Draeger Medical Systems MS18623 Telemetry Transceiver TeleSmart M300 User Manual TSC f80 en TUVdraft
Draeger Medical, Inc. Telemetry Transceiver TeleSmart M300 TSC f80 en TUVdraft
Contents
- 1. User Manual 1
- 2. User Manual 2
- 3. User Manual 3
- 4. User Manual 4
User Manual 4
The Ventilator Screen Loops Area in Ventilator Screen The real-time ventilator loops in the Ventilator screen are synchronous with the associated breath. Flow vs. Volume is shown on the left and Pressure vs. Volume on the right. Loops are drawn with the same display scale as the associated waveforms. Displaying Loops You can save and display a Reference Loop with the actual loop display. The color of the reference loop is magenta. The Ventilator screen can display a Single Loop or Multi-loop draw. Loop Parameter Box The parameter box next to the loop area contains dynamic compliance, dynamic resistance, and arterial blood gas values. If blood gas values are not available, the labels do not appear. The order and ranges of the parameters follow. Parameter Units Measurement Range pH pH, nmol/L 6.6 - 7.8 HCO3 mEq/l, mmol/L 1-200 mEq/l Hct (Hematocrit) 15-75% tHb (Hemoglobin) g/dl, g/100ml, g/L, mmol/L 5-25 g/dl PCO2 mmHg (kPa) 10-200 mmHg (1.333 - 26.66 kPa) PO2 mmHg (kPa) 10 - 700 mmHg (1.33 - 93.31 kPa) Trend Area in Ventilator Screen Three trend graphs on the Ventilator screen show the most recent 8 hours of trend data for user-selected parameters (page 15-14). If a selected parameter is not available from the bedside/MIB device, the next parameter from the Trends Setup screen is automatically displayed. If less than three parameters are available, the Ventilator screen parameter graph is blank. 15-7 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option The Ventilator Settings Review Screen Ventilator type Selected units of measure at the MIB device or ventilator Most recently updated measurement value Certain parameters, identified as measured values or settings, are derived from the values provided by the ventilator and may not reflect actual values. Most recent setting of the ventilator/MIB device Time and date the setting was modified Generates Ventilator report (Chapter 12) Scroll bar for accessing additional parameters Parameter or setting labels Accessing the Ventilator Settings Review Screen 1. Click on the patient’s parameter box. 2. Click on Review. 3. Click on Ventilator Settings Review. VF8 Infinity CentralStation TUV Draft 15-8 DRAFT The Ventilator Settings Review Screen Parameter and Settings Order The Ventilator Settings Review screen displays settings and supported parameters sent by the connected MIB device, Infinity bedside monitor, or compatible bedside monitor pod. NOTE: The Infinity CentralStation does not support AEP and SEP functions functions that are enabled at a bedside monitor. Each Ventilator Settings Review screen parameter and setting displays in a fixed order. If a setting or parameter is not available, the corresponding field on the Ventilator Settings screen is blank. Additional settings and parameters not assigned to the fixed order are at the end of data received from the MIB-connected device. Parameters/settings sent to Infinity monitors for various MIB-compliant devices are listed in tables starting on page 15-22. Order Description 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Ventilator type Ventilator mode CMV frequency SIMV frequency PEEP (End Expiratory Pressure) PEEP RRv (measured respiration rate) O2 concentration PIP (Peak Airway Pressure) MAP (Mean Airway Pressure) Pause Airway Pressure End Expiratory Flow Tvi (Tidal Volume inspired) TVe (Tidal volume expired) Tve s (Tidal Volume Expired spontaneous) Minute Volume inspired (MV i) Minute Volume expired Minute volume expired spontaneous (MVe s) Dynamic compliance (Cdyn) Dynamic resistance I of I:E I-Part E of I:E E-Part end-tidal CO2 (etCO2) CVP SpO2 iCO2 15-9 TUV DRAFT Parameter Infinity CentralStation Setting DRAFT VF8 15: VentCentral Option Order Description 27 28 etCO2* iCO2* Parameter 29 30 31 32 33 34 pH HCO3 Hematocrit (Hct) Hemoglobin (tHb) PCO2 PO2 Setting Blood Gas Parameters 35 36 37 VF8 Other Parameters and settings Barometric pressure Additional parameters from Ventilator/MIB devices (see tables starting on page 15-22) Additional settings from Ventilator/MIB devices (see tables starting on page 15-22) Infinity CentralStation TUV Draft 15-10 DRAFT The Ventilator Settings Review Screen Special Conditions Special Conditions Affecting Ventilator Settings Review Screen Condition Effect Disconnected parameter hardware No advisory message is sent to the Infinity CentralStation. The VentCentral application is not available and cannot be accessed for the respective patient. Reset of MIB- device, bedside monitor, or Infinity CentralStation The Ventilator Settings screen time stamp reflects the first setting following the reset. Bedside monitor PICK AND GO The Ventilator Settings screen time stamp reflects the monitor’s reconnect to the network. First connection of MIB-compliant ventilator, etCO2/Respiratory Mechanics Pod, or Delta/ Delta XL monitor Time stamp reflects the first setting received after the device is connected. Blood gas values stored for more than 30 minutes Values are removed from the VentCentral screen. Device sends more digits than the Ventilator Settings screen field can accommodate Instead of the parameter values, overflow characters display. 15-11 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Ventilator View Setup Screen The Ventilator View Setup screen permits selecting an individualized display for a selected patient. NOTE: You cannot modify the Loops display. The fixed order is: Flow vs. Volume and Pressure vs. Volume. Reverts to previous settings Accepts new settings/changes Opens Waveforms Setup screen Fixed - Always shows Flow vs. Volume and Pressure vs. Volume Opens Trends Setup screen Restores system defaults Saves current setup as system default for all patients Top ventilation waveform VF8 Infinity CentralStation TUV Draft 15-12 DRAFT Ventilator View Setup Screen Accessing the Ventilator View Setup Screen 1. Click on the patient’s Main Screen parameter box. To access a remote patient, see page 6-4. 2. Click on Setup. 3. Click on Ventilator View Setup. Selecting Waveforms for Display You can set up the display priority of ventilator parameters. NOTE: If a selected waveform is not available from the bedside monitor, the next waveform is selected to fill available Infinity CentralStation waveform channels. 1. Open the Ventilator View Setup screen (page 15-13). 2. Click on Setup Waveforms. The Waveforms Setup popup displays. Parameters selected for display Arrows permit changing the priority order of selected waveforms Arrows permit moving selected parameters from one window to the other Available parameters 15-13 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option 3. Select the desired display configuration. The left/right arrows move desired waveforms from the display window to the Waveforms window. The up/down arrows move parameters in a desired sort order. NOTE: You may select several parameters at once before you move them from one window to the other. 4. Click on Accept to save or Cancel to keep prior settings. 5. Click on Save as System Defaults in the Ventilator View Setup screen to retain this setup as the system default. Selecting Waveforms for the Trend Display To select and prioritize ventilator parameters for trend display: 1. Open the Ventilator View Setup screen (page 15-13). 2. Click on Setup Trends. The Trends Order Setup popup displays. Trends selected for display Arrows permit changing the priority order of selected trends Cancels current setup Arrows permit moving selected parameters from one window to the other Accepts current setup Available parameters for selection VF8 Infinity CentralStation TUV Draft 15-14 DRAFT Ventilator View Setup Screen 3. Select the desired display configuration. The left/right arrows move the desired parameters from the display window to the Trend window. The up/down arrows move parameters in a desired sort order. NOTE: You can select several parameters at once to move them from one window to the other. 4. Click on Accept to save or Cancel to keep prior settings. 5. Click on Save as System Defaults in the Ventilator View Setup screen to keep this setup as the system default. 15-15 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option VentCentral Trend Parameters Parameter Label Definition Heart Rate HR ECG measurement Ventilation AW-Temp Airway temperature Cdyn Dynamic compliance C20/Cdyn Dynamic compliance over last 20% of breath. etCO2 End-tidal carbon dioxide InspT% I:E ratio (inspiratory component)% ICO2 Inspired CO2 (etCO2) iO2 Inspired oxygen iPEEP Peak end expiratory airway pressure, intrinsic MAP Mean airway pressure Mve Minute volume, expired MV s% Minute volume, spontaneous MValv Minute volume, alveolar, total MVe Expired minute volume MVi Inspired minute volume PAP Peak airway pressure Pause Pause pressure PeCO2 Mixed expired carbon dioxide PEEP Peak end expiratory airway pressure PEF Peak expiratory flow PIF Peak inspiratory flow Raw Dynamic resistance Raw e Expired airway resistance Raw i Inspiratory dynamic resistance RRv Respiratory rate RRs Respiratory rate, spontaneous VF8 Infinity CentralStation TUV Draft 15-16 DRAFT VentCentral Trend Parameters Parameter Label Definition Ventilation (Continued) RRm Respiratory rate, mechanical RSBI Rapid shallow breathing index Te Expiratory time Ti Inspiratory time TVe Tidal volume, expired TV Leak Leakage, system TValv m Tidal volume, alveolar, mechanical TValv s Tidal volume, alveolar, spontaneous Tva Tidal volume, alveolar, total TVd/TV aw Dilution ratio, airway TVCO2 CO2, tidal volume TVe Expired tidal volume TVi Inspired tidal volume TVi m Tidal volume, inspiratory, mechanical TVi s Tidal volume, inspiratory, spontaneous TVd aw Dead space, airway (Vds) VCO2 CO2 production, minute volume WOBimp Work of Breath imposed Pulse Oximetry SpO2/SPO2* oxygen saturation PLS/PLS* Pulse rate ∆ SpO2 Delta SpO2 Respiration RR Respiratory rate RR Respiratory rate (etCO2) RV Respiratory rate Temperatures T1, T2, T3 Temperature Basic temperature 15-17 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Parameter Label Definition Pressures ART Arterial pressure CPP Cerebral perfusion pressure CVP Central venous pressure GP1 General pressure 1 GP2 General pressure 2 ICP Intracranial pressure LA Left-atrial pressure NIBP Non-invasive blood pressure P1 P1 pressure P2 P2 pressure PA Pulmonary arterial pressure PWP Pulmonary Wedge Pressure RA Right arterial pressure Ventricular pressure Cardiac Output BT Blood temperature CCO Continuous cardiac output CCI Continuous cardiac index CCO Continuous cardiac output DO2 Oxygen delivery or availability FiO2 Fraction of inspired O2 ICI Intermittent cardiac output index ICO Intermittent cardiac output PVR Pulmonary vascular resistance PVRI Pulmonary vascular resistance index SVR Systemic vascular resistance SVRI Systemic vascular resistance index VF8 Infinity CentralStation TUV Draft 15-18 DRAFT VentCentral Trend Parameters Parameter Label Definition Cardio Respiration SaO2 Saturation of arterial oxygen SvO2 Saturation of venous oxygen VO2 Oxygen consumption TCP/CO2 TCO2 Transcutaneous carbon dioxide ht pwr Heater power O2 Oxygen concentration Anesthesia etCO2 End-tidal carbon dioxide eO2 Expired O2 iCO2 Inspired CO2 FiO2 Fraction of inspired O2 RRc* Respiration rate SEV Sevoflurane iDES Inspired desflurane etDES End-tidal desflurane iENF Inspired enflurane etENF End-tidal enflurane iHAL Inspired halothane etHAL End-tidal halothane iISO Inspired isoflurane etISO end-tidal isoflurane iN2O Inspired nitrous oxide etN2O End-tidal nitrous oxide Lab data HCO3 Bicarbonate hct Hematocrit tHb Hemoglobin concentration pCO2 Partial pressure CO2 pH Blood pH pO2 Partial pressure O2 15-19 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option MIB Ventilator Alarms MIB-connected ventilators: Orange alarm messages appear in the lower right corner of the topmost Main Screen waveform channel and are available without the VentCentral option enabled. In the VentCentral screens alarm messages appear on the right side of the information area (see arrow).When an MIB-connected ventilator is active at the Infinity CentralStation and the signal is lost, the Infinity CentralStation sounds a one-shot alarm and displays the message, MIB Disconnected NOTE: MIB alarm messages will be sent to and displayed at the Infinity CentralStation when you put a patient’s bedside monitor in standby mode. Parameter boxes in the VentCentral screens that originate at MIB-connected ventilators do not flash when they are in alarm. Alarm messages that originate at MIB-connected ventilators are displayed for as long as the ventilator sends them. If multiple alarm conditions occur simultaneously, the messages rotate. Alarms that originate from the etCO2/Respiratory Mechanics Pod can be silenced remotely when the corresponding remote silence function is enabled. Ventilator Report For detailed information on ventilator reports and how to request them, see page 12-20. VF8 Infinity CentralStation TUV Draft 15-20 DRAFT VentCentral Messages VentCentral Messages Message Description Action Trend data not available When you admit a new patient to Main Screen, it takes a moment for the trend data to be compiled. Within 1 minute the database will contain trend data. Exit and re-enter the trend application. No trend parameters selected Trend parameters have not been selected. Select trend parameters (page 15-14). Serious Alarm at <%s> There is an MIB alarm at the corresponding bed. Check the patient. MIB Disconnected MIB cable is disconnected Re-connect MIB cable 15-21 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Ventilator and Device Messages/Labels Tables on the following pages list messages, labels, and settings sent by various MIBconnected devices to the Infinity bedside monitors for display at the Infinity CentralStation. Please refer to the table on page 15-9 for information about display of these data on the Ventilator Settings Review screen and the Ventilator report. CAUTION! The following tables list possible labels and messages for identification purposes. For complete information about message interpretation and device operation, please refer to the equipment documentation. Dräger Cato Anesthesia System NOTE: The Dräger Cato Anesthesia System is not available in the U.S. Parameter Label Description Displayed in... e[HAL, ISO, ENF, SEV, DES] i[HAL, ISO, ENF, SEV, DES] eCO2 iCO2 eO2 iN2O iO2 MAP MVe Pause PIP PEEP Expired agent Ventilator screen (page 15-6) RRc RRv TVe VF8 Inspired agent Expired CO2 Inspired CO2 Expired O2 Inspired N2O Inspired O2 Mean Airway Pressure Expired Minute Volume Pause Pressure Peak Inspired Airway Pressure Peak End Expiratory Airway Pressure Respiratory rate Respiratory rate Tidal volume, expired breath Infinity CentralStation TUV Draft 15-22 DRAFT Ventilator and Device Messages/Labels Dräger Cicero Anesthesia System NOTE: The Dräger Cicero Anesthesia System is not available in the U.S. Parameter Label Description Displayed in... HAL, ISO, ENF, SEV, DES eO2 iN2O iO2 MAP MVe Pause PIP PEEP RRc RRv TVe Expired and inspired agent Ventilator screen (page 15-6) Expired O2 Inspired N2O Inspired O2 Mean Airway Pressure Minute Volume, expired Pause Pressure Peak inspired airway pressure Peak end expiratory airway pressure Respiratory rate Respiratory rate Tidal volume, expired breath Selected Settings HAL, ISO, ENF, SEV, DES eO2 Tidal volume, expired breath Ventilator Settings screen (page 15-8) Tidal volume, inspired breath 15-23 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Dräger Julian/Julian Primus/Primus Anesthesia System NOTE: The Dräger Julian Primus and Dräger Primus Anesthesia Systems are not available in the U.S. Parameter Label Description Displayed in... [HAL, ISO, ENF, SEV, DES] ECO23 or etCO2 etCO2 eN2O eO2 or etO2 iN2O iCO21 iO2 MAP MVe Pause PIP PEEP RRc RRv Expired and inspired agent Ventilator Settings screen (page 15-8) TVe Cdyn1 Baro Prsr1 Leakage1 iMAC1 eMAC1 APNEAt1 Delta O21 Expired CO2 End Tidal CO2 Expired N2O Expired O2 Inspired N2O Inspired CO2 Inspired O2 Mean Airway Pressure Minute Volume, expired Pause Pressure Peak inspired airway pressure Peak end expiratory airway pressure Respiratory rate (CO2) Respiratory rate (Volume/flow/pressure/ derived) Tidal volume, expired breath Compliance Barometric Pressure Leakage Inspired MAC (minimum alveolar concentration) Expired MAC Apnea Duration (iO2 - eO2) Selected Settings iO2 set TVi set1 Ti set1 IPPV FREQ1 INT PEEP set1 P Support1 PIP set1 FLOW trig set1 F Gas Flow VF8 iO2 setting Tidal volume, inspired breath Inspiratory Time frequency Intermittent PEEP Support Pressure Maximum Inspired Airway Pressure Flow Trigger Fresh Gas Flow Infinity CentralStation Ventilator Settings screen (page 15-8) TUV Draft 15-24 DRAFT Ventilator and Device Messages/Labels Alarm Messages Message Description Displayed in... APNEA Paw > HI LIM Ventilator Alarm Apnea Airway pressure > high limit • Inspired Agent > High Limit1 • Expired Agent > High Limit1 • Mean Airway Pressure < -2 mbar • Problems with Ventilator1 • Internal Temperature High1 • Gas Supply Alarm1 • Ventilator Communication lost1 • Fresh Gas delivery failure1 • O2 Cylinder empty without wall supply1 • O2 Cylinder not connected1 • N2O Cylinder empty1 • N2O delivery failure1 • O2 delivery failure1 • Air delivery failure1 • Internal/external switch over valve error1 • Circle Occluded1 • Ventilator not in locked position1 O2 Supply Pressure Low Inspiratory O2 < low limit Breathing System Disconnected Airway temperature > high limit N20 delivery failure Air delivery failure Fresh gas failure O2 delivery failure No fresh gas Main Screen-lower right hand corner of the top waveform channel O2 SUPPLY? iO2 < LO LIM Patient Disconnect1 AW-TEMP>HI LIM1 N20 Fail1 Air Fail1 Fresh Gas Fail1 O2 Fail1 No Fresh Gas1 Bed View-information area, right below menu buttons Alarm causes that are labelled as ‘Ventilator Alarm’ refer to nonclinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Waveforms1 Paw Flow CO2 Loops Airway Pressure Ventilator Screen (page 15-5) Flow (Insp/exp) Only 2 waveforms can display. If CO2 is available, Paw displays with it. Flow is only available if CO2 is not. 15-25 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Mode Display Mode at Device IPPV SIMV PCV VCV Standby PSV Man/Spont Fresh Gas external Pressure Support added to Volume Control Pressure Support added to Pressure Control 1Applicable only to Dräger Primus In some languages IPPV is used for CMV or VC Applicable only to Dräger Julian VF8 Infinity CentralStation Mode at Infinity CentralStation IPPV2 SIMV PC VC Standby PS Man/Spont Fresh Gas EXT VC+PS PC+PS TUV Draft 15-26 DRAFT Ventilator and Device Messages/Labels Dräger Narkomed IIC / IV / 6000 / 6400 Anesthesia System Parameter Label Description Displayed in... i[HAL, ISO, ENF, SEV, DES] e[HAL, ISO, ENF, SEV, DES] etCO2 iCO2 eO2 or etO2 iO2 iN2O etN2O MAP MVe PIP PEEP RRc RRv TVe Inspired agent Ventilator Settings screen (page 15-8) Expired agent Expired CO2 Inspired CO2 Expired O2 Inspired O2 Inspired N2O Expired N2O (6000 and 6400 only) Mean Airway Pressure Minute Volume, expired Peak inspired airway pressure Peak end expiratory airway pressure Respiratory rate Respiratory rate Tidal volume, expired breath Selected Settings (IIC and IV only) iO2 set Waveforms Paw Flow Alarms APNEA Paw > HI LIM iO2 > HI LIM Ventilator Alarm O2 SUPPLY? No Fresh Gas Low Battery PEEP > HI LIM MVe < LO LIM etCO2< LO LIM etCO2>HI LIM iO2 setting Ventilator Settings screen (page 15-8) Airway Pressure Flow (Insp/exp) Ventilator Screen (page 15-5) Apnea Airway pressure > high limit Inspired O2 > high limit • Agent > High Limit • Ventilator failure • Ventilator Communication lost • Mean Airway Pressure < -2 mbar • CO2 device error • Check expiration valve O2 Supply Pressure Low No fresh gas Low battery PEEP exceeds high limit MVe below lower alarm limit etCO2 below lower limit etCO2 exceeds upper limit Main Screen-lower right hand corner of the top waveform channel Bed View-information area, right below menu buttons Alarm causes that are labelled as ‘Ventilator Alarm’ refer to nonclinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. 15-27 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Dräger Fabius GS/Fabius CE/Tiro Anesthesia System NOTE: The Dräger Fabius CE Anesthesia System is not available in the U.S. Parameter Description Displayed in... Pause iO2 MAP MVe PIP PEEP RRv TVe Air Flow4 N2O Flow4 O2 Flow4 Plateau Pressure Inspired O2 Mean Airway Pressure Minute Volume, expired Peak inspired airway pressure Peak end expiratory airway pressure Respiratory rate Tidal volume, expired breath Air flow (Fabius GS only) Nitrous oxide flow Oxygen flow Ventilator Settings screen (page 15-8) Setting Description Displayed in... TVi set I:E I part I:E E part IPPV FREQ INT PEEP set PIP set FLOW Trig set 1 i FLOW set1 P Support1 Inspired Tidal Volume setting I:E ratio - inspiratory component I:E ratio - expiratory component IPPV frequency setting Intermittent PEEP setting PIP setting Flow trigger Level setting Inspiratory flow setting Support pressure Ventilator Settings screen (page 15-8) VF8 Infinity CentralStation TUV Draft 15-28 DRAFT Ventilator and Device Messages/Labels Alarm Messages Description Displayed in... APNEA Apnea Paw > HI LIM Ventilator Alarm Airway pressure > high limit • Mean Airway Pressure < -2 mbar • PEEP > Pressure Threshold for 15 seconds • Problems with Respirator • No Fresh Gas • Check APL Valve • Pressure Measurement Inoperable2 • Internal System Fault2 • Power Supply Error2 • Problems with Ventilator2 • Loss of Data2 O2 Supply pressure low Inspiratory O2 < low limit Battery low Breathing system disconnected Check APL valve Main Screen-lower right hand corner of the top waveform channel O2 SUPPLY? iO2 < LO LIM BATTERY2 Patient Disconnect2 APL Valve?1 Bed View-information area, right below menu buttons Alarm causes that are labelled as ‘Ventilator Alarm’ refer to nonclinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Waveforms Paw Flow Loops1 Airway Pressure Flow (Insp/exp) Ventilator Screen (page 15-5) Mode Display Mode at Device IPPV SIMV1 PCV1 Standby PSV1 Man/Spont Fresh Gas external 1Not applicable to Dräger Fabius CE 2Applicable only to Dräger Fabius CE 3In some languages IPPV is used for CMV or VC 4Applicable only to Dräger Fabius GS Mode at Infinity CentralStation IPPV3 SIMV PC Standby PS Man/Spont Fresh Gas EXT 15-29 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Dräger Apollo Anesthesia System NOTE: The Dräger Apollo Anesthesia System is not available in Canada. Parameter Description Displayed in... [HAL, ISO, ENF, SEV, DES] ECO2 eO2 iN2O iO2 MAP MVe Pause PIP PEEP RRc RRv TVe Baro Prsr Leakage iMAC eMAC APNEA t Delta O2 Expired and inspired agent Ventilator Settings screen (page 15-8) Expired CO2 Expired O2 Inspired N2O Inspired O2 Mean Airway Pressure Minute Volume, expired Pause Pressure Peak inspired airway pressure Peak end expiratory airway pressure Respiratory rate Respiratory rate Tidal volume, expired breath Barometric Pressure Leakage Inspired MAC Expired MAC Apnea Duration (iO2 - eO2) Setting Description Displayed in... TVi set I:E I part I:E E part IPPV FREQ INT PEEP set PIP set Inspired Tidal Volume setting I:E ratio - inspiratory component I:E ratio - expiratory component IPPV frequency setting Intermittent PEEP setting PIP setting Ventilator Settings screen (page 15-8) VF8 Infinity CentralStation TUV Draft 15-30 DRAFT Ventilator and Device Messages/Labels Alarm Messages Description Displayed in... APNEA Apnea Paw > HI LIM Ventilator Alarm Airway pressure > high limit • Mean Airway Pressure < -2 mbar • PEEP > Pressure Threshold for 15 seconds • Problems with Respirator • No Fresh Gas • Check APL Valve • Pressure Measurement Inoperable • Internal System Fault • Power Supply Error • Problems with Ventilator • Loss of Data O2 Supply Pressure Low Inspiratory O2 < low limit Battery Low Breathing System Disconnected Main Screen-lower right hand corner of the top waveform channel O2 SUPPLY? iO2 < LO LIM BATTERY Patient Disconnect Bed View-information area, right below menu buttons Alarm causes that are labelled as ‘Ventilator Alarm’ refer to nonclinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Waveforms Paw Flow Loops Airway Pressure Flow (Insp/exp) Ventilator Screen (page 15-5) Mode Display Mode at Device IPPV SIMV PCV VCV Standby PSV Man/Spont Fresh Gas external Pressure Support added to Volume Control Pressure Support added to Pressure Control 1In some languages IPPV is used for CMV or VC Mode at Infinity CentralStation IPPV1 SIMV PC VC Standby PS Man/Spont Fresh Gas EXT VC+PS PC+PS 15-31 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Dräger Zeus Anesthesia System NOTE: The Zeus Anesthesia System is not available in the U.S.or Canada. Parameter Description Displayed in... Air Flow Baro Prsr Cdyn et[HAL, ISO, ENF, SEV, DES] etCO2 etN2O etO2 i[HAL, ISO, ENF, SEV, DES] iCO2 iN2O iO2 Leakage MAP MVe MVe s MVm N2O Flow O2 Flow O2 Supply Prsr Pause PIP Raw RRc RRm RRv TVe TVm TVs Air flow Barometric Pressure Compliance Expired agent Ventilator Settings screen (page 15-8) VF8 Expired CO2 Expired N2O Expired O2 Inspired agent Inspired CO2 Inspired N2O Inspired O2 Leakage Mean Airway Pressure Minute Volume, expired Minute Volume, spontaneous Mandatory MV Nitrous oxide flow Oxygen flow O2 supply pressure Pause Pressure Peak inspired airway pressure Resistance Respiratory rate (CO2) Respiratory rate (mandatory) Respiratory rate (volume/flow) Tidal volume, expired breath Mandatory Tidal volume Spontaneous Tidal volume Infinity CentralStation TUV Draft 15-32 DRAFT Ventilator and Device Messages/Labels Setting Description Displayed in... ASB RAMP set F Gas Flow FLOW Trig set I:E E part I:E I part INT PEEP set IPPV FREQ PEEP set PIP set Te set Ti set TVi set Assisted spontaneous breathing ramp Fresh gas flow Flow trigger Level setting I:E ratio - expiratory component I:E ratio - inspiratory component Intermittent PEEP setting IPPV frequency setting PEEP setting PIP setting Expiratory time setting Inspiratory time setting Inspired Tidal Volume setting Ventilator Settings screen (page 15-8) Alarm Messages Description Displayed in... AIR SUPPLY? AW-TEMP>HI LIM etCO2< LO LIM etCO2>HI LIM iO2 > HI LIM iO2 < LO LIM MVe < LO LIM MVe > HI LIM O2 SUPPLY? Paw > HI LIM Ventilator Alarm Air supply low Airway temperature exceeds high limit etCO2 below lower limit etCO2 exceeds upper limit Inspiratory O2 exceeds high limit Inspiratory O2 below low limit MVe below lower alarm limit MVe exceeds upper alarm limit O2 Supply Pressure Low Airway pressure > high limit • Check Flow Sensor • Battery error • CO2 device error • Problems with respirator • Check expiration valve Main Screen-lower right hand corner of the top waveform channel Bed View-information area, right below menu buttons Waveforms CO2 Flow Paw Flow (Insp/exp) Airway Pressure Alarm causes that are labelled as ‘Ventilator Alarm’ refer to nonclinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Ventilator Screen (page 15-5) Mode Display Mode at Device IPPV IPPV/AutoFlow PCV SIMV/AutoFlow Standby Mode at Infinity CentralStation IPPV IPPV PC SIMV Standby 15-33 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Ohmeda Modulus CD Anesthesia System Parameter Description Displayed in... MAP MVe Pause PIP RRv TVe Mean Airway Pressure Minute Volume, expired Pause Pressure Peak inspired airway pressure Respiratory rate (volume/flow) Tidal volume, expired breath Ventilator Settings screen (page 15-8) iO2 setting Ventilator Settings screen (page 15-8) Selected Settings iO2 set VF8 Infinity CentralStation TUV Draft 15-34 DRAFT Ventilator and Device Messages/Labels Dräger BabyLog Ventilator Parameters Gas Trans Coeff I:E l-Part iO2 TV Leak MAP MVe MVe / l MV s% PEEP PIP RRv TVeml TVhfml Gas transport coefficient Ventilator Settings screen (page 15-8) I:E ratio (Inspiratory component) Inspired O2 Leakage in system Mean airway pressure Expired minute volume - high resistance Expired minute volume - low resistance Minute volume, spontaneous fraction Peak end expiratory pressure Peak inspired airway pressure Respiratory rate - vol/flow Tidal volume, expiratory Tidal volume, high frequency Settings APNEA TIME FLOW i FLOW SIMV FREQ HFV AMPL HFV FREQHz I:E E-Part Te set I:E I-Part Ti set iO2 set MV ALM DLY MV HI LIM MV LO LIM PIP set PEEP set TRIG VOL Vent: Apnea time limit Expiratory flow setting Inspiratory flow setting Frequency, IMV High frequency ventilation (HFV) mode amplitude HFV mode frequency I:E ratio - expiratory component I:E ratio (expiratory time) I:E - inspiratory component Inspiratory time Inspired O2 setting Minute volume alarm delay Upper minute volume alarm limit Lower minute volume alarm limit PIP setting PEEP setting Trigger volume Babylog Ventilator Settings screen (page 15-8) 15-35 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Dräger Evita 1 Ventilator NOTE: Alarm Messages The Dräger Evita 1 Ventilator is not available in the U.S. Description Paw > HI LIM Paw exceeds upper alarm limit AW -TEMP>HI LIM Airway temperature exceeds upper limit AW -TEMP INOP Airway temperature measurement inoperable Ventilator Alarm • Airway temperature sensor alarm • Check expiration - valve • Failed to cycle • The gas mixer is faulty • Faulty pressure measurement • Problems with respirator (Evita) • Respirator synchronization inoperable • The device temperature of the respirator is too high • Volume measurement unsuccessful • The volume is not constant • Faulty airway temperature measurement APNEA Apnea alarm ASB>4 SEC ASB is longer than 4 sec Patient Patient Disconnect AIR SUPPLY? Gas supply, air O2 SUPPLY? iO2 > HI LIM IO2 < LO LIM % O2 ERR MVe < LO LIM MVe > HI LIM RR > HI LIM VF8 Displayed in.... Main Screen-lower right hand corner of the top waveform channel Bed View-information area, right below menu buttons Alarm causes that are labelled as ‘Ventilator Alarm’ refer to non-clinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Gas supply, O2 iO2 exceeds higher limit iO2 is below lower alarm limit iO2 measurement inoperable Mve is below lower alarm limit Mve exceeds upper alarm limit RR exceeds upper alarm limit Infinity CentralStation TUV Draft 15-36 DRAFT Ventilator and Device Messages/Labels Parameter Labels Description AW Temp Cdyn I:E I-Part iO2 MAP MVe MVe s Occlusion Press Paw MIN Pause PEEP iPEEP PIP Raw RRv RRs TVe Trapped VOL Displayed in.... Airway temperature Ventilator Settings screen (page 15-8) Dynamic compliance I:E ratio (inspiratory component) Inspired O2 Mean airway pressure Expired minute volume Spontaneous expired minute volume Occlusion pressure Minimum airway pressure Pause pressure Peak end expiratory airway pressure Peak end expiratory airway pressure, intrinsic Peak inspired airway pressure Dynamic resistance Respiratory rate - vol/flow - pediatric Spontaneous respiratory rate Tidal volume expired breath Trapped volume Selected Settings Description Displayed in.... APNEA TIME ASB RAMP set Ventilator Settings screen (page 15-8) ASB set BIPAP HI P set BIPAP HI T set BIPAP LO P set BIPAP LO T set FLOW Trig set SIMV FREQ IPPV FREQ I:E E-Part I:E I-Part iO2 set MAX iFLOW set PIP set PEEP set Apnea time Assisted spontaneous breathing ramp Assisted spontaneous breathing BIPAP high pressure HIPAP high time BIPAP low pressure BIPAP low time Flow trigger Frequency, IMV - SIMV IPPV Frequency I:E ratio (expiratory component) I:E ratio (inspiratory component) Inspired O2 setting Maximum inspired flow PIP setting PEEP setting 15-37 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Selected Settings Description (continued) Displayed in.... INT PEEP set TACHY LENGTH TACHY FREQ TVi set TRIG PRESS Vent: Ventilator Settings screen (page 15-8) VF8 Intermittent PEEP setting Tachyapnea duration Tachyapnea frequency Inspired tidal volume Trigger pressure Evita 1 Infinity CentralStation TUV Draft 15-38 DRAFT Ventilator and Device Messages/Labels Dräger Evita 2 Ventilator Alarm Messages Paw > HI LIM AW -TEMP>HI LIM Ventilator Alarm Description Paw exceeds upper alarm limit AW -TEMP exceeds upper alarm limit • Airway temperature measurement unsuccessful • Check expiration - valve • Check flow sensor • CO2 device failure • CO2 not calibrated • CO2 sensor disconnected or malfunctioning • Failure to cycle • Gas mixer inoperable • Pressure measurement unsuccessful • Problems with respirator • Respirator synchronization inoperable • Device temperature is too high. • Volume measurement unsuccessful • Volume is inconsistent. • Airway temperature sensor alarm Apnea alarm ASB is more than 4 sec Patient may be disconnected from ventilator APNEA ASB>4 SEC Patient Disconnect etCO2< LO LIM etCO2 > HI LIM etCO2 below lower alarm limit etCO2 exceeds upper alarm limit AIR SUPPLY? O2 SUPPLY? iO2 < LO LIM iO2> HI LIM % O2 ERR MVe < LO LIM MVe > HI LIM PEEP > HI LIM RR > HI LIM Gas supply alarm, air Gas supply alarm, O2 iO2 less than lower alarm limit iO2 exceeds upper alarm limit iO2 measurement unsuccessful MVe is below lower alarm limit MVe exceeds upper alarm limit PEEP exceeds upper alarm limit RR exceeds upper alarm limit 15-39 TUV DRAFT Infinity CentralStation Displayed in.... Main Screen - lower right hand corner of the top waveform channel Bed View - information area right below the menu buttons. Alarm causes that are labelled as ‘Ventilator Alarm’ refer to non-clinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. DRAFT VF8 15: VentCentral Option Parameter Labels Paw MIN AW-Temp VCO2 Cdyn TVd aw% TVd aw etCO2 I:E I-Part iO2 MAP MVe MVe s Occlusion Press Pause PEEP iPEEP PIP Raw RRv RRs TVe Trapped VOL VF8 Description Minimum airway pressure Airway temperature CO2 production, minute volume Dynamic compliance Dead space Dead space, airway end-tidal CO2 I:E ratio (inspiratory component) Inspired O2 Mean airway pressure Expired minute volume Spontaneous expired minute volume Occlusion pressure Pause pressure Peak end expiratory airway pressure Intrinsic peak end expiratory airway pressure Peak inspired airway pressure Dynamic resistance Pediatric respiratory rate - vol/flow Spontaneous respiratory rate Tidal volume expired breath Trapped volume Infinity CentralStation Displayed in.... Ventilator Settings screen (page 15-8) TUV Draft 15-40 DRAFT Ventilator and Device Messages/Labels Selected Settings APNEA TIME Description Apnea time ASB RAMP set ASB set BIPAP HI P set BIPAP HI T set BIPAP LO P set BIPAP LO T set FLOW Trig set SIMV FREQ IPPV FREQ I:E E-Part I:E I-Part iO2 set MAX iFLOW set PIP set PEEP set INT PEEP set TACHY LENGTH Assisted spontaneous breathing ramp Assisted spontaneous breathing BIPAP high pressure limit BIPAP high time limit BIPAP low pressure limit BIPAP low time limit Flow trigger setting Frequency, IMV - SIMV Frequency IPPV I:E ratio - expiratory component I:E ratio - inspiratory component Inspired O2 setting Maximum inspired flow Peak inspired airway pressure PEEP setting Intermittent PEEP setting Tachyapnea duration TACHY FREQ TVi set TRIG PRESS Vent: Tachyapnea frequency Inspired tidal volume setting Trigger pressure Evita 2 15-41 TUV DRAFT Infinity CentralStation Displayed in.... Ventilator Settings screen (page 15-8) DRAFT VF8 15: VentCentral Option Dräger Evita 2D / 4 / XL Ventilator Alarm Messages Description Displayed in.... Paw > HI LIM AW-TEMP > HI LIM Paw exceeds upper alarm limit Upper airway temperature exceeds upper alarm limit Main Screen - in the lower right hand corner of the top waveform channel Bed View - in the information area right below the menu buttons Ventilator Alarm • • • • • • • • • • • • • • • • • • • • • • • • • • • • • VF8 AW-TEMP below lower alarm limit (Evita 2D / 4) AW-TEMP measurement unsuccessful Battery error (Evita XL) Check expiration valve Check flow sensor CO2 device error CO2 not calibrated (Evita 2D / 4) CO2 Zero/Cal required CO2 window dirty (Evita XL) CO2 sensor disconnected or faulty Cycle failure Gas mixer inoperable Pressure measurement unsuccessful Device malfunction (Evita 2D / 4) Synchronization malfunctioning (Evita 2D / 4) Volume measurement unsuccessful Volume not constant (Evita 2D / 4) Neonatal flow sensor is not at the Y-piece Pediatric volume measurement inoperable (Evita 2D / 4) Neonate volume measurement inoperable (Evita XL) PEEP valve is inoperable Problems with respirator Respirator synchronizations faulty Safety mode if neonatal flow sensor not available (Evita 2D / 4) Safety mode (Evita XL) Standby Loss of data Inspiratory time in CPAP/PPS mode is less than 4 seconds (Evita 2D / 4) Inspired time is greater than 1.5 seconds (Evita XL) Infinity CentralStation Alarm causes that are labelled as ‘Ventilator Alarm’ refer to nonclinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator TUV Draft 15-42 DRAFT Ventilator and Device Messages/Labels Alarm Messages (continued) APNEA etCO2< LO LIM etCO2>HI LIM AIR SUPPLY? O2 SUPPLY? iO2 < LO LIM iO2 > HI LIM % O2 ERR MVe < LO LIM MVe > HI LIM PEEP > HI LIM PEEP ERR RR > HI LIM TVe > HI LIM ASB > 4 sec PATIENT DISCONNECT Apnea alarm etCO2 below lower limit etCO2 exceeds upper limit Gas supply alarm, air Gas supply alarm, O2 iO2 less than lower alarm limit iO2 exceeds upper alarm limit iO2 measurement unsuccessful MVe below lower alarm limit MVe exceeds upper alarm limit PEEP exceeds upper alarm limit PEEP valve inoperable (Evita 2D / 4) RR exceeds upper alarm limit TVe exceeds upper alarm limit Assisted Spontaneous Breathing exceeds 4 sec Ventilator disconnected (Evita XL) Main Screen - in the lower right hand corner of the top waveform channel Minimum airway pressure CO2 production, minute volume Dynamic compliance Dead space Dead space, airway End-tidal CO2 I:E ratio (inspiratory component) I:E ratio (expiratory component) Inspired O2 Mean airway pressure Expired minute volume Spontaneous expired minute volume spontaneous Occlusion pressure Pause pressure Peak end expiratory pressure Intrinsic peak end expiratory pressure (Evita 2D / 4) Peak inspired airway pressure Dynamic resistance Pediatric respiratory rate - vol/flow Spontaneous respiratory rate Trapped volume Tidal volume expired breath Airway temperature (Evita XL) Ventilator Settings screen (page 15-8) Bed View - in the information area right below the menu buttons Parameters Paw MIN VCO2 Cdyn TVd aw% TVd aw etCO2 I:E I-Part I:E E-Part iO2 MAP MVe MVe s Occlusion Press Pause PEEP iPEEP PIP Raw RRv RRs Trapped VOL TVe AW-Temp 15-43 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Parameters (continued) Neg iForce Vtasb Negative inspiratory force (Evita XL) Assisted spontaneous breathing, Support volume (Evita XL) Ventilator Settings screen (page 15-8) Selected Settings APNEA TIME APRV Hi Prsr APRV Hi Time APRV Lo Prsr APRV Lo Time ASB RAMP set ASB set FLOW ASSIST FLOW Trig set SIMV FREQ I:E E-Part I:E I-Part iO2 set MAX iFLOW set PIP set PEEP set INT PEEP set TACHY FREQ TVi set TV set Vent: VOL ASSIST Patient Type Apnea time (s) APRV high pressure setting APRV high time APRV low pressure setting APRV low time Assisted spontaneous breathing ramp (s) Assisted spontaneous breathing Flow assist Flow trigger Frequency, IMV - SIMV I:E ratio - expiratory component I:E ratio - inspiratory component Inspired O2 setting Maximum inspired flow setting Peak inspired airway pressure PEEP setting Intermittent PEEP setting Tachyapnea frequency • Tidal volume, inspired • Tidal volume setting Inspired time (Evita XL) The selected ventilator type Volume assist Adult, Pedi, or Neonate (Evita XL) Ventilator Settings screen (page 15-8) Ventilation Mode Display (Evita XL) Ventilation Mode at Device IPPV, IPPV/Autoflow, IPPV/Assist/Autoflow, or IPPV/Assist SIMV, SIMV/ASB, SIMV/Autoflow, or SIMV/ASB/Autoflow CPAP, CPAP/PPS, or CPAP/ASB Standby MMV, MMV/Autoflow, or MMV/ASB/Autoflow BIPAP Assist CMV Waveforms (Evita XL) Paw Airway Pressure Flow Flow (Insp/exp) Loops Ventilator loops VF8 Infinity CentralStation Mode at Infinity CentralStation IPPV SIMV CPAP Standby MMV BIPAP CMV Ventilator Screen (page 15-5) TUV Draft 15-44 DRAFT Ventilator and Device Messages/Labels Dräger Savina Ventilator Parameters Cdyn I:E I-Part I:E E-Part iO2 MAP MVe MVe s Pause PEEP PIP Raw RRv RRs TVe AW -Temp Max iFlow Ti Description Dynamic compliance I:E ratio (inspiratory component) I:E ratio (expiratory component) Inspired O2 Mean airway pressure Expired minute volume Spontaneous expired minute volume spontaneous Pause pressure Peak end expiratory pressure Peak inspired airway pressure Dynamic resistance Pediatric respiratory rate - vol/flow Spontaneous respiratory rate Tidal volume expired breath Airway temperature Peak Flow Inspired Time Displayed in... Ventilator Settings screen (page 15-8) Selected Settings APNEA TIME ASB set FLOW Trig set SIMV FREQ I:E E-Part I:E I-Part iO2 set PIP set PEEP set INT PEEP set Ti set TVi set Flow Accel Tdeconnect FREQbackup TVbackup Apnea time (s) Assisted spontaneous breathing Flow trigger Frequency, IMV - SIMV I:E ratio - expiratory component I:E ratio - inspiratory component Inspired O2 setting Peak inspired airway pressure PEEP setting Intermittent PEEP setting Inspired time setting Tidal Volume, Inspired Flow acceleration Disconnect time Backup frequency Backup of Tidal Volume 15-45 TUV DRAFT Infinity CentralStation Ventilator Settings screen (page 15-8) DRAFT VF8 15: VentCentral Option Waveforms Paw Flow Loops Airway Pressure Flow (Insp/exp) Ventilator loops Ventilator Screen (page 15-5) Alarm Messages Description Displayed in... iO2 < LO LIM iO2 > HI LIM O2 SUPPLY? MVe < LO LIM MVe > HI LIM PEEP > HI LIM TVe > HI LIM Paw > HI LIM AW-TEMP > HI LIM APNEA RRv > HI LIM ASB > 4 sec BATTERY iO2 less than lower alarm limit iO2 exceeds upper alarm limit Gas supply alarm, O2 MVe below lower alarm limit MVe exceeds upper alarm limit PEEP exceeds upper alarm limit TVe exceeds upper alarm limit Paw exceeds upper alarm limit Airway temperature exceeds upper alarm limit Main Screen - in the lower right hand corner of the top waveform channel Bed View - in the information area right below the menu buttons Apnea alarm Respiratory rate exceeds upper alarm limit Assisted spot breathing exceeds 4 seconds • Battery problem • Low battery Ventilator disconnection Patient Disconnect iO2 ERR Inspired O2 measurement inoperable Ventilator Alarm • Check flow sensor • Standby • PEEP control problems • Problems with respirator • Volume measurement inoperable • Pressure measurement inoperable • Check expiration - valve • Airway temperature measurement inoperable • Fail to cycle • Fan problem Alarm causes that are labelled as ‘Ventilator Alarm’ refer to non-clinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Ventilation Mode Display Ventilation Mode at Device BIPAP or BIPAP/ASB IPPV, IPPV/Autoflow, IPPV/Assist/Autoflow, or IPPV/Assist SIMV, SIMV/ASB, SIMV/Autoflow, or SIMV/ASB/Autoflow CPAP or CPAP/ASB Standby VF8 Infinity CentralStation Mode at Infinity CentralStation BIPAP IPPV SIMV CPAP Standby TUV Draft 15-46 DRAFT Ventilator and Device Messages/Labels P-B 7200/840 Ventilators Alarm Messages Paw > HI LIM Paw < LO LIM APNEA AIR SUPPLY O2 SUPPLY Ventilator Alarm Ventilator Alarm (P-B 7200 only) Description Displayed in... Paw exceeds upper alarm limit Main Screen - in the lower right hand corner of the top waveform channel Paw fell below lower alarm limit Apnea event Gas air supply pressure Gas O2 supply pressure I:E Alarm Leakage, system MVeHI LIM TVe HI LIM Paw exceeds upper alarm limit APNEA Expiration Valve? Patient Disconnect I:E Alarm iO2 < LO LIM iO2 > HI LIM MVe < LO LIM MVe > HI LIM PEEP > HI LIM Flow Sensor? AIR SUPPLY? O2 SUPPLY? Parameter Labels Cdyn MAP MVe MVi Pause PIP PEEP RRv TVe TVi iO2 Apnea event Check expiration - valve Main Screen - in the lower right hand corner of the top waveform channel Patient may be disconnected from ventilator I:E error iO2 is below lower alarm limit iO2 exceeds upper alarm limit MVe is below lower alarm limit MVe exceeds upper alarm limit PEEP exceeds upper alarm limit Check flow sensor Gas supply alarm, air Gas supply alarm, O2 Bed View - in the information area right below the menu buttons Alarm causes that are labelled as ‘Ventilator Alarm’ refer to non-clinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Description Displayed in... Dynamic compliance Mean airway pressure Expired minute volume Inspired minute volume Pause pressure Peak inspired airway pressure Peak end expiratory pressure Respiratory rate Tidal volume, expired Tidal volume, inspired Inspired O2 Ventilator Settings screen (page 15-8) 15-49 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Selected Settings Description Displayed in... FREQ set PEEP set TVi set TRIG PRESS VENT MODE VENT: Frequency PEEP setting Tidal volume Trigger pressure Selected ventilation mode Selected Ventilator type Ventilator Settings screen (page 15-8) Airway Pressure Flow (Insp/exp) Ventilator Screen (page 15-5) Waveforms Paw Flow VF8 Infinity CentralStation TUV Draft 15-50 DRAFT Ventilator and Device Messages/Labels Hamilton Galileo Ventilator Alarm Description Messages Paw > HI LIM Paw exceeds upper alarm limit Ventilator Alarm • Minute volume exceeds upper alarm limit • Failure to cycle • Gas supply alarm • PEEP valve inoperable • Ventilator disconnect APNEA Apnea alarm %O2 Error %O2 measurement error MVe < LO LIM MVe below lower alarm limit RR > HI LIM RR exceeds upper alarm limit Parameter Labels Cdyn Dynamic compliance I:E E-Part I:E ratio (expiratory component) I:E I-Part I:E ratio (inspiratory component) iO2 Inspired O2 MAP Mean airway pressure MVe Expired minute volume Pause Pause pressure PIP Peak inspired airway pressure PEEP Peak end expiratory airway pressure Raw Dynamic resistance RRv Pediatric respiratory rate - vol/flow RRs Spontaneous respiratory rate TVe Tidal volume, expired TVi Tidal volume, inspired iO2 Inspired O2 Displayed in... Main Screen - in the lower right hand corner of the top waveform channel Bed View - in the information area right below the menu buttons Alarm causes that are labelled as ‘Ventilator Alarm’ refer to non-clinical device conditions. All other alarm messages refer to clinical events that violate a setting that can be configured at the ventilator. Ventilator Settings screen (page 15-8) Selected Settings iO2 set INSP t% PAUSE t% PEEP set TVi set TRIG PRESS Vent: Inspired O2 setting I:E ratio, inspiratory component I:E ratio, expiratory component PEEP setting Inspired tidal volume setting Trigger pressure Selected Ventilator type Ventilator Settings screen (page 15-8) 15-51 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Maquet SV 300/SV 300A/Servoi Ventilator Alarm Messages Paw > HI LIM APNEA BATTERY CMV potentiometer GAS SUPPLY? HI CONT PRESS iO2 < LO LIM iO2 > HI LIM MAINS FAIL Description Paw exceeds upper alarm limit An apnea detected Battery alarm CMV potentiometer error Gas supply alarm High continuous pressure iO2 is below lower limit iO2 exceeds upper limit Mains failure MVe > HI / LO LIM VENT ERR % O2 ERR MVe is too high/too low Mode switch error O2 cell disconnect, or O2 potentiometer error Over range or Range switch error DEVICE ERR Displayed in... Main Screen - in the lower right hand corner of the top waveform channel Bed View - in the information area right below the menu buttons Labels/Settings BAROM PRESS AIR SUPPLY O2 SUPPLY 1I:E I-Part 1,2INSP t% iO2 MAP cmH20 MVe I MVi I Pause PEEP PIP RRv TVe TVi CMV FREQ SIMV FREQ VF8 Barometric pressure Gas air supply pressure Gas O2 supply pressure I:E ratio (inspiratory component) I:E ratio (inspiratory component)% Inspired O2 Mean airway pressure Expired minute volume Inspired minute volume Pause pressure Peak end expiratory pressure Peak inspired pressure Respiratory rate Tidal volume expired breath Tidal volume inspired breath Frequency of CMV setting Frequency of SIMV setting Ventilator Settings screen (page 15-8) Infinity CentralStation TUV Draft 15-52 DRAFT Ventilator and Device Messages/Labels Labels/Settings (continued) Description INSP t% I RISE% I:E ratio - inspiratory component Ventilator Settings screen (page 15-8) I:E ratio - inspiratory rise time component I:E ratio - pause component iO2 setting Lower alarm limit of iO2 Upper alarm limit of iO2 Lower alarm limit of MVe Upper alarm limit of MVe Patient type (Adult= 4; Pediatric=15; Neonate=16) PEEP setting Pressure control level above PEEP Upper pressure alarm limit Pressure support level above PEEP. Trigger sensitivity level below PEEP Ventilation mode setting Selected Ventilator type PAUSE t% iO2 set iO2 set LO iO2 HI LIM MVe LO LIM MVe HI LIM PATIENT RANGE PEEP set P CTL > PEEP P HI LIM P SUPPORT TRIG SENS > PEEP VENT MODE3 SV 300, SV 300A, Servoi VOL set Paw Flow Displayed in... Volume setting Airway pressure Flow (insp/exp) Ventilation Mode Display (Servoi) Ventilation Mode at Device Mode at Infinity CentralStation SIMV (PRVC) SIMV (PRVC) 1Certain parameters, identified as measured values, are derived from other values or settings provided by the ventilator and may not reflect actual values. See the operating instructions for your specific monitor or ventilator for detailed information on derived measurements. 2Display of I:E value may be affected by mode of ventilation. 3Mode value may be blanked during certain conditions and modes of ventilation. 15-53 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Maquet SV 900 Ventilator Parameters RRv TVe Tvi MVi MVe PIP MAP Pause PEEP Description Respiratory rate Tidal volume, expired Tidal volume, inspired Minute volume, inspired Minute volume, expired Peak inspired airway pressure Mean airway pressure Pause pressure Peak End Expiratory Pressure iO2 Inspired O2 VF8 Displayed in... Ventilator Settings screen (page 15-8) Infinity CentralStation TUV Draft 15-54 DRAFT Ventilator and Device Messages/Labels Viasys Bear 1000 Adult Ventilator Alarm Messages Description Displayed in... Paw > HI LIM Paw exceeds upper alarm limit Paw < LO LIM Paw is below lower limit Main Screen - in the lower right hand corner of the top waveform channel GAS SUPPLY? Gas supply alarm RR > HI LIM Respiratory rate exceeds upper alarm limit RR < LO LIM Respiratory rate is below lower limit MVe < LO LIM Minute volume is below lower limit MVe > HI LIM Minute volume exceeds upper alarm limit I:E Alarm I:E Limit (I:E Error) Cycle Failed Fail to cycle Bed View - in the information area right below the menu buttons Parameters PIP Peak inspired airway pressure MAP Mean airway pressure %MMV % Mandatory minute ventilation TVe Tidal volume, expired Ti Inspiratory time MVe Minute volume, expired MVe s Spontaneous minute volume RRv Respiratory rate Pause Pause (plateau) pressure RRs Respiratory rate, spontaneous Ventilator Settings screen (page 15-8) Settings Ti set Inspiratory time iO2 set Inspired O2 setting MAX iFLOW set Maximum inspiratory flow TVi set Tidal volume, inspired Pause t I:E ratio (Pause component) Inspiratory pause Pslope Pressure slope TRIG PRESS Pressure trigger sensitivity FLOW Trig set Flow trigger Paw set Inspiratory pressure MMV Mandatory minute ventilation Freq set Breath rate PSupport Pressure support Ventilator Settings screen (page 15-8) 15-55 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Ventilation Mode Display Ventilation Mode at Device Mode at Infinity CentralStation Assist Control Assist Control Pressure Control PCV SIMV/CPAP/PSV SIMV/CPAP/PSV PC-SIMV/CPAP/PSV PC-SIMV/CPAP/PSV Waveforms Paw Airway Pressure Flow Flow (Insp/exp) Loops Ventilator loops VF8 Infinity CentralStation Ventilator Screen (page 15-5) TUV Draft 15-56 DRAFT Ventilator and Device Messages/Labels Viasys BearCub 750 Infant Ventilator NOTE: MIB connectivity for the Viasys BearCub 750 Infant Ventilator requires FDA 510(k) review and is not yet available commercially in the U.S. MIB connectivity for the Viasys BearCub 750 Infant Ventilator is not licensed in accordance with Canadian Medical Device Regulations. Alarm Messages Description Displayed in... Paw > HI LIM Paw exceeds upper alarm limit Paw < LO LIM Paw is below lower limit Main Screen - in the lower right hand corner of the top waveform channel GAS SUPPLY? Gas supply alarm RR > HI LIM Respiratory rate exceeds upper alarm limit PEEP < LO LIM Peak End Expiratory Pressure is below lower limit MVe < LO LIM Minute volume is below lower limit APNEA Apnea Battery Low battery supply Cycle Failed Fail to cycle Bed View - in the information area right below the menu buttons Parameters PIP Peak inspired airway pressure PEEP Peak End Expiratory Pressure Te Expiratory time TVe Tidal volume, expired Ti Inspiratory time MVe Minute volume, expired RRv Respiratory rate TVi Tidal volume, inspired MAP Mean Airway Pressure O2 Supply Prsr O2 Supply pressure Ventilator Settings screen (page 15-8) Settings Ti set Inspiratory time Freq set Breath rate Vlimit Volume limit setting FLOW Trig set Flow trigger setting iFLOW set Inspiratory flow setting Ventilator Settings screen (page 15-8) 15-57 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option Ventilation Mode Display Ventilation Mode at Device Mode at Infinity CentralStation Assist Control Asst Ctrl PSV PSV SIMV/IMV SIMV/IMV CPAP CPAP SIMV/PSV SIMV/PSV SIMV (Flow Cycled) SIMV-Flow Cycle Flow Cycled A/C Asst Ctrl-Flow Cycle Waveforms Paw Airway Pressure Flow Flow (Insp/exp) Loops Ventilator loops VF8 Ventilator Screen (page 15-5) Infinity CentralStation TUV Draft 15-58 DRAFT Ventilator and Device Messages/Labels Baxter Vigilance Cardiac Output Monitor NOTE: MIB connectivity for the Baxter Vigilance Cardiac Output monitor requires FDA 510(k) review and is not yet available commercially in the U.S. MIB connectivity for the Baxter Vigilance Cardiac Output monitor is not licensed in accordance with Canadian Medical Device Regulations. Parameters Description Displayed in... BT Blood Temperature Ventilator Settings screen (page 15-8) CCO Continuous Cardiac Output CCI Continuous Cardiac Output Index ICO Intermittent Cardiac Output ICI Intermittent Cardiac Output Index SaO2 Arterial Oxygen Saturation SvO2 Venous Oxygen Saturation SVR Systemic Vascular Resistance SVRI Systemic Vascular Resistance Index VO2 O2 Consumption DO2 O2 Delivery SV Stroke Volume SVI Stroke Volume Index EDV End Diastolic Volume EDVI End Diastolic Volume Index ESV End Systolic Volume ESVI End Systolic Volume Index EF Ejection Fraction 15-59 TUV DRAFT Infinity CentralStation DRAFT VF8 15: VentCentral Option etCO2/Respiratory Mechanics Pod Parameters PIP PEEP MAP TVi s TVi m TVe s TVe m TVd aw MVe s/m Description Peak inspired pressure Peak end expiratory pressure Mean arterial pressure Inspired tidal volume, spontaneous Inspired tidal volume, mechanical Expiratory tidal volume, spontaneous Expiratory tidal volume, mechanical Raw e Dead space, airway Expiratory minute volume spontaneous/ mechanical Expiratory minute volume Respiratory rate, spontaneous/mechanical Respiratory rate Dynamic compliance Dynamic compliance of the last 20% breath Dynamic resistance PEF TValv MValv s/m VCO2 Peak Expiratory Flow Alveolar tidal volume Minute volume CO2 production, minute volume MVe RR s/m RRv Cdyn C20/Cdyn VF8 Displayed in... Ventilator Settings screen (page 15-8) Infinity CentralStation TUV Draft 15-60 DRAFT 16 Biomed Functions This chapter describes the password-protected Biomed screens intended for biomedical or service personnel. Biomed Screen Selections..........................................................................................16-2 Accessing the Biomed Screens...........................................................................16-2 Show Devices Screen..................................................................................................16-3 Configure Central Screen ...........................................................................................16-4 To edit Event Class: ..............................................................................................16-5 To modify Configure Central selections: ............................................................16-6 Configure Locked Options Screen.............................................................................16-7 Enabling Available Options..................................................................................16-7 Raid Option ..................................................................................................................16-7 System Console...........................................................................................................16-8 Rest ECG Reports........................................................................................................16-8 Available Report Formats.....................................................................................16-9 Viewing Logs..............................................................................................................16-11 Copying Logs to Disk .........................................................................................16-12 Telemetry System Set Up..........................................................................................16-13 Accessing the Telemety Setup Screens ...........................................................16-13 Infinity TeleSmart List Setup Screen .......................................................................16-13 Biomed - TeleSmart Setup Screen ..........................................................................16-14 DRAFT 16: Biomed Functions Biomed Screen Selections The Biomed functions are password-protected and intended only for the hospital’s biomedical personnel or Dräger service representatives. Selection Description Show Devices... Allows your Biomed to view the status of network devices within the monitoring unit of the Infinity CentralStation Configure Central... Provides access to setup features Configure Locked Options... Allows your Biomed to enable available options System Console... Activates a window from where you can perform remote diagnostics, shut down the Infinity CentralStation, select Rest ECG report formats, etc. Diagnostic Log Displays log of 1000 hardware and software error conditions Clinical Events Log Displays log of 1000 clinically significant events, such as alarm detection, Alarm Silence requests, recording status, and remote control of bedside monitors. Configure Telemetry... Accesses Telemetry set up functions (page 16-13) Accessing the Biomed Screens 1. Click on Biomed in the Main Screen menu bar. 2. Click on the desired menu selection. The password popup window displays. 3. Enter the Biomed password in the password popup. 4. Click on Accept in the password popup. 16-2 TUV Draft Infinity CentralStation VF8 DRAFT Show Devices Screen Show Devices Screen The Biomed - Show Devices screen lists status information for all network devices assigned to the monitoring unit of the specific Infinity CentralStation. To open the Biomed - Show Devices screen see page 16-2. Selection Description Show Central Status Opens a popup with status information for the Infinity CentralStation Radio buttons for listing device-specific information Scrolls pages of information VF8 Infinity CentralStation TUV Draft 16-3 DRAFT 16: Biomed Functions Configure Central Screen Biomed - Configure Central Screen Selections Factory Default Selection Description Available Settings Hospital Name Defines hospital name 25 character max. Language Displays the language that was set during installation Biomed Password Sets or modifies Biomed password 8 character max. Clinical Password ON/OFF Enables/disables clinical password ON / OFF ON Clinical Password Sets or modifies clinical password 8 character max. MVWS Central Layouts Password Enables/disables password protection If enabled, screen is password protected. ON / OFF OFF Printer Connected Sets printer connection • OFF • Network (Central station is connected to a network printer.) • Local (Printer is connected directly to the Infinity CentralStation.) OFF Network Printer Address Displays network printer IP address configured during installation (for viewing only) Cabrera Permits activation/deactivation of the hex axial lead configuration When you turn Cabrera on, the leads are displayed in the hex axial display format. If you turn Cabrera off, the leads appear in standard mode. ON/OFF OFF Event Class Editor Permits editing of user-selectable event classification labels (page 16-5) Edit / Hide Hide Patient Confidentiality Determines whether a patient’s name appears on Infinity CentralStation displayed screens ON / OFF OFF 16-4 TUV Draft Infinity CentralStation VF8 DRAFT Configure Central Screen Selection Description Available Settings Restore Default Settings Restores system default settings Factory Default NOTE: Whenever you restore defaults the Infinity CentralStation must be restarted. An entry is made to the clinical events log. Hospital Label Identifies the hospital label for the network 7 character max Monitoring Unit Label Identifies the monitoring unit to which 7 character max the Infinity CentralStation is assigned Care Unit Label Identifies the care unit to which the Infinity CentralStation is assigned Host Label View only Up to 7 characters To edit Event Class: 1. Open the Biomed - Configure Central screen (page 16-2). 2. Click on the toggle button next to Event Class Editor so that it displays Edit. A popup displays with ten default labels. Class Name Class Description AFIB Atrial Fibrillation ATAC Atrial Tachycardia BBB Bundle branch block PNC Pacer not captured PNP Pacer not pacing TRIG trigeminy MTI Multifocal PVC RONT R-on-T IRR Irregular HR NVTA Non-sustained VTAC 3. After you make the desired changes, click on Accept to save changes or Undo. VF8 Infinity CentralStation TUV Draft 16-5 DRAFT 16: Biomed Functions To modify Configure Central selections: 1. Open the Biomed - Configure Central screen (page 16-2). 2. Select a button or text entry box to set and click. 3. After entering information and modifying settings click on Accept to save changes or Undo. 16-6 TUV Draft Infinity CentralStation VF8 DRAFT Configure Locked Options Screen Configure Locked Options Screen This screen lists software that must be purchased separately and can only be enabled with a unique password for each Infinity CentralStation. For a list of available software options, see Appendix C, Accessories. Enabling Available Options 1. Open the Configure Locked Options screen (page 16-2). 2. Click on one of the available menu choices. 3. Enter the password for the option you wish to enable. 4. Click on Accept. After an option is enabled, a popup displays the message: The Infinity CentralStation must be restarted to allow the locked options to take effect. 5. Restart the Infinity CentralStation. Whenever you lock or enable an option, a message is stored in the clinical events log. Raid Option With the Infinity CentralStation RAID Option, RAID 1 mirroring provides disclosure disk redundancy by writing all full/event disclosure data to two identical hard drives. With this option configured, all disclosure disk data is written to a second, identical hard drive in the background. Disk hot-swapping is available via a swappable drive housing, which lets you replace the disclosure disk hard drive, if necessary. CAUTION: In the event of a RAID failure, a tone sounds and the message: Contact Biomedical Engineering Dept. displays. VF8 Infinity CentralStation TUV Draft 16-7 DRAFT 16: Biomed Functions System Console This Biomed menu selection activates a console window with a prompt from which you can: Run remote diagnostics for all network devices, Shut down or restart the Infinity CentralStation, Review an alarm history log for telemetry patient channels consisting of the last 5000 events (with time and date of the alarm occurrences), and Select Rest ECG report formats To open the System Console see page 16-2. Rest ECG Reports Rest ECG reports are available in several formats which you can customize. As soon as the data arrives from the bedside monitor, the Infinity CentralStation analyzes it and generates a printed report. Whenever the Infinity CentralStation issues a report successfully, an entry is made in the clinical events log. If a report cannot be processed successfully, an entry is made in the diagnostic log (page 16-11). If multiple printing requests exist, the Rest ECG report is queued until the assigned printer becomes available. WA R N I N G : D i a g n o s i s b a s e d o n i n t e r p r e ta t i o n o f 1 2 - l e a d m o n i t o r i n g r e s u l ts s h o u l d o n l y b e d o n e b y q u a l i f i e d p e r s o n n e l . P r io r t o f i n a l i n t e rp r e ta t i o n a n d d i a g n o s i s , q ua l i f i e d p h y s i c i a n s s h o u l d r e v i e w s u g g e s t e d d i a g n o s t i c s ta t e me nts a n d a l l o t h e r a v a i l a b l e i n f o r m a t i o n 16-8 TUV Draft Infinity CentralStation VF8 DRAFT Rest ECG Reports Available Report Formats The format of a Rest ECG report determines the layout and the type of information included in the report. For more detailed information on generating ECG reports, please refer to the bedside monitor documentation. Report Type Resolution Diagnostic Statements Y/N # of Pages Orientation 6x2 waves, 2.5 s 50 mm/s Landscape 6x2 waves, 2.5 s 6x2 waves, 2.5 s 6x2 waves, 2.5 s Portrait, standard Complexes and 3 waves (V1, II, V5) 7 s Complexes: 50mm/s Landscape, cabrera Waveforms: 25mm/s 12 waveforms, each 5 s 50 mm/s Cabrera 12 waveforms, each 5 s 50 mm/s Landscape 12 waveforms, each 10s 50 mm/s 12 waveforms, each 10s 50 mm/s 3x4 waveforms, each 2.5 s 25 mm/s 3x4 waveforms, each 2.5 s 25 mm/s 6x2 waveforms, each 5 s 25 mm/s 6x2 waveforms, each 5 s 25 mm/s VF8 Infinity CentralStation TUV Draft 16-9 DRAFT 16: Biomed Functions Accessing the Rest ECG Report Selection Menu 1. Open the System Console (page 16-2). 2. At the system prompt type the following: rekgSelect A selection list appears. 3. Enter the number before the format or function you wish to select (1 - 15, 99) or press for the default (9). If you want to change hospital name you must type the new information after making your selection, then press on the keyboard. 16-10 TUV Draft Infinity CentralStation VF8 DRAFT Viewing Logs Viewing Logs The password-protected diagnostic and clinical events logs record hardware and software conditions and clinical events. The Diagnostic log contains a record of 1000 hardware and software error conditions and are helpful in determining system status. The Clinical Events log contains information on 1000 events of clinical significance. Typical clinical events log entries may include: Transitions in/out of local alarm silence Infinity CentralStation Alarm State Change (e.g., Audible Alarm Annunciation Change from active to silenced or vice versa) Alarm Limit Change from the Infinity CentralStation Arrhythmia Setup Change from the Infinity CentralStation Bedside State Change (e.g., on-line, off-line) CPS/IDS State Change (e.g., on-line, off-line, duplicate IP address detected) Main Screen Layout Change Edits of Patient Demographics Alarm Volume Change Clinical Password Modification Language Change Restoration of Factory Default Settings Recording Status (other than cancellation of continuous or timed recordings) Recorder State Change (e.g., Recorder off-line, Recorder Failure, CPS/IDS Off-line) Time and Date Change Locked Options Change A request for SPO2 with no SPO2 license Infinity CentralStation detection of incompatible Infinity TeleSmart software Infinity TeleSmart self-test log entries Log entries appear as separate lines and are displayed in chronological order with the most recent entry at the top. Each entry includes date, time, event class, event code, and event description. To open the Diagnostic or Clinical Events logs, see page 16-2. VF8 Infinity CentralStation TUV Draft 16-11 DRAFT 16: Biomed Functions Copying Logs to Disk 1. Insert a 3.5” high-density disk into the disk drive of the Infinity CentralStation. NOTE: You do not need to format the disk before copying logs. Both the Diagnostic and Clinical Events logs are copied during a copy request. 2. Access the log you wish to copy (page 16-11). 3. Click on Copy Logs To Disk. The Infinity CentralStation formats the disk automatically. Logs are copied as individual files. During the copying process, the Infinity CentralStation is fully operational. However, the Copy Logs To Disk button remains ghosted until the process completes. If the operation fails, a status message displays and an advisory tone sounds. 16-12 TUV Draft Infinity CentralStation VF8 DRAFT Telemetry System Set Up Telemetry System Set Up The following Biomed setup functions pertain exclusively to the Telemetry system. Before you can access these functions, the Telemetry option must be enabled (page 16-7). Accessing the Telemety Setup Screens 1. Click on Biomed in the Main Screen menu bar. 2. Click on Configure Telemetry.... 3. Click on TeleSmart List Setup or TeleSmart Setup. 4. Enter the Biomed password in the password popup. 5. Click on Accept in the popup. The selected screen displays. You must use the Biomed password to access these screens. Infinity TeleSmart List Setup Screen The TeleSmart List screen permits the Biomed to configure up to 100 devices to use with the Infinity CentralStation. 1. Open the TeleSmart List Setup screen. 2. Click on the New Device button. 3. For each available device, enter the MAC Address and IP address in a row of the table. 4. Assign a unique TeleSmart ID (4 character maximum). 5. Repeat steps 2 and 3 for each device. 6. When you have added all the devices, click on the Accept. Once you assign the TeleSmart IDs, those devices are available for selection from the TeleSmart ID section of the Admit screen (page 7-4). VF8 Infinity CentralStation TUV Draft 16-13 DRAFT 16: Biomed Functions Biomed - TeleSmart Setup Screen NOTE: You can only configure the Infinity TeleSmart Alarm Pause key, STAFF ALERT key, Record key, and speaker for an individual patient (page 6-22) if Per Patient is selected during setup. Biomed - TeleSmart Setup Screen Selections Selection Description Alarm Pause Determines how the Infinity TeleSmart Alarm • All On Pause key can be used • All Off If you want to be able to individually set this • Per Patient function for each patient, you must select Per Patient (page 6-22). If you select All Off you cannot individually set this function for each patient and the the Infinity TeleSmart Alarm Pause key wil be disabled. TeleSmart Record Determines how the Infinity TeleSmart Record key can be used If you want to be able to individually set this function for each patient, you must select Per Patient (page 6-22). If you want to generate manual timed recordings when you press the Infinity TeleSmart Record key, you must select All Record or All Record/Store. TeleSmart Staff Alert Determines how the Infinity TeleSmart • All On STAFF ALERT key can be used • All Off If you want to be able to individually set this • Per Patient function for each patient, you must select Per Patient (page 6-22). If you want to generate a STAFF ALERT alarm at the Infinity Central Station when you press the Infinity TeleSmart STAFF ALERT key, you must select All On. All On Speaker Determines if the Infinity TeleSmart speaker can be enabled • All Enable • All Disable • Per Patient All Disable • OFF • 10 - 100 % OFF Unless you select Per Patient, you cannot individually set this function for each patient (page 6-22). TeleSmart Volume Determines volume of Infinity TeleSmart audible alarm Settings • • • • • Default All Off All Record All Record All Off All Record/Store All Store Per Patient If you select OFF you cannot enable this function for each patient (page 6-22) and the Infinity TeleSmart will not display a Volume screen. 16-14 TUV Draft Infinity CentralStation VF8 DRAFT Biomed - TeleSmart Setup Screen Biomed - TeleSmart Setup Screen Selections Selection Description Settings Default Display Shut Off Determines how long the Infinity TeleSmart Timer display remains on with no user activity • • • • • 1 min 2 min 3 min 4 min 5 min 2 min ECG Notch Filter Assigns Infinity TeleSmart ECG Notch filter setting • 50 Hz • 60 Hz 60 Hz Régulation Sets French Homologation mode • Par défaut • France Par défaut • Click on Accept or on Undo to return to previous settings. VF8 Infinity CentralStation TUV Draft 16-15 DRAFT 16: Biomed Functions 16-16 TUV Draft Infinity CentralStation VF8 DRAFT A Patient Preparation This appendix provides information about patient preparation and electrode placement for telemetry monitoring. General .......................................................................................................................... A-2 ECG Electrode Placement............................................................................................ A-3 Lead Wire Color Codes.......................................................................................... A-4 Attaching the Pulse Oximeter...................................................................................... A-5 DRAFT A: Patient Preparation General Careful skin preparation and proper electrode placement ensure strong signals with minimal artifact. In case of a technical alarm (e.g., a detached lead), re-prep the patient according to the following recommendations. WA R N I N G ! P l a c e t h e I n f in i t y Te l eS m a r t d e v i c e s a f e l y t o a v o i d a n y p o s s i b i l i t y o f t h e d e v i c e f a l l i n g o n o r i n j u r i n g pa t i e n t . Follow hospital protocol for preparing the patient’s skin. To ensure a good quality signal, change electrodes every 24 to 48 hours (or in accordance with manufacturer’s instructions). Electrodes may have to be changed more frequently under the following conditions: ECG signal degradation Excessive patient perspiration Patient skin irritation A wide selection of reusable and single-use electrodes is available. Select the best electrode for the monitoring situation. Dräger recommends Ag/AgCl single-use electrodes. If you are using pre-gelled electrodes, verify that there is enough gel in the electrode gel-filled area. Never use disposable electrodes after their expiration date or when the gel has dried out. Choose electrode sites in the configuration that will provide the best ECG based on the patient’s underlying cardiac condition and the number of leads you wish to monitor. (P- and T-wave amplitudes should be no more than one third of the QRS amplitude.) Select flat, non-muscular sites to maximize electrode contact and minimize muscle artifact. Avoid joints or bony protrusions. Consider the following special conditions when selecting sites for electrode placement: Surgery — Keep the electrodes as far from the surgical site as possible. Burn Patients — Use sterile electrodes. Clean the equipment thoroughly. Follow hospital infection control procedures. A-2 TUV Draft Infinity CentralStation VF8 DRAFT ECG Electrode Placement ECG Electrode Placement WA R N I N G ! W h e n p l a c i n g e l e c t r o d e s , e n s u r e a l l c o n n e c t i n g w ir e s a r e p l a c e d s a f e l y a n d c a n n o t i n j u r e t h e pa t i e n t . The following illustrations show typical ECG electrode placement for 3-, 5-, and 6wire lead sets: 3-Wire Standard 5-Wire Standard Paced 6-Wire Standard V+ is only used with 6-wire monitoring. Dräger recommends that you do not use this modified placement for TruST monitoring. Select 2 chest lead positions for V and V+ (page 6-21). Chest Lead Standard VF8 Infinity CentralStation TUV Draft A-3 DRAFT A: Patient Preparation 3-Wire Standard 5-Wire Standard Lead Wire Color Codes Lead wire color codes designated by the IEC and the AHA/AAMI appear in the table that follows.: ECG Lead AHA/AAMI IEC LA Black Yellow LL Red Green RA White Red RL Green Black Brown White V+ Gray and Brown Gray and White A-4 TUV Draft Infinity CentralStation VF8 DRAFT Attaching the Pulse Oximeter Attaching the Pulse Oximeter 1. Select a well perfused site such as a finger or a toe where patient movement is minimum. 2. Remove any nail polish (if present). 3. Cover the sensor with an opaque material to prevent interference from direct sunlight (when applicable). VF8 Infinity CentralStation TUV Draft A-5 DRAFT A: Patient Preparation A-6 TUV Draft Infinity CentralStation VF8 DRAFT B: Technical Specifications NOTE: Specifications are subject to change. The telemetry system complies with the Radio Equipment and Telecommunications Terminal Equipment Directive (1999/5/EC). Technical Data .............................................................................................................. B-2 Infinity CentralStation ................................................................................................. B-2 Infinity CentralStation Optional Touch Screen ......................................................... B-4 Uninterruptible Power Supply (350VA, 120V, 220V) ................................................. B-4 Laser Printer ................................................................................................................. B-5 Strip Recorder .............................................................................................................. B-5 Infinity Telemetry System...................................................................................... B-6 Infinity TeleSmart Programming Cable ..................................................................... B-6 Infinity TeleSmart ......................................................................................................... B-6 Infinity TeleSmart Monitoring Specifications .................................................... B-14 Electromagnetic Compatibility .................................................................................. B-18 DRAFT B: Technical Specifications Technical Data Infinity CentralStation Display Specifications Display Size 432 mm (17 in.), 533 mm (21 in.) diagonal, CRT or TFT Resolution 1280 x 1024 pixels (native resolution) User Controls Input Device Controls PS/2-compatible keyboard and PS/2-compatible optical mouse included in country-specific kit. Optional Dräger Medical supplied touch screen is also supported. Central Processing Unit (CPU) Processor Intel® XeonTM Processor 3.20 GHz Storage • (1) GB RAM, 1.44 Mb 3.5 in. floppy drive • (1) DVD/CDRW • (2) 73 GB hard drives Disk Array SCSI Raid 1 (optional) in locked drive bay Software Updates • 1.44 MB 3.5 inch floppy disk drive • CD-ROM Connections • • • • Network Connectivity • Infinity Network • Infinity TruST Telemetry Network Video Output Dual Head PCI 32M graphics board, 1280 x 1024 @ 75 Hz Audio Output Dräger Medical supplied speakers required Alarm Grades Life-threatening, Serious, Advisory (Audible and visual indicators) Number of patients supported per CPU • 16 patients with single display • 32 patients with two displays 1 IEEE 1284 parallel port 2 Asynchronous RS-232 serial ports 2 GB LAN connections 4 USB ports Electrical Specifications Power consumption 115V / 230V 4.0A/2.0A Power Output Up to 460W B-2 TUV Draft Infinity CentralStation VF8 DRAFT Technical Data Infinity CentralStation (continued) Environmental Requirements Cooling Passive heatsink moved across 1 - 120 mm fan SCA drive array and power supply cooled by dedicated 80 mm fans Operation Temperature 0 to 45oC (32 to 113oF) Non-Operating Conditions -20 to 50oC (-4 to 122oF) Altitude Operating: 3500 m (11000 feet) Storage: 10600 m (35000 feet) Acoustic Noise < 60 dBA Physical Attributes Size (H x W x D) 426.7 x 218.4 x 508.0 mm (16.8 x 8.6 x 20.0 in.) Weight 22.5 kg (50 lbs.) Chassis Color Black Regulatory Standards Compliances UL/CSA/CE Certification as required per Original Equipment Manufacturers (OEM). Infinity CentralStation is CE marked in accordance with the requirements of the 93/42/EEC Medical Device Directive. Uninterruptible Power Supply (350VA, 120V, 220V) Connections Infinity CentralStation, Infinity TruST Telemetry Receiver Audio output < 45 dB at 1 m (3 ft.) Physical Specifications Size (H x W x D) 165 x 114 x 368 cm (6.5 x 4.5 x 14.5 in.) Weight 11.3 kg (25 lbs.) Electrical Specifications Inverter Waveform Low distortion sine wave Input voltage 115, 220, 230, 240 VAC ± 20% (nominal, user-selectable) Input frequency 50/60 Hz ± 5% VF8 Infinity CentralStation TUV Draft B-3 DRAFT B: Technical Specifications Uninterruptible Power Supply (350VA, 120V, 220V) (continued) Noise Rejection Isolation With unit under power and an ANSI/IEEE C62.41 Cat. A pulse applied either normal or common mode at the input, the noise output voltage will be <10 normal mode and < 0.5V common mode in all 4 quadrants (CM-NM, NM-NM, CM-CM, NM-CM). Surge Voltage Withstand Capability Tested under power to ANSI/IEEE C62.41 Cat. A & B (formerly IEEE 587-1980). Cat. A 6000V @ 200 amps, 0.5 usec risetime, 100 kHz decay, Cat. B 6000V @ 500 amps, 0.5 usec risetime, 100 kHz decay. Battery charging time 3 to 8 hours Backup time 6 to 20 minutes (half/full loaded) Internal batteries 2 -12 volt user hot-swap batteries, recharge time 4 hours Indicators LEDs for Load level, voltage manager boost, voltage manager nominal, voltage manager buck, on battery, replace battery, overload Regulatory Standards Compliances UL 1778, cUL 1778 Laser Printer Infinity R50N Network Strip Recorder provides two-channel strip recordings of automatically captured arrhythmia or alarm events or manually initiated recordings. Strip Recorder Infinity R50N Network Strip Recorder provides two-channel strip recordings of automatically captured arrhythmia or alarm events or manually initiated recordings. B-4 TUV Draft Infinity CentralStation VF8 DRAFT Technical Data Infinity Telemetry System Infinity TeleSmart Programming Cable Connections PC via 3m or optional 20m Serial cable HxWXD 44.0 x 96.5 x 96.4 mm (1.7 x 3.8 x 3.8 in.) Weight 450 g (1 lb.) Method Directly to PC and toSpO2 connector of Infinity TeleSmart Infinity TeleSmart Physical Specifications Size, H x W x D 139.7 x 76.2 x 30.4 mm (5.6 x 3 x 1.2 in) Weight 276.4 g (9.75 oz) with battery Cooling Convection Disposal All materials must be disposed of or recycled properly and in accordance with local regulations. There are no known special disposal requirements for any accessories. Connections ECG, SpO2, Programming Cable Environmental Specifications Atmospheric Pressure Operating: -647 - 1060 hPa Storage: -500 - 1060 hPa Temperature Operating: 0 to 40° C (32 to 104 °F) Storage: -30 to 70° C (-22 to 158 °F) Shock IEC 68-2-27 50 g half-sine waveform, 11 mS duration, 3 shocks in each +/- directions/axis, 18 total shocks, 3 mutually perpendicular axes Frequency Response 0.5 - 40 Hz: ± 3 dB Sinusoidal Vibration IEC 68-2-6 5-10 Hz @ 0.098 DA, 100-500 Hz @ 2 G 10 sweep cycles/axis, 3 axes, 1 octave / minute Random Vibration IEC 60068-2-36 Reproducibility Medium ASD 10 to 20 Hz: 0.05 g2 /Hz, -3dB/Octave ASD 20 to 150 Hz: 0.05 g2 /Hz, -3dB/Octave Duration/axis/mounting: 30 min Total acceleration: 1.6g (rms) VF8 Infinity CentralStation TUV Draft B-5 DRAFT B: Technical Specifications Infinity TeleSmart (continued) Bump IEC60068-2-29 Peak acceleration: 15 g Pulse duration: 6 ms Number of bumps: 1000 Direction: Vertical (normal operating position) Free Fall IEC 60068-2-32, Procedure 1 Height of fall: 1 m Number of falls: 1 on each of six surfaces Drop Per IEC68-2-31, Packaged drop- 30" Water Resistance Per EN 60529 rating IPX7 Electrical Characteristics Power Source Rechargeable lithium ion battery Mode of operation Continuous Typical Battery Run Time ECG+SpO2 24 hours User Interface User Interface 6 fixed keys: alarm pause, view screen, staff alert, record/ mark event, up/down screen scroll, Audio annunciator, LCD Display Alarm Indicator LED Battery Charging Indicator, Visual Alarm Banners on LCD, Audible alarms via speaker Display Type Color Liquid Crystal Display (LCD) Communications Network Direct Sequence Spread Spectrum (802.11b) Operating Frequencies ISM-2.4: 2400MHz to 2483.5MHz Arrhythmia Leads Analyzed Any user-selected, non-derived single lead or Lead II and V Detected Events/Rhythms Asystole, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Ventricular Run, Accelerated Idioventricular Rhythm, Supraventricular Tachycardia, Ventricular Couplet, Ventricular Bigeminy, Sinus Tachycardia, Pause, Artifact, PVC/min ECG Available leadsAdult/Pediatric B-6 TUV Draft I, II, III, aVL, aVR, aVF, V, V+V1, V2, V3, V4, V5, V6, dV1, dV2, dV3, dV4, dV5, dV6 (dVx leads using TruST 12-lead algorithm K030738) Infinity CentralStation VF8 DRAFT Technical Data Infinity TeleSmart (continued) Measurement Range 15 to 300 bpm Accuracy ± 2 beats/minute or ± 1%, whichever is greater Degree of protection against electrical shock Type BF Defibrillation Protection = 360 Joules Event Storage Automatic Alarm violation or arrhythmia trigger Manual "Recording" key activation Central Monitor WorkStation and Input Controls1 Draeger Medical Systems Infinity CentralStation (K# to be assigned) Keyboard, mouse, touchscreen Additional predicate devices which specially support optional touchscreen input for a patient monitoring central stations are: · Philips Medical Systems: Intellivue Information Center - K050742 · GE Medical Systems: CIC Pro Clinical Information Center - K053356 VF8 Infinity CentralStation TUV Draft B-7 DRAFT B: Technical Specifications Infinity TeleSmart (continued) ST Segment Analysis (Adult/Pediatric) Available Leads for display on patient worn device Choice of any ECG lead being monitored Isoelectric Point Adjustment range: Start of QRS complex to fiducial point Default: QRS onset - 28msec ST Measurement Point Adjustment range: Fiducial point to end of QRS complex Default: QRS offset + 80msec ST Complex Length 900 msec (-300 to +600 msec from fiducial point) Update Interval 15 secs ±1, 1 normal beat required ST Level Alarm Adjustment Range -15.0 to 15.0 mm, -1.5 to 1.5 mV ST Accuracy ±0.1 mm (±0.01 mV) ST Measurement Range -15.0 to 15.0 mm, -1.5 to 1.5 mV ST Measurement Resolution ±0.1 mm (±0.01 mV) Sampling Rate for Averaged ECG 250 samples/s Pulse Oximetry (optional) Parameter Display Saturation (%SpO2), pulse rate Measurement method Absorption-spectrophotometry Measurement range SpO2: 1 - 100% Pulse rate: 30-250 bpm Measurement accuracy, Adult Mode1: SpO2: 0 to 69% not specified 70 to 100% sensor-specific as follows: Dräger: OxiSure Sensor - D±2 Nellcor: 2,3 D-25/D-25L, D-20, I-20, N-25, OxiMAX MAX-A, OxiMAX MAX-AL, OxiMAX MAX-P, OxiMAX MAX-N, OxiMAX MAXI±2 Nellcor: DS100A ±3 Masimo: 2,3 LNOPADT, LNOPPED, LNOPNEO, LNOPNEO SS,LNOPYI±2 Masimo: LNOP-DCI, LNOP-DCIP, NR125±2, EAR ±3.5 Pulse Rate: ±3 beats/min B-8 TUV Draft Infinity CentralStation VF8 DRAFT Technical Data Infinity TeleSmart (continued) Measurement accuracy, Neonatal mode 1, 2, 3, 4 SpO2: 0 to 69% not specified 70 to 100% sensor-specific as follows: Nellcor: N-25, OxiMAX MAX-N±3 Masimo: LNOPNEO, LNOPNEO SS, LNOP-YI±3 Pulse Rate: ±3 beats/min SpO2 accuracies are expressed as ± "X" digits between indicated saturation levels. Accuracy of the SpO2measurement is specified with 1 SD (standard deviation), which represents approximately 68% of the population. Saturation: decrease accuracy by ±1 digit during motion (5, 6) (ECG monitoring required). Pulse Rate: decrease accuracy by ±2 beats/min during motion (5, 6) (ECG monitoring required). Accuracy of saturation measurements on neonates is increased by ±1 digit as compared to accuracy on adult patients to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. For Masimo devices, motion is defined as either: • Periodic rubbing/tapping with an amplitude of 1-2 cm. at a periodic frequency of 2-4 Hz. or: • Aperiodic motion with amplitude of 2-3 cm. at a frequency of 1-5 Hz. 6 For Nellcor devices, motion is defined as aperiodic rubbing/tapping motion with amplitude of 1-2 cm. at a frequency of 1-4 Hz. QRS Detection Amplitude 0.5 to 5 mV Duration - Adult/Pediatric 40 to 120 msec Pacer Detection Leads (Adult/Pediatric) I, II or III Pacer Detection Amplitude ±2 to ±900 mV Pacer Detection Width 0.1 to 2.0 msec Trends Trended Telemetry Parameters HR, ST, PVC/min, % paced, SpO2, PLS, STI, STII, STIII, STaVR, STaVL, STaVF, STV1 to STV6, STdV1 to STdV6, STVM, and STCVM Storage Time 72 Hours Resolution 1 minute interval Infinity TeleSmart Bedside Charger Connections VF8 Infinity TeleSmart (supports 10 devices concurrently) Infinity CentralStation TUV Draft B-9 DRAFT B: Technical Specifications Infinity TeleSmart Bedside Charger (continued) Physical Attributes Dimensions 3.3 x 159.7 x 76.7 mm (.13 x 6.29 x 3.02 in) Weight 226.7 g (8.0 oz) Disposal All materials must be disposed of or recycled properly and in accordance with local regulations. There are no known special disposal requirements for any accessories. Electrical Specifications Input Voltage 115, 220, 230, 240 VAC ± 20% (nominal, user selectable) Input frequency (Hz) 50/60 Hz ±5% Protection Class From specified Class II power supply Mode of Operation Continuous Power Output Provides power to Infinity TeleSmart via magnetic coupling Environmental Requirements Atmospheric Pressure Operating: -647 hPa to 1060 hPa Storage: -500 hPa to 1060 hPa Temperature Operating: 0 to 40° C (32 to 104 °F) Storage: -30 to 70° C (-22 to 158 °F) Humidity (non condensing) Operating: -2 to 95% Storage: -2 to 95% Shock IEC 68-2-27 • 50 g half-sine waveform, 11 mS duration, • 3 shocks in each +/- directions/axis, 18 total shocks, • 3 mutually perpendicular axes Sinusoidal Vibration IEC 68-2-6 • 5-10 Hz @ 0.098 DA, 100-500 Hz @ 2 G • 10 sweep cycles/axis, 3 axes, 1 octave / minute Random Vibration IEC 60068-2-36 • • • • • Reproducibility Medium ASD 10 to 20 Hz: 0.05 g2 /Hz, -3dB/Octave ASD 20 to 150 Hz: 0.05 g2 /Hz, -3dB/Octave Total acceleration: 1.6g (rms) Duration/axis/mounting: 30 min Bump IEC60068-2-29 • • • • Peak acceleration: 15 g Pulse duration: 6 ms Number of bumps: 1000 Direction: Vertical (normal operating position) Free Fall IEC 60068-2-32, Procedure 1 • Height of fall: 1 m • Number of falls: 1 on each of six surfaces B-10 TUV Draft Infinity CentralStation VF8 DRAFT Technical Data Infinity TeleSmart Bedside Charger (continued) Drop Per IEC68-2-31, Packaged drop- 30" Water Resistance IPX0 & IPX4 Standards Compliances EN60601-1, UL60601-1, CSA 22.2 No. 601.1 M90, EN60601-1-2 Infinity TeleSmart Central Charger Connections Infinity TeleSmart (supports 10 devices concurrently) Physical Attributes Dimensions 520.7 x215.9 x 190.5 mm (20.5 x 8.5 x 7.5 in) Weight 6.5 Kg (13.2 lb) Cooling Convection Disposal All materials must be disposed of or recycled properly and in accordance with local regulations. There are no known special disposal requirements for any accessories. Electrical Specifications Input Voltage 115, 220, 230, 240 VAC ± 20% (nominal, user selectable) Input frequency (Hz) 50/60 Hz ±5% Protection Class From specified Class 1 power supply Mode of Operation Continuous Power Output Provides power to Infinity TeleSmart via magnetic coupling Environmental Requirements Atmospheric Pressure Operating: -647 to 1060 hPa Storage: -500 to 1060 hPa Temperature Operating: 0 to +40 ° C (32 to 104 °F) Storage: -30 to +70° C (-22 to 158 °F) Humidity (non condensing) Operating: -20 to 95% Storage: -20% to 95% Shock IEC 68-2-27 • 50 g half-sine waveform, 11 mS duration, • 3 shocks in each +/- directions/axis, 18 total shocks, • 3 mutually perpendicular axes Sinusoidal Vibration IEC 68-2-6 • 5-10 Hz @ 0.098 DA, 100-500 Hz @ 2 G • 10 sweep cycles/axis, 3 axes, 1 octave / minute VF8 Infinity CentralStation TUV Draft B-11 DRAFT B: Technical Specifications Infinity TeleSmart Central Charger (continued) Random Vibration IEC 60068-2-36 • • • • • Reproducibility Medium ASD 10 to 20 Hz: 0.05 g2 /Hz, -3dB/Octave ASD 20 to 150 Hz: 0.05 g2 /Hz, -3dB/Octave Total acceleration: 1.6g (rms) Duration/axis/mounting: 30 min Bump IEC60068-2-29 • • • • Peak acceleration: 15 g Pulse duration: 6 ms Number of bumps: 1000 Direction: Vertical (normal operating position) Free Fall IEC 60068-2-32, Procedure 1 • Height of fall: 1 m • Number of falls: 1 on each of six surfaces Drop Per IEC68-2-31, Packaged drop- 30" Water Resistance IPX1 - Protected against harmful effects of dripping water. Standards Compliances B-12 TUV Draft EN60601-1, UL60601-1, CSA 22.2 No. 601.1 M90, EN60601-1-2 Infinity CentralStation VF8 DRAFT Electromagnetic Compatibility Electromagnetic Compatibility The separation distances are written with regard to the Infinity CentralStation with Infinity Telemetry and Infinity TeleSmart. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment, and older equipment may be particularly susceptible to interference. General Notes Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or accessories may adversely impact safety, performance and electromagnetic compatibility (increased emission and decreased immunity). The equipment should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is inevitable, the equipment should be observed to verify normal operation in the configuration in which it will be used. When using wireless networking, be aware that the system operates at 2.4 GHz range. Other equipment, even if compliant with CISPR emission requirements, could interfere with reception of wireless data. When selecting new wireless systems (e.g. cell phones, pager systems, cordless phones etc) for use in installations where wireless networking is used, care should always be used to insure that operating frequencies are compatible. For example, selecting cordless phones that operate at 2.4 GHz will likely cause difficulty with the phones and networking components. NOTE: Detailed radio frequency characteristics: 2412-2472 MHZ, Direct-sequence spread spectrum (DSSS) IEEE 802.11b compliant, limited to 100 mW. Applicable to both access points and client adaptors. When used with 802.15.1 wireless, the device will transmit with the following characteristics: 2400-2485 MHz , Frequency Hopping Spread Spectrum (FHSS), limited to 2.5 mW. See the documentation that accompanies the wireless products for further details. Low level signals such as ECG are particularly susceptible to interference from electromagnetic energy. While the equipment meets the testing described below, it is not a guarantee of perfect operation, the ‘quieter’ the electrical environment the better. In general, increasing the distance between electrical devices decreases the likelihood of interference. VF8 Infinity CentralStation TUV Draft B-13 DRAFT B: Technical Specifications NOTE: The Infinity CentralStation with Infinity Telemetry and Infinity TeleSmart are intended for use in the electromagnetic environments specified below. The user of this equipment should assure that is used in such an environment. Electromagnetic Emissions Emissions Compliance according to... Electromagnetic environment RF emissions (CISPR 11) Infinity CentralStation and Infinity TeleSmart Group 1 The Infinity CentralStation and receiver use RF energy only for internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.* CISPR Emissions Classification Class B Harmonic emissions (IEC 61000-3-2) Class A Voltage fluctuations / flicker (IEC 61000-3-3) Complies The equipment is suitable for use in all establishments including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. *Note that when used with the wireless options, the Infinity TeleSmart emits electromagnetic energy in order to communicate with the Infinity Network. Nearby electronic equipment may be affected. Radio frequency characteristics are specified above. See the documentation that accompanies the wireless products for further details. Electromagnetic Immunity Immunity against... IEC 60601-1-2 test level Compliance level (of this device) Electromagnetic environment Electrostatic discharge, ESD (IEC 61000-4-2) Contact discharge: ± 6 kV ± 6 kV Air discharge: ± 8 kV ± 8 kV Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be kept at levels to reduce electrostatic charge to suitable levels. Electrical fast transients / bursts (IEC 61000-4-4) Power supply lines: ± 2 kV ± 2 kV Longer input / output lines: ± 1 kV ± 1 kV Surges on AC mains lines (IEC 61000-4-5) Common mode: ± 2 kV ± 2 kV Differential mode: ± 1 kV ± 1 kV Power frequency magnetic field 50/60 Hz (IEC 61000-4-8) 3 A/m 3 A/m B-14 TUV Draft Infinity CentralStation Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Equipment which emits high levels of power line magnetic fields (in excess of 3A/m) should be kept at a distance to reduce the likelihood of interference. VF8 DRAFT Electromagnetic Compatibility Electromagnetic Immunity Immunity against... IEC 60601-1-2 test level Compliance level (of this device) Voltage dips and short interruptions on AC mains input lines (IEC 61000-4-11) Dip >95%, 0.5 periods >95%, 0.5 periods Dip 60%, 5 periods 60%, 5 periods Dip 30%, 25 periods 30%, 25 periods Dip >95%, 5 seconds >95%, 5 seconds Conducted RF RF coupled into lines (IEC 61000-4-6) 150 kHz – 80 MHz: 3 V/m Radiated RF (IEC 61000-4-3) 80 MHz – 2.5 GHz 3 V/m Electromagnetic environment Mains power should be that of a typical commercial or hospital environment. If user requires continued operation during power mains interruptions insure that batteries are installed and charged. Insure that battery life exceeds longest anticipated power outages or provide and additional uninterruptible power source. Portable and mobile RF communications equipment should be used no closer to any part of the, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below. Recommended separation distance: d=1.2/V1]√P d=1.2/√P 80 MHz to 800MHz d=2.3√P 800 MHz to 2.5 GHz where ‘P’ is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and ‘d’ is the recommended separation distance in metres. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2. Interference may occur in the vicinity of equipment marked with the wireless symbol: 1Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment. If the frequency range is 150 kHz to 80 MHz, field strengths should be less than 3 V/m. VF8 Infinity CentralStation TUV Draft B-15 DRAFT B: Technical Specifications Recommended separation distances between portable and mobile RF communications equipment and the equipment Rated maximum output power of Transmitter (watts) Separation distance according to frequency of transmitter (meters) 150 kHz to 80 MHz d=1.2/V1]√P 80 MHz to 800MHz d=1.2/V1]√P 800 MHz to 2.5 GHz d=2.3√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed, the recommended separation distance ‘d’ (in meters) can be estimated using the equation applicable to the frequency of the transmitter, where ‘P’ is the maximum output power rating of the transmitter (in watts) according to the transmitter manufacturer. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. B-16 TUV Draft Infinity CentralStation VF8 DRAFT C: Cleaning This appendix provides general instructions for cleaning the Infinity CentralStation, the accessories, and peripherals. CAUTION! Do not sterilize any components. Cleaning the Infinity CentralStation............................................................................ D-2 Cleaning and Disinfecting Transceivers ................................................................... D-3 Recommended Cleaning Agents .......................................................................... D-3 Patient Cables ........................................................................................................ D-4 Reusable ECG Electrodes ..................................................................................... D-4 Reusable SpO2 Sensor.......................................................................................... D-4 Cleaning the MicrO2/MicrO2+® Oximeter................................................................... D-5 Oximeter.................................................................................................................. D-5 Reusable Sensor .................................................................................................... D-5 DRAFT C: Cleaning Cleaning the Infinity CentralStation CAUTION! Do not immerse the CPU or its peripherals. Do not pour or spray cleaning solution directly on equipment surfaces. Do not allow fluids to contact electrical connectors or drip into ventilation openings. During normal use the display, CPU, accessories, and peripherals may become soiled. Clean these components according to the original manufacturer's Instructions For Use or hospital protocol for computer equipment and peripherals. C-2 TUV Draft Infinity CentralStation VF8 DRAFT Cleaning and Disinfecting Infinity TeleSmart Cleaning and Disinfecting Infinity TeleSmart CAUTION! Do not use disinfectants other than those recommended by Dräger. The use of non-approved disinfectants can damage the device. Do not use disinfectants containing phenol. Do not use strong aromatic ketone, ether, or ester solvents, or sharp tools and abrasives. These will damage the device. Do not gas sterilize, steam autoclave, immerse, or rinse the device in fluids. If you accidentally spill liquid on the device, remove the battery and contact your Biomed regarding the continued safety of the unit before placing it back in operation. 1. Clean the device with gauze moistened in soapy water. 2. Thoroughly dry with a lint-free cloth. 3. Disinfect the device with gauze moistened in a cleaning agent. 4. Thoroughly dry with a lint-free cloth. Recommended Cleaning Agents Dräger recommends the following cleaning agents. Diluted isopropyl alcohol 70% Sodium hypochlorite 2.5% Cidex Plus™ 28 Day Solution Cidex® OPA Solution Cidex® OPA Solution High Level Disinfectant Cidex® Activated Dialdehyde Solution Sporicidin Sterilyzing and Disinfecting Solution Terralin 0.5% Incidin® Plus 1% CAUTION! Do not use Incidin® Plus 2% on Infinity TeleSmart. This agent will damage the device. VF8 Lysoformin 3000 1% Buraton 10F 1% Infinity CentralStation TUV Draft C-3 DRAFT C: Cleaning Enzol (Cidezyme) Cetylcide-G® Concentrate and Diluent Concentrate Metricide® 28 Long-Life Activated Dialdehyde Solution Compliance® Patient Cables Clean the patient cables with a gauze pad moistened with a soap solution. Dry thoroughly with a lint-free cloth. To disinfect patient cables, wipe the cables with a gauze moistened with diluted alcohol or a gluteraldehyde-based disinfectant. Dry thoroughly with a lint-free cloth. Reusable ECG Electrodes Clean grabber-wire clips regularly with a toothbrush. Remove any gel residue from the electrode by brushing it off under running water. Clean the electrodes with a gauze moistened with a soap solution. Dry thoroughly with a lint-free cloth. Disinfect the electrodes with a gauze moistened with diluted alcohol or a gluteraldehyde-based disinfectant. Dry thoroughly with a lint-free cloth. Reusable SpO2 Sensor See the cleaning instructions and recommendations provided with the sensor. C-4 TUV Draft Infinity CentralStation VF8 DRAFT Cleaning the MicrO2/MicrO2+® Oximeter Cleaning the MicrO2/MicrO2+® Oximeter Oximeter 1. Turn the oximeter off. 2. Clean the oximeter with gauze moistened in soapy water. 3. Thoroughly dry with a lint-free cloth. 4. Disinfect the oximeter with gauze moistened in diluted isopropyl alcohol (70%), or sodium hypochlorite (2.5%). 5. Thoroughly dry with a lint-free cloth. Reusable Sensor 1. Unplug the sensor from the oximeter. Disposable sensors are intended for single-use only and should not be reprocessed. NOTE: 2. Clean reusable sensors according to the instructions supplied with the sensor CAUTION! VF8 Do not use disinfectants containing phenol. Do not use strong aromatic ketone, ether, or ester solvents, or sharp tools and abrasives. These will damage the oximeter. Do not use disinfectants other than those recommended. The use of nonapproved disinfectants can damage the oximeter. Do not gas sterilize, steam autoclave, immerse, or rinse the oximeter and its reusable sensor in fluids. If you accidentally spill liquid on the device, remove the battery and contact your Biomed regarding the continued safety of the unit before placing it back in operation. Infinity CentralStation TUV Draft C-5 DRAFT C: Cleaning C-6 TUV Draft Infinity CentralStation VF8 DRAFT VF8 FDA DRAFTPAGE 1-1 DRAFT In the United States: Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923-1079 USA Telephone: (978) 907-7500 In all other countries: Dräger Medical AG & Co. KG Moislinger Allee 53-55 23558 Lübeck Germany Tel: +49 18 05 3 72 34 37 July 2006 / D. Swanson VF8 Printed in the United States of America Dräger Medical reserves the right to make modifications to equipment without prior notice. Article No. MS18512E575D TUV Draft VF8 FDA DRAFTPAGE 1-2 DRAFT
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