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Alaris Medley 8000 Manual(1)

1. eee eben teen eee 35 Battery Typeraind Charging s 12 o O E st EPRE ETEESI NEEE A Oe eee ET EE 35 Battery Changes 2 inti bibl bee fd edd gee ad nd a ee bhi 35 Battery a A N 36 Battery Cautions and Disposal 0 ccc eet bebe ete eet beet 36 CEEANING pees datas ates 37 38 SERVICE INFORMATION 6 scccscctsenas ae edaeir enerne sai bi E pe Ea EEE due Danek salmaaa baat 38 Technical Support ie6 manesis Aioktandsaumipsaphetasuaaedaes 39 aa dle stein oer 40 ii TABLE OF CONTENTS Programming Module 8000 Series Directions for Use INTRODUCTION SOSA About the System The Medley Medication Safety System is a modular infusion and monitoring system intended for use in today s growing professional healthcare environment for use in adult pediatric and neonatal care It consists of the Programming Module 8000 Series the Guardrails Safety Software and up to four detachable modules or channels which provide infusion or monitoring c
2. 9 ATTACHING AND 9 Attaching MOGUIE S rere scerceryseds 4 x Renan Ae hatetie aan esto peace anes EET Ae aaa alee ete Re 9 Detaching MOdule S 10 Adding Module s While System is Powered On 0 2 000 c cece eect eee eet cette 10 DNS ee wee Staessen 11 Maim Display ca Bae eden 11 12 START UR ate 12 Powering On SYSt6Ms cc 252o0c0 r E 12 Responding to Maintenance Reminder 0 006 00 cece cece EEEE EEEE EEEE eee 13 Selecting New Patient and Profile ccc nce EEEE EEEE 14 Entering Patient a a Ea a 17 Modifying iaaa 18 ADJUSTING AUDIO VOLUME lt os Bina eae se aa G a a dee eee od diac elated 20 SETTING UP TIME tae ee adden ad es aladdin E EE Gane cay 20 REVIEWING SYSTEM CONFIGURATION 2 0 0 0
3. eee 21 REVIEWING SERIAL NUMBER pies E ONNA R a eben aoe da eee eee Runge knee 22 REVIEWING SOFTWARE VERSION 0 0 0 0050 cece cece cnc ene 29 POWERING OFF aranaren mre ia aaga E 24 Powering 24 Powering Off Module 13 24 LOCKING UNLOCKING TAMPER beeen 25 COMPUTER LINK ieres E E E E E A E EE E E EEFE E n S E EEES 26 ALARMS ERRORS MESSAGES soono ta tousen eea a u en ee Meld aba aided NEEE A TETERE COSE 27 AUDIO CHARACTERISTICS orri Anaa E E A E E Aa a a NA AR 28 a EEEE DNE EE EEES 29 E R a ESSA e AA a AS 29 MESSAGES aaa aR a a e aa EEE a ARE eas E aY 30 MAINTENANCE SPECIFICATIONS oosten eek en e A N EEEE DA 33 SYSTEM CONFIGURABLE SETTINGS En EKER i 94 Sagetaad 35 Programming Module 8000 Series TABLE OF CONTENTS Directions for Use MAINTENANCE Continued BATTERY CARE AND
4. 2 gt A m Options Key When pressed allows access to available System or Channel Up Down Arrows When Options pressed increases or decreases parameter with each key press or scrolls up and down when Soft Keys see above pressed and held Enter Key When pressed illuminated indicates Medley confirms current parameter entry System is operating on battery power ete az _ J Cancel Key When pressed sequentially backs out of current setup sequence Battery Indicator When Power Indicator When illuminated indicates Medley System is connected to an AC power source Clear Key When pressed clears current r selected parameter settin Computer Monitor Mode to 0 9 Indicator When illuminated indicates Medley System is connected to a server or Decimal Key When pressed inserts a decimal point in numeric data Numeric Keypad Module Release Latch computer When blinking When pressed allows indicates data transfer module to be removed Programming Module 8000 Series GETTING STARTED 7 Directions for Use Operating Features Controls and Indicators Continued Rear View IUI Connector Right wl J 7 7 N F SJ h Use this bolt to reorient Pole Clamp 90 for attachment to a bed rail instead of a pole A P Power Cord Strap
5. Primary Audio Speaker Connector Plug over RJ45 Communication Data Port 8 GETTING STARTED Programming Module 8000 Series Directions for Use Installation Instruments are tested and calibrated before they are packaged for shipment To ensure proper operation after shipment it is recommended that an incoming inspection be performed before placing the instrument in use Prior to placing the Medley System in use 1 Perform check in procedure per Medley Maintenance Software User Manual Model 8970C or later 2 Verify whether or not Profiles feature has been enabled Reference Reviewing System Configuration section in Getting Started chapter NOTE To enable the Profiles feature a hospital defined best practice data set must be uploaded to the m Programming Module o gt A m Attaching and Detaching Modules Modules can be attached to either side of the Programming Module or to either side of another module The process to attach or detach is the same for either side whether attaching detaching to from a Programming Module or another module Attaching Module s 1 Position free module at a 45 angle aligning IUI WARNING connectors When properly secured snapped 2 Rotate free module down against Programming Module or the bottom latch provides a very attached module until bottom latch snaps in place secure connection between modules
6. Replace Battery Last module powering off System shuts off in indicated number of seconds Occurs at System On Battery has less than 50 of original capacity Press any key except SYSTEM ON key to cancel power down sequence Press either SYSTEM OFF or CONFIRM soft key to continue normal operation with reduced battery capacity Service by qualified personnel is required Programming Module 8000 Series Directions for Use ALARMS ERRORS MESSAGES 31 gt gt sI nS nw gt m O D DO n THIS PAGE INTENTIONALLY LEFT BLANK 32 ALARMS ERRORS MESSAGES Programming Module 8000 Series Directions for Use The Medley System Technical Service Manual is available from 5 Medical Systems It includes routine service schedules interconnect diagrams component parts lists and descriptions test procedures and other technical information to assist qualified service personnel in repair and maintenance of the instrument s repairable components Maintenance procedures are intended to be performed only by qualified personnel using the service manual and Medley Maintenance Software Specifications Battery Operation Battery run time is a function of the number of modules attached and module activity With a new fully charged battery the system will operate as follows before a BATTERY DISCHARGED message occurs e 8 hours with 1 Pump Module infusing at 25 mL h e 4h
7. Adult ICU A 250 0 mL B 5 5 PANEL LOCKED VOLUME AUDIO INFUSED ADJUST Midtown Hospital Adult ICU A VTBI 250 0 mL 5 5 PANEL UNLOCKED VOLUME AUDIO INFUSED ADJUST Programming Module 8000 Series Directions for Use GETTING STARTED 25 m 2 gt A m Computer Link The optional Computer Link feature allows a hospital facility computer to interact with the instrument The computer cannot start or stop the instrument set the rate or make any change in status If the feature is off the computer cannot communicate with the instrument The Computer Link option is available in the Maintenance Mode The computer interface uses a three wire RS 232 signal definition through an RJ45 type connector The table to the right shows the pin definition Do not connect anything to the unused pins Qualified service personnel can turn the Computer Link feature on or off CAUTION Only systems that have been tested and certified in compliance to IEC 601 1 60601 standard should be connected to the Medley System Computer Connections port CAUTION Use of accessories or cables other than those specified may result in degraded electromagnetic compatibility performance of this device Pin Number Description 4 Ground 5 RS 232 TxD out of Programming Module RS 232
8. DOWN gt Press Yes or No Powering Off Module Press and hold CHANNEL OFF key until a beep is heard approximately 1 5 seconds and then release to initiate power down NOTE To interrupt the power down sequence quickly press any one of the numeric keys on the Programming Module e During power off sequence Main Display flashes Powering Down Once all attached modules are powered off Programming Module automatically powers down 24 GETTING STARTED Programming Module 8000 Series Directions for Use Locking Unlocking Tamper Resist 1 Initiate operation of desired modules 2 Press and hold Tamper Resist Switch on back of Programming Module for three to four seconds An advisory tone and a three second PANEL LOCKED prompt on Main Display confirm activation When Tamper Resist is active keypad panel is locked however clinician may e Silence key for audio alarm e View volume s infused e View and test audio alarm setting e View selected parameters on SpO Module Any other key press will result in a visual PANEL LOCKED prompt and if Key Click Audio is enabled an illegal key press audio advisory 3 To unlock keypad panel press and hold Tamper Resist Switch for three to four seconds A three second PANEL UNLOCKED prompt on Main Display and if Key Click Audio is enabled an advisory tone confirms Tamper Resist is off Midtown Hospital
9. Enabled Disabled Max Patient Weight 500 kg 0 1 500 kg Patient ID Entry Disabled Enabled Disabled PM Reminder Enabled Enabled Disabled Preventive Maintenance Profiles Disabled Enabled Disabled Tamper Resist Disabled Enabled Disabled 34 MAINTENANCE Programming Module 8000 Series Directions for Use Storage Plug the Programming Module into an AC outlet during storage to ensure a fully charged battery when needed AC indicator light will be on whenever the Programming Module is plugged in Battery Care and Maintenance Battery Type and Charging The Medley Programming Module is equipped with a 12 volt 4000 mAh nickel metal hydride battery The battery is charging whenever the instrument is plugged into an AC receptacle The life expectancy of the battery is dependent on the amount of use the depth of discharge and the state of the charge that is maintained Generally the battery will have the longest life if the instrument is plugged in and battery use is infrequent Frequent use of battery power and insufficient battery charge cycles will significantly decrease the life of the battery The quality of the battery is also a significant factor in determining battery life and runtime The battery cannot be repaired and should not be opened Replace the battery with the same type size and voltage rating Use of any other brand may yield poor performance and is not recommended Batteries should be charged in a ro
10. ID section PT E U Y Last used profile displays ee p Zz gt Enter Patient ID and Press CONFIRM EXIT CONFIRM OR confirm programming is for same patient and retain all stored patient parameters press No soft key e Last used profile displays NOTE If the Profiles feature is disabled the main menu appears 2 Select correct profile Midtown Hospital To accept current profile press Yes soft key Profile e Main screen appears OR To change profile press No soft key and continue with next step gt Select Yes or No e Profile selection screen appears 16 GETTING STARTED Programming Module 8000 Series Directions for Use Start Up Continued Selecting New Patient and Profile Options Continued Patient ID Entry Feature Enabled Continued Midtown Hospital Profiles 5 1 of 2 3 select a profile press corresponding left soft key Adult General Care NOTE To view additional choices press PAGE DOWN soft Neonatal key Peds ICU 4 Toconfirm profile selection press CONFIRM soft key e Main screen appears SORR no Entering Patient ID Po When the Patient ID Entry feature is disabled the Patient ID Entry screen can only be accessed through the Systems 0 Options menu To enter a patient ID begin with step 1 of the following procedure Whe
11. If not properly latched a NOTES module can be dislodged during operation e Individual hospital facility may choose to permanently attach modules To remove permanently attached modules contact qualified service personnel e Application of adhesive tape or other materials to the sides of the Programming Module and modules may prevent proper latching Programming Module 8000 Series GETTING STARTED 9 Directions for Use Attaching and Detaching Modules Continued Detaching Module s 1 Ensure module s is powered off before detaching 2 Push module release latch located directly below IUI connectors and then rotate module s up and away from 6 Programming Module or attached module opposite to eu motion shown above to disengage connectors o S e System reidentifies and shows appropriate _ module identification A B C or D from left to right O000en OO00eH 0000 0000 6 Z ooo onl e Appropriate module position s A B or C for remaining module s appear on Main Display 5 NOTE The Medley Medication Safety System is designed to operate a maximum of four infusion or monitoring modules Release Latch Modules added in excess of four will not be recognized by the system The module s can be attached in
12. any position however when mounted on an IV pole it is recommended that a balanced configuration be maintained Adding Module s While System is Powered On Add module as described in Attaching Module s IUI Connectors e System tests module causing all LED segments and indicator lights of displays to illuminate briefly e Appropriate module identification display A B C or D illuminates Modules are always labeled left to right so if a module is added to left of other modules all modules will be reidentified Module reidentification does NOT interrupt or affect infusion or monitoring on active modules 5 e Module positions A B C or D appear on Main Display Q000en Q000e QO0008 0000 Z NOTE If any of the following conditions are observed the affected module must be removed from use and inspected by qualified personnel Ceai LED segments are not illuminated on displays during power on test e Indicator lights do not illuminate e Appropriate module identification A B C or D is not displayed If the affected module operates normally when it is attached via the alternate IUI connector it may be used until a replacement module can be substituted 10 GETTING STARTED Programming Module 8000 Series Directions for Us
13. operational instrument Very Low Battery lt 5 minutes to Battery has five minutes or less of Connect AC power cord to power system shutdown power at current power source alarm will be silenced consumption rate before operation stops gt SSS SSS 5 rs Error Meaning Response R m Channel Error Error detected Operation stops on To silence alarm and continue m a affected module operation of unaffected modules 0o press CONFIRM soft key Replace a module with an operational instrument as required Service by qualified personnel is required Defective Battery Defective battery detected To power down system press SYSTEM OFF soft key or to continue temporary operation while an operational Programming Module can be located press SILENCE key Service by qualified personnel is required Hardware Detected Error Error detected on Programming Press SYSTEM ON key to power Module Operation stops on all down system Replace modules Programming Module with an operational system Service by qualified personnel is required Programming Module 8000 Series ALARMS ERRORS MESSAGES 29 Directions for Use Errors Continued Error Meaning Response Missing Battery Battery detected as not present or not connected Power Supply Error Power supply system malfunction detected System Error Error detected on Programming Module Operation continues on all attached modules To power down system press SYSTEM
14. 0 HK 1006006 IT 0 225 158 JP 1 816 872 2 594 604 NL 0 225 158 SE 0 225 158 TW NI 107963 UK 0 225 158 0 422 855 0 431 310 Other Patents Pending 147026 007 2001 2004 ALARIS Medical Systems Inc All Rights Reserved Programming Module 8000 Series Directions for Use
15. ALARIS MEDICAL SYSTEMS Medication Safety System Programming Module 8000 Series Directions for Use 93435 0008 JINGOW ONINWVeSOdd GENERAL CONTACT INFORMATION Customer Advocacy North America Clinical and product application support Phone 800 854 7128 Ext 7812 E Mail CustomerFeedback alarismed com Technical Support North America Maintenance and service information support United States Canada Phone Phone 858 458 6003 Eastern 800 908 9918 800 854 7128 Ext 6003 Western 800 908 9919 Customer Care North America Instrument return service assistance and order placement United States Canada Phone Phone 800 482 4822 800 387 8309 TABLE OF CONTENTS INTRODUCTION ABOUT TESS YSU EM uno e eanna a Sag win a IOR E a DiS E EAE EO TE 1 FEATURES AND DEFINITIONS dei dengan eener E EEEREN E E EO E EE odd EEE E Ra 2 NOLES i E R EE es eed ARES AE 4 GETTING STARTED WARNINGS AND CAUTIONS eeporabebilnereaewadaral burke see eeanadan 5 OPERATING FEATURES CONTROLS AND cece cect 7 5
16. ANCE 33 Directions for Use Specifications Continued NOTES 1 Power Cords North America To ensure correct polarity and grounding reliability use power cords that incorporate a NEMA 5 15P 125V or NEMA 6 15P 250V plug only 2 Power Cords International Use only cords that comply with IEC 60245 or IEC 60227 designation 53 and local electrical codes and or regulations 3 Compliance to Standards The Medley Medication Safety System has been assessed and complies with the following standards UL 60601 1 CSA 22 2 No 601 1 including A1 and A2 IEC EN 60601 2 24 IEC EN 60601 1 2 and AAMI ID26 System Configurable Settings If the configuration settings need to be changed from the Factory Default settings reference the applicable Technical Service Manual or contact ALARIS Medical Systems Technical Support for technical troubleshooting and preventive maintenance information 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 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 Dose Checking Always Always Smart Key Click Audio Enabled
17. M ON Tamper Resist activate deactivate switch 4 INTRODUCTION Programming Module 8000 Series Directions for Use GETTING STARTED eee Warnings and Cautions Warnings and Cautions are provided throughout this R Only Directions for Use DFU to provide information needed to safely and effectively use the Medley Medication Safety System and its accessories Module specific Warnings and Cautions are covered in the applicable module s DFU A Ge els ag is an alert to an imminent hazard which could result in serious personal injury and or product damage if proper procedures are not followed lb lcs is an alert to a potential hazard which could result in serious personal injury and or product damage if proper procedures are not followed A is an alert to a potential hazard which could result in minor personal injury and or product damage if proper procedures are not followed m 4 gt A m 5 lt DANGER gt Explosion risk if used in the presence of flammable anesthetics oNN e When properly secured snapped the bottom latch provides a very secure connection between modules If not properly latched a module can be dislodged during operation Do not use the Medley System near Magnetic Resonance Imaging MRI Disconnect from main AC and battery power when performing maintenance e Electrical shock hazard Do not open case Refer to qualifi
18. OFF soft key or to continue temporary operation while an operational Programming Module can be located press SILENCE key Service by qualified personnel is required Disconnect AC power immediately To power down system press SYSTEM OFF soft key or to continue operation under battery power while an operational Programming Module can be located press SILENCE key Service by qualified personnel is required To power down system press SYSTEM OFF soft key or to continue temporary operation while an operational Programming Module can be located press SILENCE key Service by qualified personnel is required Messages Message Meaning Response Battery Run Time X X hours AC power cord is disconnected from power source Approximate remaining battery run time under current power consumption rate is displayed Low Battery Low battery threshold sensed remaining battery run time is limited Panel Locked Tamper Resist feature is active and key was pressed Panel Unlocked Tamper Resist feature deactivated None Connect AC power cord to power source as soon as possible Connect AC power cord to power source alarm will be silenced If appropriate deactivate Tamper Resist feature using Tamper Resist Control on back of Programming Module None 30 ALARMS ERRORS MESSAGES Programming Module 8000 Series Directions for Use Messages Continued Message Meaning Response Powering Down
19. Restore such batteries to original performance by repeating one or two cycles of fully charging and fully discharging Some temporary reduction in capacity might become apparent if the battery is partially discharged repeatedly Doing one or two cycles of full discharge and full charge can restore full performance Battery Cautions and Disposal Battery replacement should be performed by qualified service personnel while the instrument is not in use CAUTION DO NOT open incinerate or short circuit Worn out batteries must be disposed of properly according to local regulations 36 MAINTENANCE Programming Module 8000 Series Directions for Use NOT spray cleaning fluids directly onto the instrument or WARNING immerse the instrument in fluids Turn the instrument off and unplug DO NOT use solutions containing phosphoric acid Foamy the power cord from the AC power Q amp A aromatic solvents naphtha paint thinner source before cleaning Do not etc chlorinated solvents Trichloroethane MEK spray fluids directly onto the rear Toluene etc ammonia acetone benzene xylene case of the instrument Do not or alcohol other than as specified below steam autoclave EtO sterilize immerse the instrument or allow fluids to enter the instrument case Failure to follow these instructions may result in an electrical hazard DO NOT use hard or pointed objects to clean any part of the instrument Acceptable cl
20. RxD into Programming Module CAUTION To assure continued electromagnetic compatibility performance the communications cable which attaches to the instrument should be a category 5 type cable no longer than 3 meters 26 GETTING STARTED Programming Module 8000 Series Directions for Use ALARMS ERRORS MESSAGES To enhance safety and ease of operation the Medley System provides a full range of audio and visual alarms errors and messages NOTE 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 regulate the flow with the clamp and or monitor the vital parameters using an appropriate clinical alternative Advisory Message A sequence of audio and or visual signals indicating operating status of Medley Medication Safety System Audio may be silenced for approximately two minutes by pressing SILENCE key Alarm An audio and visual signal that a potentially unsafe condition is present Immediate action is required Audio may be silenced for approximately two minutes by pressing SILENCE key Error An audio and or visual signal that a failure has been detected Immediate action is required Guardrails Alert A visual message to help reduce programming errors b
21. apabilities 2 O NOTE The Medley Programming Module name will be changing in the near future to Medley Point of Care Unit During this transition there will be a period of time when screen displays software and instrument labeling might reflect either Programming Module or Point of Care Unit The Medley Programming Module is the core of the Medley System and provides a common user interface for programming infusions and monitoring which helps to reduce complexity at the point of care Guardrails Safety Software for the Medley System brings a new level of medication error prevention to the point of patient care The Guardrails Safety Software features medication dosing guidelines for up to ten patient specific care areas referred to as profiles Each profile contains a specific drug library and channel labels as well as instrument configurations appropriate for the care area Optional drug specific Guardrails Clinical Advisories provide visual messages Dosing limits for each drug entry may be either Guardrails Hard Limits that cannot be overridden during infusion programming or Guardrails Soft Limits that can be overridden based on clinical requirements A data set is developed and approved by the facility s own multi disciplinary team using the Guardrails Editor the PC based authoring tool A data set is then transferred to the Medley System by qualified pers
22. ay 1 Press OPTIONS key System Options Time of Day 2 Press Time of Day soft key Time Current time Change 09 00 CONFIRM 3 Press Change Time soft key System Options Time of Day Current time Time 20 GETTING STARTED Programming Module 8000 Series Directions for Use 4 5 Setting Up Time of Day Continued Enter current Time of Day Press Confirm soft key NOTE The format is a 24 hour clock military time System Options Time of Day Current time Change 14 30 Time CONFIRM Reviewing System Configuration 1 Press OPTIONS key 2 Press PAGE DOWN soft key System Config Module 1 of 2 m Factory Default Yes 3 Press System Configuration soft key Shared Infusion Settings 4 Select Programming Module Programming Module Pump Module SPO2 Module gt Press CANCEL or EXIT 5 review various system configuration settings press System Config PM 1 of 2 PAGE UP and PAGE DOWN soft keys Alarm audio Profile 1 Anesthesia Mode Disabled NOTES Battery meter Disabled e The Profiles option is listed only if it is disabled Clock setup 09 00 e The Dose Checking option is listed only if the Profiles Key click audio Enabled option is enabled and a valid data set is present sSelect an Option or EXIT EXIT BOWN Sys
23. ctions REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECT FOR DAMAGE Exterior Surface Each usage Pole Clamp Each usage Power Cord Each usage Keypad Each usage CLEANING As required Start Up Each usage Failure to perform these inspections may result in improper instrument operation CAUTION Regular and preventive maintenance inspections should only be performed by qualified service personnel Service Information NOTE If the 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 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 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 D During servicing an instrument s configuration settings might be reset to the factory defaults Qualified hospital facility personnel are responsible for checking in the instrum
24. e Displays The displays illustrated throughout this document are for illustration purposes only The display content will vary depending on configuration settings hospital defined data set uploaded using the Guardrails Safety Software and many other variables Main Display Title Bar OO _ Midtown Hospital Module Status viBi 250 0mL Asolid letter display indicates Q module is operating 9 4 e An outlined letter display a a indicates module is attached LO and ready for use Keys ms 3 a m Module Selected Indicator Infusion Setup Inactive Soft Key _ ___ rae 40 mun Nonhighlighted indicates a O GB 250m nonselected st ey LO Active Soft Key Highlighted indicates a selected soft key gt Press START Prompt Bar Pause SECOND starr Look here for user prompts a 8 Programming Module 8000 Series GETTING STARTED 11 Directions for Use Displays Continued Adjusting Display Contrast 1 Press OPTIONS key 2 Select Display Contrast soft key System Options 1 of 3 Display Contrast Patient ID Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT PAGE EXIT DOWN 3 adjust display for optimum viewing use System Options Lighter Darker s
25. eaning solutions are Warm water CAUTION Mild detergent such as Manu Klenz Th lutions sol identified 10 bleach solution 1 part bleach to 9 parts water e solutions solvents identified as NOT to be used can damage the i surfaces of the instrument 2 Glutaraldehyde in water Hydrogen Peroxide 3 70 Isopropyl Alcohol 2 Phenols in water O Syl 1 128 Pheno Cen 1 256 Vesphene 10 Providone lodine Betadine Quaternaries 1 512 WEX CIDE NOTE All recommended solutions must be diluted per the Manufacturer s recommendation 1 Keep instrument upright and do not allow any part of instrument to become saturated with or submersed in fluid during cleaning operation 2 Use a soft cloth dampened with warm water and a mild nonabrasive cleaning solution to clean all exposed surfaces For sanitizing or antibacterial treatment use 10 bleach solution and water NOTE A soft bristled brush may be used to clean hard to reach and narrow areas 3 Use a soft cloth dampened with water to rinse off cleaning solution gt 2 m gt O m Excluding 10 bleach solution in water Programming Module 8000 Series MAINTENANCE 37 Directions for Use Inspection Requirements To ensure the system remains in good operating condition both regular and preventive maintenance inspections are required Reference the Medley Maintenance Software User Manual Model 8970C or later for detailed instru
26. ed service personnel Use of accessories or cables other than those specified may result in degraded electromagnetic compatibility performance of this instrument Programming Module 8000 Series GETTING STARTED 5 Directions for Use Warnings and Cautions Continued CAUTIONS e The Medley System is not intended to replace supervision by medical personnel The user must become thoroughly familiar with the Medley System features operation and accessories prior to use e Always use a grounded three wire receptacle Where the integrity of the protective earth grounding system is in doubt operate on internal battery e 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 e If an instrument appears damaged contact ALARIS Medical Systems for authorization to return it for repair 6 GETTING STARTED Programming Module 8000 Series Directions for Use Operating Features Controls and Indicators Front Side View IUI Connector Left IUI Connector Right not visible Soft Keys When pressed allows selection of options or infusion parameters appearing on Main Display adjacent to soft key Silence Key When pressed during an alarm silences audio for two minutes System On Key When pressed changes Medley System from Standby to Operating mode m
27. ent and ensuring the current hospital approved data set is loaded 38 MAINTENANCE Programming Module 8000 Series Directions for Use Service Information Continued Technical Support Technical support service information applications and manuals may be obtained by contacting an ALARIS Medical Systems representative When submitting any request for service include e Model number e a description of difficulty experienced instrument settings administration set lot number solution s used message displayed at time of difficulty 9 gt 2 m gt O m Programming Module 8000 Series MAINTENANCE 39 Directions for Use WARRANTY ALARIS Medical Systems Inc hereinafter referred to as ALARIS Medical Systems warrants that A Each new ALARIS Medical Systems Medley Programming Module 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 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 fac
28. gations or liabilities of ALARIS Medical 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 See packing inserts for international warranty if applicable 40 MAINTENANCE Programming Module 8000 Series Directions for Use 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 and Medley are trademarks and registered trademarks of ALARIS Medical Systems Inc All other trademarks belong to their respective owners Patents Brevet Brevets Brevetti Ned Octrooi Patente Patenten A US 4 690 673 4 764 166 5 096 385 5 165 873 5 601 445 5 713 856 5 781 442 5 800 387 5 836 910 5 941 846 AT 0 225 158 AU 596 552 634 811 693 662 703 178 719 254 728 366 730 203 BE 0 225 158 CA 1 258 212 1 296 092 2 026 518 2 029 267 CH 0 225 158 DE P3686558 3 P690244923 0 422 855 0 225 158 0 422 855 0 431 31
29. ient ID and Press CONFIRM EXIT CONFIRM PAGE 5 To verify correct entry press CONFIRM soft key e Patient ID Entry verification screen appears Patient ID Entry A AE B F J K O D P T E 234567891EF gt Enter Patient ID and Press CONFIRM EXIT PACE 6 To accept modified Patient ID press Yes soft key e Main screen appears with new Patient ID OR To retain original old Patient ID press No soft key e Main screen appears with old Patient ID Patient ID Entry Patient ID Yes 123456789CD will be changed to No 234567891EF Is this correct gt Press Yes or No Programming Module 8000 Series Directions for Use GETTING STARTED 19 m 2 gt A m Adjusting Audio Volume 1 Press Audio Adjust soft key Midtown Hospital A 250 0 mL D VOLUME AUDIO INFUSED ADJUST 2 To change volume to desired level press either Louder Audio Volume Adjust or Softer soft key To sample alarm loudness level Test Test soft key may be pressed 43 3 return to Programming Module screen press MAIN SCREEN soft key Softer Louder e After 30 seconds without a key press Main Display appears Cancel MAIN SCREEN Setting Up Time of D
30. ility Except as provided 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 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 obli
31. ional drugs in each profile that are appropriate to anesthesiology It also features permanent pause Clinical Advisories will not be displayed in this mode Battery Run Time Display Appears on Main Display prompt bar when Programming Module is disconnected from AC If enabled this feature provides a visual display of estimated remaining battery run time under current operating conditions when operating on battery Data Set Created using Guardrails Editor authoring tool and then transferred to Programming Module A data set reflects facility s best practice guidelines for IV drug administration and includes Profile Drug Libraries Clinical Advisories instrument configurations and Channel Label Libraries Dose Checking Always Dose Checking option causes a Guardrails Soft Alert to occur each time a dose limit is exceeded Drug label in Message Display provides an indicator or LLL that infusion is beyond current Guardrails Soft Limit Smart Dose Checking option causes an initial Guardrails Soft Alert to occur when a dose limit is exceeded Subsequent programming beyond dose limit will not receive an alert Drug label in Message Display provides an indicator or LLL if infusion is beyond current Guardrails Soft Limit 2 INTRODUCTION Programming Module 8000 Series Directions for Use Features and Definitions Continued Guardrails Safety Software Designed to help prevent programming erro
32. j a e If accessed from Systems Options menu main D PT screen appears E 1294567890 e Patient ID appears on main screen current profile gt Enter Patient ID and Press screen and New Patient screen coma SE Modifying Patient ID 1 Press OPTIONS key e System Options menu appears 2 Press Patient ID soft key System Options 1 of 3 a Display Contrast e Patient ID Entry screen appears Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT PAGE EXIT DOWN 18 GETTING STARTED Programming Module 8000 Series Directions for Use Start Up Continued Modifying Patient ID Continued 3 clear entire entry press CLEAR key Patient ID Entry OR A A E B F J To back up a single character at a time press CANCEL c k 0 key D 123456789CD gt Enter Patient ID and Press CONFIRM 4 Toenter modified patient identifier use numeric data entry Patient ID Entry keys and or alpha speed keys A AE B F J NOTES K O e An alphanumeric identifier of up to 16 characters can be D P T entered E U Y e Press the soft key next to a letter group to list letters in that group Press the soft key next to an individual letter to enter that letter e To access the letter Z and special characters hyphen underscore space press the PAGE DOWN soft key gt Enter Pat
33. n the Patient ID Entry feature is enabled the Patient ID Entry screen appears after responding Yes to New Patient prompt To enter a patient ID begin with step 2 of the following procedure 1 To access Patient ID Entry screen a Press OPTIONS key e System Options menu appears b Press Patient ID soft key System Options 1 of 3 Patient ID Entry screen appears Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT PAGE EXIT DOWN Programming Module 8000 Series GETTING STARTED 17 Directions for Use Start Up Continued Entering Patient ID Continued 2 enter patient identifier use numeric data entry keys Patient ID Entry and or alpha speed keys A AE B F J NOTES c K O e An alphanumeric identifier of up to 16 characters can be D P T entered E jy e Press the soft key next to a letter group to list letters in EAE fenced eee that group Press the soft key next to an individual letter CONFIRM to enter that letter cone 295 e access the letter Z and special characters hyphen underscore space press the PAGE DOWN soft key e clear an entire entry press CLEAR key e To back up a single character at a time press CANCEL key 3 To verify correct entry press CONFIRM soft key Patient ID Entry A A E e If accessed from New Patient screen last used 3 7 profile appears
34. oft keys Diepey Canisa 4 return to main screen press MAIN SCREEN soft key ALARIS Medley Medication Safety System gt Adjust Display to Desired Contrast SCREEN Powering On System 1 Connect Programming Module to an external AC power source 2 Press SYSTEM ON 3 System self test begins e Diagnostics test causes all LED display segments and Status Indicator lights of attached module s to illuminate briefly e Power Indicator illuminates e Appropriate module identification A B C or D displays on attached module s e An Audio tone sounds Continued on Next Page 12 GETTING STARTED Programming Module 8000 Series Directions for Use Start Up Continued Powering On System Continued e At completion of system on test New Patient screen appears If PM Reminder option is enabled and scheduled preventive maintenance is due MAINTENANCE REMINDER screen appears NOTES e Previous infusion parameters are automatically cleared after eight 8 hours e If any of the following conditions are observed the Programming Module or the affected attached module must be removed from use and inspected by qualified personnel LED segments are not illuminated during system on test Indicator lights do not illuminate Appropriate module identification A B C or is not displayed Audio tone does not sound Main Display does not appear backlit appear
35. om with a temperature between 50 80 6 F 10 27 C to minimize charge time and maximize battery life Battery Charge e The Medley Programming Module is shipped with the battery in a discharged condition Before the Programming Module is released for use it should be plugged into a hospital grade AC outlet and the battery charged for at least eight hours This will ensure proper battery operation when the Medley System is first set up for patient use Whenever possible leave the power cord connected to an external AC power source while operating the instrument Programming Module 8000 Series MAINTENANCE 35 Directions for Use gt 2 m gt O m Battery Care and Maintenance Continued Battery Care The battery capacity should be checked at least once every six months Reference the Medley System Technical Service Manual for test and replacement procedures If the Programming Module is to be stored at temperatures in excess of 86 F 30 C for one or more months the battery should be removed and placed in an environment of 50 86 F 10 30 C If the batteries are to be stored for more than one year they should be charged at least once per year to prevent leakage and deterioration in performance due to self discharge When the battery is first being put into use or has been out of use for one or more months it will not have full capacity due to deactivation of reactants
36. onnel The approved data sets are maintained by the Guardrails Editor for future updates and reference Information about Guardrails Alerts that occur during use is stored within the Medley Programming Module and can be accessed using the Guardrails Continuous Quality Improvement CQI Standard Software Programming Module 8000 Series INTRODUCTION 1 Directions for Use About the System Continued Compliance with Federal Aviation Regulations The Medley Programming Module has received a Statement of Compliance with Federal Aviation Regulations for use as a Portable Electronic Device Aboard Aircraft This is pursuant to the FAA Advisory Circular No 91 21 1A and attested by an FAA Designated Engineering Representative with an FAA form 8110 3 Statement of compliance with the Federal Aviation Regulations Contraindications None known This document provides directions for use for the Medley WARNING Programming Module For additional operating instructions Read all instructions before using reference the Directions for Use DFU for the individual the Medley System Medley Module s Features and Definitions Reference the Alarms Errors Messages chapter of this DFU for the definitions of various alerts Reference the DFU that applies to the attached Medley Module s for features and definitions specific to that module Anesthesia Mode Allows anesthesiologist to access addit
37. ours with 4 Pump Modules infusing at 25 mL h e 6hours with 1 active SpO Module e 8hours with 1 Syringe Module infusing at 5 mL h e 4hours with 4 Syringe Modules infusing at 5 mL h Communication Data Port RS 232 with an RJ45 connector Dimensions 6 9 W x 8 8 H x 9 D including pole clamp Electric Classification Class 1 Internally Powered Equipment NOTE Reference module specific Directions for Use for shock protection type and defibrillation proof rating information Electronic Memory System configuration parameters stored in volatile memory will be retained for at least 6 months by the internal backup lithium battery Additionally module specific parameters are stored for 8 hours by the Programming Module and then automatically purged by the system Environmental Conditions Operating Storage Transport Temperature Range 41 to 104 F 4 to 140 F 5 to 40 C 20 to 60 C gt Relative Humidity 20 to 90 5 to 85 Avoid prolonged exposure Noncondensing Noncondensing to relative humidity gt 85 Z gt Atmospheric Pressure 525 to 4560 mmHg 375 to 760 mmHg 700 to 6080 hPa 500 to 1013 hPa O Equipment Orientation To ensure proper operation the instrument must remain in an upright position Fluid Ingress Protection IPX1 Drip Proof Leakage Current Less than 100 microamps Power Requirements 100 240V 50 60 Hz 150 VA MAX See Notes 1 and 2 Weight 7 2 Ibs Programming Module 8000 Series MAINTEN
38. ree 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 Unique alarm pattern Six short beeps secondary switching to primary Two short beeps bolus switching to continuous 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 System Configuration Variable volume can be silenced Different sound than other alarms Variable volume can be silenced and disabled in System Configuration 28 ALARMS ERRORS MESSAGES Programming Module 8000 Series Directions for Use Alarms Alarm Meaning Response Battery Discharged Operation of all modules stopped Connect AC power cord to power due to insufficient battery charge source alarm will be silenced Press RESTART key on Pump Module to continue operation of paused modules Channel Disconnected Module s disconnected while in To silence alarm and clear operation or have a communication message from screen press problem CONFIRM soft key Reattach module if desired ensuring it is securely clicked into place at Module Release Latch If alarm is still present replace module with an
39. rs by e Customizing device configurable settings to meet need of selected hospital facility area 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 4 7 O O Patient ID Entry An optional alphanumeric 16 character patient identifier can be entered and displayed e When enabled ID entry defaults to Startup screen e When disabled ID entry is only accessible from System Options screen Profile A unique set of system configuration settings and best practice guidelines for a specific patient population or patient type and consists of following three components e Instrument configuration settings e A Guardrails Drug Library which includes drug names standard concentrations dosing units Guardrails Limits and optional associated Clinical Advisories for both continuous and bolus dose infusion e AChannel Label Library with text alphanumeric labels that allows identification of modules that are actively infusing nondrug therapies for example saline or TPN Channel labels can also be used to identify route of delivery for example epidural Profile settings are established by the facility s own multi disciplinary team prior to system implementation Profile parameters are used to create a data set which is then transferred to the Programming Module System Configuration Allo
40. s 7 m Select correct profile Midtown Hospital To accept current profile press Yes soft key and proceed eee to step 5 Profle N e Main screen appears OR To change profile press No soft key and continue with next step e Profile selection screen appears To select a profile press corresponding left soft key Midtown Hospital 4 oF 2 NOTE To view additional choices press PAGE DOWN soft key To confirm profile selection press CONFIRM soft key e Main screen appears To enter Patient ID if desired reference Entering Patient ID section Adult General Care Neonatal Peds ICU Neonatal ICU gt Select a Profile and Confirm CONFIRM PAGE DOWN Programming Module 8000 Series Directions for Use GETTING STARTED 15 Start Up Continued Selecting New Patient and Profile Options Continued Patient ID Entry Feature Enabled 1 Select required NEW PATIENT option Midtown Hospital A 2 Yes e To indicate programming is for a new patient and clear Yes Clears Previous all stored patient parameters from memory a Press Yes soft key e Patient ID Entry screen appears gt Select Yes or No b If patient identifier is not required press CONFIRM Patient ID Entry soft key A AE OR B F J Enter patient identifier reference Entering Patient i D
41. s irregular or has evidence of a row of pixels not functioning properly If the affected module operates normally when it is attached via an alternate IUI connector it may be used until a replacement module can be substituted Responding to Maintenance Reminder If the Preventive Maintenance PM Reminder option is enabled and the Programming Module or an attached module is due for preventive maintenance a MAINTENANCE REMINDER message appears at power up NOTES e If necessary the reminder can be temporarily bypassed by pressing the CONFIRM soft key e Notify the appropriate facility personnel when a MAINTENANCE REMINDER occurs 1 Remove and if needed replace module requiring maintenance with a new module reference Attaching and Detaching Modules section MAINTENANCE REMINDER Module s due for routine preventative maintenance Module A YYYY MM DD CONFIRM Programming Module 8000 Series Directions for Use GETTING STARTED 13 m 2 gt A m Start Up Continued Responding to Maintenance Reminder Continued 2 If system Programming Module and attached modules was powered off to replace Programming Module reinitiate start up process OR If an attached module such as a Pump Module was powered off and removed MAINTENANCE REMINDER Module s due for routine display reflects removal of that module To continue en es s
42. tart up process press CONFIRM soft key MAINTENANCE REMINDER CONFIRM Selecting New Patient and Profile Options The option to enter and display a 16 character alphanumeric patient identifier is always available The instrument may be configured to automatically display the Patient ID Entry screen during start up or to provide access only through the Systems Options menu The following procedures assume the Profiles feature is enabled NOTE The display contrast can be adjusted at this time by pressing the DISPLAY CONTRST soft key and following the directions on the screen also reference Displays Adjusting Display Contrast section 14 GETTING STARTED Programming Module 8000 Series Directions for Use Start Up Continued Selecting New Patient and Profile Options Continued Patient ID Entry Feature Disabled Select required NEW PATIENT option To indicate programming is for a new patient and clear all stored patient parameters from memory press Yes soft key OR To confirm programming is for same patient and retain all Midtown Hospital NEW PATIENT Yes Yes Clears Previous Patient Data No gt Select Yes or No stored patient parameters press No soft key e Last used profile displays ee e NOTE If the Profiles feature is disabled the main menu 7 appear
43. tem Config PM 2 of 2 Max Pt weight 500 kg Patient ID Entry Disabled PM Reminder Disabled Profiles Disabled Tamper resist Disabled gt Select an Option or EXIT E 6 return to main screen press CANCEL key or EXIT soft key Programming Module 8000 Series Directions for Use GETTING STARTED 21 m 2 gt A m Reviewing Serial Number 1 Press OPTIONS key 2 Press Page Down soft key System Options 1 of 3 Display Contrast Patient ID Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT PAGE EXIT 3 Press Serial Numbers soft key System Options 2 of 3 Battery Runtime System Configuration Serial Numbers Software Versions gt Select an Option or EXIT Serial numbers for Programming Module and all Serial Number Review attached modules display PM nnnn nnnnnnnn Module A NOTE nnnn nnnnnnnn in the illustrated display Module B nnnn nnnnnnnn represents a serial number Module C Module D nnnn nnnnnnnn 4 Toreturn to main screen press EXIT soft key gt Press CANCEL or EXIT 22 GETTING STARTED Programming Module 8000 Series Directions for Use Reviewing Software Version 1 Press OPTIONS key 2 Press PAGE DOWN soft key System Options 1 of 3 Display Contrast Patient ID Time of Day Power Do
44. w system settings to be customized If Profiles feature is enabled system settings defined for selected profile are automatically activated Tamper Resist Provides a quick one touch lockout of front panel keypad Programming Module 8000 Series INTRODUCTION 3 Directions for Use Symbols 8 IPX1 229 R Ony D Alternating Current Indicates device should be attached to alternating current source 50 60 Hz 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 CSA C22 2 No 601 1 UL 2601 1 and IEC 60601 2 24 Communications Connector For RS 232 attachment Protection against fluid ingress Drip Proof Fuse Replacement Replace fuse only with same type and rating IUI Connector Inter Unit Interface connector used to establish power and communications between Programming Module and attached modules Main Power Connected to alternating current 100 240 VAC Manufacturing Date Number adjacent to symbol indicates month and year of manufacture Potential Equalization Conductor if so equipped Note If integrity of PEC or Hospital Earth System is in question operate instrument using internal battery power CAUTION Federal U S A law restricts this device to sale by or on order of a physician SYSTE
45. wn All Channels Anesthesia Mode PAGE EXIT DOWN gt Select an Option or EXIT 3 Press Software Versions soft key System Options 2 of 3 Battery Runtime System Configuration Serial Numbers Software Versions gt Select an Option or EXIT PAGE PAGE EAT DOWN 4 review software version information press View soft key next to desired module OR To return to main screen press EXIT soft key Software Rev Review APM View Module A View Module B View Module C View Module D View gt Select an Option or EXIT EXIT 5 return to previous screen press EXIT soft key NOTE nn nn in the illustrated display represents a software version Software Rev Review Module Software A Main processor nn nn Main boot block nn nn Keyboard nn nn gt Press CANCEL or EXIT EXIT Programming Module 8000 Series Directions for Use GETTING STARTED 23 m 2 gt A m Powering Off Powering Off System 1 Press OPTIONS key 2 Press Power Down All Channels soft key System Options 1 of 3 Display Contrast Patient ID Time of Day Power Down All Channels Anesthesia Mode gt Select an Option or EXIT PAGE EXIT 3 Press Yes soft key System Options e During power off sequence Main Display flashes Ye POWERING
46. y indicating a Guardrails Limit soft or hard has been exceeded A response is required before programming can continue gt sI nS nw gt m 3 DO n Guardrails Clinical Advisory A visual message when a designated drug is selected to remind clinician of specific hospital facility standards of practice when programming an IV medication A specific clinical advisory message can be associated with a selected drug within any of the patient care profiles Clinical Advisories will not be displayed in Anesthesia mode Maintenance Reminder A visual message that when enabled appears at module startup when scheduled preventive maintenance is due overdue for any part of Medley System Programming Module or attached module Prompt A visual message appearing on bottom line of Main Display or in Message Display Message may be accompanied by an audio signal that can be silenced for twelve seconds by pressing SILENCE key Programming Module 8000 Series ALARMS ERRORS MESSAGES 27 Directions for Use Audio Characteristics The Programming Module and Main Display provide various types of alert information The characteristics of the accompanying audio sounds are as follows Type Sound Notes Advisory Message Alarm Error Hardware Detected Error Software Detected Illegal Key Press Key Click Prompt SpO Alarm Switchover One short beep every two seconds Choice of th

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