Dräger Babylog 8000 plus User manual

Instructions for use
Babylog 8000 plus
WARNING
To properly use this medical device,
read and comply with these
instructions for use.
Intensive care ventilator for neonates
Software 5.n

2 Instructions for use Babylog 8000 plus SW 5.n
Typographical conventions
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for
example, FiO2, IPPV or Vent. Mode. Translations
of these texts are printed in bold and italics and are
placed in parentheses. These translations in
parentheses are not displayed on the device.
The "greater than" symbol > indicates the
navigation path in a dialog window, for example,
Options > VIVE. In this example, Options
represents the dialog window title and VIVE a
screen in the dialog window.
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.
Product name used
In these instructions for use, the designation
Babylog 8000 is used for "Babylog 8000 plus".
Screen reproductions
The reproductions of screen content in the
instructions for use can differ from the content
actually shown on the screen.
Trademarks
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Bullet points indicate individual actions or dif-
ferent options for action.
– Dashes indicate the listing of data, options, or
objects.
(A) Letters in parentheses refer to elements in the
related illustration.
ALetters in illustrations denote elements
referred to in the text.
Trademark Trademark owner
Babylog®
Dräger
BabyLink®
DrägerService®
MEDIBUS®
Buraton®Schülke & Mayr GmbH

Instructions for use Babylog 8000 plus SW 5.n 3
Safety information definitions
Definition of target groups
For this product, users, service personnel, and
experts are defined as target groups.
These target groups must have received
instruction in the use of the product and must have
the necessary training and knowledge to use,
install, reprocess, maintain, or repair the product.
The target groups must understand the language
of the present document.
The product must be used, installed, reprocessed,
maintained, or repaired exclusively by defined
target groups.
Users
Users are persons who use the product in
accordance with its intended use.
Service personnel
Service personnel are persons who are
responsible for the maintenance of the product.
Service personnel must be trained in the
maintenance of medical devices and install,
reprocess, and maintain the product.
Experts
Experts are persons who perform repair or
complex maintenance work on the product.
Experts must have the necessary knowledge and
experience with complex maintenance work on the
product.
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result in
death or serious injury.
CAUTION
A CAUTION statement provides important
information about a potentially hazardous
situation which, if not avoided, may result in
minor or moderate injury to the user or patient or
in damage to the medical device or other
property.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.

4 Instructions for use Babylog 8000 plus SW 5.n
Abbreviations and symbols
Explanations can be found in the sections
''Abbreviations'' and ''Symbols'' in chapter
''Overview''.

Instructions for use Babylog 8000 plus SW 5.n 5
Contents
Contents
For your safety and that of your patients.... 7
General safety information .............................. 8
Product-specific safety information.................. 12
Application..................................................... 15
Intended use.................................................... 16
Environment of use.......................................... 16
Overview......................................................... 17
Babylog 8000................................................... 18
Trolley.............................................................. 22
Range of functions........................................... 23
Abbreviations................................................... 24
Symbols........................................................... 26
Product labels.................................................. 27
Operating concept......................................... 28
Control and display unit................................... 29
Dialog windows................................................ 33
Assembly and preparation ........................... 37
Safety information............................................ 38
Preparing the trolley ........................................ 38
Mounting an additional monitor ....................... 40
Preparing the ventilator ................................... 42
Connecting a gas analyzer.............................. 48
Establishing the gas supply............................. 49
Establishing the power supply ......................... 50
MEDIBUS protocol .......................................... 51
Establishing potential equalization .................. 52
Transport within the hospital............................ 53
Getting started............................................... 54
Safety information............................................ 55
Switching on the ventilator............................... 55
Charging the battery for the power supply
failure alarm..................................................... 57
Checking readiness for operation.................... 58
Operation........................................................ 62
Setting ventilation ............................................ 63
Endotracheal suction....................................... 68
Manual inspiration ........................................... 69
Medication nebulization................................... 70
Analog and digital interface ............................. 76
Terminating operation ..................................... 80
Alarms ............................................................ 81
Display of alarms............................................. 82
Suppressing the acoustic alarm signal............ 83
Acknowledging alarm messages..................... 83
Alarm limits...................................................... 84
Trends ............................................................ 86
Displaying waveforms and measured values .. 87
Displaying trends............................................. 90
Displaying the logbook .................................... 91
Monitoring...................................................... 92
Information on monitoring................................ 93
O2monitoring .................................................. 94
Flow monitoring ............................................... 95
Configuration................................................. 98
Displaying device information.......................... 99
Setting date and time ...................................... 99
Setting the volume of the alarm signal ............ 100
Setting the screen contrast.............................. 100
Selecting the language.................................... 101
Configuring the data interfaces ....................... 101
Troubleshooting ............................................ 105
Failure of the power supply ............................. 106
Alarm – Cause – Remedy ............................... 106
Cleaning, disinfection and sterilization....... 110
Safety information ........................................... 111
Dismantling the ventilator ................................ 111
Reprocessing methods.................................... 114
Reprocessing list ............................................. 117
After reprocessing ........................................... 119
Maintenance................................................... 120
Overview ......................................................... 121
Inspection ........................................................ 122
Preventive maintenance.................................. 124
Repairs ............................................................ 125
Replacing the cooling air filter ......................... 126

Contents
6 Instructions for use Babylog 8000 plus SW 5.n
Disposal ......................................................... 127
Disposal of the medical device........................ 128
Disposal of batteries........................................ 128
Disposal of O2sensors.................................... 129
Technical data ............................................... 130
Ambient conditions .......................................... 131
Set values........................................................ 131
Performance characteristics............................ 133
Displayed measured values ............................ 134
Displayed calculated measured values ........... 137
Monitoring functions ........................................ 138
Operating characteristics................................. 139
Device outputs................................................. 141
Essential performance characteristics............. 142
Alarm criteria ................................................... 143
EMC Declaration ............................................. 146
Connection to IT networks............................... 151
Principles of operation ................................. 152
Pneumatic function description ....................... 153
Description of ventilation modes ..................... 156
Additional settings for ventilation..................... 161
Measurements................................................. 165

Instructions for use Babylog 8000 plus SW 5.n 7
For your safety and that of your patients
For your safety and that of your patients
General safety information........................... 8
Strictly follow these instructions for use........... 8
Maintenance.................................................... 8
Safety checks .................................................. 8
Accessories ..................................................... 8
Not for use in areas of explosion hazard ......... 9
Connected devices.......................................... 9
Device combinations ....................................... 9
Patient safety................................................... 10
Patient monitoring............................................ 10
Information on electromagnetic compatibility .. 10
Disposable product.......................................... 11
Sterile accessories .......................................... 11
Installing accessories ...................................... 11
Storing the instructions for use........................ 11
Training............................................................ 11
Product-specific safety information ............ 12
Ensuring ventilation using an independent
manual ventilator ............................................. 14

For your safety and that of your patients
8 Instructions for use Babylog 8000 plus SW 5.n
General safety information
The following WARNING and CAUTION
statements apply to general operation of the
medical device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this device.
Strictly follow these instructions for use
Maintenance
Safety checks
The medical device must be subject to regular
safety checks. See chapter ''Maintenance''.
Accessories
WARNING
Risk of incorrect operation and incorrect use
Any use of the medical device requires full
understanding and strict observation of all
sections of these instructions for use. The
medical device must only be used for the
purpose specified under ''Intended use'' (see
page 16) and in conjunction with appropriate
patient monitoring (see page 10). Strictly
observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels.
Failure to observe these safety information
statements constitutes a use of the medical
device that is inconsistent with its intended
use.
WARNING
Risk of medical device failure and of patient
injury
The medical device must be inspected and
serviced regularly by service personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts. Dräger recommends DrägerService
for a service contract and for repairs. Dräger
also recommends using original Dräger parts
for maintenance.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter ''Maintenance''.
WARNING
Risk due to incompatible accessories
Dräger has only tested the compatibility of
accessories that appear in the current list of
accessories or in separate declarations by
Dräger. If other, incompatible accessories are
used, there is a risk of patient injury due to
medical device failure.
Dräger recommends using the medical device
only with accessories from the current list of
accessories.

Instructions for use Babylog 8000 plus SW 5.n 9
For your safety and that of your patients
Not for use in areas of explosion hazard
Connected devices
Device combinations
This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying
documents of the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional state of the individual
devices can be compromised. The operating
organization must ensure that the device
combination complies with the applicable editions
of the relevant standards for medical devices.
Device combinations approved by Dräger meet the
requirements of the following standards:
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, software-
controlled functions)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-8 (alarm systems)
Or:
– IEC 60601-1, 2nd edition (general
requirements for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-4 (software-controlled
functions)
– IEC 60601-1-8 (alarm systems)
WARNING
Risk of fire
The device is not approved for use in areas
where combustible or explosive gas mixtures
are likely to occur.
WARNING
Risk of electric shock and of device
malfunction
Electrical connections to equipment not
listed in these instructions for use or these
assembly instructions must only be made
when approved by each respective
manufacturer.
Before operating the medical device, strictly
comply with the instructions for use of all
connected devices or device combinations.

For your safety and that of your patients
10 Instructions for use Babylog 8000 plus SW 5.n
Patient safety
The design of the medical device, the
accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical
device are restricted to persons familiar with the
most important inherent characteristics of the
medical device.
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
The instructions for use do not contain any
information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with
different underlying diseases
Medical device modification or misuse can be
dangerous.
Patient monitoring
The user of the medical device is responsible for
choosing suitable monitoring that provides
appropriate information about medical device
performance and the patient's condition.
Patient safety may be achieved by 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 selecting the best level of
patient monitoring lies solely with the user of the
medical device.
Information on electromagnetic
compatibility
General information on electromagnetic
compatibility (EMC) according to international
EMC standard IEC 60601-1-2:
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
installed and put into operation in accordance with
the EMC information provided (see ''EMC
Declaration'').
Portable and mobile radio frequency
communication equipment can affect medical
electrical equipment.
WARNING
Risk of electric shock
Do not connect connectors with an ESD
warning symbol and do not touch their pins
without implementing ESD protective
measures. Such protective measures can
include antistatic clothing and shoes,
touching a potential equilization pin before
and during connection of the pins, or using
electrically insulating and antistatic gloves.
All users concerned must be instructed in
these ESD protective measures.
WARNING
Risk of device failure
Electromagnetic fields can compromise
proper operation of the device.
Electromagnetic fields are generated by, e.g.,:
– Mobile phones
– Radio frequency electrosurgical equipment
– Defibrillators
– Shortwave therapy equipment
Maintain sufficient safety distances, see EMC
declaration in chapter ''Technical data''.

Instructions for use Babylog 8000 plus SW 5.n 11
For your safety and that of your patients
Disposable product
Sterile accessories
Installing accessories
Strictly observe the instructions for use and
assembly instructions.
Storing the instructions for use
Training
User training is offered by the responsible Dräger
organization, see www.draeger.com.
WARNING
Risk of patient injury due to failure of
accessories
Disposable products have been developed,
tested, and manufactured for disposable use
only. Reuse, reprocessing or sterilization can
lead to a failure of the accessories and cause
injuries to the patient.
Do not reuse, reprocess, or sterilize
disposable products.
CAUTION
Risk of medical device failure and of patient injury
Do not use sterile-packaged accessories if the
packaging has been opened, is damaged, or if
there are other signs of non-sterility.
CAUTION
Risk of device failure
Install the accessory on the basic device in
accordance with the instructions of the basic
device.
Check for secure connection to the basic device.
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to
the user.

For your safety and that of your patients
12 Instructions for use Babylog 8000 plus SW 5.n
Product-specific safety information
WARNING
Risk of incorrect use
This medical device is intended to be used
only by the target group "users".
WARNING
Risk of suffocation following device failure
If the gas inlet for the emergency breathing
valve is obstructed, the patient will not be
able to breathe spontaneously in the case of a
device failure.
Do not obstruct the gas inlet for the
emergency breathing valve.
WARNING
Risk of malfunction
Unallowed modifications to the medical
device lead to malfunctions.
This medical device must not be altered
without permission from Dräger.
WARNING
Risk of patient injury
During magnetic resonance imaging the
correct functioning of the medical device can
be impaired.
Do not use the medical device during
magnetic resonance imaging.
WARNING
Risk of patient injury
In hyperbaric chambers the correct
functioning of the medical device can be
impaired.
Do not use the medical device in hyperbaric
chambers.
WARNING
Risk of patient injury with PEEP <2.5 mbar
(2.5 cmH2O)
If the PEEP is set to <2.5 mbar (2.5 cmH2O)
and the following settings are also made, the
integrated pressure monitoring cannot detect
an alarm situation during disconnection or
extubation and their immediate
consequences:
– Pinsp <10 mbar (10 cmH2O)
– Ventilation mode with volume guarantee
– Change from a ventilation mode with VG
into the ventilation mode IPPV, without
switching off VG
From a PEEP of 2.5 mbar (2.5 cmH2O) the risk
of an undetected alarm situation increases
with decreasing PEEP values.
Use external ventilation monitoring as well as
the following types of monitoring with narrow
alarm limits:
– SpO2monitoring
– Bradycardia monitoring
– TcO2/TcCO2monitoring
WARNING
Risk of eye injury
With neonates, the administration of
increased O2concentrations can lead to
retinopathy of prematurity.
Use additional monitoring, e.g., external SpO2
monitoring.
WARNING
Risk of incorrect NO dosing
If a device for nitric oxide (NO) delivery
without internal NO monitoring is used,
patient monitoring is not guaranteed.
Monitor the NO concentration separately.

Instructions for use Babylog 8000 plus SW 5.n 13
For your safety and that of your patients
WARNING
Risk of fire
The flow sensor can ignite medications or
other substances based on highly flammable
substances.
– Do not nebulize medications or other
substances that are easily flammable or
spray them into the device.
– Do not use substances containing alcohol.
– Do not allow flammable or explosive
substances to enter the breathing system
or the breathing circuit.
WARNING
Risk due to failure of flow measurement
Deposits that were not removed during
reprocessing can damage the measuring
wires in the flow sensor or cause a fire.
– Before inserting the flow sensor check for
visible damage, soiling, and particles.
Repeat this check regularly.
– Replace flow sensors when damaged,
soiled, or not particle-free.
WARNING
Risk of fire
The use of unapproved O2pressure reducers
can lead to excess pressure, which can cause
a fire.
– When supplying the ventilator with
oxygen from a compressed gas cylinder,
only use pressure reducers compliant
with ISO 10524.
– Slowly open the pressure reducer
manually. Do not use tools.
WARNING
Risk of fire
The medical device may catch fire as a result
of oxygen enrichment in the ambient air.
Medical device malfunctions can increase the
O2concentration in the ambient air.
The medical device is only suitable for use in
rooms with sufficient ventilation.
WARNING
Risk of fire
Do no use the medical device together with
flammable gases or flammable solutions that
may become mixed with air, oxygen or
nitrous oxide, or other ignition sources, as
the medical device may catch fire.
Do not allow the medical device to come into
contact with sources of ignition.
WARNING
Risk of electric shock
There is a risk of electric shock if the
connectors of the interfaces and the patient
are touched simultaneously.
Do not simultaneously touch the connectors
of the interfaces and the patient.
WARNING
Risk of patient injury
Penetrating liquid may cause malfunction of
the device, which may endanger the patient.
– Do not place any containers with liquid on
or above the device.
– Make sure that no liquid penetrates into
the device when disinfecting surfaces.

For your safety and that of your patients
14 Instructions for use Babylog 8000 plus SW 5.n
Ensuring ventilation using an
independent manual ventilator
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring
parameters.
CAUTION
Risk of patient injury
Positive-pressure ventilation can lead to negative
effects, such as barotrauma or strain on the
circulatory system.
Monitor the patient's condition.
CAUTION
Reduced O2concentration
When nitric oxide (NO) is added, the set
inspiratory O2concentration may be reduced.
Monitor the O2concentration.
CAUTION
Risk of medical device overheating
The medical device may overheat due to sources
of heat such as direct sunlight, heat radiators, or
spotlights.
– Keep the medical device away from sources
of heat.
– Only operate the medical device in rooms
with sufficient ventilation.
– Do not cover the medical device or slide the
rear of the device against a wall.
CAUTION
Risk of medical device overheating
If the ventilation slots on the medical device are
covered or sealed, the medical device may
overheat.
– Air must be able to enter freely.
– An alarm is triggered if the medical device
overheats during operation.
CAUTION
Risk of personal injury
If the glass on the LC screen is damaged, a
chemical liquid may escape.
– Avoid contact with the body.
– Immediately clean affected skin areas with
soap.
WARNING
Risk of patient injury
If a fault is detected in the medical device, its
life-support functions may no longer be
assured.
Ventilation of the patient using an
independent ventilation device must be
started without delay, if necessary with PEEP
and/or an increased inspiratory O2
concentration (e.g., with a manual
resuscitator).

Instructions for use Babylog 8000 plus SW 5.n 15
Application
Application
Intended use .................................................. 16
Environment of use....................................... 16

Application
16 Instructions for use Babylog 8000 plus SW 5.n
Intended use
Babylog 8000 plus 5.n is a long-term ventilator for
premature babies, newborns, and children with a
body weight of up to approx. 20 kg (44 lbs).
The device must only be operated by doctors or,
on a doctor's order, by clinical personnel.
Each user must be trained and familiar with the
instructions for use.
Environment of use
Babylog 8000 is intended for use in intensive care
units.
Do not use Babylog 8000 in the following
environments:
– In hyperbaric chambers
– For magnetic resonance imaging (MRI, NMR,
NMI)
– In conjunction with flammable gases or
flammable solutions that can mix with air,
oxygen, or nitrous oxide
– In areas of explosion hazard
– In areas with combustible or explosive
substances
– In rooms without sufficient ventilation

Instructions for use Babylog 8000 plus SW 5.n 17
Overview
Overview
Babylog 8000 ................................................. 18
Ventilator on trolley.......................................... 18
Control and display unit................................... 19
Patient connection panel ................................. 20
Rear................................................................. 21
Trolley............................................................. 22
Range of functions ........................................ 23
Ventilation functions ........................................ 23
Monitoring functions ........................................ 23
Power supply................................................... 23
Gas supply....................................................... 23
Data transfer (optional).................................... 23
Medication nebulization................................... 23
Non-invasive ventilation................................... 23
Abbreviations................................................. 24
Symbols.......................................................... 26
Product labels................................................ 27

Overview
18 Instructions for use Babylog 8000 plus SW 5.n
Babylog 8000
Ventilator on trolley
AControl and display unit, display panel
BControl and display unit, control panel
CControl panel cover
DTrolley
EPatient connection panel
21988
A
B
C
D
E

Instructions for use Babylog 8000 plus SW 5.n 19
Overview
Control and display unit
21096
Q
N
ML
H
I
KJ
ABCD
E
F
O
P
G
ALED Trigger
BScreen
CBar display for airway pressure Paw
DVisual alarm display
– Flashes red in the event of an alarm of
medium or high priority
– Flashes yellow if set value TIis incorrect
EKey to suppress alarm tone for 2 minutes
FOK key
GKey to select dialog windows
HVent. Mode key for ventilation modes
IVent. Option key for additional settings
JPEEP/CPAP setting knob with mechanical
release for PEEP <2.5 mbar (2.5 cmH2O)
KTEsetting knob
LPinsp setting knob
MTIsetting knob
Nsetting knob
OO2-Vol.% setting knob
PCal. Config. key
Qman. Insp. key
Insp. Flow

Overview
20 Instructions for use Babylog 8000 plus SW 5.n
Patient connection panel
A"Exhaust" muffler
BRocker lever for expiratory valve
CExpiratory port "GAS RETURN"
DInspiratory port "GAS OUTPUT"
21100
ABCD