savina_300_instructions_for_use_sw_5-n_2nd_edition_.pdf
Page 1
Instructions for use
Savina 300
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Ventilator
Software 5.n
Page 2
Information about this document
Information about this document
Typographical conventions
1
Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Bullet points indicate individual actions or
different options for action.
–
Dashes indicate the listing of data, options, or
objects.
A
Letters in illustrations denote elements referred
to in the text.
>
The greater-than symbol indicates the
navigation path in a dialog window.
Bold, italicized text indicates labels on the
device and texts that are displayed on the
screen.
(A) Letters in parentheses refer to elements in the
related illustration.
Illustrations
Illustrations of products and screen content in this
document may differ from the actual products
depending on configuration and design.
Use of terms
Dräger uses the term "accessories" not only for
accessories in the sense of IEC 60601-1, but also
for consumables, removable parts, and attached
parts.
2
Instructions for use Savina 300 SW 5.n
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Information about this document
Trademarks
Trademark
Trademark owner
Trademark
Trademark owner
Savina®
Dräger
Buraton®
Schülke & Mayr
®
ATC
Mikrozid
AutoFlow®
Perform®
LPO®
acryl-des®
Spirolog®
Descogen®
DrägerService®
Dismozon
TM
MEDIBUS.X
®
Actichlor
Ecolab
Oxycide
Brulin
Virkon®
Dispatch
Clorox
®
Antiseptica
Bode Chemie
®
Medentech
®
Ecolab USA
Klorsept
BruTab 6S®
®
®
DuPont
1)
BIPAP
1)
Licensed trademark
Safety information definitions
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
CAUTION
A CAUTION statement provides important
information about a potentially hazardous
situation which, if not avoided, may result in minor
or moderate injury to the user or patient or in
damage to the medical device or other property.
Instructions for use Savina 300 SW 5.n
3
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Information about this document
Target groups
Duties of the operating organization
The tasks described in this document specify the
requirements that have to be met by each
respective target group.
The operating organization of this product must
ensure the following:
–
The target group has the required qualifications
(e.g., has undergone specialist training or
acquired specialist knowledge through
experience).
–
The target group has been trained to perform
the task.
–
The target group has read and understood the
chapters required to perform the task.
Description of target groups
The target groups may only perform the following
tasks if they meet the corresponding requirements.
Users
Task
Requirement
Service personnel
Task
Requirement
Installation
Specialist knowledge in
electrical engineering and
mechanics
Basic service work
(inspection,
maintenance
according to the
"Maintenance"
chapter)
Experience in the servicing
of medical devices
Specialized service personnel
Task
Requirement
Installation
Specialist knowledge in
electrical engineering and
mechanics
Basic and complex
service work
(inspection,
Experience in the servicing
maintenance, repair) of medical devices
Experience in complex
service work on this
product
Dräger recommends arranging a service contract
with DrägerService.
Use of the product in Specialist medical
accordance with the knowledge in ventilation
intended use
Reprocessing personnel
Task
Requirement
Reprocessing
Specialist knowledge in the
reprocessing of medical
devices
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Instructions for use Savina 300 SW 5.n
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Contents
Contents
Information about this document . . . . . . . . .
2
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
For your safety and that of your patients. . .
7
General safety information . . . . . . . . . . . . . . . . 8
Product-specific safety information. . . . . . . . . . 11
Selecting the breathing circuit and the
humidification type. . . . . . . . . . . . . . . . . . . . . . 62
Checking operational readiness . . . . . . . . . . . 63
Selecting the therapy type and the
application mode . . . . . . . . . . . . . . . . . . . . . . . 69
Selecting the start settings for ventilation . . . . 70
Starting the therapy . . . . . . . . . . . . . . . . . . . . . 72
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
73
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Contraindications . . . . . . . . . . . . . . . . . . . . . . . 16
Environment of use. . . . . . . . . . . . . . . . . . . . . . 16
Setting ventilation . . . . . . . . . . . . . . . . . . . . . .
Non-invasive ventilation (NIV) . . . . . . . . . . . . .
Suction maneuver with oxygenation . . . . . . . .
Medication nebulization . . . . . . . . . . . . . . . . .
Manual inspiration – Inspiration hold. . . . . . . .
Special maneuvers . . . . . . . . . . . . . . . . . . . . .
O2 therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Day/Night screen switch-over . . . . . . . . . . . . .
Key lock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low Pressure Oxygen (LPO) . . . . . . . . . . . . .
Transporting patients . . . . . . . . . . . . . . . . . . . .
Interrupting ventilation – standby mode . . . . .
Ending operation . . . . . . . . . . . . . . . . . . . . . . .
Storing Savina 300 . . . . . . . . . . . . . . . . . . . . .
74
79
80
82
85
86
87
89
89
90
93
94
95
96
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
97
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Savina 300 . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Range of functions . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product labels. . . . . . . . . . . . . . . . . . . . . . . . . .
18
21
22
24
28
30
Operating concept . . . . . . . . . . . . . . . . . . . . . 31
Control and display unit . . . . . . . . . . . . . . . . . . 32
Fixed function keys. . . . . . . . . . . . . . . . . . . . . . 32
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Assembly and preparation . . . . . . . . . . . . . . 37
Safety information. . . . . . . . . . . . . . . . . . . . . . .
Preparing the trolley . . . . . . . . . . . . . . . . . . . .
Mounting an additional monitor . . . . . . . . . . . .
Preparing Savina 300 . . . . . . . . . . . . . . . . . . . .
Connecting the power supply . . . . . . . . . . . . . .
Connecting the gas supply . . . . . . . . . . . . . . . .
Connecting the nurse call . . . . . . . . . . . . . . . . .
Using the MEDIBUS or MEDIBUS.X
protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Removing and refitting the filter cover . . . . . . .
Connecting a potential equalization cable . . . .
Intrahospital transport. . . . . . . . . . . . . . . . . . . .
38
38
42
43
51
53
54
55
57
57
58
Getting started . . . . . . . . . . . . . . . . . . . . . . . . 59
Safety information. . . . . . . . . . . . . . . . . . . . . . . 60
Switching on Savina 300 . . . . . . . . . . . . . . . . . 60
Instructions for use Savina 300 SW 5.n
Display of alarms. . . . . . . . . . . . . . . . . . . . . . . 98
Suppressing the acoustic alarm signal . . . . . . 100
Acknowledging the alarm message. . . . . . . . . 100
Setting the alarm limits . . . . . . . . . . . . . . . . . . 101
Trends and data . . . . . . . . . . . . . . . . . . . . . . . 103
Opening the dialog window . . . . . . . . . . . . . . .
Displaying measured values and set values . .
Displaying trends . . . . . . . . . . . . . . . . . . . . . .
Displaying the logbook . . . . . . . . . . . . . . . . . .
Displaying waveforms and measured values
on the main screen . . . . . . . . . . . . . . . . . . . . .
104
104
105
107
108
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
General information. . . . . . . . . . . . . . . . . . . . .
Flow monitoring . . . . . . . . . . . . . . . . . . . . . . . .
FiO2 monitoring . . . . . . . . . . . . . . . . . . . . . . . .
CO2 monitoring . . . . . . . . . . . . . . . . . . . . . . . .
112
112
114
116
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Contents
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 123
Information on configuration. . . . . . . . . . . . . . . 124
Configuring ventilation functions . . . . . . . . . . . 125
Configuring start settings . . . . . . . . . . . . . . . . . 126
Configuring device settings . . . . . . . . . . . . . . . 130
Configuring country-specific settings . . . . . . . . 131
Configuring the data interface . . . . . . . . . . . . . 132
Displaying and enabling options . . . . . . . . . . . 132
Scanning the QR code . . . . . . . . . . . . . . . . . . . 133
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 135
Failure of the power supply . . . . . . . . . . . . . . . 136
Failure of the gas supply . . . . . . . . . . . . . . . . . 136
High ambient temperature . . . . . . . . . . . . . . . . 136
Alarm – Cause – Remedy . . . . . . . . . . . . . . . . 137
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . 163
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Information on reprocessing. . . . . . . . . . . . . . . 167
Classifications for reprocessing . . . . . . . . . . . . 169
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 170
Reprocessing procedures . . . . . . . . . . . . . . . . 172
After reprocessing . . . . . . . . . . . . . . . . . . . . . . 176
Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Safety information . . . . . . . . . . . . . . . . . . . . . . 178
Definition of service terminology . . . . . . . . . . . 179
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Replacing the microfilter . . . . . . . . . . . . . . . . . . 182
Replacing the dust filter set . . . . . . . . . . . . . . . 183
Replacing O2 sensors . . . . . . . . . . . . . . . . . . . 184
Replacing the diaphragm of the reusable
expiratory valve . . . . . . . . . . . . . . . . . . . . . . . . 184
Performance characteristics . . . . . . . . . . . . . .
Displayed measured values . . . . . . . . . . . . . .
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating data. . . . . . . . . . . . . . . . . . . . . . . . .
Alarm system of Savina 300 . . . . . . . . . . . . . .
Automatic alarm limits . . . . . . . . . . . . . . . . . . .
Device combinations . . . . . . . . . . . . . . . . . . . .
EMC declaration . . . . . . . . . . . . . . . . . . . . . . .
Connections to IT networks. . . . . . . . . . . . . . .
Open-source software . . . . . . . . . . . . . . . . . . .
193
195
199
201
206
207
209
209
212
213
Principles of operation . . . . . . . . . . . . . . . . . 215
Ventilation modes . . . . . . . . . . . . . . . . . . . . . .
Additional settings . . . . . . . . . . . . . . . . . . . . . .
Therapy types and application modes. . . . . . .
Special maneuvers . . . . . . . . . . . . . . . . . . . . .
Low Pressure Oxygen (LPO) . . . . . . . . . . . . .
Automatic leakage compensation . . . . . . . . .
Measurements. . . . . . . . . . . . . . . . . . . . . . . . .
Pneumatic functional description . . . . . . . . . .
Overview of the menu structure . . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . .
216
228
236
237
238
240
242
243
246
250
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Labels for options . . . . . . . . . . . . . . . . . . . . . 255
Password for Savina 300 SW 5.n . . . . . . . . . 263
Information on the password . . . . . . . . . . . 263
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Safety information . . . . . . . . . . . . . . . . . . . . . . 186
Disposal of packaging material . . . . . . . . . . . . 186
Disposal of batteries . . . . . . . . . . . . . . . . . . . . 186
Disposal of O2 sensors. . . . . . . . . . . . . . . . . . . 187
Disposing of the medical device . . . . . . . . . . . 187
Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 189
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 190
Set values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
6
Instructions for use Savina 300 SW 5.n
Page 7
For your safety and that of your patients
For your safety and that of your patients
General safety information . . . . . . . . . . . . . .
8
Strictly follow these instructions for use . . . . . .
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic compatibility (EMC) . . . . . . . .
Disposable products . . . . . . . . . . . . . . . . . . . . .
Sterile-packaged accessories. . . . . . . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Storing the instructions for use . . . . . . . . . . . . .
Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
8
8
8
8
9
9
9
10
10
10
10
10
Product-specific safety information . . . . . . . 11
Functional safety . . . . . . . . . . . . . . . . . . . . . . . 13
Monitoring ventilation . . . . . . . . . . . . . . . . . . . . 13
Backup ventilation with an independent
manual ventilation device . . . . . . . . . . . . . . . . . 13
Instructions for use Savina 300 SW 5.n
7
Page 8
For your safety and that of your patients
General safety information
The following WARNING and CAUTION
statements apply to general operation of the
medical device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this medical
device.
Strictly follow these instructions for use
WARNING
Risk of incorrect operation and of incorrect
use
Any use of the medical device requires full
understanding and strict observation of all
sections of these instructions for use. The
medical device must only be used for the
purpose specified under "Intended use"
on page 16 and in conjunction with
appropriate patient monitoring (see page 9).
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels. Failure to observe these safety
information statements constitutes a use of
the medical device that is inconsistent with its
intended use.
Service
WARNING
Risk if service is not performed regularly
If service is not performed regularly,
malfunctions may occur, which can result in
personal injury and property damage.
Accessories
WARNING
Risk due to incompatible accessories
The use of incompatible accessories may
adversely affect the functional integrity of the
product. Personal injury and property damage
may occur as a consequence.
Use only compatible accessories. The
accessories that are compatible with this
product are listed in the list of accessories
supplied with the product.
Not for use in areas of explosion hazard
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur.
Connected devices
WARNING
Risk of electric shock and of device
malfunction
Electrical connections to equipment not listed
in these instructions for use or these
assembly instructions must only be made
when approved by each respective
manufacturer.
Before operating the medical device, strictly
comply with the instructions for use of all
connected devices or device combinations.
Perform the service in accordance with the
chapter "Service".
8
Instructions for use Savina 300 SW 5.n
Page 9
For your safety and that of your patients
Patient safety
Electromagnetic compatibility (EMC)
The design of the medical device, the accompanying documentation, and the labeling on the
medical device are based on the assumption that
the purchase and the use of the medical device are
restricted to persons familiar with the most
important inherent characteristics of the medical
device.
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility. During installation
and before initial operation, follow the information in
section: "EMC declaration" (page 209).
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
The instructions for use do not contain any
information on the following points:
–
Risks that are obvious to users
–
Consequences of obvious improper use of the
medical device
–
Potentially negative effects on patients with
different underlying diseases
Medical device modification or misuse can be
dangerous.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring
parameters.
Patient monitoring
This device can be affected by other electrical
devices.
WARNING
Risk due to electrostatic discharge
Malfunctions that endanger the patient may
occur if no protective measures against electrostatic discharge are employed in the following situations:
– When touching the pins of connectors that
carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the following measures and train the relevant personnel:
– Observe the ESD protective measures.
Such measures may include wearing antistatic clothing and shoes, touching a potential equalization pin before and while
making the connection, or using electrically insulating and antistatic gloves.
– Observe the requirements for the electromagnetic environment. Observe the following section: "Electromagnetic environment" (page 210).
The user of the medical device is responsible for
choosing a suitable patient monitoring system that
provides appropriate information on medical device
performance and patient condition.
Patient safety can be achieved by a wide variety of
means ranging from electronic surveillance of
medical device performance and patient condition
to direct observation of clinical signs.
The responsibility for selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Instructions for use Savina 300 SW 5.n
9
Page 10
For your safety and that of your patients
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g., cellular phones) and medical electrical equipment
(e.g., defibrillators, electrosurgical devices)
emit electromagnetic radiation. When such
devices are operated too close to this device
or its cables, the functional integrity of this device may be compromised by electromagnetic
disturbances. As a result, the patient could be
put at risk.
Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless communication devices, to ensure that the essential performance of this device is fulfilled.
Maintain an adequate distance between this
device and other medical electrical equipment.
Installing accessories
CAUTION
Risk of device failure
Install accessories to the basic device in
accordance with the instructions for use of the
basic device. Make sure that there is a safe
connection to the basic device.
Strictly observe instructions for use and assembly
instructions.
Storing the instructions for use
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the
user.
Disposable products
Training
WARNING
Risk of patient injury due to failure of
accessories
Training for users is available from the Dräger
organization responsible, see www.draeger.com.
Disposable products are developed, tested
and manufactured for disposable use only.
Reuse, reprocessing, or sterilization can lead
to a failure of accessories and cause injury to
the patient.
Do not reuse, reprocess, or sterilize
disposable products.
Sterile-packaged accessories
CAUTION
Risk of medical device failure and of patient injury
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged, or if
there are other signs of non-sterility.
10
Instructions for use Savina 300 SW 5.n
Page 11
For your safety and that of your patients
Product-specific safety information
WARNING
Risk of incorrect use
WARNING
Risk of patient injury
This medical device is only intended to be
used by the target group "users".
Penetrating liquid may cause malfunction of
the device, which may endanger the patient.
WARNING
Risk of not hearing alarm signals
Do not place any containers with liquid on or
above the device.
During surface disinfection, make sure no
liquids penetrate into the device.
If the alarm volume is too low, alarm signals
may not be heard.
– Set the alarm volume loud enough so that
the alarm signals can be heard in the
environment where the device is located.
– The user must remain within earshot of the
alarm signals.
WARNING
Risk due to modifications
Modifications to the product may lead to
malfunctions and unforeseen risks. This may
result in injury to the patient or the user or in
property damage.
Do not modify this product.
WARNING
Risk of electric shock
If the connectors of the interfaces and the
patient are touched simultaneously, there is a
risk of electric shock.
Do not simultaneously touch the connectors
of the interfaces and the patient.
Instructions for use Savina 300 SW 5.n
WARNING
Risk of fire
The flow sensor can ignite medications or
other substances based on highly flammable
substances.
– Do not nebulize medications or other
substances that are easily flammable or
spray them into the device.
– Do not use substances containing alcohol.
– Do not allow flammable or explosive
substances to enter the breathing system
or the breathing circuit.
WARNING
Risk of failure of flow measurement
Deposits that were not removed during
reprocessing can damage the measuring
wires in the flow sensor or cause a fire.
– Before inserting the flow sensor check for
visible damage, soiling, and particles.
Repeat this check regularly.
– Replace flow sensors when damaged,
soiled, or not particlefree.
11
Page 12
For your safety and that of your patients
WARNING
Risk of fire
WARNING
Risk of fire
When using O2 pressure reducers that are not
approved, excess pressure can cause a fire.
Due to oxygen enrichment in the ambient air
and overheating, the medical device can
ignite.
When supplying the ventilator with oxygen
from a compressed gas cylinder, only use
pressure reducers that comply with
ISO 10524.
Open pressure reducers slowly by hand. Do
not use tools.
WARNING
Risk of fire
Do not use the medical device in conjunction
with flammable gases or flammable solutions
that can mix with air, oxygen, nitrous oxide, or
other sources of ignition since the medical
device could ignite.
Do not allow the medical device to come into
contact with sources of ignition.
A distance of at least 10 cm (3.9 in) must be
maintained between the rear of the medical
device and walls or large-scale obstacles.
Do not cover the rear during operation or
standby mode so that air circulation is
ensured.
Only use the medical device in adequately
ventilated rooms.
CAUTION
Risk of unnoticed change in the inspiratory O2
concentration
If an additional flow (e.g., NO, nitrous oxide) is
delivered from an external flow source, the actual
O2 concentration may deviate from the displayed
values.
WARNING
Risk of patient injury
If required, use additional monitoring, e.g.,
external SpO2 monitoring.
Magnetic resonance imaging (MRI, NMR, NMI)
may impair correct functioning of the medical
device.
CAUTION
Risk of overheating of the medical device
Do not use the medical device during
magnetic resonance imaging.
Sources of heat such as direct sunlight, heat
radiators or spotlights may cause the medical
device to overheat.
WARNING
Risk of patient injury
Keep sources of heat away from the medical
device. Only use the medical device in adequately
ventilated rooms.
Hyperbaric chambers may impair correct
functioning of the medical device.
Do not use the medical device in hyperbaric
chambers.
WARNING
Risk of electric shock
CAUTION
Risk of patient injury
Positive-pressure ventilation can lead to negative
effects, such as barotrauma or strain on the
circulatory system.
Monitor the patient's condition.
There are live components under the housing
cover.
Do not remove the cover.
12
Instructions for use Savina 300 SW 5.n
Page 13
For your safety and that of your patients
CAUTION
Risk of malfunction
The touch screen has a sensitive surface.
Damage to the surface results in malfunctions of
the touch-sensitive controls.
Never use sharp objects to operate the screen.
Do not damage the surface of the screen during
cleaning or transport.
CAUTION
Risk of electric shock
Monitoring ventilation
The following parameters are monitored by the
integrated monitoring:
– Airway pressure
– Expiratory minute volume
– Respiratory rate
– Apnea
– Inspiratory O2 concentration
– Inspiratory breathing gas temperature
– Inspiratory tidal volume
– End-expiratory CO2 concentration
If a faulty device without safety extra-low voltage
(SELV) is connected to the medical device, there
is a risk of electric shock when the housing is
touched.
Changes in these parameters may be caused by:
– Acute changes in the patient's condition
– Incorrect settings and faulty handling
– Device malfunctions
– Failure of power and gas supplies
Only connect devices with safety extra-low
voltage (SELV) to the connections for the serial
port and the nurse call.
If the built-in monitoring fails, use substitute
monitoring.
During O2 therapy, the monitoring functions of the
medical device are limited.
Functional safety
The essential performance consists in a controlled
and monitored patient ventilation with user-defined
settings for the monitoring functions
– minimum ventilation flow,
– maximum airway pressure,
– minimum and maximum O2 concentration in the
breathing gas,
or, if a set limit is exceeded, an appropriate alarm.
The integrated monitoring also generates an alarm
in the following situations:
– Failure of the external power supply
– Discharge of the internal battery
– Failure of the O2 supply (HPO mode)
Backup ventilation with an independent
manual ventilation device
WARNING
Risk of patient injury
If a fault is evident at the medical device, its
life-support functions may be affected.
Ventilation of the patient using an independent ventilation device must be started
without delay, if necessary with PEEP and/or
an increased inspiratory O2 concentration
(e.g., with the manual resuscitator MR-100).
The medical device is equipped with basic safety
features to reduce the possibility of patient injury
while the cause of an alarm is remedied.
Instructions for use Savina 300 SW 5.n
13
Page 14
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14
Instructions for use Savina 300 SW 5.n
Page 15
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Contraindications . . . . . . . . . . . . . . . . . . . . . . 16
Environment of use . . . . . . . . . . . . . . . . . . . . 16
Instructions for use Savina 300 SW 5.n
15
Page 16
Application
Intended use
Savina 300 is a ventilator intended for the
ventilation of adults and pediatric patients.
Savina 300 offers mandatory ventilation modes,
ventilation modes supporting spontaneous
breathing, and airway monitoring.
Contraindications
When using small minute volumes, it takes longer
for a modified oxygen concentration to reach the
patient.
For the ventilation of neonates, the use of special
neonatal ventilators is therefore recommended.
Environment of use
Savina 300 is intended for the following
environments of use:
–
In intensive care wards, in recovery rooms and
generally for hospital use
–
–
Mechanical safety and EMC compatibility are
tested on the basis of the following standards:
Type of
transport
Standards
During the transfer of patients within the
hospital
Secondary
transport
EN 1789 Section 6.4.1:
Mechanical Safety
–
During secondary transport from one hospital to
another
Transfer flight
–
During transfer flights with airplanes
RTCA/DO-160G:
All applicable sections
related to electromagnetic
transmissions and
mechanical safety
For secondary transport and transfer flights, the
following must be considered:
–
Savina 300 is in use without a trolley.
–
There is no monitor mounted on Savina 300.
–
Savina 300 is used without CO2 monitoring.
16
Other specific requirements for transport
ventilators in the following standards are not
fulfilled:
EN 13718-1, EN 1789, ISO 10651-3
Instructions for use Savina 300 SW 5.n
Page 17
Overview
Overview
Savina 300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Ventilator with trolley. . . . . . . . . . . . . . . . . . . . .
Control and display unit . . . . . . . . . . . . . . . . . .
Patient connection panel . . . . . . . . . . . . . . . . .
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18
18
19
20
Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Range of functions . . . . . . . . . . . . . . . . . . . . . 22
Therapy types. . . . . . . . . . . . . . . . . . . . . . . . . .
Ventilation functions . . . . . . . . . . . . . . . . . . . . .
Monitoring functions . . . . . . . . . . . . . . . . . . . . .
Displays on the screen . . . . . . . . . . . . . . . . . . .
Additional functions . . . . . . . . . . . . . . . . . . . . .
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication nebulization . . . . . . . . . . . . . . . . . .
Transport of patients. . . . . . . . . . . . . . . . . . . . .
22
22
22
23
23
23
23
23
23
23
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 24
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Product labels. . . . . . . . . . . . . . . . . . . . . . . . . 30
Instructions for use Savina 300 SW 5.n
17
Page 18
Overview
Savina 300
Ventilator with trolley
Control and display unit
A
A
B
D
B
A Touch screen
B Fixed function keys
C Rotary knob
C
001
D Power supply display
A Control and display unit
B Patient connection panel
C Trolley
18
Instructions for use Savina 300 SW 5.n
003
C
Page 19
Overview
Power supply display
016
E
F
G
ext
int
E External battery
F Mains power
G Internal battery
Meaning of the LED colors:
Each LED lights up:
Green
Mains power
Yellow
Red
Off
Present
-
Insufficient
Not present
External battery
Battery operation or
battery charge at least
75 %
Charging
Overheated or
defective
Not present
Internal battery
Battery operation or
battery charge at least
75 %
Charging
Overheated or
defective
Not being charged
Patient connection panel
C Inspiratory valve with inspiratory port Insp.
(GAS OUTPUT)
D Fastening screw for cover plate (behind cover:
O2 sensors)
A
E Water trap of expiratory valve
B
H
F Expiratory valve with expiratory port Exp.
(GAS RETURN)
G
F
E
D
C
A Socket for breathing gas temperature sensor
070
G Flow sensor flap (behind flap: flow sensor)
H Gas outlet Exhaust, non-conical connection
(EXHAUST – NOT FOR SPIROMETER)
B Nebulizer port (nebulizer gas outlet for
pneumatic medication nebulizer)
Instructions for use Savina 300 SW 5.n
19
Page 20
Overview
Rear
Rear without filter cover
T
S
R
M
L
K
N
Q
J
I
H
O
P
B
C
N Cable for external battery
D
O Potential equalization cable
P Power cable
F
E
004
G
Q Connection for power cable, mains power fuse
A Filter cover
R Power supply unit
B Rating plate
S Connection for external battery
C Labels for options
T Potential equalization pin
D Cable guide and holder for power cable
E LPO port for connecting a low-pressure oxygen
source, e.g., an O2 concentrator
F Label for LPO
G HPO port for O2 compressed gas hose O2
H Port for CO2 sensor
I
COM port (serial RS232 interface)
J
Connection for nurse call
K Main switch for switching on
or off
L Fuse for the internal battery
M Storage recess for fuse
20
Instructions for use Savina 300 SW 5.n
027
A
Page 21
Overview
Trolley
A Savina 300
A
B Lateral standard rail
C Trolley column
B
D Hose holder
E Double castors with locking brake, set of 4
J
I
H
G
F Base plate, e.g., for external battery
C
G Universal holder with standard rail
H Holder for breathing gas humidifier
D
I
Alignment aid
J
Mounting with handle
F
038
E
Instructions for use Savina 300 SW 5.n
21
Page 22
Overview
Range of functions
The functions described correspond to the overall
functionality of Savina 300. Some functions are
only optional and may not be included in the
individual device configuration. The optional
functions and the part numbers of the accessories
are listed in the separate list of accessories.
Not all options are available for the product variant
Classic.
Therapy types
–
–
–
Invasive ventilation (Tube)
Non-invasive ventilation (NIV)
O2 therapy
Additional settings for ventilation
–
–
–
–
–
Apnea ventilation
Trigger settings
Sigh
AutoFlow
Tube compensation (ATC)
Special maneuvers
–
–
–
–
–
Suction maneuver with oxygenation
Medication nebulization
Manual inspiration – Inspiration hold
Manual expiration – Expiration hold
Intrinsic PEEP
Monitoring functions
Ventilation functions
For a detailed description of the ventilation modes
and the additional settings, see page 215. For
abbreviations, see page 24.
Ventilation modes
Volume-controlled ventilation:
– VC-CMV
– VC-AC
– VC-SIMV
– VC-MMV
Pressure-controlled ventilation:
– PC-AC
– PC-BIPAP
– PC-APRV
Support of spontaneous breathing:
– SPN-CPAP
22
Setting alarm limits for the following parameters:
– Expiratory minute volume MV
– Maximum airway pressure Paw
– Inspiratory tidal volume VT
– Respiratory rate RR
– Apnea alarm time Tapn
– End-expiratory CO2 concentration etCO2
– Time until disconnection alarm Tdisconnect
(during NIV)
– Inspiratory O2 concentration FiO2 (in LPO
mode)
In HPO mode, the alarm limits for the O2 concentration FiO2 are automatically linked to the FiO2 set
value.
During non-invasive ventilation and O2 therapy,
certain monitoring functions are switched off or can
be switched off.
Instructions for use Savina 300 SW 5.n
Page 23
Overview
Displays on the screen
–
–
–
–
–
–
–
Waveforms
Graphical and numeric trends
Loops
– Pressure / Volume
– Volume / Flow
– Flow / Pressure
– Volume / CO2
– Ptrach / Volume
– Flow / Ptrach
Logbook
Alarm messages with information
Configurable numerical parameters
Lists of measured values and set values
Additional functions
–
–
Day/Night screen switch-over
Key lock
O2 supply
–
High Pressure Oxygen (HPO) from the central
gas supply system or from compressed gas
cylinders
–
Low Pressure Oxygen (LPO) from an external
low-pressure oxygen source, e.g., O2 concentrator
For supply from compressed gas cylinders,
Savina 300 can be equipped with a transport
supply unit. For additional information, see
instructions for use "Transport Supply Unit".
Data transfer
The COM port (serial RS232 interface) can be used
for data transfer via the MEDIBUS or MEDIBUS.X
protocol.
Medication nebulization
Power supply
Savina 300 is supplied with mains power or with
power from the internal or external battery. The
external battery also serves as power supply during
patient transport.
Gas supply
For medication nebulization a pneumatic medication nebulizer can be connected.
Transport of patients
For transporting patients, the trolley of Savina 300
can be coupled to a bed. For additional information,
see instructions for use "Bed Coupling".
An internal turbine supplies Savina 300 with
ambient air.
Instructions for use Savina 300 SW 5.n
23
Page 24
Overview
Abbreviations
Abbreviation Explanation
Abbreviation Explanation
% PIF
EMC
Electromagnetic compatibility
Emergency
air intake
Safety air inlet, inspiratory relief
valve (EMERGENCY AIR
INTAKE)
Percentage of the peak
inspiratory flow
Percentage of the peak
inspiratory flow
Air
Gas inlet for air
ESD
Electrostatic Discharge
Alarm reset
Resetting or acknowledging
alarm messages (key on device)
ET
Endotracheal tube
Apn. Vent.
Apnea ventilation
etCO2
ATC
Automatic Tube Compensation
End-expiratory CO2
concentration
Automatic tube compensation
Exhaust
AutoFlow
Automatic optimization of
inspiratory flow
Gas outlet (EXHAUST – NOT
FOR SPIROMETER)
Exp.
BF
Insulation class Body Floating
Label on the device, expiratory
port (GAS RETURN)
BTPS
Body Temperature Pressure
Saturated
Exp.
Expiration
ext
Label on the device,
external battery
FHSS
Frequency-Hopping Spread
Spectrum
Measured values based on the
condition of the patient’s lungs,
body temperature 37 °C
(98.6 °F), water vapor saturated
gas, ambient pressure
Electrostatic discharge
Frequency-Hopping Spread
Spectrum
C
Compliance
FiO2
Inspiratory O2 concentration
CISPR
Comité International Spécial des
Perturbations Radioélectriques
FiO2
O2 concentration (set value)
Flow
Flow (measured value)
International Special Committee
on Radio Interference
FlowAcc
Flow acceleration (set value)
cmH2O
Unit of measurement for pressure
1 cmH2O = approx. 1 mbar
Flowipeak
Peak flow
Flowtrigg.
Trigger threshold, sensitivity
ΔintPEEP
Additional intermittent PEEP for
sigh (set value)
HME
Heat Moisture Exchanger
ΔPsupp
Pressure support relative (above
PEEP) (set value)
hPa
DSSS
Direct-Sequence Spread
Spectrum
Heat and moisture exchanger
Hectopascal, unit of
measurement for pressure
1 hPa = 1 mbar = approx.
1 cmH2O
Direct-Sequence Spread
Spectrum
24
Instructions for use Savina 300 SW 5.n
Page 25
Overview
Abbreviation Explanation
Abbreviation Explanation
HPO
High Pressure Oxygen
MV
Overall minute volume
High-pressure O2 supply from the
central gas supply system or an
O2 compressed gas cylinder
MVleak
Leakage minute volume
MVspon
Spontaneous breathing portion of
minute volume
I:E
Ratio of inspiratory time to
expiratory time
NIV
Non-Invasive Ventilation
IBW
Ideal Body Weight
Ideal body weight
incl. PEEP
PEEP that is included in the
intrinsic PEEP and is measured at
the end of the Intrinsic PEEP
maneuver
Insp.
Label on the device, inspiratory
port (GAS OUTPUT)
Insp.
Inspiration
Insp. term.
Termination criterion in % from
the peak inspiratory flow
Inspiration
hold
Manual inspiration (key on the
device)
int
Label on the device,
internal battery
kPa
Kilopascal, unit of measurement
for pressure
LPO
Low Pressure Oxygen
Non-invasive ventilation
NMI
Nuclear magnetic imaging
NMR
Millibar, unit of measurement for
pressure
1 mbar = approx. 1 cmH2O
MEDIBUS
Dräger communication protocol
for medical devices
MEDIBUS.X
Dräger communication protocol
for medical devices with simplified
data definition across devices
mmHg
Millimeter of mercury column
MRI
Magnetic Resonance Imaging
Magnetic resonance imaging
Instructions for use Savina 300 SW 5.n
Nuclear Magnetic Resonance
Nuclear magnetic resonance
NTPD
Normal Temperature Pressure
Dry
20 °C (68 °F), 1013 hPa, dry
O2
Label on the device,
port for O2 compressed gas hose
Paw
Airway pressure
PC-AC
Pressure Control-Assist Control
Assisted-controlled, pressurecontrolled ventilation with backup
respiratory rate
PC-APRV
Pressure Control-Airway
Pressure Release Ventilation
Spontaneous breathing under
continuous positive airway
pressure with brief pressure
releases
Low-pressure O2 supply from
external oxygen sources, e.g.,
O2 concentrator
mbar
Nuclear Magnetic Imaging
PC-BIPAP
Pressure Control-Biphasic
Positive Airway Pressure
Spontaneous breathing under
continuous positive airway
pressure with 2 different pressure
levels
PEEP
Positive end-expiratory pressure
(set value)
PEEPi
Intrinsic PEEP
Phigh
Upper pressure level in PC-APRV
(set value)
25