Alaris Medical Systems MEDLEY 8220 Directions For Use Manual
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Alaris Medical Systems MEDLEY 8220 Directions For Use Manual

Medication safety system spo2 module
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Summary of Contents for Alaris Medical Systems MEDLEY 8220

  • 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 The MEDLEY™ Medication Safety System is a modular infusion and monitoring system designed to provide SpO monitoring capabilities and accurate, automated infusion of a broad range of intravascular fluids, medications and blood products. The MEDLEY™ Medication Safety System consists of the Programming Module (Model 8000), and detachable MEDLEY™Modules (or “channels”) which provide infusion or monitoring capabilities.
  • Page 5 About the System (Continued) Principle of Operation The operation of the MEDLEY™ SpO Module is based on the principles of pulse oximetry. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry). The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethysmography).

  • Page 6: Features

    Features Ease of Use Features To enhance safety and ease of operation, the MEDLEY™ Medication System provides a full range of audio and visual alarms, advisories and prompts. Fast SAT When Fast SAT is enabled and there is one data point that is significantly different from a previous data point, averaging is disregarded and the most recent data point is displayed.

  • Page 7: Definitions

    Definitions % SpO Alarm Limits The upper and lower saturation alarm limits are displayed. % SpO Display The functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO Limit Mode The limit mode displays either the adult or neonatal monitoring mode. Pleth Waveform The plethysmographic (pleth) waveform is a graphic representation of changes in the extremity blood volume during the events of the cardiac...

  • Page 8: Symbols

    Symbols Attention: Refer to accompanying documentation. Canadian and U.S. Certification Mark: Products bearing this mark have been tested and certified in accordance with applicable U.S. and Canadian electrical safety and performance standards. Consult operating instructions. Type BF Applied Part Protection against fluid ingress: Drip Proof IPX1 IUI Connector: Inter-Unit Interface connector used to establish power and communications between the Programming Module and add-on channels.
  • Page 9 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 INTRODUCTION...

  • Page 10: 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 and patient monitoring by medical personnel. The user should become thoroughly familiar with the features and operation of the MEDLEY™...
  • Page 11 Warnings and Cautions WARNING The SpO Module should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory CO-Oximeter to completely understand the patient’s condition. WARNING Interfering Substances: Carboxyhemoglobin and methemoglobin may erroneously increase readings.
  • Page 12 Warnings and Cautions (Continued) WARNING Before use, read sensor Directions for Use, including all warnings, cautions and instructions. WARNING Do not use a sensor, cable, connector or SpO Module that appears damaged. Do not use a sensor with exposed optical components.
  • Page 13 Warnings and Cautions (Continued) User Warnings and Cautions To ensure proper performance of the MEDLEY™SpO Module and to reduce potential injury to the operator, observe the following WARNINGS CAUTIONS WARNING Do not open the instrument case. There are no user serviceable parts inside.
  • Page 14 Warnings and Cautions (Continued) User Warnings and Cautions (Continued) Radio Frequency Interference Operating the system near equipment which radiates high energy radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the device away from the source of interference or turn off the device and manually monitor the vital parameters using an appropriate clinical alternative.

  • Page 15: Measurements

    Measurements If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the MEDLEY™ SpO Module to ensure it is functioning properly. An inaccurate measurement may be caused by: •...

  • Page 16: Controls And Indicators

    Controls and Indicators Status Indicators Alarm Monitor Standby green yellow IUI Connector, Left IUI Connector, Right (not visible) %SpO Display Pulse Bar Display Pulse Rate Display Channel Identification: A, B, C or D Channel Message Display Channel Select Key: When pressed, selects the corresponding channel for patient monitoring and setup.

  • Page 17: Installation Procedure

    Remove the product from its carton. Check for any loose parts. If the product is damaged, contact ALARIS Medical Systems for authorization to return the equipment for repair, whether damage or malfunction is the responsibility of the carrier or of ALARIS Medical Systems.

  • Page 18: General Setup And Use

    Start-Up Sequence (Continued) Powering On the System (Continued) NOTE: If any of the following conditions are observed, Programming Module or the affected channel must be removed from use and inspected by qualified personnel: • LED segments are not illuminated on the channel displays during the system on test.
  • Page 19 General Setup and Use (Continued) After patient monitoring is complete, remove the sensor from the patient according to hospital protocol. Turn off the SpO Module by pressing and holding the key for one second. CHANNEL O O FF NOTE: Channel will initiate power down when CHANNEL O O FF key is released.

  • Page 20: Displays

    Displays Main Display Refer to the MEDLEY™ Programming Module (Model 8000) Directions for Use for general information in the Main Display. Title Bar SPO2 Channel Status ® SpO Module • A solid Channel Letter display PATIENT CARE SYSTEM PATIENT CARE SYSTEM % SpO 2 indicates channel is operating.
  • Page 21 Monitoring Mode (Continued) Navigating Main Display (Continued) Midtown Hospital 3. Attach the patient cable and sensor as described in the Adult ICU “General Setup and Use” section of this document. SPO2 >Select Channel AUDIO ADJUST Press the key on the SpO Module to view CHANNEL S S ELECT Adult...
  • Page 22 Monitoring Mode (Continued) Setting Alarm Limits (Continued) Press the soft key. The following limits can be LIMITS changed: Adult Alarm Limits %SPO2 • HIGH %SPO2 HIGH %SPO2 • %SPO2 LOW PULSE HIGH • PULSE HIGH PULSE • PULSE LOW >Select Parameter Limit Confirm Press the soft key for the parameter limit being changed.
  • Page 23 Monitoring Mode (Continued) Setting Alarm Limits (Continued) Press the C C o o n n f f i i r r m m soft key to return the SPO2 Main display. Adult SPO2 Main Mode % SPO2 PULSE RATE PI = 10.56 MAIN TREND LIMITS...
  • Page 24 Monitoring Mode (Continued) Navigating Trend Data View (Continued) The following information can be viewed in the Trend Data display: • period for data collection period TIME • average , with high and low values SPO2 • average rate, with high and low values PULSE •...
  • Page 25 Monitoring Mode (Continued) Navigating Trend Data View (Continued) Press the soft key to return to the SPO2 Main SPO2 M M AIN Adult SPO2 Main Mode display. % SPO2 PULSE RATE PI = 10.56 CANCEL MAIN TREND LIMITS SILENCE SCREEN Press the soft key to return to the Main MAIN S S CREEN...

  • Page 26: Setting Channel Options

    Setting Channel Options Adult SPO2 Main To access and set the channel options: Mode % SPO2 Press the key on the SpO Module to view CHANNEL S S ELECT PULSE RATE the SPO2 Main display. PI = 10.56 MAIN TREND LIMITS SCREEN Press the...
  • Page 27 Setting Channel Options (Continued) Viewing or Changing Pulse Beep Volume Press the Pulse Beep Volume soft key in Channel Options display. Test Pulse Beep Volume NOTE: The illustrated display reflects that the Pulse Beep Volume is Off. To display the volume options, press the Louder soft key.
  • Page 28 Setting Channel Options (Continued) Viewing or Changing Saturation Averaging Time (Continued) Press the C C o o n n f f i i r r m m soft key to return the SPO2 Main display. Adult SPO2 Main Mode % SPO2 PULSE RATE PI = 10.56...

  • Page 29: Powering Off

    Powering Off Powering Off the System Press the soft key to return to the Main MAIN S S CREEN Midtown Hospital Adult ICU Display. SPO2 >Select Channel AUDIO ADJUST Press the key on Programming Module. OPTIONS System Options 1 of 2 Display Contrast Press P P o o w w e e r r D D o o w w n n a a l l l l C C h h a a n n n n e e l l s s soft key.

  • Page 30: Alarms, Advisories And Prompts

    ALARMS, ADVISORIES AND PROMPTS Definitions Advisory A sequence of audio and/or visual signals indicating the operating status of the MEDLEY™ Medication Safety System. The audio may be silenced for approximately two minutes by pressing the key on the Programming SILENCE Module.

  • Page 31: Audio Characteristics

    Audio Characteristics The Programming Module and Main Display provide four types of alert information: advisories, prompts, alarms and malfunctions. For more information on the Programming Module, refer to the Directions for Use. The characteristics of the accompanying audio sounds are as follows: WARNING If an alarm condition on the SpO Module occurs while the audio alarm is silenced, the only alarm...

  • Page 32: Alarms

    Alarms Alarm Meaning Response Bad Sensor Broken, unknown or nonsystem Check sensor and patient cable. sensor or patient cable attached. Confirm correct sensor and patient cable are chosen. See Accessories for a list of sensors designed for use with this Module. Check Sensor - Electrical or Optical External interference on sensor.

  • Page 33: Advisories

    Advisories Advisory Meaning Response Check Sensor - Low Perfusion Patient’s low perfusion has inhibited Check sensor. Move sensor to a monitoring. better perfused site. Check Sensor - Low Signal I.Q. Low quality of signal being Check sensor. Confirm correct measured. sensor placement.

  • Page 34: Maintenance

    MAINTENANCE ™ System Technical Service Manual is available from ALARIS Medical Systems. It includes MEDLEY technical information to assist qualified service personnel in repair and maintenance of the instrument’s repairable components. Maintenance procedures are intended to be performed only by qualified personnel.
  • Page 35 Specifications (Continued) Fluid I I ngress P P rotection: IPX1, Drip Proof Measurement R R ange: Perfusion 0.02 to 20% Pulse Rate 25 to 240 bpm 1 to 100% Mode o o f O O peration: Continuous Pulse A A mplitude D D isplay: Pulse Amplitude Display is proportional to the height of the I.Q.

  • Page 36: Configurable Settings

    Configurable Settings System Settings Feature Default Setting Options Alarm Audio Profile 1 Profile 1, 2 or 3 Battery Meter Disabled Enabled - Disabled Clock Setup (Date and Time) Set date and time Key Click Audio Enabled Enabled - Disabled Tamper Resist Disabled Enabled - Disabled Module Settings...

  • Page 37: Instrument Cleaning

    Instrument Cleaning DO NOT spray cleaning fluids directly onto the instrument or WARNING immerse the instrument in fluids. Turn the instrument off and disconnect it from the system before DO NOT use solutions containing phosphoric acid (Foamy cleaning. Do not spray fluids directly Q&A), aromatic solvents (naphtha, paint thinner, etc.), onto rear case of instrument.

  • Page 38: Inspection Requirements

    SpO Module Technical Service Manual and supplemental service bulletins. A service agreement may be obtained from ALARIS Medical Systems for the performance of all required periodic inspections. NOTE: Periodic inspections should only be performed by qualified service personnel.

  • Page 39: Service Information

    Service Information WARNING NOTE: If the instrument shows evidence of damage in transit, notify the carrier’s agent immediately. Do not return damaged Instruments returned from the service equipment to the factory before the carrier’s agent has authorized depot to your facility may be set to repairs.

  • Page 40: Warranty

    ALARIS Medical Systems to the original purchaser. B. Each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by ALARIS Medical Systems to the original purchaser.
  • Page 41 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 MAINTENANCE...

  • Page 42: Appendix

    APPENDIX Accessories This section covers the use and cleaning of Masimo ® LNOP ® sensors and Masimo ® ® patient cables. ® ® Masimo LNOP Sensors WARNING NOTES: Inspect the SpO sensor site regularly ® • Before use, carefully read the LNOP sensor Directions for Use.
  • Page 43 Accessories (Continued) ® Masimo Sensors (Continued) The following sensors are available for use with the SpO Module: ® Masimo Single Patient Model Patient Size Site Inspection Interval SpO 2 Adhesive Sensors ® LNOP -Adt 1001 > 30 Kg Check sensor site every 8 hours and as necessary ®...
  • Page 44 Accessories (Continued) ® ® Masimo LNOP Sensors (Continued) Cleaning a Masimo ® LNOP ® Sensor: CAUTION Do not immerse in water, solvents or Reusable sensors can be cleaned, as follows: cleaning solutions. Do not sterilize by irradiation, steam autoclave or NOTE: To avoid contamination, clean sensors before each use.
  • Page 45 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 47 San Diego, California 92121 U.S.A. Mail: P.O. Box 85335 San Diego, California 92186-5335 U.S.A. ALARIS Medical Systems , Guardrails and MEDLEY™ are trademarks and registered trademarks of ALARIS Medical Systems, Inc. Masimo , DCI™, ® ® ® LNOP , SET , Signal Extraction Technology and Signal I.Q.™...

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