Alaris Medley SPO2 Module 8220 Masimo
Contents
1. 22 GETTING STARTED Setting Channel Options To access and set the channel options 5 2 Main fode 2 97 OF 1 Press the CHANNEL SELECT key on the SpO Module to view Lec Ba e the SPO2 Main display NYAS Ht iti tt ty 10 56 TREND LIMITS E O 2 Press the OPTIONS key the Programming Module The LY channe Options 1 of 1 following options are available eiie ANE Pulse Beep Volume Off uA Limit Mode Sat Averaging Time 8 gt Pulse Beep Volume Sensitivity Mode Normal a Sat Averaging Time 5 Sensitivity Mode gt Select an Option or EXIT EXIT Changing Limit Mode 1 Press the Limit Mode soft key in the Channel Options display Limit Mode Setup 2 Tochange the Limit Mode Setup press either the Adult or Em Neonatal soft key NOTE If a Profile is being used for programming the Limit Mode can not be changed Select an Option or EXIT 3 If the Limit Mode is not changed press the EXIT soft key to 5 2 return the SPO2 Main display and press the OPTIONS key 2 97 Of on the Programming Module to view other options bere 182 7 LEE 10 56 TREND LIMITS GETTING STARTED 23 Setting Channel Options Continued Viewing Changing Pulse Volume LR Press the Pulse Beep Volume soft key in Channel2. septa sepa 31 CONEDIGURABEE 33 INSTRUMENT CLEANING boe 34 INSPECTION REQUIREMENTS ata rrt ER TER Pn deni RIEF REIP Xeon 35 SERVICE INFORMATION 2 2 2 2 2 4 72 2 7 2 2 220202020020205 6 2225000 36 rame I 37 APPENDIX ACCESSORIES 2 22222222222 2 2 7 0 0 0 02 0 0 0 2 02022 2 22 2 2 2 2 2 200 0 202000000 02 0 0022 39 gt gt gt 2 ZZ 3 Ss lt 0 ag ES 94 NOILDNGOYLNI GALYVLS ONILLAD JDNVNALNIVIN XIGNAddV 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 6003 Toll free within Canada Eastern 800 227 7215 Western 800 667 2335 For more detailed information refer to the Service Information section of this document INTRODUCTION out the System About the System The MEDLEY Medication Safety System is a modular infusion and monitoring system designed to
3. 2 Attach a Masimo LNOP sensor to the Masimo patient cable Refer to the sensor s directions for use for detailed instructions 3 Ensure the sensor s red LED is on 4 Attach sensor to patient Refer to the sensor s Directions for Use for detailed instructions 5 Verify high and low alarm rates for 5 and pulse rate are correct for patient by pressing the CHANNEL SELECT key NOTE SEARCHING may appear in the Channel Message Display until the SpO and pulse readings have stabilized approximately 15 seconds NOTE If the sensor is not attached to a site after powering up the Module will display SENSOR OFF If a sensor is not attached while this message is displayed the Module will go into a sleep mode To begin monitoring once the Module is in this mode press the MONITOR key 6 Monitor the patient GETTING STARTED 15 General Setup and Use Continued 7 After patient monitoring is complete remove the sensor from the patient according to hospital protocol 8 Turn off the SpO Module by pressing and holding the CHANNEL OFF key for one second NOTE Channel will initiate power down when CHANNEL OFF key is released 16 GETTING STARTED Displays Main Display Refer to the MEDLEY Programming Module Model 8000 Directions for Use for general information in the Main Display Title Bar Channel Status aa 5 2 ee e A solid Channel Letter displa
4. 3 Press the Confirm soft key to return the SPO2 Main display 5 2 2 97 PULSE 150 RATE 82 50 10 56 TREND LIMITS E O z TENE up Viewing or Changing Sensitivity Mode Z 1 Press the Sensitivity Mode soft key in the Channel Options A 2 display Sensitivity Mode gt 2 EE g 2 To change the Sensitivity Mode press either the Normal or 5 Maximum soft key NOTES yo Hor gt Sel Opti The Normal setting is for normal patient monitoring a The Maximum setting is for improved low perfusion performance The sensitivity mode is displayed on the SPO2 Main display only when Maximum is selected 3 Once a mode is chosen the screen will return to the SPO2 5 2 Main display Press the OPTIONS key the Programming 2 97 Of Module to view other options PIESE 82 19 Ht iti i PI 10 56 TREND LIMITS E GETTING STARTED 25 Powering Off Powering Off the System 1 Press the MAIN SCREEN soft key to return to the Main Display Midtown Hospital Adult ICU A SPO2 AUDIO ADJUST 2 Press the OPTIONS key on Programming Module 3 Press Power Down all Channels soft key System Options 1 of 2 Display Contrast Time of Day Power Down All Channels Mode gt Select an Option or EXIT
5. DOWN 4 Press the Yes soft key During power off sequence Main Display flashes Powering Down Powering Off One Channel at a Time 1 Press and hold the CHANNEL OFF key on each operating channel for one second NOTE The channel will initiate the power down at the release of the CHANNEL OFF key 2 Once all attached channels are powered off the Programming Module automatically powers down During power off sequence the Main Display flashes Powering Down System Options Power Down Yes All Channels No Press Yes or No Powering Down 26 GETTING STARTED 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 SILENCE key on the Programming Module Alarm An audio and visual signal that a potentially unsafe condition is present Immediate action is required The audio may be silenced for approximately two minutes by pressing the SILENCE key on the Programming Module Error An audio and or visual signal that a failure has been detected The instrument should be taken out of service immediately and thoroughly tested and inspected by qualified service personnel to ensure its proper function prior to reuse Prompt An audio and or visual signal appearing on the b
6. Nurse call systems must be certified to UL 1069 Hospital Signaling and Nurse Call Equipment or comply with requirements specified in IEC 60601 1 Compliance with electromagnetic compatibility standard IEC 60601 1 2 is a function of all interconnected equipment and cabling and is the responsibility of the user to insure external equipment complies with applicable EMC standards Failure to verify such external equipment meets applicable EMC standards may result in degraded Electromagnetic Compatibility refer to Radio Frequency Interference Warning for additional information GETTING STARTED 11 a m a a v 2 A m iw 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 Incorrect sensor application or 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 as a surgical lamp especially one with a xenon light source bilirubin lamp fluorescent light infrared heating lamp or direct sunlight NOTE Exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material e Prolonged and or excessive pati
7. To ensure the system remains in good operating condition both regular and periodic inspections are required Regular inspections consist of a visual inspection for damage WARNING and cleanliness and performing the procedure described in the Failure to perform these inspections Start Up Sequence section of this Directions for Use before each may result in improper instrument usage of the instrument Regular inspections are not covered operation under any contract or agreement offered by ALARIS Medical Systems and must be performed by the user Regular Inspections PROCEDURE FREQUENCY Cleaning As required Inspect for Damage Case Each usage IUI Connector Each usage Keypad Each usage Start Up Sequence Each usage Periodic inspections of the hardware are required For detailed instructions on performing periodic inspections and maintenance refer to the 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 Preventive Maintenance Inspections lt PROCEDURE FREQUENCY gt Alarm Test 2 months m Channel Identification Test 2 months lt Channel Operation Test 2 months Functional Test 2 months in Keyboard Test 2 months Patient Lead Electrical Leakage Test 2 months MAINTENANCE 35 Ser
8. Options display NOTE The illustrated display reflects that the Pulse Beep Volume is Off To display the volume options press the Louder soft key The selectable options are Off Level 1 Level 2 and Level 3 Pulse Beep Volume 4 Louder gt Press CONFIRM 2 To increase the volume press Louder soft key until desired Al volume level is attained To test volume level when not Pulse Beep Volume Test attached to the patient press Test soft key To turn off Off pulse beep entirely press Off soft key mi NOTE Audio sounds for cycle Louder gt Press CONFIRM 3 Press the Confirm soft key to return the SPO2 Main display Viewing Changing Saturation Averaging Time 1 Press the Saturation Averaging Time soft key in the Channel Options display The selectable options are 2 4 8 10 12 14 and 16 seconds NOTE Fast SAT is enabled when 2 or 4 seconds is selected To change the Saturation Averaging Time press either the Increase or Decrease soft key 5 2 Off SPO2 97 90 PULSE 150 82 RATE 50 iilid PI 10 56 fren Saturation Averaging Time Increase 4 Seconds Decrease with Fast SAT gt Press CONFIRM 24 GETTING STARTED Setting Channel Options Continued Viewing Changing Saturation Averaging Time Continued
9. SPO2 Main display 2 97 9 Press the TREND soft key in the SPO2 Main display to view the Trend Data display NOTE Tabular information will not be updated while the Trend Data view is displayed The tabular data will be updated using the new trend data stored in the 5 0 gt Module after leaving the Trend Data view To view the latest data return to the Trend Data view 90 PULSE 150 RATE 82 50 10 56 TREND Limits mE Trena Data Adult lode TIME SPO2 P 2001 07 06 ave ULSE MAX AVG MIN 09 01 17 97 10 38 100 08 38 30 97 190 7 100 08 08 30 97 1 38 100 07 38 30 97 190 4 07 08 30 38 100 06 38 30 97 190 a 1 82 5 82 7 82 82cm ZOOM 15min 5min 1min 30sec gt Press UP DOWN to move cursor Keys PAGE SPO2 zoom Main PAGE DOWN 20 GETTING STARTED Monitoring Mode Continued Navigating Trend Data View Continued The following information can be viewed in the Trend Data display e TIME period for data collection period average SPO2 with high and low values average PULSE rate with high and low values e alarm icon NOTES e The 8 will only be displayed if a limit violation occurred for the indicated limit in the time window e fthere are no SPO2 or PULSE rate values for the time period displayed dashes will b
10. Systems and ALARIS Medical Systems does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of ALARIS Medical Systems any other liability in connection with the sale or use of ALARIS Medical Systems products ALARIS Medical Systems DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION lt 2 Z m Z gt See packing inserts for international warranty if applicable MAINTENANCE 37 THIS PAGE INTENTIONALLY LEFI BLANK 38 MAINTENANCE APPENDIX Accessories This section covers the use and cleaning of Masimo LNOP sensors and Masimo SET patient cables Masimo LNOP Sensors NOTES WARNING Before use carefully read the LNOP sensor Directions for Use Inspect the 5 sensor site regularly to ensure correct sensor positioning application and site integrity Tissue damage could occur over prolonged time periods depending on the patient profile such as neonates and Selecting a Masimo LNOP Sensor method of application Refer to the sensor instructions for additional information e Use only Masimo oximetry sensors for SpO Module measurements Other oxygen transducers sensors may cause improper 5 0 Module performance When selecting a sensor consider the patient s weight the adequacy of perfusion the avai
11. being changed Selected parameter will be highlighted EH or Display will prompt for a value to be entered 90 150 50 gt Enter High 6SPO2 Limit 4 Enter a numeric value for the selected alarm limit NOTES Adult Alarm Limits 5 2 HIGH limit can be Off or a numeric value p 9n Numeric values can be entered using the keypad or the lt gt 150 and keys After the field containing a valid value 50 has been highlighted for three seconds the display prompt changes to 7 Press ENTER to Confirm Press ENTER to Confirm Pressing the Confirm soft key will cause the screen to return to the SPO2 Main display 5 Press the ENTER key on the Programming Module to confirm NOTE Once the ENTER key is pressed the display highlights the next limit and prompts for an entry Adult Alarm Limits Um 98 90 150 Cow 50 gt Enter Low SPO2 Limit GETTING STARTED 19 a m a a 2 A m iw Monitoring Mode Continued Setting Alarm Limits Continued 6 Press the Confirm soft key to return the SPO2 Main display NsPo2wan 5 2 97 5 i P pd Li PI 10 56 TREND LIMITS E 7 Press the MAIN SCREEN soft key to return to the Main ica risp s Adult ICU Display A eol Navigating Trend Data View 1 Press the CHANNEL SELECT key on the SpO Module to view 5 2 the
12. g Manu Klenz 10 bleach solution 1 part bleach to 9 parts water Compublend II Envirocide 296 Glutaraldehyde in water Hydrogen Peroxide 396 7096 Isopropyl Alcohol 296 Phenols in water O Syl 1 128 Pheno Cen 1 256 Vesphene 1096 Providone lodine Betadine Quaternaries 1 512 WEX CIDE NOTE All recommended solutions must be diluted per the Manufacturer s recommendation After application rinse all surfaces with water 1 Keep the instrument upright and do not allow any part of the instrument to become saturated with or submersed in fluid during the cleaning operation 2 Use a soft cloth dampened with warm water and a mild nonabrasive cleaning solution to clean all exposed surfaces For sanitizing or antibacterial treatment use 1096 bleach solution and water NOTE A soft bristled brush may be used to clean hard to reach and narrow areas For sensor cable cleaning refer to Masimo Directions for Use Manual 1 Excluding 10 bleach solution in water GUS Turn the instrument off and disconnect it from the system before cleaning Do not spray fluids directly onto rear case of instrument Do not steam autoclave EtO sterilize immerse in fluids or allow fluids to enter the case Failure to follow these instructions may result in an electrical hazard CAUTION The solutions solvents identified as NOT to be used can damage the surfaces of the instrument 34 MAINTENANCE Inspection Requirements
13. pressed begins patient monitoring Channel Off Key When pressed and held for one second and then released stops the operation of that i channel deselects that channel and ifonly that channel had been operating the system powers down Repeat for other operating channels to power off each channel Channel Release Latch Patient Cable Connector GETTING STARTED 13 Installation Procedure Instruments are tested 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 is performed by your facility before putting the instrument into use Unpacking the 5 Module 1 Remove the product from its carton 2 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 Attaching Detaching Channels Refer to the MEDLEY Programming Module Model 8000 Directions for Use for detailed instructions on attaching and detaching channels Start Up Sequence Powering On the System 1 Connect the MEDLEY Programming Module to an external AC power source 2 Attach the SpO Module to the Programming Module ad Press the SYSTEM ON key on the Programming Module A T
14. provide SpO monitoring capabilities and accurate automated infusion of a broad range of intravascular fluids medications and blood products zZ ZJ c CO d 2 The MEDLEY Medication Safety System consists of the Programming Module Model 8000 and detachable MEDLEY Modules or channels which provide infusion or monitoring capabilities The MEDLEY System is intended for use in hospitals and healthcare facilities on adult pediatric and neonatal patients This document provides Directions for Use for the Model 8220 SpO Module Please read all instructions for both the SpO Module and the Programming Module before using the device Only one SpO Module can be connected to a MEDLEY Programming Module The SpO Module is intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin SpO and pulse rate measured by an SpO sensor The SpO Module and accessories are indicated for 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 The MEDLEY System uses a wide variety of Masimo LNOP series sensors and Masimo PC series patient cables The Masimo sensors and cables are designed for use with the Model 8220 SpO Module For specific directions for use refer to the sensor and cable packaging Contraindications The MEDLEY Sp
15. the return authorization information and return it to the appropriate service or distribution center ALARIS Medical Systems does not assume any responsibility for loss of or damage to returned instruments while in transit WARNING Instruments returned from the service depot to your facility may be set to factory defaults and not have a hospital defined data set loaded Biomedical personnel in the facility are responsible for checking in the instrument and ensuring the current hospital approved data set is loaded 800 482 4822 800 908 9918 800 908 9919 800 854 7128 extension 6003 800 227 7215 800 667 2335 36 MAINTENANCE WARRANTY ALARIS Medical Systems Inc hereinafter referred to as ALARIS Medical Systems warrants that A Each new ALARIS Medical Systems MEDLEY Medication Safety System is free from defects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by 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 If any product requires service during the applicable warranty period the purchaser should communicate directly with the relevant account representative to determine the appropriate repair facility Except as provide
16. Inter Unit Interface connector used to establish power and communications between the Programming Module and add on channels Manufacturing Date Number adjacent to symbol indicates the month and year of manufacture CAUTION Federal U S A law restricts this device to sale by or on the order of a physician INTRODUCTION 5 zZ J c d 2 THIS PAGE INTENTIONALLY LEFI BLANK 6 INTRODUCTION GETTING STARTED NOTE Although the MEDLEY System is built and tested to R Only 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 System and exercise vigilance in its utilization This heading alerts the user to potential serious outcomes death injury or serious adverse events to the patient or user CAUTION This heading alerts the user to take special care for the safe and effective use of the device Warnings and Cautions For WARNINGS and CAUTIONS for the Programming Module refer to its Directions for Use 0 m a 2 A m Oo To ensure proper performance of the MEDLEY System and to reduce potential injury observe the following WARNINGS and CAUTIONS SpO Module is NOT to be used as apnea monitor 00 13 L 5 is intended only as an adjunct in pati
17. MEDLEY MEDICATION SAFETY SYSTEM SpO MODULE Model 8220 DIRECTIONS FOR USE 0028 13G0 N a1naow ods TABLE OF CONTENTS INTRODUCTION DEN coal 1 3 DEFINITIONS 2 22 2 2 722 2 2 22 2 2 0202222 2 222 2 2020000025032 822002220020 4 SYMBOLS 2 oT 5 GETTING STARTED WARNINGS AND CAUTIONS 4 55 2 2 2 2 022 2 2 2 2 1 2 4 0 09 022 7 jussus 12 CONTROLS AND INDICATORS 5 2 rrt ERR e PIER neat EE e dd DERE 13 INSTALLATION PROCEDURE ERR RR Re EPI Xa E Re E PARU x 14 ATTACHING AND DETACHING 5 22 274230 2 2 14 STARI UP SEQUENGE re eee EE E E eee T ere 14 GENERAL SEI UIP AND USE nice sends cette 15 DIS RAN Se 17 MONITORING MODE 524 2 2 2 4 2 2 2 0222 2 00 0009 5000000 17 SETTING CHANNEL OPTIONS 2 2 2 02 2 2 2 22 22 2 2 2 2 2 2 2 2 2200202000 00202020238 23 POWERING OEE M 26 ALARMS ADVISORIES AND PROMPTS BisHh oce 27 AUDIO CHARACTERISTICS 28 29 BIOS jg XM 30 MAINTENANCE SPEGIEIGATIONS
18. O Module attached Sensor is not properly attached to patient Check sensor and patient cable Confirm correct sensor and patient cable are chosen See Accessories for a list of sensors designed for use with this Module Check sensor Identify source of external interference if other than sensor Check sensor Remove or reduce lighting Cover or reposition sensor Check sensor Move sensor to a better perfused site Check sensor Confirm correct sensor placement Move sensor to a better perfused site Access patient s condition Confirm correct alarm limit values are selected Access patient s condition Confirm correct alarm limit values are selected Access patient s condition Confirm correct alarm limit values are selected Access patient s condition Confirm correct alarm limit values are selected Attach sensor to patient cable or attach patient cable to the SpO Module Check sensor Confirm correct sensor placement Remove additional SpO Module Reattach sensor to patient ALARMS ADVISORIES AND PROMPTS 29 gt gt gt gt 5 gt Os ZS moa ag ES 94 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 Q Low quality of signal being Check sensor Confirm correct measured sensor placement Move sensor to a bette
19. O Module with Masimo LNOP series sensors and Masimo PC series patient cables are contraindicated for use as an apnea monitor INTRODUCTION 1 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 Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by the blood is related to hemoglobin oxygen saturation The SpO Module uses the Masimo proprietary Signal Extraction Technology SET to decompose the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and its value is used to find the 5 saturation in an empirically derived equation in the Masimo SET software The values in the look up table are based on human blood studies against a laboratory co oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions 2 INTRODUCTION Features Ease of Use Features Fast SAT Guardrails Safety Software Masimo Sensors PI Pre Silence Profiles Feature Sensitivity Mode SETS Signal 1 0 7 To enhance safety and ease of operation the MEDLEY Medic
20. O2 PULSE TIME 2001 07 06 Ave AVG 073917 97 19 82 15 2 07 39 00 97 1 82 150 38 100 150 07 38 30 97 190 82 150 38 100 150 07 38 00 97 82 5 07 37 30 37 100 150 07 37 00 97 190 82 19 ZOOM 30min 15min 5min 1min gt Press UP DOWN Keys to move cursor PAGE PAGE SPO2 UP zoom War GETTING STARTED 21 a m a v 2 A m iw Monitoring Mode Continued Navigating Trend Data View Continued 6 Press the SPO2 MAIN soft key to return to the SPO2 Main display lt 2 4 Mode sPo2 97 Of 90 PULSE 150 RATE 82 50 NWS 10 56 7 Press the MAIN SCREEN soft key to return to the Main Display Pre Silencing Alarm 1 Press the SILENCE key on the Programming Module to pre silence the alarm NOTE All monitoring alarms will be silenced for 120 seconds Infusion alarms will not be silenced 2 To Cancel the Pre Silence Alarm Press CHANNEL SELECT key on SpO Module Press CANCEL SILENCE soft key to cancel the pre silence alarm and return to alarmable mode TREND LIMITS s 5 Midtown Hospital Adult ICU 5 2 AUDIO Midtown Hospital Adult ICU 5 2 AUDIO 74 SPO2 Main 10 56 CANCEL MAIN TREND SILENCE uwrs 3255
21. Z z X THIS PAGE INTENTIONALLY LEFI BLANK 42 APPENDIX MEDICAL SYSTEMS t ALARIS Y ALARIS Medical Systems Inc 10221 Wateridge Circle 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 SET Signal Extraction Technology and Signal 1 0 7 are trademarks and registered trademarks of Masimo Corporation All other trademarks belong to their respective owners ALARIS U S Patent Nos 5 601 445 5 713 856 5 800 387 5 836 910 5 941 846 Australia Patent Nos 693 662 703 178 719 254 Israel Patent No 117 128 Taiwan Patent No NI 107 963 Other U S and Foreign Patents Issued and Pending Masimo U S Patent Nos 5 482 036 5 490 505 5 632 272 5 685 299 5 758 644 5 769 785 6 002 952 6 036 642 6 067 462 6 157 850 6 206 830 and international equivalents 147421 002 Copyright 2001 ALARIS Medical Systems Inc rights reserved
22. ation System provides a full range of audio and visual alarms advisories and prompts 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 For example if the readings were 9796 9696 95 and 85 the saturation level displayed would be 85 The Guardrails9 Safety System is designed to help reduce programming errors by Customizing device configurable settings to meet the need of the selected hospital area patient type Profile Comparing user programming with hospital defined best practice guidelines Providing a Guardrails Advisory prompt if an out of limits entry is made Disposable and reusable sensors are available for neonatal pediatric and adult patients Perfusion Index PI is a scaled numeric value derived from the magnitude of the pulsations displayed on the plethysmographic pleth waveform It is calculated as a percentage of pulsatile signal to nonpulsatile signal The PI is used to find the best perfused site for sensor placement the larger the PI the stronger the perfusion The operating range is 0 02 to 20 0 The desired number is 7 1 00 or as large as possible Alarms can be pre silenced for 120 seconds The pre silence alarm can be cancelled before 120 seconds are complete A profiles feature a unique set of device options configured to optimize device function for a specifi
23. beep every 2 seconds Variable volume can be silenced for two minutes Variable volume can be silenced for two minutes Variable volume can be silenced for two minutes Fixed maximum decibel volume cannot be silenced Fixed maximum decibel volume can be silenced for two minutes Variable volume cannot be silenced Fixed minimum volume can be silenced and disabled in the System Configuration Variable volume can be silenced for two minutes 28 ALARMS ADVISORIES AND PROMPTS Alarms Alarm Meaning Response Bad Sensor Check Sensor Electrical or Optical Interference Check Sensor Light Check Sensor Low Perfusion Check Sensor Low Signal 1 0 High Pulse Rate Alarm High SpO Alarm Low Pulse Rate Alarm Low SpO Alarm No Sensor No Signal Remove Module MAX 1 Sensor Off Broken unknown or nonsystem sensor or patient cable attached External interference on sensor Light interference on sensor Patient s low perfusion has inhibited monitoring Low quality of signal being measured High pulse rate alarm limit has been exceeded High SpO alarm limit has been exceeded Low pulse rate alarm limit has been exceeded Low 5 alarm limit has been exceeded Sensor not properly attached to patient cable or patient cable not properly attached to the SpO Module Failure to find a patient signal after 30 seconds of searching More than one Sp
24. c hospital area or patient type A profile is comprised of a Configuration with device settings and defaults customized by the user to best meet the needs of the profile area patient type The sensitivity mode normal or maximum of the current monitoring configuration is displayed in the options mode The normal setting is used for normal patient monitoring purposes The maximum setting is used for improved low perfusion performance Signal Extraction Technology9 SET uses adaptive filters to separate the arterial signal from the nonarterial noise SET provides for accurate readings under extreme conditions such as low perfusion and motion The Signal Q is a visual indication of the pulsation at the sensor site The height of the vertical bar indicates the quality of the measured signal The Signal Q is related to proper sensor application adequate arterial signal and intensity of motion Use the Signal 1 0 to verify optimal sensor placement INTRODUCTION 3 zZ c d 2 5 Alarm Limits SpO Display Limit Mode Pleth Waveform Pre Silence Pulse Beat Volume Pulse Rate Alarm Limits Pulse Rate Display Saturation Averaging Time System Configuration Trend Data The upper and lower saturation alarm limits are displayed The functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO The limit mode displays either the adult or ne
25. d otherwise in this warranty repair or replacement will be carried out at ALARIS Medical Systems expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to the repair facility shall be at purchaser s risk In no event shall ALARIS Medical Systems be liable for any incidental indirect or consequential damages in connection with the purchase or use of any ALARIS Medical Systems product This warranty 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 ALARIS Medical Systems shall not be responsible for any loss or damage arising in connection with the purchase or use of any ALARIS Medical Systems product which has been a repaired by anyone other than an authorized ALARIS Medical Systems service representative b altered in any way so as to affect in ALARIS Medical Systems judgment the product s stability or reliability c subjected to misuse or negligence or accident or which has had the product s serial or lot number altered effaced or removed or d improperly maintained or used in any manner other than in accordance with the written instructions furnished by ALARIS Medical Systems This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of ALARIS Medical
26. e Patient Model Patient Size Site Inspection Interval SpO Adhesive Sensors LNOP Adt 1001 gt 30 Kg Check sensor site every 8 hours and as necessary LNOP Pdt 1025 gt 10 Kg lt 50 Kg sss LNOP Neo 1002 lt 10 Kg me LNOP NeoPt 1003 1 Kg gt Masimo Reusable Masimo Patient Size Site Inspection Interval 5 Sensor Part LNOP DCI 1269 30 Kg Check and move sensor to new site every 4 hours LNOP DCIP 1276 10 Kg lt 50 Kg mace LNOP YI Multisite 1544 1 Kg Reusable Sensor LNOP EAR Ear Reusable 1399 gt 30 Kg Sensor w Ear Hanger 40 APPENDIX Accessories Continued LNOP Sensors Continued Cleaning a Masimo LNOP Sensor Reusable sensors can be cleaned as follows I NOTE To avoid contamination clean sensors before each use 1 Remove the sensor from the patient Disconnect the sensor from the SpO Module Wipe the sensor clean with a 7096 isopropyl alcohol pad ds 90e NS Allow the sensor to air dry before returning it to use Reattaching a Single Use Masimo LNOP Sensor e LNOPS single use sensors may be reattached to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin The adhesive can be partially rejuvenated by wiping it with an alcohol wipe and allowing it to thoroughly air dry prior to reattaching it to the patient NOTE If the sensor fails to track the pulse consistently the sensor may be
27. e displayed Six data collection periods are displayed on a screen page Press the PAGE UP and PAGE DOWN soft keys to navigate from page to page NOTE The last page does not have a PAGE DOWN soft key and the first page does not have a PAGE UP soft key When moving from page to page the cursor always displays on the third row of data To move the cursor press the lt gt or lt gt key on the Programming Module NOTE With further lt gt key presses the cursor stays in this position as illustrated and the data view scrolls up one row at a time Adult Trend Data Mode TIME PO2 PULSE 2001 07 06 AVS 09 01 17 97 19 82 ws 08 38 30 97 190 82 150 08 08 30 97 100 82 150 07 38 30 97 10 a 82 150 07 08 30 39 100 150 063830 97 82 150 ZOOM 15min 5min 1min 30sec gt Press UP DOWN Keys to move cursor PAGE DOWN PAGE zoom SPO2 Main To change the TIME period for the data collection period move the cursor to the desired time period and press the ZOOM soft key New time period will be highlighted in the display Each press of the ZOOM soft key will change one time period Available time periods are 30 minutes 15 minutes 5 minutes 1 minute and 30 seconds NOTE Repeated pressing of the ZOOM soft key will cycle through the time period choices Adult Trend Data Mode SP
28. e dropped or severely jarred it should be immediately taken out of use and inspected by qualified service personnel to ensure its proper function prior to reuse Maintenance Disconnect from the Programming Module when performing maintenance Operating Environment Not for use in the presence of flammable anesthetics m DANGER Explosion risk if used in the presence of flammable anesthetics DANGER o eli e EXPLOSION HAZARD 10 GETTING STARTED 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 Gem When using the SpO2 Module in combination with a Programming Module which is interconnected to hospital data communications equipment and or Nurse call systems the external systems must be certified to applicable standards to insure correct operation and electromagnetic compliance integrity Interconnected data communications systems must be certified to IEC 950 data processing equipment or IEC 60601 1 Electromedical Equipment
29. emory will be retained for at least six months by the Programming Module internal backup lithium battery Module specific SpO parameters are stored for eight hours by the Programming Module when the system is turned off After eight hours of continuous off time or if the Module is changed the system will automatically purge Module specific information Operating 41 to 104 F 5 to 40 C 20 to 90 Noncondensing 525 to 4560 mmHg 700 to 6080 hPa Storage Transport 4 to 140 F 20 to 60 C 5 to 85 Noncondensing 375 to 760 mmHg 500 to 1013 hPa MAINTENANCE 31 lt 2 Z m z gt Specifications Continued Fluid Ingress Protection IPX1 Drip Proof Measurement Range Perfusion 0 02 to 2096 Pulse Rate 25 to 240 bpm SpO 1 to 10096 Mode of Operation Continuous Pulse Amplitude Display Pulse Amplitude Display is proportional to the height of the signal Weight 2 105 0 91 kg Specifications Sensor Wave length and Power Emitted light wavelength range is within 500nm to 1000nm Output power does not exceed 1mW NOTE Compliance to Standards The MEDLEY Medication Safety System with the Programming Module and SpO Module has been assessed and complies with the following standards UL 2601 1 including A1 and A2 CSA C22 2 No 601 1 including A2 IEC EN 60601 2 24 IEC EN 60601 1 2 and AAMI ID26 EN 865 NOTES 1 4 Masimo Board perfo
30. ent assessment It must be used in conjunction with clinical signs and symptoms KB I Pulse oximetry readings and pulse signal can be affected by certain ambient conditions sensor application errors and certain patient conditions 1 1 O0 89 Inspect the 5 sensor site regularly to ensure correct sensor positioning application and site integrity Tissue damage could occur over prolonged time periods depending on the patient profile such as neonates and method of application Refer to the sensor instructions for additional information GETTING STARTED 7 Warnings and Cautions 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 Interfering Substances Carboxyhemoglobin and methemoglobin may 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 may cause erroneous readings Do not use the 5 Module or sensors during Magnetic Resonance Imaging MRI WARN NG The 5 2 Module is not rated for defibrillation use Disconnect sensor from patient or patient cable from module prior to defibrillation GUNN Carefully route patient cabling to
31. ent movement Venous pulsations Placement of a sensor on an extremity with a blood pressure cuff arterial catheter intravascular line or other causes of insufficient perfusion Nail aberrations nail polish fungus etc Remove the nail polish and or move the sensor to an unaffected site Placement too close to electrosurgery equipment The loss of a pulse signal can occur in any of the following situations The sensor is too tight Exposure to excessive illumination such as a surgical lamp especially one with a xenon light source bilirubin lamp fluorescent light infrared heating lamp or direct sunlight Placement of a sensor on an extremity with a blood pressure cuff arterial catheter intravascular line or other causes of insufficient perfusion The patient has hypotension severe vasoconstriction severe anemia or hypothermia There is arterial occlusion proximal to the sensor The patient is in cardiac arrest or is in shock Placement too close to electrosurgery equipment 12 GETTING STARTED Controls Indicators Status Indicators Alarm Monitor Standby red green yellow IUI Connector Left IUI Connector Right not visible Pulse Bar Display 0 m a a v 2 A m iw Channel Identification A B C or D Channel Select Key When pressed selects the corresponding channel for patient monitoring and setup Monitor Key When
32. gs Feature Default Setting Options Alarm Audio Profile 1 Profile 1 2 or 3 Battery Meter Disabled Enabled Disabled Clock Setup Date and Time N A Set date and time Key Click Audio Enabled Enabled Disabled Tamper Resist Disabled Enabled Disabled SpO Module Settings Feature Default Setting Options Limit Mode Pulse Beep Volume Pulse Rate Alarm Limit High Pulse Rate Alarm Limit Low SpO Alarm Limit High SpO Alarm Limit Low Saturation Averaging Time Display Update Period Sensitivity Mode Adult 1 Adult Mode 120 bpm Neonatal Mode 200 bpm Adult Mode 50 bpm Neonatal Mode 100 bpm Adult Off Neonatal 9596 Adult 9096 Neonatal 8096 8 seconds Normal Adult or Neonatal 1 2 3 or Off 31 240 bpm 30 239 bpm 21 10096 Off 20 99 2 4 8 10 12 14 or 16 seconds Normal or Maximum MAINTENANCE 33 lt 2 Z m z gt Q m Instrument Cleaning DO NOT spray cleaning fluids directly onto the instrument or immerse the instrument in fluids DO NOT use solutions containing phosphoric acid Foamy Q amp A aromatic solvents naphtha paint thinner etc chlorinated solvents Trichloroethane MEK Toluene etc ammonia acetone benzene xylene or alcohol other than as specified below DO NOT use hard or pointed objects to clean any part of the instrument Acceptable cleaning solutions are Warm water Mild detergent e
33. he system self test begins e The diagnostics test causes all LED display segments and Status Indicator lights of the attached channel s to illuminate briefly Power Indicator illuminates e Appropriate channel identification A B C or D is displayed on the attached channel s e An Audio tone sounds 5 Atthe completion of the system on test the NEW PATIENT screen appears on the Programming Module 14 GETTING STARTED 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 Indicator lights do not illuminate Appropriate channel identification A B C or D is not displayed Audio tone does not sound Main Display does not appear backlit appears irregular or has evidence of a row of pixels not functioning properly If the affected channel operates normally when it is attached via the alternate IUI connector it may be used until replacement channel can be substituted General Setup and Use NOTE Use only Masimo LNOP series sensors and PC series patient cables 1 Attach a Masimo patient cable to the SpO Module Ensure a secure connection and patient cable is not twisted sliced or frayed a m a v 2 A m iw
34. incorrectly positioned Reposition the sensor or choose different monitoring site Masimo SET Patient Cables Reusable patient cables of various lengths are available All cables that display the Masimo SET logo are designed to work with any Masimo LNOP sensor and with any SpO Module displaying the Masimo SET logo Cleaning a Masimo SET Patient Cable Patient cables can be cleaned as follows 1 Remove the cable from the sensor Disconnect the cable from the SpO Module Wipe the cable clean with a 7096 isopropyl alcohol pad W CS Allow the cable to air dry before returning it to use CAUTION Do not immerse in water solvents or cleaning solutions Do not sterilize by irradiation steam autoclave or ethylene oxide The sensors and connectors are not waterproof Refer to the cleaning instructions in the Directions for Use for the reusable Masimo LNOP sensors CAUTIONS Carefully route patient cables to reduce the possibility of patient entanglement or strangulation Do not lift the SpO Module by the patient cable Do not use damaged patient cables CAUTION Do not immerse in water solvents or cleaning solutions Do not sterilize by irradiation steam autoclave or ethylene oxide The patient cable connectors are not waterproof Refer to the cleaning instructions in the Directions for Use for the reusable Masimo patient cables APPENDIX 41 gt v v z
35. lable sensor sites and the duration of monitoring For more information refer to the CAUTION following table or contact your Masimo Sales Representative Use only Masimo SET sensors Select an appropriate sensor e Do not use damaged sensors Do not use a sensor with exposed apply it as directed and observe all warnings and cautions optical or electrical components presented in the directions for use accompanying the sensor e Always remove the sensor from the patient and completely disconnect the patient from the SpO Module before bathing the High ambient light sources such as surgical lights especially patient those with a xenon light source bilirubin lamps fluorescent light infrared heating lamps and direct sunlight can interfere with the performance of an SpO sensor To prevent interference from ambient light ensure that the sensor is properly applied and if required cover the sensor site with opaque material Clean and remove any substances such as nail polish from the application site Periodically check to ensure the sensor remains properly positioned on the patient Failure to take this precaution in high ambient light conditions may result in inaccurate measurements gt 5 m zZ 9 APPENDIX 39 Accessories Continued Masimo Sensors Continued The following sensors are available for use with the SpO Module Masimo Singl
36. lift the SpO Module by the cable or power cord because the cable or cord could disconnect from the instrument causing it to drop on the patient Do not place the SpO Module in any position that might cause it to fall on the patient CAUTION The sensor disconnect error message and associated alarm indicate the sensor is either disconnected or the wiring is faulty Check the sensor connection and if necessary replace the sensor and or pulse oximetry cable CAUTION To ensure Electromagnetic Compliance Integrity accessories including external communication systems hospital data communication equipment and or Nurse call systems must be certified to applicable standards a m a v 2 A m iw IEC 60601 1 Electromedical Equipment or IEC 950 Data Processing Equipment GETTING STARTED 9 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 and CAUTIONS Do not open the instrument case There are no user serviceable parts inside The instrument case should only be opened by qualified service personnel using proper grounding techniques When the instrument case is opened an electrical shock hazard exists which can result in serious injury to persons and instrument component damage Dropping Jarring Should an instrument b
37. onatal monitoring mode The plethysmographic pleth waveform is a graphic representation of changes in the extremity blood volume during the events of the cardiac cycle Alarms can be pre silenced for 120 seconds The pre silence alarm can be cancelled before 120 seconds are complete Pulse beat volume can be configured to a volume level of 1 2 3 or off The upper and lower pulse rate alarm limits are displayed The patient s pulse rate is displayed in beats per minute bpm The averaging time of this device can be set to 2 4 8 10 12 14 or 16 seconds The System Configuration mode provides the ability for qualified personnel to customize device settings If the profile feature is enabled the system settings defined for the selected Profile are automatically activated The trend data is a tabular display of the SpO and Pulse Rate The display shows the alarm conditions for the time period displayed and the average high and low values The data is stored for 24 hours 4 INTRODUCTION Symbols Bu 9 gt R Only 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 IUI Connector
38. ottom line of the Main Display or the Channel Message Display to perform some action The audio may be silenced for twelve seconds by pressing the SILENCE key on the Programming Module Pre Silence The alarms for the SpO Module can be silenced for up to 120 seconds by pressing the SILENCE key on the Programming Module This will not silence the infusion alarms To end the Pre Silence period press the CANCEL SILENCE soft key on the 5 Main display gt rs gt 2 ZZ 5 gt Ss ZS moa ag ES 94 ALARMS ADVISORIES AND PROMPTS 27 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 WARN NG If an alarm condition on the SpO Module occurs while the audio alarm is silenced the only alarm indications will be visual displays and symbols related to the alarm condition Type Sound Notes Advisory SpO gt Alarm HIGH PRIORITY SpO5 Alarm LOW PRIORITY SpO gt Error Hardware Detected SpO gt Error Software Detected Illegal Key Press Key Click Prompt One short beep every 2 seconds A sequence of five beeps One long beep every 4 seconds A single alarm tone volume Pairs of long beeps Two short beeps One short beep One short
39. r perfused site 30 ALARMS ADVISORIES AND PROMPTS personnel MAINTENANCE The MEDLEY System Technical Service Manual is available from ALARIS Medical Systems It includes 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 Specifications Accuracy Low Perfusion Adults Pe ics Adults Pediatrics Neonate Neonate Motion 3 Adults Pediatrics Adults Pediatrics Neonate Neonate No Motion4 Adults Pediatrics Adults Pediatrics Neonate Neonate Resolution Display Update Period Alarms Alarm Limits Pulse Rate spO2 Dimensions Electrical Classification Electronic Memory Environmental Conditions Temperature Range Relative Humidity Atmospheric Pressure Pulse Rate 25 to 240 bpm 3 digits 5 digits 3 digits 1 bpm Saturation 70 100 2 digits 3 digits 3 digits 3 digits 2 digits 3 digits 196 SpO The display update period is Approximately 1 second Audible and visual alarms for high and low saturation and pulse rate sensor condition system failure and low battery conditions LOW HIGH 30 239 BPM 31 240 BPM 20 99 21 100 3 3 W x 8 9 H x 5 5 D 8 4cm W x 22 6cm H x 14cm D Class 1 Internally Powered Equipment Type BF System configuration parameters stored in volatile m
40. reduce the possibility of patient entanglement or strangulation GUI If an alarm condition on the SpO Module occurs while the audio alarm is silenced the only alarm indications will be visual displays and symbols related to the alarm condition GUI Check alarm limits each time the SpO Module is used to ensure they are appropriate for the patient being monitored GUI Use only Masimo approved LNOP sensors and PC Series patient cables with the SpO Module Model 8220 Use of other sensors transducers cables and accessories other than those specified may cause improper SpO Module performance resulting in inaccurate readings increased emission and or decreased immunity and degraded electromagnetic compatibility performance of the SpO Module 8 GETTING STARTED Warnings and Cautions Continued Before use read sensor Directions for Use including all warnings cautions and instructions Do not use a sensor cable connector SpO Module that appears damaged Do not use a sensor with exposed optical components Do not immerse or wet the sensor or cable Clean as per manufactures instructions refer to LNOP9 Sensors Instructions For Use The sensor disconnect error message and associated alarm indicate that the sensor is either disconnected or the wiring is faulty Check the sensor connection and if necessary replace the sensor and or pulse oximetry cable WARN NG Do not
41. rmance has been validated for low perfusion accuracy in bench top testing against a BIO TEK simulator and a Masimo simulator Refer to service manual for more information The Masimo Board performance has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a nonrepetitive range of 70 100 5 against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 6896 of the population The Masimo Board performance with Masimo LNOP Neo and Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate s foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population The Masimo Board performance has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 100 SpO gt against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 6696 of the population 32 MAINTENANCE Configurable Settings System Settin
42. ttach the patient cable and sensor as described in the General Setup and Use section of this document Midtown Hospital Adult ICU A SPO2 AUDIO ADJUST A Press the CHANNEL SELECT key on the SpO Module to view the SPO2 Main display The following information can be viewed in this display limit mode Adult or Neonatal e SPO2 with high and low alarm limits e PULSE RATE with high and low alarm limits pleth waveform e Signal I Q e Pl 5 Press the MAIN SCREEN soft key to return to the Main Display Setting Alarm Limits 1 Press the CHANNEL SELECT key on the SpO Module 2 Off 90 PULSE 150 RATE 82 50 Ht tt ttt i 10 56 SPO2 97 TREND LIMITS pleth waveform Signal 1 0 7 PI 5 2 gt Select Channel AUDIO ADJUST FA SPO2 Main Adult Mode 2 97 OF PULSE 150 RATE 82 50 TREND LIMITS SCREEN MAIN 18 GETTING STARTED Monitoring Mode Continued Setting Alarm Limits Continued 2 Press the LIMITS soft key The following limits can be changed Adult Alarm Limits e 5 2 HIGH y e SPO2 LOW 150 PULSE HIGH 50 e PULSE LOW n gt Select Parameter Limit 3 Press the soft key for the parameter limit
43. vice Information NOTE Ifthe instrument shows evidence of damage in transit notify the carrier s agent immediately Do not return damaged equipment to the factory before the carrier s agent has authorized repairs If the instrument fails to respond as described in this document and the cause cannot be determined do not use the instrument Contact qualified ALARIS Medical Systems service personnel Customer Service Within the United States and Canada information or assistance may be obtained by calling one of the following Customer Service toll free numbers United States Canada Eastern Western Technical Support Technical Support can be contacted by calling one of the following toll free numbers United States Canada Eastern Western Outside the United States and Canada service information applications and manuals may be obtained by contacting your local ALARIS Medical Systems Service Department or distribution center When submitting any request for service include e a description of difficulty experienced Programming Module serial number and description and serial number of all attached channels administration set lot number solution s used message displayed at time of difficulty Product Return If it is necessary to return the instrument for service obtain a return authorization number prior to shipment Carefully package the instrument preferably in the original packaging reference
44. y B a E indicates channel is operating An outlined Channel Letter display indicates that the channel is attached and ready for use poems ADJUST NOTE Throughout the following sections of this chapter display screens are aligned with the corresponding steps Monitoring Navigating Main Display Soft Keys a m l a 2 A m iw Attach the SpO Module to the Programming Module 2 Power on the system by pressing the SYSTEM ON key on the Midtown Hospital Programming Module The NEW PATIENT screen will NEWPATIENT Yes appeal Patient Data No e A Yes selection clears the previous SpO trend data A No selection retains the previous SpO trend data gt Select Yes or No Once a selection is made either the Main Display will Midtown Hospital 4 of 2 appear or if the Guardrails Safety Software is enabled View the profiles screen as shown on the right will be Adult General View d isplayed E Neonatal View Peds ICU View NOTE When Guardrails9 Safety Software is enabled Neonatal ICU View ef Yes is selected you will be prompted to confirm the last ETE Profile selected If No is selected you will be prompted to choose a Profile EST GETTING STARTED 17 Monitoring Mode Continued AEM ELAO 570 3 A
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