Cardinal Health Alaris 8000 Series Directions For Use Manual Download Page 376

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Alaris

System Directions for Use

Appendix Section

A-14

Regulations and Standards

Trademarks

Alaris

, Guardrails

and SmartSite

are registered trademarks

of Cardinal Health, Inc. or one of its subsidiaries.

LNOP

Masimo

SET

, Signal Extraction Technology

and Signal

I.Q.

™

are trademarks of Masimo Corporation. Nellcor

and

are trademarks of Nellcor Puritan Bennett, Inc.

Microstream

is a trademark of Oridion Medical

1987

Ltd. All

other trademarks belong to their respective owners.

Summary of Contents for Alaris 8000 Series

Page 1: ...OFF RESTART PAUSE ALARM INFUSE STANDBY RATE mL h ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h CHANNEL SELECT CHANNEL OFF MONITOR ALARM MONITOR STANDBY SpO2 PULSE BPM Direct...

Page 2: ...fic Sections has its own table of contents General Contact Information i Introduction ii Installation iv PC Point of Care Unit 1 Pump and Syringe Modules 2 PCA Module 3 SpO2 Module 4 EtCO2 Module 5 Au...

Page 3: ...Maintenance and service information support troubleshooting United States Phone 858 458 6003 800 854 7128 Ext 6003 Canada Phone Eastern 800 908 9918 Western 800 908 9919 Customer Care North America In...

Page 4: ...are areas referred to as profiles Each profile contains a specific Guardrails Drug Library and channel labels as well as instrument configurations appropriate for the care area Optional drug specific...

Page 5: ...erscript number for example identifies additional information provided as a NOTE at the end of the procedure WARNINGS AND CAUTIONS Product specific warnings and cautions covered in the applicable Sect...

Page 6: ...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 1 Perfo...

Page 7: ...SILENCE OPTIONS 1 4 7 CLEAR 2 5 8 0 3 6 9 ENTER CANCEL SYSTEM ON 1 Alaris System DFU Section Alaris PC Point of Care Unit 8000 Series...

Page 8: ......

Page 9: ...POWER OFF SYSTEM 1 11 SYSTEM OPTIONS 1 11 Display Contrast 1 11 Patient ID 1 12 Time of Day 1 14 Power Down All Channels 1 16 Anesthesia Mode 1 16 Battery Runtime 1 19 System Configuration 1 20 Softw...

Page 10: ...ed BATTERY CARE AND MAINTENANCE 1 40 Battery Type and Charging 1 40 Battery Charge 1 40 Battery Care 1 40 Battery Cautions and Disposal 1 41 INSPECTION REQUIREMENTS 1 41 ii Table of Contents Alaris Sy...

Page 11: ...ce for programming infusions and monitoring which helps to reduce complexity at the point of care Alarms Errors Messages Reference Troubleshooting and Maintenance for specific PC Unit alarms errors an...

Page 12: ...1 2 Getting Started Alaris System Directions for Use PC Unit Section 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...

Page 13: ...that a balanced configuration be maintained General Setup and Operation 1 3 General Setup and Operation Attaching and Detaching Module s Alaris System Directions for Use PC Unit Section 1 Position fr...

Page 14: ...odule 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...

Page 15: ...perates normally when it is attached via an alternate IUI connector it may be used until a replacement module can be substituted General Setup and Operation 1 5 Alaris System Directions for Use PC Uni...

Page 16: ...module such as an Alaris Pump Module was powered off and removed MAINTENANCE REMINDER display reflects removal of that module To continue start up process press CONFIRM soft key Responding to Mainten...

Page 17: ...and Profile Options The following procedures assume the Profiles feature is enabled 1 Select required NEW PATIENT option To indicate programming is for a new patient and clear all stored patient param...

Page 18: ...ication band reference Alaris Auto ID Module Auto ID Module Section of this DFU EXIT A B C D PAGE DOWN Enter Patient ID and Press CONFIRM E K O F J P T U Y A E Patient ID Entry _ _ _ _ _ _ _ _ _ _ _ _...

Page 19: ...a key press Main Display appears Louder Change Setting or Cancel Audio Volume Adjust Test Softer MAIN SCREEN 3 VTBI 250 0 mL VOLUME INFUSED AUDIO ADJUST Midtown Hospital Adult ICU 1 Press AUDIO ADJUST...

Page 20: ...ked however clinician may Silence audio alarm View volume s infused View and test audio alarm setting View selected parameters on attached modules Any other key press will result in a visual PANEL LOC...

Page 21: ...automatically powers down Powering Down NOTE To interrupt the power down sequence quickly press any key except SYSTEM ON on the PC Unit System Options Display Contrast 1 Press OPTIONS key System Opti...

Page 22: ...ONFIRM soft key 1 12 General Setup and Operation Alaris System Directions for Use PC Unit Section Patient ID Entering 1 Press OPTIONS key 2 Press Patient ID soft key System Options 1 of 2 Select an Op...

Page 23: ...ter at a time press CANCEL key Patient ID Continued 4 To enter modified patient identifier use numeric data entry keys and or alpha speed keys 5 To verify correct entry press CONFIRM soft key New Pati...

Page 24: ...of Day 1 Press OPTIONS key 2 Press Time of Day soft key System Options 1 of 2 Select an Option or EXIT PAGE DOWN EXIT Display Contrast Time of Day Power Down All Channels Anesthesia Mode Patient ID N...

Page 25: ...EXIT 3 If time is correct press CONFIRM soft key OR To change time press Change Time soft key Time of Day System Options Current time __ __ Change Time CONFIRM Enter Current Time EXIT 4 Enter current...

Page 26: ...de When the Anesthesia Mode is enabled while a module is paused the module remains in an indefinite pause until restarted When Anesthesia Mode is enabled All limits are set to Soft Dose checking mode...

Page 27: ...bolus dose limits defined generic drug calculation setup Anesthesia Mode alternating with other required prompts displays in prompt bar of Main Display Callback audio for paused module is permanently...

Page 28: ...e soft key 3 Press Disable soft key 4 Press CONFIRM soft key Anesthesia Mode no longer appears on Main Display indicating it has been disabled Connecting To AC Power 1 Connect system to AC power 2 To...

Page 29: ...CONFIRM 2 Press CONFIRM soft key Battery Runtime 1 Press OPTIONS key 2 Press PAGE DOWN soft key 3 Press Battery Runtime soft key System Options 2 of 2 PAGE UP System Configuration Select an Option or...

Page 30: ...are Versions Serial Numbers Battery Runtime PAGE DOWN Press CANCEL or EXIT PAGE DOWN EXIT System Config PCU 1 of 3 Alarm audio Profile 1 Battery meter Disabled Clock setup 09 00 Anesthesia Mode Disabl...

Page 31: ...Config PCU 2 of 3 500 kg Max Pt weight Patient ID Entry Disabled Press CANCEL or EXIT PAGE DOWN Key click audio Enabled 2 m2 Max Pt BSA Pending IV Orders Enabled System Configuration Continued Softwar...

Page 32: ...to previous screen press EXIT soft key NOTE nn nn in the illustrated display represents a software version System Options Continued Software Rev Review PC Unit Module A Module B Module C Module D View...

Page 33: ...ARNINGS Explosion risk if used in the presence of flammable anesthetic agents or gasses DANGER Warnings and Cautions General Alaris System Directions for Use PC Unit Section General Information 1 23 G...

Page 34: ...system In a domestic environment this system may cause radio interference Reorienting relocating or shielding the system or filtering the connection to the public mains network are examples of steps...

Page 35: ...er can be entered and displayed When enabled ID entry defaults to Startup screen When disabled ID entry is only accessible from System Options screen Profile A unique set of system configuration setti...

Page 36: ...ed system settings defined for selected profile are automatically activated Tamper Resist Provides a quick one touch lockout of front panel keypad 1 26 General Information Alaris System Directions for...

Page 37: ...When illuminated indicates Alaris System is connected to an AC power source Computer Monitor Mode Indicator When illuminated indicates Alaris System is connected to a server or computer When blinking...

Page 38: ...Operating Features Controls Indicators Continued IUI Connector Right IUI Connector Left Primary Audio Speaker Connector Plug over RJ45 Communication Data Port Tamper Resist Switch Power Cord Strap Op...

Page 39: ...inued Displays Main Display VTBI 250 0 mL VOLUME INFUSED AUDIO ADJUST Midtown Hospital Adult ICU Title Bar Module Status A solid letter display indicates module is operating An outlined letter display...

Page 40: ...e data set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles System Configurable Settings Profile 1 2 or 3 Enabled Disabled Enabled Disa...

Page 41: ...1 Internally Powered Equipment Electronic Memory System configuration parameters stored in volatile memory are retained for at least 6 months by internal backup lithium battery Module specific paramet...

Page 42: ...gnation 53 and local electrical codes and or regulations Symbols Reference the product specific Section of this DFU that applies to the attached module s for symbols specific to that module 75 Silence...

Page 43: ...d to alternating current 100 240 VAC Manufacturing Date Number adjacent to symbol indicates month and year of manufacture Potential Equalization Conductor if so equipped Note If integrity of PEC or Ho...

Page 44: ...1 34 General Information Alaris System Directions for Use PC Unit Section 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...

Page 45: ...nt 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 Maintenance pr...

Page 46: ...Alarm Error Hardware Detected Error Software Detected Illegal Key Press Key Click Prompt One short beep every 2 seconds Choice of 3 alarm audio profiles selectable in System Configuration Pairs of lon...

Page 47: ...place module with an operational instrument Connect AC power cord to power source alarm will be silenced Alarms Errors Alarms Errors Messages Continued Alarm Meaning Response Audio System Error Channe...

Page 48: ...alified personnel is required To power down system press SYSTEM OFF soft key or to continue temporary operation while an operational PC Unit can be located press SILENCE key Service by qualified perso...

Page 49: ...y threshold sensed remaining battery run time is limited Tamper Resist feature is active and key was pressed Tamper Resist feature deactivated Last module powering off System shuts off in indicated nu...

Page 50: ...F 10 30 C Battery Care The PC Unit is equipped with a 12 volt 4000 mAh nickel metal hydride battery The battery is charging whenever the instrument is plugged into an AC receptacle The life expectancy...

Page 51: ...nance Continued Battery Cautions and Disposal Battery replacement should be performed by qualified service personnel while the instrument is not in use Do not open incinerate or short circuit Worn out...

Page 52: ......

Page 53: ...em DFU Section CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h Alaris Pump Module 8100 Series Alaris Syringe Modul...

Page 54: ......

Page 55: ...ON 2 45 Basic Infusion 2 45 Promoting Basic Infusion to Guardrails Suite MX Protection Infusion 2 47 Continuous Infusion Drug Calculation 2 47 Bolus Dose 2 50 SECONDARY INFUSION NO GUARDRAILS SUITE MX...

Page 56: ...DEFINITIONS AND FORMULAS 2 91 CONFIGURABLE SETTINGS 2 92 Shared Infusion 2 92 Pump Module 2 93 Syringe Module 2 94 SPECIFICATIONS 2 95 Pump Module 2 95 Syringe Module 2 97 SYMBOLS 2 101 Pump and Syri...

Page 57: ...ery of fluids medications blood and blood products using continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous IV intra arterial IA subcutaneou...

Page 58: ...inges Reference General Information for specific Administration Set Syringe Information Alarms Errors Messages Reference Troubleshooting and Maintenance for module specific alarms errors and messages...

Page 59: ...tion resulting in an inaccurate fluid delivery or other potential hazard For a list of compatible sets reference the Set Compatibility Card provided separately Discard if packaging is not intact or pr...

Page 60: ...t Push tubing toward back of AIL Detector Loading Continued Do not touch the administration set while closing the door Failure to follow this instruction may result in infusion rate inaccuracy To prev...

Page 61: ...Set s safety clamp fitment automatically closes to prevent accidental free flow White Slide Clamp shown in closed position 1 Prepare primary solution container in accordance with manufacturer s direc...

Page 62: ...e syringes with luer lock connectors and administration sets designed for use on syringe pumps The use of any other syringe or administration set may cause improper instrument operation resulting in i...

Page 63: ...the syringe always turn off fluid flow to the patient using the tubing clamp or stopcock Uncontrolled fluid flow can occur when the administration set is not clamped or turned off and may cause seriou...

Page 64: ...40 45 50 55 1 oz 1 2 oz 60 ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h Drive Head Fully Extended Plunger Grippers Open 45 50 55 2 oz 60 Gripper Control Drive Head Release...

Page 65: ...lose off administration set tubing and gently lower drive head against syringe plunger For smaller syringes such as 1 3 or 5 cc stabilize the syringe plunger with thumb and index finger while carefull...

Page 66: ...clusion Pressure feature definition Dynamic Pressure Display see Pressure Tracking feature definition Fast Start Syringe Module Slot in Pressure Sensing Disc Housing Pressure Sensing Disc Fluid Side P...

Page 67: ...red to the patient WARNING During priming the pressure limit alarms are temporarily increased to their maximum level CAUTION 1 Remove pressure sensing disc from instrument Using a finger apply firm do...

Page 68: ...e removed during priming Press CONFIRM and continue priming Press CONFIRM CONFIRM 3 Press Prime Set with Syringe soft key If pressure sensing disc was not removed prior to pressing Prime Set with Syri...

Page 69: ...EXIT c Press and hold PRIME soft key until fluid flows and priming of syringe administration set is complete d Release pressure sensing disc A Prime Set with Syringe Press and Hold PRIME Prime Volume...

Page 70: ...ensing disc up into slot in pressure sensing disc housing Re install Pressure Sensing Disc Press CONFIRM CONFIRM A A A 7 To return to main screen press EXIT soft key If EXIT soft key is pressed before...

Page 71: ...ually priming per hospital facility protocol and an administration set having a pressure sensing disc is in use depress the disc between 2 fingers while priming and prime uphill distal end of pressure...

Page 72: ...2 16 Getting Started Alaris System Directions for Use Pump and Syringe Modules Section 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...

Page 73: ...ary a hospital defined best practice data set must be transferred using Guardrails Editor Software and the Profiles feature must be enabled 1 Perform following steps reference PC Unit Section of this...

Page 74: ...syringe cannot be found press ALL SYRINGES soft key Ensure the displayed syringe manufacturer and syringe size correctly identify the installed syringe Mismatches may cause an under infusion or over...

Page 75: ...recognized Syringe not recognized displays b To accept press CONFIRM soft key CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTA...

Page 76: ...e Heparin K O F J P T U Z A E Guardrails Drugs Adult ICU DOPamine DRUG CALC Alteplase AMIODArone 2 Press soft key next to desired drug EXIT A A Select Therapy Type Alteplase MI Stroke DRUG LIBRARY Gua...

Page 77: ...pplicable a weight based nonweight based or BSA based option for delivery of this infusion may appear as in illustrated example which reflects use of Heparin If applicable multiple concentration listi...

Page 78: ...T WEIGHT field If hospital facility practice guidelines identify selected drug as weight based prompt for a patient weight in kilograms appears as in illustrated example which reflects use of Alteplas...

Page 79: ...key appears inactive when VTBI soft key is pressed and active when a value is entered CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUS...

Page 80: ...appears before programming can continue Infusion needs to be reprogrammed If a dose outside of Soft Limits has been entered and verified as correct Message Display also shows either LLL for a low dose...

Page 81: ...d allow the clinician to enter the desired concentration Once a patient weight is entered for any module it is automatically entered for any subsequent weight based calculation Pump Module At rates le...

Page 82: ...needs to be reprogrammed If programmed continuous dose infusion is outside Hard Limit for that care area a prompt appears before programming can continue Infusion needs to be reprogrammed Bolus Dose...

Page 83: ...n Main Display If no weight has previously been programmed in system and bolus dose is weight based weight entry is empty If programmed continuous dose is weight based programmed weight displays If bo...

Page 84: ...Duration 70 kg Rapid Bolus _ _ min 420 mL h TOTAL DOSE 6 3 mg BOLUS VTBI 6 3 mL Guardrails Drug Setup Alteplase CONT INUOUS OR A A A CONTINUOUS INFUSION Drug Calculation Heparin A Dose will recalcula...

Page 85: ...LUS soft key CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h 7 Verify parameters are correct and press START soft...

Page 86: ...meters and press BOLUS soft key 2 30 Programming Alaris System Directions for Use Pump and Syringe Modules Section Restoring Bolus Dose Bolus Dose Continued CHANNEL SELECT CHANNEL OFF RESTART PAUSE AL...

Page 87: ...no continuous rate is entered the infusion will end when the bolus has been delivered No KVO infusion will follow To see details during the bolus infusion press the CHANNEL SELECT key The Pump Module...

Page 88: ...tional hospital defined therapy or clinical indication for delivery of this infusion may appear Different limits can be defined for same drug with different therapeutic indications If applicable a wei...

Page 89: ...als ALL ALL soft key appears inactive when VTBI soft key is pressed and active when a value is entered If hospital facility practice guidelines identify selected drug as weight based prompt for a pati...

Page 90: ...eady entered enter duration or rate as follows To enter duration press DURATION soft key and use numeric data entry keys rate value is calculated and displayed To enter rate press RATE VOLUME soft key...

Page 91: ...FUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h Programming 2 35 Alaris System Directions for Use Pump and Syringe Modules Section NOTES To view additional drugs p...

Page 92: ...Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed If programmed IV Fluid is outside Hard Limit for that care area a prompt appears before progra...

Page 93: ...ed IV Fluid is outside Soft Limit for that care area a prompt appears before programming can continue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be re...

Page 94: ...ng Alaris System Directions for Use Pump and Syringe Modules Section Press START START mL h 4 17 VTBI VOLUME DURATION RATE A PAUSE Time Left h min 00 45 TPN Guardrails Fluid Setup ALL Pausing Restarti...

Page 95: ...ions etc Underestimating the volume will cause the remaining secondary solution to be infused at the primary rate overestimating will result in the primary solution being infused at the secondary rate...

Page 96: ...be used only when drug to be infused is listed in Guardrails Drug Library primary infusion is running and a check valve administration set is being used To program a primary infusion reference IV Flui...

Page 97: ...drug If applicable an optional hospital defined therapy or clinical indication for delivery of this infusion may appear Different limits can be defined for same drug with different therapeutic indicat...

Page 98: ...d use numeric data entry keys 2 42 Programming Alaris System Directions for Use Pump and Syringe Modules Section CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY Infusion Continued If sel...

Page 99: ...follows To enter duration press DURATION soft key and use numeric data entry keys rate value is calculated and displayed To enter rate press RATE VOLUME soft key and use numeric data entry keys Changi...

Page 100: ...any subsequent weight based calculation At rates less than 10 mL h the rate is displayed to 2 decimal places and the VTBI can be entered and is displayed to 2 decimal places The SEC to PRI alert does...

Page 101: ...ctions for Use Pump and Syringe Modules Section Infusion NO Guardrails Suite MX Protection CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF...

Page 102: ...Continuous Infusion procedure Pausing Restarting Restoring Infusion Reference Primary Infusion With Guardrails Suite MX Protection Continuous Infusion procedure Infusion NO Guardrails Suite MX Protec...

Page 103: ...FF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h Programming 2 47 Alaris System Directions for Use Pump and Syringe Modules Section Promoti...

Page 104: ...rate or dose entry press applicable soft key RATE or DOSE and use numeric data entry keys other value is calculated and displayed 14 To enter volume to be infused press VTBI soft key and use numeric...

Page 105: ...o the nearest one hundredth of a mL per hour as displayed on the programming screen The rate shown in the Rate Display will be rounded to the nearest one tenth of a mL per hour A A A RATE Press START...

Page 106: ...arameters are correct and press START soft key A A A DOSE PATIENT WEIGHT BOLUS DOSE Drug Calculation _ 2000 mcg mcg kg mg DURATION mg kg Conc 5000 mcg mL SETUP Select the Desired Dosing Units CONT INU...

Page 107: ...try keys To enter duration press DURATION soft key and use numeric data entry keys 3 To enter secondary volume to be infused press VTBI soft key and use numeric data entry keys 4 Open clamp on seconda...

Page 108: ...ion Continuous Infusion procedure Infusion Continued CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY Stopping Secondary and Returning to Primary Reference Secondary Infusion With Guardra...

Page 109: ...key Volume Infused TOTAL VOLUME mL LAST CLEARED Select Channels to Clear or Press CLEAR ALL PRI SEC VOLUME CLEAR ALL MAIN SCREEN 401 1 42 5 478 1 789 1 08 00 08 00 2002 03 10 2002 03 10 2002 03 11 200...

Page 110: ...nth day Pump Module A PRI SEC VOLUME soft key is available to allow secondary volume infused to be displayed If no key is pressed main screen appears after 30 seconds The illustrated example is a Syri...

Page 111: ...Drugs Pressure Limit P Channel Labels A Select an Option or EXIT EXIT Multidose Guardrails IV Fluids 4 Press Channel Labels soft key ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE...

Page 112: ...C UAC UVC White Port CLEAR LABEL CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h 6 To begin infusion press start s...

Page 113: ...d infusion begins When a delay is programmed the infusion stops when complete and no KVO is delivered The Delay for option is used to program an infusion delay for a minimum of 1 minute and up to 120...

Page 114: ...ions for Use Pump and Syringe Modules Section Delay Options Continued Delaying Infusion Continued Specifying by Minutes Continued CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM IN...

Page 115: ...em Directions for Use Pump and Syringe Modules Section Delaying Infusion Continued NOTE If the current time has been previously confirmed the Time of Day screen will not be displayed Delay Options Con...

Page 116: ...responding to desired callback option Scheduled callback appears on Main Display 3 To initiate delay press CONFIRM soft key If Delay until programming time infusion is scheduled to start appears on Ma...

Page 117: ...fter option was selected An audio prompt sounds when delayed infusion completes and continues to sound until responded to Yellow Standby Status Indicator flashes until audio is silenced Infusion compl...

Page 118: ...containers WARNINGS CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RE...

Page 119: ...mum allowable delay on a multidose infusion is 8 hours 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Multidose soft key Channel Options 1 of 2 Guardrails Drugs Pressure Limit 550 mmHg A Selec...

Page 120: ...nfused for each dose use numeric data entry keys 4 To enter duration for each dose press DURATION soft key and use numeric data entry keys 5 To enter time interval 1 to 24 hours between doses press DO...

Page 121: ...urs and all doses in the multidose program must be completed within a 24 hour program Syringe Module If NEOI is enabled the Near End of infusion message appears near the end of the last dose 1 To ente...

Page 122: ...Limit 1 Press CHANNEL SELECT key 2 Press OPTIONS key SILENCE OPTIONS 1 4 7 CLEAR 2 5 8 0 3 6 9 ENTER CANCEL SYSTEM ON Pump Module CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY NOTES R...

Page 123: ...able Pump A 3 Press Pressure Limit soft key 4 Press either Pump or Selectable pressure soft key If Selectable is pressed continue with next step otherwise proceed to last step Selecting Pressure Limit...

Page 124: ...Current limit 550 _ mmHg Pressure Limit Selection CONFIRM Change value Auto Pressure Current pressure 30 mmHg Channel Options 1 of 2 Guardrails Drugs Pressure Limit 550 mmHg A Select an Option or EXI...

Page 125: ...Selecting Pressure Limit Continued 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Pressure Limit soft key Channel Options 1 of 2 A Select an Option or EXIT EXIT PAGE DOWN Guardrails Drugs Pre...

Page 126: ...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 70 Programming Alaris System Directions for Use Pump and Syringe Modules Section...

Page 127: ...vice 4 Adjust flow rate with administration set roller clamp Setting Up for Gravity Infusion Pump Module 1 To stop infusion press PAUSE key 2 Close roller clamp 3 Remove empty solution container 4 Ins...

Page 128: ...eattach administration set to new syringe and load new syringe reference Getting Started 5 Select syringe type and size reference Programming Primary Infusion With Guardrails Suite MX Protection 6 Pre...

Page 129: ...ility personnel must ensure the performance of the common IV site is satisfactory under these circumstances To prevent a potential free flow condition ensure no extraneous object for example bedding t...

Page 130: ...The use of any other syringe or administration set may cause improper instrument operation resulting in an inaccurate fluid delivery or pressure sensing or other potential hazards For a list of compa...

Page 131: ...ldup of infusates upon correction of the occlusion To avoid an inadvertent bolus relieve the pressure before restarting the infusion Ensure the displayed syringe manufacturer and syringe size correctl...

Page 132: ...and Syringe Modules Section Guardrails Suite MX Warnings and Cautions Continued Epidural Administration Continued The Alaris System can be used for epidural administration of anesthetic and analgesic...

Page 133: ...d Syringe Modules Section Infusion Modules For specific administration set instructions reference directions for use provided with set For a list of compatible administration sets reference Set Compat...

Page 134: ...Replace every 72 hours or after 100 activations whichever occurs first For infusions of blood blood products or lipid emulsions replace every 24 hours SmartSite Infusion Set Pump Module Safety Clamp...

Page 135: ...CT CHANNEL OFF PAUSE RESTART RATE mL h The Syringe Module is calibrated and labeled for use with the following single use disposable luer lock syringes Use only the syringe size and type specified on...

Page 136: ...nel Labels Available when Profiles feature is enabled It provides a hospital defined list of labels displayed in Channel module Message Display and identifies module with catheter location or other he...

Page 137: ...ppropriate for use in as many as 10 profiles Drug Library use automates programming steps including drug name drug amount and diluent volume and activates hospital established best practice limits Dru...

Page 138: ...gularly scheduled intervals Rapid Bolus Fastest rate at which bolus dose should be delivered as defined by facility s clinical best practice guidelines Restore To simplify programming can be used to r...

Page 139: ...occurs Using Guardrails Editor Software system can be configured to allow 0 zero to 9 restart attempts within a rolling 10 minute period If allowable number of restarts is exceeded or if feature is s...

Page 140: ...ion System check valve administration set is used 2 84 General Information Alaris System Directions for Use Pump and Syringe Modules Section Pump Module Continued Features and Displays Continued Featu...

Page 141: ...ro Near End of Infusion NEOI Allows an alert to be configured to sound anywhere from 1 to 60 minutes before infusion is complete Alert will occur at configured time or when 25 of VTBI remains whicheve...

Page 142: ...ume of fluid to be delivered in order to prime administration set prior to being connected to a patient or after changing a syringe When priming a single continuous press of PRIME soft key delivers up...

Page 143: ...d during an infusion temporarily stops infusion on that module After approximately 2 minutes a visual and audio prompt begins Channel module Off Key When pressed and held until a beep is heard stops i...

Page 144: ...Cam Slide Tubing Keeper Upper Pressure Sensor Lower Pressure Sensor Safety Clamp Device Recess Air in Line Sensor Upper Occluder Lower Occluder Upper Pumping Finger Lower Pumping Finger IUI Connector...

Page 145: ...and audio prompt begins Channel module Off Key When pressed and held until a beep is heard stops infusion on that module deselects that module and if only that module had been operating system powers...

Page 146: ...0 mL VOLUME INFUSED AUDIO ADJUST Midtown Hospital Adult ICU Dynamic Pressure Display Current operating pressure is indicated by solid bar Patient side occlusion pressure set point is indicated by tic...

Page 147: ...dministration rate INFUSE AT When duration is entered total dose duration in minutes When Max Rate is used Max Rate 60 x concentration Bolus dose duration bolus VTBI bolus rate Bolus dose VTBI bolus d...

Page 148: ...al or contact Cardinal Health Technical Support for technical troubleshooting and preventive maintenance information With the Profiles feature enabled the settings are configured independently for eac...

Page 149: ...5 mmHg in 25 mmHg increments configured by profile and adjustable only in Selectable Pressure Mode Enabled Disabled Enabled Disabled Feature Accumulated Air Air in Line Settings single bolus Auto Rest...

Page 150: ...r 25 of remaining infusion time whichever comes later 25 1000 mmHg in 1 mmHg increments Low Medium High Enabled Disabled Feature ALL Mode Auto Pressure Back Off after occlusion Fast Start KVO Keep Vei...

Page 151: ...ure Noncondensing Noncondensing to relative humidity 85 Temperature Range 41 104 F 4 140 F 5 40 C 20 60 C Equipment Orientation To ensure proper operation the system must remain in an upright position...

Page 152: ...of Alaris System is 5 at rates between 1 and 999 mL h and 5 5 at rates 1 mL h 95 of the time with 95 confidence under conditions listed below Infusion Rate Range 0 1 999 mL h Ambient Temperature 68 4...

Page 153: ...mHg 0 764 0 137 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 Installing a pressure sensi...

Page 154: ...id prolonged exposure Noncondensing Noncondensing to relative humidity 85 Atmospheric Pressure 525 4560 mmHg 375 760 mmHg 700 6080 hPa 500 1013 hPa Equipment Orientation To ensure proper operation PC...

Page 155: ...Sensing Disc User selected 25 1000 mmHg in 1 mmHg increments Operating Principle Positive displacement Rate Accuracy 2 of full scale plunger travel not including syringe variation Syringe Module Conti...

Page 156: ...9 99 10 60 Weight 4 5 lbs NOTES On a high setting the actual occlusion pressure will vary based on the syringe size and manufacturer Flow rates as low as 0 01 mL h are available only with 1cc and 3cc...

Page 157: ...XX represents filter size Product contains a particular element such as DEHP in fluid pathway Product DOES NOT contain a particular element such as administration set is latex free Approximate adminis...

Page 158: ...tion window is reduced short term fluctuations have greater effect as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when cert...

Page 159: ...r Heights With a negative head height of 0 5 meters the Pump Module typically exhibits a long term accuracy offset of approximately 3 1 from mean values Resulting trumpet observation points typically...

Page 160: ...ringe Module Continued Measurements for trumpet curve rates above 5 0 mL h are also not provided as the volume of the syringe will be displaced in a very short time with a rate of up 999 mL h Accuracy...

Page 161: ...nitial Trumpet Curve at 1 mL h initial Trumpet Curve at 0 1 mL h 72 hrs Trumpet Curve at 1 mL h 72 hrs Time min Time min Observation Interval min Observation Interval min Observation Interval min Obse...

Page 162: ...umpet Curve at 999 mL h 24 hrs Time min Time min Observation Interval min Observation Interval min Observation Interval min Observation Interval min Flow Rate mL h Flow Rate mL h Flow Rate Error Flow...

Page 163: ...Observation Interval min Flow Rate Error Legend P Maximum rate error Overall rate error X Minimum rate error Start Up Curve at 5 mL h initial 1 g mL Time min mL h 1 1 1 6 4 2 0 3 2 8 0 9 2 2 1 1 1 9 1...

Page 164: ...2 108 General Information Alaris System Directions for Use Pump and Syringe Modules Section 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...

Page 165: ...e infusion device flow rate When an ECG monitoring system is not functioning under optimal conditions these currents may appear as artifacts simulating actual ECG readings To determine if ECG abnormal...

Page 166: ...wo short beeps bolus switching to continuous Variable volume can be silenced and disabled in System Configuration Audio Characteristics Type Sound Notes Alarms CHANNEL SELECT CHANNEL OFF RESTART PAUSE...

Page 167: ...de Infusion stops on affected module Partial occlusion of patient side of IV line detected by Auto Restart feature Clear air from line To continue infusion press RESET soft key and then RESTART key En...

Page 168: ...sed during an infusion Infusion stops on affected module Module paused for 2 minutes Open door and inspect pump chamber To open blockage as required massage tubing To continue infusion press RESET sof...

Page 169: ...fy syringe plunger movement is unimpeded If syringe is not empty and above actions do not correct alarm contact qualified service personnel Alarm Meaning Response Syringe Module Continued ALARM INFUSE...

Page 170: ...isengaged during operation Securely lock plunger grippers press CHANNEL SELECT key and reselect syringe Securely lock syringe barrel clamp and press RESTART key Check for potential siphoning Ensure ad...

Page 171: ...d continue normal operation press CONFIRM soft key Troubleshooting and Maintenance 2 115 Alaris System Directions for Use Pump and Syringe Modules Section Errors Error Meaning Response Alarms Errors M...

Page 172: ...ssed Press CONFIRM soft key None Press RESTART key or press CHANNEL SELECT key and then START soft key Set up a new infusion or press CHANNEL OFF key Set up a new infusion or press CHANNEL OFF key If...

Page 173: ...ning Response Pump Module CHANNEL SELECT CHANNEL OFF RESTART PAUSE ALARM INFUSE STANDBY After Call Back NEOI Near End of Infusion Syringe Not Recognized Infusion completed Syringe almost empty Install...

Page 174: ...instrument operation WARNING Regular and preventive maintenance inspections should only be performed by qualified service personnel CAUTION KVO VTBI Delayed PC Unit Display Module Display Audio Visual...

Page 175: ...ALARM INFUSE STANDBY CHANNEL SELECT CHANNEL OFF PAUSE RESTART RATE mL h Alaris Patient Controlled Analgesia PCA Module 8120 Series 3 Alaris System DFU Section...

Page 176: ......

Page 177: ...Stopping a Loading PCA or Bolus Dose 3 22 Changing Programming Parameters During an Infusion 3 22 Viewing Patient History 3 23 Clearing Patient History 3 24 Viewing Drug Event History 3 25 Configurin...

Page 178: ...INGS 3 49 SPECIFICATIONS AND SYMBOLS 3 51 Specifications 3 51 Symbols 3 53 TRUMPET AND START UP CURVES 3 55 TROUBLESHOOTING AND MAINTENANCE GENERAL 3 57 ALARMS ERRORS MESSAGES 3 57 Definitions 3 58 Al...

Page 179: ...hrough clinically acceptable routes of administration such as intravenous IV subcutaneous or epidural Up to two 2 PCA modules can be connected to the Alaris System The PCA Module uses standard or pre...

Page 180: ...A continuous dose infusion To attach Dose Request Cord Insert latching connector into Dose Request Cord attachment Red marking on latching connector should be aligned with red marking on Dose Request...

Page 181: ...e with manufacturer s directions for use 3 Attach upper fitting of administration set to syringe tip Use only standard single use disposable syringes with luer lock connectors and non dedicated admini...

Page 182: ...nge and plunger are installed and secured correctly Failure to install syringe correctly can result in uncontrolled fluid flow to the patient and may cause serious injury or death Before loading or un...

Page 183: ...ease gripper control Drive Head Fully Extended Plunger Grippers Open Gripper Control Drive Head Release in Open Position 3 Insert syringe from front of instrument by sliding flat edge of syringe barre...

Page 184: ...r control in open position gently lower drive head until it makes contact with plunger flange c Gently release gripper control d Ensure plunger grippers lock and hold plunger in place NOTE The gripper...

Page 185: ...the start of an infusion program the system prompts user to select and confirm the syringe type and size Ensure the displayed syringe manufacturer and size correctly identifies the installed syringe...

Page 186: ...e type and medication selection prior to infusion mode selection When priming Ensure patient is not connected Ensure air is expelled from line prior to beginning infusion unexpelled air in line could...

Page 187: ...of 2 Prime Set with Syringe PAGE UP A Prime Set with Syringe Press and Hold PRIME Prime Volume 0 mL CAUTION Do not prime with disposable set connected to patient PRIME EXIT SILENCE OPTIONS 1 4 7 CLEAR...

Page 188: ...f required 3 Press CHANNEL SELECT key 4 Unlock security door or set key to PROGRAM position 5 Confirm time of day or change time if necessary A Time of Day Change Time Current time 08 00 CONFIRM Time...

Page 189: ...g mL 10 mg mL Guardrails Drugs Med Surg DRUG LIBRARY Morphine 8 Press soft key next to desired concentration Drug Concentration confirmation screen appears To view additional drugs concentrations pres...

Page 190: ...n Modes Programming Parameters The PCA Module uses the following programming parameters depending on infusion mode selected Reference General Information Features and Definitions for infusion mode def...

Page 191: ...screen Infusion Modes Continued 3 To enter PCA dose use numeric data entry keys Conc 1 mg mL None _ _ _ minutes Morphine PCA Only MAX LIMIT A _ 20 mg LOADING DOSE None CHANGE MODE PCA DOSE LOCKOUT INT...

Page 192: ...ELIVERING LOAD Main Display alternates between volume remaining and PCA drug name with infusion mode When PCA dose is delivered i Green Infusing Status Indicator illuminates i Rate display flashes _ _...

Page 193: ...mg mL Continuous Morphine Select Max Limit Option 2 mg h MAX LIMIT CONT DOSE LOADING DOSE None CHANGE MODE Yes No A Enter Continuous Dose MAX LIMIT _ _ _ mg h CONT DOSE Conc 1 mg mL LOADING DOSE None...

Page 194: ...Infusion mode and drug name scroll in Channel Message Display If a loading dose has been entered DELIVERING LOAD scrolls Volume infused in mL h in Rate Display Main Display alternates between volume r...

Page 195: ...CONT DOSE MAX LIMIT _ _ _ minutes LOCKOUT INTERVAL Enter Lockout Interval LOADING DOSE None CHANGE MODE PCA Continuous Morphine None 3 To enter PCA dose press PCA DOSE soft key and use numeric data e...

Page 196: ...scrolls in Channel Message Display between PCA doses i Volume infused for continuous dose is displayed in mL h in Rate Display i Main Display alternates between volume remaining and infusion mode with...

Page 197: ...tinue If Yes soft key is pressed programming continues if No soft key is pressed infusion needs to be reprogrammed 5 Close and lock security door 6 Verify parameters on summary screen are correct and...

Page 198: ...ss START to Close Summary 2 mg h START BOLUS DOSE Cont Dose 30 mg 4 h PRO GRAM Summary Morphine Infusion Modes Continued Setting Loading Dose Only Continued 7 Press CONFIRM soft key Upon pressing Chan...

Page 199: ...ata entry keys 5 Press CONFIRM soft key If programmed bolus dose is outside soft limit for that care area a prompt appears before programming can continue If Yes soft key is pressed programming contin...

Page 200: ...h CHANGE MODE Guardrails Drug Setup IMS Pre fill 30mL 20 minutes LOCKOUT INTERVAL 2 mg PCA DOSE Press CONFIRM CONFIRM Infusion Modes Continued Stopping a Loading PCA or Bolus Dose 1 Press CHANNEL SEL...

Page 201: ...s START soft key Alaris System Directions for Use Patient Controlled Analgesia Module Section Programming 3 23 Infusion Modes Continued NOTE Previously programmed values are carried over to new progra...

Page 202: ...dule Section Clearing Patient History Total Demands Total Drug A ZOOM EXIT Delivered Press ZOOM to Change Time Scale DETAIL Patient History 09 01 CLEAR HISTORY LAST CLEARED 07 00 2003 6 10 History fro...

Page 203: ...24 hours Clearing Patient History Continued 5 To continue and clear patient history press Yes soft key To cancel and return to patient history press No soft key 6 Once patient history is cleared last...

Page 204: ...T Dose Request Setup Infusion Modes Patient History PCA Pause Limits Drug Event History Channel Options 1 of 2 PAGE DOWN Infusion Modes Continued A TIME DRUG EVENT 2003 06 10 07 08 07 08 06 10 09 01 P...

Page 205: ...d select Profile soft key for desired operation of Dose Request Cord Configuring Dose Request Cord Continued The security access level can be configured to provide varying levels of access to the devi...

Page 206: ...de Access soft key A Select an Option or EXIT EXIT Pressure Limit High Channel Options 2 of 2 Prime Set with Syringe Security Code Access PAGE UP Disabling Security Access Code 4 Press DISABLE CODE so...

Page 207: ...TART CHANNEL visual and audio prompts begin and yellow Standby Status Indicator flashes Pausing Infusion Continued 2 To reinitiate infusion Press RESTART key OR Press CHANNEL SELECT key and then press...

Page 208: ...ng numeric data entry keys c Press CONFIRM soft key Infusion Modes Continued EXIT Select Drug A Morphine Meperidine Guardrails Drug Setup Med Surg K O F J P T U Z A E RESTORE 2 To restart infusion usi...

Page 209: ...ssure Limit 1 Press CHANNEL SELECT key 2 Press OPTIONS key 3 Press Pressure Limit soft key A Select an Option or EXIT EXIT Pressure Limit High Channel Options 2 of 2 Prime Set with Syringe PAGE UP CHA...

Page 210: ...d protocol procedure or a physician s order 3 32 Programming Alaris System Directions for Use Patient Controlled Analgesia Module Section PCA Pause Protocol Feature The PCA Pause Protocol is an option...

Page 211: ...isory To continue press CONFIRM soft key To activate PCA Pause Protocol attach and start an Alaris EtCO2 Module and or Alaris SpO2 Module per facility protocol Verify appropriate monitoring modules ar...

Page 212: ...otocol Enabled Continued A VOLUME INFUSED AUDIO ADJUST Midtown Hospital Med Surg PCA Cont Morphine B C D ETCO2 SPO2 VTBI ALL 30 mL PCA Pause Protocol ON NOTES If a monitoring module s is not attached...

Page 213: ...a Pause Limit Between 2 4 CONFIRM _4 PCA Pause Limits DISABLE ETCO2 DISABLE SPO2 SPO2 LOW RR LOW 97 5 SPO2 ETCO2 ALARM LIMITS PCA PAUSE LIMITS NOTE The acceptable range for PCA Pause Protocol is confi...

Page 214: ...functionality Once disabled the alarm limits will be grayed out and will not be editable Disabling PCA Pause Alarm 1 From Main Display press CHANNEL SELECT 2 Press OPTIONS key 3 Select PCA Pause Limi...

Page 215: ...l Setup and Operation Alaris System Directions for Use Patient Controlled Analgesia Module Section System Start Up Setup Reference the PC Unit Section of this DFU General Setup and Operation for vario...

Page 216: ...3 38 General Setup and Operation Alaris System Directions for Use Patient Controlled Analgesia Module Section 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...

Page 217: ...neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions The use of positive displacement infusion devices ported together with gravity flow infusion syst...

Page 218: ...or turned off and may cause serious injury or death When an occlusion occurs there is a risk of infusing pressurized buildup of infusates upon correction of the occlusion To avoid an inadvertent bolus...

Page 219: ...c 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 standard...

Page 220: ...erious consequences WARNINGS The PCA Module uses standard single use disposable syringes with luer lock connectors and administration sets with anti siphon valves designed for use on syringe type PCA...

Page 221: ...Bolus Dose Allows an additional amount of medication to be programmed once PCA infusion has begun Current PCA infusion resumes following delivery of a bolus dose Continuous Dose Basal rate dose The PC...

Page 222: ...ary is required prior to using PCA Module Guardrails Limit Limit A programming Limit or best practice guideline determined by hospital health system and entered into system s data set Dose Limits can...

Page 223: ...nsures PCA Module is in a tamper evident position When enabled PCA Module must be located to direct right of PC Unit to allow programming an infusion Near End of Infusion NEOI Allows an alert to be co...

Page 224: ...se Protocol An optional and hospital configurable feature intended to align with hospital health system s current protocol for patient monitoring during PCA therapy When enabled PCA infusion pauses an...

Page 225: ...des Security Access Levels Security Code Four character code assigned to allow access to PC Unit for setting bolus doses and subsequent programming changes Ability to use profile specific code is depe...

Page 226: ...on on that module After approximately 2 minutes a visual and audio prompt begins Channel module Off Key When pressed and held until a beep is heard stops infusion on that module deselects that module...

Page 227: ...r to specific drug product labeling for information concerning appropriate administration techniques and dosages Reference the PC Unit Section of this DFU for system configurable settings If the confi...

Page 228: ...its 0 9 One code applies to all profiles 75 500 mL hr limited by syringe size Enabled Disabled Enabled Disabled Profile 1 2 3 Enabled Disabled Min Max 1 99 minutes Disabled 1 2 or 4 hour limit 0 1 99...

Page 229: ...lines Bolus Volume after Occlusion Maximum Bolus Volume at Intermediate Rate 5 mL h Occlusion Pressure Limit Bolus Volume High 0 997 mL Low 0 396 mL Specifications and Symbols Critical Volume Maximum...

Page 230: ...to hospital best practice guidelines Occlusion Alarm Thresholds Three settings Low Medium High Operating Principle Positive displacement PCA Dose Range Configured according to hospital best practice...

Page 231: ...Atmospheric Pressure 645 795 mmHg Back Pressure 0 mmHg before producing occlusion Humidity 20 90 Temperature 68 4 F Weight 5 5 lbs Symbols Reference the PC Unit Section of this DFU for system symbols...

Page 232: ...le Section XX m EC REP Specifications and Symbols Continued Symbols Continued Expiration date for product will be identified near hour glass symbol Do not use if package is damaged Product contains mi...

Page 233: ...windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation...

Page 234: ...Legend P Maximum rate error Overall rate error X Minimum rate error Mode Start up at 5 mL h initial 1 0 1 2 3 4 5 6 7 8 9 10 0 20 40 60 80 100 120 time min mL h Mode Trumpet Curve at 5 mL h initial 2...

Page 235: ...ocedures are intended to be performed only by qualified personnel using the Service Manual Maintenance Software and Maintenance Software User Manual Artifacts It is normal for an infusion device to pr...

Page 236: ...ired ensuring it is securely clicked into place at Channel Release Latch If alarm is still present replace module with an operational instrument Lock door and press RESTART key Clear occlusion Press R...

Page 237: ...iphoning condition Drive system disengaged during operation Securely lock plunger grippers press CHANNEL SELECT key and reselect syringe Securely lock syringe barrel clamp and press RESTART key Check...

Page 238: ...is required To silence alarm and continue operation of unaffected modules press CONFIRM soft key Replace module with an operational instrument as required Service by qualified personnel is required To...

Page 239: ...locking to PC Unit Device is not in a tamper evident position Installed syringe of unknown type and size None This is a timed event that can be set To set or change this option reference General Infor...

Page 240: ...Software User Manual v8 1 or later for detailed instructions REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Exterior Surfaces Each usage Keypad Each usage Seal Each usage Mechanical Parts...

Page 241: ...CHANNEL SELECT CHANNEL OFF MONITOR ALARM MONITOR STANDBY SpO2 PULSE BPM 4 Alaris System DFU Section Alaris SpO2 Modules 8210 and 8220 Series...

Page 242: ......

Page 243: ...SETUP AND OPERATION SYSTEM START UP SETUP 4 15 GENERAL INFORMATION WARNINGS AND CAUTIONS 4 17 General 4 17 Sensors and Cables 4 18 CABLES AND SENSORS 4 19 Nellcor Patient Cables and OXIMAX Sensors 4...

Page 244: ...ii Table of Contents Alaris System Directions for Use SpO2 Modules Section 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...

Page 245: ...r use with adult pediatric and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospitals and hospital type facilities Only 1 SpO2 Modu...

Page 246: ...nued Alarms and Messages Reference Troubleshooting and Maintenance for module specific Alarms and Messages Contraindications The SpO2 Modules are contraindicated for use as apnea monitors Electromagne...

Page 247: ...Use only approved Masimo sensors and patient cables Use of sensors transducers cables and accessories other than those specified may cause improper SpO2 Module performance resulting in inaccurate rea...

Page 248: ...4 4 Getting Started Alaris System Directions for Use SpO2 Modules Section 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...

Page 249: ...er on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 2 Attach patient cable and sensor reference Getting Started 3 Pr...

Page 250: ...Current View Setting Alarm Limits 1 Press LIMITS soft key A Adult Mode 82 SPO2 97 Off 150 90 50 LIMITS TREND MAIN SCREEN PULSE RATE SPO2 Main SatSeconds to Alarm 0 100 Press ENTER to Retain Current V...

Page 251: ...meric value 4 To move to next limit press ENTER key 5 To confirm alarm settings and return to SPO2 Main display press CONFIRM soft key 6 To return to Main Display press MAIN SCREEN soft key A A SPO2 H...

Page 252: ...MIN MAX 2001 07 06 97 90 100 82 50 150 97 100 90 82 150 50 97 90 100 82 50 150 97 88 100 82 50 150 03 01 01 01 23 01 07 01 05 01 ZOOM 60 5 minutes 1 30 120 Trend Data Adult Mode 09 00 97 90 100 82 50...

Page 253: ...nel Options Select an Option or EXIT EXIT PCA SpO2 Trend data Programming 4 9 Alaris System Directions for Use SpO2 Modules Section A Press UP DOWN Keys to Move Cursor PAGE DOWN ZOOM ZOOM minutes TIME...

Page 254: ...ctions for Use SpO2 Modules Section Presilencing Alarm Monitoring Mode Continued 1 To presilence alarm press SILENCE key All monitoring alarms are silenced for 120 seconds Infusion alarms are not sile...

Page 255: ...ptions Select an Option or EXIT EXIT 2 To test or change a To test volume level when not attached to patient press Test soft key b To increase volume press Louder soft key until desired volume level i...

Page 256: ...Mode Normal Changing SatSeconds Limit Channel Options Continued 1 Press SatSeconds Limits soft key A Pulse Beep Volume Off SatSeconds Limits 10 Limit Mode Adult Channel Options Select an Option or EXI...

Page 257: ...nds CONFIRM Press CONFIRM with Fast SAT Changing Saturation Averaging Time Continued Changing Sensitivity Mode 1 Press Sensitivity Mode soft key A Pulse Beep Volume Off Sat Averaging Time 8 Limit Mode...

Page 258: ...4 14 Programming Alaris System Directions for Use SpO2 Modules Section 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...

Page 259: ...4 15 General Setup and Operation Reference the PC Unit Section of this DFU General Setup and Operation for various system start up and setup procedures System Start Up Setup Alaris System Directions f...

Page 260: ...4 16 General Setup and Operation Alaris System Directions for Use SpO2 Modules Section 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...

Page 261: ...y erroneously increase readings The level of increase is approximately equal to the amount of carboxyhemoglobin present Dyes or any substance containing dyes that change usual arterial pigmentation ma...

Page 262: ...ables 8220 Series Use only approved Masimo sensors and patient cables Use of sensors transducers cables and accessories other than those specified may cause improper SpO2 Module performance resulting...

Page 263: ...ist of compatible sensors and cables reference the Sensor and Cable Compatibility Card provided separately 8210 Masimo Patient Cables and Sensors Reusable patient cables of various lengths are availab...

Page 264: ...ic pleth waveform is a graphic representation of changes in extremity blood volume during events of cardiac cycle Pulse Beat Volume Sound of each pulse beep may be configured to be off or to a volume...

Page 265: ...larm limit reentering nonalarm range several times During such fluctuations SpO2 Module integrates number of SpO2 points both positive and negative until either SatSeconds limit SatSeconds time settin...

Page 266: ...on Operating range is 0 02 to 20 Desired number is greater than 1 or as large as possible Saturation Averaging Time Averaging time can be set to 2 4 8 10 12 14 or 16 seconds Sensitivity Mode Sensitivi...

Page 267: ...nnel module Message Display Channel module Select Key When pressed selects corresponding module for patient monitoring and setup Channel module Identification Monitor Key When pressed begins patient m...

Page 268: ...this document are for illustration purposes only The display content will vary depending on configuration settings hospital defined data set uploaded using the Guardrails Suite MX programmed paramete...

Page 269: ...endently for each profile A hospital defined best practice data set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles Configurable Setti...

Page 270: ...pulse rate sensor condition system failure and low battery conditions Alarm Limits Low High Pulse Rate 30 239 bpm 31 240 bpm SpO2 20 99 21 100 Dimensions 3 3 W x 8 9 H x 5 5 D 8 4cm W x 22 6cm H x 14...

Page 271: ...se Rate 20 250 bpm SpO2 1 100 Pulse Amplitude Display Visual indicators for pulse signals represent proportional pulse amplitude strength Sensor Emitted light wavelength range is within 500 1000 nm Ou...

Page 272: ...idated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 4 Hz at an amplitude of 1 2 cm and a nonrepet...

Page 273: ...r use Significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin Intravascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such...

Page 274: ...n cardiac arrest or is in shock There is an arterial occlusion proximal to sensor Placement is too close to electrosurgery equipment Principle of Operation The operation of the SpO2 Module 8210 Series...

Page 275: ...mean wavelength of the sensor s red LED to accurately measure SpO2 During monitoring the instrument s software selects coefficients that are appropriate for the wavelength of that individual sensor s...

Page 276: ...was not appropriately corrected for the effects of variables that shift the relationship between PO2 and pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin To com...

Page 277: ...Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation The SpO2 Module uses the Masimo S...

Page 278: ...4 34 General Information Alaris System Directions for Use SpO2 Modules Section 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...

Page 279: ...owing system references Alarms Errors Messages Audio Characteristics Definitions Radio Frequency Note Alarms and Messages Alaris System Directions for Use SpO2 Modules Section Alarms 8210 and 8220 Ser...

Page 280: ...placement Remove Module Max 1 More than 1 SpO2 Module attached Remove additional SpO2 Module Sensor Off Sensor not properly attached to patient Reattach sensor to patient 8210 Series Check Sensor Hig...

Page 281: ...has inhibited monitoring Check sensor Move sensor to a better perfused site Check Sensor Low Signal I Q Low signal quality being measured Check sensor Confirm correct sensor placement Move sensor to...

Page 282: ...ed by qualified service personnel CAUTION Alarms and Messages Continued Check Sensor Weak Signal Low quality of signal being measured Check sensor Confirm correct sensor placement Move sensor to a bet...

Page 283: ...5 Alaris System DFU Section ALARM MONITOR STANDBY CHANNEL SELECT MONITOR CHANNEL OFF EtCO mm Hg 2 RR breaths min Alaris EtCO2 Module 8300 Series...

Page 284: ......

Page 285: ...e Scale 5 11 GENERAL SETUP AND OPERATION SYSTEM START UP SETUP 5 13 GENERAL INFORMATION WARNINGS AND CAUTIONS 5 15 General 5 15 Microstream Disposable 5 16 MICROSTREAM DISPOSABLE 5 16 FEATURES AND DIS...

Page 286: ...ii Table of Contents Alaris System Directions for Use EtCO2 Module Section 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...

Page 287: ...rbon dioxide FiCO2 and respiratory rate RR The EtCO2 Module and disposables are indicated for use with intubated and nonintubated adult geriatric pediatric and neonatal patients It is not intended for...

Page 288: ...ble other than those specified may cause improper EtCO2 Module performance resulting in inaccurate readings For a list of compatible disposables reference the Microstream Disposable Compatibility Card...

Page 289: ...he instrument and is marked with a gas inlet symbol Attaching Gas Scavenging System In the presence of high oxygen or anesthesia concentrations it may be necessary to connect a gas scavenging system t...

Page 290: ...5 4 Getting Started Alaris System Directions for Use EtCO2 Module Section 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...

Page 291: ...er on system b Choose Yes or No to New Patient c Confirm current profile or select a new profile d Enter patient identifier if required 2 Connect Microstream Disposable reference Getting Started 3 Pre...

Page 292: ...0 NOTE PC Unit display response time is approximately second longer than the EtCO2 Module response time 1 Press LIMITS soft key 2 To change a limit setting press soft key next to applicable parameter...

Page 293: ...MAX AVG MIN MAX 2001 07 06 21 28 20 58 20 28 22 58 40 38 47 41 34 45 39 37 44 13 11 26 11 10 14 12 11 14 22 28 40 44 39 12 16 11 21 58 41 39 45 13 11 20 1 120 Trend Data Adult Mode 09 00 30 PAGE UP Fi...

Page 294: ...trend data press OPTIONS key 3 To view Trend Data press PCA EtCO2 Trend data soft key Following information displays TIME period for data review Average ETCO2 Average respiratory rate RR Alarm icon T...

Page 295: ...mode Press CHANNEL SELECT key Press CANCEL SILENCE soft key A Adult Mode 13 ETCO2 34 LIMITS TREND MAIN SCREEN RR ETCO2 Main mmHg breaths min mmHg 60 25 10 5 Press ENTER to Retain Current View Time sec...

Page 296: ...ds that range Waveform Out of Range Adjust Scaling message displays until waveform falls back into range or 0 99 mmHg option is selected 99 mmHg Displays a waveform for full EtCO2 value range 0 99 mmH...

Page 297: ...ale soft key A Waveform height 80 mmHg Waveform time scale 5 sec Limit Mode Adult Channel Options Select an Option or EXIT EXIT 2 To change Waveform Time Scale select applicable time scale OR To leave...

Page 298: ...5 12 Programming Alaris System Directions for Use EtCO2 Module Section 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...

Page 299: ...5 13 General Setup and Operation System Start Up Setup Alaris System Directions for Use EtCO2 Module Section Reference the PC Unit Section of this DFU General Setup and Operation for various system st...

Page 300: ...5 14 General Setup and Operation Alaris System Directions for Use EtCO2 Module Section 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...

Page 301: ...eans then ensure EtCO2 Module is functioning correctly Do not lift the EtCO2 Module by Microstream Disposable because it may disconnect from the instrument causing it to drop on the patient Do not pla...

Page 302: ...instructions Carefully locate the patient Microstream Disposable to reduce the possibility of patient entanglement or strangulation WARNINGS 5 16 General Information Alaris System Directions for Use...

Page 303: ...ent during inhalation Limit Mode If operating outside of Guardrails Data Set limit mode can be changed for adult or neonatal default configuration settings Microstream Disposable Oridion s line of Mic...

Page 304: ...t EtCO2 mmHg Display Respiratory Rate Display Channel module Message Display Channel module Select Key When pressed selects corresponding module for patient monitoring and setup Channel module Identif...

Page 305: ...le Technical Service Manual or contact Cardinal Health Technical Support for technical troubleshooting and preventive maintenance information With the Profiles feature enabled the settings are configu...

Page 306: ...essure EtCO2 Module is equipped with automatic barometric pressure compensation and fully complies with EN 864 1997 standards There are no quantitative effects of barometric pressure for this device C...

Page 307: ...reater for EtCO2 values exceeding 18 mmHg To achieve specified accuracies for breath rates above 60 bpm Microstream neonatal airway adapter M1996A must be used Gas Interference Following have been tes...

Page 308: ...leaking Placement too close to electrosurgery equipment Mechanically ventilated patient breathes spontaneously 5 22 General Information Alaris System Directions for Use EtCO2 Module Section Measureme...

Page 309: ...guration as well as to monitor a patient s clinical status The following are examples of common problems identifiable through waveform analysis These are examples only and do not represent all potenti...

Page 310: ...Causes Waveform Analysis Continued Principle of Operation The EtCO2 Module uses Oridion s patented Microstream nondispersive infrared NDIR spectroscopy to continuously measure the amount of CO2 durin...

Page 311: ...rence channel are measured by IR detectors The microcomputer in the EtCO2 Module calculates the CO2 concentration by comparing the signals from both channels No operator intervention is required for r...

Page 312: ...e disposables Microstream Disposables are rated for up to 24 hours and 72 hours use depending on the specific Microstream Disposable The EtCO2 Module provides readings in compliance with BTPS body tem...

Page 313: ...hooting and Maintenance Troubleshooting and Maintenance 5 27 General Alaris System Directions for Use EtCO2 Module Section Reference the PC Unit Section of this DFU for the following system references...

Page 314: ...ICO2 HIGH RR LOW ETCO2 Hardware failure detected by software Microstream Disposable removed from instrument during monitoring mode EtCO2 value is above specified limit FiCO2 value is above specified l...

Page 315: ...ble to patient and module Low Priority Alarm Alarms and Messages Continued Alarms Continued Autozero in progress Clearing Disposable Disposable Disconnected Patient Not Detected EtCO2 Module performs...

Page 316: ...and Software User Manual v8 1 or later for detailed instructions REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Case Each usage IUI Connector Each usage Keypad Each usage CLEANING As requi...

Page 317: ...6 Alaris System DFU Section SCAN CANCEL READY Alaris Auto ID Module 8600 Series...

Page 318: ......

Page 319: ...5 PRIMARY INFUSION 6 6 SECONDARY INFUSION 6 7 GENERAL SETUP AND OPERATION SYSTEM START UP SETUP 6 9 GENERAL INFORMATION WARNINGS AND CAUTIONS 6 11 HAND HELD SCANNER 6 12 FEATURES 6 12 Features and Def...

Page 320: ...ii Table of Contents Alaris System Directions for Use Auto ID Module Section 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...

Page 321: ...ncentration to be automatically selected In addition to drug and concentration the Auto ID Module allows for patient association with the PC Unit Scanning a bar coded patient identification band autom...

Page 322: ...6 2 Getting Started Alaris System Directions for Use Auto ID Module Section 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...

Page 323: ...Module Ensure secure circuit connection Use only the hand held external scanner supplied by Cardinal Health Using other accessories may result in increased emissions or decreased immunity of the Alar...

Page 324: ...he PC Unit keypad reference PC Unit Section of this DFU Patient Identification Continued New Patient Continued 6 To scan bar code on patient identification band press scan trigger on hand held scanner...

Page 325: ...ce Always verify that information displayed on the PC Unit matches scanned data CAUTIONS Authorized User Mode Authorized User Mode is a feature that combines the PC Unit tamper resist feature with the...

Page 326: ...tilizing the Auto ID Module to scan IV medication containers provides the ability to verify the right medication and concentration and enhances safety through the use of the Guardrails Suite MX It com...

Page 327: ...to CONFIRM the message and the scan is cancelled Primary Infusion Continued 2 Press CHANNEL SELECT key on appropriate module 3 Program infusion reference applicable module specific Section of this DFU...

Page 328: ...6 8 Programming Alaris System Directions for Use Auto ID Module Section 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...

Page 329: ...6 9 General Setup and Operation System Start Up Setup Alaris System Directions for Use Auto ID Module Section Reference the PC Unit Section of this DFU General Setup and Operation for various system s...

Page 330: ...6 10 General Setup and Operation Alaris System Directions for Use Auto ID Module Section 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...

Page 331: ...held external scanner supplied by Cardinal Health Using other accessories may result in increased emissions or decreased immunity of the Alaris System WARNINGS General Information General Information...

Page 332: ...al scans optical character recognition and others Built In Optical Scan Engine Employs technology similar to a digital camera to read bar codes Allows use of two dimensional bar codes Hand Held Scanne...

Page 333: ...ications Two Dimensional Bar Code Can contain more information and is more easily read by Auto ID Module for example patient ID and drug ID can be in same bar code Operating Features Controls Indicato...

Page 334: ...settings are configured independently for each profile A hospital defined best practice data set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in al...

Page 335: ...em automatically purges module specific information Fluid Ingress Protection IPX1 Drip Proof Mode of Operation Continuous Weight 1 0 1 lb 436 5 43 65 g Specifications Continued Specifications and Symb...

Page 336: ...al Information Alaris System Directions for Use Auto ID Module Section Specifications and Symbols Continued Reference the PC Unit Section of this DFU for system symbols Symbols Input Hand held connect...

Page 337: ...17 General Alaris System Directions for Use Auto ID Module Section To ensure the system remains in good operating condition both regular and preventive maintenance inspections are required Reference t...

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Page 339: ...Max Load 30V 1A NURSE CALL Nurse Call Accessory Model 8010 7 Alaris System DFU Section...

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Page 341: ...e Nurse Call Accessory Section INTRODUCTION 7 1 GENERAL INFORMATION WARNINGS AND CAUTIONS 7 3 NURSE CALL JACK AND CABLE 7 4 Nurse Call Location 7 4 Nurse Call Cable Connected 7 4 SPECIFICATIONS 7 5 TR...

Page 342: ...ii Table of Contents Alaris System Directions for Use Nurse Call Accessory Section 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...

Page 343: ...on is also hospital supplied The Nurse Call Accessory uses a standard phone jack located on the rear panel of the PC Unit A cover for the jack opening is supplied with the Nurse Call Accessory The cov...

Page 344: ...7 2 Introduction Alaris System Directions for Use Nurse Call Accessory Section 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...

Page 345: ...WARNINGS To assure compliance with Electromagnetic Compatibility Standards IEC 60601 1 2 the nurse call option must only be used with a properly configured hospital interface cable assembly The approv...

Page 346: ...Nurse Call Cable Plugged into Nurse Call Jack Fair Rite Suppressor Core Assembly Nurse Call Jack and Cable Nurse Call Location Nurse Call Cable Connected NOTE The Communications Interface Board Model...

Page 347: ...pecifications Contact Closure Rating 30VDC 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 Ca...

Page 348: ...7 6 General Information Alaris System Directions for Use Nurse Call Accessory Section 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...

Page 349: ...nent 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 Maintenance...

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Page 351: ...Communications Interface CI Board Accessory Model 8012 8 Alaris System DFU Section...

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Page 353: ...e CI Board Accessory Section INTRODUCTION 8 1 GENERAL INFORMATION CI BOARD ACCESSORY AND CI BOARD LED 8 3 COMPUTER MONITOR MODE INDICATOR 8 3 TROUBLESHOOTING AND MAINTENANCE GENERAL 8 5 CI BOARD AND A...

Page 354: ...ii Table of Contents Alaris System Directions for Use CI Board Accessory Section 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...

Page 355: ...infusion by providing information obtained from Alaris Server All data entry and validation of infusion parameters are performed according to a physician s order by a trained healthcare professional I...

Page 356: ...8 2 Introduction Alaris System Directions for Use CI Board Accessory Section 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...

Page 357: ...oard LED Flashes green when Alaris System is powered up NOTE The Nurse Call Accessory Model 8010 cannot be used when the CI Board is installed Computer Monitor Mode Indicator SILENCE OPTIONS 1 4 7 CLE...

Page 358: ...8 4 General Information Alaris System Directions for Use CI Board Accessory Section 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...

Page 359: ...aris System Directions for Use CI Board Accessory Section Troubleshooting and Maintenance General CI Board and Alaris Server Connections When the Alaris System is powered up the green LED on the CI Bo...

Page 360: ...l message displays to indicate a communication error A communication error to an outside access point does not cause a Alaris System alarm or visual message Alarms Errors Messages NETWORK COMM ERROR C...

Page 361: ...A Alaris System DFU Section Appendix Maintenance Regulations and Standards...

Page 362: ......

Page 363: ...ght and do not allow any part of instrument to become saturated with or submersed in fluid during cleaning operation 2 Use a soft cloth dampened with warm water and a mild nonabrasive cleaning solutio...

Page 364: ...ealth does not assume any responsibility for loss of or damage to returned instruments while in transit Service Information The instrument case should only be opened by qualified personnel using prope...

Page 365: ...ranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Cardinal Health shall...

Page 366: ...A 4 Maintenance Alaris System Directions for Use Appendix Section 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...

Page 367: ...protection against harmful interference when the system is operated in a commercial environment This system generates uses and can radiate radio frequency energy If it is not installed and used in acc...

Page 368: ...ble 1 Electromagnetic Emissions CISPR 11 RF Emissions Group 1 Alaris System uses RF energy only for its internal function in normal product offering If optional low power wireless network card RF tran...

Page 369: ...ance Level IEC 61000 4 4 Electrical Fast Transient Burst EFT Mains power quality should be that of a typical commercial or hospital environment 2 kV for power supply lines 1 kV for input output lines...

Page 370: ...uninterruptible power supply or a battery Alaris System does employ an internal short duration battery 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles...

Page 371: ...separation distance in meters m P maximum output power rating of transmitter in watts W according to transmitter manufacturer Field strengths from fixed RF transmitters as determined by an electromag...

Page 372: ...e RF communications equipment transmitters and the Alaris System as recommended in this table based on the maximum output power of the communications equipment For transmitters rated at a maximum outp...

Page 373: ...lectromagnetic site survey should be considered If the measured field strength in the location in which the Alaris System is used exceeds the applicable RF compliance level the Alaris System should be...

Page 374: ...he interference at their own expense There is however no guarantee that interference will not occur in a particular installation If the device does cause harmful interference to radio or television re...

Page 375: ...ll System UL 60601 1 CAN CSA C22 2 No 601 1 M90 IEC 60601 1 Auto ID Module IEC 60825 1 LEDs used in Auto ID Module are not regulated by FDA in the United States however they are classified as a CLASS...

Page 376: ...ed trademarks of Cardinal Health Inc or one of its subsidiaries LNOP Masimo SET Signal Extraction Technology and Signal I Q are trademarks of Masimo Corporation Nellcor and OXIMAX are trademarks of Ne...

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Cardinal Health Alaris 8000 Series, Directions For Use Manual

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