fabius_tiro_instructions_for_use_software_3-n.pdf
Page 1
Instructions for Use
Fabius® Tiro
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.
Anesthesia Workstation
Software 3.n
Page 2
Working with these
Instructions for Use
Header Line
The header line on each page contains the title of
the chapter.
Configuration
The configuration functions available in Standby
include calibrations, system tests, and the management of default settings.
To access Standby mode:
1
Press the »Standby« key.
300
1
z The waveform window is replaced by a confirmation message and the instruction to shut off
flow.
The LED on the Standby key starts blinking and will
remain blinking until Standby is confirmed.
NOTE:
If confirmation does not occur within 15 seconds,
the ventilator remains in the previous mode and the
waveform window is restored.
522
z Confirm the mode change. The ventilator enters
Standby mode, the Standby screen replaces the
previous screen, and the Standby LED stops
blinking and remains on.
The following soft key labels appear at the bottom of the Standby screen:
– »Run System Test«
– »Calibrate Flow Sensor«
– »Calibrate O2 Sensor«
– »Leak / Compl Test«
– »Access Alarm Log«
– »Restore Site Defaults«
104
Instructions for Use Fabius GS premium SW 3.n
305
Left-Hand Column – the Text
The text in the left-hand column provides explanations and step-by-step instructions on the practical
use of the machine.
z Bullet points indicate separate actions.
1 Where several actions are described, numbers
are used to refer to relevant details in the illustrations. On each page the numbering restart
with “1”.
– Dashes indicate the listing of data, options or
objects.
Configuration Functions in Standby
Mode
501
Page Body
The page body in these Instructions for Use combines text and illustrations. The information is presented as sequential steps of action, giving the user
hands-on experience in learning how to use the
Fabius Tiro machine.
Right-Hand Column – the Illustrations
The illustrations provide visual reference for the
text and for locating the various parts of the equipment. Elements mentioned in the text are highlighted. Renderings of screen displays guide the user
and provide a way to reconfirm actions performed.
Typing Conventions in this Manual
– User controls, such as hard keys and soft keys,
and screen pages are printed in bold within quotation marks, e.g., »PEEP« or »Volume Settings«
– Screen messages are printed in bold within
quotation marks, e.g., »Flow Calibration in
progress«
– Alarm messages are printed in bold within quotation marks, including the exclamation marks
that indicate their alarm urgency level, e.g.,
»APNEA PRESSURE!!!«
2
Instructions for Use Fabius Tiro SW 3.n
Page 3
Trademarks
DrägerService®, Spirolog®, SpiroLife®,
Drägersorb®, D-Vapor®, Fabius® Tiro, Vapor®, and
Vitalink® are registered trademarks of Dräger.
Selectatec® is a registered trademark of
Datex-Ohmeda.
All other products or brand names are trademarks
of their respective owners.
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.
Abbreviations and Symbols
Please refer to "Abbreviations" on page 31 and
"Symbols" on page 32 for explanations.
Notice
This document is provided for customer information
only, and will not be updated or exchanged without
customer request.
Instructions for Use Fabius Tiro SW 3.n
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This page intentionally left blank
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Instructions for Use Fabius Tiro SW 3.n
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Contents
Contents
Working with these Instructions for Use . . . . . 2
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Abbreviations and Symbols . . . . . . . . . . . . . . . . . 3
Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
For Your Safety and that of Your Patients . . . . 7
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
System Overview . . . . . . . . . . . . . . . . . . . . . . . 15
Front View (trolley mounted) . . . . . . . . . . . . . . . 16
Compact Breathing System (Top View) . . . . . . . 17
Rear View (Pin-Index Connector). . . . . . . . . . . . 18
Side View (Threaded Connectors) . . . . . . . . . . . 19
Interface Panel . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Vaporizers (Optional) . . . . . . . . . . . . . . . . . . . . . 21
Fabius Tiro as a Ceiling Device . . . . . . . . . . . . . 22
Fabius Tiro as a Wall Device . . . . . . . . . . . . . . . 22
Auxiliary Oxygen Flowmeter. . . . . . . . . . . . . . . . 22
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Communication Ports . . . . . . . . . . . . . . . . . . . . . 24
Auxiliary Fresh Gas Outlet (Optional). . . . . . . . . 26
Auxiliary Fresh Gas Outlet Switch (Optional) . . . 27
Magill Breathing Circuit. . . . . . . . . . . . . . . . . . . . 29
Accessory Weight Limits . . . . . . . . . . . . . . . . . . 30
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Operation Concept . . . . . . . . . . . . . . . . . . . . . . 35
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
The Screen Display . . . . . . . . . . . . . . . . . . . . . . 37
Rotary Knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Fixed Function Keys . . . . . . . . . . . . . . . . . . . . . . 38
Soft Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Fresh Gas Control (three gas version) . . . . . . . . 43
LED Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Gas System Color Coding . . . . . . . . . . . . . . . . . 46
Screen Color Concept (optional) . . . . . . . . . . . . 46
Activating the Battery . . . . . . . . . . . . . . . . . . . . 49
Fitting the CO2 Absorber on the
Compact Breathing System. . . . . . . . . . . . . . . . 50
Installing the Drägersorb CLIC Adapter
(Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Connecting the Compact Breathing System . . . 52
Inserting the Flow Sensor . . . . . . . . . . . . . . . . . 53
Connecting the Waste Gas Outlet Port . . . . . . . 54
Installing the Flexible Bag Arm and Bag
(optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Connecting Pipeline Supply of N2O, AIR and
O2 (Three Gas Version). . . . . . . . . . . . . . . . . . . 55
Connecting the Reserve Gas Cylinders for O2,
O2 and N2O or O2 and AIR (for Pin-Index Mounting) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Connecting the Reserve Gas Cylinders for
N2O, AIR and O2 (for Cylinders with Threaded
Connectors). . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Connecting the AGS Scavenger System
(Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Connecting the Suction System (Optional) . . . . 62
Connecting the Breathing Hoses. . . . . . . . . . . . 63
Inserting a New O2 Sensor Capsule . . . . . . . . . 65
Connecting the O2 Sensor . . . . . . . . . . . . . . . . 65
Connecting the Pressure Sensor . . . . . . . . . . . 66
Connecting the Pressure Breathing Gauge
(Optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Connecting the Flow Sensor . . . . . . . . . . . . . . . 67
Connecting the APL Bypass and PEEP/PMAX
Hoses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Attaching the Manual (Ambu) Ventilation Bag . . 68
Preparing the Ventilator . . . . . . . . . . . . . . . . . . . 68
Ventilator Safety Features . . . . . . . . . . . . . . . . . 68
Installing Vaporizers . . . . . . . . . . . . . . . . . . . . . 69
Additional Equipment . . . . . . . . . . . . . . . . . . . . 69
Equipotential Bonding . . . . . . . . . . . . . . . . . . . . 70
Connecting AC Power . . . . . . . . . . . . . . . . . . . . 71
Daily and Pre-use Checkout . . . . . . . . . . . . . . . 71
Getting Started. . . . . . . . . . . . . . . . . . . . . . . . . 73
Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Powering-Up the Machine . . . . . . . . . . . . . . . . . 74
Power-Up Standby Screen . . . . . . . . . . . . . . . . 75
Checking Readiness for Operation . . . . . . . . . . 75
Mounting Fabius Tiro Onto A Wall (optional) . . . 48
Accessing the Connector Panel . . . . . . . . . . . . . 48
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Instructions for Use Fabius Tiro SW 3.n
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Contents
Power-Up Standby Screen . . . . . . . . . . . . . . . . . 78
Setting Fresh Gas Flow . . . . . . . . . . . . . . . . . . . 78
Setting Vaporizer Concentration. . . . . . . . . . . . . 80
O2 Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Low Flow Anesthesia . . . . . . . . . . . . . . . . . . . . . 81
Nitrogen Wash-Out (If Required) . . . . . . . . . . . . 81
Replacing CO2 Absorbent . . . . . . . . . . . . . . . . . 81
Ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Ventilator Safety Features . . . . . . . . . . . . . . . . . 97
Changing Patients . . . . . . . . . . . . . . . . . . . . . . . 98
Ending Operation . . . . . . . . . . . . . . . . . . . . . . . . 99
Preparing for Storage or Transport. . . . . . . . . . 100
Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Oxygen Monitoring . . . . . . . . . . . . . . . . . . . . . . 108
O2 Monitoring Disabled . . . . . . . . . . . . . . . . . . 112
O2 Low Supply Alarm . . . . . . . . . . . . . . . . . . . . 112
Respiratory Volume Monitoring . . . . . . . . . . . . 113
Breathing Pressure Monitoring. . . . . . . . . . . . . 115
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 117
Configuration Functions in Standby Mode . . . . 118
Configuration during Operation . . . . . . . . . . . . 139
Fault-Cause-Remedy . . . . . . . . . . . . . . . . . . . 147
Power Failure Backup . . . . . . . . . . . . . . . . . . . 148
Ventilator Fail State . . . . . . . . . . . . . . . . . . . . . 150
Overriding the Ventilator. . . . . . . . . . . . . . . . . . 150
Fault-Cause-Remedy . . . . . . . . . . . . . . . . . . . . 152
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . 175
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintenance Intervals . . . . . . . . . . . . . . . . . . .
Routine Maintenance . . . . . . . . . . . . . . . . . . .
Checking Readiness for Operation . . . . . . . . .
176
176
177
179
181
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . 185
Ambient Conditions . . . . . . . . . . . . . . . . . . . . .
Machine Data . . . . . . . . . . . . . . . . . . . . . . . . .
Fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electromagnetic Compatibility (EMC)
Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Safety Conformance . . . . . . . . . . . .
General Safety Standards for Anesthesia . . . .
Freedom from Latex . . . . . . . . . . . . . . . . . . . .
Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Anesthesia Gas Supply Module . . . . . . . . . . .
Anesthetic Agent Vaporizer Interface . . . . . . .
Breathing System . . . . . . . . . . . . . . . . . . . . . .
Low Oxygen Supply Pressure Alarm. . . . . . . .
S-ORC (Sensitive Oxygen Ratio Controller) . .
Serial Interface . . . . . . . . . . . . . . . . . . . . . . . .
Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
186
186
188
189
194
194
194
194
197
198
200
202
202
203
204
Appendix – Daily and Pre-use Checkout
Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Safety information on reprocessing . . . . . . . . . 160
Pre-cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Reprocessing methods. . . . . . . . . . . . . . . . . . . 160
Removing the Compact Breathing System. . . . 163
Removing Parts of the Ventilator . . . . . . . . . . . 165
Removing anesthetic gas scavenging system . 166
Removing the Suction System . . . . . . . . . . . . . 166
Reprocessing Breathing system. . . . . . . . . . . . 166
Care List for Fabius Tiro Components . . . . . . . 168
Reassembling the Breathing System . . . . . . . . 170
Reinstalling the Ventilator . . . . . . . . . . . . . . . . . 172
Reinstalling the Scavenger System . . . . . . . . . 173
Reinstalling the Suction System . . . . . . . . . . . . 174
Checking Readiness for Operation . . . . . . . . . 174
6
Instructions for Use Fabius Tiro SW 3.n
Page 7
For Your Safety and that of Your Patients
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use . . . . . . 8
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Not for use in areas of explosion hazard . . . . . . 8
Safe connection with other electrical
equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Safe networking of computers . . . . . . . . . . . . . . 8
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient monitoring . . . . . . . . . . . . . . . . . . . . . . . 9
General WARNINGS and CAUTIONS . . . . . . 10
Note on EMC/ESD risk for the device function 10
Accessories in sterile packaging . . . . . . . . . . . 10
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Instructions for Use Fabius Tiro SW 3.n
7
Page 8
For Your Safety and that of Your Patients
Strictly follow these Instructions for Use
WARNING
Strictly follow these Instructions for Use.
Any use of the medical device requires full
understanding and strict observation of all
portions of these instructions. The medical
device is only to be used for the purpose specified under "Intended Use" on page 14 and in
conjunction with appropriate patient monitoring (see page 9). Strictly observe all WARNING and CAUTION statements throughout
these Instructions for Use and all statements
on medical device labels.
Maintenance
WARNING
The medical device must be inspected and
serviced regularly by trained service personnel.
Repair of the medical device may also only be
carried out by trained service personnel.
Dräger Medical recommends that a service
contract be obtained with DrägerService and
that all repairs also be carried out by them.
Dräger Medical recommends that only authentic Dräger Medical repair parts be used for
maintenance. Otherwise the correct functioning of the medical device may be compromised.
See chapter “Maintenance” .
Accessories
WARNING
Only the accessories indicated on the list of
accessories 90 52 248 have been tested and
approved to be used with the medical device.
Accordingly it is strongly recommended that
only these accessories be used in conjunction
with the specific medical device. Otherwise
the correct functioning of the medical device
may be compromised.
8
Not for use in areas of explosion hazard
WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
Safe connection with other electrical equipment
WARNING
Electrical connections to equipment which is
not listed in these Instructions for Use should
only be made following consultation with the
respective manufacturers.
Safe networking of computers
When networking with electrical devices, the operator is responsible for ensuring that the resulting system meets the requirements set forth by the
following standards:
– EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
– EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility; Requirements and tests
– EN 60601-1-4 (IEC 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
Follow Assembly Instructions and Instructions for
Use.
Instructions for Use Fabius Tiro SW 3.n
Page 9
For Your Safety and that of Your Patients
Patient safety
The design of the medical device, the accompanying literature, and the labeling on the medical
device take into consideration that the purchase
and 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, 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 must recognize their responsibility for choosing appropriate
safety monitoring that supplies adequate information on medical device performance and patient
condition.
Patient safety may be achieved through a wide
variety of different 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 operator.
Dräger Medical AG & Co. KG
Instructions for Use Fabius Tiro SW 3.n
9
Page 10
For Your Safety and that of Your Patients
General WARNINGS and CAUTIONS
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 these Instructions for Use or in the device-specific Instructions for Use.
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibility (EMC) pursuant to international EMC standard
IEC 60601-1-2: 2001
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 included, see page 189.
Portable and mobile RF communications equipment can affect medical electrical equipment.
WARNING
Connector pins with an ESD warning sign should not be touched
and no connections should be
made between these connectors
without implementing ESD protective measures. Such precautionary procedures may include antistatic clothing and shoes,
the touch of a ground stud before and during
connecting the pins or the use of electrically
isolating and antistatic gloves. All staff involved in the above shall receive instruction in
these ESD precautionary procedures.
10
WARNING
Risk of electric shock.
Connecting devices to the
Medical Power Outlet Strip can
cause an increase in leakage
current beyond permissible
values if the protective conductor of a device fails. Check the leakage current
when connecting devices to the Medical
Power Outlet Strip. If connecting a device (or
devices) increases the leakage current to a
value which exceeds the permissible value, do
not use the auxiliary outlets of the Fabius Tiro:
use a separate wall socket.
The system must meet the requirements for
medical equipment in accordance with
IEC/EN 60601-1-1 and IEC/EN 60601-1-2 and
the particular standards of the connected
devices.
Accessories in sterile packaging
Do not use accessories in sterile packaging if the
packaging has been opened, damaged or if there
are other signs that the accessories are not sterile.
Reprocessing and resterilization of single-use
accessories is not permitted.
CAUTION
Risk of patient injury:
An incorrect diagnosis or misinterpretation of
measured values, or other parameters, may
endanger the patient.
Do not base therapy decision on individual measured values or monitoring parameters.
Instructions for Use Fabius Tiro SW 3.n
Page 11
For Your Safety and that of Your Patients
Software
The device's software has been developed and
tested carefully in accordance with Dräger's high
quality standards. It is therefore highly improbable
that software errors can become a hazard to the
patient.
Additionally, independent protective functions are
extensively implemented in the software, as well as
in electronics and mechanics, for all safety-related
functions of the device.
Through this, the probability that an error in the software or other functions can be detected before it
affects the patient's safety is very high. Regular
automated or manual tests ensure the effectiveness of all protective measures.
WARNING
Do not use conductive breathing hoses or
face masks.
They may cause burns during HF surgery.
WARNING
Any person involved with the setup, operation, or maintenance of the Fabius Tiro anesthesia system must be thoroughly familiar
with this instruction manual.
WARNING
This anesthesia system will not respond automatically to certain changes in patient condition, operator error, or failure of components.
The system has to be operated under the constant supervision and control of a qualified
operator in order to provide immediate corrective action.
WARNING
No third-party components shall be attached
to the anesthesia machine, ventilator, or breathing system (except for certain approved
components), otherwise the correct functioning of the device may be compromised. For
more information, contact DrägerService or
your local authorized service organization.
Instructions for Use Fabius Tiro SW 3.n
WARNING
Each institution and user has a duty to independently assess, based on its, his, or her unique circumstances, what components to
include in an anesthesia system. However,
Dräger, in the interest of patient safety, strongly recommends the use of an oxygen analyzer, pressure monitor, volume monitor, and
end-tidal CO2 monitor in the breathing circuit
at all times.
WARNING
Risk of unintentional movement of the anesthesia machine.
Apply the caster brakes when the anesthesia
machine is in use.
WARNING
Remove any equipment mounted to the
machine before transport. The writing table
should also be free of all objects and pushed
back in the locked position.
If these precautions are not followed, the
device may tip over and pose a risk to safety.
WARNING
Risk of fire.
Drugs or other substances based on inflammable solvents, such as alcohol, must not be
introduced into the patient system.
Adequate ventilation must be ensured if
highly inflammable substances are used for
disinfection.
WARNING
Explosive anesthetics, such as ether or cyclopropane, must not be used due to the risk of
fire.
11
Page 12
For Your Safety and that of Your Patients
WARNING
Do not use Fabius Tiro in areas of explosion
hazard.
This anesthesia system is neither approved
nor certified for use in areas where combustible or explosive ambient gas mixtures (e.g.
O2 or agent-enriched atmospheres) are likely
to occur.
CAUTION
Communications with external equipment may be
temporarily affected by electromagnetic interference due to the use of electrosurgical equipment.
CAUTION
Do not use Fabius Tiro during magnetic resonance (MRI, NMR, NMI)!
Device operation may be affected, thus placing
the patient at risk.
CAUTION
Risk of physical injury.
To avoid physical injury, pay special attention to
edges, moving parts and corners when working
with:
– drawers,
– the ventilator module,
– the writing tray,
– swivel arms for mounted devices,
– gas cylinders,
– vaporizer units,
– CLIC absorbers and CLIC adapters,
as well as other accessories.
NOTE:
Software must be installed by qualified personnel.
We recommend to contact DrägerService for software installation.
NOTE:
If the error-free state of the protective earthing conductor or its connection to the medical device is
doubtful, the device must be operated using the
internal power supply (battery).
12
Instructions for Use Fabius Tiro SW 3.n
Page 13
Intended Use
Intended Use
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . 14
MEDIBUS and Vitalink Protocols . . . . . . . . . . . 14
Instructions for Use Fabius Tiro SW 3.n
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Page 14
Intended Use
Intended Use
Fabius Tiro is an inhalation anesthesia machine for
use in operating, induction and recovery rooms.
It may be used with O2, N2O, and AIR supplied by
a medical gas pipeline system or by externally
mounted gas cylinders.
Fabius Tiro is equipped with a compact breathing
system, providing fresh gas decoupling, PEEP, and
pressure limitation.
The following ventilation options are available:
–
–
–
–
–
–
Volume Controlled Ventilation
Pressure Controlled Ventilation
Pressure Support (Optional)
SIMV/PS (Optional)
Manual Ventilation
Spontaneous Breathing
Fabius Tiro is equipped with an electrically driven
and electronically controlled ventilator and monitors
for airway pressure (P), volume (V), and inspiratory
oxygen concentration (FiO2).
As per IEC 60601-2-13 (Anesthetic Workstations
and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and
anesthetic agent is required when the machine is in
use.
WARNING
Explosive anesthetics, such as ether or cyclopropane, must not be used due to the risk of
fire.
IEC 60601-2-13 :2003 requires that a manual ventilation bag must be available for emergency use.
Fresh gas enrichment is provided by the Dräger
Vapor anesthetic vaporizer.
MEDIBUS and Vitalink Protocols
MEDIBUS and Vitalink are software protocols for
use in transferring data between the Fabius Tiro
and an external medical or non-medical device
(e.g., hemodynamic monitors, data management
systems, or a Windows-based computer) via the
RS-232 interface (see 9038530, 3rd edition or higher).
WARNING
Data transferred via MEDIBUS and Vitalink
interfaces are for information only and are not
intended as a basis for diagnosis or therapy
decisions.
WARNING
In order to protect patients and users from
electrical hazards, is it imperative that all systems consisting of electrical medical devices
and other electrical devices, such as but not
limited to PCs, printers, etc., be mounted
exclusively by trained personnel.
The system must meet the requirements about
medical electrical equipment in accordance to
IEC/EN 60601-1-1 and IEC/EN 60601-1-2.
NOTE:
“O2 Monitoring Disabled” is a local authorized service organization-configurable option. See "O2
Monitoring Disabled" on page 112 for more information. In this case, external FiO2 monitoring must
be available.
14
Instructions for Use Fabius Tiro SW 3.n
Page 15
System Overview
System Overview
Front View (trolley mounted) . . . . . . . . . . . . 16
Compact Breathing System (Top View) . . . . 17
Rear View (Pin-Index Connector) . . . . . . . . . 18
Side View (Threaded Connectors) . . . . . . . . 19
Interface Panel . . . . . . . . . . . . . . . . . . . . . . . . 20
Vaporizers (Optional) . . . . . . . . . . . . . . . . . . 21
Selectatec (Optional) . . . . . . . . . . . . . . . . . . . . 21
Fabius Tiro as a Ceiling Device . . . . . . . . . . 22
Fabius Tiro as a Wall Device . . . . . . . . . . . . 22
Auxiliary Oxygen Flowmeter . . . . . . . . . . . . 22
APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Communication Ports . . . . . . . . . . . . . . . . . . 24
Recommended Device Configuration . . . . . . . 24
Auxiliary Fresh Gas Outlet (Optional) . . . . . 26
Using the fresh gas outlet as common gas
outlet (CGO) . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Using the COSY . . . . . . . . . . . . . . . . . . . . . . . 26
Auxiliary Fresh Gas Outlet Switch
(Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Fresh gas flow to external non-rebreathing
system: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Fresh gas flow to COSY: . . . . . . . . . . . . . . . . . 28
Magill Breathing Circuit . . . . . . . . . . . . . . . . 29
Accessory Weight Limits . . . . . . . . . . . . . . . 30
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 31
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Instructions for Use Fabius Tiro SW 3.n
15
Page 16
System Overview
Front View (trolley mounted)
1
23
4
14
13
5
12
6
11
7
10
8
073
9
1
Ventilator control panel (settings for ventilation
parameters and airway monitoring)
2 Total fresh gas flowmeter
3 Display screen
4 Vapor mount
5 Fresh gas control
6 Gauges for Pin index O2, AIR or N2O cylinders
(optional)
7 Writing table (optional)
8 Storage drawers
9 Brake
10 Absorber
16
11
12
13
14
Breathing system
Oxygen Flush
Ventilator
Auxiliary Oxygen Flowmeter
Instructions for Use Fabius Tiro SW 3.n
Page 17
System Overview
Compact Breathing System (Top View)
1
2
3
4
5
14
6
13
12
7
8
10
9
064
11
1
2
3
4
5
6
7
8
9
10
11
12
13
Auxiliary Fresh gas outlet with switch (optional)
PEEP/PMAX valve connection port
Bag holder
Expiratory valve
Flow guard (flow sensor protection)
Expiratory port
Connector for breathing bag
Inspiratory port
Inspiratory valve
Fresh gas decoupling valve
APL bypass valve connection port
Breathing system mount
Selecting knob for »MAN« and »SPONT« on
pressure limiting (APL) valve
14 Sample gas return port
Instructions for Use Fabius Tiro SW 3.n
17
Page 18
System Overview
Rear View (Pin-Index Connector)
1 2
3
4
5
8
6
10
9
7
066
11
1
2
3
4
5
6
7
8
9
Power cable connection
Interface panel
Ventilator hose connection
ON/OFF switch
Fuse
Fresh gas outlet
Equipotential bonding
Breathing system
Connector for medical gas pipeline supply
(central supply)
10 Connector for cylinders (threaded connectors)
11 Pin-Index system
18
Instructions for Use Fabius Tiro SW 3.n
Page 19
System Overview
Side View (Threaded Connectors)
1
2
3
1
2
3
4
065
4
Vapor mount
Connector for medical gas pipeline supply
(central supply)
Connector for cylinders O2, O2 and N2O or
O2 and AIR (threaded connectors)
Cylinders
Instructions for Use Fabius Tiro SW 3.n
19
Page 20
System Overview
Interface Panel
1
2
10
3
4
5
6
9
7
074
8
1
2
3
4
5
6
7
8
9
10
20
COM 1
COM 2
APL
Oxygen Sensor
Pressure Breathing
Volume Sensor
ON/OFF switch
Fuse
Power cable connection
PEEP
Instructions for Use Fabius Tiro SW 3.n
Page 21
System Overview
Vaporizers (Optional)
The Dräger Vapor anesthetic agent vaporizers are
used to enrich the fresh gas with a precisely metered quantity of vapor from the liquid anesthetic
agent being used, i.e., Isoflurane, Halothane, Enflurane, Sevoflurane, or Desflurane.
When using a Desflurane vaporizer, it must be connected to mains power.
070
For complete information, consult the appropriate
Instruction for Use provided with the vaporizer.
Selectatec (Optional)
The interlock system for the Selectatec is built into
the vaporizers. When a vaporizer is selected for
use, the interlocking index pins will protrude from
the sides of the vaporizer thereby not allowing the
adjacent vaporizer to be opened. For more specific
information on the Selectatec, refer to the
Selectatec Vaporizer’s instruction manual.
Instructions for Use Fabius Tiro SW 3.n
21
Page 22
System Overview
Fabius Tiro as a Ceiling Device
With the use of the ceiling supply unit Movita, the
Fabius Tiro can be used as a ceiling device. For
installation instructions, see the IFU for Movita
(9037852).
Fabius Tiro as a Wall Device
The Fabius Tiro may also be mounted on the wall
see page 48.
Auxiliary Oxygen Flowmeter
069
The auxiliary oxygen flowmeter delivers a metered
flow of pure oxygen, used, for example in the
delivery of oxygen through a nasal cannula.
Auxiliary oxygen can be used in any ventilation
mode, in standby, or even if the machine is
switched off.
22
Instructions for Use Fabius Tiro SW 3.n
Page 23
System Overview
APL Valve
WARNING
Route all lines/cables away from the APL
valve to prevent interference with the APL
valve adjustment knob. Lines/cables caught
underneath the APL valve adjustment knob
could interfere with proper functioning of this
valve.
The APL valve has two functions. It limits the maximum pressure during manual ventilation. It also
exhausts excess gas into the scavenger system
during manual and spontaneous ventilation.
The APL valve is connected to the patient airway
through the ventilator. It functions only when the
ventilator is in ManSpont mode or ventilator override condition.
033
The APL valve has a labeled knob for selecting between spontaneous and manual modes of ventilation and for indicating approximate pressure
settings.
– When the APL valve knob is rotated fully counterclockwise, pressure is released for spontaneous ventilation. Spontaneous ventilation
automatically eliminates resistance to patient
exhalation.
– In manual mode, the APL valve knob can be
rotated to change the pressure threshold at
which gas will flow through the valve and into
the scavenging system. Clockwise rotation of
the APL valve knob increases the pressure
threshold, and counterclockwise rotation of the
APL valve knob decreases the pressure threshold. Lifting the top of the APL valve knob will
temporarily relieve pressure.
NOTE:
The APL valve is automatically excluded from the
breathing circuit whenever an automatic ventilation mode is selected.
Instructions for Use Fabius Tiro SW 3.n
23
Page 24
System Overview
Communication Ports
1
The Fabius Tiro has two ports on the back panel
for communication with external devices. The
ports are labeled COM 1 and COM 2 and support MEDIBUS and Vitalink communications.
WARNING
A test for leakage current must be performed
by qualified engineering personnel before use
if the Fabius Tiro is interfaced with other
equipment.
1
026
CAUTION
Only the combinations of Dräger approved monitors, mounting parts and interface cables may be
used. Otherwise the correct functioning of the
device may be compromised.
Recommended Device Configuration
NOTE:
Data Pass Through (gas analysis data) must be
enabled by DrägerService or your local authorized
service organization.
Configuration 1:
– Fabius Tiro
– Gas Analyzer
Connect gas analyzer to either COM 1 or
COM 2.
2
035
2
2
24
Instructions for Use Fabius Tiro SW 3.n
Page 25
System Overview
Configuration 2:
– Fabius Tiro
– gas analyzer
– automatic record keeper
2
2
1
Connect gas analyzer to COM 2.
Connect anesthesia record keeper to COM 1.
036
1
2
1
Configuration 3:
– Fabius Tiro
– multi parameter monitor with one COM port
– automatic anesthesia record keeper
4
3
038
Connect monitor to anesthesia record keeper.
Connect anesthesia record keeper to COM 1 or
COM 2.
Configuration 4:
– Fabius Tiro
– multi parameter monitor with two COM ports
– automatic anesthesia record keeper
5
6
7
4
5
6
6
7
5
7
Connect monitor to anesthesia record keeper.
Connect anesthesia record keeper to COM 1.
Connect monitor to COM 2.
Instructions for Use Fabius Tiro SW 3.n
039
3
4
3
25