Cardinal Health Alaris Directions For Use Manual
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Cardinal Health Alaris Directions For Use Manual

Supports guardrails suite mx with guardrails point-of-care software and v9 operating system software. with pc unit, model 8000.
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Supports Guardrails
®
Suite MX with Guardrails
ONI
% SpO 2
PULSE (BPM)
CHANNEL
SELECT
MONITOR
CHANNEL
OFF
Directions for Use
Alaris
(with PC Unit, Model 8000)
FU
RATE (mL/h)
CHANNEL
SELECT
PAUSE
CHANNEL
OFF
RESTART
®
System
®
Point-Of-Care software and v9 Operating System software.
SILENCE
SYSTEM
OPTIONS
ON
1
2
3
4
6
5
7
8
9
ENTER
.
0
CLEAR
CANCEL
February 2007
FU
RATE (mL/h)
CHANNEL
SELECT
PAUSE
CHANNEL
OFF
RESTART
Alaris
FU
RATE (mL/h)
CHANNEL
SELECT
PAUSE
CHANNEL
OFF
RESTART
®
Products

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  • Page 1 Directions for Use ® Alaris System (with PC Unit, Model 8000) Supports Guardrails ® Suite MX with Guardrails ® Point-Of-Care software and v9 Operating System software. February 2007 % SpO 2 RATE (mL/h) RATE (mL/h) RATE (mL/h) PULSE (BPM) CHANNEL...

  • Page 2: Table Of Contents

    ..................Order Numbers: Electronic Copy: 10015905 Printed Copy: 10110697 ©2006, 2007 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. ® Alaris System (with v9 Model 8000) DFU...

  • Page 3: General Contact Information

    General Contact Information Cardinal Health ® Alaris Products Wateridge Circle 10221 San Diego, California 92121 cardinal.com/alaris Customer Advocacy - North America Clinical and technical feedback. Phone: 800.854.7128, Ext. 7812 E-Mail: CustomerFeedback@cardinal.com Technical Support - North America Maintenance and service information support; troubleshooting.

  • Page 4: Introduction

    A Data Set is developed and approved by the facility’s own multi-disciplinary team using the Editor Software, the based ® authoring tool. A Data Set is then transferred to the Alaris System by qualified personnel. The approved Data Sets are maintained by the Editor Software for future updates and reference.

  • Page 5: Pc Unit

    Product-specific warnings and cautions, covered in the applicable Sections of this DFU provide information needed to ® safely and effectively use the Alaris System. DANGER is an alert to an imminent hazard which could result in serious personal injury and/or product damage if proper procedures are not followed.
  • Page 6 Instruments are tested and calibrated before they are packaged for shipment. To ensure proper operation after shipment, it is recommended that an incoming inspection be performed before placing the instrument in use. Prior to placing the Alaris ® System in use: Perform check-in procedure using System Maintenance software.
  • Page 7 ® Alaris PC Unit Model 8000 SILENCE SYSTEM OPTIONS ENTER CLEAR CANCEL ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 9 ..................................Operating Features, Controls, Indicators 1-35 ............................Displays 1-37 ........................................SYSTEM CONFIGURABLE SETTINGS 1-38 ..............................SPECIFICATIONS AND SYMBOLS 1-39 ................................Specifications 1-39 ......................................Symbols 1-40 ........................................Alaris ® System (with v9 Model 8000) DFU Table of Contents PC Unit Section...
  • Page 10 1-47 ..............................Battery Type and Charging 1-47 .................................. Battery Charge 1-48 ......................................Battery Care 1-48 ....................................... Battery Cautions and Disposal 1-48 ................................INSPECTION REQUIREMENTS 1-49 ................................. ® Alaris System (with v9 Model 8000) DFU Table of Contents PC Unit Section...

  • Page 11: Maintenance

    • System Maintenance software (and its instructions) for Alaris System check-in, maintenance, and wireless configuration CAUTION The PC Unit is the core of the Alaris ® System and provides a common user interface for programming infusions and monitoring, which helps to reduce complexity at the point of care.
  • Page 12 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K Getting Started Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 13: General Setup And Operation

    Application of adhesive tape or other materials to the sides of the PC Unit and modules may prevent proper latching. ® The Alaris System is designed to operate a maximum of infusion or monitoring modules. Modules added in excess of are recognized by the system.

  • Page 14: Detaching Module(S)

    Push module release latch and then rotate module(s) up and away from PC Unit or attached module (opposite to motion shown above) to disengage connectors. • Alaris ® System reidentifies and shows appropriate module identification ( ), from left to right.

  • Page 15: Start-Up

    If the affected module operates normally when it is attached via an alternate connector, it may be used until a replacement module can be substituted. Alaris ® System (with v9 Model 8000) DFU General Setup and Operation PC Unit Section...

  • Page 16: Responding To Maintenance Reminder

    Module A: YYYY-MM-DD at power up. Remove and, if needed, replace module requiring maintenance with a new module (see "Attaching and Detaching Modules"). If Alaris ® System was powered off to replace PC Unit, CONFIRM reinitiate start-up process. If an attached module (such as a Pump Module) was...

  • Page 17: Selecting New Patient And Profile Options

    To return to main screen, press CONFIRM soft key. Darker ©2001-2005 Cardinal Health, inc. or one of its subsidiaries. All rights reserved. Guardrails® is a registered trademark of Cardinal Health, inc. or one of its subsidiaries. >Adjust Display to Desired Contrast CONFIRM...
  • Page 18 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Auto-ID Module Section of this DFU. >Enter Patient ID and Press CONFIRM PAGE EXIT CONFIRM DOWN General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 19: Adjusting Audio Volume

    To return to PC Unit screen, press soft key. MAIN SCREEN • After seconds without a key press, Main Display Softer Louder appears. >Change Setting or Cancel MAIN SCREEN Alaris ® System (with v9 Model 8000) DFU General Setup and Operation PC Unit Section...

  • Page 20: Locking/Unlocking Tamper Resist

    An advisory tone (if Key Click Audio is enabled) and a three-second prompt on Main PANEL UNLOCKED Display confirm activation. PANEL UNLOCKED VOLUME AUDIO INFUSED ADJUST 1-10 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 21: Power Off System

    Power Down All Channels Anesthesia Mode >Select an Option or EXIT PAGE EXIT DOWN Adjust display and return to main screen (see "Start-Up", "Adjusting Display Contrast" procedure). Alaris ® System (with v9 Model 8000) DFU 1-11 General Setup and Operation PC Unit Section...

  • Page 22: Patient Id

    To verify correct entry, press soft key. CONFIRM Patient ID Entry 123456789CD_ _ _ _ _ >Enter Patient ID and Press CONFIRM PAGE EXIT CONFIRM DOWN 1-12 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...
  • Page 23 Patient ID Entry • New Patient ID Entry verification screen appears. 234567891EF_ _ _ _ _ >Enter Patient ID and Press CONFIRM PAGE EXIT CONFIRM DOWN Alaris ® System (with v9 Model 8000) DFU 1-13 General Setup and Operation PC Unit Section...

  • Page 24: Clinician Id

    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 1-14 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 25: Power Down All Channels

    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 Alaris ® System (with v9 Model 8000) DFU 1-15 General Setup and Operation PC Unit Section...

  • Page 26: Anesthesia Mode

    All limits are set to Soft. patient will be taken to when the Anesthesia Mode is discontinued. • Dose checking mode is set to Smart. This ensures that the Alaris ® System will be in the correct profile following •...
  • Page 27 The Anesthesia Mode can be disabled, and normal operation resumed, using either of the following three methods: • System Options menu. • Disconnecting from power. • Connecting to power. Alaris ® System (with v9 Model 8000) DFU 1-17 General Setup and Operation PC Unit Section...
  • Page 28 Press soft key. CONFIRM Anesthesia mode was discontinued when AC power cord was disconnected. Press CONFIRM to continue normal operation. >Press CONFIRM CONFIRM 1-18 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 29: Battery Runtime

    2 of 3 Battery Runtime System Configurations Serial Numbers Software Versions Time of Day >Select an Option or EXIT PAGE PAGE UP EXIT DOWN Alaris ® System (with v9 Model 8000) DFU 1-19 General Setup and Operation PC Unit Section...
  • Page 30 Max Pt. BSA: Max Pt. weight: 500 kg Patient ID Entry: Disabled Pending IV Orders: Enabled >Press CANCEL or EXIT PAGE PAGE EXIT DOWN 1-20 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 31: Serial Numbers

    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 serial number. Alaris ® System (with v9 Model 8000) DFU 1-21 General Setup and Operation PC Unit Section...

  • Page 32: Software Versions

    Main processor: nn.nn nn.nn Main boot block: Keyboard: nn.nn >Press CANCEL or EXIT EXIT NOTE: "nn.nn" in the illustrated display represents a software version. 1-22 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 33: Time Of Day

    >CONFIRM Time-of-Day EXIT CONFIRM Enter current Time of Day. System Options Time of Day Current time: Change Time __:__ >Enter Current Time EXIT CONFIRM Alaris ® System (with v9 Model 8000) DFU 1-23 General Setup and Operation PC Unit Section...

  • Page 34: Network Status

    This option is available only when the Communications Interface Board Accessory is installed and the PC Unit has ® been flashed to support wireless communications with Alaris Server or Mobile Systems Manager. The displayed status updates immediately when a status change takes place.
  • Page 35 Network Status Status : CONNECTED Uptime : 03:45:35 Bytes Sent: 13, 890 Bytes Recv: 1,200,150 >Press CANCEL to Exit SERVER WIRELESS ADDRESS STATUS STATUS Alaris ® System (with v9 Model 8000) DFU 1-25 General Setup and Operation PC Unit Section...

  • Page 36: Wireless Connection

    STATUS Wireless Connection This option is available only when the Communications Interface Board Accessory is installed and the PC Unit has ® been flashed to support wireless communications with Alaris Server or Mobile Systems Manager. 1. Press key. OPTIONS Press soft key times.

  • Page 37: Data Set Status

    To comply with regulations and prevent potential interference with aircraft communications, disable To enable wireless communication, press Enable soft key. wireless communication when the ® Alaris System is used in an aircraft. System Options Wireless Enable Connection Disable >Press ENABLE or...

  • Page 38: Maintenance Due

    Module A: YYYY-MM-DD Module B: YYYY-MM-DD Module C: YYYY-MM-DD Module D: YYYY-MM-DD >Press CANCEL or EXIT PAGE EXIT DOWN -- Continued Next Page -- 1-28 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...
  • Page 39 Bar Code: YYYY-MM-DD (Hand held) >Press CANCEL or EXIT PAGE UP EXIT NOTE: soft key appears only if an Auto-ID Module is PAGE DOWN attached. Alaris ® System (with v9 Model 8000) DFU 1-29 General Setup and Operation PC Unit Section...
  • Page 40 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K 1-30 General Setup and Operation Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 41: General Information

    Electrical shock hazard. Do not open case. Refer to qualified service personnel. • To comply with regulations and prevent potential interference with aircraft communications, disable wireless communication when the Alaris ® System is used in an aircraft (see "System Options", "Network Status"). ®...

  • Page 42: Electromagnetic Compatibility

    System near Magnetic Resonance Imaging ( ), 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 may result in increased emissions or decreased Alaris ®...

  • Page 43: Features And Displays

    (data processing equipment) or IEC 60950 (electromedical equipment). IEC 60601–1 ® • The Alaris System is intended for use by healthcare professionals only. This is a Class Group CISPR 11 medical system. In a domestic environment, this system may cause radio interference.
  • Page 44 Allow system settings to be customized. If Profiles feature is enabled, system settings defined for selected profile are automatically activated. Tamper Resist Provides a quick one-touch lockout of front panel keypad. 1-34 General Information Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 45: Operating Features, Controls, Indicators

    Silence Key: When pressed during an alarm, silences audio System On Key: When for 2 minutes. ® pressed, changes Alaris System from Standby to Operating mode. Options Key: When pressed, allows access to available System or Channel Options. Up/Down Arrows:...
  • Page 46 90° attachment to a bed rail instead of a pole. Primary Audio Speaker Connector Plug over RJ45 Communication Data Port Tamper Resist Switch Option Upgrade Panel 1-36 General Information Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 47: Displays

    Nonhighlighted indicates a nonselected soft key. "Active" Soft Key Highlighted indicates a selected soft key. >Press START Prompt Bar SECOND- START PAUSE Look here for user prompts. Alaris ® System (with v9 Model 8000) DFU 1-37 General Information PC Unit Section...

  • Page 48: System Configurable Settings

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

  • Page 49: Specifications And Symbols

    Atmospheric Pressure: mmHg mmHg 4560 hPa) hPa) 6080 1013 ® Equipment Orientation: To ensure proper operation, Alaris System must remain in an upright position. Fluid Ingress Protection: , Drip Proof IPX1 Mode of Operation: Continuous Power Requirements: 240V 50/60 150 VA MAX...

  • Page 50: Symbols

    Canadian electrical safety and U.S. performance standards. Communications connector for attachment. RS-232 Consult operating instructions. Type defibrillation-proof equipment. Electrostatic discharge ( 1-40 General Information Alaris ® System (with v9 Model 8000) DFU PC Unit Section...
  • Page 51 Caution: Federal ( ) law restricts this device to sale by or on order of a physician. U.S.A. " " SYSTEM ON Tamper Resist activate/deactivate switch. Alaris ® System (with v9 Model 8000) DFU 1-41 General Information PC Unit Section...
  • Page 52 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K 1-42 General Information Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 53: Troubleshooting And Maintenance

    Service Manual and System Maintenance software. Alarms, Errors, Messages ® To enhance safety and ease of operation, the Alaris System provides a full range of audio and visual alarms, errors, and messages.

  • Page 54: Audio Characteristics

    SILENCE Audio Characteristics ® The Alaris System provides various types of alert information. See the product-specific Section of this DFU that applies to the attached module(s) for audio characteristics specific to that module. Type Sound Notes...

  • Page 55: Alarms

    Replace CONFIRM module with an operational instrument. Defective Battery Defective battery. To continue temporary operation, press key. Replace SILENCE PC Unit with an operational instrument. Alaris ® System (with v9 Model 8000) DFU 1-45 Troubleshooting and Maintenance PC Unit Section...

  • Page 56: Messages

    Last module powering off. System Powering Down Press any key, except SYSTEM shuts off in indicated number of key, to cancel power down seconds. sequence. 1-46 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU PC Unit Section...

  • Page 57: Storage

    Batteries should be charged in a room with a temperature between ° ° ), to minimize charge time and 80.6 maximize battery life. Alaris ® System (with v9 Model 8000) DFU 1-47 Troubleshooting and Maintenance PC Unit Section...

  • Page 58: Battery Charge

    Battery Care The battery capacity should be checked at least once every ® months. Reference the Alaris System Technical Service Manual for test and replacement procedures. If the PC Unit is to be stored at temperatures in excess of °...

  • Page 59: Inspection Requirements

    Inspection Requirements ® To ensure the Alaris System remains in good operating WARNING condition, both regular and preventive maintenance inspections Failure to perform these are required. Reference the System Maintenance software for inspections may result in improper detailed instructions. instrument operation.
  • Page 61 ® Alaris Pump Module, Model 8100 ® Alaris Syringe Module, Model 8110 RATE (mL/h) RATE (mL/h) CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 63 MULTIDOSE MODE 2-68 ......................................Volume/Duration Enabled 2-70 ..................................Volume/Duration Disabled 2-71 ................................... SELECTING PRESSURE LIMIT 2-73 .................................. Pump Module 2-73 ......................................Syringe Module 2-74 ......................................® Alaris System (with v9 Model 8000) DFU Table of Contents Pump and Syringe Modules Section...
  • Page 64 2-116 ..................................... Alarms 2-116 ........................................... Errors 2-121 ..........................................Messages 2-122 ........................................Possible End of Infusion Messages and Alerts 2-124 .......................... INSPECTION REQUIREMENTS 2-124 ................................. Alaris ® System (with v9 Model 8000) DFU Table of Contents Pump and Syringe Modules Section...

  • Page 65: Getting Started

    Syringe Module Set Compatibility Card • Syringe Module Technical Service Manual • System Maintenance software (and its instructions) for Alaris ® System check-in, maintenance, and wireless configuration The Pump and Syringe Modules are intended for facilities that utilize infusion and/or syringe pumps for the delivery of fluids,...
  • Page 66 Introduction (Continued) Contraindications: None known. Electromagnetic Environment: See "Appendix" Section of this DFU ("Regulations and Standards", "Compliance"). Getting Started Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 67: Preparing Administration Set (Pump Module)

    (see "General Information", "Safety Clamp Fitment"). * "Safety clamp" is referred to on the device as "Flo-Stop". Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 68 Pump Module door. Open roller clamp. Verify no fluid is flowing through drip chamber. NOTE: "Safety clamp" is referred to on the device as "Flo-Stop". Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 69: Removing

    (Reference set’s directions for use.) Insert administration set spike into prepared fluid container, following accepted hospital/facility procedure, and hang container inches above Pump Module. Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 70 Prepare administration set (reference Set Compatibility Card, provided separately) in accordance with manufacturer’s directions for use. Attach upper fitting of administration set to syringe tip. Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 71: Preparing Syringe And Administration Set (Syringe Module)

    Ensure instrument is as close to level of patient as CHANNEL SELECT possible (patient should be in line with key). RATE (mL/h) Align with Patient CHANNEL SELECT PAUSE CHANNEL RESTART Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 72 Insert syringe (from front of instrument) by sliding flat edge of syringe barrel flange between barrel flange grippers. RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 73 Ensure the syringe plunger head makes contact with the small black sensor, located on the bottom of the drive head (between the plunger grippers). Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 74 CHANNEL • cavity forward (membrane toward instrument) RESTART Gently slide pressure sensing disc up into slot in pressure sensing disc housing. Pressure Sensing Disc 2-10 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 75: Priming - Using Options Menu

    Fast Start WARNING Priming - Using Options Menu When priming: The Priming option can be enabled at the time the Alaris ® PRIME System is configured for use. The Priming selection ( • Ensure administration set is not soft key) is available only after the syringe and infusion type connected to patient.
  • Page 76 After priming is completed, reinstall the pressure sensing disc. OPTIONS Press key. SILENCE SYSTEM OPTIONS ENTER CLEAR CANCEL 2-12 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 77 Press CONFIRM and continue priming. >Press CONFIRM CONFIRM Invert pressure sensing disc so that patient side is up. Hold pressure sensing disc between fingers. Patient Side 2-13 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 78 Prime Set with Syringe CAUTION: Do not prime with disposable set connected to patient! Prime Volume 2 mL >Press and Hold PRIME EXIT PRIME 2-14 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 79 A A A disc is reinstalled, a prompt to reinstall pressure Re-install Pressure Sensing sensing disc displays. Disc. >Press CONFIRM CONFIRM 2-15 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 80 To deliver PRIME additional amounts, press the soft key again. Volume used during priming is displayed but not added to VTBI 2-16 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 81: Priming - Manual

    After priming is completed, reinstall the pressure sensing disc. 2-17 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 82 Load syringe (see "Loading" procedure). If a pressure sensing disc is being used, do not install disc until priming is complete. Select syringe and infusion type (see "Programming" chapter). 2-18 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 83 PRIME soft key. Prime until fluid drips from end of tubing. Complete procedure (installing pressure sensing disc, if applicable, and exiting options menu). 2-19 Getting Started ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 84 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K 2-20 Getting Started Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 85: Programming

    Confirm current profile or select a new profile. Enter patient identifier, if required. Prepare and load syringe/administration set (see "Getting Started"). Prime (see "Getting Started"). 2-21 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 86 If a default syringe list has been enabled and correct BD 30 mL ALL SYRINGES syringe cannot be found, press soft Monoject 30 mL key. >Select Syringe Size CONFIRM SYRINGES 2-22 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 87: Continuous Infusion

    • drug selected • weight entry (if required) • rate or dose entry • entry (Syringe Module: if other than All) VTBI 2-23 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 88 Once drug or IV fluid has been >Select Therapy Type confirmed, therapy indication appears in title bar. DRUG EXIT LIBRARY -- Continued on Next Page -- 2-24 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 89 DOSING mg/kg/h To change selection, press No soft key. UNITS BOLUSABLE BOLUS mg/kg DOSING UNITS >Press Yes or No -- Continued on Next Page -- 2-25 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 90 TIME hour UNITS DOSING mg/kg/h UNITS [Conc]: 1 mg/mL >Enter Patient Weight DRUG LIBRARY NEXT Verify parameters are correct and press soft key to confirm. 2-26 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 91 VTBI ♦ When is disabled and soft key is [Conc]: 1 mg/mL pressed, estimated available volume in syringe >Select VTBI displays. PAUSE SETUP BOLUS START 2-27 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 92 Message Display also shows either ↑↑↑ " " for a low dose or " " for a high dose. -- Continued on Next Page -- 2-28 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 93 2-29 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 94 If programmed continuous dose is weight-based, CONT- SETUP INUOUS programmed weight displays. If bolus dose is not weight-based, Not Used displays • PATIENT WEIGHT field. 2-30 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 95 Accept weight change? >Select Yes or No BOLUS e. Press soft key. To enter bolus dose, use numeric data entry keys. DURATION Press soft key. 2-31 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 96 If a Soft Limit is overridden, G icon displays. When G Midtown Hospital • Adult ICU soft key is pressed, all applicable out-of-range limits VTBI = 250 mL are listed. VOLUME AUDIO INFUSED ADJUST 2-32 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 97 START BOLUS To stop bolus and start continuous infusion, press Yes soft Alteplase Stroke key. Stop Bolus and Start Continuous infusion? >Press Yes or No 2-33 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 98 Bolus dose completed - module turned off: CHANNEL SELECT Press key. RESTORE Press soft key. NEXT Verify parameters and press soft key. BOLUS Verify infusion parameters and press soft key. 2-34 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 99 • rate or duration dose entry • entry VTBI Syringe Module: The option is disabled when an intermittent infusion is programmed. Press Guardrails Drugs soft key. 2-35 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 100 If selected drug is not weight-based, Not Used • PATIENT WEIGHT displays in field. -- Continued on Next Page -- 2-36 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 101 If a Soft Limit is overridden, G icon displays. When G Midtown Hospital • Adult ICU soft key is pressed, all applicable out-of-range limits VTBI = 250 mL are listed. VOLUME AUDIO INFUSED ADJUST 2-37 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 102 If a Soft Limit is overridden, G icon displays. When G • soft key is pressed, all applicable out-of-range limits are listed. 2-38 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 103 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 DOWN 2-39 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 104 Guardrails Fluid Setup entry keys. PRIMARY INFUSION RATE mL/h 1000 VTBI >Enter VTBI VOLUME PAUSE START DURATION -- Continued on Next Page -- 2-40 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 105 VTBI = 250 mL are listed. VOLUME AUDIO INFUSED ADJUST Syringe Module: Attach administration set to patient. RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART 2-41 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 106 DURATION VTBI ALL VTBI ♦ When is disabled and soft key is pressed, estimated available volume in syringe >Enter VTBI displays. RATE START PAUSE VOLUME 2-42 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 107 -- Continued on Next Page -- 2-43 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 108 Multiple doses from a single container are not possible. -- Continued on Next Page -- 2-44 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 109 Secondary Container Secondary Container Hanger Mini Bag Bottle Primary at least 9½" Container Primary at least 9½" Container 2-45 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 110 -based option for delivery of this infusion may >Select Drug appear. DRUG PAGE EXIT DOWN CALC • If applicable, multiple concentration listings for delivery of this infusion may appear. 2-46 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 111 Hard Limit for that care area, an audio alert sounds and a visual prompt appears before programming can continue. Infusion needs to be reprogrammed. -- Continued on Next Page -- 2-47 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 112 DURATION hh:mm 1200 DOSE = mg/m [Conc]: 136.8 mg/mL >Verify Secondary Clamp Open, Then Press START RATE PAUSE SETUP START VOLUME 2-48 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 113: Secondary Infusion - With Guardrails Suite Mx Protection (Pump Module)

    Press soft key. PRIMARY Press soft key. Close clamp on secondary administration set. Disconnect secondary administration set from upper injection port. START Press soft key. 2-49 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 114: Basic Infusion

    Prepare and load syringe/administration set (see "Getting Started"). Prime (see "Getting Started"). Start applicable infusion, as described in following procedures: Basic Infusion Continuous Infusion - Drug Calculation Bolus Dose 2-50 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 115: Suite Mx Protection (Pump Module)

    PAUSE DELAY OPTIONS Rate / Volume and Volume / Duration Infusions See "Primary Infusion - With Guardrails ® Suite MX Protection", "IV Fluid Infusion" procedure. 2-51 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 116 Press soft key for appropriate unit of measure for drug amount. To enter diluent volume, use numeric data entry keys. PATIENT WEIGHT Press soft key. 2-52 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 117 15. Verify parameters are correct and press soft key. Syringe Module: Attach administration set to patient. RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART -- Continued on Next Page -- 2-53 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 118 To enter bolus duration, use numeric data entry keys. TOTAL DOSE INFUSE AT • alternates with rate. START Verify parameters are correct and press soft key. 2-54 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 119: Introduction And Setup

    • drug to be infused is not listed in Drug Library, • primary infusion is running, and • a check valve administration set is being used. 2-55 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 120: Stopping Secondary And Returning To Primary

    Secondary setup screen displays. START To resume secondary infusion, press soft key. Stopping Secondary and Returning to Primary ® See "Secondary Infusion - With Guardrails Suite MX Protection". 2-56 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 121: Pausing, Changing, Restarting Infusion

    To enter desired parameter, use up/down arrows for rate titration, or numeric data entry keys. START Verify correct infusion parameter entry and press soft key. 2-57 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 122: Restoring Infusion

    401.1 08:00 2002-03-10 42.5 07:30 2002-03-11 478.1 08:00 2002-03-10 789.1 12:00 2002-03-10 >Select Channels to Clear or Press CLEAR ALL CLEAR MAIN PRI/SEC VOLUME SCREEN 2-58 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 123 If no key is pressed, main screen appears after seconds. The illustrated example is a Syringe Module display. A Pump SEC VOLUME Module display has a soft key. 2-59 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 124: Channel Labels

    >Select an Option or EXIT EXIT Channel Options 2 of 2 Channel Labels RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART >Select an Option or EXIT PAGE EXIT 2-60 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 125 To view additional labels, press a soft key next to a letter PAGE UP group to navigate through alphabet, and/or PAGE DOWN soft keys. 2-61 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 126: Removing

    RATE (mL/h) RATE (mL/h) Anesthesia Mode CHANNEL SELECT CHANNEL SELECT PAUSE PAUSE CHANNEL CHANNEL RESTART RESTART See the PC Unit Section of this DFU. 2-62 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 127: Delay Options

    CHANNEL RESTART RESTART ® Delay Options can be enabled at the time the Alaris System is configured for use. If Delay Options is enabled, a primary infusion can be programmed to be delayed for a specified period of time and a callback can be scheduled, as described in the following procedures.
  • Page 128 Delay period counts down on Main Display. If a Before callback has not been scheduled (see • "Scheduling a Callback" procedure), infusion automatically initiates at end of delay period. 2-64 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 129 (see "Scheduling a Callback" procedure), infusion automatically initiates at end of delay period. NOTE: If the current time has been previously confirmed, the Time of Day screen is not displayed. 2-65 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 130: Scheduling A Callback

    ♦ Yellow Standby Status Indicator flashes. DELAY COMPLETE ♦ scrolls in Message Display and appears on Main Display. -- Continued on Next Page -- 2-66 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 131: Pausing Infusion

    DELAY OPTIONS Press soft key. Press Pause soft key. Delay Options 09:30 Pause Delay for Delay until CALL BACK >Select a Delay Option EXIT CONFIRM 2-67 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 132: Multidose Mode

    • Single dose piggybacking RATE (mL/h) systems employing check CHANNEL SELECT PAUSE CHANNEL valve sets are not designed RESTART for use with multidose containers. 2-68 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 133: Volume/Duration Enabled

    Pressure Limit - 550 mmHg Prime Set with Syringe >Select an Option or EXIT PAGE EXIT DOWN Start applicable infusion, as described in following procedures: Volume/Duration Enabled Volume/Duration Disabled 2-69 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 134 At completion of a multidose program, COMPLETE appears on Main Display. Syringe Module: Attach administration set to patient. RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART 2-70 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 135 To enter number of doses, press soft key and use numeric data entry keys. DELAY OPTIONS • If Delay Options is enabled, soft key appears. 2-71 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 136 2-72 Programming ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 137: Selecting Pressure Limit

    Press either Pump or Selectable pressure soft key. If Selectable is pressed, continue with next step; otherwise, Pressure Limit Selection proceed to last step. Pump Selectable >Select an Option or EXIT EXIT 2-73 Programming Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 138: Syringe Module

    CHANNEL SELECT Press key. after an infusion has started can result in a bolus to the patient. OPTIONS Press key. SILENCE SYSTEM OPTIONS ENTER CLEAR CANCEL 2-74 Programming Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 139 CONFIRM CONFIRM Verify correct pressure limit input and press soft key. Pressure Sensing Disc NOT Installed CHANNEL SELECT Press key. OPTIONS Press key. 2-75 Programming Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 140 • greater than mmHg – system adds to current pressure, to create a new alarm limit 2-76 Programming Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 141: General Setup And Operation

    To enter , press soft key and use numeric data VTBI entry keys. Open roller clamp. START To resume infusion, press soft key. 2-77 General Setup and Operation ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 142: Changing Syringe During Infusion (Syringe Module)

    ® installed as part of a second Alaris System setup. Before changing the infusion line at the patient end, start the infusion and wait for fluid to drip from the end of the tubing.

  • Page 143: General Information

    • Discard if packaging is not intact or protector caps are unattached. 2-79 General Information ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 144 RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART CAUTION Before operating instrument, verify that administration set is free from kinks and installed correctly in instrument. 2-80 General Information ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 145: Epidural Administration

    SELECT PAUSE CHANNEL RESTART ® • The Alaris System can be used for epidural administration of anesthetic and analgesic drugs. This application is only appropriate when using anesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use. Use only a Pump Module/Gemini Infusion System administration set or syringe set, without a ‘...

  • Page 146: Guardrails ® Suite Mx

    • Discard administration set per facility protocol. • For push medication (put instrument on hold), clamp tubing above port. • Flush port(s) per facility protocol. 2-82 General Information ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 147: Smartsite ® Infusion Set (Pump Module)

    • Do not leave slip luer syringes NOTE: unattended. Dry time is dependent on area temperature, humidity and ventilation. 2-83 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 148: Safety Clamp Fitment (Pump Module)

    In this closed position, flow is occluded. White Slide Clamp (shown in closed position) NOTE: "Safety clamp" is referred to on the device as "Flo-Stop". 2-84 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 149: Compatible Syringes (Syringe Module)

    When using a only the syringe size and type specified on the Main Display. syringe, Cardinal Health strongly The full list of permitted syringe models is dependent on the recommends using an extension set Syringe Module’s software version.

  • Page 150: Features And Displays

    Alert. Drug label in Message ↑↑↑ Display provides an indicator (" " or " ") that dose is beyond current Soft Limit. 2-86 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 151 RESTART Drug Calculation Allows: ® • entry of drug dose for a continuous infusion ( System Alaris calculates correct flow rate to achieve desired dose), ® • entry of flow rate for a continuous infusion ( ystem Alaris calculates corresponding drug dose).
  • Page 152 Hospital-established Limits around total dose of infusion. Volume/Duration Allows a volume-to-be-infused ( ) and duration (infusion time) VTBI to be programmed. Flow rate is automatically calculated. 2-88 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 153 PAUSE CHANNEL RESTART Auto-Restart ® Part of Alaris System’s Downstream Occlusion Detection system designed to minimize nuisance, patient-side occlusion alarms. Allows system to automatically continue an infusion following detection of a patient-side occlusion if downstream pressure falls to an acceptable level within a -second "Checking Line"...
  • Page 154 • Auto-Restart: (See "Auto-Restart" definition.) ® In addition, Alaris System provides fluid-side occlusion detection. Secondary Infusions Dual rate sequential piggyback (secondary) infusions may be infused, with limits, at delivery rates and volumes independent of primary infusion parameters.
  • Page 155 Customizable Pressure Alarm Settings (see "Occlusion Pressure") Fast Start Pressure Tracking Pressure Tracking Dynamic current pressure display is only available when pressure sensing disc is inserted. 2-91 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 156 Instrument gives an alert and stops when an empty syringe is detected. Syringe Volume Detection System automatically detects fluid volume in a syringe when it is inserted. 2-92 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 157: Operating Features, Controls, Indicators

    When pressed, resumes operation of a previously paused or alarmed infusion on that module. Module Release Latch: Door Handle When pressed, allows module to be removed. 2-93 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 158 Lower Pumping Finger Lower Pressure Sensor Safety Clamp Device Recess Tubing Keeper Air-in-Line Sensor NOTE: "Safety clamp" is referred to on the device as "Flo-Stop". 2-94 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 159 When pressed, resumes operation of a previously paused or Module Release Latch: When pressed, alarmed infusion on that module. allows module to be removed. 2-95 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 160: Displays

    The Pump Module’s range is Patient-side occlusion pressure mmHg and the Syringe Module’s set point is indicated by tick mark. range is mmHg. 1000 VOLUME AUDIO INFUSED ADJUST 2-96 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 161: Drug Calculation Definitions And Formulas

    (normalized for patient weight if specified by entering a patient weight). • Duration = / rate. VTBI • Drug concentration = drug amount / diluent volume. • Rate = / duration. VTBI 2-97 General Information ® Alaris System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 162: Configurable Settings

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

  • Page 163: Pump Module

    Selectable Pressure Pressure Mode) Alert Enabled - Disabled Enabled Secondary Enabled - Disabled Disabled Dual Rate Sequential Piggybacking 2-99 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 164: Syringe Module

    Occlusion Pressure Set Point: • With Disc mmHg mmHg in mmHg increments 1000 1000 Low, Medium, High • No Disc High Enabled - Disabled Priming Disabled 2-100 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 165: Specifications

    >85%) Temperature Range: 104° F 140° F 40° C 60° C Equipment Orientation: ® To ensure proper operation, Alaris System must remain in an upright position. Flow Rate Programming Increments (mL/h) Rate Range Increments: User Input Rates Device Calculated Rates (mL/h) 0.01...
  • Page 166 <30 Selectable Mode: User selected, mmHg in mmHg increments. Operating Principle: Positive displacement Rate Accuracy: ® Rate accuracy of Alaris System is at rates between mL/h and ±5% at rates mL/h, of the time with confidence, under conditions ±5.5% <1...

  • Page 167: Syringe Module

    0.575 0.331 mmHg 1000 0.839 0.323 Alaris ® System has a back-off safety feature which, when enabled and a pressure sensing disc is in use, is designed to reduce bolus volume on occlusion release. -- Continued on Next Page --...
  • Page 168 Atmospheric Pressure: mmHg mmHg 4560 hPa) hPa) 6080 1013 Equipment Orientation: ® To ensure proper operation, Alaris System must remain in an upright position. 2-104 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 169 Without Pressure Sensing Disc: Three settings: Low, Medium, High With Pressure Sensing Disc: User selected, mmHg in mmHg increments. 1000 Operating Principle: Positive displacement 2-105 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 170 Syringe Type: BD 50 Temperature: ± ° Volume to be Infused Range (mL) Increments (mL) Programming Increments: 0.1 - 9.99 0.01 10 - 60 Weight: 2-106 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 171: Symbols

    Authorized representative in European Community. EC REP RATE (mL/h) Pump Module CHANNEL SELECT PAUSE CHANNEL RESTART Drops per milliliter specification for product is identified on drop symbol. 2-107 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 172: Trumpet And Start-Up Curves

    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. 2-108 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 173 In this case, the linear relationship of the plunger position and velocity to syringe volume and rate is verified, and is a function of the accuracy of the design. 2-109 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 174 +100 +300 pressures, the Syringe Module typically exhibits a long-term accuracy offset of approximately or less from the mean 0.2% value. 2-110 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 175: Graphs

    Maximum rate error NOTE: The plot range has been increased to ±100% Overall rate error to allow visualization of the graph. Minimum rate error 2-111 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 176 Trumpet Curve at 999 mL/h (24 hrs) Trumpet Curve at 25 mL/h (72 hrs) Observation Interval (min) Observation Interval (min) Legend: Maximum rate error Overall rate error Minimum rate error 2-112 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 177 -1.8 -3.6 -1.9 -2.2 -4.1 -2.8 -5.3 -4.2 Observation Interval (min) Observation Interval (min) Legend: Maximum rate error Overall rate error Minimum rate error 2-113 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 178 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K 2-114 General Information Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 179: Troubleshooting And Maintenance

    Troubleshooting and Maintenance General The Pump Module and Syringe Module Technical Service Manuals are available from Cardinal Health. They include 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 180: Definitions

    "clicked" into place at Module Release Latch. If alarm is still present, replace module with an operational instrument. 2-116 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 181 Partial occlusion of patient side of Clear occlusion. Press CHANNEL SELECT IV line detected by Auto-Restart key, or press feature. START key and then soft key. 2-117 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 182 Pressure Disc Removed Reinsert pressure sensing disc and Pressure sensing disc removed. RESTART press key. Infusion stops on affected module. 2-118 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 183 CONTINUOUS INFUSION Syringe Installation of the problem. lever plunger flange clamp >Press CANCEL or Adjust Syringe CONFIRM -- Continued on Next Page -- 2-119 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 184 Drive Not Engaged Open and close plunger grippers Drive system disengaged during and syringe barrel clamp. Ensure operation. syringe is properly installed. 2-120 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 185: Errors

    Syringe Driver Head Error CONFIRM grippers open, senses excessive normal operation, press pressure being applied downward soft key. OCCLUSION on Drive Head. scrolls in Message Display. 2-121 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 186: Messages

    SELECT START key and then soft key. CONFIRM Start time for next dose has Start of next dose passed. Press soft key. passed. 2-122 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...
  • Page 187 CONFIRM press ; or use a syringe type and size that system can automatically and correctly identify. 2-123 Troubleshooting and Maintenance Alaris ® System (with v9 Model 8000) DFU Pump and Syringe Modules Section...

  • Page 188: Possible End Of Infusion Messages And Alerts

    Numeric Syringe Empty Syringe Empty Yes / Yes Inspection Requirements ® To ensure the Alaris System remains in good operating WARNING condition, both regular and preventive maintenance inspections Failure to perform these are required. Reference the System Maintenance software for inspections may result in improper detailed instructions.
  • Page 189 ® Alaris PCA Module Model 8120 RATE (mL/h) CHANNEL SELECT PAUSE CHANNEL RESTART ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 191 3-39 ....................................Epidural Administration 3-41 ..................................Dose Request Cord 3-41 ....................................® Guardrails Suite MX 3-42 ..................................... ADMINISTRATION SET INFORMATION 3-42 ..............................COMPATIBLE SYRINGES 3-43 ..................................... ® Alaris System (with v9 Model 8000) DFU Table of Contents PCA Module Section...
  • Page 192 TROUBLESHOOTING AND MAINTENANCE GENERAL 3-55 ..........................................ALARMS, ERRORS, MESSAGES 3-55 ................................Definitions 3-56 ........................................Alarms 3-56 ........................................... Errors 3-58 ..........................................Messages 3-58 ........................................INSPECTION REQUIREMENTS 3-60 ................................. ® Alaris System (with v9 Model 8000) DFU Table of Contents PCA Module Section...

  • Page 193: Getting Started

    PC Unit Section of this ® • System Maintenance software (and its instructions) for Alaris System check-in, maintenance, and wireless configuration The PCA Module is intended for facilities that utilize syringe pumps for the delivery of medications or fluids. The PCA...

  • Page 194: Attaching And Detaching Dose Request Cord

    Dose Request Cord Attachment To detach Dose Request Cord: • Hold body of latching connector and pull straight away, without twisting or turning, from Dose Request Cord attachment. ® Alaris System (with v9 Model 8000) DFU Getting Started PCA Module Section...

  • Page 195: Preparing And Loading Syringe And Administration Set

    For a list of compatible syringes, see "General Information", "Compatible Syringes". For a list of compatible administration sets, reference the Set Compatibility Card (provided separately). ® Alaris System (with v9 Model 8000) DFU Getting Started PCA Module Section...

  • Page 196: Loading Syringe And Administration Set

    Pull syringe barrel clamp out and hold. Rotate clamp to left (clockwise or counter clockwise) until it clears syringe chamber. Gently release clamp. RATE (mL/h) CHANNEL SELECT Syringe Barrel Clamp Open ® Alaris System (with v9 Model 8000) DFU Getting Started PCA Module Section...
  • Page 197 Rotate clamp to right (clockwise or counter clockwise) RATE (mL/h) until it lines up with syringe. CHANNEL Gently release clamp against syringe. SELECT PAUSE Syringe Barrel Clamp Closed ® Alaris System (with v9 Model 8000) DFU Getting Started PCA Module Section...

  • Page 198: Security Lock Key Positions

    PROGRAM unlocking security door or interrupting current infusion. • locks security door. Key must be in this position to LOCK start an infusion. ® Alaris System (with v9 Model 8000) DFU Getting Started PCA Module Section...

  • Page 199: Preparing Infusion

    (see "Service Information" in "Appendix" Section of this DFU). CHANNEL SELECT PROGRAM Press key. Key must be in RATE (mL/h) position. CHANNEL SELECT PAUSE CHANNEL RESTART PCA Module ® Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 200: Priming

    If the syringe is not recognized, Syringe not recognized displays. WARNING Priming When priming: The Priming option can be enabled at the time the Alaris ® System is configured for use. The Priming selection ( PRIME • Ensure patient is not connected.
  • Page 201 • Volume used during priming is displayed but not added disposable set VTBI connected to patient! Prime Volume >P ress and Hold PRIME PRIME EXIT ® Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 202: Programming An Infusion

    Unlock security door or set key to position. Confirm time of day or change time if necessary. Time of Day Current time: Change 08:00 Time >CONFIRM Time-of-Day EXIT CONFIRM ® 3-10 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...
  • Page 203 Advisory for that drug, a message appears. To CONFIRM continue programming, press soft key. NEXT 10. Verify parameters are correct and press soft key to confirm. 11. Prime syringe using Prime feature, if desired. ® Alaris System (with v9 Model 8000) DFU 3-11 Programming PCA Module Section...

  • Page 204: Infusion Modes

    When the PC Unit is in the Infusion Mode Selection, Infusion Setup or Bolus Setup screens, a patient dose request from the Dose Request Cord is handled as an unmet demand. ® 3-12 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 205: Setting Up Pca Dose Only

    IMS Pre-fill 30mL then Yes soft key. DOSE LOCKOUT minutes INTERVAL > > > > LIMIT LOADING None DOSE [Conc]: 1 mg/mL >Select Max Limit Option CHANGE MODE ® Alaris System (with v9 Model 8000) DFU 3-13 Programming PCA Module Section...
  • Page 206 Time (in hours) associated with Max Limit is automatically entered based on setup in system configuration. Loading dose is included in volume infused but is not included in Max Limit. ® 3-14 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 207: Setting Up Continuous Infusion Only

    Yes soft key and use numeric data entry keys. CONT mg/h DOSE > > > > LIMIT LOADING None DOSE [Conc]: 1 mg/mL >Select Max Limit Option CHANGE MODE ® Alaris System (with v9 Model 8000) DFU 3-15 Programming PCA Module Section...
  • Page 208 Time (in hours) associated with Max Limit is automatically entered based on setup in system configuration. Loading dose is included in volume infused but is not included in Max Limit. ® 3-16 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 209: Setting Up Pca Dose + Continuous Infusion

    Yes soft key and use numeric data entry keys. Morphine DOSE LOCKOUT minutes INTERVAL CONT mg/h DOSE > > > > LIMIT LOADING None DOSE [Conc]: 1 mg/mL >Select Max Limit Option CHANGE MODE ® Alaris System (with v9 Model 8000) DFU 3-17 Programming PCA Module Section...
  • Page 210 Time (in hours) associated with Max Limit is automatically entered based on setup in system configuration. Loading dose is included in but is not included in VTBI Max Limit. ® 3-18 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 211: Setting Loading Dose Only

    Dose: Main Display. [Conc]: 1 mg/mL When loading dose is complete, The Loading Dose >Press START • has Completed appears on Main Display. PRO- PAUSE START GRAM ® Alaris System (with v9 Model 8000) DFU 3-19 Programming PCA Module Section...

  • Page 212: Setting Bolus Dose

    START GRAM DOSE PROGRAM Set key to position or enter -digit authorization CONFIRM code and press soft key. To enter dose value, use numeric data entry keys. ® 3-20 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...
  • Page 213 Programmed infusion resumes. GRAM DOSE NOTE: BOLUS DOSE soft key is only available once an infusion has begun in dose only, continuous infusion, or continuous infusion modes. ® Alaris System (with v9 Model 8000) DFU 3-21 Programming PCA Module Section...

  • Page 214: Stopping A Loading, Pca Or Bolus Dose

    CONFIRM MODE Select desired infusion mode. Continue programming. See applicable procedure: Setting Up PCA Dose Only Setting Up Continuous Infusion Only Setting Up PCA + Continuous Infusion ® 3-22 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 215: Viewing Patient History

    07:00 CLEARED 2003-6-10 SHIFT TOTALS Total Drug: 22 mg Total Demands: Delivered: ZOOM: 24 1 hours >Press ZOOM to Change Time Scale CLEAR ZOOM EXIT DETAIL HISTORY ® Alaris System (with v9 Model 8000) DFU 3-23 Programming PCA Module Section...

  • Page 216: Clearing Patient History

    Time Scale CLEAR ZOOM EXIT DETAIL HISTORY To continue and clear patient history, press Yes soft key. To cancel and return to patient history, press No soft key. ® 3-24 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 217: Viewing Drug Event History

    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 EXIT DOWN ® Alaris System (with v9 Model 8000) DFU 3-25 Programming PCA Module Section...

  • Page 218: Configuring Dose Request Cord

    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 DOWN ® 3-26 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 219: Security Access Levels

    Security Access Level Initial Programming Setting Bolus Dose Subsequent Programming Level 1 Level 2 Code or Key Level 3 Code or Key Code or Key ® Alaris System (with v9 Model 8000) DFU 3-27 Programming PCA Module Section...

  • Page 220: Disabling Security Access Code

    >Press DISABLE CODE or EXIT EXIT CONFIRM Pausing Infusion PAUSE Press key. RATE (mL/h) -- Continued on Next Page -- CHANNEL SELECT PAUSE CHANNEL RESTART PCA Module ® 3-28 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 221: Changing Syringe And Restoring Infusion

    Load syringe and administration set (see "Getting Started", "Preparing and Loading Syringe and Administration Set", "Loading Syringe and Administration Set"). Select syringe type and size (see "Preparing Infusion", "Selecting Syringe Type and Size"). ® Alaris System (with v9 Model 8000) DFU 3-29 Programming PCA Module Section...
  • Page 222 To change a restored parameter: a. Press applicable soft key. b. Enter desired parameter using numeric data entry keys. CONFIRM c. Press soft key. ® 3-30 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 223: Stopping Infusion

    Option to change pressure limit can be selected: • after drug is selected, and before infusion mode is selected and infusion starts, or • after infusion starts. ® Alaris System (with v9 Model 8000) DFU 3-31 Programming PCA Module Section...

  • Page 224: Viewing And Clearing Volume Infused

    PCA Therapy. All programming, data entry and validation of PCA Pause Protocol parameters are performed by a healthcare professional according to hospital-defined protocol/procedure or a physician’s order. ® 3-32 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 225: Programming An Infusion With Pca Pause Protocol Enabled

    Start applicable infusion, as described in following procedures: Setting Up PCA Dose Only Setting Up Continuous Infusion Only Setting Up PCA Dose + Continuous Infusion Setting Loading Dose Only ® Alaris System (with v9 Model 8000) DFU 3-33 Programming PCA Module Section...

  • Page 226: Reviewing Or Changing Pca Pause Alarm Limits

    Press PCA Pause Limits 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 DOWN ® 3-34 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...
  • Page 227 ® Suite PCA PAUSE LIMITS SPO2 ETCO2 must be lower than the ALARM LIMITS PCA PAUSE LIMITS . A prompt is provided if the must be modified. ® Alaris System (with v9 Model 8000) DFU 3-35 Programming PCA Module Section...

  • Page 228: Disabling Pca Pause Alarm

    NOTES: Disabling from this screen discontinues the PCA Pause feature only, without interrupting monitoring functionality. Once disabled, the alarm limits are grayed out and are not editable. ® 3-36 Alaris System (with v9 Model 8000) DFU Programming PCA Module Section...

  • Page 229: General Setup And Operation

    General Setup and Operation System Start-Up / Setup See the PC Unit Section of this DFU "General Setup and Operation", for various system start-up and setup procedures. ® Alaris System (with v9 Model 8000) DFU 3-37 General Setup and Operation PCA Module Section...
  • Page 230 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® 3-38 Alaris System (with v9 Model 8000) DFU General Setup and Operation PCA Module Section...

  • Page 231: General Information

    "gravity only" systems, affecting their performance. Hospital/facility personnel must ensure the performance of the common site is satisfactory under these circumstances. • Each time the Alaris System is turned on, verify and/or ® set the monitoring mode, resistance alert, and/or pressure alarm limit.
  • Page 232 • Discard if packaging is not intact or protector caps are unattached. CAUTION Before operating instrument, verify that administration set is free from kinks and installed correctly in instrument. ® 3-40 Alaris System (with v9 Model 8000) DFU General Information PCA Module Section...

  • Page 233: Epidural Administration

    PCA Module used for epidural drug delivery be clearly differentiated from those used for other types of administration. ® • The Alaris System can be used for epidural administration of anesthetic and analgesic drugs. This application is only appropriate when using anesthetics and analgesics labeled for continuous epidural administration and catheters intended specifically for epidural use.

  • Page 234: Guardrails ® Suite Mx

    Do not resterilize. • Discard administration set per facility protocol. • push medication (put instrument on hold), clamp tubing above port. • Flush port(s) per facility protocol. ® 3-42 Alaris System (with v9 Model 8000) DFU General Information PCA Module Section...

  • Page 235: Compatible Syringes

    Allows an additional amount of medication to be programmed once infusion has begun. Current infusion resumes following delivery of a bolus dose. Continuous Dose Basal rate dose. ® Alaris System (with v9 Model 8000) DFU 3-43 General Information PCA Module Section...
  • Page 236 Once drugs are in Profile Drug Library, Max Accumulated Dose Limit cannot be changed. • Applies to all drug setups within Profile PCA Drug Library. ® 3-44 Alaris System (with v9 Model 8000) DFU General Information PCA Module Section...
  • Page 237 Enables a patient to self-administer a bolus infusion to be delivered at programmed lockout intervals through Dose Request Cord. When programmed in +continuous mode, continuous infusion resumes following dose. ® Alaris System (with v9 Model 8000) DFU 3-45 General Information PCA Module Section...
  • Page 238 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) hours. ® 3-46 Alaris System (with v9 Model 8000) DFU General Information PCA Module Section...

  • Page 239: Operating Features, Controls, Indicators

    Repeat for other operating modules to power off each module. Dose Request Cord Attachment Dose Request Cord ® Alaris System (with v9 Model 8000) DFU 3-47 General Information PCA Module Section...

  • Page 240: Displays

    See the PC Unit Section of this DFU for system configurable settings. The configuration settings are selected during Data Set ® development and then uploaded to the Alaris System as part of the data. With the Profiles feature enabled, the settings are configured independently for each profile.
  • Page 241 These values are configured in the Module settings within the Editor Software and can be changed by the clinician by accessing Channel Options on the PCA Module. ® Alaris System (with v9 Model 8000) DFU 3-49 General Information PCA Module Section...

  • Page 242: Specifications And Symbols

    >85%) mmHg mmHg Atmospheric Pressure: 4560 hPa) hPa) 6080 1013 Equipment Orientation: To ensure proper operation, Alaris ® System must remain in an upright position. ® 3-50 Alaris System (with v9 Model 8000) DFU General Information PCA Module Section...
  • Page 243 "Trumpet and Start-Up Curves" for data on how these factors influence rate accuracy. Shock Protection: Type , Defibrillator Proof (PCA Module) Type , Defibrillator Proof (Dose Request Cord) ® Alaris System (with v9 Model 8000) DFU 3-51 General Information PCA Module Section...

  • Page 244: Symbols

    DEHP DEHP Product is latex-free. LATEX Approximate administration set priming volume. » XX ml Expiration date for product is identified near hour glass symbol. ® 3-52 Alaris System (with v9 Model 8000) DFU General Information PCA Module Section...

  • Page 245: Trumpet And Start-Up Curves

    As the observation window is reduced, short-term fluctuations have greater effect, as represented ® Alaris System (with v9 Model 8000) DFU 3-53 General Information PCA Module Section...
  • Page 246 Trumpet and Start-Up Curves (Continued) Legend: Maximum rate error Overall rate error Minimum rate error ® 3-54 Alaris System (with v9 Model 8000) DFU General Information PCA Module Section...

  • Page 247: Troubleshooting And Maintenance

    Troubleshooting and Maintenance General The PCA Module Technical Service Manual is available from Cardinal Health. It 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 components.

  • Page 248: Definitions

    PCA Pause Alarm CONFIRM decline in respiratory status. policy. Press once patient status and monitoring values have been addressed. RESTART Press key per hospital policy. ® 3-56 Alaris System (with v9 Model 8000) DFU Troubleshooting and Maintenance PCA Module Section...
  • Page 249 Securely lock plunger grippers over syringe plunger. Drive system disengaged during Open and close plunger grippers Drive Not Engaged operation. and syringe barrel clamp. Ensure syringe is properly installed. ® Alaris System (with v9 Model 8000) DFU 3-57 Troubleshooting and Maintenance PCA Module Section...

  • Page 250: Errors

    , press specified. Infusion paused until PROGRAM soft key, and unlock time limit has expired. door or enter Authorization Code applicable for current Security Access Level. ® 3-58 Alaris System (with v9 Model 8000) DFU Troubleshooting and Maintenance PCA Module Section...
  • Page 251 CONFIRM press , or use a syringe type and size that system can automatically and correctly identify. ® Alaris System (with v9 Model 8000) DFU 3-59 Troubleshooting and Maintenance PCA Module Section...

  • Page 252: Inspection Requirements

    Inspection Requirements ® To ensure the Alaris System remains in good operating WARNING condition, both regular and preventive maintenance inspections Failure to perform these are required. Reference the System Maintenance software for inspections may result in improper detailed instructions. instrument operation.

  • Page 253: Spo Module

    ® Alaris Modules Models 8210 and 8220 % SpO 2 PULSE (BPM) CHANNEL SELECT MONITOR CHANNEL ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 255 4-27 ........................................MEASUREMENT ACCURACY 4-27 ..................................TROUBLESHOOTING AND MAINTENANCE GENERAL 4-29 ..........................................ALARMS AND MESSAGES 4-29 ..................................Alarms 4-29 ........................................... Messages 4-31 ........................................INSPECTION REQUIREMENTS 4-32 ................................. ® Alaris System (with v9 Model 8000) DFU Table of Contents Modules Section...
  • Page 256 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® ii Table of Contents Alaris System (with v9 Model 8000) DFU Modules Section...

  • Page 257: Getting Started

    Module sensor and cable Compatibility Cards • Module Technical Service Manual ® • System Maintenance software (and its instructions) for Alaris System check-in, maintenance, and wireless configuration Modules are indicated for continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin ( ) and pulse rate measured by an sensor.

  • Page 258: Attaching Cable And Sensor

    Patient Cable sensor’s directions for use for detailed instructions. Attach patient Attach sensor cable here. here. Attach sensor to patient. Reference sensor’s directions for use for detailed instructions. ® Alaris System (with v9 Model 8000) DFU Getting Started Modules Section...

  • Page 259: Monitoring Mode

    If sensor is not attached during message display, module goes into sleep mode. To begin monitoring once module is in this mode, press key. MONITOR Ensure sensor's red is on. ® Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 260: Setting Alarm Limits

    Setting Alarm Limits Press soft key. Adult LIMITS SPO2 Main Mode % SPO2 PULSE RATE SatSeconds (% to Alarm) >Press ENTER to Retain Current View MAIN TREND LIMITS SCREEN ® Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 261: Navigating Trend Data

    PULSE RATE SatSeconds (% to Alarm) >Press ENTER to Retain Current View MAIN TREND LIMITS SCREEN To navigate from page to page, press PAGE UP PAGE soft keys. DOWN ® Alaris System (with v9 Model 8000) DFU Programming Modules Section...
  • Page 262 To view the latest data, return to the Trend Data view. displays if an alarm limit is reached. If no rate values are available for the time SPO2 PULSE period displayed, dashes (---) are displayed. ® Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 263: Navigating Pca/Spo Trend Data

    To view the latest data, return to the Trend Data view. displays if an alarm limit is reached. If no rate values are available for the time SPO2 PULSE period displayed, dashes (---) are displayed. ® Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 264: Presilencing Alarm

    (profile option not being used for programming). Press Limit Mode soft key. Channel Options Limit Mode: Adult Pulse Beep Volume: Off SatSeconds Limits: >Select an Option or EXIT EXIT ® Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 265: Changing Pulse Beep Volume

    The pulse beep must be on to test the volume level. To turn pulse beep on, press the Louder soft key and adjust as needed (steps 2b and 2c). ® Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 266: Changing Satseconds Limit (Model 8210)

    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 ® 4-10 Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 267: Changing Sensitivity Mode (Model 8220)

    • Maximum: Improved low perfusion performance. Maximum >Select an Option or EXIT EXIT NOTE: The sensitivity mode displays on the display only SPO2 Main when Maximum is selected. ® Alaris System (with v9 Model 8000) DFU 4-11 Programming Modules Section...
  • Page 268 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® 4-12 Alaris System (with v9 Model 8000) DFU Programming Modules Section...

  • Page 269: General Setup And Operation

    General Setup and Operation System Start-Up / Setup See the PC Unit Section of this DFU, "General Setup and Operation", for various system start-up and setup procedures. ® Alaris System (with v9 Model 8000) DFU General Setup and Operation 4-13 Modules Section...
  • Page 270 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® 4-14 Alaris System (with v9 Model 8000) DFU General Setup and Operation Modules Section...

  • Page 271: General Information

    Module in any position that may cause it to fall onto the patient. • Respond immediately to system alarms; patient monitoring may cease under certain alarm conditions. ® Alaris System (with v9 Model 8000) DFU 4-15 General Information Modules Section...

  • Page 272: Sensors And Cables

    • Before use, read the sensor directions for use, including all warnings, cautions and instructions. CAUTION Do not immerse or dampen the sensor or cable. Clean per manufacturer’s instructions. ® 4-16 Alaris System (with v9 Model 8000) DFU General Information Modules Section...

  • Page 273: Cables And Sensors

    For a list of compatible sensors and cables, reference the Sensor and Cable Compatibility Card (provided separately). ® Alaris System (with v9 Model 8000) DFU 4-17 General Information Modules Section...

  • Page 274: Features And Displays

    Tabular display of and pulse rate. Display shows average high and low values, and alarm conditions for time period displayed. Up to hours of data is stored. ® 4-18 Alaris System (with v9 Model 8000) DFU General Information Modules Section...
  • Page 275 A SatSeconds limit can be set to allow monitoring of below selected low alarm limit for a period of time before an audible alarm sounds. ® Alaris System (with v9 Model 8000) DFU 4-19 General Information Modules Section...
  • Page 276 Signal feature is related to proper sensor application, adequate arterial signal and intensity of ™ motion. Use Signal feature to verify optimal sensor placement. ® 4-20 Alaris System (with v9 Model 8000) DFU General Information Modules Section...

  • Page 277: Operating Features, Controls, Indicators

    Repeat for other operating modules to power off each module. Module Release Latch: When pressed, allows module to be removed. Patient Cable Connector ® Alaris System (with v9 Model 8000) DFU 4-21 General Information Modules Section...

  • Page 278: Displays

    SCREEN Adult SPO2 Main Mode % SPO2 (8220) PULSE RATE Pleth Waveform PI = 10.56 Signal I.Q.™ >Press ENTER to Retain Current View MAIN TREND LIMITS SCREEN ® 4-22 Alaris System (with v9 Model 8000) DFU General Information Modules Section...

  • Page 279: Configurable Settings

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

  • Page 280: Model 8220

    Atmospheric Pressure: mmHg mmHg 4560 hPa) hPa) 6080 1013 Fluid Ingress Protection: , Drip Proof IPX1 Mode of Operation: Continuous Shock Protection: Type Weight: lbs ( 0.91 ® 4-24 Alaris System (with v9 Model 8000) DFU General Information Modules Section...
  • Page 281 100% 1% S Adults, Pediatrics: digits Adults, Pediatrics: ±3 digits; Adults, Pediatrics, digits; ±2 ±2 Neonates: digits Neonates Neonates: digits ±3 ±3 Display Update Period: Approximately second. ® Alaris System (with v9 Model 8000) DFU 4-25 General Information Modules Section...
  • Page 282 100% S co–oximeter and monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses of the population. ® 4-26 Alaris System (with v9 Model 8000) DFU General Information Modules Section...

  • Page 283: Symbols

    • Nail aberrations, nail polish, fungus, etc. Remove nail polish and/or move sensor to an unaffected site. • Placement is too close to electrosurgery equipment. • Defibrillation. ® Alaris System (with v9 Model 8000) DFU 4-27 General Information Modules Section...
  • Page 284 There is an arterial occlusion proximal to sensor. • Placement is too close to electrosurgery equipment. NOTE: Exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material. ® 4-28 Alaris System (with v9 Model 8000) DFU General Information Modules Section...

  • Page 285: Troubleshooting And Maintenance

    Troubleshooting and Maintenance General Module Technical Service Manual is available from Cardinal Health. It 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 components.
  • Page 286 Sensor not properly attached to Attach sensor to patient cable patient cable or patient cable not or attach patient cable to properly attached to Module. Module. ® 4-30 Alaris System (with v9 Model 8000) DFU Troubleshooting and Maintenance Modules Section...

  • Page 287: Messages

    Check Sensor - Excessive Ambient Light interference on sensor. Check sensor. Remove or reduce Light lighting. Cover or reposition sensor. ® Alaris System (with v9 Model 8000) DFU 4-31 Troubleshooting and Maintenance Modules Section...

  • Page 288: Inspection Requirements

    Low signal quality being measured. Check sensor. Confirm correct sensor placement. Move sensor to a better perfused site. Inspection Requirements To ensure the Alaris ® System remains in good operating WARNING condition, both regular and preventive maintenance inspections Failure to perform these are required.
  • Page 289 ® Alaris EtCO Module Model 8300 EtCO (mm Hg) RR (breaths/min) CHANNEL SELECT MONITOR CHANNEL ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 291 TROUBLESHOOTING AND MAINTENANCE GENERAL 5-27 ..........................................ALARMS AND MESSAGES 5-27 ..................................Definitions 5-27 ........................................Audio Characteristics 5-28 ..................................... Alarms 5-28 ........................................... Messages 5-29 ........................................INSPECTION REQUIREMENTS 5-30 ................................. ® Alaris System (with v9 Model 8000) DFU Table of Contents EtCO Module Section...
  • Page 292 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Table of Contents EtCO...

  • Page 293: Getting Started

    CAUTION • PC Unit Section of this DFU • System Maintenance software (and its instructions) for Alaris ® System check-in, maintenance, and wireless configuration Module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (...

  • Page 294: Connecting Microstream

    Module performance, resulting in inaccurate readings. For a list of compatible disposables, reference ® the Microstream Disposable Compatibility Card (provided separately). ® Alaris System (with v9 Model 8000) DFU Getting Started EtCO Module Section...

  • Page 295: Attaching Gas Scavenging System

    Gas scavenging system Release door. NOTE: The gas outlet is located on the lower right corner of the instrument and is marked with a gas outlet symbol ( ® Alaris System (with v9 Model 8000) DFU Getting Started EtCO Module Section...
  • Page 296 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Getting Started EtCO Module Section...

  • Page 297: Monitoring Mode

    Channel Message display until and respiratory rate readings stabilize (up to seconds). CHANNEL SELECT MONITOR CHANNEL To change settings, see "Setting Alarm Limits" procedure. -- Continued on Next Page -- ® Alaris System (with v9 Model 8000) DFU Programming EtCO Module Section...

  • Page 298: Setting Alarm Limits

    HIGH breaths/min seconds BREATH FiCO2 High : 10 mmHg >Press CONFIRM to Apply Changes FICO2 CONFIRM LIMIT To return to Main Display, press soft key. MAIN SCREEN ® Alaris System (with v9 Model 8000) DFU Programming EtCO Module Section...

  • Page 299: Navigating Trend Data

    Move Cursor. PAGE PAGE ETCO2 ZOOM DOWN MAIN To return to display, press soft ETCO2 Main ETCO2 MAIN key. To return to Main Display, press soft key. MAIN SCREEN ® Alaris System (with v9 Model 8000) DFU Programming EtCO Module Section...

  • Page 300: Navigating Pca/Etco 2 Trend Data

    TIME 08:04 08:05 • Return to display. ETCO2 MAIN 08:06 ZOOM: minutes • Return to Main Display. >Press UP/DOWN Keys to Move Cursor. ETCO2 PAGE ZOOM MAIN DOWN ® Alaris System (with v9 Model 8000) DFU Programming EtCO Module Section...

  • Page 301: Channel Options

    Press Limit Mode soft key. Channel Options Limit Mode: Adult Waveform height: 80 mmHg Waveform time scale: 5 sec >Select an Option or EXIT EXIT ® Alaris System (with v9 Model 8000) DFU Programming EtCO Module Section...

  • Page 302: Changing Waveform Height

    >Select an Option or EXIT • mmHg: Displays a waveform for full value EXIT range, mmHg. 0 – 99 To return to display, press soft key. ETCO2 Main EXIT ® 5-10 Alaris System (with v9 Model 8000) DFU Programming EtCO Module Section...

  • Page 303: Changing Waveform Time Scale

    Waveform Time Scale 5 sec 10 sec To leave Waveform Time Scale unchanged and return to display, press soft key. ETCO2 Main EXIT >Select an Option or EXIT EXIT ® Alaris System (with v9 Model 8000) DFU 5-11 Programming EtCO Module Section...
  • Page 304 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® 5-12 Alaris System (with v9 Model 8000) DFU Programming EtCO Module Section...

  • Page 305: General Setup And Operation

    General Setup and Operation System Start-Up / Setup See the PC Unit Section of this DFU, "General Setup and Operation", for various system start-up and setup procedures. ® Alaris System (with v9 Model 8000) DFU 5-13 General Setup and Operation EtCO...
  • Page 306 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® 5-14 Alaris System (with v9 Model 8000) DFU General Setup and Operation EtCO Module Section...

  • Page 307: General Information

    Module performance, resulting in inaccurate readings. For a list of compatible disposables, reference ® the Microstream Disposable Compatibility Card (provided separately). ® Alaris System (with v9 Model 8000) DFU 5-15 General Information EtCO Module Section...

  • Page 308: Microstream Disposable

    Microstream ® Disposables, contact Oridion at http://www.oridion.com or 1-888-ORIDION For a list of compatible disposables, reference the Sensor and Cable Compatibility Card (provided separately). ® 5-16 Alaris System (with v9 Model 8000) DFU General Information EtCO Module Section...

  • Page 309: Features And Displays

    Tabular display of and respiratory rate. Display shows average, high and low values and alarm conditions for time period displayed. Up to hours of data is stored. ® Alaris System (with v9 Model 8000) DFU 5-17 General Information EtCO Module Section...

  • Page 310: Operating Features, Controls, Indicators

    Microstream ® Disposable Connector ( Gas Inlet Gas Exhaust: Gas scavenging system connection. Module Release Latch: When pressed, allows module to be removed. ® 5-18 Alaris System (with v9 Model 8000) DFU General Information EtCO Module Section...

  • Page 311: Displays

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

  • Page 312: Specifications And Symbols

    Measures and reports partial pressures of in the range of mmHg at sea level. values are calculated for all valid breaths. Dimensions: 3.3" W 8.9" H 5.5" D 22.6 ® 5-20 Alaris System (with v9 Model 8000) DFU General Information EtCO Module Section...
  • Page 313 Isoflurane Sevoflurane Internal Power Source: Operating time (fully charged): hours Measurement Range: mmHg mmHg Respiratory Rate: Mode of Operation: Continuous Shock Protection: Type , Defibrillator Proof ® Alaris System (with v9 Model 8000) DFU 5-21 General Information EtCO Module Section...

  • Page 314: Symbols

    Examples of alternate means, then ensure these conditions are as follows: Module is functioning correctly. • Leaks or internal venting of sampled gas may affect accuracy. ® 5-22 Alaris System (with v9 Model 8000) DFU General Information EtCO Module Section...

  • Page 315: Waveform Analysis

    The following graphs are examples of common problems identifiable through waveform analysis. These are examples only and do not represent all potential abnormal waveforms. Abnormal waveforms are not always associated with alarms. ® Alaris System (with v9 Model 8000) DFU 5-23 General Information...
  • Page 316 Numerical values continue to be displayed on both the Module and PC Unit. ® 5-24 Alaris System (with v9 Model 8000) DFU General Information EtCO Module Section...

  • Page 317: Principle Of Operation

    In high humidity environments or extended monitoring periods ( hours), only Microstream ® Disposables designed for those instances should be used. ® Alaris System (with v9 Model 8000) DFU 5-25 General Information EtCO Module Section...
  • Page 318 (Pb - Where: is fractional concentration of in dry gas and % CO Pb is ambient pressure. is partial pressure of BTPS ® 5-26 Alaris System (with v9 Model 8000) DFU General Information EtCO Module Section...

  • Page 319: Troubleshooting And Maintenance

    Troubleshooting and Maintenance General Module Technical Service Manual is available from Cardinal Health. It 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 components.

  • Page 320: Audio Characteristics

    Respiratory rate is above specified correct alarm limit values are limit. selected. value is below specified limit. Assess patient condition. Confirm LOW ETCO2 correct alarm limit values are selected. ® 5-28 Alaris System (with v9 Model 8000) DFU Troubleshooting and Maintenance EtCO Module Section...

  • Page 321: Messages

    Patient Not Detected Monitor or Channel Select key Assess patient condition. Check pressed and patient not detected. disposable. ® Alaris System (with v9 Model 8000) DFU 5-29 Troubleshooting and Maintenance EtCO Module Section...

  • Page 322: Inspection Requirements

    Inspection Requirements ® To ensure the Alaris System remains in good operating WARNING condition, both regular and preventive maintenance inspections Failure to perform these are required. Reference the System Maintenance software for inspections may result in improper detailed instructions. instrument operation.
  • Page 323 ® Alaris Auto-ID Module Model 8600 R E A D Y S C A N CA NC EL ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 325 6-14 ................................Specifications 6-14 ......................................Symbology 6-16 ........................................Symbols 6-16 ........................................TROUBLESHOOTING AND MAINTENANCE GENERAL 6-17 ..........................................ALARMS, ERRORS, MESSAGES 6-17 ................................INSPECTION REQUIREMENTS 6-17 ................................. ® Alaris System (with v9 Model 8000) DFU Table of Contents Auto-ID Module Section...
  • Page 326 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Table of Contents Auto-ID Module Section...

  • Page 327: Getting Started

    • PC Unit Section of this ® • System Maintenance software (and its instructions) for Alaris System check-in, maintenance, and wireless configuration The addition of the Auto-ID Module to the Alaris ® System ® combines Guardrails Suite with dose limit technology and bar code technology to provide a new level of medication safety.
  • Page 328 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Getting Started Auto-ID Module Section...

  • Page 329: Patient Identification

    Cardinal Health. Using other accessories may result in increased emissions or ® decreased immunity of the Alaris System. Power on PC Unit. To select New Patient?, press Yes soft key. To accept current profile, press Yes soft key.

  • Page 330: While Infusion Is In Progress

    • Always verify that information displayed on the PC Unit matches NOTE: scanned data. Patient may be entered manually using the PC Unit keypad (see PC Unit Section of this DFU). ® Alaris System (with v9 Model 8000) DFU Programming Auto-ID Module Section...

  • Page 331: Authorized User Mode

    Auto-ID application. This feature is designed to ensure that only clinicians with a bar code on ® their badge can program the Alaris System. When this feature is enabled, the PC Unit automatically enables tamper resist mode upon power on and minutes after programming is completed.

  • Page 332: Primary Infusion

    CHANNEL SELECT Program infusion (see applicable module-specific Section of this DFU). NOTES: The Alaris ® System determines if the module selected is appropriate for the scanned medication type. If the selection is not appropriate (for example, a bag was scanned but a...

  • Page 333: Secondary Infusion

    Press key on appropriate module. CHANNEL SELECT • Primary infusion parameters display. Press soft key. SECONDARY Program secondary infusion (see Pump Module Section of this DFU). ® Alaris System (with v9 Model 8000) DFU Programming Auto-ID Module Section...
  • Page 334 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Programming Auto-ID Module Section...

  • Page 335: General Setup And Operation

    General Setup and Operation System Start-Up / Setup See the PC Unit Section of this DFU, "General Setup and Operation", for various system start-up and setup procedures. ® Alaris System (with v9 Model 8000) DFU General Setup and Operation Auto-ID Module Section...
  • Page 336 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® 6-10 Alaris System (with v9 Model 8000) DFU General Setup and Operation Auto-ID Module Section...

  • Page 337: General Information

    • Carefully locate the hand-held scanner to reduce the possibility of patient entanglement or strangulation. • Use only the hand-held external scanner supplied by Cardinal Health. Using other accessories may result in increased emissions or decreased immunity of the Alaris ®...

  • Page 338: Hand-Held Scanner

    Hand-Held Scanner The hand-held external scanner supplied by Cardinal Health is WARNINGS the only hand-held scanner approved for use with the Auto-ID • Do not open the hand-held Module. scanner case. If the case is opened, an electrical shock hazard and possible exposure to...

  • Page 339: Operating Features, Controls, Indicators

    Subsequent press cancels scan. Image Scanning Window Hand-hand external scanner connection port. Module Release Latch: When pressed, allows module to be removed. ® Alaris System (with v9 Model 8000) DFU 6-13 General Information Auto-ID Module Section...

  • Page 340: Configurable Settings

    If the configuration settings need to be changed from the Factory default settings, reference the applicable Technical Service Manual or contact Cardinal Health Technical Support, for technical, troubleshooting, and preventive maintenance information. With the Profiles feature enabled, the settings are configured independently for each profile.
  • Page 341 ( 1 ±0.1 436.5 ±43.65 Hand-Held Scanner Dimensions: 3.25" W 7.25" H 4.25" L cm L) 18.4 10.8 Housing: flammability rating UL 94V0 Weight: oz ( ® Alaris System (with v9 Model 8000) DFU 6-15 General Information Auto-ID Module Section...

  • Page 342: Symbology

    Trioptic Code Code Pharmaceutical ( Micro PARAF PDF417 PDF417 Code Symbols See the PC Unit Section of this DFU for system symbols. Input. Hand-held connection point. ® 6-16 Alaris System (with v9 Model 8000) DFU General Information Auto-ID Module Section...

  • Page 343: Troubleshooting And Maintenance

    General Alaris ® System Technical Service Manuals are available from Cardinal Health. They include 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. Maintenance procedures are intended to be performed only by qualified personnel, using the Service Manual and System Maintenance software.
  • Page 345 Nurse Call Accessory Model 8010 Max Load 30V/1A NURSE CALL ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 347 NURSE CALL JACK AND CABLE ................................Nurse Call Location ....................................Nurse Call Cable Connected ................................SPECIFICATIONS ......................................TROUBLESHOOTING AND MAINTENANCE GENERAL ..........................................ALARMS, ERRORS, MESSAGES ................................® Alaris System (with v9 Model 8000) DFU Table of Contents Nurse Call Accessory Section...
  • Page 348 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Table of Contents Nurse Call Accessory Section...

  • Page 349: Introduction

    ) instructions and information. It is used in 8010 Read all instructions, including conjunction with: those for the PC Unit and attached ® module(s), before using the Alaris • Module-specific Sections of this System. • PC Unit Section of this Communications Interface (CI) Board Accessory Section of this •...
  • Page 350 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Introduction Nurse Call Accessory Section...

  • Page 351: General Information

    • The nurse call feature should not be used as the primary source of alarm notification. The audible and visual ® alarms of the Alaris System, used in conjunction with clinical signs and symptoms, are the primary sources providing notification that an alarm condition exists.

  • Page 352: Nurse Call Jack And Cable

    Max Load 30V/1A NURSE CALL Nurse Call Cable Connected Max Load 30V/1A NURSE CALL Fair-Rite Suppressor Core Assembly Nurse Call Cable - Plugged into Nurse Call Jack ® Alaris System (with v9 Model 8000) DFU General Information Nurse Call Accessory Section...

  • Page 353: Specifications

    Specifications Contact Closure Rating: 30 VDC maximum at 1A maximum Drip Proof Protection: To ensure Alaris ® System fluid ingress rating, Nurse Call jack is covered/ sealed when not in use. Isolation: Nurse Call contacts are isolated from chassis up to 500 VAC.
  • Page 354 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU General Information Nurse Call Accessory Section...

  • Page 355: Troubleshooting And Maintenance

    General Alaris ® System Technical Service Manuals are available from Cardinal Health. They include 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. Maintenance procedures are intended to be performed only by qualified personnel, using the Service Manual and System Maintenance software.
  • Page 357 Communications Interface (CI) Board Accessory Model 8012 ® Alaris System (with v9 Model 8000) DFU, Section...
  • Page 359 ........................................GENERAL INFORMATION CI BOARD ACCESSORY AND CI BOARD LED ..........................WIRELESS NETWORK INDICATOR ................................ TROUBLESHOOTING AND MAINTENANCE GENERAL ..........................................CI BOARD AND ALARIS ® SERVER CONNECTIONS ........................ALARMS, ERRORS, MESSAGES ................................® Alaris System (with v9 Model 8000) DFU...
  • Page 360 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Table of Contents CI Board Accessory Section...

  • Page 361: Introduction

    Alaris ® System, Alaris ® Server and Mobile Systems be established or is lost. The Alaris ® Manager. Server and CI Board are designed to minimize these incidents but cannot ® Combined use of the Alaris System, CI Board, Auto-ID eliminate them.
  • Page 362 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU Introduction CI Board Accessory Section...

  • Page 363: General Information

    Flashes green when Alaris CI Board Accessory System is powered up. WIRELESS NETWORK INDICATOR Wireless Network Indicator When illuminated, indicates Alaris ® ® System is connected to Alaris Server SILENCE or Mobile Systems Manager. When SYSTEM OPTIONS blinking, indicates data transfer. ENTER...
  • Page 364 T H I S PA G E I N T E N T I O N A L LY L E F T B L A N K ® Alaris System (with v9 Model 8000) DFU General Information CI Board Accessory Section...

  • Page 365: Troubleshooting And Maintenance

    When an Alaris ® Server or Mobile Systems Manager connection is made, the Wireless Network Indicator on the PC Unit lights up. If connection to the Alaris ® Server is interrupted, the indicator light is extinguished. Some of the causes for a communications failure include: ®...

  • Page 367: Appendix Maintenance

    Appendix Maintenance Regulations and Standards ® Alaris System (with v9 Model 8000) DFU, Section...

  • Page 369: Cleaning

    A soft-bristled brush may be used to clean hard to reach and narrow areas. For sanitizing or antibacterial treatment, use bleach solution and water. Use a soft cloth dampened with water to rinse off cleaning solution. Alaris ® System (with v9 Model 8000) DFU Maintenance Appendix Section...

  • Page 370: Service Information

    Data Set is loaded. Technical Support Technical support, service information, applications, and manuals may be obtained by contacting a Cardinal Health representative. When submitting any request for service, include: • model number • a description of difficulty experienced •...

  • Page 371: Warranty

    Furthermore, this warranty shall not apply to, and Cardinal Health shall not be ® responsible for, any loss or damage arising in connection with the purchase or use of any Alaris System product which has been: repaired by anyone other than an authorized Cardinal Health Service Representative;...
  • Page 372 Maintenance ® Alaris System (with v9 Model 8000) DFU Appendix Section...

  • Page 373: 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 Cardinal Health, Inc. This Class digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulation.
  • Page 374 The type radio card, if provided, is manufactured by 4137 Symbol Technologies, Inc., Holtsville, N.Y. 11742 Tables: The Alaris ® System is intended for use in the electromagnetic environments specified in the following tables. Table 1 Electromagnetic Emissions Emissions Test...
  • Page 375 Compliance (Continued) Electromagnetic Environment (Continued) ® Alaris System (Continued) Table 2 Electromagnetic Immunity Emissions Test IEC 60601-1-2 Compliance Electromagnetic Environment - Guidance Test Level Level IEC 61000-4-2 ±6 kV contact ±8 kV contact Floors should be wood, concrete, or ceramic tile.
  • Page 376 (>95% dip in U commercial or hospital environment. Voltage Dips, Short for 0.5 cycle for 0.5 cycle ® Interruptions, and If continued operation of Alaris System is Voltage Variations required during power mains interruptions, it is 40% U 40% U recommended that Alaris ®...
  • Page 377 3 Vrms 10 Vrms Portable and mobile RF communications equipment ® Conducted RF 150 kHz - 80 MHz should be used no closer to Alaris System (including cables) than recommended separation 10 V/m IEC 61000-4-3 3 V/m distance calculated from equation applicable to Radiated RF 80 MHz - 2.5 GHz...
  • Page 378 Reduce the potential for electromagnetic interference by maintaining a minimum distance between ® portable and mobile 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...
  • Page 379 To assess the electromagnetic environment due to fixed transmitters, an electromagnetic ® site survey should be considered. If the measured field strength in the location in which the Alaris System ® is used exceeds the applicable...
  • Page 380 Cet appareil numérique de la Classe respecte toutes les exigences du Reglement sur le Matériel Brouilleur du Canada. This Class digital device meets the requirements of the International community. A-12 Alaris ® System (with v9 Model 8000) DFU Regulations and Standards Appendix Section...
  • Page 381 Compliance (Continued) Federal Aviation Regulations The following Alaris ® products have received a Statement of Compliance with Federal Aviation Regulations for use as a "Portable Electronic Device Aboard Aircraft". This is pursuant to the Advisory Circular No. and attested by an...

  • Page 382: Trademarks

    Trademarks ® ® ® Alaris , Guardrails and SmartSite are registered trademarks ® of Cardinal Health, Inc. or one of its subsidiaries. LNOP ® ® ® Masimo , Signal Extraction Technology and Signal ® are trademarks of Masimo Corporation. Nellcor I.Q.
  • Page 384 ® Alaris System (with v9 Model 8000) Directions for Use...

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