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CADD MS 3 - InfuSystem

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1. Done PJ Next gt Choose correct hour by pressing the Q and or key then press Next to move the highlight to the next value in this case minutes Continue to set values and press Next until the time and date are correct Press Done 21 Programming the Pump NOTE If the pump is programmed to display a site re minder alert see page 23 resetting the time may cause that alert to occur sooner or later than expected up to 24 hours depending on how far forward or back you set the time Time and Date is only available when pump is stopped Setup Menu Main Menu Delivery Start Delivery Time and Date Setup New Patient Delivery Program Security Load Alerts Back Select gt History Press Back Press Home 5 Invalid T ate You must specify a valid date Check your entries f you set an invalid date such as 02 31 xx this screen appears press OK and set the correct date 22 Programming the Pump Setup Menu Local Formats Local Formats determine how certain things are displayed on the pump e Time can be displayed as 12 hour AM and PM or 24 hour The date can be displayed as month day year mm dd yy or day month year dd mm yy e The decimal symbol can be displayed as either a Period xx xx or as a Comma xx xx Starting at Setup Menu screen Setup Menu Choose Time and Date New Patient Security Formats Alert
2. 39 Using the Pump 40 Using the Pump Starting the pump Continuous Rate Menu Start Delivery Review Rates Home p JSelect gt Press Select Start at any Home screen PUMP STOPPED Press CR Menu PN CR Menu Menus Review Program Review the delivery program settings Press YES Delivery Methods Continuous Rate Yes Automatic Dose Yes Demand Dose Yes Main Menu Start Delivery etup Delivery Program some pgselect gt Press Select Press Menu Load History Press No Continuous Rate 0 19 ml hr CR Wen PX Menu View Cont Rate Total 3 516 ml Time ml hr Automatic Dose Demand Dose Total 0 018 ml Time Amount 0 012 ml 12 00AM 0 016 04 00AM 06 00AM 0 19 Duration 12 min Press OK to move through the program review screens Press O or to scroll through the continuous rate and automatic dose screens if needed Continuous Rate Automatic Dose and Demand Dose will only appear here if set to Yes in both the Setup and Delivery Program menus Delivering a Demand Dose In order to deliver a Demand Dose the pump must be programmed to allow them in the Setup menu where you will need to program a Lockout time limit and dose duration as well as in the Delivery Program menu where you will program the amount A Demand Dose is initiated by pressing the Demand Dose button on the side of the pump A
3. 06 00AM 0 19 Done D Next gt Done F Beh Done Edit Auto Dose Total ml Time 04 00AM Done E Next gt To remove an Auto Dose Press Next until highlight is over time you want to delete press Q or C9 until is shown then press Next or Done Press Done Loading a cartridge The Load feature in the pump menu takes you through each step needed to load a filled cartridge in the pump and start delivering medication c Warning Always use the pump s Load feature when starting a new cartridge This will assure that the cartridge is properly loaded and the infusion or ex tension set is filled with medication c Warning Always use aseptic technique particu larly when working with the cartridge infusion set catheter and access site c Warning The CADD MS 3 pump and cartridge are not a secure system Patient must be assessed for appropriateness of pump usage Supplies required In addition to the pump you will need e One filled Smiths Medical 3 ml Medication Cartridge e One infusion or extension set with standard female luer connection for connecting to cartridge 31 Using the Pump c Warning Always read the Instructions For Use provided with the medication cartridge infusion set and any other accessory used with the CADD MS 3 Ambulatory Infusion Pump 1 Filling the cartridge Use aseptic technique Fill the cartridge according to the Instructions for Use supplied with t
4. 150 kHz to 80 MHz PPlicable g 3 5 vij p Radiated RF 3V m d 0 23 P 80MHz to 800MHz IEC61000 3 80 MHz to 25 GHz d 0 47 P 800MHz to 2 5 GHz 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 rangeb Interference may occur in the vicinity of equipment marked with the following symbol 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 a 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 pump is used exceeds the applicable RF compliance level above the pump should be observed to verify normal operation If abnormal performance is observed addi tional measures may be necessary such as reorienting or relocating the pu
5. Continuous Rate Yes Automatic Dose Yes Demand Dose TJ Tim Cont Rate Total 3 516 ml e ml hr 12 00AM 0 016 06 00AM OK M Es 0 19 Press OK Automatic Dose ml Total 0 018 Time ml 04 00AM 0 018 ok FY cits Press Edit Press Next to move through segments Press Q or to make changes to a highlighted segment Edit Cont Rate Total 3 516 ml Time ml hr 12 00AM TG Press Edit 06 00AM 0 19 mm 0 Done EX Next gt Edit Auto Dose Total 0 018 ml Time ml 04 00AM 0 018 u 0 Done EJ Next Press Next to move through segments Press Q or to make changes to a highlighted segment When finished press Done To add time rate segments Press Next until appears in highlight choose new time then press Next choose new rate then press Next or Done Edit Cont Rate Total 3 516 ml Time ml hr 12 00AM 0 016 06 00AM 0 19 0 za Done E Next gt Edit Auto Dose Total 0 018 ml Time 04 00AM Done E Next To add another Auto Dose Press Next until appears in highlight choose new time then press Next choose new amount then press Next or Done To remove time rate segments Press Next until highlight is over time you want to delete press Q or until is shown then press Next or Done Edit Cont Rate Total ml Time ml hr 12 00AM 0 016 0 15
6. Delivery stops The pumps comput er has detected a problem with the pump Siren alarm This alert occurs only during waking hours 6 00 AM to 10 00 PM A series of 4 Attention alarms given every 4 hours until battery is depleted How to make it stop Press OK There is enough medication to continue delivering the continuous rate for a short time but not enough to start a dose or complete a dose that is in process the dose may be completed when a new cartridge is loaded You must begin preparation to load a new cartridge If you are pressing a key stop pressing it If you are not pressing a key remove and reload the battery If the alarm persists there may be a problem with the keypad that requires service Disconnect the tubing from the access device Re move the battery to silence the alarm and contact Smiths Medical MD Inc to initiate pump service Do not use the pump Press OK Change the battery as soon as possible 54 Help Alerts Message in display Cartridge J Volume Low Change cartridge soon QJ Edit not saved Editing was not saved because an alarm occurred Program Defaulted Setup of cartridge volume required With no cartridge present press Next Program Defaulted Set time and date XX XX XX XX XX XX What it means Alarm The amount of medication left in the cartridge is low Alert repeats at intervals until Cartridge Very Low alarm occurs Attention alarm A
7. IEC 60601 2 24 NOTE Ut is the a c mains voltage prior to application of the test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 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 Mains power quality should be that of a typical commercial or hospital environment If the user of the Pump requires continued operation during power mains interruptions it is recommended that the Pump be powered from an uninter ruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Guidance and Manufacturer s Declaration Electromagnetic Immunity The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Environment Guidance Test Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms Not Recommended separation distance IEC 61000 4 6
8. Setup Menu Delivery Time and Date New Patient Security Alerts Back Select gt Choose New Patient then press Select PUMP STOPPED CR Menu E 4 Menu 25 Programming the Pump Choosing yes to mark New Patient will record an event in the History Log and clear all entries from the daily summary log Choosing yes to Clear Delivery will set all delivery Choose Yes or No then press Next New Patient Marker Mark New Patient Clear Delivery No lt Back Ed Wexts Press Home Main Menu Start Delivery Setup Delivery Program Load History Home pgSelect gt parameters to factory default settings New Patient Marker Mark New Patient Yes Choose Yes or No then press Next Clear Delivery lt Back Ed Next gt Press Back Setup Menu Delivery Time and Date New Patient Security Alerts lt Back hd Select gt 26 Programming the Pump Setup Menu Delivery Before programming Delivery for a new patient it is recommended that you first use the New Patient feature as shown on page 25 In Delivery you will decide which of the three types of delivery methods Continuous Rate Automatic Dose and Demand Dose will be used for the patient and program delivery Maximums Dose Duration and Dose Lockout Time Note If the pump has already been programmed you will not be able to set pump values less than wh
9. fully tightened when the battery cap o ring is not visible the cap INCORRECT CORRECT e Visually inspect the cartridge cap and battery cap Make sure they fit properly and tightly on their respective compartments Figure 12 O Ri C Warning Make sure that the battery cap is fully tightened to id avoid an interruption in battery power which can cause the NAN pump to power down and stop the delivery of drug therapy A prolonged interruption in the delivery of drug therapy can result in serious patient injury or death Collect Separately A This product contains electrical and electronic components including batteries that may contain materials which if disposed of with general waste could be damaging to the environment In accordance with Directive 2002 96 EC Waste Electrical and Electronic Equipment residents of the European Union must follow specific disposal or recycling instructions for this product Contact your local distributor or visit the following web site for specific instructions http www smiths medical com recycle index html Non European union residents must dispose of or recycle this product including batteries in accordance with the local laws or regulations that apply C Warning There are potential health hazards associated with improper disposal of batteries electronics and contaminated used infusion sets and cartridges Dispose of used batteries infusion sets cartridges and other used a
10. 1200 1500 T min 75 Technical Information Flow rate error Programmed rate 0 002 ml hr Average flow rate 0 0021 ml hr Mean flow error 2 5996 Error ofFlow 0 10 20 30 40 Epmax Tmn Trumpet Curve 76 Technical Information Safety features and fault detection Hardware safety features Key hardware safety features include a watchdog timer circuit motor driver and motor watchdog circuits and a voltage detector circuit Each safety circuit performs a unique function to ensure the overall safety of the pump Watchdog timer circuit The microprocessor must send an appropriate signal to the watchdog circuit at least once per minute If the microprocessor does not send this signal the circuit ini tiates a time out and shuts down the pump controller Watchdog timer circuitry is provided to monitor the sta tus of the microprocessor disable the motor and cause the pump to beep if the microprocessor malfunctions The microprocessor must strobe the watchdog circuit at least once per minute in order to prevent the watch dog from performing its reset function The micropro cessor tests the watchdog circuit on every power up By setting a flag in the memory and not strobing the watchdog the microprocessor can force a watchdog time out After being reset the microprocessor checks the status flag to see if this was a time out test If it was the microprocessor continues its normal power up routine
11. Demand Dose can be given only when the pump is running If the patient tries to deliver a Demand Dose during the lockout period the display will show No dose allowed If the pump is not programmed to allow Demand Doses pressing the button will have no effect Unlike Automatic Doses the patient chooses whether Press Demand Dose or not to deliver a Demand Dose If the pump is pro button Demand Dose grammed to allow demand doses the patient can choose screen appears to deliver a dose or not as long as it is not prevented by any Lockout time 41 Using the Pump 5 Demand Dose Administer demand dose of 0 66 ml To give the dose press Deliver If you do not want to give the dose press Cancel 42 Using the Pump Canceling doses Doses can be canceled while in progress The next scheduled Automatic Dose can also be canceled NOTE Instruct the patient under what circumstances they can cancel a dose Stopping the pump will stop any dose in progress Use the procedures on the following pages to stop delivering a dose without stopping the pump and any continuous rate delivery Canceling a dose Demand or Automatic while in progress Choose Cancel Start at any Dose then Home screen press Select dg P Main Menu ress Stop Delivery CR Menu Cancel Dose Setup Load History Home E Select gt Continuous Rate 0 242 ml hr ER menu E Menus Cancel Press Yes Dose
12. If the reset occurred when the microprocessor was not expecting it the microprocessor traps the event an alarm is given either beep or vibrate and an error mes sage appears in the display Motor drive motor watchdog circuit Motor drive circuitry is composed of a series of FET transistors passive components two voltage compara tors and the second microprocessor The second mi croprocessor times how long the motor runs each time it is turned on If the motor runs for longer than the primary microprocessor specifies the circuit times out and disables the motor A unique feature of this circuit is that control lines to and from the microprocessor circuit allow the microprocessor to perform the complete func tional test of the motor drive circuit without running the motor The microprocessor performs this test every several minutes to assure its continued functionality An input from the watchdog circuit prevents motor opera tion if the watchdog timer expires The software verifies this function during the watchdog test described above Voltage detector circuit Low voltage detection is performed by part of the watch dog circuit and by the microprocessor via software Three low voltage levels are detected The first two levels are detected by software and the third by hardware The first level to be reached is the Low Battery Warning threshold which occurs when the battery voltage decays to a point where less than 10 operating time
13. alarm How to make it stop Press OK If necessary go to the Delivery Program menu and program the amount for the Demand Dose Press OK Press OK The dose will not be completed and the patient must wait for the dose lockout period to expire before delivering another dose If a cartridge is installed and with the infusion set attached to the cartridge press down gently on the cartridge to push excess medication into the tubing If a cartridge is not installed install one Press Con firm If the cartridge sensor is not confirmed you will need to have the pump serviced Other messages continued Message in display No dose allowed Demand dose is currently locked out No dose allowed Dose in progress No dose allowed Cartridge volume is very low Programming Required You must completely review the delivery program Stop all delivery 57 Help What it means Alarm You attempted to deliver a Demand Dose during the lockout period Single alarm You attempted to deliver a Demand Dose while a Demand Dose or Au tomatic Dose was being delivered Single alarm You attempted to deliver a dose but the cartridge volume is too low Single alarm You have chosen to use a delivery method but have not reviewed or completed all required program ming Single alarm You have tried to stop the pump Single alarm How to make it stop Press OK The Demand Dose home screen displays t
14. cap should be free of damage If the cap shows signs of wear such as cracks or if the slot becomes worn the battery cap should be replaced before the Pump is used Contact your Pump provider or Smiths Medical for a replacement battery cap If you insert a new battery and the pump doesn t turn on check to make sure that the battery is in the correct orientation the side goes in first If it still doesn t turn on try a new battery Once the battery is correctly inserted the pump turns on automatically and performs self tests to make sure all the systems are working properly CORRECT 18 Programming the Pump Self Tests During the self tests the pumps internal computer performs tests on all the major hardware computer and electronic systems c Warning If there are any system problems dur ing the self tests the pump will stop the tests and display an alarm screen letting you know there is a problem If this happens do not use the pump After installing a new battery watch the pumps display and verify the following e The internal computers software version appears as well as the pump serial number and last error code if any The entire display becomes a darker gray Look for any blank or incomplete areas which indicates a broken display The display then briefly goes blank if the entire display is not blank it indicates a broken display The pumps internal computer tests the major hard ware
15. is avail able An analog to digital converter ADC built into the microprocessor allows the microprocessor via soft ware to monitor the battery voltage At the Low Battery Warning threshold the microprocessor enables an alarm either beep or vibrate and displays the low battery alert in the display When the battery voltage drops to a point where it is too low to guarantee proper motor operation the microprocessor via software stops delivery generates an alarm either beep or vibrate and a depleted battery alarm message appears in the display When the battery voltage drops to a value where operation of the micro processor cannot be guaranteed a hardware reset circuit is triggered which places the microprocessor in reset This prevents ambiguous microprocessor operation as the battery voltage continues to decay The hardware reset continues until the battery is completely depleted or it is removed Once the pump controller goes into low 77 Technical Information battery shutdown only replacing the depleted battery with a new battery will clear the condition Software safety features Hardware related software safety features Program memory check At power up and regular intervals thereafter the pro gram memory is tested by calculating a cyclic redun dancy code CRC on the program and then comparing it with the CRC stored with the program If the stored and calculated CRC do not match the software stops medication deli
16. is damage to the pump outer shell cracks chips the pump may no longer be watertight c Warning If the display has missing or incomplete characters or if the pump does not seem to be working correctly stop using the pump immediate ly Contact Smiths Medical MD Inc for information on servicing the pump c Warning Make sure that the battery cap is fully tightened to avoid an interruption in battery power which can cause the pump to power down and stop the delivery of drug therapy A prolonged interrup tion in the delivery of drug therapy can result in serious patient injury or death Pump development standards AAMI ID26 1998 Medical Electrical Equipment Part 2 Particular requirements for the safety of infusion pumps and controllers ANSI AAMI HE48 1993 Recommended Practice Human factors engineering guidelines and preferred practices for the design of medical devices February 5 1988 version Design guideline IEC 60601 1 Second Edition 1988 Medical Electrical Equipment Part 1 General requirements for safety Amend ment 1 1991 Amendment 2 1995 IEC 60601 1 1 Second Edition 1992 Medical Electrical Equipment Part 1 General requirements for safety 1 Collat eral standard Safety requirements for medical electrical systems Amendment 1 1995 IEC 60601 1 2 2001 General Requirements for Safety Part 2 Electromagnetic compatibility Requirements and tests European Harmonize
17. off later When cleaning the pump ONLY use a sponge or soft cloth with a solution of warm water and a mild soap such as liquid dish or hand soap Routinely clean the pump to keep it free of dirt liquids and foreign objects Use any of the following solutions to clean the pump and accessories e Soap solution e Benzalkonium chloride concentrate 0 13 e Glutaral concentrate USP 296 e 10 percent solution of household bleach one part household bleach to 9 parts water e Alcohol USP 93 e Isopropyl alcohol USP 99 e Chlorohexidine 70 59 Help e PDI Super Sani Cloth Mada Medical MadaCide 1 Dampen a soft lint free cloth with cleaning solu tion and wipe the exterior surface of the pump Do not allow the solution to soak into the pump 2 Wipe the entire surface dry with another soft lint free cloth Allow the pump to dry completely before use Make sure to clean inside the battery or cartridge com partment Moisten one end of a cotton swab such as a Q tip and gently clean inside the compartment Use the dry end of the swab to dry the compartment D Caution Never use abrasive cleaners solvents bleach scouring pads or sharp instruments when cleaning your pump as they can scratch discolor or damage the pump s outer shell If the display is scratched it may be difficult to read and you will need to have it replaced If the outer shell is chipped or cracked it may no longer be wa
18. press Load With Load still chosen press Select Install cartridge to confirm sensor Remove cartridge then press OK 5 Verify by looking through the cartridge viewing window that the cartridge is properly attached to the pushrod Fasten the cartridge cap back onto the pump Make sure the rib on the cap lines up with the rib on the pump indicating the cap is secured see Figure 10 Figure 10 35 Using the Pump 36 Using the Pump 3 Fill the tubing the tubing is not counted as medication delivered to the Filling forces medication from the cartridge and pushes patient air out of the tubing Filling is complete when you see medication come out of the end of the tubing and all air is removed The amount of medication used to fill c Warning Never use Fill Tubing when the infusion set is connected to the body or an unintended dose could be delivered Press Select Cartridge M E Load pis Press Start Tubing begins to fill When tubing is filled a Fill press Stop or Done filling automatically arene Tubing stops at 0 3 ml lt Done Fy select gt Filling NOTE once the symbol Tubing V Press Back appears next to Fill tubing 0 ml you will not be able to re enter that step unless you first press Done to return to the Main Menu then re enter the Load menu 0 09 ml Cartridge Menu Continue to fill OR Press Start El Load i tubing EZ Fill Tub
19. repeated every 10 sec onds until you press the appropriate key to silence it 51 Help e Attention alarm Indicates a problem that you need to see to however it is not serious enough to have stopped delivery Examples include low cartridge volume low battery etc Beep 4 double beeps repeated once per minute Vibrate 4 double vibrations repeated once per minute e Single alarm This is a notification alert Beep pump beeps once Vibrate pump vibrates once e Stopped alarm Indicates the pump is stopped Beep 3 beeps repeated every 5 minutes Vibrate 3 vibrations repeated every 5 minutes You can set the volume ofthe Beep alarm to Low Medium or High see page 46 If a continuous alarm occurs that is not cleared within 5 minutes the pump will switch between vibrating and beeping at the high setting in order to get your attention The backlight automatically lights whenever an alarm or alert occurs 52 Help Troubleshooting Alarms Message in display What it means Alarm Battery Delivery stops The battery does not depleted Delivery stopped Insert a new battery Blockage detected No delivery Check tubing or site for blockage Cartridge empty Insert filled cartridge to continue delivery Cartridge removed Press OK to begin load process have enough power for the pump to work Siren alarm Delivery suspended There is some thing preventing the medication from being delivered Cont
20. screen is added A Demand Dose Menu is also added where you can view but not change the dose amount and duration and cancel doses Start at Demand Choose Review Dose DD Doses then press Home screen Select Press sae Dose DD Menu can Stop Delivery Review Doses Last Demand Dose 08 00AM 0 012 ml Press pomen Home Home PYselect gt Press OK Demand Dose Press Press Home to return directly to the Home Amount 0 012ml home screen or press OK to return to the iraton Demand Dose Menu uration 12min 49 Using the Pump 50 Using the Pump About alarms Beep Vibrate settings The pump can be set to Beep or Vibrate when an alert or alarm occurs see page 46 With Beep selected you can also choose whether the pump beeps when you press a key When Vibrate is selected the pump will not beep or vibrate when keys are pressed NOTE the battery is used much more quickly when Vibrate is programmed There are several types of alarm tones vibration patterns e Siren alarm Indicates pump is not working correctly and must be removed from use Beep 2 alternating beeps repeated constantly Remove pump from use Vibrate Disabled e Continuous alarm Indicates a problem which may have caused medication delivery to be stopped See to alarms immediately Beep 4 double beeps repeating every 10 seconds until you press the appropriate key to silence it Vibrate 4 double vibrations
21. start the pump and all the rates in the Continuous Rate schedule are programmed to zero Single alarm You have tried to stop the pump while a Demand Dose is delivering Single alarm Press OK Follow the instructions for Loading the cartridge starting on page 31 How to make it stop Press OK If necessary go to the Delivery Program menu and program the amount s for the Automatic Dose schedule Press OK If necessary go to the Delivery Program menu and program the rate s for the Continuous Rate schedule To stop the pump and cancel the remainder of the Demand Dose press Yes To leave the pump running and continue delivering the Demand Dose press No 56 Help Other messages continued Message in display Demand Dose programmed to zero QJ Dose Interrupted Resuming dose Dose Not Completed Dose Duration expired while delivery was suspended No cartridge detected Cartridge missing or overfilled Install cartridge to confirm sensor What it means Alarm You have attempted to start the pump and the Demand Dose amount is programmed to zero Single alarm Dose delivery was interrupted and will now resume Single alarm Dose delivery was interrupted and the duration has since expired Single alarm You have attempted to use the Load portion of the load cartridge menu but no cartridge is detected It may also mean that you filled the cartridge too full more than 3 ml Single
22. tightened to avoid an interruption in battery power which can cause the pump to power down and stop the delivery of drug therapy A prolonged interrup tion in the delivery of drug therapy can result in serious patient injury or death Display Figure 1 The display also referred to as the screen shows all the programming operating and alarm alert information for the pump Programming keys Figure 1 There are two keys on the front of the pump right below the display that do not have any names or symbols on them These are the programming keys They have differ ent functions depending on where you are in a menu In the display right above each key is a short description of what happens if you press it Always look to the display above each key to see what the key is used for Q and QJ keys Figure 1 The Q and keys are used to move around in menus and to program amounts Whenever you can use the up and down keys the symbol EJ is shown in the bottom middle part of the display When you are at the top or bottom of a menu only one of the keys can be used and the symbol will change to k or F respectively Demand Dose button Figure 1 If Demand Doses are allowed the user can press the Demand Dose button to initiate a dose Cartridge cap Figure 1 Once you load a filled cartridge into the compartment press and turn the cartridge cap over the top of it to hold it firmly in place You can look at the cartridge vi
23. 3 Programming the Pump Display site reminder in menu optional alert deter mines whether a screen is added to the Load menu to set a reminder for when it is time to change the patient s infusion set and or access site It is factory preset to No reminder not in use If set to Yes a Site Reminder home screen is added which shows the time and date for the next scheduled site change Alerts are available whether the pump is running or stopped 24 Programming the Pump Starting at Setup Menu screen Setup Menu hoose Alerts then press Select Delivery Time and Date New Patient Securit lt Back JSelect gt Choose when to give alert 0 05 to 0 5 ml then press Next Low Cartridge Site Reminder Alert Alert Choose Yes or No IniMenu LT then press Next rH s Back Li Next Back Li Next Press Home Press Back Main Menu Setup Menu Start Delivery Delivery PUMP STOPPED CR Menu 4 Menu Time and Date New Patient Security Alerts lt Back hd Select gt Setup Delivery Program Load History lt Home kdseiec Setup Menu New Patient Before beginning to program the delivery specifics it is recommended that you ready the pump for a new patient The New Patient feature allows you to set the pump to its default values The New Patient feature is only available when the pump is stopped Starting at Setup Menu screen
24. 5 days in 1 day increments Default 3 days 12 30 AM 00 30 to 11 30 PM 23 30 in 00 30 minute increments Default 8 00 AM History User selects displayed report for viewing Complete History last 4000 events arranged from most recent to oldest Delivery Summary last 90 days arranged from most recent to oldest Beep Vibrate Beep Vibrate Beep or Vibrate Default Beep If beep choose volume Low Medium or High Default High If beep Key beeps beep with each key press Yes or No Default Yes 73 Technical Information 74 Technical Information Accuracy test results The following graphs are designed to show flow accuracy of a pump against given time periods All graphs were plotted using a Smiths Medical 3 ml Medication Cartridge 21 7450 and Unomedical Comfort Infusion Set Flow rate from startup Time interval 15 seconds Total time 1455 minutes Programmed rate 0 1 ml hr 0 16 0 14 0 12 0 10 mihe 0 08 0 06 0 04 0 02 0 00 0 300 600 900 1200 1500 T min Flow rate error Programmed rate Average flow rate Mean flow error 10 0 75 D 5 0 25 M Error Epmax of Flow 0 0 5 60 150 Epmin 339 2 5 5 0 5 10 0 0 1 ml hr 0 1000 ml hr 0 01 T min 570 930 Trumpet Curve Flow rate from startup Time interval 15 minutes Total time 1530 minutes Programmed rate 0 002 ml hr 0 004 0 003 0 002 Flow ml hr 0 001 0 000 0 300 600 900
25. 6 F 2 C or higher than 104 F 40 C when relative humidity non condensing exceeds 9096 and when atmospheric pressure is lower than 10 2 psi 70 kPa 10 000 feet above sea level or higher than 15 4 psi 106 kPa If you experience prob lems remove the pump from use D The pump may be damaged if stored in environments where temperatures are lower than 4 F 20 C or higher than 140 F 60 C when relative humidity non condens ing exceeds 9096 and when atmospheric pressure is lower than 10 2 psi 70 kPa 10 000 feet above sea level or higher than 15 4 psi 106 kPa gt Do not use NiCd nickel metal hydride carbon zinc heavy duty lithium or any rechargeable batteries They will not power the pump properly and the battery life indicator on the home screen may not show the correct amount 4 Important Information D Use only Smiths Medical MD Inc 3 ml Medication Car tridges other manufacturers products will not work with the CADD MS 3 pump D Never use abrasive cleaners solvents bleach scouring pads or sharp instruments when cleaning your pump as they can scratch discolor or damage the pump s outer shell If the display is scratched it may be difficult to read and you will need to have it replaced If the outer shell is chipped or cracked it may no longer be watertight and will require service D Never use steam or very hot water exceeding 120 F 49 C in an attempt to sterilize the pump Never put
26. Not applicable ee D Warning Use of accessories other than those indicated or adjacent to other equipment may result in increased emissions or decreased immunity of the pump The user should verify normal operation of the pump in the configuration and environment in which it is to be used 65 Technical Information 66 Technical Information Guidance and Manufacturer s Declaration Electromagnetic Immunity The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz Magnetic field IEC 61000 4 8 8 kV contact X 15 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 96 Ur 95 96 dip in Ur for 0 5 cycle 40 96 Ur 60 96 dip in Ur for 5 cycles 70 96 Ur 30 96 dip in Ur for 25 cycles 5 96 Ur 95 96 dip in Ur for 5 sec 8 kV contact 15 kV air Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 400 A m
27. Remaining Amount 0 05 ml 43 Using the Pump Canceling next Automatic Dose Start at Automatic Dose AD Home screen mu 2 988ml i AD Menu Next Auto Dose 12 00AM 0 05 ml AD Menu E Menu Press Yes Choose Cancel Next Dose then press Select Automatic Dose Menu Press Stop Delivery Cancel Next Dose Review Auto Doses Home EY Selects Cancel next Automatic Dose of 0 05 ml at 06 00 AM 44 Using the Pump History The pump stores history in two ways e As events The pump stores information for the previ ous 4000 events By the delivery date The pump stores delivery infor mation for the previous 90 days History can be viewed directly on the pump display from the History menu You can scroll through the history reports using the Q and QJ keys in History The history reports are Complete History this includes delivery totals alerts errors battery changes cartridge changes changes to the pump program etc Each event in the complete history report includes the date and time of its occurrence It includes the last 4000 events Delivery Summary this is a daily breakdown of medi cation delivery and may include the Demand Doses Automatic Doses and Continuous Rate delivered and includes a total amount delivered for that day Only those delivery options that are active set to Yes in the Setup and Delivery Program menus will appear in the De
28. UZVUR Operator s Manual CADD MS 3 Ambulatory Infusion Pump Model 7400 smiths medical Updates to the manual The following updates were made to this version 40 5470 51C of the User Manual The specific pages affected by the changes are shown For your safety review the manual carefully including all warnings and cautions If you don t understand something contact your clinician your pump provider or Smiths Medical Summary of updates Pages Warning regarding 3 10 16 62 80 tightening the battery cap Inspecting the battery cap 17 80 Added illustrations 9 17 80 WEEE Warning 16 81 WEEE Statement 81 This manual provides information on programming using and maintaining the CADD MS 3 Ambulatory Infusion Pump This manual is intended for clinicians only DO NOT permit patients to have access to this manual DO NOT disclose the pumps security pass codes or any other information that would allow inappropriate access to programming and operating functions The issue date of this manual is included on the back cover If your manual is a year or more old contact Smiths Medical MD Inc or check the web site at www smiths medical com to see if a newer manual is available If you have comments questions or problems If you have comments or questions about the pump please call the appropriate number given below You will be asked for the pump s serial number which you will
29. aa Other Tiessages cueden eese e e n MERI e en 55 Cleaning the DUIMDp c eret deer rm eee niea inte 59 Servicing th PUMA an ihe enn m te e e d ea 60 Th pump atd is te eerte e e ener e de ae ed ete 61 Extreme temperatures 4 nne terere enr m eene 61 WET uoi amate A es ite n ri e eR ee dde des Rede 61 If the pump is dropped or hit hard sss 61 Technical Information Pump development standards sss 63 Specifications cid oae ie cono tei etd ee eh n ere Rog 69 General specifications nominal sss 69 Delivery specificatlohs eterne tet entretiens Main Meniti sa err ee ee i a rented PAP M IETISUOEY aereis Accuracy test results Safety features and fault detection Hardware safety features sse Watchdog timer circuit see Motor drive motor watchdog circuit Voltage detector circuit Software safety feature Susan Sai ianari Hardware related software safety features 77 Program memory check ere ritiene ertet RAM memory check Motor circuit check eite tereti Keypad encoder check sss Data handling and software safety features 78 Data stored in RAM ann a sanad in GA 78 Data stored in NOVRAM nn a Sana a dendaan 78 Data used in calculations reete 79 Timer data FeP
30. ack Setup Menu Delivery Time and Date New Patient Security Alerts lt Back hg Select gt Delivery Program In Delivery Program you program the delivery specifics for your patient Continuous Rate schedule Automatic Dose schedule and Demand Dose amount Delivery Program only appears in the main menu when the pump is stopped 29 Programming the Pump Start at Home screen pump must be stopped Choose Delivery Program then press Select Main Menu Start Delivery Setup Delivery Program Load History Press Menu ia PUMP STOPPED If program security is set to Yes Enter the passcode then press Next Program Pass Code CR Menu E Menu gt Home Press Home Main Menu Start Delivery Setup Delivery Program Load History Home pgSelect gt Edit Demand Dose Choose Yes or No then press Next Choose Delivery Methods Continuous Rate ITI Automatic Dose No Demand Dose No Back Ed Nec Dose Press OK a E 5 a v E P o E E m o o m You cannot program an Automatic Dose for a time that would occur during another doses lockout time e m Choose Yes or No then press Next Choose Delivery Methods Continuous Rate Yes Automatic Dose No Demand Dose No PN lt Back 3 Next Limited by Maximum Press OK Choose Yes or No then press Next Choose Delivery Methods
31. at is already programmed Dose Duration is the time over which a dose Automatic and or Demand is delivered You can choose to have the dose delivered over 1 to 15 minutes programmed in 1 minute increments The default value is 12 minutes The Dose Lockout time is the minimum amount of time that can pass between the start of one dose and the start of the next dose You can choose a lockout time of 15 minutes to 24 hours programmed in 15 minute increments The default value is 1 hour Dose Lockout time cannot be 0 Delivery is only available when the pump is stopped Note Dose Duration and Dose Lockout time cannot be equal Starting at Setup Menu screen Setup Menu Delivery Time and Date New Patient Security Alerts lt Back F Select gt hoose Delivery hen press Select You cannot program a Dose Lockout that will cause one programmed Automatic Dose to lockout another Choose Yes or No then press Next Choose Yes or No then press Next Choose Yes or No then press Next Enable Delivery Methods Continuous Rate No AutomaticDose No DemandDose No Enable Delivery Methods Continuous Rate Yes Automatic Dose XT DemandDose No Enable Delivery Methods Continuous Rate Yes Automatic Dose Yes DemandDose Jy Choose 0 to 1 ml hr then press Next Max Continuous Rate os E Max Automatic PUMP STOPPED CR Menu Menu gt Pres
32. ate Current status of the pump Press the left programming key to accomplish what is indicated in this case you go to Continuous Rate menu uum 2 988 ml Press the Q and or keys to move through the home screen pages Home screen example Power remaining in the battery approximate The home screen name Press the right programming key to accomplish what is indicated in this case you will go to main menu Main Menu In a menu press A or to highlight the item you want then press Select Start Delivery Setup Delivery Programs Load History When at the top or bottom of a menu only the kg or F lt Home Select gt indicator is shown Alert Low Cartridge o2 E If the value you are editing is highlighted press Q or to scroll through the available values When the value you want appears press Next to move forward to the next screen or press Back to back up one screen Any changes you have made will be saved when you press Time and Date Time Ifl 00 AM Date 06 28 05 either Next or Back In screens with multiple fields you will press Q or to change the item then press Next to move to the next item in this case minutes Press Done to save the changes and return to the menu Sample screens Accessories Smiths Medical offers a variety of products for use wit
33. ations General specifications nominal Minimum increment of resolution 0 005 ml per activation Size 3 2 in x 1 8 in x 0 95 in 80 mm x 47 mm x 24 mm Weight Approximately 3 2 oz 90 g including battery and cartridge Classification Type CF v protection from electric shock Moisture protection IPX8 watertight to a depth of 12 ft 3 64 m for 3 min or 8 ft 2 4 m for 30 min Pump alarms alerts Pump stopped blockage low battery dead battery low cartridge volume empty cartridge system fault Optional alarms alerts site change Maximum infusion pressure 23 psi 69 Technical Information Maximum time to blockage occlusion alarm Minimum Maximum Intermediate rate 0 124 ml hr 12 min 15 min Minimum rate 0 002 ml hr 9 5 hr 19 hr Bolus volume at blockage occlusion release Minimum rate approximately 0 04 ml Intermediate rate approximately 0 21 ml Power source One AAA IEC LR03 alkaline battery D Caution Do not use NiCd nickel metal hydride carbon zinc heavy duty lithium or any rechargeable batteries They will not power the pump properly and the battery life indicator on the home screen may not show the correct amount Battery life The expected battery life is approximately 2 weeks bat tery low alert at 0 124 ml hr Data storage time An internal battery powers the clock and allows pump to store program parameters and history The internal battery is charged b
34. ccessories or a pump that has reached the end of its useful life in an environmentally safe manner and according to any regulations that may apply 81 Technical Information 82 Warranty Limited Warranty Smiths Medical MD Inc the Manufacturer warrants to the Original Purchaser that the CADD MS 3 Ambulatory Infusion Pump the Pump excluding accessories shall be free from defects in materials and workmanship under normal use if used in accordance with this Operator s Manual for a period of one 1 year from the date of pur chase by the Original Purchaser This warranty does not cover normal wear and tear or maintenance and specifically excludes all accessories including but not limited to batteries infusion sets cartridges apparel equipment computers and printers used with the Pump Limitation of Remedies The Manufacturer will repair or replace without charge except for postage and handling any Pump excluding all accessories which is determined by the Manufacturer to be defective during the one 1 year warranty period In the event the Pump is replaced or repaired the warranty period will not extend beyond the original warranty period THIS IS THE EXCLUSIVE REMEDY Parties Covered This Warranty extends only to the Original Purchaser of the Pump This Limited Warranty does not extend to subsequent purchasers The Original Purchaser may be a patient medical personnel a hospital or institution whic
35. chnical Information Regional Settings Time Format 12 hour or 24 hour Default 12 hour Date Format mm dd yy or dd mm yy Default mm dd yy Decimal Symbol Decimal shown as Period or Comma Default Period Delivery Program Delivery Methods Choose to use the following delivery methods Continuous Rate Yes or No Default No Automatic Dose Yes or No Default No Demand Dose Yes or No Default No Continuous Rate Schedule Programmable with a possible 48 time rate segments Time 12 00 AM to 11 30 PM in 00 30 increments or 00 00 to 23 30 in 00 30 increments Default Rate 0 000 ml hr to Continuous Rate Maximum up to 1 000 ml hr in 0 002 ml increments Default 0 000 ml hr Automatic Dose Schedule Programmable with a possible 24 time dose segments Time 12 00 AM to 11 30 PM in 00 30 increments or 00 00 to 23 30 in 00 30 increments Default Dose 0 000 ml to Maximum Dose up to 1 000 ml in 0 002 ml increments Default 0 000 ml Demand Dose 0 000 ml to Maximum Dose up to 1 000 ml in 0 002 ml increments Default 0 000 ml Load User loads cartridge fills tubing fills cannula and selects site change alarm if displayed Fill tubing Fills in 0 01 ml increments until Stop or Done is pressed automatically stops at 0 3 ml Fill cannula 0 000 ml to 0 012 ml in 0 001 ml increments Default 0 000 ml initially then last programmed amount Site change alert if displayed see Alert Specifications 1 to
36. cide how loud the beep is and whether you want the pump to beep each time you press Start at any Home screen Press Menu Continuous Rate P 0 19 ml hr ress Home CR Menu Menu Choose to have key beeps turned on Yes or off No then press Next Choose Beep Vibrate then press Select Choose Beep then press Next Main Menu Stop Delivery Setup Load History Beep Vibrate Alert Type Volume High Key Beep Yes Home Alert Type Volume Key Beep Back Next Alert Type Beep Volume Key Beep Yes lt Back Ed Nex Beep High Choose beep volume Low Medium or High then press Next a key Low is quietest and High is loudest It is factory preset to High Start at any Home screen Continuous Rate 0 19 ml hr CR Menu Menus Choose Beep Vibrate then press Select Main Menu Stop Delivery Setup Load History Beep Vibrate PN Home EJ Select Alert High Type Volume Key Beep Yes lt Back E Nexts Choose Vibrate then press Next Note that Vibrate uses up batteries much faster Continuous Rate Menu If the pump is programmed with a continuous rate a Continuous Rate Home screen is added A Continuous Rate Menu is also added where you can view but not change the Continuous Rate schedule 47 Start at Continuous Rate CR Home screen Continuous Rat
37. computer and electronic systems If there is a problem with any system an alarm occurs and you will not be able to start delivery When the self tests are complete power up ends and the pump beeps six times The first time you insert a battery and a new pump per forms the self tests you will see the following alert screens e A screen will appear that reads Program Defaulted Set time and date Program the current time and date by press ing Q and to set the highlighted value then pressing Next to move through the sequence When the time and date are correct press Done e Next you will see a screen that reads Program Defaulted You must program the pump Press OK e After the pump beeps 6 times a screen that reads Cartridge removed Press OK to begin load process is displayed Press OK the pump goes to the Cartridge menu If you are ready to load a cartridge follow the steps indicated starting on page 31 If you aren t ready to load a cartridge yet press Done NOTE The pump has a built in internal battery that pow ers the clock and allows the pump to store the programs and history see page 69 which is charged by the AAA alkaline battery If your internal battery has not been charged for awhile you may see a screen that reads Pro gram Defaulted Setup of cartridge volume required with no cartridge present press Next Make sure no cartridge is loaded into the pump and press Next Setup The Setup m
38. d Standard IEC 60601 1 4 1996 Medical Electrical Equipment Part 1 General requirements for safety 4 Collateral standard Pro grammable electrical medical systems 63 Technical Information IEC 60601 2 24 1998 02 Medical Electrical Equipment Part 2 24 Particular requirements for safety of infusion pumps and controllers IEC 878 First Edition 1988 Graphical symbols for electrical equipment in medical practice IEC 61000 4 2 1995 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 2 Electro static Discharge immunity test Basic EMC Publication IEC 61000 4 3 1995 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 3 Radi ated radio frequency electromagnetic fields immunity test Basic EMC Publication Amendment 1 1998 06 IEC 61000 4 8 1993 Electromagnetic Compatibility EMC Part 4 Testing and measurement techniques Section 8 Power frequency magnetic field immunity test 1993 CISPR11 1990 Limits and methods of measurement of elec tromagnetic disturbance characteristics of industrial scientific and medical ISM radio frequency equipment Amendment 1 1996 Amendment 2 1996 CISPR14 1993 International Special Committee on Radio Interference limits and methods of measurement of radio interference characteristics of household electrical appliances portable tools and similar electrical apparatus Amendmen
39. d dose programmed This home ast Demand Dose screen is only visible if Demand Dose is set 3027M 10 02 05 to Yes in use in both the Setup and Deliv pp venu EX Menus ery Program menus You can also access the Demand Dose menu from this home screen see page 49 When a Demand Dose is being delivered the screen will show Demand Dose Active e The Site Reminder SR home screen shows the date and time of your next pro grammed site reminder alert This home screen will only be visible if set to Yes in use in the Setup Alerts menu If you haven t programmed another site reminder it shows when the previous one occurred Next Site Reminder 10 02 05 at 04 30 PM Stop EXMenus A variety of symbols appear on the screen For example any time you have to answer a question before proceed ing the question appears on the screen accompanied by P Alarms and alerts are accompanied by QJ If the pump is performing a task which takes a little time you will see X Screensaver and backlight The screensaver allows the pump to save on battery power When you are at the home screen and no keys or buttons are pressed for 15 sec onds the screensaver display appears The screensaver shows the time and whether the pump is running or stopped Press any key on the keypad to deactivate the screensaver and return to the home screen Pressing the key turns on the screen backlight the backlight automatically turns
40. e 0 3 ml hr Using the Pump eR Menu EJ Menus Press CR Menu Press Home Press Home Choose Review Rates then press Select Continuous Rate Menu Stop Delivery Review Rates stone P Ysetect Press OK Cont Rate Total 8 4 ml Time ml hr 12 00AM 0 5 06 00AM 0 3 Press the Q or keys to view the entire Continuous Rate schedule if needed Press Home to return directly to the home screen or press OK to return to the LOK Home gt Continuous Rate Menu 48 Using the Pump Automatic Dose Menu If the pump is programmed to deliver automatic doses an Automatic Dose Home screen is added An Automatic Dose Menu is also added where you can view but not change the dose schedule and cancel doses Canceling the next Auto Dose is discussed on page 43 Start at Automatic Choose Review Dose AD Auto Doses then Home screen press Select IU Automatic Dose fh Press Menu AD Menu Stop Delivery Cancel Next Dose Review Auto Doses Next Auto Dose 11 30AM 0 05 ml Press poWens3Menus Home ms Press OK Automatic Dose Press p Total 0 1 ml Press the Q or keys to view the entire Home ime Auto Dose schedule if needed Press DROOAM Home to return directly to the h 11 30AM f y Some screen or press OK to return to the Automatic Dose Menu Demand Dose Menu If the pump is programmed to allow demand doses a Demand Dose Home
41. endations about any specific programming related to any therapy Whether certain features are appropriate for an individual patient must be determined before use Before using the pump the patient must receive appropriate training in all its functions and in troubleshooting problems D To avoid a risk of explosion do not use the pump in the presence of flammable anesthetics or explosive gases D System delivery inaccuracies may occur as a result of backpressure or fluid resistance which depends upon drug viscosity catheter size and extension set tubing gt The CADD MS 3 pump and accessories include small component pieces that could pose a choking hazard to small children D Before going to bed the patient should make sure the cartridge contains enough medication to last through the night Do not use the Vibrate alarm at night If the patient is a very deep sleeper they may want to set the audio volume to High the loudest setting before going to bed There are potential health hazards associated with improper disposal of batteries electronics and contaminated used infusion sets and cartridges Dispose of used batteries infu sion sets cartridges and other used accessories or a pump that has reached the end of its useful life in an environmentally safe manner and according to any regulations that may apply 2 Important Information D If there are any system problems during the self tests the pump will stop the test
42. enu is where you perform certain setup functions such as determining which delivery types should be available setting the time and date setting a new patient marker setting pump security setting up how the pump alarms for certain features and program ming the local formats c Warning The time and date must be set correctly since delivery factors are time based and all his tory is stored based on time and date Occasionally you will need to reset the time for example during daylight savings time or to adjust for a different time zone The Setup menu looks different depending on whether the pump is running or stopped Any menu items asso ciated with delivery will only appear in the menu when the pump is stopped At the home screen press Menu Press to choose Setup then press Select If security is set to Yes for the Setup menu you will need to enter a pass code This is to prevent the patient from having complete access to all pump programming 19 Programming the Pump c Warning Do not allow the patient to learn the pass code The pass code allows access to all delivery pro gramming and security settings Once inside the menu you can choose between the vari ous items Once you have entered a menu item you can either make a change to an item use the Q and QJ keys until the setting you want is displayed then press Next or press Next to accept the displayed value 20 Programming the Pump Opening the Set
43. ert chirp the cap is not fully tightened and should be tightened further If you are unable to tighten the cap and eliminate this chirp the pump should not be used Contact your pump provider or Smiths Medical Other than periodic visual inspection and cleaning of the pump no testing of the pump is required The pumps internal software hardware and dual microprocessors are constantly checked while the pump is operating and during the self tests performed during power up e Visually inspect the pump for any damage to the pumps outer shell Look for chips or cracks If the outer shell is chipped or cracked the pump may no longer be watertight Visually inspect the cartridge and battery chambers to make sure they are clean and free of foreign objects materials e InspectthePumpsbatterycap Thebatterycap Figure 11 should be free of damage If the cap shows signs of wear such as cracks or if the slot becomes worn the battery cap should be replaced before the Pump is used Contact your Pump provider or Smiths Medical for a replacement battery cap e Visually inspect the display If there are missing or incomplete characters or if the display is otherwise damaged stop using the pump immediately Reference the Cleaning the pump and Servicing the pump sections in the Help section of this manual if you need to clean or return a Battery pump for service e Makesure thatthe battery cap is fully tightened The battery cap is Cap
44. etween alerts then press Next choose time then press Next Site Reminder Reset Yes Interval 3 days Time 08 00 AM lt Back rx Next When you choose Yes the alert clock is reset to zero and will begin a new countdown in this example in 3 days at 08 00 AM the pump will give the alert Choosing No allows the alert clock to continue the countdown from the last time it was reset Press Done Cartridge Menu El Load B Fill Tubing Fill Cannula E Reminder lt Done PYSelect gt Press Home Main Menu Stop Delivery Setup Load History Beep Vibrate Home d Select gt Continuous Rate 0 106 ml hr CR Menu E Menu gt Stopping and starting the pump You can stop and start the pump from any of the Home Shown below is how to stop from the CR home screen screens or in the main menu The Delivery Program and although stopping from any of the Home screens will certain items in the Setup Menu those having an effect use the same procedure on delivery can only be accessed if the pump is stopped Start at any Home screen Continuous Rate are Men Press 0 19mi hr Press Sop OE Menu CR Menu Menu PN CR MenuEX Menus Load History Beep Vibrate Home j Select Press Select Stop Delivery Review Rates ome pg Select Press Select ivery Stop all delivery PUMP STOPPED Press Yes ER Menu Menu
45. ewing window Figure 2 to make sure the cartridge is properly loaded and to periodically check the amount of medica tion left in the cartridge Infrared IR windows Figure 2 The IR windows allow the pump to communicate with a PC or other IR accessory There is no IR functional capability available with this model pump Features Vibration alert If you dont want the pump to beep during alarms and alerts you can program it to vibrate instead This feature can be used in meetings classrooms etc If you choose Vibrate the beep that accompanies each key press is also disabled The battery is used much more quickly when you use Vibrate Occlusion blockage sensor The occlusion sensor continuously tests for blockage that prevents medication from being delivered Cartridge sensor There is a sensor in the cartridge chamber that has two functions It senses when a cartridge is correctly loaded in the chamber If the cartridge becomes loose or detached during use the sensor causes an alarm to occur When you load a new cartridge into the pump the sensor also measures how much medication is in the cartridge and displays this information in the upper left part of the home screen 11 Programming the Pump Watertight As long as the pumps labels and outer shell are intact the CADD MS 3 pump is watertight to a depth of 8 feet 2 4 meters for 30 minutes or 12 feet 3 6 meters for 3 minutes History The pump has a Hist
46. find on the back of the pump Our staff is available to help you 24 hours a day with programming and operation of the pump US Distribution Smiths Medical MD Inc St Paul MN 55112 USA 1 800 426 2448 USA 1 651 633 2556 www smiths medical com Smiths Medical International Ltd WD24 4LG UK 44 0 1923 246434 Table of contents Important Information Important safety information 0 0 0 cesses esses sees eesseeseeeseesesseene 1 Warnings cuu Explanation of symbols seen 4 Introduction uie dr iere e aree rare diea 6 Indications eene eiie rep be em 6 Contraindications eiecit d 6 Delivery features iicet eiiimen entendi haid 6 Continuous Rate dn Mana e a EI e re Deed 6 DOSES tas citet en spedire bit nde i decns 6 Other featutes aie asoeiet entere ae atan 6 Glossary of Terms ota tener irte Pr Rete 7 Programming the Pump Pump illustrations AAA PO a Ren San ana 9 Description of features and buttons sisisi 10 Battery cap With OTN orano A a tones 10 Ip c 10 Programming keys Sada AN a 10 and NOA Keys eee ctii ere trie re trice 10 Demand Dose button eterna 10 Cartridge Cap ax aues aide ti area ets 10 Infrared IR windows sse 10 ln C G 11 Vibration alert ettet tits 11 Occlusion blockage sensor ses T Cartridge sensoE sectae etre A ais 11 urine 11 History Descri
47. ghtened to avoid an interruption in battery power which can cause the pump to power down and stop the delivery of drug therapy A prolonged interruption in the delivery of drug therapy can result in serious patient injury or death gt If the display has missing or incomplete characters or if the pump does not seem to be working correctly stop using the pump immediately Contact Smiths Medical MD Inc for information on servicing the pump Cautions D Avoid strong electromagnetic fields like those present with Magnetic Resonance Imaging MRI and direct x ray as they can affect how the pump works If you cannot avoid them the pump and pouch must be taken off gt Do not expose the pump directly to ultrasound gt Do not use the pump in a hyperbaric chamber as this may affect how the pump works and may also cause dam age to the pump 3 Important Information gt Do not use cell phones within six 6 inches 15 cm of the pump Interference with the pump electronics by cell phones can occur If a cell phone interferes with the pump the pump will generate a System Fault alarm D To avoid damage when storing the pump first remove the battery and cartridge Place the pump in the original car ton and keep it away from cold heat and dampness After 30 days any pump programming will be lost and you will need to reprogram it D The pump may experience problems if operated in condi tions where temperatures are lower than 35
48. h your pump Cartridge You must use the Smiths Medical 3 ml Medication Cartridge catalog number 21 7450 with the pump Smiths Medical cartridges are latex free D Caution Use only Smiths Medical 3 ml Medication Cartridges Other manufacturers products will not work with the CADD MS 3 pump Infusion sets You can use any manufacturer s infusion set as long as it has a standard luer lock to connect to the Smiths Medical 3 ml Medication Cartridge 15 Programming the Pump 16 Programming the Pump battery into the compartment making fi rst time sure the side goes in first see Figure 4 if you insert the battery Inserting a battery programming the regional settings if wrong the pump will not start required and setting the time and date are the first things you need to do when you get the pump The expected battery life is D Caution Do not use NiCd nickel approximately 2 weeks battery low alert at 0 124 ml hr the metal hydride carbon zinc heavy Vibrate alert uses up battery power faster duty lithium or any rechargeable batteries They will not power the pump properly and the battery life indicator on the home screen may not show the correct amount Figure 4 Insert a battery 1 Put the side of a smooth edged coin into the slot on the battery cap and turn it counterclockwise left to open it see Figure 3 Remove the old battery if present Discard used batteries according to local laws a
49. h purchases the Pump for treatment of patients The Original Purchaser should retain the invoice or sales receipt as proof of the actual date of purchase Conditions of Warranty This warranty is valid only if the Pump is used in accordance with this Operator s Manual The warranty will be void in the following cases 1 The Pump has been altered misused misuse includes but is not limited to use not in accordance with this Operator s Manual used with accessories not approved by the Manufacturer and or used with a computer program other than that licensed by the Manufacturer or damaged by neglect or accident 2 The Pump has not been properly maintained or has been re paired by persons not authorized by the Manufacturer The Pump is a sealed unit and the fact that the seal has been broken will be considered conclusive evidence that the Pump has been altered or misused or 3 The Pump serial number has been removed or damaged Exclusions All other warranties express or implied are excluded including but not limited to the warranties of merchantability and fitness for a particular purpose or use The remedies provided in this Warranty are the exclusive remedies available to the Original Purchaser for any breach of this Warranty and no person has the authority to bind the Manufacturer to any representation condition or warranty except this Warranty The Pump can only be used under the supervision of medical person nel wh
50. he cartridge 32 Using the Pump 2 Attaching an infusion or extension set and loading a filled cartridge into the pump c Warning To avoid accidentally infusing medication or causing backflow of blood from the access device or site disconnect the tubing from the access device or site before removing a used cartridge or replacing an infusion set Never use the pumps Load Cartridge or Fill Tubing features while tubing is con nected to the patient or an unintended dose of medi cation can be delivered 1 Turn the cartridge cap counterclockwise left approximately 4 turn and remove it from the pump see Figure 7 If required remove the used cartridge you may get the Cartridge Figure 7 Removed alert press OK NOTE turning the cartridge cap may also turn the cartridge so it may already be disconnected from the pushrod when the cap is removed If not turn the cartridge turn to the left to disconnect it from the pushrod 2 Thread the infusion set tub Insert the new cartridge into the ing through the cartridge cap remove the protective cap from the luer end of the infusion set and insert the luer through the hole in the cap and firmly tighten it onto the tip of the filled cartridge see Figure 8 Figure 8 c Warning If not properly tightened medication could leak from the cartridge and tubing connections and disrupt delivery Signs of leakage can also mean opportunity for contaminatio
51. he time that the next dose will be available Press OK The Demand Dose home screen displays the time that the next dose will be available Press OK Load a new cartridge then deliver the dose Press OK Completely review the delivery program and program the pump as required To stop the pump press Yes To leave the pump run ning Press No 58 Help Other messages continued Message in display This will result in a Demand Dose amount of 0 ml This will result in an Automatic Dose amount of 0 ml This will result in a time period with a Continuous Rate of 0 ml hr What it means Alarm You have allowed Demand Doses but programmed the amount to zero Single alarm You have programmed an automatic dose schedule where at least one of the dose amounts is set to zero Single alarm You have programmed a continuous rate where at least one of the rates is zero Single alarm How to make it stop If you want to leave the amount at zero press OK If you want to reprogram the amount press Edit If you want the schedule to run as programmed press OK If you want to reprogram the schedule press Edit If you want the schedule to run as programmed press OK If you want to reprogram the schedule press Edit Cleaning the pump Routinely clean the pump to prevent buildup of dirt or dried fluids Try to wipe spills off the pump right away to avoid a sticky buildup which will be harder to wipe
52. infused under single fault condition Less than 0 02 ml Delivery rate during dose Approximately 0 0001 ml per second minimum 0 016667 ml per second maximum based on dose amount and dose duration dose duration configurable from 1 to 15 minutes Delivery rate during Fill tubing Fill cannula Approximately 0 01 ml per second Continuous Rate Delivery Interval Every 3 minutes approximately 20 continuous rate Delivery specifications Main Menu Setup Delivery Methods Choose to have the following delivery methods available Continuous Rate Yes or No Default No Automatic Dose Yes or No Default No Demand Dose Yes or No Default No Maximum Continuous Rate 0 000 ml hr to 1 000 ml hr in 0 002 ml increments Default 0 800 ml hr Maximum Auto or Demand Dose 0 000 ml to 1 000 ml in 0 002 ml increments Default 1 000 ml Dose Duration 1 to 15 minutes in 1 minute increments Default 12 minutes 71 Technical Information Dose Lockout Time 00 15 minutes to 24 00 hours in 00 15 15 minute increments Default 01 00 1 hour Time and Date Allows user to set time and date New Patient Mark for new patient Yes or No Default No Clear Delivery Yes or No Default No Security Delivery Program Menu Yes or No Default Yes Setup Menu Yes or No Default Yes Alerts Low cartridge volume Alert at 0 050 ml to 0 500 ml in 0 01 ml increments Default 0 2 ml Display site reminder Yes or No Default No 72 Te
53. ing Choose Yes to continue again to continue O Fill Cannula filling then press Select filling O Reminder No Done FY Select gt lt Back PY Select gt lt Back A OR With No displayed press Select if you do not want to continue filling 4 Fill cannula Filling the cannula is an important step if using an infusion set that has a separate needle or cannula that needs priming prior to use If you do not fill the cannula there is a delay in medication delivery once the pump is started Press Select Cartridge Menu El Load E Fill Tubing O Fill Cannula D Reminder PN Done Ks 37 Using the Pump Choose amount needed to fill cannula listed in instructions supplied with infusion set then press Fill once you enter an amount here that amount becomes the default and will always be shown in this screen Fill Cannula Cartridge Menu El Load E Fill Tubing M Fill Cannula O Reminder Done Pisec 38 Using the Pump 5 Set site change reminder and restart delivery The Site Change reminder screen appears here if turned on in Setup Alerts see page 23 Setting the site change reminder will cause the pump to beep or vi brate as a reminder that it is time to change the tubing or access site Press Select Cartridge Menu El Load B Fill Tubing Fill Cannula D Reminder lt Done PY Select At reset choose Yes Choose interval b
54. inuous alarm Delivery suspended The cartridge is empty Continuous alarm Delivery suspended Pump detected that cartridge was removed or not properly installed Continuous alarm How to make it stop You must change the battery immediately Power may be so low that the display goes blank or the pump continuously attempts to restart always re place the battery whenever this occurs Alarm will recur unless blockage is cleared Discon nect your infusion set from the access device until the blockage is cleared Check tubing making sure it is not kinked make sure tubing is not trapped in the patients clothing or pouch Check cannula making sure cannula is properly inserted if applicable Press OK Press OK You must load a new cartridge now Press OK Disconnect the tubing from the patient Correctly load a cartridge onto the pushrod and fill the tubing see page 32 Alarms continued Message in display Cartridge very low DB aus stuck Release key or remove battery System fault Call for service Battery low Change battery soon 53 Help What it means Alarm The cartridge is nearly empty If Continuous Rate delivery is active it will continue If Automatic or Demand Dose delivery is active de livery of doses will not start or will be suspended Continuous alarm A key has been pressed continu ously for 5 minutes or a key was pressed during the pump s power up Continuous alarm
55. livery Summary Start at any Home screen Continuous Rate 0 242 ml hr CR enu E Menu Start at any Home screen Continuous Rate 0 242 ml hr CR Meru P Menu Choose History then press Select Main Menu Stop Delivery Setup Load History Beep Vibrate lt Home E Select Press Home Choose History then press Select Main Menu Stop Delivery Setup Load History Beep Vibrate Ten Press Home 45 Using the Pump Choose Complete History then press Select History Menu Complete History Delivery Summary lt Back kd Select gt Press Back Choose Delivery Summary then press Select Complete History 10 05 05 01 41PM A sample Complete History report screen You can press the Q or amp keys to view other events in the report Press Back when you re finished viewing Continuous rate changed to 0 5 ml hour History Menu Complete History Delivery Summary Delivery Summary Today A sample Delivery Summary screen Press the Q or keys to change the date and see delivery summaries from previous dates Press Back when you re Demand Oml Auto 0 092 ml Cont 0 735 ml Total 0 827 ml lt Back FY Select gt Press Back finished viewing the report lt Back e 46 Using the Pump Beep or Vibrate Choose Beep or Vibrate to signal alarms and alerts Then if using Beep de
56. lsters 4 5 adatto bietet 79 Inspecting the PUMP aiat irent 80 Collect Separately sass nanninannan aa Limited Wattanty xo a MN diste ie iei ed Index Important safety information WARNING Read this entire manual before using the CADD MS 3 Ambulatory Infusion Pump If you do not understand something or have any questions contact Smiths Medical MD Inc Incorrect use of this pump failure to follow the instructions and important information contained in this manual or improper inadequate troubleshooting can lead to death or serious injury Warnings cautions and other important safety information can be found in this section and in bullet form throughout the manual indicated by the symbol The Help section starting on page 51 contains information on troubleshooting the pump and other important information Warnings D This manual is designed for clinicians and contains all of the information needed to fully program the pump Do not give this manual to patients as it would allow them complete access to all programming information gt The CADD MS 3 Ambulatory Infusion Pump is designed for subcutaneous intravenous epidural and intrathecal infusion of medication DO NOT use with blood or cellular blood products Use the pump only as instructed in this manual 1 Important Information D This manual describes how to use and troubleshoot the CADD MS 3 pump Smiths Medical MD Inc does not however make any recomm
57. mounts of medi cation into the body The CADD MS 3 pump systems are controlled by two microprocessors computer chips which continuously monitor each other to make sure the systems are working properly Occlusion Blockage Occlusions are associated with the infu sion set and or access site and mean that medication delivery is stopped Blockage can be caused by a number of things including the tubing being pinched or kinked the cannula or needle being blocked as well as other reasons Pushrod On the CADD MS 3 pump the cartridge is attached to the pushrod and when the pump is started the motor causes the pushrod to move forward and push medication through the infusion set into the body Pump illustrations Figure 1 Figure 2 Battery cap Cartridge cap A Ss O ring Cartridge viewing IR windows window not used CADD MS 3 on this Display model Up key pump D Dose Left A button program key Down key Right program key backlight 9 Programming the Pump 10 Programming the Pump Description of features and buttons Battery cap with o ring Figure 1 Holds the battery in place in the battery compartment The pump uses one AAA IEC LRO3 alkaline battery The approximate amount of battery life is displayed in the home screen and an alarm is given when battery power is low Keep extra batteries on hand c Warning Make sure that the battery cap is fully
58. move cartridge cartridge that contains less than 0 2 ml the screens shown at left will then Bless Oh appear Remove the cartridge then press OK or press Back to return to the previous screen If you press OK the pushrod moves forward then the screen reads Detach set from body install filled cartridge then press Load If your cartridge contains less than 0 2 ml you will need to start with a new filled cartridge With Load still chosen press Select X No cartridge Sensor X FastForward If during the loading process you intentionally or accidentally remove detected confirmed the cartridge or if the cartridge is too full more than 3 ml the screens Cartridge missing or I Now pushrodmust Mi Please wait shown at left will appear The pump needs to check to make sure that the cartridge sensor is working properly If the cartridge is not installed install it e If a cartridge is installed make sure it is not too full fill with no more than 3 ml With the tubing set attached press down gently on the cartridge this will push excess medication into the tubing Press Confirm The pump will confirm that the sensor is working properly If the sensor is not working you will get this message repeatedly and the pump will need to be serviced If the sensor is confirmed remove the cartridge and press OK The pushrod moves forward then the screen reads Detach set from body install filled cartridge then
59. mp Not applicable Over the frequency range 150 kHz to 80 MHz field strengths should be less than V V m 67 Technical Information 68 Technical Information Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Pump The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip ment transmitters and the pump 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 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz of Transmitter d 3 5 V P d 0 23 P d20 47 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated 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 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Specific
60. n 77 watchdog 76 Screensaver 13 Security 28 71 Self tests 18 Servicing your pump 60 Setup 71 Alerts 23 71 Delivery Methods 26 71 New Patient 25 71 opening the menu 20 Regional settings 72 Security 28 71 Time and Date 21 71 Site Reminder 23 38 Software safety features 77 hardware related 77 keypad encoder check 78 motor circuit check 78 RAM memory check 77 85 Index Specifications 69 Delivery 71 General 69 Stopping the pump 39 Symbols 4 System fault 53 T Time and Date 21 71 Troubleshooting 52 alarms 52 alerts 54 Messages 55 V Vibrate 11 46 51 WwW watertight 6 11 Smiths Medical MD Inc St Paul MN 55112 USA Smiths Medical International Ltd 1 800 426 2448 USA Wo AG Uk 1651 633 2556 Tel 44 0 1923 246434 www smiths medical com CADD MS 3 and the CADD and Smiths Medical design marks are trademarks of the Smiths Medical family of companies The symbol indicates the trademark is registered in the U S Patent and Trademark Office and certain other countries All other names and marks are trademarks tradenames or service marks of their respective owners The products described are covered by one or more of the following U S Patent No 7 033 338 7 041 082 and 6 241 704 Other U S and foreign patents pending 2008 Smiths Medical family of companies All rights reserved iuis apt Smiths medical
61. n alarm or alert occurred while you were programming editing a value Single alarm The cartridge volume needs to be rechecked to make sure it will be displayed correctly on the home screen Attention alarm The time and date settings in the program have been reset and must be reprogrammed Attention alarm How to make it stop Press OK Replace the cartridge as soon as practical Press OK Reprogram the value Remove the cartridge if present then press Next Press the Q or key to choose the currently high lighted setting then press Next to move highlight to next setting When time and date are correct press Done Alerts continued Message in display Program 3 Defaulted You must program the pump Site change z reminder x days since site changed Time for new site Other messages Message in display All Automatic Doses programmed to zero All Continuous Rates programmed to zero Cancel Demand Dose and stop all delivery 55 Help What it means Alarm All pump settings are reset to default How to make it stop Press OK Reprogram all pump settings values usually seen with new pumps or when internal battery is discharged Attention alarm It is time to change your infusion set and access site Attention alarm What it means Alarm You have attempted to start the pump and the Automatic Dose amounts are programmed to zero Single alarm You have attempted to
62. n leading to infection cartridge chamber see Figure 9 Gently turn the cartridge clock wise right about turn to fas ten it onto the pushrod you may need to first turn the cartridge until it drops onto the pushrod Figure 9 4 Choose Load from main menu and open the cartridge menu Start at any Home screen Continuous Rate 0 106 ml hr CR Menu Menu gt NOTE You will not be able to load a cartridge that contains less than 0 2 ml the sensor may have trouble sensing the cartridge amount Choose Load then press Select Main M Stop Deven 2 With Load chosen Setup press Select Load Cartridge History Menu Beep Vibrate L1 Load Senne apa OFill Cannula D Reminder Enn Done gSelect gt Install filled cartridge then X Loading press Load Please wait Cartridge Menu El Load O Fill Tubing See the next page for additional screens which may appear O Fill Cannula when you press Load See the next page for additional screens which may appear after the Loading screen D Reminder PN Done FY selects 33 Using the Pump 34 Using the Pump Not read X FastForward In order for the pump to assure that the cartridge is correctly connected y to the pushrod the pushrod must start in a forward position If it is not Pushrodimustmove f Please wait far enough forward when you press Load or if you attempt to load a Re
63. nd requirements 3 Place the battery cap back over the compartment Push down and turn the cap clockwise right Again use a smooth edged coin to tighten the cap Warning Make sure that the battery cap is fully tight Figure 3 D Warning There are potential health ened to avoid an interruption in battery power which hazards associated with improper disposal of batteries can cause the pump to power down and stop the deliv electronics and contaminated used infusion sets and ery of drug therapy A prolonged interruption in the cartridges Dispose of used batteries infusion sets car delivery of drug therapy can result in serious patient tridges and other used accessories or a pump that has injury or death reached the end of its useful life in an environmentally safe manner and according to any regulations that may apply Make sure that the battery cap is fully tightened The battery cap is fully tight ened when the battery cap o ring is not visible the cap fits snug and when you press on the battery cap the pump does not produce a chirp see Figures 5 and 6 If the pump sounds a brief alert chirp the cap is not fully tightened and should be tightened further If you are unable to tighten the cap and elimi nate this chirp the pump should not be used Contact your pump provider or Smiths Medical Figure 5 INCORRECT 17 Programming the Pump Inspect the Pump s battery cap The battery
64. off when the screensaver reactivates You can only turn on the backlight from screensaver When the motor is running the backlight blinks Menus To choose a menu item press the Q or key to high light the item you want then press Select 10 10 AM RUNNING 13 Programming the Pump Editing values Screens with a single field press the Q or key to change a value then press the or key to save it or continue editing or move to another screen Screens with more than one field press the key Next to move to the field you want to change and then press the Q or key to change the value On some screens pressing the key Done will save your changes and move to another screen On others pressing the key Back will save the value in the field and move to the previous field on the screen There are two exceptions 1 where your changes take effect only when you exit the screen and 2 the New Patient Screen and the Enable Delivery Methods screen c Warning Because the method of saving values varies by screen it is essential that you review the program before beginning delivery Timeout feature If you change a value using the Q or amp key and then decide you don t want to change it after all wait 45 seconds and the field will return to its original value Warning beeps or vibrations will let you know that this is happening 14 Programming the Pump Medication remaining in the cartridge approxim
65. ory feature that displays a variety of delivery history information 12 Programming the Pump Description of pump display and menus All programming operating and alarm alert information is shown in the display Programming of the pump is menu driven like a cell phone or ATM The Home screen shows various infor mation relating to pump operation If all of the delivery types are turned off the iyozos o430Pm home screen at right is shown Depending rume stoprep on which features you are using one or more of the following home screens will be shown The Continuous Rate CR home screen shows the current continuous rate being delivered This home screen will only be visible if Continuous Rate is set to Yes in use in both the Setup and Delivery Program menus You can also access the Continuous Rate menu from this home screen see page 47 Continuous Rate 0 242 ml hr cen EN Menus The Automatic Dose AD home screen shows when the next automatic dose is scheduled to be delivered This home next Auto Dose screen is only visible if Automatic Dose is 7 M set to Yes in use in both the Setup and A0 Menu Menu gt Delivery Program menus You can also access the Automatic Dose menu from this home screen see page 48 When an Automatic Dose is being delivered the screen will show Auto Dose Active The Demand Dose DD home screen shows the amount time and date of the last deman
66. ose skill and judgment determine the suitability of the Pump for a particular medical treatment and patient The Manufacturer its distributors or suppliers shall not be respon sible for any incidental special or consequential damages of any kind or nature caused by or arising out of a defect or malfunction of the Pump All recommendations information and descriptive literature supplied by the Manufacturer or its agents are believed to be accurate and reli able but do not constitute warranties Warranty Procedure Notice of the claimed warranty defect must be made in writing fax or by telephone to the Manufacturer as follows Smiths Medical MD Inc 1265 Grey Fox Road St Paul MN 55112 U S A Telephone 1 800 426 2448 or if outside the USA contact your local distributor Original Purchaser must include date of purchase by the Original Purchaser model and serial number and a description of the claimed warranty defect in sufficient detail to allow the Manufacturer to deter mine and facilitate any repairs which may be necessary AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURN ING THE PUMP If authorized the Pump must be properly and care fully packaged and returned to the Manufacturer postage prepaid Any loss or damage during shipment is at the risk of the sender This Warranty gives the Original Purchaser specific legal rights The Original Purchaser may have other legal rights which may vary from state to state 83 Warrant
67. ption of pump display and menus Screensaver and backlight sss Editing values Timeout feature Home screen example Sample screens iie etel tte titre nnna EE E EE Cari den a AAA a E Ae balai a a inia Before using the pump for the first time Insert a battery AS tts Aan NA A ian laan KB nn An Ta A an dan daaa Setup Menu New Patient Setup Menu Delivery eerte nein Setup Menu Security Delivery PYOBF in ectetur n tite beef Using the Pump Loading a cartridge ete tendente ticae 31 Supplies required essaia iiidid 31 L Filling the cartridge ener 31 2 Attaching an infusion or extension set and loading a filled cartridge into the pump 32 3 BilEthef biBg aceti atri b eren 36 A Fill cann la ctore terre nancies 37 5 Set site change reminder and restart delivery 38 Stopping and starting the pump Starting the pump Delivering a Demand Dose Canceling doses niaaa tnr Reus Canceling a dose Demand or Automatic Whilein progress aues a Canceling next Automatic Dose NSCOR ieri trente trii Deep or Vibr ate 2 on eie io ecc or ERU Continuous Rate Menu dieto dai Automatic Dose Men ain san mi ient jin Demand Dose Menu ettet ttt t Rede thea Help About alarms Beep Vibrate settings esse 51 Troubleshooting Alarms seite ee REI Aa Alerts na
68. r it is exposed to water 61 Help If the pump is dropped or hit hard If the pump is dropped or hit against something hard it will need to be immediately looked over carefully to make sure it is not damaged Instruct the patient to disconnect their infusion set from their body and stop delivery until they have made sure the pump is working correctly The patient should remove the battery then reinsert it The pump will perform the self tests and alarm if there is a problem The patient should make sure the pump display is work ing correctly If there are missing or incomplete charac ters the pump will need to be serviced The patient should look over the pumps outer shell care fully checking for cracks or chips If there are cracks or chips the pump will no longer be watertight The pump will need to be serviced if there is any damage The patient should make sure the cartridge cap and battery cap are in place and secure Have them check all connections on the cartridge and infusion set If moisture is present they must tighten the connectors If the connectors appear damaged they must replace the cartridge and infusion set 62 Help c Warning If the pump is dropped or hit against something hard it must always be inspected care fully to make sure it is still working properly Make sure the display is working correctly and the car tridge cartridge cap battery cap and infusion set are connected correctly If there
69. rtridge and an infusion set any manufacturers infusion set can be used as long as it has a standard luer lock to connect to the cartridge 7 Important Information Glossary of Terms The following is a list of terms used throughout this manual Automatic Dose Automatic Doses are programmed amounts of medication delivered at specific times of the day Continuous Rate The amount of medication delivered continu ously over 24 hours a day providing delivery of medication at all times The continuous rate is measured in milliliters per hour ml hr Cannula A small soft tube or needle inserted into the body through which medication is delivered Cartridge The container that holds the medication The Smiths Medical 3 ml Medication Cartridge looks like a small syringe Demand Dose A Demand Dose is an extra programmed amount of medication initiated by the patient as needed Dose An extra amount of medication given at specified times and or as needed Fluid path The areas inside the cartridge and infusion set that come into direct contact with the medication These areas include the inside of the tubing and connectors the inside and tip of the needle and cannula and the inside and tip of the cartridge To help protect against infection never touch or blow directly on any part of the fluid path 8 Important Information Infusion pump A small electromechanical medical device designed specifically for delivering precise a
70. s Home Main Menu Start Delivery Setup Delivery Program Load History Home select Press Back Nera or Demand Dose Choose 0 to 1 ml then press Next PN lt Back DN Dose Duration Choose 1 to 15 minutes Back E Nec Setup Menu Delivery Time and Date New Patient Security Alerts Dose Lockout Ti Ime Choose 00 15 minutes to 24 00 hours then ET hh mm f press Next lt Back gSelect gt Programming the Pump 27 28 Programming the Pump Setup Menu Security Security allows you to decide if you want to require pass codes to access the Setup and Delivery Program menus Security can be accessed when the pump is running or stopped Starting at Setup Menu screen Setup Menu Choose Yes or No then press Next c Warning If you choose not to require pass codes to access the Setup and Delivery Program menus the patient will have full access to all programming and delivery functions Choose Yes or No then press Next Security Delivery hoose Security Time and Date New Patient Security Alerts lt Back Select gt PUMP STOPPED CR Menu Menus then press Select Poss DA Setup No Security Program No Setup Do lt Back el Next Press Home Main Menu Start Delivery Setup Delivery Program Load History Home kget lt Back Li Next Press B
71. s and display an alarm screen letting you know there is a problem If this happens do not use the pump D The cartridge cap battery cap and luer connections are not childproof Tampering with them can result in over or under delivery of medication D The time and date must be set correctly since delivery factors are time based and all history is stored based on time and date Occasionally the time will need to be reset for example during daylight savings time or to adjust for a different time zone D Do not allow the patient to learn the pass code The pass code allows access to all delivery programming and security settings D If you choose not to require pass codes to access the Setup and Delivery Program menus the patient will have full access to all programming and delivery functions D Always use the pump s Load feature when starting a new cartridge This will assure that the cartridge is properly loaded and the infusion or extension set is filled with medication D Always use aseptic technique particularly when work ing with the cartridge infusion set catheter and access site to minimize the risk of infections gt The CADD MS 3 pump and cartridge are not a secure system Patient must be assessed for appropriateness of pump usage gt Always read the Instructions For Use provided with the medication cartridge infusion set and any other acces sory used with the CADD MS 3 pump D To avoid accidentally infu
72. s then press Local Formats Select lt Back f Yselect PUMP STOPPED CR Menu Menu gt When the pump is built the default settings are Time format 12 Hour Date format mm dd yy and decimal symbol Period If these are correct for your location you can skip this section If you use different settings follow the instructions below Local Formats is available whether the pump is running or stopped Choose 12 Hour AM and pm or 24 Hour then press Next Time Format Choose mm dd yy month day year or dd mm yy day month year then press Next mm dd yy Date Format Press Home Main Menu Start Delivery Setup Delivery Program Load History Home pgselect gt Decimal Symbol Choose Period or e Comma then Press Back Period press Next PN Ken Setup Menu Delivery Time and Date New Patient Security Alerts Back hd Select gt Setup Menu Alerts The pump allows you to set up certain alerts associated with treatment considerations personal preference and safety and can be personalized uniquely for each user Alert for low cartridge determines when the pump alerts the patient to an almost empty cartridge Decide how much medication should be left when the alert occurs 0 05 to 0 5 ml It is factory preset to 0 2 ml Choosing a higher amount will give more time between the low cartridge alarm and the empty cartridge alarm 2
73. sing medication or caus ing backflow of blood from the access device or site disconnect the tubing from the access device or site before removing a used cartridge or replacing an infu sion set Never use the pumps Load Cartridge or Fill Tubing features while tubing is connected to the patient or an unintended dose of medication can be delivered D If not properly tightened medication could leak from the cartridge and tubing connections and disrupt delivery Signs of leakage can also mean opportunity for contamination leading to infection D Never use Fill Tubing when the infusion set is connected to the body or an unintended dose could be delivered gt Always remove all air from the cartridge and infusion set before starting medication delivery Air bubbles in the system can slow or stop medication delivery Check all connections carefully for leaks as leakage can slow or stop medication delivery to the body and allow an open ing for contamination leading to infection D You should provide specific training on delivering a dose D If the pump is dropped or hit against something hard always inspect it carefully to make sure it is still working properly Make sure the display is working correctly and the cartridge cartridge cap battery cap and infusion set are connected correctly If there is damage to the pumps outer shell cracks chips the pump may no longer be watertight Make sure that the battery cap is fully ti
74. t 1 1996 64 Technical Information IEC 529 Degrees of protection provided by enclosures IP Code RTCA DO 160D 7 97 Environmental conditions and test procedures for airborne equipment SECT 21 Emissions of radio frequency energy Radiated Emissions Only Category M Limit UL2601 1 1998 Medical Electrical Equipment Part 1 General requirements for safety NOTE While the pump complies with the above standards there is no guarantee that interference will not occur in any particular situation If the pump malfunctions due to interference with radio or cell phones move the antenna further from the pump and or increase the distance between the pump and the radio or cell phone Guidance and Manufacturer s Declaration Electromagnetic Emissions The pump is intended for use in the electromagnetic environment specified below The customer or the user of the pump should assure that it is used in such an environment RF emissions CISPR 11 Group 1 The pump uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The pump 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 Voltage fluctuations flicker emissions IEC 61000 3 3
75. tertight and will require service D Caution Never use steam or very hot water ex ceeding 120 F 49 C in an attempt to sterilize the pump Never put your pump in the dishwasher 60 Help Exposing the pump to these high temperatures could damage the pumps electronics and result in the need to service the pump Servicing the pump If the pump becomes damaged or broken or if it is not working properly you will need to call Smiths Medical MD Inc Before contacting Smiths Medical please be sure that you know the pump serial number located on the back of the pump and are able to give a brief description of the problem In the USA contact Smiths Medical MD Inc Customer Service at 1 800 426 2448 The pump and Extreme temperatures If outside in very cold temperatures for any length of time instruct the patient to keep the pump next to their body and covered by warm clothing Avoid leaving the pump in direct sunlight Instruct the patient to remove the pump before entering a hot tub Jacuzzi or sauna as the temperatures may be too high for the pump to operate properly See Specifications in the Technical Information chapter for appropriate stor age and operation temperatures Water As long as the pumps labels and outer shell are intact no cracks or chips the pump is watertight The pump does not need to be removed when showering or bath ing Instruct the patient to dry the pump with a clean towel afte
76. tomatic Dose home screen Demand Dose home screen Site Reminder home screen Important Information BHHBHHBHH 2 99 Dansk u Deutsch EAAnvik English Espa ol Suomi Empty cartridge or low battery Keep dry Fragile handle with care Keep away from sunlight Temperature limitation Important safety information warnings and cautions Fran ais D Italiano E Nederlands Norsk Portugu s sv Svenska 6 Important Information Introduction The CADD MS 3 Ambulatory Infusion Pump provides measured medication therapy to patients in hospital or out patient settings Any medication therapy must be overseen by a physician or certified licensed healthcare professional Indications The CADD MS 3 pump is a syringe based ambulatory infu sion pump designed for subcutaneous intravenous epidural and intrathecal infusion of medication Contraindications The pump is not indicated for anyone who cannot follow the instructions for use or perform basic troubleshooting and maintenance activities associated with ambulatory pump use Delivery features The pump can be used to deliver medication in two ways as a continuous rate and as an added dose Continuous Rate The pump can be programmed to deliver a steady flow of medication called the Continuous Rate You can program up to 48 time rate segments per 24 hour period to meet the patient s medication needs throughout the day and night Doses The pump can deliver
77. two types of doses an Automatic Dose programmed to deliver a specific dose at a preprogrammed time as well as Demand Dose delivered by the patient as needed You can also program lockout times so that you can control the time between doses Other features The pump has a large display or screen where all program ming operating and alarm information is displayed Pro gramming of the pump is menu driven like an ATM or cell phone The pump is powered by one AAA IEC LR03 alkaline bat tery which is readily available at most grocery stores hard ware stores drug stores and electronic stores The expected battery life is approximately 2 weeks battery low alert at 0 124 ml hr D Caution Do not use NiCd nickel metal hydride carbon zinc heavy duty lithium or any rechargeable batteries They will not power the pump properly and the battery life indicator on the home screen may not show the correct amount As long as the pumps labels and outer shell are intact the pump is watertight to a depth of 8 feet 2 4 meters for 30 minutes or 12 feet 3 6 meters for 3 minutes Pump and delivery history is automatically tracked by the pump and can be viewed in the History menu see page 44 The pump has a Security feature which allows you to lock out the Setup and Delivery Program menus This feature helps prevent tampering with the programming of the pump The pump requires the use of the Smiths Medical 3 ml Medi cation Ca
78. ulating a CRC on the data and then comparing it with CRC stored in the data If the stored and calculated data do not match the software stops medication delivery initiates an alarm either beep or vibrate and a system fault alarm message appears in the display Data stored in NOVRAM Before use data associated with delivery and stored in NOVRAM is tested by calculating a CRC on the data and then comparing it with CRC stored in the data If the stored and calculated data do not match the soft ware stops medication delivery initiates an alarm either beep or vibrate and a system fault alarm message ap pears in the display Data used in calculations Calculations on data used in some way to control deliv ery of medication are performed redundantly The two calculated values are then compared If the two values do not match the software stops medication delivery initiates an alarm either beep or vibrate and a system fault alarm message appears in the display Timer data registers The data in the Real Time Clock is checked at regular intervals If the data is not reasonable the software stops medication delivery initiates an alarm either beep or vibrate and a system fault alarm message appears in the display 79 Technical Information 80 Technical Information fits snug and when you press on the batte ns pect In g t h e p um p cap oe does a produce a chirp i Figures 11 and 12 Ifthe pump sounds a brief al
79. up Menu Start at any Home screen pump stopped Press Menu PUMP STOPPED CR Menu Menus Press Home f the pump is running when you enter the Setup menu you will not have access to the full menu Only the Secu rity Alerts and Local Formats menu items will appear Choose Setup then press Select Main Menu Start Delivery Setup Delivery Program Load History Home E35elec Press Back to return to the If setup security is set to Yes Enter the Pass Code then press Next Setup Pass Code lt Back EY Next Choose the menu item you want to enter then press Select Setup Menu Delivery Time and Date New Patient Security Alerts Back 4Select gt To exit Setup Menu press Back main menu without entering Setup Once the Pass Code has been entered it remains in effect until the pump s screensaver activates Setup Menu Time and Date c Warning The time and date must be set correctly since delivery factors are time based and all his tory is stored based on time and date Occasionally you will need to reset the time for example during daylight savings time or to adjust for a different time zone Starting at Setup Menu screen Time and Date Setup Menu P e Choose Time Time and Date and Date then Time 00 AM New Patient press Select Date 06 28 04 Security Alerts Back Select
80. very initiates an alarm either beep or vibrate and a system fault alarm message appears in the display RAM memory check At power up the random access memory RAM is checked A series of bit patterns is written to and read from each address in the RAM If the read data is differ ent from the written data the software stops medication delivery initiates an alarm either beep or vibrate and a system fault alarm message appears in the display 78 Technical Information Motor circuit check At power up and at regular intervals thereafter the mo tor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on If the software detects power being applied to the motor at any other time it initiates an alarm either beep or vibrate and no longer attempts to deliver medication During every pump activation the software checks to see whether the motor completes one activation If the motor fails to turn or fails to complete an activation the software stops medication delivery initiates an alarm either beep or vibrate and a system fault alarm message appears in the display Keypad encoder check Every time the software receives data from the keypad it is checked If the data is not a valid keypress the soft ware disregards the keypress Data handling and software safety features Data stored in RAM Before use data associated with delivery and stored in RAM is tested by calc
81. y 84 Index Index A Accuracy test results 74 Alarm 52 Beep 11 46 51 Vibrate 11 46 51 Alerts 23 54 71 Automatic Dose 6 12 26 72 canceling 42 Menu 48 Backlight 13 Battery alkaline AAA 6 10 52 53 69 inserting 16 Battery cap 3 9 10 16 17 61 62 80 Beep 11 46 51 C Canceling a dose 43 Cartridge 11 15 23 52 53 54 Loading 31 sensor 11 33 changing the battery 16 changing the cartridge 32 Cleaning your pump 59 Continuous Rate 6 7 12 26 72 Menu 47 D Data handling and software safety features 78 data stored in NOVRAM 78 data stored in RAM 78 data used in calculations 79 timer data registers 79 Delivery Methods 26 71 Delivery Program 29 72 Demand Dose 6 12 26 72 canceling 42 delivering 41 Menu 49 Demand Dose button 10 Dose 7 Dose Duration 26 71 Dose Lockout 26 71 H History 11 44 73 viewing 45 home screen 12 Automatic Dose 12 Automatic Dose Menu 48 Continuous Rate 12 Continuous Rate Menu 47 Demand Dose 12 Demand Dose Menu 49 screensaver 13 Infusion set 15 32 Inspecting the pump 80 L Load 31 72 low cartridge volume 23 M Menus Beep Vibrate 19 Delivery Program 29 History 44 Load 33 New Patient marker 25 71 O Occlusion 8 11 52 O ring 9 10 17 80 P Pass Codes 28 Pump development standards 63 Pushrod 8 34 R Regional settings 72 S Safety features and fault detection 76 hardware 76 motor drive 76 voltage detectio
82. y the AAA alkaline battery Once fully charged approximately 40 hours after AAA battery installed the 70 Technical Information internal battery maintains pump programming and his tory for approximately 30 days The life of the internal bat tery is 10 years minimum under normal use conditions Operating conditions Temperature 2 C to 40 C 35 6 F to 104 F Humidity 9096 relative humidity non condensing maximum Atmospheric pressure 70 kPa or 10 000 feet above sea level to 106 kPa 10 2 psi to 15 4 psi D Caution Do not use the pump in hyperbaric chambers as they willaffect how the pump works and may also cause damage to the pump Transport and storage conditions Temperature 20 C to 60 C 4 F to 140 F Humidity 9096 relative humidity non condensing maximum Atmospheric pressure 70 kPa or 10 000 feet above sea level to 106 kPa 10 2 psi to 15 4 psi System delivery accuracy ml hr 396 nominal At low delivery rates this accuracy may not be achieved for short periods During the total delivery time the accuracy averages out System definition CADD MS 3 Ambulatory Infusion Pump with Smiths Medical 3 ml Medication Cartridge and a Unomedical Comfort Infusion Set Blockage occlusion alert 18 psi 5 psi Dose accuracy at set value of 0 002 ml 1596 measurement error 10 Dose accuracy at set value of 1 0 ml 0 12 0 88 Average 0 53 measurement error 0 000596 Maximum volume
83. your pump in the dishwasher Exposing the pump to these high temperatures could damage the pumps electronics and result in the need to service your pump Explanation of symbols Below is a list of symbols you will see on the CADD MS 3 pump packaging and accessories as well as explanations of what the symbols mean sn A L1 IPX8 e c P x ONLY C or 0473 Ce Serial number Attention See instructions for use Type CF equipment protection from electric shock Watertight when submerged to 8 feet 2 4 meters for 30 minutes or to 12 feet 3 6 meters for 3 minutes Date of manufacture Use by On Pump Display Wait Caution Federal USA law restricts this device to sale by or on the order of a physician Catalog number Indicates that the product was designed and manufactured in accordance with applicable standards guidelines and may be sold in the EU European Union PDB B D U Binak diais EJ Ui Appears in pump display with a message to indicate a question you must answer before programming can continue Appears in pump display along with a message as an indicator of an alarm condition Collect separately Latex free Press Q or keys to move through menu settings Top of menu press key to move through menu Bottom of menu press Q key to move through menu Approximate volume of medication left in cartridge Approximate battery life remaining Continuous Rate home screen Au

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