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Dräger Fabius Instructions For Use Manual Download Page 5

Instructions for Use Fabius MRI SW 3.n

5

Contents

Contents

Working with These Instructions for Use. . . . . 2

Trademarks  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Abbreviations and Symbols  . . . . . . . . . . . . . . . . . 3
Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Definition of target groups  . . . . . . . . . . . . . . . . . . 3
Magnetic Resonance (MR) Definitions . . . . . . . . . 4

For Your Safety and that of Your Patients . . . . 7

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Intended Use  . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . 16
Restriction of Distribution . . . . . . . . . . . . . . . . . . 16

System Overview . . . . . . . . . . . . . . . . . . . . . . . 17

Front View  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Compact Breathing System (Top View) . . . . . . . 19
Rear View (Pin-Index Connector)  . . . . . . . . . . . 20
Interface Panel   . . . . . . . . . . . . . . . . . . . . . . . . . 21
Vaporizers (Optional) . . . . . . . . . . . . . . . . . . . . . 22
Vaporizer Exclusion Systems . . . . . . . . . . . . . . . 22
Auxiliary Oxygen Flowmeter. . . . . . . . . . . . . . . . 24
O

2

 Flush Button . . . . . . . . . . . . . . . . . . . . . . . . . 25

APL Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Writing Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Communication Port . . . . . . . . . . . . . . . . . . . . . . 28
Teslameter  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Accessory Mounting . . . . . . . . . . . . . . . . . . . . . . 30
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Symbol Definition . . . . . . . . . . . . . . . . . . . . . . . . 33

Operation Concept . . . . . . . . . . . . . . . . . . . . . . 37

Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
The Screen Display  . . . . . . . . . . . . . . . . . . . . . . 39
Rotary Knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Fixed Function Keys . . . . . . . . . . . . . . . . . . . . . . 40
Soft Keys  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Fresh Gas Control  . . . . . . . . . . . . . . . . . . . . . . . 45
LED Indicators  . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Gas System Color Coding  . . . . . . . . . . . . . . . . . 48
Screen Color Concept  . . . . . . . . . . . . . . . . . . . . 48

Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Activating the Battery  . . . . . . . . . . . . . . . . . . . .  50
Fitting the CO

2

 Absorber on the Compact 

Breathing System  . . . . . . . . . . . . . . . . . . . . . . .  51
Inserting the Flow Sensor . . . . . . . . . . . . . . . . .  52
Connecting the Compact Breathing System . . .  52
Installing the Drägersorb CLIC Adapter  . . . . . .  54
Connecting the Waste Gas Outlet Port . . . . . . .  55
Installing the Breathing Bag Extension and 
Bag  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  56
Connecting Pipeline Supply of N

2

O, AIR and 

O

2

 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  57

Connecting the Reserve Gas Cylinders for 
N

2

O, AIR and O

2

 ( for Pin-Index Mounting)  . . .  58

Connecting the AGSS Anesthetic Gas 
Scavenging System. . . . . . . . . . . . . . . . . . . . . .  61
Connecting the Passive Scavenger  . . . . . . . . .  63
Connecting the Suction System  . . . . . . . . . . . .  64
Connecting the Breathing Hoses and 
Breathing Bag . . . . . . . . . . . . . . . . . . . . . . . . . .  65
Inserting a new O

2

 Sensor Capsule  . . . . . . . . .  68

Connecting the O

2

 Sensor  . . . . . . . . . . . . . . . .  68

Connecting the Pressure Sensor  . . . . . . . . . . .  69
Connecting the Breathing Pressure Gauge. . . .  69
Connecting the Flow Sensor . . . . . . . . . . . . . . .  70
Connecting the APL Bypass and PEEP/P

MAX

 

Hoses  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  70
Preparing the Ventilator. . . . . . . . . . . . . . . . . . .  71
Ventilator Safety Features . . . . . . . . . . . . . . . . .  71
Installing Vaporizers  . . . . . . . . . . . . . . . . . . . . .  72
Connecting Auxiliary Equipment . . . . . . . . . . . .  74
Auxiliary power outlets  . . . . . . . . . . . . . . . . . . .  75
Positioning the Fabius MRI at MRT System . . .  76
Connecting AC Power . . . . . . . . . . . . . . . . . . . .  78
Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  79
Daily and Pre-use Checkout . . . . . . . . . . . . . . .  80

Getting Started. . . . . . . . . . . . . . . . . . . . . . . . .  81

Powering-Up the Machine . . . . . . . . . . . . . . . . .  82
Power-Up Standby Screen  . . . . . . . . . . . . . . . .  83
Checking Readiness for Operation . . . . . . . . . .  83

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  85

Power-Up Standby Screen  . . . . . . . . . . . . . . . .  86
Setting Fresh Gas Flow. . . . . . . . . . . . . . . . . . .  86
Setting Vaporizer Concentration . . . . . . . . . . . .  88

Summary of Contents for Fabius

Page 1: ...WARNING To properly use this medical device read and comply with these Instruc tions for Use Instructions for Use Fabius MRI Anesthesia Workstation Software 3 n ...

Page 2: ...uch as hard keys and soft keys and screen pages are printed in bold within quo tation marks e g PEEP or Volume Set tings Screen messages are printed in bold within quotation marks e g Flow Calibration in progress Alarm messages are printed in bold within quo tation marks including the exclamation marks that indicate their alarm urgency level e g APNEA PRESSURE 305 Configuration 124 Instructions fo...

Page 3: ...r repair the medical device Dräger emphasizes that the medical device must be used installed reprocessed maintained or repaired exclusively by defined target groups Users Users are persons who may use the medical device in accordance with its intended use Service personnel Service personnel are persons who are responsible for the maintenance of the medical device towards the operating organization...

Page 4: ... anywhere in the MR procedure room including the center of the bore of the MRT scanner 1 tesla 10000 gauss Five Gauss Line This line specifies the perimeter around an MRT scanner within which the static magnetic fields are higher than five gauss Five gauss and below are considered safe levels of static magnetic field exposure for the general public 5 gauss 0 50 mtesla Image Artifact This is a gene...

Page 5: ...ystem 51 Inserting the Flow Sensor 52 Connecting the Compact Breathing System 52 Installing the Drägersorb CLIC Adapter 54 Connecting the Waste Gas Outlet Port 55 Installing the Breathing Bag Extension and Bag 56 Connecting Pipeline Supply of N2O AIR and O2 57 Connecting the Reserve Gas Cylinders for N2O AIR and O2 for Pin Index Mounting 58 Connecting the AGSS Anesthetic Gas Scavenging System 61 C...

Page 6: ... Removing the Suction System 174 Reprocessing Breathing system 174 Care List for Fabius MRI Components 176 Reassembling the Breathing System 178 Reinstalling the Ventilator 180 Reinstalling the Scavenger System 181 Reinstalling the Suction System 183 Checking Readiness for Operation 184 Maintenance 185 Overview 186 Routine Maintenance 189 Checking Readiness for Operation 191 Disposal 193 Disposal ...

Page 7: ...low 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 ...

Page 8: ...The medical device is only to be used for the purpose specified under Intended Use on page 16 and in con junction with appropriate patient monitoring see page 9 Strictly observe all WARNING and CAUTION statements throughout this Instruction for Use and all statements on medical device labels WARNING The medical device must be inspected and serviced regularly by trained service person nel Repair of...

Page 9: ...ous to a medical profes sional and operator of this medical device to the consequences of medical device misuse and to potentially adverse effects in patients with abnor mal conditions Medical device modification or mis use can be dangerous Patient monitoring The operators of the medical device must recog nize their responsibility for choosing appropriate safety monitoring that supplies adequate i...

Page 10: ...tor pins with an ESD war ning sign should not be touched and no connections should be made between these connectors without implementing ESD protec tive measures Such precautionary procedu res 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 invol ved in the above shall re...

Page 11: ...tilator or breathing system except for certain approved components otherwise the correct function ing of the medical device may be compro mised For more information contact DrägerService or your local authorized ser vice organization WARNING Each institution and user has a duty to inde pendently assess based on its his or her unique circumstances what components to include in an anesthesia system ...

Page 12: ...WARNING Be careful in handling the power cord and main power plug These parts still contain minor magnetic components The power cord can be attracted to MRI system WARNING Do not use any type of Desflurane vaporizer in the MR environment In an MR environment functionality of the Desflurane vaporizer will be compromised WARNING A pre use checkout procedure must be per formed immediately before each...

Page 13: ... reservoir bag in compliance with ISO 5362 and or a pressure relief valve to ensure cor rect pressure at the patient connection port If disregarded this could lead to personal injury CAUTION Risk of pinching fingers or breathing hoses and objects falling down If the writing table is not engaged correctly objects can fall down and fingers or breathing hoses can be pinched CAUTION Do not use the fol...

Page 14: ... cable is listed in the list of accessories Connection of Fabius MRI to a 240 V 60 Hz sup ply is only allowed if it is a center tapped single phase circuit and the power cable is a certified hospital grade cable 10 A 250 V AC of max 3 m 9 8 ft length with a NEMA 6 15 HG plug a SJT 3 18 AWG cable and a C13 connector In this case Dräger recommends the mains cable with part no 1868152 NOTE Software m...

Page 15: ...Instructions for Use Fabius MRI SW 3 n 15 Intended Use Intended Use Intended Use 16 Indications for Use 16 MEDIBUS and Vitalink Protocols 16 Restriction of Distribution 16 ...

Page 16: ...for emergency use Fresh gas enrichment is provided by the Dräger Vapor anesthetic vaporizer Indications for Use The Fabius MRI is indicated as a continuous flow anesthesia system useable in an MRI environment The Fabius MRI may be used for manually assisted or automatic ventilation delivery of gases and anesthetic vapor and monitoring of oxygen con centration breathing pressure and respiratory vol...

Page 17: ...1 Vaporizers Optional 22 Vaporizer Exclusion Systems 22 Dräger Vapor Interlock 2 System Optional 22 Dräger Auto Exclusion 2 Vaporizer Mount Optional 23 Auxiliary Oxygen Flowmeter 24 O2 Flush Button 25 APL Valve 26 Writing Table 27 Communication Port 28 Teslameter 29 Location of the Sensors 29 Accessory Mounting 30 Maximum Weight Loads 31 Abbreviations 32 Symbol Definition 33 ...

Page 18: ...fresh gas flowmeter 3 Display screen 4 Interlock or Auto Exclusion Vapor mount 5 Additional alarm indicators 6 Fresh gas controls 7 Gauges Pin Index cylinders 8 Writing table 9 Storage drawers 10 Central brake 11 Absorber 12 Compact Breathing System COSY 13 Oxygen flush button 14 Ventilator 15 Auxiliary oxygen flowmeter 073 1 2 4 12 14 6 7 9 10 11 15 13 8 3 5 5 ...

Page 19: ...low sensor guard flow sensor protection 5 Expiratory port 6 Connector for breathing bag 7 Inspiratory port 8 Inspiratory valve 9 Fresh gas decoupling valve 10 APL Bypass valve connection port 11 Breathing system mount with locking bolt 12 Selecting knob for MAN and SPONT on pressure limiting APL valve 13 Sample gas return port 064 1 2 4 5 6 7 8 10 13 12 3 9 11 ...

Page 20: ...dical gas pipeline supply cen tral supply 2 Sealed connector 3 Type plate 4 Ventilator hose connection 5 Interface panel 6 ON OFF switch 7 Fuse 8 Compact Breathing System COSY 9 Power cable connection 10 Pin Index system 11 Potential equalization pin 12 Auxiliary power outlets 100 1 2 5 4 6 8 10 7 3 12 9 11 ...

Page 21: ...Use Fabius MRI SW 3 n 21 System Overview Interface Panel 1 COM 1 for Service or fiber optic cable 8608376 only 2 Oxygen Sensor 3 Volume Sensor 4 ON OFF switch 5 APL 6 Fuse 7 Breathing Pressure 8 PEEP 101 1 5 7 2 3 4 6 8 ...

Page 22: ...tems available for the Fabius MRI are described below Dräger Vapor Interlock 2 System Optional The Dräger Interlock 2 system is used to ensure that only one of two vaporizers can be used at a time It has a selector lever used to select which vaporizer is enabled Moving the selector lever away from the desired vaporizer allows that vaporizer to be used and the other to be locked out of use WARNING ...

Page 23: ...er Auto Exclusion 2 Vaporizer Mount Optional This system has an automatic interlock system that ensures only one vaporizer can be used at a time When one of the two vaporizers is selected for use opened the interlock mechanism within that vaporizer s mounting system is activated automati cally preventing the other vaporizer from being used NOTE Only Dräger vaporizers labeled as AUTO EXCLUSION vapo...

Page 24: ...lfinflating resusciator bag z Test the auxiliary oxygen flowmeter Adjust the flow knob 1 and make sure the float moves freely over the full range of the flowmeter When finishing oxygen therapy make sure the flow meter is completely closed z Turn the flow knob 1 clockwise until it can no longer be turned Only then the oxygen flow is completely off ASTM F1850 22 2005 76 WARNING Risk of patient injur...

Page 25: ...rated O2 flush button 1 is located on the front of the machine When actuated the valve delivers an unmetered flow of at least 35 L min to the breathing system and breathing bag while bypassing the ventilator The Fabius MRI does not need to be switched on in order to use the O2 flush 037 1 ...

Page 26: ...ted fully coun terclockwise pressure is released for spontane ous 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 counterc...

Page 27: ...s NOTE The APL valve is automatically excluded from the breathing circuit whenever an automatic ventilator mode is selected NOTE Even in automatic ventilation the APL valve must be adjusted to a pressure that is safe for the pati ent WARNING Ensure that any loose parts that are not marked as MR safe or MR conditional are removed from the writing table at MRT room CAUTION For use pull out the writi...

Page 28: ...ice in the MRI envi ronment has to be certified by Dräger WARNING A test for leakage current must be performed by qualified engineering personnel before use if the Fabius MRI is interfaced with other equipment WARNING Only the combinations approved by Dräger with monitoring and the correspondingly defined assembly parts may be used Other wise the correct functioning of the device maybe compromised...

Page 29: ... room as required by the patient s respiration anesthesia during the MRT treatment If the fringe field strenght is exceeded an acoustic signal is annunciated and continues to annunciate until the Fabius MRI is repositioned to the required limit of 40 mtesla 400 gauss The array for detecting the magnetic field is a position ing aid towards the MRT magnet Location of the Sensors There are two sensor...

Page 30: ...30 Instructions for Use Fabius MRI SW 3 n System Overview Accessory Mounting The following figure shows the permitted mounting locations for accessories available for the Fabius MRI 310 Top shelf ...

Page 31: ...ounted to Dräger supplied IV pole 9 kg 20 lb WARNING Do not place any object on this machine writ ing table or in the drawers unless it is specif ically labeled to be used in an MR scanning room and on a Fabius MRI anesthesia system Objects placed on this machine that are not designed for use with this anesthesia system may be strongly attracted to the magnet and may cause serious injury or death ...

Page 32: ... Insp Flow Inspiratory flow L min Liters per minute Man MAN Manual ventilation mbar Millibar MEAN Mean pressure MR Magnetic resonance MRI Magnetic resonance imaging MRT Magnetic resonance tomography MV Minute volume N2O Nitrous oxide O2 Oxygen PAW Airway pressure PEAK Peak pressue PEEP Positive end expiratory pressure PINSP Pressure limitation in Pressure Control mode PLAT Plateau pressure PMAX Pr...

Page 33: ... Sensor Port Breathing Volume Sensor Port Ventilator Port Pipeline Gauge Pipeline inlet Breathing Bag C US XXX REV SN Flowmeter Level Indicator Indicates Direction Total Power Applied Partial Power Applied Cylinder Gauge Remote Cylinder Inlet Do Not Oil ESD warning symbol Do not touch contacts of interface if not electrostatically discharged No known hazards in a specified MR environment with spec...

Page 34: ...ian Transportation label see page 114 CO2 absorbent bypass Vaporizer plug in system O2 Flush Upper and Lower Alarm Limits Return to Home Screen Suppress Alarm Tone for Two Min utes Suppress Alarm Tone for Two Min utes Standby Mode Available Operating Capacity of UPS Close Menu Back to Previous Menu Upper Alarm Limit Lower Alarm Limit Mains Applied Mains Power _ XX Alarm Off Alarm Off Setup Screen ...

Page 35: ...g text label appears on the rear of the Fabius MRI 2 The following text label appears on the top view of the Fabius MRI 3 084 1 085 2 040 CAUTION After positioning in the MRI room always lock the casters by pressing the Central Brake Lever 3 CAUTION After positioning in the MRI room always lock the casters by pressing the Central Brake Lever ...

Page 36: ...36 Instructions for Use Fabius MRI SW 3 n This page intentionally left blank ...

Page 37: ...reen Display 39 Rotary Knob 40 Fixed Function Keys 40 Soft Keys 41 Selecting Setting Monitoring Functions 42 Selecting Setting Ventilation Parameters 44 Fresh Gas Control 45 Total Flow Meter 46 Fresh Gas Flow Monitoring Resolution 47 LED Indicators 48 Gas System Color Coding 48 Screen Color Concept 48 ...

Page 38: ...e 1 A screen displaying all monitoring and ventila tion information in numeric and graphic form 2 Fixed function hard keys beside the screen for quick access to major functions 3 Keys with variable functions referred to as soft keys in this manual 4 Rotary dial knob for selecting and confirming screen settings 5 LED indicators All controls and LEDs are described in detail begin ning on page 40 566...

Page 39: ...the inspiratory oxygen concentration in percent along with high and low alarm limits 4 Respiratory volume monitoring window which displays the patient s respiratory rate in breaths per minute Freq tidal volume VT minute vol ume MV and the minute volume high and low alarm limits 5 Breathing pressure monitoring window which displays the patient s positive end expiratory pressure PEEP mean or plateau...

Page 40: ...e Man ual Spontaneous ventilation mode 3 The SIMV PS key is used to select the SIMV PS ventilation mode optional 4 The Pressure Support key is used to select the Pressure Support ventilation mode optional 5 The Pressure Control key is used to select the Pressure Control ventilation mode 6 The Volume Control key is used to select the Volume Control ventilation mode 7 The Alarms key displays the Ala...

Page 41: ...page 132 for complete information 2 In any ventilation mode the soft keys labels show the ventilation parameters and functions that are available in that particular ventilation mode Volume Control mode parameters are shown in the example illustration 3 If the Setup key is pressed in any ventilation mode the following soft keys appear at the bot tom of the screen Volume Alarms On Off Auto Set Calib...

Page 42: ...desired password to display the Standby Setup screen Selecting and confirming the return arrow on the right of the Setup screen will exit the Standby Setup screen and redisplay the Standby screen z The rotary knob enables you to select the Default Settings or Configuration label Select and confirm the Default Settings label The Default Settings column is selected Selecting and confirming the retur...

Page 43: ...window appears z Select the alarm limit value that needs to change z Confirm the alarm limit value and select a new value For example in the illustration on the right the alarm limit was changed from 20 to 25 z Confirm the new value for the alarm limit The new alarm limit is saved and cursor moves to the return arrow 506 507 508 ...

Page 44: ...tion Settings window replaces the Waveform win dow 2 Press the VT soft key The key becomes high lighted z Select a new value z Confirm the new value NOTE There is a 15 second timeout period for making ventilation mode changes with a 3 tone audible sequence after the first 10 seconds If the new set ting is not confirmed within the timeout period the current ventilation setting remains in effect and...

Page 45: ...resh gas flow indicator 6 AIR electronic fresh gas flow indicator 7 O2 electronic fresh gas flow indicator 8 N2O central supply pressure gauge 9 AIR central supply pressure gauge 10 O2 central supply pressure gauge 11 O2 cylinder pressure gauge 12 AIR cylinder pressure gauge 13 N2O cylinder pressure gauge 14 O2 Low Supply Pressure Alarm LED which flashes when the supply is below the factory set mi...

Page 46: ... meter is still functional The measurement will indi cate the total flow rate prior to the fault condition To adjust the fresh gas ratios while under the fault condition shut off all flows O2 may be left on and then restore each gas flow individually For exam ple start with 2 L min O2 The total flow meter will read 2 L min If 1 L min of N2O is needed open the N2O flow con trol knob until the total...

Page 47: ...min and the flow meters on the monitor screen indicate a range of 0 to 12 L min 2 If high resolution is configured the electronic fresh gas flow indicators support 10 mL min increments format x xx L min and the flow meters on the monitor screen indicate a range of 0 to 10 L min with an emphasis on resolution at the lower end of the scale High resolution data is displayed when all indi vidual gas f...

Page 48: ... illuminated during the same Warning and Caution alarm conditions as the front panel LEDs 2 but are visible from longer distances and various vantage points In addition there are small LEDs on the Standby key and all the ventilation mode keys to indicate the currently active mode Gas System Color Coding Each connection valve gauge and flow meter on the Fabius MRI is color coded for the appropriate...

Page 49: ...ive Scavenger 63 Connecting the Suction System 64 Connecting the Breathing Hoses and Breathing Bag 65 Instructions for Use of Bacterial Filters Endotra cheal Tubes Y pieces Breathing Hoses Soda Lime and other Breathing System Accessories 67 Resistance summation of the breathing system and connected accessories 67 Inserting a new O2 Sensor Capsule 68 Connecting the O2 Sensor 68 Connecting the Press...

Page 50: ... vaporizers anesthesia workstation and MRI scanner must be tested by experts trained and factory authorized technical ser vice representatives for anesthetic machines and MRI scanners prior to the first use to ensure proper vaporizer and interface func tion in the specific magnetic fields Otherwise uncontrolled concentrations leakage and or malfunction of the interlock system may occur The testing...

Page 51: ...alling the reusable absorber see page 189 1 Fit the absorber canister into position below the breathing system and turn it counterclockwise as far as possible CAUTION Risk of unintended perioperative awareness Make sure that during ventilation the absorber canister is tightly connected to the COSY NOTE Ensure that no CO2 absorbent dust particles have been deposited between the gaskets and sealing ...

Page 52: ...sor guard 3 Reinstall the expiration port Connecting the Compact Breathing System 4 Pull out locking bolt to its full extension and hold 5 Fit the compact breathing system onto the com pact breathing system mount z Release the locking bolt and rotate the compact breathing system until the locking bolt locks into position For information on filling and installing the reusable absorber see page 189 ...

Page 53: ...Connect the ventilation hose to the ventilator and 3 attach it to the conical connector ventilator port on the compact breathing system If the Fabius MRI is equipped with a threaded con nector the sealing rings on the threaded connector must be undamaged and clean Only hand tighten the threaded connector Do not use tools 071 1 012 3 2 ...

Page 54: ...o place 1 Press the button the mounting swings open z Before fitting shake the disposable absorber e g by turning it upside down several times in order to loosen up the soda lime z Remove seal from new disposable absorber z Slide the new disposable absorber onto the mounting and 2 Push the disposable absorber in the direction of the machine until it engages optional WARNING The disposable absorber...

Page 55: ...Instructions for Use Fabius MRI SW 3 n 55 Assembly Connecting the Waste Gas Outlet Port z Screw the waste gas port into the compact breathing system from underneath 048 ...

Page 56: ...o secure 4 Attach the breathing bag to the end of the breathing bag extension optional WARNING Do not install the Dräger flexible bag arm P N 8606462 This arm contains magnetic parts and is not MR safe or MR conditional This arm would be attracted to the MRT sys tem which would create a risk of injury WARNING Risk of use of toxic or incompatible materials Breathing bags used on the Fabius MRI must...

Page 57: ...typical pressure gauge and flowmeter assembly is shown in the figure WARNING Carefully check hoses each time you connect a machine to a wall outlet to ensure that both ends of the hose are indexed for the same gas Pipeline delivery hoses used between wall outlets and anesthesia machines have caused accidents when during assembly an oxygen fitting was placed on one end of the hose and a nitrous oxi...

Page 58: ...he yoke gas inlet The use of multiple washers will inhibit the pin index safety sys tem Be sure to verify the presence of the index pins each time a cylinder is installed Never attempt to override the pin index safety system WARNING Do not oil or grease the O2 cylinder valves and O2 pressure regulator There is a risk of explo sion CAUTION Even if the gas supply is connected to a medical gas pipeli...

Page 59: ...head align with the gas inlet and index pins of the yoke assem bly 6 z Engage the indexing holes with the index pins z Turn the yoke handle 7 clockwise against the cylinder head so that the point of the yoke han dle bolt is aligned with the indent on the back of the cylinder head Verify that the washer is in place the index pins are engaged and the cyl inder hangs vertically z Tighten the yoke fir...

Page 60: ...low Indicated pressures are for E size cylinders at 70 F 21 C Cylinders measuring less than the minimum recommended pressure PSI MIN should be replaced with new full cylin ders Dimensions of Usable Cylinders Gas PSI kPa x 100 FULL typical full load PSI kPa x 100 MIN AIR 1900 131 1000 69 N2O 745 51 600 42 O2 1900 131 1000 69 E size Pin Index Cylinder 4 7 L Height 25 5 in 654 mm Diameter 4 3 in 111 ...

Page 61: ...the relevant socket of the receiving system z Connect the connector of the scavenging hose to the terminal unit of the disposal system 2 Close the connection that is not used with a screw cap z Push the transfer hose on the designated socket z Connect the other end of the transfer hose to the waste gas port located on the underside of the breathing system optional WARNING Risk of patient injury If...

Page 62: ...tivate hospital vacuum system before using scavenger system NOTE During use the float indicator in the flow indicator 1 should stay between the upper and lower marks If necessary regulate flow using the optional flow adjustment valve 2 WARNING Danger to the patient Do not cover the side openings of the recei ving system Otherwise there may be a shor tage of fresh gas in the breathing system 054 1 ...

Page 63: ...onnect one end of the transfer hose to the side fitting on the scavenger z Connect the other end of the transfer hose to the waste gas port located on the underside of the breathing system 2 Connect the waste gas hose to the bottom con nection on the scavenger z Connect the other end of the hose to the hospi tal waste gas disposal system For detailed information on the passive scavenger system ref...

Page 64: ...tall the bottle assembly in the slide mount on the bracket z Prepare the suction system according to the Instructions for Use provided with the suction system Depending on the suction system used If AIR or O2 is used as the driving gas z Secure the air connection hose of the suction system to the air outlet on the gas supply block optional or directly to the pipeline gas supply For vacuum driven s...

Page 65: ...me occluded Before each use check the breathing hoses for damage NOTE Take care not to damage the breathing hoses WARNING Risk of use of toxic or incompatible materials Breathing hoses used on the Fabius MRI must comply with current national standards WARNING Do not use antistatic or conductive breathing hoses or masks There is a risk of burns in the MRI environment or when using high fre quency e...

Page 66: ...ag and breathing hoses 1 Push patient breathing hoses onto both the inspiratory and expiratory connectors or onto optional microbial filters 2 Connect both patient breathing hoses to the Y piece 3 Connect the breathing bag to the bag fitting on the breathing system WARNING Risk of strangulation Use caution when connecting the patient 050 1 2 3 ...

Page 67: ...ter Technical Data the inspiratory and expiratory breathing resistance of the breathing system is given without considering the breathing hoses This allows for the determination of the resistance at the patient using different hose sets and or filters To calculate the Resistance R use the following formula RExpiration RBreathingsystem_exp RExpHose RExpFilter RInspiration RBreathingsystem_insp RIns...

Page 68: ...its pack aging 2 Insert the capsule in the housing with the ring shaped conductors against the contacts in the housing z Screw the cap on firmly by hand Connecting the O2 Sensor 3 Push the O2 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 051 1 2 016 3 4 ...

Page 69: ... hose barb 2 Connect the pressure measuring line to the bacterial filter and plug it firmly onto the port labeled on the connector panel on the back of the machine Connecting the Breathing Pressure Gauge z Push the pressure measuring line onto the hose barb 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 connec...

Page 70: ... connector panel on the back of the machine Connecting the APL Bypass and PEEP PMAX Hoses 3 Plug the control hose to the connection port on the PEEP PMAX valve and to the connection port marked PEEP on the connection panel 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 ...

Page 71: ...ree clasps 3 Remove the cover 4 Insert the diaphragm z Fit the cover and lock the three clasps 5 Connect pressure sensor line of the ventilator chamber to the respecive connector 1 Close the ventilator door with the attached ven tilator unit Ventilator Safety Features High pressure safety relief valve A Negative pressure safety relief valve B Ventilator chamber pressure sensor 091 A B 3 5 5 4 2 1 ...

Page 72: ... be tested by experts trained and factory authorized technical ser vice representatives for anesthetic machines and MRI scanners prior the first use to ensure proper vaporizer and interface function in the specific magnetic fields Otherwise uncon trolled concentrations leakage and or mal function of the interlock system may occur The testing has to take into consideration all positions of the anes...

Page 73: ...erromagnetic adapters or tools can be moved by magnetic attraction WARNING Risk of injury Vaporizers have to be mounted and removed outside of the MR room Do not exchange any vaporizer in the MR room Vaporizers can be moved by magnetic attrac tion WARNING Risk of injury Do not use filling adapters without a label MRI Adapters can be moved by magnetic attraction CAUTION Only Vapor 2000 vaporizers c...

Page 74: ...ver and personal injury If monitors and other equipment are placed on top of the Fabius MRI 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 MRI before moving the unit CAUTION Risk of adversely affecting imaging of MRT Inside the MR room wired RS232 cables may not be used under any circumst...

Page 75: ...ent leakage current to rise above the permitted values if a protec tive earth conductor should fail The risk of electric shock cannot be excluded in such cases WARNING Do not connect life supporting devices to the auxiliary power outlets of the anesthesia workstation The auxiliary power outlets are not powered by the uninterruptible power sup ply UPS in the event of a power failure WARNING Risk of...

Page 76: ...i magnetic tape measure mark the position for the trolley on the floor with yel low black adhesive tape and enter it in the equipment installation drawing WARNING The Fabius MRI anesthesia machine has been tested with magnets with field strengths of 1 5 tesla and 3 tesla by a fringe field strenth of 40 mtesla 400 gauss Use of the machine at higher strengths could result in ventilator and device ma...

Page 77: ...ositioning lock the castors on the trol ley by central brake at all times in the MRI room Magnetic attractive forces between the magnet and the anesthesia machine may cause unintentional movement of the anesthe sia machine if the casters are unlocked NOTE The two teslameter sensorics 1 in illustration detect and alarm independently CAUTION Make sure that the additional alarm lights at the edges of...

Page 78: ...nnected to the auxiliary power outlet s will not be supplied by the anesthesia machine s battery backup and will discon tinue operation WARNING Be careful in handling the power cord and main power plug These parts still contain minor magnetic components The power cord can be attracted to MRI system CAUTION Fabius MRI is intended to be used on 120 V 60 Hz supplies in the USA The corresponding power...

Page 79: ...l the O2 capsule in O2 sensor housing Install and connect the O2 sensor Connect the bypass and PEEP PMAX hoses Connect the pressure sensor hose Connect pipeline supply of N2O AIR and O2 Connect reserve gas cylinders for N2O AIR and O2 Install and connect the scavenger system optional mount the holster to the channel profile install the AGS scavenger or the passive scavenger connect hoses Install a...

Page 80: ...bius MRI SW 3 n Daily and Pre use Checkout At the completion of the assembly of the Fabius MRI perform the Daily and Pre use Check out procedure provided in the Appendix 1 of this manual to ensure that the machine is ready for operation ...

Page 81: ...Instructions for Use Fabius MRI SW 3 n 81 Getting Started Getting Started Powering Up the Machine 82 Power Up Standby Screen 83 Checking Readiness for Operation 83 ...

Page 82: ...nes are emitted to show speakers functionality At the end of the self diagnostics one of three pos sible conclusions to the self tests is posted on the screen FUNCTIONAL Every component of the monitoring system is in satisfactory operational order After a brief delay the Standby screen appears CONDITIONALLY FUNCTIONAL A noncritical fault was detected The Fabius MRI may be used but call DrägerServi...

Page 83: ...Standby screen appears and provides instructions on start ing the operation of the Fabius MRI Checking Readiness for Operation Check the readiness of the Fabius MRI by testing all required components as specified in the daily and pre use checkout provided in the appendix of this manual If all checks are satisfactorily com pleted begin operation as specified in Operation on page 85 WARNING The powe...

Page 84: ...84 Instructions for Use Fabius MRI SW 3 n This page intentionally left blank ...

Page 85: ...ts to note when using the CLIC adapter with neonates and infants 93 Ventilation 94 Manual Spontaneous Ventilation Mode 94 Volume Control Ventilation 97 Pressure Control Ventilation 100 Pressure Support Ventilation 102 SIMV PS Ventilation 105 When Changing Between Ventilation Modes 108 Ventilator Safety Features 110 Behavior during Lack of Fresh Gas 110 Changing Patients 111 Ending Operation 112 En...

Page 86: ... of the machine S ORC Sensitive Oxygen Ratio Controller S ORC is a control element which guarantees a minimum O2 concentration in the fresh gas flow As from a flow rate of approx 300 mL min the N2O concentration in the fresh gas can be freely set between 0 and 75 During O2 shortage S ORC limits the N2O concen tration in the fresh gas so that the O2 concentration does not drop below 23 vol S ORC pr...

Page 87: ...TION Risk of inaccurate measuring values After the O2 supply has been restored a supply pressure of at least 2 7 kPa x 100 must be applied for at least 20 seconds before another O2 short age signal can be emitted During this period do not activate any devices that consume O2 e g O2 flush O2 fresh gas flow or secretion aspiration WARNING Damage to materials and health risks Never switch off fresh g...

Page 88: ...or the pressure to balance 3 Press the button and turn the handwheel coun terclockwise to set the required anesthetic gas concentration z Regularly check the filling level on the sight glass When reaching the minimum mark fill the vaporizer with anesthetic agent For the Dräger Auto Exclusion system z Close any open vaporizers z Ensure that the vaporizer is properly seated 1 With the handwheel set ...

Page 89: ...g system and breathing bag while bypassing the ventilator The Fabius MRI does not need to be switched on in order to use the O2 flush 3 Press the O2 flush button Additional O2 flows into the compact breathing system as long as the button is pushed in The flow control ele ments and the anesthetic agent vaporizer are bypassed NOTE A NOTE provides additional information intended to avoid inconvenienc...

Page 90: ...r level exceeds the maximum water level limit Nitrogen Wash Out If Required During anesthesia induction air containing about 77 nitrogen N2 remains in the compact breath ing system and in the patient s lungs If the unit will be used for a low flow anesthesia case press the O2 Flush to remove this N2 Replacing CO2 Absorbent The CO2 absorbent in the compact breathing sys tem should be replaced when ...

Page 91: ...akdown of the inha lationanesthetic The above mentioned reactions may endanger the patient e g CO poisoning insufficient depth of anesthesia burns of the airway CAUTION Soda lime irritates the skin and there is a risk of serious damage to eyes If soda lime has leaked Powdered soda lime must not be inhaled or swallowed Put on protective gloves and goggles or a face mask In case of coming in contact...

Page 92: ...sorbent 1 Fit the absorber canister into position below the breathing system and turn it counterclockwise as far as possible NOTE Ensure that no CO2 absorbent dust particles have been deposited between the gaskets and sealing surfaces Such dust and particles can cause leaks in the system CAUTION Risk of unintended perioperative awareness Make sure that during ventilation the absorber canister is t...

Page 93: ...ilator delivers a higher tidal volume to the patient during IPPV SIMV and the airway pressure increases accordingly The effect on the tidal volume and airway pressure is negligible in adults with a lung compliance of approx 50 mL cmH2O In neonates and infants with a lung compliance of approx 5 mL cmH2O or less the tidal volume and airway pressure can increase con siderably and harm the patient if ...

Page 94: ...llowing examples and illustrations describe starting Man Spont ventilation from the present ventilation mode Volume Control For Spontaneous Breathing z Rotate the APL valve knob fully counterclock wise until the index mark on the knob lines up with the index mark on the bottom of the valve The valve is now open for spontaneous patient breathing z Set the appropriate fresh gas flow 1 Press the ManS...

Page 95: ...e alarm ON OFF see page 129 and Volume alarms ON OFF see page 127 Pressing the ON OFF soft key tog gles the corresponding alarm between ON and OFF For Manual Ventilation z Rotate the APL valve adjustment knob to the desired pressure Clockwise rotation increases the pressure and counterclockwise rotation decreases the pressure NOTE In ManSpont mode the apnea volume timer count down for caution alar...

Page 96: ...d the ManSpont LED switches from blinking to constantly on and the waveform is restored The ManSpont screen allows the user to adjust two parameters Apnea Pressure alarm ON OFF and Volume alarms ON OFF Pressing the ON OFF soft key toggles the corresponding alarm between ON and OFF z Press the O2 flush button as required to rein flate the bag z Set the appropriate fresh gas flow z Start manual vent...

Page 97: ...e Starting Volume Control Ventilation The following examples and illustrations describe starting Volume Control ventilation from the present ventilation mode Pressure Control 1 Press the Volume Control key The LED associated with this key starts blinking It remains blinking until the selected mode of operation is confirmed 2 The Waveform window is replaced by the venti lator settings window and a ...

Page 98: ...ume Control key LED switches from blinking to constantly on the ventilator switches to the Volume Control mode and the waveform is restored The parameters that can be set for Volume Control mode are shown the adjacent table along with their adjustment ranges and factory default values 502 VentilationParameter Volume Control Mode Adjustment Range Factory Default Value Pressure Limitation PMAX cmH2O...

Page 99: ...is applied at the lowest inspiration flow Insp Flow which is possible at the corresponding frequency Freq In addition a positive end expiratory pres sure PEEP can be set To avoid too high pressures the alarm limit PMAX can be set according to the physiological state of the patient The lower pressure limit PAW low is used for pres sure monitoring to detect apneas disconnection and continuous pressu...

Page 100: ... responding soft key select the correct value and confirm the change When the parameter changes are completed confirm the ventilation mode change z After the mode change is confirmed the Pressure Control key LED switches from blinking to constantly on the ventilator switches to the Pressure Control mode and the wave form is restored The parameters that can be set for Pressure Con trol mode are sho...

Page 101: ... patient compli ance The Insp Flow key is used to set the slope of the pressure waveform In addition a positive end expiratory pressure PEEP can be set The lower pressure limit PAW low is used for pres sure monitoring to detect apneas disconnection and continuous pressure An alarm is generated when the pressure curve does not cross the pres sure threshold either from above or below 110 1 PAW low P...

Page 102: ...of neuromuscular blocking agents will interfere with patient triggering Apnea Ventilation is a feature within Pressure Sup port ventilation To enable Apnea Ventilation adjust the Freq Min setting to a value other than OFF If the detected patient spontaneous breathing rate falls below the set value the ventilator automati cally delivers a Pressure Support breath Apnea ventilation is intended to pro...

Page 103: ... by the venti lator settings window and a message that pro vides instructions to confirm the mode change z If the ventilator settings are correct confirm the mode change z 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 ventilatio...

Page 104: ... e g 3 bpm 1 min is used to set a safety period safety period 1 Freq Min e g 20 s If no inspi ratory effort is detected and the safety period has expired the device applies a pressure controlled breath with PINSP ΔPPS The lower pressure limit PAW low is used for pres sure monitoring to detect apneas disconnection and continuous pressure An alarm is generated when the pressure curve does not cross ...

Page 105: ...IMV mode Refer to Pressure Support Ventila tion on page 102 for additional information on Pressure Support ventilation Starting SIMV PS Ventilation The following examples and illustrations describe starting SIMV PS ventilation from the present ven tilation mode Volume Control 1 Press the SIMV PS key The LED associated with this key starts blinking It remains blinking until the selected mode of ope...

Page 106: ...m blinking to constantly on the ventilator switches to the SIMV PS mode and the waveform is restored VentilationParameter SIMV PS Mode Adjustment Range Factory Default Value Pressure Limitation PMAX cmH2O hPa 15 to 70 min PEEP 10 and ΔPPS PEEP 40 Tidal Volume VT mL 20 to 1100 600 Frequency Freq bpm 1 min 4 to 60 12 Support pressure ΔPPS cmH2O hPa 3 to 20 OFF 10 PEEP cmH2O hPa 0 to 20 0 Trigger Sen...

Page 107: ...h is applied 5 s for frequencies Freq below 12 bpm 1 min At higher frequencies synchronization is done directly after the preceding expiration In bet ween these mandatory breaths the patient can breathe spontanously Mandatory breaths are syn chronized with the spontaneous breaths of the pati ent These spontaneous breaths can be supported with Pressure Support The lower pressure limit PAW low is us...

Page 108: ... Volume Control When changing from Volume Control or Pressure Support to Pressure Control the suggested value for Insp Flow is either the last used value or the site default value When changing from Pressure Control to Volume Control VT is set by dividing the last minute volume by the respiratory rate When changing from Pressure Control to Volume Control the suggested value for TIP TI is either th...

Page 109: ...S mode the PMAX and PEEP settings shall automatically be transferred from the previous mode to the new mode When switching from Pressure Support mode to SIMV PS mode the ΔPPS Insp Flow Trigger and PEEP settings shall automatically be transferred from the previous mode to the new mode When switching from SIMV PS mode with Pressure Support enabled to Pressure Support mode the ΔPPS and Insp Flow sett...

Page 110: ...y empties completely after two more strokes the alarm FRESH GAS LOW and additional alarms occur the ventilator absorbs its reserve volume since it is not supplied with sufficient fresh gas As long as a lack of fresh gas exists the safety valve B for ambient air is opened during expira tion Advantages Even in extreme cases emergency ventilation with limited VT is possible A sudden shutdown of the v...

Page 111: ...ribed page 136 The leak compliance test should be performed each time the absor bent or breathing hoses have been changed or when a vaporizer has been changed or filled z Set the ventilation mode as described in Venti lation on page 94 and proceed with the case WARNING Risk of inappropriate alarm settings As it is possible that Fabius MRI devices within in a care area have different site default a...

Page 112: ... key Monitoring and alarms are turned off and the venti lator stops 2 Turn vaporizers off by turning the handwheel to 0 until the button engages z Turn off fresh gas flow on the Fabius MRI Sleep mode will activate 2 5 minutes after fresh gas is turned off z Close the cylinder valves 566 1 090 T 2 ON 2 ...

Page 113: ...r Use pro vided with the vaporizer z Observe expiration date of anesthetic agent If the Vapor does not remain on the machine z see Disconnecting the Vapor and Transport of Filled Vapors in separate Instructions for Use provided with the vaporizer When Fabius MRI is not in use If Fabius MRI is not used for an extended period z Unplug the medical gas hoses from the wall supply points of the central ...

Page 114: ...ta tion to aid in maneuverability Exercise special care so that the machine does not tip when moving up or down incli nes around corners and across thresholds for example in door frames and elevators Do not attempt to pull the machine over any hoses cords or other obstacles on the floor WARNING All the procedures described in this manual require that any use of ferromagnetic tools can only be done...

Page 115: ...ning the handwheel to 0 until the button engages z Turn off fresh gas flow z Close the cylinder valves z Remove the O2 sensor from the inspiratory valve and leave it exposed to air 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 z Disconnect the scavenger hoses 566 1 010 2 ...

Page 116: ... g with the tip of your foot CAUTION Do not attempt to move the anesthesia machine while the casters are locked CAUTION Watch hoses connected to the patient while mov ing the Fabius MRI CAUTION Do not push or pull the Fabius MRI using the absorber system vaporizers ventilator or moni tor CAUTION The Fabius MRI should be moved by people who can handle its weight approximately 425 lb 192 8 kg Take e...

Page 117: ... 122 Setting Oxygen Monitoring Alarm Limits 122 Calibrating the Oxygen Sensor 123 Consequences of Incorrect O2 Calibration 125 Respiratory Volume Monitoring 126 Respiratory Volume Monitoring Window 126 Volume Monitoring Alarms 127 Setting Minute Volume Alarm Limits 127 Disabling Volume Alarms 127 Breathing Pressure Monitoring 128 Breathing Pressure Monitoring Windows 128 Breathing Pressure Monitor...

Page 118: ...cator 2 lights up an acoustic tone or sequence of tones is annun ciated The table to the right summarizes the specific way each type of alarm is indicated The alarm messages are only displayed on colored backround if the option Color display is enabled 566 1 2 Alarm Indication Warning warning message appears in red in alarm window followed by three exclamation marks red LED alarm indicator 2 blink...

Page 119: ... Example of audible alarm notification in the event of several alarms If an alarm with the category Warning is currently active and a new alarm with the category Warning is generated the alarm sequence starts again by issuing an alarm with the same priority If alarm with the category Caution is also gener ated no new audible alarm is issued The Warning alarm notification is not interrupted because...

Page 120: ...s The yellow LED lights up The symbol appears in the status bar with an indication of the silence time remaining To enable the alarm tone 1 Press the Silence key the yellow LED turns off Disabling Volume Alarms Visual and audible volume alarms can be turned on or off during operation using the Setup key See Volume Alarms On Off on page 153 566 1 ...

Page 121: ...otted line An alarm is generated when the pressure curve does not cross the pres sure threshold either from above or below z Select the alarm limit value that needs to change z Confirm the alarm limit value and select a new value z 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 ...

Page 122: ...ng window shows the following information 1 numerical value for inspiratory oxygen concen tration in percent within the range of 10 to 100 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 121 to change the high or low alarm limit CAUTION Risk of inaccurate measuring values Never r...

Page 123: ...sor can be calibrated during Standby as described in Calibrate O2 Sensor on page 154 To avoid leakage remove the oxygen sensor assembly from the inspiratory valve dome and insert the valve dome plug into the dome To calibrate the oxygen during operation follow the procedure below 1 Press the Setup key on the front panel The Setup window appears at the bottom of the screen 2 Press the Calibrate O2 ...

Page 124: ...constantly changing calibration mixture Make sure that the sensor is exposed to room air for the entire calibration period Sensor did not receive the proper waiting period If the sensor capsule was removed from the sen sor assembly a waiting period equal to the time that the capsule spent outside the sensor assem bly is necessary prior to calibration New sensors require a 15 minute waiting period ...

Page 125: ...isplays an oxygen percentage either higher or lower than the actual oxygen percentage Therefore make sure that the sensor is exposed only to room air during the entire calibration period The figure illustrates the relationship between the calibration mixture and the accuracy of oxygen measurement A Displayed O2 Percentage B Actual O2 Percentage 1 At calibration sensor exposed to 21 O2 Thus display...

Page 126: ...The display range is from 0 mL to 1400 mL 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 4 Minute Volume Alarm High Limit indicates the volume above which an alarm condition occurs L min 5 Minute Volume Alarm Low Limit indicates t...

Page 127: ...nd the system is in Man Spont mode these alarms are generated at 30 seconds Caution and 60 seconds Warning The Fabius MRI s volume alarms are automatically enabled when the ventilator is switched from Standby to a ventilation mode Setting Minute Volume Alarm Limits Follow the procedure Setting Alarm Limits on page 121 to change the high or low alarm limit Disabling Volume Alarms Visual and audible...

Page 128: ...neous pressure values recorded during each breath in cmH2O hPa The display range is from 0 to 50 cmH2O 0 to 50 hPa 3 PEAK Breathing Pressure shows the highest instantaneous pressure value for each breath in cmH2O hPa The display range is from 0 to 80 cmH2O 0 to 80 hPa 4 Pressure High Alarm Limit 5 Pressure Threshold Alarm Limit 6 Breathing Pressure Trace Window displays a breathing pressure trace ...

Page 129: ...2 While the ventilator is off and the system is in Man Spont mode these alarms are generated at 30 seconds Caution and 60 seconds Warning Setting Pressure High and Threshold Alarm Limits Follow the procedure Setting Alarm Limits on page 121 to change the breathing pressure high or threshold alarm limit NOTE The pressure threshold alarm limit should be as close as possible to the sensed plateau pre...

Page 130: ...130 Instructions for Use Fabius MRI SW 3 n This page intentionally left blank ...

Page 131: ...Sensor 134 Calibrate O2 Sensor 135 Leak Compliance Test 136 Access Alarm Log 139 Restore Site Defaults 139 Standby Setup Screen 140 Default Settings in Standby Setup 141 Configuration in Standby Setup 147 Configuration during Operation 152 Volume Alarms On Off 153 Auto Set 153 Calibrate O2 Sensor 154 Des Comp On Off 155 Access Alarm Log 156 Access Alarm Volume 156 ...

Page 132: ...y starts blinking and will remain blinking until Standby is confirmed 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 bot tom of the Standby screen Run System Test Calibrate Flow Sensor Calibrate O2 Sensor Leak Compl Test Access Alarm Log Restor...

Page 133: ...This test performs the power up diagnostic tests as described in Power Up Standby Screen on page 86 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 This System Test checks the functionality of the electronics of the system NOTE If the flow control valves were not shut off before entering...

Page 134: ...ation press rotary knob z When the calibration begins the instructions are removed and a Flow Calibration in progress message is displayed above the Standby soft keys z When the calibration is completed one of two messages is posted above the Standby soft keys Flow Calibration completed recon nect expiratory hose or Flow Calibration Failed Troubleshooting Flow Calibration Failure If the flow senso...

Page 135: ...ration begins the instructions are removed and a O2 Calibration in progress message is displayed above the Standby soft keys z When the calibration is completed one of two messages is posted above the Standby soft keys O2 Sensor Calibration completed reinsert O2 sensor or O2 Sensor Calibra tion Failed Troubleshooting O2 Sensor Calibration Failure If the O2 sensor cannot be calibrated replace the O...

Page 136: ...by a ventilator preparation message and then instructions for performing the test z Follow the instructions on the screen Close all fresh gas control valves Place Y piece on plug located on bag mount Seal sample line connector if applicable Switch APL valve to MAN and set pressure to 40 to 50 Press O2 flush button build up a pressure of 15 to 30 z Upon completion of the test the results are posted...

Page 137: ...he value is displayed on the leak test result screen and the Standby screen System Leak Test Results System leak test results are posted on the leak test result screen Measured ventilator leak mL min Displayed result mL min 150 measured value and PASSED 151 to 250 measured value and FAILED 250 250 and FAILED Measured system leak mL min Displayed result mL min 250 measured value and PASSED 251 to 3...

Page 138: ...ged breathing bag diaphragm defective vaporizer not connected correctly or filling device open absorber canister not firmly mounted in place flow sensor not installed properly breathing system not assembled and installed correctly microbial filters not connected securely breathing bag arm not tight or defective CAUTION The high pressure safety relief valve 80 hPa mbar is tested during the leak tes...

Page 139: ...arrow Restore Site Defaults 2 Press the Restore Site Defaults key on the Standby screen The predefined site defaults are restored and a Site Default settings restored message is displayed above the Standby soft keys The site default settings are password protected Changes of the settings can be made via the Standby Setup screen see page 140 CAUTION Alarm log data is deleted if Fabius MRI is swit c...

Page 140: ...le in Standby mode The operator is requested to enter a four digit pass word in order to prevent unauthorized changes to the basic functions This password is allocated when commissioning the workstation If desired DrägerService can set an individual password or disable this functionality z Select and confirm the figures successively from the line displayed using the rotary knob z The Standby Setup...

Page 141: ...the Default Settings column and redisplay the main Setup screen The following settings are available under Default Settings Volume Settings Pressure Settings Pressure Support Settings SIMV PS Settings Alarm Limits Alarm Volume Restore Factory Defaults Volume Settings z Select and confirm the Volume Settings label on the Standby Setup screen The Default Volume Settings window appears at the bottom ...

Page 142: ...soft keys z If necessary repeat the process for the other Volume Settings parameters z When all Volume Settings parameters are set to desired values confirm the default Volume Set tings as instructed by the message displayed above the soft keys The Default Volume Settings window is then removed from the screen and the cursor returns to the return arrow Pressure Settings Pressure Support Settings a...

Page 143: ...imit value that needs to change z Confirm the alarm limit value and select a new value In the example illustration the O2 alarm limit was changed from 20 to 25 z Confirm the new value for the O2 alarm limit The new alarm limit is saved and cursor moves to the return arrow z If necessary repeat the process for the other parameter alarm limits NOTE Set the alarm limits to appropriate values 506 507 ...

Page 144: ...lume value appears on the screen z Select and confirm the new alarm volume value from 1 minimum to 10 maximum range 45 dB A to 85 dB A In the example illustration the value was changed from 4 to 5 The Alarm Volume Setting window is then removed from the screen and the cursor returns to the return arrow Alarm Parameter Adjustment Range Factory Default Value O2 19 to 100 18 to 99 100 20 MV L min 0 1...

Page 145: ...the Standby Setup screen The Restore Factory Default setting window appears on the screen z Select and confirm Yes or No When Yes is selected the factory defaults are restored and replace the current default set tings The factory defaults for the Fabius MRI are shown in the table below Parameter Factory Default Settings Volume Control PMAX 40 VT 600 Freq 12 TI TE 1 2 0 TIP TI 10 PEEP 0 Pressure Co...

Page 146: ...0 Freq 12 ΔPPS 10 PEEP 0 Trigger 2 Insp Flow 30 TINSP 1 7 TIP TI 10 Alarm Default Settings for O2 High 100 Low 20 Alarm Default Settings for MV High 12 0 Low 3 0 Alarm Default Settings for Pressure High 40 Low 8 Alarm Audio Volume Volume level 5 Parameter Factory Default Settings ...

Page 147: ...label on the Standby Setup screen Selecting and confirming the return arrow will exit the Config uration column and redisplay the main Setup screen The following settings are available under Configu ration Time Set Time Format Date Set Date Format Acoustic Confirmation Alarm Tone Sequence Waveform Display Display Background 542 ...

Page 148: ...ct and confirm a new hour time value in the example illustration the hour was changed from 13 to 20 The cursor moves to the minutes field z Select and confirm a new minute time value in the example illustration the value was changed from 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 545 546 547 ...

Page 149: ...new time format value in the example illustration the value was changed from 24 Hour to AM PM The new time format value is saved the Time For mat window is removed from the screen and the cursor returns to the Time Format label 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 148 to change the date parame...

Page 150: ... can be selected for the acoustic confirmation are On or Off If On is selected an acoustic confirmation is annunciated every time that the rotary knob is pressed Use the procedure described in Time Format on page 149 to change the acoustic confirmation parameter Alarm Tone Sequence The values that can be selected for the alarm tone sequence are Standard or Dräger Use the procedure described in Tim...

Page 151: ...mat on page 149 to change the waveform display parame ter If Normal is selected the waveform is not filled with a solid pattern but appears as a line as shown in the example illustration 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 149 to change the display background param eter 552 553 560 ...

Page 152: ...e waveform and soft keys for the current ventilator mode The following soft key labels appear in the Setup window Volume Alarms On Off Auto Set Calibrate O2 Sensor Des Comp On Off Access Alarm Log Access Alarm Volume There is a 15 second timeout period for any of the Setup functions during operation If no rotary knob activity occurs within 15 seconds the Setup win dow is removed and the waveform w...

Page 153: ...hreshold is set to 4 cmH2O hPa below the current plateau pres sure data value NOTE The Volume Alarms On Off soft key label does not appear in ManSpont mode because it is select able on the ManSpont screen NOTE The threshold setting may not be less than 5 cmH2O 5 hPa or greater than 30 cmH2O 30 hPa NOTE In the absence of a current plateau pressure data value pressing the soft key will have no effec...

Page 154: ...assembly from the inspiratory valve dome and insert the valve dome plug into the dome 1 Press the Calibrate O2 Sensor soft key in the Setup window z The calibration instruction window replaces the Setup window Follow the directions provided Remove O2 Sensor and expose to room air for 2 minutes To start O2 Calibration press rotary knob Observe Calibration status in O2 data window Reinsert O2 Sensor...

Page 155: ...t be calibrated replace the O2 capsule in the O2 sensor housing see page 189 If the O2 sensor still cannot be calibrated call DrägerService or your local authorized service organization Des Comp On Off CAUTION The Des Comp On Off function is not relevant for MRI use CAUTION The Des Comp On Off parameter remains in the Off position on the Fabius MRI WARNING The Desflurane vaporizer is not useable i...

Page 156: ...l alarms from the log select and confirm the Clear Alarm Log label z To exit the alarm log and return to the Setup window select and confirm the return arrow Access Alarm Volume 2 Press the Access Alarm Volume key in the Setup window z The Setup window is replaced by the Alarm Vol ume Setting window z Select and confirm a new alarm volume value in the range of 1 minimum to 10 maximum The value is ...

Page 157: ...Instructions for Use Fabius MRI SW 3 n 157 Fault Cause Remedy Fault Cause Remedy Power Failure Backup 158 Ventilator Fail State 160 Overriding the Ventilator 160 Fault Cause Remedy 162 ...

Page 158: ...ppears in the status bar and the Mains Power LED turns off The POWER FAIL Advisory alarm message is displayed in the alarm window When the battery is discharged to 20 of its reserve power the BATTERY LOW Advi sory alarm message is displayed in the alarm window When the battery is discharged to 10 of its reserve power the BATTERY LOW Cau tion alarm message replaces the Advisory alarm message in the...

Page 159: ...rm set tings are reset to the saved default settings WARNING When the BATTERY LOW Caution alarm message is first displayed the ventilator will continue to operate for up to an additional 10 minutes Then automatic ventilation is not available until AC power is restored CAUTION Never allow the battery to completely discharge If the battery is discharged completely recharge immediately Do not use the...

Page 160: ...annot switch to manual ventilation mode through the use of the ManSpont key and rotary knob manual ventilation is still possible z Locate the ON OFF switch on the rear panel z Toggle the ON OFF switch to off and then z Toggle the ON OFF switch back to on The ventilator now performs as in ManSpont mode z Set the APL valve to MAN position WARNING Risk of patient injury If the ventilator fails the an...

Page 161: ...iagnostic tests manual ventilation is possible If the diagnostic tests result in FUNCTIONAL the Fabius MRI will automatically switch to ManSpont mode if a fresh gas flow is detected Fabius MRI respiratory monitoring is available If the diagnostic tests result in NON FUNCTIONAL manual venti lation is still possible but Fabius MRI respiratory monitoring is not available NOTE In ventilator override s...

Page 162: ...Volume Control Pressure Control SIMV PS with Freq 6 or Pressure Support with Apnea Ventilation OFF Caution VT 20 mL for 15 seconds Warning VT 20 mL for 30 seconds In ManSpont SIMV PS with Freq 6 or Pressure Support with Apnea Ventilation ON Caution VT 20 mL for 30 seconds Warning VT 20 mL for 60 seconds Breathing ventilation stops Breathing circuit disconnected or leakage Check ventilator Check br...

Page 163: ...andby Mode and switch back to the previous ventilation mode Check the APL valve setting 7 CHECK BATTERY The reserve power is 0 of a full charge Replace fuse Call DrägerService or your local authorized service orga nization 31 CONTINUOUS PRESSURE Breathing pressure above threshold for more than 15 seconds Check breathing circuit If in ManSpont mode check fresh gas flow Check actual limit for Pressu...

Page 164: ...cked kinked hose Breathing circuit disconnected or leakage Ensure adequate fresh gas supply Check hoses Check breathing circuit 13 INSP O2 HIGH Inspiratory O2 concentration exceeds the upper alarm limit Check flowmeter settings and O2 high alarm limit 31 INSP O2 LOW Inspiratory O2 concentration is below lower alarm limit Check O2 supply Check flow meter settings and O2 low alarm limit 11 INSP PRES...

Page 165: ...tion Follow the procedure to cali brate oxygen sensor see page 135 8 O2 SENSOR FAIL O2 sensor has not been cor rectly calibrated O2 sensor replaced and or not calibrated O2 sensor used up O2 sensor disconnected Faulty sensor cable Follow the procedure to cali brate O2 sensor see page 135 Follow the procedure to cali brate O2 sensor Replace sensor capsule and calibrate Connect O2 sensor assembly Re...

Page 166: ...ettings see page 143 Push the Auto Set soft key and check ventilator settings 1 RS232 COM1 FAIL External monitor cable discon nected from External Commu nication Port 1 Check monitor interface cable 1 SPEAKER FAIL Speaker failed Call DrägerService or your local authorized service orga nization 28 VENTILATOR FAIL Ventilator not assembled cor rectly Check diaphragm and close cover Check PEEP PMAX li...

Page 167: ... Parts of the Ventilator 173 Removing anesthetic gas scavenging system AGSS 174 Removing the Suction System 174 Reprocessing Breathing system 174 O2 Sensor 175 Spirolog Infinity ID and SpiroLife flow sensors 175 Care List for Fabius MRI Components 176 Reassembling the Breathing System 178 Attaching the Inspiratory Valve 178 Attaching the Expiratory Valve 178 Attaching the APL Valve 178 Screw the w...

Page 168: ... parts so that all interior spaces are completely flushed e g hoses and water can drain off freely Cleaning program z Select suitable program preferably anesthesia program Cleaning is carried out at 40 to 60 C 104 to 140 F for at least 5 minutes Thermal disinfection z Thermal disinfection is carried out at 80 to 95 C 176 to 203 F and with corresponding contact time z Carry out final rinsing with d...

Page 169: ...nsor Observe the relevant Instructions for Use z Rinse parts under running water until no clea ning agent residues are discernible z Check parts for visible soiling and damage Repeat manual cleaning if necessary Manual disinfection Manual disinfection should preferably be carried out with disinfectants based on aldehydes or qua ternary ammonia compounds The efficiency of the disinfectants used mus...

Page 170: ...cessing cycles the vaporizers remain attached to the medical device Device surfaces CAUTION Even accessories designed to be reused e g after reprocessing have a limited service life Due to a number of factors connected with handling and reprocessing e g disinfectant residues can attack the material more intensely during auto claving increased wear can occur and the service life can be markedly sho...

Page 171: ...g pressure cable z Detach the APL bypass and the PEEP PMAX lines from the breathing system and from the side of the machine z Remove the absorber for complete instruc tions see page 189 z Remove the compact breathing system 1 Remove plug for the inspiration dome Removing the Inspiratory Valve 2 Unscrew the retaining nut 3 Remove the inspection cap 4 Extract the valve disc 5 Extract the gasket on t...

Page 172: ... damage them and cause the flow measurement to fail Disinfect and clean the flow sensors as described in the Instructions for Use of the Spirolog Infinity ID flow sensor and SpiroLife flow sensors CAUTION Risk of flow measurement failure Sterilizing the Spirolog and Infinity ID flow sensors in high temperature steam will damage them and cause the flow measurement to fail Disinfect and clean the fl...

Page 173: ...Remove the APL valve z Unscrew the waste gas outlet port Removing Parts of the Ventilator 1 Open the ventilator door 2 Disconnect the pressure sensor line of the ven tilator chamber from the respective connector 3 Unlock the three clasps 4 Remove the cover 5 Remove the ventilator diaphragm 059 1 2 2 3 4 5 ...

Page 174: ...infection machine at 200 F 93 C 10 minutes Only use neutral or mild alcalic cleaning agents e g Neodisher Medizym Neodisher FA and completely demineralized water When using thermal disinfection the addition of disinfectant chemicals is not necessary risk of corrosion WARNING Risk of infection Always wear protective gloves when emptying the suction bottle Observe the hospital hygiene regulations NO...

Page 175: ...t brush etc Otherwise the thin wires in the flow sensor may be destroyed The Spirolog and Infinity ID flow sensor must not be sterilized in hot steam The flow sensor is not resistant to high temperatures and will be destroyed CAUTION Only use clean disinfectant solutions to disinfect the flow sensor Contaminants e g lint may lead to the destruction of the flow sensor WARNING Risk of fire hazard Al...

Page 176: ... Fabius MRI components which can be reprocessed Recommen ded reprocessing intervals Manual pre cleaning1 Machine cleaning and thermal disinfection2 Manual disinfection3 Hot steam sterili zation Surface disinfection Immersio n bath disinfec tion Surfaces Device surfaces Per patient No No Yes4 No No Power supply cable pressure gas hoses Per patient No No Yes4 No No Respiratory pressure meter Daily N...

Page 177: ...ral cleaner 3 Use disinfectants based on aldehydes and quaternary ammonium compounds 4 Do not use any agents containing alcohol 5 After the machine cleaning and disinfection a hot steam sterilization is required to dry the breathing system Insufficient drying of the control areas found in the valve plate can lead to an adverse effect on the functions of the medical device or to its failure 6 Valve...

Page 178: ...Expiratory Valve 6 Place the gasket on top of the valve disc 7 Place the valve disc in the valve seat 8 Fit the inspection cap 9 Tighten the retaining nut securely Attaching the APL Valve 10 Position the APL valve in the valve seat and tighten securely with the retaining nut WARNING Route all lines cables away from the APL valve to prevent interference with the APL valve adjustment knob Lines cabl...

Page 179: ...athing System Compo nents z Follow instructions beginning on page 52 to reinstall the following breathing system compo nents flow sensor breathing system ventilation hose fresh gas hose breathing bag extension and bag flow sensor and breathing pressure cables APL bypass and PEEP PMAX cables O2 sensor cable breathing system hoses z Follow instructions on page 189 to reinstall the absorber system op...

Page 180: ...with the attached ven tilator unit 2 Unlatch the three clasps 3 Remove the cover 4 Insert the diaphragm z Fit the cover and lock the three clasps 5 Connect pressure sensor line of the ventilator chamber to the respecive connector z Close the ventilator door with the attached ven tilator unit 059 1 5 5 2 3 4 ...

Page 181: ... scavenging hose to the relevant socket of the receiving system z Connect the connector of the scavenging hose to the terminal unit of the disposal system 2 Close the connection that is not used with a screw cap z Push the transfer hose on the designated socket z Connect the other end of the transfer hose to the waste gas port located on the underside of the breathing system WARNING Risk of patien...

Page 182: ... container into the scavenger body z For detailed information on the AGS refer to the specific Instructions for Use provided with the anesthetic gas receiving system AGS 9038579 z For detailed information on the passive scaven ger refer to the specific Instructions for Use WARNING Danger to the patient Do not cover the side openings of the recei ving system Otherwise there may be a shor tage of fr...

Page 183: ...vice 1 Mount the suction regulator onto the bracket z Reprocess the suction bottle according to the instructions for use included with the bottle 2 Attach the suction bottle on the swivel rail Depending on the aspiration system used With use of AIR or O2 as driving gas z Connect the air connection hose of the suction system on the air exhaust of the gas supply block optional or directly on the gas...

Page 184: ...us MRI SW 3 n Checking Readiness for Operation At the completion of the reassembly of the Fabius MRI perform the Daily and Preuse Check out procedure provided in the Appendix of this manual to ensure that the machine is ready for operation ...

Page 185: ...tenance Overview 186 Definition of Maintenance Concepts 186 Inspection 186 Safety Checks 187 Preventive maintenance 188 Routine Maintenance 189 Replacing the O2 Sensor Capsule 189 Replacing CO2 Absorbent 189 CLIC Adapter 191 Checking Readiness for Operation 191 ...

Page 186: ...must be performed by profession als Dräger recommends DrägerService to per form these tasks Concept Definition Maintenance The combination of all technical and administrative measures taken during the life cycle of a medical device intended to retain or restore operating con dition so that the medical device can perform its required functions Inspection Measures intended to determine and assess th...

Page 187: ... the electrical safety according to IEC62353 5 Check safety features Check correct functioning of the alarm genera tor Check correct functioning of the alarm genera tion of lack of O2 Check correct functioning of O2 measurement Check correct functioning of flow measurement Check correct functioning of PAW PEEP APL and PMAX pressure measurement Check correct functioning of power fail alarm and batt...

Page 188: ...r Component Interval Measure Personnel responsible Fabius MRI Every 12 months Inspection and service Professionals Breathing systems Every 12 months Inspection and service Professionals Vaporizers Every 12 months Inspection and service Professionals Sensors Every 12 months Inspection and service Professionals NOTE If desired the customer may receive a list of those parts and their assembly instruc...

Page 189: ...ing shaped conductors against the contacts in the housing z Screw the cap on firmly by hand Replacing CO2 Absorbent The CO2 absorbent in the compact breathing sys tem should be replaced when two thirds of the CO2 absorbent has changed color Dräger recommends the use of Drägersorb 800 Plus or Drägersorb FREE The color change indicates that the CO2 absorbent can no longer absorb CO2 Drägersorb 800 P...

Page 190: ...gas temperature CO formation absorption and or breakdown of the inha lation anesthetic The above mentioned reactions may endanger the patient e g CO poisoning insufficient depth of anesthesia burns of the airway CAUTION Soda lime irritates the skin and there is a risk of serious damage to eyes If soda lime has leaked Powdered soda lime must not be inhaled or swallowed Put on protective gloves and ...

Page 191: ...wise as far as possible CLIC Adapter The disposable CLIC adapter absorber can also be used on the Fabius MRI For information on install ing the CLIC adapter consult its Instructions for Use Checking Readiness for Operation Perform the Daily and Preuse Checkout procedure provided in the Appendix of this manual to ensure that the machine is ready for operation NOTE Ensure that no CO2 absorbent dust ...

Page 192: ...192 Instructions for Use Fabius MRI SW 3 n This page intentionally left blank ...

Page 193: ...Instructions for Use Fabius MRI SW 3 n 193 Disposal Disposal Disposal of the Medical Device 194 Disposal of Non Rechargeable Batteries 194 ...

Page 194: ...appropriate disposal z Comply with the applicable laws and regulati ons Disposal of Non Rechargeable Batteries z Do not recharge batteries The medical device battery contains pollutant sub stances Observe the applicable laws and regulations for battery disposal WARNING Risk of explosion Do not throw batteries into fire Risk of chemical injury Do not force batteries open ...

Page 195: ...MC 199 General information 199 Electromagnetic emissions 200 Electromagnetic immunity 201 Recommended separation distances 203 Electrical Safety Conformance 204 General Safety Standards for Anesthesia 204 Freedom from latex 204 Ventilator 204 Anesthesia Gas Supply Module 207 Anesthetic Agent Vaporizer Interface 208 Breathing System 210 Low Oxygen Supply Pressure Alarm 212 S ORC Sensitive Oxygen Ra...

Page 196: ...pplementary equipment must be noted These may restrict the area of use for the system as a whole Vaporizer units and the anesthetic agents used may restrict the area of use of the workstation in regards to its temperature range and maximum fresh gas flow The corresponding Instructions for Use of the supplementary equipment must be noted Machine Data Gas supply from medical gas pipeline system Pipe...

Page 197: ...0 Compressed gas supply at workstation inlet Dew point 5 C 41 F at ambient temperature Oil content 0 1 mg m3 Particles dust free air filtered with pores 1 µm Internal Regulator Safety Relief Valve Pressure 70 psi 4 8 kPa x 100 opening pressure Protection Class I in accordance with IEC 60601 1 Applied parts Breathing system nozzles breathing hoses Type BF Ingress of Fluids IPX0 Power supply Rating ...

Page 198: ...8 x 140 x 90 cm approx 30 7 x 55 x 36 3 in 78 x 140 x 92 cm Dimensions W x H x D with COSY left or right side mounted 1 approx 39 x 55 x 35 5 36 3 in 99 x 140 x 90 92 cm Height writing tray 38 5 in 86 cm Height Teslameter sensoric 37 8 in 96 cm 1 Width may vary with COSY arm position Fuses Mains fuses For 100 to 240 V supply voltage 2x T2 5 AL 250 V IEC 60127 2 V Fuses located on circuit board 1x ...

Page 199: ...m The non observance may result in increased emis sions or de creased immunity of the equipment The Fabius MRI should not be used adjacent to or stacked with other equipment if adjacent or stacked use is inevitable the Fabius MRI should be observed to verify normal operation in the configu ration in which it will be used Other equipment which can be used adjacent to or stacked with this device are...

Page 200: ...to Electromagnetic environment RF emissions CISPR 11 Group 1 The Fabius MRI uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class B The Fabius MRI is suitable for use in all establishments including domestic establish ments and those directly connected to the public low voltage power s...

Page 201: ...at of a typical commercial or hospital envi ronment longerinput outputlines 1 kV 1 kV surges on AC mains lines IEC 61000 4 5 common mode 2 kV 2 kV Mains power quality should be that of a typical commercial or hospital envi ronment differential mode 1 kV 1 kV power frequency magnetic field 50 60 Hz IEC 61000 4 8 3 A m 3 A m In close vicinity to the Fabius MRI no equipment with extraordinary power f...

Page 202: ... For PEIRP the highest possible equivalent isotropic radiated power of the adjacent RF transmitter has to be inserted value in Watt Also in the vicinity of equipment marked with the symbol interference may occur Field strengths from fixed portable or mobile RF transmitters at the location of the Fabius MRI should be less than 3 V m in the frequency range from 150 kHz to 2 5 GHz and less than 1 V m...

Page 203: ...EIRP W 3 V m distance1 m 1 3 V m distance to transmitters with frequencies from 150 kHz to 2 5 GHz otherwise 1 V m distance 1 V m distance1 m Note 0 001 0 06 0 17 0 003 0 10 0 30 0 010 0 18 0 55 0 030 0 32 0 95 e g WLAN 5250 5775 Europe 0 100 0 58 1 73 e g WLAN 2440 Europe Bluetooth 0 200 0 82 2 46 e g WLAN 5250 not in Europe 0 250 0 91 2 75 e g DECT devices 1 000 1 83 5 48 e g GSM 1800 GSM 1900 U...

Page 204: ...O resolution 15 to 70 hPa 1 hPa resolution setting must be at least 10 cmH2O 10 hPa above PEEP and in SIMV PS mode the PMAX setting must also be greater than ΔPPS PEEP VT Tidal volume 20 to 1400 mL 10 mL resolution VT SIMV PS Tidal volume 20 to 1100 mL 10 mL resolution f Breathing frequency 4 to 60 bpm 1 min 1 bpm resolution 4 to 60 1 min 1 min resolution TI TE Inspiration expiration ratio 4 1 to ...

Page 205: ... Inspiratory Time 0 3 to 4 0 s Pressure Support Ventilation Mode The Pressure Support Ventilation mode has been verified under the following range of simulated patient conditions Endotracheal Tube Size 0 18 in to 0 32 in 4 5 mm to 8 mm Patient Lung Compliance 10 mL cmH2O to 100 mL cmH2O 10 mL hPa to 100 mL hPa Unassisted Patient Tidal Volume 50 mL to 1000 mL Patient Breath Rate bpm 1 min 10 to 35 ...

Page 206: ...cmH2O 75 5 hPa Negative Pressure Safety Relief Valve Ambient AIR Inlet Valve 7 5 to 9 cmH2O 7 5 to 9 hPa Minimal Limit Pressure 8 5 cmH2O 8 5 hPa System Compliance Compensation Measurement 0 2 to 6 0 mL cmH2O 0 2 to 6 0 mL hPa 0 2 mL cmH2O 0 2 mL hPa or 10 of actual compliance whichever is greater ...

Page 207: ...ir flow rate will vary proportionally with supply pressures outside 50 to 55 psi 3 4 to 3 8 kPa x 100 Total Fresh Gas Flowmeter Range and accuracy 0 to 10 L min 10 of full scale at STP calibrated with 50 O2 50 N2O gas mixture 0 to 10 L min 15 of full scale at STP for all other gas mix tures Resolution 0 5 L min from 0 5 to 2 L min 1 0 L min from 2 to 10 L min O2 flush bypass at 55 psi 3 8 kPa x 10...

Page 208: ... Accuracy Condition PAW Airway pressure numeric 20 to 99 cmH2O hPa 1 cmH2O hPa 4 1 1 Max 4 of the measured value or 2 cmH2O 2 hPa whichever is greater Airway pressure wave 0 to 99 cmH2O hPa Pressure gauge mechanical 20 to 80 cmH2O hPa 5 cmH2O hPa 1 6 cmH2O hPa VE Expiratory minute volume 0 to 99 9 L min 0 1 L min 15 2 2 At standard test conditions per IEC 60601 2 13 with reference to 68 F 20 C amb...

Page 209: ...f measured value Drift Sensitivity 1 of measured value 8h Cross Sensitivity 1 vol O2 at 70 vol N2O and 5 vol CO2 with 4 vol Halothane or with 5 vol Enflurane or with 5 vol Isoflurane or with 10 vol Sevoflurane effect of humidity sensitivity max 0 02 of measured value relative humidity Service life of O2 sensor cell 12 months at 25 C 77 F 50 relative humidity 50 O2 gas mixture or 5000 hours at 100 ...

Page 210: ...trol excluding patient hoses with reusable absorber 0 35 mL cmH2O 0 35 mL hPa with Drägersorb CLIC adapter including absorber 0 35 mL cmH2O 0 35 mL hPa with Drägersorb CLIC adapter excluding absorber 0 35 mL cmH2O 0 35 mL hPa Resistance Reusable absorber or CLIC absorber with or without flexible bag arm normal operation filled with Drägersorb 800 Inspiratory Expiratory As per ISO 8835 2 dry max 6 ...

Page 211: ...Data 093 9 8 7 6 5 4 3 2 1 0 1 2 3 4 5 6 7 8 9 0 10 20 30 40 50 60 70 80 90 100 ISO 8835 2 Pressure Flow Characteristics of Breathing System COSY 2 6 averaged resistances without breathing tubes Pressure hPa Flow L min averaged Pinsp hPa averaged Pexp hPa ...

Page 212: ... APL Valve MAN mode 5 to 70 cmH2O hPa SPONT mode 1 5 cmH2O hPa accuracy from 5 to 15 L min 15 of set value or 3 cmH2O hPa greater applies pressure drop at 30 L min 3 4 cmH2O hPa wet and dry Alarm limit Warning signal when the pressure drops below 20 4 psi 1 4 0 3 kPa x 100 Alarm signal High priority alarm Warning LED indicator The red LED indicator in the O2 area of the gas flow control interface ...

Page 213: ... can be freely set between 0 and 75 During O2 shortage S ORC limits the N2O concentration in the fresh gas so that the O2 con centration does not drop below 23 vol N2O metering valve open and O2 metering valve closed or O2 flow less than 0 2 L min S ORC prevents N2O flow During N2O failure O2 may still be administered No alarm Serial Interface Type RS 232 Baud Rates 1200 2400 4800 9600 19 2 38 4 K...

Page 214: ...l Data 214 Instructions for Use Fabius MRI SW 3 n Diagrams Gas flow diagram Compact Breathing System 001 Setting PMAX PEEP Fresh Gas Decoupling Ventilator Fresh gas Absorber APL Bypass APL Valve Scavenging Bag ...

Page 215: ...Instructions for Use Fabius MRI SW 3 n 215 Technical Data 311 ...

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Page 217: ... Do not insert any additional components into or modify the anesthesia workstation after the checkout proce dure is started This is a recommended procedure Follow your institution s policies for specific checkout proce dures CAUTION If any check cannot be carried out satisfactorily the machine must not be used Call DrägerService or your local authorized ser vice organization NOTE Throughout this s...

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Page 219: ...y is fully charged If the battery does not show full a charge the bat tery operation time is not guaranteed to be 45 minutes Checking the Medical Gas Connections Visually inspect all gas supplies from the medical gas pipeline system and cylinders to make sure that they connect properly and fit securely Verify that all medical gas pipeline supplies are within acceptable pressure ranges Open reserve...

Page 220: ...d filling system Sealing key or pin inserted and closed tight when present Filler opening locked shut P Quik Fil or Funnel filling system Locking screw tight when present Checking the Condition of CO2 Absorbent P Color change is no more than half the can ister of CO2 absorbent Testing the PAW sensor Switch to standby mode and press the function key for the leak test Close all fresh gas valves Fit ...

Page 221: ...g bag to the Y piece to act as test lung P Press the Pressure Control key and con firm P Check that ventilation measurements are displayed P Check that the ventilator piston is cycling P Monitor the operation of the inspiratory and expiratory valve discs P Check that the breathing bag test lung on the Y piece is ventilating P Press the Standby key and confirm Monitors The alarm function can be tes...

Page 222: ...is squeezed air must audi bly and tangibly flow out of the mask cone when the bag is released it must rapidly recover its original shape Block off the mask connector cone with the ball of your thumb you should only be able to squeeze the bag a little P Before Connecting to Patient Verify that all vaporizers are off the handwheels are set to zero the APL Valve is set as desired all flowmeters indic...

Page 223: ...e Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date ...

Page 224: ...e Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date Pre use Checkout Signature Name Date ...

Page 225: ... machine in the MRI room in a position typical of where it is used clin ically 3 For the third scan again with the machine in the MRI room in a position typical of where it is used clinically remove the head coil from the MRI system and place the phantom in the center of the body coil The scan has to be performed with the body coil if necessary sequence parameters may be adapted to body coil scan ...

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Page 227: ..._________ Date of installation of anesthetic unit _________________________________________ Signatures Dräger representative _________________________________________ Operator _________________________________________ Fringe field definition for 40 m tesla 400 gauss Distance from the magnetic center _______________________Z axis in feet in or cm _______________________ X axis in feet in or cm or D...

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Page 229: ... 123 Care List 176 Cleaning 167 CLIC Adapter 54 93 CO2 absorbent 90 Communication Ports 28 Compact Breathing System 19 52 Compliance Test 137 Configuration 131 Configuration during Operation 152 Configuration Functions in Standby Mode 132 Configuration in Standby 147 Contents 5 Control Panel 38 Cylinder pressures 60 D Date Format 150 Date Set 149 Diagram 214 Display Background 151 Disposal 191 194...

Page 230: ...on 102 Preuse Checkout Form 217 R Rear View 20 Respiratory Volume Monitoring 126 Restrictions for Use 16 Rotary Knob 40 S Scavenger System 181 Screen Display 39 Selectatec 23 Self test 82 Silencing Alarms 120 SIMV PS Ventilation 105 Sleep Mode 133 Soda Lime 67 Soft Keys 41 SpiroLife flow sensor 175 Spirolog flow sensors 175 Spontaneous Breathing 94 Standby 42 Suction System 64 174 Symbols 33 Syste...

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Page 232: ...d without customer request Manufactured by Dräger Medical GmbH Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 20 80 http www draeger com 90 39 035 GA 5330 660 enUS Dräger Medical GmbH Edition 11 2015 01 Edition 1 2006 06 Dräger Medical reserves the right to make modifications to equipment without prior notice Distributed by Draeger Medical Inc 3135 Quarry Road Telford ...

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