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Supplement – Infinity

Delta Series Software VF10.1

Supplement for Infinity Delta Series Software

Measurement range

PCCI

0.01 to 15 L/min/m

PCCO 0.25 to 25 l/m

p-SVI

1 to 125 ml/m

SVV

0 to 50 %

p-SVR 0 to 30000 dyn.sec. cm

-5

p-SVRI 0 to 30000 dyn.sec. cm

-5

dPmax 200 to 5000 mmHg/s

GEF

1 to 99%

p-CO

0.25 to 25 L/min

GEDV

40 to 4800 ml

GEDVI 80 to 2400 ml/m

EVLW

10 to 5000 ml

EVLWI 0 to 50 ml/kg

PVPI

0.1 to 10

p-BT

25 ºC to 43 ºC (77 ºF to 109 ºF)

Accuracy

PCCI

Not applicable

PCCO

Coefficient of variation

≤

p-SVI

Not applicable

SVV

Not applicable

p-SVR

Not applicable

p-SVRI

Not applicable

dPmax

Not applicable

GEF

Not applicable

p-CO

Coefficient of variation

≤

GEDV

Coefficient of variation

≤

GEDVI

Not applicable

EVLW

Not applicable

EVLWI

Not applicable

PVPI

Not applicable

Zero balance range

±200 mmHg

Additional technical data

Summary of Contents for Infinity Delta Series

Page 1: ...Supplement Infinity Delta Series Infinity Patient Monitoring Series Software VF10 1 WARNING To properly use this medical device read and comply with the instructions for use and this supplement ...

Page 2: ......

Page 3: ...edical Systems CAPNOSTAT is a trademark of Philips A 2000 BIS BISx Bispectral Index Microstream INVOS and Nellcor are trademarks and registered trademarks of a Medtronic company CNAP is a trademark of CNSystems Medizintechnik AG Masimo Masimo SET and Signal Extraction Technology SET are trademarks of Masimo Corporation Dismozon is a trademark of BODE Chemie Oxycide is a trademark of Ecolab USA SIL...

Page 4: ...cessed maintained or repaired exclusively by defined target groups Users Users are persons who use the product in accordance with its intended use Service Personnel Service personnel are persons who are responsible for the maintenance of the product Service personnel must be trained in the maintenance of medical devices and install reprocess and maintain the product WARNING A WARNING statement pro...

Page 5: ...nitor can detach from the docking station and fall if the mount is faulty the monitor is not securely locked in the docking station If any part of the docking station appears faulty do not install it or attach a monitor to it Contact your hospital s service personnel Follow the installation instructions provided with the mount Position the docking station in a safe location away from the patient T...

Page 6: ...ponents Applicable Software Options on a memory option card include Options for Delta only Delta second PodPort option Pod Comm Delta Delta XL and Kappa 4 to 5 channel option Delta 4 5 Channels 6 to 8 channel option Delta 6 8 Channels 3 Lead ST segment analysis option ST Monitoring ARIES option Aries S W Hemodynamic Calculations option Hemodynamic Calculations ACE full arrhythmia option Arrhythmia...

Page 7: ...Main Menu Monitor Setup Monitor Options submenu Date and time changes are only permitted by qualified hospital technical personnel or Dräger Service personnel in the password protected Service menu Unit Manager The Unit Manager menu lets supervisory personnel configure monitoring functions for the clinical staff Access to this menu is restricted by a password 1 External lead acid battery compartme...

Page 8: ...en the alarm volume is set to OFF a reminder tone sounds every 30 seconds at 50 volume For monitors in OR mode At the end of an alarm silence or an alarm off period if the alarm condition is still active the parameter box flashes and a reminder tone high medium or low sounds every 30 seconds at 50 volume Disabled There is no reminder tone when alarm volume is set to OFF The CODE Setup submenu This...

Page 9: ...e table in the section on device markings in the main IFU Caution This product contains natural rubber latex which may cause an allergic reaction Manufacturer s reorder code Date of manufacture Device serial number Acceptable storage temerature ECG waveform out Acceptable atmospheric pressure range ECG Sync out Acceptable humidity range Arterial waveform out Contains DEHP Medical Device ...

Page 10: ...omed Quick Reference Biomed Menu Menu Item Description Settings Procedures Mainstream CO2 Component Log This read only field contains information to assist with system upgrades and diagnosing field issues The display is read only Press the Menu fixed key Select Monitor Setup Biomed Logs Component Log ...

Page 11: ...cable NeoMed Hemo2 Hemo4 pod or the MPod Quad Hemo When acquired via the MultiMed or NeoMed pod temperature signals are displayed as Ta value or Tb value If you are using a MultiMed without a Y cable only Ta displays a value When monitoring temperature using the Hemo2 Hemo4 pod or the MPod Quad Hemo temperature values are further identified according to where they are connected to the monitor The ...

Page 12: ...Arterial Blood Pressure CNAP Pod 30 CNAP Calibration 31 Status Messages 31 Maintenance CNAP 31 Overview 31 Definition of Maintenance Concepts 32 Inspection 33 Visual Inspection 33 Inspection Safety Check 33 Metrological checks 34 Calculations 35 Pulse Oximetry SpO2 35 Quick Reference Table SpO2 Setup 37 New Status Message 37 Dräger Mainstream etCO2 Monitoring 38 Application 38 Precautions 38 Conne...

Page 13: ...fecting 83 IBP Infinity PiCCO Pod 83 etCO2 84 To dry the sidestream pump subsystem 85 Technical Data 85 Electromagnetic Compatibility EMC 85 Electromagnetic Emissions 88 Electromagnetic Immunity 89 Recommended separation distances 90 EMC declaration 91 General information 91 Electromagnetic environment 91 Recommended separation distances from wireless communication devices 92 System Components 93 ...

Page 14: ...a interface e g RS232 LAN USB printer interface that is described in standards and conventions During operation this device can exchange information with other devices by means of IT networks and supports the following functions Display of waveforms and parameter data Signaling of alarms Recording storing and printing Remote control e g alarm management Bed view by remote access Access to saved pa...

Page 15: ... of layer n switches Other data traffic is decoupled by means of separate VLAN networks Configure the network settings of the device in accordance with these instructions for use and the network specifications Specifications for LAN connections are described in the following standards Wired networks IEEE 802 3 Wireless networks IEEE 802 11 b g If the device is used with a layer 2 switch or a layer...

Page 16: ...o EIA RS232 CCITT V 24 V 28 for the following applications MEDIBUS MEDIBUS X Paging systems Connections to medical devices from other manufacturers Interfaces conforming to IEEE 1073 Medical Information Bus for connection to medical devices from other manufacturers The requirements of IEEE 1073 3 2 or the combined requirements of IEEE 1073 3 1 and IEEE 1073 4 1 must be complied with Consequences o...

Page 17: ...y by its handle Slide the lever to the left to disengage the power supply The mon itor automatically switches to battery power 2 Continue to move the lever to the left until it clicks Use both hands to tilt the monitor forward and lift it off the IDS or Docking Station 3 When docking and undocking the monitor to and from an IDS a minimum 15 second delay between undocking and redocking the monitor ...

Page 18: ...scharge NOTE To change the patient s category adult pediatric or neonatal you must access the Patient Setup menu at the bedside monitor If you change a patient s category the weight selection is cleared and must be entered again In neonatal mode additional settings gestational age and birth weight are available at the bedside monitor only Day of Life and corrected GA values also appear in a read o...

Page 19: ... to your patient s prevailing condition within the predefined ranges of the monitor as listed in the following table Parameter Predefined Alarm Range and Resolution Default State Default Alarm Setting inCO2 inCO2 2 to 10 mmHg 0 3 to 1 3 kPa upper limit only increments of 1 mmHg or 0 1 kPa ON High 4 mmHg 0 5 kPa PLS 30 to 240 in increments of 5 bpm ON Adult Low 45 bpm High 120 bpm Pediatric Low 50 ...

Page 20: ... outside the range for that parameter the parameter s alarm limits remain unchanged Parameters Upper Limit Lower Limit Ta T1a T1b T2a T2b T3a T3b 107 of current value 93 of current value ΔT1 ΔT2 ΔT3 PVC min inCO2 inCO2 No change No change SpO2 SpO2 Adults 100 Neonates 98 Current value value x 5 ΔSpO2 Current value 20 None ST Current value 2 0 mm Current value 2 0 mm MultiGas Agent 105 of current v...

Page 21: ...of patient category and records whenever you perform an All Alarms OFF All Alarms Paused or Audio Paused Alarm Silence Switching the device on and off is not recorded Alarm Latching Some alarms are latched they continue to annunciate visually and audibly until you acknowledge them manually even if the condition that caused the alarm no longer exists Other alarms may be latched only partially as in...

Page 22: ...mber of available ECG leads depends on the type of pod and cable set you are using as shown in the following tables Regular ECG Leads ECG Pod Number of Lead Wires Channels Leads Available NeoMed 3 lead ECG1 I II III3 MultiMed 5 3 lead 5 lead ECG1 ECG1 ECG2 ECG3 1 I II III2 I II III aVR aVL aVF V 2 MultiMed 6 3 lead 5 lead 6 lead ECG1 ECG1 ECG2 ECG3 1 ECG1 ECG2 ECG3 1 I II III I II III aVR aVL aVF ...

Page 23: ...le pacemaker detection Select OFF default to disable pacemaker detection Pacer Detection continued Observe the following Select Fusion mode only in situations where it becomes necessary to suppress repeated false asystole and or false low heart rate alarms Before selecting Fusion mode be certain that the patient has a bipolar pacemaker external or implanted and that it is accurately programmed as ...

Page 24: ...VT rate Not adjustable 3 to VT rate 1 Str Rec AIVR MED Not adjustable VT rate 1 Not adjustable 3 OFF SVT MED 120 to 200 150 Increments of 10 3 to 10 3 Increments of 1 Str Rec TACH MED 100 to 200 130 Increments of 10 5 to 15 8 Increments of 1 OFF BRDY MED 30 to 105 50 Increment of 5 Not adjustable 8 OFF CPT LOW Not adjustable Not adjustable Str Rec BGM LOW Not adjustable Not adjustable Str Rec PAUS...

Page 25: ...t of label choices for updating the third channel of the OCRG menu RESP etCO2 etCO2 Timed Displays Time Base choices NOTE Selecting Time Base displays the clinical password menu The new OCRG Time Base takes effect after you enter the password 3min 6min The OxyCRG Review Summary Menu Menu item Description Settings Hours Changes the time interval for data on the OCRG Summary screen Press the rotary ...

Page 26: ...patients NBP measurements for accuracy testing occurred on the same limb NBP effectiveness for pregnant and pre eclamptic patients has not been established according to ISO 81060 2 The accuracy is compromised with patients having dysrhythmias arterial sclerosis experiencing seizures or any type of cardiac or vascular malformation which results in an abnormal arterial waveform Blood pressure measur...

Page 27: ... Cuff Diagram A Cuff size indicators D Range labels B Artery label E Label This side to patient C Index line A B C E D NOTE This illustration provides a general description that can be applied to all cuffs For additional information see the instructions for use included with your NBP cuff as applicable ...

Page 28: ... supports venous stasis in adult mode only with adult based inflation pressures NOTE The accuracy of the oscillometric blood pressure signal can decrease up to loss of measurement under the following conditions Weak pulses Irregular pulses Patient movement artifacts Tremor artifacts Respiratory artifacts Pulses generated from a ventricular assist device These conditions may prevent the monitor fro...

Page 29: ...heck the patient and treat if necessary Move the cuff to a limb with less movement Restart measurement If the message persists contact the hospital s technical personnel or DrägerService Take a manual measurement if the condition persists NBP Measurement Timeout A measurement was aborted usually due to motion artifact because it lasted longer than two minutes adult or pediatric or 90 seconds neona...

Page 30: ...oller cable B to the cuff controller A 3 Connect the cuff controller cable B to the CNAP E 4 Connect the CNAP pod E to the monitor s Aux Hemo or PodCom connector F via the PodCom cable G A B C D E F G A Cuff controller with sliding mount E CNAP pod B Cuff controller cable F Aux Hemo or PodCom connector C Forearm strap G PodCom cable D Sensor cuff NOTE During CNAP measurements the NBP Interval Time...

Page 31: ...ioning of the medical device Maintenance measures must be performed by the responsible personnel NOTE A rectangular or square waveform displays for previous firmware versions Message Cause Remedy CNAP Calibrating CNAP calibration is in progress Wait until calibration is complete NOTE Calibration could take up to 2 5 minutes Depending on the pod firmware version a triangular waveform or intermitten...

Page 32: ...s we recommend that you contact DrägerService CAUTION When servicing devices from Dräger always use replacement parts that are qualified to Dräger standards Dräger does not warrant or ensure the safe performance of third party replacement parts for use with the devices CAUTION If you spill liquid on the equipment battery or accessories or immerse these components in liquid allow them to dry comple...

Page 33: ...rly engaged at each end Inspection Safety Check Inspection and safety checks of devices must be performed according to suggested intervals Scope of inspection safety checks for the CNAP Pod Cuff Controller Safety checks are no substitute for preventive maintenance measures including preventive replacement of wear parts as identified by the manufacturer Perform safety checks at the indicated interv...

Page 34: ...he following measurement functions must be checked every two years by qualified DrägerService personnel Body temperature Non invasive blood pressure Preventive Maintenance The following table shows the preventive maintenance intervals WARNING Risk of faulty components Device failure is possible due to wear or material fatigue of the components To maintain proper operation of all components this de...

Page 35: ...y instruments to completely understand the condition of the patient WARNING The pulsations from intra aortic balloon support can elevate the pulse rate Verify the pulse rate of the patient against the heart rate WARNING Risk of patient injury If the SpO2 sensor is used in the presence of significant concentrations of dyshemoglobins such as carboxyhemoglobin or methemoglobin measurement accuracy ma...

Page 36: ...e signal failure Do not position the SpO2 sensor where it might be affected in this way WARNING To reduce the hazard of burns during surgery keep the sensor or transducer and their associated cables away from the surgical site the electro surgical unit return cathode and the earth ground CAUTION For Masimo SET pod after connection of the sensor observe monitor for any messages if the sensor does n...

Page 37: ...ne Volume Sets the volume of the pulse tone NOTE You can also set the pulse tone volume from the ECG menu OFF 5 10 20 30 40 50 60 70 80 90 or 100 SpO2 Alarm Accesses SpO2 alarms on the Alarm Limits table SpO2 OxiSure 20 100 in increments of 1 Pulse OxiSure 30 240 in increments of 5 SpO2 Masimo 20 100 in increments of 1 Pulse Masimo 30 240 in increments of 5 SpO2 Nellcor 20 100 in increments of 1 P...

Page 38: ...ecautions WARNING For premature infants do not carry out CO2 measurements because the CO2 cuvette significantly increases the dead space NOTE The Dräger Mainstream CO2 module is compatible with Delta and Delta XL monitors The Dräger Mainstream CO2 module is not compatible with Kappa WARNING Risk of misinterpretation Misdiagnosis or misinterpretation of the measured values or other parameters can e...

Page 39: ...ince the last breath was detected Clinical diagnosis of a true apneic event however requires multiple physiological signals WARNING In an ambient temperature of 104 degrees F 40 degrees C the CO2 mainstream sensor reaches a surface temperature of 110 degrees F 43 degrees C WARNING Do not use the CO2 mainstream sensor in an explosive or oxygen enriched environment atmosphere 100 oxygen is allowed i...

Page 40: ...m sensor and measureing cuvette for damage before use A damaged CO2 sensor may impair electrical isolation or may introduce debris into the breathing circuit CAUTION Only use the mainstream CO2 sensor with the approved CO2 measuring cuvettes for adult or pediatric applications See the Approved options and accessories section The measuring function may otherwise be inaccurate NOTE In this chapter a...

Page 41: ... the Dräger mainstream CO2 module into the slot on the rear of the monitor until it rests securely A B C D E A Dräger mainstream CO2 module D Connection port for external SpO2 pod B Infinity MCable CO2 mainstream sensor cable connection E External SpO2 pod C Connection port for the CO2 module to monitor ...

Page 42: ...CO2 module input port as depicted by B on the Hardware Module Connection diagram 2 Select a suitable mainstream cuvette H whose windows are clean and dry replace the cuvette if necessary 3 Insert the cuvette H between the endotracheal tube adapter I and the ventilator G 4 Snap the Dräger mainstream CO2 sensor F firmly into the cuvette H and make sure that the cable is directed away from the patien...

Page 43: ...under Cuvette Type only zero a Dräger sensor when the measurement value is suspect Otherwise perform zeroing once a day or when prompted to rezero Initialization Upon start up the sensor goes through a warm up period status message CO2 Warming Up appears During this time approximately 30 seconds concentrations for CO2 may not be available Device Conflicts CO2 can be sourced from many devices When ...

Page 44: ...e monitor for example a Dräger ventilator and a Scio Four module that is connected to the IDS In addition to the message the etCO2 parameter menu appears You can select the desired CO2 device as described in the Quick Reference Table Or you can physically disconnect the undesired CO2 device A label in the upper left corner of the etCO2 waveform identifies the CO2 device that is providing informati...

Page 45: ...n phase Respiration Rate RRc The patient s respiration rate derived from the etCO2 signal by calculating a n average rate over the two most recent breaths etCO2 Param eter Box Typical etCO2 parameter box displays are shown below A etCO2 end tidal CO2 label and value B etCO2 alarm limits C inCO2 inspired CO2 label and value D inCO2 alarm limit upper limit only E Respiration rate label and value F R...

Page 46: ...vice read only If two CO2 devices are connected the settings are made available to the user to select the desired CO2 device See also the Multiple CO2 Devices section SCIO Mainstream Scale Sets the etCO2 waveform scale 40 60 80 100 mmHg 40 mmHg default 5 8 12 16 kPa 5 kPa default 5 8 12 16 5 default Resp Sweep Speed Sets the respiratory waveform sweep speed on the screen s display 6 25 12 5 25 50 ...

Page 47: ...the on the cuvette during zeroing Apnea Alarm Displays the Apnea Alarm menu RRc Apnea Time Apnea Archive etCO2 Alarm Accesses the Alarm Limits table where you can set upper and lower alarm thresholds See the Alarms chapter for more information about setting and displaying alarm limits WARNING etCO2 alarms do not activate until the second breath is detected after turning on the monitor admitting a ...

Page 48: ...ores and or records an alarm event automatically for apnea You can later review stored alarms on the Event Recall screen OFF 10 15 20 25 30 s Adult OFF default Pediatric neonatal 15 s default MultiGas Zero Manually zeros the SCIO module parameter values disappear during zeroing Not applicable Auto Zero Delay Delays automatic zeroing for 5 minutes for uninterrupted monitoring WARNING Delaying the a...

Page 49: ...y alarm annunciates At 60 seconds a high priority alarm annunciates Capnograms The monitor also displays an instantaneous CO2 waveform or capnogram Function Description Settings RRc Apnea Time Specifies time monitor waits before reporting a cessation of breathing as an apnea event OFF 10 15 20 25 and 30 s Apnea Archive Allows you to automatically store and or record an alarm event for apnea You ca...

Page 50: ...ear from the screen during this cycle 3 Fit the Dräger mainstream CO2 sensor onto the cuvette If zero was successful the monitor displays the message CO2 Zero Accepted after approximately 30 seconds If zero was unsuccessful the monitor displays the message CO2 Zero Failed Repeat the zeroing operation If the zero remains unsuccessful check whether the sensor is contaminated clean it if necessary an...

Page 51: ... filter on the sensor cable 2 Access the etCO2 parameter menu 3 Select Calibration Check The monitor starts the check and displays the progress and result of the check in the message area If the check was successful The monitor displays the message Filter Check Successful The test value is within the permissible tolerance Fit the Dräger mainstream CO2 sensor back on the cuvette If the check was no...

Page 52: ...g at a high respiratory rate Check patient condition Check ventilation settings or spontaneous respiratory rate RRc has exceeded the upper alarm limit Check ventilation settings Medium RRc RRc has fallen below the lower alarm limit Check patient condition Check ventilation settings Medium escalates in OR mode see Smart Apnea section RRc Apnea No breathing or ventilation Start manual ventilation Ch...

Page 53: ...matches that selected on the monitor the zero may have drifted Check zero Inspiratory CO2 concentration high Check ventilation settings Check CO2 absorber Check patient condition Medium CO2 Window Occluded Window is contaminated or occluded Ensure window is clean Low CO2 Sensor Too Warm Dräger mainstream CO2 sensor too warm as a result of the ambient clinical environment Correct ambient clinical e...

Page 54: ...t are followed by a Alarm history displays CO2 Reduced Accuracy When this condition is removed the alarm history displays CO2 Reduced Accuracy Ended Parameter box Pbox question marks are not transmitted displayed over the network They only appear in Pboxes Wait until the warm up phase has ended before relying on the displayed etCO2 values for clinical evaluation Correct ambient clinical environmen...

Page 55: ... been updated in the Respiratory Mechanics chapter Updated label Former label MValv mand MValv m MValv spon MValv s MVemand MVe m MVespon MVe s Pmean MAP Re Raw e Ri Raw i RR RRv RRmand RR m RRspon RR s Vds TVd aw Vds VTe TVd TV aw VT lk TV lk VTalv mand TValv m VTalv spon TValv s VTalv TValv VTCO2 TVCO2 VTe TVe VTemand TVe m VTespon TVe s VTi TVi VTimand TVi m VTispon TVi s ...

Page 56: ...s a simple navigation aid for anesthetic agent delivery The xMAC is the MAC multiple calculated from the current expiratory measured values and the age dependent MAC values MAC minimum alveolar concentration is the anesthetic gas concentration in the blood at 760 mmHg 1013 hPa at which 50 of patients no longer respond to a skin incision with movement The integrated xMAC algorithm is based on the M...

Page 57: ...rd calculation assumes a patient age of 40 Standard xMAC example exp conc Anesth1 etIso 0 65 Vol exp conc N2O etN2O 69 Vol NOTE These values are guiding values only The binding values are specified on the package information leaflet of the anesthetic agent NOTE The xMAC Calc selection in the Agent menu determines whether standard age corrected or no xMAC values are used NOTE When connecting to a D...

Page 58: ... Corrected xMAC example exp conc Anesth1 etIso 0 65 Vol exp conc N2O etN2O 69 Vol age 72 years MACage corrected Iso 72 years 1 15 Vol x 10 0 00269 x 72 40 0 94 Vol MACage corrected N2O 72 years 105 Vol x 10 0 00269 x 72 40 86 1 Vol xMACage corrected 0 65 Vol 0 94 Vol 69 Vol 86 1 Vol 0 69 0 80 1 49 CAUTION Risk due to incorrect setting for patient age The patient s age is derived from the birth dat...

Page 59: ...ic agents has been detected Wait for the transition phase to end after changing anesthetic agents Check vaporizer filling level Flush system if necessary Check fresh gas settings Medium Inspired MAC High Inspiratory anesthetic gas concentration exceeds 3 MAC for a period of 30 or more seconds Check vaporizer and fresh gas settings Low MultiGas Module Disconnected Gas analyzer is disconnected Check...

Page 60: ...over the network They only appear in Pboxes Wait until the warm up phase has ended before relying on the displayed MultiGas values for clinical evaluation If Auto Zero Delay has been selected allow the auto zero to occur If the problem persists call DrägerService MultiGas Zero Accepted The zeroing cycle was successful No action is required Message Condition Suggested action WARNING To avoid seriou...

Page 61: ...ameters The following parameters are not cleared for use by the FDA in the US market dPmax GEF and PVPI Precautions Overview of the Infinity PiCCO Pod The Infinity PiCCO pod has connections for Up to four 4 invasive pressure transducers One 1 cardiac output C O cable WARNING Do not use the PiCCO pod on patients for which placement of an indwelling arterial or central venous catheter is contraindic...

Page 62: ...nication cable 3 Transducer slots NOTE On the Infinity PiCCO pod the transducers are attached to a separate transducer plate and are available from the applicable manufacturer pur chase them locally or contact your Dräger representative for information 7 CO connector 4 Pulsion blood pressure transducer 8 10 pin transducer adapter cable NOTE Cables are permanently fastened to the back of the Infini...

Page 63: ...dCom connection to Delta series monitor 3 p CO thermistor cable 9 10 pin transducer adapter cable 4 p CO intermediate cable 10 Pulsion arterial thermodilution catheters1 5 Infinity PiCCO pod 11 p CO catheter cable 6 CO connector 12 Pressure transducer interface cable 1 Catheters and blood pressure transducers required for use with the PiCCO pod are only available from Pulsion Medical Systems Conta...

Page 64: ...the pressure label is CVP on the monitor 11 Connect the PiCCO catheter with the blood pressure transducer 12 Use the 10 pin cable to connect the blood pressure transducer to the Delta Delta XL Kappa Delta series monitor 13 If you have not already done so enter the patient specific input parameters height and weight in the Patient Admit menu 14 A zero adjustment of the pressure transducer is now ne...

Page 65: ...Accepted If the procedure fails the monitor displays the message IBP Did Not Zero Check the waveform If spikes exceed three millimeters repeat the procedure If the procedure fails after two attempts replace the transducer or consult your hospital s technical personnel Single Transducer Zero Simultaneous Smart Zero NOTE Make sure all patient connections are secure and that valid blood temperature a...

Page 66: ... least three thermodilution measurements to calibrate the PCCO measurement Wait until READY is displayed before injection Check that valid C O average values are obtained before saving these values Pulse Contour Parameters Setup Menu Menu Item Description Available Settings CVP Value Allows user to select a CVP Value NOTE The auto CVP Value if available is used until the manual CVP Value menu is e...

Page 67: ...es via the general Medical Information Bus MIB interface protocol or the MEDIBUS X interface protocol These protocols significantly expand the monitor s capabilities The MIB protocol and the MEDIBUS X protocol require the monitor to be connected to an Infinity Docking Station IDS The MEDIBUS X interface protocol allows the peripheral device to be connected directly to the IDS The MIB interface pro...

Page 68: ...of parameters available from specific peripheral devices later in this chapter an asterisk identifies parameters that duplicate the monitor s parameters Consult device documentation for details on setup and operation Compatible devices The following table lists the devices supported by the Delta series monitors NOTE Delta series monitors support Medibus X version 1 07 MIB II Duo Protocol Converter...

Page 69: ...thesia machine Yes No GE Aestiva Aspire 7900 anesthesia machine Yes No Puritan Bennett 840 ventilator Yes No Siemens Maquet Servo i ventilator Yes No Covidien Medtronic INVOS 5100C Cerebral Somatic Oximeter Yes No Edwards Vigileo SvO2 CCO monitor Yes No Device MIB Interface Protocol MEDIBUS X Interface Protocol WARNING The above table lists all of the external devices that Dräger has validated Drä...

Page 70: ...ystem and Infinity network NOTE The Patient Category and Patient Category specific settings align with the configured patient category on the Delta monitor and are independent of that selected on the source device The selected patient category determines specific monitoring settings for the selected patient Make sure you select the appropriate patient category for the monitored patient on the Delt...

Page 71: ...RS232 connection Only connect peripheral medical devices to a patient monitor if those devices comply with the electrical safety requirements found in IEC 60601 1 Refer to the Electrical Safety section for information on how to connect devices safely NOTE The MIB II option will not work if a network cable is connected to it Likewise the MIB II duo protocol converter will not work if it is connecte...

Page 72: ...eters When the inO2 parameter is received from a connected ventilator the inO2 parameter is trended as FiO2 on the Delta Series monitor The following table lists the parameters for all ventilators NOTE For information on calculating parameter values see the documentation for the peripheral device you are using CAUTION The parameter abbreviations on the bedside monitor may differ from those display...

Page 73: ...l Parameters screen Ventilation split screen RRv Expiratory minute volume MVe 1 L min Vent Flow and Volume parameter box Ventilation split screen Expiratory tidal volume VTe 2 ml TVe End tidal CO2 concentration etCO2 mmHg kPa etCO2 parameter box Show All Parameters screen Inspiratory oxygen fraction inO2 NOTE may show as FiO2 on the network or source device MultiGas parameter box when MultiGas is ...

Page 74: ...namic compliance 4 Cdyn ml cmH2O Resistance 4 R cmH2O l s Raw Inspiration Time 5 InspT Ventilation split screen 1 Appears as MV on the following non MEDIBUS X devices Evita V500 Primus Apollo and Zeus 2 Appears as VT on non MEDIBUS X Evita V500 devices 3 Supported by MEDIBUS X devices only 4 Available for Evita Evita XL MEDIBUS X Evita V500 and MEDIBUS X Savina 300 only 5 Not supported by MEDIBUS ...

Page 75: ...agent parameter box displays agent concentrations for anesthetic gases Parameter values acquired from the anesthesia machine are trended in graphical and tabular form The anesthesia machine provides the range and resolution for all parameters Parameter settings alarms and error messages are not displayed on the monitor They are displayed on the network device such as an Infinity CentralStation Inn...

Page 76: ...ide concentration inCO2 mmHg kPa etCO2 parameter box Show All Parameters screen CO2 End tidal CO2 concentration etCO2 mmHg kPa MAC multiple derived from expiratory concentrations xMAC NOTE may appear as MAC exp on the network Agent parameter box Show All Parameters screen MAC Inspiratory oxygen fraction inO2 NOTE may appear as FiO2 on the network or source device MultiGas parameter box Show All Pa...

Page 77: ...dal sevoflurane concentration etSev etSEV Inspiratory desflurane concentration inDes iDES Inspiratory enflurane concentration inEnf iENF Inspiratory halothane concentration inHal iHAL Inspiratory isoflurane concentration inIso i ISO Inspiratory sevoflurane concentration inSev iSEV End tidal nitrous oxide concentration etN2O MultiGas parameter box when MultiGas is enabled O2 N2O parameter box when ...

Page 78: ...neous respiratory rate RRspon min RRs Mandatory respiratory rate RRmand min RRm Dynamic compliance Cdyn ml cmH2O Resistance R cmH2O l s Raw Inspiratory concentration of primary agent 1 inPrimA End tidal concentration of primary agent 1 etPrimA Inspiratory concentration of secondary agent 1 inSecA End tidal concentration of secondary agent 1 etSecA 1 Supported by MEDIBUS X devices only Parameter Be...

Page 79: ...SO 17664 Safety information NOTE The Covidien Medtronic INVOS Cerebral Somatic Oximeter 5100C is now available in adult pediatric and neonatal patient categories WARNING Risk due to inappropriately reprocessed products Reusable products must be reprocessed otherwise there is an increased risk of infection Observe the hygiene regulations and reprocessing regulations of the healthcare facility Obser...

Page 80: ...rve the instructions for use for the components The following classification is a recommendation from Dräger Non critical Delta series monitors Semi critical A N A Semi critical B N A Critical N A Classification Explanation Non critical Components that come only into contact with skin that is intact Semi critical A B Components that carry breathing gas or come into contact with mucous membranes or...

Page 81: ...nts listed in the following table showed good material compatibility They can be used in addition to the surface disinfectants listed in the section Validated reprocessing procedures The manufacturers of the surface disinfectants have verified at least the following spectra of activity Bactericidal Yeasticidal Virucidal or virucidal against enveloped viruses Observe the specifications of the surfa...

Page 82: ...hlorine releasing agents Actichlor plus Ecolab BruTab 6S Brulin Clorox Professional Disinfecting Bleach Cleaner Clorox Dispatch Hospital Cleaner Disin fectant Towels with Bleach Klorsept 17 Medentech Oxygen releasing agents Descogen Liquid Antiseptica Descogen Liquid r f u Dismozon plus BODE Chemie Dismozon pur Oxycide Ecolab USA Perform Schülke Mayr Virkon DuPont Quaternary ammonium com pounds Mi...

Page 83: ...ps 1 to 5 if necessary 6 Check the product for visible damage and replace if necessary Cleaning and Disinfecting IBP Infinity PiCCO Pod Agents tested by Dräger and shown to have no harmful effect at the time of testing on the materials utilized in the Infinity PiCCO Pod include Isopropyl alcohol 40 Higher concentrations could damage Compliance this cleaning agent may discolor soft plastic material...

Page 84: ...stream Module 1 Disconnect the sensor cable SpO2 cable if using from the Dräger etCO2 mainstream module 2 Wipe the module surfaces with a cloth moistened with a soap solution 3 Dry thoroughly with a lint free cloth To disinfect the Mainstream Module 1 Disconnect the sensor cable including the SpO2 cable if using from the Dräger etCO2 Mainstream Module 2 Wipe the module surfaces with a gauze moiste...

Page 85: ...stream pump fails to start make sure the Capnostat sensor is disconnected The pump is designed to shut down while a connected sensor is warming up NOTE Sidestream accessories are for single use only Do not reuse This equipment is intended for use in the electromagnetic environment specified below The user of this equipment should assure that is used in such an environment Immunity against IEC 6060...

Page 86: ...uring power mains interruptions the monitor should be powered from an uninterruptible power supply or a battery Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the monitor including cables than the recommended separation distance calculated from the equation that applies to the frequency of the transmitter listed below In...

Page 87: ...lular 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 ab...

Page 88: ...lta Class B Delta XL Class B Kappa Class A Infinity Docking Station IDS integrated MIB Class A SCIO Four Module Class A BISx pod Class A 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 Harmonic emissions IEC 61000 3 2 Class A Volta...

Page 89: ... 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Voltage dips and short interruptions on AC mains input lines IEC 61000 4 11 Dip 95 0 5 periods Dip 60 5 periods Dip 30 25 periods Dip 95 5 seconds 95 0 5 per 60 5 per 30 25 per 95 5 sec Mains power quality should be that of a typical commercial or ho...

Page 90: ...etically 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 nece...

Page 91: ...st be followed Electromagnetic environment NOTE For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m 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 W according to the transmitter manufacturer At 80 MHz and 800 MHz the separation d...

Page 92: ...ainst Test level and required electromagnetic environ ment Electrostatic discharge ESD IEC 61000 4 2 Contact discharge 8 kV Air discharge 15 kV Fast transient electrical disturbances bursts IEC 61000 4 4 Power cable 2 kV Longer signal input lines output lines 1 kV Impulse voltages surges IEC 61000 4 5 Voltage external conductor external conductor 1 kV Voltage external conductor protective ground c...

Page 93: ...dB A to 69 dB A 56 dB A to 76 dB A Medium priority alarms 56 dB A to 69 dB A 54 dB A to 72 dB A Low priority alarms 52 dB A to 65 dB A 41 dB A to 58 dB A NOTE The Infinity alarm volume must be set at 20 or higher to comply with the minimum audio sound pressure of 45 db specified in standard 60601 2 49 Environmental Requirements Temperature range Operating 10 to 45 C 50 to 113 F Storage 15 to 45 C ...

Page 94: ...Operating 5 to 45 C 41 to 113 F Storage 40 to 70 C 40 to 158 F Relative humidity Operating 10 to 95 non condensing Storage 10 to 95 with packaging Atmospheric pressure Operating 485 to 795 mmHg 65 to 106 kPa Storage 375 to 795 mmHg 50 to 106 kPa Physical specifications Size H x W x D Module 150 x 95 x 43 mm 5 9 x 3 7 x 1 7 in Sensor 32 x 55 x 22 mm 1 26 x 2 17 x 0 87 in Weight Module 0 3 kg or les...

Page 95: ...ronmental requirements Temperature range Operating 10 to 40 C 50 to 104 F Storage 40 to 75 C 40 to 167 F Relative humidity Operating 20 to 90 non condensing Storage 10 to 95 with packaging Atmospheric pressure Operating 525 to 795 mmHg 70 to 106 kPa Storage 86 to 825 mmHg 11 5 to 110 kPa Physical specifications Frequency ranges DC to 8 16 or 32 Hz 10 user selectable Accuracy 1 mmHg or 1 exclusive ...

Page 96: ...breaths per min Additional technical data Measurement method PCCI Continuous Pulse Contour Analysis PCCO Continuous Pulse Contour Analysis p SVI Continuous Pulse Contour Analysis SVV Continuous Pulse Contour Analysis p SVR Continuous Pulse Contour Analysis p SVRI Continuous Pulse Contour Analysis dPmax Continuous Pulse Contour Analysis GEF Transpulmonary Thermodilution p CO Transpulmonary Thermodi...

Page 97: ...n GEDV 40 to 4800 ml GEDVI 80 to 2400 ml m2 EVLW 10 to 5000 ml EVLWI 0 to 50 ml kg PVPI 0 1 to 10 p BT 25 ºC to 43 ºC 77 ºF to 109 ºF Accuracy PCCI Not applicable PCCO Coefficient of variation 3 p SVI Not applicable SVV Not applicable p SVR Not applicable p SVRI Not applicable dPmax Not applicable GEF Not applicable p CO Coefficient of variation 1 GEDV Coefficient of variation 2 GEDVI Not applicab...

Page 98: ... kPa 1 3 kPa Neonatal 140 110 mmHg 10 mmHg 14 7 kPa 1 3 kPa Inflation pressure after a valid measurement 10 mmHg Adult 270 Previous NBPSYS 25 mmHg 3 3 kPa Pediatric 180 Previous NBPSYS 25 mmHg 3 3 kPa Neonatal 140 Previous NBPSYS 30 mmHg 4 0 kPa Inflation pressure after an alarm Adult 270 160 mmHg 10 mmHg 21 3 kPa 1 3 kPa Pediatric 180 120 mmHg 10 mmHg 16 0 kPa 1 3 kPa Neonatal 140 110 mmHg 10 mmH...

Page 99: ...S Diastolic CNAP D Mean CNAP M NOTE Only values for systolic diastolic and mean are displayed in the p box Labels are not displayed Units mmHg kPa Measuring range Systolic 40 to 250 mmHg 5 3 to 33 3 kPa Diastolic 30 to 210 mmHg 4 to 28 kPa Mean 35 to 230 mmHg 4 66 to 30 7 kPa HR range for CNAP measurements 20 to 200 bpm Accuracy 5 mmHg 0 6 kPa Display resolution 1 mmHg 0 1 kPa Inflation pressure D...

Page 100: ...100 SpO2 against a laboratory co oximeter and ECG monitor This variation equals 1 Arms of the value measured by a co oximeter 3 The Masimo SET pod with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non repetitive motion...

Page 101: ...splay Saturation SpO2 pulse rate perfusion Measurement range SpO2 1 to 100 Pulse rate 25 to 239 min Perfusion 0 02 to 20 Measurement accuracy The following are for all Masimo RD SET sensors Saturation SpO2 During conditions with no motion 0 to 69 not specified 70 to 100 Adults pediatrics 2 Neonates 3 Saturation SpO2 During motion conditions 0 to 69 not specified 70 to 100 Adults pediatrics 3 Neona...

Page 102: ...r Clip D YS with D YSPD Spot Clip 3 5 80 to 100 sensor specific as follows Nellcor MAX R 3 5 Pulse Rate 3 3 beats min or 3 whichever is greater NOTES 1 Since pulse oximeter measurements are statistically distributed only about two thirds of those measurements can be expected to fall within 1 Arms of the value measured by a co oximeter 2 The Infinity Nellcor Oximax SpO2 SmartPod pulse oximeter with...

Page 103: ...min at 80 breaths min Pressure drop of the cuvettes Adult cuvette 0 1 mbar at 2 5 L min 0 2 mbar at 15 L min 0 4 mbar at 30 L min 1 2 mbar at 60 L min Pediatric cuvette 0 1 mbar at 2 5 L min 1 4 mbar at 15 L min 5 4 mbar at 30 L min 20 0 mbar at 60 L min Compliance of the cuvettes 0 3 mL mbar or mL hPa or mL cmH2O Leakage of the cuvettes 3 mL min Disposable cuvette 0 3 mL min Reusable cuvette Reso...

Page 104: ...ure user selectable 540 to 800 mmHg 72 106 7 kPa Gas Compensation user selectable Air N2O O2 O2 60 HeliOx NOTE regarding Gas Compensation Selection for Gas Compensation must be made for the automatic correction of the influence of a balance gas Description Value The user has to manually set the total gas pressure ambient or barometric pressure in the monitor the mainstream CO2 sensor uses to autom...

Page 105: ...n Vol at 0 Vol CO2 Halothane 5 Vol 0 02 Enflurane 5 Vol 0 03 Isoflurane 5 Vol 0 02 Sevoflurane 5 Vol 0 02 Desflurane 20 Vol 0 00 Ethanol 4 0 00 Isopropanol 1 Vol 0 00 Acetone 1 0 00 Methane 3 Vol 0 02 NO 100 ppm 0 01 NO2 50 ppm 0 00 CO 4 Vol 0 00 Freon R21 100 Vol 0 07 Freon R134a 100 Vol 0 19 Water vapor 37 C saturated 0 01 NOTE Given readings are pure interfering gas effects balance N2 if applic...

Page 106: ...ber of twitches displayed if TOF Ratio 4 or number of twitches 4 PTC 0 to 20 number of twitches Measurement interval None 1s 10s 20s default 1min 5min 15min 30min Impedance range 1 2 Ω to 6000 Ω 1 Accuracy NMT Temp 1 C Single 10 TOF Ratio 10 Display resolution NMT Temp 1 C Single TOF Ratio 1 TOF Count PTC 1 Trend scale range NMT Temp 20 to 40 C incr of 1 C Single 0 to 200 incr of 5 TOF Ratio 0 to ...

Page 107: ... on setting 1 Stimulation current accuracy is 5 within this range Stimulation current is disabled at impedance values greater than 8900 Ω 2 At a stimulation current of 30 mA voltage and current values are approximately half 50 of those listed for 60 mA NOTE There is no output in an open circuited load condition A B C Output voltage and current at stimulation current of 60mA 2 Load impedence 1 2 Ω ...

Page 108: ...onnector IEC1 European color code MP03402 ECG 3 lead grabber 1m single pin connector IEC2 AHA color code MP03403 ECG 5 lead grabber 1 1 5m single pin connector IEC1 European color code MP03404 ECG 5 lead grabber 1 1 5m single pin connector IEC2 AHA color code MP03405 ECG 6 lead grabber 1 1 5m single pin connector IEC1 European color code MP03406 ECG 6 lead grabber 1 1 5m single pin connector IEC2 ...

Page 109: ...f monitoring occurs 12 hours a day This duration is monitored by a chip inside the cable ROW PN USA PN Japan PN Description MP00790 MP03011 MP03089 Masimo SpO2 Sen LNCS Adtx Bx20 MP00793 MP03012 MP03090 Masimo SpO2 Sen LNCS Pdtx Bx20 MP00791 MP03013 MP03091 Masimo SpO2 Sen LNCS Inf Bx20 MP00792 MP03014 MP03092 Masimo SpO2 Sen LNCS Neo Bx20 MP00794 MP03015 MP03093 Masimo SpO2 Sen LNCS Neo PtBx20 RO...

Page 110: ...Sen LNCS DBI Adult NOTE Masimo does not make any claims regarding motion for this sensor NOTE Only for use with Masimo SET technology ROW PN USA PN Japan PN Description ROW PN USA PN Japan PN Description 7496933 MP03045 MP03147 SpO2 Posey Wrap Masimo 12pcs 7496917 MP03046 MP03148 SpO2 Wrap for Masimo LNOP YI 7496909 MP03047 MP03149 SpO2 Masimo Petite Wrap 100pcs 7496875 MP03048 MP03150 SpO2 Masimo...

Page 111: ...20 MS40091 MS40089 MS40090 RD SET Trauma Inf Pd Bx20 MS40094 MS40092 MS40093 RD SET Trauma Neo Bx20 CAUTION With specialty sensors the sensor off detection performance may be compromised NOTE Trauma Sensors are only for use with Masimo SET technology ROW PN USA PN Japan PN Description MS33740 MS33759 MS33778 Masimo SpO2 Sen RD SET DC I MS33741 MS33760 MS33779 Masimo SpO2 Sen RD SET DCIP MS40067 MS...

Page 112: ...437 SpO2 intermediate cable Masimo RD SET 3 m NOTE For connecting Masimo RD SET sensors to the respective Masio SET Pod For additional instructions refer to Instructions for Use Infinity Delta Series Infinity Patient Monitoring Series Software VF9 chapter 18 PN Description MS34677 Nellcor FLEXMAX Adt SpO2 sensor adult finger MS34678 Nellcor FLEXMAX Pdt SpO2 sensor pediatric finger NOTE Only for us...

Page 113: ...pressure transducer to PiCCO pod interface cable 20 cm 1 PiCCO pod C O injectate thermistor cable 1 PiCCO pod C O catheter cable 1 PiCCO pod C O intermediate cable 1 5 m 1 PodCom Cable to monitor 3 m 1 Universal Pole Mount NOTE All disposables are delivered by PULSION directly MS23133 Infinity PiCCO pod PN Description MS22532 Dräger 10 pin Transducer Adapter Cable Adapter cable to connect PULSION ...

Page 114: ...try unit only those ST parameters displayed on the Delta ST parameter box will have their ST trend data transferred to the M300 Delta does not transfer the FiO2 inO2 parameters when they originated from a Medibus X device Discharging a Patient When a patient is discharged from the Delta monitor and is placed on another Delta monitor but the first monitor is not placed on a new patient the Gateway ...

Page 115: ...s the monitor resumes normal operation Cursor In the OCRG screen if inaccurate measurement values are suspected when a cursor rests on a point on a waveform allow the OCRG screen to populate data for a full 3 minutes if the configured time duration is 3 minutes or 6 minutes if the configured time duration is 6 minutes Accessing OxyCRG Review Summary Screen When reviewing the OxyCRG Review Summary ...

Page 116: ...ally disconnect the undesired device from the monitor When the message Duplicate Device Connected appears and if the CO2 waveform label disagrees with the parameters being monitored e g the CO2 module waveform label displays when MIB is the active CO2 source device disconnect one of the CO2 devices wait a few second then reconnect the CO2 source device NOTE If a MultiGas parameter box appears afte...

Page 117: ...s trended information should be available directly from the blood gas analyzer or interfaced information systems Independent Surgical Display ISD When MultiGas is turned off on the Delta the ISD may display additional invalid waveforms and parameter fields Refer to the primary source device for all diagnostic and therapeutic decisions If an ISD is used in the OR with PiCCO measurements ensure that...

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Page 120: ...Inc 3135 Quarry Road Telford PA 18969 1042 U S A 215 721 5400 800 4DRAGER 800 437 2437 FAX 215 723 5935 http www draeger com in Europe Middle East Africa Latin America Asia Pacific distributed by Drägerwerk AG Co KGaA Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 20 80 http www draeger com MS32649 RI 05 en Drägerwerk AG Co KGaA Edition 5 2020 03 Edition 1 2015 12 Dräg...

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