remove the battery pack. Connect the battery by plugging the
white-keyed battery cable connector into the keyed slot. Push
the connector in until it locks in place as shown in Figure 3.
Battery compartment
White-keyed
battery cable
connector
Battery pack
Figure 3: Connect the battery cable connector to the keyed slot.

4. Replace the battery pack in the battery compartment, close the
cover, and tighten the screws. Connect the power cord.

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Setup
Mounting
The BiPAP Focus System can be placed on a flat surface or secured to a
stand as seen in Figure 4.
WARNING: If placing the BiPAP Focus System on a flat surface or

the stand, ensure that the surface is stable.
Complete assembly instructions

are provided with the universal
roll stand,P/N 1041139 and
mounting plate, P/N 1048874.
BiPAP Thumbwheel
Focus Platform
Figure 4: BiPAP Focus on the Mobile Stand

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Setup
Connecting to Power
WARNING: To avoid the risk of electrical shock, this equipment
must only be connected to AC mains with protective earth.To avoid
the risk of electrical shock, this equipment must only be connected
to AC mains with protective earth.
WARNING: The AC power mains outlet used for the ventilator shall
be easily accessible by the operator. This is to provide the ability to
disconnect the BiPAP Focus system from electrical mains if this
should be necessary.The AC power mains outlet used for the
ventilator shall be easily accessible by the operator. This is to
provide the ability to disconnect the BiPAP Focus system from
electrical mains if this should be necessary.
WARNING: The DC power supply provided with the BiPAP Focus

system is part of the equipment. Use only the DC power supply
approved for use with the BiPAP Focus system. Failure to use the
approved DC power supply can result in improper operation or
failure of the BiPAP Focus system.The DC power supply provided
with the BiPAP Focus system is part of the equipment. Use only the
DC power supply approved for use with the BiPAP Focus system.
Failure to use the approved DC power supply can result in improper
operation or failure of the BiPAP Focus system.
WARNING: To prevent the premature depletion and reduced life

expectancy of the battery, store the ventilator with AC power
connected and the ON/OFF switch in the ON (I) position. When the
ventilator is stored disconnected from AC power with the power
ON/OFF switch ON (I) and in standby, the battery may become
depleted within two weeks. When the ventilator is stored with the
ON/OFF switch in the OFF (O) position, the battery typically
becomes depleted in three months.
If a 343 error code is displayed, contact Service. The battery needs

replacement.
CAUTION: The battery is intended for back-up and intra-hospital
transport only, and is not intended to be the main power source.
The BiPAP Focus System is powered by a DC power supply connected to

AC mains (Figure 5). The unit also has an internal battery as a backup
power source. The internal battery can run the system for a minimum of

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Setup
45 minutes at default settings (see “Specifications” on page 67 for default

settings).
The internal battery charging cycle is active whenever the system is
connected to AC power and the back panel ON/OFF switch is ON ( | ) and
the BATTERY CHARGING LED is illuminated.
ON/OFF switch
DC power supply
BiPAP Focus connection and
System retaining clip
DC power supply
To AC power
Figure 5: Connecting to AC (Wall) Power

NOTE: The BiPAP Focus System is shipped with the battery
disconnected. The battery must be connected before the BiPAP Focus
System will operate. Connect battery during initial setup (see page 11).
NOTE: If the unit is being set-up for the first time (out of the box), it is
recommended that the unit gets a full battery charge. This also applies
after the unit has been stored for 2 weeks or longer.
NOTE: For maximum battery performance, a new battery or a battery that

has been in storage should be fully charged and discharged two to three
times.

1027404 Rev K
Setup
Connecting to an External Device
ON/OFF switch
USB DC power Shown in the
port supply input OFF position
Nurse call station/serial

communications port Power cord retention clip
Figure 6: BiPAP Focus Back Panel

The nurse call station/serial communications port can connect the BiPAP
Focus System to a nurse call monitoring station or provide serial
communications output for service purposes.
The nurse call station alarm is activated when the ventilator is turned
OFF, or put into Standby, an alarm occurs, or a system error occurs. The
nurse call station alarm is deactivated when all active alarms are silenced
or auto-reset.
Most nurse call station systems require only normally open (NO) or
normally closed (NC) connections. NO and NC nurse call station cables
are available from Respironics. See “Accessories” on page 87 for cable
ordering information. See “Specifications” on page 67 for pinout
information.
The communication and USB ports allow service technicians to upgrade
system software.
WARNING: To avoid the risk of electrical shock, do not touch the

communication ports on the ventilator and the patient
simultaneously.

1027404 Rev K
Setup
CAUTION: The nurse call station port is intended to connect only to

a SELV (Safety Extra-Low Voltage) and ungrounded system with
basic insulation to ground, in accordance with IEC 60601-1. To
prevent damage to the nurse call circuit, the signal input should not
exceed the maximum rating of 24 VAC (Volts of Alternating Current)
or 36 VDC (Volts of Direct Current) at 500 mA (milliamps), with a
minimum current of 1 mA.

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Setup
Installing Air Inlet Filters

Install the air inlet filter(s) as shown (Figure 7). To avoid introducing
foreign matter into the system, a reusable air inlet filter must be installed.
(See “Care and Maintenance” on page 57 for information on how to clean
the reusable air inlet filter.) An additional ultra-fine disposable filter is also
recommended for enhanced particulate filtering.
Reusable gray
foam filter
(required)
Disposable white ultra-

fine filter (optional)
Figure 7: Installing Air Inlet Filters
Language Selection
The following instructions describe how to select the desired language
that the BiPAP Focus will display in Normal Mode.

1. Connect mains power to the unit and turn the ON/OFF switch at
the rear of the unit to the ON ( | ) position.
2. Simultaneously press and hold the Alarm Reset and Alarm
Silence keys.
3. Press the Standby key once, while continuing to hold the Alarm
Reset and Alarm Silence keys.

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Setup
4. The unit will power up and will display the following screen:
Figure 8: Warning Screen

5. Press ENTER to continue past the Warning screen. The Menu
screen shown in Figure 9 will appear:
Figure 9: Menu Screen

6. Scroll using the DOWN arrow key until System Settings is
highlighted, and then press ENTER.

1027404 Rev K
Setup
7. Press ENTER again to display a list of available languages

(Figure 10). Use the UP and DOWN arrow keys to scroll through
the list. Highlight the desired language, and then press ENTER
to select that language.
Figure 10: System Settings Screen

8. After selecting the desired language, the unit will display the
message below and will power off automatically after 5 seconds.
Figure 11: Updating Languages Screen

9. The unit must be restarted to activate the language selection.

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Setup
Connecting the Patient Circuit

WARNING: All components of the breathing circuit are intended for
single patient use only: do not attempt to sterilize or reuse. Follow
all applicable federal and local regulations for disposal or recycling.
WARNING: Use the BiPAP Focus System with Respironics-

approved patient interfaces and circuits only, to assure accuracy of
patient data and correct alarm performance. To avoid the risk of
increased mask pressure during exhalation, do not use any
component or accessory other than those listed in this manual.
WARNING: Do not use a Heat and Moisture Exchanger (HME) with

the BiPAP Focus due to high resistance to flow.
The BiPAP Focus System patient interface (Figure 13) includes:

• Patient interface (nasal or full face mask)
• Breathing circuit tubing
• Proximal pressure line (this line is not used, but should be
terminated on the output port mounting post to avoid introducing a
leak)
• Bacteria filter
• Humidifier (optional)
Connecting the Pressure Tube and Filter

Connect the pressure tube and filter in the following order:
1. Connect the proximal pressure line
Attach the pressure tubing to the proximal pressure mounting
post (Figure 12). This terminates the line to avoid introducing a
leak when using the BiPAP Vision circuit.
2. Connect the bacteria filter
The use of the bacteria filter is mandatory

1027404 Rev K
Setup
Proximal pressure mounting post
Proximal pressure line
Bacteria filter
The use of this filter is mandatory.
Figure 12: Attaching the pressure tube and filter
Breathing
circuit
connection
Bacteria filter
(mandatory)
Breathing circuit tubing
(to patient interface)
Proximal pressure line

(not used)
Figure 13: Patient Circuit
WARNING: Use of the bacteria filter at the outlet port of the machine
is mandatory. The displayed pressure compensates for the pressure
drop due to the BiPAP Vision single patient use circuit and the
bacteria filter (see “Accessories” on page 87 for ordering
information).
1027404 Rev K
Setup
Connecting Supplemental Oxygen

If required, connect supplemental oxygen to the patient circuit as shown
(Figure 14).
Bleed in oxygen at the outlet of the BiPAP Focus System, using
Respironics-supplied oxygen enrichment adapter and bleed-in safety
valve (see “Accessories” on page 87). The oxygen flow into the oxygen
valve must not exceed 15 L/min.
Oxygen enrichment adapter
Bacteria filter
(mandatory)
To flow Oxygen safety valve

meter
Figure 14: Connecting Oxygen to the Patient Circuit
WARNING: Check that the orientation of the oxygen safety valve is

correct.
Table 1 shows the potential range of oxygen concentration for given tidal
volume, supplemental oxygen flow, and pressure values. Substantial
leaks around the patient interface can reduce the expected oxygen
concentration levels. Use this information for reference when beginning
oxygen therapy and adjust oxygen flow gradually to meet patient oxygen
needs.
CAUTION: The Oxygen Safety Valve introduces a pressure drop of
approximately 1 cmH2O.

1027404 Rev K
Setup
Sample FiO2 values for different tidal volumes with RR=20 I:E = 1:2 10L/
min patient leak, and using a Vision Circuit with IPAP/EPAP settings of
10/5,20/5,30/5.
Table 1: Oxygen Concentration
Tidal Volume FiO2 @ 5 L/min FiO2 @ 10 L/min

(mL) Supplemental Flow Supplemental Flow
600 37 +/- 3% 50 +/- 3%
1000 30 +/- 3% 40 +/- 3%
WARNING: Connect oxygen only on order of a physician.
WARNING: When connecting oxygen to the circuit, use an in-line

safety valve and do not allow oxygen to be entrained through the air
inlet.
WARNING: Observe the patient and monitor continuously using

pulse oximetry and arterial blood gas measurements as needed
during oxygen administration.
WARNING: Inspired oxygen concentration can vary according to

settings, patient breathing patterns, and leak rate.
WARNING: To avoid oxygen accumulation in the ventilator, put it

into Normal operating mode before turning the oxygen ON, and turn
oxygen OFF before putting it into Standby or turning the unit OFF.
WARNING: To avoid the risk of fire, use this device in well-ventilated

areas away from flammable anesthetics. Do not use in a hyperbaric
chamber or other similarly oxygen-enriched environments.

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Setup

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Operation
Chapter 4: Operation
Pre-Operational Check
The Pre-Operational Check is a check of LEDs and alarms to be used at
the discretion of the clinician. This test is recommended and may be
useful for initial setup or following storage periods.
WARNING: Do not perform the Preoperational Check with a patient

attached.
Follow these steps to perform a pre-operational check:

1. Connect system to AC power and set the ON/OFF switch to the
ON ( | ) position.
2. Verify that the ON AC POWER and green BATTERY
CHARGING indicators are on.
3. Press the STANDBY button to turn the system on and verify that
the red ALARM indicator blinks and the audible alarm sounds.
NOTE: If the ventilator has been in storage for 2 weeks or longer, allow
the internal battery to charge for at least 30 minutes before performing the
following step.
NOTE: If a Low Battery or Battery Depleted alarm occurs during Pre-

Operational Check, then the battery requires charging. If a Batt Charge
Failure alarm occurs, the battery may be fully depleted. A re-charge is
recommended before proceeding. If the battery does not begin to charge
after one hour and the Batt Charge Failure persists, contact customer
service for a replacement battery.

1027404 Rev K
Operation
CAUTION: To prevent the premature depletion and reduced life

becomes depleted in three months. For maximum battery
performance, a new battery or a battery that has been in storage
should be fully charged and discharged two to three times.

replacement.
4. Once the system begins normal operation, disconnect the power

cord from wall power. Verify the following indicators are
functioning:
• Yellow ON BATTERY indicator turns on.
• ON AC POWER and green BATTERY CHARGING indicators
turn off.
• Red ALARM indicator flashes, audible alarm sounds.
5. Press ALARM RESET. Verify that the ALARM LED and audible
alarm turn off.
The audible alarm sounds (beeps) once a minute, alerting the
user that unit is running on the internal battery.
6. Reconnect AC power. Verify that the ON AC POWER LED is on
and the ON BATTERY LED is off. Press ALARM SILENCE and
verify that the yellow ALARM SILENCE indicator turns on. Press
ALARM RESET to cancel the silence and verify that ALARM
SILENCE indicator turns off.
7. Use the CHANGE SCREEN, UP/DOWN arrow, ENTER, and
CANCEL keys to step through screens and verify the operation
of each key.
8. Enter CPAP mode with a patient circuit attached and allow the
ventilator to deliver gas for more than 15 seconds. Verify that a
Disconnect (i.e., patient disconnect) alarm occurs.

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Operation
9. Enter S/T mode, then step to the ALARM SETTINGS screen.

Select an APNEA setting of 20 seconds and verify that an
APNEA alarm occurs after 20 seconds.
10. Reenter CPAP mode, clear any alarms, and connect a nurse call
station cable. Turn the ON/OFF switch OFF and verify:
• The backup alarm sounds.
• The nurse call station alarm activates.
Pre-Operational Check is complete.
System Startup
Once the BiPAP Focus System is set up, follow these steps to start
operation:
1. Confirm that the back panel ON/OFF switch is in the ON ( | )
position.
2. Press the STANDBY button on the front panel.
3. Perform the pre-operational check as required.
4. Select the appropriate settings. See "Normal Operation" for more
information.
5. Select a mask (See “Accessories” on page 87.) Attach to the
patient circuit.
NOTE: Direct the exhalation port gas-flow away from the patient. This
helps to maintain patient comfort.
The system is now ready to be connected to the patient.
WARNING: To minimize the risk of personal injury, do not connect

the system to the patient until normal operation begins.

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Operation
Normal Operation
The BiPAP Focus System features these operating modes:
Continuous Positive Airway Pressure (CPAP) Mode

Provides a single level of positive pressure through the patient interface.
Spontaneous/Timed (S/T) Mode

Provides two levels of positive pressure (one during inspiration and
another during exhalation) through the patient interface. S/T mode
ensures that the patient receives a minimum number of breaths per
minute based on the Rate setting. If the patient does not spontaneously
breathe within the cycle time determined by the Rate setting, the
ventilator delivers a timed breath at the set level of IPAP. The I-Time
setting determines the duration of each timed breath.
In S/T mode, the system triggers to deliver Inspiratory Positive Airway
Pressure (IPAP) in response to spontaneous inspiratory effort and cycles
to Expiratory Positive Airway Pressure (EPAP) during exhalation (see
Figure 15). The level of pressure support in S/T mode is the difference
between the IPAP and EPAP settings.
Cycle
IPAP
Trigger
EPAP
Rise Time
Inspiratory Time
Figure 15: Triggering and Cycling in S/T Mode

The Ramp Time and Ramp Start settings (Figure 16) allow the ventilator
to begin at a reduced pressure (the Ramp Start setting) then gradually
increase the pressure breath by breath to the prescription pressure
(CPAP or EPAP), allowing the patient to fall asleep more comfortably.

1027404 Rev K
Operation
Airflow
turned on
Ramp time
IPAP setting entered
Pressure
CPAP/EPAP
Pressure
lta
Ramp Start de
Setting
0 cmH2O
Ramp Time
Minutes
Figure 16: Ramp Time and Ramp Start Settings

1027404 Rev K
Operation
Auto-Trak™ Sensitivity Function

The ventilator monitors flow through the patient circuit to determine
whether the patient is inhaling or exhaling using Digital Auto-Trak™
Sensitivity technology. The BiPAP Focus System adjusts its output to
support breathing and compensates for normal leaks in the patient circuit
using Digital Auto-Trak™ leak compensation technology.
Leak Estimation
The system monitors the total flow in the patient circuit and estimates
patient leak using leak estimation algorithms.
Sensitivity
An essential feature of S/T mode is effective detection of spontaneous
breathing effort, which causes the ventilator to trigger to IPAP and cycle
to EPAP. Because no preset sensitivity threshold can ensure patient and
machine synchrony with changing breathing efforts and circuit leaks, the
BiPAP Focus continuously tracks patient breathing patterns and
automatically adjusts its sensitivity thresholds to ensure optimum
sensitivity as breathing patterns or circuit leaks change. The system uses
volume trigger, shape signal, and Spontaneous Expiratory Threshold
(SET) algorithms to ensure optimum sensitivity:
• The Volume Trigger algorithm triggers IPAP during spontaneous
and timed breaths. The volume trigger threshold is 6 mL of
accumulated patient inspiratory volume. When patient effort
generates inspiratory flow causing 6 mL of volume, IPAP is
triggered.
• The Shape Signal algorithm (Figure 17) continuously tracks patient
inspiratory and expiratory flow and adjusts the spontaneous trigger
and cycle thresholds for optimum sensitivity. The shape signal is a
shadow image of the patient’s actual flow and functions as a
sensitivity threshold at either inspiration or exhalation. When the
patient’s flow rate crosses the shape signal, the system changes
pressure levels. The shape signal is created by offsetting the signal
from the actual patient flow by 15 L/min and delaying it for 300
milliseconds. This causes the shape signal to be slightly behind the
patients flow rate. A sudden change in patient flow causes the
shape signal to be crossed, causing the pressure level to change.

1027404 Rev K
Operation
• The spontaneous expiratory threshold (SET) algorithm (Figure 18)

raises the threshold in proportion to the inspiratory flow rate for
each breath. When the SET and actual patient flow value are equal,
the system cycles to EPAP.
• Maximum inspiratory time: A maximum IPAP time of 3.0 seconds
acts as a safety mechanism to limit the time spent at the IPAP level
during spontaneous breathing in S/T mode. If 3.0 seconds elapse in
IPAP, the system automatically cycles from IPAP to EPAP.
• Flow reversal: As flow begins to decrease during IPAP, a flow
reversal can occur due to a large leak around the mask or because
the patient’s mouth is open. When the system senses this flow
reversal, the unit automatically cycles to EPAP.
IPAP
PRESSURE
EPAP
Cycle to
Shape EPAP
signal crossover
point
Estimated
patient
flow
FLOW
Trigger to
IPAP
crossover
point
Figure 17: Shape Signal

1027404 Rev K
Operation
IPAP
PRESSURE
EPAP
Spontaneous
Expiratory
Threshold
FLOW
Figure 18: Spontaneous Expiratory Threshold
System Shut Down

WARNING: Failure to enter Standby mode before switching the ON/
OFF switch on the back of the unit to the OFF position (O) will cause
the unit to alarm for two minutes indicating the unit was not
powered off correctly. This is a safety feature. If it occurs, turn the
unit back ON ( | ) in Normal mode and then shut it down correctly.

1. Put the system into Standby mode by pressing the STANDBY

button on the front panel and selecting OK to confirm.
2. If AC power is available, store the ventilator connected to AC
power and with ON/OFF switch set to ON (|) (Figure 19). The
battery charging cycle will be active.

1027404 Rev K
Operation
3. If AC power is unavailable, store the ventilator with ON/OFF

switch set to OFF (O) and disconnected from AC power.
Always recommended: Not recommended: Recommended only if AC

Battery charging and Battery NOT charging power is unavailable
storage
X
Figure 19: Battery Charging and Storage

1027404 Rev K
Operation
The BiPAP Focus Front Panel

Figure 20 shows the English version and Figure 21 shows the
international version of the BiPAP Focus front panel. Table 2 summarizes
the functions of the front panel elements.
WARNING: To avoid damage to the keypad, do not use pens or other

sharp objects to change settings.
Figure 20: BiPAP Focus System English Front Panel
Figure 21: BiPAP Focus System International Front Panel

1027404 Rev K
Operation
Table 2: BiPAP Focus System Front Panel Controls

English Int’l Description
ALARM indicator shows if an alarm is active

(flashing) or auto-reset (steadily lit indicator).
NOTE: In STANDBY mode only, an active
ALARM LED indicates a missing or faulty battery
or a charging circuit fault.
ALARM RESET clears active and auto-reset

alarms or cancels an alarm silence.
ALARM SILENCE mutes the audible alarm for

2 minutes. Each key press restarts the 2-minute
interval. The indicator lights (yellow) when alarm
silence is active.
Alarm presilence: press when no alarm is active
for two minutes of silence.
AC indicator lights (green) to show that the

system is powered by AC (mains) power.
Battery Status lights to show if the system is

powered by battery power (yellow) or the battery
charge cycle is active during AC operation
(green). The green indicator turns off when the
battery is fully charged during AC operation.
STANDBY turns the system ON or puts the unit

into Standby mode. Standby mode allows the
internal battery to charge.
UP and DOWN arrow keys navigate the on-

screen buttons or adjust values.

1027404 Rev K
Operation
Table 2: BiPAP Focus System Front Panel Controls

English Int’l Description
CANCEL clears changes. Press and hold

CANCEL for 5 seconds to lock and unlock the
keypad.
CHANGE SCREEN steps through available

screens.
ENTER selects or confirms a new setting.
Screen Navigation
Press the Change Screen key to step through the available screens.
The settings screen allows you to view or change the current mode and
settings. This screen also displays real-time patient data.
The alarm settings screen allows you to view or change the settings for
the Apnea and Apnea Rate (#Apnea) alarms. This screen also displays
real-time patient data.
The options screen allows you to view or change the ventilator’s audio
and visual settings (display units, alarm volume, contrast, brightness,
reverse video, and screen lock timer enable/disable).
WARNING: Do not use the system if the screen is unreadable. If this

occurs turn the ON/OFF switch to the OFF position (O).

1027404 Rev K
Operation
Changing Settings
1. Use the arrow keys to highlight the desired setting and press
ENTER. A pop-up window for the setting appears (Figure 22).
2. Use the arrow keys to adjust the setting.
3. Press ENTER to put the new setting into effect, or press
CANCEL to exit without changing the setting.
Figure 22: Changing Setting
Pop-up window
shows selected
setting
Changing Modes
1. Use the UP or DOWN arrow to highlight the ‘Mode CPAP’ or
‘Mode S/T’ button, and press ENTER to see the list of modes.
2. User the UP or DOWN arrow to highlight the desired mode from
the list and then press ENTER.
3. Review and adjust the intended settings for the proposed Mode
as required.
4. Scroll to highlight Activate (Figure 23) at the bottom of the
screen to activate the mode change. Note that ‘Proposed
(Mode)’ will flash at the top of the screen until the new mode is
activated or cancelled.
Figure 23: Activating a New Mode

1027404 Rev K
Operation
CPAP Mode Settings Screen

Figure 24 shows the CPAP Mode settings screen.
Figure 24: CPAP Mode Settings Screen

The CPAP screen includes these elements:
Settings
CPAP The level of continuous positive airway pressure delivered

throughout the breath cycle.
Ramp Period over which the ventilator increases inspiratory pressure

Time from Ramp Start setting to CPAP setting.
Ramp The initial CPAP pressure (less than or equal to the CPAP setting).
Start
Patient Data
Rate Measured respiratory rate.
Est. Vt Estimated delivered tidal volume. Flashes when peak inspiratory

flow for successive breaths varies by more than 15 L/min.
Est. MV Estimated exhaled minute volume.
Leak Estimated patient leak.
#Apnea The number of periods (10 seconds or more) in the previous hour
where the patient has not initiated a spontaneous breath.
NOTE: For the first hour, this value is an estimate only.

1027404 Rev K
Operation
Trigger Indicates whether the patient (Patient) or ventilator (Timed) is

triggering a breath.
Bar Continuous display of measured patient circuit pressure.

graph
NOTE: ‘+++’ is displayed for any parameter outside of upper ranges. ‘---’
is displayed for any parameter outside of lower ranges.
See “Specifications” on page 67 for more information.
S/T Mode Settings Screen

Figure 25 shows the S/T Mode settings screen.
Figure 25: S/T Mode

Settings Screen
The S/T screen includes these elements:
Settings
IPAP Inspiratory positive airway pressure, the inspiration pressure

setting. IPAP cannot be set below EPAP.
EPAP Expiratory positive airway pressure, the exhalation pressure

setting.
Rise- How quickly the ventilator increases inspiratory pressure from

Time EPAP pressure to 67% of the pressure support level.
Ramp Period over which the ventilator increases respiratory pressure

Time from Ramp Start setting to EPAP setting.

1027404 Rev K
Operation
Ramp The initial EPAP pressure (less than or equal to the EPAP setting).
Start
Rate Respiratory rate, used to determine if a timed breath is delivered. I-

Time and Rate settings cannot allow I-Time to exceed expiratory
time.
The system will reduce the I-Time automatically as required to
satisfy this rule.
I-Time Inspiratory time. I-Time and Rate settings cannot allow I-Time to
exceed expiratory time.
The system will reduce the I-Time automatically as required to
satisfy this rule.
NOTE: Pressure support = IPAP - EPAP.
Patient Data

NOTE: For the first hour, this value is an estimate only.
Trigger Indicates whether the patient (Patient) or ventilator (Timed) is

triggering a breath.
Bar Continuous display of measured patient circuit pressure.

graph
NOTE: ‘+++’ is displayed for any parameter outside of upper ranges. ‘---’
is displayed for any parameter outside of lower ranges.
See “Specifications” on page 67 for more information.

1027404 Rev K
Operation
Alarm Settings Screen

Figure 26 shows the Alarm Settings screen.
NOTE: The system automatically selects all other alarm settings.
Figure 26: Alarm

Settings Screen
The Alarm Settings screen includes these elements:
Settings
Apnea The length of time without a spontaneous breath that triggers

Apnea alarm. OFF setting disables the alarm (no apnea detection).
#Apnea The number of apnea periods (10 seconds or more) within 60

minutes that triggers an Apnea Rate (#Apnea) alarm.
Patient Data

For the first hour, this value is an estimate only.
Bar graph Continuous display of measured patient circuit pressure.

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Operation
Options Screen
Figure 27 shows the Options screen.
Figure 27: Options Screen

The Options screen includes these elements:
Display Selects units of pressure: centimeters of water (cmH2O),

Units hectoPascals (hPa), or millibars (mbar).
Alarm Selects audible alarm volume.

Volume
Contrast Selects screen contrast from 20% to 100%.
Brightness Selects screen brightness from 10% to 100%.
Reverse Toggles reverse video ON and OFF.

Video
Screen Toggles screen lock timer ON or OFF.

Lock When the screen lock timer is ON, the keypad locks if no key is
Timer pressed for 2 minutes. If any key other than CANCEL is pressed,
a pop-up message will appear stating “Hold Cancel button for 5
sec. to unlock.” Press OK to remove this pop-up before
proceeding to the next step. Then, press and hold CANCEL for 5
seconds to unlock the keypad.
NOTE: You can manually lock the keypad by pressing and
holding CANCEL for 5 seconds.

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Operation
Battery Back-up Operation

The BiPAP Focus contains an internal battery. When the internal battery
is fully charged, the Battery Back-up feature allows the unit to continue
operation for a limited time in the event of mains power loss or during
intra-hospital transport. If loss of mains power occurs, the unit will
automatically switch to operate from the internal battery and will generate
the Loss of AC alarm (this alarm can be silenced, see “Alarms” on
page 47). The internal battery is NOT intended to serve as a primary
power source.
When the BiPAP Focus is operating on the internal battery, the
ON AC POWER LED (green) will extinguish, the ON BATTERY LED
(yellow) will illuminate, and the On battery message will appear on the
screen.
Figure 28: Running on Internal Battery

When the BiPAP Focus estimates that there are approximately
10 minutes of internal battery power remaining, the unit will generate a
silenceable Low Battery alarm. Mains power should be reconnected
immediately to avoid loss of power.
When up to 2 minutes of internal battery power remain, the Battery
Depleted alarm (non-silenceable) will occur. Mains power must be
reconnected immediately to avoid loss of power to the ventilator.
CAUTION: When using the Focus for patient intra-hospital transport,
ensure that the DC power supply and power cord are also
transported with the unit to recharge the battery whenever AC power
is available.

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Operation
Battery Operating Time

The amount of time the ventilator will operate on the internal battery
depends primarily on the machine settings being used. The following
table shows the approximate internal battery life expectancy for a fully
charged battery.
Table 3: Internal Battery Life Expectancy

CPAP or IPAP Setting Approximate Battery Life
10 cmH2O 60 minutes
15 cmH2O 50 minutes
20 cmH2O 40 minutes
25 cmH2O 30 minutes
30 cmH2O 20 minutes
WARNING: When running on battery, the high flows that occur

during a patient disconnect will cause the battery to deplete in as
little as 2 minutes. Connect AC power immediately if the Battery
Depleted Alarm sounds to avoid total loss of power.
Battery Charging
The internal battery technology is NiMH (Nickel Metal Hydride). The
battery will automatically charge when the unit is connected to mains
power (AC) via the DC power supply and when the power switch on the
back of the ventilator is in the ON ( | ) position. The ON AC POWER LED
will illuminate indicating that mains is connected and the BATTERY
CHARGING LED will illuminate indicating that the charging cycle is in
progress. The battery is fully charged when the BATTERY CHARGING
LED turns off.
The charging cycle operates in Normal mode and in Standby mode.
Battery charge time is typically less than 5 hours, but can be longer
depending on environmental conditions (primarily temperature).
It is important to maintain a fully charged internal battery in case of a
mains power outage. Any time the BiPAP Focus has been in storage, a

1027404 Rev K
Operation
full charge cycle should be run. A fully charged battery will deplete within
3 months if unused and not charged. This is the normal depletion rate
when the unit is stored with the ON/OFF switch in the OFF (O) position. If
the unit is left in Standby mode with the ON/OFF switch in the ON ( | )
position and it is not connected to AC mains power, the internal battery
will deplete within 2 weeks.

replacement.
CAUTION: During battery charging, disconnecting AC mains power

before charging completes may result in a Battery Depleted
message. Connect AC power immediately if Battery Depleted alarm
annunciates to avoid total loss of power.

times.

1027404 Rev K
Operation
Battery Care
It is recommended that the battery be tested every 3 months, at a
minimum, as described in “Testing the Battery” on page 61. A fully
charged battery is designed to operate for a minimum of 45 minutes at
default settings (see “Battery backup” on page 73). If it appears that the
battery does not meet these specifications, perform this test and replace
the battery as needed.
When the unit is in Standby mode, if the red ALARM LED illuminates this
indicates that there is a problem with the battery charging cycle. If the
BATTERY CHARGING and the ON BATTERY LEDs are illuminated
simultaneously then contact Respironics Customer Service.
The BiPAP Focus self tests will also indicate when the battery needs to
be replaced by displaying a Batt Charge Failure message (see “Alarms”
on page 47). Contact Customer Service to purchase a replacement
battery.

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Alarms
Chapter 5: Alarms
When an alarm is active:

• The ALARM indicator flashes,
• The alarm message is displayed, and
• The system sounds a repeating sequence of beeps.
Certain alarms can be auto-reset, meaning that the system automatically
resets the alarm once the alarm condition is corrected. Alarms that do not
auto-reset must be manually reset.
The options screen allows you to select alarm volume. If an alarm auto-
resets, the ALARM indicator remains steadily lit to indicate that the alarm
occurred.
Alarm Reset
Press ALARM RESET to clear audible and visual alarm

indicators, or to cancel an Alarm Silence.
Alarm Silence
The ALARM SILENCE key silences the audible portion of

an alarm for two minutes. Pressing the ALARM SILENCE
key again restarts the two-minute interval.
ALARM SILENCE is cancelled by a new alarm or by
pressing the ALARM RESET key.
The ALARM SILENCE key does not affect the visual ALARM indicator.
The ALARM SILENCE key lights when Alarm Silence is active.

1027404 Rev K
Alarms
Alarm Pre-silence
Press ALARM SILENCE when no alarms are active to silence any alarm
that may occur in the two minutes following the key press. Alarm Pre-
silence is useful for avoiding nuisance alarms during certain procedures.
A new alarm will not sound if Alarm Pre-silence is active.
Press ALARM RESET when Alarm Pre-silence is no longer required.
Alarm Message Window

An alarm message window appears when an alarm occurs (Figure 29).
The window can display up to three alarm messages in order of priority.
Figure 29: Alarm Message Window

1027404 Rev K
Alarms
Alarm Descriptions
Table 4 summarizes alarms. When more than one corrective action is
listed, follow them in order until the alarm is resolved. If the suggested
corrective actions do not resolve the problem, provide alternate breathing
support and contact a qualified service technician.
Table 4: BiPAP Focus Alarms

Alarm Message Description Corrective Action
Apnea The patient has not Check patient and settings.

(auto-resets) triggered a spontaneous
breath within the set Apnea
Alarm period.
Auto-resets when patient
triggers a spontaneous
breath.
NOTE: Timed breaths are
not used in determining
apnea duration.
Apnea Rate The number of periods (10 Check patient and settings.
(#Apnea) second or more) in the
(no auto-reset) previous hour where the
patient has not initiated a
spontaneous breath, has
exceeded the #Apnea per
hour alarm setting.
NOTE: The number of
periods for the first hour is
estimated.
NOTE: Pressing Alarm
Reset when the Apnea Rate
(#Apnea) Alarm is active,
will clear the #Apnea
display to 0.
Batt. Charge Battery not connected or Check battery connection.

Failure voltage remains low after Replace battery.
(no auto-reset) recharge.

1027404 Rev K
Alarms

Battery Depleted Up to 2 minutes of battery Check connection to AC

(auto-resets) power remain. power and verify that AC
Auto-resets when AC power POWER and green
is connected. BATTERY STATUS
indicators are lit.
Cannot be manually reset
or silenced. If battery was depleted
earlier than expected, refer
to “Testing the Battery” on
page 61.
Replace battery if
necessary.
Disconnect Ventilator has detected a Check patient.

(auto-resets) patient disconnect condition Check breathing circuit
for at least 15 seconds. connections.
Auto-resets when
disconnect condition no
longer exists.
Hi P Reg High pressure regulation Check patient and settings.

(no auto-reset) alarm. Circuit pressure 5 Verify that breathing circuit
cmH2O above set CPAP or is not obstructed.
IPAP for 500 msec.
High Batt Temp Battery is overheating. Check patient.

(auto-resets) Battery may be almost Connect ventilator to AC
depleted; or there may be a power.
patient or breathing circuit
Check for causes of
disconnect, causing the
overheating, including a
blower to run at high speed.
patient or breathing circuit
Auto-resets when AC power disconnect.
is connected.

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Alarms

High High temperature detected Check room temperature is

Temperature inside the ventilator. within specified operating
conditions. Allow the
ventilator to acclimate to the
ambient conditions.
Key Stuck One or more of the user Check the keypad.

interface keys has been Run pre-use check.
detected as permanently
Contact customer service.
pressed or stuck closed.
Lo P Reg Low pressure regulation Check patient and settings.

(no auto-reset) alarm. Circuit pressure is 5 Check for leaks in breathing
cmH2O below set CPAP or circuit or mask fitting.
IPAP for 60 sec. Press ALARM RESET to
clear.
Loss of AC Ventilator has switched to If not in use for transport,

(auto-resets) battery operation. This is a check connection to AC
notification alarm. power and verify that AC
indicators are lit.
After the Alarm Reset is
pressed the unit beeps
once a minute when on
battery.

1027404 Rev K
Alarms

Low Battery Approximately 10 minutes Check connection to AC

(auto-resets) of battery power remain. power and verify that AC
indicators are lit.
If battery was depleted
earlier than expected, refer
to “Testing the Battery” on
page 61.
Replace battery if
necessary.
Low Temperature Low temperature detected Check room temperature is

inside the ventilator. within specified operating
conditions. Allow the
ventilator to acclimate to the
ambient conditions.
System Error: The system has halted and Check patient and provide
XXX is not providing breathing alternate breathing support.
(no auto-reset) support to the patient. Cycle power: if problem
persists, remove ventilator
from use and contact a
qualified service technician.
Any alarm not Contact customer service.

shown above

1027404 Rev K
Symbols
Chapter 6: Symbols
Symbol Meaning
Canadian Standards Association approval.
Drip-proof enclosure ingress protection.
Type BF protection rating.
Compliant with the Waste Electrical and Electronic

Equipment (WEEE) Recycling Directive.
Keep dry
Fragile, handle with care.
This side up.
Nurse call station connection.
Serial port connection.
Universal Serial Bus (USB) connection.
18V Direct Current (DC) input.

18V
Alternating Current (AC)

1027404 Rev K
Symbols
Symbol Meaning
ON/OFF switch
(press “O” to turn OFF; press “|” to turn ON).
Manufacturer approved power supply for use with the

ventilator.
Electrical Input
Gas inlet port
Gas output port
LOT code
Serial number
Catalogue number
Battery (battery compartment door)
Alarm indicator. Shows if an alarm is active (flashing) or

autoreset (steadily lit indicator).
Alarm reset. Clears active and autoreset alarms or
cancels an Alarm Silence.
Alarm Silence. Mutes the audible alarm for 2 minutes.
Each key press restarts the 2-minute interval. The
indicator lights (yellow) when Alarm Silence is active.
Standby turns the system ON or puts it into Standby
mode.
Power indicator LED lights up to show that the ventilator is

operating from an AC power source.

1027404 Rev K
Symbols
Symbol Meaning
Battery Status LEDs indicate that either the system is
powered by internal battery power (yellow) or the battery
charge cycle is active during AC operation (green). The
green indicator turns off when the battery is fully charged
during AC operation.
Mandatory - Consult ACCOMPANYING DOCUMENT
(IEC 60601-1:2005 + CORR. 1 [2006] + CORR. 2 [2007])
• Attention, consult ACCOMPANYING DOCUMENTS

(IEC 60601-1:1988 + A1:1991 + A2:1995)
• Caution! (IEC 60601-1:2005 + CORR. 1 [2006] +
CORR. 2 [2007])
Consult ACCOMPANYING DOCUMENT (IEC 60601-
1:2005 + CORR. 1 [2006] + CORR. 2 [2007)])

1027404 Rev K
Symbols

1027404 Rev K
Care and Maintenance
Chapter 7: Care and Maintenance
WARNING: Maintenance and service work not listed in this chapter

shall only be performed by a qualified service technician. Only a
qualified service technician can assure that the BiPAP Focus
system is properly serviced for safe operation.
Table 5 summarizes maintenance procedures for the BiPAP Focus

System.
To ensure correct operation, perform all maintenance at the
recommended intervals.
Table 5: BiPAP Focus System Maintenance

Part Interval Procedure
Battery Replace the battery The battery must be connected before

if a Batt Charge use. Follow “Setup” instructions
Failure alarm beginning on page 9.
occurs, or as NOTE: If the unit has been in storage
indicated in “Battery without DC power or has not been used
Care” on page 46 for 3 months, the battery will require a
full charge. For maximum battery
performance, a new battery or a battery
that has been in storage should be fully
charged and discharged two to three
times.
Patient Circuit Between patients or Replace circuit and interface. Do not

(including as needed. attempt to clean or reuse single patient
bacteria filter) use circuit components.

1027404 Rev K
Table 5: BiPAP Focus System Maintenance

Part Interval Procedure
Air inlet Reusable: clean Follow the “Cleaning the Reusable Air
filter(s) monthly or as Inlet Filter” on page 8.
needed. Replace.
Reusable: every
year or as needed. Do not attempt to clean or reuse
Disposable: replace disposable filters.
as needed.
NOTE: The air path
cannot be cleaned.
Internal valve Every 10,000 hours Qualified service technician only.

assembly of operation.
Refer to the BiPAP
Focus Service
Manual to check
hours of operation.
System As needed. Clean the exterior of the ventilator with

exterior a soft damp cloth moistened with any of
the following solutions:
• Mild detergent or soapy water
• 10% bleach solution (90% water)
• Isopropyl alcohol (91%)
• Quaternary ammonium
germicides (sprays or disposable
cloths)
Do not spray or immerse in liquid. Do
not allow liquid to penetrate the system.

1027404 Rev K
Storing the BiPAP Focus

When the BiPAP Focus is not in use for periods of 2 weeks or longer, it is
recommended that the unit be stored in a clean, sanitized plastic bag.
While the unit is being stored, ensure that the power switch on the back of
the unit is in the OFF (O) position. If the switch is not turned OFF, the
internal battery will be depleted within two weeks. If the unit is stored with
the power switch in the OFF (O) position, the internal battery will deplete
within 3 months.

replacement.
CAUTION: During battery charging, disconnecting AC mains power

before charging completes may result in reduced battery life when
system is used.

times.

1027404 Rev K
Cleaning the Reusable Air Inlet Filter

Follow these steps to clean the reusable air inlet filter (Figure 30):
1. Remove the filter and examine for damage or debris.
2. Wash using one of the following solutions, then rinse thoroughly:
• Palmolive® or Dawn® • White distilled vinegar (5%

dishwashing detergent acidicy)
• Isopropyl alcohol (99.9%) • Hydrogen peroxide (3%)
• Clorox Ultra® bleach • Sodium hypochloride (6%)
3. Allow the filter to dry completely before reinstalling.
Figure 30: Reusable Air Filter

Filter door
Reusable
air inlet filter
(gray)
CAUTION: Never reinstall a wet filter.
CAUTION: Use only Respironics-approved filters.
CAUTION: Replace any filter that is damaged.
CAUTION: Do not attempt to clean or reuse disposable air inlet

filters.

1027404 Rev K
Replacing the Air Inlet Filter(s)

WARNING: It is important to inspect and replace the air inlet filters at
the recommended intervals to avoid introducing foreign matter into
the system
The reusable air inlet filter (gray) must be installed and replaced every
year. An additional ultra-fine disposable filter (white) is also
recommended for enhanced particulate filtering.
Testing the Battery

Follow these steps to test the battery. The battery should be tested every
three months at a minimum and whenever it does not meet specifications.

NOTE: Make sure nothing is attached to the ventilator outlet while you run
this test.
1. With AC power connected, turn on the ventilator, set the mode to

S/T, and set IPAP to 20 cmH2O.
2. Make sure the BATTERY CHARGING LED is off, indicating a
fully charged battery. If the battery is not fully charged, allow it to
fully charge.
3. Turn the ventilator off.
4. Simultaneously press and hold the ALARM RESET and ALARM
SILENCE keys.
5. Press the STANDBY key once, while continuing to hold the
ALARM RESET and ALARM SILENCE keys.

1027404 Rev K
6. The unit will power up and will display the following screen.
Figure 31: Warning Screen

7. Press ENTER to continue past the Warning screen. The Menu
screen will appear:
Figure 32: Menu Screen

1027404 Rev K
8. If the blower is on, turn it off as follows:

a. Scroll using the DOWN arrow key until System Test is
highlighted, and then press ENTER. The System Test
screen shown in Figure 4 will appear.
Figure 33: System Test Screen

b. Scroll using the DOWN arrow key until the Blower status is
highlighted, and then press ENTER to toggle it Off.
c. Press CHANGE SCREEN to return to the Menu screen.
9. Disconnect the ventilator from AC power.
10. Record the VBATT reading with the blower off, as follows:
a. From the Menu screen, scroll using the arrow keys until
Sensor Readings is highlighted, and then press ENTER.
The Sensor Readings screen will appear (Figure 5).
Figure 34: Sensor Readings Screen

1027404 Rev K
b. Record the VBATT reading.

11. Press CHANGE SCREEN to return to the Menu screen.
12. Turn the blower on by repeating step 8, but setting Blower to On.
13. Wait 1 minute for the VBATT reading to stabilize. Record the
VBATT reading by repeating step 10.
14. Subtract the second VBATT reading from the first reading. If the
difference is greater than 2.5 V, install a new battery. If the
difference is less than 2.5 V, the battery is acceptable.

1027404 Rev K
Replacing the Battery

WARNING: To avoid the risk of fire, use only Respironics-approved
batteries. All battery connections are keyed to ensure proper
connection.
Replace the battery (Figure 35) if a Batt. Charge Failure alarm occurs, or
as indicated in “Battery Care” on page 46.
NOTE: If a Low Battery or Battery Depleted alarm occurs during Pre-
Operational Check, then the battery requires charging. If a Batt Charge
Failure alarm occurs, the battery may be fully depleted. A re-charge is
recommended before proceeding. If the battery does not begin to charge
after one hour and the Batt Charge Failure persists, contact customer
service for a replacement battery.
Figure 35: Replacing the Battery
Battery cable
Battery compartment
Follow these steps:

1. Turn the system OFF and disconnect the DC power supply.
2. Remove the two screws that secure the battery compartment
door.
3. Unplug the battery cable and remove the old battery from its
compartment.
4. Insert a new Respironics-approved battery (see “Accessories”
on page 87) into the compartment and plug the battery cable into
its connector.
1027404 Rev K
5. Replace the battery compartment door and screws.

6. Reconnect the DC power supply.
WARNING: Use only Respironics recommended batteries.

1027404 Rev K
Specifications
Chapter 8: Specifications
Default Settings
S/T mode RR = 4/min
IPAP = 12 I-Time = 1 sec

cmH2O
EPAP = 4 Ramp Time = 0 min

cmH2O
Rise-Time = 2 Ramp Start = 4 cmH2O
Settings: CPAP Mode

CPAP Range: 4-20 cmH2O (4-20 hPa)
Continuous Resolution: 1 cmH2O (1 hPa)
Positive Airway
Dynamic accuracy: ±5 cmH2O (5 hPa)
Pressure
Ramp Time Range: 0-45 min.

Period over Resolution: 5 min.
which the Accuracy: ±10% of setting
ventilator
increases
inspiratory
pressure from
Ramp Start
setting to CPAP
setting.
Ramp Start Range: 4 cmH2O to CPAP setting (4 hPa to CPAP setting)

Initial Resolution: 1 cmH2O (1 hPa)
inspiratory
pressure

1027404 Rev K
Specifications
Settings: S/T Mode

IPAP Range: 4-30 cmH2O (4-30 hPa)
Inspiratory Resolution: 1 cmH2O (1 hPa)
positive airway
pressure, the
inspiration IPAP cannot be set below EPAP.
pressure setting
EPAP Range: 4-25 cmH2O (4-25 hPa)

Expiratory Resolution: 1 cmH2O (1 hPa)
positive airway
pressure, the
exhalation
pressure setting
Rise-Time Range: 1-6 (where 1 = 0.1 sec and 6 = 0.6 sec)

How quickly the Resolution: 1
ventilator Accuracy: ± (0.15 + 10% of setting) sec
increases
inspiratory
pressure from
EPAP pressure
to 67% of
pressure
support level
Rate Range: 1-30/min

Respiratory Resolution: 1/min
rate, used to Accuracy: ±1/min or ±10% of setting, whichever is greater
determine if a over a 4-minute period.
timed breath is
I-Time and Rate settings cannot allow I-Time to exceed
delivered
expiratory time.

1027404 Rev K
Specifications
Settings: S/T Mode

I-Time Range: 0.5-3 sec
Inspiratory time Resolution: 0.1 sec
Accuracy: ± (0.1 + 10% of setting) sec
I-Time and Rate settings cannot allow I-Time to exceed
expiratory time.
Ramp Time Range: 0-45 min

Resolution: 5 min
Accuracy: ±10% of setting
Ramp Start Range: 4 cmH2O to EPAP (4 hPa to EPAP)

Initial Resolution: 1 cmH2O (1 hPa)
inspiratory
pressure
Measured Data
Patient circuit Range: 0-35 cmH2O (0-35 hPa)
pressure bar
Resolution: 1 cmH2O (1hPa)
graph
(continuous Accuracy: ±10% of scale
display) In the event of total loss of power, the inspiratory and
expiratory pressure measured at the patient exhalation port
at 60 L/min is less than 1 cmH2O by virtue of mask and
ventilator design.
Rate Range: 0-60/min

Measured Resolution: 1/min
respiratory rate Accuracy: ± (1 + 10% reading)

1027404 Rev K
Specifications
Measured Data
Est. Vt Range: 0-4000 mL
Estimated Resolution: 1 mL
delivered tidal Accuracy (S/T Mode): ± (50 mL + 10% reading) (when leak
volume <60 L/min, using the Vision circuit)
Accuracy (CPAP Mode): ± (100 mL + 10% reading) (when
leak <60 L/min, using the Vision circuit)
Vt display flashes when peak inspiratory flow for successive
breaths varies by more than 15 L/min.
Est. MV Range: 0-99 L/min

Estimated Resolution: 0.1 L/min
exhaled minute Accuracy: ± 1 L or ± 10% actual, whichever is greater (when
volume leak is <60 L/min using the Vision circuit).
Leak Range: 0-150 L/min

Estimated Resolution: 1 L/min
Patient leak Accuracy: ± (15 L/min +10%)
#Apnea Range: 0-99/hour

Brief apnea Resolution: 1/hour
periods Accuracy: ± 1/hour (after 1 hour)
Trigger Range: Patient or Timed (ventilator)

Breath trigger
NOTE: Est. Vt and Est. MV estimates are at ambient temperature and

pressure, dry (ATPD). Pressure signals are filtered using a 50-Hz low pass
Butterworth filter.
Alarm Settings
Apnea Range: 20, 40, 60 sec or
The length of time without a spontaneous OFF
breath that triggers the Apnea alarm Default setting: 20 sec

1027404 Rev K
Specifications
Alarm Settings
#Apnea Range: 5, 10, 20, or OFF
The number of periods (10-seconds or more) in Default setting: OFF
the previous hour where the patient has not
initiated a spontaneous breath.
NOTE: For the first hour, this value is an
estimate only.
Options
Display Units Range: cmH2O, hPa, or mbar
Unit of pressure: centimeters of water
(cmH2O), hectoPascals (hPa), or millibars
(mbar).
Alarm Volume Range: OFF, or minimum

Audible alarm volume volume, to maximum volume,
in 5 discrete settings.
Contrast Range: 20% to 100%

Screen contrast
Brightness Range: 10% to 100%

Screen brightness
Reverse Video Range: ON or OFF

Toggles reverse video
Screen Lock Timer Range: ON or OFF

1027404 Rev K
Specifications
Nurse Call Station/Serial Communications Connector Pinout
Pin Signal
Nurse Call Station
1 Nurse call station common

6 Normally open (NO) during normal (non-alarm) operation
9 Normally closed (NC) during normal (non-alarm) operation
Serial Communications
2 Respironics advanced serial protocol (RASP) RS-232 Transmit (Tx)

3 RASP RS-232 Receive (Rx)
4 Not used
5 RS-232 signal ground
7 RS-232 Tx (reserved for Respironics Technical Support)
8 RS-232 Rx (reserved for Respironics Technical Support)
NOTE:
• When pins 1 and 6 are used, the relay is open during normal operation,
and closed during an alarm condition including loss of power.
• When pins 1 and 9 are used, the relay is closed during normal operation,
and open during an alarm condition including loss of power.
• Female DB9 connector pin configuration:
WARNING: Use only Respironics-supplied cables with the nurse call

station/serial communications connector.
Physical
BiPAP Focus 355-mm H x 290-mm W x 140-mm D (14.0-in. H x 11.4-
System Dimensions in. W x 5.5-in. D)
Excluding accessories, gas inlets, patient connections.
Weight 4.5 kg (10 lbs.)

1027404 Rev K
Specifications
Power
Input range 100-240 V~, 50/60 Hz, 3.0-1.5 A
Battery backup 3.8 amp-hour (Ah) nickel metal hydride (NiMH) battery
provides a minimum of 45 minutes of operation at
default settings. System automatically activates the
battery charge cycle when connected to AC power and
the ON/OFF switch is ON ( | ) (during normal operation
or Standby mode).
Recharge time is typically under 5 hours, but may
extend further depending on machine settings if
operating on battery prior to recharge, or if operating in
elevated ambient temperature (above 28°C). Charge is
complete when the green CHARGING LED
extinguishes.
Nurse call station The nurse call station port is intended to connect only to
relay a SELV (Safety Extra-Low Voltage) and ungrounded
system with basic insulation to ground, in accordance
with IEC 60601-1. To prevent damage to the nurse call
circuit, the signal input should not exceed the maximum
rating of 24 VAC (Volts of Alternating Current) or 36
VDC (Volts of Direct Current) at 500 mA (milliamps),
with a minimum current of 1 mA.
Fuse type No replaceable fuses.
Power cord Use the BiPAP Focus System only with the following
power cords:
Europe: Plug type CEE 7/7
(P/N 1029985)
UK/Ireland: Plug type BS 1363
(P/N 1029982)
USA/Canada: Plug type NEMA 5-15
(P/N 1029989)
Contact your local distributor for other countries.

1027404 Rev K
Specifications
Patient Circuit Details

Pressure Drop Versus Flow for Patient Circuits
The BiPAP Focus System automatically compensates for pressure drops
associated with a Vision® single patient use circuit and the mandatory
bacteria filter (see “Accessories” on page 87 for ordering information).
The pressure drop increases as restrictive elements (for example,
humidifiers) are added to the circuit. Always use a manometer to verify
patient mask pressure.
Circuit Resistance
10
7
Pressure (cmH20)
0
0 10 20 30 40 50 60 70 80 90 100 110 120 130 140
Flow (lpm)
Vision Disposable Circuit 582073
Respironics H2 Humidifier 1009491 & Vision Invasive circuit 652002

Fisher & Paykel 850 Humidifier & FP circuit 1020523

1027404 Rev K
Specifications
Maximum Pressure Drop for Disconnect

The Disconnect alarm relies on a fixed relationship between the patient
pressure settings and the open circuit flow of the Vision® single patient
use circuit. The alarm works correctly unless the circuit is excessively
restrictive. Use the pre-operational check to confirm that the Disconnect
alarm operates properly with the circuit.
Triggers and Cycles

Volume-based trigger
Flow reversal cycle
Shape signal
Timed trigger
IPAP maximum of 3.0 seconds
Peak flow cycle
Supplemental Oxygen
Flow and pressure into Maximum flow: 15 L/min at ambient pressure
oxygen valve
Environmental
Temperature Operating: +5 to +35°C at 10 to 95% relative
humidity
Storage: -20 to 60°C at 95% relative humidity
Atmospheric pressure Operating: 83 to 102 kPa (830 to 1020 mBar)
Storage When the BiPAP Focus is not in use for periods

of 2 weeks or longer, it is recommended that the
unit be stored in a clean, sanitized plastic bag.

1027404 Rev K
Specifications
Bacteria Filter
Dead space 68 mL
Bacteria/viral filter >99.99%

efficiency P/N 342077
Resistance 0.7 cmH2O/L/s at 0.5 L/s
Connectors Male connector 15-mm I.D./22-mm O.D.

Female connector 22-mm I.D.
Date of Manufacture
The 12-digit serial number located on the base of the unit indicates the
date of manufacture. From left to right, the fifth and sixth digits indicate
the year; the seventh and eighth, the month; the ninth and tenth, the day.
For example, the serial number 0001050903-20 indicates that the device
was manufactured 3 September, 2005.

1027404 Rev K
Specifications
Pneumatics
BiPAP Focus System pneumatic diagram:
BiPAP Focus System Diffuser

Bacteria filter
Air inlet (mandatory)
filter Flow sensor
Patient circuit
(to mask outlet)
Blower Control
(motor) valve
Air inlet Muffler
port
Tubing (elbow)
Pressure sensor Oxygen adapter
(if using oxygen)
Outlet port and
pressure sensor Oxygen valve
(if using oxygen)

1027404 Rev K
Specifications
This page is intentionally blank

1027404 Rev K
Compliance
Chapter 9: Compliance
International Standards
• IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC
60601-1:1988 + A1:1991 + A2:1995
Medical Electrical Equipment Part 1: General Requirements for
Safety, plus 1st and 2nd Amendments to the standard
• EN 60601-1-2 + A1:2000, Second Edition
Medical Electrical Equipment - Electromagnetic Compatibility
Requirements and Tests
• EN ISO 10651-6:2004
Lung Ventilators for Medical Use - Particular Requirements for
Basic Safety and Essential Performance
IEC 60601-1 Classification

Class I, Type BF, internally powered, drip-proof equipment, continuous
operation.

1027404 Rev K
Compliance
Electromagnetic Emissions
WARNING: Using cables other than those supplied by Respironics
may result in increased emissions and/or decreased immunity of the
BiPAP Focus System.
Guidance and manufacturer’s declaration: electromagnetic emissions,

IEC 60601-1-2 + A1:2000.
The BiPAP Focus System is suitable for use in the specified
electromagnetic environment. The customer and/or the user of the BiPAP
Focus System should ensure that it is used in an electromagnetic
environment as described below:
Electromagnetic Environment
Emissions Test/Compliance
Guidance
RF emissions CISPR 11/Group 1 The BiPAP Focus System uses RF

energy only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions CISPR 11/Class B The BiPAP Focus System is suitable

for use in all establishments other
Harmonic emissions IEC 61000-3-2/ than domestic and those directly
(not applicable) connected to the public low-voltage
power supply network that supplies
Voltage fluctuations/flicker emissions
buildings used for domestic purposes.
IEC 61000-3-3/ (not applicable)
Guidance and manufacturer’s declaration: electromagnetic immunity, IEC

60601-1-2 + A1:2000.

1027404 Rev K
Compliance

IEC 60601 Compliance Electromagnetic

Immunity Test
Test Level Level Environment Guidance
Electrostatic ± 6 kV ± 6 kV Floors should be wood,

discharge (ESD) contact contact concrete, or ceramic tile. If
IEC 61000-4-2 ± 8 kV air ± 8 kV air floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast ± 2 kV for ± 2 kV for Mains power quality should

transient/burst power power be that of a typical
IEC 61000-4-4 supply lines supply lines commercial and/or hospital
± 1 kV for ± 1 kV for environment.
input/output input/output
lines lines
Surge ± 1 kV ± 1 kV Mains power quality should

IEC 61000-4-5 differential differential be that of a typical
mode mode commercial and/or hospital
± 2 kV ± 2 kV environment.
common common
mode mode
NOTE: UT is the AC mains voltage prior to application of the test level.

1027404 Rev K
Compliance
IEC 60601 Compliance Electromagnetic

Immunity Test
Test Level Level Environment Guidance
Voltage dips, <5% UT <5% UT Mains power quality should

short (>95% dip in (>95% dip in be that of a typical
interruptions and UT) for 0,5 UT) for 0,5 commercial and/or hospital
voltage variations cycle cycle environment. If the BiPAP
on power supply 40% UT 40% UT Focus System user
input lines (60% dip in (60% dip in requires continued
IEC 61000-4-11 UT) for 5 UT) for 5 operation during power
cycles cycles mains interruptions, it is
recommended that the
70% UT 70% UT
BiPAP Focus System be
(30% dip in (30% dip in
powered from an
UT) for 25 UT) for 25
uninterruptable power
cycles cycles
supply or a battery.
<5% UT <5% UT
(>95% dip in (>95% dip in
UT) for 5 sec UT) for 5 sec
Power Frequency 3 A/m 3 A/m Power frequency magnetic

(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial and/or hospital
environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration: electromagnetic immunity, IEC

60601-1-2.

1027404 Rev K
Compliance

IEC
Immunity 60601-1-2 Compliance Electromagnetic Environment
Test Test Level Guidance
Level
Conducted 3 Vrms 3V Portable and mobile RF

RF 150kHz to communications equipment should
IEC 61000- 80MHz be used no closer to any part of the
4-6 BiPAP Focus System, including
cables, than the recommended
Radiated RF 3 V/m 3 V/m separation distance calculated
IEC 61000- 80mHz to from the equation appropriate for
4-3 2.5GHz the frequency of the transmitter.
Recommended separation
distance:
d = 1.2 P
d = 1.2 P 80MHz to 800MHz

d = 2.3 P 800MHz to 2.5GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya,
should be less than the compliance
level in each frequency rangeb.
Interference may occur in the
vicinity of equipment marked with
the following symbol:

1027404 Rev K
Compliance
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environ-
ment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in
which the BiPAP Focus System is used exceeds the applicable RF
compliance level above, the BiPAP Focus System should be observed
to verify normal operation. If abnormal performance is observed, addi-
tional measures may be necessary, such as reorienting or relocating
the BiPAP Focus System.
b. Over the frequency range 150kHz to 80MHz, field strengths should be
less than 3 V/m.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

1027404 Rev K
Compliance
Recommended separation distances between portable and mobile RF

communications equipment and the BiPAP Focus IEC 60601-1-2:
Frequency of 150 kHz to 150 kHz to 800 MHz to 2.5

transmitter 80 MHz 800 MHz GHz
Equation
d = 1.2 P d = 1.2 P d = 2.3 P
Rated maximum Separation distance Separation distance Separation distance
output power of (m) (m) (m)
transmitter (W)
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the separation
distance can be estimated using the equation in the corresponding column, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

1027404 Rev K
Compliance

1027404 Rev K
Accessories
Chapter 10: Accessories
Use the BiPAP Focus System with the following Respironics accessories.
Please contact your local Respironics representative before using other
accessories with the BiPAP Focus System.
Description Order Code
BiPAP Focus Ventilator System Contact your

Contact your local dealer for complete part number, which is Respironics
determined by country and configuration. representative
Breathing circuits and components
Adapter, oxygen enrichment, Qty 10 312010
BiPAP Vision® single patient use circuit, for use without 582073
humidifier, Qty 10
BiPAP Vision single patient use circuit, for use with humidifier, 652002
Qty 10
Single-limb heated wire circuit, Qty 10 1020523
Safety valve, oxygen bleed-in, Qty 1 302418
Patient interfaces Contact your

Respironics
representative
Other parts
Filter, bacteria 342077
Filter, particulate, disposable (white) 1005945
Filter, particulate, reusable (gray) 1005964
Battery, BiPAP Focus 1028006
Nurse call station cable, BiPAP Focus, normally closed (NC), 1027712
50 ft.

1027404 Rev K
Accessories
Description Order Code
Nurse call station cable, BiPAP Focus, normally open (NO), 1027713
50 ft.
Operator’s Manual, BiPAP Focus System, English 1027404
Service Manual, BiPAP Focus System 1029568
Power supply, DC, BiPAP Focus System 1025775
Universal roll stand (also requires BiPAP Focus mounting 1041139

plate, P/N 1048874, and power brick holder, P/N 1004829)
O2 cylinder kit for universal roll stand 1048903

1027404 Rev K
Warranty
Chapter 11: Warranty
Warranty
Respironics warrants the BiPAP® Focus™ Ventilator to be free from
defects in material and workmanship for a period of 12 months from the
date of purchase, provided that the unit is operated under conditions of
normal use as described in this manual. At its discretion, Respironics will
make replacements, repairs, or issue credits for equipment or parts that
are found to be defective.
THE WARRANTY SET FORTH ABOVE IS THE SOLE AND EXCLUSIVE WARRANTY
WITH RESPECT TO THE PRODUCT AND RESPIRONICS DOES NOT MAKE, AND
HEREBY SPECIFICALLY DISCLAIMS, ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE. THE REPAIR, REPLACEMENT OR CREDIT REMEDY SET FORTH ABOVE
WILL BE THE SOLE REMEDY FOR BREACH OF WARRANTY. IN NO EVENT SHALL
RESPIRONICS BE LIABLE FOR LOST PROFITS, LOSS OF GOOD WILL, OR
INCIDENTAL OR CONSEQUENTIAL DAMAGES EVEN IF RESPIRONICS HAS BEEN
ADVISED OF THE POSSIBILITY OF THE SAME.
Exclusions
This warranty does not apply to any unit or individual parts which have
been repaired or altered in any way that in Respironics’ judgement, affect
its ability or reliability, or which has been subjected to misuse, negligence,
abuse, or accident.
Unauthorized service and/or failure to perform periodic maintenance may
void this warranty.
This warranty does not cover damage that may occur in shipment.
This warranty does not cover internal battery replacement.

1027404 Rev K
Warranty

1027404 Rev K
Respironics welcomes your feedback.

1027404 Rev K
Please help us provide you with the best ventilation
systems available by letting us know what you think.
Philips Healthcare Customer Service
In the United States: +1-800-345-6443
Outside the United States: +1-724-387-4000
Fax: +1-724-387-5012
email: [email protected] or
[email protected]
www.philips.com/healthcare

1027404 Rev K

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Noninvasive Ventilator System

Philips Healthcare Australia

ii BiPAP® Focus™ Noninvasive Ventilator System

BiPAP® Focus™ Noninvasive Ventilator System iii

iv BiPAP® Focus™ Noninvasive Ventilator System

BiPAP® Focus™ Noninvasive Ventilator System v

vi BiPAP® Focus™ Noninvasive Ventilator System

Chapter 1: System Description

About BiPAP Focus

BiPAP® Focus™ Noninvasive Ventilator System 1

respiratory insufficiency or to maintain airway patency and provide

2 BiPAP® Focus™ Noninvasive Ventilator System

WARNING: To avoid the risk of fire, use this device in well-ventilated

WARNING: When using the BiPAP Focus System, an alternative

WARNING: To reduce the risk of electric shock, ensure that the AC

WARNING: The BiPAP Focus System should not be used adjacent to

WARNING: To minimize the risk of overheating the device, do not

WARNING: The patient should be disconnected if operating in any

WARNING: Failure to enter Standby mode before switching the ON/

WARNING: Medical electrical equipment requires special

WARNING: All components of the breathing circuit are intended for

BiPAP® Focus™ Noninvasive Ventilator System 3

WARNING: Do not use antistatic or electrically conductive tubing.

WARNING: This device is not for use with intubated patients.

WARNING: Do not use this device close to MRI or high-frequency

WARNING: Do not use this device with anesthetic gases.

WARNING: Do not use flammable disinfectants on or near this

WARNING: Before using the BiPAP Focus System on a patient,

WARNING: Do not use the system if the screen is unreadable. If this

WARNING: Service on this device should only be performed by

WARNING: Do not make any unauthorized changes to the ventilator.

WARNING: Use only Respironics recommended batteries.

WARNING: Keep any sources of ignition as far as possible from the

WARNING: Use the BiPAP Focus System with Respironics-

WARNING: Do not cover or block the exhalation port on the Vision

4 BiPAP® Focus™ Noninvasive Ventilator System

WARNING: Check that the orientation of the oxygen safety valve is

WARNING: Connect oxygen only on order of a physician.

WARNING: When connecting oxygen to the circuit, use an in-line

WARNING: Observe the patient and monitor continuously using

WARNING: Inspired oxygen concentration can vary according to

WARNING: To avoid oxygen accumulation in the ventilator, put it

WARNING: Do not use a Heat and Moisture Exchanger (HME) with

WARNING: The BiPAP Focus System can deliver pressures up to 30

WARNING: It is important to inspect and replace the air inlet filters at

WARNING: The BiPAP Focus System is shipped with the battery

WARNING: To avoid the risk of fire, use only Respironics-approved

BiPAP® Focus™ Noninvasive Ventilator System 5

WARNING: When running on battery, the high flows that occur

WARNING: To avoid the risk of electrical shock, do not touch the

WARNING: Do not perform the Preoperational Check with a patient

WARNING: To avoid the risk of electrical shock, this equipment

WARNING: The DC power supply provided with the BiPAP Focus

WARNING: If placing the BiPAP Focus System on a flat surface or

WARNING: To prevent possible patient injury, verify that the battery

WARNING: Do not use the BiPAP Focus for physical support.

WARNING: Stow the machine, patient circuits, power cords and

6 BiPAP® Focus™ Noninvasive Ventilator System

WARNING: When using oxygen bleed-in, verify that the orientation

WARNING: (Chapter 7, Care and Maintenance) Maintenance and