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Alaris Medley Pump Module 8100 Version 4b

1. 18 Verify parameters are correct and then press START soft key Midtown Hospital e Rate appears in Channel Rate Display a 250 0 mL e Dose scrolls in Channel Message Display ec e VTBI volume remaining appears in Main Display D VOLUME AUDIO INFUSED ADJUST Setting Bolus Dose Drug Calculation with Drug Library This section provides the procedure on how to program a bolus at the beginning of an infusion with a drug calculation programmed using the Drug Library NOTE If Bolus is enabled the BOLUS DOSE soft key will appear in the Drug Calculation screen 1 Setup Drug Calculation as described in Setting Up Drug Calculation with Drug Library section steps 1 13 Drug Calculation lidocaine CONTINUOUS INFUSION 135 muh 250 mL 9 mg min Conc 4 mg mL gt Press START PAUSE SETUP BOLUS START 30 GETTING STARTED Setting Bolus Dose Drug Calculation with Drug Library Continued Press BOLUS soft key NOTE If the programmed continuous infusion is outside the Guardrails Limit for that care area a prompt will appear before the bolus dose can be programmed If Yes soft key is pressed programming will continue if No soft key is pressed the infusion will need to be reprogrammed N Drug Calculation lidocaine Dose exceeds the Guardrail limit of 8 mg min Proceed BOLUS VTBI mL Conc 4 mg mL Use numeric keypad entry keys to enter desire
2. GETTING STARTED 21 Primary Mode Continued AutoRestart The AutoRestart feature is part of the MEDLEY System s 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 15 second Checking Line period It this feature is enabled the Checking Line function will occur when downstream pressure exceeds the Pressure Limit e In Selectable Pressure Mode the Pressure Limit will be either user adjustable or locked in system configuration e n Pump Pressure Mode the Pressure Limit is a function of flow rate and is automatically determined by the device If the downstream pressure decreases to a predetermined level below 50 of the Pressure Limit during the 15 second Checking Line period the infusion automatically continues If the condition is not cleared within 15 seconds a Partial Occlusion Patient Side alarm occurs Qualified Service personnel can configure the system to allow from zero 0 to nine 9 restart attempts within a rolling 10 minute period If the allowable number of restarts is exceeded or if the feature Is set to zero an Occluded Patient Side alarm will occur when the system detects downstream pressure over the Pressure Limit 22 GETTING STARTED Seco
3. 0 1 9 99 0 01 10 999 9 0 1 1000 9999 1 Weight 2 5 Ibs 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 CSA C22 2 No 601 1 including Al and A2 IEC EN 60601 2 24 IEC EN 60601 1 2 and AAMI ID26 Configurable Settings NOTE With the Profiles feature enabled the settings are configured independently for each profile A hospital defined best practice data set must be uploaded to enable the Profiles feature Date and Time is a system setting and is the same in all profiles System Settings Feature Default Setting Options Alarm Audio Profile 1 Profile 1 2 or 3 Anesthesia Mode Disabled Enabled Disabled Battery Meter Disabled Enabled Disabled Clock Setup Date and Time N A Set date and time Key Click Audio Enabled Enabled Disabled Max Patient Weight 500 kg 0 1 500 kg z Tamper Resist Disabled Enabled Disabled 2 gt m MAINTENANCE 53 Configurable Settings Continued Pump Module Settings Feature Default Setting Options Accumulated Air in Line Enabled Enabled Disabled Alr in Line Settings 75 microliters 50 75 or 250 microliters single bolus Anesthesia Mode only 500 microliters AutoRestart Attempts 0 0 9 attempts Anesthesia Mode only 9 attempts Drug Calculation Disabled Enabled Disabled e Bolus Dose Disabled Enabled Disabled KVO Rate Adjust 1 ml h 0 1 20 m
4. Key Click Prompt Switchover One short beep every two seconds Choice of three alarm audio profiles selectable in System Configuration Pairs of long beeps Pairs of long beeps Two short beeps One short beep One short beep every two seconds Six short beeps 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 Variable volume can be silenced and disabled in the System Configuration 46 ALARMS ADVISORIES AND PROMPTS Alarms Alarm Meaning Accumulated Air in Line Air in Line Channel Disconnected Check IV Set Close Door Flo Stop Open Close Door Occluded Fluid Side Empty Container Occluded Patient Side Partial Occlusion Patient Side Restart Channel A large number of air bubbles smaller than current air in line limit has recently passed detector Air has been detected in set during an infusion Infusion stops on affected channel Channel s have either been disconnected while in operation or have a communication problem Administration set is not properly installed Infusion stops on affected channel Door opened during an infusion Inf
5. 250 mL Cone 1600 mcg mL gt Select PATIENT WEIGHT 8 Press PATIENT WEIGHT soft key A Drug Calculation eT 400 9 Press either Yes or No soft key to indicate whether patient BEG 7 VOLUME m weight is to be used in Drug Calculation E gt gt gt gt No A Note Press Yes only if Patient NOTE Do not enter a patient weight if weight is not used in weight is used in the calculation For Example Dosing units the calculation mg kg h gt Use Patient Weight in Calculation LIBRARY 10 Use numeric data entry keys to enter patient weight in FLY Drug Calculation kilograms if required and then press ENTER AT 400 mg votume 250 mL me __70k9 UNITS Cone 1600 mcg mL gt Select Time Units LIBRARY 11 Press either Min Hour or Day soft key to select time base for drug calculation AMOUNT 400 mg votume 250 mL wen 70kg Min thie gt gt gt gt Hour ES Day Conc 1600 mcg mL gt Select Time Units DRUG LIBRARY 34 GETTING STARTED Setting Up Drug Calculation for Non Library Drugs Continued 12 Press soft key next to desired DOSING UNITS y Drug Calculation 400 mg 250 mL 70 kg meg kg min gt gt mg kg min Conc 1600 mcg mL gt Select the Desired Dosing Units DRUG LIBRARY 13 Verity correct drug calculation infusion parameter input and press NEXT soft key rug Calculation EY o RR 400 mg 103 250 mL WE
6. 6 Close Pump Module door 7 Press CHANNEL SELECT key on desired Pump Module 8 Press VTBI soft key and use numeric data entry keys to enter desired VTBI 9 Open roller clamp 10 Press START soft key Drug Calculation Parameters The MEDLEY System uses the following parameters entered by the user during the drug calculation setup procedure e Bolus dose units Units device will use in calculating bolus dose Bolus dose units are selected by user from alternatives provided e Diluent volume Volume of fluid used as diluent for drug mL e Dosing units Units device will use in calculating continuous infusion drug dose Dosing Units are selected by user from alternatives provided e Drug amount Amount of drug in IV container gram mg mcg mEq or units e Patient weight Weight of patient kg this is an optional parameter that is not needed unless drug dose is normalized for patient weight e Time units Time base for all calculations minute or hour The bolus dose drug dose and flow rate parameters are calculated using the above parameters as follows e Bolus dose Bolus dose x Patient weight if used e Bolus dose duration Bolus VTBI Bolus rate e Bolus dose VTBI Bolus dose Drug concentration e Bolus rate Bolus VTBI Duration e Drug concentration Drug amount Diluent volume e Drug dose Flow rate x Drug concentration normalized for patient weight if specified by entering
7. System provides a full range of audio and visual alarms advisories and prompts 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 Immediate action is required Guardrails Advisory A visual popup requiring a Yes or No response designed to help reduce programming errors Prompt An audio and or visual signal appearing on the bottom 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 gt gt gt I A U nm D gt O g lt lt uN YS MTI U ALARMS ADVISORIES AND PROMPTS 45 Audio Characteristics The Programming Module and Main Display provide four types of alert information advisories prompts alarms and maltunctions The characteristics of the accompanying audio sounds are as follows Type Sound Notes Advisory Alarm Error Hardware Detected Error Software Detected Illegal Key Press
8. gt Select RATE or DOSE 11 Use numeric data entry keys to enter rate or dose value FEY 389 Caleculation other value is calculated and displayed CONTINUOUS INFUSION 13 1 mun NOTE In the Drug Calculation mode the device infuses at lt a the calculated rate rounded to the nearest one hundredth of a DOSE O B l ___ _OD mcg kg min mL per hour The rate shown on the Main Display Channel Programming screen is this rate The rate shown in the Conc 1600 meg mL Channel Rate Display will be rounded to the nearest one tenth gt Select VTBI fa mL per hour of a mL per hou 32 GETTING STARTED Setting Up Drug Calculation with Drug Library Continued 12 Press VTBI soft key Drug Calculation dopamine CONTINUOUS INFUSION 13 1 mLh _ 250 mL 5 mcg kg min 13 Use numeric data entry keys to enter volume to be infused NOTE At rates less than 10 mL h the rate is displayed to two decimal places and the VTBI can be entered and is displayed to two decimal places Conc 1600 mcg mL gt Press START PAUSE SETUP 14 Verify drug parameters are correct and then press START soft Midtown Hospital Key A vTBI 250 0 mL O E m e Rate appears in Channel Rate Display E y Z NOTE Ifa dose outside of the Guardrails Limits has been D C entered and verified as correct the Channel Message Display Z will also show either LLL for a low dose or TTT for a high La
9. 8 1 6 1 4 1 2 1 0 0 8 0 6 0 4 0 2 0 0 0 2 Flow Rate mL h 0 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 1 ml h initial _ a a Flow Rate Error O 5 10 15 i i i 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 1 mL h 72 hrs 15 a 5 Flow Rate Error om 0 5 10 15 20 25 30 Observation Interval min Legend Overall rate error NW Maximum rate error Minimum rate error 58 APPENDIX Flow Rate Error Flow Rate mL h Flow Rate Error Trumpet and Start Up Curves Start Up at 25 ml h initial 50 45 40 35 30 25 20 15 10 5 0 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 25 mL h initial 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 25 ml h 72 hrs 0 5 10 15 20 25 30 Observation Interval min Continued mL h A U Flow Rate Error 9 Flow Rat Flow Rate Error 9 Start Up at 999 ml h initial 2000 1800 1600 1400 1200 1000 800 600 400 200 200 0 10 20 30 40 50 60 70 80 90 100 110 120 Time min Trumpet Curve at 999 mL h initial 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 999 mL h 24 hrs 0 5 10 15 20 25 30 Observation Interval min Legend NW Maximum rate error Overall rate error Minimum rate error
10. Down NOTE The channel will initiate the power down at the release of the CHANNEL OFF key 2 Once all attached channels are powered off Programming Module automatically powers down During power off sequence Main Display flashes Powering Down Powering Off the System Refer to the MEDLEY Programming Module Model 8000 Directions for Use for instructions on Powering Off the System G m G Z D JJ mH UO Changing Primary Solution Container 1 Press PAUSE key on desired Pump Module to stop infusion Close roller clamp Remove empty solution container Spike new container Press CHANNEL SELECT key on desired Pump Module ee e S N Press VTBI soft key and use numeric data entry keys to enter desired VTBI Open roller clamp 8 Press START soft key Changing and Reloading Set During Infusion 1 Press PAUSE key on desired Pump Module to stop infusion 2 Close roller clamp 3 Open Pump Module door Administration set s Flo Stop Device will automatically close to prevent accidental free flow 4 Remove administration set Flo Stop Device first by gently pulling tubing below Air in Line Detector forward and out and then lifting upper fitment vertically from upper fitment recess GETTING STARTED 29 Changing and Reloading Set During Infusion Continued 5 Prime and load a new administration set as described in Preparing Infusion section
11. While in Anesthesia Mode 1 Connect system to AC power 2 Press YES soft key to continue using Anesthesia Mode while connected to AC power connected es Continue ANESTHESIA MODE gt Select Yes or No GETTING STARTED 43 Reviewing Serial Number 1 Press OPTIONS key on Programming Module 2 Press Page Down soft key and then press Serial Numbers soft key Serial numbers for Programming Module and all attached channels are displayed as shown 3 Press EXIT soft key to return to main screen Serial Number Review PM nnnn nnnnnnnn Module A nnnn nnnnnnnn Module B nnnn nnnnnnnn Module C nnnn nnnnnnnn Module D nnnn nnnnnnnn gt Press CANCEL or EXIT EXIT Reviewing Software Version 1 Press OPTIONS key on Programming Module 2 Press PAGE DOWN soft key and then press Software Versions soft key System Options 2 of 2 System Configuration Serial Numbers Software Versions Guardrails Event Counter gt Select an Option or EXIT PAGE UP I exit 3 Press View soft key next to desired channel 4 Press EXIT soft key to return to Software Review screen 5 Press EXIT soft key to return to main screen Software Rev Review PM View Module A View Module B View Module C View Module D View gt Select an Option or EXIT 44 GETTING STARTED ALARMS ADVISORIES AND PROMPTS To enhance safety and ease of operation the MEDLEY
12. not opened the fluid will be delivered trom the primary container e The secondary set must be primed prior to beginning the secondary infusion 1 Set up and start primary infusion as previously described using a check valve administration set 2 Open secondary administration set package remove set and close clamp 3 Insert set spike into prepared fluid container and hang secondary container following accepted hospital procedure 4 Fill drip chamber to 2 3 full 5 Open secondary set and prime set Close clamp 6 Attach secondary set to upper injection site on primary set GETTING STARTED 23 Secondary Mode Continued 7 Lower primary fluid container using hanger provided with secondary set NOTE The secondary container should be at least 91 2 inches above the top of the fluid level in the primary container 8 Press CHANNEL SELECT key on Pump Module gt Press START 9 Press SECONDARY soft key EJ Infusion Setup RESTORE soft key may be pressed to bring back previous i n infusion m from memory if available cli secondary infusion parameters fro emory if available a a gt Select Rate or Restore Previous Infusion 10 Press RATE soft key EN Infusion Setup nm SECONDARY LP 11 Enter secondary infusion rate 100 mun o mL gt Select VTBI 12 Press VTBI soft key EN Infusion Setup SECONDARY 13 Enter secondary volume to be intused 100 mu
13. parameter input and press SECONDARY soft key to return to secondary setup screen 6 Press START soft key Stopping Secondary Infusion and Returning to Primary Infusion 1 Press CHANNEL SELECT key on Pump Module A Infusion Setup SECONDARY 100 ml h 55 mL gt Press START PRIMARY START A Infusion Setup SECONDARY 100 mL h 43 4 mL gt Press START PAUSE START 2 Press PRIMARY soft key on Programming Module 3 Close clamp on secondary administration set or disconnect secondary administration set trom upper injection port A Infusion Setup PRIMARY 50 mL h 240 mL gt Press START SECOND PAUSE START 4 Press START soft key 5 Press Yes soft key selection to stop secondary infusion and begin infusing primary e Secondary infusion stops and primary infusion begins e Main screen appears NOTE The SEC to PRI alert does NOT sound when the infusion is manually ended and returned to primary A Infusion Setup PRIMARY 50 mL n 240 mL Stop Secondary and Infuse Primary gt Select Yes or No 26 GETTING STARTED Channel Labels Selecting Channel Label 1 Press CHANNEL SELECT key on desired Pump Module FY channel Options 1 of 1 Drug Calculation Setup 2 Press OPTIONS key on Programming Module Pressure Limit P Channel Labels 3 Press Channel Labels soft key gt Select an Option or EXIT NA A 4 Pre
14. step 7 Pump Selectable gt Select an Option or EXIT 5 Use either Up or Down soft key to select desired occlusion pressure limit Pressure Limit Selection Selectable Pressure 525 mmHg Up Down 6 Verity correct occlusion pressure limit input and press Confirm soft key 7 Press START soft key CONFIRM Viewing and Clearing Volume Infused for ALL Channels 1 Press VOLUME INFUSED soft key on Programming Module Volume Infused TOTAL VOLUME mL aip e Total Volume Infused Primary Secondary and time a A 401 A 2062 03 10 and date Volume Infused was last cleared is displayed B 425 970 2002 03 11 for each infusion channel Cc 4781 22 Om 12 00 NOTE Date format is year month day D 189 1 20020340 e If no key is pressed main screen appears after Pa e al 30 seconds e To view Primary and Secondary volume s infused press Volume Infused PRI SEC VOLUME soft key PRI mL SEC mL A 401 1 0 0 B 425 0 0 C 428 1 50 0 D 739 1 50 0 gt Select Channels to Clear or Press CLEAR ALL TOTAL CLEAR MAIN VOLUME ALL SCREEN 20 GETTING STARTED Primary Mode Continued Viewing and Clearing Volume Infused for ALL Channels Continued 2 Press CLEAR ALL soft key Volume Infused l PRI mL e f no key is pressed main screen appears after Al 00 0 0 30 seconds 0 0 0 0 e Press MAIN SCREEN so
15. term fluctuations have greater effect as represented by the mouth of the trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Because the clinical impact of short term fluctuations on rate accuracy depends on the half life of the drug being infused and on the degree of Intravascular integration the clinical effect cannot be determined from the trumpet curves alone Knowledge of the start up characteristics should also be considered The start up curves represent continuous flow rate versus operating time for two hours from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data FLOW CHARACTERISTICS UNDER VARYING DELIVERY CONDITIONS Effects of Pressure Variations Under conditions of 100 mmHg pressure the MEDLEY Pump Module typically exhibits a long term accuracy offset of approximately 0 7 trom mean values Under conditions of 300 mmHg pressure the MEDLEY Pump Module typically exhibits a long term accuracy offset of approximately 4 2 from mean values Under conditions of 100 mmHg pressure the MEDLEY Pump Module typically exhibits a long term accuracy offset of approximately 4 4 trom mean values Resulting trumpet observation points typically track those of ac
16. AC power From System Options Menu 1 While operating in Anesthesia Mode press OPTIONS key on Programming Module 2 Press Anesthesia Mode soft key idt o O WwW Hospital t p zz O B 3 GAWD S D E 0 Q gt o O 5 idtown Hospital U gt a e e gt UOQU S o a Q 3 lt O Cc System Options 1 of 2 Display Contrast Time of Day Power Down All Channels Anesthesia Mode Battery Runtime gt Select an Option or EXIT EXIT 42 GETTING STARTED Anesthesia Mode Continued Disabling Anesthesia Mode Continued From System Options Menu Continued 3 Press Disable soft key ell Anesthesia Mode 4 Press confirm soft key Anesthesia Mode is no longer displayed on Main Display indicating it has been disabled Disable Air Detection 75 microliters gt Select an Option or Press CONFIRM Disconnecting System from AC Power While in Anesthesia Mode 1 If system is connected to AC power while running in Anesthesia Mode disconnect system trom AC GsALYVLS ONILLAD e Anesthesia Mode is automatically disabled e All currently running infusions continue e A prompt appears as an alert that Anesthesia Mode has been discontinued Anesthesia mode was discontinued when AC power cord was Press CON Fl RM soft key disconnected Press CONFIRM to continue normal operation NO CONFIRM Connecting System to AC Power
17. APPENDIX 59 gt V U m Z z gt x lt THIS PAGE INTENTIONALLY LEFT BLANK 60 APPENDIX X ALARIS MEDICAL SYSTEMS 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 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 US Pat Nos 4 764 166 4 690 673 5 165 873 5 601 445 5 713 856 5 781 442 5 800 387 5 836 910 5 941 846 6 347 553 AU Patent Nos 634 811 693 662 703 178 703 203 719 254 728 366 AT 0 225 158 BE Brevet Belge No 0 225 158 CA Patented Brevet 1 258 212 2 026 518 CH 0 225 158 DE D B P Nos 0 422 855 P3686558 3 FR Brevet Nos 0 225 158 0 422 855 GB Patent Nos 0 225 158 0 422 855 IT Brevettato Vol R A No 0 225 158 JP Patent Nos 8 1 816 872 5 2 594604 NL Ned Octrooi No 0 225 158 SE Sv pat nr 0 225 158 TW Patent No NI 107963 Other Patents Pending 147029 003 Copyright 2002 ALARIS Medical Systems Inc All Rights Reserved
18. ARTED Warnings and Cautions Continued Parallel Infusions There are no contraindications regarding the use of the MEDLEY System with any other positive displacement infusion device when ported together into a common IV site location User Precautions To ensure proper performance of the MEDLEY System and to reduce potential injury to the operator observe the following precautions e Disconnect from main AC and battery power when performing maintenance e Do not open the instrument case There are no user serviceable parts inside The case should only be opened by qualified service personnel using proper grounding techniques When the case Is opened an electrical shock hazard exists which can result in serious injury to persons and instrument component damage Administration Sets e A list of approved IV sets recommended by ALARIS Medical Systems for use with the MEDLEY Medication Safety System Pump Module is listed on the Set Compatibility Card e Before operating the instrument verify that the administration set is free from kinks and installed correctly in the instrument e MEDLEY Gemini Series sets are supplied with a sterile fluid path for one time use Do not resterilize e For set replacement interval refer to facility protocol and or government standards such as CDC guidelines in the United States e For IV push medication put instrument on hold clamp tubing above t
19. CE Each usage Periodic inspections of the hardware are required For detailed instructions on performing periodic inspections and maintenance refer to the MEDLEY 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 Service Information Refer to the MEDLEY Programming Module Model 8000 Directions for Use lt gt 2 mi Z D Z al mi MAINTENANCE 55 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 The main battery and 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 provided otherwise in this warranty repair or replaceme
20. D Environmental Conditions Operating Temperature Range 41 to 104 F 5 to 40 C Relative Humidity 20 to 90 Avoid prolonged exposure Noncondensing to relative humidity gt 85 Atmospheric Pressure 525 to 4560 mmHg 700 to 6080 hPa Equipment Orientation Electrical Classification Class 1 Type CF Defibrillator Proof The maximum over infusion which can occur in the event of a single fault condition is Storage Transport 4 to 140 F 20 to 60 C 5 to 85 Noncondensing 375 to 760 mmHg 500 to 1013 hPa To ensure proper operation the system must remain in an upright position Flow Rate Programming Rate Range Increments mL h Increments mL h User Input Rates Device Calculated Rates Oe 0 01 0 1 10 99 9 0 1 WOO 992 1 1 Fluid Ingress Protection IPX1 Drip Proof MAINTENANCE 51 lt gt 2 m Z D Z O m Specifications Continued Infusion of Air Means to Protect Patient from Ultrasonic Air in Line Detection Maximum single bolus size selectable 50 75 or 250 microliters nominal 500 microliters in Anesthesia Mode Infusion Pressure Maximum 683 mmHg KVO Keep Vein Open Rate Factory Default Setting is 1 0 mL h If set rate is 1 0 mL h or above or set rate if rate is 0 9 mL h or below KVO Selection Range KVO rate can be set in System Configuration from 0 1 20 ml h in 0 1 ml h increments Occlusion Alarm Thresholds Pump Mode 525 m
21. E 70 kg WE Min ogee meg kg min Conc 1600 mcg mL gt Press NEXT to Confirm DRUG ES 14 Press elther RATE or DOSE soft key A Drug Calculation CONTINUOUS INFUSION RATE mL h vrs mi mcg kg min Conc 1600 mcg mL gt Select RATE or DOSE SETUP BOLUS 15 Use numeric data entry keys to enter rate or dose value other value is calculated and displayed NOTE In the Drug Calculation mode the device infuses at the calculated rate rounded to the nearest one hundredth of a mL per hour The rate shown on the Main Display Channel Programming screen is this rate The rate shown in the Channel Rate Display will be rounded to the nearest one tenth of a mL per hour A Drug Calculation CONTINUOUS INFUSION 13 1 mih O ml DOSE to mcg kg min Conc 1600 mcg mL gt Select VTBI SETUP BOLUS GETTING STARTED 35 G m Z G z D JJ rr UO Setting Up Drug Calculation for Non Library Drugs Continued 16 Press VTBI soft key FY Drug Calculation CONTINUOUS INFUSION 13 1 muh 250 mt 17 Use numeric data entry keys to enter volume to be intused NOTE At rates less than 10 mL h the rate is displayed to two 5 a DOSE kg decimal places and the VTBI can be entered and is displayed to meee two decimal places Conc 1600 mcg mL gt Press START PAUSE SETUP BOLUS START
22. IEWING OO TL VV ARE VERSI N sirisser darini na Eiir a a EA EE sorted 44 ALARMS ADVISORIES AND PROMPTS OE UPI eros pedas a a E pis ads 45 AUDIO CHARACTERISTICS EEEE EEEE EEEE EEEE 46 PUPS EEEE EIEE EE EES TEE EE EE EE EEN 47 PAO VIS ORIG Os O a III E E E 48 EIS OR ox eese nedat R E E EE E E E E EEE E AEE A E E EE E E 49 MAINTENANCE SPECIFICA HONS a o UA II 51 CONFIGURABLE SETTINGS lt 0 cocndecedupsatteeioh gape ron dada 53 CBG RN AND COIN PGOU RATION sar ts aora 54 LEAN oo cora rra rr dei 54 IN OFE CHON REOUIR E MERI 0 qancraneit E eat cae 55 SERVICE INFORMAN 95 ages nessa aneaket cond 52 ERE s EEEIEE e EEE E de es 55 WARRANTY oa EEEE EEEE EEEE EEE EEEE EEEE EE EEEE EEEE 56 APPENDIX TRUMPET TAND STARTUP CURVE S urraca arco ETEEN aes a4 57 gt gt gt I A E nm D gt O g lt lt uN ae MTI U NOILDNAOYLNI GERRANS E 1 JINVNALNIVIN 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
23. MEDLEY MEDICATION SAFETY SYSTEM INFUSION PUMP MODULE Model 8100 DIRECTIONS FOR USE 0013 1300IN JINGOIN dINNd NOISNANI TABLE OF CONTENTS INTRODUCTION ABOUT TAES TSIEN erro cortar des aneny E aint pene ssresyaa 1 SS A OO Om IS 2 A N 4 GETTING STARTED WARNINGS AND CAUTIONS ooo 5 CONTROLS AND INDICATORS 5 cxicirctenpsqtnmameeisasganmihtianardeseguin aai ada Eea E aeai sees 10 INS MON PROCEDURE AS 12 ATTACHING AND DETACHING CHANNELS aaaea 12 START UP SEQUENCE secnursorrra ripio isa ia EEREN 12 PREPARING INFUSION ci cccenevachanshtnansteeadesionnsachanantaeaseanndsrsgnehachaerens ieuges oidos 13 DFA ga ae epee vs o Io vp4 A A E 15 PIER OIE oscense eae ies ee ad E E E eaten oops 15 SECONDARY MODE copccsyciintavveda napa nd heeewronast payed inpen arropado aie ane newts anaes atasca aora 23 SAIN CADEC pun scooter EE in E ER E OPTE EAE EEEE 27 O A EAEE EESE 29 CHANGING PRIMARY SOLUTION CONTAINER scnsri sertans senres utni ninpa eain aaa E E E 29 CHANGING AND RELOADING SET DURING INFUSION oaa 29 DRUG CALCULATION PARAMETERS csasosscaniisisdnpiddipsininpoteaiitaaid ipud Saeni iai E sedii kaisi haaba as 30 SETTING UP DRUG CALCULATION WITH DRUG LIBRARY o a 3l SETTING UP DRUG CALCULATION FOR NON LIBRARY DRUGS oa Be SETTING BOLUS DOSE DRUG CALCULATION WITH DRUG LIBRARY ooo 36 SETTING BOLUS DOSE DRUG CALCULATION FOR NON LIBRARY DRUGS aaan 38 ANESTHESIA MODE e e no o iar ES E aE a SEEREN as 41 Al RN O on III 44 REV
24. Units CONTI SETUP Press MAX RATE soft key to automatically calculate duration or press DURATION soft key and use numeric keypad entry keys to enter desired duration NOTE The MAX RATE soft key allows the bolus dose to be programmed to infuse at the maximum rate for that profile The bolus DURATION would be automatically calculated Press START soft key to begin bolus infusion BOLUS VTBI counts down on main screen Yong Calculation BOLUS DOSE 500 0 meg PATIENT Not Used lt 1 min BOLUS VTBI 0 313 mL Conc 1600 mcg mL gt Press Start to Begin Infusing Bolus Dose E Midtown Hospital Adult ICU A BOLUS VTBI 0 3 mL VOLUME AUDIO INFUSED ADJUST GETTING STARTED 39 ERRANEN M E 1 Setting Bolus Dose Drug Calculation for Non Library Drugs Continued 8 During any bolus infusion press CHANNEL SELECT key on Pump Module to see detail screen A ite Calculation BOLUS DOSE Dose Remaining 400 mcg Pt Weight Not Used Time Left lt 1 min L BOLUS VTBI 0 25 mL Conc 1600 mcg mL gt Press START to Continue Infusing Bolus Dose 9 At conclusion of bolus infusion e System beeps twice e BOLUS DOSE COMPLETE scrolls in Channel Message Display e Continuous infusion initiates e VTBI counts down in Main Display Stopping Bolus Dose Press CHANNEL SELECT key on Pump Module 2 Press STOP BOLUS soft key 3 To stop bolus and start continuous i
25. a patient weight e Flow rate Drug dose Drug concentration normalized for patient weight if specified by entering a patient weight 30 GETTING STARTED Setting Up Drug Calculation with Drug Library To access the Drug Library a hospital defined best practice data set must be uploaded and the Profiles feature enabled 1 Prime and load set as previously described Press CHANNEL SELECT key on Pump Module Press OPTIONS key on Programming Module ww E Press Drug Calculation Setup soft key WARNING D The Drug Calculation feature is to be used only by personnel properly trained in the administration of continuously infused medications Extreme caution should be exercised to ensure the correct entry of the drug calculation infusion parameters References in this document to specific drug and drug doses are only examples Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages NN Channel Options 1 of 1 Drug Calculation Setup Pressure Limit P Channel Labels gt Select an Option or EXIT 5 Press DRUG LIBRARY soft key A Drug Calculation 6 Press soft key next to desired drug and concentration Use alpha index speed select and or PAGE UP and PAGE DOWN soft keys to view available drugs concentrations Drug Calculation Adult ICU aminophylline 500mg 250mL bretylium 500 mg 250mL dopamine__ mg __ mL d
26. adjacent to symbol indicates the month and year of manufacture Consult operating instructions CAUTION Federal U S A law restricts this device to sale by or on the order of a physician Single Use Do not re use Product contains a particular element such as DEHP in fluid pathway Product DOES NOT contain a particular element such as set is latex free Drops per milliliter specification for product will be identified on drop symbol Product incorporates SmartSite Needle Free Valve Ports and should not be accessed by a needle Approximate set priming volume Expiration date for product will be identified near hour glass symbol 4 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 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 G EE G Z D JJ m UO To ensure proper performance of the MEDLEY Sy
27. cal 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 See packing Inserts for international warranty If applicable 56 MAINTENANCE APPENDIX Trumpet and Start Up Curves DESCRIPTION AND EXPLANATION OF TRUMPET AND START UP CURVES In this instrument as with all infusion systems the action of the pumping mechanism and variations in individual administration sets cause short term fluctuations in rate accuracy The following graphs show typical performance of the system for both Pressure and Resistance Modes in two ways 1 Accuracy during various time periods over which fluid delivery is measured trumpet curves 2 Delay in onset of fluid flow when infusion commences start up curves Trumpet curves are named for their characteristic shape They display discrete accuracy data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window Is reduced short
28. curacy therefore no significant change in short term variations result under these pressure conditions Effects of Negative Solution Container Heights With a negative head height of 0 5 meters the MEDLEY Pump Module typically exhibits a long term accuracy offset of approximately 3 1 from mean values Resulting trumpet observation points typically track those of accuracy therefore no significant change in short term variations result under negative head height conditions NOTE Tests conducted in accordance with IEC EN 60601 2 24 Particular requirements for safety of infusion pumps and controllers and AAMI ID26 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers using MEDLEY Gemini Model 2210 Administration Sets APPENDIX 57 D aa Y a Z z x Flow Rate mAh Flow Rate Error 0 02 Flow Rate Error Trumpet and Start Up Curves Continued Start Up at 0 1 ml h initial 0 20 0 18 0 16 0 14 0 12 0 10 0 08 0 06 0 04 0 02 0 00 100 110 120 0 10 20 30 40 50 60 70 80 90 Time min Trumpet Curve at 0 1 ml h initial 100 0 5 10 15 20 25 30 Observation Interval min Trumpet Curve at 0 1 mL h 72 hrs 0 5 10 15 20 25 30 Observation Interval min NOTE The plot range has been increased to 100 to allow visualization of the graph Start Up at 1 ml h initial 2 0 1
29. d bolus dose Enter patient weight Press DURATION soft key Press MAX RATE soft key to automatically calculate duration or use numeric keypad entry keys to enter desired duration NOTE The MAX RATE soft key allows the bolus dose to be programmed to infuse at the maximum rate for that profile The bolus DURATION would be automatically calculated Press START soft key to begin bolus infusion Main screen alternates between BOLUS VTBI and drug name with dose BOLUS DOSE 1 00 mg kg 70 00 kg 1 min BOLUS VTBI 17 5 mL Conc 4 mg mL gt Press Start to Begin Infusing Bolus Dose Midtown Hospital Adult ICU A Bolus VTBI 17 5 mL Midtown Hospital Adult ICU A lidocaine 1 mg kg Bolus VOLUME AUDIO INFUSED ADJUST GETTING STARTED 37 GsALYVLS ONILLAD Setting Bolus Dose Drug Calculation with Drug Library Continued 6 During any bolus infusion press CHANNEL SELECT key on Pump Module to see detail screen gt Press Start to Continue Infusing Bolus Dose PAUSE START 7 At conclusion of bolus infusion VTBI 241 3 mL e System beeps twice A m e BOLUS DOSE COMPLETE scrolls in Channel Message Display e Continuous infusion initiates e VTBI counts down in Main Display N F A F VOLUME AUDIO NOTE During continuous infusion main screen alternates between VTBI and drug name with dose Midtown Hospital Adult ICU A caine VOLUME AUDIO INFUSED ADJUST Setti
30. dose VOLUME AUDIO OU e Dose and drug name scroll in Channel Message Display e Main Display alternates between VTBI and drug name with dose Setting Up Drug Calculation for Non Library Drugs 1 Prime and load set as previously described WARNING 2 Press CHANNEL SELECT key on Pump Module The Drug Calculation feature is to be used only by personnel properly 3 Press OPTIONS key on Programming Module trained in the administration of continuously infused medications Extreme caution should be exercised to ensure the correct entry of the drug calculation infusion parameters References in this document to specific drug and drug doses are only examples Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages 4 Press Drug Calculation Setup soft key FEY Drug Calculation DRUG mca AMOUNT mcg ILUENT gt Enter Amount of Drug in Container DRUG LIBRARY GETTING STARTED 33 Setting Up Drug Calculation for Non Library Drugs Continued 5 Use numeric data entry keys to enter amount of drug added Drug Calculation to IV container 400 mcg ie mg 6 Press soft key for appropriate unit of measure for DRUG gram AMOUNT unit mEq gt Select Unit of Measure LIBRARY 7 Use numeric data entry keys to enter diluent volume FEY Drug Calculation 400 mg
31. e 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 filters and intra arterial infusion It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions ARI Hospital personnel must ensure the compatibility of the drugs as well as the performance of each channel as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates inaccurate pressure alarms and nuisance alarms ARI Do not use the MEDLEY System during Magnetic Resonance Imaging MRI ARI Use only MEDLEY Gemini Series administration sets The use of any other set may cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard ARI The use of positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site may impede the flow of common gravity only systems affecting their performance Hospital personnel must ensure the performance of the common IV site is satisfactory under these circumstances ARI References in this document to specific drugs and drug doses are for example only Refer to specific drug product labeling for information concerning appropriate administration techniques and dosages 6 GETTING ST
32. ea unit profile e Comparing user programming with hospital defined best practice guidelines e Providing a Guardrails Prompt if an out of limits entry is made Z JJ O J N O Z Occlusion Pressure The MEDLEY System provides a complete range of Downstream Occlusion Detection options including e Pump mode where the downstream occlusion alarm threshold is 525 mmHg at flow rates of 30 ml h or greater For rates lt 30 ml h the occlusion pressure is rate dependent to ensure rapid response to occlusions e Selectable pressure mode where the downstream occlusion alarm threshold can be adjusted by the user in 25 mmHg increments up to the maximum occlusion pressure of 525 mmHg e AutoRestart see previous page In addition the MEDLEY System provides fluid side occlusion detection Profiles The Profiles feature allows a unique set of system options profile to be configured to optimize system function for a specific hospital area or patient type A profile is comprised of a configuration with system settings and defaults customized by the user to best meet the needs of the profile area patient type Secondary Infusions Dual rate sequential piggyback Secondary infusions may be infused at delivery rates and volumes independent of the primary infusion parameters Automatic changeover occurs to the primary infusion parameters when the secondary infusion is complete if a MEDLEY Gemini Check Valve Administrat
33. ft key to return to main screen C 0 0 0 0 D 0 0 0 0 gt Select Channels to Clear or Press CLEAR ALL TOTAL CLEAR MAIN VOLUME ALL SCREEN Viewing and Clearing Volume Infused for Individual Channels 1 Press VOLUME INFUSED soft key Volume Infused TOTAL VOLUME mL aoip G m G p D JJ rr UO e Total Volume infused Primary Secondary and time de A 401 1 20 and date Volume Infused was last cleared is displayed B 42 5 72 i 2002 03 11 for each infusion channel 4781 E e If no key is pressed main screen appears after D 789 1 22o 30 seconds AA l l l gt Select Channels to Clear e To view Primary and Secondary volume s infused press jor Press CLEAR ALL __ PRI SEC CLEAR MAIN PRI SEC VOLUME soft key 2 Press soft key s corresponding to channel where volume intused Is to be cleared Volume Infused TOTAL VOLUME mL ganen A 401 1 o B ADS e C 478 1 2 ID 789 1 ooo gt Press CLEAR CHANNEL to Clear Selected PRI SEC CLEAR MAIN VOLUME CHANNEL SCREEN 3 Press CLEAR CHANNEL soft key Volume Infused TOTAL VOLUME mL St Al 401 1 200203 10 0 0 2002 03 11 C 478 1 Bho D 789 1 oo e Selected channel s volume is cleared e After 30 seconds main screen appears 4 Press MAIN SCREEN soft key to return to main screen gt Select Channels to Clear or Press CLEAR ALL PRI SEC CLEAR MAIN VOLUME ALL SCREEN
34. he MEDLEY System calculates the correct flow rate to achieve the desired dose OR enter the desired flow rate and the MEDLEY System calculates the corresponding drug dose The Dynamic Pressure Display is located just below the Channel Status information in the Main Display of the Programming Module If enabled it graphically displays the current patient side occlusion pressure set point and the current patient side operating pressure for that channel The flow rate range is from 0 1 to 999 ml h Rates between 0 1 and 99 9 may be selected in 0 1 mL h increments Rates from 100 to 999 mL h are selected in 1 mL h increments All MEDLEY Gemini Disposable Sets utilize a unique clamping device the Flo Stop Device to prevent inadvertent free flow when the set Is removed from the instrument The Guardrails Drug Library feature is a Drug Calculation mode available when the Profiles feature is enabled It provides a hospital defined list of up to 100 drugs and concentrations appropriate for use in the selected profile Using the Drug Library automates programming steps including the drug name drug amount and diluent volume and activates the hospital established best practice Guardrails Limit 2 INTRODUCTION Features Continued Guardrails Prompt The Guardrails Safety Software Is designed to help prevent programming errors by e Customizing device configurable settings to meet the need of the selected hospital ar
35. he port e Flush port s per facility protocol e Discard administration set per facility protocol Use only MEDLEY Gemini Series administration sets The use of any other set may cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard GETTING STARTED GsALYVLS ONILLAD 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 ECG monitoring system is not functioning under optimal conditions these currents may appear as artifacts simulating actual ECG readings To determine if ECG abnormalities are caused by patient condition or the ECG equipment place the infusion device on hold If the ECG readings become normal the ECG equipment requires attention Proper setup of the ECG equipment should eliminate these artifacts Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance Dropping Jarring Should an instrument be 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 Operating Environment lt q DANGER Not for use in the presence of flammable anesthetics Explosion risk if used in the presence of flammable anesthetic
36. ia Mode it is important to select the profile that corresponds with the care area the patient will be taken to when the Anesthesia Mode is discontinued This will ensure that the MEDLEY System will be in the correct profile following the use of the Anesthesia Mode Enabling Anesthesia Mode 1 Press OPTIONS key on Programming Module 2 Press Anesthesia Mode soft key Display Contrast Time of Day Power Down All Channels Anesthesia Mode Battery Runtime gt Select an Option or EXIT EXIT GETTING STARTED 41 Anesthesia Mode Continued Enabling Anesthesia Mode Continued 3 Press Enable soft key 4 Press CONFIRM soft key System Options Anesthesia Mode Enable Disable Air Detection 75 microliters Select an Option or Press CONFIRM 5 Press soft key corresponding to channel Anesthesia Mode infusion is to be programmed on 6 Program Anesthesia Mode infusion using same procedure as for any other continuous infusion NOTE In Anesthesia Mode when a channel with a drug calculation infusion is turned off and then turned back on pressing the RESTORE soft key will bypass the Drug Calculation Setup screen and go directly to the Continuous Infusion screen Disabling Anesthesia Mode The Anesthesia Mode can be disabled and normal operation resumed using either of the following three methods e System Options menu e Disconnecting system trom AC power e Connecting system to
37. imary parameters 48 ALARMS ADVISORIES AND PROMPTS Errors Error Meaning Response Channel Error System has detected an error on a Press CONFIRM soft key to silence pumping channel Infusion stops on alarm and continue operation of affected channel unaffected channels Replace Pump Module with an operational unit as required Service by qualified personnel is required gt gt gt I A E U nm D gt O g lt lt uN YS MTI U ALARMS ADVISORIES AND PROMPTS 49 THIS PAGE INTENTIONALLY LEFT BLANK 50 ALARMS ADVISORIES AND PROMPTS MAINTENANCE The MEDLEY System Technical Service Manual is available from ALARIS Medical Systems and includes 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 repalrable components Maintenance procedures are intended to be performed only by qualified personnel Specifications Accumulated Air Window Single Bolus Setting mL Volume Window Air that Causes Alarm 50 2 8 10 75 8 0 20 250 8 0 30 500 12 0 30 In Anesthesia Mode only Bolus Volume following Pressure Limit mmHg Occlusion Maximum Rate mL h 50 25 lt 0 3 mL 525 lt 0 6 mL Critical Volume 0 6 mL Dimensions 3 3 Wx8 9 H x 5 5
38. inistration Set Continued 4 Close roller clamp 5 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 6 Using a finger tip firmly push tubing toward back of Air in Line Detector 7 Close Pump Module door and open roller clamp Verify no fluid is flowing through drip chamber 7 1 Load upper tubing fitment 073 O O O Y f y Ke 2 Load Flo Stop Fitment fi EA 3 Firmly push tubing toward back of ee Alr in Line Detector Preparing Set to Deliver Primary Fluids with Gravity Infusion 1 Prime set per steps 1 4 in Loading Primary Administration Set section 2 Attach set to patient s vascular access device 3 Adjust flow rate with set roller clamp 14 GETTING STARTED Displays WF Tale EN Refer to the MEDLEY Programming Module Model 8000 Directions for Use for general information in the Main Display Title Bar Channel Status A VTBI 250 0 mL e Asolid Channel Letter display indicates channel is operating C e An outlined Channel Letter display indicates channel is attached and ready for use Soft Keys ADJUST Dynamic Pressure Disp
39. ion Set is used System Configuration The System Configuration mode provides the ability for qualified personnel to customize device settings If the Profiles feature is enabled the system settings defined for the selected profile are automatically activated Tamper Resist The Tamper Resist feature provides a quick one touch lockout of the front keypad Volume Duration The Volume Duration infusion option allows the user to program a volume to be infused VTBI and duration infusion time and the flow rate is automatically calculated Volume To Be Infused VTBI The volume to be intused VTBI range is from 0 1 to 9999 mL Volumes between 0 1 and 999 9 may be selected in 0 1 mL increments VTBIs trom 1000 to 9999 mL are selected in 1 mL increments INTRODUCTION 3 Symbols MM YYYY Ma R Only Single Use D O Y S XX m z 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 CSA C22 2 No 601 1 UL 2601 1 and IEC 60601 2 24 Electrical Shock Protection Rating Type CF Defibrillation proof Protection against fluid ingress Drip Proof Attention Refer to accompanying documentation IUI Connector Inter Unit Interface connector used to establish power and communications between the Programming Module and add on channels Manufacturing Date Number
40. l h Keep Vein Open Max Rate 999 ml h 0 1 999 mL h in 0 1 ml h increments to 99 9 then 1 0 mL h Increments from 100 to 999 mL h Max VTBI 9999 mL 0 1 9999 mL Pressure Dynamic Disabled Enabled Disabled Dynamic Pressure Display Pressure Mode Pump P Unlocked Pump P Selectable S Locked or Unlocked Profiles Disabled Enabled Disabled SEC to PRI Alert Enabled Enabled Disabled Secondary Disabled Enabled Disabled Dual Rate Sequential Piggybacking Volume Duration Infusion Disabled Enabled Disabled Check In and Configuration Refer to the MEDLEY Programming Module Model 8000 Directions for Use Refer to the MEDLEY Programming Module Model 8000 Directions for Use 54 MAINTENANCE Inspection Requirements 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 cla rie and alii e iia pco In 7 Failure to perform these inspections art Up Sequence section of this directions for use before eac may result in improper instrument usage of the instrument Regular inspections are not covered f operation under any contract or agreement offered by ALARIS Medical Systems and must be performed by the user REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Enclosure Each usage O Connector Each usage CLEANING As required START UP SEQUEN
41. lay Midtown Hospital Adult ICU A VTBI 250 0 mL Dynamic Pressure Display 5 Current operating pressure Ae indicated by solid bar D VOLUME AUDIO INFUSED ADJUST GERR AASEN M E 1 Patient side occlusion pressure set point is indicated by tick mark Primary Mode Primary Rate Volume Infusion NOTE Throughout this section the Main Display screens are aligned so that they coincide with the applicable step EY infusion Setup a zoi f _ __ mL h 1 Prime and load administration set as described in L Preparing Infusion section 2 Press CHANNEL SELECT key on desired Pump Module gt Select RATE GETTING STARTED 15 Primary Mode Continued Primary Rate Volume Infusion 3 Press RATE soft key and use numeric data entry keys to enter desired flow rate A Infusion Setup 40 mun ml gt Select VTBI 4 Press VTBI soft key and use numeric data entry keys to enter desired VTBI 5 Attach set to patient s vascular access device A Infusion Setup 40 mL n 250 mL gt Press START SECOND PAUSE ARY START 6 Verity correct infusion parameter entry and press START soft key on Programming Module NOTE The infusion may also be paused by pressing the PAUSE soft key on the Programming Module e Green Infusing Status Indicator illuminates e Channel Rate Display displays Rate e VTBI c
42. mHg at rates gt 30 mL h Varying level based on rate and patient back pressure at rates lt 30 mL h Selectable Mode User selected from 50 to 525 mmHg in 25 mmHg increments Operating Principle Positive displacement Rate Accuracy Rate accuracy of the MEDLEY Medication Safety System Is 5 at rates between 1 0 and 999 ml h and 5 5 at rates lt 1 0 ml h 95 of the time with 95 confidence under the conditions listed below Refer to the Trumpet and Start Up Curves for additional information Infusion Rate Range 0 1 to 999 mL h Ambient Temperature 68 4 F 20 2 C Source Container Height 20 inches above the top of the Pump Module Test Solution Distilled Water Distal Back pressure O mmHg 0 kPa Needle 18 gauge Set Model 2210 ARI Variations of head height back pressure or any combination of these may affect rate accuracy Factors that can influence head height and back pressure are IV set configuration IV solution viscosity and IV solution temperature Back pressure may also be affected by type of catheter Refer to the APPENDIX Trumpet and Start Up Curves for data on how these factors influence rate accuracy Time to Alarm Maximum Pressure Limit mmHg Rate mL h 50 525 1 lt 5 minutes lt 45 minutes 25 lt 15 seconds lt 2 minutes 52 MAINTENANCE Specifications Continued Volume to be Infused Range Increments Programming Increments mL mL
43. n 14 Open clamp on secondary set 99 mL gt Press START PAUSE PRIMARY START 24 GETTING STARTED Secondary Mode Continued 15 Verify correct infusion parameter input and press START soft key AV SEC VTBI 55 0 mL B VTBI 497 0 mL VIBI 57 0 mL e Channel Rate Display displays secondary rate D TBI 249 0 mL e Green Infusing Status Indicator illuminates e Secondary VTBI counts down in Main Display e SECONDARY scrolls in Channel Message Display e Upon completion of secondary infusion switchover alert sounds with six beeps unless disabled in system configuration primary rate displays and infusion continues at primary rate Changing Primary Infusion Parameter During Secondary Infusion 1 Press CHANNEL SELECT key on Pump Module F Infusion Setup SECONDARY 100 mL h 55 mL G EE G p D JJ m UO gt Press START 2 Press PRIMARY soft key on Programming Module EN Infusion Setup PRIMARY 40 mLh 240 mL gt Press START SECOND PAUSE START 3 Press RATE soft key EN infusion Setup PRIMARY _ 50 mL 240 mL 4 Use numeric data entry keys to enter desired primary Flow Rate gt Press START SECOND PAUSE ARY START GETTING STARTED 25 Secondary Mode Continued Changing Primary Infusion Parameter During Secondary Infusion Continued 5 Verify correct primary infusion
44. ndary Mode This mode is designed to support automatic secondary infusions WARNINGS piggybacking in the same instrument channel When the e Secondary applications require the secondary VTBI reaches zero a audio tone will sound indicating use of a check valve set on the completion of the secondary infusion The primary infusion primary IV line resumes automatically e The secondary solution container When the instrument is programmed and delivering in the must be higher than the primary secondary mode the primary infusion is temporarily stopped solution container and fluid is drawn from the secondary container Delivery from The secondary VTBI settings require consideration of such variables as factory overfill medication additions etc the primary container resumes when the fluid level in the secondary line is level with the fluid in the primary container NOTE Prepare the secondary container and set Lower the l Underestimating the volume will primary container using the hanger included with the secondary set If a flow sensor is being used it must be placed on the PaA the remaining secondary orimary line solution to be infused at the primary rate overestimating will result in the primary solution being infused at the secondary rate Multiple doses from a single container are not possible G m G Z D JJ m UO e The clamp on the secondary set must be opened If the clamp is
45. nfusion press Yes soft key 4 To stop continuous infusion press and hold CHANNEL OFF key for 2 seconds Restoring Bolus Dose A bolus dose can be restored after it has completed either prior to or after the channel has been turned off as indicated in the following sections Bolus Dose Completed Channel Not Turned Off 1 Press CHANNEL SELECT key on Pump Module Press BOLUS soft key Press RESTORE soft key oo Verity dosing parameters and press START soft key Midtown Hospital Adult ICU A VTBI 249 5 mL VOLUME AUDIO INFUSED ADJUST 40 GETTING STARTED Setting Bolus Dose Drug Calculation for Non Library Drugs Continued Restoring Bolus Dose Continued Bolus Dose Completed Channel Turned Off 1 Press CHANNEL SELECT key on Pump Module Press RESTORE soft key Verify Drug Calculation screen and press NEXT soft key Verify dosing parameters and press BOLUS soft key Press RESTORE soft key O E Verify dosing parameters and press START soft key Anesthesia Mode When the MEDLEY System is operating in Anesthesia Mode a channel can be paused indefinitely without an alarm and the alr In line limits can be set for up to 500 microliters Anesthesia Mode also makes it possible to have additional drugs in each profile which are only accessible when operating in Anesthesia Mode G m G Z D JJ m UO NOTE When the MEDLEY System is set up for use in Anesthes
46. ng Bolus Dose Drug Calculation for Non Library Drugs This section provides the procedure on how to program a bolus at the beginning of an infusion with a drug calculation programmed without the use of the Drug Library NOTE If Bolus is enabled the BOLUS DOSE soft key will appear in the Drug Calculation screen 1 Setup Drug Calculation as described in Setting Up Drug A Drug Calculation Calculation for Non Library Drugs section steps 1 15 CONTINUOUS INFUSION RATE 13 1 muh vts O mL DOSE mcg kg min Conc 1600 mcg mL gt Select VTBI SETUP BOLUS 38 GETTING STARTED Setting Bolus Dose Drug Calculation for Non Library Drugs Continued Press VTBI soft key Use numeric data entry keys to enter Volume to be Intused NOTE At rates less than 10 mL h the rate is displayed to two decimal places and the VTBI can be entered and is displayed to two decimal places Press BOLUS soft key A Drug Calculation CONTINUOUS INFUSION 13 1 mun _250 mL 5 mcg kg min Conc 1600 mcg mL gt Press START PAUSE SETUP BOLUS START Use numeric keypad entry keys to enter desired bolus dose Press soft key next to desired dosing unit NOTE In this example mcg was selected as the dosing unit so a PATIENT WEIGHT entry can not be made Fors Calculation RAI C TRI BOLUS VTBI Conc 1600 mcg mL gt Select the Desired Dosing
47. ng and loading instructions refer to the Start Up Sequence section of this document Contraindications None known INTRODUCTION 1 Features Anesthesia Mode AutoRestart Bolus Dose Channel Labels Drug Calculation Dynamic Pressure Display Flow Rates Free Flow Protection Guardrails Drug Library 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 The AutoRestart feature Is part of the MEDLEY System s advanced Downstream Occlusion Detection system If enabled the AutoRestart feature minimizes nuisance patient side occlusion alarms caused by momentary kinking of tubing IV pushes etc The Bolus Dose mode enables the clinician to program a bolus infusion It is possible to program a bolus using the Guardrails Drug Library or using the Drug Calculation feature The bolus infusion can be programmed with or without a continuous infusion following the bolus The Channel Label feature is available if the Profiles feature is enabled It provides a hospital defined list of labels which can be displayed in the Channel Message Display allowing the user to identity the channel with the solution being infused the catheter location or other helpful information The Drug Calculation mode allows the user to enter the desired drug dose and t
48. nt 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 nN a b repaired by anyone other than an authorized ALARIS Medical Systems service representative a 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 Systems and ALARIS Medi
49. ntrol and then press START soft key Clear occlusion press RESTART key or appropriate select control and then press START soft key Close door press RESTART key or appropriate channel select control and then press START soft key ALARMS ADVISORIES AND PROMPTS 47 gt gt gt I A E nm D gt O g Z y UM a m U Advisories Advisory Meaning Anesthesia Mode Bolus Dose Complete Checking Line Infusion Complete KVO Panel Locked Panel Unlocked Pause Secondary Anesthesia Mode has been enabled Channel is running in continuous infusion mode if programmed A patient side occlusion has occurred and AutoRestart feature is monitoring downstream pressure to determine if infusion can continue Programmed volume to be infused has been delivered channel is running at KVO rate Occurs following a key press when Tamper Resist feature Is active Occurs when Tamper Resist feature is deactivated Pause control has been pressed infusion is stopped A secondary infusion is in progress on indicated channel Response None None None Set up a new infusion or press CHANNEL OFF key If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of Programming Module None To resume infusion press RESTART key or press CHANNEL SELECT key and then press START soft key None When secondary VTBI 0 infusion will revert to programmed pr
50. opamine 400mg 250mL dopamine 800mg 250mL gt Select Drug Name EXIT GETTING STARTED 31 G m Z G 2 D JJ m UO Setting Up Drug Calculation with Drug Library Continued 7 Confirm selected drug concentration is drug to be administered 400mg in 250mL was selected e Press Yes soft key to continue programming a oei UNITS meg kg min e Press No soft key to change selection NOT BOLUSABLE e Bolus dose units appear If Bolus Dose is enabled e Anesthesia Mode appears if enabled gt Press Yes or No 8 DRUG AMOUNT DILUENT VOLUME TIME UNITS and DOSING Drug Salculation UNITS are automatically entered for selected drug PBL 250 m _ 70 kg TIME UNITS Min e f hospital practice guidelines identity selected drug as weight based system will prompt for a patient weight in kilograms units mecg kg min Conc 1600 mcg mL NOTE If a patient s weight has been previously entered it lSpress NEXT io Coni is automatically displayed It can be added without affecting the weight based continuous infusions on this channel e f selected drug is not weight based system will not permit a patient weight entry 9 Review drug calculation setup parameter If setup is correct press NEXT soft key to confirm 10 Press either RATE or DOSE soft key FY Dig Salgulation CONTINUOUS INFUSION mlh mL pose A mcg kg min Conc 1600 mcg mL
51. ounts down in Main Display e At completion of infusion an audio prompt sounds INFUSION COMPLETE KVO scrolls in Channel Message Display and red Alarm Status Indicator flashes Rate Display changes to KVO rate and KVO displays next to channel indicator in Main Display Primary Volume Duration Infusion 1 Prime and load administration set 2 Press CHANNEL SELECT key on desired Pump Module A Infusion Setup gt Select Rate or Restore VOLUME Midtown Hospital Adult ICU A VTBI 250 0 mL D VOLUME AUDIO INFUSED ADJUST mbh vrai ____ml Previous Infusion 16 GETTING STARTED Primary Mode Continued Primary Volume Duration Infusion Continued 3 Press VOLUME DURATION soft key FY infusion Setup RATE mh me DURATION h min gt Select VTBI RATE RESTORE VOLUME 4 Press VTBI soft key and use numeric data entry keys to enter FY infusion Setup desired VTBI RATE mlh 1000 mt CO G m Z G z D JJ m UO gt Select DURATION VOLUME 5 Press DURATION soft key and use numeric data entry keys to EN Infusion Setup enter desired duration of the infusion RATE 125 mLih 1000 mt _ 8 00 hh mm gt Press START RATE SECOND PAUSE a Oa START 6 Attach set to patient s vascular access device 7 Verify correct infusion parameter entry and press START soft key e Green Infusing Status Indicator illumina
52. overing inside surface of pumping unit Is not cut or torn 4 Check for loose parts 5 Perform Periodic Inspection see Inspection Requirements section in Maintenance chapter 6 Perform check in procedure see Check In and Configuration section in Maintenance chapter It the Pump Module 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 ALARIS Medical Systems Attaching and Detaching Channels Refer to the MEDLEY Programming Module Model 8000 Directions tor Use for detailed instructions on attaching and detaching channels Start Up Sequence Powering On the System 1 Connect MEDLEY Programming Module to an external AC power source 2 Press SYSTEM ON key on Programming Module 3 System self test begins e Diagnostics test causes all LED display segments and Status Indicator lights of attached channel s to illuminate briefly e Power Indicator illuminates 12 GETTING STARTED Start Up Sequence Continued Powering On the System Continued e Appropriate channel identification A B C or D Is displayed on attached channel s e An Audio tone sounds 4 Atcompletion of system on test New Patient screen appears on Programming Module NOTE Ifany of the following conditions are observed the Programming Module or the affected channel m
53. r one second and then released stops infusion on that channel deselects that channel and if only that channel had been operating system powers down Repeat for other operating channels to power off each channel Restart Key When pressed resumes operation of a previously paused or alarmed infusion on that channel Door Handle Channel Release Latch 10 GETTING STARTED Controls and Indicators Continued Front View Door Open IUI Connector Left not visible Upper Tubing Fitment Retainer Platen Upper Occluder Upper Pumping Finger Door Latch Cam Slide Lower Occluder Lower Pumping Finger a Lower Pressure Sensor ol e Mi a Flo Stop Recess Tubing Keeper iui il il Ure Air in Line Sensor GETTING STARTED 11 G Z G 2 D JJ rr UJ 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 Unpacking the Pump Module 1 Remove Pump Module from Its carton 2 Verify door operates freely 3 Verity membrane c
54. s DANGER A 1 00 moy EXPLOSI N HAZARD 8 GETTING STARTED 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 If this happens reposition the compatibility performance of this device away from the source of interference or turn off the device device and manually regulate the flow with the clamp and or monitor the vital parameters using an appropriate clinical alternative G m G Z D JJ m UO GETTING STARTED 9 Controls and Indicators Front Side View Door Closed IUI Connector Right Status Indicators not visible Alarm Infusing Standby IUI Connector Left red green yellow Rate Display Channel Message Display Channel Identification Channel Select Key When pressed selects corresponding channel for infusion parameter entry and infusion setup Pause Key When pressed during an infusion temporarily stops infusion on that channel After 2 minutes PRESS START visual and audio prompt begins Channel Off Key When pressed and held fo
55. ss soft key for desired label PLY chame Label Display m 0 9 NaCl A E Z e Selected label will scroll in Channel Message Display 7 Z l 3 NaCl F J M e Use alpha index speed select and BACK soft keys and or CVVHDF Dialysate ko z PAGE UP and PAGE DOWN soft keys to view available NE Ppr gt labels Epidural u z w gt Select Channel Label Channel Label Display Adult ICU Peripherial Art Line Replacement Solution Swan Triple Lumen gt Select Channel Label Pace Dore PAGE 5 Press START soft key or program infusion as previously described GETTING STARTED 27 Channel Labels Continued Removing Channel Label 1 Press CHANNEL SELECT key on desired Pump Module 2 Press OPTIONS key on Programming Module w Press Channel Labels soft key FY channel Options 1 of 1 Drug Calculation Setup Pressure Limit P Channel Labels gt Select an Option or EXIT EXIT 4 Press CLEAR LABEL soft key Labels stop scrolling A Channel Label Display Adult ICU 0 9 NaCl A E 3 NaCl F J CVVHDF Dialysate K O D5 1 2 NS P T Epidural U Z gt Select Channel Label CLEAR PAGE ENE LABEL DOWN 5 Press START soft key EN Infusion Setup 50 mL h 240 mL gt Press START VOLUME SECOND 28 GETTING STARTED Powering Off Powering Off a Channel 1 Press and hold CHANNEL OFF key on channel s for one second Powering
56. stem and to reduce potential injury observe the following precautions Epidural Administration WARNING The MEDLEY System can be used for epidural administration Epidural administration of drugs of anesthetic and analgesic drugs This application is only other than those indicated for appropriate when using analgesics and anesthetics labeled epidural use could result in serious for continuous epidural administration and catheters injury to the patient intended specifically for epidural use Use only a MEDLEY Gemini Series set without a Y connector or WARNING A taludes injection port tor epidural infusions It is strongly recommended that the e Epidural administration of anesthetic drugs Use infusion pump source container and indwelling catheters specifically indicated for short term MEDLEY Gemini Administration Set 96 hours or less anesthetic epidural drug delivery used for epidural drug delivery be e Epidural administration of analgesic drugs Use indwelling Clearly differentiated from those used catheters specifically indicated for either short term or for other types of administration long term analgesic epidural drug delivery GETTING STARTED 5 Warnings and Cautions Continued CA 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 A S This infusion device is a positiv
57. tes e Channel Rate Display displays Rate e VTBI counts down in Main Display e At completion of infusion a An audio prompt sounds b INFUSION COMPLETE KVO scrolls in Channel Message Display Red Alarm Status Indicator flashes Rate Display changes to KVO rate KVO displays next to channel indicator in Main Display Channel infuses at KVO rate SDan GETTING STARTED 17 Primary Mode Continued Pausing an Infusion 1 Press PAUSE key on Pump Module eu oe e PAUSE scrolls in Channel Message Display A B VTBI 497 0 mL e PAUSED appears next to appropriate channel in Main C vIBi 57 0mL Display D VT8I 249 0 mL e Yellow Standby Status Indicator illuminates e After two minutes PAUSE RESTART CHANNEL visual and audio prompts begin 2 To reinitiate an infusion e Press RESTART key on Pump Module OR e Press CHANNEL SELECT key and press START soft key Restarting an Infusion Following Infusion Complete KVO 1 Press CHANNEL SELECT key on Pump Module FN infusion Setup 40 min O mL gt Select VTBI VOLUME RESTORE Aa 2 Press VTBI soft key on Programming Module and use F infusion Setup numeric data entry keys to enter desired VTBI or press AO muh RESTORE soft key to bring back original volume to be _500 mL infused from system memory 3 Replace solution container and refill drip chamber if necessary gt Press START 4 ahi correct inf
58. the Service Information section of this document About the System INTRODUCTION bout the System The MEDLEY Medication Safety System is a modular infusion 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 Z JJ O J N O Z The MEDLEY Pump Module is intended for facilities that utilize infusion pumps for the delivery of fluids medications blood and blood products using continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous IV intra arterial IA subcutaneous epidural enteral or irrigation of fluid spaces The MEDLEY Medication Safety System consists of the Programming Module Model 8000 the Guardrails Safety Software and detachable modules or channels which provide infusion or monitoring capabilities This document provides directions for use for the Model 8100 Infusion Pump Module Please read all instructions for both the Pump Module and Programming Module before using the device The MEDLEY System uses a wide variety of ALARIS MEDLEY Gemini Administration Sets The sets are designed for use with the Pump Module as well as for gravity flow stand alone use For specific administration set instructions refer to the directions for use provided with the set For set primi
59. usion parameter entry and press START soft ey i 18 GETTING STARTED Primary Mode Continued Changing Rate or VTBI During an Infusion 1 Press CHANNEL SELECT key on Pump Module F infusion Setup 40 muh 240 mL 2 Press either RATE or VTBI soft key on Programming Module gt Press START SECOND PAUSE ARY START 3 Use numeric data entry keys or Up and Down keys for Rate Y infusion Setup titration to enter desired parameter _50 mun 240 mL 4 Verity correct infusion parameter entry and press START soft key G m G p D JJ m UO gt Press START SECOND PAUSE START Stopping an Infusion on a Channel Press and hold CHANNEL OFF key on Pump Module for one second NOTE The channel will initiate the power down at the release of the CHANNEL OFF key Selecting Pressure Mode Pump P Selectable S 1 Press CHANNEL SELECT key on Pump Module MN channel Options 1 of 1 Drug Calculation Setup 2 Press OPTIONS key on Programming Module Pressure Limit P Channel Labels gt Select an Option or EXIT GETTING STARTED 19 Primary Mode Continued Selecting Pressure Mode Pump P Selectable S Continued Pressure Limit Selection 3 Press Pressure Limits soft key 4 Press either Pump or Selectable pressure soft key If Selectable is pressed continue with next step otherwise proceed to
60. usion stops on affected channel The Flo Stop Device is in open position while door is open Indicates either upstream occlusion or empty container Infusion stops on affected channel Increased back pressure sensed while infusing in the pump delivery mode Infusion stops on affected channel A partial occlusion of the patient side of IV line has been detected by the AutoRestart feature Door was opened during an infusion and then closed Infusion stops on affected channel Response Clear air from line and press RESET soft key and then press RESTART key to continue infusion Ensure tubing is properly installed in Air in Line Detector If air is present clear air from administration set Press RESTART key or appropriate CHANNEL SELECT key and then press START soft key Press CONFIRM soft key to silence alarm and clear message from screen Reattach channel if desired If alarm is still present replace channel with an operable instrument Close roller clamp remove and reinstall administration set close door open roller clamp and then press RESTART key Close door press RESTART key or appropriate select control and then press START soft key Close roller clamp on administration set or close door Clear occlusion on fluid side of device If necessary refill drip chamber Press RESTART or CHANNEL SELECT key and then press START soft key Clear occlusion press RESTART key or appropriate select co
61. ust be removed from use and inspected by gualified personnel e LED segments are not illuminated during system on test e Indicator lights do not illuminate e Appropriate channel identification A B C or D is not displayed e Audio tone does not sound e Main Display does not appear backlit appears irregular or has evidence of a row of pixels not functioning properly G G Z D JJ mH UO If the affected channel operates normally when it is attached via the alternate IUI connector it may be used until a replacement channel can be substituted Preparing Infusion Preparing Primary Solution Container Prepare the primary solution container in accordance with the manufacturer s directions for use Preparing Primary Administration Set Use only a MEDLEY Gemini Series administration set refer to Set Compatibility Card for a list of compatible sets Open the administration set package remove the set and close the roller clamp Refer to the set s Directions For Use on the administration set packaging Loading Primary Administration Set 1 W N Insert set spike into prepared fluid container following accepted hospital procedure and hang container 20 inches above Pump Module Fill drip chamber to 2 3 full Open roller clamp slowly to prime tubing and clear air from injection sites and tubing fitments GETTING STARTED 13 Preparing Infusion Continued Loading Primary Adm

Alaris Medley Pump Module 8100 Version 4b

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