Savina Instructions for Use sw 3.1n Edition 2 Jan 2019.pdf
Page 1
Instructions for use
Savina
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Ventilator
Software 3.1n
Page 2
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 parentheses refer to elements in the
related illustration.
A Letters in illustrations denote elements referred
to in the text.
Any text shown on the screen and any labeling on
the device are printed in bold and italics, e.g.,
PEEP, O2, or Audio paused 2 min..
The "greater than" symbol > indicates the
navigation path in a dialog window, e.g.,
Configuration > Configuration 2/4. In this
example, Configuration represents the dialog
window title and Configuration 2/4 the second
page of four pages in the dialog window.
Screen reproductions
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 SW 3.1n
Page 3
Trademarks
Trademark
Trademark owner
Trademark
Trademark owner
Savina®
Dräger
Descogen®
Antiseptica
AutoFlow
®
Dismozon
LPO®
Actichlor®
BruTab 6S
®
Buraton
Mikrozid
Oxycide
Ecolab
®
Brulin
Schülke & Mayr
Virkon®
Bode Chemie
®
Medentech
®
Ecolab USA
Klorsept
Dräger-Spirolog®
®
DuPont
1)
BIPAP
1)
Trademark used under license
®
Perform®
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.
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.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.
Instructions for use Savina SW 3.1n
3
Page 4
Definition of target groups
For this product, users, service personnel, and
experts are defined as target groups.
Service personnel
These target groups must have received instruction
in the use of the product and must have the
necessary training and knowledge to use, install,
reprocess, maintain, or repair the product.
Service personnel are persons who are responsible
for the maintenance of the product.
The product must be used, installed, reprocessed,
maintained, or repaired exclusively by defined
target groups.
Service personnel must be trained in the
maintenance of medical devices and install,
reprocess, and maintain the product.
Experts
Users
Experts are persons who perform repair or complex
maintenance work on the product.
Users are persons who use the product in
accordance with its intended use.
Experts must have the necessary knowledge and
experience with complex maintenance work on the
product.
Abbreviations and symbols
For explanations refer to sections "Abbreviations"
and "Symbols" in chapter "Overview".
4
Instructions for use Savina SW 3.1n
Page 5
Contents
Contents
Typographical conventions . . . . . . . . . . . . . . . .
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety information definitions . . . . . . . . . . . . . .
Definition of target groups . . . . . . . . . . . . . . . .
2
3
3
4
For your safety and that of your patients. . .
7
Getting started . . . . . . . . . . . . . . . . . . . . . . . .
65
66
66
67
70
General safety information . . . . . . . . . . . . . . . . 8
Product-specific safety information. . . . . . . . . . 12
Safety information . . . . . . . . . . . . . . . . . . . . . .
Switching on Savina . . . . . . . . . . . . . . . . . . . .
Device check after reprocessing . . . . . . . . . . .
Checking operational readiness . . . . . . . . . . .
Selecting Tube or Mask/NIV application
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Starting therapy . . . . . . . . . . . . . . . . . . . . . . . .
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
75
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Environment of use. . . . . . . . . . . . . . . . . . . . . . 16
Setting ventilation . . . . . . . . . . . . . . . . . . . . . .
Non-Invasive Ventilation (NIV) . . . . . . . . . . . .
Suction maneuver with oxygen enrichment. . .
Medication nebulization . . . . . . . . . . . . . . . . .
Manual inspiration – Insp. hold . . . . . . . . . . . .
Bright and dark screen background . . . . . . . .
Key lock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low Pressure Oxygen (LPO) . . . . . . . . . . . . .
Transporting patients . . . . . . . . . . . . . . . . . . . .
Interrupting ventilation – Standby mode . . . . .
Ending operation . . . . . . . . . . . . . . . . . . . . . . .
Storing Savina . . . . . . . . . . . . . . . . . . . . . . . . .
76
79
81
82
86
87
87
88
91
92
93
94
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
95
Display of alarms. . . . . . . . . . . . . . . . . . . . . . .
Suppressing the acoustic alarm signal . . . . . .
Acknowledging an alarm message . . . . . . . . .
Setting the alarm limits . . . . . . . . . . . . . . . . . .
Show alarm history . . . . . . . . . . . . . . . . . . . . .
Inactive alarm limits and monitoring
functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
96
98
98
99
101
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Savina. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trolley. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Range of functions . . . . . . . . . . . . . . . . . . . . . .
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . .
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product labels. . . . . . . . . . . . . . . . . . . . . . . . . .
18
24
25
26
29
30
Operating concept . . . . . . . . . . . . . . . . . . . . . 33
Control and display unit . . . . . . . . . . . . . . . . . . 34
Dialog windows. . . . . . . . . . . . . . . . . . . . . . . . . 36
Main screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Assembly and preparation . . . . . . . . . . . . . . 41
Safety information. . . . . . . . . . . . . . . . . . . . . . .
Preparing the trolley . . . . . . . . . . . . . . . . . . . . .
Mounting an additional monitor . . . . . . . . . . . .
Preparing Savina . . . . . . . . . . . . . . . . . . . . . . .
Mains power supply . . . . . . . . . . . . . . . . . . . . .
Power supply from on-board power supply
or batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MEDIBUS protocol . . . . . . . . . . . . . . . . . . . . . .
Removing and refitting the filter cover . . . . . . .
Connecting a potential equalization cable . . . .
Intrahospital transport. . . . . . . . . . . . . . . . . . . .
Instructions for use Savina SW 3.1n
42
42
46
48
54
55
57
59
61
62
64
64
73
74
101
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
General information. . . . . . . . . . . . . . . . . . . . . 104
FiO2 monitoring . . . . . . . . . . . . . . . . . . . . . . . . 104
Flow monitoring . . . . . . . . . . . . . . . . . . . . . . . . 107
Configuration. . . . . . . . . . . . . . . . . . . . . . . . . 109
General information. . . . . . . . . . . . . . . . . . . . .
Adjusting screen contrast . . . . . . . . . . . . . . . .
Selecting measured values for the main
screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting the volume of the alarm signal . . . . . .
110
110
110
111
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Page 6
Contents
Configuring ventilation functions . . . . . . . . . . . 111
Configuring country-specific settings . . . . . . . . 112
Configuring the data interface . . . . . . . . . . . . . 113
Displaying information about the device. . . . . . 113
Enabling options. . . . . . . . . . . . . . . . . . . . . . . . 113
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 115
Failure of the power supply . . . . . . . . . . . . . . . 116
Failure of the gas supply . . . . . . . . . . . . . . . . . 116
High ambient temperature . . . . . . . . . . . . . . . . 116
Alarm – Cause – Remedy . . . . . . . . . . . . . . . . 117
Cleaning, disinfection and sterilization . . . . 135
Information on reprocessing. . . . . . . . . . . . . . . 136
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Reprocessing methods. . . . . . . . . . . . . . . . . . . 140
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 144
After reprocessing . . . . . . . . . . . . . . . . . . . . . . 146
EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 180
Connections to IT networks. . . . . . . . . . . . . . . 185
Principles of operation . . . . . . . . . . . . . . . . . 187
Ventilation modes . . . . . . . . . . . . . . . . . . . . . .
Additional settings . . . . . . . . . . . . . . . . . . . . . .
Non-invasive ventilation (NIV) . . . . . . . . . . . . .
Low Pressure Oxygen (LPO) . . . . . . . . . . . . .
Automatic leakage compensation . . . . . . . . .
Measurements. . . . . . . . . . . . . . . . . . . . . . . . .
Pneumatic functional description . . . . . . . . . .
References . . . . . . . . . . . . . . . . . . . . . . . . . . .
188
195
200
201
203
205
206
208
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Labels for options . . . . . . . . . . . . . . . . . . . . . 213
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Information on maintenance. . . . . . . . . . . . . . . 148
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Preventive maintenance. . . . . . . . . . . . . . . . . . 150
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Replacing the microfilter . . . . . . . . . . . . . . . . . . 152
Replacing the dust filter set . . . . . . . . . . . . . . . 153
Replacing O2 sensors . . . . . . . . . . . . . . . . . . . 154
Replacing the diaphragm of the reusable
expiratory valve . . . . . . . . . . . . . . . . . . . . . . . . 155
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
Safety information . . . . . . . . . . . . . . . . . . . . . . 158
Disposal of packaging material . . . . . . . . . . . . 158
Disposal of batteries . . . . . . . . . . . . . . . . . . . . 158
Disposal of O2 sensors. . . . . . . . . . . . . . . . . . . 159
Disposal of the medical device . . . . . . . . . . . . 159
Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 161
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 162
Setting values. . . . . . . . . . . . . . . . . . . . . . . . . . 162
Performance characteristics . . . . . . . . . . . . . . . 164
Displayed measured values . . . . . . . . . . . . . . . 167
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Operating data . . . . . . . . . . . . . . . . . . . . . . . . . 172
Factory settings . . . . . . . . . . . . . . . . . . . . . . . . 176
Alarm system of Savina . . . . . . . . . . . . . . . . . . 177
Automatic alarm limits . . . . . . . . . . . . . . . . . . . 178
6
Instructions for use Savina SW 3.1n
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 . . . . . .
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Not for use in areas of explosion hazard . . . . .
Connected devices . . . . . . . . . . . . . . . . . . . . . .
Device combinations . . . . . . . . . . . . . . . . . . . .
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . .
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . .
Information on electromagnetic compatibility . .
Disposable products . . . . . . . . . . . . . . . . . . . . .
Sterile accessories . . . . . . . . . . . . . . . . . . . . . .
Installing accessories . . . . . . . . . . . . . . . . . . . .
Storing the instructions for use . . . . . . . . . . . . .
8
8
8
9
9
9
9
10
10
10
11
11
11
11
Product-specific safety information . . . . . . . 12
Functional safety . . . . . . . . . . . . . . . . . . . . . . . 14
Monitoring ventilation . . . . . . . . . . . . . . . . . . . . 14
Backup ventilation with an independent
manual ventilation device . . . . . . . . . . . . . . . . . 14
Instructions for use Savina SW 3.1n
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 10).
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.
8
Maintenance
WARNING
Risk of medical device failure and of patient
injury
The medical device must be inspected and
serviced regularly by service personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter "Maintenance".
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService.
For maintenance Dräger recommends the use
of authentic Dräger repair parts.
Safety checks
The medical device must be subject to regular
safety checks. See chapter "Maintenance".
Instructions for use Savina SW 3.1n
Page 9
For your safety and that of your patients
Accessories
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of
accessories listed in the current list of
accessories. If other, incompatible
accessories are used, there is a risk of patient
injury due to medical device failure.
Dräger recommends that the medical device is
only used together with accessories listed in
the current list of accessories.
Device combinations
This device can be operated in combination with
other Dräger devices or devices from other
manufacturers. Observe the accompanying
documentation of the individual devices.
If a device combination is not approved by Dräger,
the safety and the correct functioning of the
individual devices can be compromised. The
operating organization must ensure that the device
combination complies with the applicable editions
of the relevant standards for medical devices.
Savina as from serial number ASFF-1000
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.
Instructions for use Savina SW 3.1n
Device combinations approved by Dräger meet the
requirements of the following standards:
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, softwarecontrolled functions)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-8 (alarm systems)
Or:
– IEC 60601-1, 2nd edition (general
requirements for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-4 (software-controlled
functions)
– IEC 60601-1-8 (alarm systems)
Savina up to serial number ASFF-0999
Device combinations approved by Dräger meet the
requirements of the following standards:
– IEC 60601-1, 2nd edition (general
requirements for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-4 (software-controlled
functions)
– IEC 60601-1-8 (alarm systems)
9
Page 10
For your safety and that of your patients
Patient safety
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.
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.
Information on electromagnetic
compatibility
General information on electromagnetic
compatibility (EMC) according to international EMC
standard IEC 60601-1-2:
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
installed and put into operation in accordance with
the EMC information provided on see page 180.
Portable and mobile radio frequency
communication equipment can affect medical
electrical equipment.
WARNING
Risk of device malfunction
Do not connect connectors with an
ESD warning symbol and do not touch
their pins without implementing ESD
protective measures. Such protective
measures can include antistatic clothing and
shoes, touching a potential equalization pin
before and during connection of the pins, or
using electrically insulating and antistatic
gloves.
All users concerned must be instructed in
these ESD protective measures.
Patient monitoring
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.
10
Instructions for use Savina SW 3.1n
Page 11
For your safety and that of your patients
WARNING
Risk of device failure
Electromagnetic fields can compromise
proper operation of the device.
Electromagnetic fields are generated by, e.g.,
radio frequency communication equipment
such as:
– Cellular phone
– Radio frequency electrosurgical
equipment
– Defibrillators
– Shortwave therapy equipment
Only use radio frequency devices at a
sufficient safety distance.
See electromagnetic compatibility information
on page 180.
Disposable products
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.
WARNING
Risk of patient injury due to failure of
accessories
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 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.
Instructions for use Savina SW 3.1n
11
Page 12
For your safety and that of your patients
Product-specific safety information
WARNING
Risk of incorrect use
WARNING
Risk of fire
This medical device is only intended to be
used by the target group "users".
Adjust the volume of alarm signals so that
they can be perceived.
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 malfunctions
WARNING
Risk of failure of flow measurement
Prohibited modifications to the medical
device lead to malfunctions.
WARNING
Risk of electric shock
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.
If the connectors of the interfaces and the
patient are touched simultaneously, there is a
risk of electric shock.
WARNING
Risk of fire
Do not simultaneously touch the connectors
of the interfaces and the patient.
When using O2 pressure reducers that are not
approved, excess pressure can cause a fire.
WARNING
Failure to hear alarm signals in a loud
environment
Alarm situations go unnoticed.
This medical device must not be modified
without permission from the manufacturer.
WARNING
Risk of patient injury
Penetrating liquid may cause malfunction of
the device, which may endanger the patient.
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.
Do not place any containers with liquid on or
above the device.
During surface disinfection, make sure no
liquids penetrate into the device.
12
Instructions for use Savina SW 3.1n
Page 13
For your safety and that of your patients
WARNING
Risk of fire
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.
Due to oxygen enrichment in the ambient air
and overheating, the medical device can
ignite.
Do not allow the medical device to come into
contact with sources of ignition.
WARNING
Risk of patient injury
Magnetic resonance imaging (MRI, NMR, NMI)
may impair correct functioning of the medical
device.
Do not use the medical device during
magnetic resonance imaging.
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
WARNING
Risk of patient injury
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
value.
Hyperbaric chambers may impair correct
functioning of the medical device.
If required, use additional monitoring,
e.g., external SpO2 monitoring.
Do not use the medical device in hyperbaric
chambers.
WARNING
Risk of electric shock
There are live components under the housing
cover.
Do not remove the cover.
CAUTION
Risk of overheating of the medical device
Sources of heat such as direct sunlight, heat
radiators, or spotlights may cause the medical
device to overheat.
Keep sources of heat away from the medical
device. Only use the medical device in adequately
ventilated rooms.
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.
Instructions for use Savina SW 3.1n
13
Page 14
For your safety and that of your patients
CAUTION
Risk of electric shock
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.
Only connect devices with safety extra-low
voltage (SELV) to the connections for the serial
port and the nurse call.
Functional safety
The essential performance consists in a controlled
and monitored patient ventilation with user-defined
settings for the monitoring functions
– minimum breathing gas 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)
The medical device is equipped with basic safety
features to reduce the possibility of patient injury
while the cause of an alarm is remedied.
14
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
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
If the built-in monitoring fails, use substitute
monitoring.
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).
Instructions for use Savina SW 3.1n
Page 15
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Environment of use . . . . . . . . . . . . . . . . . . . . 16
Instructions for use Savina SW 3.1n
15
Page 16
Application
Intended use
Savina®
Long-term ventilator for intensive care. For patients
requiring a tidal volume of 50 mL and up.
Environment of use
Savina is intended for the following environments of
use:
–
In intensive care wards, in recovery rooms and
generally for hospital use
–
During the transfer of patients within the
hospital
16
Instructions for use Savina SW 3.1n
Page 17
Overview
Overview
Savina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Ventilator with trolley. . . . . . . . . . . . . . . . . . . . .
Control and display unit . . . . . . . . . . . . . . . . . .
Patient connection panel . . . . . . . . . . . . . . . . .
Rear of the device up to serial number
ASFF-0999 . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rear of the device as from serial number
ASFF-1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18
19
21
22
23
Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Range of functions . . . . . . . . . . . . . . . . . . . . . 25
Ventilation functions . . . . . . . . . . . . . . . . . . . . .
Monitoring functions . . . . . . . . . . . . . . . . . . . . .
Displays on the screen . . . . . . . . . . . . . . . . . . .
Additional functions . . . . . . . . . . . . . . . . . . . . .
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . .
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . .
Medication nebulization . . . . . . . . . . . . . . . . . .
25
25
25
25
26
26
26
26
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 26
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Product labels. . . . . . . . . . . . . . . . . . . . . . . . . 30
Instructions for use Savina SW 3.1n
17
Page 18
Overview
Savina
Ventilator with trolley
A
B
MT-0030-2008
C
A Control and display unit
B Patient connection panel
C Trolley
18
Instructions for use Savina SW 3.1n
Page 19
Overview
Control and display unit
A
U
B
Trigger
T
S
Suction
R
Insp.
hold
O2
Audio
Pinsp.
VT
mL L
Nebul.
paused
2 min
mbar
Tinsp.
Alarm
Reset
PASB
sec
abovePEEP
f
PEEP
bpm
mbar
Lock
C
D
E
F
G
O2
Vol.%
Curves
Q
Settings
Alarms
Values
Config.
H
ext.
int.
IPPV
SIMV
BIPAP
Start/
Standby
K
I
J
003
P O N ML
CPAP
ASB
A Screen
O Settings
key
B Keys for ventilation parameters VT, Tinsp., f, O2,
Pinsp., ΔPASB above PEEP, PEEP with a display
of the current values
P Curves
key
C The red LED flashes for alarms with high priority
D Yellow LED:
– Flashes for alarms with medium priority
– Lights up for alarms with low priority
E
Audio paused 2 min. or
Q
key
R Insp. hold key
S O2 ↑ Suction key
T
Nebul. key
U Trigger LED
2 min key
F Alarm Reset key
G
Lock key
H LED indicating the power supply (for more
information, see page 20)
I
J
Start/Standby or
Standby key
Rotary knob
K Keys for ventilation modes IPPV, SIMV,
CPAP/ASB, BIPAP
L Config.
key
M Values
key
N Alarms
key
Instructions for use Savina SW 3.1n
19
Page 20
Overview
Indication of power supply
V
W
ext.
int.
016
X
V Mains power
W External battery or DC on-board power supply
X Internal battery
Meaning of the LED colors:
Each LED lights up:
Mains power
External battery
DC on-board power
supply
Internal battery
20
Green
Yellow
Red
Off
Present
-
-
Not present
Battery operation
or fully charged
Charging
Overheated or
defective
Not present
Present
-
Overheated or
defective
Not present
Battery operation
or fully charged
Charging
Overheated or
defective
Not being charged
Instructions for use Savina SW 3.1n
Page 21
Overview
Patient connection panel
H
G
A
B
F
C
D
070
E
A Socket for breathing gas temperature sensor
B Inspiratory valve with inspiratory port Insp.
(GAS OUTPUT)
C Nebulizer port (nebulizer gas outlet for
pneumatic medication nebulizer)
D Bacterial filter
E Fastening screw for cover plate (behind cover:
O2 sensors)
F Gas outlet Exhaust, non-conical connection
(EXHAUST – NOT FOR SPIROMETER)
G Flow sensor
H Expiratory valve with expiratory port Exp.
(GAS RETURN)
Instructions for use Savina SW 3.1n
21
Page 22
Overview
Rear of the device up to serial number ASFF-0999
Rear of the device without filter cover
A
L
K
M
N
R
J
I
H
Q
G
P
F
C
B
A Filter cover
B On the side of the device: Labels for Options
C Rating plate
D LPO port for connecting a low-pressure oxygen
source, e.g., an O2 concentrator
O
350
D
347
E
L Connection for external battery or DC on-board
power supply
M Potential equalization pin
N Power supply unit
O Power cable
E Label for LPO
P Potential equalization cable
F On the side of the device: HPO port for
O2 compressed gas hose O2
Q Cable for external battery or DC on-board
power supply
G COM port (serial RS232 port)
R Connection for power cable, mains power fuse
H Connection for nurse call
I
Main switch for switching on
J
Fuse for the internal battery
or off
K Storage recess for fuse
22
Instructions for use Savina SW 3.1n
Page 23
Overview
Rear of the device as from serial number ASFF-1000
Rear of the device without filter cover
B
A
M
N
O
L
S
K
J
I
H
Q
027
R
F
E
D
C
M Connection for external battery or DC on-board
power supply
004
G
P
N Potential equalization pin
A Filter cover
O Power supply unit
B Labels for Options
P Cable for external battery or DC on-board
power supply
C Rating plate
Q Potential equalization cable
D Cable guide
E LPO port for connecting a low-pressure oxygen
source, e.g., an O2 concentrator
R Power cable
S Connection for power cable, mains power fuse
F Label for LPO
G On the side of the device: HPO port for O2
compressed gas hose O2
H COM port (serial RS232 port)
I
Connection for nurse call
J
Main switch for switching on
or off
K Fuse for the internal battery
L Storage recess for fuse
Instructions for use Savina SW 3.1n
23
Page 24
Overview
Trolley
A
B
I
H
C
D
G
E
038
F
A Savina
B Lateral standard rail
C Trolley column
D Hose holder
E Castors without locking brake, set of 2
F Castors with locking brake, set of 2
G Base plate, e.g., for external battery
H Holder for breathing gas humidifier
I
24
Mounting with handle
Instructions for use Savina SW 3.1n
Page 25
Overview
Range of functions
The functions described correspond to the overall
functionality of Savina. 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.
Ventilation functions
For a detailed description of the ventilation modes
and the additional settings, see page 187. For
abbreviations, see page 26.
Monitoring functions
Setting alarm limits for the following parameters:
– Expiratory minute volume MV
– Airway pressure Paw
– Inspiratory tidal volume VTi
– Respiratory rate ftot
– Apnea alarm time TApnoea
– Time until disconnection alarm TDisconnect
(during NIV)
– Inspiratory O2 concentration FiO2 (in LPO
mode)
Application modes
In the HPO mode, alarm limits for the O2
concentration FiO2 are automatically linked to the
set value for O2.
–
–
During non-invasive ventilation, certain monitoring
functions are switched off or can be switched off.
Invasive ventilation (Tube)
Non-invasive ventilation (Mask/NIV)
Ventilation modes
Volume-controlled ventilation:
– IPPV, IPPVAssist, CPPV, IRV, PLV
– SIMV, ASB, PLV
Pressure-controlled ventilation:
– BIPAP, ASB, SB
Support of spontaneous breathing:
– CPAP, ASB, SB
Additional settings for ventilation
–
–
–
–
Apnea ventilation
Trigger
Sigh
AutoFlow
Displays on the screen
–
–
–
Waveforms and measured values
Alarm messages
Information
Additional functions
–
–
Key lock
Change between bright and dark screen
background
Special maneuvers
–
–
–
Suction maneuver with oxygen enrichment
Medication nebulization
Manual inspiration – Insp. hold
Instructions for use Savina SW 3.1n
25