Babylog VN500 Instructions for Use Sw 1.n Dec 2018.pdf
Page 1
Babylog VN800 / VN600
Intensive care ventilator
Software 1.n
Instructions for use
WARNING
To properly use this medical device, read and comply
with these instructions for use.
Babylog VN800 / VN600
Page 2
This page has been left blank intentionally.
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Contents
Contents
Babylog VN800
Intensive
care ventilator
/ VN600
Information about this document
Typographical conventions
Use of terms
Illustrations
Additional documents
Trademarks
Safety-related information
Intended use
Indications
Contraindications
Environments of use
Essential performance characteristics
User group requirements
Information on safety instructions and precautionary statements
Safety instructions
Further information
Overview
Intensive care ventilator
Display unit
Ventilation unit
Trolley
GS500 gas supply unit
Range of functions
Abbreviations
Symbols
Product labels
Operating concept
Screen
Using the screen
Setting the ventilation
Operating the monitoring area
Using the help function
Assembly and preparation
Safety instructions
Maximum loads
Attaching and adjusting the holders and accessories
Attaching compressed gas cylinders to the trolley
Preparing the display unit
Preparing the ventilation unit
Establishing the power supply
Checking the main switch
Connecting the potential equalization cable
Establishing the gas supply
Connecting the nurse call
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Contents
Closing the lateral device flaps
Intrahospital device transport
Getting started
Safety instructions
Turning on the device
Checking operational readiness
Selecting the therapy type
Admitting a new patient
Starting the therapy
Operation
Safety instructions
Ventilation settings
Changing the therapy type during therapy
Changing the body weight during ventilation
Non-invasive ventilation (NIV)
Apnea ventilation
Loops
Smart Pulmonary View
Maneuvers
Medication nebulization
GS500 gas supply unit
Intrahospital patient transport
O2 therapy
Interrupting therapy – standby mode
Battery operation
Ending operation
Shutting down the device
Interrupting the gas supply
Storing the device
Disassembly
Alarms
Display of alarms
Alarm logbook
Confirming alarm messages
Alarm limits
Setting the alarm volume
Alarm silence
Alarm delay
Alarm system behavior during power supply failure or after turning
off the device
Trends
Opening the dialog
Displaying trends
Displaying current values
Displaying the logbook
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Contents
Displaying the test results
Performing a data export
Monitoring
Safety instructions
Information on monitoring
Flow monitoring
O2 monitoring
CO2 monitoring
Configuration
Safety instructions
Information on configuration
Configuring the screen display
Configuring the alarm settings
Configuring ventilation settings
Configuring the start settings
Importing and exporting configurations
Activating software options
Performing and configuring the battery test
Changing the system settings
Troubleshooting
Displaying alarm messages
Confirming alarm messages
Alarm – Cause – Remedy
Service
Safety instructions
Prerequisites
Definition of service terminology
Inspection
Maintenance
Repair
Replacing the room air filter
Replacing the diaphragm of the expiratory valve
Replacing the neonatal expiratory valve
Maintenance of the gas supply unit GS500
Battery maintenance
Disposal
Safety instructions
Disposing of the device
Disposing of the packaging material
Disposing of the batteries
Disposing of the flow sensors
Technical data
Ambient conditions
Set values
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Contents
Performance characteristics
Displayed measured values
Displayed calculated values
Monitoring
Operating characteristics
Interfaces and ports
Measurements and weight
Automatic alarm limits
Device combinations
EMC declaration
Connections to IT networks
Open-source software
Principles of operation
Ventilation modes
Additional settings for ventilation
Maneuvers
Smart Pulmonary View
Therapy types
Leakage adaptation and leakage compensation
Linking the maximum airway pressure to the upper alarm limit –
Pmax/Paw high autoset
Flow reduction – Anti-air shower
Measurements
Battery concept
Pneumatic functional description
Menu structure
List of references
Password
User password for Babylog VN800 / VN600 Software 1.n
Information about the user password
Index
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Information about this document
1
Information about this document
1.1
Typographical conventions
Text
Bold, italicized texts indicate labels on the device and screen texts.
1.
Numbers followed by a period indicate individual action steps in a
sequence of actions. Numbering begins with the number 1 for each new
sequence of actions.
a.
Lowercase letters followed by a period indicate subordinate action steps.
Numbering begins anew with the letter a. for each new subordinate action
step.
Ɣ
This bullet point indicates individual process steps with no specific
sequence.
Ź
This triangle in safety instructions and precautionary statements indicates
ways to avoid danger.
(1)
Numbers in parentheses refer to elements in figures.
1
Numbers in figures indicate elements referred to in the text.
–
Dashes indicate listings.
>
The greater-than symbol indicates the navigation path in a dialog.
This symbol indicates information that makes it easier to use the product.
1.2
This arrow indicates the result of an action step.
ᅚ
This check mark indicates the result of a sequence of actions.
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.
The products "Babylog VN800" and "Babylog VN600" are also referred to as
"Babylog".
1.3
Illustrations
Illustrations of products and screen content in this document may differ from the
actual products depending on configuration and design.
The figures display the product "Babylog VN800". The information they contain also
applies to the product "Babylog VN600".
1.4
Additional documents
The reprocessing for this product is described in the separate reprocessing
instructions delivered with the product.
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Information about this document
1.5
Trademarks
1.5.1
Trademarks owned by Dräger
Trademark
Babylog®
ATC®
QuickSet®
Infinity®
MEDIBUS®
MEDIBUS.X®
The following web page provides a list of the countries in which the trademarks are
registered: www.draeger.com/trademarks
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Safety-related information
2
Safety-related information
2.1
Intended use
The intensive care ventilator Babylog is intended for the ventilation of neonates
from 0.4 kg (0.88 lb) up to 10 kg (22 lb), and pediatric patients from 5 kg (11 lb) up
to 20 kg (44 lb) bodyweight. This device provides mandatory ventilation modes and
ventilation modes for supporting spontaneous breathing as well as ventilation
monitoring.
2.2
Indications
The device is used for treating patients who require temporary or longer-term
respiratory support for different medical reasons.
2.3
Contraindications
There are no additional contraindications apart from the contraindications contained
in the sections on safety instructions.
It is the responsibility of the user to select the appropriate ventilation 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 condition need to be monitored continuously.
2.4
Environments of use
The device is intended for stationary use in hospitals and medical rooms or for
intrahospital patient transport.
Do not use the device in the following environments of use:
– Hyperbaric chambers
– Magnetic resonance imaging
– Together with flammable gases or flammable solutions that can mix with air,
oxygen, or nitrous oxide
– Areas with danger of explosion
– Areas with combustible and highly flammable substances
– Rooms with insufficient ventilation
Do not operate the device with helium or helium mixtures.
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Safety-related information
2.5
Essential performance characteristics
If the essential performance characteristics function correctly, this guarantees that
the product can be used in accordance with its intended use. The product has the
following essential performance characteristics:
– Controlled and monitored ventilation with settings defined by the user for the
following monitoring functions:
– Minimum tidal volume
– Maximum airway pressure
– Minimum and maximum O2 concentration in the breathing gas
– If one of the set limits is exceeded, a corresponding alarm is issued.
Additionally, the integrated monitoring issues an alarm in the following situations:
– Failure of the external power supply
– Battery discharge
– Failure of the gas supply
2.6
User group requirements
The term "user group" describes the personnel responsible who have been
assigned by the operating organization to perform a particular task on a product.
2.6.1
Duties of the operating organization
The operating organization must ensure the following:
– Every user group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
– Every user group has been trained to perform the task.
– Every user group has read and understood the relevant chapters in this
document.
2.6.2
User groups
Clinical users
This user group operates the product in accordance with the intended use.
Users have medical specialist knowledge in the field of ventilation. Users have
knowledge of device monitoring and ventilation care.
Reprocessing personnel
This user group carries out the necessary activities to reprocess the product.
Reprocessing personnel has specialist knowledge in the reprocessing of medical
devices.
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Safety-related information
Service personnel
This user group installs the product and performs the service activities.
Service personnel has specialist knowledge in electrical and mechanical
engineering and experience in the servicing of medical devices.
Where product specific knowledge or tools are required, the service activities must
be carried out by specialized service personnel. The specialized service personnel
was trained by Dräger for these service activities on this product.
2.7
Information on safety instructions and precautionary
statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.
2.7.1
Safety instructions
This document contains sections with safety instructions which warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.
2.7.2
Precautionary statements
Precautionary statements relate to action steps and warn of risks that may arise
when performing the action steps. Precautionary statements precede the action
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of non-compliance.
Warning sign Signal word
WARNING
Consequences of non-compliance
May result in death or serious injury.
CAUTION
May result in moderate or minor injury.
NOTICE
May result in property damage.
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Safety-related information
2.8
Safety instructions
2.8.1
Instructions for use
Failure to use the product in accordance with the information contained in these
instructions for use may result in personal injury and property damage.
Ź Follow these instructions for use.
Ź Use this product only according to its intended use.
Ź Keep these instructions for use close to hand.
Ź Follow these instructions for use and those for any products used in conjunction
with this product.
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 product
– Potentially negative effects on patients with one or more illnesses
2.8.2
Symbols and product labels
Failure to observe symbols and product labels may result in personal injury and
property damage.
Ź Observe the symbols and product labels.
2.8.3
Monitoring the patient's condition
Monitoring of a patient's condition can range from direct observation to electronic
monitoring by means of medical devices. The patient may be put at risk if his or her
condition is not adequately monitored.
Ź Monitor the patient's condition by suitable means and at appropriate intervals.
2.8.4
Monitoring
Integrated monitoring
The integrated monitoring uses certain parameters to monitor the therapy (see
"Monitoring functions of ventilation monitoring", page 29).
The following factors may cause changes to these parameters:
– Acute changes in the patient's condition
– Incorrect settings and faulty handling
– Device malfunction
– Failure of the power supply and the gas supply
Ź If a fault occurs in the integrated monitoring, use separate measuring
instruments.
Monitoring during O2 therapy
During O2 therapy, the monitoring functions of the medical device are limited.
Ź Observe the following information: "O2 therapy", page 131.
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Safety-related information
2.8.5
Standby mode
Ventilation does not take place in standby mode. If connected, the patient may be
put at risk.
Ź Connect the patient only after the therapy has been started.
2.8.6
Keeping a manual ventilation device ready
If a fault is detected in the medical device, its life-support functions may no longer
be assured. The patient may be put at risk.
Ź Keep an independent ventilation device (e.g., a manual resuscitator) ready.
Ź Immediately start the ventilation of the patient using the independent ventilation
device. If required, perform ventilation with PEEP and/or with an increased
inspiratory O2 concentration.
2.8.7
Alarms
Alarm volume
If the alarm volume is too low, alarm signals may not be heard. The patient may be
put at risk.
Ź Set the alarm volume loud enough so that the alarm signals can be heard in the
environment where the device is located.
Ź The user must remain within hearing distance of the alarm signals.
2.8.8
Device
Ventilation slots
Obstructing or closing off the ventilation slots may cause the device to overheat. An
alarm is issued if the device overheats.
Ź Make sure air can easily enter the device at the ventilation slots.
Sources of heat
Direct sunlight or other external sources of heat may cause the device to overheat.
Ź Keep away from sources of heat such as direct sunlight, radiant warmer, or
spotlights.
Penetrating liquid
Penetrating liquid may cause the following:
– Damage to the device
– Electric shock
– Device malfunctions
As a result, the patient may be put at risk.
Ź Ensure that no liquid penetrates the device.
Ź Do not place any containers with liquids on or above the device.
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Safety-related information
Housing
Under the housing, there are live electrical components, which may cause an
electric shock.
Ź Do not open the housing of the device.
2.8.9
Display unit
If the touchscreen is cleaned or disinfected during therapy, the settings may
inadvertently be changed. The patient may be put at risk.
Ź Clean and disinfect the touchscreen only if no patient is connected.
2.8.10
Ventilation unit
Gas inlet for the inspiratory valve
If the gas inlet for the inspiratory valve is covered, it is not possible to perform
spontaneous breathing using the emergency breathing valve in the event of device
failure. The patient may suffocate.
Ź Do not obstruct the gas inlet for the inspiratory valve.
2.8.11
Accessories
Compatible accessories
The use of incompatible accessories may adversely affect the functional integrity of
the product. Personal injury and property damage may occur as a consequence.
Ź Use only compatible accessories. The accessories that are compatible with this
product are listed in the list of accessories supplied with the product.
Disposable products
Disposable products whose packaging has been opened may be contaminated with
infectious agents.
Ź Keep disposable products packaged until they are used. Do not use disposable
products whose packaging is damaged.
Disposable products are developed, inspected, and produced exclusively for single
use. Reuse, reprocessing or sterilization may lead to a failure of the accessories
and cause injuries to the patient.
Ź Do not reuse, reprocess, or sterilize disposable products.
Installing accessories
If accessories are not securely fastened, they may fall down. This may result in
personal injury and property damage.
Ź Install accessories to the main device in accordance with the instructions for use
of the main device.
Ź Make sure that there is a safe connection to the main device.
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Safety-related information
2.8.12
Gases and solutions
Combustible or explosive gas mixtures
If oxygen concentrations over 25 Vol% or combustible or explosive gas mixtures
occur, there is an increased risk of explosion and fire that may result in personal
injury and property damage.
Ź Do not operate the device in areas where oxygen concentrations exceeding
25 Vol% or combustible or explosive gas mixtures may occur.
Ź Do not operate the device in areas where combustible solvents or explosive
anesthetic agents are used.
Ignition sources
Ignition source (e.g., open flames or sparks) may lead to fires in the presence of
oxygen. There may be a risk of personal injury.
Ź Keep the device away from ignition sources.
Increased oxygen concentration in the ambient air
Medical device malfunctions may increase the O2 concentration in the ambient air.
As a result, the medical device may ignite.
Ź Do not use the medical device in rooms that are enriched with oxygen.
Ź The medical device is suitable only for use in rooms with sufficient ventilation.
2.8.13
External flow source
Unnoticed change in inspiratory O2 concentration
If an additional flow is delivered by an external flow source, the actual O2
concentration delivered may deviate from the displayed values. The patient may be
put at risk.
Ź If necessary, use additional monitoring, e.g., external SpO2 monitoring.
Negative impacts on the measured values
An additional flow delivered by an external flow source may affect the measured
values for airway pressure and flow.
Ź Do not use additional flow.
2.8.14
Modifications to the product
Modifications to the product may lead to malfunctions and unforeseen risks. This
may result in injury to the patient or the user or in property damage.
Ź Do not modify this product.
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Safety-related information
2.8.15
Connected devices and device combinations
Any connected devices or device combinations that do not comply with the
requirements mentioned in these instructions for use may compromise the
functional integrity of the medical device. Personal injury and property damage may
occur as a consequence.
Ź Connections to electric devices not listed in this document may be made only if
approved by their manufacturer.
Ź Before this device is commissioned, the instructions for use of all connected
devices and device combinations must be heeded.
2.8.16
Data transfer
As a result of misinterpretation of the measured values or other parameters, an
incorrect diagnosis may be made and thus the patient may be put at risk.
Ź Do not use individual measured values and monitoring parameters as the sole
basis for therapeutic decisions.
2.8.17
Reprocessing
Reusable products must be reprocessed, otherwise there is an increased risk of
infection.
Ź Perform reprocessing according to the reprocessing instructions delivered with
the product.
2.8.18
Service
If service activities are not performed regularly, malfunctions may occur, which may
result in personal injury and property damage.
Ź Perform service activities in accordance with the chapter "Service".
2.8.19
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary measures
concerning electromagnetic compatibility. During installation and before initial
operation, follow the information in section: "EMC declaration" (page 246).
Electrostatic discharge
When components that bear the ESD warning symbol are handled, protective
measures against electrostatic discharge must be complied with. Otherwise,
malfunctions may occur that put the patient at risk.
To prevent malfunctions, observe the following measures and train the relevant
personnel:
Ź Follow the ESD protective measures, such as:
– Wear antistatic clothing and shoes.
– Use electrically insulating and antistatic gloves.
– When establishing connections, touch a potential equalization pin.
Ź Observe the requirements for the electromagnetic environment. Observe the
following section: "Electromagnetic environment" (page 247).
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Safety-related information
Electromagnetic disturbances
Wireless communication devices (e.g., cellular phones) and medical electrical
equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic
radiation. When such devices are operated too close to this device or its cables, the
functional integrity of this device may be compromised by electromagnetic
disturbances. As a result, the patient could be put at risk.
Ź Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless
communication devices, to ensure that the essential performance of this device
is fulfilled.
Ź Maintain an adequate distance between this device and other medical electrical
equipment.
In case of short electromagnetic disturbances as tested according to
IEC 60601-1-2, the following performance degradations may occur:
– Temporary black screens
– Disturbances of CO2 measurement
After elimination of the electromagnetic disturbances, the performance
degradations end at the latest after 8 seconds. In case of present alarms, the
secondary acoustic alarm system will be activated. The ventilation performance is
not affected. The ventilation unit operation display will indicate pressure, volume,
and FiO2.
The ventilator was tested according to the recommendations of
IEC TR 60601-4-2: Medical. During burst coupling of ±1 kV on mains, the following
performance degradations may occur:
– Temporary black screens
– Disturbances of CO2 measurement
After the burst coupling, the degradation of performance ends at the latest after
8 seconds without any user intervention. Changing to another power socket may
help. Burst coupling in the power network can be minimized or prevented by using a
corresponding mains filter in the power network.
2.8.20
Network security
Impermissible usage of data interfaces may result in new risks.
Ź Only create connections to data interfaces if permission for this has been
obtained from the organization responsible (party responsible for IT and party in
charge of the devices for the hospital).
Ź Observe the following information: "Connections to IT networks", page 248.
2.9
Further information
2.9.1
Training
Training for users is available via the Dräger organization responsible (see
www.draeger.com).
2.9.2
Mandatory reporting of adverse events
Serious adverse events with this product must be reported to Dräger and the
responsible authorities.
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Overview
Overview
3.1
Intensive care ventilator
41923
3
No.
1
2
3
4
5
1
1
2
2
3
3
4
4
5
5
Designation
Display unit
Ventilation unit
GS500 gas supply unit
PS500 power supply unit
Trolley
For additional accessories, see the separate list of accessories.
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Overview
Display unit
3.2.1
Front
1
6 5
No. Designation
1
Alarm bar
2
Screen
3
4
5
6
(Alarm silence
key)
Rotary knob
2
38310
3.2
4 3
Description
The alarm bar flashes briefly during
the system startup and indicates that
the alarm system is functioning properly.
For further information see: "Optical alarm
signals",
page 144.
In the event of an alarm, the alarm bar
flashes in the color corresponding to
the alarm priority.
The screen is a touchscreen.
For further information see:
"Screen",
page 42.
Pressing this key pauses all acoustic For further inforalarm signals for 2 minutes.
mation see:
"Alarm silence",
page 150.
The rotary knob is used to select and
confirm settings or functions.
LED for mains voltage
For further information see:
LED for the internal battery
"Power supply
LED for the power supply unit PS500 indicators",
page 20.
For further inforOn/off key
mation see:
This key is used to switch the device
"Turning on the
on or off. The LED in the key lights up
device", page 90.
when the device is switched on.
For further information see:
"Shutting down
the device",
page 138.
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Overview
3.2.1.1
Power supply indicators
LED for
mains voltage
LED for the
internal battery
LED for the
power supply unit
PS500
LED lights up green LED lights up yellow
Mains voltage is
available, and the
main switch is activated
Battery charge is
Battery charge is
greater than approx. between approx.
90 %.
10 % and 90 %.
Battery charge is
greater than approx.
90 %.
Battery charge is
between approx.
10 % and 90 %.
LED does not light
up
The device is disconnected from the
mains voltage.
The internal battery is
faulty or discharged,
or the device is
switched off with the
main switch.
The power supply
unit is faulty or discharged, or the
device is switched off
with the main switch.
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Overview
Rear
1
2
37930
3.2.2
3
3
43 5
No. Designation
1
Alarm bar
2
COM
3
4
5
LAN
HDMI
Description
The alarm bar flashes briefly during
the system startup and indicates that
the alarm system is functioning properly.
In the event of an alarm, the alarm bar
flashes in the color corresponding to
the alarm priority.
Serial ports (RS-232) for exchanging
data via communication protocols
(MEDIBUS)
USB ports for exporting data, configuration exchange, and installing software options
Port for service purposes
Port for external device (e.g., projector)
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For further information see: "Optical alarm
signals",
page 144.
For further information see: "Connecting external
devices to the
data interfaces",
page 74.
Page 22
Overview
3.3
Ventilation unit
3.3.1
Front
40298
Front, flap closed:
6
5
1
2
4
3
No. Designation
1
Insp.
Description
Inspiratory valve with inspiratory port
3
4
(GAS OUTPUT)
Emergency air
intake
Water trap
Exp.
Gas inlet for the inspiratory valve, non-tapered connector,
do not obstruct (EMERGENCY AIR INTAKE)
Water trap container of the expiratory valve
Neonatal expiratory valve with expiratory port
5
(GAS RETURN)
Flap
Cover of the expiratory unit
2
6
For further information see: "Handling the flap", page 75.
Operation display During ventilation, a bar display indicates the inspiratory
and expiratory phases. The measured values for the minute volume MVe and inspiratory O2 concentration FiO2
are also displayed.
If the device is switched off and the power plug is connected to the mains voltage, the charge status indicator of
the batteries and the symbol
batteries are charging.
are displayed when the
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Overview
40297
Front, flap folded upwards:
7
8
9
10
9
No. Designation
7
Exhaust
8
Muffler
9
10
Connectors
Nebulizer port
Description
Gas outlet, non-tapered connector
For further information see: "Preparing the neonatal expiratory valve", page 76.
Ports for future extensions
Gas outlet for the pneumatic medication nebulizer
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Overview
Rear
38314
3.3.2
1
2
3
4
5
6
7
No. Designation
1
F3
2
Neo Flow
3
4
5
6
7
Description
Fuse for the internal battery
Port for the neonatal flow sensor
Ports for future extensions
Port for the CO2 sensor
CO2
Potential equalization pin
F1, F2
Fuse for the mains power supply
Port for the mains power supply
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Overview
Left side
38315
3.3.3
1
2
3
4
5
5
V2
6
7
No. Designation
1
Description
Port for the system cable which leads to the display unit
2
USB port
3
Port for nurse call
4
5
V2
Port for future extensions
Main switch
6
7
Room air filter with cover
Strain relief for cable
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