Dräger Babylog VN500 User manual

Instructions for Use
Infinity Acute Care System
Babylog VN500
Ventilation Unit
SW 2.n
WARNING
For a full understanding of the
performance characteristics of this
medical device, the user should
carefully read these Instructions for
Use before use of the medical device.

2Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
Working with these Instructions for Use
The title of the main chapter in the header line
helps with orientation and navigation.
The instructions for the user combine text and il-
lustrations, providing a comprehensive overview of
the device. The information is presented as se-
quential steps of action, allowing the user to learn
directly how to use the device.
The text provides explanations and instructs the
user step-by-step in the practical use of the prod-
uct, with short, clear instructions in easy-to-follow
sequence.
The illustrations show the relationship between
the text and the device. Elements mentioned in the
text are highlighted. Unnecessary details are omit-
ted.
Schematic renderings of screen images guide the
user and allow to reconfirm actions performed. The
actual screen images differ in look or in configua-
tion.
ALetters denote elements referred to in the text.
Typing conventions
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for exam-
ple, PEEP, Air or Alarm Settings.
The "greater than" symbol >indicates the naviga-
tion path in a dialog window, for example, System
setup > Ventilation > Basic settings. In this ex-
ample, System setup represents the dialog win-
dow title, Ventilation represents a horizontal tab
and Basic settings a vertical tab.
Trademarks
– Infinity®
– Babylog®
– QuickSet®
–ATC
®
– Acute Care SystemTM
– Medical CockpitTM
are trademarks owned by Dräger.
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
zBullet 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
relevant illustration.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 3
Definitions
Abbreviations and Symbols
Please refer to "Abbreviations" on page 25 and
"Symbols" on page 29 for explanations.
WARNING
A WARNING statement provides important in-
formation about a potentially hazardous situa-
tion which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important infor-
mation about a potentially hazardous situation
which, if not avoided, may result in minor or mod-
erate 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.

4Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
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Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 5
Content
Content
Working with these Instructions for Use . . . . . . 2
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Abbreviations and Symbols . . . . . . . . . . . . . . . 3
For Your Safety and that of Your Patients . . 7
General WARNINGS and CAUTIONS . . . . . . 10
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Indications for use and contraindications . . . . . 16
Environment of use. . . . . . . . . . . . . . . . . . . . . . 16
System Overview . . . . . . . . . . . . . . . . . . . . . . 17
Infinity Acute Care System – Workstation
Neonatal Care . . . . . . . . . . . . . . . . . . . . . . . . . 18
Babylog VN500. . . . . . . . . . . . . . . . . . . . . . . . . 19
Trolley 2 - 90 cm . . . . . . . . . . . . . . . . . . . . . . . 21
Gas supply unit GS500. . . . . . . . . . . . . . . . . . . 22
Power supply unit PS500 . . . . . . . . . . . . . . . . . 22
Range of functions . . . . . . . . . . . . . . . . . . . . . . 23
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Operating Concept . . . . . . . . . . . . . . . . . . . . . 31
Operating concept for Infinity C500 . . . . . . . . . 32
Operating concept for Babylog VN500 . . . . . . 32
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Safety information on preparation . . . . . . . . . . 38
Preparing Trolley 2 - 90 cm . . . . . . . . . . . . . . . 38
Preparing Infinity C500 . . . . . . . . . . . . . . . . . . . 41
Preparing Babylog VN500 . . . . . . . . . . . . . . . . 44
Transportation of patients within the
hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . 57
Safety information on getting started . . . . . . . . 58
Switching on Babylog VN500 and Infinity C500 58
Select patient . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Selecting the breathing circuit and the
breathing gas humidifier . . . . . . . . . . . . . . . . . . 62
Check readiness for operation . . . . . . . . . . . . . 63
Selecting Tube or NIV application mode . . . . 68
Select therapy type . . . . . . . . . . . . . . . . . . . . . 69
Start therapy . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Displaying the status of accessories . . . . . . . . 71
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Setting ventilation . . . . . . . . . . . . . . . . . . . . . . 74
NIV – Non-invasive ventilation . . . . . . . . . . . . 82
Display curves and measured values . . . . . . . 85
Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Oxygen enrichment for suction maneuver. . . . 90
Manual inspiration – Manual inspiration/hold . 92
Medication nebulization . . . . . . . . . . . . . . . . . 93
Gas supply unit GS500 . . . . . . . . . . . . . . . . . . 99
O2Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Standby mode . . . . . . . . . . . . . . . . . . . . . . . . 102
Ending operation . . . . . . . . . . . . . . . . . . . . . . . 103
Storing Babylog VN500 . . . . . . . . . . . . . . . . . . 104
Mains power supply / DC power supply . . . . . 105
Power supply unit PS500 . . . . . . . . . . . . . . . . 107
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Display of alarms. . . . . . . . . . . . . . . . . . . . . . . 112
Displaying information on alarms . . . . . . . . . . 113
Alarm history . . . . . . . . . . . . . . . . . . . . . . . . . 114
Setting the alarm limits . . . . . . . . . . . . . . . . . . 114
Setting the volume of the alarm tone . . . . . . . 116
Suppressing the alarm tone . . . . . . . . . . . . . . 116
Position of the user to the alarm system . . . . . 117
Failure of the acoustic alarm . . . . . . . . . . . . . 117
Trends and Data. . . . . . . . . . . . . . . . . . . . . . . 119
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Displaying trends . . . . . . . . . . . . . . . . . . . . . . 120
Display data . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Display logbook . . . . . . . . . . . . . . . . . . . . . . . . 125
Data export . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Content
6Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Information on calibrating the sensors . . . . . . . 128
Neonatal flow sensor calibration . . . . . . . . . . . 129
Calibrating the O2sensor . . . . . . . . . . . . . . . . 130
Calibrating the CO2sensor . . . . . . . . . . . . . . . 131
Deactivating or activating monitoring . . . . . . . . 137
Neonatal flow monitoring . . . . . . . . . . . . . . . . . 139
Possible displays for measured values . . . . . . 140
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 141
Information on configuration. . . . . . . . . . . . . . . 142
Configuring the screen display . . . . . . . . . . . . 142
Configuring alarm settings . . . . . . . . . . . . . . . . 149
Configuring ventilation settings . . . . . . . . . . . . 151
Importing and exporting configurations . . . . . . 159
Installing applications . . . . . . . . . . . . . . . . . . . . 160
Exchange intervals . . . . . . . . . . . . . . . . . . . . . . 161
System settings . . . . . . . . . . . . . . . . . . . . . . . . 162
Service dialog. . . . . . . . . . . . . . . . . . . . . . . . . . 164
Alarm – Cause – Remedy . . . . . . . . . . . . . . . 165
Cleaning, Disinfection and Sterilization . . . 193
Safety information on reprocessing . . . . . . . . . 194
Dismantling. . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Reprocessing methods . . . . . . . . . . . . . . . . . . 199
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 202
Assembling parts . . . . . . . . . . . . . . . . . . . . . . . 204
Before reusing on patient . . . . . . . . . . . . . . . . . 206
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Maintenance intervals for Babylog VN500 . . . . 208
Safety inspections . . . . . . . . . . . . . . . . . . . . . . 209
Exchanging the ambient air filter . . . . . . . . . . . 210
Exchanging the diaphragm of the expiratory
valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Safety information on disposal . . . . . . . . . . . . . 212
Disposing of packaging material . . . . . . . . . . . 212
Disposal of batteries . . . . . . . . . . . . . . . . . . . . 212
Disposal of a neonatal flow sensor . . . . . . . . . 213
Disposal of the medical device . . . . . . . . . . . . 213
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 215
Ambient conditions . . . . . . . . . . . . . . . . . . . . . 216
Set values . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
Performance characteristics . . . . . . . . . . . . . . 219
Displayed measured values . . . . . . . . . . . . . . 221
Displayed calculated values . . . . . . . . . . . . . . 223
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Operating data. . . . . . . . . . . . . . . . . . . . . . . . . 226
Device ports . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Automatic alarm limits . . . . . . . . . . . . . . . . . . . 231
Description. . . . . . . . . . . . . . . . . . . . . . . . . . . 235
Description of the ventilation modes . . . . . . . . 236
Additional settings for ventilation. . . . . . . . . . . 249
Special procedures . . . . . . . . . . . . . . . . . . . . . 261
Description of the therapy types . . . . . . . . . . . 264
Automatic leakage compensation . . . . . . . . . 265
Measurements. . . . . . . . . . . . . . . . . . . . . . . . . 266
Pneumatic functional description . . . . . . . . . . 268
Main menu bar structure . . . . . . . . . . . . . . . . 271
Factory-set screen views. . . . . . . . . . . . . . . . . 275
Literature references . . . . . . . . . . . . . . . . . . . 276
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277
Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 7
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use. . . . . . 8
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safety inspections . . . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Not for use in areas of explosion hazard . . . . . 8
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . . 9
Functional safety . . . . . . . . . . . . . . . . . . . . . . . 10
General WARNINGS and CAUTIONS . . . . . . 10
Note on EMC/ESD risk for the device
function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 12
Installing accessories . . . . . . . . . . . . . . . . . . . . 12
Keep the Instructions for Use . . . . . . . . . . . . . . 12
Monitoring ventilation . . . . . . . . . . . . . . . . . . . . 13
Back-up ventilation with an independent
Manual ventilation device . . . . . . . . . . . . . . . . . 13
Handling Infinity ID components. . . . . . . . . . . . 13

For Your Safety and that of Your Patients
8Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
Strictly follow these Instructions for Use
Maintenance
Safety inspections
The medical device must be subject to regular safe-
ty inspections. See chapter "Maintenance".
Accessories
Not for use in areas of explosion hazard
Safe connection with other electrical
equipment
WARNING
Any use of the medical device requires full un-
derstanding and strict observation of all por-
tions of these Instructions for Use. The medi-
cal device is only to be used for the purpose
specified under "Intended use" on page 16
and in conjunction with an appropriate patient
monitoring system (see page 9). Observe all
WARNING and CAUTION statements through-
out these Instructions for Use and all state-
ments on medical device labels. Failure to ob-
serve these statements means that the medi-
cal device is used outside of its intended use.
WARNING
The medical device must be inspected and
serviced regularly by properly trained service
personnel.
Repair of the medical device may also only be
carried out by properly trained service per-
sonnel.
Dräger recommends that a service contract be
obtained with DrägerService and that all re-
pairs also be carried out by them. Dräger rec-
ommends that only authentic Dräger Medical
repair parts be used for maintenance. Other-
wise the correct functioning of the medical de-
vice may be compromised.
See chapter "Maintenance".
WARNING
Only the accessories indicated on the list of
accessories 9039002 (1st edition or higher)
have been tested and approved to be used
with the medical device. Accordingly it is
strongly recommended that only these acces-
sories be used in conjunction with the specific
medical device. Otherwise the correct func-
tioning of the medical device may be compro-
mised.
WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
WARNING
Patient hazard
Electrical connections to equipment which is
not listed in these Instructions for Use should
only be made following consultation with the
respective manufacturers.

Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 9
For Your Safety and that of Your Patients
Networking
Device combinations approved by Dräger (see In-
structions for Use of the individual devices or units)
meet the requirements set forth by the following
standards:
– IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-1 (EN 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety;
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2 (EN 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compati-
bility; Requirements and tests
– IEC 60601-1-4 (EN 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
If Dräger devices or units are connected with other
Dräger devices or third-party devices and the re-
sulting combination is not approved by Dräger, the
operator is responsible for ensuring that the result-
ing system meets the requirements set forth by the
above standards.
Strictly follow Assembly Instructions and Instruc-
tions for Use for each networked device.
Patient safety
The design of the medical device, the accompany-
ing literature, and the labeling on the medical de-
vice take into consideration that the purchase and
use of the medical device are restricted to trained
professionals, and that certain inherent characteris-
tics of the medical device are known to the trained
operator. Instructions, WARNING and CAUTION
statements are limited, therefore, largely to the spe-
cifics of the Dräger medical device.
This publication excludes references to various
hazards which are obvious to a medical profession-
al and operator of this medical device, to the conse-
quences of medical device misuse, and to poten-
tially adverse effects in patients with abnormal con-
ditions. Medical device modification or misuse can
be dangerous.
Patient monitoring
The operators of the medical device are responsi-
ble for choosing appropriate safety monitoring that
supplies adequate information on medical device
performance and patient condition.
Patient safety may be achieved through a wide va-
riety of means ranging from electronic surveillance
of medical device performance and patient condi-
tion, to simple, direct observation of clinical signs.
The responsibility for the selection of the best level
of patient monitoring lies solely with the medical de-
vice operator.
CAUTION
Patient hazard
Individual measured values und monitoring pa-
rameters should not be used as the sole basis for
therapeutic decisions.

For Your Safety and that of Your Patients
10 Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
Functional safety
The essential performance consists in controlled
and monitored patient ventilation with user-defined
settings for the monitoring functions
– minimum breathing gas flow
– maximum airway pressure
– minimum and maximum O2concentration in the
breathing gas
or, if a set limit is exceeded, by an appropriate
alarm. The medical device is equipped with basic
safety features to reduce the possibility of patient
injury while the cause of an alarm is remedied.
General WARNINGS and CAUTIONS
The following WARNINGS and CAUTIONS apply to
general operation of the device. WARNINGS and
CAUTIONS specific to subsystems or particular
features appear with those topics in later sections
of these Instructions for Use or in the Instructions
for Use of any product being used with this device.
WARNING
This medical device is only intended to be
used by trained medical personnel.
WARNING
Medications and other substances based on
inflammable solvents, such as alcohol, must
not be used in the patient system. Fire hazard!
Adequate ventilation must be ensured if high-
ly inflammable substances are used for disin-
fection.
WARNING
Fire hazard!
Do not use the medical device in conjunction
with flammable gases or flammable solutions
that can mix with air, oxygen or 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 ig-
nition.
WARNING
Do not use the medical device during magnet-
ic resonance (MRI, NMR, NMI)! This may im-
pair correct functioning of the medical device
and endanger the patient.
WARNING
Do not use the medical device in hyperbaric
chambers! This may impair correct function-
ing of the medical device and endanger the pa-
tient.