Dräger Babylog 8000 plus User manual

Babylog 8000 plus
Infant Care Ventilator
Operating Instructions
Software 5.n
MT-549-97
D
MEDIC L

NOTICE
Proprietary Information
This document contains information in which Draeger Medical, Inc.
claimed proprietary rights. The information may not be reproduced in
whole or in part except as authorized in writing by Dräger.
This information is the property of Draeger Medical, Inc., it is provided
solely for the use intended.
Repairs/Modifications
Repairs on this device shall be performed only by DrägerService or
Factory Authorized Service Centers. Information about repairs can be
obtained from Dräger or Authorized Dealers. Draeger Medical, Inc. will
not be responsible for injury to persons or damage to property arising
directly or indirectly out of unauthorized repairs or modifications to this
device. Furthermore, any unauthorized repairs or modifications void any
warranty extended by Dräger.
This document is provided for your information only. It will not be
exchanged or updated without request.
Trademarks
The Dräger name and logo are registered trademarks of Dräger.
Babylogis a registered trademark of Dräger.
ThinkJetis a registered trademark of Hewlett Packard Corporation
Dräger Medical AG & Co. KGaA,1997-2001
All rights reserved, subject to modifications

MT 550-97

Working with these Operating Instructions
Header line – the title...
of the main chapter
The title of the respective sub-section is printed
underneath the main header – to help you find your way
quickly from subject to subject.
Page body...
the Operating Instructions
combine text and illustrations. The information is
presented in the form of required steps of action, giving
the user hands-on experience in learning how to use the
ventilator.
Left-hand column...
the text
provides explanations and instructs users step-by-step in
the practical use of the product, with short, clear
instructions in easy to follow sequences.
Bullet points indicate separate actions. Where several
actions are described, numbers are used to refer both to
relevant details in the illustrations and to specify the
sequence of actions.
Right-hand column...
the illustrations
provide the visual reference for the text and make it easier
to locate the various parts of the device. Elements
mentioned in the text are highlighted. Unnecessary details
are omitted.
Rendering of screen displays guide the user and allow to
reconfirm actions performed.
Typing conventions...
Controls are designated as »Control Name« , e.g:
»PEEP/CPAP«
Screen messages are printed in bold, e.g:
Calibrate flow sensor!
Working with these Operating Instructions
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
4
Calibrating the O2-Sensor Manually
After sensor has been replaced, but possible at all
times.
1Press »Cal Config.« menu key.
2Press »O2-Cal« menu key.
3After about 5 minutes, O2-Cal disappears from
the display, calibration is now completed.
The respective text message may now be cleared:
1Press »Confirm« key.
DBabylog 8000 plus
1
Preparation
Calibrations
WARNING !
Strictly follow this Operator's Instruction Manual
Any use of the product requires full under-
standing and strict observation of all portions of
these instructions. The equipment is only to be
used for the purpose specified under "Intended
Use" (see page 18) and in conjunction with
appropriate airway monitoring (see page 19).
Observe all WARNINGS and CAUTIONS as
rendered throughout this manual and on labels
on the equipment.
3
DBabylog 8000 plus
1
2

Contents
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
Contents
Index 144
Important Safety Information READ THIS FIRST ! 7
Intended Use 17
Operating Concept 21
Preparation 27
Operation 51
Care 97
Troubleshooting 105
What's What 111
Technical Data 119
Theory of Operation 129
Ordering Information 143
5

Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
6
This page intentionally left blank

Contents
Operator's Responsibility for Patient Safety.................................................8
Limitation of Liability.................................................................................... 8
Warranty.....................................................................................................9
Definitions................................................................................................. 10
Summary of WARNINGS and CAUTIONS................................................ 10
General Precautions..................................................................................10
Precautions During Preparation................................................................. 12
Precautions During Operation....................................................................13
Precautions During Care........................................................................... 15
Precautions During Maintenance............................................................... 16
Important Safety Information
Contents
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
7
Important Safety Information

Limitation of Liability
Dräger's liability, whether arising out of or related to
manufacture and sale of the goods, their installation,
demonstration, sales representation, use, performance,
or otherwise, including any liability based upon Dräger's
Product Warranty, is subject to and limited to the exclu-
sive terms and conditions as set forth, whether based
upon breach of warranty or any other cause of action
whatsoever, regardless of any fault attributable to
Dräger and regardless of the form of action (including,
without limitation, breach of warranty, negligence, strict
liability, or otherwise).
THE STATED EXPRESSED WARRANTlES ARE IN LlEU
OF ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED, INCLUDING, WITHOUT LIMITATION,
WARRANTlES OF MERCHANTABILITY, FITNESS
FOR ANY PARTICULAR PURPOSE, OR
NONINFRINGEMENT.
Dräger shall not be liable for, nor shall buyer be entitled
to recover any special incidental, or consequential
damages or for any liability incurred by buyer to any third
party in any way arising out of or relating to the goods.
Operator's Responsibility for Patient Safety
The design of the equipment, the accompanying
literature, and the labeling on the equipment take into
consideration that the purchase and use of the equipment
are restricted to trained professionals, and that certain
inherent characteristics of the equipment are known to
the trained operator. Instructions, warnings, and caution
statements are limited, therefore, largely to the specifics
of the Dräger design. This publication excludes refe-
rences to various hazards which are obvious to a medical
professional and operator of this equipment, to the
consequences of product misuse, and to potentially
adverse effects in patients with abnormal conditions.
Product modification or misuse can be dangerous.
Dräger disclaims all liability for the consequences of
product alterations or modifications, as well as for the
consequences which might result from the combination
of this product with other products whether supplied by
Dräger or by other manufacturers if such a combination is
not endorsed by Dräger.
The operators of the ventilator system must recognize
their responsibility for choosing appropriate safety moni-
toring that supplies adequate information on equipment
performance and patient condition. Patient safety may be
achieved through a wide variety of different means
ranging from electronic surveillance of equipment perfor-
mance 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
equipment operator (see also page 19, "Mandatory
Ventilation Monitoring").
WARNING !
Strictly follow this Operator's Instruction
Manual.
Any use of the product requires full under-
standing and strict observation of all portions
of these instructions. The equipment is only to
be used for the purpose specified under
"Intended Use" (page 18) and in conjunction
with appropriate airway monitoring (see page
19). Observe all WARNINGS and CAUTIONS
as rendered throughout this manual and on
labels on the equipment.
Important Safety Information
Operator's Responsibility for Patient Safety
Limitation of Liability
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
8

Application of this warranty is subject to the following
conditions:
1. Dräger or its authorized representative must be
promptly notified, in writing, upon detection of the
defective material or equipment.
2. Defective material or equipment must be returned,
shipping prepaid, to Dräger or its authorized
representative.
3. Examination by Dräger or its authorized represen-
tative must confirm that the defect is covered by
the terms of this warranty.
4. Notification in writing, of defective material or
equipment must be received by Dräger or its
authorized representative no later than two (2)
weeks following expiration of this warranty.
The above is the sole warranty provided by Dräger.
No other warranty expressed or implied is intended. Rep-
resentatives of Dräger are not authorized to modify the
terms of this warranty.
Draeger Medical, Inc., Telford, PA
Warranty
All Dräger products are guaranteed to be free of
defects for a period of one year from date of delivery.
The following are exceptions to this warranty:
1. The defect shall be a result of workmanship or
material. Defects caused by misuse, mishandling,
tampering, or by modifications not authorized by
Dräger or its representatives are not covered.
2. Rubber and plastic components and materials are
warranted to be free of defects at time of delivery.
3. Oxygen sensors capsules have a six-month limited
warranty from the date of delivery.
Any product which proves to be defective in workman-
ship or material will be replaced, credited, or repaired
with Dräger holding the option. Dräger is not respon-sib-
le for deterioration, wear, or abuse. In any case, Dräger
will not be liable beyond the original selling price.
Important Safety Information
Warranty
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
9

Summary of WARNINGS and
CAUTIONS
General Precautions
WARNING !
DANGER, risk of explosion if used in the
presence of flammable anesthetics.
This device is neither approved nor certified
for use in areas where combustible or explo-
sive gas mixtures with air or with nitrous oxide
are likely.
WARNING !
This device is to be used only in rooms with
line power installations complying with
national safety standards for hospital patient
rooms. (e.g., IEC 601.1, "Safety of Medical
Equipment).
To maintain grounding integrity, connect only
to a"hospital grade" receptacle.
Always disconnect supply before servicing.
WARNING !
Babylog 8000 plus is solely intended for use by
physicians or by allied health care profession-
als on the order of a physician. All users must
be properly trained and completely familiar with
these Operating Instructions.
WARNING !
Strictly follow this Operator's Instruction
Manual
Any use of the product requires full under-
standing and strict observation of all portions
of these instructions. The equipment is only to
be used for the purpose specified under
"Intended Use" (page 18) and in conjunction
with appropriate airway monitoring (see page
19). Observe all WARNINGS and CAUTIONS
as rendered throughout this manual and on
labels on the equipment.
Definitions
NOTE: A NOTE provides additional information
intended to avoid inconveniences during operation.
Inspection = examination of actual condition
Service = measures to maintain specified
condition
Repair = measures to restore specified
condition
Maintenance = inspection, service, and repair,
where necessary
Preventive = Maintenance measures at regular
Maintenance intervals
Typing conventions in this manual
Controls (knobs, hard keys and menu keys) are
designated as »Control Name«, e.g.:
»PEEP/CPAP«
On-screen messages are printed in bold, e.g.:
Calibrate flow sensor!
CAUTION !
A CAUTION statement designates the possibility
of damage to equipment if disregarded.
WARNING !
A WARNING statement refers to conditions
with a possibility of personal injury if
disregarded.
Important Safety Information
Definitions
Summary of W RNINGS and C UTIONS
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
10

CAUTION !
Restriction of Distribution
Federal Law and Regulations in the United
States and Canada restrict this device to sale by
or on the order of a physician.
WARNING !
If a fault is detected in the ventilator and its
life-support functions are in doubt, ventilation
must be started without delay with an inde-
pendent ventilation device (resuscitation bag)
- using PEEP and/or increased inspiratory O2
concentration where necessary and appro-
priate. The unit should then be removed from
use and serviced by an authorized service
technician.
WARNING !
In case of malfunction of any of the built-in
monitoring a substitute must be provided in
order to maintain an adequate level of moni-
toring. The operator of the ventilator must still
assume full responsibility for proper venti-
lation and patient safety in all situations.
WARNING !
Always use independent apnea monitor when
the built-in apnea monitoring has been
switched off. The operator of the ventilator
must still assume full responsibility for proper
ventilation and patient safety in all situations.
WARNING !
Whenever a patient is connected to the venti-
lator, constant attention by qualified medical
staff is required in order to provide immediate
corrective action in case of a malfunction.
WARNING !
Sidestream monitors may cause negative
pressures in the event of a blocked inspiratory
circuit. Always connect monitoring lines of a
suctioning sidestream monitor via adapter
84 12 448 with safety valve.
WARNING !
Do not use ventilator in conjunction with
nuclear spin tomography (MRT, NMR, or NMI)!
Equipment malfunction may result.
WARNING !
Mobile telephones must not be used within 10
meters (33 feet) of the equipment. Mobile
telephones can interfere with the function of
electromedical equipment and therefore
endanger the patient!
Important Safety Information
Summary of WARNINGS and CAUTIONS
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
11

WARNING !
Note arrows for inspiratory and expiratory
connector on ventilator ports. If circuit ends
are confused, humidification will not be
effective.
WARNING !
In order to avoid any risk of electric shock in
the event of faulty grounding of patient moni-
toring equipment, do not use antistatic or
electrically conductive patient circuits
WARNING !
Dräger cannot warrant or endorse the safe
performance of third party ventilator circuits
for use with the Babylog 8000 plus infant
ventilator. Increased pneumatic resistance
caused by some circuit systems may result in
inaccurate airway pressure readings.
Only use circuits with an inner diameter of at
least 10 mm (0.4 inch)
We recommend contacting the manufacturers
/distributors of infant patient circuits
regarding compliance of their products with
the requested performance characteristics
(see p. 32).
WARNING !
Dräger cannot warrant or endorse the safe
performance of third party humidifiers for use
with the Babylog 8000 plus infant ventilator.
Specifically, combinations of humidifiers not
intended for use with infant patients bear risks
of delivering breathing gas not maintained at a
proper temperature.
Excessive rainout in the inspiratory line of the
breathing circuit may disable the flow and
volume measuring capabilities of the Babylog
8000 plus ventilator.
Increased pneumatic resistance and compli-
ance in the inspiratory line caused by
a humidifier may result in inaccurate airway
pressure readings.
We recommend contacting the manufacturers
/distributors of heated humidifying devices
about compliance of their products with the
requested performance characteristics.
Precautions During Preparation
WARNING !
To maintain grounding integrity, connect only
to a "hospital grade" receptacle. Always
disconnect supply before servicing.
WARNING !
Always provide adequate ventilation!
When the equipment is being operated with
O2, ensure that the ambient concentration
does not exceed 24% O2. Otherwise, the risk
of fire may be increased.
WARNING !
Always use medical grade oxygen and air that
is dry and free from dust and oil. Contami-
nated gas may cause ventilator malfunction.
WARNING !
Treatment of batteries and O2-sensor
capsules:
Do not throw into fire! Risk of explosion.
Do not force open! Danger of bodily injury.
Follow all local, state, and federal regulations
with respect to environmental protection when
disposing of batteries and O2-sensor
capsules.
WARNING !
Always install expiratory valve that has been
cleaned and disinfected.
Important Safety Information
Summary of W RNINGS and C UTIONS
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
12

Precautions During Operation
WARNING !
The operator of the ventilator must still
assume full responsibility for proper
ventilation and patient safety when switching
off flow measurement during nasal CPAP.
Use appropriate external monitoring to assure
patient's oxygenation status and to detect
apnea.
WARNING !
In case of malfunction of any of the built-in
monitoring, a substitute must be provided in
order to maintain an adequate level of moni-
toring. The operator of the ventilator must still
assume full responsibility for proper ventila-
tion and patient safety in all situations. This is
particularly important when, during a nebulizer
treatment, the Babylog flow sensor has been
removed to protect it against contamination.
WARNING !
If a fault is detected in the ventilator and its
life support functions are in doubt, ventilation
must be started without delay with an inde-
pendent ventilation device (resuscitation bag)
- using PEEP and/or increased inspiratory O2
concentration where necessary and appro-
priate. The unit should then be removed from
use and serviced by an authorized service
technician.
WARNING !
Whenever a patient is connected to the venti-
lator, constant attention by qualified medical
staff is required in order to provide immediate
corrective action in case of a malfunction.
Not any and every critical condition can be
expected to cause a ventilator alarm.
WARNING !
Always use ventilator that has been cleaned
and disinfected and has been successfully
tested to be ready for operation.
CAUTION !
Always hold end cuffs when pulling a circuit from
a port. Otherwise damage to the patient circuit
will result.
CAUTION !
If Air and O2supply lines are contaminated with
particles or moisture, as is likely during the use
with a medical air compressor, use high pressure
line filters that retain at least 0.1 micron particles
and stop water droplets (e.g. Dräger part no.
D 800 130, D 800 132).
CAUTION !
Do not place containers of liquids on top of the
Babylog 8000 plus ventilator. Liquids penetrating
the ventilator can cause equipment malfunction
and damage.
WARNING !
The ventilator is ready for operation only when:
- it is completely assembled with all required
auxiliary equipment in place,
- all sensors are calibrated (O2, Flow),
- all checks have been completed successfully.
WARNING !
Always use safety valve when connecting
sampling CO2or NO monitors. Otherwise
negative airway pressures may result in the
event of a blocked inspiratory circuit.
WARNING !
To maintain grounding integrity, connect only
to a "hospital grade" receptacle. Always
disconnect supply before servicing.
Important Safety Information
Summary of W RNINGS and C UTIONS
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
13

WARNING !
When the flow and volume measuring system of
the Babylog 8000 plus ventilator is not operable,
detection of spontaneous breathing activity is
not possible. Therefore no apnea alarm is pro-
vided at that time.
Tidal volumes for ventilated infants are signifi-
cantly influenced by the compressible volume of
the breathing circuit (in addition to parameters
of the patients lungs). Adjustment of inspiratory
time, expiratory time, pressure limits, and inspir-
atory flow rate all affect the tidal volume deliv-
ered to the patient. Assessment of ventilator set-
tings must be made with special care during pe-
riods where no patient flow/volume information
is available. Otherwise, lung damage due to ex-
cessive tidal volumes and/or pressures may re-
sult.
WARNING !
The wires of the Babylog 8000 plus flow sensor
operate at a high temperature. If the sensor is
left in the patient circuit for an extended period
of time while nebulizing without cleaning,
residue buildup might result from the pharma-
ceutical aerosols that would impair flow
measurement.
As a worst case, these residues might ignite!
To prevent this, it is not sufficient to remove the
electrical connector from the flow sensor.
Therefore, it is mandatory to physically remove
the flow sensor from the circuit, (resp. the flow
sensor element from the wye) before beginning
any nebulizer treatment.
WARNING !
Aerosol medications may clog bacteria filters
which can impair ventilation.
Therefore, do not use bacteria filters at the
nebulizer output or in the expiratory side of
the patient circuit.
WARNING !
Aerosol medications may clog expiratory
valves which can impair ventilation.
Therefore, exchange expiratory valve
immediately after nebulizing aerosols.
WARNING !
Do not block air intake. Ventilator malfunction
will result.
Be careful not to cause back pressure when
using scavenging systems.
WARNING !
• Always use extreme caution when using
oxygen!
• Oxygen intensely supports any burning!
No smoking, no open fire in areas where
oxygen is in use!
• Always provide adequate ventilation in order to
maintain ambient O2concentrations < 24 %.
• Always secure O2cylinders against tipping, do
not expose to extreme heat.
• Do not use oil or grease on O2equipment
such as tank valves or pressure regulators.
Do not touch with oily hands. Risk of fire!
• Open and close valves slowly, with smooth
turns. Do not use any tools.
WARNING !
The accuracy of the concentration of oxygen
delivered to the patient must be monitored at
all times. If the oxygen analyzer integrated
into the Babylog 8000 plus ventilator is not
operable, an independent oxygen monitor
must be connected to the inspiratory limb of
the patient circuit.
WARNING !
Always heed all precautions and follow all
hospital protocols with respect to the admin-
istration of oxygen. It is absolutely essential
that the ventilation regime and the oxygen
concentration administered is selected on the
basis of arterially measured oxygen partial
pressure in the blood of the infant. This is the
only way of minimizing the risk of both hyper-
oxemia, which might cause, above all, retro-
lental fibroplasia, and hypoxemia, which
might contribute to intraventricular hemor-
rhage and damage to the baby's brain.
Important Safety Information
Summary of W RNINGS and C UTIONS
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
14

Precautions During Care
CAUTION !
Ensure that no liquid remains in the pressure
measuring canal of the expiratory valve, as it
might cause malfunction.
CAUTION !
Do not process flow sensor element in cleaning
and disinfection equipment.
Do not use compressed air, a brush or similar
tools to clean the flow sensor element, as this
would possibly damage the thin wires in the flow
sensor.
CAUTION !
Certain components of the ventilator consist of
materials that are sensitive to certain organic
solvents sometimes used for cleaning and
disinfecting (e.g., phenols, halogen releasing
compounds, oxygen releasing compounds,
strong organic acids, etc.). Exposure to such
substances may cause damage that is not always
immediately apparent. Sterilization with ethylene
oxide (EtO) is also not recommended.
WARNING !
The ventilator is only ready for operation when
it has been completely assembled and the flow
sensor been calibrated after switching the
ventilator on.
WARNING !
Follow all accepted hospital procedures for
disinfecting parts contaminated by body fluids
(protective clothing, eyewear, etc.).
WARNING !
Always follow accepted hospital procedures
for handling equipment contaminated with
body fluids.
CAUTION !
Do not place containers of liquids on top of the
Babylog 8000 plus ventilator. Liquids penetrating
the ventilator can cause equipment malfunction
and damage.
CAUTION !
Use only dry and clean compressed air and oxy-
gen. Water and/or oil in the air or oxygen supply
will cause equipment malfunction and damage.
WARNING !
Therapeutic decisions should not be made solely
on the basis of the data transmitted via the com-
munications Interface. Always use other diag-
nostic means in addition.
WARNING !
The alarm silence button is intended to provide a
way of muting audible alarms while corrective
action is taken. The operator of the ventilator
must still assume responsibility for proper venti-
lator function and patient safety in the event of
an alarm. Failure to identify and correct alarm
situations may result in patient injury.
WARNING !
Warning or Caution level audible alarms
require immediate operator attention to avert
or to prevent development of situations with
the possibility of patient injury.
WARNING !
Water traps should be used in appropriate loca-
tions of the breathing circuit in order to prevent
water accumulation in the tubing from being
drained toward the patient's airway.
Important Safety Information
Summary of WARNINGS and CAUTIONS
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
15

CAUTION !
The device must be inspected and serviced at
regular 6 month intervals. A record must be kept
on this preventive maintenance. We recommend
obtaining a service contract with DrägerService
through your vendor.
For repairs of the Babylog 8000 plus infant venti-
lators, we recommend that you contact
DrägerService.
WARNING !
Treatment of batteries and O2-sensor
capsules:
Do not throw into fire! Risk of explosion.
Do not force open! Danger of bodily injury.
Follow all local, state, and federal regulations
with respect to environmental protection when
disposing of batteries and O2-sensor
capsules.
Precautions During Maintenance
For ventilators with liquid crystal displays (LCD):
WARNING !
If, in case of damage to the ventilator, the
glass of the LCD screen is broken, a liquid
chemical may escape that should not come
into contact with the skin. In case of
contamination, wash off with soap
immediately.
WARNING !
Never operate the ventilator if it has suffered
physical damage or does not seem to operate
properly. In this case always refer servicing to
properly trained and factory authorized service
personnel.
WARNING !
Disconnect power!
Before opening the unit, always disconnect
plug at the wall outlet first.
WARNING !
When servicing the ventilator, always use
replacement parts that are qualified to
Dräger standards.
Dräger cannot warrant or endorse the safe
performance of third party replacement parts
for use with the Babylog 8000 plus ventilator.
WARNING !
Preventive Maintenance work on the Babylog
8000 plus ventilator shall be performed by
properly trained and factory authorized staff
onl
y
.
WARNING !
To avoid any risk of infection, clean and disin-
fect ventilator and accessories before any
maintenance according to established
hospital procedures - this applies also when
returning ventilators or parts for repair.
Important Safety Information
Summary of W RNINGS and C UTIONS
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
16

Contents
Intended Medical Applications.................................................................18
Available Ventilation Modes.....................................................................18
Mandatory Ventilation Monitoring............................................................ 19
Backup Ventilation With an Independent Manual Ventilation Device......19
Intended Use
Contents
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
17
Intended Use

Restrictions of Use
____________
*Dräger medical equipment conforms to the interference immunity
requirements laid down in product-specific standards or in
EN 60601-1-2 (IEC 601-1-2). However, depending on the design
of a mobile phone and the use situation, field strengths exceeding
the values laid down in the specified standards may be generated
in the immediate vicinity of mobile phones, thereby causing
interference and malfunctions.
WARNING !
Do not use ventilator in conjunction with
nuclear spin tomography (MRT, NMR, or NMI)!
Equipment malfunction may result.
WARNING !
Mobile telephones must not be used within 10
meters (33 feet) of the equipment. Mobile
telephones can interfere with the function of
electromedical equipment and therefore
endanger the patient*!
WARNING !
DANGER, risk of explosion if used in the
presence of flammable anesthetics.
This device is neither approved nor certified
for use in areas where combustible or explo-
sive gas mixtures with air or with nitrous oxide
are likely.
WARNING !
This device is to be used only in rooms with
line power installations complying with
national safety standards for hospital patient
rooms. (e.g., IEC 601.1, "Safety of Medical
Equipment).
To maintain grounding integrity, connect only
to a"hospital grade" receptacle.
Always disconnect supply before servicing.
CAUTION !
Restriction of Distribution
Federal Law and Regulations in the United States
and Canada restrict this device to sale by or on the
order of a physician.
Intended Medical Application
Babylog 8000 plus is a long term ventilator to be used in
the intensive care of premature and newborn babies and
of infants up to 10 kg (22 lbs).
Available Ventilation Modes
CMV Continuous Mandatory Ventilation,
Time-controlled, time-cycled, pressure-
limited continuous flow ventilation.
A/C Assist Control Ventilation
Time-controlled, volume triggered, time-
cycled, pressure-limited continuous flow venti-
lation that is synchronized with each spontane-
ous patient breath.
SIMV Synchronized Intermittent Mandatory
Ventilation,
Time-controlled, volume triggered, time-
cycled, pressure-limited continuous flow venti-
lation, synchronized with patient's spontane-
ous breathing at the set ventilation rate.
PSV Pressure Support Ventilation
(available option),
Time-controlled, volume-triggered, flow
cycled, pressure-limited ventilation synchron-
ized with each spontaneous patient breath.
CPAP Continuous Positive Airway Pressure,
Spontaneous breathing with positive
airway pressure.
Ventilation Mode Extensions
VG Volume Guarantee (available option)
Volume controlled ventilation. The ventilator
controls inspiratory pressure in order to
deliver the preset tidal volume. May be com-
bined with A/C, SIMV, and PSV.
VIVE Variable Inspiratory, Variable Expiratory Flow
Separate continuous flow during expiration in
mandatory ventilation modes.
WARNING !
Babylog 8000 plus is solely intended for use by
physicians or by allied health care profession-
als on the order of a physician. All users must
be properly trained and completely familiar with
these Operating Instructions.
Intended Use
Intended Medical Applications
Restrictions of Use
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
18

Mandatory Ventilation Monitoring
Babylog 8000 plus includes monitoring for:
– inspiratory O2concentration
– airway pressure
– flow
– tidal volumes
– respiration rate (tachypnea monitoring)
An optional communications interface for the Babylog
8000 plus ventilator is available for communicating
measured data and ventilator settings to other devices,
such as patient monitors or computers.
For administering pharmaceutical aerosols, the ventilator
may be combined with a pneumatic nebulizer.
Backup Ventilation With an Indepen-
dent Manual Ventilation Device
(Resuscitation Bag)
WARNING !
If a fault is detected in the ventilator and its
life-support functions are in doubt, ventilation
must be started without delay with an inde-
pendent ventilation device (resuscitation bag)
- using PEEP and/or increased inspiratory O2
concentration where necessary and appro-
priate. The unit should then be removed from
use and serviced by an authorized service
technician.
WARNING !
In case of malfunction of any of the built-in
monitoring a substitute must be provided in
order to maintain an adequate level of moni-
toring. The operator of the ventilator must still
assume full responsibility for proper ventilation
and patient safety in all situations.
WARNING !
Always use independent apnea monitor when
the built-in apnea monitoring has been
switched off. The operator of the ventilator
must still assume full responsibility for proper
ventilation and patient safety in all situations.
WARNING !
Whenever a patient is connected to the venti-
lator, constant attention by qualified medical
staff is required in order to provide immediate
corrective action in case of a malfunction.
WARNING !
Sidestream monitors may cause negative
pressures in the event of a blocked inspiratory
circuit. Always connect monitoring lines of a
suctioning sidestream monitor via adapter
84 12 448 with safety valve.
Intended Use
Mandatory Ventilation Monitoring
Backup Ventilation With an Independent Manual Ventilation Device (Resuscitation Bag)
Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
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Operating Instructions Babylog 8000 plus SW 5, USA, 3rd. ed.
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