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1 Introduction ..................................................................................................................... 3
1.1 What is the Vivo 30? ......................................................................................... 4
1.2 Intended Use..................................................................................................... 4
1.3 Contraindications .............................................................................................. 5
1.4 About this Manual .......................................................................................... 6
2 Safety Information........................................................................................................... 8
2.1 General User Precautions ............................................................................... 8
2.2 Electrical Safety ............................................................................................ 10
2.3 Environmental Conditions ............................................................................. 11
2.4 Usage of Patient Circuit ............................................................................... 12
2.5 Usage of Filters ............................................................................................... 13
2.6 Humidification ............................................................................................... 14
2.7 Cleaning and Maintenance ............................................................................. 14
2.8 Adverse Patient Symptoms............................................................................. 15
2.9 Usage of Oxygen .......................................................................................... 16
3 Product Description....................................................................................................... 18
3.1 Main Components ........................................................................................... 18
3.2 Accessories ........................................................................................ 20
3.3 The Vivo 30s Front Panel .......................................................................... 22
3.4 The Vivo 30's Back and Side Panels ........................................................... 23
3.5 Equipment Designation and Safety Label .................................................. 24
4 Functions and Parameters of the Vivo 30 ..................................................................... 25
4.1 Ventilation Mode.............................................................................................. 25
4.2 Device Mode ................................................................................................... 25
4.3 Settings ........................................................................................................... 25
4.4 The PCV Mode (Pressure Control Ventilation)................................................ 28
4.5 The PSV Mode (Pressure Support Ventilation)............................................... 29
4.6 The Difference between PCV and PSV Mode ................................................ 30
4.7 The CPAP Mode ............................................................................................. 30
4.8 Standby and Operating Mode ......................................................................... 31
4.9 Low Leakage Detection................................................................................... 31
4.10 Humidifier (optional) ........................................................................................ 31
5 Using the Vivo 30 .......................................................................................................... 32
5.1 Set up the Vivo 30 Before Use........................................................................ 32
5.2 Switching the Vivo 30 On and Off ................................................................... 33
5.3 Using the Menu ............................................................................................... 34
5.4 Monitoring Section .......................................................................................... 40
5.5 Transferring Data between the Vivo 30 and a PC ......................................... 41
5.6 Using the HA 01 Humidifier ....................................................................... 45
5.7 Using Batteries................................................................................................ 45
5.8 Vivo 30 Operating Time................................................................................... 47
6 Preparing the Vivo 30 for Use ....................................................................................... 48
6.1 Installing the Vivo 30 ....................................................................................... 48
6.2 Placing the Vivo 30 ....................................................................................... 49
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6.3 Connecting the Vivo 30 to the AC Power Source .......................................... 49
6.4 Connecting the Patient Circuit......................................................................... 50
7 Setting Up the Vivo 30 ................................................................................................ 51
7.1 Settings Applicable for the Different Modes ................................................... 52
7.2 Selecting the Mode ......................................................................................... 53
7.3 Setting the Parameters ................................................................................. 54
8 Alarms .......................................................................................................................... 58
8.1 Alarm Function ................................................................................................ 58
8.2 Physiological Alarm......................................................................................... 61
8.3 Technical Alarm............................................................................................... 66
9 Complete Function Check............................................................................................. 69
9.1 Pre-use Check ................................................................................................ 69
9.2 Alarm Check ................................................................................................... 70
10 Cleaning the Vivo 30 and Replacement of Accessories ............................................... 72
10.1 Cleaning the Vivo 30 ...................................................................................... 72
10.2 Cleaning and Replacing the Patient Air Filters................................................ 74
10.3 Change of Patient ........................................................................................... 75
11 Maintenance ................................................................................................................. 76
11.1 Regular Maintenance Control ......................................................................... 76
11.2 Service and Repair.......................................................................................... 77
11.3 Storage............................................................................................................ 77
11.4 Disposal .......................................................................................................... 77
12 Technical Specifications ................................................................................................ 78
12.1 System Description ...................................................................................... 78
12.2 Data ................................................................................................. 79
12.3 Compliance of Standards ............................................................................. 83
12.4 Delivery Settings ...................................................................................... 85
13 Accessories................................................................................................................... 87
13.1 Breas Accessories List.................................................................................... 87
2 Table of Contents
BREAS Vivo 30 clinicians manual Doc. 003887 En-Us A-1e
1 Introduction
WARNING!
CAUTION!
WARNING!
Do not use the Vivo 30 for any kind of life support treatment.
Introduction 3
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1.1 What is the Vivo 30?
The Vivo 30 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 ventilators expiratory
trigger can also be adjusted allowing the ventilator to more easily match
each patients 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 30 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.
The internal memory of the Vivo 30 can be downloaded to a PC where you can
view the patient compliance data in the Breas Vivo PC Software.
For more information about the Breas Vivo PC Software, please contact your
Breas representative.
4 Introduction
Vivo 30 clinicians manual Doc. 003887 En-Us A-1e
The Vivo 30 is intended for use in clinical settings (e.g., hospitals, sleep labora-
tories, sub-acute care institutions) and home environments. The Vivo 30 must
always be prescribed by a licensed physician.
The Vivo 30 is intended for treatment of adult patients only.
The Vivo 30 is intended to be operated by qualified and trained personnel, or by
personnel who have been taught using the clinicians manual.
The CPAP function is intended to deliver continuous positive airway pressure
therapy for the treatment of obstructive sleep apnea, via non-invasive nasal or
full-face masks.
1.3 Contraindications
The use of the Vivo 30 is contraindicated on patients with severe respiratory
failure without a spontaneous respiratory drive.
The use of the Vivo 30 for positive pressure therapy may be contraindicated on
patients:
Incapable of maintaining life- sustaining ventilation in the event of a brief
circuit disconnection or loss of therapy.
Unable to maintain a patent airway or adequately clear secretions.
At risk for aspiration of gastric contents.
With a history of allergy or hypersensitivity to the mask materials where the
risk from allergic reaction outweighs the benefit of ventilatory assistance.
Therapy with the Vivo 30 should not be prescribed when the following specific
diseases or conditions are present:
Bullous lung disease
Pathologically low blood pressure
Severe cardiac arrhythmias
Coronary artery disease
Unstable angina pectoris
Decompensated cardiac failure or hypotension, particularly if associated
with intravascular volume depletion
Recent thoracic surgery
Pneumothorax
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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 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.
Audience
This manual is primarily intended for care providers, clinical personnel, physi-
cians and others who require a working knowledge of the Breas Vivo 30 system.
The manual comprises detailed information on the settings and functions of the
Vivo 30 to be handled by trained health care personnel only.
Patients and other lay users operating the Vivo 30 will find all the informa-
tion they need in the User Manual.
Service personnel may order the Vivo 30 Service Manual that contains
detailed technical information for maintenance, service and repair.
6 Introduction
Vivo 30 clinicians manual Doc. 003887 En-Us A-1e
Icons
In this manual, icons are used to highlight specific information. The meaning of
each icon is explained in the table below.
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.
Introduction 7
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2 Safety Information
U.S. Federal law restricts this device for sale by or on order of a physician.
The Vivo 30 should not be used for any kind of life support treatment.
The Vivo 30 shall only be used by patients with spontaneous breathing.
Advice contained in this manual should not supersede instructions given by
the prescribing physician.
If the patient is admitted to a hospital or is prescribed any other form of
medical treatment, always inform the medical staff that the patient is on
mechanical ventilation treatment.
Vivo 30 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 30 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 30 is abnormally hot or
emits an odor. Contact your responsible care provider for an inspection.
Inadequate use of device or accessories may cause loss of treatment or
decreased performance.
The Vivo 30 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.
8 Safety Information
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Clinical personnel must read the Clinicians manual thoroughly and under-
stand the Vivo 30 operation before setting up and using the machine.
The user must read the user manual thoroughly and understand the
Vivo 30 operation before using the machine.
All the physiological alarms of the Vivo 30 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 30 with care.
Do not use the Vivo 30 while in a carry bag. Attach the rear lid and place
the swivel in a down position when placing the Vivo 30 in the bag.
If using the Vivo 30 for a short intra hospital or vehicle transportation, the
following cautions need to be observed:
Do not mount the Vivo 30 on a wheelchair or in a vehicle.
Make sure that the Vivo 30 stands securely in a upright position and cannot
tilt or fall.
Do not use the Vivo 30 outdoors during rain or snowfall.
If the HA 01 humidifier is attached, make sure that it is not in use and that
it is empty.
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2.2 Electrical Safety
10 Safety Information
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2.3 Environmental Conditions
Do not use the Vivo 30 while positioned in a warm place, such as direct
sunlight.
The device complies with the EMC requirements of standards listed in
Compliance of Standards on page 83. Necessary measures should be
taken in order to assure that field levels exceeding 10 V/m are avoided,
since this may impair the safety and performance of the Vivo 30. 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 30.
Examples include: radio emitting devices such as cellular or cordless tele-
phones, microwave ovens and high-frequency surgery apparatus.
The Vivo 30, 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 30 and treatment of the patient may deterio-
rate if the operation conditions in Technical Specifications on page 78
are not fulfilled. Do not use the Vivo 30 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 30 with a mask, patient tube and leakage port recom-
mended by Breas Medical AB and your health care professional.
The Vivo 30 requires an intentional leak port instead of an actively control-
led exhalation valve to remove exhaled gases from the patient circuit.
Therefore, specific masks and patient circuits using an intentional leakage
are required for normal operation. The pressurized air from the Vivo 30
causes a continuous flow of air to exhaust from the leak ports, flushing
exhaled gas from the circuit. The Vivo 30 should be turned on and the
intentional leak ports should be checked before application.
Do not breathe in the connected patient circuit unless the Vivo 30 is turned
on and operating properly.
Do not use patient hoses or tubes made of static or electrically conductive
material.
Always use a new mask, tube and leakage port when the Vivo 30 is to be
used by a new patient.
Patient connected parts and filter must be replaced regularly to ensure cor-
rect function of the Vivo 30. 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 30 to ensure no water will flow back into the Vivo 30. The
frequency at which these checks must be performed will depend on the
patients own condition and the device used. You should assess this on an
individual basis in accordance with the patients needs.
If the patient is using a full face mask (covering mouth and nose), the mask
must be equipped with a safety entrainment valve.
12 Safety Information
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Make sure that the ventilation holes in the mask or 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 min-
utes can, in some circumstances, lead to suffocation.
At low CPAP pressures, the air flow through the ventilation holes in the
mask or the leakage ports may be inadequate 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 patients head or neck while sleeping.
Always follow the instructions of the mask manufacturer.
Always use the Vivo 30 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 30, especially when changing patient. Failure to replace or clean a
dirty filter may cause the Vivo 30 to operate at higher temperatures than
intended.
When operating the Vivo 30, make sure that the air inlet and filters are not
obstructed or occluded.
If the Vivo 30 is used in a clinic by several patients, a low resistance bacteria
filter is recommended between the air outlet and the patient circuit to pre-
vent patient cross-contamination. Breas Medical AB recommends the
usage of the Breas filter 004185, see Breas Accessories List on page 87.
Reuse of mask or bacteria filter may expose patients to contagious agents.
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 01 humidifier.
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2.6 Humidification
The use of an HME (Heat and Moisture Exchanger, artificial nose) or an exter-
nal humidifier may require readjustment of the Vivo 30s low-pressure alarm.
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2.8 Adverse Patient Symptoms
Safety Information 15
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2.9 Usage of Oxygen
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Safety Information 17
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3 Product Description
2
4
5
6
18 Product Description
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NO. COMPONENT FUNCTION PART NO.
1 Carry bag Storage for transportation 003519
2 User manual Product and usage information 003820
3 Patient tube 004465
4 Power cord 003522
5 Filter (white, disposa- Inlet air filtration 003526
ble)
6 Filter (grey, washable) Inlet air filtration 003527
7 Rear lid For usage without 003591
the HA 01 humidifier
8 Vivo 30 main unit
Product Description 19
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3.2 Accessories
9 10 11
12 13 14 15
16 18
17
20 Product Description
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NO. COMPONENT FUNCTION PART NO.
12 Vivo-PC data cable Data cable: PC and Vivo 30 003588
(RJ45 to D-sub)
13 Vivo-iCom Data cable: Vivo 30 and iCom 003574
data cable (RJ45 to D-sub)
14 iCom-PC data cable Data cable: iCom and PC 003721
D-sub (D-sub to D-sub)
15 iCom-PC data cable Data cable: iCom and PC 003722
USB (USB to USB)
16 Memory card Vivo 30 settings, patient data 003619
and usage data
17 Memory card reader/ Read/write memory card 002185
writer
18 Vivo PC software kit Data monitoring software 004145
Product Description 21
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3.3 The Vivo 30s Front Panel
11
2 12
17
13
3
4 14
18
5 15
1 6 16
7, 8, 9, 10
22 Product Description
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3.4 The Vivo 30's Back and Side Panels
1
2
3
4
5
6
7
8
9
Product Description 23
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3.5 Equipment Designation and Safety Label
1, 2
3, 4
5, 6, 7, 8, 9
NO . SYMBOL EXPLANATION
1 Model designation
2 Serial number (last seven alphanumeric charac-
ters)
3 Data connection port (for iCom or PC)
4 Before using the data connection port, read
Transferring Data between the Vivo 30 and a
PC on page 41 carefully.
5 Class II electrical equipment; double insulation
6 Body floating (IEC 60601-1 Type BF, Isolated
Applied Part)
7 Read the clinicians manual thoroughly before
connecting the Vivo 30 to the patient.
8 CE marking applies in accordance with the direc-
tive MDD 93/42/EEC.
9 Read Disposal on page 77 for information
about recycling and disposal.
24 Product Description
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4 Functions and Parameters of the Vivo 30
This chapter includes descriptions of the modes and parameters used for con-
trolling the ventilation of the Vivo 30.
4.3 Settings
All the parameters that are used for controlling the breathing by the Vivo 30 are
listed below.
Read the chapter Settings Applicable for the Different Modes on page 52 for
information about the modes and ranges the different settings work with.
EPAP
EPAP
During CPAP mode the ramp function provides a pressure increase from the
ramp start pressure to the set CPAP pressure during a set time.
Start of EPAP
breath seconds
Insp. time PCV
Patient flow
Patient exhales
seconds
EPAP
seconds
Insp. time PSV
Flow
Max. flow
Pressure PSV
cmH2O
PCV
IPAP
EPAP
seconds
Insp. time PSV
seconds
Switching On
1 Make sure the AC power
source is connected and the
On/Off switch is switched on.
Switching Off
1 Press the Start/Stop button on
the front panel for 2 seconds (max
4 seconds).
Read chapter The Vivo 30s Front Panel on page 22 for exact position of the
buttons.
The navigation buttons are used to view the different sections defined above
each navigation button. The same navigation button can also be used to view
additional information in some sections.
Use the up or down button to enter the menu list.
During operation and when no button has been pressed for 20 seconds, the
menu will automatically switch to the clock in home mode and to the simple set-
up in clinical mode.
The up and down buttons are used to select values in a section. The plus and
minus buttons are used to alter a value.
Ramp
The Vivo 30 menu has the following section layout in the home mode:
Wake Up Alarm
Device Settings
Device Information
Memory Card
(standby only)
Wake up Alarm
Navigate to the section Others and
select Wake up Alarm to reach the
Wake up Alarm page.
Device Settings
Navigate to the section Others and
select Device Settings to reach the
Device Settings page.
When handing out the Vivo 30 to a patient, the panel should always be
locked.
The Vivo 30 is unlocked from the home mode by pressing the + and - but-
tons again simultaneously for 5 seconds.
Clinical Mode
The monitoring section contains a
bargraph to display current pressure,
information about max and min pres-
sure, mode, estimated tidal volume,
leakage, HA 01 humidifier, remaining
ramp time, total rate and the I:E ratio.
In some screens, the information will
adapt in size and amount depending
on the page layout.
Home Mode
The monitoring section contains a
bargraph, information about the
alarm time, HA 20 humidifier,
remaining ramp time and the panel
lock is shown.
The Vivo-PC data cable shall not be used for data transfer while the
patient is connected to the Vivo 30. Only a PC that complies to the
IEC 60601-1 standards can be used for copying and transferring
data during treatment of a patient.
Never connect the Vivo 30 directly to a network port.
2 Connect the other end of the Vivo-iCom data cable to the iCom.
3 Connect the iCom-PC data cable between the iCom and a PC. Do only use
either the D-sub cable or the USB cable.
Only use a Breas external DC cable to connect the Vivo 30 to the external
battery.
An external battery must be disconnected when the Vivo 30 is switched
off, otherwise the battery can be discharged.
3 If stored more than 1 month, connect the Vivo 30 to the AC power supply
and switch on the On/Off switch to recharge the alarm battery in standby
mode.
4 Check that the air filters are
installed.
2 Connect the other end of the patient tube to the mask and the leakage port,
if applicable.
Intentional Leakage
The leakage from the mask or leakage/exhalation port should be at least
12 liter/min at 4 cmH2O, to prevent re-breathing of exhaled air. The recom-
mended mask leakage is 20 to 40 liter/min at 10 cmH2O pressure.
This leakage may be achieved by:
integrated leakage in the mask
an adjoining leakage port
This chapter describes how to set the different parameters that are used for con-
trolling the ventilation of the Vivo 30.
Always document the set values before the patient returns home.
IPAP 4 to 30 cmH2O
CPAP 4 to 20 cmH2O
Breath rate 4 to 40 BPM (Breaths
Per Minute)
Inspiration time 0.3 to 5 sec
Min inspiration time Off, 0.3 to 3 sec
Max inspiration time 0.3 to 3 sec, Off
Rise time 1 to 9
Insp. trigger (PCV) 1 to 9, Off
Insp. trigger (PSV) 1 to 9
Exp. trigger 1 to 9
Ramp time (PSV, 10 to 60 min
PCV, CPAP)
Ramp start pressure 2 cmH2O to EPAP
Ramp start pressure 3 cmH2O to CPAP
HA 01 humidifier 1 to 9, Off
The ventilation modes and setting parameters are described in detail in the chapter
Functions and Parameters of the Vivo 30 on page 25.
The ventilator always starts in the mode and with the settings that were active
when it was switched off.
This chapter describes the alarm functions used for the Vivo 30, and how to
adjust the alarm levels for each ventilation mode.
Alarm Indication
As soon as an alarm condition is set, the Vivo 30 will alarm without delay.
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Audible signals: indicates the priority of the active alarm condition.
High priority: 3 signals followed by 2 more. The signal sequence is repeated
after a 0.5 seconds pause.
Medium priority: 3 signals only, with a lower frequency than the high priority
alarm. The signal sequence is repeated after a 6 seconds pause.
Function failure. Same signal as the high priority alarm or a constant signal,
depending on the kind of function failure.
Alarm Reset
An alarm will automatically be reset once the cause of the alarm has been cor-
rected.
If an alarm condition cannot be corrected, discontinue use and refer the
Vivo 30 for service.
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Alarm History Screen
Alarm History will display the 6 last
alarms, when the alarm occurred and
what type of alarm it was. The latest
alarm will be placed in top of the list.
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8.2 Physiological Alarm
ITEM DESCRIPTION
Definition A low pressure alarm will be given when the
Vivo 30s pressure fails to reach the low pressure
alarm limit for 15 seconds.
Possible cause Disconnection of patient circuit.
Setting is higher than IPAP.
Leakage from the mask or other components
of the patient circuit.
Setting Parameter: Low pressure
Min: Max: Resolution:
2 cmH2O IPAP 1.0 cmH2O
Ventilator action The Vivo 30 will continue to give breaths with the
same settings.
Indication
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High Pressure Alarm
ITEM DESCRIPTION
Definition A high pressure alarm will be given when the
Vivo 30s pressure exceeds 10 cmH2O more than
IPAP, for 3 consecutive breaths.
Possible cause Only activated under exceptional conditions,
such as a strong cough during the ventilators
inspiration phase.
Setting Self adjusting
Ventilator action The Vivo 30 will terminate inspiration from the
first high pressure breath. The Vivo 30 will then
continue to give breaths with same settings.
Indication
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Low Volume Alarm
ITEM DESCRIPTION
Definition A low volume alarm will be given when the
Vivo 30s volume fails to reach the low volume
alarm limit for 15 seconds (45 seconds after start-
up and after cancelling a high leakage alarm).
Possible cause Restrictions in airways.
Obstructed or occluded patient circuit.
Setting Parameter: Low volume
Min: Max: Resolution:
Off, 0.03 l 2.0 l 0.05 l
Ventilator action The Vivo 30 will continue to give breaths with the
same settings.
Indication
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Low Leakage Alarm
ITEM DESCRIPTION
Definition A low leakage alarm will be given when the meas-
ured flow is lower than the expected leakage flow
at set pressure.
Possible cause Incorrect patient circuit leakage.
Obstructed or occluded patient circuit.
Setting Self adjusting
Ventilator action The Vivo 30 tries to continue delivering breaths
according to settings.
Indication
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High Leakage Alarm
ITEM DESCRIPTION
Definition A high leakage alarm will be given when the meas-
ured flow exceeds the expected leakage flow at set
pressure during more than 15 seconds.
Possible cause Leakage in patient circuit.
The patient has removed the mask.
Setting Self adjusting
Ventilator action The Vivo 30 tries to continue delivering breaths
according to settings.
Indication
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8.3 Technical Alarm
ITEM DESCRIPTION
Definition A low external DC warning will be given when
the external DC is the last power source and it
falls below the voltage warning limit.
Possible cause A discharged external battery.
Warning limits These limits are only applicable on a power
source specified by Breas Medical AB.
12 V source: 24 V source:
11.3 V 22.7 V
Ventilator action The Vivo 30 will continue to give breaths with the
same settings.
Indication
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Low Power Alarm
ITEM DESCRIPTION
Definition A low power alarm will be given when the last
power source has fallen lower than its voltage
alarm limit.
Possible cause Lost connection to AC power.
Discharged batteries.
Alarm limits These limits are only applicable on a power
source specified by Breas Medical AB.
AC power: External DC:
65 15 V 12 V:
10.0 0.5 V
24 V:
20.0 0.5 V
Ventilator action The Vivo 30 stops giving breaths and gives an
alarm for 2 minutes.
If connected to AC power with a too low voltage,
the Vivo 30 will enter standby mode.
Indication
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Internal Function Failure Alarms
ITEM DESCRIPTION
Definition An internal function failure alarm will be given
when the Vivo 30 has an internal function failure.
Ventilator action The Vivo 30 will continue or stop the treatment
depending on the type and priority of the alarm.
Indication The alarm is given audibly with a tone and visible
by a display message at least for 120 seconds.
Ventilator reset In order to stop the alarm the ventilator must be
switched off by the On/Off switch on the side
panel.
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9 Complete Function Check
This chapter describes the complete function check of the Vivo 30. This func-
tion check should be performed after changing the ventilation mode, or if the
ventilator function needs to be checked for any other reason.
For information on the short function check, which should be performed once
a day, see Set up the Vivo 30 Before Use on page 32.
To perform a complete function check, all tasks in this chapter needs to be com-
pleted in the written number order.
Inspection of device
Check that there is no visible damage.
Check that the surface is clean.
Check that the rear lid (or the HA 01 humidifier if applicable) is connected
properly.
Inspection of cables
Check that they are Breas cables.
Check that the cables are undamaged.
Check that the cables are properly connected.
Inspection of placement
The Vivo 30 shall be placed on solid flat surface below the patient level.
Make sure that nothing can block the patient air inlet at the rear.
SETTING VALUE
Mode PCV
IPAP 14 cmH2O
EPAP 2 cmH2O
Set rate 10 BPM
Inspiration time 1.5 sec
Rise time 4
Inspiration trigger Off
Low pressure alarm 2 cmH2O
Low volume alarm 0.05 l
Always be careful when cleaning to ensure that you do not damage any
equipment.
Fluid must not be allowed to enter into the Vivo 30.
Do not sterilize the Vivo 30.
Main Unit
1 Switch off the Vivo 30 and dis-
connect the supply.
2 Remove the patient circuit.
HA 01 Humidifier
The HA 01 humidifier should be cleaned, maintained and replaced in
accordance with the manufacturers instructions.
For more information, see Breas HA 01 Humidifier User Manual.
Patient Circuit
The patient circuit should always be cleaned, disinfected and replaced in accordance
with the applicable manufacturers instructions.
Always replace the patient circuit with a new one when the Vivo 30 is to be used
by a new patient.
All parts that come into contact with the respiration gas must be cleaned as fol-
lows:
1 Place the dismantled parts in hot water containing mild detergent.
2 Remove fouling with a brush.
3 Rinse parts thoroughly under running hot water.
4 Shake water out of all parts.
WARNING!
Vivo 30 should be subjected to maintenance, service and control
and any applicable upgrades, in accordance with Breas service
instructions.
Vivo 30 shall only be repaired or modified in accordance with
Breas service manuals, technical bulletins, and any special serv-
ice instructions, by service technicians that have been authorized
after Breas Vivo 30 service training, or have an equivalent techni-
cal knowledge on medical device.
Do not under any circumstances attempt to service or repair the
Vivo 30 yourself. If you do so, the manufacturer will no longer be
responsible for the performance and safety of the Vivo 30.
Do not use the device and contact your responsible care provider for an
inspection of the device in the event of:
Unexpected patient symptoms during treatment.
Unexplainable or sudden pressure, performance or sound changes
during operation.
Suspected damage to the device.
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11.2 Service and Repair
The service and repair of the Vivo 30 must be carried out by authorized service
personnel in accordance with Breas service instructions. Service inspections
must always be carried out after any repair of the device.
Authorized service workshops can order the Vivo 30 Service Manual that con-
tains all technical documentation required for the maintenance and service of the
Vivo 30.
11.3 Storage
Empty, clean and dry the HA 01 humidifier (if applicable) before storage of the
Vivo 30.
11.4 Disposal
The Vivo 30, any accessories and all replaced parts must be disposed of and
recycled in accordance with the local environmental regulations regarding the
disposal of used equipment and waste.
Batteries used with the Vivo 30 shall be recycled in
accordance with the local environmental regulations.
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12 Technical Specifications
4
3 12
2
9
1 5 10 11
Yellow
Grey
Pink
8 Blue
6 7
Pink
Blue 6
NO. DESCRIPTION
1 Air inlet filter
2 Blower
3 Silencer box
4 Vivo 30 casing
5 Pressure regulating valve
6 Pressure sensor
7 Flow sensor
8 Ambient
9 Humidifier (HA 01)
10 Patient tube
11 Leak hole
12 Mask
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12.2 Data
Technical Specifications 79
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SETTING/VALUE RANGE/PERFORMANCE RESOLUTION
Inspiratory trig- 1 to 9, Off. 1
ger effort level
Expiratory trig- 1 to 9, where 1 is the lowest 1
ger effort level effort and 9 is the highest
effort setting.
Ramp function On, Off, Disabled
HA 01 humidi- Settings: Off, 1 to 9, corre- 1
fier sponds to 10 to 30 mgH2O/l,
<100% RH. Heat-up time
from 73F (23C): less than
1 hour. Max gas temperature
at patient port: 109F (43C).
Audible alarm 1 to 9, where 1 is the lowest 1
level and 9 is the highest volume
setting.
Maximum flow > 200 liter/min
Maximum lim- PCV, PSV:
ited pressure 60 cmH2O
during single CPAP: 30 cmH2O
fault condition
Maximum steady Set IPAP + 10 cmH2O, toler-
limiting pressure ance: 10%
Max flow in 1/3 of max press.: 110 liter/
CPAP mode min
2/3 of max press.: 150 liter/
min
Max pressure: 155 liter/min
Breathing resist- 4 cmH2O at 30 liter/min
ance under sin- 6 cmH2O at 60 liter/min
gle-fault
Sound level at Less than 30 dB(A) Measured at 1 m
10 cmH2O
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INDICATOR SPECIFICATION RESOLUTION
Pressure 0 to 30 cmH2O 2% of full scale and
4% of actual reading
Estimated tidal liter (BTPS, Body Tempera- 20% or 20 ml, which-
volume ture and Pressure Saturated) ever is the greatest.
Leakage liter/min (BTPS) 1 liter/min, 20%
Total rate BPM (Breath Per Minute) 1
I:E 1:10 to 10:1 0.1 unit, 1 unit
Technical Specifications 81
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ALARM SPECIFICATION INDICATION
Internal function Red or yellow LED, audi-
failure alarms ble alarm and a warning
message on the display.
ENVIRONMENTAL
SPECIFICATION
CONDITIONS
Operating temperature 41 to 100F (5 to 38C)
range
Storage and transport tem- -4 to +140F (-20 to +60C)
perature
Ambient pressure range 600 to 1060 cmH2O, corresponding to
~4000 metres above sea level to ~375 metres
below sea level, at normal atmospheric pres-
sure.
Humidity 10% to 95%, non-condensing
DIMENSIONS SPECIFICATIONS
W H D 7.48 8.86 8.78 inch (with rear lid)
Weight 6.8 lbs (with rear lid)
Air outlet 22 mm male conical standard connector
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12.3 Compliance of Standards
STANDARD SPECIFICATION
IEC 60601-1 (1988) Medical electrical equipment - Part 1: General
A1 (1991) requirements for safety.
A2 (1995)
IEC 60601-1-2 (2001) Medical electrical equipment - Part 1-2: Gen-
eral requirements for safety - Collateral stand-
ard: Electromagnetic compatibility -
requirements and tests.
IEC 60601-1-4 (2000) Medical electrical equipment - Part 1-4: Gen-
eral requirements for safety - Collateral Stand-
ard: Programmable electrical medical systems.
IEC 60601-1-8 (2003) Medical electrical equipment - Part 1-8: Gen-
eral requirements for safety - Collateral stand-
ard: Alarm systems - requirements, tests and
guidelines.
ISO 10651-6 (2004) Lung ventilators for medical use - Particular
requirements for basic safety and essential
performance - Part 6: Home care ventilatory
support devices.
ISO 17510-1 (2002) Sleep apnea breathing therapy - Part 1: Sleep
apnea breathing therapy devices.
ISO 8185 (2007) Respiratory tract humidifiers for medical use -
Particular requirements for respiratory humid-
ification systems.
CAN/CSA-C22.2 Medical electrical equipement Part 1: General
No. 601.1-M90 requirements for safety.
CAN/CSA-C22.2 Supplement no. 1-94 to CAN/CSA-C22.2
No. 601.1S1-94 No. 601.1-M90--Medical electrical equipe-
ment Part 1: General requirements for safety
CSA 601.1 Amendment 2:1998
UL Std No. 60601-1, 1st Ed. Medical electrical equipement Part 1: General
requirements for safety.
Technical Specifications 83
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CLASSIFICATION SPECIFICATION
Class II (IEC 60601-1) Class II, Type BF.
Electrical equipment with dual isolation and
body floating (isolated) applied part according
to IEC 60601-1.
Class IIb Classification according to the European
Medical Device Directive 93/42/EEC.
The Vivo 30 and its packaging do not contain any natural rubber latex.
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12.4 Delivery Settings
PARAMETERS SETTING
IPAP 10 cmH2O
EPAP 4 cmH2O
CPAP 10 cmH2O
Breath rate 10 BPM
Inspiration time 1.5 sec
Inspiration trigger 3
Expiration trigger 3
Rise time 3
Max inspiration time Off
Min inspiration time Off
Ramp time 10 min
CPAP ramp start pressure 4 cmH2O
IPAP ramp start pressure 4 cmH2O
Technical Specifications 85
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ALARMS SETTING
Low pressure 2 cmH2O
Low volume 0.25 l
OTHERS SETTING
Time format 12 h AM/PM
Patient operating time 0h
Pressure unit cmH2O
Wake up alarm sound 1
Sound level (alarm) 5
Display light Delayed
Light intensity 5
Display contrast 6
Wake up time 07:30, Off
Humidity level 6
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13 Accessories
Accessories 87
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Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC standards (e.g. IEC 60950 for data
processing equipment and IEC 60601-1 for medical equipment). Furthermore
all configurations shall comply with the valid version of the system standard
IEC 60601-1-1. Everybody who connects additional equipment to the signal
input part or signal output part configures a medical system, and is therefore
responsible that the system complies with the requirements of the valid version
of the system standard IEC 60601-1-1. If in doubt, consult the technical service
department or your local representative.
88 Accessories
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