Breas Vivo 40 User manual

1Table of Contents
Vivo 40 users manual
Doc. 003821 En-Uk E-1
Table of Contents
1 Introduction ..................................................................................................................... 3
1.1 What is the Vivo 40? ......................................................................................... 4
1.2 Intended Use..................................................................................................... 4
1.3 Contraindications .............................................................................................. 5
1.4 About this Manual .......................................................................................... 6
2 Safety Information........................................................................................................... 7
2.1 General User Precautions ............................................................................... 7
2.2 Electrical Safety .............................................................................................. 9
2.3 Environmental Conditions ............................................................................. 10
2.4 Usage of Patient Circuit ............................................................................... 11
2.5 Invasive Use ................................................................................................... 13
2.6 Usage of Filters............................................................................................... 14
2.7 Humidification ............................................................................................... 15
2.8 Cleaning and Maintenance ............................................................................. 16
2.9 Adverse Patient Symptoms............................................................................. 16
2.10 Usage of Oxygen .......................................................................................... 17
3 Product Description....................................................................................................... 18
3.1 Main Components ........................................................................................... 18
3.2 Accessories ................................................................................. 20
3.3 The Vivo 40’s Front Panel ......................................................................... 21
3.4 The Vivo 40's Back and Side Panels ........................................................... 22
3.5 Equipment Designation and Safety Label .................................................... 23
4 Functions and Parameters of the Vivo 40..................................................................... 25
4.1 Ventilation Mode.............................................................................................. 25
4.2 Settings ........................................................................................................... 25
4.3 Standby and Operating Mode ......................................................................... 25
4.4 Low Leakage Detection................................................................................... 26
4.5 Humidifier (optional) ........................................................................................ 26
5 Using the Vivo 40.......................................................................................................... 27
5.1 Set up the Vivo 40 Before Use........................................................................ 27
5.2 Switching the Vivo 40 On and Off ................................................................... 28
5.3 Using the Menu............................................................................................... 29
5.4 Monitoring Section .......................................................................................... 32
5.5 Using the HA 20 Humidifier ....................................................................... 33
5.6 Using Batteries................................................................................................ 34
5.7 Vivo 40 Operating Time................................................................................... 38
6 Preparing the Vivo 40 for Use ....................................................................................... 39
6.1 Installing the Vivo 40 ....................................................................................... 39
6.2 Placing the Vivo 40 ....................................................................................... 40
6.3 Connecting the Vivo 40 to the Mains Supply .................................................. 40
6.4 Connecting the Patient Circuit......................................................................... 41
7 Alarms .......................................................................................................................... 43
7.1 Alarm Function................................................................................................ 43
7.2 Physiological Alarm......................................................................................... 45

2 Table of Contents
Vivo 40 users manual Doc. 003821 En-Uk E-1
7.3 Technical Alarm............................................................................................... 52
8 Cleaning the Vivo 40 and Replacement of Accessories ............................................... 55
8.1 Cleaning the Vivo 40 ...................................................................................... 55
8.2 Cleaning and Replacing the Patient Air Filters................................................ 58
9 Maintenance ................................................................................................................. 59
9.1 Regular Maintenance Control ......................................................................... 59
9.2 Service and Repair.......................................................................................... 60
9.3 Storage............................................................................................................ 60
9.4 Disposal .......................................................................................................... 60
10 Technical Specifications ................................................................................................ 61
10.1 Data ................................................................................................. 61
11 Accessories...................................................................................................................67
11.1 Breas Accessories List.................................................................................... 67
12 Patient Settings............................................................................................................. 69

3Introduction
Vivo 40 users manual
Doc. 003821 En-Uk E-1
1Introduction
WARNING!
Vivo 40 must only be used:
• For the intended treatment in accordance with this operating
manual and with the instructions given by the responsible clinical
personnel.
• In accordance with the operating conditions specified in this
operating manual.
• In original and unmodified shape and only with accessories spec-
ified or approved by Breas Medical AB.
Every other use may lead to risk of personal injury!
CAUTION!
Read this operating manual thoroughly so that you completely under-
stand how the Vivo 40 is operated and maintained before taking it
into use, to ensure correct usage, maximum performance and serv-
iceability.
WARNING!
Do not use the Vivo 40 for any kind of life support treatment.
Breas Medical AB reserves the right to make changes to this product
without any prior notification.

4 Introduction
Vivo 40 users manual Doc. 003821 En-Uk E-1
1.1 What is the Vivo 40?
The Vivo 40 is a pressure-supported and pressure-controlled ventilator.
It has three modes of operation: PCV (Pressure Control Ventilation) , PSV (Pres-
sure Support Ventilation)
and CPAP (Continuous Positive Airway Pressure) . The
PCV and PSV modes have an adjustable inspiratory trigger sensitivity setting
which allows the patient to initiate ventilator-assisted breaths.
• In the PCV mode (Pressure Control Ventilation), the ventilator provides
assisted or controlled pressure-regulated breathing. In PCV mode, the clini-
cian sets an inspiration time. The inspiratory pressure is set by the IPAP
(Inspiratory Positive Airway Pressure) setting. The end-expiratory pressure
is set by the EPAP (Expiratory Positive Airway Pressure) setting.
• In the PSV mode (Pressure Support Ventilation), the ventilator’s expiratory
trigger can also be adjusted allowing the ventilator to more easily match
each patient’s needs. The inspiratory pressure is set by the IPAP setting. The
end-expiratory pressure is set by the EPAP setting.
• In the CPAP mode (Continuous Positive Airway Pressure), the ventilator
provides a continuous positive airway pressure.
The Vivo 40 has a pressure sensor that continuously monitors output pressure
to the patient and reference ambient pressure, so that the device automatically
will compensate for altitude changes.
1.2 Intended Use
The Vivo 40 is not intended for life support or life-sustaining applications or
for transport of critical care patients.
The Vivo 40 shall only be used by patients with spontaneous breathing.
The Vivo 40 is designed for patients who require long-term support by
mechanical ventilation during night and part of the day, up to a maximum of
20 hours of use per day.
The Vivo 40 is intended for non-invasive use, or invasive use with appropriate
patients.
The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep labora-
tories, sub-acute care institutions) and home environments. The Vivo 40 must
always be prescribed by a licensed physician.

5Introduction
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The Vivo 40 is intended for treatment of both adult and paediatric (who weigh
more than 10 kg) patients.
The Vivo 40 is intended to be operated by qualified and trained personnel, or by
personnel who have been taught using the clinician’s manual.
1.3 Contraindications
The use of the Vivo 40 is contraindicated on patients with severe respiratory
failure without a spontaneous respiratory drive.
Therapy with the Vivo 40 may be contraindicated when the following specific
diseases or conditions are present:
• Pathologically low blood pressure
• Severe cardiac arrhythmias
• Unstable angina pectoris
• Decompensated cardiac failure or hypotension, particularly if associated
with intravascular volume depletion
• Untreated 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
Caution should be used when prescribing positive airway pressure 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.

6 Introduction
Vivo 40 users manual Doc. 003821 En-Uk E-1
1.4 About this Manual
Audience
This manual is intended for patients and other lay users operating the Vivo 40.
Icons
In this manual, icons are used to highlight specific information. The meaning of
each icon is explained in the table below.
Always read this manual before setting up and using the Vivo 40 or per-
forming maintenance on the machine, to ensure correct usage, maxi-
mum performance and serviceability.
Breas Medical AB reserves the right to make changes to the contents of
this manual without any prior notification.
Care providers, clinical personnel, physicians and others who require a working
knowledge of the Vivo 40 will find additional information on settings and func-
tions in the Clinician’s Manual.
ICON EXPLANATION
Warning!
Risk of death and serious personal injury.
Caution!
Risk of minor or moderate injury. Risk of equipment damage,
loss of data, extra work, or unexpected results.
Note
Information that may be valuable but is not of critical impor-
tance, tips.
Reference
Reference to other manuals with additional information on a
specific topic.

7Safety Information
Vivo 40 users manual
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2 Safety Information
2.1 General User Precautions
• The Vivo 40 must be switched off and on at least once a day. This is neces-
sary in order for the Vivo 40 to perform a self test.
• The Vivo 40 should not be used for total life support treatment.
• The Vivo 40 shall only be used by patients with spontaneous breathing.
• If you are admitted to a hospital or are prescribed any other form of medi-
cal treatment, always inform the medical staff that you are on mechanical
ventilation treatment.
• Vivo 40 must only be used:
– for the intended treatment in accordance with this operating manual and
with the instructions given by the responsible clinical personnel;
– in accordance with the operating conditions specified in this operating
manual;
– in original and unmodified shape and only with accessories specified or
approved by Breas Medical AB.
• Do not use the Vivo 40 in the event of suspected damage to the device,
unexplainable or sudden pressure, performance or sound changes during
operation, or if the delivered air from the Vivo 40 is abnormally hot or
emits an odour. Contact your responsible care provider for an inspection.
• Inadequate use of device or accessories may cause loss of treatment or
decreased performance.
• The Vivo 40 therapy settings must always be based on medical supervision
and must be changed by authorized clinical personnel only. Blood gas
measurement should be performed when changing settings or changing to
another device.
• Always perform the procedure “Set up the Vivo 40 Before Use” on
page 27 before using the Vivo 40.
• Only use accessories recommended by Breas Medical AB.

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Vivo 40 users manual Doc. 003821 En-Uk E-1
• Clinical personnel must read the Clinician’s manual thoroughly and under-
stand the Vivo 40 operation before setting up and using the machine.
• The user must read the user manual thoroughly and understand the
Vivo 40 operation before using the machine.
• All the physiological alarms of the Vivo 40 must be set at safe levels that
will effectively warn the user of any risk. The alarm levels should be
assessed considering the patient settings. Any change of settings or compo-
nents may require the readjustment of the alarm levels.
• Handle the Vivo 40 with care.
• Make sure to place and pack the device in a way that prevents unintentional
start of the machine. Due to the internal battery, the Vivo 40 may start if the
Start/Stop button is pressed even without the mains being connected.
• Do not use the Vivo 40 while in a carry bag. Attach the rear lid and place
the swivel in a down position when placing the Vivo 40 in the bag.
• If using the Vivo 40 for a short intra hospital or vehicle transportation, the
following cautions need to be observed:
– Do not mount the Vivo 40 on a wheelchair or in a vehicle.
– Make sure that the Vivo 40 stands securely in a upright position and cannot
tilt or fall.
– Do not use the Vivo 40 outdoors during rain or snowfall.
– If the HA 20 is attached, make sure that it is not in use and that the water
chamber is empty.

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2.2 Electrical Safety
• Do not operate the Vivo 40 if it has a damaged power cord or casing.
• The Vivo 40 may not work properly if any part has been dropped, damaged
or submerged in water.
• To avoid electrical shock, disconnect the electrical supply to the Vivo 40
before cleaning. Do not immerse the Vivo 40 into any fluids.
• The operator shall not touch accessible contacts of connectors and the
patient simultaneously.
• When handling the HA 20 heating unit, always turn off the Vivo 40 and
disconnect the Vivo 40 from the mains supply.
• Before detaching or attaching the HA 20 water chamber, always turn off
the Vivo 40.
• If an external battery is used, always disconnect it when the Vivo 40 is
switched off. Otherwise there is a risk that the battery will discharge.
• If the mains power source fails and the internal or the external battery acti-
vates, the HA 20 humidifier will be turned off automatically. It must be
activated again manually, if humidification during battery use is necessary.
• The data connection port is only to be used by your care provider.

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2.3 Environmental Conditions
• Do not use the Vivo 40 in any toxic environment.
• Do not use the Vivo 40 in environments where there are explosive gases or
other flammable anesthetic agents present.
• If a room humidifier is used, place it at least 2metres away from the
Vivo 40.
• The performance of the Vivo 40 may deteriorate at ambient temperatures
below 5°C (41°F) and above 38°C (100°F).
• Do not use the Vivo 40 while positioned in a warm place, such as direct
sunlight.
• The device complies with the EMC requirements of standards. Measures
should include but not be limited to:
– normal precautions with regard to relative humidity and conductive char-
acteristics of clothing in order to minimize the build-up of electrostatic
charges.
– avoiding the use of radio emitting devices closer than 1 m to the Vivo 40.
Examples include: radio emitting devices such as cellular or cordless tele-
phones, microwave ovens and high-frequency surgery apparatus.
• The Vivo 40, all accessories and replacement parts must be disposed of in
accordance with the local environmental regulations regarding the disposal
of used equipment and waste.
• The performance of the Vivo 40 and treatment of the patient may deterio-
rate if the operation conditions in “Technical Specifications” on page 61
are not fulfilled. Do not use the Vivo 40 immediately after storage or trans-
port outside the recommended operating conditions.

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2.4 Usage of Patient Circuit
• Only use the Vivo 40 with a mask, patient tube and leakage port recom-
mended by Breas Medical AB and your health care professional.
• The Vivo 40 requires a leak port instead of an actively controlled exhalation
valve to remove exhaled gases from the patient circuit. Therefore, specific
masks and patient circuits using a leakage are required for normal opera-
tion. The pressurized air from the Vivo 40 causes a continuous flow of air
to exhaust from the leak ports, flushing exhaled gas from the circuit. The
Vivo 40 should be turned on and the leak ports should be checked before
application.
• Do not breathe in the connected patient circuit unless the Vivo 40 is turned
on and operating properly.
• Do not use patient hoses or tubes made of static or electrically conductive
material.
• Patient connected parts and filter must be replaced regularly to ensure cor-
rect function of the Vivo 40. All replaced parts must be disposed of accord-
ing to local environmental regulations regarding the disposal of used
equipment and parts.
• Periodically check for moisture in the patient circuit. When present,
remove the moisture. Before attempting to dry the circuit, disconnect it
from the Vivo 40 to ensure no water will flow back into the Vivo 40.
• If the patient needs assistance to take off the patient interface, the patient
shall not be left alone. This is to avoid the risk of re-breathing of CO
2
in
case of accidental ventilator failure.
• If the patient is using a full face mask (covering mouth and nose), the mask
must be equipped with a safety entrainment valve.

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• Make sure that the leakage ports are never blocked or obstructed. These
ports are used to prevent 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 leakage ports may be inad-
equate to clear all exhaled gases. Some re-breathing may occur.
• Do not leave long lengths of air tubing around the top of the bed. It could
twist around the patient’s head or neck while sleeping.
• Always follow the instructions of the mask manufacturer.

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2.5 Invasive Use
• For invasive applications, assure that an intentional leakage port is present
in the patient circuit. Install the leakage port as close as possible to the
patient connection, to reduce the risk of rebreathing CO
2
.
• When using the Vivo 40 invasively the low volume alarm and the low
breath rate alarm must be carefully set, to ensure safe use.
• The highest output from the HA 20 humidifier is 30 mgH
2
O/litre, which
means that it does not fulfill the humidifier standard for invasive use.
• The Vivo 40 is equipped with a low leakage alarm. The low leakage alarm is
not a substitute for operator vigilance in ensuring that the leakage ports
remains clear at all times. Periodically check the leakage ports during ther-
apy.
• In general as pressure decreases the potential of rebreathing increases.
Lower pressures produce less flow through the leakage ports which may
not clear all CO
2
from the circuit to prevent rebreathing.
• In general as inspiratory time increases the potential of CO
2
rebreathing
increases. A higher inspiratory time decreases the expiratory time allowing
less CO
2
to be cleared from the circuit before the next breath. I:E (inspira-
tion time : expiration time) ratios close to 1:1 increase the potential of CO
2
rebreathing.
• Endotracheal tubes, oral/nasal tubes etc with small inner diameters
increase the resistance in the breathing circuit.
• An external heated humidifier approved for invasive use or an appropriate
HME (Heat and Moisture Exchanger, artificial nose)/HCH (Hygroscopic
Condenser Humidifier) is recommended.

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2.6 Usage of Filters
• Always use the Vivo 40 with patient air inlet filters installed. Only use filters
that are specified in this manual.
• Replace or clean the filters regularly to ensure correct function of the
Vivo 40, especially when changing patient. Failure to replace or clean a
dirty filter may cause the Vivo 40 to operate at higher temperatures than
intended.
• When operating the Vivo 40, make sure that the air inlet and filters are not
obstructed or occluded.
• The use of a high resistance bacteria filter on the output of the device may
interfere with the operation of the patient disconnect function. It may also
interfere with the device trigger function.
• Do not connect any filter to the HA 20 humidifier.

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2.7 Humidification
• The HA 20 humidifier is intended for non-invasive use only.
• Humidification must only be used if this has been prescribed by your phy-
sician. The Vivo 40 therapy settings must always be prescribed by a physi-
cian or other licensed health care professional, and be carried out by
authorized clinical personnel.
• Before transportation of the Vivo 40 with the installed HA 20 humidifier,
always disconnect the water chamber from the heating unit.
• Do not place the Vivo 40 with the HA 20 humidifier in a bag when the
water chamber is attached.
• When the HA 20 humidifier is installed, the Vivo 40 must be located below
the patient and on a flat surface. This is to prevent personal injury from
accidental spillage or from excess water or condensation flowing down the
patient tube and into the patient’s mask. Extra cautions should be taken for
patients who are unable to guard their airways or cannot pull off the mask.
• When using an external heated humidifier, it should be located below the
Vivo 40 and the patient to prevent injury from accidental spillage.
• If the condensation in the patient circuit is excessive, the use of a heated
humidifier may require the installation of a water trap in the circuit. The
water trap prevents any condensated water in the patient circuit from run-
ning into the patient airways and causing personal injury.
• The use of an HME (Heat and Moisture Exchanger, artificial nose) or an
external humidifier may require readjustment of the Vivo 40’s low-pressure
alarm.
• Certain HME’s and HCH’s (Hygroscopic Condenser Humidifiers) are suf-
ficient to provide humidification when the Vivo 40 is used invasively.
Check specific suppliers recommended use.

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2.8 Cleaning and Maintenance
2.9 Adverse Patient Symptoms
• The Vivo 40 should be cleaned and maintained in accordance with this
operating manual.
• Do not attempt to autoclave or sterilise the Vivo 40.
• Vivo 40 should be subjected to maintenance, service and control and any
applicable upgrades, in accordance with Breas service instructions.
• Vivo 40 shall only be repaired or modified in accordance with Breas service
manuals, technical bulletins, and any special service instructions, by service
technicians authorized by Breas Medical AB.
• Do not under any circumstances attempt to service or repair the Vivo 40
yourself. If you do so, the manufacturer will no longer be responsible for
the performance and safety of the Vivo 40. Furthermore, no warranty will
be valid.
If the patient experiences discomfort or any of the following symptoms while
using the Vivo 40, a physician or responsible clinician shall be contacted
immediately:
• Bloated feeling from excessive swallowing of air while awake
• Air continually leaking from the mouth while sleeping
• Dryness of air passages or nose
• Ear pain, runny nose or sinus discomfort
• Day time sleepiness
• Disorientation or memory lapse
• Mood change or irritability
• Skin sensitivity

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2.10 Usage of Oxygen
• The presence of oxygen can speed up combustion of inflammable materi-
als.
• 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 con-
centration will vary, depending on the pressure delivered, patient’s breath-
ing pattern, mask selection, and leak rate.
• When oxygen is used with the Vivo 40, the oxygen flow must be turned off
when the Vivo 40 is not operating.
• Ventilate the room adequately.
• 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.
• Do not use aerosols or solvents close to the oxygen supply, even when the
oxygen supply is shut off.
• When the Vivo 40 is not in operation, and the oxygen flow is left on, oxy-
gen delivered into the patient tubing may accumulate within the machine
enclosure. Oxygen accumulated in the machine enclosure will create a risk
of fire.
• Supplemental oxygen may trigger the low leakage alarm prematurely.
• Supplemental oxygen flow may not exceed 15 litre/min.
• Supplemental oxygen affects the accuracy of the volume and flow measure-
ments. It is not recommended to use supplemental oxygen when target vol-
ume is active.

18 Product Description
Vivo 40 users manual Doc. 003821 En-Uk E-1
3 Product Description
3.1 Main Components
The Vivo 40 system contains the following components:
1
2
3
6
7
8
4
5

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NO. COMPONENT FUNCTION PART NO.
1 Carry bag Storage for transportation 003519
2 User manual Product and usage information 003821
3 Patient tube 004465
4 Power cord 003521
(EU:
003520)
5 Filter (white, disposa-
ble)
Inlet air filtration 003526
6 Filter (grey, washable) Inlet air filtration 003527
7 Rear lid For usage without
the HA 20 humidifier
003591
8 Vivo 40 main unit

20 Product Description
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3.2 Accessories
NO. COMPONENT FUNCTION PART NO.
9 HA 20 Humidifier Humidifies patient air 2230 XX
10 Trach elbow Trach connection 004810
11 Hygroscopic Con-
denser Humidifier
(HCH)
Humidifier 003974
12 Leakage/Exhalation
port
Providing a leakage 004426
13 Battery cable 12/24 V
DC
004258
14 EB 2 Battery kit Includes:
•Charger
•Trafobox
•Isolation
•Batterypack
• Carry bag
•Powercord24VAC
•Powercord24VDC
•Powercordmains
•EB2Usermanual
004128
910
11
13
12
14