Dräger Babylog VN500 Instructions For Use Manual
Instructions for Use
Infinity Acute Care System
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.
Babylog VN500
Ventilation Unit
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 illustrations, providing a comprehensive overview of
the device. The information is presented as sequential 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 product, with short, clear instructions in easy-to-follow
sequence.
1 Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
z
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
relevant illustration.
The illustrations show the relationship between
the text and the device. Elements mentioned in the
text are highlighted. Unnecessary details are omitted.
Schematic renderings of screen images guide the
user and allow to reconfirm actions performed. The
actual screen images differ in look or in configuation.
A Letters 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 example, PEEP, Air or Alarm Settings.
The "greater than" symbol > indicates the navigation path in a dialog window, for example, System
setup > Ventilation > Basic settings. In this example, System setup represents the dialog window title, Ventilation represents a horizontal tab
and Basic settings a vertical tab.
Trademarks
– Infinity
– Babylog
– QuickSet
–ATC
– Acute Care System
– Medical Cockpit
are trademarks owned by Dräger.
2 Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
®
®
®
®
TM
TM
Definitions
WARNING
A WARNING statement provides important in-
formation about a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
Abbreviations and Symbols
Please refer to "Abbreviations" on page 25 and
"Symbols" on page 29 for explanations.
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 Infinity Acute Care System – Babylog VN500 SW 2.n 3
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4 Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
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
2 Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
O
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
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 5
Content
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Information on calibrating the sensors . . . . . . . 128
Neonatal flow sensor calibration . . . . . . . . . . . 129
Calibrating the O
2 sensor . . . . . . . . . . . . . . . . 130
Calibrating the CO2 sensor . . . . . . . . . . . . . . .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
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
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
6
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
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
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 7
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use
WARNING
Any use of the medical device requires full un-
derstanding and strict observation of all portions of these Instructions for Use. The medical 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 throughout these Instructions for Use and all statements on medical device labels. Failure to observe these statements means that the medical device is used outside of its intended use.
Maintenance
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 personnel.
Dräger recommends that a service contract be
obtained with DrägerService and that all repairs also be carried out by them. Dräger recommends that only authentic Dräger Medical
repair parts be used for maintenance. Otherwise the correct functioning of the medical device may be compromised.
See chapter "Maintenance".
Accessories
WARNI NG
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 accessories be used in conjunction with the specific
medical device. Otherwise the correct functioning of the medical device may be compromised.
Not for use in areas of explosion hazard
WARNI NG
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
Safe connection with other electrical equipment
WARNI NG
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.
Safety inspections
The medical device must be subject to regular safety inspections. See chapter "Maintenance".
8
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
For Your Safety and that of Your Patients
Networking
Device combinations approved by Dräger (see Instructions 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 compatibility; 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 resulting combination is not approved by Dräger, the
operator is responsible for ensuring that the resulting system meets the requirements set forth by the
above standards.
Strictly follow Assembly Instructions and Instructions for Use for each networked device.
This publication excludes references to various
hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can
be dangerous.
CAUTION
Patient hazard
Individual measured values und monitoring parameters should not be used as the sole basis for
therapeutic decisions.
Patient monitoring
The operators of the medical device are responsible for choosing appropriate safety monitoring that
supplies adequate information on medical device
performance and patient condition.
Patient safety may be achieved through a wide variety of means ranging from electronic surveillance
of medical device performance and patient condition, to simple, direct observation of clinical signs.
The responsibility for the selection of the best level
of patient monitoring lies solely with the medical device operator.
Patient safety
The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase and
use of the medical device are restricted to trained
professionals, and that certain inherent characteristics of the medical device are known to the trained
operator. Instructions, WARNING and CAUTION
statements are limited, therefore, largely to the specifics of the Dräger medical device.
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 9
For Your Safety and that of Your Patients
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 O
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.
2 concentration in the
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 highly inflammable substances are used for disinfection.
WARNI NG
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 ignition.
WARNI NG
Do not use the medical device during magnet-
ic resonance (MRI, NMR, NMI)! This may impair correct functioning of the medical device
and endanger the patient.
WARNI NG
Do not use the medical device in hyperbaric
chambers! This may impair correct functioning of the medical device and endanger the patient.
10
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
For Your Safety and that of Your Patients
WARNING
Correct functioning of the medical device may
be impaired by operation of high-frequency
electrosurgery units, defibrillators or shortwave therapy equipment and endanger the patient.
WARNING
Do not open the housing of the medical de-
vice. Danger of electrical shock.
WARNING
Fire hazard!
Do not use the medical device in oxygenenriched rooms since the medical device
could ignite.
Medical device malfunctions can increase the
2 concentration in the ambient air. The med-
O
ical device is only suitable for use in rooms
with adequate ventilation.
WARNING
Do not obstruct the gas inlet for the safety
valve. Otherwise, spontaneous breathing via
the emergency breathing valve is not possible
in the event of a device failure.
CAUTION
Do not use the medical device outside of the
specified ambient conditions. This can disrupt the
proper functioning of the medical device.
CAUTION
Keep away from sources of heat such as direct
sunlight, heat radiators or spotlights! Otherwise
the medical device may become too hot.
CAUTION
Do not obstruct or close off the vents on the medical device. Make sure there is an adequate supply of air. Otherwise the medical device may become too hot. An alarm is triggered if the medical
device overheats during operation.
CAUTION
Positive-pressure ventilation can lead to negative
effects, such as barotrauma or strain on the circulatory system.
WARNING
With neonates, the administration of in-
creased O2 concentrations can lead to retinopathy of prematurity.
Use additional monitoring, e.g. external SpO
2.
WARNING
During HFO, the disconnection detection and
MV monitoring are only possible to a limited
extent. For this reason, use external monitoring for MV and disconnection during HFO.
CAUTION
Do not expose the medical device to strong infrared radiation. This can disrupt the proper functioning of the medical device.
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 11
For Your Safety and that of Your Patients
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibility EMC/ESD pursuant to international EMC standard IEC 60601-1-2:
Electromedical devices are subject to special precautionary measures concerning electromagnetic
compatibility (EMC) and must be installed and put
into operation in accordance with the EMC information provided. Observe the separate Instructions for
Use "Workstation Critical Care and Workstation
Neonatal Care".
Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING
Connector pins with an electrostatic discharge (ESD) warning
sign should not be touched and no
connections should be made be-
tween these connectors without
implementing ESD protective measures. Such
precautionary procedures may include antistatic clothing and shoes, the touch of a
ground stud before and during connecting the
pins or the use of electrically isolating and antistatic gloves. All staff involved in the above
shall receive instruction in these ESD precautionary procedures.
Sterile accessories
CAUTION
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged or there
are other signs of non-sterility. Disposable articles
may not be reprocessed and resteralized.
Reuse, reprocessing or sterilization of disposable
medical products can lead to a failure of the medical devices and cause injuries to the patient.
Installing accessories
CAUTION
Installation to the basic device must be in accordance with the Instructions for Use for the basic
device. Check that connection is secure with the
basic device system.
Strictly follow Assembly Instructions and Instructions for Use.
Keep the Instructions for Use
CAUTION
The Instructions for Use must be kept in an accessible location for users.
WARNING
Do not use portable and mobile HF communi-
cations equipment, e.g., mobile phones, in the
vicinity of the medical device.
12
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
For Your Safety and that of Your Patients
Monitoring ventilation
The following parameters are monitored by the
built-in monitoring facilities of Babylog VN500:
– Airway pressure
– Expiratory minute volume
– Respiratory rate
– Apnea alarm time
– Inspiratory O
– End-expiratory CO
2 concentration
2 concentration
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 a fault occurs in this equipment, separate measuring instruments should be used.
During O
2 therapy, the monitoring functions of the
medical device are restricted. See chapter
"O2 Therapy" on page 100.
Back-up ventilation with an independent Manual ventilation device
WARNING
If a fault is detected in the medical device, its
life-support functions may no longer be assured. Ventilation of a patient using an independent ventilation device must be started
without delay, if necessary with PEEP and/or
an increased inspiratory O
(e.g., with manual breathing bag MR-100).
2 concentration
Handling Infinity ID components
Through ownership or purchase of this medical device equipped with RFID technology, you have only
acquired the right to use the medical device and
RFID technology in conjunction with products approved by Dräger and in strict compliance with
these Instructions for Use. No intellectual property
rights or any rights to the use of the medical device
or RFID technology are hereby granted, either explicitly or implicitly, which are contrary to the abovementioned conditions.
WARNING
Patient hazard
Although Babylog VN500 does not exceed the
valid limit values for electromagnetic fields,
radiation can interfere with the functioning of
pacemakers. Wearers of pacemakers must
keep a distance of at least 25 cm (10 inches)
from the medical device.
Emission of high-frequency energy
This medical device is equipped with an RFID
(Radio Frequency Identification) system to enable
wireless communication with Infinity ID accessories. Any changes or modifications to the RFID system may only be carried out by properly trained service personnel. Otherwise this may compromise
patient safety.
This medical device has been designed and manufactured to comply with emission limit values for
high-frequency energy. These limit values are incorporated in international safety standards like
IEC 60601-1-2 (EN 60601-1-2) which have been
defined by regulation authorities, such as the Federal Communications Commission (FCC Rules), Industry Canada (Radio Standards Specifications)
and the European Telecommunications Standards
Institute (ETSI standards).
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 13
For Your Safety and that of Your Patients
The RFID system of this medical device complies
with Part 15 of the FCC regulations, and its operation is subject to the following conditions:
1 This medical device does not cause any dan-
gerous interference.
2 The medical device is not liable to damage
caused by the reception of interference, including interference causing undesired operating
conditions.
Dräger hereby declares that the ventilation unit
Babylog VN500 is in compliance with the basic requirements and the other pertinent regulations of
Directive 1999/5/EC.
14
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Indications for use and contraindications . . 16
Environment of use . . . . . . . . . . . . . . . . . . . . 16
Application
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 15
Application
Intended use
The Babylog VN500 ventilation unit of the
Infinity Acute Care System is intended for the ventilation of neonatal and pediatric patients.
Babylog VN500 offers mandatory ventilation
modes and ventilation modes for spontaneous
breathing support and airway monitoring. The
Babylog VN500 ventilation unit is used with
Infinity C Series Dräger Medical Cockpits. The
Babylog VN500 ventilation unit is intended for use
in different medical care areas.
Indications for use and contraindications
Indications
The Babylog VN500 ventilation unit is used in combination with Infinity C Series Dräger Medical Cockpits. Babylog VN500 is intended to be used on patients needing respiratory support for different
medical reasons temporarily or for longer time.
Contraindications
There are no additional contraindications apart
from the contraindications contained in chapter
"For Your Safety and that of Your Patients".
It is up to the medical user to select the appropriate
respiratory mode for the underlying disease of the
patient. For all ventilator settings, the user needs to
consider the respiratory status and the general
state of health of the patient in order to optimally
adapt the ventilation settings to the patient's condition. Any changes to the patient's state need to be
monitored continuously.
Environment of use
Babylog VN500 is intended for stationary use in
hospitals and medical rooms or for patient transportation within the hospital.
Babylog VN500 must not be used:
– In hyperbaric chambers
– For magnetic resonance imaging
(MRT, NMR, NMI)
– In conjunction with flammable gases or flamma-
ble solutions that can mix with air, oxygen or
nitrous oxide
– In areas of explosion hazard
– In areas with combustible or explosive
substances
16
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
– In rooms without adequate ventilation
System Overview
Infinity Acute Care System –
Workstation Neonatal Care . . . . . . . . . . . . . . 18
How to use the Workstation Neonatal Care . . . 18
Babylog VN500 . . . . . . . . . . . . . . . . . . . . . . . . 19
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Left side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Right side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Trolley 2 - 90 cm . . . . . . . . . . . . . . . . . . . . . . . 21
Gas supply unit GS500 . . . . . . . . . . . . . . . . . 22
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Power supply unit PS500. . . . . . . . . . . . . . . . 22
Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
System Overview
Range of functions . . . . . . . . . . . . . . . . . . . . . 23
Ventilation functions of Babylog VN500 . . . . . . 23
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Connections for the breathing hoses . . . . . . . . 24
Electrical power supply. . . . . . . . . . . . . . . . . . . 24
Gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Medication nebulizer. . . . . . . . . . . . . . . . . . . . . 24
Connecting accessories . . . . . . . . . . . . . . . . . . 24
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 25
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 17
System Overview
D
B
A
E
C
Infinity Acute Care System – Workstation Neonatal Care
How to use the Workstation Neonatal Care
The Workstation Neonatal Care can consist of the
following units:
– Infinity C500 (Medical Cockpit)
– Babylog VN500 (ventilation unit)
– Trolley 2 - 90 cm (trolley)
– GS500 (gas supply unit)
– PS500 (power supply unit)
– Transport Supply Unit (transport supply unit)
Before using the Workstation Neonatal Care, carefully read the following Instructions for Use:
– Instructions for Use for "Workstation Critical
Care and Workstation Neonatal Care"
– Instructions for Use for "Infinity Medical Cock-
pits"
– Instructions for Use for "Babylog VN500"
– Instructions for Use for "Transport Supply Unit"
The Workstation Neonatal Care may include additional accessories, see separate list of accessories.
A Infinity C500 – control and display unit (Medical
Cockpit). Strictly follow the Instructions for Use
for "Infinity Medical Cockpits".
B Babylog VN500 – ventilation unit
C GS500 – gas supply unit
D PS500 – power supply unit
E Trolley 2 - 90 cm
18
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
001
Babylog VN500
A
B
C
E
F
D
G
H
J
I
System Overview
Front
Front, flap closed
A Operation display of ventilation
During ventilation, the inspiratory and expiratory phases are indicated by a bar display. The
measured values for minute volume MV and the
inspiratory O
played.
B Infinity ID neonatal expiratory valve with
expiratory port Exp. (GAS RETURN)
C Inspiratory unit (safety valve with inspiratory
port) Insp. (GAS OUTPUT)
D Gas inlet for the safety valve Emergency air
intake, non-tapered connection (EMERGENCY
AIR INTAKE), do not obstruct
E Water trap
F Flap
2 concentration FiO2 are also dis-
Front, flap folded upwards
G Silencer
070
H Gas outlet Exhaust, non-tapered connection
(EXHAUST – NOT FOR SPIROMETER)
I Connections for future extensions
J Nebulizer port (nebulizer gas outlet for pneu-
matic medication nebulizer)
071
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 19
System Overview
A
B
F
E
G
D
C
A
B
D
E
G
C
F
Rear
A Fuse for the internal battery
B Connection for the neonatal flow sensor V5
C Connections for future extensions V6, V8
D Connection for CO
E Potential equalization pin
F Fuse for mains power supply F1, F2
G Connection for mains power supply
2 sensor V7
Left side
004
005
A Connection for system cable to Infinity C500 V1
B Connections for future extensions V2, V3
C Connection for nurse call V4
D Toggle switch
E Ambient air filter with cover
F Strain relief for cable
G Left device flap
20
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
System Overview
C
D
E
B
A
A
B
F
H
D
C
G
E
D
Right side
Trolley 2 - 90 cm
A Connection for data cable to the gas supply unit
GS500 V9
B Connection for gas connection to the gas
supply unit GS500
C Connection for Air compressed gas hose Air
(FRESH GAS)
D Connection for O
(FRESH GAS)
E Right device flap
014
A Holder for Infinity C500
B Handle
C Trolley column
D Hose hooks
E Alignment aid
F Humidifier holder, can be swiveled
G Universal holder with standard rail
H Double castors with locking brake, set of 4
2 compressed gas hose O2
038
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 21
System Overview
A
B
C
D
A
C
B
E
F
G
Gas supply unit GS500
Front
A LED for display of mains power supply
Power supply unit PS500
Front
Rear
333
B Rating plate
C Gas connection
Rear
330
A Fault indicator
B Charge indicator
C Standby key
D LED for display of mains power supply
22
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
332
E Cable duct
F Toggle switch of the power supply unit
G Rating plate
331
Range of functions
System Overview
The functions described correspond to the overall
functionality of Babylog VN500. Some functions
are only optional and may not be included in the
individual device configuration. Optional functions
are shown in the separate list of accessories.
Ventilation functions of Babylog VN500
Ventilation modes:
– Pressure-controlled ventilation:
– PC-CMV
–PC-AC
–PC-SIMV
–PC-PSV
–PC-APRV
– PC-HFO
–PC-MMV
– Support of spontaneous breathing:
– SPN-CPAP/PS
– SPN-CPAP/VS
–SPN-PPS
Additional settings for ventilation:
– Apnea Ventilation
– Flow trigger
–Sigh
– Volume Guarantee
–ATC
– AutoRelease
–HFO-Sigh
– Volume Guarantee (HFO)
Special procedures:
– Suction maneuver
– Manual inspiration/hold
– Medication nebulization
Therapy types:
– Invasive ventilation (Tube)
2 Therapy
–O
– Non-invasive ventilation (NIV)
Additional information
For a detailed description of the ventilation modes
and the additional settings see page 236. Abbreviations see page 25.
Monitoring
Patient monitoring is supported by the following
alarm limit settings:
– Maximum airway pressure Paw
– Expiratory minute volume MV
– Apnea alarm time Tapn
– Respiratory rate RR
– End-expiratory CO
The inspiratory O2 concentration is monitored by
automatically set limits.
Babylog VN500 offers the following displays:
– Curves
– Graphic trends
– Numeric trends
– Loops
– Alarm history
– Logbook
– Numeric parameters
– Preconfigured lists for measured values and set
values
– Customized lists for measured values and set
values
– Smart Pulmonary View
During non-invasive ventilation and O
certain monitoring functions are switched off or can
be switched off.
2 concentration etCO2
2 therapy,
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 23
System Overview
Connections for the breathing hoses
For connection of the breathing hoses, the standard IEC 60601-2-12 stipulates conical inspiratory
ports and expiratory ports as per ISO 5356-1 with
a diameter of 15 mm (0.59 inches) or 22 mm
(0.87 inches). Babylog VN500 has, like
Babylog 8000, conical inspiratory ports and expiratory ports with a diameter of 11 mm (0.43 inches).
Electrical power supply
Babylog VN500 is designed for connection to the
hospital's mains power supply with 100 to 240 V at
50/60 Hz. If the mains power supply fails,
Babylog VN500 switches over (without interruption) to the internal battery in order to ensure that
operation can continue for at least 30 minutes (provided that the battery is fully charged and new).
Power supply unit PS500
The Workstation Neonatal Care may also be
equipped with the external power supply unit
PS500.
PS500 is designed for connection to the hospital's
mains power supply (voltage ranges, see page 51).
If the mains power supply fails, PS500 switches
over (without interruption) to the internal batteries in
order to ensure that the operation of the Workstation Neonatal Care can continue for at least
100 minutes (provided that the batteries are new,
fully charged and ventilation is typical). Battery operation is possible for longer in the absence of the
gas supply unit GS500.
Gas supply
Gas supply unit GS500
The Workstation Neonatal Care may also be
equipped with the external gas supply unit GS500.
GS500 supplies Babylog VN500 with compressed
air.
Data transfer
A variety of interfaces can be used for transferring
data:
– USB port for data export and configuration ex-
change using a USB storage media
– USB port for installation of optional applications
using an SIM card reader with SIM card
– RS 232 port on Infinity C500 for data transfer
with the MEDIBUS protocol
Medication nebulizer
For medication nebulization a pneumatic medication nebulizer can be connected.
Connecting accessories
A humidifier and other approved accessories can
be connected to the lateral rails of Babylog VN500.
In so doing, it must be ensured that the maximum
weight of 4 kg (8.8 lbs) does not exceed a maximum distance of 10 cm (3.9 inches).
For hose holders connected to the lateral rails of
Babylog VN500, the maximum weight of 1 kg
(2.2 lbs) must not exceed a maximum distance of
100 cm (39.4 inches).
The accessories can also be connected to the holders provided on the trolley.
Babylog VN500 features country-specific connections for the gas supply with oxygen and medical
air.
24
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
Abbreviations
System Overview
Abbreviation Explanation
% leak Leakage in percent
% Tplat Plateau time in % to the inspiratory
time (set value)
%MVspon Spontaneous breathing portion of
minute volume in percent
Air Connection for Air compressed gas
hose (FRESH GAS)
ALARM
RESET
Acknowledging an alarm message
that is no longer active ("Reset")
Ampl hf Pressure amplitude for HFO
(set value)
Apnea Vent. Apnea ventilation
APRV Airway Pressure Release
Ventilation
ATC Automatic Tube Compensation,
compensation of the tube
resistance
BF Insulation class Body Floating
BTPS Body Temperature Pressure
Saturated, measured values based
on the condition of the patient’s
lungs, body temperature 37 °C
(98.6 °F), water vapor-saturated
gas, atmospheric pressure
C Compliance
C20/Cdyn Index of the last 20 % of compli-
ance in relation to the dynamic total
compliance
Cdyn Dynamic compliance
2O Measuring unit for pressure
cmH
1cmH
2O = approx. 1 mbar
Compens. Degree of tube compensation
COPD Chronic Obstructive Pulmonary
Disease
Cycles sigh Number of cycles during a sigh
phase (set value)
Abbreviation Explanation
2 Dissociation coefficient for CO2
DCO
with HFO
ΔintPEEP Additional intermittent PEEP for
sigh (set value)
ΔPhf Maximum pressure difference of
amplitude with HFO
ΔPsupp Pressure support relative
(above PEEP) (set value)
E Elastance
EIP End Inspiratory Pressure,
end-inspiratory pressure
EMC Electromagnetic compatibility
Emergency
air intake
Safety air inlet, inspiratory relief
valve (EMERGENCY AIR INTAKE)
ESD Electrostatic Discharge
ET Endotracheal tube
2 End-expiratory CO2 concentration
etCO
ETSI European Telecommunications
Standards Institute, European
Telecommunications Standards
Institute
Exhaust Gas outlet (EXHAUST – NOT FOR
SPIROMETER)
Exp. Label on the device, Expiratory port
(GAS RETURN)
Exp. Expiration
Exp. term. Termination criterion in % from the
peak expiratory flow
FCC Federal Communications
Commission, approval authority
for communications devices in
the U.S.
fhf Frequency of oscillation for HFO
(set value)
2 Inspiratory O2 concentration
FiO
(set value)
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 25
System Overview
Abbreviation Explanation
Flow Flow (set value)
Flow Assist Flow support in SPN-PPS
(set value)
Flow trigger Trigger threshold, sensitivity
(set value)
Flowsigh Flow of sighs for HFO
FRC Functional Residual Capacity
GS500 Gas supply unit
HF High frequency
HFO High Frequency Oscillation
HME Heat Moisture Exchanger
hPa Hectopascal, measuring unit for
pressure
1hPa = 1mbar = approx. 1cmH
2O
I:E Ratio of inspiratory time to
expiratory time
I:Ehf I:E for HFO (set value)
I:Espon I:E during spontaneous breathing
IEC/CEI Alarm tone as per IEC 60601-1-8
Insp. Label on the device, Inspiratory
port (GAS OUTPUT)
Insp. Inspiration
Insp. flow Inspiratory flow
Interval sigh Time interval between two sigh
phases (set value)
LAN Local Area Network
MAPhf Mean airway pressure for HFO
(set value)
mbar Millibar, measuring unit for
pressure 1 mbar = approx.
2O
1cmH
MEDIBUS Dräger communication protocol for
medical devices
mmHg Measuring unit for end-expiratory
2 concentration
CO
More... Show more alarms
MRI Magnetic resonance imaging
Abbreviation Explanation
MV Overall minute volume
MV high Upper alarm limit for minute volume
MV low Lower alarm limit for minute volume
MVleak Leakage minute volume
MVmand Mandatory portion of minute
volume
MVspon Spontaneous breathing portion of
minute volume
Neo. Neonates patient category
NIV Non-Invasive Ventilation
NMI Nuclear magnetic imaging
NMR Nuclear magnetic resonance
NTPD Normal Temperature Pressure Dry,
20 °C (68 °F), 1013 hPa, dry
2 Connection for O2 compressed gas
O
hose (FRESH GAS)
2 suction Suction maneuver
O
Palv Alveolar pressure
Paw Airway pressure
Paw high Upper alarm limit for airway
pressure
PC-AC Pressure Control-Assist Control,
assisted-controlled, pressurecontrolled ventilation with back-up
respiratory rate
PC-APRV Pressure Control-Airway Pressure
Release Ventilation, spontaneous
breathing under continuous
positive airway pressure with brief
pressure releases
PC-CMV Pressure Control-Continuous
Mandatory Ventilation, continuous
pressure-controlled ventilation
PC-HFO Pressure Control-High Frequency
Oscillation, pressure-controlled
ventilation with high-frequency
oscillation
26
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
System Overview
Abbreviation Explanation
PC-MMV Pressure Control-Mandatory
Minute Volume Ventilation,
pressure-controlled ventilation to
ensure a mandatory volume per
minute
PC-PSV Pressure Control-Pressure
Support Ventilation, spontaneous
breathing at continuous positive
pressure level with pressure
support and back-up respiratory
rate
PC-SIMV Pressure Control-Synchronized
Intermittent Mandatory Ventilation,
intermittent, triggered, pressurecontrolled ventilation
Ped. pat. Pediatric patient category
PEEP Positive end-expiratory pressure
Phigh Upper pressure level in APRV
(set value)
Pinsp Inspiratory pressure (set value)
PIP Peak Inspiratory Pressure
Plow Lower pressure level in APRV
(set value)
PmanInsp Pressure of the mandatory breath
for the manual inspiration during
NIV (patient category Neo.,
ventilation mode SPN-CPAP)
Pmax Maximum allowed airway pressure
(set value)
Pmax/Paw
high autoset
Linking the maximum airway
pressure to the alarm limit Paw
high
Pmean Mean airway pressure
Pmin Minimum airway pressure
Pplat Airway pressure on the plateau
PS Pressure Support
PS500 Power supply unit
Psigh Inspiratory pressure of sigh for
HFO (set value)
Psupp Pressure support absolute
Abbreviation Explanation
Ptrach Pressure in the trachea
R Resistance (resistance)
r² Correlation coefficient for the
calculation method "Least Mean
Square" for R, C and Τau
REF Material and revision number of the
medical device
RFID Radio Frequency Identification
RR Respiratory rate (set value)
RRapn Respiratory rate of apnea
ventilation (set value)
RRmand Mandatory portion of respiratory
rate
RRsigh Respiratory rate of sighs for HFO
(set value)
RRspon Spontaneous breathing portion of
respiratory rate
RSB Rapid Shallow Breathing, quotient
of spontaneous respiratory rate
and tidal volume
SIM Subscriber Identity Module,
participant identification
Slope Pressure rise time (set value)
Slopesigh Pressure rise time of sighs for HFO
Smart
Pulmonary
Graphic display of lung
characteristics
View
SN Device serial number
SPN-CPAP Spontaneous-Continuous Positive
Airway Pressure, spontaneous
breathing with continuous positive
pressure level
SPNCPAP/PS
Spontaneous-Continuous Positive
Airway Pressure/Pressure
Support, spontaneous breathing
with continuous positive pressure
level with or without pressure
support
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 27
System Overview
Abbreviation Explanation
SPNCPAP/VS
Spontaneous-Continuous Positive
Airway Pressure/Volume Support,
spontaneous breathing with
continuous positive pressure level
with or without volume support
SPN-PPS Spontaneous-Proportional
Pressure Support, spontaneous
breathing with flow-proportional
and volume-proportional pressure
support
2 Partial O2 saturation
SpO
Tapn Apnea alarm time (set value)
Τau Time constant tau
Tdisconnect Time for disconnection alarm
(set value)
Te Expiratory time (set value)
Thigh Time of upper pressure level in
APRV (set value)
Ti Inspiratory time (set value)
Timax Maximum inspiratory time for flow
during pressure or volume support
(set value)
Tisigh Inspiratory time of sigh for HFO
(set value)
Tispon Inspiratory time of sigh for
spontaneous breathing
Tisupp Inspiratory time during pressure
support
Tlow Time of lower pressure level in
APRV
Tlow max Maximum expiratory time during
APRV (set value)
TmanInsp Duration of the breath for the
manual inspiration during NIV
(Neo. patient category, SPN-CPAP
ventilation mode)
Tplat Time of inspiratory plateau
Trach. Tracheostomy tube
Tube Ø Inside diameter of tube (set value)
Abbreviation Explanation
UIP Upper Inflection Point
UMDNS Universal Medical Device
Nomenclature System,
nomenclature for medical devices
N Rated voltage
U
USB Universal Serial Bus, serial bus
system
VG Volume Guarantee
VG (HF) Volume Guarantee for HFO
Vol. Assist Volume support in SPN-PPS
(set value)
VS Volume Support
VT Tidal Volume
VTapn Tidal volume of apnea ventilation
(set value)
VTe Expiratory tidal volume
VTemand Expiratory tidal volume during a
mandatory breath
VTespon Expiratory tidal volume during a
spontaneous breath
VThf Tidal volume for HFO (set value for
VG (HF))
VTi Inspiratory tidal volume
VTimand Inspiratory tidal volume during a
mandatory breath
VTispon Inspiratory tidal volume during a
spontaneous breath
VTmand Tidal volume during a mandatory
breath
VTspon Tidal volume during a spontaneous
breath
WOB Work of Breathing
28
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
Symbols
123
123
123
Audio
paused
System Overview
Symbol Explanation
Temporarily suppress acoustic alarm
Group Views, screen displays
Group Trends/Data, information on the
course of ventilation
Group Special procedures
Group Alarms
Group Therapy, ventilation parameter
settings
Group configuration, system settings
and settings for sensors
Group Start/Standby
System on or off (at the key on
Infinity C500)
Switching the power supply unit on or off
(at the key on PS500)
Alarm limit off
Configure trends
Save screen display
View 1
View 2
View 3
Medication nebulizer
Charge state of internal batteries
(Babylog VN500, PS500) 90 to 100 %
Charge state of internal batteries
(Babylog VN500, PS500) 60 to <90 %
Charge state of internal batteries
(Babylog VN500, PS500) 40 to <60 %
Charge state of internal batteries
(Babylog VN500, PS500) 20 to <40 %
Symbol Explanation
Charge state of internal batteries
(Babylog VN500, PS500) <20 %
Internal batteries (Babylog VN500,
PS500) defective or no information
available on their charge state
Lower alarm limit
Upper alarm limit
Setting or access locked
Expiratory valve locked
Setting or access unlocked
Expiratory valve unlocked
Exhaust
Gas outlet (EXHAUST – NOT FOR
SPIROMETER)
Patient category pediatric patients (Ped.
pat.)
Neonates patient category (Neo.)
Display additional information or open
Help
Hide additional information or close Help
Scroll in tables or lists
Scroll in tables or lists
Close dialog window
Active test in the device check
Spontaneous breathing activity by the
patient
Suppress acoustic alarm for 2 minutes
Mains power supply (AC voltage)
PS500, GS500: Mains power supply
(AC voltage)
Power supply from the internal battery of
Babylog VN500
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n 29
System Overview
Symbol Explanation
Caution: Observe important safety
information and precautions in the
Instructions for Use.
Observe the Instructions for Use
PS500: Failure, fault
Connection for equipotential bonding
Application part type BF
Nurse call
Marking point on the trolley – do not
lean, press, push or pull against the
trolley above the marking points
ESD warning symbol
ESD warning symbol
Information on disposal
Manufacturer
2009
Manufacturing date
Connection for the neonatal flow sensor
Device ready to switch on
Device switched off
Labeling for FCC approval
Labeling in accordance with Directive
93/42/EEC concerning medical products
Labeling in accordance with Directive
1999/5/EC on radio equipment and telecommunications terminal equipment
Serial interface (on Infinity C500)
Additional symbols on Infinity C500 (Medical
Cockpit) that are not described in these Instructions
for Use are described in the Instructions for Use for
"Infinity Medical Cockpits".
30
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
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