Breas Medical PV 10 User manual

PV 10 Clinician’s Manual Table of Contents
Doc. No. 003379 En S-1 BREAS MEDICAL 1
Table of Contents
1 Intended Use of the PV 10 .............................................................................................3
1.1 What is the PV 10?............................................................................................ 4
1.2 Indications for Use.............................................................................................4
1.3 Contraindications...............................................................................................5
1.4 About this Manual..............................................................................................6
2 Important Safety Information ...........................................................................................7
2.1 General User Precautions .................................................................................7
2.2 Electrical Safety.................................................................................................8
2.3 Environmental Conditions .................................................................................8
2.4 Usage of Patient Tube and Mask ....................................................................10
2.5 Usage of Filters ............................................................................................... 11
2.6 Cleaning and Maintenance.............................................................................. 11
2.7 Adverse Patient Symptoms .............................................................................12
2.8 Usage of a Humidifier......................................................................................12
2.9 Usage of Oxygen.............................................................................................13
3 Product Description .......................................................................................................14
3.1 Main Components ...........................................................................................14
3.2 Front and Setting Panel...................................................................................16
3.3 Rear Panel ......................................................................................................19
3.4 Equipment Designation and Safety Label .......................................................20
3.5 Output Connector for Data Transfer................................................................21
4 Preparing the PV 10 for Use .........................................................................................23
4.1 Installing the PV 10 .........................................................................................23
4.2 Placing the PV 10............................................................................................23
4.3 Connecting the PV 10 to the Mains Supply.....................................................24
4.4 Connecting the Patient Tube and Mask ..........................................................24
4.5 Checking the PV 10 before Use ......................................................................26
5 Setting up the PV 10 .....................................................................................................27
5.1 Description of the CPAP and Ramp functions .................................................27
5.2 Setting the CPAP Pressure .............................................................................27
5.3 Setting the Ramp Time.................................................................................... 28
5.4 Locking/Unlocking the Setting Panel...............................................................28
5.5 Setting the Default Display ..............................................................................29
5.6 Setting the Alarm Clock...................................................................................30
5.7 Setting the Actual Time ...................................................................................31
6 Using the PV 10 ............................................................................................................32
6.1 Switching the PV 10 On and Off......................................................................32
6.2 Starting and Stopping a Ramp Period.............................................................33
6.3 Displaying the Operating Time ........................................................................34
6.4 Displaying the Internal Firmware Version ........................................................35
7 Cleaning the PV 10 and Replacing the Filters...............................................................36
7.1 Cleaning the PV 10 .........................................................................................36
7.2 Cleaning the Patient Tube and Mask ..............................................................36
7.3 Cleaning and Replacing the Patient Air Filter..................................................37

Table of Contents PV 10 Clinician’s Manual
2 BREAS MEDICAL Doc. No. 003379 En S-1
8 Alarms ........................................................................................................................... 40
8.1 Power Failure Alarm........................................................................................ 40
8.2 Function Error Alarm ....................................................................................... 41
9 Trouble-shooting ...........................................................................................................42
10 Maintenance..................................................................................................................44
10.1 Regular Maintenance Control..........................................................................44
10.2 Service and Repair.......................................................................................... 45
10.3 Disposal........................................................................................................... 45
11 Technical Specifications ................................................................................................ 46
12 Accessories ...................................................................................................................48
12.1 BREAS Accessories List .................................................................................48
12.2 Using an External Battery with the PV 10 ....................................................... 50
12.3 Using a Remote Control with the PV 10.......................................................... 52

PV 10 Clinician’s Manual Intended Use of the PV 10
Doc. No. 003379 En S-1 BREAS MEDICAL 3
1 Intended Use of the PV 10
WARNING!
The PV 10 must only be used:
• for the intended treatment in accordance with the User Manual and
with the instructions given by the responsible health care profes-
sional;
• in accordance with the operating conditions specified in the User
Manual;
• in its original and unmodified shape and only with accessories speci-
fied or approved by BREAS Medical AB.
Any other use may lead to risk of bodily harm!
CAUTION!
Read this manual thoroughly before using the PV 10 so that you
completely understand how the PV 10 is operated and maintained, to
ensure correct usage, maximum performance and serviceability.
WARNING!
Do not use the PV 10 for any kind of life support treatment.

Intended Use of the PV 10 PV 10 Clinician’s Manual
4 BREAS MEDICAL Doc. No. 003379 En S-1
1.1 What is the PV 10?
Correctly used, the PV 10 is a CPAP system that provides a continuous pos-
itive airway pressure. This can prevent the user’s upper airways from col-
lapsing and therefore avoid breathing problems associated with airway
collapse and obstruction.
The PV 10 can be operated from a normal mains power supply or from an
external battery supply. The BREAS external battery cable with converter
can be connected to, for example, a cigarette lighter socket in a car. The low
power consumption of the PV 10 allows long operation when running from
a battery. This, together with the small size and low weight of the machine,
makes it ideal for use in the home or while away from home.
The PV 10 has a pressure sensor that continuously monitors the output pres-
sure to the patient and the reference ambient pressure, so that the device will
automatically compensate for altitude changes.
The internal memory of the PV 10 can be downloaded to a PC to allow you
to view the patient compliance data in the BREAS PV 10 Calendar Soft-
ware.
1.2 Indications for Use
The BREAS PV 10 CPAP system is intended to deliver continuous positive
airway pressure (CPAP) therapy for the treatment of Obstructive Sleep
Apnea in adults.
The PV 10 may be used in clinical settings (e.g. hospitals, sleep laborato-
ries, sub-acute care institutions) and home environments. It must always be
prescribed by a licensed physician.
BREAS Medical reserves the right to make changes to this product
without any prior notification.
For more information about the BREAS PV 10 Calendar Software, please
contact your BREAS representative.
The PV 10 is not intended for life support or life-sustaining applications
or for transport of critical care patients.

PV 10 Clinician’s Manual Intended Use of the PV 10
Doc. No. 003379 En S-1 BREAS MEDICAL 5
1.3 Contraindications
Therapy with the PV 10 should not be prescribed when the following spe-
cific diseases or conditions are present:
• Bullous lung disease
• Pathologically low blood pressure
• Severe cardiac arrythmias
• Unstable angina pectoris
• Decompensated cardiac failure or hypotension,
particularly if associated with intravascular volume depletion
• Recent thoracic surgery
• Pneumothorax
• Pneumomediastinum
• Massive epistaxis or previous history of massive epistaxis
(risk of recurrence)
• Pneumoencephalus, recent trauma or surgery that may have produced
cranio-nasopharyngeal fistula
• Cerebral spinal fluid (CSF) leaks
• Acute or unstable respiratory failure or insufficiency
Caution should be used when prescribing CPAP therapy for susceptible
patients, such as patients with abnormalities of the cribriform plate, or prior
history of head trauma.
The use of CPAP therapy may be temporarily contraindicated if the patient
exhibits signs of a sinus or middle ear infection.
The PV 10 is not intended for life support or life-sustaining applications
or for transport of critical care patients.

Intended Use of the PV 10 PV 10 Clinician’s Manual
6 BREAS MEDICAL Doc. No. 003379 En S-1
1.4 About this Manual
Audience
This manual is primarily intended for care providers, clinical personnel,
physicians and others who require a working knowledge of the BREAS
PV 10 system. The manual comprises detailed information on the settings
and functions of the PV 10 to be handled by trained health care personnel
only.
Icons
In this manual, icons are used to highlight specific information. The mean-
ing of each icon is explained in the table below.
Always read this manual before setting up and using the PV 10 or per-
forming maintenance on the machine, to ensure correct usage, maxi-
mum performance and serviceability.
BREAS Medical reserves the right to make changes to the contents of
this manual without any prior notification.
Patients and other lay users operating the PV 10 will find all the informa-
tion they need in the PV 10 User Manual.
Service personnel may order the PV 10 Service Manual, which contains
detailed technical information for maintenance, service and repair.
ICON EXPLANATION
Warning!
Risk of death or serious bodily harm.
Caution!
• Risk of minor or moderate bodily harm.
• Risk of equipment damage, loss of data, extra work, or unexpected
results.
Note
Information that may be valuable but is not of critical importance, tips.
Reference
Reference to other manuals or sources with additional information on a
specific topic.

PV 10 Clinician’s Manual Important Safety Information
Doc. No. 003379 En S-1 BREAS MEDICAL 7
2 Important Safety Information
This chapter lists all the important safety information for the PV 10. In the
following chapters of this manual, safety notices are also listed where appli-
cable.
2.1 General User Precautions
• The PV 10 should not be used for any kind of life support treatment.
• If you are admitted to a hospital or are prescribed any other form of
medical treatment, always inform the medical staff that you are on nasal
CPAP treatment.
• The PV 10 must only be used:
– for the intended treatment in accordance with this manual and with the
instructions given by the responsible health care professional;
– in accordance with the operating conditions specified in this manual;
– in its original and unmodified shape and only with accessories speci-
fied or approved by BREAS Medical AB.
• Do not use the PV 10 and contact the responsible care provider for an
inspection in the event of suspected damage to the device, inexplicable
or sudden pressure, performance or sound disturbances during opera-
tion, or if the delivered air from the PV 10 is abnormally hot or emits an
odour.
• The patient and the responsible health care professional must read the
User Manual thoroughly and understand the operation of the PV 10
before setting up and using the device.
• The PV 10 therapy settings must always be prescribed by a physician or
another licensed health care professional and be carried out by an
authorised health care provider.

Important Safety Information PV 10 Clinician’s Manual
8 BREAS MEDICAL Doc. No. 003379 En S-1
2.2 Electrical Safety
2.3 Environmental Conditions
• Do not operate the PV 10 if it has a damaged cord or plug, if it is not
working properly or if any part of the PV 10 has been dropped,
damaged, or submerged in water.
• To avoid electrical shock, disconnect the electrical supply to the PV 10
before cleaning. Do not immerse the PV 10 into any fluids.
If an external battery is used, it must be disconnected when the PV 10 is
switched off. Otherwise the battery will discharge continuously until it is
fully discharged.
• Do not use the PV 10 in any toxic environment.
• Do not use the PV 10 in environments where there are explosive gases
or other flammable anaesthetic agents present.
• Under certain conditions, the temperature of the air flow from the
PV 10 can be as much as 8°C (15°F) higher than the temperature of the
room. Caution should be exercised if the room temperature is higher
than 32°C (90°F).

PV 10 Clinician’s Manual Important Safety Information
Doc. No. 003379 En S-1 BREAS MEDICAL 9
• The performance of the PV 10 may deteriorate at ambient temperatures
below 5°C (41°F) and above 40°C (104°F).
• The device complies with the requirements of IEC 601-1-2 with
regards to “Electromagnetic compatibility”. Necessary measures must
be taken in order to be certain that the specified limits are not exceeded
as this may impair the safety of the PV 10. Such measures should
include, but not be limited to:
– normal precautions with regard to relative humidity and conductive
characteristics of clothing in order to minimise the build-up of elec-
trostatic charges;
– avoiding the use of radio emitting devices in close proximity to the
PV 10, such as high-frequency surgery apparatus, cellular or cordless
telephones, CB radios, microwave ovens, etc. resulting in a field level
exceeding 10 V/m. A higher field level might interfere with the oper-
ation of the PV 10.
• The PV 10, any accessories and all replaced parts must be disposed of
in accordance with the local environmental regulations regarding the
disposal of used equipment and waste.

Important Safety Information PV 10 Clinician’s Manual
10 BREAS MEDICAL Doc. No. 003379 En S-1
2.4 Usage of Patient Tube and Mask
• Only use the PV 10 with a mask, patient tube and ventilation valve (if
applicable) recommended by BREAS or your health care professional.
• Do not use the connected mask unless the PV 10 is turned on and oper-
ating properly.
• Do not use patient hoses or tubes made of electrically conductive mate-
rial.
• Always use a new mask, tube and ventilation valve, if applicable, for
each new patient.
• Patient-connected parts must be replaced regularly to ensure correct
function of the PV 10.
• If the patient is using a full face mask (covering face and nose), the
mask must be equipped with a safety entrainment valve.
• Ensure that the ventilation holes in the mask or the adjoining ventilation
valve are never blocked or obstructed. These devices are used for venti-
lating the mask in order to prevent unwanted re-breathing of exhaled
air. Re-breathing of exhaled gases for longer than several minutes can,
in some circumstances, lead to suffocation.
• At low CPAP pressures, the air flow through the ventilation holes in the
mask or the adjoining ventilation valve may be inadequate to clear all
exhaled gases from the mask. Some re-breathing may occur.
• The leakage provided by the patient mask should be at least 12 litres per
minute at 4 mbar pressure, to prevent unwanted re-breathing of exhaled
air.

PV 10 Clinician’s Manual Important Safety Information
Doc. No. 003379 En S-1 BREAS MEDICAL 11
2.5 Usage of Filters
2.6 Cleaning and Maintenance
• Never use the PV 10 without a patient air filter installed.
• Only use filters that are specified in this manual.
• Replace or clean the filters regularly to ensure correct function of the
PV 10. Failure to replace or clean a dirty filter may cause the PV 10 to
operate at higher temperatures than intended.
• When operating the PV 10, ensure that the air inlet and filter are not
obstructed.
• Do not wash and reuse the disposable filter.
• If the PV 10 is used in a clinic by several patients, a bacteria filter is
recommended between the air outlet and the patient tube to prevent
patient cross-contamination.
• The PV 10 should be cleaned and maintained in accordance with this
manual.
• To avoid electrical shock, disconnect the electrical supply to the PV 10
before cleaning. Do not immerse the PV 10 into any fluids.
• The PV 10 should be subjected to maintenance, service and control and
any applicable upgrades, in accordance with BREAS service instruc-
tions.
• The PV 10 should only be repaired and/or modified in accordance with
the BREAS PV 10 Service Manual, technical bulletins and any special
service instructions, by service technicians that have been authorised
after BREAS PV 10 service training, or have an equivalent technical
knowledge on medical devices.
• Do not under any circumstances attempt to service or repair the PV 10
yourself. If you do so, the manufacturer will no longer be responsible
for the performance and safety of the PV 10.

Important Safety Information PV 10 Clinician’s Manual
12 BREAS MEDICAL Doc. No. 003379 En S-1
2.7 Adverse Patient Symptoms
2.8 Usage of a Humidifier
• If you experience any of the following symptoms while using the
PV 10, consult your physician or responsible health care provider
immediately:
– bloated feeling from excessive swallowing of air while you are
awake;
– air continually leaking from your mouth while sleeping;
– dryness of air passages or nose;
– ear pain, runny nose or sinus discomfort;
– daytime sleepiness;
– disorientation or memory lapse;
– mood change or irritability;
– skin sensitivity
• If a humidifier or moisture exchanger is used together with the PV 10, it
must comply with the ISO 8185 standard. The BREAS HA 50 is recom-
mended.
• Humidification must only be used if this has been prescribed by a
licensed physician.
• When using a humidifier, it should be located below the PV 10 and the
patient to prevent adverse consequences from accidental spillage.
• Moisture build-up in the PV 10 system can cause damage. Be careful to
disconnect the tubing at the PV 10 air outlet first so that no water flows
back into the PV 10.
• If a room humidifier is used, place it at least 2 metres away from the
PV 10.

PV 10 Clinician’s Manual Important Safety Information
Doc. No. 003379 En S-1 BREAS MEDICAL 13
2.9 Usage of Oxygen
• The presence of oxygen can speed up combustion of inflammable
materials.
• If oxygen has been prescribed, connect the oxygen supply tube to the
appropriate oxygen port of the nasal mask or breathing system
connector.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen
concentration will vary, depending on the pressure delivered, the
patient’s breathing pattern, mask selection and leak rate.
• When oxygen is used with the PV 10, the oxygen flow must be turned
off when the PV 10 is not operating.
• Do not smoke in a room where oxygen is being used.
• Naked light bulbs and other sources of ignition must be kept a
minimum of 2 metres away from the oxygen cylinder or any part of the
patient circuit.
• Ventilate the room adequately.
• Do not use aerosols or solvents close to the oxygen supply, even when
the oxygen supply is shut off.
• When the PV 10 is not in operation and the oxygen flow is left on,
oxygen delivered into the patient tubing may accumulate within the
tube and device. Oxygen accumulated in the tube or device will create a
risk of fire.

Product Description PV 10 Clinician’s Manual
14 BREAS MEDICAL Doc. No. 003379 En S-1
3 Product Description
3.1 Main Components
The PV 10 and its packaging do not contain any natural rubber latex.
The PV 10 standard package contains the following components:
1
23
4
6
7
5

PV 10 Clinician’s Manual Product Description
Doc. No. 003379 En S-1 BREAS MEDICAL 15
NO DESCRIPTION
1PV 10 main unit
2Filter (grey, washable), installed
3Filter (white, disposable), 1 pc
4
Patient tube
5Carrying bag
6Power cord
• European, or
• British.
7PV 10 User Manual

Product Description PV 10 Clinician’s Manual
16 BREAS MEDICAL Doc. No. 003379 En S-1
3.2 Front and Setting Panel

PV 10 Clinician’s Manual Product Description
Doc. No. 003379 En S-1 BREAS MEDICAL 17
Patient air outlet and control buttons
NO COMPONENT DESCRIPTION
1Patient air outlet Used for connecting the PV 10 to the patient tube and
mask. ∅22/15 mm (ISO 5356-1).
2Setting panel See details below.
3I/O button User control used for switching the PV 10 on or off.
4Mode button Used for switching between the different modes for
settings and display.
5Ramp button User control used for manually starting a ramp period
with preset start pressure before the PV 10 switches
over to the set CPAP pressure.
6Setting display Used for showing the actual time, the alarm time, the
ramp time, the operating time, the internal firmware
version and the set or actual pressure.
7+Setting button User control used for:
• increasing the value for various settings
• activating the alarm clock
• locking/unlocking the setting panel
• setting the default display and the CPAP pressure
• displaying the machine operating time
8– Setting button User control used for:
• decreasing the value for various settings
• deactivating the alarm clock
• locking/unlocking the setting panel
• setting the default display and the CPAP pressure
• displaying the patient operating time

Product Description PV 10 Clinician’s Manual
18 BREAS MEDICAL Doc. No. 003379 En S-1
Indicator LEDs
NO INDICATOR LED DESCRIPTION
APower indicator
LED
LED indicating whether the PV 10 is switched on or
off:
• Steady green light – PV 10 is switched on.
• Flashing light – PV 10 is switched off, but still
connected to the power source.
BRamp LED LED indicating that the PV 10 is operating at a ramp
period with the start pressure.
CAlarm clock LED LED indicating that the mode for displaying and
setting the alarm clock is active.
DPressure LED LED indicating that the mode for displaying and
setting the CPAP pressure is active.
ELock function
LED
LED indicating that the setting panel has been locked.
• Green light – locked by the PV 10 setting panel.
• Yellow light – locked by the remote control/PC.
FOperating time
LED
LED indicating that the mode used for displaying the
operating time is active.

PV 10 Clinician’s Manual Product Description
Doc. No. 003379 En S-1 BREAS MEDICAL 19
3.3 Rear Panel
NO SYMBOL COMPONENT DESCRIPTION
1Analogue/
digital output
connector
Used for connecting the PV 10 to either a
remote control, a PC or sleep diagnostic equip-
ment.
Read the PV 10 Clinician’s Manual
thoroughly before using the analogue/
digital connector.
2Connector for
external battery
Used for connecting the PV 10 with BREAS
converter cable to an external battery supply.
Read the PV 10 User or Clinician’s
Manual thoroughly before using the
battery connector.
3~100 - 240V Mains power
socket
The main power socket is connected to the
mains through the power cord.
4– Patient air filter The filter is used for filtering incoming patient
air. For more information, see page 37.
5
9876
4321
1
2
3
4
1
2

Product Description PV 10 Clinician’s Manual
20 BREAS MEDICAL Doc. No. 003379 En S-1
3.4 Equipment Designation and Safety Label
The equipment designation and safety label is located underneath the
PV 10.
NO SYMBOL EXPLANATION
1– Model designation
2– Serial number (the last six alphanumeric characters)
3Pressure set in the unit mbar
4Class II equipment; dual isolation
5Body floating (IEC 601-1 Type BF, Isolated Applied
Part)
6Read the User Manual thoroughly before connecting the
PV 10 to the patient.
7CE marking applies in accordance with the directive
MDD 93/42/EEC.
8CSA International Certification Mark, Master Contract
No 211871
9GOST R Certification Mark
1
2
3
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