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Summary of Contents for Dräger Medical Fabius GS premium
- Page 1 Instructions for Use ® Fabius GS premium Anesthesia Workstation WARNING! For a full understanding of the Software 3.n performance characteristics of this medical device, the user should care- fully read these Instructions for use before use of the medical device.
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Page 2: Working With These Instructions For Use
– »Restore Site Defaults« trations. On each page the numbering restart with “1”. Instructions for Use Fabius GS premium SW 3.n – Dashes indicate the listing of data, options or objects. Right-Hand Column – the Illustrations The illustrations provide visual reference for the text and for locating the various parts of the equip- ment. -
Page 3: Trademarks
Please refer to "Abbreviations" on page 32 and "Symbols" on page 33 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 GS premium SW 3.n... - Page 4 Instructions for Use Fabius GS premium SW 3.n...
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Page 5: Table Of Contents
Breathing System ......48 Setting Vaporizer Concentration ... . 78 Instructions for Use Fabius GS premium SW 3.n... - Page 6 Maintenance ......173 Definitions......174 Instructions for Use Fabius GS premium SW 3.n...
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Page 7: For Your Safety And That Of Your Patients
Accessories in sterile packaging ... 10 Software ......10 Instructions for Use Fabius GS premium SW 3.n... -
Page 8: Strictly Follow These Instructions For Use
Follow Assembly Instructions and Instructions for strongly recommended that only these acces- Use. sories be used in conjunction with the specific medical device. Otherwise the correct func- tioning of the medical device may be compro- mised. Instructions for Use Fabius GS premium SW 3.n... -
Page 9: Patient Safety
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 GS premium SW 3.n... -
Page 10: General Warnings And Cautions
DrägerService or measured values, or other parameters, may your local authorized service organization. endanger the patient. Do not base therapy decision on individual mea- sured values or monitoring parameters. Instructions for Use Fabius GS premium SW 3.n... - Page 11 For Your Safety and that of Your Patients WARNING! WARNING! Each institution and user has a duty to inde- Do not use Fabius GS premium in areas of pendently assess, based on its, his, or her explosion hazard. unique circumstances, what components to This anesthesia system is neither approved include in an anesthesia system.
- Page 12 Instructions for Use Fabius GS premium SW 3.n...
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Page 13: Intended Use
Intended Use ......14 MEDIBUS and Vitalink Protocols ... 14 Instructions for Use Fabius GS premium SW 3.n... -
Page 14: Intended Use
MEDIBUS and Vitalink are software protocols for use in transferring data between the Fabius GS premium is equipped with a compact Fabius GS premium and an external medical or breathing system, providing fresh gas decoupling, non-medical device (e.g., hemodynamic monitors, PEEP, and pressure limitation. -
Page 15: System Overview
Abbreviations ......32 Symbols ......33 Instructions for Use Fabius GS premium SW 3.n... -
Page 16: Front View
15 Auxiliary Oxygen Flowmeter 5 Lamp 6 Fresh gas control 7 Gauges for Pin index O AIR and N O cylinders (optional) 8 Writing table (optional) 9 Storage drawers 10 Central brake Instructions for Use Fabius GS premium SW 3.n... -
Page 17: Compact Breathing System (Top View)
9 Fresh gas decoupling valve 10 APL bypass valve connection port 11 Breathing system mount 12 Selecting knob for »MAN« and »SPONT« on pressure limiting (APL) valve 13 Sample gas return port Instructions for Use Fabius GS premium SW 3.n... -
Page 18: Rear View (Pin-Index Connector)
2 Connector for medical gas pipeline supply (cen- tral supply) 3 Type plate 4 Power cable connection 5 Interface panel 6 Ventilator hose connection 7 ON/OFF switch 8 Fuse 9 Breathing system 10 Pin-Index system Instructions for Use Fabius GS premium SW 3.n... -
Page 19: Rear View (Threaded Connectors)
2 Connector for medical gas pipeline supply (central supply) 3 Type plate 4 Power cable connection 5 Interface panel 6 Ventilator hose connection 7 ON/OFF switch 8 Fuse 9 Breathing System 10 Cylinders Instructions for Use Fabius GS premium SW 3.n... -
Page 20: Interface Panel
System Overview Interface Panel 1 COM 1 2 COM 2 3 APL 4 Oxygen Sensor 5 Pressure Breathing 6 Volume Sensor 7 ON/OFF switch 8 Fuse 9 Power cable connection 10 PEEP Instructions for Use Fabius GS premium SW 3.n... -
Page 21: Vaporizers (Optional)
Note that the selector lever is shown in the center position. This ensures that both vaporizers are in the locked position. Also, this is the recommended position for the selector lever when moving the Fabius GS premium. Instructions for Use Fabius GS premium SW 3.n... -
Page 22: Selectatec (Optional)
Extended >10 to Dräger auto exclusion ≤ Operating 15 L/min vaporizer concentration Range output accuracy may be reduced. When using a Desflurane vaporizer, it must be con- nected to mains power. Instructions for Use Fabius GS premium SW 3.n... -
Page 23: Auxiliary Oxygen Flowmeter
Auxiliary oxygen can be used in any ventilation mode, in standby, or even if the machine is switched off. Instructions for Use Fabius GS premium SW 3.n... -
Page 24: Apl Valve
APL valve knob decreases the pressure thresh- old. 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 GS premium SW 3.n... -
Page 25: Communication Ports
System Overview Communication Ports 1 The Fabius GS premium 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... - Page 26 – multi parameter monitor with two COM ports – automatic anesthesia record keeper 5 Connect monitor to anesthesia record keeper. 6 Connect anesthesia record keeper to COM 1. 7 Connect monitor to COM 2. Instructions for Use Fabius GS premium SW 3.n...
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Page 27: Auxiliary Fresh Gas Outlet (Optional)
1 Connect the fresh gas hose to auxiliary fresh gas outlet. 2 Connect the external non-rebreathing system to the auxiliary fresh gas outlet. Follow the Instructions for Use included with the external non-rebreathing system. Instructions for Use Fabius GS premium SW 3.n... -
Page 28: Auxiliary Fresh Gas Outlet Switch (Optional)
(2) on the Fabius. Connect the horizontal port of the auxiliary fresh gas outlet switch (3) to the external non-rebreathing system. Connect the fresh gas hose (4) to auxiliary fresh gas outlet. Instructions for Use Fabius GS premium SW 3.n... -
Page 29: Fresh Gas Flow To External Non-Rebreathing
Instructions for Use. Fresh gas flow to COSY: 2 Set lever of the switch to »COSY«. Lever points in direction of auxiliary fresh gas outlet and shows »COSY«. Instructions for Use Fabius GS premium SW 3.n... -
Page 30: Magill Breathing Circuit
The Magill breathing system makes no allow- ances for pressure or O monitoring. Risk of patient hazard. For more specific information on the Magill Breath- ing Circuit, refer to the Magill Breathing Circuit’s Instructions for use. Instructions for Use Fabius GS premium SW 3.n... -
Page 31: Accessory Weight Limits
7.6 cm from the rail, at any position on the rail. CAUTION! Do not place more than 40 lb (18 kg) on top of the Fabius GS premium monitor housing. Risk of tip-over and personal injury! Instructions for Use Fabius GS premium SW 3.n... -
Page 32: Abbreviations
Vacuum (e.g. for secretion suction) Hectopascal Expiratory minute volume in./insp. Inspiratory Tidal volume Insp Flow Inspiratory flow L/min Liters per minute mbar Millibar Manual ventilation MEAN Mean pressure Minute volume Nitrous oxide Oxygen Airway pressure Instructions for Use Fabius GS premium SW 3.n... -
Page 33: Symbols
System Overview Symbols The following symbols appear on the labels on the Indicates Direction back of the Fabius GS premium and are defined below: Total Power Applied Caution: Refer to accompanying documents Partial Power Applied before operating equipment. Caution: Risk of electric shock, do not Cylinder Gauge, Remote Cylinder remove. - Page 34 Suppress Alarm Tone for Two Min- utes Standby Mode Available Operating Capacity of XX % Close Menu, Back to Previous Menu Upper Alarm Limit Lower Alarm Limit Mains Applied/Mains Power Alarm Off Setup Screen Instructions for Use Fabius GS premium SW 3.n...
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Page 35: Operation Concept
Gas System Color Coding ....46 Screen Color Concept ....46 Instructions for Use Fabius GS premium SW 3.n... -
Page 36: Control Panel
Operation Concept Control Panel The control panel on the Fabius GS premium is NOTE: characterized by a small number of elements, clear On U.S. machines, the following fixed function keys layout, and ease of operation. are labeled with text in addition to the graphical Its main elements are: symbols: »Alarms«, »Setup«, »Home«,... -
Page 37: The Screen Display
2 Alarm window which displays up to four of the highest priority alarms. NOTE: 3 Oxygen monitoring window which displays the On some non-U.S. Fabius GS premium units, the inspiratory oxygen concentration in percent (%) positions of the O and N O virtual flow tubes are along with high and low alarm limits. -
Page 38: Rotary Knob
4 The »SIMV/PS« key is used to select the SIMV/PS ventilation mode (optional). 5 The »Pressure Support« key is used to select the Pressure Support ventilation mode (optional). Instructions for Use Fabius GS premium SW 3.n... -
Page 39: Soft Keys
The »Volume Alarms On/Off« soft key label does not appear in ManSpont mode because it is select- able on the ManSpont screen. See "Configuration during Operation" on page 137 for complete information. Instructions for Use Fabius GS premium SW 3.n... -
Page 40: Selecting/Setting Monitoring Functions
»Default Settings« or »Configuration« label. Select and confirm the »Default Settings« label. The Default Settings column is selected. (Selecting and confirming the return arrow will exit the Default Settings column and redisplay the main Setup screen.) Instructions for Use Fabius GS premium SW 3.n... - Page 41 (For example in the illustration on the right, the alarm limit was changed from 20 to 25.) Confirm the new value for the alarm limit. The new alarm limit is saved and cursor moves to the return arrow. Instructions for Use Fabius GS premium SW 3.n...
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Page 42: Selecting/Setting Ventilation Parameters
10 seconds. If the new set- ting is not confirmed within the timeout period, the current ventilation setting remains in effect and the Ventilation Settings window returns to the Wave- form window. Instructions for Use Fabius GS premium SW 3.n... -
Page 43: Fresh Gas Control
O central supply pressure gauge 9 AIR central supply pressure gauge 10 O central supply pressure gauge Only used with Pin-Index connectors (not present with threaded connectors). Instructions for Use Fabius GS premium SW 3.n... -
Page 44: Total Flow Meter
2 L/min. If 1 L/min of N O is needed, open the N O flow con- trol knob until the total flow meter reads 3 L/min: 2 L/min O plus 1 L/min N Instructions for Use Fabius GS premium SW 3.n... -
Page 45: Fresh Gas Flow Monitoring Resolution
Operation Concept Fresh Gas Flow Monitoring Resolution The Fabius GS premium can be configured by DrägerService or your local authorized service organization to display fresh gas flow rates either in a standard resolution mode or in a high resolution mode:... -
Page 46: Led Indicators
Gas System Color Coding Each connection, valve, gauge, and flow meter on the Fabius GS premium is color-coded for the appropriate gas, as shown the table below: Yellow Black/White... -
Page 47: Assembly
Connecting the Pressure Breathing Gauge (Optional) ......63 Instructions for Use Fabius GS premium SW 3.n... -
Page 48: Activating The Battery
Such dust and particles can cause leaks in the system. 2 Fit the absorber canister into position below the breathing system and turn it counterclockwise as far as possible. Instructions for Use Fabius GS premium SW 3.n... -
Page 49: Installing The Drägersorb Clic Adapter
Installing the Drägersorb CLIC Adapter (Optional) The disposable absorber Drägersorb CLIC Free or Drägersorb CLIC 800 plus can be used on the Fabius GS premium by using the Drägersorb CLIC adapter. For information on installing the Drägersorb CLIC adapter, consult its Instructions for Use. -
Page 50: Connecting The Compact Breathing System
Release the plunger and rotate the compact breathing system until the plunger locks into position. 3 Connect the fresh gas hose from the Fabius GS premium to the compact breathing system. Instructions for Use Fabius GS premium SW 3.n... -
Page 51: Inserting The Flow Sensor
Only hand-tighten the threaded connectors. Do not use tools. Inserting the Flow Sensor Unscrew and remove the expiration port and the flow guard (flow sensor protection) 3 Insert the flow sensor. 4 Reinstall the expiration port. Instructions for Use Fabius GS premium SW 3.n... -
Page 52: Connecting The Waste Gas Outlet Port
1 Tighten the two thumb screws to secure. 2 Attach the 90° fitting to the end of the bag arm, and attach the breathing bag to the other end of the fitting. Instructions for Use Fabius GS premium SW 3.n... -
Page 53: Connecting Pipeline Supply Of N 2 O, Air And O 2
41 and 87 psi (2.8 and 6 kPa x 100). NOTE: The loss of the pipeline supply could cause the loss of combined devices. Instructions for Use Fabius GS premium SW 3.n... -
Page 54: Connecting The Reserve Gas Cylinders For N 2 O, Air And O 2 (For Pin-Index Mounting)
NOTE: If cylinder valves are leaky or difficult to open or close, they must be repaired in accordance with the manufacturer’s specifications. Instructions for Use Fabius GS premium SW 3.n... - Page 55 Verify that the washer is in place, the index pins are engaged, and the cyl- inder hangs vertically. Tighten the yoke firmly. Instructions for Use Fabius GS premium SW 3.n...
- Page 56 (PSI - MIN) should be replaced with new, full cylin- ders. PSI/kPa x 100 - PSI/kPa x 100 - FULL (typical full load) 1900/131 1000/69 745/51 600/42 1900/131 1000/69 Instructions for Use Fabius GS premium SW 3.n...
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Page 57: Connectors)
Screw the pressure regulators onto the cylinder valves. 2 Screw the compressed gas hoses to the pres- sure regulators and to the connections of the gas inlet block. Open the cylinder valves. Instructions for Use Fabius GS premium SW 3.n... -
Page 58: Connecting The Ags Scavenger System
NOTE: During use, the float indicator in the flow indicator (3) should stay between the upper and lower marks. If necessary, regulate flow using the optional flow adjustment valve (4). Instructions for Use Fabius GS premium SW 3.n... -
Page 59: Connecting The Suction System (Optional)
Connecting the Suction System (Optional) The optional suction system for the Fabius GS premium consists of a suction regulator and a bracket that attaches to the side of the anes- thesia machine. The bracket is used to hold the reg- ulator and a suction bottle assembly of the customer’s choice. -
Page 60: Connecting The Breathing Hoses
2 Connect both patient breathing hoses to the Y-piece. 3 Push hose with bag onto the connector. WARNING! Use caution when connecting the patient. Risk of strangulation. Instructions for Use Fabius GS premium SW 3.n... -
Page 61: Accessories
When using coaxial hoses, leaks between the inner and outer hoses cannot be detected during the self- test/leak test. Instructions for Use Fabius GS premium SW 3.n... -
Page 62: Inserting A New O 2 Sensor Capsule
3 Push the O sensor into the port opening of the inspiratory port dome, and 4 plug the connector into the fitting labeled on the connector panel on the back of the machine. Instructions for Use Fabius GS premium SW 3.n... -
Page 63: Connecting The Pressure Sensor
(3), the breathing pressure gauge port (4) to the pressure gauge connector, and then to the bacterial filter and onto the port labeled on the connector panel on the back of the machine (5). Instructions for Use Fabius GS premium SW 3.n... -
Page 64: Connecting The Flow Sensor
4 Plug the control hose to the connection port on the APL Bypass valve and to the connection port marked APL on the connection panel. NOTE: The APL bypass hose is larger than the PEEP/P hose. Instructions for Use Fabius GS premium SW 3.n... -
Page 65: Installing The Cosy Shielding
Install the COSY shielding on top of the breathing system, being careful to guide all cables through the provided slots. Attaching the Manual (Ambu) Ventilation Bag 1 Hang the fully prepared and tested bag on the rail at the right. Instructions for Use Fabius GS premium SW 3.n... -
Page 66: Preparing The Ventilator
1 Swing the ventilator unit back into position. Ventilator Safety Features – High pressure safety relief valve (A). – Negative pressure safety relief valve (B). – Ventilator chamber pressure sensor. Instructions for Use Fabius GS premium SW 3.n... -
Page 67: Installing Vaporizers
CAUTION! Risk of tip-over and personal injury! If monitors and other equipment are placed on top of the Fabius GS premium, the risk of tipping over the unit is increased, especially when rolling over thresholds etc. Remove all monitors and other equipment from the top of the Fabius GS premium before moving the unit. -
Page 68: Equipotential Bonding
Connect equipotential bonding to the auxiliary equipment. Connecting AC Power Fabius GS premium can be operated at mains volt- ages from 100 V to 240 V. Push power plug into supply mains socket. 2 Switch on the machine by using the ON/OFF switch on the rear of the machine. -
Page 69: Daily And Pre-Use Checkout
Assembly Daily and Pre-use Checkout At the completion of the assembly of the Fabius GS premium, perform the Daily and Pre- use Checkout procedure provided in the Appendix of this manual to ensure that the machine is ready for operation. - Page 70 Instructions for Use Fabius GS premium SW 3.n...
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Page 71: Getting Started
Powering-Up the Machine ....72 Power-Up Standby Screen ....73 Checking Readiness for Operation ..73 Instructions for Use Fabius GS premium SW 3.n... -
Page 72: Powering-Up The Machine
After a brief delay, the Standby screen appears. CONDITIONALLY FUNCTIONAL A noncritical fault was detected. The Fabius GS premium may be used, but call DrägerService or your local authorized service organization. Press the rotary knob to continue operation. -
Page 73: Power-Up Standby Screen
WARNING! The power-on self-test should be carried out once a day. Switch Fabius GS premium off and on or start the self-test by pressing the soft key »Run System Test«. Power-Up Standby Screen Following a successful power-up, the Standby screen appears and provides instructions on start- ing the operation of the Fabius GS premium. - Page 74 Instructions for Use Fabius GS premium SW 3.n...
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Page 75: Operation
Ending Operation ..... 98 When Fabius GS premium is not in use ..98 Preparing for Storage or Transport ..99... -
Page 76: Power-Up Standby Screen
Power-Up Standby Screen Following a successful power-up, the Standby screen appears and provides instructions on start- ing the operation of the Fabius GS premium. Setting Fresh Gas Flow Set the fresh gas flow to the desired concentration using the flow control knobs on the front of the machine. - Page 77 However, S-ORC is not an oxygen-specific moni- toring device and therefore cannot provide any pro- tection against the effects of accidental use of the wrong gas. Therefore always monitor the O concentration. Instructions for Use Fabius GS premium SW 3.n...
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Page 78: Setting Vaporizer Concentration
3 Press the button and turn the handwheel coun- terclockwise to set the required anesthetic gas concentration. Regularly check the filling level on the sight glass. When reaching the minimum mark, fill the vaporizer with anesthetic agent. Instructions for Use Fabius GS premium SW 3.n... -
Page 79: O 2 Flush
The flow control ele- ments and the anesthetic agent vaporizer (Vapor) are bypassed. NOTE: In ManSpont mode, pressure may rise rapidly up to the setting of the APL valve. Instructions for Use Fabius GS premium SW 3.n... -
Page 80: Low Flow Anesthesia
Drägersorb 800 Plus or Drägersorb FREE. The color change indicates that the CO absorbent can no longer absorb CO (Drägersorb 800 Plus and Drägersorb FREE change from white to violet). Instructions for Use Fabius GS premium SW 3.n... - Page 81 Absorbent is caustic and is a strong irritant to the eyes, skin, and respiratory tract. When replacing the absorbent, take care not to spill its caustic contents and always wear protec- tive gloves and an appropriate mask. Instructions for Use Fabius GS premium SW 3.n...
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Page 82: Clic Adapter (Optional)
CLIC Adapter (Optional) The disposable CLIC adapter absorber can also be used on the Fabius GS premium. For information on installing the CLIC adapter, consult its Instruc- tions for Use. Instructions for Use Fabius GS premium SW 3.n... -
Page 83: Ventilation
It remains blinking until the selected mode of operation is confirmed. 2 The Waveform window is replaced by the ManSpont window and a message that pro- vides instructions to confirm the mode change. Instructions for Use Fabius GS premium SW 3.n... - Page 84 It remains blinking until the selected mode of operation is confirmed. 2 The Waveform window is replaced by the ManSpont window and a message that pro- vides instructions to confirm the mode change. Instructions for Use Fabius GS premium SW 3.n...
- Page 85 Set the appropriate fresh gas flow. Start manual ventilation. The pressure will be limited to the value set on the APL valve. To temporarily relieve pressure: Pull up on the APL valve knob. Instructions for Use Fabius GS premium SW 3.n...
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Page 86: Volume Control Ventilation
When the ventilator settings for Volume Control cause the ventilator to operate at its limits of perfor- mance, it is not possible for the Fabius GS premium to apply compliance compensation. If the ventilator's performance limit is reached, it is not possible to... - Page 87 20 to 1400 [mL] Frequency 4 to 60 Freq [bpm] ([1/min]) Insp time: 4:1 to 1:4 Exp time Insp pause time: 0 to 50 Insp time PEEP [cmH O] ([hPa]) 0 to 20 Instructions for Use Fabius GS premium SW 3.n...
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Page 88: Pressure Control Ventilation
Freq Min might not be applied accu- Freq [bpm] ([1/min]) rately in the Pressure Control Mode. Insp time: 4:1 to 1:4 Exp time Inspiratory Flow 10 to 75 Insp Flow [L/min] PEEP [cmH O] ([hPa]) 0 to 20 Instructions for Use Fabius GS premium SW 3.n... -
Page 89: Pressure Support Ventilation (Optional)
, Freq Min, Insp Flow, and PEEP. If two consecutive Apnea Ventilation breaths occur, the Caution message »APNEA VENTILATION!!« appears in the Alarm window. The alarm is cleared when a spontaneous breath is detected. Instructions for Use Fabius GS premium SW 3.n... - Page 90 After the mode change is confirmed, the Pres- sure Support key LED switches from blinking to constantly on, the ventilator switches to the Pressure Support mode, and the waveform is restored. Instructions for Use Fabius GS premium SW 3.n...
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Page 91: Simv/Ps Ventilation (Optional)
OFF will enable Pressure Support during SIMV mode. (Refer to "Pressure Support Ventila- tion (Optional)" on page 89 for additional informa- tion on Pressure Support ventilation.) Instructions for Use Fabius GS premium SW 3.n... - Page 92 If the ventilator settings are not correct, for each parameter that needs to change, press the cor- responding soft key, select the correct value, and confirm the change. When the parameter changes are completed, confirm the ventilation mode change. Instructions for Use Fabius GS premium SW 3.n...
- Page 93 O] ([hPa]) 0 to 20 Trigger Sensitivity 2 to 15 Trigger [L/min] Inspiratory Flow 10 to 85 Insp Flow [L/min] SIMV insp. time 0.3 to 4.0 [seconds] INSP Insp pause time: 0 to 50 Insp time Instructions for Use Fabius GS premium SW 3.n...
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Page 94: When Changing Between Ventilation Modes
Pressure Control. When changing from Volume Control or Pressure Control to Pressure Support, the suggested value for Insp Flow is either the last used value or the site default value. Instructions for Use Fabius GS premium SW 3.n... - Page 95 Insp Flow settings shall automatically be transferred from SIMV/PS to Pressure Support. When switching from SIMV/PS mode to Pressure Support mode, the Trigger and PEEP settings shall automatically be transferred from SIMV/PS to Pres- sure Support. Instructions for Use Fabius GS premium SW 3.n...
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Page 96: Ventilator Safety Features
NOTE: The user should then take action to resolve this, for example by increasing the fresh-gas flow. Fabius GS premium behaviour in case of no action taken by the user – breathing bag gradually empties completely – after two more strokes the alarm »FRESH GAS LOW«... -
Page 97: Changing Patients
Operation Changing Patients WARNING! As it is possible that Fabius GS premium devices within a care area have different site default alarm limit configurations, check whether the pre-set alarm limits are appropri- ate to the new patient. Also check that the alarm system has not been rendered useless by setting the alarm limits to extreme values. -
Page 98: Ending Operation
2.5 minutes after fresh gas is turned off. Close the cylinder valves. When Fabius GS premium is not in use If Fabius GS premium is not used for an extended period: Unplug the medical gas hoses from the wall supply points of the central gas supply. -
Page 99: Preparing For Storage Or Transport
This precau- tion prolongs the service life of the sensor. 2 Switch off system power using the switch on the back of the machine, and disconnect the power plug. Disconnect the scavenger hoses. Instructions for Use Fabius GS premium SW 3.n... - Page 100 Operation 1 Remove the pipeline supply hoses from the central supply. Press the O flush to depressurize the entire system. Instructions for Use Fabius GS premium SW 3.n...
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Page 101: Monitoring
Limits ....... 114 Instructions for Use Fabius GS premium SW 3.n... -
Page 102: Main Screen
Monitoring Main Screen 1 To display the main screen at any time, press the » « key (Home). The Fabius GS premium main screen displays cur- rent alarms, oxygen monitoring, breathing pressure monitoring, and respiratory volume monitoring information. Alarms Fabius GS premium alarms are organized into three categories based on urgency: –... -
Page 103: Sorting Of Displayed Alarms
If an alarm with the category Caution is active and an alarm with the category Warning is generated, the alarm sequence is started for the warning because the warning is assigned the highest prior- ity. Instructions for Use Fabius GS premium SW 3.n... -
Page 104: Silencing Alarms
« key (Silence), the yellow LED turns off. Disabling Volume Alarms Visual and audible volume alarms can be turned on or off during operation using the » « key (Setup). See "Volume Alarms On/Off" on page 138. Instructions for Use Fabius GS premium SW 3.n... -
Page 105: Setting Alarm Limits
Confirm the new value for the alarm limit. The new alarm limit is saved and the cursor moves to the return arrow. The adjustment range and factory default values for all alarms on the Fabius GS premium are shown in the following table. Alarm Adjustment... -
Page 106: Oxygen Monitoring
2 high oxygen concentration alarm limit 3 low oxygen concentration alarm limit Setting Oxygen Monitoring Alarm Limits Follow the procedure "Setting Alarm Limits" on page 105 to change the high or low alarm limit. Instructions for Use Fabius GS premium SW 3.n... -
Page 107: Calibrating The Oxygen Sensor
« key (Setup) on the front panel. The Setup window appears at the bottom of the screen. 2 Press the »Calibrate O Sensor« soft key. 3 The calibration instruction window replaces the Setup window. Follow the directions provided. Instructions for Use Fabius GS premium SW 3.n... - Page 108 »O SENSOR FAIL!« appears in the Alarm window. If this happens, ensure that the sensor is correctly assembled and recalibrate the oxygen sensor. Instructions for Use Fabius GS premium SW 3.n...
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Page 109: Consequences Of Incorrect O 2 Calibration
When a calibra- tion gas mixture is excessively rich or lean in oxy- gen, the Fabius GS premium will not complete an attempted calibration; however, if the calibration gas is rich or lean but is within certain limits, the Fabius GS premium will complete the calibration. -
Page 110: O 2 Monitoring Disabled
Monitoring Monitoring Disabled The following oxygen monitoring functions are dis- abled if the Fabius GS premium is configured by DrägerService to run using the O Monitoring Dis- abled option. – "Oxygen Monitoring Window" on page 106 – "Setting Oxygen Monitoring Alarm Limits" on page 106 –... -
Page 111: Respiratory Volume Monitoring
3 Minute Volume Measurement (MV) continu- ously displays the volume of exhaled gas accu- mulated during the previous minute of respiration in units of liters/minute (L/min). The display range is from 0.0 L/min to 99.9 L/min. Instructions for Use Fabius GS premium SW 3.n... -
Page 112: Volume Monitoring Alarms
While the ventilator is off and the system is in ManSpont mode, these alarms are generated at 30 seconds (Caution) and 60 seconds (Warning). The Fabius GS premium's volume alarms are auto- matically enabled when the ventilator is switched from Standby to a ventilation mode. -
Page 113: Breathing Pressure Monitoring
The breathing pressure monitoring windows show the following breathing pressure information in numeric and graphic form: NOTE: The Fabius GS premium can be configured by DrägerService or your local authorized service organization to display mean pressure (MEAN) instead of plateau pressure (PLAT). -
Page 114: Breathing Pressure Monitoring Alarms
NOTE: The pressure threshold alarm limit should be as close as possible to the sensed plateau pressure without exceeding it, approximately 4 cmH O (hPa) below the plateau pressure. Instructions for Use Fabius GS premium SW 3.n... -
Page 115: Configuration
Access Alarm Log ..... 143 Access Alarm Volume ....143 Instructions for Use Fabius GS premium SW 3.n... -
Page 116: Configuration Functions In Standby Mode
Standby screen: – »Run System Test« – »Calibrate Flow Sensor« – »Calibrate O Sensor« – »Leak/Compl Test« – »Access Alarm Log« – »Restore Site Defaults« Turn off freshgas flow. Instructions for Use Fabius GS premium SW 3.n... -
Page 117: Sleep Mode
"Power-Up Standby Screen" on page 76). Pressing this key restores the site defaults. The test results are posted on the screen. Following successful completion, the system returns to the Standby screen. Instructions for Use Fabius GS premium SW 3.n... -
Page 118: Calibrate Flow Sensor
Failed«. Troubleshooting Flow Calibration Failure If the flow sensor cannot be calibrated, retry the cal- ibration. If the flow sensor still cannot be calibrated, call DrägerService or your local authorized service organization. Instructions for Use Fabius GS premium SW 3.n... -
Page 119: Calibrate O 2 Sensor
If the O sensor cannot be calibrated, replace the capsule in the O sensor housing (see page 177). If the O sensor still cannot be calibrated, call DrägerService or your local authorized service organization. Instructions for Use Fabius GS premium SW 3.n... -
Page 120: Leak/Compliance Test
15 to 30. Upon completion of the test, the results are posted on the screen. Press the rotary knob to return to the Standby screen. Instructions for Use Fabius GS premium SW 3.n... - Page 121 The valve may not be able to relieve an unexpected high pressure. Clean the valve or activate the valve manually, and repeat the leak test. If the test fails again Contact DrägerService. Instructions for Use Fabius GS premium SW 3.n...
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Page 122: Access Alarm Log
To delete all alarms from the log, select and confirm the »Clear Alarm Log« label. To exit the alarm log and return to the Standby screen, select and confirm the return arrow. Instructions for Use Fabius GS premium SW 3.n... -
Page 123: Restore Site Defaults
Changes of the settings can be made via the Standby Setup screen (see page 124). WARNING! After site default settings have been restored check whether the ventilation and monitoring settings are appropriate to the patient. Risk of inappropriate ventilation settings. Instructions for Use Fabius GS premium SW 3.n... -
Page 124: Standby Setup Screen
»Default Settings« (see below) or »Configuration« (see page 131). (Selecting and confirming the return arrow on the right of the Setup screen will exit the Standby Setup screen and redisplay the Standby screen.) Instructions for Use Fabius GS premium SW 3.n... -
Page 125: Default Settings In Standby Setup
– »Alarm Volume« – »Restore Factory Defaults« Volume Settings Select and confirm the »Volume Settings« label on the Standby Setup screen. The Default Volume Settings window appears at the bottom of the screen. Instructions for Use Fabius GS premium SW 3.n... - Page 126 Pressure Settings, Pressure Support Settings, and SIMV/PS Settings Use the procedure described in "Volume Settings" to change the parameters associated with these ventilator modes. Instructions for Use Fabius GS premium SW 3.n...
- Page 127 Confirm the new value for the O alarm limit. The new alarm limit is saved and cursor moves to the return arrow. If necessary, repeat the process for the other parameter alarm limits. Instructions for Use Fabius GS premium SW 3.n...
- Page 128 Configuration The adjustment range and factory default values for all alarms on the Fabius GS premium are shown in the following table. Alarm Adjustment Factory Parameter Range Default Value 19 to 100 18 to 99 0.1 to 20.0 12.0 L/min 0.0 to 19.9...
- Page 129 Select and confirm »Yes« or »No«. When is selected, the factory defaults are restored and replace the current default settings. The factory defaults for the Fabius GS premium are shown in the table below: Parameter Factory Default Settings...
- Page 130 Settings for O Alarm High = 12.0 Default Low = 3.0 Settings for MV Alarm High = 40 Default Low = 8 Settings for Pressure Alarm Audio Volume level = 5 Volume Instructions for Use Fabius GS premium SW 3.n...
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Page 131: Configuration In Standby Setup
The following settings are available under Configu- ration: – »Time Set« – »Time Format« – »Date Set« – »Date Format« – »Language« – »Pressure Unit« – »Acoustic Confirmation« – »Alarm Tone Sequence« – »Waveform Display« – »Display Background« Instructions for Use Fabius GS premium SW 3.n... - Page 132 »15« to »30«). The new time values are saved, the Time Set win- dow is removed from the screen, and the cursor returns to the Time Set label. Instructions for Use Fabius GS premium SW 3.n...
- Page 133 Date Set The values that can be selected are two-digit numerical values for day, month, and year. Use the procedure described in "Time Set" on page 132 to change the date parameter. Instructions for Use Fabius GS premium SW 3.n...
- Page 134 The values that can be selected are hPa (Hecto Pascal), cmH O (centimeters of water, and mbar (millibar). Use the procedure described in "Time Format" on page 133 to change the pressure unit parameter. Instructions for Use Fabius GS premium SW 3.n...
- Page 135 The values that can be selected for the alarm tone sequence are »Standard« or »Dräger«. Use the procedure described in "Time Format" on page 133 to change the alarm tone sequence parameter. Instructions for Use Fabius GS premium SW 3.n...
- Page 136 Display Background The values that can be selected for the display background are »Dark« or »Light«. Use the procedure described in "Time Format" on page 133 to change the display background parameter. Instructions for Use Fabius GS premium SW 3.n...
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Page 137: Configuration During Operation
15 seconds, the Setup win- dow is removed and the waveform window is redis- played. The waveform window can be also be displayed by pressing the » « key (Home). Instructions for Use Fabius GS premium SW 3.n... -
Page 138: Volume Alarms On/Off
In the absence of a current plateau pressure data value, pressing the soft key will have no effect. NOTE: In SIMV/PS mode, the breathing pressure thresh- old will be set relative to the mandatory ventilation stroke. Instructions for Use Fabius GS premium SW 3.n... -
Page 139: Calibrate O 2 Sensor
Sensor and expose to room air for 2 minutes. – To start O Calibration, press rotary knob. – Observe Calibration status in O data window. – Reinsert O Sensor after successful Calibra- tion. Instructions for Use Fabius GS premium SW 3.n... -
Page 140: Des Comp On/Off
2 Press the »Des Comp Off« soft key in the Setup window. The key label changes from »Des Comp Off« to »Des Comp On«, and des- flurane compensation is activated. Instructions for Use Fabius GS premium SW 3.n... - Page 141 CAUTION! Desflurane has characteristics that affect the sen- sitivity of the Fabius GS premium flow sensor. To help assure that the volume measurements from the monitor are accurate, activate Desflurane compensation when Desflurane is used in the breathing circuit.
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Page 142: Automatic Desflurane Compensation
Configuration Automatic Desflurane Compensation If Desflurane concentration data is communicated to the Fabius GS premium by an external agent analyzer, the following occurs: 1 Des auto appears in the status bar at the top of the screen 2 the »Des Comp On/Off« soft key label is... -
Page 143: Access Alarm Log
Select and confirm a new alarm volume value in the range of 1 (minimum) to 10 (maximum). The value is saved and the Alarm Volume Setting window is replaced by the Setup window. Instructions for Use Fabius GS premium SW 3.n... - Page 144 Instructions for Use Fabius GS premium SW 3.n...
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Page 145: Fault-Cause-Remedy
Overriding the Ventilator ....148 Fault-Cause-Remedy ....150 Instructions for Use Fabius GS premium SW 3.n... -
Page 146: Power Failure Backup
Minute Volume Low Caution (»MINUTE VOLUME LOW!!«) alarm messages are dis- played in the alarm window. – The internal monitors continue to operate until the battery is completely discharged and all electronics are shut down. Instructions for Use Fabius GS premium SW 3.n... - Page 147 Never allow the battery to completely discharge. If the battery is discharged completely, recharge immediately. When the battery is completely discharged Fabius GS premium switches off. As a conse- quence all individual settings including alarm limits, which are not saved in the default settings, will be lost.
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Page 148: Ventilator Fail State
Fault-Cause-Remedy Ventilator Fail State If the Fabius GS premium does not recover from a »VENTILATOR FAIL!!!« condition: Switch to ManSpont mode by pressing the Man- Spont key and confirming the mode change by pressing the rotary knob. Set the APL valve to MAN position. - Page 149 It may be necessary to press the O flush button again to reinflate the breathing bag. Contact DrägerService or your local authorized service organization before using the ventilator. Instructions for Use Fabius GS premium SW 3.n...
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Page 150: Fault-Cause-Remedy
In ManSpont, SIMV/PS with Freq <6, or Pressure Support with Apnea Ventilation ON: Caution = P does not cross the pressure threshold for >30 seconds Warning = P does not cross the pressure threshold for >60 seconds Instructions for Use Fabius GS premium SW 3.n... - Page 151 Check tubing of expiration Pressure Control, or Pressure control line. Support mode. Check flow sensor. Follow the procedure to cali- brate flow sensor. Call DrägerService or your local authorized service orga- nization. Instructions for Use Fabius GS premium SW 3.n...
- Page 152 Check ventilator, patient cir- (11) 3 cmH O (hPa) below the cuit, and P settings. INSP setting and the INSP expected Plat while ventilating in Pressure Control, Pressure Support, or SIMV/PS mode. Instructions for Use Fabius GS premium SW 3.n...
- Page 153 Follow the procedure to cali- calibrated. brate O sensor. sensor used up. Replace sensor capsule and calibrate. sensor disconnected. Connect O sensor assembly. Faulty sensor cable. Replace O sensor housing assembly. Instructions for Use Fabius GS premium SW 3.n...
- Page 154 Push the Auto Set soft key changed without changing and check ventilator settings. alarm settings (see page 127). RS232 COM1 FAIL External monitor cable discon- Check monitor interface nected from External Commu- cable. nication Port 1. Instructions for Use Fabius GS premium SW 3.n...
- Page 155 Check diaphragm and close (28) correctly. cover. Check PEEP/P line for disconnect or leak. Select Standby Mode and switch back to the previous ventilation mode. VOLUME ALARMS OFF Volume alarms disabled by operator. Instructions for Use Fabius GS premium SW 3.n...
- Page 156 Instructions for Use Fabius GS premium SW 3.n...
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Page 157: Cleaning
Reconnecting the Scavenger System ..171 Reinstalling the Suction System ..171 Checking Readiness for Operation ..171 Instructions for Use Fabius GS premium SW 3.n... -
Page 158: Cleaning And Disinfection
5 Remove the gasket on top of the valve disc. Dismantling the Expiratory Valve 6 Unscrew the retaining nut. 7 Remove the inspection cap. 8 Extract the valve disc. 9 Remove the gasket on top of the valve disc. Instructions for Use Fabius GS premium SW 3.n... -
Page 159: Dismantling Parts Of The Ventilator
3 Open the ventilator door. 4 Disconnect the ventilator chamber pressure sensor line from the ventilator chamber pres- sure sensor line port. 5 Unlock the three clasps. 6 Remove the cover. 7 Remove the ventilator diaphragm. Instructions for Use Fabius GS premium SW 3.n... -
Page 160: Removing The Scavenger System
Observe the hospital hygiene regulations. Risk of infection. NOTE: For cleaning/disinfection instructions for the reus- able suction bottle and the suction regulator, refer to their respective Instructions for Use. Instructions for Use Fabius GS premium SW 3.n... -
Page 161: What Is Meant By Cleaning
Subsequent vacuum dis- infection in hot steam or steam sterilization is rec- ommended to dry off the remaining water. Instructions for Use Fabius GS premium SW 3.n... - Page 162 This measure is omitted if the compo- nents and device parts are not to be stored or trans- ported. CAUTION! When moving the writing table, monitoring arms, drawers or doors, keep hands clear of edges to avoid pinching. Instructions for Use Fabius GS premium SW 3.n...
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Page 163: Disinfecting/Cleaning/Sterilizing
Device surfaces CAUTION! Risk of equipment damage. Do not treat surfaces of Fabius GS premium, pressurized gas hoses, and cables with alcohol- containing agents! Wipe off contamination with a damp disposable cloth. -
Page 164: Breathing System
After washing, sterilization is necessary to dry out the breathing system. Insufficient drying of the control spaces located in the breathing system can lead to impairment of device functions or to device failure! Instructions for Use Fabius GS premium SW 3.n... -
Page 165: O 2 Sensor
(Bode Chemie Co., Hamburg, Germany) – Gigasept FF, Gigasept AF (Schülke & Mayr Co., Norderstedt, Germany) Sterilization CAUTION! Risk of equipment damage. The Spirolog flow sensor must not be sterilized! Observe its own Instructions for Use. Instructions for Use Fabius GS premium SW 3.n... -
Page 166: Spirolife Flow Sensors
SpiroLife flow sensors are not suitable for plasma or radiation sterilization. Observe its own Instructions for Use. In the Care List for Fabius GS premium Compo- nents on page 167, all components are listed with the suitable cleaning options. Observe the hospi- tal's hygiene regulations! Instructions for Use Fabius GS premium SW 3.n... -
Page 167: Care List For Fabius Gs Premium Components
Cleaning Care List for Fabius GS premium Components The following table lists Fabius GS premium com- ponents with recommended processing methods. Processing refers to cleaning, disinfection, and/or sterilization, as appropriate for a given component. The table is intended as a guide. Follow the institu- tion’s policies regarding specific methods and... - Page 168 7) Disinfect flow sensor for about 1 hour in a 70 % ethanol or isopropanol solution. Then leave it out to dry in air for at least 30 minutes. Observe its own Instructions for Use. Instructions for Use Fabius GS premium SW 3.n...
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Page 169: Reassembling The Breathing System
Lines/cables caught underneath the APL valve adjustment knob could interfere with proper functioning of this valve. 10 Position the APL valve in the valve seat, and tighten securely with the retaining nut. Instructions for Use Fabius GS premium SW 3.n... -
Page 170: Reinstalling The Ventilator
Fit the cover and lock the three clasps. 5 Connect the ventilator chamber pressure sen- sor line to the ventilator chamber pressure sen- sor line port. Swing the ventilator unit back into position. Instructions for Use Fabius GS premium SW 3.n... -
Page 171: Reinstalling The Scavenger System
59. Checking Readiness for Operation At the completion of the reassembly of the Fabius GS premium, perform the Daily and Pre- use Checkout procedure provided in the Appendix of this manual to ensure that the machine is ready for operation. - Page 172 Instructions for Use Fabius GS premium SW 3.n...
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Page 173: Maintenance
Absorbent ....177 CLIC Adapter (Optional) ....179 Checking Readiness for Operation ..179 Instructions for Use Fabius GS premium SW 3.n... -
Page 174: Definitions
(e.g., disinfectant residues corroding the material when autoclaving). These parts must be replaced if signs of wear become visible, such as cracks, deformation, discoloration, peeling, etc. Instructions for Use Fabius GS premium SW 3.n... -
Page 175: Maintenance Intervals
Dräger Medical recommends DrägerService. Fabius GS premium Breathing systems Vaporizers Sensors Ventilator hose Replace the bacterial filter on the pressure measuring line. Replace the diaphragm in the ventilator (patient). Replace vaporizer O-Rings Instructions for Use Fabius GS premium SW 3.n... - Page 176 By trained service personnel: Replace pressure reducer. NOTE: If desired, the customer may receive a list of those parts and their assembly instructions to be replaced in the event of repairs being necessary. Instructions for Use Fabius GS premium SW 3.n...
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Page 177: Routine Maintenance
CO (Drägersorb 800 Plus and Drägersorb FREE change from white to violet). NOTE: Please refer to the specific Instructions for Use for "Drägersorb 800 Plus or Drägersorb FREE". Instructions for Use Fabius GS premium SW 3.n... - Page 178 Absorbent is caustic and is a strong irritant to the eyes, skin, and respiratory tract. When replacing the absorbent, take care not to spill its caustic contents and always wear protec- tive gloves and an appropriate mask. Instructions for Use Fabius GS premium SW 3.n...
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Page 179: Checking Readiness For Operation
CLIC Adapter (Optional) The disposable CLIC adapter absorber can also be used on the Fabius GS premium. For information on installing the CLIC adapter, consult its Instruc- tions for Use. Checking Readiness for Operation... - Page 180 Instructions for Use Fabius GS premium SW 3.n...
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Page 181: Disposal
Disposal of Bacterial Filter ....182 Disposal of Flow Sensor ....182 Instructions for Use Fabius GS premium SW 3.n... -
Page 182: Disposal
Can be incinerated at temperatures above 1472 °F (800 °C) with minimal environmental pollution. Disposal of Flow Sensor Dispose of spent sensor with infectious special waste. We recommend low-emission incineration at more than 1472 °F (800 °C). Instructions for Use Fabius GS premium SW 3.n... -
Page 183: Technical Data
Diagram ......200 Gas flow diagram ..... . 200 Instructions for Use Fabius GS premium SW 3.n... -
Page 184: Ambient Conditions
(2.7 to 8.3 kPa x 100) Gas supply from supplementary O and N O cylinders (with threaded NIST connections) Pressure at machine connector 73 psi (5 kPa x 100) Each inlet is fitted wih a non-return valve Instructions for Use Fabius GS premium SW 3.n... - Page 185 100 to 240 VAC, 50/60 Hz, 70 VA Rechargeable batteries Rating: 24 V; 3.5 Ah Type: sealed, gelled lead-acid ≤16 hours on the mains or full operation time Recharging time: Operation time with fully charged batteries: 45 minutes, minimum Instructions for Use Fabius GS premium SW 3.n...
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Page 186: Fuses
2x T2.5AH 250 V IEC 60127-2/V Fuses located on circuit board: 1x T1.6AL 250 V IEC 60127-2/III 1x T4AL 250 V IEC 60127-2/III 1x T2.5AL 250 V IEC 60127-2/III Battery fuse: 1x T3.15AH 250 V IEC 60127-2/V Instructions for Use Fabius GS premium SW 3.n... -
Page 187: Electromagnetic Compatibility (Emc)
The non-observance may result in increased emissions or decreased immunity of Fabius GS premium. The Fabius GS premium should not be used adja- cent to or stacked with other equipment; if adjacent or stacked use is inevitable, Fabius GS premium should be observed to verify normal operation in the configuration in which it will be used. -
Page 188: Electromagnetic Emissions
Technical Data Electromagnetic emissions The Fabius GS premium is intended for use in the electromagnetic environment specified below. The user should assure that it is used only in such an environment. Emissions Compliance Electromagnetic environment according to RF emissions (CISPR 11) -
Page 189: Electromagnetic Immunity
Technical Data Electromagnetic immunity The Fabius GS premium is intended for use in the electromagnetic environment specified below. The user should assure that it is used only in such an environment. Immunity against IEC 60601-1-2 test level Compliance Electromagnetic environment... - Page 190 Field strengths from fixed, portable or mobile RF transmitters at the location of the Fabius GS premium should be less than 3 V/m in the fre- quency range from 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz.
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Page 191: Recommended Separation Distances
3.000 3.16 9.49 1) 3 V/m distance to transmitters with frequencies from 150 kHz to 2.5 GHz, otherwise 1 V/m distance. Information re separation distances (IEC 60601-1-2: 2001, tables 205 and 206) Instructions for Use Fabius GS premium SW 3.n... -
Page 192: Electrical Safety Conformance
(0 to 20 hPa resolution) Inspiratory pressure 5 to 65 cmH O (1 INSP resolution)) (5 to 65 hPa (1 hPa (setting must be at least 5 cmH O (5 hPa) above PEEP) Instructions for Use Fabius GS premium SW 3.n... - Page 193 ±1 bpm (1/min) of setting Inspiration/expiration ratio ±5 % of setting Inspiration pause ±25 % of setting PEEP End-expiratory pressure ±2 cmH O (±2 hPa) or ±20 % of setting, whichever is greater Instructions for Use Fabius GS premium SW 3.n...
- Page 194 Minimal Limit Pressure –8.5 cmH O (–8.5 hPa) System Compliance Measurement 0.2 to 6.0 mL/cmH O (0.2 to 6.0 mL/hPa) ±0.2 mL/cmH O (±0.2 mL/hPa) or ±10 % of actual compliance, whichever is greater Instructions for Use Fabius GS premium SW 3.n...
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Page 195: Anesthesia Gas Supply Module
13 psi (0.9 kPa x 100), maximum Auxiliary Oxygen Flowmeter (optional) Connection Staged connector for use with different hose diameters Fresh-gas flow 0 to 10 L/min Accuracy ±5 % of full scale Resolution 0.5 L/min Instructions for Use Fabius GS premium SW 3.n... -
Page 196: Anesthetic Agent Vaporizer Interface
ISO 21647 1) Max. ±4 % of the measured value or ±2 cmH O (±2 hPa), whichever is greater. 2) At standard test conditions per IEC 60601-2-13. Instructions for Use Fabius GS premium SW 3.n... -
Page 197: Breathing System
Resistance test in compliance with ISO 8835-2:1999 at 10 L/min ISO 8835-2:1999 at 10 L/min Inspiratory 5.0 hPa (cmH 5.0 hPa (cmH Resistance Expiratory 4.6 hPa (cmH 4.6 hPa (cmH Resistance typical leak <50 mL/min Instructions for Use Fabius GS premium SW 3.n... -
Page 198: Low Oxygen Supply Pressure Alarm
23 vol.%. O metering valve open S-ORC prevents N O flow and O metering valve closed or O flow less than 0.2 L/min During N O failure may still be administered. No alarm. Instructions for Use Fabius GS premium SW 3.n... -
Page 199: Serial Interface
Pin 5 GND Galvanic Isolation 500 V Baud Rates: 1200, 2400, 4800, 9600, 19200, 38400 Parity: Odd, Even, None Data Bits: 7 or 8 Start Bits: Stop Bits: 1 or 2 Protocol: Vitalink, MEDIBUS Instructions for Use Fabius GS premium SW 3.n... -
Page 200: Diagram
Technical Data Diagram Gas flow diagram Compact Breathing System Ventilator setting /PEEP Fresh Gas Decoupling Fresh gas Bypass Valve Absorber Scavenging Instructions for Use Fabius GS premium SW 3.n... -
Page 201: Appendix - Daily And Pre-Use Checkout
Appendix – Daily and Pre-use Checkout Form Appendix – Daily and Pre-use Checkout Form Before operating the Fabius GS premium, the fol- lowing checkout verification form must be com- pleted to ensure that the machine is ready for use. Do not insert any additional components into or modify the anesthesia system after the checkout procedure is started. - Page 202 Instructions for Use Fabius GS premium SW 3.n...
- Page 203 Checking the Medical Gas Connections into consideration all possible configurations of the Visually inspect all gas supplies from the Fabius GS premium. The clinician need only use medical gas pipeline system and cylinders those areas that apply to their specific to make sure that they connect properly Fabius GS premium configuration.
- Page 204 "0" to ±2 is OK. If the deviation is screw tight (when present) greater, contact DrägerService. Reconnect the hose of the connection socket for the breathing pressure sensor on the rear. Instructions for Use Fabius GS premium SW 3.n...
- Page 205 (e.g., a flat line), flip the APL-valve to SPONT to release pressure. Check the CO monitor and alarm module. Peak pressure display on monitor reads Check the anesthetic agent monitor and 24 to 36 cmH O (hPa). alarm module. Instructions for Use Fabius GS premium SW 3.n...
- Page 206 (the bag is in place and all hoses are Pre-use Checkout Signature connected properly). Name If any check can not be carried out satisfacto- Date rily, the machine must not be used. Instructions for Use Fabius GS premium SW 3.n...
- Page 207 Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Instructions for Use Fabius GS premium SW 3.n...
- Page 208 Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Pre-use Checkout Signature Pre-use Checkout Signature Name Name Date Date Instructions for Use Fabius GS premium SW 3.n...
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Page 209: Index
Compliance Test ..... . . 121 Configuration ......115 Instructions for Use Fabius GS premium SW 3.n... - Page 210 Y-pieces ......61 Instructions for Use Fabius GS premium SW 3.n...
- Page 211 Instructions for Use Fabius GS premium SW 3.n...
- Page 212 These Instructions for Use only apply to Fabius GS premium SW 3.n with the Serial-Nr.: If no Serial No. has been filled in by Dräger, these Instructions for Use are provided for general information only and are not intended for use with any specific machine or device.
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