Dräger Primus Infinity Empowered Instructions For Use Manual
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Dräger Primus Infinity Empowered Instructions For Use Manual

Anesthesia workstation
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Instructions for use
Primus Infinity Empowered
WARNING
To properly use this medical device,
read and comply with these instruc-
tions for use.
Anesthesia workstation
SW 4.5n

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Summary of Contents for Dräger Primus Infinity Empowered

  • Page 1 Instructions for use Primus Infinity Empowered Anesthesia workstation WARNING To properly use this medical device, SW 4.5n read and comply with these instruc- tions for use.
  • Page 2 Trademark owner ® ® DrägerService Neodisher Dr. Weigert Medizym ® Drägersorb ® D-Vapor ® Infinity ® Spirolog Dräger ® SpiroLife ® Vapor ® VacuSmart ® WaterLock ® Durasensor Nellcor ™ OxiMax Covidien Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 3 NOTE A NOTE provides additional information intended to avoid inconvenience during operation. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 4 Experts must have the necessary knowledge and ance with its intended use. experience with complex maintenance work on the product. Abbreviations and symbols Explanations are listed in chapter "Overview" in the sections "Abbreviations" and "Symbols". Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 5: Table Of Contents

    (optional) ....69 Park holder for vaporizer units (optional) ..69 Connecting the electrical connections ..70 Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 6 Disposal ......245 Disposing of the medical device... . 246 Disposal of non-rechargeable batteries ..246 Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 7 Product-specific safety information ..12 Functional safety ..... . . 14 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 8: For Your Safety And That Of Your Patients

    Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 9: Not For Use In Areas Of Explosion Hazard

    Risk of explosion and fire on page 276. The medical device is not approved for use in areas where oxygen concentrations greater than 25 Vol%, or combustible or explosive gas mixtures are likely to occur. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 10: Patient Safety

    The responsibility for selecting the best level of pa- tient monitoring lies solely with the user of the med- ical device. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 11: Sterile Accessories

    Part 15 of the FCC regulations and its opera- tion is subject to the following conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 12: Product-Specific Safety Information

    The workstation may only be used under the permanent supervision of qualified medical personnel so that assistance can be provided immediately in the event of any malfunctions. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 13 The appli- cation of a wall or ceiling mount is designated for buildings. Do not use the anesthesia machine for mobile fa- cilities such as ambulances, helicopters or ships. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 14: Functional Safety

    If excessively high anesthetic gas concentra- tions are delivered, an alarm is issued. – Monitoring the airway pressure and the expira- tory minute volume Alarms are issued depending on the set alarm limits. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 15: Application

    Further information on application..18 Environment of use..... . 18 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 16: Intended Use

    – Functional oxygen saturation (SpO ) and pulse Ventilation modes rate – Volume-controlled ventilation in Volume Mode. Optional activation of: Synchronization, Press. Support (Pressure support) (optional) – Pressure-controlled ventilation in Pressure Mode Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 17: The Following Parameters Can Be Displayed

    – Inspiratory tidal volume, expiratory tidal volume, and leakage tidal volume – Volumeter – Pressure – Econometer for indicating fresh-gas utilization (optional) Trends showing the measured values over time and a logbook are also available. optional Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 18: Indications And Contraindications

    Magnetic fields may negatively influence the proper function of the medical device, thus endangering the patient or user. The medical device must not be used in the vi- cinity of magnetic resonance imagers (MRI, NMR, NMI). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 19: Overview

    Units ....... . . 32 Symbols......33 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 20: Components

    T Vapor units with Interlock system J Release button for ventilator module U Ext. fresh-gas outlet (optional) K Disposable absorber Drägersorb CLIC V Auxiliary power outlet (for desflurane vaporizer) (or reusable absorber) Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 21: Rear

    F Potential equalization pin for auxiliary systems G Scavenging nozzle H Anesthetic gas receiving system AGS Only use the AGS specified in the list of acces- sories. Power cord J Potential equalization pin K Gas inlets Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 22: Gas Inlets

    E AIR outlet for endotracheal aspiration system (optional) F Connection for N O cylinder* G Connection for central N O gas supply* This connection is not available with the "Operation with- out nitrous oxide" option. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 23: Screen With User Interface

    Key for calling up the standard screen (optional) J Soft keys for ventilation settings U Parameter field for gas monitoring K Rotary knob: "select, set, confirm" L Key for switching over to Standby Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 24: Interface Panel

    Overview Interface panel Socket for SpO sensor (optional) COM 1 MEDIBUS, MEDIBUS.X interface COM 2 MEDIBUS, MEDIBUS.X interface IV System Connection for Dräger IV System Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 25: Flexible Arm For Breathing Bag (Optional)

    Overview Flexible arm for breathing bag (optional) A Flexible arm B Knurled screws (for mounting on the breathing system) C Circuit plug (for selftest) Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 26: Auxiliary Flowmeter And Mechanical

    B Mechanical breathing pressure gauge (optional) The mechanical breathing pressure gauge is, in addition to the electronic pressure measure- ment feature, a pressure measurement gauge for displaying the inspiratory breathing pres- sure. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 27: Gas Flow Diagram

    G Flow control -Flush Breathing bag J Vaporizer K APL valve L Anesthetic gas receiving system AGS M Absorber N Exp. valve O PEEP/P P Sample line sensor R Exp. flow sensor Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 28: Additional Functions

    MEDIBUS and MEDIBUS.X are software protocols for use in transferring data between Primus Infinity – Primus Infinity Empowered is equipped with an Empowered and an external medical or non-medi- Infinity ID module capable of exchanging data cal device (e.g., hemodynamic monitors, data man- with Infinity ID accessories.
  • Page 29 The system must fulfill the requirements for medical electrical equipment in accordance with the relevant standards, see chapter "Technical data", page 270. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 30: Abbreviations

    Pressure Support mode PAW-V loop Pressure/volume loop Hal. Halothane PEAK Peak pressure Heart lung machine PEEP Positive end-expiratory pressure Ratio of inspiratory time to expira- Inspiratory pressure in Pressure INSP tory time Mode Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 31 Trigger level Rise time SLOPE Vent. mode Ventilation mode V-Flow loop Volume flow loop Volume AF Volume mode AutoFlow Volume/ Volume Mode Vol. Mode Volume-controlled ventilation tidal volume Measured inspiratory tidal volume INSP Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 32: List Of General Abbreviations

    Millibar Ventilation pressures: cmH O = mbar = hPa. Milliliter For readability only the units hPa and cmH O are used. mmHg Millimeter of mercury Supply pressures: bar = kPa x 100. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 33: Symbols

    Alarm monitoring temporarily inac- Exit menu, tive return to preceding menu Apnea alarm disabled Remaining battery capacity (uninterruptible power supply UPS) Upper and lower alarm limit disa- Battery supply bled Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 34 Label for auxiliary AC socket (for moving, leaning on, leaning Desflurane vaporizer) against, etc. the device. Outlet Pressure regulator connection Fuse Order number Serial number Protect from sunlight! Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 35: Operating Concept

    ..... . . 45 Menu structure overview ....46 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 36: Screen Ergonomics

    – confirm the selected carrier gas or a ventila- tion mode – set and confirm the parameters for fresh gas and ventilation modes – set and confirm the monitoring functions Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 37: Keys With Permanent Functions (Hard Keys)

    Display in succession the three basic monitoring screens: standard screen, data screen, and trend screen. Briefly press the key until the required screen is displayed. Return to the standard screen. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 38: Keys With Variable Functions (Soft Keys)

    1 Push the hard key Man.Spont. (A). The LED in the key flashes. In addition, a flashing help text is displayed in the prompt field. 2 Confirm = push the rotary knob (B). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 39: Selecting/Setting Ventilation Parameters

    Confirm the PEEP value = push the rotary knob (B). The color changes from yellow to dark green. Confirm the symbol (C) to exit the menu Selecting/setting monitoring functions = push the rotary knob (B) Press the key (D). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 40: Selecting/Setting Configuration Parameters

    MEDIBUS MEDIBUS time interval interfaces log- baud rate(k) baud rate(k) MEDIBUS.X book 5 10 MEDIBUS V4 Alarm Caution 4 Select and confirm the arrow (F) to exit the menu. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 41: Color Concept

    2 Change, confirm the value = turn, push the ro- tary knob. The color changes from yellow to dark green, the set value has been confirmed and is now effective. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 42: Color Examples For Vertical Soft Keys

    Parameter bar – Orange cursor frame (D) around the menu title: selected submenu. – Parameters with dark green background (E): current selection. – Parameters in gray type: inactive and cannot be selected. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 43: Led Indicators Of The Device

    Malfunction of the corresponding C Power supply green input pressure reducer Primus Infinity Empowered can be supplied via the mains power or via a battery. The LED of the active power supply lights up green. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 44: Functions

    Operating concept General information about Infinity ID functions The Primus Infinity Empowered is equipped with an In addition, Primus Infinity Empowered issues Infinity ID module capable of exchanging data with an alarm if not all the expected breathing hoses Infinity ID accessories. Primus Infinity Empowered are connected, e.g., if the breathing bag is miss-...

  • Page 45: Loading Therapy-Related Data From Infinity Id Breathing Circuits

    Infinity ID hose set only remain valid for two hours, if not used. Only available when TVS (Transfer of Ventilation Set- tings) has been enabled by DrägerService and is in the Standby configuration. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 46: Menu Structure Overview

    Standby alarm limits self test results soda lime changed undo change leak test logbook page 1 page 2 delete trend do not delete delete 1) Only without configured CLIC absorber. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 47 COM 1 MEDIBUS COM 2 MEDIBUS select MEDIBUS screen layout layout 1 layout 2 layout 3 Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 48 1 trace 2 trace 3 remote service monitor. mode Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 49 (optional) alarms on/off 1) Only available with modes Volume, Volume AF, Pressure, Press. Support 2) Only available with modes Man.Spont., Ext. Outlet 3) Only available, when HLM mode is active Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 50 Operating concept paramet. settings scaling amplitude units agent monitoring logbook entries logbook entries triggered by system info general info trace 1 trace 2 trace 3 exit config. start timer Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 51: Assembly And Preparation

    Connecting the power supply ....72 Fuses for auxiliary outlets....72 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 52: Before First Use

    The green LED (A) lights up. of 35 °C (95 °F). Leave Primus Infinity Empowered connected to the electrical power supply for 10 hours. It does not need to be switched on. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 53: Information About Transport Within The Clinic

    – moving the device, other than for pure cali- jury to the patient and/or user. bration purposes. Observe the following points to prevent this haz- – removing the ceiling/wall-mounted device ard. from the corresponding holder. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 54 CLIC ab- sorbers and CLIC adapters. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 55: Accessory Weight Limits

    10 cm (4 in) distance of 10 cm max. (4 in) max. A maximum weight of 35 kg (77 lbs) may be applied to the rear of the device (gas cylinders, holders and ac- cessories). Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 56 Maximum weight per arm = 15 kg (33 lbs). CAUTION Risk of inadvertent movement If not properly secured, the device may move in- advertently during operation. Apply the brakes on the device to ensure it cannot be moved accidentally. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 57: Primus Infinity Empowered As A Wall/ Ceiling Device (Optional)

    Assembly and preparation Primus Infinity Empowered as a wall/ceiling device (optional) Characteristics – wall device Access to the back of the device The Primus Infinity Empowered can be The wall device is permanently installed and can be swiveled up to 90° from the wall.

  • Page 58: Characteristics - Ceiling Device

    Forta lift or Movita lift. The ceiling supply units can accommodate the Primus Infinity Empowered anesthesia machine if device receptacle M is used. An upper adapter (A) and a lower adapter (B) are required for this. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 59: Connecting The Gas Supply

    2 Connect the compressed gas hoses to the ter- minal units. 3 Make sure all supplies are connected correctly and functioning properly. With the "Operation without nitrous oxide" option, con- nection of an N O gas supply is not possible. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 60: Connecting The Backup Gas Cylinders

    Risk of supply failure If the valves remain open when connected to the central gas supply, gas may be withdrawn from the reserve gas cylinders. Close cylinder valves whenever the central supply is sufficient. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 61: Connecting The Anesthetic Gas Scavenging System Ags

    According to the particular requirements for an- 1 Connect the gray transfer hose (A) to the noz- esthesia workstations, the use of an anesthetic gas zles on the Primus Infinity Empowered and on scavenging system is required. the AGS. 2 Connect the scavenging hose to the scaveng- ing nozzle (B) of the AGS.

  • Page 62: Connecting The Endotracheal Aspiration System (Optional)

    If Air is used as driving gas: Secure the Air connecting hose of the endotra- cheal aspiration system to the central gas sup- ply (CS) for Air. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 63: Connecting The Patient System

    Use a Y-piece filter or filter on the inspiratory port. WARNING Risk of strangulation If not positioned with care, hoses, cables, and similar machine components may endanger the patient. Take special care when connecting the pa- tient. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 64 3 Connect both breathing hoses to the Y-piece (C). 4 Connect breathing bag (D) to breathing bag hose. 5 Attach the breathing bag hose to the bag elbow and hang the breathing bag on the hook. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 65 Y-piece and to the water trap. 8 Use the clip (G) for the sample line to ensure the sample line is correctly routed. This clip should be attached to the expiratory port of the breathing system. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 66 HME filters or other filters at the Y-piece if sample gas is being taken at the tube adapter. Note the resistance of the breathing system and connected accessories. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 67 (air trap- ping). In pressure-controlled ventilation, an increased re- sistance can reduce the inspiratory or expiratory volume. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 68 Every time a new Infinity ID hose system is con- 6.0 hPa (cmH O) at 60 L/min may not be exceeded. nected to the Primus Infinity Empowered the com- pliance and leakage values stored on the hose can The "Technical Data" chapter states the inspiratory...

  • Page 69: Connecting The Flexible Arm For The Breathing Bag (Optional)

    To avoid contaminating the ambient environment and endangering the patient, always double- check to make sure the correct vaporizer is being opened before doing so. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 70: Connecting The Electrical Connections

    1 Connect to auxiliary outlets (A) at the back of the workstation. 2 Install the Desflurane vaporizer in its mount and connect it to the outlet on the side of the ma- chine, see page 79. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 71: Establishing Potential Equalization

    2 Connect the potential equalization cable to a potential equalization connector of the hospital (e. g. wall, ceiling supply unit, operating table). 3 Establish potential equalization to additional de- vices using the potential equalization pin (B). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 72: Connecting The Power Supply

    Fuses for auxiliary outlets If a fuse is tripped (position 0): Remedy the fault, then press the switch at the automatic fuse to the position I. The fuse is active again. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 73: Getting Started

    Self test results ......88 Emergency start ..... . . 89 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 74: Device Check

    CAUTION Risk of inadvertent movement If not properly secured, the device may move in- 1 Switch on Primus Infinity Empowered: press the advertently during operation. system power switch (A), an acous- Apply the brakes on the device to ensure it cannot tic tone sounds.

  • Page 75: Check List

    – Gas scavenger connected and flow ad- justed? – Soda lime OK? D Miscellaneous – Water trap fill level OK? – Suction OK? – Emergency resuscitator present and functional? Only without configured CLIC absorber. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 76: Central Gas Supply Cs

    Standby Conf., see page 175. Only these gas supplies will then be checked during the self test and an alarm issued in the event of a fault dur- See page 266 for precise details on cylinder pres- sures. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 77: O 2 -Flush

    3 Breathing bag (C) inflates with an audible flow. 4 Turn safety knob (D) back to its original position to discontinue O emergency delivery and press it inwards. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 78: Emergency Resuscitator

    1 Locking levers (A) point to the left = locked po- sition. 2 Check the sight glasses (B) and ensure an ad- equate filling level. 3 Ensure that the control dial is set to 0 and button (C) is engaged. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 79 Avoid catching the D-Vapor power cable be- using a short cable. hind/underneath the housing. Make sure that the D-Vapor is upright. Always perform a leak test after mounting the vaporizer. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 80: Breathing System

    If during operation the absorber is for any reason no longer able to be identified by the anesthesia machine, an alarm condition will be generated. If confirmed, this alarm condition will no longer be displayed. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 81: Anesthetic Gas Scavenging System Ags

    For diaphragm location and disassembly instruc- tion see page 220. 3 The AGS is functioning when the float in the flow tube is between the two marks (C). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 82: Emptying The Water Trap

    20 mL) without a cannula into the blue socket (F). 3 Extract water, remove syringe and dispose of full syringe as infectious hospital waste. 4 Slide the water trap back into its holder – until it engages tangibly. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 83: Preparing Primus Infinity Empowered For The Self Test

    2 Make sure the sample line (B) is connected to the Y-piece and to the water trap. 3 Set the APL valve (C) to position Man and to 30 hPa (cmH Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 84: Self Test

    The self test is started. It proceeds automatically and takes approx. 5 minutes. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 85: System Compliance

    WARNING Risk of device failure and patient injury Functions coded red must be remedied before starting, e.g., if there is no O supply. The device cannot be operated in this state. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 86: Locating And Eliminating Leakages

    123. O Breathing bag Leakage Man. Spont. – Leak test in the complete system. – Indication of leakages >150 mL/min and with red/yellow/green test result indicator. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 87: Proposals On How To Systematically Rule Out Components When Looking For Leaks

    – 15 mm circuit plug for occluding the Y-piece is scratched or damaged – Vaporizer fill or drain connections leaky or opened, vaporizer not mounted correctly, O-ring missing or handwheel not set to 0. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 88: Self Test Results

    Yellow CONDITIONALLY FUNCTIONAL be detected by the Primus Infinity Empowered and A non-critical fault has been detected. can be stored in the self test results. Primus Infinity Empowered may be used, but call DrägerService or your lo-...

  • Page 89: Emergency Start

    35 seconds. After ten cancellations, the self test cannot be can- celed the next time that Primus Infinity Empowered is started and a complete self test must be carried out.
  • Page 90 To start Primus Infinity Empowered: 1 Set the safety knob for O emergency delivery to 0 and press it inwards. 2 Select the fresh-gas setting and ventilation mode, see "Operation" on page 91. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 91: Operation

    Changing between ventilation modes..117 Using non-rebreathing systems ..119 Ending the external fresh gas mode..120 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 92: Operation

    Ventilation Settings Ventilation settings are automatically transferred. Ventilation mode settings, which are different from those offered in Primus Infinity Empowered, are au- tomatically transferred into that mode offering the most similar respiratory support. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 93 The numerical values are taken as is, for the follow- port the patient’s spontaneous breathing efforts, ing alarm limits: Primus Infinity Empowered will also take this set- ting, as long as the software option has been acti- – minute volume high and low vated.

  • Page 94: Loading Default Settings

    Changing the patient weight during Volume, Vol- ume AF, Pressure, and Press. Support has no ef- Press the soft key restore default settings (A) fect on the current ventilation settings. and push the rotary knob to confirm. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 95: Setting Fresh-Gas Concentrations

    Standby mode (soft keys = light green). A corresponding text No fresh-gas delivery! (C) is displayed. The fresh-gas flow is not enabled until a ventilation mode has been started (soft keys = dark green). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 96: Selecting The Carrier Gas

    (hypoxic gas mixtures) in the breathing system. To avoid this risk, use a suitable soda lime such as, e.g., Drägersorb Free, or set higher fresh-gas flows. Always use the patient-gas measurement module of the anesthesia machine. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 97: Sorc (Sensitive Oxygen Ratio Controller)

    18.00 (maximum) composition. Carefully check the gas composition. Fresh-gas flow [L/min] WARNING Primus Infinity Empowered is fitted with an elec- tronic O minimum delivery system to avoid hy- Risk of patient awareness poxic gas mixtures when N O is selected as carrier If a complete gas supply failure occurs, fur- gas.

  • Page 98: Setting The Vapor

    2 Press 0 key (B), engage handwheel at 0. Wait 5 seconds for pressure to equalize. 3 Press 0 key and turn handwheel (C) counter- clockwise to set the required anesthetic gas concentration. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 99: Ventilation

    Route all cables away from the APL valve. Do not hang lines, hoses or cables, e.g., the sam- ple line, on or near the APL valve. Release pressure from the breathing system by lifting the valve head. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 100: Start Manual Ventilation/Spontaneous

    Man.Spont. Certain alarms are disabled automatically in the Man.Spont. ventilation mode in order to avoid arti- facts. See page 132 for a list of alarms which are active in the Man.Spont. mode. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 101: O 2 -Flush

    O while bypassing the va- porizer. Press the O + (A) button. O flows into the breathing system without anesthetic agent as long as the button is held down. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 102: Volume Mode

    ∆ . The maximum time interval for controlled ventilation is set via the frequency. To maintain a constant frequency, a time interval triggered prema- turely is compensated in the next cycle. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 103 1 Press the soft key extra settings (A). The trig- ger sensitivity soft key Trigger (B) is displayed. sync. Volume 2 Press the soft key Trigger (B). The last value set appears as default value when the key is ac- tivated. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 104 V Pressure support is automatically deactivated when the trigger is deactivated and set to OFF. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 105 I:E remains constant. Only applies if trigger = OFF, see "Ventilator and gas delivery" on page 175. 4) The resultant ratio of inspiration to expiration I:E is also displayed in parallel. 5) Optional Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 106: Volume Mode Autoflow - Volume Af (Optional)

    T 6.9 s at Freq. INSP tory breath is volume-controlled in order to identify 100/min the necessary pressure level, if it is not known from a previous ventilation mode. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 107 A mandatory breath triggered by the patient is rep- resented in the pressure curve and in the flow curve by a continuous vertical black line (trigger indica- Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 108 V Pressure support is automatically deactivated when the trigger is deactivated and set to OFF. The current trigger status is shown above the keys for the ventilation parameters (H). Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 109 I:E remains constant. Only applies if trigger = OFF, see "Ventilator and gas delivery" on page 175. 4) The resultant ratio of inspiration to expiration I:E is also displayed in parallel. 5) Optional Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 110: Pressure Mode Ventilation Mode

    . The maximum time interval for controlled ventilation is set via the frequency. To maintain a constant frequency, a time interval trig- gered prematurely is compensated in the next cy- cle. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 111 A mandatory breath triggered by the patient is rep- tion will now be activated automatically with the last resented by a continuous vertical black line in the trigger setting used. pressure curve and in the flow curve (trigger indica- Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 112 Insp. pause time: 0 to 60 Insp. time INSP PEEP 0 to 20 [hPa (cmH max. P –5 INSP Trigger sensitivity OFF, Trigger 0.3 to 15 (Pressure [L/min] Support) (Volume Mode/ Pressure Mode) Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 113 4) Depending on the configuration, the pressure limit value can also be changed automatically when the PEEP INSP value is changed. See "Starting the preset ventilation mode" on page 116 and "Ventilator and gas delivery" on page 175. 5) Optional Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 114: Pressure Support Mode (Optional)

    Inspiration is ended as soon as the current inspira- tion flow drops below 25 % of the inspiratory peak flow. Any leakage is compensated simultaneously by means of the actual airway pressure. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 115: Continuous Positive Airway Pressure Cpap - In Pressure Support Mode (Optional)

    2) The inspiratory time is limited by adjustment of Freq Apnea ventilation with minimum frequency is not to yield a maximum ratio of 1:1 for I:E, thus ensuring an adequate expiratory time. appicable in the CPAP mode. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 116: Presetting The Ventilation Mode

    10 seconds an audible tone sequence of 5 seconds is issued. 2 Adjust the ventilation parameter Frequency via the rotary knob and push the rotary knob to con- In this example, the system returns to the volume- firm. controlled mode. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 117: Changes In Peep

    Trigger were set to OFF, the last values Changes in T INSP used are adopted in Pressure Support mode. The configured default settings are used in all other may be reduced simultaneously if T SLOPE INSP cases. reduced. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 118 Mode) is used for the first time, the pre-config- ured default settings can be adopted. This also ap- plies when the patient is ventilated in an automatic ventilation mode (e. g., Pressure Mode) before switching to manual ventilation Man.Spont.. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 119: Using Non-Rebreathing Systems

    Place a T-piece with filter between the mask Certain alarms are disabled automatically in order pipe and fresh gas connection port. to avoid artifact, see table on page 132. If applicable, use the Luer Lock connector on a filter. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 120: Ending The External Fresh Gas Mode

    Ventilation via the internal rebreathing system in Primus Infinity Empowered is restored directly in this way. When changing from the external non-rebreathing system to the rebreathing system in Primus Infinity Empowered: Reconnect the sample line to the Y-piece. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 121: Changing Patients

    Restored default settings may contain set- tings inappropriate for a new patient. After default settings have been restored, make sure the ventilation and monitoring set- tings are appropriate to the patient connected. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 122: Disposable Absorber Drägersorb Clic

    2 Slide the disposable absorber off the mount (B). 3 Dispose of the spent absorber. Refer to the instructions for use of the Drägersorb CLIC absorber for information on disposal. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 123: Reusable Absorber

    5 Fill the absorber to the upper mark with fresh soda lime. 6 Fit the absorber into the breathing system from below and turn it clockwise as far as it will go. Only without configured CLIC absorber. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 124 Volume Mode/Pressure Mode in about Close the vaporizer unit, turn the handwheel to 30 seconds, then system compliance is determined for volume correction and the overall system is checked for leaks in the breathing system. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 125: End Of Operation

    3 Leave Primus Infinity Empowered plugged into mode. the power supply in order to charge the uninter- ruptible power supply UPS. During this time, Primus Infinity Empowered can be restarted immediately by pressing the system 4 We strongly recommend switching off the de- power switch again.

  • Page 126: Switch Off The Anesthetic Gas Scavenging System Ags

    Risk of battery failure Allowing the battery to run low can damage it. It must be charged at least every four weeks. If Primus Infinity Empowered is not used for an ex- tended period: Unplug the medical gas hoses from the terminal units of the central gas supply.

  • Page 127: Alarms

    Setting the alarm tone ....139 Alarms in the Standby mode....139 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 128: Alarm Displays

    When this soft key is pressed, the upper curve dis- play (D) is replaced by up to six additional alarm fields for 15 seconds. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 129: Alarm Priorities And Alarm Signals

    Tone sequence* Standard: In the case of a short alarm duration, only half of the se- E-E-E--E-B -----E-E-E--E-B quence (5 tones) is annunciated. *** The third tone is one octave lower. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 130: Suppressing Alarms

    (B). If the upper and lower alarm limits of a monitoring parameter have been disabled, but the respective apnea monitoring feature is still active, the symbol appears next to the parameter. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 131: Alarm Behaviour When Changing Ventilation

    (D) next to the date with an indication of the si- lence time remaining (minutes:seconds). To enable the alarm tone: Press the key (C), the yellow LED turns off. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 132: Limit-Based Alarms Activated In Respective Ventilation Modes

    Support Man.Spont. Alarm Press. Support CPAP – – Pulse [1/min] etCO [mmHg] – – inCO [mmHg] [L/min] – – [Vol%] inHal [Vol%] – – inIso [Vol%] – – inEnf [Vol%] – – Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 133 15/30 seconds depending on the set frequency/Freq All apnea and limit-based O , CO O, and agent alarms are only active if a breath has already been detected (AutoWakeUp). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 134: Enabling/Disabling Co

    Standby for switching to Man.Spont.. When the alarm limits are enabled the value is adopted from the automatic ventilation mode, see page 171. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 135: Hlm Mode

    1 Press the soft key config. (A) on the standard or data screen. The submenu volumes/ alarms is opened. 2 Select and confirm the column alarms on/off (B) via the rotary knob. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 136: Enabling/Disabling Spo

    3 Select and confirm the line SpO (C) via the ro- tary knob. 4 Select and confirm on or off via the rotary knob. Suppressed alarm limits are identified by the sym- in the parameter field. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 137: Displaying And Setting Alarm Limits

    To set an alarm limit: [Vol%] 0 to 8.3 Place the cursor on the alarm limit by turning the rotary knob and push to confirm. The alarm limit is highlighted in yellow. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 138: Adapting Alarm Limits

    The new alarm limits for P are calculated by 3.6 8.4 10 30 Primus Infinity Empowered on the basis of the mean values for PEAK, PLAT, and PEEP over the last four mechanical breaths. Spontaneous breaths by the patient and triggered pressure support breaths are not taken into account.

  • Page 139: Setting The Alarm Tone

    All technical alarms, e.g., failure of device compo- nents and a number of special operating states, are also indicated by Primus Infinity Empowered when in Standby. A corresponding message appears in the alarms field, but without any acoustic warning. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 140 This page was intentionally left blank. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 141: Monitoring

    Mini trend for CPAT/PEEP ....155 Selecting the data screen ....156 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 142: Selecting The Standard Screen

    By pressing the key (B), By pressing the key (A) repeatedly. Display (example): Volume The most important parameters are grouped to- gether on the right (C) and left sides of the screen. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 143: Monitoring Mode

    Select, edit, and confirm the curve or module to be changed and confirm with the rotary knob. All three screen layouts with three curves and indi- vidual modules can only be configured in the menu Standby Conf., see page 170. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 144: Displayed Parameters

    : Minimum alveolar concentration : Measured inspiratory tidal vol- INSP – Trend curve for anesthetic gases and MAC ∆ : Difference between inspiratory and expiratory tidal volume : Spontaneously breathed expira- SPON tory minute volume Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 145: Volumeter

    MV SPON cit. – Trend curve for MV and C see page 151 for a detailed description see page 152 for a detailed description Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 146: Loops (Optional)

    15 minutes for the fol- lowing parameters: – MV*CO – O Uptake and – C /PEEP. see page 153 for a detailed description see page 154 for a detailed description Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 147: Gas Measurement

    The MAC values are dependent on the age of the CAL. patient. The values indicated in the table relate to an age of 40 years. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 148: Age-Dependent Mac Values

    MAC calculation according to the ambient pres- sure. NOTE The age "1" is used when the age is set to "<1". Special attention is required for patients younger than one year. 40 years Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 149: Xmac Display (Mac Multiple)

    0.1 MAC or greater. The gas with the higher expir- atory xMAC value is displayed above the second- ary gas. 10 years Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 150: Automatic Agent Alarm Activation

    It adapts only to increasing xMAC values. Primus Infinity Empowered generates an advisory message MAC low as soon as the expiratory xMAC value falls be- low the alarm limit (B). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 151: Using The Volumeter Function

    60 seconds. The measured values are displayed Lower bar graph for 4 minutes and then deleted. 1000 Volumeter 47 s Expiratory phase Volumeter (minute volume measurement). Numerical indication of the expiratory minute vol- ume. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 152: Econometer (Optional)

    – leakage, and – the CO volume absorbed. surplus efficient deficit fresh-gas flow If data for calculation are not available, the legend appears in gray and the bar graph is not active. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 153: Loops (Optional)

    The scale of the P and flow axis depends on the scale selected for the real-time curves. The scale of the volume axis depends on the scale of the volum- eter. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 154: Mini Trends (Optional)

    Press the Screen Layout softkey (A). The scaling depends on the expiratory tidal volume Select a parameter module and select the corre- and is automatically adjusted. sponding mini trend. MV*CO 1000 1000 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 155: Mini Trend For O 2 Uptake

    The scaling for PEEP is set to 20 mbar. uptake The scaling for C depends on the expiratory tidal volume V and is automatically adjusted. 1000 1000 1000 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 156: Selecting The Data Screen

    P (B). The bottom right-hand field (C) shows the pressure values for the central supply of O O, and Air, as well as for the O and N O reserve gas cylinders. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 157: Selecting The Trend Screen

    C Recruitment (optional) / PEEP Trend / MV*CO Trend / Uptake trend D SpO pulse (optional) Press the key repeatedly until the trend screen is displayed. The trend page agents (A) is displayed first. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 158: Zoom Function

    This soft key is ineffective if there is insufficient trend data available (e.g., less than 30 minutes of operation). To delete: Press the soft key delete (B). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 159: Selecting The Logbook

    Volume ters, such as SpO and pulse. Volume To return to the standard screen: Press the soft key exit logbook (D). Press the soft key logbook (A). Press the key. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 160: Using The Timer Function

    Only OxiMax sensors or Durasensors from Nellcor must be used (see separate list of accessories). The OxiMax modules implemented in Primus Infinity Empowered are only compatible with the OxiMax sensors (purple probe or white probe for MAX FAST). Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 161 Mobility of Limited activity Inactive Limited Inactive Limited the patient patients activity patients activity only only, must checked at least every 8 hours Preferred Ball of the Finger Nose Forehead measuring foot point Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 162: Safety-Relevant Information

    The pulse signal might fail. Do not position the SpO sensor where it might be affected in this way. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 163: Applying The Durasensor Ds-100 A

    The pulse signal might fail. – In the presence of shock, low blood pressure, severe vasoconstriction, major anemia, hypo- thermia, arterial occlusion proximal to the sen- sor and asystolia, the pulse signal may fail. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 164 CAUTION Risk of inaccurate data If simulators are used as calibrators, the SpO module may produce incorrect data. Simulators must not be used as a calibrator. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 165: Configuration

    Setting the patient's age and weight during operation ..... . . 183 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 166: Configuring The Default Settings

    DrägerService or a new password set. 3 Select and confirm the figures successively from the line displayed (E) via the rotary knob. The password is represented by asterisks (* * * *) below the line of numbers. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 167: Basic Settings And Audible Signals

    Primus Infinity Empowered takes into account the national regulations of certain countries which re- quire a minimum volume of 45 dB(A). Settings 1 to 3 are not available for these countries. Only in connection with breathing sound module. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 168: Parameters

    <1 year: 50 mL, unsuccessful. A 21 Vol% O calibration is per- 1 to 2 years: 150 mL, formed automatically if the calibration is >2 to 10 years: 500 mL, aborted. >10 years: 1000 mL. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 169: Interfaces/Logbook

    The logbook stores up to 600 entries. If the logbook caution alarms: yes/no is full and new entries are to be stored, the logbook Entries are made when a deletes the oldest entries. caution message is is- sued. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 170: Screen Layout

    / MV agent eter or status displays. The available modules are displayed when a vent. vent. vent. module is selected. supply Each curve/module can also be configured as be- ing blank. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 171: Setting Alarm Limits

    0 to 8.3 – – Pulse 21 to 250 [1/min] 20 to 249 inIso 0.1 to 8.4 [Vol%] 0 to 8.3 – – 19 to 99; – – – – [Vol%] 18 to 98 Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 172 Man.Spont. can be activated or deactivated in Standby. When the alarm limits are set to Yes, the value set in the automatic ventilation mode is adopted. For further information, see "Remedying faults" on page 185. Standby Conf. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 173 Select whether Infinity ID ventilation circuits (patients <6 years): yes/no are used or not. Further information, see page 172. Only available if the Infinity ID functionality for the Infinity ID CLIC absorber has been activated by DrägerService. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 174 Standby. Certain alarms are automatically turned off in Man.Spont., Monitoring, and Ext. Outlet, see ta- ble on page 132. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 175: Ventilator And Gas Delivery

    The same also applies with ∆ regard to adopting the value for although this cannot be configured in the Volume Mode, Vol- ume AF Mode and Pressure Mode. – Gas delivery (G) Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 176 –2 will not be exceeded. This is also ∆ valid for changes to Factory setting: yes Only available when the transfer of ventilation settings for Infinity ID breathing hoses has been activated by DrägerService. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 177 Press exit (I), to exit the menu. ferred to the patient's body weight, the initial value for V can be selected in accordance with the Radford nomogram. Factory setting: yes – preset configuration: (G) Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 178: System Information

    Only use the Remote Service Link on medical devices which are not otherwise in use. This is a law according to the MPG. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 179 Shut down the device after completion. 3 Connect the Remote Service Link to the COM 1 interface. The service data of Primus Infinity Empowered can now be transferred. For further operation, see in- structions for use for the Remote Service Link.

  • Page 180: Configuration During Operation

    The volume depends on the set patient age. This dependency allows optimal volume at all flow lev- els. All alarms are still audible with the breathing sound volume set to the maximum. Only in connection with breathing sound module. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 181 – Alarm scaling frame is exceeded. Entries are triggered when a warning is is- sued. – Caution Entries are made when a caution message is issued. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 182: Screen Layout

    F trace 1, trace 2, trace 3 ble modules. Description of internal equipment states and pa- rameters. Press the soft key exit sys. info (G) to exit the system information. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 183: Setting The Patient's Age And Weight During

    The keys can be accessed directly in the Man.Spont., Ext. Outlet, and Monitoring mode. Man.Spont. Select the soft key age (D) or weight (E) to change and confirm with rotary knob. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 184 This page was intentionally left blank. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 185: Remedying Faults

    System failure ......193 Alarm – Cause – Remedy....194 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 186: Power Failure

    If all electrical power fails, all individual settings, in- will be dark and automatic ventilation will cluding alarm limits which are not saved in the de- cease. fault settings, will be lost. The patient must be ventilated manually! Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 187: Gas Failure

    LED below the screen will light up red. Primus Infinity Empowered then delivers air or instead of the set gas mixture: – Primus Infinity Empowered delivers 100 % Air if has failed. – Primus Infinity Empowered delivers 100 % O O has failed.
  • Page 188 When the central gas supply is connected, the smallest internal leakage can cause contami- nation of the supply gases. Disconnect the compressed gas hoses from the terminal unit if the central gas supply fails during operation. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 189: Ventilator Failure

    Set the APL valve to a correct pressure limit- ing value and ventilate the patient manually. WARNING Risk of patient injury If pressure and volume monitoring fails, the patient cannot be adequately monitored. Ensure adequate substitute monitoring! Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 190: Fresh Gas Delivery Failure

    Risk of patient injury If the fresh-gas delivery fails, the anesthesia machine automatically discontinues the fresh-gas flow. An O flow must be delivered to the patient. Check vaporizer setting, Set O emergency supply. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 191: Ventilator And Fresh Gas Delivery Failure

    Monitoring mode. 1 Check vaporizer setting. 2 Set the safety knob of the O emergency deliv- ery to the required flow. Range: 0 to 12 L/min. This flow streams through the vaporizer. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 192: Gas Measurement Failure

    5 Ensure adequate substitution monitoring. User interface failure If the soft keys or the rotary knob are not opera- tional: 1 Select the Monitoring mode, see page 143. 2 The patient must be ventilated manually. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 193: System Failure

    Disconnect the workstation from the patient and use an alternative method of ventilation. 1 Switch Primus Infinity Empowered off and on again: press the system power switch (A). 2 Cancel the self test: Press the soft key cancel test (B).

  • Page 194: Alarm - Cause - Remedy

    (in Standby only) Call DrägerService. Note/ AIR CYLIND. CONNECT.? * Pressure sensor for re- Check pressure sensor serve gas cylinder not con- connection. – nected. (8/–) Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 195 (detected by pres- be ventilated manually! sure, volume, and CO Check patient's spontane- monitoring). ous breathing ability. Check ventilation setting. Check fresh-gas setting. Make sure everything is connected. Check hose system and tube! Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 196 (24) Check patient's spontane- Warning ous breathing ability. (31) Make sure everything is connected. Check hose system and tube. Breathing/ventilation has Patient must immediately stopped. be ventilated manually! Check ventilation setting. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 197 Insufficient fresh gas sup- Check fresh-gas setting. ply. page 174) Leak or blockage in tube or Check hose system, tube, hose system. and microbial filter. (31) Patient not connected. Connect patient correctly. ≥0 >30 sec. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 198 (in Standby only) Call DrägerService. Note COM 1 FAIL Communication via the cor- Check the plug connection responding COM port has on Primus Infinity COM 2 FAIL been interrupted. Empowered and the on-line equipment. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 199 Workstation must be inside the device is defec- switched off! tive. A defective fan together with an internal leak may cause higher O concentra- tions inside the worksta- tion. Risk of fire Call DrägerService. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 200 (29/10) required O flow, between 0 and 12 L/min. Make sure the fresh gas flows into the breathing cir- cle used (breathing system or ext. fresh-gas outlet). Call DrägerService. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 201 Breathing hoses and other Exchange breathing hoses. accessories, which are Use only compatible acces- – connected, are not in- sories with Primus Infinity (11/–) tended to be used with Empowered. Primus Infinity Empowered. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 202 Dead space ventilation. Check ventilation settings. Note INSP. FLOW SENSOR FAIL Insp. flow sensor is defec- Replace flow sensor, tive. see page 220. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 203 Warning (31) = Insp. gas concentration > upper alarm limit for >180 seconds. Inspiratory anesthetic gas Check the vaporizer and concentration exceeds the fresh-gas settings. upper alarm limit for at least 2 breaths. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 204 Data loss of the settings Check the current settings and/or the system configu- and the default settings. – ration. Repeat settings if neces- (14/–) sary. Call DrägerService. Alarm can be canceled by pressing Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 205 Confirm alarm, if case is alarm limit of the automatic closed. (14/7) agent alarm. Check vaporizer fill level. Check correct position of vaporizer. Check for leakages in breathing system. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 206 O supply not (25/7) available or not connected. Use the central gas supply. Note O SENSOR FAIL O gas measurement Use external gas measur- system has failed. ing system. (in Standby only) Call DrägerService. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 207 No pulse signal detected Check patient's condition! with the SpO measure- Check application of SpO (31) ment for approx. sensor. 10 seconds. NiBP measurement on the Measure blood pressure on same arm. the other arm. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 208 Restore central gas supply. Note Observe battery capacity. (12/7) Prepare manual ventilation. Short-circuit in one of the Unplug appliance connec- units connected to an auxil- tor from auxiliary outlet. iary outlet. Restore central gas supply. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 209 Negative pressure due to Make sure upper dia- fault in ventilator. phragm is correctly in- stalled. Call DrägerService. Anesthetic gas scavenging Check anesthetic gas scav- system is defective. enging system. Call DrägerService. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 210 Absorber expired. (Only available if this func- tionality is activated by DrägerService.) Caution SODA LIME DISCONN.* Infinity ID CLIC Absorber Check and connect not correctly connected. Infinity ID CLIC Absorber. – (11/–) Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 211 Note tion. Anesthetic gas scav- (27/10) enging system is not active when the ventilator unit is disconnected. The ambient air may be- come contaminated with anesthetic agents! Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 212 Connect sample line. ured values values concerned have Connect SpO Sensor. been temporarily disabled. Connect patient. The alarm system is wait- ing for automatic measure- For more details ment wake-up see page 130. (AutoWakeUp). Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 213 171. next to measured values cerned has/have been dis- abled. Grayed out measured val- The specified accuracy cannot be maintained. Grayed out values The set value differs from the delivered value. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 214 This page was intentionally left blank. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 215: Cleaning, Disinfection And Sterilization

    AGS ......234 Connecting the secretion aspirator..235 Before using on patients on again ..236 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 216: Disassembly

    Sample gas lines are single-use articles and must be replaced, not disinfected. The sample line is a single-use article which must be disposed of in accordance with the hospital's hy- giene regulations. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 217: Removing The Patient System

    Always check the breath- ing hoses for damage prior to use. Damaged breathing hoses must be replaced. Removing the microbial filter (optional) Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 218: Removing The Ventilator Module

    1 Press the button (A); the mounting swings Removing the flexible arm and breathing open. 2 Slide the disposable absorber off the mounting (B). 1 Take the breathing bag off the arm. Note the Drägersorb CLIC instructions for use. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 219: Removing The Breathing System

    1 Loosen the three sealing screws (A) on the ven- tilator a quarter turn counterclockwise using the key supplied. 3 Remove the insert from the absorber (D). The inner and outer sealing rings remain on the ab- sorber insert. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 220: Removing The Ventilator Diaphragm

    Remove the upper diaphragm (A) and prepare Disinfect and clean the flow sensor as described it for conditioning in a cleaning and disinfecting in the instructions for use of the Spirolog and machine. SpiroLife flow sensors. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 221: Opening The Breathing System

    5 Place the metal valve plate in the cleaning and disinfecting machine. Removing the anesthetic gas scaveng- ing system AGS 1 Loosen the five sealing screws (A) a quarter turn counterclockwise using the key (B) sup- plied. 2 Remove the cover. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 222: Removing The Secretion Aspiration System

    The particle filter may be disposed of with ordi- nary domestic waste after being sealed, see "Maintenance" on page 237. Note the instructions for use of the anesthetic gas scavenging system AGS. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 223 Note the instructions for use of the suction unit. The system has been designed and verified for the procedures, chemicals, and values given in this chapter. If other procedures, chemicals, and/or val- ues are used, the user assumes all responsibility. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 224: Reprocessing Procedure

    2 Perform surface disinfection (scrub-and-wipe Machine cleaning: disinfection). – Neodisher Medizym by Dr. Weigert 3 After the contact time has elapsed, remove dis- infectant residues. Machine disinfection: – Thermal, 93 °C (199.4 °F) for 10 min Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 225: Semicritical Medical Devices

    3 Check parts for visible dirt and damage. If nec- The valve plate must be sterilized after wash- essary, repeat manual disinfection. ing in order to dry it. 4 Thoroughly shake out residual water. Allow items to dry thoroughly. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 226: Visual Inspection

    Only sterilize cleaned and disinfected items. For sterilization, use a vacuum steam sterilizer (in accordance with DIN EN 285), preferably with frac- tionated vacuum. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 227: Reprocessing List

    The instructions of the hospital's hygiene officer shall prevail! 2) Drain any water which may have collected in the ventilator diaphragm. Larger quantities of condensation may impair operation of the workstation and/or lead to failure of the equipment! Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 228 2) The valve plate must be sterilized after washing in order to dry it. Correct operation of the workstation may be impaired and lead to failure of the workstation if the control areas in the valve plate are not dried completely. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 229: Assembly

    2 Fit the metal valve plate (B) onto the bottom nection in the slot. section. 2 Push in the expiratory and inspiratory ports (B), with the nose of the port in the slot. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 230: Filling And Fitting The Absorber

    This ensures that the absorber is in- cluded in the leak and compliance test of the ma- chine. To click the absorber into place: 5 Hang the breathing system (D) into the ventila- tor module. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 231 6 Reset the soda lime change log to current date can impair the functionality of Primus Infinity by pressing the soft key soda lime changed, Empowered. see page 88. Function not available at present. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 232: Installing The Flexible Arm (Optional) And Breathing Bag

    88. 1 Position the socket of the arm on the breathing system and tighten it with the two knurled screws (A). 2 Check that the arm is fixed securely! Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 233: Inserting The Ventilator Module

    63. WARNING Risk of burns Conductive breathing hoses or face masks may cause burns during HF surgery. Do not use these types of hoses and masks in combination with HF surgery. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 234: Connecting The Anesthetic Gas Scavenging

    NOTE Primus Infinity Empowered (no accessories) is not made with natural rubber latex. To minimize the risk of exposure to latex, use la- tex-free breathing bags and breathing hoses. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 235: Connecting The Secretion Aspirator

    Note the instructions for use of the anesthetic gas scavenging system AGS. 3 Grip the silicone sleeve of the bottle cover and fit it on the bottle (D). Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 236: Before Using On Patients On Again

    Observe the instructions for use of the endotra- cheal aspiration system. Before using on patients on again 1 Re-assemble all equipment, see "Assembly and preparation" on page 51. 2 Check readiness for operation, see "Getting started" on page 73. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 237: Maintenance

    Replacing the water trap....243 Replacing the O sensor ....244 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 238: Overview

    Preventive maintenance Recurrent specified measures intended to maintain the functional condition of a medical device Repair Measures intended to restore the functional condition of a medical device af- ter a device malfunction Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 239: Inspection

    – Check O measurement. – Check CO measurement and AGAS meas- urement. – Check flow measurement. – Check pressure measurement. – Check battery backup for function. – Check concentration delivery of anesthetic vaporizer. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 240: Preventive Maintenance

    Replace when blocked. Replace Users Filter of the endo- Replace every two Replace Users tracheal aspiration weeks. system Upper diaphragm of Must be replaced after Replace Users ventilator unit one year at most. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 241 Filter mat, housing Every 2 years Replace Service personnel cover Sintered filter, gas Every 2 years Replace Service personnel inlet PEEP diaphragm, Every 2 years Replace Service personnel breathing system Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 242: Repair

    Technical customers documentation according to IEC/EN 60601 is available upon request. Repair Dräger recommends that all repairs are carried out by DrägerService and that only authentic Dräger repair parts are used. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 243: Emptying Or Replacing The Water Trap

    Such contamination affects the gas measure- ment which may fail as a result. The water trap must be replaced after a serv- ice life of four weeks. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 244: Replacing The O 2 Sensor

    It must be replaced if – the message O SENSOR FAIL is displayed or – the sensor can no longer be calibrated. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 245: Disposal

    For countries subject to the EU Directive 2002/96/EC ....246 Disposal of non-rechargeable batteries ..246 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 246: Disposing Of The Medical Device

    Therefore, the battery in the device must be removed by a suitably qualified person before disposal of the device. Ob- serve the applicable laws and regulations for bat- tery disposal. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 247: Technical Data

    Device combinations ....276 Connections to IT networks ... . . 276 Information on connecting to the IT-network . . 277 Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 248: Technical Data

    50 %. If more than one of the ambient con- ditions are changed, the accuracy may change by up to 100 %. All patient-related volume values and flow values have been standardized to the cur- rent ambient conditions. (ATPD) Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 249: Ambient Conditions

    2) The longer-term storage at a temperature outside this range may shorten the life of the batteries. 3) The maximal permissible fresh-gas flow may be limited depending on the anesthetic agent vaporizer used. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 250: Ventilator

    ±10 % of set value or at least ±3 hPa (±3 cmH Inspiration pressure P INSP In Pressure Mode (PEEP +5) to 70 hPa [(PEEP +5) to 70 cmH Accuracy ±10 % of set value or at least ±3 hPa (±3 cmH Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 251 1) Due to gas measurement sampling, leakage (both at the patient and in the device), and resistance/compliance of the pa- tient and the breathing circuit, the maximum delivered tidal volume may be limited. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 252: Breathing System

    1) Due to gas measurement sampling and leaks (both at the patient and in the device), the end-expiratory PEEP value may be lower than specified at the end of long expiratory phases. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 253 (±6 cmH O), with hose set for adults (–4.4 cmH (4.2 cmH M30146 As per ISO 8835-2, dry, sole breath- –3.5 hPa 3.2 hPa ing system without patient hoses (–3.5 cmH (3.2 cmH Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 254: Fresh-Gas Outlet For Non-Rebreathing Systems (Optional)

    Graduated connection for use with various hose diameters Flow range 0 to 10 L per minute Resolution of the displayed value 0.5 L per minute Accuracy of the flow display ±10 % of full scale Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 255: Measuring Systems

    0 to 9.8 kPa x 100 (0 to 140 psi) Resolution of the displayed value 0.1 kPa x 100 (1.5 psi) Accuracy ±4 % or ±0.2 kPa x 100 (±4 % or ±3 psi), the greater value applies Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 256 0 to 9999 mL Resolution of the displayed value 1 mL Accuracy ±8 % of the measured value or ±5 mL, the greater value ap- plies 1) Valid for Silverline pressure reducers Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 257 Measuring range 0 to 99.9 L per minute Resolution of the displayed value 0.1 L per minute Accuracy ±8 % of measured value or ±0.1 L per minute, the greater value applies Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 258 Endtidal measured values are calculated for each breath from the local maxima and minima of the real- time measurements during expiration. If CO respiratory phases are detected, the sample flow is com- pensated during ventilation and flow measurement. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 259 5 to 100 Vol% ±5 Vol% within a measuring range of 50 to 100 Vol% 1) The respective value depends on the PGM used which is displayed on System Information page. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 260 Resolution of the displayed value 0.1 Vol% (for insp. and exp.) anesthetic gas) Accuracy ±(0.2 Vol% +15 % rel.) 1) At respiratory rates up to 60 per minute and an insp./exp. ratio of 1:1. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 261 1) Exception: At a Desflurane concentration of more than 4 Vol% a mixture will be detected at the latest when the concen- tration of the second anesthetic gas increases to over 10 % of the Desflurane concentration. 2) The respective value depends on the PGM used which is displayed on System Information page. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 262 Depending on the sensor model, applies for DS-100 A Adults Within a range of 70 to 100 % SpO ±3 % Neonates Within a range of 70 to 100 % SpO ±4 % Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 263: Interfaces

    IEC 60601-1 (as of the 2nd edition) for touchable secondary circuits with a max- imum nominal voltage of 24 VDC. System alarm delay time = 600 ms (typical value). Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 264 Hardware handshake is not supported. Settings 1200 or 9600 Baud Even parity 8 data bits 1 stop bit IV System (Dräger Base) Power supply for IV System For connecting an SpO sensor Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 265: Operating Data

    (auxiliary outlets not supplied) At least 30 minutes Maximum 90 minutes (depending on ventilation parameters) Charging time At least 10 hours (to reach full power) Charging power Maximum 70 W Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 266 ISO 3744) at a height of 1.5 m in a distance of 1 m to the front of the anesthesia system: ≤35 dB(A) (Standby) ≤46 dB(A) ("Peak" during ventilation) ≤42 dB(A) Leq (5 cycles) Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 267 Swivel cupboard + approx. 13 kg (29 lbs) Oval pole swivel arm + approx. 4 kg (9 lbs) Pump mount + approx. 6 kg (13 lbs) Permitted total weight 300 kg (662 lbs) Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 268 Protection class Workstation I, as per IEC 60601-1 IP class as per IEC 60529 IPX0 sensor Type BF electrically isolated from protective conductor (breathing system nozzles) Deviations possible depending on the configuration. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 269: Use Of Latex

    System – nomenclature for medical de- 10-134 vices GMDN code Global Medical Device Nomenclature – 37710 global nomenclature for medical devices Use of latex Primus Infinity Empowered is not made with natural rubber latex. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 270: Relevant Standards

    Part 1: Medical electrical equipment General requirements for basic safety and essential perform- ance IEC 60601-1-2 Part 1-2: Medical electrical equipment General requirements for safety Collateral standard: Electromagnetic compatibility; Require- ments and tests Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 271: Emc Declaration

    Dräger, the correct operation of the device in this configuration must be tested before the product is used. In any case, strictly observe the instructions for use of the other devices. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 272: Electromagnetic Emissions

    Harmonic emissions Not applicable directly connected (without transformer) to the public (IEC 61000-3-2) low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations/flicker Not applicable (IEC 61000-3-3) Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 273: Electromagnetic Immunity

    (IEC 61000-4-11) mains power supply interruptions, it is recommended that the medical device is Dip >95 %, >95 %, powered from an uninterruptible power 5 seconds 5 seconds supply or a battery. Instructions for use Primus Infinity Empowered SW 4.5n...
  • Page 274 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz. 2) ISM bands in this frequency range are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; 40.66 MHz to 40.70 MHz. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 275: Recommended Separation Distances To Portable And Mobile Radio Frequency Communication Devices

    GSM 1800, GSM 1900 (limited to 1 W ERP) 0.38 m (1.2 ft) UMTS, DECT (limited to 0.25 W ERP) 0.19 m (0.62 ft) Bluetooth, WLAN 2450, RFID 2450 (limited to 0.1 W ERP) 0.20 m (0.66 ft) Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 276: Device Combinations

    Before the device is con- nected to the network or the network is changed, these risks must be identified, analyzed, and eval- uated, and appropriate measures taken. Instructions for use Primus Infinity Empowered SW 4.5n...

  • Page 277: Information On Connecting To The It-Network

    – Alarms or data is transmitted with a delay. – False alarms are triggered. – During an interruption of the network connec- tion: – Alarms are not transmitted. – Suppressed alarms or alarm tones are not reactivated, but remain suppressed. Instructions for use Primus Infinity Empowered SW 4.5n...

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