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Dräger Fabius plus Instructions For Use Manual Download Page 197

Instructions for use Fabius plus SW 3.n

197

Technical data

ISO 21647
Medical electrical equipment

Particular requirements for the basic safety and 
essential performance of respiratory gas monitors

The following also apply for devices manufactured from July 2014 on:
IEC 60601-1 3rd ed.
Medical electrical equipment

Part 1:
General requirements for basic safety and essential 
performance

IEC 60601-1-2
Medical electrical equipment

Part 1-2:
General requirements for safety, collateral stan-
dard: Electromagnetic compatibility – Requirements 
and tests

IEC 60601-1-8

Part 1-8:
General requirements for basic safety and essential 
performance – collateral standard: General require-
ments, tests, and guidance for alarm systems in 
medical equipment and medical electrical systems

ISO 80601-2-13
Medical electrical equipment

Part 2-13:
Particular requirements for basic safety and essen-
tial performance of an anaesthetic workstation

ISO 80601-2-55

Part 2-55:
Particular requirements for basic safety and essen-
tial performance of respiratory gas monitors

Relevant standards (continued)

Summary of Contents for Fabius plus

Page 1: ...Instructions for use Fabius plus WARNING To properly use this medical device read and comply with these instructions for use Anesthesia workstation Software 3 n ...

Page 2: ...or in configuration from the illustrations Trademarks 1 Consecutive numbers indicate steps of action with the numbering restarting with 1 for each new sequence of actions Bullet points indicate individual actions or dif ferent options for action Dashes indicate the listing of data options or objects A Letters in parentheses refer to elements in the related illustration A Letters in illustrations d...

Page 3: ...re persons who are responsible for the maintenance of the product Service personnel must be trained in the maintenance of medical devices and install reprocess and maintain the product Experts Experts are persons who perform repair or complex maintenance work on the product Experts must have the necessary knowledge and experience with complex maintenance work on the product WARNING A WARNING state...

Page 4: ...4 Instructions for use Fabius plus SW 3 n Abbreviations and symbols Explanations can be found in the sections Abbreviations and Symbols in chapter Symbols ...

Page 5: ...preparation 50 Before first operation 51 Connecting the gas supply 54 Ensuring the gas supply 60 Assembling the breathing system 61 Connecting the sensors and measurement lines 79 Fastening the manual resuscitator 82 Instructions for mounting the accessories 82 Getting started 85 Daily checkout and pre use checkout 86 Switching on 86 Checking the readiness for operation 88 Operation 89 Standby pag...

Page 6: ...chnical data 190 General information 191 Ambient conditions 191 Device data 192 Fuses 195 External fresh gas outlet 195 Electrical safety 195 General safety standards for anesthesia workstations 196 Ventilator 198 Anesthetic gas supply module 200 Vaporizer interface 201 Breathing system 203 Alarm for low oxygen supply pressure 206 Alarm tone sequence IEC 206 Characteristics of additional acoustic ...

Page 7: ... instructions for use 8 Maintenance 8 Safety checks 8 Accessories 9 Connected devices 9 No operation in potentially explosive areas 9 Safe coupling with electrical equipment 10 Patient safety 10 Patient monitoring 10 Information on electromagnetic compatibility 11 Installing accessories 11 Keeping the instructions for use 11 Training 11 Product specific safety information 12 ...

Page 8: ...nstructions for use The medical device must only be used for the purpose specified under Intended use on page 16 and in conjunction with an appropriate patient monitoring system see page 10 Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels Failure to observe these safety information statements constitutes a use of ...

Page 9: ...d device malfunction Any connected devices or device combinations not complying with the requirements in these instructions for use may compromise correct functioning of the medical device Before using the medical device refer to and strictly comply with the instructions for use of all connected devices and device combinations WARNING Risk of device malfunction This medical device can be operated ...

Page 10: ...ntially adverse effects in patients with different underlying diseases Medical device modification or misuse can be dangerous Patient monitoring The user of the medical device is responsible for choosing suitable monitoring that provides appropriate information about medical device performance and the patient s condition Patient safety may be achieved by a wide variety of means ranging from electr...

Page 11: ...tion of the pins or using electrically insulating and antistatic gloves All relevant users must be instructed in these ESD protective measures WARNING Risk of device failure Electromagnetic fields e g those generated by radio frequency communication equipment such as mobile phones high frequency electrical surgery equipment defibrillators or shortwave therapy devices can disrupt the function of th...

Page 12: ...nitor the medical device so that corrective measures can be initiated immediately WARNING Risk of device failure The device can fail if the power supply is interrupted Always connect the device on an uninterruptible power supply WARNING Risk of patient injury Every user has the obligation to assess independently which components are required corresponding to the specific prerequisites for the anes...

Page 13: ...or spray them into the device Do not use substances containing alcohol Do not allow combustible or explosive substances to enter the breathing system or breathing circuit Do not use cyclopropane or ether WARNING Risk due to failure of flow measurement Deposits that were not removed during reprocessing can damage the measuring wires in the flow sensor or cause a fire Before inserting the flow senso...

Page 14: ... the following points to avoid electric shock The covers of the components must not be removed Maintenance work must only be performed by DrägerService Use only grounded electrical connections and power cables that meet hospital standards Before connecting the medical device make sure that external devices are grounded to meet the hospital standard in accordance with national applicable regulation...

Page 15: ...ius plus SW 3 n 15 Application Application Intended use 16 Indications Contraindications 17 Indications 17 Contraindications 17 Further information on application 18 Environment of use 18 The MEDIBUS and Vitalink protocols 19 ...

Page 16: ...port pressure supported ventilation SIMV PS synchronized intermittent ventilation with pressure support ManSpont manual ventilation spontaneous breathing optional WARNING Risk of patient injury In accordance with the general safety standards for anesthesia systems additional monitoring of the concentrations of CO2 and anesthetic agent is required WARNING Risk of insufficient ventilation Device fai...

Page 17: ... status must be continuously monitored for potential changes NOTE CO2 values and anesthetic gas values can be monitored if the Fabius is combined with a gas monitor e g Vamos or a gas analyzer e g Scio with Dräger patient monitor NOTE O2 monitoring can be deactivated on site by an authorized service partner More information can be found in chapter Deactivating the O2 monitoring on page 125 If O2 m...

Page 18: ...ters WARNING Risk of explosion This medical device is neither approved nor certified for use in areas where oxygen concentrations greater than 25 Vol combustible or explosive gas mixtures are likely to occur WARNING Risk of device malfunctions and or patient injury and user injury Magnetic fields can negatively influence the correct functioning of the medical device and therefore endanger the pati...

Page 19: ...01 1 2 or of IEC 60601 1 2005 for medical electrical equipment WARNING Risk of patient injury All data transferred via the MEDIBUS interface are for information only and must not be used as the sole basis for diagnostic or therapeutic decisions The data accessible via this interface are not intended for use with a distributed alarm system in accordance with IEC 60601 1 8 2012 in the sense of remot...

Page 20: ... 25 Screw connections 26 Interface panel 27 Vaporizer 28 Ceiling mounted version optional 29 Wall mounted version optional 30 Supplemental O2 delivery optional 31 Functional check of the supplemental O2 delivery 31 APL valve 32 Interfaces 33 Recommended device configuration 33 External fresh gas outlet 34 Using the external fresh gas outlet as a common gas outlet 35 Use of the external fresh gas o...

Page 21: ...ges for gas cylinders O2 and N2O D Pressure gauges for the central supply O2 Air N2O E Flow tubes F Fresh gas delivery G Writing tray H Drawers I Locking brake J Power supply unit for COSY breathing system heating K CO2 absorber L Compact breathing system COSY M Ventilator N Supplemental O2 delivery for O2 insufflation O Vaporizer mount P O2 flush 25292 O2 plus A B C D E F G H I J K L M N O P opti...

Page 22: ...r guard or COSY guard not illustrated F Expiratory port G Connection for breathing bag H Inspiratory port I Inspiratory valve J Fresh gas decoupling valve K Connection for APL bypass valve L Mount with locking pin M APL valve with selection for manual ventilation Man and spontaneous breathing Spont N Connection for sample line O Holder for sample line optional 20983 A B C D E F G H I J K L M N O o...

Page 23: ...Instructions for use Fabius plus SW 3 n 23 Overview Power supply unit for COSY heating front view A LED indicator for COSY heating B On Off switch C Fuse 21014 A B C ...

Page 24: ...Overview 24 Instructions for use Fabius plus SW 3 n Power supply unit for COSY heating rear view A Power inlet B LED indicator for power supply C Cable clamp 21015 A B C ...

Page 25: ... Power inlet with main fuses D On Off switch E Battery fuse F Potential equalization pin G Interface panel H Connection for ventilator hose 25295 O2 N2O 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar AIR O2 N2O AIR 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar C D E G H B A F optional ...

Page 26: ... gas hoses of gas cylinders with O2 O2 and N2O or O2 and Air screw connections B Connections for central supply hoses C Gas cylinders 25298 O2 N2O 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar AIR O2 N2O AIR 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar A B C ...

Page 27: ...use Fabius plus SW 3 n 27 Overview Interface panel A COM 1 port B Connection for PEEP hose C Connection for APL hose D Socket for O2 sensor E Socket for airway pressure sensor F Socket for flow sensor 25301 A B C D E F ...

Page 28: ... Vapor D Vapor 3000 is a heated calibrated anesthetic vaporizer for enriching dry medical fresh gas of an anesthesia workstation with the anesthetic agent desflurane There are various connector systems with which vaporizes can be connected to an anesthesia workstation Dräger recommends using only anesthetic vaporizers that are listed in the list of accessories More information can be found in the ...

Page 29: ...nt free space CAUTION Risk of crushing When the medical device is set on the floor body parts can be crushed Make sure there is sufficient free space CAUTION Risk of injury or risk of damage to the medical device If the medical device is let down to the floor obstructions can damage the medical device If the medical device is lifted or lowered protruding parts can be damaged Remove all obstruction...

Page 30: ...ed position parts can be damaged or their function can be comprised Do not use the anesthesia workstation at an inclination over 1 CAUTION Risk of injury or risk of damage to the medical device If the maximum weight is exceeded the holder can release from the wall mount The total weight of the anesthesia workstation including all accessories must not be exceeded see Instructions for mounting the a...

Page 31: ...the supplemental O2 delivery Turn the flow control valve A counterclockwise Check that the float can move freely in the flow tube After the O2 insufflation is ended the flow control valve of the supplementary O2 delivery must be completely closed Turn the flow control valve A clockwise to the final position stop WARNING Risk due to overpressure When the patient s connection to the supplemental O2 ...

Page 32: ...nt Setting of the maximum airway pressure for manual ventilation WARNING Risk of patient injury Wires and cables can get caught under the APL valve adjustment knob and block the APL valve Lay all cables and wires e g sample line so that they do not get caught 20956 NOTE The APL valve is automatically separated from the breathing system as soon as an automatic ventilation mode is selected WARNING R...

Page 33: ...age current may rise above the permissible values Only connect with the approval of the respective device manufacturer Have the leakage current checked by service personnel If the permissible value is exceeded disconnect the devices from the MEDIBUS interface A CAUTION Risk to electrical safety To ensure electrical safety only connect devices to the serial port COM 1 with a maximum nominal voltage...

Page 34: ...ected to the external fresh gas outlet When using a non rebreathing system ensure an adequate gas monitoring WARNING Risk of misinterpretation of measured values The values for O2 pressure and volume displayed on Fabius do not correspond to the values for the patient connected to external fresh gas outlet as they are based on measurements taken at the compact breathing system When using the extern...

Page 35: ...breathing system e g Bain Use of the external fresh gas outlet with an additional switch The switch enables the simple switching of the fresh gas supply from the compact breathing system to the non rebreathing system Overview A External fresh gas outlet with an additional switch B Long fresh gas hose on Fabius C Short fresh gas hose on compact breathing system D Compact breathing system E Sample l...

Page 36: ...charge FiO2 Inspiratory oxygen fraction Freq Respiratory rate Freq Min Mandatory minimal respiratory rate in Pressure Support mode HF High frequency hPa Hectopascal Insp Flow Inspiratory flow kPa Kilopascal L min Liters per minute lbs Pound unit of mass LED Light emitting diode ManSpont Manual ventilation Spontaneous breathing mbar Millibar MEAN Mean airway pressure MEDIBUS X Dräger communications...

Page 37: ... TI TINSP Inspiratory time TE Expiratory time TI TE Ratio of inspiratory time to expi ratory time TIP TI Ratio of inspiratory pause to inspiratory time Trigger Trigger UMDNS Universal Medical Device Nomenclature System nomen clature for medical devices USB Universal Serial Bus computer interface VT Tidal volume PPS Differential pressure of the pres sure support in Pressure Sup port mode Abbreviati...

Page 38: ...ation on electromagnetic com patibility on page 11 Risk of crushing Label on device surfaces where the risk of tipping is increased by e g leaning on or against the surface or pushing Serial number Order number XXXX REF Batch designation Keep away from sunlight Storage temperature Relative humidity Atmospheric pressure Do not use if package damaged Do not reuse Alarm inactive The alarm tone is sup...

Page 39: ...per and lower alarm limits Lower alarm limit Upper alarm limit Socket for O2 sensor Socket for flow sensor Socket for airway pressure sen sor Ventilator connection Fuse Do not oil Close menu Key for access to alarm limits Key to call up main screen Symbol Explanation Key for switching the workstation light on and off Key to call up the configuration menu Key for suppressing the acoustic alarm sign...

Page 40: ...t instructions see Preparing for storage or transport on page 115 Trolley version Observe the weight of the nominal configuration and the total permissible weight see Technical data Wall mounted version ceiling mounted version Observe the weight of the nominal configuration and the total permissible weight see Technical data nom 110 kg max 280 kg nom 69 kg max 125 kg ...

Page 41: ...and setting 45 Monitoring settings and system settings 45 Changing the ventilation mode 45 Selecting and setting the ventilation parameters 46 Fresh gas delivery version for 3 gases 47 LED indicators 48 LEDs for operating status 48 LEDs for alarm status 48 Color coding for anesthetic agents and medical gases 49 Screen colors optional 49 ...

Page 42: ... window with alarm limits In the mode Standby Opens a menu for configuring the system settings and default settings see chapter Configuration in standby mode on page 131 In a ventilation mode Opens a menu for displaying and chang ing the monitoring settings see chapter Configuration during operation on page 147 Changes from displayed screen to the main screen The alarm tone of all active alarms is...

Page 43: ...cators Softkeys The labeling on the softkeys depends on the active ventilation mode In all ventilation modes the softkeys only display those ventilation parameters and ventilation functions that are available in the respective ventilation mode Example for Volume Control mode PMAX VT Freq TI TE TIP TI PEEP More information can be found in chapter Configuration in standby mode on page 131 ...

Page 44: ...the status bar Current ventilation mode Remaining time of alarm tone suppression Status of the desflurane compensation Remaining battery charge Current time B Alarm message field Display of a maximum of 4 alarm messages with highest priority C O2 monitoring Display of the inspiratory oxygen concentration in percent as well as the upper and lower alarm limits 25358 A B C D E F G for Japan and China...

Page 45: ... requires a selection and confirmation by pressing the rotary knob To change a value or parameter or to navigate in the menus turn the rotary knob In this document these procedural steps are simply called select To confirm a value or a selection press the rotary knob Without confirmation with the rotary knob the value or parameter is not changed In this document these procedural steps are simply c...

Page 46: ...ation settings C The key D is highlighted 2 Select new value and confirm The pressure waveform is displayed again 25360 25361 Volume Control A B Volume Control C D NOTE The time limit for changes of ventilation parameters is 15 seconds After 10 seconds an acoustic signal consisting of 3 tones is sounded If the new setting is not confirmed within the time limit the current ventilation settings rema...

Page 47: ...a color coding see chapter Color coding for anesthetic agents and medical gases on page 49 The O2 flow control valve is additionally provided with grooves on the gripping surface A Pressure gauge for the central O2 supply B Pressure gauge for the central Air supply C Pressure gauge for the central N2O supply D Flow tubes E O2 flow control valve F Air flow control valve G N2O flow control valve If ...

Page 48: ... the standby key B and all keys of the ventilation modes C have small LEDs that light up when the respective mode is active LEDs for alarm status Fabius has alarm LEDs that signal alarms and indicate the alarm priority Further information in chapter Alarms Alarm LEDs Red LED A flashes indicates a warning Yellow LED B flashes indicates a caution Yellow LED B lit constantly indicates a note Red LED ...

Page 49: ... agents and medical gases The colors for O2 Air and N2O are adapted according to locally applicable standards Screen colors optional For improved visibility Fabius displays the following screen elements in different colors Softkeys Default Alarm messages see chapter Alarm priorities Screen background bright dark The screen elements are only represented in color when the Color display option is act...

Page 50: ...er to the compact breathing system 62 Mounting the COSY heating and the power supply unit optional 65 Connecting the compact breathing system 66 Inserting the flow sensor 67 Connecting the exhaust port 67 Connecting the breathing bag 68 Connecting the endotracheal suction system optional 70 Connecting the breathing hoses and the filters 72 Inserting a new O2 sensor capsule 78 Connecting the sensor...

Page 51: ...ew the fuse holder in securely with a quarter turn clockwise WARNING Risk of device malfunction If the battery is not sufficiently charged and the mains power supply fails operation cannot be maintained long enough Before first operation or after storage charge the battery for at least 8 hours WARNING Risk due to reduced power supply from the internal battery Batteries are wear parts The capacity ...

Page 52: ... the device lights up green 3 Set On Off switch A to position 4 Check the status bar for the battery indicator 25413 WARNING Risk of electric shock and device malfunction If the device is connected to a power socket with incorrect mains voltage or without a protective ground the user can be injured and the device damaged Only connect the power cable to power sockets with a protective ground see Te...

Page 53: ... fails the leakage current may rise above the permissible values Only connect with the approval of the respective device manufacturer Have the leakage current checked by service personnel If the permissible value is exceeded use a mains power socket on a wall instead of the auxiliary power socket of the device WARNING Risk of device malfunction If the mains power fails devices connected to the aux...

Page 54: ...ly connected to the rear side of the device After connecting the gas supply check for correct function Even when the anesthesia machine is connected to the central gas supply the gas cylinders should remain at the device with valves closed as backup WARNING Risk of contamination of ambient air and risk of fire explosion O2 or N2O can get into the ambient air as a result of leakages Make sure the c...

Page 55: ...ply hoses between the central gas supply and Fabius are interchanged serious accidents can occur If Fabius is connected to the central gas supply it must be checked whether the marks on the hoses agree with the connections of the central gas supply 25414 O2 N2O 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar AIR A B CAUTION Risk of insufficient gas pressure If the supply pressure...

Page 56: ...ten the handle I of the cylinder holder J If required the gas cylinder valve C can be opened with the supplied wrench G If the gas cylinder is removed insert the plug H in the mounted gas cylinder holder and tighten WARNING Risk due to incorrect mounting of the gas cylinder When using several sealing washers between the gas cylinder and the gas inlet of the cylinder holder the pin index safety sys...

Page 57: ...Maximum permissible dimensions of the gas cylinders Observe the following points Do not exceed the maximum length of the gas cylinder including the pressure reducer pin index connection The gas cylinders must not protrude over the lower edge of the trolley observe maximum length of the gas cylinders The O2 cylinder must not be mounted on the right side looking from the rear 25416 Gas PSI FULL kPa ...

Page 58: ...Do not touch with oily or greasy fingers WARNING Risk of explosion If the gas cylinder valves are opened too quickly a sudden increase in pressure may occur Open and close the gas cylinders valve slowly by hand Do not use tools CAUTION Risk due to gas supply failure Leave gas cylinders as a backup at the anesthesia workstation even if there is a connection to the central gas supply CAUTION Risk of...

Page 59: ...to incorrect anesthetic agent delivery If the vaporizer is filled with the wrong anesthetic agent or if it is not filled sufficiently incorrect anesthetic gas concentrations or concentrations that are too low can occur as a result Strictly observe the instructions for use of the vaporizer Compare the color coding on the vaporizer with the anesthetic agent bottle WARNING Risk due to improperly moun...

Page 60: ...transfer hose B to the provided port 4 Connect the other end of the transfer hose to the exhaust port on the bottom of the COSY 5 Connect the scavenging hose C to the corresponding port of the receiving system 6 Connect the probe of the scavenging hose C to the terminal unit of the anesthetic gas scavenging system Observe the associated instructions for use of the AGSS terminal unit The top edge o...

Page 61: ...r D and close the 3 clamps B 6 Connect the pressure sensor line E of the ventilator chamber with the appropriate connector 7 Close the ventilator door with the attached ventilator unit Safety functions of the ventilator Overpressure safety valve F Underpressure safety valve G Pressure sensor in the ventilator chamber WARNING Risk of insufficient anesthetic gas concentrations If the component conne...

Page 62: ...soda lime and inhalational anesthetic used Decreased CO2 absorption increased generation of heat in the CO2 absorber resulting in increased breathing gas temperature formation of CO absorption and or degradation of the inhalational anesthetics Do not use unnecessarily high fresh gas flows Only use the supplemental O2 delivery if necessary Do not leave the flow control valves open unnecessarily lon...

Page 63: ...non pelletized soda lime is used then a soda lime dust filter must be used 3 Insert a new soda lime dust filter E Only use soda lime dust filters indicated in the list of accessories Only use undamaged filters as exterior damage to the filter decreases protection 4 Place the CO2 absorber F below the compact breathing system in position and turn counterclockwise to the final position stop 21022 210...

Page 64: ... few times 3 Remove the seal of the new disposable CO2 absorber Push the disposable CO2 absorber in the Clic adapter 4 Push the disposable CO2 absorber H upwards into the CLIC adapter until the CLIC adapter engages CAUTION Risk of patient recovering consciousness If the CO2 absorber is not correctly locked into place system leakage may occur Make sure that the absorber container is connected tight...

Page 65: ...athing system When doing so align the red mark of the plug to the red mark of the socket After installation of the breathing system heating perform the leakage test on Fabius The heating must be switched off if it is not being used This will prevent drying out of the soda lime 25425 A B WARNING Risk due to soda lime drying out The soda lime loses moisture If the moisture falls below the minimum mo...

Page 66: ...tem until the locking pin engages 4 Connect the fresh gas hose C to the corresponding connection of the compact breathing system 5 Connect the ventilator hose to the corresponding connector D on the anesthesia workstation 6 Connect the other end of the ventilator hose to the ventilator connector E of the compact breathing system If Fabius has a screw connection the sealing rings of this screw conn...

Page 67: ...ing system from below WARNING Risk of fire Residual vapors of easily flammable disinfectants e g alcohols and deposits that were not removed during reprocessing can ignite when the flow sensor is in use Ensure particle free cleaning and disinfection After disinfection allow the flow sensor to air for at least 30 minutes Before inserting the flow sensor check for visible damage and soiling such as ...

Page 68: ... the arm is fixed securely 3 Fasten the elbow D at the end of the flexible arm 4 Fasten the breathing bag C on the other end of the elbow WARNING Risk of use of toxic or incompatible materials The breathing bag used must comply with the current standards WARNING Risk of too high airway pressure or insufficient fresh gas If the breathing bag is pinched excessive airway pressures or a lack of fresh ...

Page 69: ...tion and align the connection adapter A of the rigid arm on the connection of the compact breathing system 2 Tighten the knurled screws B Check that the arm is fixed securely 3 Fasten the breathing bag C at the other end of the rigid arm Mounting the bag elbow 1 Attach the bag elbow A on the connection of the compact breathing system 2 Attach the breathing bag B on the connector of the bag elbow 2...

Page 70: ...eal suction system for Fabius consists of Suction regulator A Suction bottle D 1 The suction regulator A is attached to a holder B The holder is fastened on the side GCX rail C on Fabius 2 The suction bottle D is attached to a separate holder Version with two suction bottles Version with one suction bottle 20949 A B C D 21442 A B C D ...

Page 71: ...3 way adapter to the gas supply block or the central gas supply For vacuum suction Connect the vacuum hose of the suction system directly to the central gas supply Prepare the suction system in accordance with the associated instructions for use WARNING Risk of patient injury Only use the suction system if the ventilation mode ManSpont is active or the patient is disconnected from the Y piece ...

Page 72: ...cement of hoses cables and similar device components can endanger the patient Use particular caution when establishing connections to the patient WARNING Risk of use of toxic or incompatible materials The breathing hoses must comply with the current standards WARNING Risk due to particles and dust In order to protect the patient from particles and dust a filter must be used between the inspiratory...

Page 73: ...and breathing hoses Adults Pediatric patients Neonates Tidal volume 700 mL 201 to 700 mL 50 to 200 mL 50 mL Breathing bag 3 L 2 L 1 L 0 5 L Breathing circuit Adults Pediatric Neonates or pedi atric Filter Filter HMEF or HME Use filters with low resistance and compliance NOTE When applying tidal volumes in the range of the maximum or minimum values indicated for each patient category use the smalle...

Page 74: ...ry port optional with microbial filter installed 3 Connect both breathing hoses on the Y piece B 4 Connect the sample line D to the connector of the Y piece B and to the connector of the water trap E on the patient gas measurement module 5 Connect the breathing bag hose C with the breathing bag to the corresponding connector 21456 A B C D E ...

Page 75: ...eonates Filter or HMEF with connection for sample line between Y piece and patient Or Filter at inspiratory port and expiratory port connection for sample line at Y piece Filter at inspiratory port connec tion for sample line as close to patient as possible Lateral connections for the sam ple line support CO2 measure ment and help to flush the dead space between Y piece and hose adapter LQVS H S L...

Page 76: ... immediately cause underpressure in the lungs When ventilating pediatric patients and neonates do not use HMEF or other filters at the Y piece in connection with a hose adapter that have a patient side connection for a sample line WARNING Risk due to accessory components in breathing circuit When using additional components or hose configurations which deviate from the standard breathing circuit t...

Page 77: ... the breathing hoses In this manner it is possible to determine the respective resistance of the patient when using different breathing hose sets and or filters The following formula is used to calculate the resistance R RInspiration RBreathing system_insp RInsp hose RBreathing bag hose RInsp filter port RInsp filter Y piece RExpiration RBreathing system_exsp RExsp hose RExsp filter port RExsp Y p...

Page 78: ...ring shaped conductor touches the contacts in the housing 5 Screw on the screw cap A tightly by hand 6 Reinsert the O2 sensor housing in the inspiratory valve WARNING Risk of electric shock If the O2 sensor is replaced during operation it can lead to transferring of leakage current Do not touch the patient 20971 WARNING Danger of erroneous O2 measurement An incorrectly mounted O2 sensor will lead ...

Page 79: ...r cable with the connection marked with on the rear of the device Connecting the pressure sensor 1 Connect the pressure measurement hose C to the corresponding connection on the bottom of the compact breathing system Make sure that the pressure measurement hose is not pinched 2 Connect the other end of the pressure measurement hose with the bacterial filter B 3 Plug in the bacterial filter into th...

Page 80: ...the pressure measurement hose and the pressure gauge 3 Connect the other end of the pressure measurement hose with the bacterial filter B 4 Plug in the bacterial filter into the connection D marked with on the rear of the device Connecting the flow sensor 1 Connect the flow sensor cable to the corresponding connection A on the bottom of the compact breathing system 2 Plug in the other end of the f...

Page 81: ... compact breathing system 2 Connect the other end to the hose on the connection marked with APL C on the rear of the device 3 Connect the PEEP PMAX hose to the corresponding connection port of the PEEP PMAX valve D on the compact breathing system 4 Connect the other end of the hose on the connection marked with PEEP B to the rear of the device 25454 NOTE The APL bypass hose is thicker than the PEE...

Page 82: ...d on the holder Instructions for mounting the accessories 25455 A CAUTION Observe the assembly instructions of the accessory WARNING Risk of tipping and risk of injury If the maximum permissible weight is exceeded or if monitors and other auxiliary devices are placed on the medical device the device can fall Especially if the medical device is rolled over door thresholds and similar obstacles Befo...

Page 83: ...aded with max 5 kg 11 lbs The individual drawers in the trolley may be loaded with maximum 6 8 kg 15 lbs On the rear of the device a maximum of 35 kg 77 lbs gas cylinders including holder and acces sories can be attached O2 plus Left side Top of device Right side The maximum per missible weight of the accessories is 15 kg 33 lbs A max of 10 kg 22 lbs may be attached in the rear top GCX rail at a d...

Page 84: ...shelf Dismount any additional devices mounted to the swivel arms or the top of the device e g patient monitors data management systems syringe pumps Clear the writing tray and slide it completely into the device Position the optional flexible arm for breathing bag close to the device Prepare additional components as described in the respective instructions for use ...

Page 85: ...or use Fabius plus SW 3 n 85 Getting started Getting started Daily checkout and pre use checkout 86 Switching on 86 Checking the readiness for operation 88 FUNCTIONAL 88 CONDITIONALLY FUNCTIONAL 88 NON FUNCTIONAL 88 ...

Page 86: ...To prevent condensation and resulting failures of electrical components do not switch on the device after abrupt temperature changes for 1 to 2 hours e g after storage in unheated rooms WARNING Risk of device malfunction Some safety systems are only checked during start up A selftest should be performed once daily Switch the Fabius on and off or press the softkey Run System Test WARNING Risk of ex...

Page 87: ...d to test the speakers To hear these tones do not stand any further than 4 meters 13 feet from the device After completion of the system test the default settings for ventilation are loaded 25413 A CAUTION Malfunction of the device function The user must check whether the test tones were actually sounded The device only checks whether the speakers are connected A complete loss of the ventilation f...

Page 88: ...e Standby is displayed CONDITIONALLY FUNCTIONAL A non critical malfunction was found The anesthesia workstation can be used To open the page Standby press the rotary knob Check if an alarm message is displayed Contact DrägerService or the authorized local service partner NON FUNCTIONAL A serious malfunction was found and the operation of the monitoring functions and ventilation functions are block...

Page 89: ...pport optional 103 Ventilation mode SIMV PS optional 105 Adopting ventilation settings during mode change 107 Safety functions of the ventilator 108 Behavior with too low fresh gas supply 108 Behavior of Fabius if the user does not take any action 108 Patient change 109 Using the external fresh gas outlet as a common gas outlet optional 110 Preparation 110 Operation 111 Ending operation 111 Using ...

Page 90: ... gas mixtures if N2O is selected as the carrier gas Starting at a flow of approx 200 mL min the N2O concentration in the fresh gas can be set to a value between 0 and 75 When a lack of O2 is present the S ORC limits the N2O concentration in the fresh gas so that the O2 concentration will not fall below 23 Vol S ORC inhibits the N2O flow under the following conditions N2O flow control valve is open...

Page 91: ...e is stable for at least 20 seconds Do not use any functions during this time that require O2 for example O2 flush O2 fresh gas flow Endotracheal suction WARNING Risk of material damage and risk to health A vaporizer must never remain in operation without a fresh gas flow High concentrations of the anesthetic gas flow into the ventilation circuit and the ambient air This can lead to material damag...

Page 92: ...thetic gas concentration 3 Check the filling level on the sight glass C regularly The filling level must be between minimum and maximum 4 When the refill mark D is reached 250 mL normal anesthetic agent bottle can be refilled 5 Fill the vaporizer at the latest when the minimum mark E is reached refer to instructions for use of the respective vaporizer 20964 WARNING Risk of patient injury When the ...

Page 93: ... the vaporizer During this an unmetered flow of at least 35 L min is given to the breathing system and the breathing bag Press the A key O2 flows for as long as the key is held down Use of the O2 flush can increase airway pressure very quickly and abruptly change the gas concentration 20960 NOTE In ManSpont mode the pressure can increase quickly and thus trigger the APL valve A ...

Page 94: ... contains a fraction of approx 77 nitrogen If the device is used for a low flow anesthesia press the key This removes the nitrogen WARNING Risk due to the accumulation of acetone in the patient Do not perform low flow anesthesia on patients with ketoacidosis or patients under the influence of alcohol The risk of accumulation of acetone in the patient increases in such cases CAUTION Risk of patient...

Page 95: ...l anesthetic used Decreased CO2 absorption increased generation of heat in the CO2 absorber resulting in increased breathing gas temperature formation of CO absorption and or degradation of the inhalational anesthetics Do not use unnecessarily high fresh gas flows Only use the supplemental O2 delivery if necessary Do not leave the flow control valves open unnecessarily long CAUTION Risk of chemica...

Page 96: ... described Changing to spontaneous breathing 1 Turn the APL valve head counterclockwise to its final position stop The label Spont and both points are vertical to each other The valve head lifts The pressure limitation is disabled and the valve is open for free spontaneous breathing 2 Set suitable fresh gas flow 3 Press the ManSpont A key 4 Confirm the new mode WARNING Risk of strangulation Neglig...

Page 97: ...r Volume alarms on page 127 Changing to manual ventilation 1 Set the APL valve head to the desired maximum airway pressure Settings between the grid marks are also possible 2 Press the ManSpont A key 3 Confirm the new mode 25466 ManSpont B B NOTE In ManSpont mode the apnea alarm time for triggering apnea volume alarms is extended from 15 seconds to 30 seconds Caution category and from 30 seconds t...

Page 98: ...tilation modes on page 128 Volume Alarms see chapter Volume alarms on page 127 4 To refill the breathing bag press the key 5 Set suitable fresh gas flow 6 Start manual ventilation with the breathing bag The pressure is limited to the value that is set on the APL valve Pressure release In the ManSpont mode lifting the valve head relieves pressure from the breathing system 25466 20947 ManSpont B B 2...

Page 99: ... test and compliance test must also be used during operation This guarantees an exact compliance compensation Changing to Volume Control mode In the following examples and illustrations the change from Pressure Control mode to Volume Control mode is described 1 Press the Volume Control A key 2 Adjust ventilation settings B 3 Confirm the new mode NOTE If the ventilator works at its performance limi...

Page 100: ...at the corresponding respiratory rate Freq In addition a positive end expiratory pressure PEEP can be set To prevent too high pressure the alarm limit PMAX can be set corresponding to the physiological condition of the patient The lower alarm limit of the airway pressure PAW low is used for the airway pressure monitoring to detect apnea disconnection and continuous pressure If the pressure wavefor...

Page 101: ...compliance and resistance the set value for Freq Min in Pressure Control mode might not exactly be applied In the following table all parameters B in Pressure Control mode together with the corresponding setting ranges and factory settings are listed 25472 25473 A B Volume Control Pressure Control Parameter Setting range Factory set ting Inspiratory pressure PINSP cmH2O hPa 5 to 65 min PEEP 5 15 R...

Page 102: ...ent compliance The parameter Insp Flow is used to set the increase of the slope of the pressure waveform In addition a positive end expiratory pressure PEEP can be set The lower alarm limit of the airway pressure PAW low is used for the airway pressure monitoring to detect apnea disconnection and continuous pressure If the pressure waveform does not cross the pressure threshold either from above o...

Page 103: ...ion is available which can ensure a minimum ventilation To activate apnea ventilation for the setting Freq Min another setting must be selected than OFF If the detected spontaneous respiratory rate of the patient drops under the set value for Freq Min a mechanical breath is applied Apnea ventilation is not intended to be a primary ventilation mode For apnea ventilation Fabius uses the settings for...

Page 104: ... Min e g 20 seconds If no inspiratory effort is detected and the safety period has elapsed the device generates a pressure controlled breath with PINSP PPS The lower alarm limit of the airway pressure PAW low is used for the airway pressure monitoring to detect apnea disconnection and continuous pressure If the pressure waveform does not cross the pressure threshold either from above or below an a...

Page 105: ...Freq TINSP TIP TI PEEP To support the inspiratory effort of the patient in ventilation SIMV mode pressure support PPS can be switched on The setting of PPS to another value than OFF activates the mode Pressure Support see chapter Ventilation mode Pressure Support optional on page 103 Changing to SIMV mode In the following examples and illustrations the change from Volume Control mode to SIMV PS mo...

Page 106: ...s breaths of the patient These spontaneous breaths can be supported with PPS The lower alarm limit of the airway pressure PAW low is used for the airway pressure monitoring to detect apnea disconnection and continuous pressure If the pressure waveform does not cross the pressure threshold either from above or below an alarm is sounded Parameter Setting range Factory set ting Pressure limita tion P...

Page 107: ...ue that lies 10 cmH2O hPa above the plateau pressure PLAT that occurred in Pressure Control When changing from Volume Control to Pressure Support Insp Flow is set to the last used value or the factory setting PPS is set to the last used value or the factory setting Trigger is set to the last used value or the factory setting When changing from Pressure Control to Pressure Support Insp Flow is set ...

Page 108: ...ce the ventilator does not contain sufficient fresh gas the reserve volume is absorbed As long as there is insufficient fresh gas the safety valve B for ambient air remains open during expiration This allows for emergency ventilation with limited VT even with extremely low fresh gas supply There will be no sudden switch off of the ventilator 20979 NOTE To remedy this the user must take actions e g...

Page 109: ... test in the following cases When the soda lime is replaced When the breathing hoses are replaced When a vaporizer is replaced or filled 5 Set the ventilation mode and continue see chapter Ventilation on page 96 WARNING Risk due to incorrect settings For anesthesia machines within the same care area different standard alarm limits or ventilation settings might be configured The user must observe t...

Page 110: ...ntilation or spontaneous breathing and must only be connected to the external fresh gas outlet When using a non rebreathing system ensure an adequate gas monitoring WARNING Risk of misinterpretation of measured values The values for O2 pressure and volume displayed on Fabius do not correspond to the values for the patient connected to external fresh gas outlet as they are based on measurements tak...

Page 111: ...ation 1 Change to Standby mode 2 Set the fresh gas flow To prevent rebreathing the fresh gas supply must be at least double the minute volume 3 Operate the non rebreathing system according to the corresponding instructions for use Ending operation 1 Close all flow control valves on the device 2 Disconnect the non rebreathing system from the external fresh gas outlet 3 Connect the fresh gas hose to...

Page 112: ... supply to the patient Non rebreathing systems are only intended for manual ventilation or spontaneous breathing and must only be connected to the external fresh gas outlet When using a non rebreathing system ensure an adequate gas monitoring WARNING Risk of misinterpretation of measured values The values for O2 pressure and volume displayed on Fabius do not correspond to the values for the patien...

Page 113: ...gas supply must be at least double the minute volume 3 Operate the non rebreathing system according to the corresponding instructions for use Operation with the compact breathing system COSY Diverting the fresh gas flow to the compact breathing system 1 Place the switch lever to COSY The lever points in the direction of the fresh gas inlet Ending operation 1 Close all flow control valves on the de...

Page 114: ...5 minutes 4 Close the cylinder valves 25411 20965 A B WARNING Risk of material damage and risk to health A vaporizer must never remain in operation without a fresh gas flow High concentrations of the anesthetic gas flow into the ventilation circuit and the ambient air This can lead to material damage and contamination of the ambient air with anesthetic gases Never cut off the fresh gas flow before...

Page 115: ...dical device may tip over if handled incorrectly Observe the following points when transporting medical devices The medical device may only be moved by people who have the physical ability to do so To improve the maneuverability transport the device with 2 persons When transporting over inclines around corners or over thresholds e g through doors or in elevators make sure that the medical device d...

Page 116: ...nstructions for use Fabius plus SW 3 n 8 Remove central supply hoses C 9 To bring the entire system to normal pressure press the key 25414 O2 N2O 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar 2 8 6 0 kPa x 100 bar AIR C ...

Page 117: ...Instructions for use Fabius plus SW 3 n 117 Alarms Alarms Alarm signaling 118 Display of alarms 118 Acoustic signal 118 Alarm priorities 119 Suppressing the alarm tone 120 Adjusting the alarm limits 120 ...

Page 118: ...ssage with 3 excla mation points is displayed in the alarm message field A The red LED B flashes accom panied by a repeating alarm tone sequence E E E E Bb E E E E Bb The alarm tone sequence 2x5 alarm tones sounds every 10 seconds A B Caution A message of caution category with 2 exclamation points is displayed in the alarm message field A The yellow LED B flashes accompanied by a repeating alarm t...

Page 119: ... are listed in the table in chapter Alarm Cause Remedy on page 160 A maximum of 4 alarm messages can be displayed at the same time in a list Alarm messages with higher priority are displayed before alarm messages with lower priority Alarm messages with low priority are only displayed if the cause for a high priority alarm is remedied Color Priority of the alarm message Action required Red Warning ...

Page 120: ...D in the key A goes out Adjusting the alarm limits If an alarm is triggered due to a value falling below or exceeding the alarm limit it might be necessary to adjust the standard alarm limits More information for setting the alarm limits can be found in chapter Changing the alarm limits on page 141 Setting the alarm limits in current ventilation mode Press the key More information can be found in ...

Page 121: ... Consequences of incorrect O2 calibration 124 Deactivating the O2 monitoring 125 Breathing volume monitoring 126 Parameter field for breathing volume 126 Volume alarms 127 Setting the minute volume alarm limits 127 Deactivating the volume alarms 127 Airway pressure monitoring 128 Parameter field and waveform window for airway pressure 128 Setting the upper alarm limit and the pressure threshold 12...

Page 122: ... The inspiratory oxygen concentration is measured with a dual galvanic sensor which is located in the cover of the inspiratory valve see chapter Compact breathing system COSY top view on page 22 25411 A CAUTION Risk of inaccurate measured values If the O2 sensor is removed this can lead to leaks in the breathing system When the O2 sensor is replaced or removed it must be recalibrated NOTE If the a...

Page 123: ...tion in Setting the O2 alarm limits The standard alarm limits configured for the ventilation mode can be used unchanged see chapter Restoring the factory settings on page 142 or The alarm limits can be set individually for the current case 1 Press the A key The dialog window with the alarm limits B opens 2 Adjust the upper and lower alarm limit values of the O2 concentration C see setting ranges o...

Page 124: ...ts Fabius completes the calibration even with non optimal conditions This can have the consequence that the displayed measured sensor values indicate an O2 percentage that is higher or lower than the actual percentage During the entire calibration it must therefore be ensured that the O2 sensor is only exposed to ambient air The diagram illustrates the correlation between the air mixture during ca...

Page 125: ...ing are deactivated Parameter field for O2 monitoring Setting of O2 alarm limits Calibration of O2 sensor Alarm for the inspiratory O2 concentration and the O2 sensor The message No Integrated O2 Monitoring is displayed in the O2 monitoring window A 25481 NOTE If the internal FiO2 monitoring is deactivated an external FiO2 monitoring must be available in accordance with general safety standards A ...

Page 126: ...ume VT indicates the expiratory volume for every breath in milliliters mL The display range is between 0 mL and 1400 mL C The measured value for the minute volume MV continually indicates the volume of the gas breathed out in the past minute in liters per minute L min The display range is between 0 0 L min and 99 9 L min D Upper alarm limit of the minute volume in L min E Lower alarm limit of the ...

Page 127: ...G The volume alarm messages are automatically activated when changing from Standby mode in a ventilation mode Setting the minute volume alarm limits The standard alarm limits configured for the ventilation mode can be used unchanged see chapter Changing the alarm limits on page 141 or the alarm limits can be set individually for the current case 1 Press the A key The dialog window B with the alarm...

Page 128: ...Pa D Upper alarm limit E Pressure threshold F Pressure waveform G Pressure threshold as a line The pressure threshold is used for the detection of apnea disconnection and continuous pressure If the pressure waveform does not cross the pressure threshold either from above or below an alarm is sounded H Scale of the pressure waveform with display range from 0 to 20 0 to 50 or 0 to 100 cmH2O 0 to 20 ...

Page 129: ...141 or The alarm limits can be set individually for the current case 1 Press the A key The dialog window B with the alarm limits opens 2 Adjust upper alarm limit and pressure threshold of the peak pressure PEAK C see chapter Changing the alarm limits on page 141 3 Confirm new values 25411 25480 A B C C Volume Control NOTE The pressure threshold is preferably to be set so that the value lies approx...

Page 130: ...he default settings 138 Page Standby Set up 139 Changing the default settings 139 Changing the configurations 143 Configuration during operation 147 Switching the volume alarms on and off 148 Automatic setting of the pressure threshold 148 Calibrating the O2 sensor 149 Switching the desflurane compensation on and off 150 Automatic desflurane compensation 150 Accessing the alarm logbook 151 Clearin...

Page 131: ...shing It flashes until the Standby mode is confirmed 2 Confirm the new mode The ventilator changes to Standby mode The previous screen is replaced by the start screen Standby and the standby LED is continually lit The following softkeys C are displayed on the start screen 25411 25491 NOTE If the confirmation is not done within 15 seconds the ventilator remains in the previous mode and the pressure...

Page 132: ... is activated The screen is then replaced by the screensaver Press any key to end the screensaver Performing the system test In Standby mode a system test can be started This test corresponds to the test that is performed automatically after switching on the anesthesia workstation More information can be found in chapter Switching on on page 86 1 Press the Run System Test softkey A Electrical syst...

Page 133: ... the instructions on the screen At the start of the calibration the instructions are hidden and the following message is displayed above the standby softkeys B Flow Calibration in progress After the calibration one of the following two messages are displayed above the standby softkeys B Flow Calibration completed reconnect expiratory hose or Flow Calibration Failed Troubleshooting with failed flow...

Page 134: ...n the screen At the start of the calibration the instructions are hidden and the following message is displayed above the standby softkeys B O2 Calibration in progress After the calibration one of the following two messages are displayed above the standby softkeys B O2 Sensor Calibration completed reinsert O2 sensor or O2 Sensor Calibration Failed Troubleshooting with failed O2 calibration Replace...

Page 135: ...and Y piece The system compliance is required to ensure in Volume Control mode that the applied tidal volume corresponds to the set tidal volume The value of the compliance is displayed on the Standby screen Results of the ventilator leakage test The test of the ventilator leakage can have the following results 25463 21984 Standby A Standby B System compliance mL cmH2O Displayed result mL cmH2O 6 ...

Page 136: ... to fail contact DrägerService or the authorized local service partner System leakage mL min Displayed result mL min 250 Measured value and PASSED 251 to 350 Measured value and FAILED 350 350 and FAILED 21464 SLHFH RFFOXGHG XHU RFN FRQQHFWRU FORVHG 6HWWLQJ 30 3 3 3 E SDVV 3 YDOYH UHDWKLQJ EDJ 6FDYHQJLQJ 2 DEVRUEHU 9HQWLODWRU 9DSRUL HU UHVK JDV GHFRXSOLQJ 2 IOXVK ORZ WXEHV 2 WARNING Risk of unexpec...

Page 137: ... 1 Press the Access Alarm Log softkey A 2 To scroll through the alarm logbook B turn the rotary knob Clearing the alarm logbook Select Clear Alarm Log C and confirm Closing the alarm logbook Select the input arrow D and confirm The screen changes to Standby mode 25463 25495 A Standby B C D Standby CAUTION Risk of losing data All data in the alarm logbook are cleared in the following cases Fabius i...

Page 138: ...Defaults softkey A The default settings are restored The following message is displayed using the standby softkeys B Site Default settings restored The default settings can be adjusted on the Standby Set up screen Adjustment of the default settings is password protected 25463 WARNING Risk due to unsuitable ventilation settings After the default settings are restored check whether the settings for ...

Page 139: ...ault settings and configurations 1 Press the A key The Standby Set up screen opens 2 Select Default Settings B or Configuration C with the cursor By selecting and confirming with the input arrow D the screen changes back to the Standby screen Changing the default settings 1 On the Standby Set up screen select Default Settings A and confirm The screen with the password query opens 2 In the displaye...

Page 140: ...nd confirm Default settings for Volume Control 1 Select Volume Settings E and confirm 2 Press softkey F of the parameter to be changed 3 Select new value and confirm 4 If necessary repeat steps 2 and 3 for other parameters 5 Finally confirm all changes once again The window is closed the cursor is on the input arrow D Default settings for Pressure Control Pressure Support and SIMV PS Change the pa...

Page 141: ...ng ranges and factory settings are listed for all alarm limits of Fabius Changing the minimum alarm volume 1 Select Minimum Alarm Volume K and confirm The current minimum alarm volume L is displayed on the screen 2 Set the new minimum alarm volume to a value between 1 minimum and 10 maximum and confirm The window is closed the cursor is on the input arrow J 22109 Alarm parame ter Setting range Fac...

Page 142: ...Parameter Factory setting 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 TE 1 2 0 Insp Flow 30 PEEP 0 M N Standby Set up Pressure Support PPS 10 Freq Min 3 Trigger 2 Insp Flow 30 PEEP 0 SIMV PS PMAX 40 VT 600 Freq 12 PPS 10 PEEP 0 Trigger 2 Insp Flow 30 TINSP 1 7 TIP TI 10 Alarm limits for O2 Upper value 100 Lower value 20 Alarm limits for M...

Page 143: ... Set Time Format Date Set Date Format Language Pressure Unit Acoustic Confirmation Waveform Display Display Background To return to the Standby Set up screen select the input arrow A and confirm Changing the time 1 Select Time Set B and confirm The cursor is in the hour field 2 Select new value and confirm The cursor moves to the minute field 3 Select new value and confirm The window is closed 221...

Page 144: ... Select Date Set D and confirm 2 Select new value and confirm The window is closed Changing the date format 1 Select Date Format E and confirm 2 Select new format and confirm The window is closed Changing the language 1 Select Language F and confirm 2 Select language and confirm The window is closed 22129 22131 Standby Set up C Standby Set up D 22133 22135 Standby Set up E Standby Set up F ...

Page 145: ...ted hPa cmH2O mbar kPa 2 Select new unit and confirm The window is closed Activating the acoustic confirmation When the function Acoustic Confirmation is switched on a tone is sounded when pressing the rotary knob 1 Select Acoustic Confirmation H and confirm 2 Select On or Off and confirm The window is closed 22136 Standby Set up G 22137 Standby Set up H ...

Page 146: ...The window is closed When the setting Normal is selected the pressure waveform J is not shown as a filled area but as a line Changing the screen brightness 1 Select Display Background K and confirm 2 Select Light or Dark screen brightness and confirm The window is closed 22139 25496 Standby Set up I Volume Control J available only with optional color screen 22143 Standby Set up K ...

Page 147: ...settings Changing configurations The pressure waveform is no longer displayed The following softkeys C are displayed on the screen e g in Volume Control mode Volume Alarms ON OFF Auto Set Calibrate O2 Sensor DesComp ON OFF Access Alarm Log Access Alarm Volume If no change is made within 15 seconds the pressure waveform is displayed again Pressing the key B will also cause the pressure waveform win...

Page 148: ...sure threshold for the peak pressure PEAK is set to 4 cmH2O hPa below the current plateau pressure PLAT 25505 NOTE The function Volume Alarms ON OFF is available in the standard view of the ManSpont mode If the key is pressed in ManSpont mode the softkey Volume Alarms ON OFF is not displayed Volume Control A 25505 NOTE The pressure threshold must not be below 5 cmH2O 5 hPa or above 30 cmH2O 30 hPa...

Page 149: ...n the O2 value in the window B of the O2 monitoring is replaced by the word CAL The calibration time is approx 15 seconds After successful calibration the O2 measured value is again displayed If the calibration was not successful replace the O2 sensor capsule in the O2 sensor housing see chapter Inserting a new O2 sensor capsule on page 78 If the calibration continues to fail contact DrägerService...

Page 150: ...h desflurane is not being used the accuracy of the volume measurement can be influenced Only switch on desflurane compensation if desflurane is used CAUTION Risk of inaccurate measured values If an anesthetic gas monitor is used the automatic desflurane compensation is activated Faulty anesthetic gas monitors can influence the accuracy of the measured volume Make sure that the anesthetic gas monit...

Page 151: ...ssage Des auto in the status bar A is no longer displayed The softkey DesComp OFF B is displayed To switch the desflurane compensation back on Press the DesComp OFF softkey B The label of the softkey changes to DesComp ON Accessing the alarm logbook 1 Press the AccessAlarm Log softkey A 2 To scroll through the alarm logbook D turn the rotary knob Clearing the alarm logbook Select Clear Alarm Log C...

Page 152: ...firm The lower value is limited by the setting in the standby configuration see chapter Changing the minimum alarm volume on page 141 The pressure waveform and softkeys are displayed again WARNING Risk of not hearing the alarm tone When operating in a loud environment the acoustic alarm signals may not be heard Always set the alarm tone to a sufficient volume 25505 25509 A Volume Control Volume Co...

Page 153: ...ing leakages 154 Possible causes of leakage 154 Systematic localization of leakages 155 Power supply failure 156 Mains power supply failure 156 Ventilator failure 158 Alarm VENTILATOR FAIL 158 Failure of the O2 sensor 159 Causes for faulty calibration 159 Low O2 supply 159 Alarm Cause Remedy 160 ...

Page 154: ...or missing The flow sensor is incorrectly installed or damaged The rear O ring is missing The valves or seals of the breathing system are damaged The cone for occluding the Y piece is scratched or damaged The filling or emptying connections on the vaporizer are leaking or are open The vaporizer is incorrectly fitted The O ring is missing or damaged The control dial is not in the 0 position CAUTION...

Page 155: ...e test on page 135 2 Contact service personnel if the leakages cannot be localized Component Measure Sample line Remove the sample line Occlude the Luer Lock con nector on the Y piece Breathing hoses Disconnect the breathing hoses Connect the inspiratory port and expiratory port with a hose that is known to be with out leakages Connect the breathing bag directly to the breathing system Vaporizers ...

Page 156: ...is replaced by the alarm BATTERY LOW Shortly before the battery is empty the ventilator is switched off and the alarm VENTILATOR FAIL is displayed in the alarm window If no manual ventilation follows the following alarm messages are displayed APNOEA PRESSURE APNOEA FLOW MINUTE VOLUME LOW The monitoring functions remain in operation until the battery is completely discharged and all electronic comp...

Page 157: ...ible Manual ventilation Spontaneous breathing All pneumatic functions of Fabius are still available APL valve Pressure gauge for the airway pressure Pressure gauge for gas cylinders and central gas supply Fresh gas supply and anesthetic agent delivery S ORC Flow control valves for O2 Air and N2O WARNING Incorrect patient settings When the power supply is restored and Fabius is restarted all ventil...

Page 158: ...or must be bypassed so that the ventilation can be continued The ventilator does not return to its initial state after a malfunction and The spontaneous breathing mode cannot be activated To bypass the ventilator proceed as follows 1 Set the On Off switch on the rear of Fabius to off 2 Set the On Off switch back to on Fabius restarts and performs a selftest More information on the selftest can be ...

Page 159: ...Cause Remedy During the calibration the O2 sensor was exposed to an air mixture with extremely high or low oxygen concentration Make sure that the O2 sensor is exposed to ambi ent air during the entire calibration During the calibration the O2 sensor was exposed to an air mixture with fluctuating oxygen concentra tion Make sure that the O2 sensor is exposed to ambi ent air during the entire calibr...

Page 160: ...messages are assigned internal priorities In the following table these internal priorities are indicated as numbers The alarm message with the highest priority has the number 31 The lower the priority the lower the number The table shows possible causes for an alarm and corresponding remedies Causes and remedies must be worked through in the order listed until the alarm has been resolved The alarm...

Page 161: ...breathing sys tem or the alarm limit 23 31 APNOEA FLOW The apnea flow alarm based on a time staggering In the Volume Control Pressure Control SIMV PS modes with Freq 6 or in Pressure Support mode with apnea ventilation deacti vated Caution VT 20 mL for 15 seconds In the ManSpont SIMV PS modes with Freq 6 or in Pressure Support mode with apnea ventilation acti vated Caution VT 20 mL for 30 seconds ...

Page 162: ...q 6 or in Pressure Support mode with apnea ventilation deacti vated Warning VT 20 mL for 30 seconds In the ManSpont SIMV PS modes with Freq 6 or in Pressure Support mode with apnea ventilation acti vated Warning VT 20 mL for 60 seconds Breathing ventilation stopped Check ventilator Leakage or disconnection in the breathing system Check breathing system Alarm priority Alarm Cause Remedy ...

Page 163: ...lation deacti vated Caution PAW did not exceed the pressure thresh old value for a duration of 15 seconds In the ManSpont SIMV PS modes with Freq 6 or in Pressure Support mode with apnea ventilation acti vated Caution PAW did not exceed the pressure thresh old value for a duration of 30 seconds Breathing ventilation stopped Check ventilator Leakage or disconnection in the breathing system Check br...

Page 164: ...old value for a duration of 60 seconds Breathing ventilation stopped Check ventilator Leakage or disconnection in the breathing system Check breathing system 20 APNOEA VENTILATION Breathing ventilation stopped Check ventilator Leakage or disconnection in the breathing system Check breathing system If two or more successive breaths of the apnea ventila tion are automatically trig gered the settings...

Page 165: ...e for the pressure threshold value 5 EXP PORT LEAKAGE In mode Volume Control Pressure Control or Pres sure Support an expiratory flow of more than 15 mL was measured during the inspira tion Check expiratory valve and valve disk Check hose line of the expiratory control line Check flow sensor Perform the procedure for calibration of the flow sen sor see page 133 Con tact DrägerService or the author...

Page 166: ...system 13 INSP O2 HIGH Inspiratory O2 concentration is above the upper alarm limit Check the setting of the flow control valve and upper O2 alarm limit 31 INSP O2 LOW Inspiratory O2 concentration is below the lower alarm limit Check O2 supply Check the setting of the flow con trol valve and lower O2 alarm limit 11 INSP PRES NOT REACH The plateau pressure during ventilation in Pressure Con trol Pre...

Page 167: ...valve for fresh gas delivery 6 O2 SENSOR CAL DUE More than 18 hours have passed since the last O2 sen sor calibration Perform the procedure for calibration of the O2 sensor see page 134 8 O2 SENSOR FAIL The O2 sensor was not cor rectly calibrated Perform the procedure for calibration of the O2 sensor see page 134 O2 sensor replaced and or not calibrated Perform the procedure for calibration of the...

Page 168: ...ings for PMAX 25 PRESSURE NEGATIVE The measured PAW value is 6 5 cmH2O hPa Check the breathing sys tem and ventilator settings 8 PRESSURE SENSOR FAIL Sensor faulty or pressure not calibrated Contact DrägerService or the authorized local service partner 1 RS232 COM1 FAIL External monitor cable not connected with external com munication connector 1 Check connection cable of the monitor 1 SPEAKER FAI...

Page 169: ... expiratory valve 172 Removing the exhaust port 172 Removing the flow sensor 173 Removing the APL valve 173 Removing the ventilator parts 173 Removing the anesthetic gas receiving system 173 Removing the endotracheal suction system 174 Reprocessing procedures 174 Classification of medical devices 174 Testing of procedures and agents 174 Non critical medical devices 175 Semi critical medical device...

Page 170: ...Disassemble the breathing circuit and the filters 10 Unscrew the holder for the breathing bag 11 Remove the compact breathing system Remove the breathing system cover optional Remove the inspiratory valve Remove the expiratory valve Unscrew the exhaust port Unscrew the inspiratory port and the expiratory port Remove the flow sensor Unscrew the APL valve 12 Remove the ventilator parts WARNING Risk ...

Page 171: ...Sensors and cables IT systems AGS Single use articles without instructions for use Soda lime dust filter optional Sample line WARNING Risk of infection Used sample lines may be infectious due to the breathing gases that passed through them Replace the sample lines regularly see table Semicritical medical devices CAUTION Material damage due to disinfectants When the sample line is disinfected and r...

Page 172: ...ose PEEP PMAX hose Removing the inspiratory valve 1 Remove the valve cover plug B or the O2 sensor from the dome C of the inspiratory valve 2 Screw off the cap nut A 3 Remove the dome C 4 Take out the valve plate D 5 Remove the sealing ring E from the socket F Removing the expiratory valve 1 Screw off the cap nut G 2 Remove the sight glass H 3 Take out the valve plate I 4 Remove the sealing ring J...

Page 173: ...emove the valve Removing the ventilator parts 1 Open the ventilator door 2 Remove the pressure sensor line B of the ventilator chamber from the corresponding connection 3 Release the 3 clamps D 4 Remove the cover A 5 Remove the ventilator membrane C Removing the anesthetic gas receiving system To disassemble follow the steps in reverse order as listed in chapter Connecting the anesthetic gas recei...

Page 174: ...sing the following procedures and agents The following agents showed good material compatibility and effectiveness at the time of the test Non critical medical devices Manual disinfection with simultaneous cleaning Incidin Extra N from Ecolab Incidur from Ecolab Semi critical medical devices Manual cleaning Neodisher FA Neodisher Medizym from Dr Weigert Manual disinfection Korsolex extra from Bode...

Page 175: ...e cleaned can be reached Use suitable brushes if necessary 3 Thoroughly rinse components under running water until cleaning agent residues are no longer discernible 4 Inspect components for visible soiling and damage Repeat manual cleaning if necessary Manual disinfection When selecting a suitable disinfectant adhere to the country specific lists of disinfectants The list of the German Association...

Page 176: ...thoroughly Visual inspection Check all parts for damage and external wear such as cracking brittleness or severe hardening and remnants of contamination WARNING Risk of device failure If the control areas located in the valve plate are not sufficiently dried this may compromise the device function or may lead to failure of the medical device After cleaning the breathing system must be sterilized w...

Page 177: ... accordance with DIN EN 285 preferably with fractional vacuum WARNING Risk of fire Residual vapors of easily flammable disinfectants e g alcohols and deposits that were not removed during reprocessing can ignite when the flow sensor is in use Ensure particle free cleaning and disinfection After disinfection allow the flow sensor to air for at least 30 minutes Before inserting the flow sensor check...

Page 178: ...infection control officer responsible have priority Uncritical medical devices Items which can be reprocessed Recommended repro cessing intervals Manual Cleaning Disinfection Control elements and device sur faces including Screen Softkeys Rotary knob O2 flush key Flow control valves APL valve Writing tray Grip bar on trolley Drawer handles Standard rails on both sides Clic adapter Clic absorber Af...

Page 179: ...ins plug Gas cylinder valves Transfer hose of the anes thetic gas receiving system Cables and hoses that lie on floor Brake Daily Outside Outside Surfaces which are touched less frequently Network cables and data cables Compressed gas hoses Pressure reducers Gas cylinders Drawer surfaces outside and inside Anesthetic gas receiving sys tem Holder for sample line Weekly Outside Outside Items which c...

Page 180: ...sible Possible Possible Breathing hoses After each patient Observe the associated instructions for use Absorber container and absorber insert Weekly Yes Yes Possible Possible Possible Soda lime dust filter optional Replace each time soda lime is changed No No No No No Sample line Replacement only No No No No No When the sample line is fitted to the filter on the Y piece Daily When the sample line ...

Page 181: ...2 Mount the parts in the reverse oder of the disassembly see Disassembly on page 170 3 Check readiness for operation see Checking the readiness for operation on page 88 Flow sensor Weekly Observe the associated instructions for use Items which can be reprocessed Recommended reprocessing intervals Pre cleaning Machine cleaning and disinfection Manual Steriliza tion Cleaning Disinfec tion ...

Page 182: ...Maintenance 182 Instructions for use Fabius plus SW 3 n Maintenance Overview 183 Inspection 184 Safety checks 184 Preventive maintenance 185 Repair 186 ...

Page 183: ... remove the housing cover Maintenance measures must be performed by the personnel responsible Dräger recommends DrägerService for repairs and complex maintenance tasks WARNING Risk of fire When replacing the battery short circuits or excessive temperatures can occur resulting in fire or explosion The battery must only be replaced by experts Term Definition Maintenance All measures inspection preve...

Page 184: ...eck that the device combination is in good condition All labels are complete and legible There is no visible damage Fuses which are accessible from the outside are in compliance with the specified values Country specific labeling of gas types 4 Using the instructions for use check that all components and accessories needed to use the product are available 5 Check for electrical safety in complianc...

Page 185: ...nterval Measure Personnel responsible CO2 absorber If colored violet Replace Users Water trap As needed or if soiled Replace Users Flow sensor As needed or if calibration is no longer possible Clean Replace Users Internal lithium battery Every 36 months Replace Experts Fabius plus Every 12 months Inspection and service Experts Breathing system Every 12 months Inspection and service Service personn...

Page 186: ...Maintenance 186 Instructions for use Fabius plus SW 3 n Repair For repairs Dräger recommends DrägerService and the use of original Dräger parts ...

Page 187: ... for use Fabius plus SW 3 n 187 Disposal Disposal Disposing of the medical device 188 For countries subject to the EU Directive 2002 96 EC 188 Disposal of accessories 188 Disposal of non rechargeable batteries 189 ...

Page 188: ...nitiate collection or for further information visit Dräger on the Internet at www draeger com Use the search function with the keyword WEEE to find the relevant information If access to the Dräger website is not possible contact the local Dräger organization Disposal of accessories When disposing of the following accessory parts observe the hospital hygiene regulations and the respective instructi...

Page 189: ...ining toxic material to the distributor or the public waste management organization The battery used in this device must therefore be removed by experts prior to disposal of the device In countries other than Germany the respective national regulations must be complied with WARNING Risk of explosion and chemical burns Improper handling of batteries can result in explosions and chemical burns Do no...

Page 190: ... acoustic signals 206 S ORC Sensitive Oxygen Ratio Controller 207 Device outlets 207 Essential performance characteristics 208 EMC declaration 209 General information 209 Electromagnetic emissions 209 Electromagnetic environment 210 Electromagnetic immunity 211 Recommended safety clearance for portable and mobile high frequency communication equipment 213 Reduced safety clearance for portable and ...

Page 191: ...ment value 4 at standard conditions At 10 C the accuracy changes to 6 at 10 C and 20 relative humidity to 8 All patient related volumes and flow values are nor malized to the conditions in the lungs BTPS During operation Temperature 10 to 35 C 50 to 95 F Air pressure 700 to 1060 cmH2O hPa Relative humidity 20 to 80 without condensation Height Up to 3000 m 9843 ft During storage and transport Tempe...

Page 192: ...ssure at the device connection O2 N2O 73 psi 5 kPa x 100 Every gas inlet is equipped with a non return valve Medical gas supply from O2 O2 and N2O or O2 and Air cylinders with pin index connections Cylinder connection Pin index hanger yokes CGA V 1 1994 Gas cylinder pressure O2 Air 1900 psi 131 kPa x 100 normal full load at 21 C 70 F N2O 745 psi 51 3 kPa x 100 Pressure gauge for gas cylinders In a...

Page 193: ...devices 10 134 GMDN Code Global Medical Device Nomencla ture worldwide nomenclature for medical devices 37710 Use of latex Not made with natural rubber latex Penetration of liquids IP20 in accordance with IEC 60529 Power supply The power rating cannot be configured with optional Dräger power socket strip see instructions for use of power socket strip for medical devices 9038776 100 to 240 VAC 50 6...

Page 194: ...s trolley version Basic device with COSY but no gas cylinders or vaporizers 110 kg 242 5 lb Total weight including all accessories 280 kg 617 3 lb Dimensions W x H x D Trolley version with compact breathing system and 2 vaporizer mounts1 91 x 140 x 77 cm 35 8 x 55 x 30 3 in Wall mounted version with compact breathing sys tem and 2 vaporizer mounts1 85 x 73 x 50 cm 33 5 x 28 7 x 19 7 in 1 Width var...

Page 195: ...x T2 5AH 250 V IEC 60127 2 V Size Length 20 mm ø5 mm glass 4 4 mm Battery fuse 1x T3 15AH 250 V IEC 60127 2 V Size Length 20 mm ø5 mm glass 4 4 mm Connection 22 mm outer taper 15 mm inner taper ISO Pressure limitation Max 80 cmH2O hPa at 18 L min Fresh gas flow 0 and 0 2 to 18 L min In compliance with UL 60601 1 IEC 60601 1 CAN CSA C22 2 No 601 1 M90 ...

Page 196: ...neral requirements for safety collateral stan dard Programmable electrical medical systems IEC 60601 1 8 Medical electrical equipment Part 1 8 General requirements for safety collateral stan dard General requirements tests and guidance for alarm systems in medical electrical systems IEC 60601 2 13 Medical electrical equipment Part 2 13 Particular requirements for the safety of anaesthetic systems ...

Page 197: ...t 1 2 General requirements for safety collateral stan dard Electromagnetic compatibility Requirements and tests IEC 60601 1 8 Part 1 8 General requirements for basic safety and essential performance collateral standard General require ments tests and guidance for alarm systems in medical equipment and medical electrical systems ISO 80601 2 13 Medical electrical equipment Part 2 13 Particular requi...

Page 198: ...ve end expiratory pressure PEEP 0 to 20 cmH2O resolution 1 cmH2O 0 to 20 hPa resolution 1 hPa Inspiratory pressure PINSP 5 to 65 cmH2O resolution 1 cmH2O 5 to 65 hPa resolution 1 hPa setting must be at least 5 cmH2O 5 hPa above PEEP Inspiratory flow Insp Flow 10 to 75 L min resolution 1 L min in Pressure Control mode 10 to 85 L min resolution 1 L min in Pressure Support and SIMV PS modes Support p...

Page 199: ...TE 5 of the setting Inspiratory pause TIP TI 25 of the setting Positive end expiratory pressure PEEP 2 cmH2O 2 hPa or 20 of the setting depending on which value is higher Inspiratory pressure PINSP 2 cmH2O 2 hPa or 20 of the setting depending on which value is higher Overpressure safety valve 75 5 cmH2O 75 5 hPa Underpressure safety valve inlet valve for ambi ent air 7 5 to 9 cmH2O 7 5 to 9 hPa Mi...

Page 200: ...een 1 and 12 L min Fresh gas flow stability O2 and N2O 10 of the setting at supply pressures of 41 to 87 psi 2 8 to 6 kPa x 100 Air 10 of the setting at supply pressures of 50 to 55 psi 3 4 to 3 8 kPa x 100 Outside the range of 50 to 55 psi 3 4 to 3 8 kPa x 100 the Air flow varies proportionally to the supply pressures O2 flush at 87 psi 6 kPa x 100 max 75 L min at 41 psi 2 8 kPa x 100 min 25 L mi...

Page 201: ...lurane Dräger D Vapor Technical data of the vaporizers are contained in the corresponding instructions for use Measured value or waveform Range Resolution Accuracy Condition PAW Airway pressure numeric 20 to 99 cmH2O hPa 1 cmH2O hPa 4 1 Airway pressure waveform 0 to 99 cmH2O hPa Pressure gauge mechanical 20 to 80 cmH2O hPa 2 cmH2O hPa 1 28 cmH2O hPa MVe Expiratory minute volume 0 to 32 0 L min 0 1...

Page 202: ...2 hPa depending on which value is higher 2 With standard test conditions in accordance with ISO 80601 2 13 O2 sensor Response time T90 Less than 16 seconds Measured values are not pressure compensated Heat up time after 5 minutes Error with 3 of the measured value Drift sensitivity 1 of the measured value 8 h Cross sensitivity 1 Vol O2 at 70 Vol N2O and 5 Vol CO2 With 4 Vol halothane or with 5 Vol...

Page 203: ... absorber CLIC absorber Free 1200 mL Disposable CO2 absorber CLIC Absorber 800 Free 1200 mL Compliance including ventilator hose without breathing hoses 0 8 mL cmH2O 0 8 mL hPa Flexible arm for breathing bag optional Volume 0 13 L Compliance 0 13 mL cmH2O 0 13 mL hPa Rigid arm for breathing bag optional Volume 0 11 L Compliance 0 11 mL cmH2O 0 11 mL hPa Resistance In accordance with ISO 80601 2 13...

Page 204: ...mode 5 to 70 cmH2O hPa Spontaneous breathing mode 1 5 cmH2O hPa Accuracy from 5 to 15 L min 15 of the set value or 3 cmH2O hPa the higher value applies Pressure drop at 30 L min 3 4 cmH2O hPa wet and dry 1 Depending on the current ventilation settings the indicated values may deviate by 0 3 cmH2O 0 3 hPa ...

Page 205: ... use Fabius plus SW 3 n 205 Technical data 22229 62 3UHVVXUH IORZ FKDUDFWHULVWLFV RI WKH FRPSDFW EUHDWKLQJ V VWHP 26 DYHUDJH UHVLVWDQFHV ZLWKRXW EUHDWKLQJ KRVHV 3UHVVXUH K3D ORZ PLQ QVSLUDWRU SUHVVXUH SLUDWRU SUHVVXUH ...

Page 206: ...easured in accordance with IEC 60601 1 8 Alarm volume high priority Settable from approximately 57 dB A to 70 dB A Alarm volume medium priority Settable from approximately 52 dB A to 64 dB A Alarm volume low priority Settable from approximately 49 dB A to 62 dB A Alarm in the event of failure of power supply and battery supply Continuous tone approx 30 s at approx 56 dB A Confirmation of selection...

Page 207: ...closed or set at less than 0 2 L min S ORC prevents N2O flow In case of N2O failure O2 can continue to be supplied No alarm Serial interfaces COM 1 Only connect to devices that meet the require ments of IEC 60950 1 for ungrounded SELV circuits and the requirements of IEC 60601 1 as of the 2nd edition for exposed secondary circuits with maximum 24 Vdc nominal voltage Protocol Vitalink MEDIBUS Conne...

Page 208: ...g gas contains insufficient levels of O2 an alarm is issued Monitoring of the airway pressure and the expiratory minute volume Alarms are issued depending on the set alarm limits Measurement accuracy of the O2 measurement Alarms are issued depending on the set alarm limits If the O2 sensor fails an alarm is issued Pin assignment Pin 1 n c Pin 2 TXD Pin 3 RXD Pin 4 n c Pin 5 GND Pin 6 n c Pin 7 n c...

Page 209: ... with CISPR emission requirements can interfere with reception of wireless data When selecting wireless systems wireless communication media pager systems etc for use in installations where wireless networking is used care must always be used to ensure that operating frequencies are compatible For example selecting wireless communication media that operate at 2 4 GHz will likely cause difficulty w...

Page 210: ...ical device uses radio frequency energy only for its internal function Therefore its radio frequency emissions are very low and are not likely to cause any interference in nearby electronic equipment Class A The medical device is suitable for use in all establishments other than domestic establishments and those directly connected without transformer to the public low voltage power supply net work...

Page 211: ...r hospital environment Longer input lines out put lines 1 kV 1 kV Surges IEC 61000 4 5 Common mode 2 kV 2 kV Mains voltage quality should be that of a typical commer cial or hospital environment Differential mode 1 kV 1 kV Magnetic field with sup ply frequency 50 60 Hz IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital e...

Page 212: ...50 kHz to 80 MHz 3 V outside ISM bands2 3 V 1 For PEIRP insert the highest possible equivalent isotropic radiated power of the adjacent radio frequency transmitter In the vicinity of equipment marked with the symbol interference can occur Field strengths from fixed portable or mobile radio frequency transmitters at the location of the medical device should be less than 3 V m in the frequency range...

Page 213: ...r frequen cies Examples 0 03 0 32 m 1 1 ft 0 96 m 3 2 ft WLAN 5250 5775 Europe 0 10 0 58 m 1 9 ft 1 8 m 5 9 ft WLAN 2440 Europe 0 17 0 76 m 2 5 ft 2 3 m 7 6 ft Bluetooth RFID 2 5 GHz 0 20 0 82 m 2 7 ft 2 5 m 8 2 ft WLAN 5250 not in Europe 0 25 0 92 m 3 0 ft 2 8 m 9 2 ft UMTS mobiles 0 41 1 2 m 3 9 ft 3 5 m 12 ft Cordless DECT devices 0 82 1 7 m 5 6 ft 5 0 m 16 ft RFID 13 56 MHz 1 00 1 8 m 5 9 ft 5...

Page 214: ...ust ensure that the device combination complies with the applicable editions of the relevant standards for medical devices Device combinations approved by Dräger meet the requirements of the following standards as applicable IEC 60601 1 3rd edition general requirements for safety device combinations software controlled functions IEC 60601 1 2 electromagnetic compatibility IEC 60601 1 8 alarm syste...

Page 215: ...e consulted in advance The following documents must be followed Accompanying documents of this device Descriptions of the network interface Description of the network based alarm systems Dräger recommends complying with IEC 80001 1 risk management for IT networks with medical devices Serial interfaces The following interfaces are supported RS232 interfaces complying with EIA RS 232 CCITT V 24 V 28...

Page 216: ...6 Instructions for use Fabius plus SW 3 n Illustrations Gas flow plan of the breathing system 22234 6HWWLQJ 30 3 3 9HQWLODWRU UHVK JDV UHVK JDV GHFRXSOLQJ 2 DEVRUEHU UHDWKLQJ EDJ 3 E SDVV 3 YDOYH UHDWKLQJ JDV VFDYHQJLQJ ...

Page 217: ...Instructions for use Fabius plus SW 3 n 217 Technical data Gas delivery unit 3 gas version 25537 RPPRQ JDV RXWOHW N3D N3D N3D N3D ORZ WXEHV 2 1 2 9DSRUL HU 2 IOXVK 6 25 2 2 2 1 2 1 2 ...

Page 218: ...Annex 218 Instructions for use Fabius plus SW 3 n Annex Form for daily checkout and pre use checkout 219 Checklist 220 ...

Page 219: ...tarting the check no additional components may be added and no changes may be made to the anesthesia workstation This is a recommendation The checking guidelines of the respective healthcare facility must be followed CAUTION If one of the checks does not pass the device must not be used Contact DrägerService or the responsible service partner NOTE The following applies in this section cmH2O mbar h...

Page 220: ...g O2 monitor ing and external monitors e g breathing gas monitor are switched on and function ing The system test for Fabius has been per formed P The sample line for gas monitoring if present is connected to the Luer Lock connection on the Y piece P An appropriate anesthetic agent was selected P D Vapor if present is switched on Battery P Make sure that the battery is completely charged Battery o...

Page 221: ...ensors Remove the O2 sensor housing from the cover of the inspiratory valve Expose the O2 sensor to ambient air for 2 minutes Start the calibration Insert the O2 sensor housing back in the cover of the inspiratory valve Calibrate the flow sensor Check type of gas Set the O2 flow control valve to 3 L min Check whether the measured O2 concen tration is at approx 90 to 100 Vol Close the O2 flow contr...

Page 222: ...he leakage test After the leakage test has ended switch off the D Vapor again Change to Standby mode and then press the Leak ComplTest softkey Follow the instructions on the screen If the system has leakage the pressure drops Check all plug connections and screw con nections for a tight seat Replace missing or damaged seals If nec essary contact DrägerService or the authorized local service partne...

Page 223: ...d ule are functional Anesthetic gas scavenging system P Hoses are correctly connected P Set the flow control valve on the anes thetic gas receiving system so that the float is located between the Min and Max marks P Occlude the Y piece Close all flow control valves P Change to the Standby screen Set the APL valve to spontaneous breathing Turn the APL valve head counterclockwise until the Spont mar...

Page 224: ...o the desired pres sure All fresh gas flow indicators show 0 The scavenging flow of the endotracheal suction is present The breathing system is ready for opera tion the breathing bag is correctly posi tioned and all hoses are correctly connected CO2 absorber is present on the device and is adequately filled Signature for the daily checkout Name Date Signature for pre use checkout Name Date Signatu...

Page 225: ...te Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date ...

Page 226: ...te Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date Signature for pre use checkout Name Date ...

Page 227: ...ation password Information for the configuration password To prevent unauthorized alteration the default settings of Fabius plus are protected by a 4 digit password For information on the start settings see page 139 The configuration password appears on this page of the instructions for use Cut out the area with the password and keep in a place which is safe from access by unauthorized persons Upo...

Page 228: ...228 Instructions for use Fabius plus SW 3 n This page intentionally left blank ...

Page 229: ... Bag elbow 69 Flexible arm 68 Rigid arm 69 Breathing hose configurations 75 Breathing hoses and filters 72 Breathing system 203 Assembling 61 Breathing volume monitoring 126 C Checklist 219 CO2 absorber Mounting 62 Reusable 62 CO2 absorber Disposable with CLIC adapter 64 Compact breathing system Connecting 66 Removing 172 Compact breathing system COSY 22 Compliance 76 Configuration Automatically s...

Page 230: ... 35 110 F Flow sensor Calibrating 133 Connecting 80 Inserting 67 Removing 173 Fresh gas delivery 47 Fresh gas flow Setting 90 Fuses 195 G Gas cylinders screw connections 58 Gas flow plan 216 Gas supply 54 I Indications 17 Intended use 16 Interfaces 33 IT networks 215 L Leakages 154 LED indicators 48 Low flow anesthesia 94 M Mains power supply Connecting 52 Maintenance intervals 185 Manual resuscit...

Page 231: ...cessing 175 Sensors and measurement lines 79 Setting the anesthetic gas concentration 92 Soda lime Replacing 95 Softkeys 43 Spontaneous breathing 96 Sterilization 177 Storage 115 Suction system Connecting 70 Removal 174 Symbols 38 S ORC 90 207 T Transport 115 V Vaporizer 28 Vaporizer interface 201 Ventilation 96 Ventilation mode Changing 45 ManSpont 96 Ventilation mode Pressure Control 101 Ventila...

Page 232: ...ctions for use are provided for customer information only and will only be updated or exchanged upon customer request Directive 93 42 EEC concerning medical devices Manufacturer Dräger Medical GmbH Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 2080 http www draeger com As of 2015 08 Dräger Medical GmbH changes to Drägerwerk AG Co KGaA 9054673 GA 5330 450 en Dräger Med...

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