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.

2 Instructions 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 example, PEEP, Air, or Alarm
settings.
The "greater than" symbol >indicates the
navigation path in a dialog window, for example,
System configuration > Monitoring > Basic
settings. In this example, System configuration
represents the dialog window title, Monitoring
represents a horizontally aligned tab, and Basic
settings a vertically aligned tab.
Screen reproductions
The reproductions of screen content in the
instructions for use can differ from the content
actually shown on the screen.
Trademarks
Safety information definitions
1Consecutive numbers indicate steps of action,
with the numbering restarting with "1" for each
new sequence of actions.
Bullet 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 Trademark owner
Oxylog®Dräger
AutoFlow®Dräger
DrägerService®Dräger
Sekusept®Ecolab
BIPAP1)
1) Trademark used under license
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.

Instructions for use Oxylog 3000 plus SW 1.n 3
Definition of target groups
For this medical device, users, maintenance
personnel, and experts are defined as target
groups.
These target groups must have received instruction
in the use of the medical device and must have the
necessary training and knowledge to use, install,
reprocess, maintain, or repair the product.
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.
Maintenance personnel
Maintenance personnel are persons who are
responsible to the operating company for the
maintenance of the product.
Maintenance personnel are persons authorized to
install, reprocess or maintain the medical device.
Experts
Experts are persons who are authorized to perform
repair or complex maintenance work on the
medical device.
Abbreviations and symbols
For explanations refer to "Abbreviations" on
page 23 and "Symbols" on page 24.

4 Instructions for use Oxylog 3000 plus SW 1.n
This page has been left blank intentionally.

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. . . . . . . . . 12
Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . 14
Indications/Contraindications . . . . . . . . . . . . . 14
Environment of use. . . . . . . . . . . . . . . . . . . . . 14
System overview . . . . . . . . . . . . . . . . . . . . . 17
Basic unit with all options . . . . . . . . . . . . . . . . 18
Range of functions . . . . . . . . . . . . . . . . . . . . . 22
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 23
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Operating concept . . . . . . . . . . . . . . . . . . . . 27
Switching on and off . . . . . . . . . . . . . . . . . . . . 28
Ventilation controls . . . . . . . . . . . . . . . . . . . . . 29
Display operating controls . . . . . . . . . . . . . . . 30
Additional function keys . . . . . . . . . . . . . . . . . 31
On-screen window structure. . . . . . . . . . . . . . 32
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Internal rechargeable battery . . . . . . . . . . . . . 37
Connecting the power supply . . . . . . . . . . . . . 38
External power supply . . . . . . . . . . . . . . . . . . 39
Connecting the gas supply . . . . . . . . . . . . . . . 41
Connecting the reusable breathing circuit for
adults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Connecting the disposable breathing circuit for
adults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Connecting the disposable breathing circuit for
pediatric patients . . . . . . . . . . . . . . . . . . . . . . 46
Connecting a bacterial filter or HME. . . . . . . . 47
Connecting the CO2sensor and the cuvette . 48
Attaching the Oxylog 3000 plus to standard rail
systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Charging the battery. . . . . . . . . . . . . . . . . . . . 52
Determining the approximate pneumatic operating
time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Checking readiness for operation. . . . . . . . . . 54
Performing the device check . . . . . . . . . . . . . 54
CO2zero calibration and filter check before ventila-
tion (optional). . . . . . . . . . . . . . . . . . . . . . . . . 58
Preparation for use after system check, CO2zero
calibration and CO2 filter check . . . . . . . . . . 60
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Starting operation . . . . . . . . . . . . . . . . . . . . . 62
Preparing the ventilation mode . . . . . . . . . . . 64
VC-CMV, VC-AC . . . . . . . . . . . . . . . . . . . . . . 65
VC-SIMV, VC-SIMV/PS. . . . . . . . . . . . . . . . . 68
PC-BIPAP, PC-BIPAP/PS . . . . . . . . . . . . . . . 70
Spn-CPAP, Spn-CPAP/PS . . . . . . . . . . . . . . . 72
Non-invasive ventilation (NIV) . . . . . . . . . . . . 75
Special functions . . . . . . . . . . . . . . . . . . . . . . 76
O2concentration by "O2blending" . . . . . . . . 78
Setting the HME correction . . . . . . . . . . . . . . 79
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Screen brightness . . . . . . . . . . . . . . . . . . . . . 80
Alarm volume . . . . . . . . . . . . . . . . . . . . . . . . 80
Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Safety information . . . . . . . . . . . . . . . . . . . . . 84
Alarm priorities . . . . . . . . . . . . . . . . . . . . . . . 84
Alarm indication. . . . . . . . . . . . . . . . . . . . . . . 85
Setting alarm limits . . . . . . . . . . . . . . . . . . . . 87
Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Displaying curves . . . . . . . . . . . . . . . . . . . . . 90
Displaying measured values . . . . . . . . . . . . . 90
CO2measurement (optional) . . . . . . . . . . . . 91
Data communication (optional) . . . . . . . . . . . 94
Configuration. . . . . . . . . . . . . . . . . . . . . . . . 95
Displaying configuration and information . . . 96
Customer Service Mode . . . . . . . . . . . . . . . . 97
Customer service manual . . . . . . . . . . . . . . . 108
Problem solving . . . . . . . . . . . . . . . . . . . . . 109
Alarm – Cause – Remedy . . . . . . . . . . . . . . . 110
Messages in the alarm message field . . . . . . 110

Contents
6 Instructions for use Oxylog 3000 plus SW 1.n
Additional messages in
the alarm message field . . . . . . . . . . . . . . . . . 117
Messages in the information field . . . . . . . . . . 118
Error messages during the device check . . . . 120
Cleaning, Disinfection and Sterilization . . . 121
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Information on reprocessing. . . . . . . . . . . . . . 125
Reprocessing procedure . . . . . . . . . . . . . . . . 125
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . 129
Assembling parts . . . . . . . . . . . . . . . . . . . . . . 129
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 131
Maintenance intervals of Oxylog 3000 plus . . 132
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Safety checks . . . . . . . . . . . . . . . . . . . . . . . . . 133
Preventive maintenance. . . . . . . . . . . . . . . . . 134
Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
In case of ventilator failure . . . . . . . . . . . . . . . 135
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Disposing of the medical device. . . . . . . . . . . 138
Disposal instructions . . . . . . . . . . . . . . . . . . . 138
Technical data. . . . . . . . . . . . . . . . . . . . . . . . 139
Ambient conditions . . . . . . . . . . . . . . . . . . . . . 140
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Performance characteristics. . . . . . . . . . . . . . 142
Measured values and curves display . . . . . . . 144
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Operating data . . . . . . . . . . . . . . . . . . . . . . . . 146
Device specifications . . . . . . . . . . . . . . . . . . . 148
Materials used . . . . . . . . . . . . . . . . . . . . . . . . 150
EMC declaration. . . . . . . . . . . . . . . . . . . . . . . 151
Description . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Ventilation modes . . . . . . . . . . . . . . . . . . . . . . 156
AutoFlow . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Dead space . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Determining cycle time, inspiratory time and expir-
atory time . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Functional description . . . . . . . . . . . . . . . . . . 163
List of accessories . . . . . . . . . . . . . . . . . . . 165
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Accessing Customer Service Mode . . . . . 171
Accessing Customer Service Mode . . . . . . . 172
Accessing Customer Service Mode
Oxylog 3000 plus SW 1.n . . . . . . . . . . . . . . . 173

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
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring. . . . . . . . . . . . . . . . . . . . . . 9
Information on Electromagnetic Compatibility 9
Functional safety . . . . . . . . . . . . . . . . . . . . . . 10
Appropriate monitoring . . . . . . . . . . . . . . . . . . 10
Connection to other devices. . . . . . . . . . . . . . 10
Product-specific safety information . . . . . . 12
Installing accessories . . . . . . . . . . . . . . . . . . . 12
Only one copy of instructions for use included 12

For Your Safety and that of Your Patients
8 Instructions for use Oxylog 3000 plus SW 1.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 used with this medical device.
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.
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 maintenance personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter "Maintenance".
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.
WARNING
Risk when using unauthorized accessories
If unauthorized accessories are used, patients
may be put at risk due to malfunctions of the
medical device. Only use the medical device
together with authorized 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
Patient safety
The design of the medical device, the
accompanying 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 medical device are known to
the trained user. Instructions, warnings, and
caution statements are therefore largely limited to
the specifics of the Dräger design.
This publication excludes references to various
hazards which are obvious to a medical
professional and user 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 users 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
surveillance 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 user.
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 "EMC
declaration" on page 151.
WARNING
Risk of electric shock and of device
malfunction
Any connected devices or device combination
not complying with the requirements set out in
these instructions for use may 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.
WARNING
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
Risk of patient injury
Do not make therapeutic decisions based
solely on individual measured values and
monitoring parameters.
WARNING
Do not use portable and mobile HF
communications 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 alarm
limits for the following parameters:
– Airway pressure, Paw
– Expiratory minute volume, MVe
– Respiratory rate (if applicable), RR
–etCO
2(if applicable)
If appropriate alarm limits are not set, alarms may
not be triggered in the following cases:
– Acute changes in the patient’s condition
– Incorrect settings and faulty handling
– Hose system leakage
Connection to other devices
Device combinations (Dräger devices + Dräger
devices or Dräger devices + third-party devices)
approved by Dräger (see instructions for use of the
individual devices) comply with the following
standards:
– IEC 60601-1 (3rd edition)
Medical electrical equipment
Part 1-1: General requirements for safety and
essential performance
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety
and essential performance
Collateral standard: Electromagnetic
compatibility – Requirements and tests
– IEC 60601-1-8
Medical electrical equipment
Part 1-8: General requirements for safety
Collateral standard: General requirements,
tests, and guidance for alarm systems in
medical equipment and medical electrical
systems
– IEC 60601-1 (2nd edition)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 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
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic
compatibility; Requirements and tests
– IEC 60601-1-4
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable
electrical medical systems
CAUTION
Always use a separate SpO2monitor for
patients who are dependent on an exact O2
concentration.