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1. GES Instrument is designed to stop fluid flow under alarm conditions other than Low Battery and KVO Periodic patient monitoring must be performed to ensure the infusion is proceeding as expected GES Instrument is a positive pressure delivery system capable of developing positive fluid pressures to overcome widely varying resistances to flow encountered in practice including resistances to flow imposed by small gauge catheters filters and intra arterial infusion It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions GES Hospital personnel must ensure compatibility of drugs as well as performance of each channel as part of the overall infusion Potential hazards include drug interactions inaccurate delivery rates inaccurate pressure alarms and nuisance alarms GES Use only Instrument 28 Series administration sets The use of any other set may cause improper instrument operation resulting in an inaccurate fluid delivery or other potential hazard GER 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 performance of common IV site is satisfactory under these circumstances GES References in this document to specific drugs and drug doses are for example only Refer to specific
2. for 5 sec Compliaues Level Electromagnetic Environment Guidance 8 RV contact NOTE2 15 kV air NOTE2 2 kV for power supply lines 1 RV for input output lines 1 kV differential mode 2 kV common mode 400 A m 50 Hz NOTE2 400 A m 60 Hz NOTE2 5 UT 295 95 dip in UT for 0 5 cycle 40 UT 60 96 dip in UT for 5 cycles 70 UT 30 96 dip in UT for 25 cycles 5 UT 095 95 dip in UT for 5 sec NOTE 1 UT is the AC mains voltage prior to application of the test level NOTE 2 Compliance levels raised by IEC 60601 2 24 NOTE 3 Performed at the Minimum and Maximum Rated Input Voltage Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 If connector testing exemption is used the following symbol for ESD sensitivity appears adjacent to each connector Caution Do Not Touch Ata Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Instrument requires continued operation during power mains interruptions it is recommended that
3. 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 Long term accuracy of the Instruments in combination with the specified administration set is considered to be within 5 FLOW CHARACTERISTICS UNDER VARYING DELIVERY CONDITIONS Effects of Pressure Variations Under conditions of 100mmHg pressure the Instrument typically exhibits a long term accuracy offset of approximately 0 4 Under conditions of 100mmHg pressure the Instrument typically exhibits no significant offset in long term accuracy Resulting Trumpet observation points typically track that of accuracy Therefore no significant change in short term variations result under negative solution container height conditions Effects of Negative Solution Container Heights With a negative head height of 0 5 meters the Instrument typically exhibits a long term accuracy offset of approximately 0 4 Resulting
4. Suspend secondary solution container at least 8 inches 20 cm above primary solution container Press P A P B Sor C 9to select channel AK ALANIS E TN Directions for Use Getting Started 27 MedSystem III9 infusion pump Models 2865 2866 Secondary Mode Continued Programming Secondary Infusion 1 Press A 9 B Sor C c 9 A Infusing Primary Primary Programming Page is displayed A Primary Rate 50 ml h A Pri VolRem VR EJ ml MORE 2 Press snos A Pri Time TR 09h 00m A Pri Vollnf VI 50 ml 3 Press 2 Sec softkey since 12 37p 01 Feb 02 Press desired function Secondary Programming Page is displayed mmm m NOTE Secondary Programming Page is reverse highlighted To Set Secondary Volume Remaining VR 1 Press Select to highlight secondary VR if necessary 2 Press REPEAT to enter the last VR selected A Infusing Primary A Secondary Rate 100 ml h OR A Sec VolRem VR O mi A Sec Time TR 3 Press f Fast f or Fast to change VR d ri Pet e Value flashes since 12 37p 01 Feb 02 I Start Switches to Secondary 4 Press Enter to confirm Secondary time remaining TR is calculated automatically based on VR and Rate Highlight moves to secondary volume infused VI To Clear Secondary Volume Infused VI 1 Press Select if current VI is desired OR 2 Press Clear to reset volume infused to zero Date and time are cleared
5. To ensure instrument remains in good operating condition both regular and periodic inspections are required Any WARNING instrument that does not meet listed specifications should be Failure to perform these inspections serviced may result in improper instrument Regular inspections consist of performing the procedures operation described in the Basic Operation and Cleaning sections of this manual before use of instrument Regular inspections are not covered under any contract or agreement offered by Cardinal Health and must be performed by the user When programming infusions verify that the display Is complete and not blurred Reads the same as described in this manual Responds with the intended function for that key press NOTE Detailed instructions for performing periodic inspections and maintenance can be found in the Technical Service Manual for the Instrument and in supplemental service bulletins Periodic inspections must be performed every 12 months A service agreement may be obtained from Cardinal Health for the performance of all required periodic inspections The periodic inspections must be performed in accordance with Cardinal Health requirements and guidelines Customers within the United States and Canada should note that these inspections are also intended to complement the intent of Joint Commission on the Accreditation of Healthcare Organizations requirements 70 Maintenance Direction
6. infusing on AC au M MedSysterm II Flashing infusing on battery power Red Slow flashing Advisory Rapid flashing Alert Channel Select Keys CASSETTE Portion of administration set inserts into cassette holder S N YY UI KDB q iE LOWER ASSEMBLY 3 Cassette Holders Air in Line Sensor Tubing Collar Recess Pump Latch Mechanism Detects bubbles of air during Holds tubing collar in place Drives the cassette piston infusion to move fluid through the tubing Directions for Use Introduction 5 MedSystem III infusion pump Models 2865 2866 System Components Continued CONNECTOR PANEL NOTE When inserting or removing connectors into or from receptacles avoid excessive force or twisting To remove AC adapter from pump first remove clip that is on connector External Power m ACTEN emm External power receptacle connects rd AC Adapter Fower Cord A 120V 60 Hz three pronged with power cord d grounded adapter with 4 pin locking connector 230V 50 Hz adaptor international Plug Symbol Green light on indicates AC power is connected batteries are charging COMM Communications line receptacle connects with RS 232 Container Hook Enc ae One hook on each side of instrument Rotating Latch Allows clamp to spin 360 and position at every 90 Adjustable Pole Clamp Jaw with clutch feature mounts pump to a
7. anesthetic and analgesic drugs This application is only appropriate when using analgesics and anesthetics labeled for continuous epidural administration and catheters intended specifically for epidural use Use only a instrument without a Y connector or injection port for epidural infusions e Epidural administration of anesthetic drugs Use indwelling catheters specifically indicated for short term 96 hours or less anesthetic epidural drug delivery Epidural administration of analgesic drugs Use indwelling catheters specifically indicated for either short term or long term analgesic epidural drug delivery WARNING The use of any accessory transducer or cable with instrument other than those specified may result in increased emissions or decreased immunity or electromagnetic compatibility performance of this device KZITB Only connect equipment approved to IEC EN 60601 1 or UL 1069 approved medical or hospital signaling equipment EE Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient WARNING It is strongly recommended that instrument source container and instrument Administration Set used for epidural drug delivery be clearly differentiated from those used for other types of administration Directions for Use MedSystem III9 infusion pump Models 2865 2866 Getting Started 9 Warnings and Cautions Continued
8. it has a low power RF transmitter installed refer to the Instructions for Use for guidance Q2 e A RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Instrument is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Directions for Use MedSystem 111 infusion pump Models 2865 2866 Appendix 77 EMC Tables Continued Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity Instrument is intended for use in the electromagnetic environment specified below Customer or user of instrument should assure that it is used in such an environment Immunity Test IEC 61000 4 2 Electro Static Discharge ESD IEC 61000 4 4 Electrical Fast Transient Burst EFT NOTE 3 IEC 61000 4 5 Power Line Surge NOTE 3 IEC 61000 4 8 Power Frequency Magnetic Field 50 60 Hz IEC 61000 4 11 Voltage Dips Short Interruptions and Voltage Variations NOTE 3 IEC 60601 1 2 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT NOTE 1 795 95 dip in UT for 0 5 cycle 40 96 UT 60 96 dip in UT for 5 cycles 70 96 UT 30 96 dip in UT for 25 cycles 5 UT 095 dip in UT
9. s 8 si 5 5 au Man p 2 a o 0 et o Or mimm t to ac ac 3 5 5 m T gi Fa Max Rate Error 101 Overall Rate Error amp Max Rate Error 4 Min Rate Error penal Rate Error 4 Min Rate Error rj Dn 45 0 5 10 15 20 25 30 0 5 10 15 20 25 30 Observation Time minutes Observation Time minutes 76 Appendix Directions for Use MedSystem III9 infusion pump Models 2865 2866 EMC Tables The following information is to be provided to the User as directed by IEC 60601 1 2 2001 a Collateral Standard for Electromagnetic Compatibility The information provided herein provide certain Warnings and Caution text that must be included into the Instructions for Use and the attached Tables of informative information as to the emission and immunity levels of the testing performed Table 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions Instrument is intended for use in the electromagnetic environment specified below Customer or user of instrument should assure that it is used in such an environment CISPR 11 Group 1 RF Emissions CISPR 11 Class B RF Emissions IEC 61000 3 2 Class A Harmonic Emissions IEC 61000 3 3 Complies Voltage Fluctuations Flicker Emissions The Instrument uses RF energy only for its internal function in the normal product offering An option is available for a low power wireless network card If the following icon appears on the product
10. 2 through 5 An asterisk appears beside settings which are not factory default Directions for Use Getting Started 41 MedSystem III infusion pump Models 2865 2866 Config Configuration The Config option allows the user to view and or change some Instrument settings There are five pages in this option Items shown on page 1 of the Config option can be changed by the user see Table 2 Pages 2 5 of the Config option can only be changed by qualified personnel using FMS software To Access Instrument Settings Information 1 Press sl 2 Press ots TotVol Device Config and Note softkeys appear 3 Press Config softkey The first of five Instrument Settings pages are displayed e An asterisk indicates options that have been changed from factory settings 4 Pressing Select moves the highlight through the list Press f and to change a highlighted setting Select softkey changes to Enter and NextPg softkey changes to Recall when a setting is changed 6 Press Enter to accept new setting Infusing 100 ml h VR 450 VI 50 Sto A channel A Device Instrument Settings 1 of 5 Audio Volume Sec Complete Advisory Yes Setup Line Option No Time am pm 9 56a 01 Feb 02 Press Stnd Display to Exit OR 7 Press Recall to recall previous iis p Table 2 9 Option Choices Description ON OFF it i 8 Press Eg to exit instrument Audio Volume low A
11. 325 scarlett tos and sent nose 35 Programming Concentration nri senes aci data dommen to ee eo dodo de a TB Pectus dant aca duet 36 iscontinuing PION MEER DEVICE ze iii Pes Es ide ae i Es a Les Dada EE pd ei aU mon aa ea E ea NE cim a Ed cama A 39 ALARMS ADVISORIES AND PROMPTS RESPONDING TO AN ADVISORY ALARM OR FAULT MESSAGE LL LL LL Le 45 ALARM RESPONSE KEYS a xa a eee exuta Es ala Ron DE ea i a RD cR d doe a A Rl e das 46 ADVISORIES sn zoas ane dean girl anton nee econ dode deden ded dende deinende selene tat and sited 47 ALARMS cus xia wee a Es dS nele Leer aed Sinead Bani nete dere ae rr eared ea Sra ed 48 MAINTENANCE SPECIFICATIONS san saar serveren nne a A bata ates EE pA dida tiek 55 CE CR IN peepi ts nera O Som De Da A Et a Se ee a ee 57 ENC 57 Checkeln TEStS saar anssen danae wend densan dare Bea denied da eaten ae ters EG i ce AA 58 New Instument Volume Accuracy Test eee eee 63 Watchdog Audio Tests ann stamden et eae ban EE ern BR Ad ar de soto etos 64 INSPECTION REQUIREMENTS aan zene aon zate a Ben edn Bas 70 SERVICE INFORMATION eee 71 WARRANTY cera m dan a tat dores cialis sanes hkdh nin ne voe Find 72 ii Table of Contents Directions for Use MedSystem III infusion pump Models 2865 2866 GLOSSARY ABBREVIATIONS ACRONYMS UNITS OF MEASURE LL LL LL LL 73 APPENDIX TRUMPET AND START UP CURVES gt ara sotd deed Bede Beek an
12. Clear softkey switches to Recall 3 Enter to confirm OR 4 Press Recall softkey to recall previous VI value date and time 28 Getting Started Directions for Use MedSystem 111 infusion pump Models 2865 2866 Secondary Mode Continued To Set Secondary Rate 1 Press Enter to confirm A Infusing Secondary A Secondary Rate 100 ml h 2 Press Select if current rate is desired OR A Sec VolRem VR ml A Sec Time TR 3 Press f Fast f or Fast to change Rate A Pri Vollnf VI 200 ml since 12 37p 01 Feb 02 Value flashes Stop affects Secondary 4 Press Enter to confirm 5 Open regulating clamp on secondary administration set START NOS 6 Press fe to begin infusion Four tones sound if primary infusion is in progress Pump starts infusing at secondary rate Current date and time are entered 7 Press OR Display reverts to Standard Display page after one minute 8 Verify settings 9 Verify solution flow from secondary container To Set Rate Of Infusion From A Time Entry The infusion rate can be set with the volume remaining VR and time entry 1 Press from the Standard Display 2 Press Config softkey at bottom of display 3 Select Change Instrument Settings from menu 4 Press f or softkey to change Setup Line Option from NO to YES 5 Return to the Standard Display and press a channel The display will read Setup Select VR and Rate 6 Step down t
13. DI 0 0 mg 2 If infusing press SES Jto stop infusion Press Select to choose line 3 Press s 2 Sec and CalcOn softkeys appear Directions for Use Getting Started 31 MedSystem 111 infusion pump Models 2865 2866 Dose Rate Calculator Drc Programming Using A Specific Drug Name Continued 4 Press CalcOn Dose Rate Calculator Programming Page is displayed DRUG is highlighted Programming Drug NOTE Changing drug name clears previous values and changes drug concentration and dose rate parameters to parameters appropriate for the selected drug Scroll using arrow softkeys to display alphabetized abbreviated drug names moves AtoZ e 4 moves Zto A e Fast f and Fast moves alphabetically through the drug name list By default Fast goes to the next letter of the alphabet N Press Enter when desired drug name is highlighted Highlight moves to Wt Programming Weight A Stopped EEN AZUN wt 70 0 KG 154 3LB 1 Choose patient s kilogram weight using the 1 Fast 1 A Cone 400 mg 250ml and Fast softkeys A Dose 5 0 mcg kg min M A Rate 13 1 ml h 2 Press Enter when desired weight is displayed AVR 250 ml Vol Rem ANI 0 ml DI 0 0 mg Highlight moves to Conc Press Select to choose line Programming Concentration 1 Choose concentration using the 1 Fast f and Fast softkeys 2 Press Enter when desired concentration is displayed Highligh
14. Getting Started 33 MedSystem III infusion pump Models 2865 2866 Dose Rate Calculator DRC Programming using a specific drug name Continued Clearing the Volume Infused VI and Dose Infused DI 1 Press Clear then Enter to reset volume infused to zero Highlight moves to DI 2 Press Clear then Enter to reset dose infused to zero 3 Open regulating clamp 4 Press SAX to begin infusion Channel starts infusing 5 Press OR Display reverts to Standard Display page after one minute DRC parameters are displayed Verify settings 7 Verify solution flow from solution container NOTE Stop infusion to make changes to the drug name weight or concentration Changing DRC values while infusing 1 Press A Se B Por l c ch Dose Rate Calculator Programming Page is displayed Dose value is highlighted 2 Press Select to scroll through values that can be changed 3 When highlight is on value to be changed Dose Rate VR VI DI use 7 Fast t or Fast softkeys until desired value is displayed When dose is changed rate is automatically recalculated When rate is changed dose is automatically recalculated o 4 When highlight is on value for VI or DI Clear softkey becomes active Pressing the Clear softkey changes the value to 0 0 5 Press Enter after each value change to accept the new value e New rate begins infusing immediately 34 Getting Started Directions for Use
15. Intra arterial Subcutaneous Epidural e Accurate delivery of a variety of fluids e Uses administration sets that provide free flow protection e Six available Device Types vvith configurable parameters maximum and minimum rates maximum volumes baseline and maximum pressures and air in line thresholds to achieve specific clinical applications General Purpose Neonatal Controller Pressure Operating Room General Purpose II Operating Room II Directions for Use Introduction 1 MedSystem III9 infusion pump Models 2865 2866 About MedSystem III Infusion Pump Continued Display infusion status for rate volume remaining and volume infused e e e e e e e Infusions can be programmed to deliver at a specified rate or over a specified period of time Secondary mode allows fluids and medications to be delivered at two different rates sequentially Dose Rate Calculator DRC feature performs volumetric rate and or dose rate calculations With DRC activated instrument displays infusion status for rate dosing regimen and drug name Communications Protocol allows clinical monitoring instrument configuration and maintenance Field Maintenance Software FMS available for Biomed to configure service and troubleshoot instrument Contraindications None known Multi channel Fluid Delivery System Combines three independent infusion channels in an unparalleled small size Lightweight p
16. 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 Other Precautions The AC adapter must be connected to a properly grounded 3 wire receptacle Hospital Use or Hospital Grade Avoid excessive force or twisting of detachable power cords when inserting or removing connector terminals e Use AC adapter indoors only nstruments should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary instrument should be observed to verify normal operation in the configuration used Prepare solution container in accordance with the manufacturer s instructions A syringe can be used as the container for the IV fluid to be infused Syringe sizes from 20cc to 60cc of such as the B D and Monoject brands can be used Directions for Use Getting Started 13 MedSystem III infusion pump Models 2865 2866 Preparing Infusion Connect the container to the IV set Prime the Instrument administration set in accordance with the Pressure Dome Administration Set Directions for Use Slide It is important to prime the set properly to eliminate air Clamp bubbles NOTE The Model 8631A Syringe Holder is availabl
17. drug product labeling for information concerning appropriate administration techniques and dosages 10 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Warnings and Cautions Continued Parallel Infusions There are no contraindications regarding the use of an instrument with any other positive displacement infusion device when ported together into a common IV site location To ensure proper instrument performance and to reduce potential injury to the operator observe the following precautions Disconnect from mains AC and battery power when performing maintenance To disconnect AC power unplug power cord from back of instrument Do not open 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 Alist of approved IV sets recommended by Cardinal Health for use with instrument is listed on the Set Compatibility Card The use of any other set may cause improper instrument operation resulting in inaccurate fluid delivery Before operating instrument verify that the administration set is free from kinks and installed correctly nstrument administration sets are disposable have a sterile fluid path and are inte
18. housing slide link and latch 1 ES VVipe instrument exterior using a cloth dampened vvith cleaning solution Remove the lovver housing to access instruments lower assembly by pressing all four black release tabs simultaneously while pulling straight down Set instrument upright Clean the slide link and instrument latch mechanism using a small soft bristled brush or lint free swab dampened with the appropriate cleaning solution as specified in the Cleaning section If dried residue is difficult to remove or the slide link or Instrument latch sticks spray the cleaning solution on the residue and allow it to soak until it can be more easily removed After removing residue rinse with a lint free swab dampened with water Water may be sprayed on the cleaned surfaces to rinse areas that are difficult to reach with a swab Directions for Use MedSystem III9 infusion pump Models 2865 2866 Maintenance 67 Cleaning Continued To Clean Continued 6 Dry with a lint free swab or cloth or allow to air dry Air Sensor Recess NOTE Air in line alarms may occur when dried residue builds up in the air in line sensor tubing recess 1 Inspect the air in line sensor module to ensure that there is no separation or breakage of the glued seams NOTE Defective air in line sensor modules must be replaced before using instrument 2 Place instrument in the upright position 3 Clean the tubing recess
19. kHz to 80 MHz field strengths should be less than 10 V m Directions for Use Appendix 79 MedSystem III infusion pump Models 2865 2866 EMC Tables Continued Table 4 Recommended Separation Distances For LIFE SUPPORT Equipment between portable and mobile RF communications equipment and the Instrument Instrument is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled Customer or user of instrument can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and instrument as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Rated Maximum Output Power of 450 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Transmitter Outside ISM bands In ISM bands For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM Industrial Scientific and Medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 1
20. ml Caution Federal U S A law restricts this device to sale by or on order of a physician Single Use Do not reuse DEHP in fluid pathway No DEHP in fluid pathway Product is latex free Product incorporates SmartSite Needle Free Valve ports and should not be accessed by a needle Approximate administration set priming volume Drops per milliliter specification for product will be identified on drop symbol Expiration date for product will be identified near hour glass symbol 8 Introduction Directions for Use MedSystem III infusion pump Models 2865 2866 Getting Started NOTE Although instrument is built and tested to exacting specifications it is not intended to replace the supervision of IV infusions by medical personnel The user should become thoroughly familiar with the features and operation of instrument and exercise vigilance in its utilization CAUTION E Only Warnings and Cautions A Zul lem 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 Mee Ni is an alert to a potential hazard which could result in minor personal injury and or product damage if proper procedures are nat followed To ensure proper performance of instrument and to reduce potential injury observe the following precautions Epidural Administration Instrument can be used for epidural administration of
21. result in the Secondary Programming Page is displayed remaining secondary medication 3 Press E being delivered at the primary muy rate if the regulating clamp on the 1 Pri and CalcOn softkeys appear secondary set was not closed 4 Press 1 Pri softkey Primary Programming Page is displayed 5 Press to begin primary infusion and stop secondary infusion Four tones will sound Infusion starts at primary rate Dose Rate Calculator Drc Programming Using A Specific Drug Name NOTE Dose Rate Programming Page will not display if channel is infusing If infusing in secondary mode switch to primary mode and stop infusion before proceeding WARNING gt gt Ensure correct entry of all dru NOTE Pressing A 9 B Sor c Jat any time during DRC calculation nd set up returns the highlight to the top of the page Consult the drug manufacturer s labeling for information concerning 8 appropriate administration With this feature instrument calculates a volumetric or guidelines and dosages dose rate based on values entered for patient weight drug concentration drug amount and diluent volume and dosing parameters If a dose is entered the volumetric rate is calculated If a volumetric rate is entered the dose is calculated A Stopped BREA wt KG 0 0LB mg ml 1 Press A 9 B Jor c 9 meg kg min T mi h Primary Programming Page is displayed ml Vol Rem I I O ml
22. the Instrument be powered from an uninterruptible power supply or a battery The Instrument does employ an internal short duration battery 78 Appendix Directions for Use MedSystem 111 infusion pump Models 2865 2866 EMC Tables Continued Table 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity LIFE SUPPORT Equipment Instrument is intended for use in the electromagnetic environment specified below Customer or user of instrument should assure that it is used in such an environment Immunity Test IEC 606011 2 Compliance Electromagnetic Environment Guidance Test Level Level IEC 61000 4 6 3 V rms Portable and mobile RF communications equipment should be Conducted RF 150 kHz to 80 MHz used no closer to any part of the Instrument including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter IEC 61000 4 3 Recommended Separation Distance Radiated RF 3 V m 80 MHz to 2 5 GHz VP 80 MHz to 800 MHz 1 12 VP 80 MHz to 2 5 GHz E where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipmen
23. using a downward motion with a lint free swab dampened with the appropriate cleaning solution as specified in the Cleaning section 4 Rinse with a lint free swab dampened with water 5 Dry with a lint free swab or allow to air dry Optomodule 1 Place the Instrument in the upright position 2 Gently clean the optomodule using a lint free swab dampened with the appropriate cleaning solution as specified in the Cleaning section The cleaning solution may be sprayed on difficult to remove residue to help wet and soften the residue for easier removal 3 After removing residue gently rinse with a lint free swab dampened with water Water may be sprayed on the cleaned surfaces to rinse areas that are difficult to reach with a swab 4 Gently dry with a lint free swab or allow to air dry Valve Actuator Place the Instrument in the upright position 2 Gently clean the valve actuator and actuator seal using a lint free swab dampened with the appropriate cleaning solution as specified in the Cleaning section The cleaning solution may be sprayed on difficult to remove residue to help wet and soften the residue for easier removal SLIDE LINK ASSY Instrument LATCH CAUTION Use of abrasives or abrasive cleaners on air sensor recess may cause false Air in Line or Check Air Sensor alarms ES AIR SENSOR 68 Maintenance Directions for Use MedSystem 111 infusion pump Models 2865 2866 Cleaning Conti
24. 0 ft cord Model 1560A 7 5 Vdc 1 65 Amp with 10 5 ft cord Directions for Use MedSystem III infusion pump Models 2865 2866 Maintenance 55 Specifications Continued Voltage 90 VAC to 132 VAC AC POWER REQUIREMENTS Frequency 47 Hz to 63 Hz FUSES 3 amp fast blow internal GROUND CONTINUITY Maximum 0 1 ohm LEAKAGE CURRENT Maximum 100 microamps Long term accuracy specified per IEC 60601 2 24 under the following conditions Head height 30 cm Test solution Distilled water Environmental Ambient temperature Back pressure 18 gauge needle IVset Model 28034 56 Maintenance Directions for Use MedSystem III9 infusion pump Models 2865 2866 Check In This is a Quick Reference Procedure for check in and configuration of a new and recently serviced Instrument The following check in and configuration procedures are taken from the current service manual Electrical Safety Test Power Tests Cassette and Sensor Test Patient side Occlusion Detector Test Fluid side Occlusion Detector Test Air in Line Test Volume Accuracy Test Watchdog Audio Test References used in conjunction with this document nstrument models 2860 and 2863 Technical Service Manual Physical Inspection Before unpacking check the shipping container for damage that may have affected contents Report any shipping damage to Customer Service Check to insure that all accessories are included in the pac
25. 3 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Alaris and MedSystem III are registered trademarks of Cardinal Health Inc or one of its subsidiaries 80 Appendix Directions for Use MedSystem 111 infusion pump Models 2865 2866 THIS PAGE INTENTIONALLY LEFT BLANK Dire i Seite Appendix 81 MedSystem pump Models pire CardinalHealth MedSystem III infusion pump Models 2865 2866 Directions For Use
26. ClrAir softkey on channel s Alarm Information page Three beeps indicate air bubble is no longer in front of air sensor NOTE Each press of the ClrAir softkey displaces approximately 0 2 ml of air fluid and updates channel s VR and VI values If air is still present remove cassette and manually clear air according to hospital policy If no significant air is present clean air sensor recess as directed in cleaning instructions Setup instrument at or slightly below IV site to minimize formation of micro bubbles Press START to resume infusion Check administration set for leaks Check lower tubing for multiple small air bubbles Press ClrAir softkey on channel s Alarm Information page Three beeps indicate air bubble is no longer in front of air sensor 48 Alarms Advisories and Prompts Directions for Use MedSystem 111 infusion pump Models 2865 2866 Alarms Continued Alarm Meaning Response Air In Line Tubing continued NOTE Each press of the ClrAir softkey displaces approximately 0 2 ml of air fluid and updates channel s VR and VI values If air is present clear air according to hospital policy Setup instrument at or slightly below IV site to minimize formation of micro bubbles If no significant air is present press to resume infusion Battery Depleted Insufficient battery povver Connect AC adapter povver cord Instrument vvill shut dovvn in 5 to instrument and plug i
27. Directions for Use MedSystem III Infusion Pump Models 2865 2866 With Advanced Dose Rate Calculation and Drug List Editor June 2006 CN MET START LB G Kx y MedS ate I CardinalHealth Alaris Products General Contact Information Cardinal Health Cardinal Health Alaris Products The Crescent Jays Close 10221 Wateridge Circle Basingstoke Hampshire RG22 4BS San Diego California 92121 United Kingdom http www cardinal com alaris http www cardinalhealth co uk alaris Customer Advocacy Clinical and technical feedback Phone North America 800 854 7128 Ext 7812 E Mail North America CustomerFeedback cardinal com E Mail International international product complaints cardinal com Technical Support North America Maintenance service information support and troubleshooting 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 800 482 4822 Phone 800 387 8309 Technical and Customer Services UK Maintenance and service information support Instrument return service assistance and order placement Customer Service Technical Service Freephone 0800 917 8776 Freephone 0800 389 6972 E Mail UK Customer E Mail UK Technical Service cardinal com Support cardinal com Part Number 10014781 groe Gardi
28. ECT soft key to highlight Pri Time TR 16 Press the arrow soft key until the TR is set to 00h 03m 17 Press the ENTER soft key to accept setting 18 Press the CLEAR soft key to set the Pri Vol Inf VI to Oml 19 Press the ENTER soft key to accept setting 20 The Primary Rate should read 360 ml h 21 Press the START STOP key to start Channel A Channel A will run for 3 minutes 22 Press the START STOP key within 1 second after the channel goes into KVO alarm 23 The volume collect will be between 17 1 ml and 18 9 ml Directions for Use Maintenance 65 MedSystem III9 infusion pump Models 2865 2866 Check In Continued New Instrument Volume Accuracy Test Continued 24 Repeat steps 7 23 for Channels B and C 25 After testing all three channels repeat steps 1 6 with the exception in step 5 to toggle setting to No Watchdog Audio Test Manually test the Watchdog Alarm Audio from the Standard Display Press the More Options button two times until a softkey labeled Demo WD appears Press this key and follow the directions on the screen for completing the Watchdog Test Cleaning Clean the Instrument regularly to maintain proper working order and optimum performance DO NOT Invert instrument during cleaning or rinsing DO NOT Clean instrument without first inspecting the WARNING a condition of the housings for damage Turn the Instrument off and disconnect th df the AC DO NOT Use pressurized air
29. Enter to enable programming option 8 Press channel P A 9 P Bore c 9 24 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Programming Option Continued To Setup An Infusion By Rate volume Or Volume time Continued 9 Press Select to move highlight to Setup Select VR and Time OR Setup Select VR and Rate 10 If highlighted choice is not desired press f or to change setup choice Choice flashes 11 Press Enter to accept Highlight moves to top of page Enter desired settings NOTE Rate will highlight but cannot be changed if Volume Time option is active Time remaining selection will highlight but cannot be changed if Rate Volume option is active A Stopped A Primary Rate 100 ml h A Pri VolRem VR 500 ml A Pri Time TR 05h 00m A Pri Vollnf VI 1 ml since 02 16p 01 Jul 02 Setup ERC Us EC ete Bus Press Select to choose line ETA EES ES eee A Stopped A Primary Rate 100 ml h A Pri VolRem VR 500 ml A Pri Time TR 05h 00m A Pri Vollnf VI 1 ml since 02 16p 01 Jul 02 Setup Ee UE se BREI Press Enter or Recall KVO Status To resume infusion when VR 0 KVO With a channel infusing at KVO rate Green light on channel key remains on Redlight on channel key flashes Two toned advisory sounds 1 Press appropriate channel EA a C B Sor c 9 twice e VR is highlighted 2 Press REPEAT to recall previo
30. MedSystem III infusion pump Models 2865 2866 Dose Rate Calculator DRC Programming using a specific drug name Continued Changing DRC values while infusing Continued 6 Press a OR Display reverts to Standard Display page after one minute 7 Verify settings 8 Verify solution flow from solution container Dose Rate Calculator Programming with DRUG NOTE Dose Rate Programming Page will not display if channel is infusing If infusing in secondary mode switch to primary mode and stop infusion before proceeding The DRUG selection can be used to calculate a drug not listed in the pump or for an alternative dosing regimen 1 Press A 9 C B Jorf c 9 Primary Programming Page is displayed 2 Press if channel is infusing 3 Press otras 2 Sec and CalcOn softkeys appear A Stopped 4 Press CalcOn Wt KG 0 0 LB Dose Rate Calculator Programming Page is displayed em DRUG is highlighted ml h ml Vol Rem 5 Press Select AVI 0 m DI 0 0 mg Press Select to choose line Highlight moves to Wt Programming Weight 1 Choose patient s kilogram weight using 1 Fast f and Fast softkeys 2 Press Enter when desired weight is displayed Highlight moves to Conc Directions for Use Getting Started 35 MedSystem III9 infusion pump Models 2865 2866 Dose Rate Calculator Programming with DRUG Continued Programming Concentration 1 Choose concentra
31. Trumpet observation points typically track that of accuracy Therefore no significant change in short term variations result under back pressure conditions The following graphs represent tests performed per IEC FDIS 60601 2 24 Particular Requirements for Safety of Instruments and Controllers using Instrument with Model 28034 IV sets 76cm of headheight and no back pressure Directions for Use MedSystem 111 infusion pump Models 2865 2866 Appendix 75 Trumpet and Start Up Curves Continued Start up 1 ml hr Start up 25 ml hr 2 0 50 1 8 457 1 6 40 a 14 35 lt E RENNEN AMINE E LI LI LL mU sell bad 25 MBA LAN ARM RDA AO Aa Ar e AAA AARAU iau 2 M pepe tte 4 T Ml MB LA SUN A haet AN 2 M y m C og 20 3 3 2 0 6 2 15 0 4 10 0 21 51 0 04 0 si minded a 0 20 40 60 80 100 120 0 20 40 50 ee 109 120 Time minutes Time minutes Trumpet 1 ml hr nitial Trumpet 1 ml hr 48 Hours 15T 15 10 10 A 8 5 amp st 5 i 8 ui js ui E a A aE t Pp A 7a ac ac LI a E F ee u pra MM Li qe om 107 4 Max Rate Error 10 AS Ma aE Overall Rate Error Es Rate Error Min Rate Error Min Rate Error 15 e caiac aci a Sa NE 0 5 10 15 20 25 30 0 5 10 20 25 30 Observation Time minutes Dbserv tiun Time minutes Trumpet 25 ml hr Initial Trumpet 25 ml hr 48 Hours 15T 15 10 10
32. afety Test Equipment Required NAME MANUFACTURER MODEL NUMBER ELECTRICAL SAFETY TESTER DALE TECHNOLOGY CORPORATION LT544D OR EQUIVALENT This checks the ground continuity and leakage current of the AC adapter Instrument and can only be performed with the AC adapter connected to the Instrument NOTE The pole clamp is isolated from the internal electronics and therefore is not grounded It should not be used while performing the electrical safety test To perform Electrical Safety Test 1 Refer to the operation manual for the electrical safety tester for the proper setup and measurement technique 2 Connect the AC adapter to the MedSystem III infusion pump 3 Plug the AC adapter into the electrical safety tester 58 Maintenance Directions for Use MedSystem III infusion pump Models 2865 2866 Check In Continued Electrical Safety Test Continued Test Point Black coated Chassis only gt A Measure the ground continuity and leakage current Any point of an instrument with an aluminum chassis can be used for testing A black coated chassis can only be tested at the uncoated test point located toward the back of the chassis under the lower housing Verify the following Ground continuity not to exceed 0 1 ohm Retaining Leakage current not to exceed 100pA Nuts hese A Power Up Test Charge the Instrument for at least one hour before performing this test Proceed with the power up test as
33. ainer which is at least half full Prime the set and eliminate all air 2 Connect the apparatus as shown in Test Equipment Setup below Use a volumetric burette marked in 0 1 milliliter increments class A glassware 3 Install the cassette to the channel to begin test SOLUTION IN 500 ml CONTAINER HALF FLUID LEVEL AT END OF TEST FULL AT BEGINNING OF TEST READ AT BOTTOM OF MENISCUS FLUID LEVEL AT START OF TEST HEAD HEIGHT READ AT BOTTOM OF FROM DRIP MENISCUS CHAMBER STOPCOCK gt Test Equipment Setup 64 Maintenance Directions for Use MedSystem 111 infusion pump Models 2865 2866 Check In Continued New Instrument Volume Accuracy Test Continued Test Procedure Power up the Unit Under Test UUT Press the MORE OPTIONS key Press the CONFIG soft key Press the SELECT soft key twice to highlight the Setup line option Oo M 2g Press the f arrow soft key to toggle setting to Yes Press the ENTER soft key to accept setting Set the meniscus level to O in the burette Press the A key to select Channel A Press the SELECT soft key 4 times to highlight Setup option oo NH o go 10 Press the f arrow soft key to toggle setting to Select VR and Time 11 Press the ENTER soft key to accept setting 12 Press the SELECT soft key to highlight Pri VolRem VR 13 Press the 1 arrow soft key until the VR is set to 18 ml 14 Press the ENTER soft key to accept setting 15 Press the SEL
34. 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 Not for use in the presence of flammable anesthetics Radio Frequency Interference This equipment system is intended for use by healthcare professionals only This is a CISPR 11 Class B Group 2 Medical equipment system In a domestic enviornment this equipment or system may cause radio interference in which case it may be necessary to take adequate mitigation measures such as re orienting relocating or shielding instrument or filtering the connection to the public mains network DANGER Explosion risk if used in the presence of flammable anesthetics DANGER EXPLOSION HAZARD 12 Getting Started Directions for Use MedSystem 111 infusion pump Models 2865 2866 Warnings and Cautions Continued Medical Electrical Equipment needs special precautions WEEER regarding EMC and needs to be installed put into es cr accessor soreabies service and used according to the EMC information de other than those specified may provided in the accompanying documents result in degraded electromagnetic Portable and Mobil RF communications can affect compatibility performance of this Medical Electrical Equipment device Operating the system near equipment which radiates high energy radio frequencies electrosurgical
35. ane 22 To Clear Volume infused During Infusion eeen 22 To Simultaneously Clear Total Volume Infused For All Channels on 23 To Place A Channel On Standby During Infusion liliis 24 To Start An Infusion From Standby Status oane 24 PROGRAMMING OPTION insane rte atd A EX RA EM OEE on be EA 24 To Setup An Infusion By Rate Volume or Volume Time oen 24 KVO STATUS ae eden peo nans n Rl over at br a p Red E RUE A Bei RU Pr e RR Ru 25 To Resume Infusion When VR 0 KVO LL ou ooo Is 25 SECONDARY MODE was ora san cn cre gaten ain SEE eran EA ed ra DEER Ea RE SIDA de PRE Ear 26 To Set Secondary Rate esos oer exe Oka ee dub Re mer e der tnt Hun dod IR CHEER doa E 29 To Set Rate Of Infusion From A Time EA assen are se mur ke exin Ros ranks m ctae Rate uei e inst 29 To Titrate Or Change Secondary Rate During Infusion n iliis 30 To Review Or Change Primary Value s During Secondary Infusion ne 30 To Start Primary Infusion Before Secondary Completes oo 31 Programming DIU mE TEENS a Car la ac 32 Programming Weight nennen ne EE RSE ea hae eben IR TR a A DES ER 32 Directions for Use Table of Contents MedSystem III9 infusion pump Models 2865 2866 GETTING STARTED CONTINUED DOSE RATE CALCULATOR DRC USING A SPECIFIC DRUG NAME CONTINUED Programming DOSE sa 0 deed RS D tekende ie ee EE EBRE 33 Changing Volumettic Rate i e vaan ita a E S wa ide caos ene oles are RON CH Re ran 33 Programming Weight
36. arm Alarms Continued Meaning Response Check Fluid Side Faulty Cassette Fluid Side Occluded Possible upstream restrictions to flow Cassette may be damaged or inoperable Possible malfunction of cassette sensor located in holder Upstream restriction to flow Check tubing between container and instrument for a closed regulating clamp closed vent with unvented container kinked tubing empty syringe or any restriction to flow If NO occlusion is present press CONFIRM Press to resume infusion Verify fluid is flowing in drip chamber A appears on standard display to indicate Confirm has been pressed Reinsert cassette in another channel If alarm recurs in second channel replace administration set If alarm recurs with two cassettes in the same channel discontinue use and contact qualified service personnel Check tubing between container and instrument for a closed regulating clamp closed vent with unvented container kinked tubing empty syringe or any restriction to flow Clear occlusion Press to resume infusion Verify fluid is flowing in drip chamber Directions for Use MedSystem III infusion pump Models 2865 2866 Alarms Advisories and Prompts 51 Alarms Continued Alarm Meaning Response Patient Side Occluded Pumping Latch Closed INCORRECT INCORRECT Rate Vol Settings Cleared Dovvnstream restriction to flovv Pu
37. ate 1 Choose volumetric rate using arrow softkeys if dose calculation is not desired N Press Enter when desired rate is displayed When rate is changed dose is automatically calculated Highlight moves to VR Changing Volumetric Remaining 1 Choose VR value using the arrow softkeys 2 Press Enter when desired VR is displayed Highlight moves to VI Clearing Volume Infused VI Or Dose Infused DI Press Clear then Enter to change VI value to 0 Highlight moves to DI 2 Press Clear then Enter to change DI value to O 3 Open regulating clamp 4 Press to begin infusion Channel starts infusing 5 Press OR Display reverts to Standard Display page after one minute DRC parameters are displayed 6 Verify settings 7T Verify flow Editing Drug List The Drug List Editor can be used to edit customize drug list See DFU for Drug List Editor DLE Directions for Use Getting Started 37 MedSystem III infusion pump Models 2865 2866 Discontinuing DRC Option 1 me 2019 Dose Rate Calculator Programming with DRUG Continued Press A JE B Jorf C I Dose Rate Calculator Programming Page is displayed Press EF to stop if infusing Press racks Press CalcOff Display reverts to primary Programming Page Volumetric rate volume remaining and volume infused from DRC are carried over to the primary Programming Page Facts about DRC Drug name patient weight o
38. ate correct cassette installation and fluid in the sensor pathway The cassette should latch easily and smoothly If the air in line sensor detects air when a cassette is installed a Check Air Sensor advisory will be displayed Press the START STOP key The message Infusing will appear on the channel status line While the channel is pumping pull out the cassette slide clamp You will hear a repeating four beep audio alarm and the red LEDs will blink Infusion will stop and the display will indicate a Cassette Not Latched alarm Remove the cassette The alarm display should read Cassette Removed Reset the alarm by pressing the channel select key A B or C for the channel in use and press the CANCEL softkey Cassette I Slide Clamp Tubing Collar Slide Clamp Not In Place ES A Slide Clamp In Place Directions for Use MedSystem III9 infusion pump Models 2865 2866 Maintenance 61 Check In Continued Patient side Occlusion Detector Test This test verifies the proper functioning of the alarm which detects occlusion between the Instrument and the patient Repeat the following steps for each of the three channels A B and C 1 Configure the Instrument in the Controller Pressure Device Type 2 Prime a set which contains no filters or check valves and has macrobore tubing on the patient side Install the primed set into the Channel Under Test CUT Set the infusion rate for 1 ml h for th
39. ations Acronyms Units of Measure 1 Pri 2 Sec a AAMI ABS AC BatLog Calc CalcOff CalcOn ClrAir cm Cntrst COMM Conc Config CP CSA DemoWD DI ECG ES FMS Gm GP GP II Hz LD IEC Inf JCAHO KG kg KVO Primary infusion Secondary infusion am American Association of Medical Instrumentation acrylonitrile butadiene styrene alternating current electrical power Battery History Log Calculator Calculator Off Calculator On Clear Air centimeter Contrast Communications Port Concentration Configuration Controller Pressure Canadian Standards Association Demonstrate Watchdog Dose Infused Electro cardiogram Electro static Field Maintenance Software gram General Purpose General Purpose II hour Hertz inch identification International Electrotechnical Commission infused intravenous Joint Commission on the Accreditation of Health Care Organizations 1 000 for numbers 10 000 or greater kilogram keep vein open Directions for Use MedSystem III infusion pump Models 2865 2866 Glossary 73 Abbreviations Acronyms Units of Measure Continued LB Ib mcg mEq mg min mn ml mMol mUn ul N A Neontl NextPg Ng NiCd OR OR II p Pri psi Sec Stnd Disp STNDBY TotVol TR UL Un V VI Vol VolRem VR Wt pound microgram milliequivalent milligram minute milliliter millimole milliunit microliter not applicable Neonatal Next Page Na
40. d Directions for Use MedSystem III infusion pump Models 2865 2866 Device NOTE The Device Type programming selection affects all three channels It is not possible to program different Device Types for a channel independently Stopped l 100 There are six Device Types with preset parameters that ml h accommodate specific clinical applications They are VR 450 Vl 50 General Purpose Operating Room Device General Purpose Neonatal General Purpose II EI Controller Pressure Operating Room Il When setting up the pump select the device type that best suits your clinical needs The abbreviated name of the Device Type appears as a softkey on the Standard Display page Pressing the softkey displays the device type in non abbreviated form on the prompt line Maximum rate maximum volume pressure and air in line threshold are configured at the factory See Table 1 for a complete listing of preset parameters Refer to the Config softkey section for programmable and configurable parameters These parameters can be modified to meet the institution s specific requirements using FMS software To Change Device Type reSS pispray J Infusin LP 2 Press otros 100 ml h TotVol Device Config and Note softkeys appear VR 450 VI 50 3 Press Device softkey Stop affects channel A Currently selected Device Type has an asterisk and is Tonor highlighted Press Select to move the highlight throug
41. de Ge dw en BE eden 75 EMC TABLES ona EC a EE EE CE nnee EE TT TRADEMARKS 22 senda tensa e Nan es A bree ROGA NE Mina SUR E sul s Pone BRE pu Ed ESE NO OR RR 80 Directions for Use Table of Contents iii MedSystem III infusion pump Models 2865 2866 THIS PAGE INTENTIONALLY LEFT BLANK iv Table of Contents Dire sor Me a ie stem s pump Models eod Introduction PO AboutMedSystemll Infusion Pump About MedSystem III Infusion Pump MedSystem III infusion pump instrument with Drug List Editor is intended for use in today s growing professional healthcare environment including healthcare facilities and home care for use on adults pediatrics and neonates Instrument 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 Instrument is a multi channel infusion pump intended to deliver multiple infusions to a single patient Instrument with Drug List Editor features Three independent fluid delivery systems in the space of one Compact size reduces bedside clutter simplifies patient transport e Easy to Setup and use yet provides advanced features e Accommodates assorted container types e Multiple delivery methods Intravenous
42. e personnel Watchdog Blank screen continuous tone red and green lights continuous all infusions stop Blank Screen Safety checks built into software have detected an instrument error condition Attempt to reset Instrument Turn instrument off then on again Press to resume each channel that had been infusing If Watchdog alarm recurs or instrument cannot be turned on replace pump and notify qualified service personnel Directions for Use Alarms Advisories and Prompts 53 MedSystem 111 infusion pump Models 2865 2866 Other Conditions Screen is too light or dark to Press ia read with instrument on Press Cntrst softkey to change screen contrast Instrument Shut Off Low Power Connect AC adapter cord to Instrument shut down after a Instrument and plUg into wal Battery Depleted alarm had not outlet been corrected AB next to External Power receptacle is lit green when AC power is properly applied 54 Alarms Advisories and Prompts Directions for Use MedSystem III infusion pump Models 2865 2866 Maintenance STANDARDS CASE MATERIAL DIMENSIONS WEIGHT AIR IN LINE DEFAULT OCCLUSION PRESSURE DEFAULT OPERATING TEMPERATURE TRANSPORT STORAGE TEMPERATURE RATE RANGE VOLUME RANGE KVO RATE RANGE RATE ACCURACY ADMINISTRATION SETS POWER CONSUMPTION BATTERIES BATTERY CHARGE AC ADAPTER amp CORD LENGTH Specifications UL 544 CSA C22 2 No 125 Impact resistant
43. e CUT Press the START STOP key to start infusion Raise the patient side tubing 2 2 66 04 cm above the cassette The CUT should not sound an alarm B Ur e 7T Slowly raise the tubing outlet to 3 8 96 52 cm above the cassette The CUT should sound an alarm within 10 seconds 8 After completing steps 1 7 for all three channels configure the Instrument in the General Purpose Device Type Fluid side Occlusion Detector Test This test verifies the proper functioning of the alarm which detects occlusion between the Instrument and the fluid container Repeat the following steps for each of the three channels A B and C 1 Install a primed set in the selected channel 2 Startthe selected channel at 125 ml h 3 Close the roller clamp between instrument and fluid container Occlusion should be detected within two minutes 62 Maintenance Directions for Use MedSystem III infusion pump Models 2865 2866 Check In Continued Fluid side Occlusion Detector Test 4 The Standard Display screen will show an alarm for the channel under test and also the message Fluid Side Occluded The red LED in the key for the test channel will blink and an audible four beep alarm will sound 5 Open the roller clamp and press the START STOP key to reset the alarm Air In Line Detector Test This test verifies the proper functioning of the alarm which detects air in a line Repeat the following procedure for each of the c
44. e as an accessory that provides a convenient place to hold syringes while they are being used as containers for IV fluid The Syringe Holder is designed to be easily installed and removed Tubing Collar from the top of the pump and to support up to three syringes Do not use the Syringe Holder as a handle to carry the pump Clear portion of cassette Preparing Administration Set Ensure the cassette slide clamp is pushed in completely so tubing is not occluded WARNING An open regulating clamp and slide clamp can cause a free flow condition and may result in serious injury to the patient Invert the cassette so tubing is up Slowly open the regulating clamp and establish fluid flow to fully prime the set Gently tap the cassette and Y sites as necessary to remove all air Gently massage the pressure dome to ensure no air bubbles are trapped Close the regulating clamp before inserting and removing the cassette to reduce the risk of free flow 14 Getting Started Directions for Use MedSystem III9 infusion pump Models 2865 2866 Loading Set Ensure cassette slide clamp is pulled out in the closed position prior to loading Press to turn pump on With tubing down use a 45 degree upward motion to insert cassette into channel U U CS a oN 4 Push on clear portion of cassette until completely seated Then push in slide clamp flush with entire cassette pn 5 Pull down gently on tubin
45. follows 1 Disconnect the AC adapter from instrument Remove any cassettes installed in instrument Turn instrument on and verify proper power up Pe pec m Instrument performs initial self test during power up and if it detects any problems it will indicate a fault e Check audio and keypad operation by ensuring there is a Soft beep for each key press o Press any key and ensure the LCD backlight turns on NOTE For a complete memory self test instrument should be turned on for a minimum of 18 minutes for the Models 2865 or 2866 It is not necessary for the unit to be pumping to perform this test If operating on battery power a cassette must be installed in at least one of the channels and that channel put in standby mode otherwise instrument will automatically shut off after five minutes of inactivity Directions for Use Maintenance 59 MedSystem III infusion pump Models 2865 2866 Check In Continued Power Tests Continued AC Power Test Turn on instrument without the AC adapter attached Install a primed cassette in each instrument channel on gt W Start all channels at any rate Verify the green LED on each channel blinks during operation gt Attach the AC adapter to instrument Verify instrument beeps three times when the connector is properly installed Verify that the green plug shaped light on the side connector panel is lit and does not blink if connector is wiggled Ve
46. g collar Press with thumb to seat tubing collar in recess beneath cassette NOTE Three beeps sound when inserted properly Front Panel Overview Instrument Control Keys ON OFF Key STANDARD DISPLAY MORE OPTIONS Key START STOP Key Turns the pump on and ney Allows the user to Starts or stops infusion off Allows the user to display additional on selected channel display Standard softkey functions Display page to view infusion settings for all channels ON OFF STANDARD DISPLAY Standby MedSystem III Infusion Pump Standby Directions for Use Getting Started 15 MedSystem III infusion pump Models 2865 2866 Front Panel Overview Continued Standard Display Page ss E BM E 3 E BM E 3 MedSystem III Status Line Displays infusion status Infusing Stopped Standby KVO ALARM FAULT SERVICE for each channel l NOTE Status line in selected channel is highlighted Infusion Rate Infusion Pump Volume Remaining ml VR 996 2 VI Volume Infused ml Start affects channel C Prompt Line STNDBY Displays messages that prompt the user to make programming choices and or take appropriate actions Softkey Prompts Displays function of specific softkey STNDBY Appears in softkey information line when is pressed during infusion Cntrst Contrast Brightens or dims display GP When pressed indicates full name of selected Device Type on the
47. gramming Primary Function To Set Primary Rate 1 Press A 9 B Jor c 9 Programming Page is displayed A Stopped Rate is highlighted A Primary Rate min A Pri VolRem VR 500 ml 2 Press Select if current rate is desired A Pri Time TR 05h 00m A Pri Vollnf VI 1 ml OR since 12 37p 01 Feb 02 Press Select to choose line 3 Press f Fast f or Fast to change rate Value flashes 4 Press Enter to confirm Highlight moves to volume remaining VR 20 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Programming Primary Function Continued To Set Primary Volume Remaining VR 1 Press Select if current VR is desired OR 2 Press f Fast f or Fast to change VR Value flashes 3 Press Enter to confirm Primary time remaining TR is calculated automatically based on VR and rate Highlight moves to volume infused VI To Clear Primary Volume Infused VI 1 Press Select if current VI is desired OR 2 Press Clear to reset volume infused to zero Date and time are cleared Clear softkey switches to Recall 3 Press Enter to confirm OR 4 Press Recall softkey to recall previous VI date and time 5 Open regulating clamp on administration set 6 Press to begin infusion Channel starts infusing Current date and time are entered Green infusion light on channel key stays lit T Press OR Display reverts to Standard Disp
48. h the list Press Enter when the desired device is highlighted If preset values are compatible with the newly selected eee General Purpose device type Neonatal Controller Pressure e An asterisk appears next to the device name Operating Room General Purposell If channel is not infusing when device type is changed Operating Room II and preset values are not compatible with the newly eee selected device type Directions for Use Getting Started 39 MedSystem III infusion pump Models 2865 2866 Device Continued To Change Device Type Continued The display switches to a notification screen Incompatible Channel s indicated Choice is given to continue If Yes Incompatible values are cleared Display reverts to Standard Display Page New Device Type becomes active If No Display reverts to Change Device Type page If channel is infusing when device type is changed and preset values are not compatible with the newly selected device type The display switches to the notification screen ncompatible Channel s is indicated Choice is given to continue If No Display reverts to Change Device Type page for user to select another device type If Yes The pump will alarm Infusion will stop on affected channel s Display reverts to Standard Display with Alarm indicated in affected channel Press affected channe A J PB J of c 9 7 Follow instructions dis
49. hannels A B and C 1 Disconnect the drip chamber from the solution bottle or inject a large air bubble into the tubing via the upstream y site NOTE The injected air bubble size should be approximately twice the threshold value of the air detector plus one milliliter to fill the cassette air trap For example if the threshold is 500 microliters then inject a 2 milliliter air bubble To determine the threshold value check the Clinical Configuration settings in instrument 2 Press the START STOP key on the selected cassette When the bubble is pumped through the cassette the Standard Display should show an alarm for the channel under test with the message Air In Line An audible four beep alarm will sound and the red LEDs will blink Directions for Use MedSystem III9 infusion pump Models 2865 2866 Maintenance 63 Check In Continued New Instrument Volume Accuracy Test Accuracy of fluid delivery is determined by measuring the volume of fluid delivered over a known time period and comparing this to the expected value To ensure accurate measurements during the test a volumetric glass burette class A must be used to collect the fluid The infusion time interval must be 180 seconds or greater to minimize measurement errors During a 180 second test a one second error by the operator results in an error of 0 6 A Test Equipment Setup 1 Obtain a new administration set and connect it to a 500 milliliter cont
50. he factory defaults Qualified hospital facility personnel are responsible for checking in the Instrument and ensuring the current hospital approved data set is loaded Directions for Use MedSystem III9 infusion pump Models 2865 2866 Maintenance 71 WARRANTY Cardinal Health warrants that A Each new MedSystem III infusion pump 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 Cardinal Health 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 90 days from the date of delivery by Cardinal Health to the original purchaser If any product requires service during the applicable vvarranty period the purchaser should communicate directly with Cardinal Health to determine the appropriate repair facility Except as provided otherwise in this warranty repair or replacement will be carried out at Cardinal Health s 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 Cardinal Health be liable for any incidental indirect or consequential damages in connection with the purchase or use of any MedSystem III infusion pump This warranty shall apply solely to the original purchaser T
51. his warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Cardinal Health shall not be responsible for any loss or damage arising in connection with the purchase or use of any MedSystem III2 infusion pump which has been 1 repaired by anyone other than an authorized Cardinal Health Service Representative 2 altered in any way so as to affect in Cardinal Health s judgment the product s stability or reliability 3 subjected to misuse or negligence or accident or which has had the product s serial or lot number altered effaced or removed or 4 improperly maintained or used in any manner other than in accordance with the written instructions furnished by Cardinal Health This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of Cardinal Health and Cardinal Health does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of Cardinal Health any other liability in connection with the sale or use of MedSystem III infusion pump CARDINAL HEALTH 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 72 Maintenance Directions for Use MedSystem III infusion pump Models 2865 2866 Abbrevi
52. kage Check for any physical damage to the Instrument or accessories If any is found report it to Customer Service Functional Test Refer to your institutions policies for specific requirements regarding inspection and testing of incoming equipment before use Recommended functional tests are given in the following pages As a minimum the following steps should be performed before use Charge battery for 14 hours Perform electrical safety checks Turn Instrument on to verify normal power up and operation of LEDS display and audio Directions for Use Maintenance 57 MedSystem III9 infusion pump Models 2865 2866 Check In Continued Check In Tests WARNING For proper grounding the AC Check In tests are recommended prior to clinical use When a adapter must always be connected test requires a primed cassette it is recommended that clean to a three wire outlet Never operate tap water be used for such tests If any of the functions are the Instrument from a two wire not as described in the check procedures then the Instrument ungrounded outlet requires service Refer to general contact informatin preceeding the introduction of this manual WARNING Do not perform any of the following NOTE Upon completion of Check In tests reset the following tests while instrument is in use on a Volume Remaining Time and Rate patient Review all precautions in the DFU before performing these tests Electrical S
53. lapsed since cassette was installed or infusion was stopped Verify tubing collar is fully seated in air sensor recess Verify tubing in air sensor recess is not damaged twisted or dirty Press ClrAir on channel s Alarm Information page Three beeps indicate air bubble is no longer in front of air sensor If air is still present remove cassette and manually clear air according to hospital policy If no air is present clean air sensor recess as directed in cleaning instructions Enter new VR or if same volume is desired press REPEAT Press Enter Press to resume primary infusion rate Verify fluid flow Connect AC adapter power cord to instrument Plug into wall outlet Press STNDBY to place channel on Standby OR Press SAE to start infusion OR Remove cassette Directions for Use MedSystem III9 infusion pump Models 2865 2866 Alarms Advisories and Prompts 47 Alarms Four rapid beeps infusion stops rapidly flashing red light on channel key Alarm Meaning Response Air In Line Air detected in fluid pathway during infusion or air sensor is dirty Air In Lower Tubing Air bubbles detected in fluid pathway with a total volume exceeding the air in line threshold setting Possible outgassing and or leaks in administration set Verify tubing collar is fully seated in air sensor recess Verify tubing in air sensor recess is not damaged twisted or dirty Press
54. lay page after one minute 8 Verify settings 9 Verify solution flow from primary container A Stopped A Primary Rate 100 ml h A Pri VolRem VR Elm A Pri Time TR 05h 00m A Pri Vollnf VI 1 ml since 12 37p 01 Feb 02 Press Select to choose line A Stopped A Primary Rate 100 ml h A Pri VolRem VR 500 ml A Pri Time TR 05h 00m A Pri Volinf VI Em since 12 37p 01 Feb 02 Press Select to choose line ETA END NN LEA A Stopped A Primary Rate 100 ml h A Pri VolRem VR 500 ml A Pri Time TR 05h 00m A Pri Vollnf VI Mm Press Enter or Recall EH E NND E Directions for Use MedSystem 111 infusion pump Models 2865 2866 Getting Started 21 Programming Primary Function Continued To Titrate Or Change Primary Rate During Infusion 1 Press A 9 C B Sor c 9 Programming Page is displayed Rate is highlighted 2 Press f Fast t or Fast to change Rate Value flashes 3 Press Enter to confirm e New rate begins infusing immediately To Change Volume Remaining During Infusion 1 Press A J P B Sor c 9 Programming Page is displayed Rateis highlighted Press Select to highlight VR Press 1 Fast f or Fast to change VR Value flashes 4 Press Enter to confirm nfusion continues with new volume remaining To Clear Volume Infused During Infusion subtracted from the volume on the TotVol page 1 Press A 9 B Sor c 9 Program
55. ming Page is displayed Rateis highlighted Press Select to highlight VI Press Clear then Enter to reset volume infused to zero Date and time are cleared Clear softkey switches to Recall 22 Getting Started Directions for Use MedSystem 111 infusion pump Models 2865 2866 Programming Primary Function Continued To Clear Volume Infused During Infusion Continued 4 Press Enter to confirm Infusion continues with volume infused reset to zero Current date and time are entered OR 5 Press Recall softkey to recall previous VI value date and time Making Changes While Infusing To Simultaneously Clear Total Volume Infused For All Channels d Press mmus Stopped Stopped Stopped l edi TotVI A Tovi B TotVi C Standard Display page is displayed Pri 20 Pri 20 Pi 20 2 Press 959 Sec 0 see 0 Sec 0 i I Total VI IESU mi TotVol Device Config and Note softkeys appear since 03 25p 10 Feb 02 Press ClrTot to clear TotVI 3 Press TotVol softkey EE EEES FEE Total Volume page is displayed e VI for each channel and total pump VI values are highlighted 4 Press ClrTot to reset volume infused to zero Stopped j Slopped TotVI A TotVI B TotVI C Pi 0 Pri 0 Pi 0 Date and time are cleared Sec 0 0 Sec 0 i EH 0 5 Press Enter to accept clearing of all values Tola EN since OR press Enter or Recall gt A Ed a EE A SEN 6 Press Recall sof
56. mping latch javv located to right of air sensor is closed or broken Air Sensor Pumping SEES Check tubing between instrument and patient for kinks closed clamps closed stopcocks clogged filters site problems etc Clear occlusion or change infusion site Press to resume infusion Verify fluid is flowing in drip chamber Using only your finger push down pumping latch jaw until it snaps open If pumping latch jaw is visibly broken contact qualified service personnel UJ e e A Ten LN ex ST Latch Jaw Rates and or volumes are incompatible with newly selected Device Type xc CORRECT O rr CORRECTIVE ACTION CORRECT Re enter settings as required Press to resume infusion 52 Alarms Advisories and Prompts Directions for Use MedSystem 111 infusion pump Models 2865 2866 Numeric message European siren rapid flashing red light infusion stops Alarm Meaning Response Channel Out of Order Safety checks built into software have detected a faulty channel Fault Number Safety checks built into software have detected a fault condition CORRECTIVE ACTION for resumable faults only Press affected channel A O B O or O C O Follow instructions on channel s Alarm Information page Press RETRY to clear fault If fault recurs press SERVICE and contact qualified servic
57. n for a beep to ensure that the audio alarm transducer functions properly Instrument information page is momentarily displayed Continuing to hold down ON OFF key will keep the Information page on the display e When the ON OFF key is released the Standard Display page is displayed To Turn Pump Off Press and hold oworr Display disappears Pump is turned off To View Infusion Settings For All Active Channels Press e Standard Display page is displayed To Activate Additional Standard Display Softkey Prompts With the Standard Display page displayed Press once TotVol Device Config and Note softkeys appear To Select Channel And Display Programming Pages Press again Batlog and DemoWD softkeys appear Press Ce Jorf c 9 Selected channel Programming Page is displayed 18 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Programming Page Continued To Program Infusion With Programming Page displayed 1 Press Select to choose value to change Value is highlighted N Scroll through values using 1 Fast t or Fast f and Fast f increase highlighted values in single or multiple increments and Fast decrease highlighted values in single or multiple increments Pressing f or changes direction of the Fast f or Fast Highlight remains flashing until Enter is pressed If Enter is not pressed the entry incomplete adviso
58. nded only for one time use Do not resterilize Always power on instrument before inserting the set Do not insert a cassette into a channel with a SERVICE prompt Remove any cassettes from channel s requiring service Ensure the cassette is properly installed before starting infusions Directions for Use Getting Started 11 MedSystem III9 infusion pump Models 2865 2866 Warnings and Cautions Continued 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 the port Flush port s per facility protocol Discard administration set per facility protocol 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
59. nogram nickel cadmium Operating Room Operating Room Il pm Primary pounds per square inch Secondary Standard Display Standby Total Volume time remaining Underwriters Laboratories Inc unit Volts volume infused volume volume remaining volume remaining weight 74 Glossary Directions for Use MedSystem III infusion pump Models 2865 2866 Appendix A Trumpet and Start Up Curves 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 curves show typical performance of the system in two ways 1 the accuracy during various time periods over which fluid delivery is measured trumpet curves and 2 the 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 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
60. nto vvall minutes outlet Press Stop _ to resume infusion s NOTE Drug List is lost if instrument battery is totally depleted Drug List can be reloaded into the pump with FMS software only Directions for Use Alarms Advisories and Prompts 49 MedSystem III infusion pump Models 2865 2866 Alarms Continued Alarm Meaning Response Cassette Jammed Cassette piston is difficult to Remove cassette check move or piston sleeve is loose placement of soft plastic piston sleeve and reposition if necessary If condition continues try cassette in a different channel Replace administration set if alarm recurs or if piston does not move freely If alarm recurs with several cassettes channel may need service piston sleeve CORRECT INCORRECT Cassette Not Latched Cassette is partially disengaged Push cassette completely in or latching mechanism is dirty Ensure slide clamp is flush with i START entire cassette Press to resume infusion If condition continues try cassette in a different channel Replace administration set if alarm recurs Clean lower assembly according to cleaning instruction described in MAINTENANCE section of this document Cassette Removed Cassette is removed from holder Reinstall cassette and press while channel is infusing ES resume infusion OR Press Cancel 50 Alarms Advisories and Prompts Directions for Use MedSystem 111 infusion pump Models 2865 2866 Al
61. nued To Clean Continued 3 After removing residue gently rinse with a lint free swab dampened with water Water may be sprayed on the cleaned surfaces to rinse areas that are difficult to reach with a swab 4 Gently dry with a lint free swab or allow to air dry 5 After cleaning inspect the exposed tips of the valve actuators A broken tip may be supported by the actuator seal and not appear defective Lightly attempt to push the tips of the valve actuators from side to side with a dry lint free swab If a tip is not rigid then it is broken and must be replaced before using the Instrument After cleaning Inspect the exposed tips of the valve actuators for damage by lightly pushing the tips of the valve actuators side to side with a dry swab If a tip is not rigid it is broken and must be replaced before using instrument EEE Failure to perform these inspections may result in improper Instrument operation CAUTION Do not use isopropyl alcohol on the optomodule C L J valve SAT Actuator Optomodule Care must be taken when cleaning the vicinity of the valve actuators to avoid damage and breakage of the actuator tips Damage or breakage of the actuator tips could cause an uncontrolled flow condition CAUTION Do not use isopropyl alcohol to clean the valve actuators Directions for Use MedSystem III9 infusion pump Models 2865 2866 Maintenance 69 Inspection Requirements
62. o Set Select VR and Rate 7 Press Accept to set a time 1 Press A 9 Bore c 4 Directions for Use Getting Started MedSystem III9 infusion pump Models 2865 2866 Secondary Mode Continued To Titrate Or Change Secondary Rate During Infusion NOTE Channel display on the Standard Display is reverse highlighted Secondary Programming Page is displayed Rateis highlighted 2 Press f Fast f or Fast to change rate Value flashes Infusing 3 Press Enter to confirm e New rate begins infusing immediately Stop affects channel A en EX To Review Or Change Primary Value S During Secondary Infusion A Stopped O O O O O O 1 Press A B or C A Primary Rate 100 ml h Secondary Programming Page is displayed A Pri VolRem VR 500 ml A Pri Time TR 05h 00m 2 Press 455 A Pri Vollnf VI 1 ml since 02 16p 01 Jul 02 e 1 Pri and CalcOn softkeys appear o Press Select to choose line 3 Press 1 Pri softkey Primary Programming Page is displayed Press Select to highlight value s to change 5 Press ft Fast f or Fast to change value s 6 Press Enter to confirm 30 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Secondary Mode Continued To Start Infusion Before Secondary Completes 1 Close regulating clamp on secondary infusion set Press A 9 B Jof c9 WEL 1 5 2 n Pressing 393 will
63. ortable Instrument with pole clamp weighs just over 5 pounds 2 3 kg and is easy to transport Unique rotating pole clamp May be attached to a variety of surfaces Dose Rate Calculator DRC Calculates a volumetric or dose rate based on values entered for patient weight drug concentration drug amount and diluent volume and dosing parameters A Stopped Drug List Editor DLE Drug list can be customized using Drug List Editor software BIEN Wt RG 0 0 LB mg ml mcg kg min ml h ml Vol Rem 0 ml DI 0 0 mg Press Select to choose line 2 Introduction Directions for Use MedSystem 111 infusion pump Models 2865 2866 Features Continued Six Device Types available Six available Device Types with configurable parameters maximum and minimum rates maximum volumes baseline and maximum pressures and air in line thresholds to achieve specific clinical applications General Purpose Operating Room Neonatal General Purpose II Controller Pressure Operating Room II Free flow Protection Administration Sets contain a cassette that provides protection from free flow conditions Upon removal of cassette from instrument cassette s slide clamp is pulled to full extension occluding the tubing and preventing fluid from flowing Monitoring System Continuously monitors instrument conditions and alerts with adjustable audio tones and visual messages Da
64. played e Rate Vol Settings Cleared Alarm Info Press channel A EN CCA NEN IV 40 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Device Continued To Change Device Type Continued Table 1 Default General Neonatal Controller Operating General Operating Parameter Purpose Pressure Room Purpose II Room Il Occlusion I n i A Detection Baseline Baseline Absolute Baseline Baseline Baseline Method Threshold Occlusion Sm Baseline 5 psi Baseline 3 psi 3 ft H2O Baseline 5 psi Baseline 5 psi Baseline 5 psi etting Maximum Pressure 15 psi 15 psi 3 ft H O 15 psi 15 psi 15 psi Air in line Alarm 500 ul 50 ul 500 ul 500 ul 500 pl 500 ul Threshold E d E E KVO Rate 3 ml h 1 0 ml h 3 ml h 3 ml h 3 0 ml h 3 0 ml h Rate Range 1 999 ml h 0 1 99 9 ml h 1 299 ml h 1 999 ml h 0 1 999 ml h 0 1 999 ml h Maximum VR Setting 9999 ml 9999 ml 9999 ml 9999 ml 9999 ml 9999 ml Pump Not In Use Yes Yes Yes No Yes No Advisory ALL Setting I for VR N A N A N A Option N A Option d eanne will infuse at the KVO rate shown in table or at the current infusion rate whichever is ower NOTE Values shown in table can be modified to meet the institution s requirements using FMS software To review actual default parameters on a Instrument DLE Select a Device Type and refer to Instrument Settings pages
65. pole or bedside NOTE Instrument is designed to function in any orientation However the effectiveness of the administration set air trap is diminished when instrumet is in other than vertical position 6 Introduction Directions for Use MedSystem III infusion pump Models 2865 2866 System Components Continued Attaching Pole Clamp To attach pole clamp position clamp jaw over mounting surface and turn knob until the clamp is tightened and pump feels secure When knob is as tight as possible continued turning will i make it click and spin freely without over tightening Symbols Canadian and U S Certification Mark Products bearing this mark have been tested GB and certified in accordance with applicable U S and Canadian electrical safety and ES performance standards IPXI Protection against fluid ingress Drip Proof A Caution Refer to accompanying documentation U S Certification Mark Products bearing this mark have been tested and certified ST E Ur in accordance with applicable U S electrical safety and performance standards UL 544 MM Manufacturing Date Number adjacent to symbol indicates month and year of vat av manufacture Bu Consult operating instructions Explosion risk if used in presence of flammable anesthetics Directions for Use Introduction 7 MedSystem III infusion pump Models 2865 2866 Symbols Continued R Only Single Use D e GO XX
66. polycarbonate ABS alloy Height 7 875 inches 20 00 centimeters Width 6 inches 15 24 centimeters Depth 2 10 inches 5 33 centimeters Approximately 5 1 pounds 2 3 kilograms including pole clamp 500 ul except for Neonatal device type which is 50ul 15 psi except for Controller Pressure device type which is 3 ft H 0 50 104 Fahrenheit 10 40 Celsius 4 to 131 Fahrenheit 20 to 55 C lt 95 F or 35 C for optimum battery life 0 1 999 milliliter per hour each channel 0 1 9999 milliliter each channel 0 1 20 0 milliliter per hour 1 0 999 ml hr 5 with a standard deviation of 1 96 under specified conditions 0 1 0 9 ml hr 10 with a standard deviation of 1 96 Use only Instrument Administration Sets 6 watts AC power Use only Instrument AC Adapter Model 1555 or 1560A ordered as part number 2861089 Main Rechargeable NiCd Battery Pack Memory Back up Non rechargeable Lithium NOTE Use only approved Cardinal Health Battery packs A fully charged battery has a minimum of 6 hours running time with all channels running at 125 milliliters per hour and backlight usage of 2 minutes per hour The main battery retains 80 of its capacity after 500 charging cycles and retains 90 of its capacity after 3 months of continuous AC charging NOTE Replacement of both the main and memory backup batteries must be performed by qualified service technicians Model 1555 7 5 Vdc 1 Amp with 1
67. prompt line NOTE Additional softkey prompts are displayed by pressing 295 Softkey Pads 4 16 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Programming Page Selected channel is indicated by the letter displayed at the beginning of the first five lines Status Line Displays infusion status for selected channel Infusion Rate Volume Remaining Time Remaining Volume Infused Date Time Displays when volume infused was last cleared and infusion began Prompt Line Displays messages that prompt user to make programming choices and or take appropriate action Softkey Prompts Displays function of specific softkey Select Moves highlight bar through programmable infusion parameters 7 Increases highlighted value Decreases highlighted value Increases or decreases highlighted value at greater increments Ne Primary Rate Pri VolRem VR Pri Time TR Pri Vollnf VI since 12 37p O1 Feb 02 A A A A A STANDARD MORE START DISPLAY OPTIONS STOP MedSystem III Infusion Pump Stopped mi h 250 ml 10h 00m 10 ml Press Select to choose line C3 C ats dE Directions for Use MedSystem III9 infusion pump Models 2865 2866 Getting Started 17 Programming Page Continued To Turn Pump On Press oworr Upon start up instrument performs an automatic self test Liste
68. r drug concentration cannot be changed while infusing Changes to patient weight or concentration will recalculate volumetric rate but maintain dose rate Drug names may be abbreviated if the name contains more than eight letters Weight can only be entered in Kg s but is displayed in Kg s and Lbs Weight units can be switched to grams by pressing to value of 1Kg then repressing A two tone advisory sounds If dose measurement parameters and concentration measurement parameters are unrelated a volumetric rate will not calculate Attempts to start will display a prompt message Verify all dose settings When a drug amount is 10 000 or greater a K is used to replace 000th i e 10 000 10K 12 000 12K If a recalculated dose results in a rate outside the rate ranges a prompt message is displayed Rate too High reenter value or Rate too Low reenter value If a recalculated rate results in a dose outside the dose range the channel will infuse at the entered rate but the dose will display the minimum or maximum allowable limit i e 0 1 or 29991 Secondary option cannot be used when the Dose Rate Calculator is enabled If Instrument is off for more than five minutes the DRC mode will revert to the primary mode A Stopped RENT Wt 70 0 KG 154 3LB A Conc 400 mg 250 ml A Dose 0 mcg kg min A Rate 1 ml h A VR ml Vol Rem A VI O ml DI 0 0 mg Press Select to choose line ee eo 38 Getting Starte
69. rify that the green LEDs for each channel key A B and C are steadily illuminated If they are blinking then the Cassette and Sensor Test Instrument is not recognizing that AC power is connected a This test verifies the proper functioning of the cassette and latch sensors as well as the latching mechanisms Repeat the following procedures for all three channels A B and C 1 With the Instrument off remove any cassettes that are installed 2 Turn on the Instrument 3 Verify that the Instrument latch mechanism of each channel returns to the Home position at the top of the stroke nearest to the chassis 4 Press the channel select key A B or C and then press the START STOP key A two tone advisory will sound and the highlighted message Install Cassette will appear in the prompt line near the bottom of the screen 60 Maintenance Directions for Use MedSystem III infusion pump Models 2865 2866 Cassette and Sensor Test Continued 5 o N Check In Continued Install a primed cassette into the appropriate channel A B or C but do not push the cassette slide clamp into place Ensure that there are no air bubbles Press the START STOP key again A two tone sound will be emitted and the message Push Slide Clamp In will appear at the bottom of the page Push the cassette slide clamp in and seat the tubing collar in the recess below the cassette Three beeps will sound to indic
70. ry History Log page This page is provided for the Biomedical Engineering staff to review and record battery history data Press ES Infusing 2 Press twice 1 B BatLog and DemoWD softkeys appear VR 450 3 Press BatLog softkey ME 30 The Battery History page is displayed CES bie EES 4 Press ovorr to exit Battery History page OR Display switches to Standard Display page after 1 minute Directions for Use Getting Started 43 MedSystem III9 infusion pump Models 2865 2866 THIS PAGE INTENTIONALLY LEFT BLANK 44 Getting Started Dire ad Me x en stem is pump Models Mp Alarms Advisories and Prompts Use this troubleshooting information in conjunction with appropriate hospital procedures Responding to an advisory alarm or fault message 1 Press QUIET Audio tone stops e Red light flashes on affected channel 2 Press affected channel P A kl P B 9 orl c aL Alarm Information page is displayed 3 Take appropriate action s indicated on the display 4 Press to resume infusion Channel starts infusing 5 Press OR Display reverts to Standard Display after one minute 6 Verify settings 7 Verify flow Directions for Use Alarms Advisories and Prompts 45 MedSystem 111 infusion pump Models 2865 2866 NOTE Channel s VR and VI values are updated with each press Alarm Response Keys of ClrAir softkey NOTE A appears on Standard Display page to indicate CONFIRM ha
71. ry will sound p Press Enter to accept new value Highlight moves to next programmable value if channel status is Stopped or Standby e If status is Infusing highlight remains on selected value gt To recall a previous value after a new value is introduced but not entered press otros Recall soft key appears e Press Recall Number returns to previous value Press i Infusion starts or stops immediately unless the channel s programming is incomplete or if an advisory alarm or fault condition exists on selected channel o ALARM is displayed in affected channel status line Alarm condition is displayed on the Standard Display of the affected channel Directions for Use Getting Started MedSystem III9 infusion pump Models 2865 2866 Programming Page Continued To Access Alarm Information See the ALARMS ADVISORIES AND Press affected channel P A 9 g B 9 orl c 3 PROMPTS section of this s manual for more alarm Alarm Information page is displayed for that channel information To Activate Additional Programming Page Softkeys With the Programming Page displayed 1 Press 2 Press 2 Sec to access Secondary page See the GETTING OR STARTED section of this manual for information on 3 Press CalcOn to access Dose Rate Calculation page the use of the Dose Rate Calculator function 4 Press and press CalcOff to discontinue use of the Dose Rate Calculator Pro
72. s been pressed QUIET CANCEL ClrAir CONFIRM RETRY SERVICE Silences Advisories Alarms and Faults for two minutes Softkey is accessible during alarm status Clears alarm and advisory messages and stops tone Use when alarm or advisory condition cannot be corrected or user chooses not to correct Moves air bubbles past air in line sensor Each press of the ClrAir softkey displaces approximately 0 2 ml of air fluid Three beeps indicate when air bubble is no longer in front of the air in line sensor Is present during Check Fluid Side alarms Allows infusion to continue if no upstream occlusion is found Resets resumable fault conditions Used when attempting to re establish normal operation of a channel Disables use of affected channel Once pressed servicing of instrument is required before channel can be used 46 Alarms Advisories and Prompts Directions for Use MedSystem 111 infusion pump Models 2865 2866 Advisories Two beeps slow flashing red light on infusing channel s channel key infusion continues Alarm Meaning Response Check Air Sensor Infusion Complete VR 0 Low Battery Channel Not In Use At installation of cassette a air is detected in tubing b tubing collar is not properly seated or c air sensor is dirty or damaged VR has counted down to zero Channel is infusing at KVO rate 30 minutes or less battery power remaining Two minutes have e
73. s for Use MedSystem III infusion pump Models 2865 2866 Service Information If instrument shows evidence of damage in transit notify the carrier s agent immediately Do not return damaged equipment EEN f to the factory before the carrier s agent has authorized repairs If instrument fails to respond as described in this document and the cause cannot be determined do not use instrument Contact qualified Cardinal Health service personnel If it is necessary to return instrument for service obtain a return authorization number prior to shipment Carefully package instrument preferably in the original packaging reference the return authorization information and return it to appropriate service or distribution center Cardinal Health does not assume any responsibility for loss of or damage to returned instruments while in transit Technical Support Technical support service information applications and manuals may be obtained by contacting a Cardinal Health representative When submitting any request for service include Model number A description of difficulty experienced Instrument settings Administration set lot number Solution s used Message displayed at time of difficulty Instrument case should only be opened by qualified personnel using proper grounding techniques Prior to performing maintenance disconnect from AC power During servicing instruments configuration settings might be reset to t
74. t marked with the following symbol 123 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 Compliance levels raised by IEC 60601 2 24 a The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges b Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Instrument is used exceeds the applicable RF compliance level above the Instrument should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Instrument c Over the frequency range 150
75. t moves to value for diluent volume 3 Choose diluent volume using the arrow softkeys 32 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Dose Rate Calculator Drc Programming Using A Specific Drug Name Continued Programming Concentration Continued 4 Press Enter when desired volume is displayed e VR is automatically set when the diluent volume value is entered but can be changed if desired Highlight moves to Dose NOTE Calculated rates for infusion are fractional and will be displayed as a fraction on the Standard Display even if Device Type is set for whole numbers Programming Dose NOTE In Neonatal Device type the concentration will always start at a numeric value of 0 1 1 Choose dose using the 1 Fast f or Fast softkeys 2 Press Enter when desired dose is displayed e Volumetric rate is automatically calculated Highlight moves to Rate Changing Volumetric Rate 1 Choose rate value using the 1 Fast f or Fast softkeys if dose rate is not as desired 2 Press Enter when desired volumetric rate is displayed Infusing When rate is changed dose value is automatically DOPAMINE calculated Stop affects channel A I EEES Highlight moves to VR Changing Volume Remaining 1 Change VR value using the 1 Fast f or Fast softkeys 2 Press Enter when desired VR is displayed Highlight moves to VI Directions for Use
76. ta Monitoring Can be configured to communicate with a remote computer such as a centralized patient monitoring nurse s station The COMM receptacle is compatible with RS 232 cabling A communications manual that describes the programming and hardware involved is available Field Maintenance Software FMS Can be modified to accommodate specialized clinical applications The Device Type parameters occlusion limit and air in line threshold can be configured with the FMS software Directions for Use Introduction MedSystem III infusion pump Models 2865 2866 Features Continued n M Secondary Mode A Infusing Secondary A Secondary Rate 100 ml h A Sec VolRem VR ml A Sec Time TR 1 hr Allows user to program two different rates of infusion to run sequentially A Sec Vollnf VI 1 ml since 12 37p 01 Feb 02 Syringe Delivery Stop Affects Secondary Accommodates 20cc to 60cc syringes Full Range of Delivery Rates Rates from 0 1 to 999 milliliters per hour Battery Capacity A nevv fully charged battery provides 6 to 8 hours of operating time with rates at 125 ml h per channel 4 Introduction Directions for Use MedSystem 111 infusion pump Models 2865 2866 System Components FRONT PANEL Instrument Keys Display Screen Softkey Pads Channel Indicator Lights MEDICAL SYSTEMS bk ALARIS ap AL S Green Steady
77. tion using 1 Fast f and Fast softkeys 2 Press Enter when desired concentration is displayed Highlight moves to concentration parameters 3 Choose desired concentration parameters using 1 Fast and Fast softkeys 4 Press Enter when desired parameter is displayed Highlight moves to value for diluent volume 5 Choose diluent volume value using 1 Fast f and Fast softkeys 6 Press Enter when desired volume is displayed VRis automatically set when the diluent volume is entered but can be changed if desired Highlight moves to Dose parameters NOTE In Neonatal Device type the concentration will always start at a numeric value of 0 1 Programming Dose 1 Choose dose parameters measure weight time using 1 Fast f and Fast softkeys Press Enter when each desired dose parameter is displayed N Highlight moves to next parameter each time Enter is pressed Highlight moves to Dose when Enter is pressed to accept time value Choose dose using 1 Fast f and Fast softkeys Press Enter Pe Highlight moves to Rate parameters Drug concentration parameters Gm mg mcg mMol mEq mUn Un Dose parameters measure Gm mg mcg Ng weight time mMol mEq mUn Un kg min h or day 36 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Dose Rate Calculator Programming with DRUG Continued Changing Volumetric R
78. tkey to recall the previous Total VI date and time Directions for Use Getting Started 23 MedSystem III9 infusion pump Models 2865 2866 Making Changes While Infusing Continued To Place A Channel On Standby During Infusion NOTE When a channel is Stopped for two minutes with a cassette in place a Channel Not In Use advisory sounds When a channel is on Standby the advisory does not sound NOTE Infusing channel should always be stopped prior to removing cassette 100 ml h VR 450 Press appropriate channel P A 9 B Jorf c 9 Vl 50 Press SAR to stop infusion Ger P Start affects channel A Piss EEES Standard Display page is displayed 4 Press STNDBY To Start An Infusion From Standby Status Press appropriate channel CA 3e Bore Press to start infusion Programming Option To Setup An Infusion By Rate volume Or Volume time 1 Press if channel is infusing N 2 Press if Standard Display page not already Instrument Settings 1 of 5 displayed Audio Volume highest SORE Sec Complete Advisory No 3 Press Setup Line Option TotVol Device Config and Note softkeys appear Time am pm 02 16p 01 Jul 02 4 Press Config softkey Press Stnd Display to Exit The first of five Instrument Settings pages is displayed 5 Press Select to move the highlight to Setup Line Option 6 Press f or to choose Yes fand will not be displayed if pump is infused 7 Press
79. to dry instrument as the o ee source before cleaning Do not spray fluids directly onto the rear case of the DO NOT Use organic solvents ammonia ammonium Instrument Do not steam autoclave based agents and or abrasive cleansers EtO sterilize immerse the Instrument or allow fluids to enter the Instrument case Failure to follow these instructions may DO NOT Use sharp or metallic tools to remove residue result in an electrical hazard NOTE If the power cord is permanently attached to instrument ensure cleaning solution does not enter the connector force may move fluid past the moisture seals DO NOT Damage valve actuators 66 Maintenance Directions for Use MedSystem III infusion pump Models 2865 2866 Cleaning Continued Before Cleaning 1 N e Unplug the AC adapter power cord from the wall outlet Disconnect the power cord from the external power connector on the side of instrument Inspect the Instrument s outside surfaces for damage Anycracks or punctures may allow fluid to enter For cleaning applications Use solutions of non abrasive non staining detergent i e commercially available alcohol free dish washing liquid well diluted with warm water e Use either Cavicide or 10 chlorine bleach and water for disinfecting Rinse with distilled or de ionized water Use soft non abrasive cloths soft bristled brushes and or non abrasive lint free swabs Instrument lower
80. tone accompanies each level to aid in Settings page medium determining volume choice If an alarm high is ignored the volume will ramp to the hi Past highest audio unless disabled by FMS 9 Factory default is highest Pump sounds two tones and Nus lays Sec Complete Advisory Hos san when secondary V ex Factory default is No Enables infusion to be Setup as rate ASUS Option ve volume or volume time Stop infusion before modifying this line option Factory default is No Time 24 hr Allows pump to be set with a 12 or 24 am pm hour clock aci n default is am pm Hour minutes 0000 2359 Day 1 31 Each item can be adjusted when Month Jan Dec highlighted Years 00 99 42 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Note Soft Key The Note soft key accesses the Special Note Message page When a Note is programmed it appears when the pump is turned on Infusing To Access NOTE s 100 ml h VR 450 Press Mus 2 Press E si affects channel TotVol Device Config and Note softkeys appear 3 Press NOTE softkey NOTE information is displayed e f no information has been programmed on the NOTE ml h page there will be a two tone advisory and the VR 450 message There is no Special Note will display on the VI 50 prompt line BatLog Battery History Log To Access Battery History Log The BatLog softkey accesses the Batte
81. us VR OR 3 Press f Fast f or Fast to change VR Value flashes KVO 100 Infusion Complete VR O0 Alarm Info Press A HEN QUIET A KVO 3 0 ml h A Primary Rate 100 ml h A Pri VolRem VR Man A Pri Time TR A Pri Vollnf VI 100 ml since 12 37p 01 Feb 02 Press Select to choose line Directions for Use MedSystem III9 infusion pump Models 2865 2866 Getting Started 25 KVO Status Continued To Resume Infusion When Vr 0 KVO 4 Press Enter to confirm 5 Press to resume infusion and stop KVO rate NOTE If current infusion rate is set below KVO rate channel will infuse at the lower rate Secondary Mode This option allows two different rates of infusion to be administered sequentially When secondary volume remaining reaches Zero primary infusion resumes automatically To avoid the possibility of concurrent flow during secondary delivery of intermittent medications Setup the administration set as recommended below 26 Getting Started Directions for Use MedSystem III infusion pump Models 2865 2866 Secondary Mode Continued Preparing The Administration Set And Container WARNING Setting a secondary rate over e For Needle Free sets attach secondary to upper primary Y 275 ml h may result in concurrent site below a check valve flow with the primary container e Prepare the secondary IV container according to your institution s policy
82. val tea O A CE 0086 Table of Contents INTRODUCTION ABOUT THE MEDSYSTEM III INFUSION PUMP eeen dc DU Ip TIMERE SYSTEM COMPONENTS si iii na cachet ara ee ceca eit n ta a ice tct dee n ua dd aa dr SYMBOLS TREE NIJ N gt GETTING STARTED WARNINGS AND CAUTIONS aar rra dte mes i ec i ae ee ale ede too he err ete ae nb cess 9 PREPARING THE INFUSION 3 0550 2i bee zestig edi aa doe it Re a een and ee ke Era ea 14 LOADING THE SET ze san on ander cames os ee ed et ede aca don daad DES A REE A EE Rd E 15 Instrument Control K amp yS uasa en Et ene REE APO E EE GR C HR COR XU Rr aC ee 15 Standard Display Page si ss ie ra ex ok eae Odes ted x E Rau b Da dal oe ea 16 PROGRAMMING PAGE scott iots Roco Renren don DE b RR ir ies Rd LE 17 TO T r PUMP OM zetten tet beendet Dette dieken Des toek Dau io oy eae deet 18 To Turn PUMP Ofici echec PSE ee oe Bied Pere es ters EE A 18 To View Infusion Settings For All Active Channels oe 18 To Activate Additional Standard Display Softkey Prompts one 18 To Select Channel And Display Programming Page 18 TO Program INTUSION VEU 19 To Access Alarm Information ul toati tedite 20 To Activate Additional Programming Page Softkeys on 20 PROGRAMMING PRIMARY FUNCTION eeen 20 TO Set Primary Rate neni Anner en nd ee n decla place ERO E P RR ee ak RR 20 To Set Primary Volume Remaining VR 21 To Clear Primary Volume Infused VI eee 21 To Change Volume Remaining During Infusion o

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