Alaris Medical Systems MEDLEY 8100 Manual
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Alaris Medical Systems MEDLEY 8100 Manual

Infusion pump module
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Summary of Contents for Alaris Medical Systems MEDLEY 8100

  • Page 2: Table Of Contents

    TABLE OF CONTENTS INTRODUCTION ABOUT THE SYSTEM ..................FEATURES .
  • Page 3 GENERAL CONTACT INFORMATION Customer Advocacy For clinical and technical questions, feedback, and troubleshooting assistance. Phone, toll-free, within the United States and Canada: (800) 854-7128, Ext. 7812 E-Mail: CustomerFeedback@alarismed.com Technical Support For technical information related to maintenance procedures and service manual support. Phone: (858) 458-6003 Toll-free, within the United States: (800) 854-7128, Ext.

  • Page 4: Introduction

    INTRODUCTION About the System Medication Safety System is a modular infusion MEDLEY™ and monitoring system intended for use in today’s growing professional healthcare environment, including healthcare facilities and home care, for use on adults, pediatrics and neonates. Pump Module is intended for facilities that utilize MEDLEY™...

  • Page 5: Features

    Features Anesthesia Mode The Anesthesia Mode allows the anesthesiologist to access additional drugs in each profile that are appropriate to anesthesiology. This mode also features permanent pause and the ability to set higher air-in-line settings. AutoRestart The AutoRestart feature is part of the System’s advanced MEDLEY™...
  • Page 6 Features (Continued) Guardrails Prompt The Guardrails Safety Software is designed to help prevent ® ® programming errors by: • Customizing device configurable settings to meet the need of the selected hospital area/unit (profile). • Comparing user programming with hospital-defined best-practice guidelines.

  • Page 7: Symbols

    Symbols Canadian and Certification Mark: Products bearing this mark have been tested and U.S. certified in accordance with applicable and Canadian electrical safety and performance U.S. standards ( CSA C22.2 601.1 UL 2601-1 IEC 60601–2–24 Electrical Shock Protection Rating: Type , Defibrillation-proof Protection against fluid ingress: Drip Proof IPX1...

  • Page 8: Getting Started

    GETTING STARTED NOTE: Although the MEDLEY™ System is built and tested to exacting specifications, it is not intended to replace the supervision of IV infusions by medical personnel. The user should become thoroughly familiar with the features and operation of the MEDLEY™...
  • Page 9 Warnings and Cautions (Continued) WARNING This instrument is designed to stop fluid flow under alarm conditions. Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected. WARNING This infusion device is a positive pressure delivery system, capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice, including resistances to flow imposed by small gauge catheters,...
  • Page 10 Warnings and Cautions (Continued) Parallel Infusions There are no contraindications regarding the use of the System with any other positive displacement MEDLEY™ infusion device when ported together into a common IV site location. User Precautions To ensure proper performance of the System and to MEDLEY™...
  • Page 11 Warnings and Cautions (Continued) User Precautions (Continued) Artifacts It is normal for an infusion device to produce nonhazardous currents when infusing electrolytes. These currents vary proportional to the infusion device flow rate. When the monitoring system is not functioning under optimal conditions, these currents may appear as artifacts, simulating actual readings.
  • Page 12 Warnings and Cautions (Continued) User Precautions (Continued) Radio Frequency Interference WARNING Operating the system near equipment which radiates high Use of accessories or cables other energy radio frequencies (electrosurgical/cauterizing than those specified may result in equipment, portable radios, cellular telephones, etc.) may degraded electromagnetic cause false alarm conditions.

  • Page 13: Controls And Indicators

    Controls and Indicators Front/Side View - Door Closed IUI Connector, Right Status Indicators (not visible) Alarm Infusing Standby (red) (green) (yellow) IUI Connector, Left Rate Display Channel Message Display Channel Identification Channel Select Key - When pressed, selects corresponding channel for infusion parameter entry and infusion setup.
  • Page 14 Controls and Indicators (Continued) Front View - Door Open IUI Connector, Left (not visible) Upper Tubing Fitment Retainer Platen IUI Connector, Right Upper Pressure Sensor Upper Occluder Upper Pumping Finger Door Latch Cam/Slide Lower Occluder Lower Pumping Finger Lower Pressure Sensor Flo-Stop Recess ®...

  • Page 15: Installation Procedure

    Installation Procedure Instruments are tested and calibrated before they are packaged for shipment. They met the specifications listed in the Directions for Use at that time. To ensure proper operation after shipment, it is recommended that an incoming inspection be performed before placing the instrument in use.

  • Page 16: Preparing Infusion

    Start-Up Sequence (Continued) Powering On the System (Continued) • Appropriate channel identification ( ) is displayed on attached channel(s). • An Audio tone sounds. At completion of system-on test, “New Patient?” screen appears on Programming Module. NOTE: If any of the following conditions are observed, the Programming Module or the affected channel must be removed from use and inspected by qualified personnel: •...
  • Page 17 Preparing Infusion (Continued) Loading Primary Administration Set (Continued) Close roller clamp. Open Pump Module door. Install administration set pumping chamber by properly positioning upper fitment into fitment recess and then inserting the Flo–Stop Fitment ® into recess below mechanism, with arrow pointing into Pump Module.

  • Page 18: Displays

    Displays Main Display Refer to the Programming Module (Model MEDLEY™ 8000 Directions for Use for general information in the Main Display. Title Bar Channel Status VTBI = 250.0 mL • A solid Channel Letter display indicates channel is operating. • An outlined Channel Letter display indicates channel is attached and ready for use.
  • Page 19 Primary Mode (Continued) Primary - Rate/Volume Infusion Press soft key and use numeric data entry keys to enter RATE Infusion Setup desired flow rate. RATE mL/h VTBI >Select VTBI Press soft key and use numeric data entry keys to enter VTBI Infusion Setup desired...
  • Page 20 Primary Mode (Continued) Primary - Volume/Duration Infusion (Continued) Press soft key. VOLUME/DURATION Infusion Setup RATE = mL/h _ _ _ _ VTBI DURATION >Select VTBI RATE RESTORE VOLUME Press soft key and use numeric data entry keys to enter VTBI Infusion Setup desired VTBI...
  • Page 21 Primary Mode (Continued) Pausing an Infusion Press key on Pump Module. PAUSE Midtown Hospital Adult ICU PAUSED • “ scrolls in Channel Message Display. PAUSE” VTBI = 497.0 mL • “ appears next to appropriate channel in Main PAUSED” VTBI = 57.0 mL Display.
  • Page 22 Primary Mode (Continued) Changing Rate or VTBI During an Infusion Press key on Pump Module. CHANNEL S S ELECT Infusion Setup RATE mL/h Press either soft key on Programming Module. RATE VTBI VTBI >Press START SECOND- PAUSE START Use numeric data entry keys, or Up and Down keys for Rate Infusion Setup titration, to enter desired parameter.
  • Page 23 Primary Mode (Continued) Selecting Pressure Mode - Pump (P) / Selectable (S) (Continued) Press P P r r e e s s s s u u r r e e L L i i m m i i t t s s soft key. Pressure Limit Selection Press either P P u u m m p p or S S e e l l e e c c t t a a b b l l e e pressure soft key.
  • Page 24 Primary Mode (Continued) Viewing and Clearing Volume Infused for ALL Channels (Continued) Press soft key. CLEAR A A LL Volume Infused PRI (mL) SEC (mL) • If no key is pressed, main screen appears after seconds. • Press soft key to return to main screen. MAIN S S CREEN >Select Channels to Clear or Press CLEAR ALL...
  • Page 25 Primary Mode (Continued) AutoRestart The AutoRestart feature is part of the System’s MEDLEY™ Downstream Occlusion Detection system designed to minimize nuisance, patient side occlusion alarms. It allows the 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 26: Secondary Mode

    Secondary Mode This mode is designed to support automatic secondary infusions WARNINGS (“piggybacking”) in the same instrument channel. When the • Secondary applications require the secondary reaches zero, a audio tone will sound indicating VTBI use of a check valve set on the completion of the secondary infusion.
  • Page 27 Secondary Mode (Continued) Lower primary fluid container using hanger provided with secondary set. NOTE: The secondary container should be at least 9½ inches above the top of the fluid level in the primary container. Press key on Pump Module. CHANNEL S S ELECT Infusion Setup RATE mL/h...
  • Page 28 Secondary Mode (Continued) 15. Verify correct infusion parameter input and press soft START Midtown Hospital Adult ICU key. SEC VTBI = 55.0 mL VTBI = 497.0 mL • Green Infusing Status Indicator illuminates. VTBI = 57.0 mL • Channel Rate Display displays secondary rate. VTBI = 249.0 mL •...
  • Page 29 Secondary Mode (Continued) Changing Primary Infusion Parameter During Secondary Infusion (Continued) Verify correct primary infusion parameter input and press Infusion Setup soft key to return to secondary setup screen. SECONDARY SECONDARY RATE mL/h Press soft key. START VTBI >Press START START PAUSE PRIMARY...

  • Page 30: Channel Labels

    Channel Labels Selecting Channel Label Press key on desired Pump Module. CHANNEL S S ELECT Channel Options 1 of 1 Drug Calculation Setup Press key on Programming Module. OPTIONS Pressure Limit - P Channel Labels Press C C h h a a n n n n e e l l L L a a b b e e l l s s soft key. >Select an Option or EXIT EXIT...
  • Page 31 Channel Labels (Continued) Removing Channel Label Press key on desired Pump Module. CHANNEL S S ELECT Channel Options 1 of 1 Drug Calculation Setup Press key on Programming Module. OPTIONS Pressure Limit - P Channel Labels Press C C h h a a n n n n e e l l L L a a b b e e l l s s soft key. >Select an Option or EXIT EXIT...

  • Page 32: Powering Off

    Powering Off Powering Off a Channel Press and hold key on channel(s) for one CHANNEL O O FF second. Powering Down NOTE: The channel will initiate the power down at the release of the key. CHANNEL O O FF Once all attached channels are powered off, Programming Module automatically powers down.

  • Page 33: Drug Calculation Parameters

    Changing and Reloading Set During Infusion (Continued) Prime and load a new administration set, as described in “Preparing Infusion” section. Close Pump Module door. Press key on desired Pump Module. CHANNEL S S ELECT Press soft key and use numeric data entry keys to enter VTBI desired VTBI...

  • Page 34: Setting Up Drug Calculation With Drug Library

    Setting Up Drug Calculation with Drug Library To access the Drug Library, a hospital-defined best-practice data WARNING set must be uploaded and the Profiles feature enabled. The Drug Calculation feature is to be used only by personnel properly trained in the administration of continuously infused medications.
  • Page 35 Setting Up Drug Calculation with Drug Library (Continued) Confirm selected drug/concentration is drug to be Drug Calculation Adult ICU administered. dopamine 400mg in 250mL was • Press Y Y e e s s soft key to continue programming. selected. Is this correct? DOSING mcg/kg/min •...

  • Page 36: Setting Up Drug Calculation For Non-Library Drugs

    Setting Up Drug Calculation with Drug Library (Continued) 12. Press soft key. VTBI Drug Calculation dopamine CONTINUOUS INFUSION 13. Use numeric data entry keys to enter volume-to-be-infused. 13.1 RATE mL/h VTBI NOTE: At rates less than 10 mL/h, the rate is displayed to two DOSE mcg/kg/min decimal places and the VTBI can be entered and is displayed to...
  • Page 37 Setting Up Drug Calculation for Non-Library Drugs (Continued) Use numeric data entry keys to enter amount of drug added Drug Calculation container. DRUG AMOUNT DILUENT VOLUME Press soft key for appropriate unit of measure for DRUG PATIENT gram PATIENT WEIGHT WEIGHT AMOUNT TIME...
  • Page 38 Setting Up Drug Calculation for Non-Library Drugs (Continued) 12. Press soft key next to desired DOSING U U NITS Drug Calculation DRUG AMOUNT DILUENT VOLUME PATIENT WEIGHT TIME mcg/kg/min UNITS DOSING mg/kg/min > > UNITS [Conc]: 1600 mcg/mL >Select the Desired Dosing Units DRUG LIBRARY...

  • Page 39: Setting Bolus Dose (Drug Calculation With Drug Library)

    Setting Up Drug Calculation for Non-Library Drugs (Continued) 16. Press soft key. VTBI Drug Calculation CONTINUOUS INFUSION 17. Use numeric data entry keys to enter volume–to-be-infused. 13.1 RATE mL/h VTBI NOTE: At rates less than 10 mL/h, the rate is displayed to two DOSE mcg/kg/min decimal places and the VTBI can be entered and is displayed to...
  • Page 40 Setting Bolus Dose (Drug Calculation with Drug Library) (Continued) Press soft key. BOLUS Drug Calculation lidocaine Dose exceeds the NOTE: If the programmed continuous infusion is outside the Guardrail limit of 8 mg/min. Guardrails Limit for that care area, a prompt will appear ®...

  • Page 41: Setting Bolus Dose (Drug Calculation For Non-Library Drugs)

    Setting Bolus Dose (Drug Calculation with Drug Library) (Continued) During any bolus infusion, press key on CHANNEL S S ELECT A A A Drug Calculation lidocaine Pump Module to see detail screen. BOLUS DOSE Dose 0.085 Remaining: Pt. Weight: < Time Left: Rate BOLUS VTBI =...
  • Page 42 Setting Bolus Dose (Drug Calculation for Non-Library Drugs) (Continued) Press soft key. VTBI Drug Calculation CONTINUOUS INFUSION Use numeric data entry keys to enter Volume–to-be-Infused. 13.1 RATE mL/h VTBI NOTE: At rates less than 10 mL/h, the rate is displayed to two DOSE mcg/kg/min decimal places and the VTBI can be entered and is displayed to...
  • Page 43 Setting Bolus Dose (Drug Calculation for Non-Library Drugs) (Continued) During any bolus infusion, press key on CHANNEL S S ELECT A A A Drug Calculation Pump Module to see detail screen. BOLUS DOSE Dose Remaining: Pt. Weight: Not Used < Time Left: Rate 0.25...

  • Page 44: Anesthesia Mode

    Setting Bolus Dose (Drug Calculation for Non-Library Drugs) (Continued) Restoring Bolus Dose (Continued) Bolus Dose Completed - Channel Turned Off Press key on Pump Module. CHANNEL S S ELECT Press soft key. RESTORE Verify Drug Calculation screen and press soft key. NEXT Verify dosing parameters and press soft key.
  • Page 45 Anesthesia Mode (Continued) Enabling Anesthesia Mode (Continued) Press E E n n a a b b l l e e soft key. System Options Anesthesia Mode Press soft key. CONFIRM Enable Disable Air Detection = Change microliters Select an Option or Press CONFIRM CONFIRM Press soft key corresponding to channel Anesthesia Mode...
  • Page 46 Anesthesia Mode (Continued) Disabling Anesthesia Mode (Continued) From System Options Menu (Continued) System Options Press D D i i s s a a b b l l e e soft key. Anesthesia Mode Press c c o o n n f f i i r r m m soft key. “Anesthesia Mode” is no longer Enable Disable displayed on Main Display, indicating it has been disabled.

  • Page 47: Reviewing Serial Number

    Reviewing Serial Number Press key on Programming Module. OPTIONS Serial Number Review nnnn-nnnnnnnn Press P P a a g g e e D D o o w w n n soft key and then press S S e e r r i i a a l l N N u u m m b b e e r r s s Module A: nnnn-nnnnnnnn soft key.

  • Page 48: Alarms, Advisories And Prompts

    ALARMS, ADVISORIES AND PROMPTS To enhance safety and ease of operation, the System provides a full range of audio and visual MEDLEY™ alarms, advisories and prompts. Definitions Advisory A sequence of audio and/or visual signals indicating the operating status of the Medication Safety System.

  • Page 49: Audio Characteristics

    Audio Characteristics The Programming Module and Main Display provide four types of alert information: advisories, prompts, alarms, and malfunctions. The characteristics of the accompanying audio sounds are as follows: Type Sound Notes Advisory One short beep every two seconds Variable volume; can be silenced for two minutes.

  • Page 50: Alarms

    Alarms Alarm Meaning Response Accumulated Air-in-Line A large number of air bubbles Clear air from line and press RESET smaller than current air-in-line limit soft key, and then press RESTART has recently passed detector. to continue infusion. Air-in-Line Air has been detected in set during Ensure tubing is properly installed in an infusion.

  • Page 51: Advisories

    Advisories Advisory Meaning Response Anesthesia Mode Anesthesia Mode has been enabled. None Bolus Dose Complete Channel is running in continuous None infusion mode if programmed. Checking Line None A patient side occlusion has occurred and AutoRestart feature is monitoring downstream pressure to determine if infusion can continue.

  • Page 52: Errors

    Errors Error Meaning Response Channel Error System has detected an error on a Press soft key to silence CONFIRM pumping channel. Infusion stops on alarm and continue operation of affected channel. unaffected channels. Replace Pump Module with an operational unit as required.
  • Page 53 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 ALARMS, ADVISORIES AND PROMPTS...

  • Page 54: Maintenance

    MAINTENANCE System Technical Service Manual is available from Medical Systems and includes MEDLEY™ ALARIS routine service schedules, circuit diagrams, component parts lists and descriptions, calibration and test procedures, and other technical information, to assist qualified service personnel in repair and maintenance of the instrument’s repairable components.
  • Page 55 Specifications (Continued) Infusion o o f A A ir, M M eans t t o Protect P P atient f f rom: Ultrasonic Air-in-Line Detection Maximum single bolus size = selectable microliters nominal ( microliters in Anesthesia Mode) Infusion P P ressure, Maximum: mmHg KVO ( ( Keep V V ein O O pen)

  • Page 56: Configurable Settings

    Specifications (Continued) Volume t t o b b e I I nfused Range Increments Programming I I ncrements: (mL) (mL) 9.99 0.01 999.9 1000 9999 Weight: 2.5 lbs NOTE: Compliance to Standards The MEDLEY™ Medication Safety System has been assessed and complies with the following standards: UL 2601–1, including A1 and A2;...

  • Page 57: Check-In And Configuration

    Configurable Settings (Continued) Pump Module Settings Feature Default Setting Options Accumulated Air-in-Line Enabled Enabled - Disabled Air-in-Line Settings 75 microliters 50, 75 or 250 microliters Anesthesia Mode only: 500 microliters single bolus AutoRestart Attempts 0-9 attempts Anesthesia Mode only: 9 attempts Drug Calculation Disabled Enabled - Disabled...

  • Page 58: Inspection Requirements

    Inspection Requirements To ensure the system remains in good operating condition, both regular and periodic inspections are required. R R e e g g u u l l a a r r i i n n s s p p e e c c t t i i o o n n s s consist of a visual inspection for damage WARNING and cleanliness, and performing the procedure described in the Failure to perform these inspections...

  • Page 59: Warranty

    WARRANTY Medical Systems, Inc., (hereinafter referred to as “ Medical Systems”) warrants that: ALARIS ALARIS A. Each new Medical Systems Medication Safety System is free from defects in ALARIS MEDLEY™ material and workmanship under normal use and service for a period of one ( ) year from the date of delivery by Medical Systems to the original purchaser.

  • Page 60: Appendix

    APPENDIX Trumpet and Start-Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET AND FLOW CHARACTERISTICS UNDER VARYING START-UP CURVES DELIVERY CONDITIONS In this instrument, as with all infusion systems, Effects of Pressure Variations the action of the pumping mechanism and Under conditions of + mmHg pressure, the variations in individual administration sets cause Pump Module typically exhibits a long-...
  • Page 61 Trumpet and Start-Up Curves (Continued) Start-Up at 1 mL/h (initial) Start-Up at 0.1 mL/h (initial) Time (min) Time (min) Trumpet Curve at 0.1 mL/h (initial) Trumpet Curve at 0.1 mL/h (initial) Trumpet Curve at 1 mL/h (initial) Observation Interval (min) Observation Interval (min) Trumpet Curve at 0.1 mL/h (72 hrs) Trumpet Curve at 1 mL/h (72 hrs)
  • Page 62 Trumpet and Start-Up Curves (Continued) Start-Up at 25 mL/h (initial) Start-Up at 999 mL/h (initial) Time (min) Time (min) Trumpet Curve at 25 mL/h (initial) Trumpet Curve at 999 mL/h (initial) Observation Interval (min) Observation Interval (min) Trumpet Curve at 25 mL/h (72 hrs) Trumpet Curve at 999 mL/h (24 hrs) Observation Interval (min) Observation Interval (min)
  • Page 63 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 APPENDIX...
  • Page 64 To Purchase, Visit Avobus.com or call 1-800-674-3655...
  • Page 65 P.O. Box 85335 San Diego, California 92186-5335 U.S.A. ALARIS , ALARIS Medical Systems , Flo-Stop , Guardrails , MEDLEY™, and SmartSite are trademarks and registered trademarks of ALARIS Medical Systems, ® ® ® ® ® Inc. All other trademarks belong to their respective owners.

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