manualshive.com logo in svg

Dräger Fabius OS, Инструкция по эксплуатации, Страница: 1 / 206

Поделиться
Скачать
Dräger Fabius OS Скачать руководство пользователя страница 1

WARNING

For a full understanding of the

performance characteristics of this

medical device, the user should care-

fully read these Instructions for Use 

before use of the medical device.

Instructions for Use

Fabius OS

Anesthesia Workstation

Software 3.n

Содержание Fabius OS

Страница 1: ...standing of the performance characteristics of this medical device the user should care fully read these Instructions for Use before use of the medical device Instructions for Use Fabius OS Anesthesia Workstation Software 3 n ...

Страница 2: ...s 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 118 Instructions for Use Fabius OS...

Страница 3: ...t to the use of the medical device Professionals These users are persons who have been instructed on the medical device and who are medical professionals or have recei ved technical training and who are authorized to use and reprocess or to instal and maintain the medical device in accor dance with the intended use Dräger recommends that the medical device is used exclusively by professionals WARN...

Страница 4: ...4 Instructions for Use Fabius OS SW 3 n This page intentionally left blank ...

Страница 5: ... Flexible Bag Arm or Breathing Bag Extension and Bag 46 Connecting Pipeline Supply of N2O AIR and O2 47 Connecting the Reserve Gas Cylinders for N2O AIR and O2 for Pin Index Mounting 48 Connecting the AGS Anesthetic Gas Receiving System 51 Connecting the Passive Scavenger 53 Connecting the Suction System 54 Connecting the Breathing Hoses 55 Inserting a new O2 Sensor Capsule 57 Connecting the O2 Se...

Страница 6: ...moving the Suction System 154 Reprocessing Breathing system 154 Care List for Fabius OS Components 156 Reassembling the Breathing System 158 Reinstalling the Ventilator 160 Reinstalling the Scavenger System 161 Reinstalling the Suction System 163 Checking Readiness for Operation 164 Maintenance 165 Overview 166 Routine Maintenance 169 Checking Readiness for Operation 171 Disposal 173 Disposing of ...

Страница 7: ...se Instructions for Use 8 Maintenance 8 Accessories 8 Not for use in areas of explosion hazard 8 Safe connection with other electrical equipment 8 Safe networking of computers 8 Patient safety 9 Patient monitoring 9 General WARNINGS and CAUTIONS 10 Note on EMC ESD risk for the device function 10 Accessories in sterile packaging 10 Software 11 ...

Страница 8: ...ical device is only to be used for the purpose spe cified under Intended Use on page 14 and in conjunction with appropriate patient monito ring see page 9 Strictly observe all WAR NING and CAUTION statements throughout these Instructions 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 th...

Страница 9: ...ous to a medical professio nal and operator of this medical device to the con sequences of medical device misuse and to potentially adverse effects in patients with abnor mal conditions Medical device modification or misuse 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...

Страница 10: ...nector 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...

Страница 11: ...attached to the anesthesia workstation ventilator or breathing system except for certain approved components otherwise the correct functio ning 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 uni que circumstances what com...

Страница 12: ...N Communications with external equipment may be temporarily affected by electromagnetic interfe rence due to the use of electrosurgical equipment CAUTION Do not use Fabius OS during magnetic reso nance MRT NMR NMI Device operation may be affected thus placing the patient at risk CAUTION Risk of physical injury To avoid physical injury pay special attention to edges moving parts and corners when wo...

Страница 13: ...Instructions for Use Fabius OS SW 3 n 13 Intended Use Intended Use Intended Use 14 MEDIBUS and Vitalink Protocols 14 Restriction of Distribution 14 ...

Страница 14: ...003 requires that a manual ven tilation bag must be available for emergency use Fresh gas enrichment is provided by the Dräger Vapor anesthetic vaporizer MEDIBUS and Vitalink Protocols MEDIBUS and Vitalink are software protocols for use in transferring data between the Fabius OS and an external medical or non medical device e g hemodynamic monitors data management systems or a Windows based comput...

Страница 15: ...em Top View 17 Rear View Pin Index Connector 18 Interface Panel 19 Vaporizers 20 Vaporizer Exclusion Systems 20 Dräger Auto Exclusion 2 Vaporizer Mount 20 Auxiliary Oxygen Flowmeter 21 APL Valve 22 Communication Ports 23 Recommended Device Configuration 23 Accessory Weight Limits 25 Abbreviations 26 Symbols 27 ...

Страница 16: ...rway monitoring 2 Total fresh gas flowmeter 3 Display screen 4 Vapor mount 5 Fresh gas control 6 Gauges for Pin index O2 AIR and N2O cylin ders 7 Writing table 8 Storage drawers 9 Brake 10 Absorber 11 Oxygen Flush 12 Compact Breathing System COSY 13 Ventilator 14 Auxiliary oxygen flowmeter 073 O 1 2 5 6 7 10 12 8 13 14 9 11 3 4 optional ...

Страница 17: ...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 090 1 3 5 6 7 8 10 12 13 2 9 11 4 ...

Страница 18: ...ctor 1 Sealed connector 2 Connector for medical gas pipeline supply cen tral supply 3 Power cable connection 4 Interface panel 5 Ventilator hose connection 6 ON OFF switch 7 Fuse 8 Compact Breathing System COSY 9 Potential equalization pin 10 Pin Index system 066 1 2 3 4 5 6 8 10 7 9 ...

Страница 19: ...se Fabius OS SW 3 n 19 System Overview Interface Panel 1 COM 1 2 COM 2 3 APL 4 Oxygen Sensor 5 Breathing Pressure 6 Volume Sensor 7 ON OFF switch 8 Fuse 9 Power cable connection 10 PEEP 002 5 3 4 1 2 9 10 6 7 8 optional ...

Страница 20: ...his 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 When using a Desflurane vaporizer it must be con nected to mains power optional NOTE Only Dräger vaporiz...

Страница 21: ...ating 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 optional ASTM F1850 22 2005 76 WARNING Risk of patient in...

Страница 22: ...iminates resistance to patient exhalation In manual mode the APL valve knob can be rotated to change the pressure threshold at which gas will flow through the valve and into the scavenging system Clockwise rotation of the APL valve knob increases the pressure threshold and counterclockwise rotation of the APL valve knob decreases the pressure thres hold Lifting the top of the APL valve knob will t...

Страница 23: ... analyzer to either COM 1 or COM 2 optional WARNING A test for leakage current must be performed by qualified engineering personnel before use if the Fabius OS is interfaced with other equip ment CAUTION Only the combinations of Dräger approved moni tors mounting parts and interface cables may be used Otherwise the correct functioning of the device may be compromised NOTE Data Pass Through gas ana...

Страница 24: ... 3 Connect monitor to anesthesia record keeper 4 Connect anesthesia record keeper to COM 1 or COM 2 Configuration 4 Fabius OS multi parameter monitor with two COM ports automatic anesthesia record keeper port COM 2 5 Connect monitor to anesthesia record keeper 6 Connect anesthesia record keeper to COM 1 7 Connect monitor to COM 2 optional 006 OXYGEN SENSOR BREATHING PRESSURE VOLUME SENSOR 1 1 2 2 ...

Страница 25: ... Do not place more than 11 lb 5 kg in any drawer CAUTION Risk of tip over and personal injury Trolley mounted units with left hand COSY the combined weight of the accessories shall not exceed 30 lb 14 kg at 16 40 cm on the side of the Fabius OS where the COSY is mounted and shall not exceed 39 lb 18 kg at 12 30 cm on the side opposite the COSY CAUTION Risk of tip over and personal injury Trolley m...

Страница 26: ...Pa Hectopascal in insp Inspiratory Insp Flow Inspiratory flow L min Liters per minute Man MAN Manual ventilation mbar Millibar MEAN Mean pressure MV Minute volume N2O Nitrous oxide O2 Oxygen PAW Airway pressure PCB Printed Circuit Board PEAK Peak pressure PEEP Positive end expiratory pressure PINSP Pressure limitation in Pressure Control mode PLAT Plateau pressure PMAX Pressure limitation in Volum...

Страница 27: ...Connection for equipotential bon ding Oxygen Concentration Sensor Port Breathing Pressure Sensor Port Breathing Volume Sensor Port Ventilator Port Pipeline Gauge Pipeline inlet Breathing Bag Flowmeter Level Indicator Indicates Direction XXXX 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 electro...

Страница 28: ... Fabius OS monitoring user interface Upper and Lower Alarm Limits Return to Home Screen Suppress Alarm Tone for Two Minu tes Standby Mode Available Operating Capacity of UPS Close Menu Back to Previous Menu Upper Alarm Limit Lower Alarm Limit Mains Applied Mains Power Alarm Off Setup Screen XX _ ...

Страница 29: ...el 30 The Screen Display 31 Rotary Knob 32 Fixed Function Keys 32 Soft Keys 33 Selecting Setting Monitoring Functions 34 Selecting Setting Ventilation Parameters 36 Fresh Gas Control 37 Total Flow Meter 38 Fresh Gas Flow Monitoring Resolution 39 LED Indicators 40 Gas System Color Coding 40 ...

Страница 30: ... 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 32 566 ...

Страница 31: ...ing window which displays 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 minute volume and the minute volume high and low alarm lim its 5 Breathing pressure monitoring window which displays the patient s positive end expiratory pressure ...

Страница 32: ...cts the Man ual Spontaneous ventilation mode 3 The Lamp key turns the tabletop light ON and OFF 4 The Pressure Support key is used to select the Pressure Support ventilation mode optional 5 The Pressure Control key optional 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 key Alarms displays the Alarm Limit...

Страница 33: ...page 108 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 key Setup is pressed in any ven tilation mode the following soft keys appear at the bottom of the screen Volume Alarms On Off Auto Set Calib...

Страница 34: ...esired 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 return...

Страница 35: ...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 ...

Страница 36: ...tion Settings window replaces the Wave form window 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...

Страница 37: ...ed gases combined 5 N2O electronic fresh 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 th...

Страница 38: ...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 ...

Страница 39: ...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...

Страница 40: ...minated to indicate the degree of urgency of currently active alarms Warning red blinking Caution yellow blinking Advisory yellow continuous 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 OS is color coded for the appropriate gas as shown the...

Страница 41: ...ssive Scavenger 53 Connecting the Suction System 54 Connecting the Breathing Hoses 55 Instructions for Use of Bacterial Filters Endotra cheal Tubes Y pieces Breathing Hoses Soda Lime and other Breathing System Accessories 56 Resistance summation of the breathing system and connected accessories 56 Inserting a new O2 Sensor Capsule 57 Connecting the O2 Sensor 57 Connecting the Pressure Sensor 58 Co...

Страница 42: ...sorber on the Compact Breathing System z Fill the absorber with fresh CO2 absorbent Dräger recommends the use of Drägersorb 800 Plus or Drägersorb FREE For detailed information on filling and installing the reusable absorber see page 169 2 Fit the absorber canister into position below the breathing system and turn it counterclockwise as far as possible CAUTION Risk of unintended perioperative awar...

Страница 43: ...absorber into 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 into the machine until it engages optional WARNING The disposable absorber mu...

Страница 44: ...lt to its full extension and hold 2 Fit the Compact Breathing System onto the Compact Breathing System mount z Release the locking bolt and rotate the Com pact Breathing System until the locking bolt locks into position 3 Connect the fresh gas hose from the Fabius OS to the Compact Breathing System 011 1 2 071 3 ...

Страница 45: ...Fabius OS 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 Inserting the Flow Sensor z Unscrew and remove the expiration port and the flow sensor guard flow sensor protection 3 Insert the flow sensor 4 Reinstall the flow guard 5 Reinstall the expiration port 012 1 2 047 5 3 4 ...

Страница 46: ... the side of the breathing system z Align the bracket on the assembly with the holes on the breathing system 3 Tighten the two thumb screws to secure 4 Attach the 90 fitting to the end of the flexible bag arm and attach the breathing bag to the other end of the fitting breathing bag extension assembly optional WARNING Risk of use of toxic or incompatible materials Breathing bags used on the Fabius...

Страница 47: ... 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 oxide fitting on the other end CAUTION To ensure that gas supplies are at adequate pres sure pipeline pressure gauges must in...

Страница 48: ... 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 CAUTION Even if the gas supply is connected to a medical gas pipeline the cylinders should remain on the device as a reserve NOTE If cylinder valves are leaky or difficult to open or close they must be r...

Страница 49: ...ead 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 firm...

Страница 50: ... cylinder valves Cylinders attached to the hanger yokes must con tain gas at the recommended pressures shown in the table below 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 Gas PSI kPa x 100 FULL typical full load PSI kPa x 100 MIN AIR 1900 131 1000 69 N2O 745 51 600 42 O...

Страница 51: ...ocket 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 the side open...

Страница 52: ...e 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 Do not block the openings in the AGS scaven ger system Blocking the openings could result in a shortage of fresh gas in the breath ing system 054 1 2 ...

Страница 53: ...nnect 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 refe...

Страница 54: ... bottle assembly of the customer s choice z Attach the suction system bracket to the side rail on the side of the anesthesia workstation 1 Mount the suction regulator onto the bracket 2 Install 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 optional WARNING Risk of equipment damage The suctio...

Страница 55: ...breathing bag 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 Push the bag onto the end of the breathing bag extension NOTE Take care not to damage the breathing hoses WARNING Risk of use of toxic or incompatible materials Breathing hoses used on the Fab...

Страница 56: ...tected during the self test leak test Resistance summation of the breathing system and connected accessories In the chapter 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 ...

Страница 57: ...k 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 OXYGEN SENSOR on the connector panel on the back of the machine 051 1 2 016 4 3 ...

Страница 58: ... the pressure measuring line to the bacterial filter and plug it firmly onto the port labeled BREATHING PRESSURE on the con nector panel on the back of the machine Connecting the Pressure Breathing 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 BREATHING PRE...

Страница 59: ... on the 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 th...

Страница 60: ...Assembly 60 Instructions for Use Fabius OS SW 3 n Attaching the Manual Ventilation Bag 1 Hang the fully prepared and tested bag on the rail at the right 057 1 ...

Страница 61: ...ee 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 respective 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 082 A B 1 3 4 5 2 5 ...

Страница 62: ...used Additional Equipment Prepare additional equipment as specified in the specific Instructions for Use WARNING Risk of spillage or mix up Use only suitable adapters for filling and emp tying the vaporizer CAUTION Risk of tip over and personal injury If monitors and other equipment are placed on top of the Fabius OS the risk of tipping over the unit is increased especially when rolling over thres...

Страница 63: ...ct equipotential bonding to the auxiliary equipment Connecting AC Power Fabius OS can be operated at mains voltages from 100 V to 240 V z Push power plug into supply mains socket 2 Switch on the machine by using the ON OFF switch on the rear of the machine WARNING Only connect device to approved hospital grade outlets having the appropriate ground ing reliablity WARNING Do not connect life support...

Страница 64: ...urrent 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 increased le...

Страница 65: ...Instructions for Use Fabius OS SW 3 n 65 Getting Started Getting Started Powering Up the Machine 66 Power Up Standby Screen 67 Checking Readiness for Operation 67 ...

Страница 66: ...re 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 OS may be used but call DrägerService or ...

Страница 67: ... Standby screen appears and provides instructions on star ting the operation of the Fabius OS Checking Readiness for Operation Check the readiness of the Fabius OS 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 completed begin operation as specified in Operation on page 69 WARNING The power ...

Страница 68: ...68 Instructions for Use Fabius OS SW 3 n This page intentionally left blank ...

Страница 69: ... 73 Replacing CO2 Absorbent 73 CLIC Adapter 75 Ventilation 76 Manual Spontaneous Ventilation Mode 76 Volume Control Ventilation 79 Pressure Control Ventilation 82 Pressure Support Ventilation 84 Starting Pressure Support Ventilation 85 When Changing Between Ventilation Modes 87 Ventilator Safety Features 88 Behaviour during Lack of Fresh Gas 88 Changing Patients 89 Ending Operation 90 When Fabius ...

Страница 70: ...ront of the machine S ORC Sensitive Oxygen Ratio Controller S ORC is a control element which provides a mini mum O2 concentration in the fresh gas flow From a flow rate of approx 300 mL min the N2O concen tration in the fresh gas can be 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 prevents...

Страница 71: ...alues 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 shortage 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 gas flow before the vaporizer is swit...

Страница 72: ...concentration z Regularly check the filling level on the sight glass When reaching the minimum mark fill the vaporizer with anesthetic agent O2 Flush A manually operated O2 flush valve 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 OS does not need to ...

Страница 73: ...er 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...

Страница 74: ...reakdown 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 goggles or a face mask In case of coming in cont...

Страница 75: ...t counterclockwise as far as possible CLIC Adapter The disposable CLIC adapter absorber can also be used on the Fabius OS For information on installing the CLIC adapter consult its Instructions for Use 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 periope...

Страница 76: ...lowing examples and illustrations describe starting ManSpont ventilation from the present ven tilation 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 ManSp...

Страница 77: ...ure alarm ON OFF see page 106 and Volume alarms ON OFF see page 104 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 al...

Страница 78: ...the ManSpont key 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 ve...

Страница 79: ...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 ope ration is confirmed 2 The Waveform window is replaced by the venti lator settings window and a m...

Страница 80: ...me Control key LED switches from blin king 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...

Страница 81: ... VT 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 pr...

Страница 82: ...nding 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 waveform is restored The parameters that can be set for Pressure Con trol mode are shown in t...

Страница 83: ...patient compli ance The Insp Flow key is used to set the slope of the pressure waveform In addition a positive endexpiratory 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 Time Time F...

Страница 84: ...uromuscular 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 provide ...

Страница 85: ...er that needs to change press the cor responding soft key select the correct value and confirm the change When the parameter changes are completed confirm the ventilation mode change z After the mode change is confirmed the Pressure Support key LED switches from blinking to constantly on the ventilator switches to the Pressure Support mode and the waveform is restored The parameters that can be se...

Страница 86: ...of maximum inspiratory flow Insp Flow or after a maximum of 4 s The value Freq Min e g 3 bpm 1 min is used to set a safety period safety period 1 Freq Min e g 20 s If no inspiratory effort is detected and the safety period has expired the device applies a pressure con trolled breath with PINSP ΔPPS The lower pressure limit PAW low is used for pres sure monitoring to detect apneas disconnection and...

Страница 87: ...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 the last used value or the site default value When changing from Pressure Control to Volume Control PMAX is set 10 cmH2O hPa higher than the plateau pressure devel...

Страница 88: ...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 ven...

Страница 89: ...bed on page 112 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 76 and proceed with the case WARNING Risk of inappropriate alarm settings As it is possible that Fabius OS devices within a care area have different site default alar...

Страница 90: ...not in use If Fabius OS is not used for an extended period z Unplug the medical gas hoses from the wall supply points of the central gas supply z Close the cylinder valves on the reserve gas cylinders WARNING Damage of materials and health risks Never switch off fresh gas flow before the vaporizer is switched off A vaporizer must never be left switched on without a fresh gas flow because high conc...

Страница 91: ...connect the power plug z Disconnect the scavenger hoses WARNING When moving the anesthesia work station remove all monitors and equipment from the top shelf and hinged arms remove the absorber system vaporizers and reserve gas cylinders push in the writing tray The anesthesia workstation should only be moved by people who are physically capable of handling its weight Dräger recommends that two peo...

Страница 92: ...Operation 92 Instructions for Use Fabius OS SW 3 n 1 Remove the pipeline supply hoses from the central supply z Press the O2 flush to depressurize the entire system 013 1 ...

Страница 93: ...en Monitoring Window 98 Setting Oxygen Monitoring Alarm Limits 98 Calibrating the Oxygen Sensor 99 Consequences of incorrect O2 Calibration 101 O2 Low Supply Alarm 102 Respiratory Volume Monitoring 103 Respiratory Volume Monitoring Window 103 Volume Monitoring Alarms 104 Setting Minute Volume Alarm Limits 104 Disabling Volume Alarms 104 Breathing Pressure Monitoring 105 Breathing Pressure Monitori...

Страница 94: ... specific way each type of alarm is indicated 566 2 1 Alarm Indication Warning warning message appears in red in alarm window followed by three excla mation marks red LED alarm indicator 2 blinks alarm tone sequence of five beeps repeated two times sounds every 10 seconds red LED flashes accompanied by a repetetive tone sequence Tone sequence Standard E E E E Bb E E E E Bb Caution caution message ...

Страница 95: ...xample 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 genera ted no new audible alarm is issued The Warning alarm notification is not interrupted because i...

Страница 96: ... The yel low 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 key Silence the yellow LED turns off Disabling Volume Alarms Visual and audible volume alarms can be turned on or off during operation using the key Setup See Volume Alarms On Off on page 128 566 1 ...

Страница 97: ...otted line An alarm is generated when the pressure curve does not cross the pressure 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 a...

Страница 98: ...g 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 97 to change the high or low alarm limit CAUTION Risk of inaccurate measuring values Never rem...

Страница 99: ...or can be calibrated during Standby as described in Calibrate O2 Sensor on page 111 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 key Setup on the front panel The Setup window appears at the bottom of the screen 2 Press the Calibrate O2 S...

Страница 100: ...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 ...

Страница 101: ... plays 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 displaye...

Страница 102: ...pressure drops below the minimum pressure permitted approximately 20 psi or 1 4 kPa x 100 an additional O2 SUPPLY LOW alarm is generated and the LED 1 starts blinking If the alarm occurs in Standby mode and the user changes to a ventilation mode a continuous alarm tone sounds for seven seconds 566 1 ...

Страница 103: ...idal Volume Measurement VT displays the expired volume for each breath in units of milli liters mL The display range is from 0 mL to 1400 mL 3 Minute Volume Measurement MV conti nuously displays the volume of exhaled gas accumulated 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 CAUTION The functioning of the respiratory ...

Страница 104: ... a valid breath for a specified period see APNEA FLOW on page 140 While the ventilator is off and the system is in ManSpont mode these alarms are generated at 30 seconds Caution and 60 seconds Warning The Fabius OS 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...

Страница 105: ...eous pressure values recor ded 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 ...

Страница 106: ...40 While the ventilator is off and the system is in ManSpont 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 97 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 pres...

Страница 107: ...e O2 Sensor 111 Leak Compliance Test 112 Access Alarm Log 115 Restore Site Defaults 115 Standby Setup Screen 116 Default Settings in Standby Setup 117 Configuration in Standby Setup 122 Configuration during Operation 127 Volume Alarms On Off 128 Auto Set 128 Calibrate O2 Sensor 129 Des Comp On Off 130 Automatic Desflurane Compensation 132 Access Alarm Log 133 Access Alarm Volume 133 ...

Страница 108: ...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...

Страница 109: ...Test 1 Press the Run System Test key This test performs the power up diagnostic tests as described in Power Up Standby Screen on page 70 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 NOTE If the flow control valves were not shut off before entering Standby mode a Gas still flowing mess...

Страница 110: ...ration 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 sens...

Страница 111: ...ation begins the instructions are removed and a O2 Calibration in progress message is dis played 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...

Страница 112: ...w is replaced 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 resu...

Страница 113: ...D the value is displayed on the leak test result screen and the Standby screen System Leak Test Results System 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 350...

Страница 114: ...ed 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 cmH2O hPa is tested during the leak tes...

Страница 115: ... 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 116 CAUTION Alarm log data is deleted if Fabius OS is switch...

Страница 116: ...e 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 ...

Страница 117: ...ll exit 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 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 of the sc...

Страница 118: ...e the 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 remo ved from the screen and the cursor returns to the return arrow Pressure Settings and Pressure Support...

Страница 119: ...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 ...

Страница 120: ...ume 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 ...

Страница 121: ...creen The Restore Factory Default setting window appears on the screen z Select and confirm Yes or No When is selected the factory defaults are restored and replace the current default settings The factory defaults for the Fabius OS 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 Control PINSP 15 Freq 12 TI...

Страница 122: ...lumn 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 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 Par...

Страница 123: ...t 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 ...

Страница 124: ...ew time format value in the example illustration the value was chan ged 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 123 to change the date parame...

Страница 125: ...an 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 124 to change the acoustic confirmation para meter Alarm Tone Sequence The values that can be selected for the alarm tone sequence are Standard or Dräger Use the procedure described in Time...

Страница 126: ...at on page 124 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 124 to change the display background para meter 552 553 560 ...

Страница 127: ...rm 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 window is...

Страница 128: ...t soft key in the Setup win dow The breathing pressure threshold 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 selec table 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 pres...

Страница 129: ...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...

Страница 130: ...ll be restored If the O2 sensor cannot be calibrated replace the O2 capsule in the O2 sensor housing see page 169 If the O2 sensor still cannot be calibrated call DrägerService or your local authorized service organization Des Comp On Off This parameter is used to activate or deactivate desflurane compensation 2 Press the Des Comp Off soft key in the Setup window The key label changes from Des Com...

Страница 131: ...nalyzer Inaccurate data from the analyzer may affect measured volume accuracy CAUTION Desflurane has characteristics that affect the sen sitivity of the Fabius OS flow sensor To help assure that the volume measurements from the monitor are accurate activate Desflurane com pensation when Desflurane is used in the brea thing circuit The Fabius OS will automatically compensate for the change in flow ...

Страница 132: ...automatically perform the corresponding flow sensor compensation Automatic Desflurane compensation always overri des the functionality of the Desflurane compensa tion soft key If communication is disconnected or lost between the Fabius OS and an external agent analyzer while Desflurane is in use z The Des auto message is removed from the status bar z The Des Comp On Off soft key label reap pears a...

Страница 133: ... 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 Volume Setting window z Select and confirm a new alarm volume value in the range of 1 minimum to 10 maximum The value is sa...

Страница 134: ...134 Instructions for Use Fabius OS SW 3 n This page intentionally left blank ...

Страница 135: ...Instructions for Use Fabius OS SW 3 n 135 Fault Cause Remedy Fault Cause Remedy Power Failure Backup 136 Ventilator Fail State 138 Overriding the Ventilator 138 Fault Cause Remedy 140 ...

Страница 136: ...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...

Страница 137: ...d all ventilation and alarm 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 i...

Страница 138: ...the Ventilator In the unlikely event of a fault in which the ventilator does not recover and the user cannot 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...

Страница 139: ...g the diagnostic tests manual ventilation is possible If the diagnostic tests result in FUNCTIONAL the Fabius OS will automatically switch to ManSpont mode if a fresh gas flow is detected Fabius OS respiratory monitoring is available If the diagnostic tests result in NON FUNCTIONAL manual venti lation is still possible but Fabius OS respiratory monitoring is not available NOTE In ventilator overri...

Страница 140: ...q 6 or Pressure Support with Apnea Ventilation OFF Caution VT 20 mL for 15 seconds Warning VT 20 mL for 30 seconds In ManSpont 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 Leak or disconnect in brea thing circuit Check ventilator Check breathing circuit 23 31 APNEA PRESSURE2 2 APNEA PRESSURE al...

Страница 141: ...ator diaphragm and close cover Check APL bypass valve con nection for disconnect or leak Select Standby 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 seco...

Страница 142: ...sor and calibrate Call DrägerService or your local authorized service orga nization 21 FRESH GAS LOW Inadequate fresh gas supply in all ventilation modes Blocked kinked hose Leak or disconnect in brea thing circuit 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 alar...

Страница 143: ...rocedure to calib rate flow sensor see page 110 and replace if necessary 31 NO FRESH GAS Inadequate fresh gas supply Fresh gas control valve closed Negative pressure safety relief valve opens automatically Ensure adequate fresh gas supply Open fresh gas control valve 6 O2 SENSOR CAL DUE More than 18 hours passed since last O2 sensor calibra tion Follow the procedure to calib rate O2 sensor see pag...

Страница 144: ...or setting Check ventilator and PMAX settings 25 PRESSURE NEGATIVE Measured PAW is 5 cmH2O hPa or MEAN is 2 cmH2O hPa Check breathing circuit and ventilator settings 8 PRESSURE SENSOR FAIL Faulty sensor or pressure not calibrated Call DrägerService or your local authorized service orga nization 2 PRES THRESHOLD LOW Ventilation parameters were changed without changing alarm settings see page 119 Pu...

Страница 145: ...thorized service organization 28 VENTILATOR FAIL Ventilator not assembled correctly Check diaphragm and close cover Check PEEP PMAX line for disconnect or leak Select Standby Mode and switch back to the previous ventilation mode 1 VOLUME ALARMS OFF Volume alarms disabled by operator Priority Alarm Message Probable Cause Remedy ...

Страница 146: ...146 Instructions for Use Fabius OS SW 3 n This page intentionally left blank ...

Страница 147: ...g the Flow Sensor 152 Removing the APL Valve 153 Removing Parts of the Ventilator 153 Removing anesthetic gas scavenging system AGSS 154 Removing the Suction System 154 Reprocessing Breathing system 154 O2 Sensor 155 Care List for Fabius OS Components 156 Reassembling the Breathing System 158 Attaching the Inspiratory Valve 158 Attaching the Expiratory Valve 158 Attaching the APL Valve 158 Screw t...

Страница 148: ...erve Instructions for Use of washer disinfector z Position 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 c...

Страница 149: ... for the flow sensor 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 disinf...

Страница 150: ...g the reprocessing 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 m...

Страница 151: ...ve the breathing pressure cable z Detach the APL bypass and the PEEP PMAX hoses from the breathing system and from the side of the machine z Remove the absorber for complete instruc tions see page 169 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 Remove t...

Страница 152: ...by machine will 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 a...

Страница 153: ...etaining nut z 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 ...

Страница 154: ...minutes Only use neutral or mild alcalic cleaning agents e g Neodisher Medizym and completely demineralized water When using thermal disinfection the addition of disinfectant chemicals is not necessary risk of corrosion NOTE For cleaning disinfection instructions for the pas sive scavenger system refer to its Instructions for Use WARNING Risk of infection Always wear protective gloves when emptyin...

Страница 155: ...ed air water jet brush etc Otherwise the thin wires in the flow sensor may be destroyed The Spirolog and Infinity ID flow sensors must not be sterilized in hot steam The flow sensors are 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...

Страница 156: ...n and cleaning Fabius OS 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 ...

Страница 157: ...alkaline or neutral 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...

Страница 158: ... Attaching the 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 ...

Страница 159: ...g Remaining Breathing System Components z Follow instructions beginning on page 44 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 169 to reinstall the abso...

Страница 160: ...entilator door 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 to the ventilator chamber to the respective connector z Close the ventilator door with the attached ven tilator unit 059 1 5 5 2 3 4 ...

Страница 161: ... the 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 pa...

Страница 162: ...chine 3 Tighten the retaining nut z Reinstall the buffer volume container into the scavenger body For detailed information on the AGS refer to the specific Instructions for Use provided with the anesthetic gas receiving system AGS 9038579 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 025...

Страница 163: ... anesthesia device 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 direc...

Страница 164: ...ons for Use Fabius OS SW 3 n Checking Readiness for Operation At the completion of the reassembly of the Fabius OS perform the Daily and Pre use Check out procedure provided in the Appendix of this manual to ensure that the machine is ready for ope ration ...

Страница 165: ...enance Overview 166 Definition of Maintenance Concepts 166 Inspection 166 Safety Checks 167 Preventive maintenance 168 Routine Maintenance 169 Replacing the O2 Sensor Capsule 169 Replacing CO2 Absorbent 169 CLIC Adapter 171 Checking Readiness for Operation 171 ...

Страница 166: ...k must be performed by professio nals 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 condition so that the medical device can perform its required functions Inspection Measures intended to determine and assess t...

Страница 167: ... 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...

Страница 168: ...athing systems Every 12 months Inspection and service Professionals Vaporizers Every 12 months Inspection and service Professionals Sensors Every 12 months Inspection and service Professionals Service set major overhaul for high pres sure cylinder connec tion1 1 optional After 6 years Replace Professionals Service set major overhaul for high pres sure cylinder connec tion label gas types1 After 6 ...

Страница 169: ...ng 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 Pl...

Страница 170: ...g 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 an...

Страница 171: ...wise as far as possible CLIC Adapter The disposable CLIC adapter absorber can also be used on the Fabius OS For information on installing the CLIC adapter consult its Instructions for Use Checking Readiness for Operation Perform the Daily and Pre use 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 p...

Страница 172: ...172 Instructions for Use Fabius OS SW 3 n This page intentionally left blank ...

Страница 173: ...Instructions for Use Fabius GS premium SW 3 n 173 Disposal Disposal Disposing of the medical device 174 Disposing of non rechargeable batteries 174 ...

Страница 174: ...d of in accordance with applicable laws and regulations Disposing of non rechargeable batteries z Do not recharge batteries Observe the applicable laws and regulations for battery disposal WARNING Risk of explosion and of chemical burns Improper handling of batteries can result in explosions and chemical burns Do not throw batteries into fire Do not force batteries open ...

Страница 175: ...romagnetic emissions 180 Electromagnetic immunity 181 Recommended separation distances 183 Electrical Safety Conformance 184 General Safety Standards for Anesthesia 184 Freedom from Latex 184 Ventilator 184 Anesthesia Gas Supply Module 187 Anesthetic Agent Vaporizer Interface 188 Breathing System 190 Low Oxygen Supply Pressure Alarm 192 S ORC Sensitive Oxygen Ratio Controller 192 Serial Interface ...

Страница 176: ...ns for Use of the supplementary equipment must be noted Machine Data Gas supply from medical gas pipeline system Pipeline System Pressure Range at Machine Connector O2 N2O AIR 50 to 55 psi 3 4 to 3 8 kPa x 100 Note Pipeline system supply pressure variation shall not exceed 10 Gas supply connectors Each inlet is fitted with a non return valve DISS Pipeline Pressure Indicator Accuracy 3 of full scal...

Страница 177: ...F Ingress of Fluids IPX0 Dimensions and Weight Approximate Weight Base unit with COSY and without supplementary cylinders and vaporizers 296 lb 134 2 kg Dimensions W x H x D with COSY and 3 Vaporizer Mount 1 approx 40 7 x 52 x 33 in 103 5 x 132 x 84 cm Dimensions W x H x D without COSY with 2 Vaporizer Mount 1 approx 30 x 52 x 33 in 76 x 132 x 84 cm Power supply Rating Non configurable 100 to 240 ...

Страница 178: ...24 V 3 5 Ah Type sealed gelled lead acid Recharging time 16 hours on the mains or full operation time Operation time with fully charged batteries 45 minutes minimum Fuses Mains fuses For 100 to 240 V supply voltage 2x T2 5AH 250 V IEC 60127 2 V Battery fuse 1x T3 15AH 250 V IEC 60127 2 V ...

Страница 179: ...r reasons interdict the use of them The non observance may result in increased emissions or decreased immunity of Fabius OS The Fabius OS should not be used adjacent to or stacked with other equipment if adjacent or sta cked use is inevitable Fabius OS should be obser ved to verify normal operation in the configuration in which it will be used Designation Order no O2 Sensor housing with cable 8606...

Страница 180: ...ent RF emissions CISPR 11 Group 1 The Fabius OS 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 A The Fabius OS is suitable for use in all esta blishments excluding domestic establish ments and those directly connected to the public low voltage power supply network that supplies ...

Страница 181: ...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 OS no equipment with extraordinary power frequency magnetic fields power transformers etc should be opera ted voltage dips and short interruptions on AC m...

Страница 182: ...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 OS should be less than 3 V m in the frequency range from 150 kHz to 2 5 GHz and less than 1 V m above 2 5 GHz 2 ISM ban...

Страница 183: ...IRP 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 UM...

Страница 184: ...Control Inputs Ranges PMAX Pressure limiting 15 to 70 cmH2O 1 cmH2O resolution 15 to 70 hPa 1 hPa resolution setting must be at least 10 cmH2O 10 hPa above PEEP VT Tidal volume 20 to 1400 mL 10 mL resolution f Breathing frequency 4 to 60 bpm 1 bpm resolution 4 to 60 1 min 1 min resolution TI TE Inspiration expiration ratio 4 1 to 1 4 TIP TI Inspiration pause 0 to 50 1 resolution PEEP End expirator...

Страница 185: ... Pressure Support Ventilation mode has been verified under the following range of simulated patient conditions Endotracheal Tube Size 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 Delivery Accuracy PMAX Pressure limiting 5 cmH2O 5 hPa of setting VT Tidal volume 5 of ...

Страница 186: ... 75 5 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 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 ...

Страница 187: ...r 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 100...

Страница 188: ...a 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 2 cmH2O hPa 1 28 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 ambient pres sure and satura ted gas Expiratory tidal volume 0 to 1...

Страница 189: ...ue 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 15 vol Desflurane 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 77 F 25 C 50 relative humidity 50 O2 gas mixture or 5000 h...

Страница 190: ...ntrol excluding patient hoses with reusable absorber 0 35mL cmH2O 0 35 mL hPa with Drägersorb CLIC adapter including absorber 0 35mL cmH2O 0 35 mL hPa with Drägersorb CLIC adapter excluding absorber 0 35mL 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 hP...

Страница 191: ...ata 092 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 ...

Страница 192: ...00 Alarm signal High priority alarm Warning LED indicator The red LED indicator in the O2 area of the gas flow control interface will flash until the O2 supply is restored 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 s...

Страница 193: ...l Interface Type RS 232 C Connector 9 pin Sub D Female Shield on housing Pin 2 TXD Pin 3 RXD Pin 5 GND Galvanic Isolation 500 V Baud Rates 1200 2400 4800 9600 19200 38400 Parity Odd Even None Data Bits 7 or 8 Start Bits 1 Stop Bits 1 or 2 Protocol Vitalink MEDIBUS ...

Страница 194: ...al Data 194 Instructions for Use Fabius OS SW 3 n Diagram Gas flow diagram Compact Breathing System 001 Ventilator Fresh gas Setting PMAX PEEP Fresh Gas Decoupling Absorber APL Bypass APL Valve Bag Scavenging ...

Страница 195: ...chine is ready for use Do not insert any additional components into or modify the anesthesia system after the checkout procedure is started This is a recommended procedure Follow your institution s policies for specific checkout procedu res 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 T...

Страница 196: ...196 Instructions for Use Fabius OS SW 3 n This page intentionally left blank ...

Страница 197: ... Reserve Power P Verify that battery 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 acce...

Страница 198: ...esent P Key indexed filling system Sealing key or pin inserted and closed tight when pre sent Filler opening locked shut P Quik Fil or Funnel filling system Locking screw tight when present D Vapor when present P Fastening Latched down firmly and set ver tically P Handwheel In zero position and engaged P Filling level between min and max P Operational light lit Checking the Condition of CO2 Absorb...

Страница 199: ... window stabilizes e g a flat line flip the APL valve to SPONT to release pressure P Peak pressure display on monitor reads 24 to 36 cmH2O hPa Checking Ventilator Operation P Connect a breathing bag to the Y piece to act as test lung P Press the Pressure Control key and confirm P Check that ventilation measurements are displayed P Check that the ventilator piston is cycling P Monitor the operation...

Страница 200: ...sure is equal or greather 0 cmH2O hPa Manual Ventilation Bag for Emergency Ventila tion Check that the bag is functioning correctly by pumping manually When the bag is squeezed air must audibly 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 th...

Страница 201: ...se 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 Pre use Checkout Signature Name Date ...

Страница 202: ...se 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 Pre use Checkout Signature Name Date ...

Страница 203: ...LIC adapter 43 75 CO2 absorbent 73 COM 1 23 COM 2 23 Communication Ports 23 Compact Breathing System 17 44 151 Compliance Test 113 Configuration 107 Configuration during Operation 127 Configuration Functions in Standby Mode 108 Configuration in Standby 122 Contents 5 Control Panel 30 Cylinder pressures 50 D Date Format 125 Date Set 124 Desflurane compensation 131 Diagram 194 Display Background 126...

Страница 204: ...ation 84 R Respiratory Volume Monitoring 103 Rotary Knob 32 S S ORC 70 Scavenger System 161 Screen Display 31 Self test 66 Sensitive Oxygen Ratio Controller 70 Silencing Alarms 96 Sleep Mode 109 Soda Lime 56 Soft Keys 33 SpiroLife flow sensor 155 Spirolog flow sensor 155 Spontaneous Breathing 76 Standby 34 Suction System 54 154 Symbols 27 System Test 109 T Technical Data 175 Time Format 124 Time S...

Страница 205: ...Instructions for Use Fabius OS SW 3 n 205 This page intentionally left blank ...

Страница 206: ...ithout customer request Manufactured by Dräger Medical AG Co KG Germany Moislinger Allee 53 55 D 23542 Lübeck 49 451 8 82 0 FAX 49 451 8 82 20 80 http www draeger com 90 52 124 GA 5330 570 enUS Dräger Medical GmbH Edition 4 2015 01 Edition 1 2009 05 Dräger reserves the right to make modifi cations to the equipment without prior notice Distributed in US by Draeger Medical Inc 3135 Quarry Road Telfo...

Отзывы:

Нет отзывов