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Dräger Atlan A300, Instructions For Use Manual

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Dräger Atlan A300 Instructions For Use Manual Download Page 292

292 

 Instructions for use

  |  

Atlan A300, A300 XL, A350, A350 XL SW 1.0n

Technical data

16.22.2 Electromagnetic 

environment

This device may only be used in environments specified in section "Environments 
of use" on page 10.

NOTICE

The emissions characteristics of this equipment make it suitable for use in industrial 
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for 
which CISPR 11 class B is normally required), this equipment might not offer 
adequate protection to radio-frequency communication services.

►

The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.

16.22.3 Recommended 

separation distances from wireless 

communication devices

To ensure that the full functional integrity of this device is not compromised, there 
must be a separation distance of at least 1.0 m (3.3 ft) between this device and 
wireless high-frequency communication equipment.

Emissions

Compliance

Radiated emissions

Class A, group 1 (30 MHz to 1 GHz)

Conducted emissions

Class A, group 1 (150 kHz to 30 MHz)

Immunity against

Test level and required electromagnetic environ-
ment

Electrostatic discharge (ESD) 
(IEC 61000-4-2)

Contact discharge: ±8 kV
Air discharge: ±15 kV

Fast transient electrical disturbances (bursts) 
(IEC 61000-4-4)

Power cable: ±2 kV
Longer signal input lines/output lines: ±1 kV

Impulse 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 
supply 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)

80 MHz to 2.7 GHz: 3 V/m

Conducted high-frequency disturbances 
(IEC 61000-4-6)

150 kHz to 80 MHz: 3 V, ISM bands: 6 V

Electromagnetic fields in the vicinity of wireless 
communication devices

Various frequencies from 385 MHz to 5785 MHz: 
9 V/m to 28 V/m

Summary of Contents for Atlan A300

Page 1: ...Instructions for use Atlan A300 A300 XL A350 A350 XL WARNING To properly use this medical device read and comply with these instructions for use Anesthesia workstation Software 1 0n ...

Page 2: ...2 Instructions for use Atlan A300 A300 XL A350 A350 XL SW 1 0n This page has been left blank intentionally ...

Page 3: ... 15 3 1 Hardware 15 3 2 Functional scope 31 3 3 Gas flow diagram 42 4 Assembly and preparation 45 4 1 Safety instructions 45 4 2 Mounting of accessories 52 4 3 Before first operation 55 4 4 Intrahospital transport 59 4 5 Gas supply 59 4 6 Connecting to the gas scavenging system 65 4 7 Preparation for an operation day after cleaning and sterilization 67 4 8 Selecting and connecting patient specific...

Page 4: ...ion 151 9 1 At the end of the OR day 151 9 2 Storing the device 151 9 3 Disconnecting the mains power supply 151 10 Alarms 152 10 1 Safety instructions 152 10 2 Displaying alarms 152 10 3 Response to alarms 154 10 4 Adopting alarm settings when changing the ventilation mode 159 10 5 Alarm delay and alarm escalation 160 10 6 Activation of alarms after breath detection 163 10 7 Intelligent alarm beh...

Page 5: ...3 10 Machine reprocessing 242 13 11 Fitting and assembly 249 13 12 Preparation before the next use 258 13 13 Brief instructions for reprocessing 260 14 Service 262 14 1 Safety instructions 262 14 2 Definition of service terminology 262 14 3 Inspection 262 14 4 Maintenance 265 14 5 Repair 265 15 Disposal 266 15 1 Safety instructions 266 15 2 Disposing of the device 266 15 3 Disposing of accessories...

Page 6: ... software 297 17 Principles of operation 297 17 1 Safety instructions 297 17 2 Description of the ventilation modes 298 17 3 Description of the ventilation drive 307 17 4 Improving the CO2 measurement by means of an HME filter 308 17 5 Minimum O2 delivery 310 17 6 Influence of patient category weight and age on device behavior 311 17 7 Support of Infinity ID accessories 312 17 8 Schematic illustra...

Page 7: ...zed text indicates labels on the device and screen text 1 Numbers with a period indicate the individual steps within a process sequence The numbering for each new process sequence starts once more at number 1 a Lower case letters with a period indicate secondary process steps The let tering for each new higher level process step starts once more with the letter a This triangle indicates individual...

Page 8: ...ed by third party manufacturers E Vent Trademark Trademark Trademark owner Selectatec Datex Ohmeda Dismozon BODE Chemie Mikrobac Korsolex Neodisher Mediclean Dr Weigert acryl des Schülke Mayr Mikrozid Perform Actichlor Ecolab USA OxyCide BruTab 6S Brulin Dispatch Clorox Klorsept Medentech Descogen Antiseptica Oxygenon Virkon DuPont SteriMax Aseptix Cleanisept Dr Schumacher Trademark used under lic...

Page 9: ...eathing system can be used with partial rebreathing low flow or minimum flow A non rebreathing system such as the Bain Mapleson Kuhn or Waters system may be used at the external fresh gas outlet 2 2 Indications The device is specified for inhalational anesthesia and or patient ventilation in accordance with the intended use during surgical or diagnostic interventions 2 3 Contraindications The devi...

Page 10: ... in accordance with its intended use The product has the following essential performance features General Supply of the anesthesia workstation with O2 If the O2 supply central gas supply or gas cylinder fails an alarm is issued Supply of the patient with adequately oxygenated breathing gas If the breathing gas contains insufficient levels of O2 an alarm is issued Supply of an adequate anesthetic g...

Page 11: ...ities Service personnel This user group installs the product and performs service activities If product specific skills or tools are required then the service activities must be performed by specialized service personnel The specialized service personnel have been trained by Dräger to perform these specific service activities on this specific product 2 7 Information on safety instructions and prec...

Page 12: ...with one or more diseases 2 8 2 Symbols and product labels Failure to observe symbols and product labels may result in personal injury and property damage Observe the symbols and product labels 2 8 3 Monitoring the patient s condition The monitoring of the patient s condition can range from direct observation to electronic monitoring by means of medical devices If the patient s condition is not ad...

Page 13: ...ncorrect use or incorrect reprocessing Personal injury and property damage may occur as a consequence Follow the instructions for use for all accessories e g Water traps Flow sensors CLIC adapter CLIC absorber Soda lime Breathing hoses Masks Filter Bronchial suction Vaporizer Manual resuscitator AGSS terminal unit 2 8 5 Color codes and labels In some countries the arrangement and display of the ga...

Page 14: ...the patient or the user or in property damage Do not modify this product 2 8 10 Network security The impermissible use of data interfaces may result in property damage and personal injury Only make connections to data interfaces with permission from the responsible organization IT representative and the hospital equipment officer Observe the following information Connections to IT networks page 29...

Page 15: ...ual mode in the event of malfunctions of the device 4 Gas mixing unit Produces a gas mixture from the selected gases e g O2 and Air 5 Work surface Used for storing e g documents 6 Pull out writing tray option Provides additional work surface 7 Viewing window for piston ven tilator Allows visual checking of the movement of the piston ventilator 8 Lockable drawer Provides additional storage space 9 ...

Page 16: ...ail Used for fastening additional components No Designation Description 36438 No Designation Description 1 Screen Enables user inputs by touchscreen and rotary knob 2 Plug in connectors for vaporiz ers Enable the connection of up to 2 vaporizers 3 Backup manual switch behind the flap Used to switch to backup manual mode in the event of malfunctions of the device 4 Swiveling shelf option Used for s...

Page 17: ...xternal fresh gas outlet Gas outlet for a mixture of fresh gas and anesthetic gas which is fed to a non rebreathing system 13 Rail Used for fastening additional components No Designation Description 36441 No Designation Description 1 Touchscreen Calls up functions or dialogs when touched 2 Alarm silence key Suppresses the alarm tones of all active alarms for 2 minutes 3 Rotary knob Used for select...

Page 18: ...est 4 APL valve Limits the maximum airway pressure in the Manual Spontaneous mode 5 Breathing system cover Protects the breathing system underneath and provides climate control for the breath ing system 6 Expiratory port Used to connect the expiratory hose to the device 7 Holder Used for parking the breathing bag hose 8 Handles Used for aligning the device and for stowing used breathing hoses 9 CO...

Page 19: ...e line Collects condensed water which forms in the sample line 12 Patient gas measurement module Measures and monitors various gas con centrations in the breathing gas O2 CO2 N2O and anesthetic gases 13 Guide clip Used to securely lay the O2 insufflation hose No Designation Description 36447 No Designation Description 1 O2 sensor Measures the inspiratory O2 concentration in the breathing gas 2 Sea...

Page 20: ...rom left 36462 No Designation Description 1 Castor brake Prevents movement of the rear castor 2 Gas cylinder holder option Secures the gas cylinders 3 Rail Used for fastening additional components 4 Hanger yoke system option Enables the connection of gas cylinders with a pin index connector ...

Page 21: ...A300 XL A350 A350 XL SW 1 0n 21 Overview 3 1 5 Side view from right 36468 No Designation Description 1 Standard rail with handle Allows the device to be maneuvered during intrahospital transport and also the attach ment of accessories ...

Page 22: ...side of the device 36469 No Designation Description 1 Column cover Depending on the version allows a patient monitor or other workplace components to be mounted 2 Holder for hoses and cables Used for storing and winding up central sup ply hoses and cables 3 Cable holder with cable channels For passing hoses and cables through ...

Page 23: ...the central gas supply system and for gas cylin ders 4 Gas cylinder holder option Secures the gas cylinders 5 Strain relief for compressed gas hoses Protects the compressed gas hoses from loosening inadvertently 6 Auxiliary power sockets option Allow other devices to be connected 7 Vent Discharges warmed air from the device into the environment 8 Ventilation slot Feeds ambient air to the device fo...

Page 24: ...ers 4 Hanger yoke system option Enables the connection of gas cylinders with a pin index connector 5 Strain relief for compressed gas hoses Protects the compressed gas hoses from loosening inadvertently 6 Vent Discharges warmed air from the device into the environment 7 Gas cylinder holder option Secures the gas cylinders 8 Auxiliary power sockets option Allow other devices to be connected 9 Venti...

Page 25: ...is pulled out To be used when the device is to be disconnected from the power supply for longer than 2 weeks and during service activities 3 Connector for workplace light option Used for connecting an external workplace light 4 Power inlet connector for power cable Used to connect the device to the mains power supply 5 Potential equalization pin Used for connecting a potential equalization cable T...

Page 26: ...the pressure reducers on the gas cylinders 2 Connectors for central gas supply system Enable the device to be supplied with gases from the central supply 3 Connectors for gas cylinders option Enable the device to be supplied with gases from the gas cylinders 4 Label Advanced Cylinder Sup port On devices that are equipped with Advanced Cylinder Support the gas cylin der valves can also remain open ...

Page 27: ...ignation Description 1 Protection bar Protects the connectors for the gas cylin ders from damage 2 Hanger yoke system with three pin index connections option Enables the connection of gas cylinders with a pin index connector 3 Wrench For opening and closing the gas cylinder valves 4 Connecting cable Enables electronic gas pressure measure ment ...

Page 28: ...Instructions for use Atlan A300 A300 XL A350 A350 XL SW 1 0n Overview 3 1 11 Auxiliary power sockets option 36477 No Designation 1 Fuses 2 each per power socket 2 Auxiliary power sockets 4 pcs 3 Main fuse ...

Page 29: ...ls for mains power supply and power supply from internal battery 3 Symbols for gas supply O2 Air N2O or O2 Air from central supply and gas cylinders 4 O2 flowmeter for O2 insufflation Aux O2 and emergency O2 delivery Add O2 5 O2 switch for switching between O2 insufflation Aux O2 and emergency O2 delivery Add O2 6 Outlet for O2 insufflation e g for nasal cannula 7 Display of pressure in the intern...

Page 30: ...mains power supply and power supply from internal battery 3 Symbols for gas supply O2 Air N2O or O2 Air from central supply and gas cylinders 4 O2 flowmeter for O2 insufflation Aux O2 option 5 Outlet for O2 insufflation e g for nasal cannula option 6 Flow control valves O2 Air N2O or O2 Air 7 Total flow tube 8 Display of the set fresh gas flows 9 Display of pressure in the internal breathing syste...

Page 31: ...nlarged with a folding table extension on the side option When heavy workplace components monitors or syringe pumps are attached a counterweight is required for increased tipping stability option Large version model des ignation A300 XL A350 XL Version with large trolley for normal OR environ ments with adequate space 1 large and 2 small drawers Available with plug in connectors for 2 or 3 vaporiz...

Page 32: ...breathing system Integrated patient gas measurement module Measurement monitoring and display of the inspi ratory and expiratory gas concentrations of O2 anesthetic gases CO2 and N2O Detection and indication of anesthetic gas mixtures Display of the xMAC O2 detection During the self test a check is made using the inte grated patient gas measurement module to ensure that the connected O2 supply is ...

Page 33: ...table pressure support requires the spontaneous breathing support option Advanced trends Includes the following functions Graphical trends of measured values Mini trends next to the waveforms Export of trend data to USB mass storage device Advanced ventilation monitoring Includes the following functions Display of patient compliance with trend Display of loops Pressure Volume and Flow Vol ume Volu...

Page 34: ... and Air with 2 gas mixer and 3 gas mixer O2 and N2O with 3 gas mixer Usable anesthetic agents Sevoflurane Desflurane Isoflurane Halothane Enflurane 3 2 4 Ventilation modes Manual Spontaneous CPAP PSV PC CMV PC SIMV PC SIMV PS VC CMV VC SIMV VC SIMV PS VC CMV AutoFlow Advanced neonatal sup port Includes advanced ventilation functions and monitor ing functions for the ventilation of neonates Minimu...

Page 35: ...trations only available with the integrated patient gas measurement module Inspiratory and expiratory N2O concentrations only available with the integrated patient gas measurement module Apnea pressure flow and CO2 Occurrence of anesthetic gas mixtures only available with the integrated patient gas measurement module Lack of fresh gas in the breathing system and the breathing circuit 3 2 7 Display...

Page 36: ...tocol 3 2 11 2 USB port After a suitable USB flash drive is connected the USB port enables e g the following actions Saving the screen contents as a screenshot Saving and loading device configurations Saving system test results or records as a text file Note the additional information on the specification of the USB port see Technical data page 267 3 2 11 3 Network port If an appropriate service c...

Page 37: ...ctronically controlled gas mixer CAUTION Risk of increased anesthetic agent delivery When the emergency O2 delivery Add O2 is in use anesthetic agent continues to be delivered into the breathing system in accordance with the vaporizer setting When the emergency O2 delivery is used during low flow anesthesia or minimal flow anesthesia an increased quantity of anesthetic agent may enter the breathin...

Page 38: ... manual switch 2 Follow the instructions on the product label 3 or the screen 4 3 Set the O2 switch to Add O2 4 Open the flow control valve on the emergency O2 delivery and set an adequate O2 flow The set O2 flow constitutes the total fresh gas flow 5 Ventilate the patient manually a During mechanical ventilation or in the Man Spon ventilation mode Ventilate manually with the breathing bag b When ...

Page 39: ...2 Follow the instructions on the product label 3 or the screen 4 3 Ventilate the patient manually a During mechanical ventilation or in the Man Spon ventilation mode Ventilate manually with the breathing bag b When using the external fresh gas outlet Ventilate manually with the breathing bag on the non rebreathing system 4 Set the fresh gas flow 5 Check the vaporizer setting 40677 39763 ...

Page 40: ...ventilation and spontaneous breathing are available Emergency O2 delivery electronically controlled gas mixer Fresh gas delivery mechanically controlled gas mixer Delivery of anesthetic agents via connected vaporizers Failure of the central gas supply system Use of the connected gas cylinders Complete failure of the gas supply Mechanical ventilation with ambient air possible the hose with the brea...

Page 41: ...vated Manual ventilation or spontaneous breathing possible Emergency O2 delivery electronically controlled gas mixer or fresh gas delivery mechanically controlled gas mixer available Anesthetic agent delivery from connected vaporizers possible Complete device failure If backup manual mode is activated Manual ventilation or spontaneous breathing possible Emergency O2 delivery electronically control...

Page 42: ... Manual Spontaneous 4 Anesthetic gas receiving system 5 Anesthetic gas scavenging valve 6 APL valve 7 Breathing bag 8 PEEP Pmax valve 9 Patient gas measurement module 10 Expiratory valve 11 Expiratory pressure measurement 12 Pressure gauge option 13 Patient 14 Expiratory flow sensor 15 Inspiratory flow sensor 16 Inspiratory valve 17 Inspiratory pressure measurement 18 Inspiratory O2 sensor 19 Vent...

Page 43: ...verview 3 3 2 Gas supply electronically controlled gas mixer 36484 No Designation 1 Gas supply central supply or gas cylinders 2 Gas mixer 3 O2 flowmeter 4 O2 switch 5 Vaporizer 6 Ejector 7 O2 flush 8 Breathing system 9 Switch over valve 10 External fresh gas outlet ...

Page 44: ...ly mechanically controlled gas mixer 36485 No Designation 1 Gas supply central supply or gas cylinders 2 Flow control valves 3 Minimum O2 delivery 4 Total flow tube 5 Vaporizer 6 Ejector 7 O2 flush 8 Breathing system 9 Switch over valve 10 External fresh gas outlet 11 O2 flowmeter option ...

Page 45: ...r The patient or the user may be put at risk due to the following Reduction of the depth of anesthesia Incorrect gas measurements The applied volume is less than the set volume Accumulation of anesthetic gas in the ambient air Contamination of the supply gases The sample line is damaged The CO2 absorber is incorrectly locked in place Connect the sample line correctly Perform the leakage test befor...

Page 46: ...uch as Drägersorb Free Do not use any soda lime based on potassium hydroxide Soda lime is caustic and is a strong irritant for eyes skin and airway Handle the soda lime carefully and do not spill it Water trap and integrated patient gas measurement module Due to the technical characteristics of gas measurement the measured gas values might be inaccurate at high respiratory rates and certain I E ra...

Page 47: ...ation for long enough if the mains power supply fails If there is a mains power supply failure devices connected to the auxiliary power sockets are not supplied from the internal battery As a result the patient could be put at risk Before first operation or after storage charge the battery for at least 8 hours Check the functional integrity of the battery by performing regular inspections Auxiliar...

Page 48: ...This device is not approved for use in areas where oxygen concentrations greater than 25 Vol combustible or explosive gas mixtures are likely to occur Maintain a distance of at least 200 mm 7 9 in between electrical connections and components which conduct oxygen and nitrous oxide Cables and connections must be sufficiently insulated and must not be damaged Check cables for damage daily Disconnect...

Page 49: ...pact version with counterweight page 54 Check the functional integrity of the support arm end stops after the following activities After fitting accessories After transporting the device Trapping of body parts Movable components or attached parts may cause crushing due to trapping Pay special attention to edges movable parts and corners when working with the following components Breathing system c...

Page 50: ... the castor brakes while the device is being moved Do not lean against the device 4 1 4 Color codes and labels If the vaporizer is filled with the wrong anesthetic agent or if the filling level is too low incorrect anesthetic gas concentrations or concentrations that are too low can occur as a result Compare the color code and labeling on the vaporizer used with the anesthetic agent bottle and the...

Page 51: ...etween the set value and the actual value for fresh gas flow and O2 concentration in the fresh gas Inaccurate measured values for volume anesthetic agent consumption econometer and low flow wizard Accumulation of argon in low flow operation and minimal flow operation Do not use any O2 concentrators A failure of the gas supply can result in a risk of patient injury In the following cases the availa...

Page 52: ... take account of the weight of gas cylinders including the pressure reducers and the hanger yoke system Other components Mounting position Maximum weight Additional restrictions All accessories on a single arm 25 kg 55 lbs Maximum arm length 75 cm 29 in Accessories distrib uted over several arms on both sides 40 kg 88 lbs Maximum arm length 40 cm 16 in Accessories on both sides distributed over 2 ...

Page 53: ... 40 kg 88 lbs In addition to the accessories this must also take account of the weight of gas cylinders including the pressure reducers and the hanger yoke system Other components Mounting position Maximum weight Additional restrictions All accessories on a single arm 15 kg 33 lbs Maximum arm length Left side 75 cm 29 in Right side 40 cm 16 in Accessories that are not mounted on arms See product l...

Page 54: ...oaded with a maximum of 40 kg 88 lbs In addition to the accessories this must also take account of the weight of gas cylinders including the pressure reducers and the hanger yoke system Other components Mounting position Maximum weight Additional restrictions All accessories on a single arm 20 kg 44 lbs Maximum arm length 75 cm 29 in Accessories distrib uted over several arms on both sides 30 kg 6...

Page 55: ...sensor an O2 sensor cell must be inserted into the O2 sensor 1 Disassemble the O2 sensor see Disassembling the O2 sensor page 233 2 Insert the new O2 sensor cell 1 into the O2 sensor After the O2 sensor cell has been inserted the initialization phase of the O2 sensor takes place The initialization lasts 30 minutes The 30 minutes start when the mains power supply is established 4 3 2 Assembling and...

Page 56: ...Assembly and preparation 2 Turn the knurled nut 2 about 90 clockwise Turn it until the palpable resistance is overcome and a click is heard The sensor cap is now fitted 3 Insert the O2 sensor 3 into the sensor port 4 Turn the O2 sensor 4 clockwise 37179 38271 38272 ...

Page 57: ...sockets with correct mains voltage and a protective ground conductor WARNING Risk of electric shock If the device is connected to an additional power socket strip this may lead to increased leakage current The leakage current may exceed the permissible values Do not connect the device to additional power socket strips Do not connect additional power socket strips to the integrated auxiliary power ...

Page 58: ...ntial equalization cable must be removable without tools 4 3 6 1 Connecting the potential equalization cable Connect the potential equalization cable to the potential equalization pin on the device see Connectors page 25 Connect the potential equalization cable to a potential equalization connector of the hospital e g wall ceiling supply unit operating table 4 3 7 Connecting devices to the data in...

Page 59: ... than 8 kg from the rails 5 Remove the vaporizers 6 Remove all objects from the writing tray and the work surface 7 Slide the writing tray completely into the device 8 Position the breathing bag arm if present close to the device 9 Push in and lock the drawers if present 4 4 2 Parking the medical device When parking always engage the brakes central brake for front castors and castor brake at rear ...

Page 60: ...s 4 5 2 1 Connecting gas cylinders with screw connections 1 WARNING Danger to the patient and user If the strain relief for the compressed gas hoses is not used the device may be damaged Use the strain relief for the compressed gas hoses WARNING Risk of fire Ignition sources together with oxygen can cause fires Do not position oxygen sources in the vicinity of ignition sources e g electrical conne...

Page 61: ...e Tightly screw the pressure reducers 4 to the gas cylinder valves The connectors must fit each other directly Do not use an adapter 4 5 2 2 Connecting suspended gas cylinders with pin index connectors Before first use 1 Insert the compressed gas hoses into the strain relief 1 on the rear of the device Tighten the strain relief 2 Connect the pressure measurement lines to the connectors 2 3 The gas...

Page 62: ...er 5 from below 5 Allow the pin index pins 2 to engage in the pin index holes 6 Turn the handle 6 clockwise until the threaded stud is slightly screwed into the visible recess on the head of the cylinder Align the gas cylinder 4 so that it is hanging vertically 7 Tighten the handle 6 8 Secure the gas cylinders 4 with hook and loop straps not shown here Replacing the gas cylinder 1 Remove the old s...

Page 63: ...a Dräger Auto Exclusion plug in adapter or a Selectatec plug in adapter Dräger recommends using only vaporizers that are listed in the list of accessories and have been tested The vaporizers used must conform to the ISO 8835 4 or ISO 80601 2 13 standard The illustration shows vaporizers of the type Dräger Vapor 3000 Connecting the vaporizers WARNING Risk due to improperly mounted vaporizers Incorr...

Page 64: ... Check the filling levels in the sight glasses 2 Fill the vaporizers if required 4 Turn the control dial on each vaporizer to the 0 position The key 3 engages Checking the metering interlock The vaporizers have an interlock system which by means of a metering interlock prevents the simultaneous opening of 2 vaporizers 1 Turn the control dial on one of the vaporizers to a position other than 0 2 Te...

Page 65: ...the ventilation slots on the underside of the AGS are not blocked 4 6 1 Active anesthetic gas scavenging 1 CAUTION Risk of ambient air contamination If the anesthetic gas receiving system is not connected to the disposal system contamination of the ambient air with anesthetic gas may result Connect the anesthetic gas receiving system correctly to the disposal system Connect the scavenging hose 1 t...

Page 66: ...active anesthetic gas scavenging system a negative pressure may arise in the patient s lungs Connecting a passive AGS to an active anesthetic gas scavenging system is not allowed WARNING Risk of overpressure If the overpressure valve in the passive AGS or the scavenging hose is blocked overpressure in the breathing circuit and in the patient s lungs will occur Only connect the passive AGS to kink ...

Page 67: ... circuit and the filters This device is made without natural rubber latex To minimize the risk of contact with latex use breathing bags and breathing hoses that are not made with natural rubber latex The device can be used with Infinity ID breathing hoses or conventional breathing hoses If no leakage test has yet been performed after switching on the device hose compliance and hose resistance will...

Page 68: ... been used at the Y piece or at the expiratory port The breathing system is being used for the first time Perform the following measures Reprocess the breathing system before the first use Reprocess the breathing system if necessary To prevent future contamination use bacteria filters close to the patient CAUTION Risk due to too low tidal volumes The hose configuration can influence the values for...

Page 69: ...e hose configurations page 69 When attaching or removing the breathing hoses always hold them by the connection sleeve and not by the hose itself 4 8 1 1 Permissible hose configurations Breathing hoses sample line and filters etc must be arranged carefully and adapted to the patient particularly for neonates and pediatric patients For further information see Improving the CO2 measurement by means ...

Page 70: ...ient Extract the sample gas at a connector in which the gas has laminar flow without turbulence If no filter can be used at the expira tory port e g if there is intrinsic PEEP due to Air trapping reprocess the breathing system after every patient X X X When using fine pored filters between the Y piece and the patient do not con nect the sample line between the tube and the filter but rather to the...

Page 71: ...breathing bag hose to the bag elbow 2 WARNING Risk due to pinched breathing bag If the breathing bag is pinched excessive airway pressures or a lack of fresh gas may result When attaching ensure the following The breathing bag is not pinched The breathing bag can inflate freely Lay the breathing bag hose in the holder 1 in a loop so that the bag hangs on the left of the holder Make sure that the b...

Page 72: ...e flow conditions 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_exp RExp hose RExp filter port RExp filter Y piece If necessary take into consideration other parts such as water traps or additional hoses The specifications for the resistance of the b...

Page 73: ...It is the responsibility of the user of the medical device to select the most suitable remedial measure 4 8 4 Connecting a non rebreathing system Non rebreathing systems are suitable and intended only for manual ventilation or spontaneous breathing This connection is only possible with the External fresh gas outlet option Since no rebreathing via the breathing system takes place when a non rebreat...

Page 74: ...hine Provide for suitable gas monitoring conforming to ISO 80601 2 55 Provide suitable O2 monitoring for devices with inspiratory O2 measurement Screw the sample line securely to the mask 1 on the non rebreathing system and to the water trap 2 For masks without a connector for the sample line optionally proceed as follows Place the T piece with a T piece filter directly on the elbow Screw the samp...

Page 75: ... 9 Connecting and replacing consumables 4 9 1 Disposable CO2 absorber Connect or replace the CLIC absorber in accordance with its instructions for use 4 9 2 Reusable CO2 absorber As an alternative to disposable CO2 absorbers a reusable CO2 absorber may also be used 4 9 2 1 Dismounting and emptying 1 Unscrew the CO2 absorber 1 from the breathing system 2 Remove and dispose of the disposable dust fi...

Page 76: ...for eyes skin and airway Handle the soda lime carefully and do not spill it Fill the CO2 absorber with fresh soda lime to the upper mark Recommendation Use Drägersorb 800 Plus or Drägersorb Free 3 WARNING Risk of hypoventilation and incorrect gas measurement Reuse of the disposable dust filter can increase the filter resistance and impair the ventilation function of the device If soda lime from th...

Page 77: ...re the following when ventilating pediatric patients and neonates When fine pored filters are used do not connect the sample line between the tube and the filter If the sample line is connected close to the patient set the alarm limits for MV low and Paw high to suitable values Observe the following information Improving the CO2 measurement by means of an HME filter page 308 WARNING Risk due to in...

Page 78: ...orrect course of the sample line Do not use adapters Particularly when ventilating pediatric patients and neonates a sample line connection close to the patient can improve the quality of the measured CO2 values Observe the following information Improving the CO2 measurement by means of an HME filter page 308 When tube adapters are used for the sample line connection make sure the volume dead spac...

Page 79: ...ader bar The header bar shows the following information Patient category Patient data System information date time device name Alarms messages and notifications Information regarding temporarily deactivated alarms 2 Main menu bar The main menu bar contains buttons to open dialogs and activate functions These buttons are assigned to various groups For further information see the following chapter O...

Page 80: ...sure Volume and Flow Volume Mini trends Virtual flow tubes For further information see Customizing the current view page 109 4 Therapy bar The ventilation settings can be adjusted in the therapy bar Electronically controlled gas mixer Ventilation modes Ventilation parameters Fresh gas delivery Mechanically controlled gas mixer Ventilation modes Ventilation parameters No Designation 34766 No Design...

Page 81: ...justment of ventilation pressures ventilation times or during electronically controlled fresh gas delivery Example The device can be configured so that a change to the PEEP setting automatically causes a change to Pinsp as a result the difference between PEEP and Pinsp and therefore the tidal volume remain constant Linking therapy controls see page 175 34752 No Designation 1 Name of active ventila...

Page 82: ... in which a parameter cannot be changed any more the device displays a corresponding message in the notification field 3 5 1 4 Quick setup dialog Depending on the parameter field or waveform this dialog contains various setting possibilities e g for limits or scales This dialog can be opened by touching the corresponding parameter field in the monitoring area This dialog can be configured so that ...

Page 83: ... system configuration see page 167 In the flow waveform spontaneous breathing and pressure support are displayed in a light brown color Color Example Meaning Dark green Available element function activated Yellow Selected element not yet confirmed with rotary knob Light green Available element function not activated Dark gray Control element currently not available function activated Gray Unavaila...

Page 84: ...eters Changes to these settings always require confirmation by pressing the rotary knob 1 Select Touch the control element 1 The color turns yellow For therapy controls the unit of the parameter to be set is displayed 2 Set Turn the rotary knob For some therapy controls faster turning raises the increment value 3 Confirm Press the rotary knob The color of the control element changes to green In th...

Page 85: ... confirmation The color immediately turns to dark green Examples Selecting a view Deactivating the CO2 alarms 5 3 4 Operating the flow control valves The flow control valves of the mechanically controlled gas mixer and the O2 flowmeter are operated as follows Opening the flow control valve Turn the flow control valve counterclockwise Closing the flow control valve Turn the flow control valve clock...

Page 86: ...o the mains power supply 2 Set the main switch to position I 3 CAUTION Risk of device malfunction Condensed water may form when the device is brought from a cold storage location into a warm environment To prevent condensation and resulting failures of electrical components do not turn on the device after abrupt temperature changes for 1 to 2 hours Press the key 1 The device starts The Standby pag...

Page 87: ... perform a specific test 3 Additionally the current system leakage is displayed in area 5 To view details regarding the status of the device touch the Details button 2 or the Tests button 4 see page 126 Dräger recommends performing the system test every 24 hours Otherwise it will not be possible to ensure that the device is functional 35034 Color Meaning Green System is fully operational Yellow Sy...

Page 88: ...zer 6 Ventilate the patient manually 7 Turn on the device 8 As soon as the Standby page is displayed start the therapy see page 93 9 Set the O2 switch 3 to Aux O2 10 Close the flow control valve 2 6 5 2 Mechanically controlled gas mixer 1 Adjust the APL valve 2 Open the flow control valve 1 and set the desired O2 flow If necessary press the O2 key 3 to quickly fill the breathing bag 3 Monitor the ...

Page 89: ... cause permanent alarms Contact service personnel to deactivate the Infinity ID alarms 7 1 2 Therapy and applications Therapy with known pre existing conditions Volatile anesthetic agent may trigger malignant hyperthermia As a result the patient could be put at risk For patients suspected of malignant hyperthermia Do not use any volatile anesthetic agent or devices with residual concentrations of ...

Page 90: ... has failed The values on the status display do not match the values on the total flow tube The following situations could result in misdiagnoses which could put the patient at risk Measured values are misinterpreted Measured values are incorrectly or inaccurately displayed The accuracy of the measurements of flow and volume may be impaired if the breathing system warmer is switched off The parame...

Page 91: ...e sample gas from a gas sampling site close to the patient minimize leakage adjust the ventilation settings The measured values are not meaningful during the warm up time of the patient gas measurement module Data e g measured values alarms which the anesthesia machine transfers to other systems such as patient monitors or EMR systems may be displayed there incompletely or incorrectly and may thus...

Page 92: ... is suspected in the device or its vicinity Do not operate the device and contact service personnel Keep ignition sources away from the device If a fire starts in the immediate vicinity of the patient the device could also catch fire Personal injury and property damage may occur as a consequence Disconnect the oxygen carrying connections from the device and the patient Extinguish the fire and tend...

Page 93: ...tomatically to the Manual Spontaneous mode Take care that the quick start does not happen unintentionally Or Touch the Quick start Man Spon button 1 and open the flow control valves Normal start with customized settings 1 Optionally perform one of the following steps Touch the Start button 2 Touch the screen in the monitoring area 4 Squeeze the breathing bag 2 Adjust the patient data and ventilati...

Page 94: ...esired patient category 1 For new patients the device uses defined start settings for ventilation settings and alarm limits see page 166 The set value for Ti is automatically set based on RR in such a way that the resulting I E ratio is 1 1 for neonates and 1 2 for all other patient categories 7 2 1 2 Continuing a case after an interruption Touch the Continue case button 2 The device continues to ...

Page 95: ...gs the start settings for alarms and the alarm settings during a change of ventilation mode Only turn off alarms if the safety of the patient will not be compromised as a result CAUTION Risk due to incorrect setting for patient age Incorrectly setting the patient age can lead to incorrect xMAC values and thus to an incorrect anesthetic agent delivery Always set the patient age correctly Adjust the...

Page 96: ...ered For further information see Minimum O2 delivery page 310 Electronically controlled gas mixer Select the carrier gas 3 Set the O2 concentration 5 and fresh gas flow 4 Mechanically controlled gas mixer Open and set the flow control valves for the required gases Also use the total flow tube to check the total flow set see page 29 3 Adjust the ventilation settings 2 4 Press the rotary knob The th...

Page 97: ...he breathing system 7 3 1 2 Spontaneous breathing Turn the APL valve counterclockwise as far as it will go The dots are aligned vertically over one another The valve lifts The pressure limitation is canceled and the valve is open for free spontaneous breathing 7 3 2 Using the O2 flush The O2 flush is used for flushing and quickly filling the breathing system and breathing bag with oxygen The vapor...

Page 98: ...asurement If the device is equipped with inspiratory O2 measurement the accuracy of the flow measurement can be ensured by the anesthetic gas compensation 1 Touch area 1 a further dialog 2 will open 2 CAUTION Risk of inaccurate measured flow values If the anesthetic gas compensation is incorrectly set the resulting incorrect measured flow values can lead to incorrect measured values for the tidal ...

Page 99: ...rm settings are adjusted to reasonable values see page 159 2 Adjust the therapy controls 3 or the buttons 2 3 Activate the ventilation mode with the rotary knob A signal tone is emitted when the mode is changed 7 3 6 Synchronizing the breaths Prerequisite The device has the Spontaneous breathing support option Turning on the synchronization activates the set pressure support for example see page 2...

Page 100: ...reathing system particularly during low flow anesthesia flow 1 0 L min The breathing system warmer reduces this condensation In particular cases e g during minimal flow anesthesia lasting several hours condensed water may accumulate in the piston ventilator The device can detect condensed water in the piston ventilator and in the breathing hoses A message is displayed when condensed water is detec...

Page 101: ...mucus or relocation of the patient This mode is also useful during regional anesthesia The patient s respiration can be monitored via the sample gas measurement without distracting alarms being issued Gas delivery is also stopped with electronically controlled gas mixers The gas concentration measurement remains active and waiting for respiratory phases The device remains in this operation mode un...

Page 102: ...ressure apnea alarms are inactive The CBM mode can be used in all active ventilation modes When ventilation modes are changed the CBM mode remains active Changing to the standby mode deactivates the CBM mode Deactivating the CBM mode activates the apnea monitoring Activating 1 Open the Alarms dialog 2 Touch the Settings tab 1 3 For Cardiac bypass mode CBM touch the On button 3 Deactivating Deactiv...

Page 103: ...nt expiratory measured values and the age dependent MAC values If no respiratory phases are detected expiratory values and xMAC cannot be displayed The integrated MAC algorithm is based on the MAC values shown in the following table These values are guiding values only The binding values are specified on the package information leaflet of the anesthetic agent The MAC values depend on the age of th...

Page 104: ...ics is not considered in the xMAC calculation 7 5 2 Econometer Prerequisite The device has the Advanced gas monitoring option During operation the device monitors the breathing bag for sufficient filling The bar graph indicates whether the device is supplied with sufficient fresh gas 1 40 years For gas mixtures the respective multiples for N2O and anesthetic agents are summed up according to the f...

Page 105: ... the parameter field 2 Set the timer Using the timer The timer always starts with the last time set 1 Touch the Start button 1 to start 2 Touch the Stop button 1 to stop 3 To reset the timer to zero touch the Reset button 1 Range Color Meaning Surplus Yellow Indication of an opportunity to save fresh gas and therefore volatile anesthetic agents Efficient Green No action necessary Breathing bag suf...

Page 106: ...mmed volume 4 is displayed next to the bar graph 2 Touch the Stop button 2 to stop 3 To reset the volumeter and time display to zero touch the Reset button 2 The volumeter stops automatically after 60 seconds The measured values are displayed for 4 minutes and then deleted 7 5 6 Low flow wizard Prerequisite The device has the Advanced gas monitoring option The low flow wizard displays bar graphs f...

Page 107: ...iew Up to three waveforms 1 2 and 3 are displayed along with their associated parameter fields Expert view In addition to the standard view the 4 additional parameter fields 4 5 6 and 7 are displayed Too low Red The fresh gas flow is too low Check the fresh gas flow Check the position of the breathing bag Refill bag Red The fresh gas flow is too low Check the filling of the breathing bag If necess...

Page 108: ...e Views button 2 Touch the button for the desired view Opens the standard view 1 Opens an expert view 2 or 3 The views can be renamed see page 166 Changing with the View button Touch the View button The screen displays the 2nd view Touch the View button The screen displays the 3rd view Touch the View button The screen displays the 1st view 35688 1 2 3 1 2 3 Views 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 ...

Page 109: ... displayed Always consider the relevant regulations when configuring the screen layout For Content 1 select the desired content For a list of the possible screen content see page 184 3 For Scale 2 select the desired setting 7 6 3 1 Restoring the current view The changes to the current view can be canceled 1 Open the Views dialog 2 Touch the Restore current view button 7 6 4 Using loops Prerequisit...

Page 110: ...Loops button The following information is displayed The current loop 1 and 5 previous loops The parameters 2 Cdyn R and TC On the device version with integrated patient gas measurement module the area 3 can be configured so that the pressure volume loop is displayed Saving or deleting reference loops 35866 35868 36396 1 2 3 2 1 ...

Page 111: ...i trends Prerequisite The device has the Advanced trends option Mini trends 2 can be displayed for the waveforms 1 1 Open the Views dialog 2 Touch the Mini trends button For larger and more detailed graphical and numerical trends see page 114 7 6 6 Displaying alarm limits and units of measurement The alarm limits and the units of measurement can also be displayed in the waveform and parameter fiel...

Page 112: ...ing the sweep speed Touch the button 2 and set the sweep speed Adjusting the waveform scale To change the scale touch one of the buttons 3 and select the value 7 6 8 Changing the color scheme and the screen brightness 1 Open the System setup dialog 2 Touch the Screen General tab 1 3 Set the color scheme 2 4 Set the screen brightness 3 35875 1 3 3 2 1 System setup 35883 2 1 1 3 System setup ...

Page 113: ...ook The logbook can save up to a maximum of 20000 entries The entries in the logbook cannot be deleted and are retained even after the device has been turned off and on again or following a power supply failure When the storage limit is reached the oldest entries are overwritten Logbook data are displayed in table form 1 Open the Trends Data dialog 2 Touch the Logbook tab 1 Use the rotary knob or ...

Page 114: ...ayed time period can be enlarged or diminished Changing the time period Touch the Zoom or the Zoom button 4 Displaying the standard time period and the current point in time Touch the Reset zoom button 5 Moving the cursor The exact measured values for a specific point in time are displayed numerically in area 6 To view the values move the cursor to the corresponding position The following options ...

Page 115: ...ror During operation in louder environments the acoustic alarm signals might not be heard Always set the alarm tone to be sufficiently loud Touch the System Sound volume tab 1 3 For Alarm volume 2 set the desired value Vertical tab Overview Accessories Accessories when Dräger Infinity ID accessories are used and information as to when the accessory must be replaced Supply Status display of the con...

Page 116: ...ing using the Alarms dialog Setting using the Quick setup dialog 1 Touch the respective waveform or the parameter field 2 Set the upper alarm limit 1 3 Set the lower alarm limit 2 Manual setting In the Alarms dialog the alarm limits can be set either manually or automatically 1 Open the Alarms dialog 2 Open the Limits tab 1 3 Set the upper alarm limit 2 4 Set the lower alarm limit 3 35922 35935 1 ...

Page 117: ...on in the main menu bar Only use the automatic adjustment when measured values and set values are stable The lower alarm limit for the xMAC level is also adjusted during automatic setting see page 118 Configuration and algorithm see page 169 7 9 2 Activating and deactivating CO2 alarms Prerequisite The device has the Integrated patient gas measurement module option The CO2 monitoring alarms for in...

Page 118: ...ue is greater than the expiratory xMAC value The expiratory xMAC value reaches approximately 0 3 If the xMAC value rises the xMAC monitoring 1 is activated and the lower alarm limit for the xMAC level is automatically adapted to the anesthetic gas concentration The lower alarm limit 2 can reach a maximum value of 1 0 The lower alarm limit can be recalculated by touching the Autoset button 3 This a...

Page 119: ...ing the patient data Patient data can be changed during operation 1 Open the Patient dialog 2 Modify the patient data Changes influence the therapy suggestions among others which is indicated by the position of the arrow on the therapy controls The current therapy settings remain unaffected Observe the following information Influence of patient category weight and age on device behavior page 311 W...

Page 120: ...ata can be exported to a USB mass storage device System test results Logbook Selection from the following time periods is possible Last case Today All Alarm logbook Trends 1 Open the Trends Data dialog 2 Touch the Export tab 1 3 Touch the respective button 2 The data will be saved as a txt file 7 12 Other settings 7 12 1 Switching the breathing system warmer on or off The breathing system warmer c...

Page 121: ...ccur in the breathing system Increase the fresh gas flow if necessary Remove the condensed water from hoses water traps and the breathing system regularly Have service personnel repair the faulty breathing system warmer 7 12 2 Creating additional logbook entries The following events can generate a logbook entry with measured values for the parameters etCO2 MV Pmean PIP Pplat PEEP FiO2 expiratory c...

Page 122: ...ults button and confirm 7 13 Ending the therapy 7 13 1 Switching to the standby mode 1 Touch the Standby button in the main menu bar Or Press the key below the screen 2 Confirm with the rotary knob 3 With mechanically controlled gas mixer Close the flow control valves 7 13 2 O2 insufflation 7 13 2 1 Overview On the electronically controlled gas mixer O2 insufflation is performed using the O2 flowm...

Page 123: ...l in the Aux O2 position 3 Mechanically controlled gas mixer Prerequisite The mechanically controlled gas mixer is equipped with the O2 flowmeter option External O2 flowmeter Prerequisite The device is equipped with an external O2 flowmeter This option is only available for a device with a mechanically controlled gas mixer 35294 35295 37140 3 1 2 1 2 ...

Page 124: ... valve on the O2 flowmeter to the end position When O2 outlets are in use e g for insufflation do not use any ignition sources in the immediate vicinity Do not position oxygen sources in the vicinity of ignition sources e g electrical connectors Connect the appropriate accessories to the outlet for O2 insufflation 1 2 WARNING Risk due to overpressure When the patient is connected to the outlet for...

Page 125: ... filter on the Y piece replace it daily If there is no filter fitted to the Y piece and the sample line is connected directly to the Y piece replace the sample line after every patient Remove the sample line from the water trap Initially leave the water trap fitted to prevent infectious fluid from spurting out Remove the water trap only after surface disinfection Replace the water trap after each ...

Page 126: ...he following information is displayed using different colors Influence of the individual device functions on the functional integrity of the device Leakage values 35069 Color Meaning Green Successfully tested fully available Yellow A non critical fault has been detected The device can be operated with restricted function Red A serious fault has been detected Operation is not possible or is for bid...

Page 127: ... cause operational restrictions e g high leakage incor rect setting of APL valve Calibration of the O2 sensor every 7 days The initialization takes approximately 2 to 3 minutes Remain by the device during this time Make correc tions if necessary Scope of test Calibration of all valves and sensors Test of all device functions Performance of leakage test Leakage test Type and duration Automatic appr...

Page 128: ... prevent patient injury do not perform the system test and leakage test if a patient is connected Touch the button for the system test 2 Complete the tabular checklist 1 It is possible to switch from the tabular checklist to the walk through mode if required To do this touch the button 2 For further information see Checklist in the walk through mode page 136 3 If the O2 sensor is to be calibrated ...

Page 129: ...nent is not operational touch the button 5 The walk through mode will start The components 6 are polled one after the other The buttons 7 are used to document whether the check passed The automatic test starts after all the checks in the walk through mode are complete 35083 Button Meaning Check passed Check failed 35085 6 7 System test 9 8 Test results System test ...

Page 130: ... repeat the test of the component Accepting the irregularity Touch the Accept button 2 and continue the test Accepted irregularities prevent the total result of the system test from indicating fully operational and are protocoled in the logbook 8 3 2 Manual check for leakage 8 3 2 1 Checking a vaporizer for leakage The leakage of a vaporizer can be determined with 2 tests Quick tightness check Che...

Page 131: ...The pressure must remain stable and may only drop at a minimally slow rate If the pressure drops faster the vaporizer is leaking 8 Close the vaporizer To do this set the control dial to the 0 position 9 Exit the System test again To do this touch the Cancel button For leaky vaporizers the compete leakage test can be used to determine how large the leakage is Complete leakage test Testing the vapor...

Page 132: ...following checks are possible Quick tightness check Checks whether there is leakage Complete leakage test Determines the leakage value For both checks first the inner inspiratory hose and then the outer expiratory hose is tested Prerequisites The vaporizers are closed The control dial is in the 0 position The APL valve is set to 30 Gas mixer With electronically controlled gas mixer The flow contro...

Page 133: ...ing circuit as follows a Connect the hose 1 to the inspiratory port 2 b Remove the coaxial test adapter 3 from the expiratory port 4 c Connect the elbow 5 to the hose 6 d Plug the hose 6 with the elbow connected on to the circuit plug 7 e Connect the hose 8 to the expiratory port 4 2 Touch the Tests button 3 Touch the System test button The checklist opens and the breathing system pressure is disp...

Page 134: ...inner hose 1 Connect the breathing circuit as follows a Connect the hose 1 to the inspiratory port 2 b Connect the coaxial test adapter 3 to the expiratory port 4 c Remove the elbow 5 from the hose 6 d Connect the hose 6 to the coaxial test adapter 3 2 Touch the Tests button 3 Touch the Leakage test button The value determined for leakage is displayed as Leakage mech vent Note down the value as th...

Page 135: ... value as the leakage of the expiratory hose Evaluation of the values determined for leakage 39555 Test of the inspira tory hose Test of the expira tory hose Evaluation 150 mL 150 mL The breathing circuit is intact 150 to 500 mL 150 mL Low leakage Check whether the breathing circuit is suitable for the particular patient category 500 mL 150 mL Do not use the breathing circuit There is a risk of re...

Page 136: ... a device with an electronically controlled gas mixer active AGS O2 sensor and factory defaults The scope of the checklist and the test steps displayed may vary due to differing system settings The instructions on the screen take precedence Prerequisites 1 Connect the hoses 1 2 Seal the Y piece 2 3 Set the APL valve to 30 4 Close the flow control valve 35102 35100 35103 2 1 20 40 30 ...

Page 137: ...300 A300 XL A350 A350 XL SW 1 0n 137 Tests 5 Set the O2 switch to Aux O2 8 4 1 Vaporizers For each vaporizer check 1 The locking lever points left indicating the vaporizer is locked 2 The filling inlet is closed 35104 35105 35108 ...

Page 138: ...for use Atlan A300 A300 XL A350 A350 XL SW 1 0n Tests 3 The control dial is set to position 0 and the key is locked in placed 4 Check the filling level in the sight glass Refill anesthetic agent if required 35107 35106 ...

Page 139: ...t read the pressure from the pressure gauge 2 Close the gas cylinder valves On devices that are equipped with Advanced Cylinder Support the gas cylinder valves can remain open during operation These devices are identified by an appropriate label near the gas inlets see Gas inlets page 26 8 4 2 2 Checking the emergency O2 delivery with electronically controlled gas mixer Prerequisite Y piece is sea...

Page 140: ...SW 1 0n Tests 2 Open the flow control valve 1 Set the desired O2 flow The O2 flowmeter indicates a flow the breathing bag fills and the inflow of gas is audible 3 Close the flow control valve 3 4 Set the O2 switch 4 back to the Aux O2 position 35112 35111 3 4 ...

Page 141: ... connected properly 2 Extendable hoses 3 are extended to the length intended for use Do not change the length of the hoses after the test is done 3 Remove the water from the hoses 4 4 Prerequisite Patient gas measurement module present Setting Sample line is connected during test Off Setting Test breathing circuit On Electronically controlled gas mixer or mechanically controlled gas mixer with O2 ...

Page 142: ...trolled gas mixer or mechanically controlled gas mixer with O2 detection A check is made to ensure that the inspiratory hose expiratory hose and breathing bag hose are connected correctly This can be deactivated in the System setup System System test dialog 2 Verify O2 delivery Prerequisite Patient gas measurement module present Sample line is connected during test On Electronically controlled gas...

Page 143: ... O2 flush 1 Press the O2 key and keep it pressed until the pressure stabilizes The pressure does not exceed 45 hPa cmH2O 2 Release the O2 key again and wait until the pressure stabilizes The pressure does not fall below 15 hPa cmH2O 3 Lift the APL valve The pressure is released 35118 35118 35120 20 40 30 ...

Page 144: ...ver The non return valves have been fitted 8 4 5 Components 8 4 5 1 Loudspeakers Touch the button and wait for 2 different acoustic signals If the acoustic signals are not emitted contact service personnel 8 4 5 2 Bronchial suction Check the functional integrity of the bronchial suction 37962 35123 35124 ...

Page 145: ...iving system With active anesthetic gas scavenging Have the flow for the anesthetic gas scavenging system set so that the red flow indicator 1 floats in range 2 normal range If the flow indicator 1 is floating in range 3 restricted range certain fresh gas flows should not be exceeded see Anesthetic gas receiving system in chapter Technical data Contamination of the ambient air can be prevented by ...

Page 146: ...a visual inspection of the overpressure valve for damage and soiling Check that the scavenging hose is run correctly The hose must not be blocked 2 Perform the visual inspection of the overpressure valve 4 8 4 6 Accessories 8 4 6 1 Soda lime Make sure that the soda lime does not need to be exchanged Change the soda lime if it is discolored or when its maximum period of use has been reached see pag...

Page 147: ...s with the CLIC absorber locked into place because the CLIC absorber affects the system compliance values 8 4 6 2 Sample line Check that the sample line is correctly connected 8 4 6 3 Water trap 1 Check the water level in the water trap 2 Check the period of use of the water trap Replace the water trap when necessary With Infinity ID function Water traps of type Infinity ID WaterLock 2 will automa...

Page 148: ... ambient air i e 21 oxygen concentration Fluctuating oxygen concentrations must be avoided The following notes must be adhered to Do not fill vaporizers during the calibration Close all the flow control valves Do not blow into the sensor Do not use any disinfectants 1 If the O2 sensor is to be calibrated despite a valid calibration proceed as follows Touch the Calibrate button 2 Touch the button a...

Page 149: ...o the sensor port and turn it clockwise until it reaches the end position 7 After the calibration the fully automatic main test is continued Note on the expiry of the life span of the O2 sensor cell The life span of the O2 sensor cell is 2 years and is monitored by the device As soon as there are 28 days or fewer of the life span left the remaining life span will be displayed in the system test Wh...

Page 150: ...on is possible despite the expired O2 sensor cell the O2 measurement will continue to be available With an expired O2 sensor cell a yellow test result operational with limitations can be achieved at best Replace the sensor cell when the O2 sensor can no longer be calibrated see page 55 39676 ...

Page 151: ...ontrol valves are closed 2 Press the key 3 Follow the instructions on the screen 9 2 Storing the device Proceed as follows when the device is to be disconnected from the mains power supply for longer than 2 weeks 1 Set the main switch to the 0 position 2 Disconnect the power plug This will prevent deep discharge of the battery 9 3 Disconnecting the mains power supply When the device is disconnecte...

Page 152: ...er remains in the vicinity of the anesthesia machine i e within a distance of up to 4 meters 12 feet This facilitates fast recognition and response in the event of an alarm If the causes of the alarm are only temporary the alarms will likewise only be indicated temporarily Impaired Infinity ID functions Electromagnetic disturbances or faults in Infinity ID components can cause permanent alarms Con...

Page 153: ...larms Current alarms dialog with information about all active alarms see page 154 10 2 2 Acoustic alarm signals It always is the alarm with the highest priority that is acoustically signaled The signal is emitted until either the cause of the alarm is remedied or the alarm silence key is pressed In situations where several alarms occur at the same time alarms with higher priority may only be signa...

Page 154: ...larms can optionally be displayed as follows Touch the alarm in the header bar Open the Alarms dialog and touch the Current alarms tab 1 2 In the list 2 touch the corresponding alarm or select it with the rotary knob 3 Refer to the information under Cause 4 and Remedy 3 to remedy the error A list of all possible alarms can be found in chapter Alarm Cause Remedy see page 201 Background color Alarm ...

Page 155: ... higher alarm priority or a higher internal priority number compared with the silenced alarm are acoustically signaled For further information see Alarm Cause Remedy page 201 10 3 2 1 Reactivating the alarm tone Press the alarm silence key again 10 3 3 Downgrading and acknowledging alarm messages Some alarms can be downgraded to low priority note or they can be cleared completely The relevant alar...

Page 156: ...arms Option 1 Or Option 2 36008 36011 Option 1 Option 2 Touch the ALARM RESET button 1 in the header bar and confirm In the Alarms Current alarms dialog 2 touch the Reset all button 3 and confirm All the alarms displayed in the alarm message field will be downgraded or reset All alarms will be downgraded or reset 1 2 3 Alarms ...

Page 157: ...ry knob or the arrow buttons 2 to scroll the cursor up or down The alarm logbook is cleared when the device is shut down or a new case is started 10 3 5 Adjusting the alarm limits If an alarm is triggered because a lower limit or an upper limit is exceeded it might be necessary to adjust the alarm limits To do this either set the alarm limits see page 116 or change the alarm limits using the Quick...

Page 158: ...XL A350 A350 XL SW 1 0n Alarms The relevant alarm limit 2 is preselected 2 Adjust the value 2 and confirm The device can be configured so that the Quick setup dialog opens automatically in the event of an alarm see page 170 36016 2 Quick setup ...

Page 159: ...Psupp 5 hPa cmH2O Ext FGO VC VC AF PC PSV with Psupp 5 hPa cmH2O FiO2 low1 1 With inspiratory O2 measurement with O2 sensor Is adopted Is adopted Not measured Is restored or remains active FiO2 high1 Configurable Configurable FiO2 low2 2 With integrated patient gas measurement module Is adopted inAgent high2 Apnea no CO2 2 Off Off3 3 The alarm remains suppressed until respiratory activity is detec...

Page 160: ...o a ventilation mode with higher respiratory support the Apnea no CO2 alarm is reset If the apnea situation persists an alarm appears after the time specified in table Alarm delay and alarm escalation 10 5 Alarm delay and alarm escalation To prevent unnecessary alarms some alarms are not displayed immediately after a limit violation but after a delay In addition certain circumstances can cause the...

Page 161: ...st after 20 seconds for RR 6 or At the latest after 35 seconds for RR 6 or at the latest after 65 seconds for the Pause Manual Sponta neous and Ext FGO modes 15 seconds later for RR 6 or 30 seconds later for RR 6 No CO2 detected 60 s O2 measurement not available N2O measurement not available Agent measurement not available O2 measurement tem porarily inaccurate CO2 sensor accuracy low Agent measur...

Page 162: ...o pressure Apnea At the latest after 20 seconds for RR 6 or At the latest after 35 seconds for RR 6 or at the latest after 65 seconds for the Pause Manual Sponta neous and Ext FGO modes 15 seconds later for RR 6 or 30 seconds later for RR 6 Apnea Ventilation At the latest after 20 seconds 15 seconds for RRmin 4 configurable see page 168 Tidal volume not achieved After 3 consecutive breaths Airway ...

Page 163: ...th regard to an O2 concentration that is too low or an anesthetic gas concentration that is too high At the same time the message Waiting for respiratory phases is displayed in the CO2 waveform Once 2 breaths have been detected the message disappears and only then are the O2 CO2 N2O and anesthetic gas alarms active Cardiac bypass mode still active If a minute volume of 50 of the suggested value is...

Page 164: ...urement function If this measurement function monitors parameters no alarms based on these parameters can be generated Example Problem Alarms occurring at the same time Combined alarm Several causes of apnea are present Apnea no flow Apnea no pressure Apnea no CO2 Apnea Faults in multiple compo nents This causes failure of a system function Example Insp press sensor failure Exp pressure sensor fai...

Page 165: ...of the New adult New pediatric or New neonate buttons The start settings can be adjusted after the configuration password is entered If required the device can be delivered with start settings that may differ from the factory defaults 11 1 3 User specific settings User specific settings can be adjusted by the user without a configuration password The settings take effect immediately but are discar...

Page 166: ...ry defaults are marked in bold format 11 3 2 System setup Screen 11 3 2 1 Vertical tab General 11 3 2 2 Vertical tab Views Headline Parameter Setting range Description Color scheme Day light Day dark Night Sets the color scheme Observe the information in the following section Daytime colors and nighttime colors page 84 Screen bright ness 10 to 100 80 Sets the screen brightness Headline Parameter S...

Page 167: ... Auto 5 to 5 10 to 10 30 to 30 60 to 60 120 to 120 Auto 5 to 5 10 to 10 30 to 30 60 to 60 120 to 120 Specifies the scale for the flow wave form O2 scale Auto 0 to 100 15 to 35 25 to 45 35 to 55 45 to 65 55 to 75 65 to 85 75 to 95 85 to 105 Specifies the scale for the O2 wave form CO2 scale kPa Auto 0 to 6 0 to 12 mmHg Auto 0 to 50 0 to 100 Specifies the scale for the CO2 wave form Paw scale mbar h...

Page 168: ...o 74 Off 0 0 to 9 7 Off 0 to 74 inCO2 kPa mmHg 0 1 to 1 4 Off 1 1 1 to 10 Off 8 0 1 to 1 4 Off 1 1 1 to 10 Off 8 0 1 to 1 4 Off 1 1 1 to 10 Off 8 Inspiratory CO2 concentration Paw high mbar hPa cmH2O 5 to 99 40 5 to 99 25 5 to 99 20 Airway pressure If the airway pressure is above the value set for Paw low for longer than 15 s the Airway press continuously high alarm is issued Paw low mbar hPa cmH2...

Page 169: ... alarm volume 10 to 100 10 Sets the minimum volume with which an alarm tone will be signaled Headline Parameter Setting range Description Offset for Autoset limits function Automatic adjustment of the parameters to current measured values For further information see the following section Setting the alarm limits page 116 By touching the Autoset button the alarm limits are adjusted so that the uppe...

Page 170: ...ure is detected xMAC low alarm On Off Activates the xMAC low alarm FiO2 too high for neonates thresh old value 50 25 to 90 Sets the FiO2 value that is considered critical for neonates If this value is exceeded for a certain time the FiO2 too high for neonates alarm will be trig gered FiO2 too high for neonates alarm after h mm Off 0 10 to 9 50 0 15 Sets the time after which the FiO2 too high for n...

Page 171: ...m behavior at the start of the therapy is defined by the configuration in the vertical tab Limits MV low Yes No MV high Yes No xMAC low Yes No etCO2 low Yes No etCO2 high Yes No inCO2 high Yes No inAgent low Yes No Deactivate the alarm limit in cardiac bypass mode CBM FiO2 high Yes No Specifies the alarm behavior in the CBM mode MV low Yes No MV high Yes No inAgent low Yes No Headline Parameter Se...

Page 172: ...e tidal volume and the respiratory rate based on the patient category VT mL 5 to 1500 500 5 to 1500 150 5 to 1500 50 RR min 3 to 100 12 3 to 100 20 3 to 100 30 Selected Ideal body weight Specifies the tidal volume and the respiratory rate that are based on the ideal body weight Set the tidal volume and the respiratory rate for the supporting points 5 15 75 100 kg 11 33 165 220 lbs For calculated v...

Page 173: ...80 10 Off 3 to 80 10 Off 3 to 80 10 Insp term 5 to 80 25 5 to 80 25 5 to 80 25 PEEP mbar hPa cmH2O Off 2 to 35 3 Off 2 to 35 3 Off 2 to 35 3 Slope s 0 to 2 0 2 0 to 1 5 0 2 0 to 1 5 0 2 RRmin min Off 3 to 25 6 Off 3 to 25 10 Off 3 to 25 15 Tplat 0 to 60 20 0 to 60 20 0 to 60 20 Trigger L min 0 3 to 15 4 0 0 3 to 15 2 0 0 3 to 15 1 0 Sync SIMV CMV SIMV CMV SIMV CMV Headline Parameter Setting range ...

Page 174: ...ults 100 for pediatric patients and 50 for neonates Carrier gas Air N2O Air N2O Air N2O Sets the carrier gas Headline Parameter Setting range Description Default selection for Start dialog Continue case New adult New pediatric New neonate Specifies which button is preselected the first time the Start dialog is opened and after changes to the system setup Weight kg lbs Off 30 to 300 Off Off 67 to 6...

Page 175: ...reathing system warmer on or off Auto Wake up opens start dia log upon respira tory activity On Off Determines whether the Start dialog opens automatically when ventilation activity is detected e g as a result of repeated squeezing of the breathing bag Anesthetic gas compensation Auto Off Des Sev Corrects the accuracy of the flow mea surement on devices with inspiratory O2 measurement Select the v...

Page 176: ...anguage set tings Time source MEDIBUS 1 MEDIBUS 2 NTP server None Selects the source for the time synchro nization Prerequisite The connected device supports this function Date and time day month year hour minute Sets the date and time The change is applied on leaving the General verti cal tab Automatic switch to daylight sav ings time On Off Activates or deactivates the automatic changeover to da...

Page 177: ...2 kPa mmHg Volatile agents kPa Headline Parameter Setting range Description General Always use walk through mode On Off Sets the walk through mode function When On is configured system tests and leakage tests will always be exe cuted in walk through mode Sample line is connected during test On Off Specifies whether the sample line is connected to the Y piece or to the filter on the Y piece during ...

Page 178: ...her the automatic tests will check that the breathing circuit is correctly connected During this test a check is made as to whether the breathing gas can flow from the inspiratory port via the Y piece to the expiratory port If Sample line is connected during test is set to On this test is performed fully automatically If Sample line is con nected during test is set to Off addi tional manual checks...

Page 179: ...IP address by the DHCP server Restart the device after each change to the network settings The network set tings are not affected by a reset to fac tory defaults Accept the changes to IP address Sub net mask or Default gateway with the Apply button The changes are only active after the device has been restarted IP address XXX XXX XXX XXX Subnet mask XXX XXX XXX XXX Default gateway XXX XXX XXX XXX ...

Page 180: ...rm Headline Parameter Setting range Description Monitoring of Infinity ID accessories Breathing circuit On Off Activates or deactivates the Infinity ID functionality On Generates a message when the maximum period of use is exceeded Generates a message when Infinity ID breathing hoses are incor rectly connected Off Messages are suppressed Water trap On Off Flow sensors On Off CO2 absorber On Off Ex...

Page 181: ...ly be transferred completely if the hardware and software characteristics are identical on both devices If these characteristics e g gas mixer gas measurement are different or if configuration data are missing certain settings will be reset to the factory defaults or switched off To achieve as complete a transfer as possible use a device with the greatest possible range of features as the starting...

Page 182: ...s storage device The following settings are neither imported nor exported Device name Date and time IP address 11 4 1 Importing the configuration 1 Touch one of the configurations in the list 4 2 Touch the Import button 2 and confirm 3 Restart the device 4 Check the device configuration for correctness 11 4 2 Exporting the configuration To export configurations touch the Export button 3 and confir...

Page 183: ... USB mass storage device Prerequisite A USB mass storage device with valid licenses is connected to the USB port Touch the Load from USB button 3 The activation codes are read and displayed in the list 5 Entering the activation code 1 Touch the Enter code button 4 2 Enter the activation code and confirm with OK The license is displayed in the list 5 Activating the licensed software option The lice...

Page 184: ...in the Quick setup dialog see page 109 11 6 1 Waveforms and associated parameter fields etCO2 CO2 in et CO2 in et RR Paw Paw 3 Volume controlled modes Parameters PIP Pplat PEEP All other modes Parameters PIP Pmean PEEP Paw 4 Parameters PIP Pplat Pmean PEEP Volume MV VT RR Volume MV VT 36158 36156 36157 36162 36163 36164 36165 36214 CO2 CO2 CO2 Paw Paw Paw Volume Volume ...

Page 185: ...Instructions for use Atlan A300 A300 XL A350 A350 XL SW 1 0n 185 Configuration Volume VT MV RR Volume VT MV O2 O2 Primary agent Empty 36166 36216 36160 36161 36155 36159 Volume Volume O2 O2 Iso ...

Page 186: ...meters PIP Pmean PEEP Paw 4 MVmand spon MV VT RR MV VT VT MV RR VT MV O2 O2 Primary agent RR Econometer Low flow wizard Gases in et CO2 et in CO2 et CO2 et RR in Paw PIP Paw PIP Pmean PEEP Pmean Paw PIP Pplat PEEP MV Mand Spon Volume MV VT RR Volume MV VT Volume VT MV RR Volume VT MV O2 in O2 in Iso in et RR Econometer Deficit Efficient Surplus Required FG flow Total flow Efficient Gases in et O2 ...

Page 187: ...Gas supply Volumeter Stopwatch Timer VT Compliance trend MV CO2 trend O2 uptake trend Econometer trend Compliance 42195 Gas supply O2 N2O Air Volumeter VT Volume Start Stopwatch Start Timer Set Start VT VTi VT Paw Cdyn PEEP MV CO2 O2 uptake Econometer trend Compliance Cdyn mean Volume Paw ...

Page 188: ...tlan A300 A300 XL A350 A350 XL SW 1 0n Configuration Flow tubes electronically controlled gas mixer with econometer Flow tubes mechanically controlled gas mixer 36178 42191 Econometer O2 N2O Surplus Efficient Deficit O2 Air N2O ...

Page 189: ...Instructions for use Atlan A300 A300 XL A350 A350 XL SW 1 0n 189 Configuration When the PV loop parameter field is displayed the flow tubes will be displayed at reduced size 42192 O2 Air N2O ...

Page 190: ... or missing The flow sensors are incorrectly installed or damaged The rear O ring is missing The upper part of the breathing system is incorrectly fitted or damaged The breathing system is not locked The valves or seals of the breathing system are damaged The sensor port for the O2 sensor is not sealed with the sealing cap The circuit plug is scratched or damaged The filling or emptying connection...

Page 191: ...atus display The breathing system warmer is deactivated during battery operation The peak inspiratory flow may be limited to 75 L minute 12 2 2 Mains power supply failure and battery discharged If mains power supply fails and the battery is discharged a signal tone is emitted Manual ventilation and spontaneous breathing are still available O2 and anesthetic agent can still be delivered using the e...

Page 192: ... power supply is restored 1 Restart the device see page 86 2 Charge the discharged battery for at least 8 hours 3 Check the displays for mains power supply and battery on the status display 12 3 Failure of the gas supply A failure of the central supply can result in simultaneous device malfunctions on all systems connected to it The device generates alarms if the gas supply for the gases O2 Air or...

Page 193: ...ct the pressure reducer to the new filled gas cylinder see page 60 6 Open the valve of the filled gas cylinder slowly 12 3 3 Complete failure of the gas supply WARNING Risk of patient recovering consciousness If the gas supply fails completely further operation takes place through gas supply of the anesthesia machine with ambient air The ventilation continues with the ambient air however no more a...

Page 194: ...very has failed the emergency O2 delivery can be used to deliver oxygen and anesthetic agent The current ventilation mode and the fresh gas deficiency detection remain active In the event of a fault illustrations and instructions showing how to start the emergency O2 delivery are displayed in areas 1 and 2 The emergency O2 delivery is started as follows WARNING Risk of patient injury If the gas mi...

Page 195: ...the O2 measurement has failed 1 WARNING Risk due to faulty O2 sensor If the O2 measurement fails it will no longer be possible to monitor the patient adequately Make sure that substitute O2 monitoring conforming to the general safety requirements is available Perform a system test and calibrate the O2 sensor 2 If the calibration fails and the O2 sensor failure alarm is displayed refer to the follo...

Page 196: ...PGM Prerequisite There is no patient connected The device is switched off The device is disconnected from the power supply To do this disconnect the power plug The water trap has been removed 1 WARNING Incorrect gas measurement Faulty or non functional PGMs can cause incorrect gas measurements As a result the patient could be put at risk Have the PGM replaced by service personnel The O2 sensor cel...

Page 197: ...e side surfaces 3 of the RFID antenna together Pull the RFID antenna off downwards and leave it on the device Do not pull on the antenna cable Do not kink the antenna cable 3 Remove the 2 screws and the fixing plate 4 4 Withdraw the patient gas measurement module from the compartment 5 Fit a new patient gas measurement module Proceed in reverse order to do this 6 Insert a new water trap 7 Turn on ...

Page 198: ...vate the backup manual switch see page 38 2 Use the emergency O2 delivery see page 37 3 Check the vaporizer setting 4 Ventilate the patient manually 5 Ensure appropriate substitute monitoring 12 9 Complete failure The device no longer responds to user operation WARNING Risk of device malfunction If the breathing bag does not fill with fresh gas the patient cannot be sufficiently ventilated Check t...

Page 199: ...ing system AGSS is insufficient Have the function of the AGSS terminal unit checked Follow the corre sponding instructions for use The particle filter is con taminated or blocked Replace the particle filter The flow indicator is above the normal range The suction power of the ejector in the AGSS termi nal unit is too high Have the suction power of the ejector in the AGSS terminal unit adjusted to ...

Page 200: ... receiving system AGS This chapter describes the replacement using the example of an active AGS which is connected to the device with the transfer hose and to the anesthetic gas scavenging system with the scavenging hose Disassembly 1 Disconnect the transfer hose 1 2 Disconnect the scavenging hose 2 3 Unfasten the 2 screws 3 4 Withdraw the AGS to the side 5 Dispose of the AGS The AGS must not be r...

Page 201: ...tical alarm within an alarm priority is given the number 255 The following table lists the alarm messages in alphabetical order If an alarm occurs the table helps to quickly identify causes and remedies The possible causes and remedial measures should be looked through in the order they are listed until the alarm is resolved Some alarms are listed several times because their priority may change un...

Page 202: ...hing gas Wait until anesthetic agent identification is complete There is electromagnetic interference Check for electromagnetic radiation in the vicinity Ambient temperature is too high Check ambient conditions 255 Agent measurement tem porarily inaccurate The sensor has not yet warmed up Wait for the automatic cali bration The ambient air used for cali brating the sensor was impure Position the d...

Page 203: ...g hoses are blocked or the tube is kinked Check breathing circuit and tube 255 Airway pressure negative Fresh gas flow is insuffi cient breathing bag is blocked or positioned incor rectly Check fresh gas settings and position of breathing bag Suction maneuver during ventilation Check the bronchial suction system Failure of the anesthetic gas scavenging system Check anesthetic gas scav enging syste...

Page 204: ...pontaneous breath ing ability of the patient Fresh gas flow is insuffi cient breathing bag is blocked or positioned incor rectly Check fresh gas settings and position of breathing bag The breathing hoses are blocked or leaking Check breathing circuit and tube 255 Apnea no flow No breathing or ventilation Start manual ventilation Check ventilation settings Check spontaneous breath ing ability of th...

Page 205: ... ing ability of the patient Adjust the setting for Trig ger Change to pressure con trolled or volume controlled ventilation mode 100 Backup manual mode acti vated The backup manual switch has been activated Start manual ventilation Check vaporizer and fresh gas settings To exit backup manual mode return the switch to its normal position 100 Backup manual mode acti vated The backup manual switch ha...

Page 206: ... Dräger 100 Battery temperature high The battery temperature is high Charging of the battery has been suspended to pro tect it from damage Ensure that the system is connected to the mains power supply Check the ambient tempera ture 100 Breathing circuit expired Accessory has been used too long Replace the accessory if nec essary Use ALARM RESET to acknowledge alarm 120 Breathing system failure The...

Page 207: ...ng system warmer If necessary proceed as fol lows Turn off the device with the main switch then ventilate the patient with the breathing bag Or Discon nect the patient then use a manual resuscitator 100 Breathing system warmer failure The breathing system warmer is faulty Check breathing circuit for condensation Increase fresh gas flow if necessary Call Dräger 100 Cardiac bypass mode still active ...

Page 208: ...rnative gas mea surement system If the problem persists call Dräger 255 CO2 sensor accuracy low The sensor has not yet warmed up Wait for the automatic cali bration The ambient air used for cali brating the sensor was impure Position the device in an environment with clean ambi ent air 0 Communication failure The network connection could not be established Re establish the connection Use ALARM RES...

Page 209: ...räger 100 Expiratory flow sensor expired Accessory has been used too long Replace the accessory if nec essary Use ALARM RESET to acknowledge alarm 255 Expiratory flow sensor failure The sensor is not calibrated The breathing system has been replaced or discon nected since last calibration Perform the leakage test Failure of the flow sensor Replace the flow sensor and perform a leakage test 200 Ext...

Page 210: ...Check O2 supply 135 FiO2 too high for neonates FiO2 has exceeded the threshold value for longer than the time configured in the system setup Check O2 concentration and fresh gas settings Use ALARM RESET to acknowledge alarm 30 Flow control valve is open At least one flow control valve is open Close all flow control valves 80 Flow sensor calibration required The flow sensor calibration is invalid P...

Page 211: ...m priority Call Dräger 255 Hose connected to wrong port A breathing hose is not cor rectly connected Connect breathing hoses correctly 100 Hose does not fit to pat category The detected breathing hose is not suitable for the selected patient category Use compatible accessory Use ALARM RESET to acknowledge alarm 100 Hose does not fit to pat category The detected breathing hose is not suitable for t...

Page 212: ...exceeded the upper alarm limit Check vaporizer and fresh gas settings 255 Inspiratory enflurane high Inspiratory anesthetic gas concentration has exceeded the upper alarm limit Check vaporizer and fresh gas settings 255 Inspiratory enflurane low The inspiratory anesthetic gas concentration is below the lower alarm limit Check vaporizer and fresh gas settings Refill the vaporizer Check the breathin...

Page 213: ... Check fresh gas composi tion Press the O2 button to flush the breathing system 255 Inspiratory O2 measure ment temporarily inaccu rate The O2 measurement accu racy is currently reduced Perform the system test 255 Inspiratory sevoflurane high Inspiratory anesthetic gas concentration has exceeded the upper alarm limit Check vaporizer and fresh gas settings 255 Inspiratory sevoflurane high Inspirato...

Page 214: ...ve ventilation set tings are applied e g high respiratory rate high inspira tory pressure short slopes Check ventilation settings A fan is faulty Call Dräger 150 Internal FG flow failure The internal gas delivery sys tem is not operational A sys tem test may be able to resolve the issue Deliver O2 1 Set the O2 switch to Add O2 2 Set the O2 flowmeter to the desired flow Check the vaporizer setting ...

Page 215: ...nt air used for cali brating the sensor was impure Position the device in an environment with clean ambi ent air Wait for the automatic cali bration 0 MEDIBUS COM 1 failure Communication via the cor responding COM port is interrupted Re establish the connection Use ALARM RESET to acknowledge alarm The configured baud rate is not sufficient for the amount of data to be transferred Increase the baud...

Page 216: ...s flow so that it equals or exceeds the minute volume 255 N2O measurement failed There is electromagnetic interference Check for electromagnetic radiation in the vicinity There is an internal failure Use an alternative gas mea surement system If the problem persists call Dräger 255 N2O measurement not available The ambient air used for cali brating the sensor was impure Position the device in an e...

Page 217: ...g Air instead Check central O2 supply or use cylinder Use ALARM RESET to downgrade alarm priority 255 O2 concentration implausi bly high The O2 sensor calibration is invalid Use substitute O2 monitoring Perform the system test 220 O2 cylinder almost empty The cylinder is almost empty Replace the cylinder Use the central supply 210 O2 cylinder empty The cylinder is empty or closed Replace the cylin...

Page 218: ...Use substitute O2 monitoring Use ALARM RESET to downgrade alarm priority Perform the system test Call Dräger 255 O2 sensor failure The O2 sensor is faulty Use substitute O2 monitoring Use ALARM RESET to downgrade alarm priority When the case has been completed perform a sys tem test Replace the sensor cell if necessary If the problem persists call Dräger 255 O2 sensor not ready A new O2 sensor cel...

Page 219: ...switched to battery opera tion Restore mains power supply 100 Power supply failure Internal fault in the power supply Operation of the device can be continued Call Dräger 100 Pressure sensor failure There is condensate in the breathing hoses Check the breathing hoses Sensor calibration failed Perform the system test If the problem persists call Dräger 255 Pressure relief valve opened The internal ...

Page 220: ...patient then use a manual resuscitator Call Dräger 0 Therapy settings not applied The last changes to the ther apy settings were not applied Change to Man Spon mode then switch back to the desired ventilation mode Use ALARM RESET to acknowledge alarm If the problem persists call Dräger 100 Third agent detected A mixture of more than 2 anesthetic agents has been detected Flush the system if neces s...

Page 221: ...reathing sys tem but there is no oxygen delivery Change to Man Spon mode and ventilate the patient manually Breathing activity has been detected at an inactive breathing system Check if the patient is con nected to the correct breath ing system 80 xMAC low Inspiratory and expiratory gas concentrations are lower than the automatically calcu lated limit Check patient condition Check filling level Re...

Page 222: ... of wear and replace them if necessary Disposable products Disposable products such as e g the sample line and the water trap have been designed tested and manufactured exclusively for single use Reuse reprocessing or sterilization can result in failure of the accessory incorrect measurements and injury to the patient Do not reuse disposable products Do not reprocess disposable products Do not use...

Page 223: ...fection or cleaning Do not use plasma sterilization or radiation sterilization Do not use water jets compressed air brushes or similar Do not use ultrasonic baths Do not use hot steam sterilization on the Spirolog and Infinity ID flow sensors Clean and disinfect the flow sensor in accordance with the associated instructions for use Use only clean disinfectant solutions to disinfect the flow sensor...

Page 224: ...n return valves yellow and blue Fresh gas decoupling valve black Sensor cap of the O2 sensor Bag elbow Absorber container and absorber insert Piston diaphragm Breathing bag arm option CLIC adapter option Critical The device does not contain any components that are classified as critical Classification Explanation Reprocessing Non critical Components that come only into contact with skin that is in...

Page 225: ... with thermal disinfection Device surfaces Yes No Breathing system mount1 1 Special reprocessing measure see page 236 Yes No Ports No Yes Non return valves yellow blue and black No Yes APL valve Yes exterior Yes Upper part of the breathing system and lower part of the breathing system No Yes Sensor cap of the O2 sensor2 2 Special reprocessing measures see page 245 No Yes Absorber container and abs...

Page 226: ...cidal or virucidal against enveloped viruses Follow the manufacturer s instructions for the surface disinfectants Other surface disinfectants are used at one s own risk Do not use purely alcohol based disinfectants Disinfectants based on alcohol or with a high alcohol concentration have only limited effectiveness and may cause property damage Class of active ingre dient Surface disinfectants Manuf...

Page 227: ...o the filter on the Y piece replace it daily If there is no filter fitted to the Y piece and the sample line is connected directly to the Y piece replace the sample line after every patient Remove the sample line from the water trap Initially leave the water trap fitted to prevent infectious fluid from spurting out Remove the water trap only after surface disinfection Replace the water trap after ...

Page 228: ... Risk of injury to patients due to failure of accessories Disposable products have been designed tested and manufactured exclusively for single use Reuse reprocessing or sterilization can result in failure of the accessory and injury to the patient Do not reuse reprocess or sterilize disposable products Dispose of the disposable accessories Sample line Breathing circuit Breathing bag Filter 2 Repr...

Page 229: ...evice CAUTION Risk of contaminating the device If the water trap is removed fluid may get into the main device while it is being disinfected Leave the water trap fitted during surface disinfection Perform the surface disinfection of the entire device by wiping backwards and forwards at least 3 times In particular disinfect device surfaces and hand contact points that are touched frequently Follow ...

Page 230: ...Disconnect all power plugs 13 8 2 Disassembling the water trap The water trap is only present if the device is equipped with the integrated patient gas measurement module Prerequisite The sample line has been removed WARNING Risk of infection The water trap may contain infectious fluid Proceed carefully when emptying and take protective measures if necessary Follow the infection prevention policie...

Page 231: ...2 absorber 1 Unscrew the CO2 absorber 1 from the breathing system 2 Remove and dispose of the optional disposable dust filter 2 3 CAUTION Risk of chemical burns Soda lime is caustic and is a strong irritant for eyes skin and airway Handle the soda lime carefully and do not spill it Empty out the used soda lime and dispose of it according to its instructions for use 39629 37107 ...

Page 232: ...CLIC adapter flips open 2 Withdraw the CLIC absorber 2 upwards from the holder 3 3 Fold the holder back again until it engages audibly 4 Dispose of the CLIC absorber in accordance with its instructions for use 13 8 4 Disassembling the breathing bag arm option 1 Unfasten the knurled screws on the attachment piece 1 for the breathing bag arm 2 Remove the attachment piece 1 with the breathing bag arm...

Page 233: ...use Atlan A300 A300 XL A350 A350 XL SW 1 0n 233 Reprocessing 13 8 5 Disassembling the O2 sensor 1 Remove the breathing system cover 1 2 Turn the O2 sensor 2 counterclockwise 3 Take out the O2 sensor 3 37062 37079 37080 ...

Page 234: ... This may result in a waiting time when putting the device back into operation 6 WARNING Risk of incorrect gas measurement Reprocessing and sterilization can damage the O2 sensor cell This may result in a malfunctioning measurement and the patient may be put at risk Do not disinfect or sterilize the O2 sensor cell or immerse it in other fluids Place the O2 sensor as shown 6 The sealing cap 7 remai...

Page 235: ...ime into the breathing system make sure that the reusable CO2 absorber has been removed Prerequisite The breathing system cover has been removed 1 To unlock turn the 3 levers 1 counterclockwise by approximately 120 2 CAUTION Risk of injury due to breathing system warmer When the breathing system warmer is switched on the bottom side of the breathing system and the heating plate beneath it can beco...

Page 236: ... piston diaphragm 1 from the ventilator If necessary remove any residual moisture present 13 8 8 Disinfecting the breathing system mount Note the following information Do not use alcohol based disinfectants Remove any residues Ensure lint free cleaning and disinfection Do not allow fluid to penetrate Prerequisite The breathing system cover has been removed The breathing system has been removed 370...

Page 237: ...shock Device malfunctions Ensure that no liquid penetrates the device Perform the following steps 1 Use a cloth soaked in disinfectant or use a ready to use disposable cloth 2 Perform the surface disinfection of the breathing system mount by wiping backwards and forwards at least 3 times Take particular care to disinfect the pneumatic connections 1 3 Repeat steps 1 and 2 4 times each 39534 ...

Page 238: ... their own instructions for use 5 Lower part of the breathing system 6 Non return valve black 7 CLIC adapter option 8 Incident flow mesh expiration Remains in the expiratory port 9 Expiratory port 10 Inspiratory port 11 Bag elbow Remains at the lower part of the breathing system 12 Breathing bag arm option When the breathing bag arm is used there is no bag elbow fitted to the lower part of the bre...

Page 239: ...d ports CAUTION Risk of failure of flow measurement Improper reprocessing and soiling such as residues 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 Spirolog and Infinity ID flow sensors Clean and disinfect the flow sen...

Page 240: ...Unfasten and remove the inspiratory port 3 4 Remove the inspiratory flow sensor 4 If the breathing system is equipped with a bag elbow the bag elbow remains on the breathing system 13 9 2 3 Upper part of the breathing system 1 To unlock turn the 3 levers 1 counterclockwise by approximately 120 2 Lift off the upper part of the breathing system 2 37071 37174 39630 ...

Page 241: ...ssing measures This can lead to leaks in the breathing system Always remove the APL valve prior to reprocessing Using the lower knurled nut 1 unscrew the APL valve from the upper part of the breathing system 13 9 2 5 Non return valves and fresh gas decoupling valve On the top side of the lower part of the breathing system Remove the yellow inspiratory valve 1 and the blue expiratory valve 2 from t...

Page 242: ...the breathing system Lower part of the breathing system Sensor cap of the O2 sensor APL valve Inspiratory port Expiratory port Inspiratory valve yellow Expiratory valve blue Fresh gas decoupling valve black Piston diaphragm Breathing bag arm option Optionally present are Absorber container and absorber insert CLIC adapter option 13 10 Machine reprocessing 13 10 1 Preparation Prerequisite The breat...

Page 243: ... Breathing bag arm option Optionally present are Absorber container and absorber insert CLIC adapter option Required aids Hose for connecting the breathing bag arm Hose for connecting the absorber insert 13 10 2 Positioning the components Depending on device configuration it is possible that not all components will be present Position the components securely in the load carrier Ensure the followin...

Page 244: ...50 A350 XL SW 1 0n Reprocessing Upper part of the breathing system Position the upper part of the breathing system with a slight tilt Lower part of the breathing system Position the lower part of the breathing system with a slight tilt 38566 39500 ...

Page 245: ...ial flushing adapter is required for the sensor cap 1 Push the flushing adapter together with the silicone hose 1 onto a flushing nozzle 2 Insert the sensor cap 2 into the flushing adapter APL valve Lay the APL valve in the basket Inspiratory port and expiratory port Lay the ports in the basket 42213 38569 39014 ...

Page 246: ...ards Breathing bag arm option 1 Connect the breathing bag arm 1 to a hose 2 2 Lay the breathing bag arm together with the hose in the load carrier 3 Connect the hose 2 to a flushing nozzle 3 Absorber insert 1 Connect the absorber insert 1 to a hose 2 2 Lay the absorber insert together with the hose in the load carrier 3 Connect the hose 2 to a flushing nozzle 3 39501 39502 39503 ...

Page 247: ...equirements of the standard ISO 15883 Dräger recommends the use of a load carrier for anesthesia accessories and ventilation accessories Follow the list of validated disinfectants see Validated reprocessing procedures page 225 Prerequisite The components have been positioned appropriately in the load carrier 1 Use a suitable cleaning agent 2 Select a suitable cycle Use a cycle with the following p...

Page 248: ...cessing procedures Additional reprocessing procedures have not been tested by Dräger with regard to their effectiveness However the materials in the following components permit steam sterilization up to a maximum of 137 C 278 6 F Upper part of the breathing system Lower part of the breathing system Sensor cap of the O2 sensor APL valve Inspiratory port Expiratory port Inspiratory valve yellow Expi...

Page 249: ...rs when damaged soiled or not particle free 1 Inspect the following components for damage and wear Upper part of the breathing system Lower part of the breathing system Incident flow mesh in the inspiratory limb of the lower part of the breathing system Sensor cap of the O2 sensor APL valve Inspiratory port Expiratory port Incident flow mesh in the expiratory port Inspiratory valve yellow Expirato...

Page 250: ...is chapter 13 11 2 1 Inserting the non return valves The non return valves yellow inspiratory valve and blue expiratory valve must be fitted on the top side of the lower part of the breathing system There are recesses in the valve cages of the non return valves to facilitate correct fitting These recesses are arranged differently on the inspiratory valve than on the expiratory valve Perform the fo...

Page 251: ... of the breathing system over 2 Insert the valve 1 and lock it by turning it clockwise 13 11 2 3 Fitting the APL valve 1 WARNING Risk of an incorrectly set pressure limitation If the lower dot marked on the APL valve is not aligned correctly the APL valve may be set or read off incorrectly When fitting take care that the lower dot is facing the user during operation Align the APL valve correctly T...

Page 252: ...upper part of the breathing system 3 3 Tighten the knurled nut 4 13 11 2 4 Fitting the upper part of the breathing system 1 Make sure the levers 1 are rotated outward 2 Place the upper part of the breathing system 2 on the lower part of the breathing system 3 3 Turn the levers 1 by approximately 120 clockwise 39507 39505 ...

Page 253: ... 2 Tighten the knurled nut 3 Insert the inspiratory flow sensor 3 4 Push in the inspiratory port 4 Tighten the knurled nut 13 11 2 6 Fitting the CLIC adapter optional 1 Press the release button 1 The holder 2 flips open 2 Remove the cleaning plate 3 from the adapter 3 Close the holder 2 so that it engages 4 Screw the CLIC adapter 4 on to the lower part of the breathing system 39508 39509 39510 ...

Page 254: ...heck the correct orientation of the adapter 4 The two symbols 5 must align vertically 13 11 3 Inserting the piston diaphragm 1 Insert the piston diaphragm 1 in the ventilator Make sure that the Dräger inscription on the base of the piston diaphragm can be read from above 39511 36496 ...

Page 255: ...m 1 vertically into the breathing system mount 2 Turn the levers 2 by approximately 120 clockwise The breathing system is now locked On the product variant with integrated patient gas measurement module seal the O2 sensor port with the sealing cap 3 13 11 5 Assembling and inserting the O2 sensor 1 Place the sensor cap 1 on the O2 sensor 36503 36504 37178 ...

Page 256: ...W 1 0n Reprocessing 2 Turn the knurled nut 2 about 90 clockwise Turn it until the palpable resistance is overcome and a click is heard The sensor cap is now fitted 3 Insert the O2 sensor 3 into the sensor port 4 Turn the O2 sensor 4 clockwise 37179 38271 38272 ...

Page 257: ... Align the breathing bag arm so that collisions with other components are prevented 13 11 7 Fitting the reusable CO2 absorber If there is no CLIC absorber being used use the reusable CO2 absorber 1 Push the absorber insert 1 into the absorber container 2 2 CAUTION Risk of chemical burns Soda lime is caustic and is a strong irritant for eyes skin and airway Handle the soda lime carefully and do not...

Page 258: ...use undamaged filters 4 Attach the CO2 absorber 4 to the breathing system from below Rotate it in the direction of the arrow until it reaches the stop Follow the instructions for use for the particular soda lime 13 12 Preparation before the next use 13 12 1 Fitting patient specific accessories and consumables WARNING Risk due to particles and dust In order to protect the patient from particles and...

Page 259: ... A350 XL SW 1 0n 259 Reprocessing 13 12 2 Checking the operational readiness Prerequisite The device is assembled and prepared ready for operation Check the operational readiness with a system test Observe the following information Tests page 126 ...

Page 260: ...all power plugs Disassembling the water trap 9 Pull out and dispose of the water trap Disassembling the CO2 absorber 10 Reusable CO2 absorber a Unscrew the absorber b Remove and dispose of the disposable dust filter c Empty out and dispose of the used soda lime d Remove the absorber insert from the absorber con tainer 11 CLIC absorber disposable absorber a Remove and dispose of the CLIC absorber D...

Page 261: ...8 The following parts must be free from residues Incident flow meshes for the flow sensors Valve plates of the non return valves Assembling the breathing system 29 Insert the non return valves Inspiratory valve yellow Expiratory valve blue 30 Insert the fresh gas decoupling valve black and lock it by turning 31 Fit the upper part of the breathing system 32 Fit the APL valve 33 Fit the flow sensors...

Page 262: ...ich may cause an electric shock The housing may only be opened by those user groups that are assigned to that particular measure Risk of infection If the product has not been reprocessed properly it may be contaminated with pathogens As a result persons could be put at risk Perform the following measure before servicing before returning the device and before disposal Reprocess the product in accor...

Page 263: ...structions for use Emergency O2 delivery 3 Check that the product is in good condition All labels are complete and legible No visible damage to the following components Trolley and castors Housing parts Brakes Vaporizer mount Water trap and water trap mount O rings of the water trap mount Sample line Screen Gas inlets Status display Breathing system Piston drive and piston diaphragm AGS and AGS va...

Page 264: ...rement 5 Vol Accuracy 0 83 Vol 7 Check the accuracy of the O2 measurement Ambient air 21 Vol Accuracy 3 Vol 100 Vol Accuracy 5 Vol 8 Check sample gas flow of the patient gas measurement module Accuracy 200 20 mL min 9 Check the patient gas measurement module for leakage Leakage at 200 hPa cmH2O 20 hPa min cmH2O min 10 Check the non return valves in the central supply for leakage Leakage 20 mL min ...

Page 265: ...nfigured Infinity ID replacement interval Replace see page 77 Users Flow sensors As required if calibra tion is no longer possi ble or according to the configured Infinity ID replacement interval Replace see page 198 Users Piston diaphragm Annually Replace see page 236 Users Inspiratory O2 sensor option Every 2 years Replace see page 55 Users AGS As required when soiled Replace Specialized service...

Page 266: ...c devices is subject to special guidelines This device must be disposed of in accordance with national regulations In countries of the European Union Dräger will organize the return of the device Additional information is available at www draeger com search term WEEE 15 3 Disposing of accessories When disposing of the following accessories follow the infection prevention policy of the hospital and...

Page 267: ...netic environment page 292 Electromagnetic disturbances Wireless communication devices e g cellular phones and medical electrical equipment e g defibrillators electrosurgical devices emit electromagnetic radiation 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 c...

Page 268: ...more than one of the ambient conditions is changed the accuracy may change by up to 100 Example Accuracy of a measured pressure value 4 under standard conditions At 10 C the accuracy changes to 6 at 10 C and 20 relative humidity to 8 Standardization All patient related volumes and flows are based on dry oxygen converted to the conditions in the lungs BTPS 16 3 Ambient conditions During operation T...

Page 269: ... with integrated flowmeter Range Off 2 to at least 10 L min at 2 7 kPa x 100 39 psi or 0 27 MPa supply pressure Accuracy 10 of the set value for flows 2 0 L min Resolution of displayed value 1 L min up to 10 L min 5 L min starting at 10 L min O2 flow with external flowmeter Range Off 1 to at least 10 L min at 2 7 kPa x 100 39 psi or 0 27 MPa supply pressure Accuracy 10 of the set value Resolution ...

Page 270: ...ectronic measurement of fresh gas flow Range 0 to 15 L min O2 Air and N2O Accuracy 10 or 0 12 L min the larger value applies Resolution of the value displayed on the screen 0 01 L min from 0 to 0 2 L min 0 02 L min from 0 2 to 0 5 L min 0 05 L min from 0 5 to 1 L min 0 10 L min from 1 to 15 L min Resolution of the value displayed in the status display 0 1 L min Total flow tube Standardization All ...

Page 271: ...ory time Tplat for mandatory breaths in the VC CMV VC SIMV and VC SIMV PS modes 0 to 60 10 of the set value or 100 ms the larger value applies Volume based and flow based settings Tidal volume VT 10 to 1500 mL with Advanced neonatal sup port option 5 to 1500 mL 10 of the set value or 10 mL the larger value applies in the range from 5 to 150 mL 5 of the set value or 15 mL the larger value applies i...

Page 272: ...es Positive end expiratory pressure PEEP Off 2 to 35 hPa cmH2O 10 of the set value or 2 hPa cmH2O the larger value applies Minimum pressure limit as per ISO 8835 5 and ISO 80601 2 13 3 hPa cmH2O 16 8 Breathing system Total volume when applying a maximum tidal volume of 1500 mL with CLIC absorber 800 disposable CO2 absorber 3 65 L 150 mL with reusable CO2 absorber and Drägersorb 800 3 83 L 150 mL C...

Page 273: ...mL Compliance 0 11 0 05 mL hPa mL cmH2O corresponds to 3 3 1 5 mL at 30 hPa cmH2O Rigid breathing bag arm Volume 0 13 L 50 mL Compliance 0 13 0 05 mL hPa mL cmH2O corresponds to 3 9 1 5 mL at 30 hPa cmH2O Total leakage 150 mL min at 30 hPa cmH2O standardized to BTPS conditions APL valve Setting range Open 5 to 70 hPa cmH2O Accuracy at a flow of 20 1 L min 20 of the set value or 3 hPa the larger va...

Page 274: ...e tidal volume 16 9 External fresh gas outlet Connection 22 mm outer taper 15 mm inner taper ISO Delivery See Fresh gas delivery Pressure limitation Not pressure limited 16 10 Anesthetic gas receiving system AGS Information The device is equipped with an active or a pas sive anesthetic gas receiving system 16 11 Active AGS Information This system is designed for connection to an anesthetic gas sca...

Page 275: ...or the scavenging hose Scavenging hose Maximum length 8 m 26 ft Minimum diameter 19 mm 0 75 in Connection for sample gas disposal when using external patient gas measurement Outer hose diameter 3 to 6 mm Maximum inlet flow 500 mL min 16 13 Measuring systems and displays Information Alarms and internal calculations are based on values that are more precise than the displayed values Consequently the...

Page 276: ...with PGM 10 of the measured value or 15 mL the larger value applies Accuracy without PGM 20 of the measured value or 40 mL the larger value applies Resolution of displayed value 1 mL Difference between inspiratory and expira tory tidal volumes VT Range 0 to 2500 mL Accuracy for gas measurement with PGM 20 of the measured value or 30 mL the larger value applies Accuracy without PGM 40 of the measur...

Page 277: ... 0 to 100 min Accuracy 10 or 1 min the larger value applies Resolution of displayed value 1 min T0 90 45 s RR 6 min 105 s RR 6 min Dynamic compliance Dynamic compliance Cdyn Mean dynamic compliance Cdyn mean Range 0 to 200 mL hPa mL cmH2O Accuracy for gas measurement with PGM 15 or 1 mL hPa mL cmH2O the larger value applies Accuracy without PGM 40 or 3 mL hPa mL cmH2O the larger value applies Info...

Page 278: ...er value applies 4 or 3 psi the larger value applies 4 or 0 02 MPa the larger value applies Resolution of displayed value 0 1 kPa x 100 1 psi 0 01 MPa Gas cylinders Range 0 to 250 kPa x 100 0 to 3600 psi 0 to 25 MPa Accuracy 4 or 6 kPa x 100 the larger value applies 4 or 87 psi the larger value applies 4 or 0 6 MPa the larger value applies Resolution of displayed value 1 kPa x 100 1 psi 0 1 MPa Re...

Page 279: ...nd minima of the real time measurements during expira tion Standardization All data are standardized to ATPS conditions Accuracies Due to the T10 90 time and the sample gas flow the measurement accuracies for O2 CO2 N2O and anesthetic agent may deviate at respiratory rates of 60 min or higher and an I E ratio of 1 1 The influence of respiratory rate and the I E ratio on the accuracy has been veri ...

Page 280: ...m and used as the sample gas O2 Range 0 to 100 Vol Accuracy 2 5 Vol 2 5 relative Resolution of displayed value 1 Vol T10 90 500 ms CO2 Range 0 to 13 6 Vol 0 to 13 6 kPa 0 to 102 mmHg Accuracy 0 43 Vol 8 relative 0 43 kPa 8 relative 3 3 mmHg 8 relative Resolution of displayed value 0 1 Vol 0 1 kPa 1 mmHg T10 90 350 ms N2O Range 0 to 100 Vol Accuracy 2 Vol 8 relative Resolution of displayed value 1 ...

Page 281: ...thresholds refer to ris ing anesthetic gas concentrations e g at the start of surgery If the anesthetic gas concen tration falls a concentration of down to 0 05 Vol will be measured based on the last anesthetic agent detected Below this concen tration a value of 0 Vol will be displayed xMAC Based on the age of the patient the anesthetic gas concentration and the nitrous oxide con centration the xM...

Page 282: ...tion per minute Standardization The following data are standardized to STPD conditions Range 0 to 9999 mL min Accuracy 25 or 100 mL min the larger value applies Resolution of displayed value 1 mL min O2 uptake per minute Standardization The following data are standardized to STPD conditions Range 0 to 9999 mL min Accuracy 25 or 100 mL min the larger value applies Resolution of displayed value 1 mL...

Page 283: ...O2 concentration Airway pressure Volume only for loops Flow Sweep speed 6 25 12 5 25 0 mm s Scale Airway pressure 20 to 80 hPa cmH2O Flow 120 to 120 L min Volume 0 to 2000 mL O2 0 to 100 Vol CO2 0 to 100 mmHg 0 to 12 Vol 0 to 12 kPa Anesthetic agent Halothane 0 to 5 Vol kPa Enflurane 0 to 6 Vol kPa Isoflurane 0 to 5 Vol kPa Sevoflurane 0 to 10 Vol kPa Desflurane 0 to 20 Vol kPa Loops Pressure Volu...

Page 284: ... consumption Standby without charging the internal battery 40 W During mechanical ventilation PC CMV Pinsp 15 hPa RR 8 min I E 1 2 PEEP 0 hPa FG flow 4 L min O2 without charging the internal battery 95 W Maximum 400 W Peak inrush current Approx 8 to 14 A Approx 6 to 10 A quasi RMS Internal battery Type Lead gel battery Sealed maintenance free Capacity 7 2 Ah Voltage 24 V Fuse F15A 80V UL248 14 bre...

Page 285: ...y connected bronchial suction system 130 L min N2O 40 L min Drive gas Not needed Gas supply connection Depending on configuration NIST DISS CGAV 5 B or CGAV 5 N French standard NFS90 116 Gas cylinders dimensions Diameter 100 to 140 mm 3 94 to 5 51 in for versions with upright gas cylinders 100 to 102 mm 3 94 to 4 01 in for versions with hanger yoke system for gas cylinders with pin index connectio...

Page 286: ...Width 933 mm 36 74 in Height 1403 mm 55 24 in Depth 750 mm 29 53 in Dimensions of the work surface on the com pact version Width Approx 470 mm 18 50 in Depth Approx 380 mm 14 96 in Dimensions of the work surface on the large version Width Approx 710 mm 27 95 in Depth Approx 380 mm 14 96 in Additional pull out work surface width x depth Approx 340 mm 13 39 in x 245 mm 9 65 in Weight of the compact ...

Page 287: ...t keying Electromagnetic compatibility Tested in compliance with IEC 60601 1 2 Protection classes Device I in compliance with IEC 60601 1 Applied parts connections for breathing hoses TYPE BF Degree of protection IP20 according to IEC 60529 meets ISO 80601 2 13 Classification in compliance with Directive 93 42 EEC Annex IX II b UMDNS code 10 134 Use of latex The device is made without natural rubb...

Page 288: ...B 2 0 Supported devices USB flash drive formatted with FAT16 or FAT32 Dräger recommends USB mass storage devices with encryption conforming to FIPS 140 2 and their own encryption facility Network port Only for Dräger Remote Service Only connect devices or networks that meet the requirements of IEC 60950 1 for ungrounded SELV circuits and the requirements of IEC 60601 1 as of the 2nd edition for to...

Page 289: ...60601 1 8 Medical electrical equipment Part 1 8 General requirements for basic safety and essential performance Collateral standard Alarm systems General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical sys tems IEC 60601 2 13 Medical electrical equipment Part 2 13 Particular requirements for the safety of anaes thetic systems ISO 8835 2 Syst...

Page 290: ... hose Pexp hPa cmH2O with adult breathing hose Pexp hPa cmH2O without breathing hoses Pinsp hPa cmH2O with neonatal breathing hose Pinsp hPa cmH2O with pediatric breathing hose Pinsp hPa cmH2O with adult breathing hose Pinsp hPa cmH2O without breathing hoses Breathing system dry with filled reusable CO2 absorber and soda lime dust filter MX50115 Peak flow in use L min Resistance hPa cmH2O Man Spon...

Page 291: ...ce arrangement If no approval has been given by Dräger it must be ensured that this device functions correctly in the desired arrangement before use The instructions for use for the other devices must be followed With breathing circuit for adults MP00349 inspiratory filter MP01730 60 5 6 5 5 30 2 0 3 4 With breathing circuit for pediatric patients MP01340 and MP01343 inspiratory filter MP01815 15 ...

Page 292: ...frequency communication equipment Emissions Compliance Radiated emissions Class A group 1 30 MHz to 1 GHz Conducted emissions Class A group 1 150 kHz to 30 MHz Immunity against Test level and required electromagnetic environ ment Electrostatic discharge ESD IEC 61000 4 2 Contact discharge 8 kV Air discharge 15 kV Fast transient electrical disturbances bursts IEC 61000 4 4 Power cable 2 kV Longer s...

Page 293: ...stems 16 24 Emission of high frequency energy This medical device is equipped with an RFID module radio frequency identification to enable wireless communication with Infinity ID accessories This medical device has been designed and manufactured to comply with emission limit values for high frequency energy These limit values are incorporated in international safety standards such as IEC 60601 1 2...

Page 294: ...s on devices that are connected to the network 16 25 1 LAN interface 16 25 1 1 Service In conjunction with the Dräger SCG ServiceConnect Gateway or a DrägerService computer the LAN interface enables the following functions Using the SNMP protocol Monitoring the service status of the device querying the service status support during the installation of device software and during software download c...

Page 295: ...rk loading e g caused by denial of service attacks may lead to a shut down of the device side network interface The interface will not be available again until the device is restarted 16 25 2 RS 232 ports The RS 232 port supports the MEDIBUS X protocol MEDIBUS X is a communication protocol for data exchange between the device and e g the following external medical or non medical equipment Hemodyna...

Page 296: ... transmission conforming to IEC 60601 1 8 However the data must not be used as a substitute for Atlan as the primary alarm source 16 25 2 1 Required characteristics The RS 232 port is a point to point connection A connected device must prevent access by unauthorized users to the data that are sent over the RS 232 port and must itself be protected from infections by malware and computer viruses 16 ...

Page 297: ...the accessories If these accessories are not checked the patient may be put at risk Use the appropriate Infinity ID accessories to utilize the additional functions Check the current condition and the period of use of the accessories regularly Check regularly that the hoses are correctly connected There are product specific data saved on the Infinity ID accessories which are further processed by th...

Page 298: ...PEEP level and inspiratory pressure This pressure support is only available if synchronization of spontaneous breath ing SIMV and in PSV mode is switched on When pressure support is switched on the naming of the following ventilation modes changes Without pressure support With pressure support PC SIMV PC SIMV PS VC SIMV VC SIMV PS VC SIMV AutoFlow VC SIMV PS AutoFlow CPAP PSV PSV Pinsp Inspiratory...

Page 299: ...y time At the end of the expi ratory phase an inspiratory trigger window is activated so that the mandatory breath can be initiated prematurely by up to 5 seconds patient category Adult or 1 5 seconds patient categories Ped and Neo If the spontaneous inspiratory flow reaches the set value of the flow trigger Trigger during this trigger window a pre mature mandatory breath is triggered If no sponta...

Page 300: ...py bar Additional parame ters expanded therapy bar Manual ventila tion spontaneous breathing Man Spon Manual Sponta neous CPAP1 Assisted ventila tion PSV1 CPAP PSV Trigger Psupp RRmin PEEP Slope Insp term Pressure con trolled ventilation PC PC CMV Pinsp RR PEEP Ti CMV Slope PC SIMV Pinsp Psupp1 Off RR PEEP Ti SIMV Trigger Slope PC SIMV PS1 Pinsp Psupp1 0 RR PEEP Ti SIMV Trigger Insp term1 Slope ...

Page 301: ...IMV Trigger Psupp1 Off Slope VC SIMV PS AutoFlow1 Pmax VT RR PEEP Ti SIMV Trigger Psupp1 0 Insp term1 Slope VC VC CMV Pmax VT RR PEEP Ti CMV Tplat VC SIMV Pmax VT RR PEEP Ti SIMV Trigger Psupp1 Off Tplat VC SIMV PS1 Pmax VT RR PEEP Ti SIMV Trigger Psupp1 0 Insp term1 Slope Tplat 1 Requires the PSV option Group Tabs Ventilation mode Basic parameter normal therapy bar Additional parame ters expanded...

Page 302: ...tory effort is detected mandatory breaths are delivered at the set minimum respiratory rate RRmin and with pressure support Psupp Patient triggered breaths are ended as soon as the inspiratory flow falls below the flow defined by the Insp term setting The duration of a machine triggered breath is additionally defined by the patient category and the set minimum respiratory rate RRmin Purely spontan...

Page 303: ...mber of mandatory breaths is predefined When synchronization is switched on the breaths are adapted to the spontaneous breathing efforts of the patient If spontaneous breathing effort by the patient is detected during the inspiratory trigger window a patient triggered breath will be initiated 17 2 5 4 PC SIMV PS This mode is similar to PC SIMV except that the patient s spontaneous breathing at the...

Page 304: ...ant with the integrated patient gas measurement module the applied VT is corrected by the amount of suction flow as soon as CO2 respiratory phases are detected 17 2 6 2 VC 17 2 6 3 VC CMV Volume controlled Pressure limited Time controlled Machine triggered Constant inspiratory flow In this volume controlled ventilation mode the patient receives the set tidal volume VT with each mandatory breath 36...

Page 305: ...the inspiratory trigger window a patient triggered breath will be initiated 17 2 6 5 VC SIMV PS This mode is similar to VC SIMV except that the patient s spontaneous breathing at the PEEP level during the expiratory phase is pressure supported with Psupp when outside the trigger window 17 2 6 6 VC AF With AutoFlow the set tidal volume VT is applied for all mandatory volume controlled breaths with ...

Page 306: ...uced by a greater amount if necessary 17 2 6 7 VC CMV AutoFlow Volume controlled Pressure limited Time controlled Machine triggered Decelerating inspiratory flow The mandatory breaths are machine triggered and are not triggered by the patient 17 2 6 8 VC SIMV AutoFlow Volume controlled Pressure limited Time controlled Machine triggered or patient triggered Decelerating inspiratory flow Synchronize...

Page 307: ...ng system The electric motor 3 moves the piston 4 by means of a spindle 2 Thus the fresh gas is moved out of the piston diaphragm and through the breathing system to the patient The user can check through a viewing window whether the piston is moving During inspiration the ventilator applies the tidal volume with the required pressure and at a defined respiratory rate 40162 No Designation 1 Piston...

Page 308: ...eaches the patient The basis for the compliance compensation is the breathing hose compliance determined in the system test or in the leakage test 17 3 3 Fresh gas decoupling The device is equipped with fresh gas decoupling This function decouples the ventilation from the fresh gas flow and the O2 flush Consequently changes to the fresh gas flow have no influence on the applied tidal volume and th...

Page 309: ...lue and is not subject to the waveform fluctuations 17 4 2 Reasonable alarm settings If the HME is clogged or soiled the suction flow for the gas measurement may cause negative pressure in the patient s lungs To detect imminent clogging of the HME e g by sputum set the alarm limits for MV low and Paw high to suitable values Volume controlled ventilation modes also with AutoFlow If the HME filter i...

Page 310: ... HME filter The transparent HME housing allows visual checking of the amount of sputum If there are signs alarm air trapping visual check which suggest clogging of the HME check the HME and replace it if in doubt 17 5 Minimum O2 delivery The device is equipped with a minimum O2 delivery function which ensures that a minimum quantity of oxygen is delivered 41394 OHDU 0 6RLOHG 0 Paw high Gas mixer M...

Page 311: ...d ideal body weight affects the following Start settings for tidal volume VT Start settings for respiratory rate RR Start settings for alarm limits for VT and MV Ventilation algorithms Trigger threshold insp synchronization of the mandatory breaths Sensitivity and resolution of the volume monitoring Rate of concentration changes affecting the patient For neonates the patient category and the ideal...

Page 312: ...ed see page 180 17 7 1 Infinity ID functionality 17 7 1 1 Replacement interval monitoring Automatic monitoring of the period of use is available for Infinity ID products An exceeded period of use is signaled during the system test The replacement interval for the connected Infinity ID accessories can be adjusted This interval must be specified in accordance with the applicable infection prevention...

Page 313: ...m system fails It plays the acoustic alarm signals of the Warning and Caution alarm priorities at a constant tone frequency and unchanged volume 17 8 2 Tone signals during operation Alarm priority Standard according to IEC 60601 1 8 Repeated Warning Depending on the overall alarm situation this acoustic alarm signal may also be played as only a 5 tone sequence due to the timing of the individual a...

Page 314: ...s index BTPS Body Temperature and Pressure Saturated 37 C 98 6 F ambient pressure 100 relative humidity CAL Display when a measurement value is calibrated CBM mode Cardiac bypass mode Cdyn Dynamic compliance patient CISPR Comité International Spécial des Perturbations Radioélectriques International special committee on radio interference cmH2O Centimeters of water CMV Controlled Mandatory Ventilat...

Page 315: ...o Isoflurane kg Kilogram kPa Kilopascal L Liter LAN Local area network lbs Pound unit of mass LED Light emitting diode LGPL Lesser General Public Licence MAC Minimum Alveolar Concentration Man Spon Manual Spontaneous Manual ventilation Spontaneous breathing mbar Millibar MEDIBUS X Communication protocol for medical devices with uniform data definition for all devices min Minute mL Milliliter mmHg ...

Page 316: ...adio Frequency Identification RR Respiratory rate RRmin Minimum respiratory rate Sev Sevoflurane Slope Pressure rise time SNMP Simple Network Management Protocol STAPD Standard Temperature Ambient Pressure Dry 20 C 68 F dry gas STPD Standard Temperature and Pressure Dry 20 C 68 F 1013 hPa TC Time constant Ti Inspiratory time UMDNS Universal Medical Device Nomenclature System Nomenclature for medic...

Page 317: ...ructions for use Warning Strictly follow these instructions for use Caution Follow the accompanying documentation Symbol Attention safety sign Risk of tipping over Do not take hold of the device above this mark in order to push it or pull it Group Views Group Trends Data Group Alarms Group Procedures Group System setup Group Start Standby Device on Standby Key Start Standby Main switch off on Main...

Page 318: ...e Central supply not connected or pressure not within specified range Gas cylinder full Gas cylinder empty or gas cylinder valve turned off Gas cylinder pressure sensor not connected Oxygen cylinders on this side of the device only No oxygen cylinders on this side of the device Key for switching on and off and dimming the workplace illumi nation Emergency O2 delivery Add O2 Applied part of type BF...

Page 319: ...D label follow the information on electromagnetic compati bility Locked Unlocked Inspiration Labeling on breathing system and breathing system cover Expiration Labeling on breathing system and breathing system cover Breathing bag Vaporizer plug in system fixed position Auto Exclusion Plug in connection Part number Serial number Lot number Use by YYYY MM DD Expiration date Hot surface Do not touch ...

Page 320: ... center of the float Advanced Cylinder Support Identifies N2O cylinders The color code conforms to the locally applicable standard Identifies O2 cylinders The color code conforms to the locally applicable standard Identifies Air cylinders The color code conforms to the locally applicable standard Maintain the correct minimum distance between electrical con nectors and gas cylinders see product lab...

Page 321: ...mple representation of the weight distribution of the nominal weight and the maximum total weight see Technical data Weight Main device Weight Load Label Do not place any weight on this surface of the device Activate backup manual mode Switch to Add O2 Set fresh gas on O2 flowmeter Set fresh gas flow Ventilate manually Check vaporizer setting Backup manual mode Direct connection from mains supply ...

Page 322: ...tructions see Intrahospital transport page 59 Ensure that the control dial of the vapor izer is correctly positioned Do not leave the control dial in the T position while the vaporizer is connected to the medi cal device Observe the correct flow of the anes thetic gas receiving system see Anes thetic gas receiving system page 145 ...

Page 323: ...1 2 Switch CBM mode on or off1 1 Only during operation not in Standby mode 2 Only available for the device equipped with integrated patient gas measurement module CO2 alarms off 1 3 3 Only in the modes Manual Spontaneous Ext FGO Pause Deactivate CO2 alarms Autoset limits 1 4 4 Only in the modes PSV PC VC CMV AutoFlow VC CMV Automatically adapt alarm limits to current measured or set values Exit CB...

Page 324: ...verview of current measured val ues Gases 1 Device Logbook Display the logbook Export 2 2 Only in Standby mode Export data to a USB mass storage device Group Button in main menu bar Horizontal tab Vertical tab Description System setup Configure device functions and start set tings see page 166 Patient 1 1 Only during operation not in Standby mode Set patient data Tests 2 2 Only in Standby mode Dis...

Page 325: ...otected by the following configuration password 19 1 1 Information for the configuration password To prevent unauthorized alteration the start settings for Atlan A300 A300 XL A350 A350 XL are protected by a password with 0 to 8 digits Information on the start settings see page 166 The configuration password appears on this page of the instructions for use Cut out the area with the password and kee...

Page 326: ...326 Instructions for use Atlan A300 A300 XL A350 A350 XL SW 1 0n This page has been left blank intentionally ...

Page 327: ...ting 65 Replacing 200 Anti interchange security 312 APL valve 18 Fitting 251 Setting 96 Assisted ventilation with pressure support 302 AutoFlow 305 Automatic leakage compensation 191 Auxiliary power socket Connecting other devices 58 B Backup manual mode 38 Backup manual switch 38 Backup mode 38 Battery Charging 57 Breathing bag Connecting 71 Breathing hoses Fitting 67 Breathing system Assembling ...

Page 328: ...ure Complete failure 198 Flow measurement 198 Fresh gas delivery 194 Gas supply 193 O2 sensor 195 Piston ventilator 195 Screen 198 Filters Fitting 67 Flow measurement Failure 198 Flow sensors Fitting 253 Flow waveform scale Specifying 167 G Gas cylinders Advanced Cylinder Support 139 Checking 139 Connecting 60 Connectors 26 Replacing 193 Gas mixer mechanically controlled Total flow tube 30 44 88 G...

Page 329: ...h 29 43 O2 waveform scale Specifying 167 O2 29 30 43 44 Checking 143 Using 97 Open source software 297 OR working hours 176 P Parameter fields 184 Parameters Setting 84 Passive anesthetic gas scavenging 66 Password 325 Patient category 311 Patient data Changing 119 Checking 95 Influence of device behavior 312 Loading 94 Pause 101 Potential equalization Establishing 58 Potential equalization pin 25...

Page 330: ...nfectants 226 Symbols 317 Safety instruction 12 Synchronized ventilation 99 System test 127 T Technical data 267 Test results 87 Testing the device 127 Tests Performing 127 Therapy Ending 122 Setting and starting 95 Therapy controls 81 83 Linking 81 Time Setting 176 Tipping stability Increasing 59 Trademarks 7 Transport 59 Trends Displaying 114 Exporting 120 Turning off the device 17 151 151 151 T...

Page 331: ...ons for use Atlan A300 A300 XL A350 A350 XL SW 1 0n 331 Index W Water trap 18 Checking 147 Emptying or exchanging 77 Waveforms Configuring 167 Overview 184 Saving view 167 Specifying the scale 167 X xMAC 103 118 ...

Page 332: ...ons 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 Directive 2014 53 EU concerning radio equipment Manufacturer Drägerwerk AG Co KGaA Moislinger Allee 53 55 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 2080 http www draeger com 9056001 GA 6500 350 en Drägerwerk AG Co KGaA Edition 2 ...

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