CareFusion Alaris 8015 User Manual
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CareFusion Alaris 8015 User Manual

Alaris system with guardrails suite mx
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Table of Contents

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Alaris™ System with Guardrails™ Suite MX
(with Alaris™ PC unit, Model 8015 Software Version 9.33)
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Summary of Contents for CareFusion Alaris 8015

  • Page 1: User Manual

    User Manual Alaris™ System with Guardrails™ Suite MX (with Alaris™ PC unit, Model 8015 Software Version 9.33) February 2017 Alaris PC ® ® Guardrails % SpO 2 RA TE (mL/h) RA TE (mL/h) RA TE (mL/h) PULSE (BPM) CHANNEL CHANNEL SELECT SELECT CHANNEL...
  • Page 2 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...

  • Page 3: Table Of Contents

    Battery Care and Maintenance ..................A-24 Wireless Connection......................A-26 Cleaning...........................A-28 Service Information......................A-33 Regulations and Standards....................A-35 Compliance........................A-35 Trademarks........................A-46 Order Number: Printed Copy: P00000158 © 2005-2017 CareFusion Corporation or one of its affiliates. All rights reserved. Alaris System User Manual – with v9.33 Model 8015...
  • Page 4 10020 Pacific Mesa Blvd San Diego, California 92121 United States Authorized European Representative CareFusion UK 305 Ltd., The Crescent, Jays Close, Basingstoke, Hampshire RG22 4BS, UK Authorized Australian/New Zealand Representative CareFusion Australia and New Zealand Unit 3, 167 Prospect Highway...
  • Page 5 Introduction The Alaris™ PC unit section of this User Manual provides WARNING procedures and information applicable to the Alaris System and Read all instructions before using the PC unit. Each of the other major sections provides product- the Alaris System. specific procedures and information.
  • Page 6 Intended Use Introduction (Continued) The Alaris™ System with Guardrails™ Suite MX is intended for use in professional healthcare facilities that utilize infusion devices for the delivery of fluids, medications, blood, and blood products. The Alaris System with Guardrails Suite MX is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter...
  • Page 7 Introduction (Continued) WARNINGS AND CAUTIONS: Product-specific warnings and cautions, covered in the applicable sections of this User Manual, provide information needed to safely and effectively use the Alaris System. WARNING A statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device.
  • Page 8 CareFusion. Any 510(k) clearance from the Food and Drug Administration (FDA) or regulatory approval secured by CareFusion to market Alaris pumps was based on use of only CareFusion manufactured parts and equipment. If non- CareFusion parts, add-ons or disposables are used for the...
  • Page 9 Alaris PC Unit Model 8015 Alaris System User Manual – with v9.33 Model 8015 Section...
  • Page 10 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...
  • Page 11 Table of Contents Getting Started Introduction............................. 1-1 General Setup and Operation Attach and Detach Module ........................1-3 Attach Module..........................1-3 Detach Module ..........................1-4 Add Module While System is Powered On..................1-5 Start-Up ..............................1-6 Power On System........................... 1-6 Respond to Maintenance Reminder ....................1-7 Adjust Display Contrast ........................
  • Page 12 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Table of Contents PC Unit Section 1-iv Alaris System User Manual – with v9.33 Model 8015...

  • Page 13: Introduction

    Getting Started Introduction This section of the User Manual provides PC unit (Model WARNING 8015) and Alaris System instructions and information. It is used , including those in conjunction with: Read all instructions for the attached module(s) and • PC Unit/ Pump Module Technical Service Manual applicable accessories, before using the Alaris System.
  • Page 14 Introduction (Continued) Alarms and Alerts: See "Appendix A - Troubleshooting and Maintenance" for specific PC unit alarms and alerts. Contraindications: None known. Electromagnetic Environment: See "Appendix" section of this User Manual ("Regulations and Standards," "Compliance"). Getting Started PC Unit Section Alaris System User Manual –...

  • Page 15: Attach And Detach Module

    General Setup and Operation Attach and Detach Module Modules can be attached to either side of the PC unit or to either side of another module. The process to attach or detach is the same for either side, whether attaching/detaching to/from a PC unit or another module.

  • Page 16: Detach Module

    Attach and Detach Module (Continued) Attach Module (Continued) Rotate free module down against PC unit or attached WARNING module until release latch snaps in place. When properly secured/snapped, the provides a very secure release latch connection between modules. If not properly latched, a module can be dislodged during operation.

  • Page 17: Add Module While System Is Powered On

    Attach and Detach Module (Continued) Add Module While System is Powered On Add module as described in "Attach Module." • System tests module, causing all LED segments and indicator lights of displays to illuminate briefly. • Appropriate module identification display (A, B, C, or D) illuminates.

  • Page 18: Start-Up

    Start-Up Power On System Connect PC unit to an external AC power source. Press key. SYSTEM ON System self test begins: • Diagnostics test causes all LED display segments and Status Indicator lights of attached module(s) to illuminate briefly. • Power Indicator illuminates.

  • Page 19: Respond To Maintenance Reminder

    Start-Up (Continued) Respond to Maintenance Reminder If the Preventive Maintenance (PM) Reminder option is enabled MAINTENANCE REMINDER and the PC unit or an attached module is due for preventive Module(s) due for routine preventive maintenance: maintenance, a message appears MAINTENANCE REMINDER Module A: YYYY-MM-DD at power up.

  • Page 20: Select New Patient And Profile Options

    Start-Up (Continued) Adjust Display Contrast (Continued) To adjust display for optimum viewing, use Lighter/Darker System Options soft keys. Display Contrast To return to main screen, press soft key. ® CONFIRM Lighter Darker >Adjust Display to Desired Contrast CONFIRM Select New Patient and Profile Options The following procedures assume the Profiles feature is enabled.
  • Page 21 Start-Up (Continued) Select New Patient and Profile Options (Continued) To select a Profile, press corresponding left soft key. Midtown Hospital 1 of 2 Profiles To view additional choices, press soft key. PAGE DOWN Adult ICU Adult General Care To confirm Profile selection, press soft key.

  • Page 22: Adjust Audio Volume

    Start-Up (Continued) WARNING Adjust Audio Volume The user should check that the current alarm preset is appropriate prior to use on each patient. WARNING A hazard can exist if different Alarm Presets are used for the same or similar equipment in a single area, such as an Intensive Care Unit or a Cardiac Operating Theatre.

  • Page 23: Lock/Unlock Tamper Resist

    Start-Up (Continued) Lock/Unlock Tamper Resist Initiate operation of applicable module. Press and hold Tamper Resist Switch, on back of PC unit, Midtown Hospital Adult ICU for 3 to 4 seconds (see "General Information," "Features VTBI = 250.0 mL and Displays," "Operating Features, Controls, Indicators"). •...

  • Page 24: Power Off System

    Power Off System Press and hold key until a beep is heard CHANNEL OFF (approximately 1.5 seconds) and then release to initiate power down. • During power off sequence, Main Display flashes Powering Down. • To interrupt power down sequence, quickly press any key Powering Down (except ) on PC unit.

  • Page 25: System Options

    System Options Display Contrast Press key. OPTIONS SILENCE SYSTEM OPTIONS ENTER CLEAR CANCEL Press Display Contrast soft key. System Options 1 of 3 Display Contrast Patient ID Clinician ID Power Down All Channels Anesthesia Mode >Select an Option or EXIT PAGE EXIT DOWN...
  • Page 26 System Options (Continued) Patient ID (Continued) Enter (Continued) Scan or manually enter patient identifier: • To manually enter patient identifier, use numeric data entry keys and/or alpha speed keys. ◦ An alphanumeric identifier, of up to characters, can be entered. ◦...
  • Page 27 System Options (Continued) Patient ID (Continued) Modify 1. Press key. OPTIONS Press Patient ID soft key. To clear entire entry, press key. CLEAR SILENCE SYSTEM OPTIONS To back up a single character at a time, press CANCEL key. ENTER CLEAR CANCEL To enter modified patient identifier, use numeric data entry keys and/or alpha speed keys.

  • Page 28: Clinician Id

    System Options (Continued) Patient ID (Continued) Modify (Continued) To accept modified Patient ID, press Yes soft key. Patient ID Entry Main screen appears with new Patient ID. Patient ID 123456789CD will be changed to 234567891EF To retain original (old) Patient ID, press No soft key. Is this correct? Main screen appears with old Patient ID.

  • Page 29: Power Down All Channels

    System Options (Continued) Clinician ID (Continued) To verify correct entry, press soft key. CONFIRM Clinician ID Entry 123456789CD_ _ _ _ _ >Enter Clinician ID and Press CONFIRM PAGE EXIT CONFIRM DOWN Power Down All Channels Press key. OPTIONS System Options 1 of 3 Press Power Down All Channels soft key.

  • Page 30: Anesthesia Mode

    System Options (Continued) Anesthesia Mode When the Anesthesia Mode is enabled and then the pause WARNING feature is used - the module remains in an indefinite pause until When the Alaris System is set up for restarted. use in Anesthesia Mode, it is When Anesthesia Mode is enabled: important to select the Profile that corresponds with the care area the...
  • Page 31 System Options (Continued) Anesthesia Mode (Continued) Enable (Continued) Press Anesthesia Mode soft key. Press Enable soft key. System Options Press soft key. Anesthesia Mode CONFIRM Enable Disable Pump Module Change Air Detection = microliters >Select an Option or Press CONFIRM CONFIRM Disable The Anesthesia Mode can be disabled, and normal operation...
  • Page 32 System Options (Continued) Anesthesia Mode (Continued) Disable (Continued) Connect to AC Power Connect system to AC power. To continue using Anesthesia Mode, press Yes soft key. To discontinue Anesthesia Mode, press No soft key. AC power cord was connected. Continue ANESTHESIA MODE >Select Yes or No Disconnect from AC Power...

  • Page 33: Battery Runtime

    System Options (Continued) Battery Runtime Press key. OPTIONS Press soft key. PAGE DOWN Press Battery Runtime soft key. System Options 2 of 3 Battery Runtime System Configurations Serial Numbers Software Versions Time of Day >Select an Option or EXIT PAGE PAGE UP EXIT DOWN...
  • Page 34 System Options (Continued) Press PC Unit soft key. System Configuration - Module Factory Default: Shared Infusion Settings PC Unit Pump Module SPO2 Module >Press CANCEL or EXIT PAGE EXIT DOWN To review various system configuration settings, press System Config - PCU 1 of 3 ...

  • Page 35: Serial Numbers

    System Options (Continued) System Configurations (Continued) To return to main screen, press key or soft CANCEL EXIT System Config - PCU 3 of 3 key. PM Reminder: Disabled Tamper resist: Disabled >Press CANCEL or EXIT PAGE EXIT NOTE: The Profiles option is listed only if it is disabled. ...

  • Page 36: Software Versions

    System Options (Continued) Serial Numbers (Continued) To return to main screen, press soft key. EXIT Serial Number Review PC Unit: nnnn-nnnnnnnn Module A: nnnn-nnnnnnnn Module B: nnnn-nnnnnnnn Module C: nnnn-nnnnnnnn Module D: nnnn-nnnnnnnn >Press CANCEL or EXIT EXIT NOTE: "nnnn-nnnnnnnn" in the illustrated display represents a model ...
  • Page 37 System Options (Continued) Software Versions (Continued) To return to previous screen, press soft key.  EXIT Software Rev. Review Module Software: A Main processor: nn.nn Main boot block: nn.nn nn.nn Keyboard: >Press CANCEL or EXIT EXIT NOTE: "nn.nn" in the illustrated display represents a software ...

  • Page 38: Network Status

    System Options (Continued) Time of Day (Continued) Enter current Time of Day. System Options Time of Day Change Current time: Time __:__ >Enter Current Time EXIT CONFIRM Press soft key. CONFIRM System Options Time of Day Current time: Change 14:30 Time >Press CONFIRM EXIT...
  • Page 39 System Options (Continued) System Options 3 of 3 Network Status (Continued) Network Status Wireless Connection To view network status and wireless status information, Data Set Status press Network Status soft key. Maintenance Due >Select an Option or EXIT EXIT PAGE UP Enter password (refer to v9.5 or later System Maintenance software instructions) and press soft key.
  • Page 40 System Options (Continued) Network Status (Continued) To view network address information, press System Options soft key. ADDRESS Network Status Status : CONNECTED • Address of wireless card attached to PC unit Uptime : 03:45:35 is displayed. • displays , PC unit is set to use a Static DHCP Bytes Sent: 13, 890...

  • Page 41: Wireless Connection

    System Options (Continued) Network Status (Continued) • Information based on a status of DISABLED , or DISCONNECTED CONNECTING CONNECTED displayed. • If status is , PC unit is connected to Alaris CONNECTED Systems Manager and the following information is displayed: ◦...

  • Page 42: Data Set Status

    System Options (Continued) Wireless Connection (Continued) Wireless connection can be disabled or enabled: • To disable wireless communication, press Disable soft key. ◦ If wireless connection is disabled, it remains disabled until PC unit is powered off. Setting defaults to Enable when PC unit is powered back ◦...

  • Page 43: Maintenance Due

    System Options (Continued) Data Set Status (Continued) A status of Current, Pending, Transferring, or Not System Options Activated is displayed. Data Set Status Current: (none available) ID: 83442BB ID: 83442BB Activated: 2005-09-18 08:45 Activated: 2005-09-18 08:45 Pending: Midtown Hospital Dataset ID: 83442BB Not Activated >Press EXIT EXIT...
  • Page 44 System Options (Continued) Maintenance Due (Continued) NOTE: soft key appears only if an Auto-ID module is  PAGE DOWN attached. General Setup and Operation PC Unit Section 1-32 Alaris System User Manual – with v9.33 Model 8015...

  • Page 45: Warnings And Cautions

    • Disconnect from main (AC) and battery power when performing maintenance. • Use only CareFusion batteries. The use of third party batteries could affect the safety and efficacy of Alaris products. • The battery cannot be repaired and should not be opened.
  • Page 46 Warnings and Cautions (Continued) General (Continued) WARNINGS • Electrical shock hazard. Do not open case. Refer to qualified service personnel. • Due to the intermittent nature of a wireless environment, some data can be lost if a connection cannot be established or is lost.
  • Page 47 • If an instrument appears damaged, contact CareFusion for authorization to return it for repair. PC Unit Section General Information Alaris System User Manual –...

  • Page 48: Electromagnetic Compatibility

    Warnings and Cautions (Continued) Electromagnetic Compatibility WARNINGS • Do not use the Alaris System near Magnetic Resonance Imaging (MRI), including Stereotaxis technology. • Do not use the Alaris System near Therapeutic Radiation equipment, such as Linear Accelerators. • Use of any accessory, transducer or cable other than those specified can result in increased emissions or decreased Alaris System immunity.

  • Page 49: Features And Displays

    Warnings and Cautions (Continued) Electromagnetic Compatibility (Continued) CAUTIONS • The Alaris System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, monitor the Alaris System to verify that it is operating normally in that setup. •...
  • Page 50 Features and Displays (Continued) Features and Definitions (Continued) Feature Definition Guardrails Suite MX Designed to help prevent programming errors by: • Customizing device configurable settings to meet need of selected hospital/facility area/unit (Profile). • Comparing user-programming with hospital-defined best-practice guidelines. •...

  • Page 51: Operating Features, Controls, Indicators

    Features and Displays (Continued) Operating Features, Controls, Indicators IUI Connector, Left IUI Connector, Right (not visible) Main Display Soft Keys: When pressed, allows selection of options or infusion parameters appearing on Main Display adjacent to soft key. Silence Key: When pressed during an alarm, silences audio System On Key: When pressed, changes Alaris System...
  • Page 52 Features and Displays (Continued) Operating Features, Controls, Indicators (Continued) Rear Panel - IEC 802.11 a/b/g/n Wireless Network Card IUI Connector, Right IUI Connector, Left Power Cord Strap Use this bolt to reorient Pole Clamp 90° for Rear Cover attachment to a bed rail instead of a pole.
  • Page 53 Features and Displays (Continued) Operating Features, Controls, Indicators (Continued) Rear Panel - Compact Flash b/g or a/b/g Wireless Card IUI Connector, Right IUI Connector, Left Power Cord Strap Use this bolt to reorient Pole Clamp 90° for attachment to a bed rail Compact Flash Wireless Network instead of a pole.

  • Page 54: Displays

    Features and Displays (Continued) Displays The displays illustrated throughout this document are for illustration purposes only. The display content varies, depending on configuration settings, hospital-defined Data Set uploaded using the Guardrails Suite MX, and many other variables. A color versus monochrome display option is available when creating a hospital-defined, best-practice Data Set.

  • Page 55: System Configurable Settings

    System Configurable Settings If the configuration settings need to be changed from the Factory default settings, refer to the applicable Technical Service Manual or contact CareFusion Technical Support, for technical, troubleshooting, and preventive maintenance information. With the Profiles feature enabled, the settings are configured independently for each Profile.

  • Page 56: Specifications

    Specifications and Symbols Specifications Battery Operation: Battery run time is a function of the number of modules attached and module activity. With a new, fully charged battery, the system operates as follows before a "BATTERY DISCHARGED" message occurs: • 1 hour with four Pump modules infusion at 999 mL/h and one Auto-ID module •...
  • Page 57 Specifications and Symbols (Continued) Specifications (Continued) Environmental Conditions: Symbol Meaning Operating Storage/Transport Atmospheric 525 - 4560 mmHg 375 - 760 mmHg Pressure (700 - 6080 hPa) (500 - 1013 hPa) Relative Humidity 20 - 90% 5 - 85% Noncondensing Noncondensing (Avoid prolonged exposure to relative humidity...

  • Page 58: Symbols

    Specifications and Symbols (Continued) Symbols See the product-specific section of this User Manual that applies to the attached module(s) for symbols specific to that module. Symbol Meaning Alternating Current: Indicates device should be attached to alternating current source, 50/60 Hz only. Warnings or Caution: Refer to accompanying documentation.
  • Page 59 Specifications and Symbols (Continued) Symbols (Continued) Symbol Meaning Manufacturer Potential Equalization Conductor (if so equipped). Note: If integrity of PEC or Hospital Earth System is in question, operate instrument using internal battery power. Radio frequency (RF) transmission. Caution: Federal (U.S.A) law restricts this device to sale by or on order of a physician. Tamper Resist activate/deactivate switch.
  • Page 60 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Information PC Unit Section 1-48 Alaris System User Manual – with v9.33 Model 8015...
  • Page 61 Figure , “Alaris Pump Module, Model 8100 Alaris Syringe Module, Model 8110,” on ™ ™ page -5Alaris Pump Module/Alaris Syringe Module Alaris Pump Module, Model 8100 Alaris Syringe Module, Model 8110 RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL...
  • Page 62 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...
  • Page 63 Table of Contents Getting Started Introduction............................. 2-1 Prepare Administration Set (Pump Module)................... 2-3 Load..............................2-3 Remove ............................2-6 Prime .............................. 2-6 Prepare Syringe and Administration Set (Syringe Module)..............2-7 Load ............................... 2-11 Prime—Using Options Menu........................2-15 Prime—Manual............................2-20 Programming Introduction............................. 2-23 Manual Programming with Guardrails Suite MX Manual Programming—Primary Infusion ....................
  • Page 64 General Programming Pause, Change, Restart Infusion ......................2-96 Pause and Restart Infusion ......................2-96 Change Rate or VTBI During Infusion .................... 2-97 Restore Infusion ..........................2-97 View and Clear Volume Infused ......................2-98 Channel Labels ............................2-99 Select.............................. 2-99 Remove ............................2-101 Anesthesia Mode............................
  • Page 65 Symbols..............................2-159 Trumpet and Start-Up Curves ........................ 2-160 Pump Module ..........................2-160 Syringe Module..........................2-161 Graphs............................2-162 Pump and Syringe Modules Section Table of Contents Alaris System User Manual – with v9.33 Model 8015...
  • Page 66 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Pump and Syringe Modules Section 2-vi Alaris System User Manual – with v9.33 Model 8015...
  • Page 67 Getting Started Introduction This section of the User Manual provides Pump module (Model WARNING 8100) and Syringe module (Model 8110) instructions and information. It is used in conjunction with: , for both the Read all instructions infusion modules and PC unit, before •...

  • Page 68: Getting Started

    Introduction (Continued) If a procedure/information applies to a specific module, the following identifiers indicate the module it applies to. RATE (mL/h) Pump module: CHANNEL SELECT PAUSE CHANNEL RESTART RATE (mL/h) Syringe module: CHANNEL SELECT PAUSE CHANNEL RESTART Administration Sets/Syringes: See "General Information" for specific "Administration Set/Syringe Information.

  • Page 69: Prepare Administration Set (Pump Module)

    RATE (mL/h) Prepare Administration Set (Pump Module) CHANNEL SELECT PAUSE CHANNEL RESTART For instructions on how to go from checking in a Pump module WARNING to preparing it for an infusion setup, see "General Setup and • Administration Sets: Operation." •...
  • Page 70 RATE (mL/h) Prepare Administration Set (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Load (Continued) CAUTION If a new set is being loaded, prime the set, see Prime on • Avoid use of manifolds with ports page 2-6. containing high pressure valves. Open the Pump module door.
  • Page 71 RATE (mL/h) Prepare Administration Set (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Load (Continued) c. Press safety clamp fitment into recess below CAUTION mechanism. To reduce the potential for nuisance d. Using a finger tip, firmly push tubing toward back of alarms, ensure that tubing is Air-in-Line (AIL) Detector.

  • Page 72: Remove

    RATE (mL/h) Prepare Administration Set (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Remove Close roller clamp. Open Pump module door. Set’s safety clamp fitment automatically closes to prevent accidental free-flow. White Slide Clamp (shown in closed position) Remove set, as follows: a.

  • Page 73: Prepare Syringe And Administration Set (Syringe Module)

    RATE (mL/h) Prepare Administration Set (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime (Continued) If container requires venting, open vent cap on administration set spike. To prime tubing and clear air from injection sites and tubing fitments, slowly open roller clamp. When priming is complete, close roller clamp.
  • Page 74 Prepare Syringe and Administration Set (Syringe Module) (Continued) RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART WARNINGS • Raising a syringe pump may result in a bolus of medication or fluid due to changes in hydrostatic pressure. Lowering a syringe pump while infusing may result in a delay in the infusion (or possible under-infusion) due to the changes in hydrostatic pressure.
  • Page 75 Prepare Syringe and Administration Set (Syringe Module) (Continued) RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART • CAUTION • Use compatible components which have the smallest internal volume or "deadspace" to minimize residual volumes between the syringe and the patient when administering medications or fluids at low infusion rates (e.g.,<...
  • Page 76 Prepare Syringe and Administration Set (Syringe Module) (Continued) RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART For instructions on how to go from checking in a Syringe module to preparing it for an infusion setup, including how to change a syringe during infusion, see "General Setup and Operation."...

  • Page 77: Load

    RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART WARNING Load Before loading or unloading the syringe, always turn off fluid flow to the patient, using the tubing clamp or stopcock. Uncontrolled fluid flow can occur when the administration set is not clamped or turned off, and can cause serious injury or death.
  • Page 78 Prepare Syringe and Administration Set (Syringe Module) (Continued) RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART Load (Continued) Open syringe barrel clamp. a. Pull syringe barrel clamp out and hold. b. Rotate clamp to left (clockwise or counter clockwise) until it clears syringe chamber. RATE (mL/h) c.
  • Page 79 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Load (Continued) Lock syringe in place. WARNING a. Pull syringe barrel clamp out and hold. Ensure that syringe barrel, flange, b. Rotate clamp to right (clockwise or counter clockwise) and plunger are installed and until it lines up with syringe.
  • Page 80 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Load (Continued)  10. Insert pressure sensing disc (if used), as follows: WARNING When the pressure sensing disc is not being used and an occlusion occurs, there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion.

  • Page 81: Prime-Using Options Menu

    RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Load (Continued) NOTES: WARNING The gripper control is spring loaded. When twisted to the open  position and then released, it (and the plunger grippers) returns Electronically prime the syringe to the closed position.
  • Page 82 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime—Using Options Menu (Continued) Administration Set With Pressure Sensing Disc Ensure that administration set is not connected to patient. If installed, remove pressure sensing disc from instrument. CAUTION Using a finger, apply firm downward pressure on pressure The pressure sensing disc, if left...
  • Page 83 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime—Using Options Menu (Continued) Administration Set With Pressure Sensing Disc (Continued) If pressure sensing disc was not removed prior to pressing A A A Prime Set with Syringe soft key, a pressure sensing disc removal prompt is displayed.
  • Page 84 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime—Using Options Menu (Continued) Administration Set With Pressure Sensing Disc (Continued) Gently massage pressure sensing disc to ensure that all air is expelled. The disc must remain inverted only until the air is expelled.
  • Page 85 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime—Using Options Menu (Continued) Administration Set With Pressure Sensing Disc (Continued) c. Apply firm upward pressure on pressure sensing disc (not tubing) until disc snaps into place. Pressure Sensing Disc 12.

  • Page 86: Prime-Manual

    RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime—Using Options Menu (Continued) Press and hold soft key until fluid flows and priming PRIME is complete. Fluid is delivered during priming only while soft PRIME key is pressed.
  • Page 87 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime—Manual (Continued) Administration Set With Pressure Sensing Disc Ensure that administration set is not connected to patient. If installed, remove pressure sensing disc from instrument. CAUTION Using a finger, apply firm downward pressure on pressure The pressure sensing disc, if left...
  • Page 88 RATE (mL/h) Prepare Syringe and Administration Set (Syringe Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Prime—Manual (Continued) Administration Set With No Pressure Sensing Disc Prime per hospital protocol. When priming is complete (no air exists), close set clamp. Eliminate Mechanical Slack To eliminate mechanical slack or free play, and minimize start-up delays and delivery inaccuracies, especially when infusing at low flow rates, it is recommended that the...

  • Page 89: Programming

    Programming Introduction The Alaris System can be programmed with Guardrails Suite MX Protection or with no Guardrails Suite MX protection: • Guardrails Suite MX Protection • Manual Programming (see page 2-24) • Programming with Interoperability (see page 2-58) • Auto-ID (Refer to Section "Auto-ID") •...

  • Page 90: Manual Programming With Guardrails Suite Mx

    Manual Programming with Guardrails Suite MX RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART The following procedures are to be used only when the drug to be infused is listed in the Drug Library. To access the Drug Library, a hospital-defined best-practice Data Set must be transferred to the Alaris System and the Profile feature must be enabled.
  • Page 91 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Press key. CHANNEL SELECT Syringe module: Select syringe type and size, as  follows; otherwise, proceed to step If the installed syringe is loaded correctly, but not recognized, check for the following: RATE (mL/h) CHANNEL...

  • Page 92: Continuous Infusion

    RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART WARNING Selecting an incorrect syringe may cause an under infusion or over infusion to the patient. Syringe Selection c. Press soft key next to installed syringe type and size. If BD 30 mL a default syringe list has been enabled and correct Monoject 30 mL...
  • Page 93 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Continuous Infusion When using a drug listed in the Drug Library, the drug parameters are automatically calculated, based on: • drug selected •...
  • Page 94 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Continuous Infusion (Continued) • If applicable, a weight-based or non weight-based Guardrails Drugs ® option for delivery of this infusion could appear (as in Adult ICU Heparin illustrated example, which reflects use of Heparin).
  • Page 95 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Continuous Infusion (Continued) • was selected and facility has defined a Clinical Alteplase Advisory for that drug, a message appears. To indicate Stroke Clinical Advisory: information has been noted and continue...
  • Page 96 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Continuous Infusion (Continued) An optional hospital-defined and editable starting value for Continuous Infusion dose might already be entered. To make a rate or dose entry, press applicable soft key, A A A Alteplase Stroke...
  • Page 97 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Continuous Infusion (Continued) • Syringe module: A A A Alteplase Stroke ◦ If ALL Mode is enabled for syringe configuration in CONTINUOUS INFUSION Data Set, is displayed in field and...
  • Page 98 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Continuous Infusion (Continued) • If the programmed continuous dose infusion is outside Alteplase Stroke the Soft Limit for that care area, an audio alert sounds Dose exceeds and a visual prompt appears before programming can Guardrail limit of...
  • Page 99 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Continuous Infusion (Continued) Syringe module: • Unclamp tubing and attach administration set to patient. RATE (mL/h) CHANNEL SELECT • Unclamping tubing and starting infusion before PAUSE CHANNEL RESTART...
  • Page 100 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Bolus Dose (Continued) A A A Alteplase Stroke Press soft key. BOLUS CONTINUOUS INFUSION 56.7 RATE mL/h • If the programmed continuous dose infusion is outside VTBI the Soft Limit for that care area, an audio alert sounds 0.81...
  • Page 101 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Bolus Dose (Continued) a. To enter a weight when continuous dose is not weight- based: • Press soft key PATIENT WEIGHT • To enter patient weight, use numeric data entry keys.
  • Page 102 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Bolus Dose (Continued) To enter bolus duration, use numeric data entry keys. A A A Alteplase Stroke BOLUS DOSE To deliver Bolus Dose at maximum safe rate possible for 0.090 selected drug and setup, and automatically calculate DOSE...
  • Page 103 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Bolus Dose (Continued) • If a Bolus Dose outside of Soft Limits has been entered and verified as correct, Message Display also shows either "LLL"...
  • Page 104 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Bolus Dose (Continued) Stop Bolus Dose (Continued) To stop bolus and start Continuous Infusion, press Yes Alteplase soft key. Stroke Stop Bolus and Start Continuous infusion? >Press Yes or No To stop Continuous Infusion, press and hold...
  • Page 105 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Bolus Dose (Continued) Restore Bolus Dose (Continued) c. Press soft key. RESTORE d. Verify dosing parameters and press soft key. START Bolus Dose completed - module turned off: a.
  • Page 106 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Intermittent Infusion When using a drug listed in the Drug Library, the drug parameters are automatically delivered, based on: • drug selected •...
  • Page 107 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Intermittent Infusion (Continued) • If Yes was selected and facility has defined a Clinical Advisory for that drug, a message appears. To indicate information has been noted and continue programming, press soft key.
  • Page 108 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Intermittent Infusion (Continued) • If a dose outside of Soft Limits has been entered and verified as correct, Message Display also shows either "LLL"...
  • Page 109 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Intermittent Infusion (Continued) Guardrails Drug Setup If an optional hospital-defined and editable starting value Methotrexate PRIMARY INFUSION for intermittent duration is not already entered, enter RATE = mL/h duration or rate, as follows:...
  • Page 110 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Intermittent Infusion (Continued) Syringe module: • Unclamp tubing and attach administration set to patient. RATE (mL/h) CHANNEL SELECT • Unclamping tubing and starting infusion before PAUSE CHANNEL RESTART...
  • Page 111 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Fluid Infusion Press Guardrails IV Fluids soft key. Guardrails IV Fluids Oncology Packed Red Cells Press soft key next to IV fluid to be delivered. Platelets >Select IV Fluid PAGE...
  • Page 112 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Fluid Infusion (Continued) Rate/Volume Infusion (Continued) To enter , press soft key and use numeric data VTBI VTBI Guardrails Fluid Setup entry keys. PRIMARY INFUSION RATE mL/h...
  • Page 113 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Fluid Infusion (Continued) Rate/Volume Infusion (Continued) Verify correct infusion parameter entry and press START  soft key. • If the programmed fluid is outside the Soft Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue.
  • Page 114 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Fluid Infusion (Continued) Volume/Duration Infusion (Continued) To enter , press soft key and use numeric data VTBI VTBI Guardrails Fluid Setup entry keys.. PRIMARY INFUSION _ _ _ mL/h...
  • Page 115 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Fluid Infusion (Continued) Volume/Duration Infusion (Continued) To enter volume duration, press soft key and DURATION Guardrails Fluid Setup use numeric data entry keys. PRIMARY INFUSION Rate is automatically calculated.
  • Page 116 RATE (mL/h) RATE (mL/h) Manual Programming—Primary Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Fluid Infusion (Continued) Volume/Duration Infusion (Continued) NOTES: The infusion can be paused by pressing the PAUSE soft key.  See "Pause, Change, Restart Infusion," "Pause and Restart Infusion"...

  • Page 117: Manual Programming-Secondary Infusion (Pump Module)

    RATE (mL/h) Manual Programming—Secondary Infusion (Pump Module) CHANNEL SELECT PAUSE CHANNEL RESTART This mode is designed to support the delivery of secondary WARNING infusions ("piggybacking") in the same module. A secondary infusion can be programmed as a "Basic Infusion" or "Drug Secondary applications require the Library Infusion."...

  • Page 118: Infusion

    RATE (mL/h) Manual Programming—Secondary Infusion (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Setup (Continued) Secondary Container Secondary Container Hanger Bottle Primary at least 9½" Container at least 9½" Primary Container NOTE: The top of the fluid container should never be lower than the ...
  • Page 119 RATE (mL/h) Manual Programming—Secondary Infusion (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Infusion (Continued) Press soft key. SECONDARY Press soft key next to desired drug. Guardrails Drugs Peds Oncology • To view additional drugs, press a soft key next to a Amifostine letter group to navigate through alphabet, and/or PAGE...
  • Page 120 RATE (mL/h) Manual Programming—Secondary Infusion (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Infusion (Continued) • If selected drug had "_ _ / _ _ mL" concentration, drug amount and diluent volume need to be entered. • If selected drug is not weight-based, Not Used is displayed in field.
  • Page 121 RATE (mL/h) Manual Programming—Secondary Infusion (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Infusion (Continued) VTBI entry: WARNING • When is less than 10 mL/h, entry can be to VTBI The secondary settings two decimal places (one-hundredth of a mL). VTBI require consideration of such variables as factory...
  • Page 122 RATE (mL/h) Manual Programming—Secondary Infusion (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Infusion (Continued) Open clamp on secondary administration set. WARNING The clamp on the secondary Verify correct parameters and press soft key. administration set must be opened. If START the clamp is not opened, the fluid is •...

  • Page 123: Stop Secondary And Return To Primary

    RATE (mL/h) Manual Programming—Secondary Infusion (Pump Module) (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Infusion (Continued) NOTE: It is possible to program an infusion with a rate that is displayed with two decimal places (one-hundredth of a mL per hour) on the PC unit for the Pump module. However, due to space limitations on the Pump module rate display, the rate is displayed to the nearest one-tenth of a mL per hour on the Pump module.

  • Page 124: Programming With Interoperability And Guardrails Suite Mx

    Alaris System. For information on infusion status messages, refer to the following four guides: • Infusion Status Message Specification for CareFusion Coordination Engine—Regulated Infusion Adapter v1.3 • HL7 Order Message Specification for CareFusion Coordination Engine—Regulated Infusion Adapter v1.3 •...
  • Page 125 Programming with Interoperability and Guardrails Suite MX (Continued) Pre-population of infusion parameters applies to initial and subsequent infusions started in the Guardrails Library, as follows: The following primary infusions can be pre-populated for both initial and subsequent infusion: • Continuous •...
  • Page 126 Programming with Interoperability and Guardrails Suite MX (Continued) NOTE: There is a potential that the concentration displayed on the Alaris System PC unit will use different units of measure than the concentration displayed in the EMR/HIS. The Alaris System PC unit displays the concentration (drug amount per 1 mL) using the dosing units assigned to that Guardrails drug entry.
  • Page 127 Programming with Interoperability and Guardrails Suite MX (Continued) NOTE: If the infusion order does not specify whether the infusion is to be pre-populated as a primary or secondary infusion, the Alaris System will determine whether to pre-populate the infusion as primary or secondary based on the state of the intended Module and on the Guardrails Drug Library configuration.

  • Page 128: Programming With Interoperability-Initial Primary Infusion

    Programming with Interoperability—Initial Primary Infusion Perform the following steps on the PC unit (see the PC unit section of "General Setup and Operation” and "Start-Up" beginning on page 1-3): a. Power on system. (Scanning the module will not power on the device.) b.
  • Page 129 Programming with Interoperability—Initial Primary Infusion (Continued) The generic workflow for pre-population of infusion parameters is as follows. Contact your EMR/HIS vendor for detailed instructions. Using the EMR/HIS system scanner used for barcode medication administration: • Scan Patient's ID Band • Scan fluid/medication barcode label •...
  • Page 130 Programming with Interoperability—Initial Primary Infusion (Continued) For the Pump module, proceed to step 6. WARNING Ensure that the displayed syringe For the Syringe module, select the syringe type and size; manufacturer and syringe size otherwise proceed to step 5. If the installed syringe is correctly identify the installed loaded correctly, but not recognized, check the following: syringe.
  • Page 131 Programming with Interoperability—Initial Primary Infusion (Continued) d. To accept the Syringe type and size, press the soft key. CONFIRM Syringe Selection BD 30 mL Monoject 30 mL >Confirm Syringe Size CONFIRM SYRINGES Guardrails Drugs If applicable, select the Therapy on the PC unit. Adult ICU Alteplase •...

  • Page 132: Continuous Infusion

    Programming with Interoperability—Initial Primary Infusion (Continued) The Patient ID and, depending on the infusion type, the following infusion parameters are pre-populated on the Alaris System from the automated programming request: • Drug or Fluid name (alias or NDC) • Drug amount •...
  • Page 133 Programming with Interoperability—Initial Primary Infusion (Continued) Continuous Infusion The following workflow assumes that the Patient's ID band, medication/fluid barcode label, and the module barcode labels have been scanned, see Programming with Interoperability— Initial Primary Infusion on page 2-62. Review and verify that all parameters pre-populated on the Alaris System are correct prior to starting the infusion.
  • Page 134 Programming with Interoperability—Initial Primary Infusion (Continued) Continuous Infusion (Continued) For the Syringe module, unclamp tubing and attach administration set to patient. NOTE: Unclamping tubing and starting infusion before attaching administration set to patient minimizes any potential bolus that can be released from pressure built up in set due to normal syringe loading and priming.
  • Page 135 Programming with Interoperability—Initial Primary Infusion (Continued) Fluid Infusion The following workflow assumes that the Patient's ID band, medication/fluid barcode label, and the module barcode labels have been scanned, see Programming with Interoperability— Initial Primary Infusion on page 2-62. Review and verify that all parameters pre-populated on the Alaris System are correct prior to starting the infusion.
  • Page 136 Programming with Interoperability—Initial Primary Infusion (Continued) Intermittent Infusion The following workflow assumes that the Patient's ID band, medication/fluid barcode label, and the module barcode labels have been scanned, see Programming with Interoperability— Initial Primary Infusion on page 2-62. NOTE: Syringe Module: The KVO option is disabled when an intermittent infusion is programmed.
  • Page 137 Programming with Interoperability—Initial Primary Infusion (Continued) A A A Guardrails Drug Setup Intermittent Infusion (Continued) Potassium Chloride PRIMARY INFUSION Review and verify that all parameters pre-populated on the Alaris System are correct prior to starting the infusion. RATE= mL/h The rate, VTBI, and duration are pre-populated from the VTBI automated programming request.

  • Page 138: Programming With Interoperability-Subsequent Primary Infusion (Pump Module)

    Programming with Interoperability—Subsequent Primary Infusion (Pump RATE (mL/h) Module) CHANNEL SELECT PAUSE CHANNEL RESTART Hospital policy should determine the preferred method for programming subsequent infusions. Subsequent infusion for the Pump module refers to new bags, syringes, or containers used with the Pump module. An automated programming request for a matching subsequent infusion can be sent to a Pump module that is infusing, paused, delayed, or alarming (including Infusion...

  • Page 139: Continuous Infusion

    Programming with Interoperability—Subsequent Primary Infusion (Pump Module) (Continued) The following procedures assume that the Pump module has already been programmed with an Initial Primary Infusion. NOTE: If an infusion is in Delay when a subsequent automated programming request is sent and matching criteria: •...
  • Page 140 Programming with Interoperability—Subsequent Primary Infusion (Pump Module) (Continued) Continuous Infusion The following workflow assumes that the Pump module has already been programmed with an Initial Primary Continuous Infusion and that the Patient’s ID band, medication/fluid barcode label, and the module barcode labels have been scanned, see Programming with Interoperability—Initial Primary Infusion on page 2-62.
  • Page 141 Programming with Interoperability—Subsequent Primary Infusion (Pump Module) (Continued) Continuous Infusion (Continued) If the subsequent automated programming request contains an infusion parameter (rate or dose) that changes Infusion Setup the current infusion rate, a message appears with a recalculation of the rate notification. New bag scan results in a recalculation of the rate to 45 mL/h...
  • Page 142 Programming with Interoperability—Subsequent Primary Infusion (Pump Module) (Continued) Fluid Infusion The following workflow assumes that the Pump module has already been programmed with an Initial Primary Fluid Infusion and that the Patient's ID band, medication/fluid barcode label, and the module barcode labels have been scanned, see Programming with Interoperability—Initial Primary Infusion on page 2-62.
  • Page 143 Programming with Interoperability—Subsequent Primary Infusion (Pump Module) (Continued) Fluid Infusion (Continued) Review and verify that all parameters pre-populated on the Alaris System are correct. 0.45% Sodium Chloride Press the soft key. START PRIMARY INFUSION mL/h RATE _1000 VTBI >Press START DELAY VOLUME SECOND-...
  • Page 144 Programming with Interoperability—Subsequent Primary Infusion (Pump Module) (Continued) Intermittent Infusion The following workflow assumes that the Pump module has already been programmed with an Initial Primary Intermittent Infusion and that the Patient's ID band, medication/fluid Potassium Chloride barcode label, and the module barcode labels have been DRUG scanned, see Programming with Interoperability—Initial AMOUNT...
  • Page 145 Programming with Interoperability—Subsequent Primary Infusion (Pump Module) (Continued) Intermittent Infusion (Continued) If the subsequent automated programming request contains an infusion parameter (rate or dose) that affects or changes the current infusion rate, a message appears with a recalculation of the rate notification. From the screen: Infusion Setup...
  • Page 146 Programming with Interoperability—Subsequent Primary Infusion (Syringe Module) RATE (mL/h) CHANNEL SELECT PAUSE Hospital policy should determine the preferred method for CHANNEL RESTART programming subsequent infusions. Subsequent infusion for the Syringe module refers to new syringes used with the Syringe module. An automated programming request for a subsequent infusion can be sent to a Syringe module when it is infusing or in an idle state.

  • Page 147: Programming With Interoperability-Secondary Infusion (Pump Module)

    Programming with Interoperability—Secondary Infusion (Pump Module) This mode is designed to support programming of secondary infusions ("piggybacking") on the same module as a primary WARNING fluid. When the secondary VTBI reaches zero, an audio tone Secondary applications require the sounds (if enabled) indicating completion of the secondary use of a check valve or clamp on the infusion.
  • Page 148 Programming with Interoperability—Secondary Infusion (Pump Module) (Continued) Infusion (Continued) WARNING The secondary solution container Setup (Continued) must be higher than the primary solution container. Using the hanger provided with secondary administration set, lower the primary fluid container to the height indicated in following illustrations.
  • Page 149 Programming with Interoperability—Secondary Infusion (Pump Module) (Continued) Infusion (Continued) Infusion The generic workflow for pre-population of infusion parameters is as follows. Contact your EMR/HIS vendor for detailed instructions. Using the EMR/HIS system scanner used for barcode medication administration • Scan Patient's ID Band •...
  • Page 150 Programming with Interoperability—Secondary Infusion (Pump Module) (Continued) Infusion (Continued) 10. Review and verify that all parameters pre-populated on the Alaris System are correct prior to starting the infusion. The rate, VTBI, and duration are pre-populated from the automated programming request. WARNING The secondary VTBI settings require consideration of such variables as...
  • Page 151 Programming with Interoperability—Secondary Infusion (Pump Module) (Continued) Change Primary Infusion Parameter Press key. CHANNEL SELECT Press soft key. SET UP Press soft key. PRIMARY To change primary infusion parameter, press applicable soft key ( ) and use numeric data entry keys. RATE VTBI Verify correct primary infusion parameters and press...

  • Page 152: Stop Secondary And Return To Primary

    Programming with Interoperability—Secondary Infusion (Pump Module) (Continued) Stop Secondary and Return to Primary Press the key. CHANNEL SELECT Press the soft key. SETUP Press the soft key. PRIMARY Close the clamp on the secondary administration set. -or- Disconnect the secondary administration set from the upper injection port.

  • Page 153: Programming-No Guardrails Suite Mx Protection

    Programming—NO Guardrails Suite MX Protection The following procedures should be used only when the drug to be infused is not listed in the Drug Library. When programming a drug not listed in the Drug Library, the drug calculation must be programmed using the soft DRUG CALC key within the Drug Library.

  • Page 154: Manual Programming-No Guardrails Suite Mx Protection

    RATE (mL/h) RATE (mL/h) Manual Programming—NO Guardrails Suite MX Protection CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART If Delay Options is enabled, the soft key becomes PAUSE DELAY OPTIONS (see PC unit section of this User Manual, "General Setup and Operation,"...

  • Page 155: Promote Basic Infusion To Guardrails Software Protection Infusion

    RATE (mL/h) RATE (mL/h) Manual Programming—NO Guardrails Suite MX Protection (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Promote Basic Infusion to Guardrails Software Protection Infusion Press key on module running infusion CHANNEL SELECT to be promoted. Press key.
  • Page 156 RATE (mL/h) RATE (mL/h) Manual Programming—NO Guardrails Suite MX Protection (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Basic Infusion with Drug Calculation (Continued) To enter diluent volume, use numeric data entry keys. Press soft key. PATIENT WEIGHT To indicate whether or not patient weight is to be used in Drug Calculation, press either Yes or No soft key.
  • Page 157 RATE (mL/h) RATE (mL/h) Manual Programming—NO Guardrails Suite MX Protection (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Basic Infusion with Drug Calculation (Continued) • Pump module: ◦ When is less than 10 mL, entry can be to two VTBI RATE (mL/h) CHANNEL...

  • Page 158: Bolus Dose

    RATE (mL/h) RATE (mL/h) Manual Programming—NO Guardrails Suite MX Protection (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Basic Infusion with Drug Calculation (Continued) 16. Syringe module: • Unclamp tubing and attach administration set to patient. • Unclamping tubing and starting infusion before RATE (mL/h) attaching administration set to patient minimizes CHANNEL...
  • Page 159 RATE (mL/h) RATE (mL/h) Manual Programming—NO Guardrails Suite MX Protection (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Bolus Dose (Continued) Verify correct parameters and press soft key. START To see details during bolus infusion, press CHANNEL key.

  • Page 160: Secondary Infusion

    RATE (mL/h) Manual Programming—NO Guardrails Suite MX Protection (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Secondary Infusion See Manual Programming—Secondary Infusion (Pump Module) on page 2-51 for a description of the secondary infusion mode and for setup instructions. Infusion The following procedure should be used only when: •...

  • Page 161: Stop Secondary And Return To Primary

    RATE (mL/h) CHANNEL SELECT PAUSE Manual Programming—NO Guardrails Suite MX Protection (Continued) CHANNEL RESTART Infusion (Continued) Enter secondary infusion rate or duration, as follows: • To enter secondary infusion rate, press soft key RATE and use numeric data entry keys. •...

  • Page 162: General Programming

    General Programming RATE (mL/h) RATE (mL/h) Pause, Change, Restart Infusion CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Pause and Restart Infusion  Press key. PAUSE • scrolls in Message Display. PAUSE • appears on Main Display. PAUSED •...

  • Page 163: Change Rate Or Vtbi During Infusion

    RATE (mL/h) RATE (mL/h) Pause, Change, Restart Infusion (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Pause and Restart Infusion (Continued) To reinitiate infusion: Press key. RESTART Press key and then press soft CHANNEL SELECT START CHANNEL key.

  • Page 164: View And Clear Volume Infused

    RATE (mL/h) RATE (mL/h) View and Clear Volume Infused CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART To view volume infused, press soft key. VOLUME INFUSED Midtown Hospital Midtown Hospital Adult ICU Adult ICU • Total volume infused (primary + secondary), and time PAUSED PAUSED and date volume infused was last cleared, display for...

  • Page 165: Channel Labels

    RATE (mL/h) RATE (mL/h) View and Clear Volume Infused (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART • To return to main screen, press soft MAIN SCREEN Volume Infused Volume Infused  key. PRI (mL) PRI (mL) SEC (mL) SEC (mL) >Select Channels to Clear...
  • Page 166 RATE (mL/h) RATE (mL/h) Channel Labels (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Select (Continued) Syringe module: Press soft key. PAGE DOWN Channel Options 1 of 2 Guardrails Drugs Guardrails IV Fluids RATE (mL/h) Multidose CHANNEL SELECT PAUSE CHANNEL...

  • Page 167: Remove

    RATE (mL/h) RATE (mL/h) Channel Labels (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Select (Continued)  Press soft key for desired label. Channel Label Display NICU • Selected label is highlighted and scrolls in Message Broviac Display.

  • Page 168: Anesthesia Mode

    RATE (mL/h) RATE (mL/h) Channel Labels (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Remove (Continued) Press soft key. CLEAR LABEL Channel Label Display NICU Label stops scrolling in Message Display. Broviac PICC White Port >Select Channel Label CLEAR PAGE EXIT...

  • Page 169: Delay Infusion

    RATE (mL/h) RATE (mL/h) Delay Options (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Delay Infusion The delay period for an infusion can be programmed as a specific number of minutes or a time of day, as described in the following procedures.
  • Page 170 RATE (mL/h) RATE (mL/h) Delay Options (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Delay Infusion (Continued) Specify by Minutes (Continued) Press Delay for soft key. Delay Options 08:00 Pause Delay for Delay until CALL BACK >Select a Delay Option EXIT CONFIRM To enter number of minutes (up to 120) infusion is to be...
  • Page 171 RATE (mL/h) RATE (mL/h) Delay Options (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Delay Infusion (Continued) Specify by Time of Day (Continued) If Current time displayed is correct, press soft CONFIRM Delayed Options key; otherwise, press Change Time and enter correct Time of Day time.

  • Page 172: Schedule A Callback

    RATE (mL/h) RATE (mL/h) Delay Options (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Schedule a Callback When programming a Delay for or Delay until infusion, a callback can be scheduled for that infusion. There are three types of callback: •...

  • Page 173: Pause Infusion

    RATE (mL/h) RATE (mL/h) Delay Options (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Schedule a Callback (Continued) • If After option was selected: ◦ An audio prompt sounds when delayed infusion completes, and continues to sound until responded ◦...

  • Page 174: Multidose Mode

    RATE (mL/h) RATE (mL/h) Delay Options (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Pause Infusion (Continued) Press soft key. CONFIRM • scrolls in Message Display. PAUSE • appears on Main Display. PAUSED • Yellow Standby Status Indicator illuminates. •...

  • Page 175: Volume/Duration Enabled

    RATE (mL/h) RATE (mL/h) Multidose Mode (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART The Delay Options function for multidose infusions is similar to Delay Options for continuous drug infusions, with the following differences: • Delay for option (when scheduling a callback) is not available in Multidose Mode.
  • Page 176 RATE (mL/h) RATE (mL/h) Multidose Mode (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Volume/Duration Enabled If Current time displayed is correct, press soft CONFIRM Multidose key; otherwise, press Change Time and enter correct Time of Day time.

  • Page 177: Volume/Duration Disabled

    RATE (mL/h) RATE (mL/h) Multidose Mode (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Volume/Duration Enabled (Continued) To see detail screen during or between infusions, press key. CHANNEL SELECT • During infusion, Volume Remaining is displayed. • Between infusions: ◦...
  • Page 178 RATE (mL/h) RATE (mL/h) Multidose Mode (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Volume/Duration Disabled (Continued) Syringe module: • Unclamp tubing and attach administration set to patient. RATE (mL/h) CHANNEL SELECT • Unclamping tubing and starting infusion before PAUSE CHANNEL RESTART...

  • Page 179: Select Pressure Limit

    Select Pressure Limit RATE (mL/h) Pump Module CHANNEL SELECT PAUSE CHANNEL RESTART Press key. CHANNEL SELECT Press key. OPTIONS SILENCE SYSTEM OPTIONS ENTER CLEAR CANCEL Press Pressure Limit soft key. Channel Options Guardrails Drugs Guardrails IV Fluids Multidose Pressure Limit - P Channel Labels >Select an Option or EXIT EXIT...

  • Page 180: Syringe Module

    Select Pressure Limit (Continued) RATE (mL/h) Pump Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART To select occlusion pressure limit, press either Up or Down soft key. Pressure Limit Selection Selectable Pressure Verify correct occlusion pressure limit input and press mmHg soft key.
  • Page 181 Select Pressure Limit (Continued) RATE (mL/h) Syringe Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Pressure Sensing Disc Installed (Continued) Press Pressure Limit soft key. Channel Options 1 of 2 Guardrails Drugs Guardrails IV Fluids Multidose Pressure Limit - 550 mmHg Prime Set with Syringe >Select an Option or EXIT PAGE...
  • Page 182 Select Pressure Limit (Continued) Syringe Module (Continued) RATE (mL/h) Pressure Sensing Disc Installed CHANNEL SELECT PAUSE CHANNEL RESTART (Continued) WARNING To minimize the amount of time it takes the pump to recognize an occlusion (blockage) and generate an alarm while infusing at low rates (for example, <...
  • Page 183 Select Pressure Limit (Continued) RATE (mL/h) Syringe Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Pressure Sensing Disc Installed (Continued) NOTES: The optimal occlusion alarm limit setting achieves a balance  between the risk of false alarms and timely response to occlusions.
  • Page 184 Select Pressure Limit (Continued) RATE (mL/h) Syringe Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Pressure Sensing Disc NOT Installed WARNING When the pressure sensing disc is not being used and an occlusion occurs, there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion.
  • Page 185 Select Pressure Limit (Continued) Syringe Module (Continued) RATE (mL/h) CHANNEL SELECT Pressure Sensing Disc NOT Installed PAUSE CHANNEL RESTART WARNING To minimize the amount of time it takes the pump to recognize an occlusion (blockage) and generate an alarm while infusing at low rates (for example, <...
  • Page 186 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Programming Pump and Syringe Modules Section 2-120 Alaris System User Manual – with v9.33 Model 8015...

  • Page 187: General Setup And Operation

    General Setup and Operation System Start-Up/Setup See Alaris Pump Module, Model 8100 Alaris Syringe Module, Model 8110, General Setup and Operation on page 1-3, for various system start-up and setup procedures. RATE (mL/h) Set Up for Gravity Infusion (Pump Module) CHANNEL SELECT PAUSE...

  • Page 188: Change Syringe During Infusion (Syringe Module)

    System Start-Up/Setup (Continued) RATE (mL/h) Change Syringe During Infusion (Syringe Module) CHANNEL SELECT PAUSE CHANNEL RESTART If a critical medication is being infused at a flow rate less than 1.0 mL/h and the patient is not stable enough to experience even a short period of time without the drug, it is recommended that the new syringe and administration set be installed as part of a second Alaris System setup.
  • Page 189 System Start-Up/Setup (Continued) RATE (mL/h) Change Syringe During Infusion (Syringe Module) CHANNEL SELECT PAUSE CHANNEL RESTART Press soft key. RESTORE To enter VTBI and rate, press soft key and use RATE numeric data entry keys, and then soft key and use VTBI numeric data entry keys.
  • Page 190 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Setup and Operation Pump and Syringe Modules Section 2-124 Alaris System User Manual –...

  • Page 191: General Information

    General Information Warnings and Cautions RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART General WARNINGS • Ensure syringe sizes and models are compatible with the Syringe module. The use of any other syringe or administration set can cause improper pump operation, resulting in inaccurate fluid delivery, insufficient occlusion ...
  • Page 192 Warnings and Cautions (continued) General (continued) WARNINGS • The Pump and Syringe modules are designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected. It is a positive displacement delivery system, capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice, including resistances to flow imposed by small...
  • Page 193 Warnings and Cautions (continued) General (continued) CAUTIONS • Use compatible components which have the smallest internal volume or "deadspace" to minimize residual volumes between the syringe and the patient when administering medications or fluids at low infusion rates (e.g., < 5 mL/h, and especially flow rates < 0.5 mL/h). This reduces the amount of time it takes for fluid to reach the patient, maintains delivery accuracy, and reduces occlusion detection times.

  • Page 194: Administration Sets

    Warnings and Cautions (continued) Administration Sets WARNINGS • When priming: ◦ Ensure that administration set is not connected to patient. ◦ Ensure that air is expelled from line prior to beginning infusion (unexpelled air in line could have serious consequences). Failure to prime correctly can delay infusion delivery and cause the total volume to be infused to read higher than the actual total delivered to the patient.
  • Page 195 RATE (mL/h) RATE (mL/h) Warnings and Cautions (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Administration Sets (Continued) WARNINGS • Use only Alaris Pump module/GEMINI Infusion System administration sets with the Pump module. The use of any other set can cause improper instrument operation, resulting in an inaccurate fluid delivery or other potential hazard.
  • Page 196 RATE (mL/h) RATE (mL/h) Warnings and Cautions (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Administration Sets (Continued) NOTE: For a list of compatible syringes, refer to Compatible Syringes  (Syringe Module) on page 2-136 and the Alaris Syringe Module Set Compatibility Card.
  • Page 197 Warnings and Cautions (Continued) RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Occlusions (Continued) WARNINGS When addressing or clearing an occlusion: • Ensure that the fluid flow to the patient is to prevent administering an unintended bolus. An occlusion may pressurize the infusion tubing and syringe, which can result in an unintended bolus of drug when the occlusion is cleared.

  • Page 198: Epidural Administration

    Warnings and Cautions (Continued) RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Epidural Administration WARNING • Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. •...

  • Page 199: Guardrails Suite Mx

    RATE (mL/h) RATE (mL/h) Warnings and Cautions (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Guardrails Suite MX WARNINGS • The Guardrails Suite MX incorporates dosing limits and instrument configuration parameters based on hospital/facility protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital/facility.

  • Page 200: Smartsite Tm Infusion Set (Pump Module)

    Administration Set/Syringe Information (Continued) The Pump module uses a wide variety of Alaris Pump RATE (mL/h) module/GEMINI Infusion System administration sets. CHANNEL SELECT PAUSE CHANNEL RESTART The sets are designed for use with the Pump module as well as for gravity-flow, stand-alone use. •...

  • Page 201: Safety Clamp Fitment (Pump Module)

    Administration Set/Syringe Information (Continued) RATE (mL/h) Safety Clamp Fitment (Pump Module) CHANNEL SELECT PAUSE CHANNEL RESTART The primary administration set’s safety clamp fitment is a unique clamping device, on the pumping segment, that prevents inadvertent free-flow when the administration set is removed from the instrument.

  • Page 202: Compatible Syringes (Syringe Module)

    Main Display. The When using a mL or smaller full list of permitted syringe models is dependent on the syringe, CareFusion strongly software version of the Syringe module. recommends using an extension set with a pressure disc, for improved pressure monitoring and shorter times to occlusion alarm.

  • Page 203: Features And Displays

    Features and Displays Features and Definitions See the PC unit section of this User Manual for system features and definitions. RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL Feature Definition—Pump and Syringe Modules RESTART RESTART Anesthesia Mode When operating in Anesthesia Mode, a module can be paused indefinitely without an alarm.
  • Page 204 Features and Displays (Continued) Features and Definitions (Continued) RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL Feature Definition—Pump and Syringe Modules RESTART RESTART Drug Library When Profiles feature is enabled, it provides a hospital-defined list of drugs and concentrations appropriate for use in as many as 30 Profiles.
  • Page 205 Features and Displays (Continued) Features and Definitions (Continued) RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL Feature Definition—Pump and Syringe Modules RESTART RESTART Therapies An optional hospital-defined therapy or clinical indication for delivery of that infusion. Different Limits can be defined for same medication with different therapeutic indications.
  • Page 206 Features and Displays (Continued) Features and Definitions (Continued) RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL Feature Definition—Pump Module RESTART Free Flow Protection All Alaris Pump module/GEMINI Infusion System administration sets use a unique clamping device (safety clamp on the lower fitment) to prevent inadvertent free-flow when administration set is removed from instrument.
  • Page 207 Features and Displays (Continued) Features and Definitions (Continued) RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL Feature Definition—Syringe Module RESTART All Mode When is selected as the volume to be infused (VTBI), the entire contents of syringe is delivered. Auto Pressure When enabled and a pressure sensing disc is in use, Auto Pressure option is displayed in Pressure Limit screen.
  • Page 208 Features and Displays (Continued) Features and Definitions (Continued) RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART Feature Definition—Syringe Module NEOI Snooze Optional capability to remind users NEOI alarm has been silenced. This is shared Syringe and PCA setting. Numeric Pressure Dynamic pressure display is numerical and only available when pressure Display sensing disc is inserted.

  • Page 209: Operating Features, Controls, Indicators

    Features and Displays (Continued) RATE (mL/h) Operating Features, Controls, Indicators CHANNEL SELECT PAUSE CHANNEL RESTART Status Indicators Alarm Infusing Standby (red) (green) (yellow) IUI Connector, Left IUI Connector, Right Rate Display Channel (module) Message Display RATE (mL/h) Channel (module) Identification Channel (module) Select Key: W pressed, selects corresponding module CHANNEL...
  • Page 210 Features and Displays (Continued) RATE (mL/h) Operating Features, Controls, Indicators (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART IUI Connector, Left Upper Tubing Fitment (not visible) Retainer Platen IUI Connector, Right Upper Pressure Sensor Upper Occluder Upper Pumping Finger Lower Occluder Door Latch Cam/Slide Lower Pumping Finger Lower Pressure Sensor Safety Clamp...
  • Page 211 Features and Displays (Continued) RATE (mL/h) Operating Features, Controls, Indicators (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Gripper Control/Drive Head Release (shown in closed position) Status Indicators Plunger Grippers Alarm Infusing Standby (shown in closed position) (red) (green) (yellow) IUI Connector, Left Barrel Flange Grippers Rate Display Syringe Barrel Sensor...

  • Page 212: Displays

    Features and Displays (Continued) RATE (mL/h) RATE (mL/h) Displays CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART The displays illustrated throughout this document are for illustration purposes only. The display content varies, depending on configuration settings, type of administration set in use, hospital-defined Data Set uploaded using the Guardrails Suite MX, programmed drug calculation parameters, and many other variables.

  • Page 213: Drug Calculation Definitions And Formulas

    RATE (mL/h) RATE (mL/h) Drug Calculation Definitions and Formulas CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART The Pump Module and Syringe module use the following parameters, WARNING entered during the drug calculation setup procedure: The Drug Calculation feature is to be •...

  • Page 214: Configurable Settings

    If the configuration settings need to be changed from the settings, refer to the applicable Technical Factory default Service Manual or contact CareFusion Technical Support, for technical, troubleshooting, and preventive maintenance information. With the Profiles feature enabled, the settings are configured independently for each Profile.

  • Page 215: Shared Infusion

    Configurable Settings (Continued) Shared Infusion RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Feature Default Setting Options Delay Options Disabled Enabled - Disabled • Callback After None, Before, After, Before and After Drug Calculation Disabled Enabled - Disabled •...

  • Page 216: Pump Module

    RATE (mL/h) RATE (mL/h) Configurable Settings (Continued) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART RATE (mL/h) Pump Module CHANNEL SELECT PAUSE CHANNEL RESTART Feature Default Setting Options Accumulated Air Enabled Enabled - Disabled Air-in-Line Settings 75 mcL 50, 75, or 250 mcL (single bolus) Anesthesia Mode only: 500 mcL...

  • Page 217: Syringe Module

    Configurable Settings (Continued) RATE (mL/h) Syringe Module CHANNEL SELECT PAUSE CHANNEL RESTART Feature Default Setting Options ALL Mode Disabled Enabled - Disabled Auto Pressure Enabled - Disabled Disabled Back Off (after occlusion) Enabled Enabled - Disabled Fast Start Enabled Enabled - Disabled KVO (Keep Vein Open) Disabled Enabled - Disabled...
  • Page 218 Specifications RATE (mL/h) Pump Module CHANNEL SELECT PAUSE CHANNEL RESTART Accumulated Air Window: Single Bolus Volume Window % Air that Causes Volume (mL) that  (mL) Alarm Causes Alarm Setting (mcL) 0.28  12.0 NOTE: In a standard bore tubing set: ...
  • Page 219 Specifications (Continued) RATE (mL/h) Pump Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Flow Rate Programming Increments (mL/h) Rate Range Increments: (mL/h) User Input Rates Device Calculated Rates 0.1 - 9.99 0.01 10 - 99.9 100 - 999 Fluid Ingress Protection: IPX1, Drip Proof Infusion of Air, Means to Ultrasonic Air-in-Line Detection...
  • Page 220 Specifications (Continued) RATE (mL/h) Pump Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Rate Accuracy: Rate accuracy of Alaris System is ±5% at rates between 1 and 999 mL/h and ±5.5% at rates <1 mL/h, 95% of the time with 95% confidence, under conditions listed below.
  • Page 221 Specifications (Continued) Syringe Module RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART Bolus Volume, Maximum after WARNING Occlusion: Installing a pressure sensing disc after an infusion has started can result in a bolus to the patient. Without Pressure Sensing Disc: Pressure Setting Bolus Volume (mL) 0.512 Medium...
  • Page 222 Specifications (Continued) RATE (mL/h) Syringe Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Bolus Volume, Maximum after Maximum Bolus Volume specifications are based on following standard Occlusion: (Continued) operating conditions: Atmospheric Pressure: 645 - 795 mmHg Disposable Type: No Pressure Disc: #30914 With Pressure Disc: #30920...
  • Page 223 Specifications (Continued) RATE (mL/h) Syringe Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Flow Rate Programming: Flow rate range is from 0.01 to 999 mL/h and can be selected as follows: Flow Rates (mL) Selectable Increments (mL/h) 0.01 - 9.99 0.01 10 - 99.9 100 - 999 Rate Restriction by Syringe Size:...
  • Page 224 Specifications (Continued) RATE (mL/h) Syringe Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Rate Accuracy: ±2% of full scale plunger travel (not including syringe variation) WARNING Syringe size and running force, variations of back pressure, or any combination of these can affect rate accuracy. Factors that can influence back pressure are: Administration set configuration, IV solution viscosity, and IV solution temperature.

  • Page 225: Symbols

    Symbols RATE (mL/h) RATE (mL/h) CHANNEL SELECT See the PC unit section of this User Manual for system symbols. CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART Symbol Meaning—Pump and Syringe Modules The Infusion Alarm Silence symbol indicates that infusion alarms have been acknowledged and silenced.

  • Page 226: Trumpet And Start-Up Curves

    Trumpet and Start-Up Curves In this instrument, as with all infusion systems, the action of the pumping mechanism and variations in individual administration sets cause short-term fluctuations in rate accuracy. The following graphs show typical performance of the system, as follows: •...

  • Page 227: Syringe Module

    Trumpet and Start-Up Curves (Continued) RATE (mL/h) Pump Module (Continued) CHANNEL SELECT PAUSE CHANNEL RESTART Under conditions of +300 mmHg pressure, the Pump module typically exhibits a long-term accuracy offset of approximately -6.2% from mean values. Under conditions of -100 mmHg pressure, the Pump module typically exhibits a long-term accuracy offset of approximately +0.5% from mean values.

  • Page 228: Graphs

    Trumpet and Start-Up Curves (Continued) Graphs RATE (mL/h) Pump Module CHANNEL SELECT PAUSE CHANNEL RESTART Legend: Maximum rate error NOTE: The plot range has been increased to ±100% Overall rate error to allow visualization of the graph. Minimum rate error General Information Pump and Syringe Modules Section 2-162...
  • Page 229 Trumpet and Start-Up Curves (Continued) Graphs—Pump Module (Continued) RATE (mL/h) Pump Module CHANNEL SELECT PAUSE CHANNEL RESTART Legend: Maximum rate error Overall rate error Minimum rate error Pump and Syringe Modules Section General Information Alaris System User Manual – with v9.33 Model 8015 2-163...
  • Page 230 Trumpet and Start-Up Curves (Continued) Graphs (Continued) RATE (mL/h) Syringe Module CHANNEL SELECT PAUSE CHANNEL RESTART Start-Up Curve at 1 mL/h (initial) 1 g/mL Start-Up Curve at 5 mL/h (initial) 1 g/mL Time (min) Time (min) Trumpet Curve at 5 mL/h (initial) Trumpet Curve at 1 mL/h (initial) -0.7 -1.4...
  • Page 231 Alaris PCA Module Model 8120 RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART Alaris System User Manual – with v9.33 Model 8015 Section...
  • Page 232 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...
  • Page 233 Table of Contents Getting Started Introduction............................. 3-1 Attach and Detach Dose Request Cord ....................3-2 Prepare and Load Syringe and Administration Set ................3-3 Prepare Syringe and Administration Set ..................3-3 Load Syringe and Administration Set ..................... 3-4 Security Lock Key Positions ......................3-6 Programming Prepare Infusion .............................
  • Page 234 Administration Set/Syringe Information ....................3-48 Compatible Syringes ..........................3-49 Features and Displays..........................3-49 Features and Definitions......................... 3-49 Operating Features, Controls, Indicators..................3-55 Displays ............................3-56 Configurable Settings ..........................3-56 Specifications and Symbols ........................3-58 Specifications ..........................3-58 Symbols............................3-61 Trumpet and Start-Up Curves ........................ 3-62 Table of Contents PCA Module Section 3-iv...

  • Page 235: Getting Started

    Getting Started Introduction This section of the User Manual provides PCA module (Model WARNING 8120) instructions and information. It is used in conjunction with: Read all instructions, for both the PCA module and PC unit, before • Alaris product administration set instructions using the Alaris System.

  • Page 236: Attach And Detach Dose Request Cord

    Attach and Detach Dose Request Cord The Dose Request Cord must be attached to the PCA module WARNING when delivering a dose or + continuous dose infusion. Carefully locate the Dose Request Cord to reduce the possibility of patient entanglement or strangulation.

  • Page 237: Prepare And Load Syringe And Administration Set

    Prepare and Load Syringe and Administration Set For instructions on how to go from checking in a PCA module to preparing it for an infusion setup, see "General Setup and Operation." Prepare Syringe and Administration Set Prepare syringe (see Compatible Syringes on page 3-49") WARNING in accordance with manufacturer’s User Manual.

  • Page 238: Load Syringe And Administration Set

    Prepare and Load Syringe and Administration Set (Continued) Load Syringe and Administration Set Open syringe barrel clamp. a. Pull syringe barrel clamp out and hold. b. Rotate clamp to left (clockwise or counter clockwise) until it clears syringe chamber. c. Gently release clamp. RATE (mL/h) CHANNEL SELECT...
  • Page 239 Prepare and Load Syringe and Administration Set (Continued) Load Syringe and Administration Set (Continued) Lock syringe in place. WARNING a. Pull syringe barrel clamp out and hold. Ensure that syringe barrel, flange, b. Rotate clamp to right (clockwise or counter clockwise) and plunger are installed and until it lines up with syringe.

  • Page 240: Security Lock Key Positions

    Prepare and Load Syringe and Administration Set (Continued) Security Lock Key Positions There are three key positions associated with the security lock: • UNLOCK unlocks security door. Key must be in this position when loading or changing a syringe. • PROGRAM allows for initial programming or changes in programming without unlocking security door or interrupting ...

  • Page 241: Programming

    Programming References throughout this procedure to specific drugs and drug doses are for illustration purposes only. Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages. See "General Information," "Features and Displays" and the PC unit section of this User Manual for information about: •...

  • Page 242: Prime

    Prepare Infusion (Continued) Select Syringe Type and Size (Continued) Press soft key next to installed syringe type and size. If Syringe Selection installed syringe is not listed, press soft ALL SYRINGES IMS Pre-fill 30 mL key and select syringe from list. •...
  • Page 243 Prepare Infusion (Continued) Prime (Continued) Press key. OPTIONS SILENCE SYSTEM OPTIONS ENTER CLEAR CANCEL Press Prime Set with Syringe soft key. Channel Options 2 of 2 Pressure Limit - High Prime Set with Syringe >Select an Option or EXIT PAGE EXIT Press and hold soft key until fluid flows and priming...

  • Page 244: Program An Infusion

    Prepare Infusion (Continued) Program an Infusion Perform steps in "Getting Started," "Prepare Syringe and Administration Set." Perform following steps (see PC unit section of this User Manual, "General Setup and Operation," "Startup"): a. Power on system. b. Choose Yes or No to New Patient? c.
  • Page 245 Prepare Infusion (Continued) Program an Infusion (Continued) Press soft key next to desired concentration. Guardrails Drugs Med Surg • Drug/Concentration confirmation screen appears. Morphine 1 mg/mL • To view additional drugs/concentrations, press PAGE 5 mg/mL soft keys. PAGE DOWN 10 mg/mL •...

  • Page 246: Infusion Modes

    Prepare Infusion (Continued) Program an Infusion (Continued) Drug Amount Diluent Volume Drug Amount Diluent Volume • If a Soft Limit is overridden, G icon is displayed. When G soft key is pressed, all applicable out-of-range limits are listed. 10. Verify correct parameters and press soft key to NEXT confirm.

  • Page 247: Set Up Pca Dose Only

    Infusion Modes (Continued) Set Up PCA Dose Only Perform steps in "Prepare Infusion." Press PCA Dose Only soft key from Infusion Mode Guardrails Drug Setup screen. Morphine INFUSION MODES PCA Dose only Continuous Infusion Dose + Continuous Loading Dose Only >Select an Option DRUG SETUP...
  • Page 248 Infusion Modes (Continued) Set Up PCA Dose Only (Continued) To enter loading dose, press soft key, press LOAD DOSE Yes soft key, and use numeric data entry keys. Loading dose is included in volume infused but is not included in Max Limit. soft key.

  • Page 249: Set Up Continuous Infusion Only

    Infusion Modes (Continued) Set Up PCA Dose Only (Continued) 10. Verify correct parameters on second nurse summary Second Nurse Summary screen and press soft key. Morphine START PCA Dose: • Infusion mode and PCA drug name scroll in Channel Lockout minutes Interval: Message Display.
  • Page 250 Infusion Modes (Continued) Set Up Continuous Infusion Only (Continued) To enter maximum limit, press soft key, press MAX LIMIT Continuous Yes soft key, and use numeric data entry keys. Morphine Time (in hours) associated with Max Limit is automatically entered based on setup in system configuration. CONT mg/h DOSE...

  • Page 251: Set Up Pca Dose And Continuous Infusion

    Infusion Modes (Continued) Set Up Continuous Infusion Only (Continued) Drug Amount 1 mg Diluent Volume 1 mL Drug Amount 30 mg Diluent Volume 30 mL • If a Soft Limit is overridden, G icon is displayed. When G soft key is pressed, all applicable out-of-range limits are listed.
  • Page 252 Infusion Modes (Continued) Set Up PCA Dose and Continuous Infusion (Continued) To enter PCA dose, press soft key and use PCA DOSE PCA + Continuous numeric data entry keys. Morphine DOSE LOCKOUT _ _ _ INTERVAL minutes CONT _ _ _ mg/h DOSE None...
  • Page 253 Infusion Modes (Continued) Set Up PCA Dose and Continuous Infusion (Continued) • If the programmed parameters are outside the Hard Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue. Infusion must be reprogrammed. •...

  • Page 254: Set Loading Dose Only

    Infusion Modes (Continued) Set Up PCA Dose and Continuous Infusion (Continued) 10. Verify correct parameters on second nurse summary Second Nurse Summary Morphine screen and press soft key. START PCA Dose: Lockout During PCA dose + Continuous Infusion: minutes Interval: Cont.
  • Page 255 Infusion Modes (Continued) Set Loading Dose Only (Continued) Verify correct dose value and then press soft CONFIRM Guardrails Drug Setup IMS Pre-fill 30mL key. • Loading dose is included in VTBI but is not included in Max Limit. • If the programmed parameters are outside the Soft LOADING _ _ 1 DOSE...

  • Page 256: Set Bolus Dose

    Infusion Modes (Continued) Set Loading Dose Only (Continued) • If a Soft Limit is overridden, G icon is displayed. When G soft key is pressed, all applicable out-of-range limits are listed. Close and lock security door. Verify correct parameters on summary screen and press Second Nurse Summary Morphine soft key.
  • Page 257 Infusion Modes (Continued) Set Bolus Dose (Continued) Press soft key. BOLUS DOSE Summary Morphine Cont. Dose mg/h Max Limit: mg/4 h [Conc]: 1 mg/mL >Press START to Close Summary BOLUS PRO- START GRAM DOSE Set key to position or enter -digit authorization PROGRAM code and press...
  • Page 258 Infusion Modes (Continued) Set Bolus Dose (Continued) Drug Amount 1 mg Diluent Volume 1 mL Drug Amount 30 mg Diluent Volume 30 mL Guardrails Drug Setup IMS Pre-fill 30mL • If a Soft Limit is overridden, G icon is displayed. When G soft key is pressed, all applicable out-of-range limits Cont.

  • Page 259: Stop A Loading, Pca, Or Bolus Dose

    Infusion Modes (Continued) PCA syringe sizes and the correlating 35% of the syringe capacity Syringe Size 35% of Syringe Capacity 60mL 21mL 35mL 12.25mL 30mL 10.5mL 25mL 8.75mL 20mL Stop a Loading, PCA, or Bolus Dose Press key. CHANNEL SELECT Press , or soft key as...

  • Page 260: Change Programming Parameters During An Infusion

    Infusion Modes (Continued) Change Programming Parameters During an Infusion Press key. CHANNEL SELECT Press soft key. PROGRAM Set key to program position, or if Authorization Code is enabled, enter -digit code. Press soft key. CHANGE MODE Guardrails Drug Setup IMS Pre-fill 30mL DOSE LOCKOUT INTERVAL...

  • Page 261: View Patient History

    Infusion Modes (Continued) View Patient History Press key. CHANNEL SELECT From Main Display, press key. OPTIONS Press Patient History soft key. Channel Options 1 of 2 PCA Pause Limits Infusion Modes Patient History Dose Request Setup History Drug Event >Select an Option or EXIT PAGE EXIT...

  • Page 262: Clear Patient History

    Infusion Modes (Continued) View Patient History (Continued) To return to Main Display, press soft key. EXIT NOTES: Total drug delivered includes applicable loading dose, PCA  dose, continuous dose, and Bolus Dose. Total drug delivered does not include priming volume. Patient History stores a rolling 24-hour log and is ...
  • Page 263 Infusion Modes (Continued) Clear Patient History (Continued) Once patient history is cleared, the last 24 hours of patient history data can be retrieved and viewed. To retrieve last Morphine 1mg/mL 24 hours, press 24 h Totals soft key from Patient History History from 07:01 - 09:01 screen.

  • Page 264: View Drug Event History

    Infusion Modes (Continued) View Drug Event History Press key. CHANNEL SELECT From Main Display, press key. OPTIONS Press Drug Event History soft key. Channel Options 1 of 2 PCA Pause Limits Infusion Modes Patient History Dose Request Setup Drug Event History >Select an Option or EXIT...
  • Page 265 Infusion Modes (Continued) Configure Dose Request Cord (Continued) From Main Display, press key. OPTIONS Press soft key. DOSE REQUEST SETUP Channel Options 1 of 2 PCA Pause Limits Infusion Modes Patient History Dose Request Setup History Drug Event >Select an Option or EXIT PAGE EXIT...

  • Page 266: Security Access Levels

    Infusion Modes (Continued) Security Access Levels The security access level can be configured to provide varying levels of access to the device. Security access is accomplished either through the use of the key or a -digit authorization code. Default configuration for the security access level is established for each Profile or care area and can be changed in the system configuration.

  • Page 267: Pause Infusion

    Infusion Modes (Continued) Disable Security Access Code (Continued) Press DISABLE CODE soft k Security Code Access Press soft key. CONFIRM Press DISABLE CODE to temporarily turn off code access Security access code remains disabled until New capabilities for current patient. Patient?, Yes is selected in infusion startup or when instrument remains powered off for more than 8 hours.

  • Page 268: Change Syringe And Restore Infusion

    Infusion Modes (Continued) Pause Infusion (Continued) To reinitiate infusion: RATE (mL/h) Press key. RESTART Press key and then press soft CHANNEL SELECT START CHANNEL SELECT key on Main Display. PAUSE CHANNEL RESTART PCA Module Change Syringe and Restore Infusion If syringe requires replacement: a.

  • Page 269: Stop Infusion

    Infusion Modes (Continued) Change Syringe and Restore Infusion (Continued) Verify restored drug/concentration. Press soft key. NEXT Prime administration set (see "Prepare Infusion," "Prime"). For restored parameters, verify valid parameters and press soft key. CONFIRM To change a restored parameter: a. Press applicable soft key. b.

  • Page 270: Select Pressure Limit

    Infusion Modes (Continued) Select Pressure Limit Press key. CHANNEL SELECT Press key. OPTIONS  Press Pressure Limit soft key. Channel Options 2 of 2 Pressure Limit - High Prime Set with Syringe >Select an Option or EXIT PAGE EXIT To select a pressure limit, press appropriate soft key. Press soft key.

  • Page 271: Pca Pause Protocol Feature

    Infusion Modes (Continued) View and Clear Volume Infused (Continued)  To clear volume infused: • If only selected channels are to be cleared, press soft key next to applicable channel(s) and press CLEAR soft key. CHANNEL • If all channels are to be cleared, press soft CLEAR ALL Volume Infused...
  • Page 272 Guardrails PCA Pause Protocol Feature (Continued) Program an Infusion (Continued) Review Clinical Advisory. Clinical Advisory: • To continue, press soft key. CONFIRM Attach an SpO2 or EtCO2 module now. • To activate PCA Pause Protocol, attach and start an The drug selected will EtCO module and/or SpO module per facility...

  • Page 273: Review Or Change Pca Pause Alarm Limits

    Guardrails PCA Pause Protocol Feature (Continued) Program an Infusion (Continued) Midtown Hospital NOTES: Med Surg To review PCA pause limits, see "Review or Change PCA PCA + Cont Morphine  Pause Alarm Limits." VTBI = ALL (30 mL) ETCO2 Once the soft key is pressed, the Main Display screen START ...

  • Page 274: Disable Pca Pause Alarm

    Guardrails PCA Pause Protocol Feature (Continued) Review or Change PCA Pause Alarm Limits (Continued) To change PCA pause limits, press soft key that PCA Pause Limits corresponds to alarm limit and enter a value within SPO2/ETCO2  acceptable range. PAUSE LIMITS ALARM LIMITS %SPO2 >Enter a Pause Limit...
  • Page 275 Guardrails PCA Pause Protocol Feature (Continued) Disable PCA Pause Alarm (Continued) Press soft key. CONFIRM Press soft key. START To enable PCA Pause feature, follow steps 1-3 above and press soft key, as ENABLE SPO2 ENABLE ETCO2 appropriate. PCA Module Section Programming Alaris System User Manual –...
  • Page 276 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Programming PCA Module Section 3-42 Alaris System User Manual – with v9.33 Model 8015...

  • Page 277: General Setup And Operation

    General Setup and Operation System Start-Up/Setup See the PC unit section of this User Manual, "General Setup and Operation" for various system start-up and setup procedures. PCA Module Section General Setup and Operation Alaris System User Manual – with v9.33 Model 8015 3-43...
  • Page 278 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Setup and Operation PCA Module Section 3-44 Alaris System User Manual – with v9.33 Model 8015...

  • Page 279: General Information

    General Information Warnings and Cautions General WARNING • The PCA module is designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected. It is a positive displacement delivery system, capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice, including resistances to flow imposed by small gauge...
  • Page 280 Warnings and Cautions (Continued) Administration Sets (Continued) WARNING • Before loading or unloading the syringe, always turn off fluid flow to the patient, using the tubing clamp or stopcock. Uncontrolled fluid flow can occur when the administration set is not clamped or turned off, and can cause serious injury or death.

  • Page 281: Epidural Administration

    Warnings and Cautions (Continued) Epidural Administration WARNING • Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient. • It is strongly recommended that the syringe, administration set, and PCA module used for epidural drug delivery be clearly differentiated from those used for other types of administration.

  • Page 282: Guardrails Software

    Warnings and Cautions (Continued) Guardrails Software WARNING • The Guardrails Suite MX incorporates dosing limits and instrument configuration parameters based on hospital/facility protocol. The software adds a test of reasonableness to drug programming based on the limits defined by the hospital/facility. Qualified personnel must ensure the appropriateness of drug dosing limits, drug compatibility, and instrument performance, as part of the overall infusion.

  • Page 283: Compatible Syringes

    Compatible Syringes The PCA module is calibrated and labeled for use with the following single-use disposable luer-lock syringes. Use only the syringe size and type specified on the Main Display. The full list of permitted syringe models is dependent on the PCA module’s software version.
  • Page 284 Features and Displays (Continued) Features and Definitions (Continued) Feature Definition Concentration Drug amount per volume of fluid. For example, a 30 mL syringe with a concentration of 1 mg/1 mL can be entered in one of two ways: Drug Amount 1 mg Diluent Volume 1 mL Drug Amount...
  • Page 285 Features and Displays (Continued) Features and Definitions (Continued) Feature Definition Lockout Interval A configurable interval of time (1-99 minutes) that must pass between PCA Patient Doses. The lockout interval begins when the patient dose infusion starts. The Lockout Interval range is 1-99 minutes. Max Dose Limit (Max Optional configuration that limits total amount of drug allowed to be Accumulated Dose...
  • Page 286 Features and Displays (Continued) Features and Definitions (Continued) Operating Modes Four operating modes are available: • PCA only • Continuous Infusion • PCA + Continuous Infusion • loading dose only All programming of infusions in each of four modes are completed using Drug Library as defined by hospital-established best-practice.
  • Page 287 Features and Displays (Continued) Features and Definitions (Continued) Feature Definition PCA Dose Enables a patient to self-administer a bolus infusion to be delivered at programmed lockout intervals through Dose Request Cord. When programmed in PCA+continuous mode, Continuous Infusion resumes following PCA dose. PCA Pause Protocol An optional and hospital-configurable feature intended to align with hospital/health system’s current protocol for patient monitoring during PCA...
  • Page 288 Features and Displays (Continued) Features and Definitions (Continued) Feature Definition Therapies An optional hospital-defined therapy or clinical indication for delivery of that infusion. Different Limits can be defined for same medication with different therapeutic indications. Time Window (h) 1, 2, or 4 hours. General Information PCA Module Section 3-54...

  • Page 289: Operating Features, Controls, Indicators

    Features and Displays (Continued) Operating Features, Controls, Indicators Gripper Control/ Security Lock Drive Head Release (shown in closed position) Status Indicators Alarm Infusing Standby (red) (green) (yellow) Plunger Grippers (shown in closed position) IUI Connector, Left Barrel Flange Gripper Rate Display Message Display Syringe Barrel RATE (mL/h)

  • Page 290: Displays

    Features and Displays (Continued) Displays The displays illustrated throughout this document are for illustration purposes only. The display content varies, depending on configuration settings, type of administration set in use, hospital-defined Data Set uploaded using the Guardrails Suite MX, programmed drug calculation parameters, and many other variables.

  • Page 291: Specifications And Symbols

    Specifications and Symbols (Continued) Feature Default Setting Options Max Accumulated Dose Range 4-hour limit Disabled; 1, 2, or 4-hour limit  Max Rate (for Continuous Dose) 999 mL/h 0.1 - 99.9 mL/h in 0.1 mL/h increments; 100 - 999 mL/h in 1 mL/h increments NEOI Disabled Enabled - Disabled...

  • Page 292: Specifications

    Specifications and Symbols Specifications Bolus Dose Range: Configured according to hospital best-practice guidelines. Bolus Volume, Maximum after Occlusion Pressure Limit Bolus Volume (mL) Occlusion: 0.994 High 0.396 Maximum Bolus Volume specifications are based on following standard operating conditions: Atmospheric Pressure: 645 - 795 mmHg Disposable Type: #30883...
  • Page 293 Specifications and Symbols (Continued) Specifications (Continued) Flow Rate Programming: Flow rate range is from mL/h and can be selected as follows: Flow Rates (mL/h) Selectable Increments (mL/h) 0.10 - 9.99 0.01 10 - 99.9 100 - 999 Rate Restriction by Syringe Size: Syringe Size (mL) Flow Rate Range (mL/h) 0.1 - 500...
  • Page 294 Specifications and Symbols (Continued) Specifications (Continued) Time to Alarm, Maximum: Rate (mL) High 120 minutes 37 minutes 30 minutes 7 minutes Maximum Time to Alarm specifications are based on following standard operating conditions: Atmospheric Pressure: 645 - 795 mmHg Back Pressure: 0 mmHg before producing occlusion Disposable Type: #30883...

  • Page 295: Symbols

    Specifications and Symbols (Continued) Symbols See the PC unit section of this User Manual for system symbols. Symbol Meaning—Alaris Pump Module and Alaris Syringe Module The Infusion Alarm Silence symbol indicates that infusion alarms have been acknowledged and silenced. Press the CANCEL SILENCE soft key to reactivate a previously silenced alarm audio. If the alarm condition has not been resolved, the alarm audio will resume.

  • Page 296: Trumpet And Start-Up Curves

    Specifications and Symbols (Continued) Symbols (Continued) Symbol Meaning—Alaris Pump Module and Alaris Syringe Module Product is latex-free. LATEX Approximate administration set priming volume. ≈ XX ml Expiration date for product is identified near hourglass symbol. Do not use if package is damaged. Product contains micron filter, where represents filter size.
  • Page 297 Trumpet and Start-Up Curves (Continued) The start-up curves represent continuous flow rate versus operating time for two hours from the start of the infusion. They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from the second hour of this data.
  • Page 298 Trumpet and Start-Up Curves (Continued) Start-Up Curve at 1 mL/h (initial) 1 g/mL Mode Start-up at 1 mL/h (initial) time (min) Time (min) Trumpet Curve at 5 mL/h (initial) Mode Trumpet Curve at 5 mL/h (initial) -0.3 -1.1 -1.3 -0.9 -1.6 -4.2 -1.8...
  • Page 299 Alaris SpO Module Alaris SpO Module Models 8210 and 8220 % SpO 2 PULSE (BPM) CHANNEL SELECT MONITOR CHANNEL Alaris System User Manual – with v9.33 Model 8015 Section...
  • Page 300 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...
  • Page 301 Table of Contents Getting Started Introduction............................. 4-1 Attach Cable and Sensor ........................4-2 Programming Monitoring Mode............................. 4-3 Set Alarm Limits ..........................4-4 Navigate Trend Data ........................4-5 Navigate PCA/Alaris SpO ModuleTrend Data ................4-6 Presilence Alarm ..........................4-7 Channel Options............................. 4-8 Change Limit Mode ........................
  • Page 302 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Module Section 4-iv Alaris System User Manual – with v9.33 Model 8015...

  • Page 303: Getting Started

    Getting Started Introduction This section only applies to legacy SpO users upgraded with v9.33 software. This section of the User Manual provides SpO module WARNING (Models 8210 and 8220) instructions and information. It is used Read all instructions for the in conjunction with: module and PC unit, before •...

  • Page 304: Attach Cable And Sensor

    Introduction (continued) Cables and Sensors: See "General Information" for "Cables and Sensors" information. Alarms, and Messages: See "Troubleshooting and Maintenance" for module-specific "Alarms and Messages." Contraindications: The SpO modules are contraindicated for use as apnea monitors. Electromagnetic Environment: See "Appendix" section of this User Manual ("Regulations and Standards,"...

  • Page 305: Monitoring Mode

    Programming Display references throughout this procedure are for illustration purposes only. See "General Information," "Features and Displays" and the PC unit section of this User Manual for information about: • Displays • Operating Features, Controls, Indicators The majority of user interface programming is identical for both modules.

  • Page 306: Set Alarm Limits

    Monitoring Mode (Continued) Alarm limits: Adult SPO2 Main Mode (8210) • To change settings, see "Set Alarm Limits" procedure. % SPO2 PULSE RATE SatSeconds (% to Alarm) >Press ENTER to Retain Current View MAIN TREND LIMITS SCREEN Adult SPO2 Main Mode % SPO2 (8220)

  • Page 307: Navigate Trend Data

    Monitoring Mode (Continued) Set Alarm Limits (Continued) To change a limit setting, press soft key next to applicable parameter. Adult Alarm Limits %SPO2 HIGH %SPO2 PULSE HIGH PULSE >Select Parameter Limit CONFIRM Enter a numeric value for selected alarm limit. limit can be Off or a numeric value.
  • Page 308 Monitoring Mode (Continued) Navigate Trend Data (Continued) To scroll data one row at a time, press key. SILENCE SYSTEM OPTIONS ENTER CLEAR CANCEL To change increments for data review, move cursor TIME Trend Data 09:00 Adult Mode to desired time period and press soft key.

  • Page 309: Presilence Alarm

    Monitoring Mode (Continued) Navigate PCA/SpO Trend Data (Continued) See "Navigate Trend Data" procedure for instructions on Trend Data 09:00 how to: Adult Mode 2001-07-06 ETCO2 TIME • Navigate from page to page. 22:28 21:58 • Change increments. TIME 21:28 20:58 •...

  • Page 310: Channel Options

    Channel Options Change Limit Mode The following procedure can be performed only when the Guardrails Suite MX is not enabled (Profile option not being used for programming). Press Limit Mode soft key. To change Limit Mode Setup, press applicable soft key. Limit Mode Setup Adult To leave Limit Mode Setup unchanged and return to...

  • Page 311: Change Satseconds Limit

    Channel Options (Continued) Change Pulse Beep Volume (Continued) To test or change: a. To test volume level (when not attached to patient), Test Pulse Beep Volume press Test soft key. Pulse beep must be on to test volume level. To turn pulse beep on, press Louder soft key and adjust as Softer Louder...

  • Page 312: Change Saturation Averaging Time

    Channel Options (Continued) Change Saturation Averaging Time (8220) Press Saturation Averaging Time soft key. Channel Options Limit Mode: Adult Pulse Beep Volume: Off Sat. Averaging Time: 8 Sensitivity Mode: Normal >Select an Option or EXIT EXIT To change Saturation Averaging Time, press applicable soft key.
  • Page 313 Channel Options (Continued) Change Sensitivity Mode (Continued) (8220)  To change Sensitivity Mode, press applicable soft key. • Normal: Normal patient monitoring. Sensitivity Mode Normal • Maximum: Improved low perfusion performance. Maximum >Select an Option or EXIT EXIT NOTE: The sensitivity mode is displayed on the display SPO2 Main ...
  • Page 314 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Programming Module Section 4-12 Alaris System User Manual – with v9.33 Model 8015...

  • Page 315: General Setup And Operation

    General Setup and Operation System Start-Up/Setup See the PC unit section of this User Manual, "General Setup and Operation," for various system start-up and setup procedures. Module Section General Setup and Operation Alaris System User Manual – with v9.33 Model 8015 4-13...
  • Page 316 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Setup and Operation Module Section 4-14 Alaris System User Manual – with v9.33 Model 8015...

  • Page 317: General Information

    General Information Warnings and Cautions General WARNINGS • The SpO module is not to be used as an apnea monitor. • Pulse oximetry readings and pulse signal can be affected by certain ambient conditions, sensor application errors, and certain patient conditions. •...

  • Page 318: Sensors And Cables

    Warnings and Cautions (Continued) Sensors and Cables WARNINGS • Inspect the sensor site regularly to ensure correct sensor positioning, application, and site integrity. Tissue damage could occur over prolonged time periods, depending on the patient Profile (such as neonates) and method of application.

  • Page 319: Cables And Sensors

    Cables and Sensors Nellcor Patient Cables and Sensors (8210) The Nellcor patient cables interface the SpO module with the patient sensors. When selecting a sensor, consider the patient’s weight, the adequacy of perfusion, the available sensor sites, and the duration of monitoring. Use only Nellcor sensors. Select an appropriate sensor, apply it as directed, and observe all warnings and cautions presented in the User Manual accompanying the sensor.

  • Page 320: Features And Displays

    Features and Displays Features and Definitions See the PC unit section of this User Manual for system features and definitions. Models 8210 and 8220 Feature Definition % SpO Alarm Limits Upper and lower saturation limits for %SpO alarm can be adjusted by clinician.
  • Page 321 Features and Displays (Continued) Features and Definitions (Continued) Model 8210 Feature Definition SatSeconds™ SatSeconds™ limits controls time %SpO level can fall outside the alarm limits before an audible alarm sounds. Method of calculation is as follows: Number of percentage points %SpO falls outside of the alarm limit is multiplied by number of seconds %SpO level remains outside that...
  • Page 322 Features and Displays (Continued) Features and Definitions (Continued) Model 8220 Feature Definition Fast SAT When Fast SAT is enabled and there is one data point that is significantly different from a previous data point, averaging is disregarded and most recent data point is displayed. For example, if readings were 97%, 96%, 95%, and 85%, displayed saturation level would be 85%.

  • Page 323: Operating Features, Controls, Indicators

    Features and Displays (Continued) Operating Features, Controls, Indicators Status Indicators Alarm Monitoring Standby (red) (green) (yellow) IUI Connector, Right IUI Connector, Left (not visible) %SpO Display Pulse Bar Display Pulse Rate Display Channel (module) Identification Channel (module) Message Display Channel (module) Select Key: When pressed, selects corresponding module for patient...

  • Page 324: Displays

    Features and Displays (Continued) Displays The displays illustrated throughout this document are for illustration purposes only. The display content varies, depending on configuration settings, hospital-defined Data Set uploaded using the Guardrails Suite MX, programmed parameters, and many other variables. Main Display See the PC unit section of this User Manual.

  • Page 325: Configurable Settings

    If the configuration settings need to be changed from the Factory default settings, refer to the applicable Technical Service Manual or contact CareFusion Technical Support for technical, troubleshooting, and preventive maintenance information. With the Profiles feature enabled, the settings are configured independently for each Profile.

  • Page 326: Specifications And Symbols

    Configurable Settings (Continued) Model 8220 Feature Default Setting Options Saturation Averaging Time 8 seconds 2, 4, 8, 10, 12, 14, 16 seconds (display update period) Sensitivity Mode Normal Normal, Maximum Specifications and Symbols Specifications Models 8210 and 8220 Alarms: Audible and visual alarms for high and low saturation and pulse rate, sensor condition, system failure, and low battery conditions.
  • Page 327 Specifications and Symbols (Continued) Specifications (Continued) Models 8210 and 8220 Mode of Operation: Continuous Shock Protection: Type BF patient applied part Weight: lbs ( 0.91 Model 8210 Accuracy Tolerance:    Low Perfusion Adult Neonate Pulse Rate 20 - 250 bpm 20 - 250 bpm 20 - 250 bpm ±3 digits...
  • Page 328 Specifications and Symbols (Continued) Specifications (Continued) Model 8220 Display Update Period: Approximately second. Measurement Range: Perfusion: 0.02 Pulse Rate: 100% Pulse Amplitude Display: Proportional to height of signal. I.Q. Sensor: Emitted light wavelength range is within nm. Output power does not 1000 exceed NOTE:...
  • Page 329 Specifications and Symbols (Continued) Specifications (Continued) NOTES: Specification applies to monitor performance.  Adult specifications are shown for O MAX-A and MAX-N  sensors. Neonate specifications are shown for O MAX-N sensors. Saturation accuracy varies by sensor type. Masimo Board performance has been validated for low ...

  • Page 330: Symbols

    Specifications and Symbols (Continued) Symbols See the PC unit section of this User Manual for system symbols. Symbol Meaning Silenced alarm. Note: When displayed, the dashed lines through the symbol might appear as solid lines due to the small display size. Is displayed in Trend Data screen to identify an exceeded alarm limit.
  • Page 331 Measurement Accuracy (Continued) • Sensor placed on an extremity with a blood pressure cuff, arterial catheter, intravascular line or other causes of insufficient perfusion. • Nail irregularity, such as nail polish or fungus. Remove nail polish and/or move sensor to an unaffected site. •...
  • Page 332 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Information Module Section 4-30 Alaris System User Manual – with v9.33 Model 8015...
  • Page 333 Alaris EtCO Module Model 8300 Alaris EtCO Module Model 8300 EtCO (mm Hg) RR (breaths/min) CHANNEL SELECT MONITOR CHANNEL Alaris System User Manual – with v9.33 Model 8015 Section...
  • Page 334 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...
  • Page 335 Table of Contents Getting Started Introduction............................. 5-1 Connect Microstream™ Disposable....................... 5-2 Attach Gas Scavenging System......................5-4 Programming Monitoring Mode............................. 5-5 Set Alarm Limits ..........................5-6 Navigate Trend Data ........................5-8 Navigate PCA/Alaris EtCO ModuleTrend Data................5-9 Presilence Alarm ..........................5-10 Channel Options.............................
  • Page 336 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K EtCO Module Section 5-iv Alaris System User Manual – with v9.33 Model 8015...
  • Page 337 Getting Started Introduction This section of the User Manual provides EtCO module WARNING (Model 8300) instructions and information. It is used in Read all instructions, for both the conjunction with: EtCO module and PC unit, before • EtCO module Technical Service Manual using the Alaris System.

  • Page 338: Getting Started

    Connect Microstream™ Disposable Open gas inlet/outlet door by turning door counterclockwise until gas inlet is clearly visible. Hold in open position. Gas inlet is located on lower left corner of instrument and is marked with a gas inlet symbol ( Closed Position Gas Inlet Open Position...
  • Page 339 Connect Microstream Disposable (Continued) Release door. Connect Microstream Disposable to patient. Connection site and manner are dependent on patient intubation status and type of Microstream Disposable being used (refer to disposable's User Manual). NOTE: The Covidien Disposable may be used with 5 liters of oxygen with a nasal cannula.

  • Page 340: Attach Gas Scavenging System

    Attach Gas Scavenging System In the presence of high oxygen or anesthesia concentrations, it might be necessary to connect a gas scavenging system to the WARNING EtCO module. There is a risk of patient Open gas inlet/outlet door by turning door cross-infection if the sampled gas is counterclockwise until gas outlet is clearly visible.

  • Page 341: Monitoring Mode

    Programming Display references throughout this procedure are for illustration purposes only. See "General Information," "Features and Displays" and PC unit section of this User Manual for information about: • Displays • Operating Features, Controls, Indicators Monitoring Mode Perform following steps (see PC unit section of this User Manual, "General Setup and Operation,"...

  • Page 342: Set Alarm Limits

    Monitoring Mode (Continued) • To accept settings and begin monitoring, press ENTER key.  screen displays following information: ETCO2 Main Adult ETCO2 Main Mode ◦ Capnography waveform (scale adjustable). ETCO2 mmHg ◦ EtCO value, as well as minimum and maximum breaths/min EtCO alarm limits.
  • Page 343 Monitoring Mode (Continued) To move to next limit, press key. ENTER Adult Alarm Limits To confirm alarm settings and return to ETCO2 Main Mode ETCO2 _ 40 display, press soft key. CONFIRM mmHg HIGH ETCO2 mmHg breaths/min HIGH breaths/min seconds BREATH FiCO2 High : 10 mmHg >Press CONFIRM to...

  • Page 344: Navigate Trend Data

    Monitoring Mode (Continued) Navigate Trend Data To view Trend Data, press soft key. TREND Trend Data 09:00 Adult Mode Following information is displayed: 2001-07-06 ETCO2 TIME 22:58 • period for data review. TIME 22:28 21:58 • Average with high and low values. ETCO2 21:28 20:58...

  • Page 345: Navigate Pca/Alaris Etco Moduletrend Data

    Monitoring Mode (Continued) Navigate Trend Data (Continued) To return to display, press soft ETCO2 Main ETCO2 MAIN key. To return to Main Display, press soft key. MAIN SCREEN Navigate PCA/Alaris EtCO ModuleTrend Data To access and view shared trend data when a PCA module is present, perform the following steps.

  • Page 346: Presilence Alarm

    Monitoring Mode (Continued) Presilence Alarm SILENCE SYSTEM To presilence alarm, press key. SILENCE OPTIONS All monitoring alarms are silenced for 120 seconds and an Monitoring Alarm Silence symbol is displayed on the PC unit main screen. Subsequent infusion alarms are not silenced.

  • Page 347: Change Waveform Height

    Channel Options (Continued) Change Limit Mode (Continued) To change , press applicable soft key. Limit Mode Setup Limit Mode Setup Adult To leave unchanged and return to Limit Mode Setup Neonatal display, press soft key. ETCO2 Main EXIT >Select an Option or EXIT EXIT Change Waveform Height...

  • Page 348: Change Waveform Time Scale

    Channel Options (Continued) Change Waveform Time Scale Press soft key. Waveform time scale Channel Options Limit Mode: Adult Waveform height: 80 mmHg Waveform time scale: 5 sec PCA/EtCO2 Trend data >Select an Option or EXIT EXIT To change , select applicable time Waveform Time Scale scale.

  • Page 349: General Setup And Operation

    General Setup and Operation System Start-Up/Setup See the PC unit section of this User Manual, "General Setup and Operation," for various system start-up and setup procedures. EtCO Module Section General Setup and Operation Alaris System User Manual – with v9.33 Model 8015 5-13...
  • Page 350 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Setup and Operation EtCO Module Section 5-14 Alaris System User Manual – with v9.33 Model 8015...

  • Page 351: General Information

    General Information Warnings and Cautions General WARNINGS • and respiratory rate readings can be affected by certain ambient environmental and patient conditions. • The EtCO module is not to be used as an apnea monitor. • The EtCO module is intended only as an adjunct in patient assessment.

  • Page 352: Microstream Disposable

    Warnings and Cautions (Continued) Microstream Disposable (Continued) WARNINGS • Before use, read Microstream Disposable User Manual, including all warnings, cautions, and instructions. • Carefully locate the patient Microstream Disposable to reduce the possibility of patient entanglement or strangulation. CAUTIONS • Do not immerse or dampen the Microstream Disposable.

  • Page 353: Features And Displays

    Features and Displays Features and Definitions See the PC unit section of this User Manual for system features and definitions. Feature Definition Breaths per minute. Capnography Real-time graphical display of CO concentration throughout respiration. Waveform Data Display Waveforms, trended data, and numerical values are displayed. EtCO concentration in mmHg at end of exhalation.

  • Page 354: Operating Features, Controls, Indicators

    Features and Displays (Continued) Operating Features, Controls, Indicators Status Indicators Alarm Monitoring Standby (red) (green) (yellow) IUI Connector, Right IUI Connector, Left (not visible) EtCO mmHg Display Respiratory Rate Display Channel (module) Channel (module) Identification Message Display Channel (module) Select Key: When pressed, selects corresponding module for patient monitoring setup.

  • Page 355: Displays

    If the configuration settings need to be changed from the Factory default settings, refer to the applicable Technical Service Manual or contact CareFusion Technical Support, for technical, troubleshooting, and preventive maintenance information. Please consult the facility’s best practices guidelines on the preferred alarm settings for the monitoring of patients that are not continuously attended by a clinician.

  • Page 356: Specifications And Symbols

    Configurable Settings (Continued) Feature Default Setting Options Respiratory Rate Alarm Adult Mode: Limit, High Neonatal Mode: Respiratory Rate Alarm Adult Mode: Limit, Low Neonatal Mode: Specifications and Symbols Specifications Accuracy: readings: CO 2 Partial Pressure  Accuracy (at sea level) 0 - 38 mmHg ±2 mmHg 39 - 99 mmHg...
  • Page 357 Specifications and Symbols (Continued) Specifications (Continued) Alarm Limits: High EtCO 2 0 - 98 mmHg 5 - 99 mmHg FiCO 2 Not Applicable 2 - 99 mmHg No Breath 10 - 60 sec Not Applicable Respiration Rate 0 - 149 breaths/min 1 - 150 breaths/min Audible and visual alarms for high and low and respiratory rate, high...
  • Page 358 Specifications and Symbols (Continued) Specifications (Continued) Frequency Response: accuracy applies for breath rates of up to bpm. For maintaining CO 2 accuracy for respiration rates above bpm, accuracy is mmHg or ±12% reading, whichever is greater, for values exceeding mmHg. To CO 2 achieve specified accuracies for breath rates above bpm, Microstream...

  • Page 359: Symbols

    Specifications and Symbols (Continued) Symbols See the PC unit section of this User Manual for system symbols. Symbol Meaning Type patient applied part. Gas inlet. Gas outlet. Monitoring alarm or presilence. Note: When displayed, the dashed lines through the symbol might appear as solid lines due to the small display size.

  • Page 360: Measurement Accuracy

    Measurement Accuracy The EtCO module has been designed and manufactured WARNINGS to exacting standards and should perform well within given • If uncertain about measurement environmental and performance standards. There are certain accuracy, assess patient’s conditions under which an inaccurate measurement or the loss condition and vital signs by of respiratory rate signal can occur.
  • Page 361 Measurement Accuracy (continued) Respiration Rate Test The following test method is used to determine the module’s rated respiration rate range and the corresponding effects of end-tidal gas readings accuracy as a function of respiratory rate: • The system is set for operation. •...
  • Page 362 Measurement Accuracy (continued) Respiration Rate Test (continued) Expected Results Test Action 10 bpm ±2mmHg/±1bpm Measure Accuracy/RR Tolerance mmHg / bpm for Adult/Pediatric FilterLine Sets at respiration rates of 40 bpm  10, 40, and 60 bpm. 60 bpm ±2mmHg/±1bpm  ...

  • Page 363: Waveform Analysis

    Waveform Analysis The EtCO module provides the option to display EtCO readings as a waveform. The following graph is an example of a normal waveform (normal ventilation, 35 - 45 mmHg). In the event the EtCO value is above the waveform display range, the top of the waveform will be clipped. Numerical EtCO values continue to be displayed on both the EtCO module and PC unit.
  • Page 364 Waveform Analysis (Continued) Waveforms can be used to troubleshoot problems with equipment or monitor configuration, as well as to monitor a patient’s clinical status. The following graphs are examples of common problems identifiable through waveform analysis. These are examples only and do not represent all potential abnormal waveforms.

  • Page 365: Principle Of Operation

    Principle of Operation The EtCO module uses Covidien's patented Microstream nondispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO during every breath, the amount of CO present at the end of exhalation (EtCO ) and during inhalation (FiCO ), and the Respiratory Rate.
  • Page 366 Principle of Operation (Continued) used. In the event of humidity or condensate outside the EtCO module’s operating specifications, the EtCO module will present a "Remove Blocked Disposable" message. Due to the relatively small sampling size needed for EtCO readings, partial pressure does not affect the ability of the EtCO module to measure EtCO , as long as the 50 mL/min...
  • Page 367 EtCO Module Section General Information Alaris System User Manual – with v9.33 Model 8015 5-31...
  • Page 368 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Information EtCO Module Section 5-32 Alaris System User Manual – with v9.33 Model 8015...
  • Page 369 Alaris Auto-ID Module Model 8600 READY SCAN CANCEL Alaris System User Manual – with v9.33 Model 8015 Section...
  • Page 370 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...
  • Page 371 Table of Contents Getting Started Introduction............................. 6-1 Programming Patient Identification ..........................6-3 New Patient ............................ 6-3 While Infusion is in Progress ......................6-4 Authorized User Mode* .......................... 6-6 Primary Infusion ............................. 6-8 Secondary Infusion..........................6-9 General Setup and Operation System Start-Up/Setup........................... 6-11 General Information Warnings and Cautions ..........................
  • Page 372 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Auto-ID Module Section 6-iv Alaris System User Manual – with v9.33 Model 8015...

  • Page 373: Getting Started

    Auto-ID module contains an internal barcode image scanner and supports an optional handheld scanner supplied by CareFusion. Scanning a barcoded clinician ID and/or a barcoded patient identification band supports verification of the correct patient and associates the CQI event logs with the clinician and/or patient.
  • Page 374 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Getting Started Auto-ID Module Section Alaris System User Manual – with v9.33 Model 8015...

  • Page 375: Patient Identification

    WARNING Attach handheld scanner to connection port on Auto-ID module. Ensure a secure circuit connection. Use only the handheld external scanner supplied by CareFusion. Using other accessories can result in increased emissions or decreased immunity of the Alaris System. Power on PC unit.

  • Page 376: While Infusion Is In Progress

    Patient Identification (Continued) New Patient (Continued) CAUTION To scan barcode on patient identification band, press  scan trigger on handheld scanner. • : Do not CLASS 1 LED PRODUCT stare into the beam or allow beam • If scan is successful, an audible tone sounds and to strike patient's face.
  • Page 377 Patient Identification (Continued) New Patient (Continued) To scan barcode on patient identification band, press  scan trigger on handheld scanner. If scan is successful, an audible tone sounds and patient CAUTIONS ID appears on Main Display. • : Do not CLASS 1 LED PRODUCT NOTE: stare into the beam or allow beam...

  • Page 378: Authorized User Mode

    Authorized User Mode* Authorized User Mode is a feature that: • Combines PC unit tamper resist feature with Auto-ID application. • Is designed to ensure that only clinicians with a barcode on their ID badge can program Alaris System. • Is available only if it is enabled in selected Profile and there is an Alaris Auto-ID module attached.
  • Page 379 Authorized User Mode* (Continued) Program infusion. When no keys have been pressed on PC unit for a 5-minute period, tamper resist mode is automatically enabled. NOTE: There are three events that make the Authorized User Mode unavailable: a channel error, system error, or a discharged battery alarm.

  • Page 380: Primary Infusion

    Primary Infusion Using the Auto-ID module to scan IV medication containers provides the ability to select the correct medication and Drug Amount/Diluent Volume from the drug library, and enhances safety through the use of the Guardrails Suite MX. It compares the medication identifier from the IV container barcode with the medication identifier from the Drug Library.

  • Page 381: Secondary Infusion

    Subsequent Primary Infusion A subsequent primary infusion may be scanned with the Pump module running if the following criteria match between the scanned label and the running infusion: • Drug or Fluid name (Alias or NDC) • Drug Amount • Drug Amount Units •...
  • Page 382 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Programming Auto-ID Module Section 6-10 Alaris System User Manual – with v9.33 Model 8015...

  • Page 383: General Setup And Operation

    General Setup and Operation System Start-Up/Setup See the PC unit section of this User Manual, "General Setup and Operation", for various system start-up and setup procedures. Auto-ID Module Section General Setup and Operation Alaris System User Manual – with v9.33 Model 8015 6-11...
  • Page 384 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K General Setup and Operation Auto-ID Module Section 6-12 Alaris System User Manual – with v9.33 Model 8015...

  • Page 385: General Information

    To avoid potential harm, avoid looking into the beam or allowing the beam to strike the patient's face. Handheld Scanners The handheld external scanners supplied by CareFusion are WARNINGS the only handheld scanners approved for use with the Auto-ID module.

  • Page 386: Features

    Features Features and Definitions See the PC unit section of this User Manual for system features and definitions. Feature Definition Audible Scan Indicator Provides audible confirmation of a successful scan. Barcode A machine-readable label used for automatic identification. Automatic identification (Auto-ID) is the broad term given to a host of technologies used to help machines identify objects and is often coupled with automatic data capture.

  • Page 387: Operating Features, Controls, Indicators

    Features (Continued) Operating Features, Controls, Indicators IUI Connector, Left IUI Connector, Right (not visible) READY Indicator: Green LED illuminates to provide visual confirmation that module or handheld scanner is ready to scan SCAN/CANCEL Key: When initially pressed, scanning is initiated by embedded scanner. Subsequent press cancels scan.

  • Page 388: Configurable Settings

    If the configuration settings need to be changed from the Factory default settings, refer to the applicable Technical Service Manual or contact CareFusion Technical Support, for technical, troubleshooting, and preventive maintenance information. With the Profiles feature enabled, the settings are configured independently for each Profile.

  • Page 389: Symbolology

    Specifications and Symbols (Continued) Specifications (Continued) Alaris Auto-ID Module Fluid Ingress Protection: IPX1, Drip Proof Mode of Operation: Continuous Shock Protection: Type BF patient applied part. Weight: lbs ( 1 ±0.1 436.5 ±43.65 Handheld Scanner Dimensions: 3.25" W 7.25" H 4.25"...

  • Page 390: Troubleshooting And Maintenance

    Troubleshooting and Maintenance Errors and Messages Alarms and Alerts: See “Appendix A” "Troubleshooting and Maintenance" for the following system references: Alarms and alerts Audio Characteristics Definitions Display Color Radio Frequency Note Errors Error Meaning Response Clinician ID is invalid Clinician ID is not recognized. Ensure that ID label is legible.

  • Page 391: Messages

    Errors and Messages (Continued) Messages Message Meaning Response Drug or Fluid not in current Profile Drug and its concentration might Ensure that correct Profile is not be in currently selected Profile. selected and that it has correct drug and concentration. Channel Unavailable Channel is currently infusing and If secondary infusion was scanned,...
  • Page 392 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K Troubleshooting and Maintenance Auto-ID Module Section 6-20 Alaris System User Manual – with v9.33 Model 8015...
  • Page 393 Appendix A Troubleshooting and Maintenance Alaris System User Manual – with v9.33 Model 8015 Section...
  • Page 394 T H I S P A G E I N T E N T I O N A L L Y L E F T B L A N K...

  • Page 395: Alaris Pc Unit Model 8015

    Alaris Auto-ID Module, Model 8600 Technical Service Manual Alaris Auto-ID Module, Model 8600 The Service Manuals and System Maintenance software are available from CareFusion. The Service Manuals includes routine service schedules, interconnect diagrams, component parts lists and descriptions, test procedures, and other technical information to assist qualified service personnel in repair and maintenance of the instrument’s repairable...

  • Page 396: Alaris Systems Manager Connections

    Alaris Systems Manager Connections When an Alaris Systems Manager connection is made, the Wireless Network Indicator on the PC unit illuminates. If connection to the Alaris Systems Manager is interrupted, the indicator light is extinguished. Some of the causes for a communications failure include: •...

  • Page 397: Alarms And Alerts

    Alarms and Alerts Clinician’s Position for Alarm Monitoring CareFusion recommends that the clinician's position should be at a distance no greater than 1 meter to monitor visual alarm signals, four meters to monitor alarm condition and priority, and in proximity of the device so that any auditory alarm can be heard.
  • Page 398 Alarms and Alerts (continued) Definitions (continued) Terms Definitions High Priority A high-priority alarm is initiated by any alarm condition requiring immediate user response. Medium Priority A medium-priority alarm is initiated by any alarm condition requiring prompt user response. Low Priority A low-priority alarm is initiated by any condition requiring user awareness.

  • Page 399: Troubleshooting And Maintenance

    Alarms and Alerts (continued) Definitions (continued) The Alaris System alarms are further categorized by type: Terms Definitions Technical Alarms An alarm arising from a hardware or software failure condition. The signal priority is indicated by an audio tone and visually, by the color of the title bar on the PC unit screen, which may include flashing behavior.
  • Page 400 Alarms and Alerts (continued) Definitions (continued) Terms Definitions Infusion Alarms An alarm arising from an infusion module (PCA, Syringe, Pump). Monitoring Alarms An alarm arising from a monitoring module. Status Indicators Monitoring and Infusion high priority alarms—Module status indicator flashes red Standby Alarm Infusing...
  • Page 401 Alarms and Alerts (continued) Definitions (continued) Terms Definitions Advisory/Message A sequence of audio and/or visual signals indicating the system operation status. Alarm Signal An audible and visual indicator of a potential or actual hazardous condition. Alarm Silence Alarms can be silence for up to 120 seconds by pressing the SILENCE key. The alarm indicator remains on and the alarm silence symbol is displayed.
  • Page 402 Alarms and Alerts (continued) Definitions (continued) Terms Definitions Maintenance Reminder A visual message that when enabled appears at startup when a scheduled preventive maintenance is due/overdue for component of Alaris System (PC unit or attached module). Medium Priority Alarm A medium-priority alarm is initiated by any alarm condition requiring a prompt user response. NEOI Snooze (Reminder signal) Configurable alert, if enabled, provides an audio only tone when a Near End of Infusion alarm had been previously silenced.
  • Page 403 Alarms and Alerts (continued) Audio Characteristics Profile Priority Audio Characteristics Visual Indicator High Repeating sequence of 10 beeps followed by an approximate 7 second pause for a monitoring Flashing Red Profile 1 alarm Repeating sequence of 2 beeps followed by an approximate 1.5 second pause for an infusion alarm Medium Repeating sequence of 6 beeps followed by an approximate 4 second pause for a monitoring...
  • Page 404 High Repeating sequence of 10 beeps followed by an approximate 4 second pause Flashing Red Profile 4 Medium Repeating sequence of 3 beeps followed by an approximate 6 second pause Flashing Yellow Repeating sequence of 3 beeps followed by an approximate 15 second pause Steady Yellow Troubleshooting and Maintenance...
  • Page 405 Alarms and Alerts (continued) Audio Characteristics (continued) Sound Pressure Level Ranges for Alarm Signals Alarm Volume 5 (Max) Volume 1 (Min) Average SPL (dBA) Average SPL (dBA) HIGH - Malfunction HIGH - Monitoring HIGH - Infusion MED - Monitoring MED - Infusion LOW - Infusion/PC unit CAUTION Profile 4 audio setting supports standards compliance.
  • Page 406 Alarms and Alerts (continued) Alarms Alarms Alarm Message Device Priority Meaning Response ATTACH HANDSET The Dose Request Cord Reattach the Dose Request Cord and detached from the device during press the RESTART key. an active infusion. The Dose Request Cord is required only for PCA and PCA + Continuous Infusion modes.
  • Page 407 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response AUDIO SYSTEM PC unit Medium The audio system has failed and Replace the PC unit as soon as ERROR the backup system is in use. The possible. PC Unit currently in use may be continued temporarily with backup audio system.
  • Page 408 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response BATTERY PC unit HIgh The battery is completely Plug in or replace the device and DISCHARGED discharged and the device is restart the modules. POWERING DOWN powering down. CHANNEL Syringe High...
  • Page 409 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response CHECK SENSOR - SpO2 Medium The patient’s motion has Check the sensor. Move the sensor to MOTION inhibited monitoring. a site with less motion. INTERFERENCE CHECK SENSOR - SpO2 Medium The SpO...
  • Page 410 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response COMMUNICATION All modules High The module has lost Replace module ERROR communication with the PC unit. DEFECTIVE PC unit High A battery failure is detected Replace the device immediately. The BATTERY during normal operations.
  • Page 411 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response HIGH ETCO2 EtCO High The EtCO value is above the Assess the patient's condition. Confirm specified limit. that the correct alarm limit values are selected. HIGH FICO2 EtCO High FiCO...
  • Page 412 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response LOW ETCO2 EtCO High The EtCO value is below the Assess the patient's condition. Confirm specified limit. that the correct alarm limit values are selected. LOW RR EtCO High The respiratory rate is below the...
  • Page 413 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response NEAR END OF Syringe, The syringe is almost empty. To silence the alarm, press the INFUSION This is a timed event that can be SILENCE key. The module remains configured in the Data Set.
  • Page 414 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response PARTIAL Pump High A partial occlusion of the patient Clear the occlusion. Press the OCCLUSION - side of the IV line detected by RESTART key, or press the PATIENT SIDE the Auto-Restart feature.
  • Page 415 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response PRESSURE DISC Syringe High The Pressure Sensing Disc was Press the CONFIRM soft key and then INSERTED installed during a running the RESTART key. infusion. The infusion stops on affected module.
  • Page 416 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response SENSOR OFF Medium The sensor is not connected to Check the patient. Attach the sensor to the patient while monitoring or the patient. after approximately 30 seconds of searching for patient.
  • Page 417 Alarms and Alerts (continued) Alarms (continued) Alarms Alarm Message Device Priority Meaning Response VERY LOW BATTERY PC unit High The battery has an estimated Connect the AC power cord to the <5 MIN TO run time of five minutes prior to power source (alarm silenced).

  • Page 418: Storage

    Normally a battery will last 2 years if used under proper maintenance. See Proper Battery Maintenance on page A-25. Use only CareFusion batteries. The use of third party batteries could affect the safety and efficacy of Alaris products. Battery Charging The PC unit is shipped with the battery in a discharged condition.
  • Page 419 Battery Care and Maintenance (Continued) Battery Storage and Use Conditions If you plan to store the PC unit at temperatures in excess of 86°F (30°C) for one or more months, remove the battery from the PC unit and store the battery in an environment of 50 - 86°F (10 - 30°C).

  • Page 420: Wireless Connection

    Wireless Connection Wireless Connection Soft Key Send the PC unit to Biomed to resolve wireless connectivity issues. The Wireless Connection soft key is inactive (grayed out) for one of the following reasons: • The System Maintenance software was used to disable the wireless connection.
  • Page 421 Inspection Requirements To ensure that the Alaris System remains in good operating WARNING condition, both regular and preventive maintenance inspections Failure to perform these are required. Refer to the System Maintenance software for inspections can result in improper detailed instructions. instrument operation.

  • Page 422: Cleaning

    Cleaning Products ◦ Do not spray fluids directly onto the instrument or into the Refer to the following website for cleaning product information: IUI connectors. www.carefusion.com/alarissystemcleaning. ◦ Do not steam autoclave, EtO sterilize, immerse the Procedure instrument in fluids, or allow...
  • Page 423 DO NOT use any hard, abrasive or pointed objects to clean NOT be used: any part of the instrument. www.carefusion.com/alarissystemcleaning • Do not use chemicals that can damage the surface of the instrument. When possible use...
  • Page 424 Cleaning (Continued) Alaris System (Continued) Follow the cleaner manufacturer’s instructions on the time to leave it on the device surface. Then, remove the cleaner using a soft cloth dampened with water. DO NOT allow the cleaner to collect on the instrument. Cleaning the IUI Apply 70% isopropyl alcohol directly to the dedicated IUI cleaning brush.
  • Page 425 Cleaning (Continued) Alaris System (Continued) Drying and Inspection Confirm that the instruments and IUI connectors are thoroughly dry before using them again. DO NOT attach devices that have not fully dried to one another. “Wet mating” can hinder proper instrument operation.
  • Page 426 Cleaning (Continued) Alaris System (Continued) Inspect the IUI connectors on each PC unit and module prior to use. Replace any IUI connector with surface contaminants, blue or green deposits, or cracks. DO NOT use a device with any cracks or surface contaminants on the IUI connectors.

  • Page 427: Service Information

    Technical Support checking in the instrument and Technical support, service information, applications, and ensuring the current hospital- manuals can be obtained by contacting a CareFusion approved Data Set is loaded. representative. 888-812-3229. When submitting any request for service, include: •...
  • Page 428 CareFusion warrants that: A. Each new Alaris System product is free from defects in material and workmanship under normal use and service for a period of one (1) year from the date of delivery by CareFusion to the original purchaser.

  • Page 429: Regulations And Standards

    The authority to operate this system is conditioned by the requirement that no modifications are made to the system unless the changes or modifications are expressly approved by CareFusion Corporation. This Class B digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulation.

  • Page 430: Electromagnetic Emissions

    Compliance (Continued) Electromagnetic Environment (Continued) Cet appareil numerique de la Classe B respecte toutes les exigences du Reglement sur le materiel brouilleur du Canada. The Alaris System includes an IEEE 802.11 RF transmitter, as designated by the icon on the rear of the system. It operates on the following frequencies with a maximum radiated power of 100 mW: •...

  • Page 431: Electromagnetic Immunity

    Compliance (Continued) Electromagnetic Environment (Continued) Alaris System (Continued) Table 2 Electromagnetic Immunity Compliance Electromagnetic Environment - 60601-1-2:2007 Immunity Test  Guidance Level  Test Level  IEC 61000-4-2 For Model 8015, ±8 kV contact Floors should be wood, concrete, or ceramic ...
  • Page 432 Compliance (Continued) Electromagnetic Environment (Continued) Alaris System (Continued) Table 2 (Continued) Electromagnetic Immunity IEC 60601-1-2 Compliance Electromagnetic Environment - Immunity Test   Guidance Test Level Level <5% U IEC 61000-4-11 <5% U Mains power quality should be that of a typical (>95% dip in U ) for Voltage Dips, Short...
  • Page 433 Compliance (Continued) Electromagnetic Environment (Continued) Alaris System (Continued) Table 3 Electromagnetic Immunity - Life Support Equipment Compliance Electromagnetic Environment - IEC 60601-1-2 Immunity Test Test Level   Level Guidance IEC 61000-4-6 10 Vrms 10 Vrms Portable and mobile RF communications Conducted RF 150 kHz - equipment should be used no closer to...
  • Page 434 Compliance (Continued) Electromagnetic Environment (Continued) Alaris System (Continued)  Table 4 Recommended Separation Distances Reduce the potential for electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters), and the Alaris System as recommended in this table, based on the maximum output power of the communications equipment. For transmitters rated at a maximum output power not listed in this table, the recommended separation distance (d) in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) based on the...
  • Page 435 Compliance (Continued) Electromagnetic Environment (Continued) Alaris System (Continued) NOTES: Compliance levels raised by IEC 60601-2-24 (Edition 2.0 2012).  Performed at the minimum and maximum rated input voltage.  is the AC mains voltage prior to application of the test level. ...
  • Page 436 Reglement sur le Matériel Brouilleur du Canada. This Class B digital device meets the requirements of the International community. Australian Communications Authority Applicant: CareFusion Australia 316 Pty LTD P.O. Box 355 Seven Hills West, NSW Australia 2147 Phone: 02 9838 0255...
  • Page 437 Compliance (Continued) Standards The Alaris System has been assessed and complies with the following standards: PC unit and overall System: CAN/CSA C22.2 No. 60601-1-1 (3.0 Edition 2014), IEC 60601–1 (3.1 Edition 2012), 60601-1-2 (2007), 60601-1-8 (2012) Auto-ID module: IEC 60825–1 (Edition 3.0 2014) (LEDs used in Auto-ID module are not regulated by FDA in the United States;...
  • Page 438 Compliance (Continued) Standards (Continued) The Alaris System when upgraded to v9.33 software only has been assessed and complies with the following standards: PC unit and overall System: UL 60601–1 (2003), CAN/CSA C22.2 No. 601.1-M90 (2.0 Edition 1990), IEC 60601–1 (2.0 Edition 1988) Auto-ID module: IEC 60825–1 (2007) (LEDs used in Auto-ID module are not regulated by FDA in the United States;...
  • Page 439 Compliance (Continued) Hardware Dependencies Additional test evidence is available for the EtCO hardware included in devices manufactured with v9.33 software. This test evidence will not apply to devices upgraded to v9.33. EtCO2 Hardware v9.33 Software Upgrade Device Manufactured with Dependencies Only v9.33 Software Note 1 for Accuracy of EtCO...

  • Page 440: Trademarks

    Trademarks CareFusion, Alaris, Guardrails, SmartSite, and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its affiliates. All other trademarks are the property of their respective owners. Regulations and Standards Appendix Section A-46 Alaris System User Manual – with v9.33 Model 8015...
  • Page 442 Alaris System User Manual – with v9.33 Model 8015...

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