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Supplement to the instructions for use

Supplement

Fabius plus SW 3.n

Fabius

plus

Anesthesia workstation

Supplement to the instructions for use



Keep this supplement with the instructions for

use of the medical device.

The supplement updates the information of the

instructions for use in the following chapters:

Trademarks

The following trademarks have been added:

Device

Part number

Edition

Fabius Plus

9054673

Up to 1. Edition

Trademark

Trademark owner

Actichlor

Ecolab

BruTab 6S

Brulin

Buraton

Schülke & Mayr

Mikrozid

Perform

Descogen

Antiseptica

Dismozon

Bode Chemie

Klorsept

Medentech

Oxycide

Ecolab USA

Virkon

DuPont

Содержание 9054673

Страница 1: ...Supplement Fabius plus WARNING To properly use this medical device read and comply with the instructions for use and this supplement Anesthesia workstation Software 3 n ...

Страница 2: ...al device The supplement updates the information of the instructions for use in the following chapters Trademarks The following trademarks have been added Device Part number Edition Fabius Plus 9054673 Up to 1 Edition Trademark Trademark owner Actichlor Ecolab BruTab 6S Brulin Buraton Schülke Mayr Mikrozid Perform Descogen Antiseptica Dismozon Bode Chemie Klorsept Medentech Oxycide Ecolab USA Virk...

Страница 3: ... are other signs that the accessories are not sterile Reuse reprocessing and sterilization of disposable products is not permitted WARNING Risk due to electrostatic discharge Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situations When touching the pins of connectors that carry the ESD warning symbol When e...

Страница 4: ...adiation When such devices are operated too close to this device or its cables the functional integrity of this device may be compromised by electromagnetic disturbances As a result the patient could be put at risk Maintain a distance of at least 0 3 m 1 0 ft between this device and wireless communication devices to ensure that the essential performance of this device is fulfilled Maintain an adeq...

Страница 5: ...ansport 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 does not bump against anything Remove any devices mounted to the holding arms or the top of the device Clear the writing tray and slide it completely into the device Do not pull the medical device over hoses cables or other obstacle...

Страница 6: ...e alarm volume loud enough so that the alarm signals can be heard in the environment where the device is located The user must remain within earshot of the alarm signals NOTE The use of a serial interface for an analog or optical link and the routing of data via the MEDIBUS or Vitalink protocol to external devices systems or networks LAN WLAN PDMS etc is the responsibility solely of the system man...

Страница 7: ... Fabius plus SW 3 n 7 Overview The views of the power supply unit for the COSY heater have changed Power supply unit for COSY heating front view A LED indicator for COSY heating B On Off switch C Fuse 21014 A B C ...

Страница 8: ...Overview 8 Supplement 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 ...

Страница 9: ...r inlet has changed 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 G Power inlet with power fuses H On Off switch I Fuse for internal battery J Potential equalization pin 25301 A B C D E F G H I J ...

Страница 10: ...ISO 80601 2 13 and IEC 60601 1 with regard to tipping stability and transport stability Precautionary measures must be taken The medical device may tip over if handled incorrectly The medical device may only be moved by people who have the physical ability to do so Use 2 persons to transport the device Make sure that there is sufficient clear space Remove any devices mounted on attached support ar...

Страница 11: ... 80601 2 13 and IEC 60601 1 with regard to tipping stability and transport stability Precautionary measures must be taken The medical device may tip over if handled incorrectly The medical device may only be moved by people who have the physical ability to do so Use 2 persons to transport the device Make sure that there is sufficient clear space Remove any devices mounted on attached support arms ...

Страница 12: ...h and ventilator lock option 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 APL bypass hose for the ventilator lock D Short fresh gas hose on compact breathing system E Compact breathing system F Sample line G Non rebreath...

Страница 13: ...iation Explanation RI Revision Index STPD Standard Temperature and Pres sure Dry 20 C 68 F 1013 hPa dry gas Symbol Explanation Applied part of type BF body floating Applied part of type B Keep free of oil and grease DC voltage AC voltage Fragile handle with care Keep dry Connection for sample gas return line The fiollowing symbol has been deleted Caution Risk of electric shock Do not remove cover ...

Страница 14: ...the weight of the nominal configuration and the total permissi ble weight see chapter Technical data Use of the external fresh gas outlet with an addi tional switch When a controlled ventilation mode Volume Con trol Pressure Control Pressure Support SIMV PS or the ManSpont ventilation mode is used set the switch on the external fresh gas out let to the COSY position For further information see Usi...

Страница 15: ...on has changed WARNING Risk due to reduced power supply from the internal battery The charging capacity of the battery may be reduced as a result of long term storage If the battery has not been charged for 6 months check its functional integrity To do this charge the battery for 16 hours and ventilate a test lung for at least 45 minutes in battery operation ...

Страница 16: ...899 for the breathing system heating Connecting the breathing hoses and the filters The data for the tidal volumes for adults and pediatric patients have been changed 1 Select suitable accessories for the respective patient category Adults Pediatric patients Neonates Tidal volume 700 mL 301 to 700 mL 50 to 300 mL 50 mL Breathing bag 3 L 2 L 1 L 0 5 L Breathing circuit Adults Pediatric Neonates or ...

Страница 17: ...ors touch the contacts in the O2 sensor housing 5 Screw on the screw cap C tightly by hand 6 Insert the O2 sensor A back in the inspiratory valve WARNING Risk of electric shock If the O2 sensor capsule is replaced during operation leakage currents may be transferred Do not touch the patient 20971 C B A WARNING Risk of incorrect O2 measurement An incorrectly fitted O2 sensor capsule will result in ...

Страница 18: ...with an additional switch and ventilator lock option the following must be observed when connecting the APL bypass hose The APL bypass hose consists of a long hose with a T piece and a short hose 1 Connect the long APL bypass hose to connectors A and B 2 Connect the short APL bypass hose to connectors E and F 3 Connect the PEEP PMAX hose to connectors C and D 25454 NOTE The APL bypass hose is thic...

Страница 19: ...ode Volume Control Pressure Control Pressure Support SIMV PS from being started The following alarms are issued From software version 3 37 VENTILATOR FAIL CHECK APL EXT FGO With older software versions VENTILATOR FAIL CHECK APL VALVE 1 Set the switch of the external fresh gas outlet to COSY The function of the ventilator lock is only available with the External fresh gas outlet with switch and ven...

Страница 20: ... regaining consciousness or risk of hypoxia If the gas supply fails further operation of the anesthesia machine takes place with ambient air Oxygen and anesthetic gas are no longer delivered Due to the patient s rebreathing the inspiratory concentration of anesthetic gases and oxygen in the breathing gas falls Monitor the gas concentrations carefully and use intravenous anesthetic agents if necess...

Страница 21: ...G Insufficient gas 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 val...

Страница 22: ...ction of the fresh gas inlet 2 Screw the sample line back to the Y piece on the breathing circuit When the switch of the external fresh gas outlet is set to operation with a non rebreathing system the ventilator lock prevents a controlled ventilation mode Volume Control Pressure Control Pressure Support SIMV PS from being started The following alarms are issued From software version 3 37 VENTILATO...

Страница 23: ...n Pathogenic germs can be transmitted between patients by the circuit plug If a previously used Y piece or filter is plugged onto the circuit plug and if a reprocessed component is attached later in the process e g during a leakage test the new component may become contaminated Only plug reprocessed components onto the circuit plug ...

Страница 24: ...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 does not bump against anything Remove any devices mounted to the holding arms or the top of the device Clear the writing tray and slide it completely into the device Do not pull the medical device over ...

Страница 25: ...st Do not operate the device if the safety valve test continues to fail Contact DrägerService or the authorized local service partner Results of the compliance test The value for the system compliance has changed WARNING Risk of unexpectedly occurring overpressure or negative pressure A soiled or non functioning safety valve is not able to compensate for suddenly occurring overpressure or negative...

Страница 26: ...ure unit The following text has changed 1 Select menu item Pressure Unit G and confirm The screen with the password query opens 2 Enter the password H and confirm The following units can be selected hPa cmH2O mbar kPa 3 Select new unit and confirm The window is closed 22136 22107 Standby Set up G Standby Set up H ...

Страница 27: ...afety information has been amended Ventilator failure Alarm VENTILATOR FAIL The first step has been added 1 Set the switch of the external fresh gas outlet with ventilator lock option to COSY 2 Change to ManSpont ventilation mode 3 Set the APL valve to the Man position 4 Set the APL valve to the desired pressure 5 Fill the breathing bag if necessary with the aid of the O2 flush key 6 Manually vent...

Страница 28: ...ed to an air mixture with fluctuating oxygen concentra tion Make sure that the O2 sensor is exposed to ambi ent air during the entire calibration The O2 sensor was not exposed to ambient air long enough before the calibration Expose the O2 sensor to ambient air for 2 minutes If a new O2 sensor capsule has been inserted expose the O2 sensor to ambient air for 15 minutes The maximum period of use of...

Страница 29: ...ousing unit 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 chapter on calibrating the O2 sensor Alarm priority Alarm Cause Remedy 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 Incorrec...

Страница 30: ...ck in the wrong position instead of the COSY position Set the switch of the exter nal fresh gas outlet to the COSY position Alarm priority Alarm Cause Remedy Alarm priority Alarm Cause Remedy 26 CHECK APL EXT FGO Fault in APL bypass valve Check membrane of the ventilator and close cover Check the connection of the APL bypass valve for correct connection and for leakage Select Standby mode and then...

Страница 31: ...ystem The terminology for the O2 sensor has changed Before removing the compact breathing system the following hoses and cables must be removed Flow sensor cable O2 sensor cable and O2 sensor Pressure measurement hose APL bypass hose PEEP PMAX hose WARNING Risk of infection If no microbial filters are used the breathing system may become contaminated with pathogens In this case reprocess the breat...

Страница 32: ...ducts Check the products for signs of wear and replace them if necessary CAUTION Risk of failure of flow measurement Improper reprocessing and soiling such as deposits or particles can damage the flow sensor No machine cleaning or disinfection No plasma sterilization or radiation sterilization No water jets compressed air brushes or the like No ultrasonic bath No hot steam sterilization with Spiro...

Страница 33: ...e 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 with steam until it is completely dry Classifica tion Explanation Non critical Components that come only into contact with skin that is intact Semi critical Components that carry breathing gas or come into contact with ...

Страница 34: ...cylinder valves Transfer hose of the anesthetic gas receiving system Cables and hoses that lie on floor Brake 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 system Lamp Holder for sample line Semi critical Breathing system Breathing system housing Inspiratory ...

Страница 35: ...Yes No No No Breathing system housing Yes Yes Yes Yes Ports No Yes Yes Yes APL valve Yes exterior Yes Yes Yes Inspiratory valve expiratory valve No Yes Yes Yes Bag elbow Yes Yes Yes Yes Rigid arm for breathing bag optional Yes Yes Yes Yes Flexible arm for breathing bag optional Yes Yes Yes Yes Absorber con tainer and absorber insert No Yes Yes Yes Clic adapter option Yes Yes Yes Yes Ventilator lid...

Страница 36: ...ated reprocessing procedures The manufacturers of the surface disinfectants have verified at least the following spectra of activity Bactericidal Yeasticidal Virucidal or virucidal against enveloped viruses Observe the specifications of the surface disinfectant manufacturers Other surface disinfectants are used at one s own risk Procedure Agent Manufacturer Concentra tion Contact time Tempera ture...

Страница 37: ...fectant Towels with Bleach Klorsept 17 Medentech Oxygen releasing agents Descogen Liquid Antiseptica Descogen Liquid r f u Oxygenon Liquid r f u Dismozon plus Bode Chemie Dismozon pur1 1 Discontinued by the manufacturer Oxycide Ecolab USA Perform Schülke Mayr Virkon DuPont SteriMax Wipes Maxi Aseptix Quaternary ammonium com pounds Mikrozid sensitive liquid2 2 Virucidal against enveloped viruses Sc...

Страница 38: ...ace if necessary Disinfection by immersion 1 Prepare the disinfectant solution in accordance with the manufacturer s instructions 2 Swirl the product backwards and forwards several times in the solution Make sure that the solution reaches all surfaces and interior spaces 3 After the contact time has elapsed rinse the product with water at least drinking water quality until residual disinfectant is...

Страница 39: ...als Technical documentation is available on request Safety checks An additional check point has been added to Check safety features Checks Interval Responsible personnel Inspection and safety checks1 1 Designation applies to the Federal Republic of Germany corresponds to the Recurring safety inspection in the Federal Republic of Austria Every 12 months Service personnel 6 Check safety features Che...

Страница 40: ... colored violet Replace User Water trap As needed or if soiled Replace User Flow sensor As needed or if calibration is no longer possible Clean replace User O2 sensor As needed if cali bration is no lon ger possible or if the O2 SENSOR FAIL message is displayed Replace User Internal lithium battery Every 36 months Replace Experts Lead gel battery Every 3 years Replace Experts Cylinder pressure red...

Страница 41: ... cmH2O hPa 10 9 to 15 9 psi Relative humidity 20 to 80 without condensation Height Up to 3000 m 9843 ft During storage and transport Temperature 10 to 60 C 14 to 140 F Ambient pressure 700 to 1060 cmH2O hPa 10 9 to 15 9 psi Relative humidity 10 to 90 without condensation The conditions for use when using additional devices can limit the environment of use of a system as a whole Vaporizers and anes...

Страница 42: ...y of the tidal volume has been changed Medical gas supply through central gas supply Average inlet flow at 2 8 kPa x 100 40 6 psi supply pressure 60 L min Power supply Inrush current approx 25 to 50 A peak The part number of the instructions for use for the power socket strip has been deleted The power rating cannot be configured with optional Dräger power socket strip see instructions for use for...

Страница 43: ...e volume 1 to 32 0 L min 0 1 L min 15 or 0 2 L min depending on which value is higher 1 L min 0 1 L min 20 mL x respiratory rate or 0 2 L min depending on which value is higher VTe Expiratory tidal volume 100 to 1500 mL 1 mL 15 100 mL 1 mL 20 mL Note If the endtidal desflurane concentration increases to above 12 the measurement accuracy of the tidal volume and minute volume can deviate by more tha...

Страница 44: ...nsitivity 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 enflurane or with 15 Vol desflurane or with 5 Vol isoflurane or with 10 Vol sevoflurane Measurement deviation due to humidity Max 0 02 of the measured value per relative humidity No demonstrable quantitative effect on the gas measurement due to ambient conditions Maximum ...

Страница 45: ...11 mL cmH2O 0 11 mL hPa at 30 hPa Resistance Peak flow L min Resistance cmH2O hPa Inspiratory Expiratory In accordance with ISO 80601 2 13 dry with adult breathing hose set M301461 1 Depending on the ventilation settings the indicated values may deviate by 0 3 cmH2O 0 3 hPa 60 4 7 4 4 30 0 6 4 2 15 0 4 3 4 In accordance with ISO 80601 2 13 dry with neo natal breathing hose set M336811 2 5 1 0 2 9 ...

Страница 46: ...d that this device functions correctly in the desired arrangement before use The instructions for use for the other devices must be followed Electromagnetic emissions The chapter has been deleted Electromagnetic environment This device may only be used in environments specified in the instructions for use under Environments of use in the chapter Application Emissions Compliance Radiated emis sions...

Страница 47: ...mpulse voltages surges IEC 61000 4 5 Voltage external conductor external conductor 1 kV Voltage external conductor protective ground con ductor 2 kV Magnetic fields at mains frequency IEC 61000 4 8 50 Hz 30 A m Voltage dips and short interruptions in the sup ply voltage IEC 61000 4 11 Voltage dips of 30 to 100 8 3 ms to 5 s different phase angles Radiated high frequency disturbances IEC 61000 4 3 ...

Страница 48: ... KGaA Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 2080 http www draeger com 9055305 en Drägerwerk AG Co KGaA Edition 3 2018 07 Edition 1 2015 05 Dräger reserves the right to make modifications to the medical device without prior notice ...

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