Dräger Oxylog VE300 User manual

Instructions for use
Oxylog VE300
WARNING
To properly use this medical device,
read and comply with
these instructions for use.
Emergency and transport ventilator
Software 1.n

2 Instructions for use | Oxylog VE300 SW 1.n
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Instructions for use | Oxylog VE300 SW 1.n 3
Contents
Contents
1Information regarding the instructions for use..................................... 6
1.1 Typographical conventions ............................................................. 6
1.2 Use of terms ................................................................................... 6
1.3 Illustrations...................................................................................... 6
1.4 Trademarks..................................................................................... 6
2Safety-related information ...................................................................... 8
2.1 Intended use ................................................................................... 8
2.2 Indications....................................................................................... 8
2.3 Contraindications ............................................................................ 8
2.4 Environment of use......................................................................... 8
2.5 Essential performance characteristics ............................................ 9
2.6 Target groups ................................................................................. 9
2.7 Information on safety instructions and precautionary statements... 10
2.8 Basic safety instructions ................................................................. 10
2.9 Product-specific safety information................................................. 15
2.10 Additional information ..................................................................... 16
3Overview ................................................................................................... 17
3.1 Main device..................................................................................... 17
3.2 Main device with carrying system ................................................... 20
3.3 Breathing circuits ............................................................................ 21
3.4 Range of functions.......................................................................... 23
3.5 Abbreviations.................................................................................. 24
3.6 Symbols .......................................................................................... 25
4Operating concept ................................................................................... 28
4.1 Control elements............................................................................. 28
4.2 Structure of the screen ................................................................... 29
4.3 Color concept.................................................................................. 32
4.4 Selecting and setting ...................................................................... 32
5Assembly and preparation...................................................................... 33
5.1 Assembling the main device with carrying system (option) ............ 33
5.2 Attaching the accessories bag (option)........................................... 35
5.3 Internal battery................................................................................ 35
5.4 Connecting the power supply ......................................................... 36
5.5 External power supply .................................................................... 36
5.6 Connecting the gas supply ............................................................. 37
5.7 Connecting the breathing circuit ..................................................... 41
5.8 Connecting bacteria filters, HME, or catheter mounts .................... 45
5.9 Connecting the CO2sensor and the CO2cuvette (option) ............. 45
5.10 Attaching the device to rail systems ............................................... 46
6Getting started ......................................................................................... 47
6.1 Charging the battery ....................................................................... 47
6.2 Determining the approximate pneumatic duration of operation ...... 48

4 Instructions for use | Oxylog VE300 SW 1.n
Contents
6.3 Performing the system tests ........................................................... 49
6.4 CO2zero calibration and CO2filter test (option)............................. 51
7Operation .................................................................................................. 55
7.1 Switching on the device .................................................................. 55
7.2 Preparing the ventilation mode ....................................................... 55
7.3 Selecting the ventilation mode........................................................ 56
7.4 Changing the ventilation mode ....................................................... 63
7.5 Non-invasive ventilation (NIV) ........................................................ 64
7.6 O2/air mix........................................................................................ 66
7.7 Switching to standby mode and turning off the device ................... 67
8Alarms....................................................................................................... 69
8.1 Safety information........................................................................... 69
8.2 Alarm priorities................................................................................ 69
8.3 Alarm indication .............................................................................. 70
8.4 Setting alarm limits ......................................................................... 71
9Configuration ........................................................................................... 74
9.1 Setting configuration parameters.................................................... 74
9.2 Adjusting the screen brightness...................................................... 75
9.3 Setting the breathing circuit ............................................................ 75
9.4 Setting the HME correction............................................................. 75
9.5 Setting the ventilation mode for the ventilation category "Ventilation
(volume)" 75
9.6 Setting the CO2cuvette type (option) ............................................. 76
9.7 Using the Bluetooth function (option).............................................. 76
9.8 Activating the screenshot function (option)..................................... 77
9.9 Advanced system setup.................................................................. 78
10 Logbook and system information .......................................................... 86
10.1 Logbook .......................................................................................... 86
10.2 System information ......................................................................... 87
11 Troubleshooting....................................................................................... 88
11.1 Alarm – Cause – Remedy............................................................... 88
11.2 Messages in the alarm message field ............................................ 88
11.3 Messages in the notification field.................................................... 96
11.4 Error messages during the system test .......................................... 97
12 Reprocessing ........................................................................................... 98
12.1 Disassembly ................................................................................... 98
12.2 Information on reprocessing ........................................................... 101
12.3 Safety information........................................................................... 101
12.4 Classification for reprocessing ........................................................ 101
12.5 Recommendations for reprocessing............................................... 102
12.6 Reprocessing the non-critical components..................................... 104
12.7 Reprocessing list ............................................................................ 104
12.8 Assembly ........................................................................................ 105

Instructions for use | Oxylog VE300 SW 1.n 5
Contents
13 Service ...................................................................................................... 106
13.1 Safety information........................................................................... 106
13.2 Definition of service terminology..................................................... 106
13.3 Inspection ....................................................................................... 106
13.4 Maintenance ................................................................................... 107
13.5 Repair ............................................................................................. 108
13.6 Technical documentation................................................................108
13.7 In the event of a device error or device malfunction ....................... 108
14 Disposal .................................................................................................... 109
14.1 Disposal of the product ................................................................... 109
14.2 Disposal of the rechargeable battery .............................................. 109
14.3 Disposal of the breathing circuit and the CO2cuvettes .................. 109
15 Technical data .......................................................................................... 110
15.1 Safety information........................................................................... 110
15.2 Device specifications ...................................................................... 110
15.3 Ambient conditions ......................................................................... 112
15.4 Settings........................................................................................... 113
15.5 Performance data ........................................................................... 114
15.6 Displayed measured values............................................................ 115
15.7 Monitoring ....................................................................................... 116
15.8 Operating data ................................................................................ 118
15.9 Materials used ................................................................................ 119
15.10 Pneumatic diagram......................................................................... 120
15.11 EMC Declaration............................................................................. 121
15.12 Emission of high-frequency energy ................................................ 122
15.13 Connections to IT networks ............................................................ 123
15.14 Open-source software .................................................................... 124
16 List of accessories................................................................................... 125
16.1 List of accessories .......................................................................... 125
17 Password .................................................................................................. 128
17.1 Password protection ....................................................................... 128
Index.......................................................................................................... 130

6 Instructions for use | Oxylog VE300 SW 1.n
Information regarding the instructions for use
1 Information regarding the instructions for use
1.1 Typographical conventions
1.2 Use of terms
Dräger uses the term "accessory" not only for accessories in the sense of
IEC 60601-1, but also for consumable parts, removable parts and attached parts.
1.3 Illustrations
Depending on the configuration, the products and screen content shown in this
document may differ from the actual on-site products.
1.4 Trademarks
Trademarks owned by Dräger
The trademarks are registered in the following countries:
Text Texts printed in bold and italics indicate device labels and screen texts.
1. Consecutive numbers indicate steps of action, with the numbering
restarting with "1" for each new sequence of actions.
●Bullet points indicate individual actions or different 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.
> The "greater than" symbol indicates the navigation path in a dialog.
This symbol indicates information which makes it easier to use the prod-
uct.
►This triangle is used in safety instructions and precautionary statements
to indicate possible ways of avoiding the risk.
Trademark Country
Oxylog® Germany, EU, USA, Australia
DrägerService® Germany, USA
MEDIBUS.X® EU, USA
ClassicStar® EU, USA
NovaStar® EU, USA

Instructions for use | Oxylog VE300 SW 1.n 7
Information regarding the instructions for use
Trademarks owned by third-party manufacturers
Trademark
Trademark Trademark owner
Dismozon® BODE Chemie
Korsolex® BODE Chemie
Neodisher® Chemische Fabrik Dr. Weigert
Buraton® Schülke & Mayr
Perform® Schülke & Mayr
Mikrozid® Schülke & Mayr
acryl-des® Schülke & Mayr
Actichlor® Ecolab
Sekusept® Ecolab
Oxycide® Ecolab USA
Dispatch® Clorox
Descogen® Antiseptica
Virkon® DuPont
BruTab 6S® Brulin
Klorsept® Medentech
Trademark
BIPAP1)
1) Licensed trademark

8 Instructions for use | Oxylog VE300 SW 1.n
Safety-related information
2 Safety-related information
2.1 Intended use
Oxylog VE300 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 100 mL upward.
2.2 Indications
For patients with a tidal volume of 100 mL upward.
2.3 Contraindications
Patients with a tidal volume of 100 mL or less.
2.4 Environment of use
Intended environments of use:
– Mobile use for emergency patients, for outdoor and indoor environments
– During transport in ambulances, airplanes, helicopters, and on board ships
– In accident and emergency departments
– During intrahospital transport of ventilated patients
WARNING
Risk of patient injury
The device is not intended for long-term use.
►Do not use the device as an intensive care ventilator.
WARNING
Risk of patient injury and device malfunction
Do not use the device in hyperbaric chambers.
►This may result in danger to the patient and malfunctioning of the device.
WARNING
Risk of patient injury and device malfunction
Do not use the device in conjunction with magnetic resonance imaging (MRI).
►This may result in danger to the patient and malfunctioning of the device.
WARNING
Risk of explosion and fire
The device is not approved for use in areas where oxygen concentrations greater
than 25 Vol% and combustible or explosive gas mixtures are likely to occur.
►This may result in risk of explosion and fire.

Instructions for use | Oxylog VE300 SW 1.n 9
Safety-related information
2.5 Essential performance characteristics
Provided that the essential performance characteristics are functioning correctly,
the product can be used for its intended purpose. The product has the following
essential performance characteristics:
Provision of controlled and monitored patient ventilation with user-defined pressure
limitation for airway pressure or the triggering of a corresponding alarm.
If CO2measurement (option) is active, the product has the following additional
essential performance characteristics:
– Adherence to the specified CO2measurement accuracy
– Triggering of an alarm if the alarm limit set by the user is exceeded
– Triggering of an alarm if the specified CO2measurement accuracy cannot be
maintained
In the event of an external power supply failure, the device automatically switches
to the internal battery.
2.6 Target groups
2.6.1 Intended users
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.
2.6.2 Definition of target groups
The target groups may only carry out the following activities if they meet the
necessary requirements.
2.6.2.1 Users
2.6.2.2 Reprocessing personnel
2.6.2.3 Service personnel
Task Requirement
Use of the product in accordance with
the intended use
Specialist medical knowledge in respira-
tory care and the use of the medical
device
Task Requirement
Reprocessing Specialist knowledge in the reprocess-
ing of medical devices
Task Requirement
Installation Specialist knowledge in electrical engi-
neering and mechanics
Experience in the servicing of medical
devices
Basic service work (inspection, mainte-
nance according to the "Service" chap-
ter)

10 Instructions for use | Oxylog VE300 SW 1.n
Safety-related information
2.6.2.4 Specialized service personnel
Dräger recommends arranging a service contract with DrägerService.
2.7 Information on safety instructions and precautionary
statements
Safety instructions and precautionary statements warn of risks and give instructions
for the safe use of the product. Failure to observe them may lead to personal injury
or property damage.
2.7.1 Safety instructions
This document contains sections with safety instructions which warn of risks. The
type of risk and the consequences of non-compliance are described in each safety
instruction.
2.7.2 Precautionary statements
Precautionary statements relate to action steps and warn of risks that may arise
when executing the action steps. Precautionary statements precede the action
steps.
The following warning signs and signal words indicate precautionary statements
and differentiate the possible consequences of non-compliance.
2.8 Basic safety instructions
2.8.1 Instructions for use
Failure to use the product in accordance with the information contained in these
instructions for use may result in personal injury and property damage.
►Follow these instructions for use and those for any products used in conjunction
with this product.
►Only use this product for the purpose specified in "Intended use".
►Keep these instructions for use close to hand.
Task Requirement
Installation Specialist knowledge in electrical engi-
neering and mechanics
Experience in the servicing of medical
devices
Experience in complex service work on
this product
Basic and complex service work
(inspection, maintenance, repair)
Warning sign Signal word Consequences of non-compliance
WARNING May result in death or serious injury.
CAUTION May result in moderate or minor injury.
NOTICE May result in property damage.

Instructions for use | Oxylog VE300 SW 1.n 11
Safety-related information
The instructions for use do not contain any information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the product
– Potentially negative effects on patients with different underlying diseases
2.8.2 Symbols and product labels
Failure to observe symbols and product labels may result in personal injury and
property damage.
►Observe the symbols and product labels.
2.8.3 Monitoring the patient's condition
Monitoring of a patient's condition can range from direct observation to electronic
monitoring by means of medical devices. The patient may be put at risk if his or her
condition is not adequately monitored.
►Monitor the patient's condition by suitable means and at appropriate intervals.
2.8.4 Duties of the operating organization
The tasks described in this document specify the requirements which have to be
met by each respective target group. If the respective target group is not
appropriately qualified, personal injury and property damage may result.
The operating organization of this product must ensure the following:
►The target group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
►The target group has been trained to perform the task.
►The target group has read the sections of these instructions for use relating to
the activity concerned and noted the safety instructions and precautionary
statements they contain.
2.8.5 Operation of the device by persons outside the defined target
groups
The device is not intended for use by non-specialists (persons not defined as target
group). Responsibility for use of the device that is inconsistent with its intended use,
particularly by non-specialists, lies with the operating organization. If the operating
organization nevertheless allows non-specialists to interact with the device,
appropriate instruction and supervision must be provided.
If non-specialists (e.g., visitors) are given access to the device, the following
precautions must be taken:
►Non-specialists must be informed that unauthorized interactions may lead to
injury.
2.8.6 Modifications to the product
Modifications to the product may lead to malfunctions and unforeseen risks. This
may result in injury to the patient or the user or in property damage.
►Do not modify this product.

12 Instructions for use | Oxylog VE300 SW 1.n
Safety-related information
2.8.7 Alarms
Failure to notice alarm signals may put the patient at risk.
►Before operation, check that the visual and acoustic alarm signals are working
correctly. To do so, generate any alarm, e.g. O2supply pressure low.
►Set the alarm volume so that alarm signals can be heard.
►The user must stay within hearing range of the acoustic alarm signal.
►Pay additional attention in environments where the surrounding noise interferes
with hearing the maximum alarm volume of the device (e.g., in a helicopter).
►Make sure that the alarm system has not been rendered useless by setting the
alarm limits to extreme values.
►Check the display regularly for optical alarm signals when the acoustic alarm
signals are silenced.
2.8.8 Accessories
The use of incompatible accessories may adversely affect the functional integrity of
the product. Personal injury and property damage may result.
►Use only compatible accessories. The accessories that are compatible with this
product are listed in the list of accessories supplied with the product.
►Do not use any antistatic or electrically conductive breathing circuits.
2.8.9 Connected devices
Any connected devices or device combinations not complying with the
requirements mentioned 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.
►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.
2.8.10 Service
If service is not performed regularly, malfunctions may occur, which can result in
personal injury and property damage.
►Perform service work as described in "Service".
2.8.11 Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special precautionary measures
concerning electromagnetic compatibility. During installation and before initial
operation, follow the information in section: "EMC Declaration" (page 121).
This device can be affected by other electrical devices.

Instructions for use | Oxylog VE300 SW 1.n 13
Safety-related information
Electromagnetic interferences
Wireless communication devices (e.g., cellular phones) and medical electrical
equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic
radiation. When such devices are operated too close to this device or its cables, the
functional integrity of this device may be compromised by electromagnetic
interferences. As a result, the patient could be put at risk.
►Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless
communication devices, to ensure that the essential performance characteristics
of this device are fulfilled.
►Maintain an adequate distance between this device and other medical electrical
equipment.
2.8.12 Use of oxygen
Oxygen enhances combustion of other substances and can intensify fires.
►No smoking or open flames.
►Protect the oxygen cylinder from tipping over, and do not expose it to excessive
heat.
►Always provide adequate ventilation in the area where the ventilator is being
operated, in order to maintain ambient oxygen concentration below 25 Vol%,
to prevent risk of fire.
►Do not use any combustible gases or anesthetic gases with the ventilator.
►Do not use any flammable drugs with the ventilator.
Special care must be taken when using oxygen fittings.
►Do not grease or lubricate cylinder valves and pressure reducers or device
ports, and do not handle with greasy hands.
►Operate cylinder valves by hand and rotate slowly to prevent the risk of fire or
explosion.
►Do not use tools.
►Do not use a control valve or flowmeter in the gas supply line.
►Only use medical oxygen or 93 % oxygen.
Special care must be taken when providing gas supply from an oxygen cylinder.
►Always use gas cylinders and pressure reducers that comply with all applicable
regulations and have a pressure gauge.
►Always use full oxygen cylinders.
►To protect the patient from hypothermia, do not use oxygen cylinders that are too
cold.
►Only use O2inhalation in conjunction with a pressure reducer for patients with
sufficient spontaneous breathing.
►Only use a pressure reducer with a blow-off valve at the outlet to limit the outlet
pressure to a maximum of 1000 kPa in the event of a malfunction.

14 Instructions for use | Oxylog VE300 SW 1.n
Safety-related information
2.8.13 Use of the rechargeable battery
Observe the following instructions when using the rechargeable battery:
►Remove the battery if the device is not going to be used for an extended period
of time.
►In the absence of the rechargeable battery, the integrated clock is powered by a
button cell. In the event of permanent storage without the rechargeable battery,
replace the button cell after 2 years.
►Fully charge the battery if the device has not been used for an extended period
of time.
►Always fit the battery correctly in the device, applying only a small amount of
force to do so.
►Before each use, make sure that the battery is sufficiently charged.
►Always keep a fully-charged battery in reserve.
►Do not throw the battery into a fire or try to open by force.
2.8.14 Cleaning and service
Disinfectants and cleaning agents
Residues of disinfectants or cleaning agents left in the device after reprocessing
may put the patient at risk due to irritation to the skin or mucous membranes.
►Observe the instructions relating to disinfectants and cleaning agents.
►Make sure that the device is adequately ventilated after reprocessing.
Risk of infection
The device must be reprocessed, otherwise there is an increased risk of infection
and the function of the device may be impaired.
►Observe the hygiene regulations at the operating location (e.g., hospital or
ambulance station), including the reprocessing intervals and reprocessing
procedures.
►Have reprocessing personnel perform reprocessing with validated procedures.
►Reprocess reusable products before their first use and after each use.
►Follow the manufacturer's instructions in respect of cleaning agents and
disinfectants.
►Reprocess the product before performing service activities or returning it for
repair. For further information, see the following chapter:
"Reprocessing", page 98.
Service
This product must be maintained at regular intervals and in the appropriate manner.
Failure to perform service activities correctly may result in personal injury and
property damage.
►Perform service activities. For further information, see the following chapter:
"Service", page 106.
►Service must be performed by those target groups that are assigned to the
particular measure.
►Only carry out service activities when there is no patient connected to the
device.

Instructions for use | Oxylog VE300 SW 1.n 15
Safety-related information
Checks prior to use of the device
Reprocessing, wear and tear, and improper storage may damage parts of the
device such that they no longer function correctly. This puts the patient at risk. Make
sure that the following preconditions are met before operating the device:
►There are no cracks or sharp edges on the device.
►All hoses are undamaged and correctly connected.
►The touchscreen and the rotary knob are working correctly.
►The visual and acoustic alarm signals are working correctly.
Undetected damage to the device
Reprocessing, wear and tear, and improper storage may damage the device such
that it no longer functions correctly. The patient is put at risk.
►If a device is behaving suspiciously or is clearly malfunctioning, replace it with a
device in proper working order.
2.9 Product-specific safety information
Patient monitoring
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 the event of a malfunction.
►The user must not rely solely on the built-in ventilation monitoring.
►The user bears full responsibility for proper ventilation, and for the patient's
safety, in all situations.
►Do not make therapeutic decisions based solely on individual measured values
and monitoring parameters.
►An etCO2value is insufficient as a basis for medical decisions. Always consider
multiple values as part of the decision-making process.
Settings on the device
To ensure proper ventilation, the total dead space of the breathing circuit must be
considered when setting the ventilation parameters. This applies particularly when
using low tidal volumes.
►Observe for signs of CO2rebreathing.
►The factory presettings of the device must be compared with standard
procedures and the valid guidelines, e.g., of the American Heart Association or
the European Resuscitation Council.
►The device settings must be checked for each patient and adjusted to the
patient’s condition as necessary.
Device malfunction
If a malfunction is detected in the ventilator, and its life-preserving function can no
longer be ensured (e.g., in the event of a power failure or an interruption of the gas
supply), ventilation with an independent ventilation device (breathing bag) must be
started immediately.
►Keep a manual resuscitator at the ready.
►Ventilate with PEEP and/or increased inspiratory O2concentration if necessary.

16 Instructions for use | Oxylog VE300 SW 1.n
Safety-related information
Transporting the device
If the device is operated during transport, there is a risk of selecting undesired
settings or the device falling down.
►Transport the device safely and in a stable manner.
►Place the device on a flat and stable surface for operation.
2.10 Additional information
2.10.1 Training
User training is offered by the responsible Dräger organization, see
www.draeger.com.

Instructions for use | Oxylog VE300 SW 1.n 17
Overview
3 Overview
3.1 Main device
Upper side
28169
No. Designation Description
A Carrying handle To transport the device
B Start/standby key To switch the device on and off and
to switch to standby mode
C Rotary knob To select, change and confirm set-
tings
D LED To display the state of charge of the
battery and the power supply
E Start dialog key To return from any dialog to the start
dialog
F Screen rotation key To rotate the screen orientation by
180°
G Screen To display and operate the applica-
tion-specific dialog pages
H Alarm silence key To suppress the acoustic alarm
signal for 2 minutes
I Color LEDs To visually indicate alarms
J USB port To export data. Compatible with
USB 2.0
K Battery compartment cover
ABCD
E
F
GH
I
JK

18 Instructions for use | Oxylog VE300 SW 1.n
Overview
Rear
28170
No. Designation Description
A Carrying handle To transport the device
B Compressed gas port with standard
connector
To connect an O2compressed gas
hose
C Connector for the DC power supply To connect to an external power
supply
A
B
C

Instructions for use | Oxylog VE300 SW 1.n 19
Overview
Front
CAUTION
Ventilator malfunction
Do not block the emergency air inlet.
►A blocked emergency air inlet may result in ventilator malfunction.
Devices with the Plus option are indicated by labels on the sides of the device.
28171
No. Designation Description
A Breathing circuit port To connect a disposable or reusable
breathing circuit
B Measuring line ports To connect the measuring lines of
the breathing circuit
CCO
2sensor port To connect the CO2sensor cable
D Emergency air and ambient air inlet To suction ambient air
E Additional quick-coupling port For additional gas supply from the
wall terminal unit, to swap the gas
supply without interrupting ventila-
tion.
AB C E
D

20 Instructions for use | Oxylog VE300 SW 1.n
Overview
3.2 Main device with carrying system
Side view, right
33377
No. Designation Description
A Protection bar To protect the compressed gas cyl-
inder and the pressure reducer.
B Strap brackets (on front and rear) For diagonal fixing of the carrying
strap (option).
C Closure To open the carrying system.
Height-adjustable. For further infor-
mation, see the following chapter:
"Assembling the main device with
carrying system (option)", page 33.
D Hinge (when the closure is raised) To open the carrying system.
Height-adjustable. For further infor-
mation, see the following chapter:
"Assembling the main device with
carrying system (option)", page 33.
E Pins To attach the accessories bag
(option)
ABCD AE