2. Dräger
  3. Babylog 8000 plus
Babylog 8000 plus

Dräger Babylog 8000 plus Instructions For Use Manual

  • Hello! I am an AI chatbot trained to assist you with the Dräger Babylog 8000 plus Instructions For Use Manual. I’ve already reviewed the document and can help you find the information you need or explain it in simple terms. Just ask your questions, and providing more details will help me assist you more effectively!
Intensive Care Ventilator
for Neonates
Software 5.n
Instructions for Use
Babylog 8000 plus
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.
Working with these Instructions for Use
2
Working with these Instructions for Use
Header line...
the title of the main chapter.
The title of the specific sub-section is printed underneath the
main header – to help you find your way quickly from subject
to subject.
Page body...
the Instructions for Use
in combined text/illustrations. The information is expressed in
the form of practical actions, giving the user direct hands-on
experience in learning how to use the machine.
Left-hand column...
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.
Bullet points indicate separate actions. Where several actions
are described, numbers are used both to refer to the 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 equipment. Elements mentioned
in the text are highlighted. Unnecessary details are avoided.
Screen displays prompt the user to proceed and confirm
correct actions.
Definitions
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 equipment or other property.
NOTE
A NOTE provides additional information intended to avoid
inconvenience during operation.
Preparation
24
Calibration
Calibration
For oxygen measurement:
– This is done automatically every 24 hours during operation.
– It must be done manually each time the sensor is replaced.
– It may be done manually at any time.
For flow measurement:
– This must be done each time the ventilator is switched on
and
– each time the sensor is replaced.
For pressure measurement:
– This is done automatically each time the ventilator is
switched on.
Calibrating the O
2 sensor manually
This is required only when the sensor is replaced, but may be
done at any time.
1 Press the key »Cal. Config.«.
2 Press the key »O
2-Cal«.
3 After about 5 minutes, the display »O
2-Cal« disappears
from the status window, indicating that calibration is
complete.
222
1
027
2
028
3
Contents
3
Contents
For Your Safety and that of Your Patients 5
Intended Use 8
Operating Principle 9
Preparation 15
Operation 31
Fault – Cause – Remedy 77
Care 81
Maintenance intervals 93
What’s What 95
Technical Data 101
Description 113
Parts List/Order List 131
Index 136
4
5
For Your Safety and that of Your Patients
For Your Safety and that of Your
Patients
Strictly follow these Instructions for Use
Maintenance
Accessories
Not for use in areas of explosion hazard
Safe connection with other electrical equipment
WARNING
Any use of the medical device requires full
understanding 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 8 and in conjunction with appropriate patient
monitoring. 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 product that is inconsistent with its intended use.
WARNING
The device must be inspected and serviced regularly by
trained service personnel. Repair of the device may also
only be carried out by trained service personnel.
Dräger recommends that a service contract be obtained
with DrägerService and that all repairs also be carried
out by DrägerService. Dräger recommends that only
authentic Dräger repair parts be used for maintenance.
Otherwise, the correct functioning of the device may be
compromised.
Observe chapter "Maintenance Intervals".
WARNING
Only the accessories indicated on the Order List have
been tested and approved to be used with the device.
Accordingly, it is strongly recommended that only these
accessories be used in conjunction with the specific
device. Otherwise, the correct functioning of the device
may be compromised.
WARNING
The device is neither approved nor certified for use in
areas of explosion hazard.
WARNING
Risk of patient injury
Electrical connections to equipment not listed in these
Instructions for Use should only be made following
consultation with the respective manufacturers.
Networking
Device combinations approved by Dräger (see Instructions for
Use of the individual devices or units) meet the requirements of
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 to other Dräger
devices or third-party devices and the resulting combination is
not approved by Dräger, the owner must ensure that the
resulting system meets the requirements of the above-
mentioned standards.
Strictly observe Assembly Instructions and Instructions for Use
for each networked device.
Patient safety
The design of the medical device, the accompanying docu-
mentation, and the labelling on the medical device are based
on the assumption that the purchase and the 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 therefore largely limited to the
specifics of the Dräger device.
These Instructions for Use exclude references to various
hazards which are obvious to medical professionals, to the
consequences of medical device misuse, and to potentially
adverse effects in patients with different underlying diseases.
Medical device modification or misuse can be dangerous.
6
For Your Safety and that of Your Patients
Patient monitoring
The operators of the medical device must recognise their
responsibility for choosing appropriate safety monitoring that
supplies adequate information on device performance and
patient condition.
Patient safety may be achieved through a wide variety of
means ranging from electronic surveillance of device perform-
ance and patient condition to simple, direct observation of clin-
ical signs.
The responsibility for selecting the best level of patient moni-
toring lies solely with the medical device operator.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely on individual
measured values and monitoring parameters.
General safety information
The following WARNINGS and CAUTIONS apply to general
operation of the medical device.
WARNINGS and CAUTIONS specific to subsystems or partic-
ular 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 medical device.
WARNING
The medical device must only be operated by trained
medical professionals.
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. Keep igni-
tion sources away from medical devices.
WARNING
If PEEP is set to <2.5 mbar, additional respiratory
monitoring and external saturation monitoring (SpO
2 with
narrow alarm limits) or Bradycardia monitoring (heart
rate) or TcO
2 / TcCO2 monitoring (also using narrow alarm
limits) must be used.
With the following equipment settings and a PEEP
of <2.5 mbar, a patient disconnection or extubation or
their immediate consequences can only be detected
securely and flagged as an alarm situation by these
monitoring combinations, and not by the integrated
pressure monitoring of the device:
– Ventilation mode with VG and PEEP of <2.5 mbar
simultaneously.
– Pinsp <10 mbar and PEEP of <2.5 mbar simultane-
ously.
– Switching from a ventilation mode using VG to IPPV
without turning VG off and with a PEEP of <2.5 mbar.
Therefore: Turn VG off when switching to IPPV.
Due to equipment and hose system tolerances, in
these cases no exact PEEP limits can be indicated for
omission of the alarm. This risk increases with a PEEP
of 2.5 mbar and lower.
CAUTION
Extractive monitors can generate a vacuum in the airway
if the inspiration tube becomes blocked.
Connect the sampling line of the extractive monitor only via
the adapter with safety valve 84 12 448.
CAUTION
If the integrated apnoea monitor is switched off, use
a separate apnoea monitoring device, otherwise apnoea
monitoring will not take place.
7
For Your Safety and that of Your Patients
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibility EMC/
ESD declaration according to international EMC standard
IEC 60601-1-2:
Medical electrical equipment requires special precautions
regarding electromagnetic compatibility (EMC) and needs to
be installed and put into service according to the EMC informa-
tion provided in the technical documentation. See Technical
Data, "EMC Declaration" on page 109.
Portable and mobile RF communications equipment can affect
medical electrical equipment.
Ensuring ventilation using an independent manual
ventilator
WARNING
Pins of connectors identified with the ESD
warning symbol shall not be touched and
shall not be connected unless ESD precautio-
nary procedures are used. Such protective measures
may include antistatic clothing and shoes, touching
a ground stud before and during connection of the pins,
or using electrically insulating and antistatic gloves.
All personnel involved in the above shall receive instruc-
tion in these ESD protective measures
.
WARNING
In the case of an obvious defect in the device, the life-
support function may be endangered. The patient must
be ventilated immediately using an independent venti-
lator. If necessary, PEEP and/or an increased inspiratory
O
2 concentration should be applied (e. g. with the
manual ventilation bag MR-100).
8
Intended Use
Intended Use
Babylog 8000 plus 5.n
Long-term ventilator for premature and newborn babies and for
infants weighing up to 20 kg.
It is intended for use in an intensive care area.
The unit should only be operated by qualified personnel.
All users must be suitably trained and must be familiar with the
Instructions for Use.
Use of the ventilation modes
– IPPV/IMV (Intermittent Positive Pressure Ventilation and
Intermittent Mandatory Ventilation)
Controlled ventilation according to a predetermined pattern
and frequency, regardless of the patient's spontaneous
breathing.
– SIPPV (Synchronized Intermittent Positive Pressure
Ventilation)
Controlled ventilation with a predetermined pattern or
predetermined tidal volume, synchronised with each
spontaneous breath by the patient.
– SIMV (Synchronized Intermittent Mandatory Ventilation)
Controlled ventilation with a predetermined pattern or
predetermined tidal volume and frequency, synchronised
with the patient's spontaneous breathing. The patient
breathes spontaneously between the synchronised ventila-
tion strokes.
– PSV (Pressure Support Ventilation) – optional
Synchronised ventilation with a predetermined inspiration
pressure or predetermined tidal volume. The patient
determines the duration of the inspiration and the ventilation
frequency.
– CPAP (Continuous Positive Airway Pressure)
Spontaneous breathing with positive airway pressure.
The above ventilation modes can be combined with the
following special functions:
– VG (Volume Guarantee) – optional
Volume-controlled ventilation. The unit automatically regu-
lates the inspiration pressure in order to achieve a predeter-
mined tidal volume.
This can be combined with SIPPV, SIMV and PSV.
– HFV (High
Frequency Ventilation) – optional
High-frequency ventilation for patients weighing up to 2 kg.
This can be combined with IPPV/IMV or CPAP.
– VIVE (Variable Inspiratory Variable Expiratory Flow)
Separately adjustable continuous flow during the expiration
phase of mandatory ventilation. This cannot be combined
with HFV.
The ventilator monitors:
– inspiratory oxygen concentration,
– airway pressure,
– flow,
–tidal volume and
– breathing rate (for panting breathing).
The Babylog 8000 plus can be equipped with an interface for
the transfer of measured data and settings to units such as
patient monitors or computers.
If necessary, the ventilator can also be combined with a medical
nebulizer.
MEDIBUS
Software protocol for the transfer of data between
Babylog 800 plus and an external medical or non-
medical device (e.g. patient monitors or computers
for data management systems) via an RS 232 port, see
"MEDIBUS for Dräger Intensive Care Devices" (9029205).
All transferred data are for information only and should not
be used as a basis for diagnostic or therapeutic decisions.
To protect the patient and the user against electrical hazards,
it is essential that all systems consisting of medical devices
as well as other electrical devices which are not restricted
to computers, printers etc., are only assembled by trained
personnel.
The system must meet the requirements of the
IEC/EN 60601-1-1 and IEC/EN 60601-1-2 standards.
Operating Principle
9
Operating Principle
Layout of the front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Display panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Layout of the screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Ventilation menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Monitoring menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Calibration/Configuration menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Operating Principle
10
Layout of the front panel
Operating Principle
Layout of the front panel
The front panel consists of the control panel and the display
panel with a screen.
Control panel
This carries the keys for ventilation modes and rotary knobs for
adjusting important ventilation parameters.
The rotary knobs which can be adjusted for current selected
ventilation modes are indicated by green LEDs. These LEDs
blink if any adjustments are limited internally or still need to be
acknowledged.
1 Rotary knobs for ventilation parameters.
2 Pressing the key »Vent. Mode« selects the menu for
ventilation modes.
3 Pressing the key »Vent. Option« selects the menu for
additional functions for ventilation modes.
201
111
1
11
2
3
11
Operating Principle
Layout of the screen
Display panel
This carries the screen, the pressure display and various keys
with fixed or variable functions.
1 Pressing the key » « suppresses audible alarms for
2 minutes.
2 Pressing the key »OK« acknowledges messages or
settings.
3 Pressing the key »man. Insp.« initiates manual inspiration
breaths.
4 Pressing the key »Cal. Config.« selects the
calibration menu.
5 The six keys below the screen are used in various menus
for selecting monitoring functions and ventilation modes.
6 The bargraph display above the screen shows airway
pressure.
Layout of the screen
1 The graphics window displays either the pressure curve
or the flow curve, as desired.
2 The measured-value window displays measured values
such as MV, FiO
2, Peak, Mean, PEEP in numerical format.
3 The status window displays the currently selected
ventilation mode and other status information.
4 The menu line gives the current function of the menu key
in text and symbols.
In some cases, the graphics window and the measured-value
window are combined to form a single window.
Messages are displayed in a superimposed window on the
current display:
Display (example):
Apnoea
202
6
1
2
3
4
5
003
1
2
3
4
004
Operating Principle
12
Menu structure
Menu structure
Ventilation menu
005
006007008009010
13
Operating Principle
Menu structure
Monitoring menu
011
012013014015016017
Operating Principle
14
Menu structure
Calibration/Configuration menu
018
019020021022023
Preparation
15
Preparation
Mounting Babylog 8000 plus on a trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Inserting the expiration valve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Inserting the O
2 sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Connecting the gas supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Connecting the electrical supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Breathing gas humidifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Connecting the ventilation hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Installing the bacterial filter (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
For high-frequency ventilation (HFV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Installing the Y-piece and the flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Before using for the first time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Calibrating the O
2 sensor manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Calibrating the flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Replacing the insert of the flow sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Checking the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Preparation
16
Mounting Babylog 8000 plus on a trolley
Preparation
Mounting Babylog 8000 plus on a trolley
z Turn the trolley so that the two lockable castors are on
the right.
Safety information for using the trolley 0.5 B (84 09 280)
Mount the Babylog 8000 plus on the trolley in this position:
1 Tilt the Babylog 8000 plus forwards.
2 Engage the front latches in the slots of the mounting plate.
3 Lower the Babylog 8000 plus, insert the rear latches in the
slots of the mounting plate and secure the unit with the
knurled screws on the rear.
z Place the shelf on the Babylog 8000 plus, engaging the two
tabs in the slots at the rear of the unit.
CAUTION
The operator must be physically capable of safely moving the
trolley with ventilator.
Remove monitors and accessories (e.g. hinged arm, brea-
thing gas humidifier) before transportation. Failure to observe
this may result in the device toppling over.
Hold the trolley at the handle and move no faster than at
a walking pace. There is an increased danger of the trolley
toppling over at thresholds, uneven surfaces, corners and
ramps. Reduce the speed of transport further. Do not move
the trolley over hoses, lines and other obstacles. Danger of
damage to device or personal injury.
CAUTION
Do not place containers with liquids above or on the device!
Any liquids entering the ventilator may impair its operation!
203204
1
2
3
205
17
Preparation
Inserting the expiration valve
Inserting the expiration valve
Use a sterile expiration valve!
1 Lift the lever upwards to unlock the expiration valve.
z Slide the expiration valve as far as possible onto the
guide rods.
2 Push the lever down again to lock the expiration valve.
3 Fit the silencer on the exhaust nozzle of the expiration valve.
Inserting the O2 sensor
This must be done:
– before the ventilator is used for the first time,
– when the sensor is exhausted and can no longer be
calibrated.
z Unscrew the two slotted screws in the cover on the right-
hand side and pull the cover out.
z Pull out the exhausted O2 sensor.
z Insert the new O2 sensor with the circular printed wiring
towards the cover.
z Press the cover into place and tighten the two screws.
z Allow the O2 sensor to run for 15 minutes and then
calibrate the O
2 measurement manually (page 24).
z Dispose of the old O2 sensor as special waste (page 94).
206
1
2
3
207
Babylog 8000 plus
Preparation
18
Connecting the gas supply
Connecting the gas supply
z Screw the medical air and oxygen hoses into the rear of the
Babylog 8000 plus and insert the plug connectors into the
wall outlets.*
If the medical air is supplied from a compressor:
z Screw the high-pressure water trap 84 12 628 onto the air
connector and screw the medical air hose into the high-
pressure water trap.
Connecting the electrical supply
The mains voltage must lie within the supply voltage range
specified on the rating plate on the rear of the ventilator.
z Insert the mains plug of the Babylog 8000 plus into the
outlet socket.
Breathing gas humidifier
– The humidifier must comply with the standard EN ISO 8185.
– The hose resistance must be less than 20 mbar/L/s
inspiratory resistance ≤12 mbar/L/s,
expiratory resistance ≤8 mbar/L/s.
– The combination of the humidifier with the Babylog 8000 plus
should not impair the safety and function of either unit.
z Prepare the humidifier for use as described in the related
Instructions for Use.
* EN 794-1, Ventilation equipment:
"If the unit is used with O
2, adequate ventilation must be provided in
order to avoid an increased risk of fire due to an O
2 concentration of
more than 24 % by volume".
NOTE
The gases must be dry and connectors free of oil and dust,
otherwise the device may malfunction!
Either: 100 V
~
to 127 V
~
or: 220 V
~
to 240 V
~
208
Air O2
209
Air O2
19
Preparation
Assembly
Assembly
Connecting the ventilation hoses
z Fit the ventilation hoses on the nozzles. Observing the
permissible hose lengths (in metres).
When not using in combination with an incubator
Use the hinged arm with claw:
z Swing both nozzles downwards or towards the patient.
z Fit the ventilation hoses on the nozzles. Observing the
permissible hose lengths (in metres).
z Install the water trap in a vertical position.
WARNING
Only use antistatic or non-conductive hoses, to avoid
risk to the patient.
Only use hose systems that are described here or if they
have an internal diameter of at least 10 mm, since the
measurement of the airway pressure may otherwise be
impaired!
NOTE
Always hold the hoses by their sleeves when fitting and
removing them since they can otherwise be damaged.
210211
0.5m
0.4m
1.1m
1m
Preparation
20
Assembly
When using with Dräger Incubator 8000
or Dräger Incubator Caleo
z Install the water trap in a vertical position.
z Mount the holder for the ventilation hoses in the incubator.
z Press the rubber sleeves of the ventilation hoses into the
clamp of the holder.
Installing the bacterial filter (optional)
A bacterial filter can be fitted on the inspiration side in order to
protect against contamination.
z Use modification kit 84 10 230.
1 Fit the 0.25 metre ventilation hose to the inspiration nozzle.
2 Insert the Ø15 / Ø22 diameter adapter in the
ventilation hose.
3 Plug the bacterial filter into the adapter.
4 Plug a size II catheter connector into the bacterial filter.
z Connect the ventilation hoses.
z Observe the Instructions for Use for the bacterial filter.
For high-frequency ventilation (HFV)
Use the "HF Fisher & Paykel" (84 11 153) hose set with reusable
chamber Fisher & Paykel MR 430 (84 11 047) or with single-use
chamber Fisher & Paykel MR 290 (84 18 282).
The low compliance of this hose system reduces the damping
of high frequency oscillations, thus ensuring adequate gas
volumes.
z Fit the ventilation hoses on the nozzles, observing the
permissible hose lengths (in meters).
z Install the water trap in a vertical position.
212213
1
2
4
3
214
0.4m
0.75m
0.65m
Ø12mm
0.4m
0.4m
/