Dräger Oxylog 3000 plus User manual

Instructions for Use
Oxylog 3000 plus
Emergency and Transport Ventilator
Software 1.n
WARNING
To properly use this medical device,
read and comply with these
Instructions for Use.

2Instructions for Use Oxylog 3000 plus SW 1.n
Typographical Conventions
Any text shown on the screen and any labeling on
the device are printed in bold and italics, for exam-
ple, PEEP, Air, or Alarm settings.
The "greater than" symbol >indicates the naviga-
tion path in a dialog window, for example, System
setup > Monitoring > Basic settings. In this
example, System setup represents the dialog win-
dow title, Monitoring represents a horizontally
aligned tab, and Basic settings a vertically aligned
tab.
Screen images
Schematic renderings of screen images are used,
which may differ in appearance or in configuration
from the actual screen images.
Trademarks
– Oxylog®
– AutoFlow®
– DrägerService®
are trademarks owned by Dräger.
– Sekusept®
is a trademark of ECOLAB.
– BIPAP*
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
zBullet points indicate individual actions or differ-
ent 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 used under license

Instructions for Use Oxylog 3000 plus SW 1.n 3
Safety Information Definitions
Definition of target groups
For this medical device, users, service personnel,
and experts are defined as target groups.
These traget groups must have been instructed in
the use of the medical device and must have the
necessary expertise, training, and knowledge to
use, install, reprocess, maintain or repair the medi-
cal device.
Dräger emphasizes that the medical device must
be used, installed, reprocessed, maintained or
repaired exclusively by the defined target groups.
Users
Users are intended operators as defined on
page 14 hereof for the use of the medical device in
accordance with its intended use.
Service Personnel
Service Personnel are persons who are responsi-
ble for the maintenance of the medical device
towards the operating organization.
Service Personnel are persons who are authorized
to install, reprocess, or maintain the medical
device.
Experts
Experts are persons who are authorized to carry
out repair or complex maintenance work on the
medical device.
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.

4Instructions for Use Oxylog 3000 plus SW 1.n
Abbreviations and Symbols
Please refer to "Abbreviations" on page 23 and
"Symbols" on page 24 for explanations.

Instructions for Use Oxylog 3000 plus SW 1.n 5
Contents
Contents
For Your Safety and that of Your Patients .7
General Safety Information. . . . . . . . . . . . . . . 8
Product-specific Safety Information . . . . . . . . 11
Application . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . 14
Indications / Contraindications . . . . . . . . . . . . 14
Environment of use. . . . . . . . . . . . . . . . . . . . . 15
System Overview . . . . . . . . . . . . . . . . . . . . . 17
Front panel with all options. . . . . . . . . . . . . . . 18
Range of functions . . . . . . . . . . . . . . . . . . . . . 22
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 23
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Operating Concept . . . . . . . . . . . . . . . . . . . . 27
Switch on or off. . . . . . . . . . . . . . . . . . . . . . . . 28
Ventilation controls . . . . . . . . . . . . . . . . . . . . . 29
Display operating controls . . . . . . . . . . . . . . . 30
Additional function keys . . . . . . . . . . . . . . . . . 31
Screen window structure . . . . . . . . . . . . . . . . 32
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Internal rechargeable battery . . . . . . . . . . . . . 37
Connecting the power supply . . . . . . . . . . . . . 38
External power supply . . . . . . . . . . . . . . . . . . 39
Connecting the gas supply . . . . . . . . . . . . . . . 41
Assembling the adult reusable hose system . 43
Connecting the adult disposable hose system 45
Connecting the paediatric disposable hose
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Connecting the bacterial filter or HME . . . . . . 47
Connecting the CO2sensor and the cuvette . 48
Hanging the Oxylog 3000 plus on standard
rail systems. . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Getting Started . . . . . . . . . . . . . . . . . . . . . . . 51
Charging the battery. . . . . . . . . . . . . . . . . . . . 52
Determining the approximate pneumatic
operating time. . . . . . . . . . . . . . . . . . . . . . . . . 53
Checking readiness for operation. . . . . . . . . . 54
CO2zero calibration and filter check before
ventilation (optional) . . . . . . . . . . . . . . . . . . . . 58
Preparation for use after system check, CO2
zero calibration and filter check. . . . . . . . . . . 60
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Starting operation . . . . . . . . . . . . . . . . . . . . . 62
Preparing ventilation mode . . . . . . . . . . . . . . 64
VC-CMV, VC-AC . . . . . . . . . . . . . . . . . . . . . . 65
VC-SIMV, VC-SIMV/PS. . . . . . . . . . . . . . . . . 68
PC-BIPAP, PC-BIPAP/PS . . . . . . . . . . . . . . . 71
SpnCPAP, SpnCPAP/PS . . . . . . . . . . . . . . . . 73
NIV – Non-invasive ventilation (Mask
ventilation) . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Special functions . . . . . . . . . . . . . . . . . . . . . . 77
O2 concentration with "O2 blending". . . . . . . 79
Setting HME correction . . . . . . . . . . . . . . . . . 80
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Screen brightness . . . . . . . . . . . . . . . . . . . . . 81
Alarm volume . . . . . . . . . . . . . . . . . . . . . . . . 81
Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Types of alarms . . . . . . . . . . . . . . . . . . . . . . . 84
In the event of an alarm. . . . . . . . . . . . . . . . . 85
Setting alarm limits . . . . . . . . . . . . . . . . . . . . 87
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Displaying curves . . . . . . . . . . . . . . . . . . . . . 90
Displaying measured values . . . . . . . . . . . . . 90
CO2measurement (optional) . . . . . . . . . . . . 91
Configuration. . . . . . . . . . . . . . . . . . . . . . . . 95
Setting configuration parameters / display
information. . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Displaying configuration and information . . . 97
Customer Service Mode . . . . . . . . . . . . . . . . 98
Customer service manual . . . . . . . . . . . . . . . 110
Problem Solving . . . . . . . . . . . . . . . . . . . . . 111
Alarm - Cause - Remedy. . . . . . . . . . . . . . . . 112
Messages in the alarm window . . . . . . . . . . . 112
Messages in the information window . . . . . . 120
Error messages during the device check . . . 122

Contents
6Instructions for Use Oxylog 3000 plus SW 1.n
Cleaning, Disinfection and Sterilization . . . 123
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Safety Information on reprocessing . . . . . . . . 127
Reprocessing procedure . . . . . . . . . . . . . . . . 127
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . 131
Assembling parts . . . . . . . . . . . . . . . . . . . . . . 131
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 133
Maintenance intervals of Oxylog 3000 plus . . 134
Safety inspections . . . . . . . . . . . . . . . . . . . . . 135
Exchanging the internal battery . . . . . . . . . . . 136
In case of ventilator failure . . . . . . . . . . . . . . . 136
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Disposing of the medical device. . . . . . . . . . . 138
Disposal instructions . . . . . . . . . . . . . . . . . . . 138
Technical Data . . . . . . . . . . . . . . . . . . . . . . . 139
Ambient conditions . . . . . . . . . . . . . . . . . . . . . 140
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Performance data. . . . . . . . . . . . . . . . . . . . . . 143
Measured values and curves display . . . . . . . 144
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Operating data . . . . . . . . . . . . . . . . . . . . . . . . 146
Device specifications . . . . . . . . . . . . . . . . . . . 149
Materials used . . . . . . . . . . . . . . . . . . . . . . . . 150
Technical Documentation for the
Oxylog 3000 plus according to EMC
standard IEC 60601-1-2 . . . . . . . . . . . . . . . . . 152
Principles of Operation . . . . . . . . . . . . . . . . 157
Ventilation modes . . . . . . . . . . . . . . . . . . . . . . 158
AutoFlow . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Dead space . . . . . . . . . . . . . . . . . . . . . . . . . . 164
Determining the cycle time, inspiratory time
and expiratory time. . . . . . . . . . . . . . . . . . . . . 164
Functional description . . . . . . . . . . . . . . . . . . 165
List of Accessories . . . . . . . . . . . . . . . . . . . 167
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Instructions for Use Oxylog 3000 plus SW 1.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
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Connected Devices . . . . . . . . . . . . . . . . . . . . 9
Safe connection with other electrical
equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Modifications. . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . 9
Information on Electromagnetic Compatibility 9
Functional safety . . . . . . . . . . . . . . . . . . . . . . 10
Appropriate monitoring . . . . . . . . . . . . . . . . . . 10
Product-specific Safety Information. . . . . . 11
Installing accessories . . . . . . . . . . . . . . . . . . . 11
Instructions for Use only available once . . . . . 11

For Your Safety and that of Your Patients
8Instructions for Use Oxylog 3000 plus SW 1.n
General Safety Information
The following WARNINGS and CAUTIONS apply to
general operation of the device. WARNINGS and
CAUTIONS specific to subsystems or particular
features appear with those topics in later sections
of the manual.
Strictly follow these Instructions for Use
Maintenance
Accessories
WARNING
Risk of incorrect operation and of 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"
on page 14 and in conjunction with
appropriate patient monitoring.
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 work car-
ried out on the medical device must be per-
formed by experts.
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService. For
maintenance Dräger recommends the use of
authentic Dräger repair parts.
If the above are not complied with, medical
device failure and patient injury cannot be
excluded.
Observe chapter "Maintenance".
WARNING
Risk due to unreleased accessories
If unreleased accessories are used, there is a
risk of patient injury due to medical device
failure.
Only use the medical device together with
released accessories listed in the current list
of accessories.

Instructions for Use Oxylog 3000 plus SW 1.n 9
For Your Safety and that of Your Patients
Connected Devices
Safe connection with other electrical
equipment
Modifications
Patient safety
The design of the medical device, the accompany-
ing literature, and the labeling on the medical
device are based on the assumption that the use of
the equipment is restricted to trained professionals,
and that certain inherent characteristics of the med-
ical device 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 references to various
hazards which are obvious to a medical
professional and operator of this medical device, to
the consequences of medical device misuse, and
to potentially adverse effects in patients with
abnormal conditions.
Medical device modification or misuse can be
dangerous.
Patient monitoring
The operators of the medical device are
responsible for choosing appropriate safety
monitoring that provides adequate information on
medical device performance and patient condition.
Patient safety may be achieved through a wide
variety of means, ranging from electronic surveil-
lance of medical device performance and patient
condition, to simple, direct observation of clinical
signs.
The responsibility for the selection of the best level
of patient monitoring lies solely with the medical
device operator.
Information on Electromagnetic
Compatibility
General information on electromagnetic
compatibility (EMC) pursuant to international EMC
standard IEC 60601-1-2:
Electromedical devices are subject to special
precautionary measures concerning
electromagnetic compatibility (EMC) and must be
installed and put into operation in accordance with
the EMC information. Refer to section "Technical
Documentation for the Oxylog 3000 plus according
to EMC standard IEC 60601-1-2" on page 152.
WARNING
Risk of electric shock and of device malfunc-
tion
Any connected devices or device combina-
tion, not complying with the requirements
mentioned in these Instructions for Use can
compromise the correct functioning of the
medical device and lead to an electric shock.
Before operating the medical device, strictly
comply with the Instructions for Use of all
connected devices or device combinations.
CAUTION
Risk of patient injury
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.
WARNING
Modification of the device is not allowed.
WARNING
Do not use portable and mobile HF communi-
cations equipment, e.g., mobile phones, in the
vicinity of the medical device.

For Your Safety and that of Your Patients
10 Instructions for Use Oxylog 3000 plus SW 1.n
Functional safety
The essential performance of the Oxylog 3000 plus
is defined as:
Appropriate delivery of ventilation to the patient-
connection port or generation of an alarm condition.
Appropriate monitoring
The monitoring functionality of the
Oxylog 3000 plus ensures appropriate monitoring
of ventilation therapy. To ensure appropriate
monitoring during ventilation, always set the
following alarm limits:
– Airway pressure, Paw
– Expiratory minute volume, MVe
– Respiratory rate (if applicable), RR
–etCO
2(if applicable)
Not setting appropriate alarm limits could suppress
alarms related to:
– Acute changes in the patient’s condition
– Incorrect settings and faulty handling
– Hose system leakage
CAUTION
Always use a separate SpO2monitor for
patients who are dependent on an exact O2
concentration.

Instructions for Use Oxylog 3000 plus SW 1.n 11
For Your Safety and that of Your Patients
Product-specific Safety Information
Installing accessories
Strictly follow the Assembly Instructions and
Instructions for Use.
Instructions for Use only available once
WARNING
Ventilation monitoring is mandatory at all
times! Whenever a patient is connected to the
ventilator, constant attention by qualified
medical staff is required in order to provide
immediate corrective action in case of a
malfunction.
The operator shall not solely rely on the built-
in monitoring of the ventilator and must
always assume full responsibility for proper
ventilation and patient safety in all situations.
WARNING
Keep a manual breathing bag available.
If a failure is detected in the ventilator and its
life-support functions can no longer be
guaranteed (e.g. in case of a power supply
failure or interruption in the O2supply),
ventilation must be started without delay with
an independent ventilator (breathing bag) –
using PEEP and/or increased inspired O2
concentration as necessary.
WARNING
To ensure proper ventilation, consider the
total dead space of the breathing circuit, espe-
cially when using small tidal volumes.
Observe for signs of rebreathing.
Risk of CO2rebreathing.
NOTE
An etCO2value by itself is insufficient as a basis
for medical decisions.
CAUTION
Installations on the Oxylog 3000 plus must be
done in accordance with these Instructions for
Use. Make sure that the connections are securely
fitted onto the basic system.
NOTE
Only one copy of the Instructions for Use is
included in the clinical package and should there-
fore be kept in an accessible location for users.

12 Instructions for Use Oxylog 3000 plus SW 1.n
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Instructions for Use Oxylog 3000 plus SW 1.n 13
Application
Application
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . 14
Indications / Contraindications. . . . . . . . . . 14
Environment of use . . . . . . . . . . . . . . . . . . . 15

Application
14 Instructions for Use Oxylog 3000 plus SW 1.n
Intended use
The Oxylog 3000 plus is a time-cycled, volume-
controlled and pressure-controlled emergency and
transport ventilator for patients requiring mandatory
or assisted ventilation with a tidal volume from
50 mL upwards.
Intended operator: the device is intended for use by
and under the supervision of trained healthcare
professionals, e.g. doctors, nurses, emergency
medical technicians, respiratory therapists, and
paramedics.
Indications / Contraindications
The device is intended for use with patients with a
tidal volume of 50 mL upwards.
WARNING
The Oxylog 3000 plus ventilator may only be
used under the supervision of trained
healthcare professionals in case immediate
corrective action is required in the event of a
device failure.

Instructions for Use Oxylog 3000 plus SW 1.n 15
Application
Environment of use
Intended environment of use:
– Mobile use for emergency patients, in both
outdoor and indoor environments.
– During transport in ambulances or aircraft,
including helicopters.
– In accident and emergency departments.
– When moving ventilated patients around the
hospital.
– In the recovery room.
WARNING
Do not use the medical device in hyperbaric
chambers.
The medical device may malfunction, causing
danger to the patient.
WARNING
Do not use the medical device in conjunction
with magnetic resonance imaging (MRI, NMR,
NMI).
The medical device may malfunction, causing
danger to the patient.
WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.

16 Instructions for Use Oxylog 3000 plus SW 1.n
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Instructions for Use Oxylog 3000 plus SW 1.n 17
System Overview
System Overview
Front panel with all options. . . . . . . . . . . . . 18
Side view, right . . . . . . . . . . . . . . . . . . . . . . . . 19
Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Adult hose system, reusable . . . . . . . . . . . . . 20
Adult hose system, disposable. . . . . . . . . . . . 20
Paediatric hose system, disposable . . . . . . . . 21
Range of functions . . . . . . . . . . . . . . . . . . . . 22
Ventilation functions of the Oxylog 3000 plus. 22
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . 23
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

System Overview
18 Instructions for Use Oxylog 3000 plus SW 1.n
Front panel with all options
AScreen with screen pages for the specific
application
BKey Alarms to display the alarm settings
in the "Settings and Alarms" window and to
change screen pages
CKey Settings to display ventilation
parameters (ventilation screen) in the "Settings
and Alarms" window and to change screen
pages
DKey for setting the ventilation mode SpnCPAP
EKey for setting the ventilation modes VC-CMV /
VC-AC
FKey for setting the ventilation mode VC-SIMV
GKey for setting the ventilation mode PC-BIPAP
HRed and yellow alarm indicators
IKey for suppressing the acoustic alarm sig-
nal for 2 minutes
JKey Alarm Reset for acknowledging alarm
messages
KKey O2inhalation for O2inhalation or key
100 % O2for 100 % O2application, depending
on the option installed at manufacture
LKey Insp. Hold for initiating a manual inspira-
tion or for extending the current inspiratory time.
MKey Start/Standby
NDisplay symbols for the power supply
Charge status of the internal battery
Mains power supply connected
ORotary knob for making selections, changing
and confirming settings
PControl knob for setting the O2concentration
FiO2
QControl knob for setting the maximum
inspiratory pressure Pmax
RControl knob for setting the respiratory rate RR
SControl knob for setting the tidal volume VT
TExplanation of color codes for quick pre-setting
of RR and VT
UKey Curves to change between the
pressure, flow or CO2(optional) curve in small
and large presentation
VKey Values to change screen pages in
the "Measured Values" window
Front
ABCDEFG
H
I
J
K
L
M
NOPQRS
T
U
V
Curves

Instructions for Use Oxylog 3000 plus SW 1.n 19
System Overview
Side view, right
AEmergency air intake
BKnob to secure the battery compartment cover
CConnectors for flow measuring lines
DGas outlet for breathing hose
EConnector for O2supply
FConnector for power supply
GConnector for CO2sensor
HConnector for data communication cable
Rear view
AEmergency air intake
BFresh-gas intake with a filter cartridge
CProtection bracket
Side
CAUTION
Do not block the emergency air intake. This may
result in ventilator malfunction.
B
C
D
E
F
A
G
H
Rear
CAUTION
Do not block the air intake. This may result in
ventilator malfunction.
CAUTION
Do not use the protection bracket as a handle.
Tilting the device to a vertical position may lead to
airway pressure oscillation.
A
B
C

System Overview
20 Instructions for Use Oxylog 3000 plus SW 1.n
Adult hose system, reusable
AAngled connector
BFlow sensor
CBreathing valve
DBreathing hose
EFlow and pressure measuring hoses
Adult hose system, disposable
AAngled connector
BFlow sensor
CBreathing valve
DBreathing hose
EFlow and pressure measuring hoses
001
AE
B
C
D
002
E
D
C
A
B