Dräger Infinity Delta Series Supplement Manual
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Dräger Infinity Delta Series Supplement Manual

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

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Summary of Contents for Dräger Infinity Delta Series

  • Page 1 Supplement Infinity Delta Series ® Infinity ® Patient Monitoring Series WARNING To properly use this medical device, Software VF10.1 read and comply with the instructions for use and this supplement.
  • Page 3 Supplement for Infinity Delta Series Software Infinity Delta Series Instructions for use Software VF10.1 ©Drägerwerk AG & Co. KGaA All rights reserved. Reproduction in any manner, in whole or in part, in English or in any other languages, except for brief excerpts in reviews and scientific papers, is prohibited without prior written permission of Dräger.
  • Page 4 Supplement for Infinity Delta Series Software For your safety and that of your patients Mandatory reporting of adverse events Serious adverse events with this product must be reported to Dräger and the responsible authorities. Safety information WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.
  • Page 5 Supplement for Infinity Delta Series Software Experts Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product. Training Training for users is available via the responsible Dräger organization (see www.draeger.com).
  • Page 6 Supplement for Infinity Delta Series Software Introduction Changes in Delta VF10.1 Starting with Delta VF10.1, the following VGA Display requirement has been removed from the Display Unit (Kappa only) table under the Displays heading. Output resolution: High resolution mode: 1024 x 768...
  • Page 7 Supplement for Infinity Delta Series Software Cybersecurity and Network Stability Corrected vulnerabilities that may cause device to reboot, lose functionality, and/or lose communication. Base Unit Monitor Rear View – Delta XL External (lead-acid) battery compartment (not supported with software VF9.0 or higher)
  • Page 8 Supplement for Infinity Delta Series Software Unit Manager Menu Menu Item Description Available Settings The Alarm Control 1 and Alarm Control 2 submenus: This menu allows the unit manager to configure alarm annunciation. Open the Unit Manager menu, click on Alarm Control 1 or Alarm Control 2, and then follow the procedures outlined in this table to execute the indicated functions.
  • Page 9 Supplement for Infinity Delta Series Software Device Markings The following table contains symbols that have been modified or added to the table in the section on device markings in the main IFU. Caution: This product contains Manufacturer’s reorder code natural rubber latex which may...
  • Page 10 Supplement for Infinity Delta Series Software Biomed Quick Reference - Biomed Menu Menu Item Description Settings/Procedures Mainstream CO2 This read-only field contains information to The display is read-only. Component Log assist with system upgrades and diagnosing  Press the Menu fixed key.
  • Page 11 Supplement for Infinity Delta Series Software Temperature Display All temperature readings appear on the main screen according to their position in Parameter Priority (see page 2-6). The following display conventions govern temperature labels and values. The monitor displays temperature values in one parameter box for each pod connector (MultiMed, He- mo2/Hemo4).

  • Page 12: Table Of Contents

    Supplement for Infinity Delta Series Software Network Applications Network Message (Delta/Delta XL/Kappa)..14 Definition of Maintenance Concepts ..32 Remote View ......14 Inspection .
  • Page 13 Supplement for Infinity Delta Series Software Quick Reference - PiCCO Setup ... 66 System Components ....93 Optimizing Results for PiCCO Monitoring Accessories .

  • Page 14: Network Message (Delta/Delta Xl/Kappa)

    Supplement for Infinity Delta Series Software Network Message (Delta/Delta XL/Kappa) The Condition for the Duplicate Address message should read as follows: More than one monitor configured for the same IP address. CAUTION If the Duplicate Address network message is displayed, contact your Biomed or local DrägerService.

  • Page 15: Information About Connecting To An It Network

    Supplement for Infinity Delta Series Software – Adding new devices to the network – Performing upgrades or updates on devices that are connected to the network Information about connecting to an IT network Prerequisites This device must only be connected to the network by service personnel. The IT representative of the hospital must be consulted in advance.
  • Page 16 Supplement for Infinity Delta Series Software VLAN networks If data is being exchanged within a single physical network and a clinical information system is used, an independent VLAN network must be set up for the clinical information system. Additionally, at least one of the following independent VLAN networks must be set up: –...

  • Page 17: Disconnecting The Monitor From The Network

    Supplement for Infinity Delta Series Software – Data have incorrect time stamps. Requirements for the electrical characteristics of connected devices and networks The LAN interfaces and the serial interfaces are only suitable for the connection of devices or networks that have a rated voltage of at most 24 V DC on the network side and that meet the requirements of one of the following standards: –...

  • Page 18: Admission, Transfer, And Discharge

    Supplement for Infinity Delta Series Software Admission, Transfer, and Discharge Admitting a patient at the Central Station 1 Select the viewport that corresponds to the room/patient monitor. 2 Click on Admit/Standby. 3 Click on the Demographics tab if it is not already selected.

  • Page 19: Alarms

    Supplement for Infinity Delta Series Software Alarms General Requirements - Alarm Setup Upper and Lower Alarm Limits In addition to those listed in the main IFU, alarm limits should be set according to your patient’s prevailing condition within the predefined ranges of the monitor as listed in the following table:...
  • Page 20 Supplement for Infinity Delta Series Software Auto Set Alarm Limits Alarm Limits Table Function Description Available Settings Auto Set Sets alarm limits based on current values: Not applicable Parameters Upper Limit Lower Limit NOTE: Ta, T1a, T1b, < 107% of <...

  • Page 21: Alarm History Table

    Supplement for Infinity Delta Series Software Alarm History Table The monitor stores up to 50 physiological alarm events for each patient (the oldest log entry is overwritten). Events are deleted when the patient is discharged. Data is stored in the monitor and remains with the patient during Pick and Go transports.

  • Page 22: Ecg And Heart Rate

    Supplement for Infinity Delta Series Software ECG Signal Processing and Display The monitor identifies QRS complexes with amplitudes between 0.2 and 5.0 mV and a QRS width of 70 to 120 ms for adults (or 40 to 120 ms for neonates). It calculates heart rates within a range of 15 to 300 beats per minute, using the R-R intervals of the last 10 seconds and diisregarding the two longest and two shortest R-R intervals.

  • Page 23: Ecg Setup Menu

    Supplement for Infinity Delta Series Software ECG Setup Menu Menu selection Description Available Settings The ECG Options submenu This submenu allows you to configure the following functions: Pacer Detection Determines the monitor’s ability to In basic mode: identify pacemaker pulse. Allows user –...

  • Page 24: Arrhythmia Monitoring

    Supplement for Infinity Delta Series Software Arrhythmia Monitoring Arrhythmia Ranges and Defaults Parameter Alarm Priority Rate (default) Count (default) Alarm Archive Factory Default Default Setting HIGH Not adjustable Not adjustable Str./Rec. HIGH Not adjustable Not adjustable Str./Rec. HIGH 100 to 200 (120) 5 to 15 (10) Str./Rec.

  • Page 25: Respiration

    Supplement for Infinity Delta Series Software Respiration Quick Reference Table - OCRG Setup OxyCRG Setup Menu Menu item Description Settings Parameter 2 Displays a list of label choices for updating the – SpO2 second channel of the OCRG menu. – tpO2 –...

  • Page 26: Non-Invasive Blood Pressure

    Supplement for Infinity Delta Series Software Non-Invasive Blood Pressure Overview The monitor can acquire and process non-invasive blood pressure (NBP) signals and display the results for neonatal, pediatric, and adult patients. NBP accuracy was established using intra-arterial blood pressure monitoring as a reference (within the limits prescribed by the Association for Advancement of Medical Instrumentation, Electronic Automated Sphygmomanometers).
  • Page 27 Supplement for Infinity Delta Series Software NBP Cuff Diagram Cuff size indicators Range labels Artery label Label: This side to patient Index line 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: Nbp Setup

    Supplement for Infinity Delta Series Software NBP Setup 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 –...

  • Page 29: Status Messages

    Supplement for Infinity Delta Series Software Status Messages Message Possible Cause Suggested Action NBP Cannot The pulse profile is too poor to make a • Check the patient and treat, if necessary. Measure reliable measurement (usually due to • Move the cuff to a limb with less persistent motion artifact).

  • Page 30: Continuous Non-Invasive Arterial Blood

    Supplement for Infinity Delta Series Software Continuous Non-invasive Arterial Blood Pressure (CNAP) Pod Cuff controller with sliding mount CNAP pod Cuff controller cable Aux/Hemo or PodCom connector Forearm strap PodCom cable Sensor cuff To connect CNAP pod and sensor cuff 1 Connect the sensor cuff (D) to the cuff controller (A).

  • Page 31: Cnap Calibration

    Supplement for Infinity Delta Series Software CNAP Calibration Each time a CNAP measurement starts or the inflation pressure alternates between the dual finger cuffs, CNAP automatically calibrates. Calibration consists of a pulse determination phase followed by an NBP correlation measurement. During calibration a triangular wave (for pod firmware version 2.14.14.) displays in the CNAP waveform area and then the message CNAP @ Calibrating displays and the CNAP values are blank.

  • Page 32: Definition Of Maintenance Concepts

    Supplement for Infinity Delta Series Software WARNING Risk of electric shock Components that carry current are located under the cover. Do not remove the cover. Maintenance measures must be performed by the responsible personnel. Dräger recommends DrägerService to perform these measures.

  • Page 33: Inspection

    Supplement for Infinity Delta Series Software Inspection Perform inspections at regular intervals and observe the following specifications. CNAP / Cuff Controller Checks Interval Responsible personnel Inspection/safety checks Every 2 years Service personnel Metrological checks Every 2 years Service personnel Visual Inspection Perform a visual inspection before every use and in accordance with your hospital's policy.

  • Page 34: Metrological Checks

    Supplement for Infinity Delta Series Software – Perform device checks (for example, calibration of pod with cuff controller, sensor cuff, and NBP cuff) – Check/Visual inspection 3 Check that the device combination is in good condition: – All labels are complete and legible –...

  • Page 35: Calculations

    Supplement for Infinity Delta Series Software Calculations The following table lists the parameter labels that have been updated in the Calculations chapter. Updated label Former label Cstat inO2 Pmean Pplat PAUSE Raw e Raw i Pulse Oximetry (SpO WARNING A pulse oximeter should be considered an early warning device. If a trend towards patient hypoxemia is observed, blood samples should be analyzed by laboratory instruments to completely understand the condition of the patient.
  • Page 36 If the sensor LED does not light up, replace sensor and/or intermediate cable. CAUTION Refer to the “Pulse Oximetry (SpO )” chapter in the Infinity Delta Series Instructions for Use for Software VF9 for additional precautions regarding safe device operation. CAUTION Do not immerse the sensor or patient cable in any liquid.

  • Page 37: Quick Reference Table - Spo2 Setup

    The sensor or the cable is Replace the sensor or the cable. expired or defective. MicrO2+ Standalone Pulse Oximeter As of the Infinity Delta Series Software VF10.1 release, MicrO2+ is no longer supported. Supplement – Infinity ® Delta Series Software VF10.1...

  • Page 38: Dräger Mainstream Etco2 Monitoring

    Supplement for Infinity Delta Series Software Dräger Mainstream etCO2 Monitoring Application Intended Use The Dräger Mainstream CO module, when connected to a monitor, allows the monitor to measure and display mainstream etCO2 (end-tidal CO ), inCO2 (inspired CO ), and RRc (Respiration Rate) for neonate, pediatric, and adult patients.
  • Page 39 Supplement for Infinity Delta Series Software WARNING The etCO2, inCO2, and RRc alarms do not activate until the second breath is detected after turning on the monitor or discharging a patient. WARNING RRc apnea alarms are NOT reported if the setting RRc Apnea Time is set to OFF in the etCO2 setup menu and the RRc alarm feature is deactivated.

  • Page 40: Connection

    See the “Approved options and accessories” section. The measuring function may otherwise be inaccurate. NOTE In this chapter, all Infinity Delta Series patient monitors are referred to as “patient monitor.” NOTE When etCO2, inCO2 or RRc is followed by * (for example, etCO2*), the * indicates the origin of this parameter is from an external device such as an A500, A350, or A300.
  • Page 41 Supplement for Infinity Delta Series Software Slide the Dräger mainstream CO module into the slot on the rear of the monitor until it rests securely. Dräger mainstream CO module Connection port for external SpO Infinity MCable - CO mainstream External SpO...

  • Page 42: Connecting The Sensor

    Supplement for Infinity Delta Series Software Connecting the Sensor Before you connect any CO hardware, make sure the cuvette setting of the monitor matches the cuvette in use. For example, the Delta must be configured for a disposable cuvette if a disposable cuvette is being used.

  • Page 43: Getting Started

    Supplement for Infinity Delta Series Software CAUTION Always use the mainstream CO measuring cuvettes with the windows in an upright position. Otherwise, condensation deposits from the breathing system may collect, which could impair proper function. Getting Started Patient Preparation for Dräger Mainstream CO...
  • Page 44 Supplement for Infinity Delta Series Software Source dialog When Delta detects both a mainstream and SCIO device are connected, the Source dialog appears. The user must select the preferred device from the dialog, or disconnect either the mainstream or SCIO device to exit the screen lock.

  • Page 45: Display Features

    Supplement for Infinity Delta Series Software The suggested action is to disconnect the duplicate device. Display Features etCO2 Monitoring The etCO2 waveform displays the instantaneous CO concentration. The etCO2 parameter box displays the following parameters: – End-tidal CO (etCO2) — The level of CO2 in the airway at the end of expiration.
  • Page 46 Supplement for Infinity Delta Series Software etCO2 Setup To access the etCO2 setup menu  Click on the etCO2 parameter box. 1 Press the Menu fixed key. 2 Click on Patient Setup. 3 Click on Parameters to display a list of available parameters.
  • Page 47 Supplement for Infinity Delta Series Software Menu Item Description Settings Calibration Checks the calibration of the CO2 sensor with a test filter. The monitor reports Check whether the calibration check has passed or failed. NOTE The sensor must be removed from the cuvette and zeroed before performing a calibration check.
  • Page 48 Supplement for Infinity Delta Series Software Menu Item Description Settings 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 Sets the respiratory waveform sweep speed on 6.25, 12.5, 25, 50 mm/s...

  • Page 49: Capnograms

    Supplement for Infinity Delta Series Software Quick Reference Table--Apnea Alarm submenu The following table explains apnea alarm submenu functions. Function Description Settings RRc Apnea Time Specifies time monitor waits before reporting a OFF, 10, 15, 20, 25, and cessation of breathing as an apnea event.
  • Page 50 Supplement for Infinity Delta Series Software Expiratory or alveolar plateau (level of CO in lungs ceases to increase significantly) End-tidal concentration point (end of expiration phase, where CO is measured) Onset of inspiration phase Onset of expiratory phase Baseline during inspiration Zeroing ...

  • Page 51: Troubleshooting

    Supplement for Infinity Delta Series Software Checking Calibration of the Dräger Mainstream CO Sensor with Test Filter  Perform the calibration check of the Dräger mainstream CO sensor with test filter at intervals of one month. Test filter Before the check Prerequisite: The monitor is switched on and at least the warm-up phase for the CO sensor has elapsed.
  • Page 52 Supplement for Infinity Delta Series Software The following table lists the alarm messages in order of priority. Alarm Priority Alarm Cause Remedy Medium inCO2 > # Leakage in the breathing Exchange breathing system. system. lnspired CO concentration has Check ventilation.
  • Page 53 Supplement for Infinity Delta Series Software Alarm Priority Alarm Cause Remedy Medium etCO2 @ Out of Expiratory gas concentration • Check ventilation. Range (Low) has fallen below the lower • Check zero. measuring range. Medium RRc @ Out Of Range...

  • Page 54: Status Messages

    Supplement for Infinity Delta Series Software Status Messages Message Condition Suggested action CO2 Please Zero Zero has drifted Perform a zeroing operation CO2 Reduced Measurement values have reduced • Wait until the warm-up phase has ended before relying on the...

  • Page 55: Respiratory Mechanics

    Supplement for Infinity Delta Series Software Respiratory Mechanics The following table lists the parameter labels that have been updated in the Respiratory Mechanics chapter. Updated label Former label MValv mand MValv m MValv spon MValv s MVemand MVe m MVespon...

  • Page 56: Fio2 (Fractional Inspired O2) Monitoring

    Supplement for Infinity Delta Series Software FiO2 (Fractional Inspired O2) monitoring Display Features NOTE When FiO2 is followed by * (FiO2*), the * indicates the origin of this parameter is from a ventilator. For more information on FiO2*, see the main IFU.
  • Page 57 Supplement for Infinity Delta Series Software NOTE These values are guiding values only. The binding values are specified on the package information leaflet of the anesthetic agent. The age-corrected MAC values are calculated using an equation developed by W. W. Mapleson (British Journal of Anaesthesia 1996, pp.
  • Page 58 Supplement for Infinity Delta Series Software MAC (Iso) = 1.15 Vol% MAC (N2O) = 105 Vol% xMAC standard (0.65 Vol% / 1.15 Vol%) + (69 Vol% / 105 Vol%) = 0.57 + 0.66 = 1.2 Age-Corrected xMAC Calculation When calculating the Age-Corrected xMAC for gas mixtures, the respective multiples for N...

  • Page 59: Status Messages

    Supplement for Infinity Delta Series Software Troubleshooting The following table describes alarms in alphabetical order by alarm message: Alarm priority Alarm Cause Remedy 2 Mixed Agents A second anesthetic – Wait for the transition phase agent has been detected. to end after changing anesthetic agents.

  • Page 60: Monitoring

    Supplement for Infinity Delta Series Software Message Condition Suggested action MultiGas Reduced Warm-up phase in progress. – Wait until the warm-up phase has ended Accuracy before relying on the displayed MultiGas NOTES values for clinical evaluation. – Measured parameter labels –...

  • Page 61: Monitoring

    Supplement for Infinity Delta Series Software Pulse Contour Cardiac Output (PiCCO) Monitoring Pulse Contour parameters/Transpulmonary Thermodilution parameters The following parameters are not cleared for use by the FDA in the US market: dPmax, GEF, and PVPI. Precautions WARNING Do not use the PiCCO pod on patients for which placement of an indwelling arterial or central venous catheter is contraindicated.
  • Page 62 Supplement for Infinity Delta Series Software Initiates a zeroing of all connected Transducer plate pressures Starts a p-CO measurement Monitor connector (to pod communication cable) Transducer slots CO connector NOTE: On the Infinity PiCCO pod, the transducers are attached to a separate transducer plate and are available from the applicable manufacturer;...

  • Page 63: To Set Up The Picco Pod

    Supplement for Infinity Delta Series Software To set up the PiCCO Pod CVP catheter Pulsion blood pressure transducer Pulsion injectate temperature sensor PodCom connection to Delta series monitor housing p-CO thermistor cable 10-pin transducer adapter cable p-CO intermediate cable Pulsion arterial thermodilution catheters...
  • Page 64 Supplement for Infinity Delta Series Software 1 Insert a central venous catheter (CVC) into the patient. 2 Prepare a pressure monitoring kit for arterial pressure monitoring. Fill the transducer kit carefully using the flush clip. Air bubbles in the pressure lines or in the transducer influence the transmission and can cause measuring errors.
  • Page 65 Supplement for Infinity Delta Series Software Single Transducer Zero Simultaneous “Smart Zero” NOTE: If the procedure is successful, the monitor displays the message: <IBP> @ Zero Accepted. If the procedure fails, the monitor displays the message: <IBP> @ Did Not Zero Check the waveform.

  • Page 66: Quick Reference - Picco Setup

    Supplement for Infinity Delta Series Software Quick Reference - PiCCO Setup Pulse Contour Parameters Setup Menu Menu Item Description Available Settings CVP Value Allows user to select a CVP Value. 5 mmHg (default) 0 mmHg to 50 mmHg (in increments of 1 mmHg)

  • Page 67: Software

    Supplement for Infinity Delta Series Software  During a measurement, if p-IT or p-BT readings become invalid or go out of range, the averaging screen disappears. Check that p-ITand p-BT are in range before restarting the measurement. [p-IT range: -3 to 31 °C (27 to 88 °F), p-BT range: 25 to 43 °C (77 to 109 °F)]...

  • Page 68: Compatible Devices

    Supplement for Infinity Delta Series Software When a MEDIBUS.X device is in standby, the Delta series monitor does not process parameters, settings, waveforms, or modes (i.e., this data is not displayed on the Delta series monitor and is not sent to the Infinity network).
  • Page 69 Supplement for Infinity Delta Series Software MEDIBUS.X Device MIB Interface Protocol Interface Protocol Dräger Primus Infinity Empowered Dräger Zeus Dräger Zeus Infinity Empowered Dräger ventilators Dräger Babylog Dräger Babylog VN500 Dräger Evita 4 Dräger Evita XL Dräger Evita V500 Dräger Evita V300 Dräger Savina...
  • Page 70 Supplement for Infinity Delta Series Software MEDIBUS.X Protocol Support NOTE Delta series software VF10 and IDS software VF6.0 or higher support the MEDIBUS.X protocol for integrating external device information into the monitor system and Infinity network. MEDIBUS.X ventilators and anesthesia devices send parameters, settings, text messages or modes, and waveforms to the network via the Delta series monitor.

  • Page 71: Precautions

    Supplement for Infinity Delta Series Software Precautions See sections “Electro surgery” and “General Electrical Safety” for general precautions regarding device operation. CAUTION – Data transferred using the MEDIBUS protocol or MEDIBUS.X protocol is for information only and is not intended as a basis for diagnostic or therapeutic decisions. Always refer to the primary data source for these decisions.
  • Page 72 Supplement for Infinity Delta Series Software The monitor displays a ventilator pressure waveform next to the Airway Pressure (Paw) parameter box and a ventilator flow waveform next to the Flow/Volume (Vent) parameter box. For MEDIBUS.X devices, the monitor can also display the CO waveform next to the End-Tidal CO (etCO2*) parameter box.
  • Page 73 Supplement for Infinity Delta Series Software Ventilation Parameters Parameter Bedside Bedside and Where locally displayed Former monitor Infinity label label network units of measure Peak inspiratory cmH2O • Paw (Flow and Volume) parameter box pressure • Show All Parameters screen...
  • Page 74 Supplement for Infinity Delta Series Software Parameter Bedside Bedside and Where locally displayed Former monitor Infinity label label network units of measure Tidal volume • Show All Parameters screen Minute volume L/min Spontaneous RRspon /min respiratory rate Mandatory RRmand /min...

  • Page 75: Atlan, Primus, Zeus, Apollo, And Perseus Anesthesia Devices

    Supplement for Infinity Delta Series Software Atlan, Primus, Zeus, Apollo, and Perseus Anesthesia Devices The Delta/Delta XL/Kappa monitor displays data from the devices listed at the beginning of this chapter. When the monitor is connected to an Infinity Primus, Apollo, Perseus,or Atlan anesthesia machine, it...
  • Page 76 Supplement for Infinity Delta Series Software Anesthesia Parameters Parameter Bedside Bedside and Where locally displayed Former monitor Infinity label label network units of measure Peak inspiratory cmH2O • Paw (Flow and Volume) parameter box pressure • Show All Parameters Mean airway...
  • Page 77 Supplement for Infinity Delta Series Software Parameter Bedside Bedside and Where locally displayed Former monitor Infinity label label network units of measure End-tidal desflurane etDes • MultiGas parameter box etDES (when MultiGas is enabled) concentration • Agent parameter box (when...
  • Page 78 Supplement for Infinity Delta Series Software Parameter Bedside Bedside and Where locally displayed Former monitor Infinity label label network units of measure Plateau pressure Pplat cmH2O • Show All Parameters screen Pause Tidal volume Spontaneous minute MVspon L/min volume Mandatory minute...

  • Page 79: Covidien/Medtronic Invos Cerebral/Somatic Oximeter 5100C

    Supplement for Infinity Delta Series Software Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C The monitor, when connected to a Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C via MIB, displays cerebral oximetry. NOTE The Covidien/Medtronic INVOS Cerebral/Somatic Oximeter 5100C is now available in adult, pediatric, and neonatal patient categories.

  • Page 80: Classifications For Reprocessing

    Supplement for Infinity Delta Series Software Classifications for reprocessing Classification of medical devices Medical devices and their components are classified according to the way they are used and the resulting risk. Classification Explanation Non-critical Components that come only into contact with skin that is intact...

  • Page 81: Reprocessing List

    Supplement for Infinity Delta Series Software Reprocessing list Components Surface Manual Machine Steam Special disinfection cleaning cleaning with sterilization reprocessing with cleaning followed by thermal measures disinfection disinfection by immersion Delta series monitors Reprocessing procedures Validated reprocessing procedures At the time of product-specific validation, the following reprocessing procedures showed good material...
  • Page 82 Supplement for Infinity Delta Series Software Other surface disinfectants are used at one's own risk. Class of active ingredient Surface disinfectant Manufacturer Chlorine-releasing agents Actichlor plus Ecolab BruTab 6S Brulin Clorox Professional Disinfecting Clorox Bleach Cleaner Dispatch Hospital Cleaner Disin-...

  • Page 83: Surface Disinfection With Cleaning

    Supplement for Infinity Delta Series Software Surface disinfection with cleaning WARNING Risk due to penetrating liquid Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions Ensure that no liquid penetrates the device.

  • Page 84: Etco2

    Supplement for Infinity Delta Series Software To clean the Infinity PiCCO Pod 1 Disconnect the Infinity PiCCO pod from the bedside monitor. 2 Clean the Infinity PiCCO pod with a gauze pad moistened with soapy water or with an approved cleaning agent.

  • Page 85: To Dry The Sidestream Pump Subsystem

    Supplement for Infinity Delta Series Software To dry the sidestream pump subsystem 1 Reattach the etCO2 module or pod to the monitor. The sidestream sampling pump starts running, and there is suction at the input port on the face of the module or pod.
  • Page 86 Supplement for Infinity Delta Series Software Power frequency 3 A/m 3 A/m Power frequency magnetic fields magnetic field should be at levels characteristic 50/60 Hz of a typical location in a typical (IEC 61000-4-8) commercial or hospital environment. Voltage dips and Dip >95%, 0.5 periods...
  • Page 87 Supplement for Infinity Delta Series Software Compliance Recommended Separation Immunity test IEC 60601 Test Level: Level: Distance: Conducted RF 150 kHz to 80 MHz rf coupled into lines See note 3. (IEC 61000-4-6) Radiated rf 80 MHz to 800 MHz...

  • Page 88: Electromagnetic Emissions

    Supplement for Infinity Delta Series Software Electromagnetic Emissions 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. Emissions: Compliance according to: Electromagnetic environment:...

  • Page 89: Electromagnetic Immunity

    Supplement for Infinity Delta Series Software Electromagnetic Immunity 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. Compliance Immunity against IEC 60601-1-2 test level:...

  • Page 90: Recommended Separation Distances

    Supplement for Infinity Delta Series Software Compliance Recommended separation Immunity test IEC 60601 test level: level: distance: 1.2 ∗ P Conducted RF 150 kHz to 80 MHz 3 Vrms rf coupled into lines (IEC 61000-4-6) 1.2 ∗ P Radiated rf...

  • Page 91: Emc Declaration

    Supplement for Infinity Delta Series Software 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.

  • Page 92: Recommended Separation Distances From Wireless Communication Devices

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

  • Page 93: System Components

    Supplement for Infinity Delta Series Software System Components Delta/Delta XL base unit Electrical specifications Alarm tone sound pressure L(A) alarm Free field measurements (complying with ISO 3744) tone sequence IEC/Infinity – High-priority alarms - 56 dB(A) to 69 dB(A) / 56 dB(A) to 76 dB(A) –...

  • Page 94: Monitoring Accessories

    Supplement for Infinity Delta Series Software Monitoring Accessories Infinity PiCCO Pod Physical attributes Size (H x W x D) 110 x 205 x 40 mm (4.3 x 8.1 x 1.6 in) Weight < 0.9 kg (1.9 lb) NOTE: Weight includes four transducer cables and excludes mounting clamp and mounting rod.
  • Page 95 Supplement for Infinity Delta Series Software Physical specifications Mode of operation Continuous Protection against electric Sensor: Type BF shock Defibrillator protection Environmental requirements Temperature range Operating: 10 to 40 °C (50 to 104 °F) Storage: –40 to 75 °C (–40 to 167 °F)

  • Page 96: Monitoring Specifications

    Supplement for Infinity Delta Series Software Monitoring Specifications WARNING The following parameters and functions are not monitored in neonatal mode: Arrhythmia, cardiac output, ST, pacer detection,% paced, and all MultiGas parameters. Description Value V/s pacer detected 3.18 V/s Respiration Description...
  • Page 97 Supplement for Infinity Delta Series Software Additional technical data Measurement range PCCI 0.01 to 15 L/min/m PCCO 0.25 to 25 l/m p-SVI 1 to 125 ml/m 0 to 50 % p-SVR 0 to 30000 dyn.sec. cm p-SVRI 0 to 30000 dyn.sec. cm...
  • Page 98 Supplement for Infinity Delta Series Software Non-Invasive Blood Pressure (NBP) NOTE For neonatal patients with high blood pressure and a heart rate close to 30 bpm, the monitor may not be able to measure NBP within the maximum measurement time of 90 seconds.
  • Page 99 Supplement for Infinity Delta Series Software Static cuff accuracy ±3 mmHg (± 0.4 kPa) Calibration range Adult and Pediatric:10 to 260 mmHg ±3 mmHg (1.3 to 34.7 kPa ± 0.4 kPa) Neonatal: 10 to 150 mmHg ±3 mmHg (1.3 to 20.0 kPa ± 0.4 kPa)
  • Page 100 Supplement for Infinity Delta Series Software Pulse Oximetry (Masimo SET SpO via Pod) Description Value Intended use The Infinity Masimo SET® pod and accessories are indicated for use during both motion and non-motion conditions and for patients who are well or poorly perfused.
  • Page 101 Supplement for Infinity Delta Series Software Pulse Oximetry (Masimo RD SET SpO via pod) Description Value Intended use The Infinity Masimo SET ® pod and accessories are indicated for use during both motion and non-motion conditions and for patients who are well or poorly perfused.
  • Page 102 Supplement for Infinity Delta Series Software Pulse oximetry (Nellcor Oximax SpO via pod) Parameter display Saturation (%SpO ), pulse rate Measurement range %SpO : 1 - 100% Pulse rate:25 - 239 /min Measurement accuracy, adult mode (1, 2, 4) Saturation (%SpO...
  • Page 103 Supplement for Infinity Delta Series Software Concentrations Via Mainstream CO Module and Sensor Description Value Parameter display etCO2, inCO2, RRc Measuring principle Dual wavelength infrared absorption Measurement range etCO2 and inCO2: 0 to 99 mmHg (0 to 13.2 kPa or 0 to 13.0 Vol% at sea level)
  • Page 104 Supplement for Infinity Delta Series Software Description Value Rise time <35 ms Delay time <165 ms Time until availability <10 s Data sample rate Sensor: 20 ms Display update period Time until specified accuracy is attained <120 s (at 23 °C (73 °F)) Measurement accuracy drift Over 6 hours is <0.03 Vol% at 5 Vol% CO...
  • Page 105 Supplement for Infinity Delta Series Software How performance is affected by interfering gases and vapors NOTE Regarding interfering gases and vapors: These additional errors are not corrected for automatically through the Gas Compensation selection. Gas or Vapor Concentration reading in Vol% at 0 Vol.% CO Halothane, 5 Vol% 0.02...
  • Page 106 Supplement for Infinity Delta Series Software NMT via Trident Pod Stimulation current Auto mode: read-only; displayed value is based on reference measurement at startup (max. 60 mA) Manual mode: 5 mA (default) to 60 mA, in increments of 5 mA Pulse width 100, 200 (default), or 300 μs...
  • Page 107 Supplement for Infinity Delta Series Software Output signals Graphical signal of the output voltage and current stimulation pulse: A – Voltage (V ) or Current (I ) when pulse is not delivered (OFF) B – Voltage (V ) or Current (I ) when pulse is delivered (ON) C –...

  • Page 108: Approved Options And Accessories

    Supplement for Infinity Delta Series Software Approved Options and Accessories NOTE All Draeger approved pods and associated accessories that have patient contact are manufactured without natural rubber latex, with the exception of the 7014616 temperature probe covers. Some articles are not available worldwide because they are not approved in all countries.

  • Page 109: Invasive Blood Pressure (Ibp)

    Supplement for Infinity Delta Series Software Invasive Blood Pressure (IBP) IBP accessories 5196998 Hemo pod adapter, Abbott/Medex/(Transtar) (One for each DualHemo and two for each QuadHemo/HemoMed pod) Pulse Oximeter (SpO NOTE For Masimo sensors, unique part numbers for USA and Japan apply.
  • Page 110 Supplement for Infinity Delta Series Software ROW PN USA PN Japan PN Description MP00795 MP03020 MP03098 Masimo SpO -Sensor LNCS DC-IP MP00788 MP03021 MP03099 Masimo Sen LNCS-TC-I Ear* MP00799 MP03022 MP03101 Masimo Sen LNCS-TF-I* MP00789 MP03023 MP03102 Masimo Sen LNCS-YI Multi...
  • Page 111 Supplement for Infinity Delta Series Software RD SET adhesive SpO sensors ROW PN USA PN Japan PN Description MS33726 MS33745 MS33764 Masimo SpO RD SET Adt Bx20 MS33727 MS33746 MS33765 Masimo SpO RD SET Pdt.Bx20 MS33728 MS33747 MS33766 Masimo SpO...

  • Page 112: Nellcor Flexmax Reusable Sensors

    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. Nellcor FLEXMAX reusable sensors...

  • Page 113: Mainstream Etco2

    Supplement for Infinity Delta Series Software Mainstream etCO2 Description 6871950 Dräger Infinity MCable - Mainstream CO 6870279 etCO2 cuvette adult, reusable (resistance 0.4 mbar at 60 L/min, internal volume 7 mL) for CO sensors 6871500, 6870300, 6871950. 6870280 etCO2 cuvette pediatric, reusable (resistance 3.0 mbar at 30 L/min, internal volume 5 mL), for CO sensors 6871500, 6870300, 6871950.

  • Page 114: Troubleshooting

    Supplement for Infinity Delta Series Software Troubleshooting Admission, Transfer, and Discharge Admitting a Patient Configuring the Menu Time Limit to OFF can obscure waveform data and other information while the Patient Admit menu remains active. Under this configuration, due to the lack of a menu timeout, as soon as the Patient Admit menu is no longer required, users should cancel the menu so that the monitor can display all information of monitored parameters.

  • Page 115: Trends

    Supplement for Infinity Delta Series Software Trends Mini-Trends When viewing Mini-Trend data and removing and re-connecting parameter cables (e.g., ECG MultiMed cable), allow the monitor 10 seconds to update Mini-Trend data so that the trend data color matches that of the monitored parameters.

  • Page 116: Pulse Oximetry (Spo2)

    Supplement for Infinity Delta Series Software Pulse Oximetry (SpO Quick Reference Table – SpO Setup If double-pulsing occurs when Pulse Tone Volume is enabled under the SpO2 parameter menu, disable the pulse tone volume for SpO2 and enable the pulse tone volume in the ECG Options menu.

  • Page 117: Monitoring

    Supplement for Infinity Delta Series Software Pulse Contour Cardiac Output (PiCCO) Monitoring Pulse Contour Parameters and Thermodilution Setup Menus On the Pulse Contour Parameters Setup Menu table and the Thermodilution Setup Menu table, the CVP Value Description and Available Settings are changed.
  • Page 118 This page has been left blank intentionally. Supplement – Infinity ® Delta Series Software VF10.1...
  • Page 120 This supplement only applies to Infinity Delta SW VF10.1 with the Serial No.: If no Serial No. has been filled in by Dräger, this supplement is provided for general information only and is not intended for use with any specific machine or unit.

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