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Medfusion® Model 3500 pump V6

Operator’s Manual

Technical specifications & other information

Pump development standards

Medical Electrical Equipment Safety

Reference (Year)

Title

IEC 60601-1 (1988)

Medical Electrical Equipment, Part 1: General Requirements for Safety, Amendment

1 (1991), Amendment 2 (1995)

IEC 60601-1-4 (2000)

Medical electrical equipment -- Part 1-4: General requirements for safety - Collateral

standard: Programmable electrical medical systems

IEC 60601-1-6 (2010)

Medical electrical equipment – Part 1-6: General requirements for safety – collateral

standard: usability

IEC 60601-2-24 (1998) Medical Electrical Equipment, Part 2: Particular requirements for safety of infusion

pumps and controllers

IEC 62304 (2006)

Medical device software - Software life cycle processes

IEC 62366 (2007)

Medical Devices, Application of usability engineering to medical devices

EN 60601-1 (1990)

Medical Electrical Equipment, Part 1: General Requirements for Safety

EN 60601-1-4 (1996)

Medical electrical equipment -- Part 1-4: General requirements for safety - Collateral

standard: Programmable electrical medical systems. Amendment 1 (1999)

EN 60601-1-6 (2010)

Medical electrical equipment – Part 1-6: General requirements for safety – collateral

standard: usability

EN 60601-2-24 (1998)

Medical Electrical Equipment, Part 2: Particular requirements for safety of infusion

pumps and controllers

EN 475 (1995)

Medical Devices - Electrically -generated alarm signals

UL 60601-1 (2006)

Medical Electrical Equipment, Part 1: General Requirements for Safety (US

Deviations to IEC 60601-1)

CAN/CSA-C22.2 No.

601.1-M90 (1990)

Medical Electrical Equipment, Part 1: General Requirements for Safety – November

1990 (Canadian Deviations to IEC 60601-1) Update No. 2 (November 2003)

AS/NZS 3200.1.0 (1998) Australian/New Zealand Standard, Medical electrical equipment - Part 1.0: General

requirements for safety - Parent Standard (Australian Deviations to IEC 60601-1)

AS/NZS 3200.2.24

(1999)

Medical Electrical Equipment: Part 2-24: Particular requirements for safety-

Infusion pumps and controllers

Electromagnetic Compatibility

Reference (Year)

Title

IEC 60601-1-2 (2007)

Medical electrical equipment - Part 1.2: General requirements for safety - Collateral

standard: Electromagnetic compatibility - Requirements and tests. Amendment 1

(2004)
(Applies to all sections except IEC/EN 61000-4-2, Electrostatic Discharge Immunity

test)

EN 60601-1-2:2007/

AC:2010

Medical electrical equipment - Part 1.2: General requirements for safety - Collateral

standard: Electromagnetic compatibility - Requirements and tests.
(Applies to all sections except IEC/EN 61000-4-2, Electrostatic Discharge Immunity

test)

Summary of Contents for Medfusion 3500

Page 1: ...Medfusion Syringe Pump Model 3500 Operator s Manual Software Version 6 This manual and its contents are valid for use with software Version 6 V6 f ...

Page 2: ... Version 6 Medfusion Model 3500 pump V6 please call the appropriate number given below When calling please specify the pump s software version This information is located on the start up screen Our staff at Smiths Medical in the USA is available to help clinicians 24 hours a day with the programming and operation of the Medfusion Model 3500 pump V6 Smiths Medical ASD Inc 1265 Grey Fox Road St Paul...

Page 3: ...ng a syringe and syringe model setup 33 Unloading the syringe 37 Programming Infusions 38 Continuous mode mL hr 38 Dose Min and Dose Hr 39 Dose Day 41 Dose Time 43 Body weight surface area infusion deliveries 45 Volume weight infusions 47 Dose kg time dose m2 time 49 Volume weight time 51 Volume time 53 Intermittent volume time 54 Recall last settings 56 Priming the system 58 Options 60 Bolus dosi...

Page 4: ...22 Specifications 122 Safety Features 126 Safety Features and Fault Detection 126 Hardware Safety Features 126 Software Safety Features 126 Hardware related Software Safety Features 126 Program Memory Check FLASH memory POST or BGND 126 RAM Memory Check RAM BGND 126 Motor Circuit Check pump motor phase A or B POST and Motor rate error during operation 126 Keyboard Encoder Check Control key POST or...

Page 5: ... the battery pack Unauthorized modification and or the use of unauthorized service replacement parts will also void the Limited Warranty Before using any Medfusion Model 3500 pump V6 users must be thoroughly familiar with the contents of the operator s manual including all warnings cautions and instructions for use The user should ensure that the performance offered by the pump is fit for the inte...

Page 6: ...e syringe may cause improper pump operation delayed occlusion sensing larger post occlusion bolus at higher occlusion limit settings delivery inaccuracies or other potential hazards Bolus Volume Delivering a bolus volume less than the recommended bolus volume for the syringe used may result in delivery inaccuracies Use an infusion set with the smallest diameter tubing available that does not resul...

Page 7: ...er cord before servicing the pump Alwaysmaintainthispumpfollowingmanufacturer recommended instructions in the Technical Service Manual Improperly maintained pumps may cause either under infusion or over infusion to patient Toavoidelectricshock usersshouldneveropenthe pump case or battery compartment for any reason Service personnel should always disconnect the AC power cord before servicing the pu...

Page 8: ...nner toluene methylbenzene chlorinated solvents such as methyl ethyl ketone MEK trichloroethane ether such as ethylene glycol monobutyl ether diethylene glycol butyl ether or oxidizing acids such as phosphoric acid sulfuric acid or accelerated hydrogen peroxide Use of the solutions or solvents listed as DO NOT USE could damage plastic parts and cause premature failure or device malfunction Use onl...

Page 9: ...osure use this higher level of insulation instead of safety grounding A Indicates the product was designed and manufactured in accordance with applicable standards guidelines and may be sold in the EU European Union UL Mark for Canada and the United States Indicates the product was manufactured in accordance with the requirements of UL Underwriter s Laboratory Ö External DC jack connection Tip neg...

Page 10: ...lay allowing earlier opportunities for intervention as well as a post occlusion bolus reduction feature Indications for use The Medfusion Model 3500 pump V6 is indicated for the following uses In the administration of fluids requiring precisely controlled infusion rates including blood or blood products lipids drugs antibiotics enteral solutions and other therapeutic fluids By the following delive...

Page 11: ...tions or fluids are compatible with the syringe catheters tubing and fittings used in the infusion setup Always ensure fluids are compatible with each other when infusing more than one fluid or medication through the same infusion site If connecting more than one pump to the same infusion site use one way checkvalves to prevent pumps from interfering with each other Verify that the pumps will oper...

Page 12: ...fication of the individual keypad keys and what they are used for 10 AC Power Connection Port Plug the AC power cord into connection port to allow pump to operate on AC mains power 1 Display pump operating and status information appears on the display The lower portion of the display corresponds with the 4 softkeys their function changes depending on the pump programming being accomplished on the ...

Page 13: ...ower supply into port Note The DC Connector Port is functional only on pumps where the External DC Jack Connection symbol Ö appears on the pump serial number label located on the bottom of the pump 13 Infrared Connection Port Align RS232 converter box or IR to USB with port to allow upload of data from and download of data to a pump from a PC See Technical Specifications Keypad closeup ...

Page 14: ...gins priming after confirmation Displays the programmed bolus programming or confirmation Begin Delivery screen Indicator What it means ò Alarm The Alarm indicators yellow or red are on whenever the pump is in an alarm condition The specific details of each alarm are covered in the Alarm section later in this manual ô AC Line The AC Line indicator green is on whenever the pump is connected to main...

Page 15: ...osen in customization certain features may or may not be available when programming any specific pump Each user is responsible to determine which features are present on the pump they are using and to program them accordingly For this reason the following warning is included throughout the steps for programming and delivering fluids throughout this manual WARNING Confirm All Settings Before starti...

Page 16: ...n that they can be used in Drug Programs or can be menu items on their own while others can only be used in the creation of Drug Programs such as Dose Kg Time and Dose M2 Time Possible Options Bolus Dose Delayed Start KVO Loading Dose Override Alarm Loudness Override Occlusion Limit Periodic Callback Alarm Standby Toggle Vol Empty Tone Toggle FlowSentry Toggle Near Empty Tone Toggle PVD PDD Volume...

Page 17: ...s Hard Limits Values that cannot be exceeded under any conditions Hard limits show up as Max and Min on the pump If an attempt is made to exceed a hard limit a screen similar to the following figure displays BACKSPACE ENTER INPUT OUT OF RANGE GREATER THAN MAX VALUE CLEAR mL 62 DISABLE MAX 59 HIGH 50 LOW 10 MIN 1 The pump then prompts entry of a new value Soft Limits The normal range Soft Limits sh...

Page 18: ...ograms from the available libraries Types of programmable Library Categories There are two types of Library Categories in the Medfusion Model 3500 pump V6 Library Category Type What it does Standard Standard library categories contain programs with parameters that are applied when programming an infusion These libraries require stepping through and reviewing each setting This allows modifying stan...

Page 19: ...ug program category Gen Peds A D opens 3 Custom drug programs are displayed on the Drug Program screen To use a drug program use the number keys to select the desired drug program see page 31 for a full explanation of this screen For example if entry 2 is selected the preset infusion parameters for Abelcet 2 mg mL is chosen 4 You are next prompted to load a syringe then confirm accept each level o...

Page 20: ...PRESS THE NUMBER TO SELECT ANESTHESIA QUICK LIBRARY The softkey on the far left of this screen reflects the name of the Quick Library the above is an example only Press this key to re enter the Quick Library The Quick Library is exited when Main Menu is pressed The CHG Profile key responds the same here as with all others If there is only one profile on the pump and a Quick Library is enabled the ...

Page 21: ... infusion and pauses at the Begin Infusion screen 2 All the infusion settings display on the Begin Infusion screen You have the option to change the default settings for weight and dose using the softkeys displayed All settings should be confirmed to ensure they are correct Always check the infusion settings accuracy You are responsible for ensuring the safety of any infusion the pump is programme...

Page 22: ...imits imposed by the syringe size in use are not exceeded 1 When attempting to enter or change infusion parameters of a drug program the soft limits are displayed on screen as High and Low 2 If a value is entered that is outside the range an audible alarm sounds and the message Outside Range Limit Silence Alarm to Continue appears 3 Once the alarm is silenced the message Confirm Limit Override app...

Page 23: ...usion Parameter Combination or Calculated Rate Out of Range is displayed At this point the only possible corrective action is to silence the alarm look at the prompt to determine which values were to be entered press âone or more times and attempt to re enter valid values An example of an invalid infusion parameter combination is one where the pump physical maximum is lower than the software minim...

Page 24: ...able PharmGuard Supported Syringes PSS Series 2 The Medfusion Standard Syringe Series 2 models and sizes are listed in the Technical Information section of this manual on page 128 Specific technical information including syringe flow rate and minimum volume is also supplied in the literature accompanying PharmGuard Toolbox 2 and the PharmGuard Supported Syringes PSS Series 2 Refer to www smiths me...

Page 25: ... the choices is reached the More key becomes Beginning indicating Beginning can be pressed to go back to the first page of the menu If a mistake is made in programming or a menu opened accidentally press âto return to a previous screen or menu Legend In this manual menu information that appears onscreen is shown in bold and small capitals for instance Select the Profile Text associated with softke...

Page 26: ...rm Settings Pause Program Options Setup Connect to Patient Deliver Infuse Loading Dose Program Options Change Rate Dose Bolus Dose Infusion Complete Syringe Empty OR Flush KVO Confirm Syringe Continue YES Continue NO Optional Workflow Required Workflow Function Dependent Required KEY Prime Power On Power Off Volume Limit Reached OR Start ...

Page 27: ... syringe plunger tip affect delivery startup and flow continuity The bigger the syringe the greater the friction and compliance the slower the startup Use a smaller syringe when running at a lower rate The tables on page 129 show the recommended minimum delivery rates for the standard syringes included with PharmGuard Toolbox 2 by syringe size Similar information is provided in the documentation s...

Page 28: ...ns it is recommended to use appropriate internal diameter tubing as well as to minimize residual volumes between syringe and patient by reducing a Tubing internal diameter generally for rates under 5 mL hr small internal diameter tubing is recommended for rates 5 mL hr or above tubing with a larger internal diameter should be used to reduce occlusion alarms b Tubing length c Size of in line filter...

Page 29: ...example it is called HOSPITAL The pump serial number will appear at the middle right in this example it is M001234 3 Verify the display indicates successful completion of system startup self tests If the pump does not turn on with successful completion of self tests remove it from service and have it checked by a trained biomedical technician IMPORTANT Do not move the Syringe Plunger Driver or oth...

Page 30: ...using 1 Press and hold ë The Press Power Again to Shutdown screen appears Infusion has not stopped at this point If ëis not pressed again a low priority alarm sounds every two minutes until ëis pressed again or Cancel or âis pressed 2 Press and hold ëagain to turn the pump off To cancel press Continue or â Infusion stops when the pump is turned off With the pump stopped 1 Press and hold ë The pump...

Page 31: ...to the pump the pump will stop at the Select the Profile Main menu If no Custom Configuration was sent to the pump the pump will stop at the Medfusion Standard Configuration Main menu If the Custom Configuration sent to the pump consists of only one profile containing a Quick Library the pump stops at the Quick Library menu If only one profile is programmed and Quick Library not used the pump goes...

Page 32: ...odel Size If not done previously load desired syringe Verify model and size Program required infusion parameters as they appear in programming process If desired and if available program desired Options Prime infusion set and pump Start infusion PRESS THE NUMBER TO SELECT THE PROFILE MORE 1 ANESTHESIA 5 CARDIAC 2 NICU 6 HEM ONC 3 PICU 7 TICU 4 GENERAL PEDS 8 ED 1 3 Saline mL kg time 2 Abelcet 2 mg...

Page 33: ...re dependent on how the pump was configured and whether a custom Configuration was created using PharmGuard Toolbox 2 performed by whomever is responsible for customizing the pump before it was delivered to a work area The actual screens on the pump may look very different from those shown here After successfully completing its system startup self tests the pump displays one of the following menus...

Page 34: ... programs available on the following screens are dependent on which were set up in the custom Configuration The actual screen on the pump may look very different from the ones shown here 1 Press any number key to select the desired profile If a mistake is made press â to return to the Select the Profile screen 2 If the desired profile is not displayed press More to display the next page of profile...

Page 35: ...ect the actual name assigned to the Quick Library in the Configuration Quick Library is only an example Select a Drug Program 5 Select a Drug Program by pressing its number Note the number of pages in the category is displayed along with the current page in this example 2 8 If the desired drug program is not displayed and provided the category contains more drug programs press Next or if you know ...

Page 36: ...page 33 Specific information for programming the various delivery types follows the instructions for the syringe Select a Delivery Mode Medfusion Standard Configuration 1 If the pump does not have a custom Configuration the Medfusion Standard Configuration menu displays 2 Select a delivery mode by pressing its number If the desired mode is not displayed press More to display additional delivery mo...

Page 37: ... sensing or other potential hazards SELECT SYRINGE MODEL 1 B D 2 MONOJECT 3 TERUMO CONFIRM CONFIRM SYRINGE MODEL SIZE LOADING B D Note Pharmacy labels placed on the syringe may interfere with the pump s syringe sensors To avoid interference place pharmacy labels at least 1 inch from the flange so that the Syringe Barrel Clamp does not rest on a label and orient the syringe so the label faces upwar...

Page 38: ...he way outward WARNING Verify that the plunger holders securely capture the syringe plunger Make sure to capture the syringe barrel and flange Failure to properly secure the syringe could result in uncontrolled fluid flow to the patient which could result in serious injury or death 6 Load the syringe onto the pump as illustrated making sure the flange of the syringe barrel is pressed or rolled int...

Page 39: ...d fluid flow to the patient which could result in serious injury or death Always use the Prime function on the pump when loading a new syringe in order to remove any mechanical slack Failure to prime correctly can delay infusion delivery and cause Total Volume Delivered to read higher than the amount actually delivered to the patient The size should now appear in the display Note If the syringe is...

Page 40: ...art of the PharmGuard Supported Syringes PSS Series 2 and always confirm that the syringe model and size displayed on the pump matches the model and size loaded onto the pump Use of unapproved syringes may cause improper pump operation resulting in inaccurate fluid delivery or occlusion sensing or other potential hazards 10 Thread the tubing through the three Tubing Holders on the top left side of...

Page 41: ...on set is not clamped or turned off resulting in inappropriate delivery rate and may cause serious injury and or death Unload a syringe exactly the opposite way as it was loaded Just use the following steps 1 Press áto stop delivery 2 Clamp or close infusion line from the syringe to the patient 3 Unthread the tubing from the Tubing Holders on the top left side of the pump 4 Lift and swivel the syr...

Page 42: ...sion values are set the pump pauses at the Begin Infusion screen the pump may be configured with additional confirmation screens requiring confirmation of all settings twice before beginning the infusion 3 If desired program a Bolus Dose Loading Dose or Volume Limit see Options page 60 4 Prior to connecting to the patient press è to initiate the priming sequence page 58 5 Confirm the settings and ...

Page 43: ...ited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press Enter to accept the setting 3 Use the number keys to set the delivery units The actual units available on a pump depends on the custom setup If only one delivery unit is available for the concentration units selected this screen will not appear Press Enter to accept the delivery units 4 Use the number keys to...

Page 44: ...e settings and start the infusion or use the four menu softkeys shown at right to modify the settings 7 Prior to connecting to the patient press è to initiate the priming sequence page 58 8 If desired program a Bolus Dose Loading Dose or Volume Limit see Options page 60 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original orde...

Page 45: ...e the syringe model and size and load the syringe as instructed on page 33 1 Use the number keys to select the medication concentration units The actual units available on a pump depends on the custom setup Press Enter to accept the medication concentration units 2 Use the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace...

Page 46: ...Volume Limit see Options page 60 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death 9 When all delivery settings are confirmed as correct press Éto begin infusion ...

Page 47: ...lect the medication concentration units The actual units available on a pump depends on the custom setup Press Enter to accept the medication concentration units 2 Use the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press Enter to accept the setting 3 Use the number keys to set the delivery unit...

Page 48: ... Confirm the settings and start the infusion or use the three menu softkeys shown at right to modify the settings 8 Prior to connecting to the patient press èto initiate the priming sequence page 58 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed wil...

Page 49: ...inge as instructed on page 33 1 Press the number keys to set the medication concentration units The actual units available on a pump depends on the custom setup Press Enter to accept the medication concentration units 2 Press the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press Enter to accept ...

Page 50: ...equence page 58 9 Confirm the settings and start the infusion or use the four menu softkeys shown at right to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or ...

Page 51: ...ient weight setting The pump may be customized with an additional patient weight confirmation screen Re enter the patient weight then press Enter to accept the setting 2 At the Volume Kilogram screen press the number keys to set the volume per weight setting Range limits are determined by the installed syringe size patient weight and or the custom setup in the Configuration When the setting is cor...

Page 52: ...er than that prescribed will cause inappropriate delivery which can result in serious injury or death 7 When all delivery settings are confirmed as correct press Éto begin infusion OPTIONS CLEAR TOTALS PRESS TO BEGIN INFUSION CHG DOSE MAIN MENU PVD 0 mL WEIGHT 5 KG DOSE 0 3 mL kg hr RATE 1 5 mL hr Main Menu returns to the Main Menu Chg Dose allows modifying the set dosage without starting from scr...

Page 53: ...ucted on page 33 The following procedure is an example of how an infusion might be programmed The actual procedure depends on how the infusion was initially customized 1 Press the number keys to set medication concentration Concentration is limited to 4 digits Press Clear to clear an entry Press Backspace to erase a character Press Enter to accept the setting 2 Press the number keys to set the pat...

Page 54: ...ngs and start the infusion or use the menu softkeys shown at right to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death 8 When all delivery settings are c...

Page 55: ...hen press Enter to accept the setting 2 At the Volume Kilogram screen press the number keys to set the volume per weight setting Range limits here are determined by the installed syringe size patient weight and or the custom setup in the Configuration When the setting is correct press Enter to accept it 3 The time setting screen appears Press the number keys to set the time in hours and minutes th...

Page 56: ... TIME REMAINING 00 30 00 RATE 150 mL hr 6 Confirm the settings and start the infusion or use the menu softkeys shown at right to modify the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in...

Page 57: ...ss Enter 3 At the Begin Infusion screen all values are set and the pump pauses the pump may be configured with additional confirmation screens requiring confirmation of all settings again before beginning the infusion 4 Prior to connecting to the patient press è to initiate the priming sequence page 58 5 Confirm the settings and start the infusion or use the three menu softkeys to modify the setti...

Page 58: ...imited to 500 mL regardless of syringe size in use as some infusions may require multiple syringes 2 Use the number keys to set the delivery time Maximum and minimum times are calculated for the syringe in use and or the custom setup in the Configuration When ready press Enter 3 Use the number keys to set the time between starts value Maximum and minimum times are calculated for the delivery time ...

Page 59: ...fy the settings WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death 7 When all delivery settings are confirmed as correct press Éto begin infusion Main Menu returns to the Main...

Page 60: ...nstructed on page 33 1 Select Recall Last Settings from the selection menu If it isn t shown press the More key and search for it In this example press the number 4 When selected press Enter to confirm the syringe type and size if the syringe has been replaced After the syringe has been confirmed the Continue Same Infusion screen appears 2 Prior to connecting to the patient press è to initiate the...

Page 61: ...her than that prescribed will cause inappropriate delivery which can result in serious injury or death 4 When all delivery settings are confirmed as correct press Éto begin infusion Be sure all pump settings are correct before starting infusion TVD and PVD PDD Retention The pump also retains TVD and PVD PDD from the last infusion If these values are not wanted they must be manually cleared before ...

Page 62: ...ringe and infusion lines before connecting to the patient Periodically check the fluid pathway and all connections including the catheter administration set connection for leaks Leaks in the system may cause fluid loss resulting in under delivery as well as allowing an opening for contamination 1 Press è to initiate priming 2 The priming screen opens To prime a loaded syringe press and hold è whil...

Page 63: ...c pressure Lowering the system below the patient even briefly can cause significant interruptions in flow due to changes in hydrostatic pressure This could cause improper pump operation resulting in inaccurate fluid delivery that could result in serious injury or death Place the pump as close to the patient s infusion site as possible Once the system is primed press Exit then connect the tubing to...

Page 64: ... Settings was used to access that screen These options are available when the pump is at the Begin Infusion screen prior to starting an infusion Override Occlusion Limit Override Alarm Loudness Disable Enable Near Empty Alarm Tone Disable Enable Volume Empty Alarm Tone Bolus Dose Delayed Start KVO Periodic Callback Alarm Change to Dose Change to Volume Loading Dose Standby Volume Limit Disable Ena...

Page 65: ... the number keys to choose Bolus Dose Steps 3 through 5 are the bolus programming screens If Autoprompt is Enabled in PharmGuard Toolbox 2 they are part of the normal infusion programming workflow 3 If the initial infusion is programmed in one of the body weight modes e g Dose Kg Min the bolus dose may be programmed in the parameters of that dose mode e g Mg Kg or in Total Dose e g Mg Use the numb...

Page 66: ...n custom configuration in PharmGuard Toolbox 2 or if no default value is set the pump defaults to the maximum bolus rate Maximum minimum time is calculated from the maximum minimum rate for the syringe size currently in use and or the custom setup in the Configuration If using a manual delivery mode and the Bolus Time feature has been disabled the pump will default to the maximum bolus rate When t...

Page 67: ...NING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death 3 If Yes was pressed the Bolus Delivery screen appears with Delivering and the drug program name alternately appearing If No wa...

Page 68: ...y what was remaining press Yes Press No to exit the bolus screen cancel bolus delivery and return to the main infusion CONTINUE SAME BOLUS BOLUS 2 mg kg DELIVERED 1 7770 mL REMAINING 02 52 MM SS 17 7700 MG TOTAL BOLUS 80 MG RATE 130 mL hr YES NO OCCLUSION CHECK INFUSION LINE Ketamine 10 mg mL BOLUS 2 mg kg DELIVERED 1 7770 mL REMAINING 02 52 MM SS 17 7700 MG TOTAL BOLUS 80 MG RATE 130 mL hr CANCEL...

Page 69: ...tup etc 1 Press í to silence the alarm Bolus delivery continues at the reduced rate The pump continues to monitor the infusion and may reduce the rate multiple times only the first alarm produces an audible tone if the first alarm is silenced additional rate reductions will not cause an audible tone to sound however the amber yellow LED and the alarm message will display and can be cleared by pres...

Page 70: ... by entering the Options menu and reprogramming the bolus Dose and or Time or by pressing the CHG Bolus key at the Begin Bolus Delivery screen and reprogramming the bolus Dose and or Time the last bolus rate setting from just prior to the bolus cancellation will continue to be applied Reprogram the bolus if desired OPTIONS CLEAR TOTALS RESTRICTED FLOW BOLUS CANCELLED CHG DOSE MAIN MENU CONC 10 mg ...

Page 71: ...e settings and total loading dose are correct If incorrect press No and the pump returns to the Enter Loading Dose screen If correct press Yes Note that the bolus dose may be entered in dose kg or Total Dose for weight based modes depending on pump customization The confirmation screen highlights in reverse the value that the pump calculates A loading dose may be programmed at the Begin Infusion s...

Page 72: ...reen If this is a new infusion prior to connecting to the patient press è to initiate the priming sequence page 58 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death OPTIONS C...

Page 73: ...sed the Loading Dose Delivery screen appears and the infusion begins with Delivering and the drug program name alternately appearing The pump delivers the loading dose then automatically switches to the normal delivery rate and screen The loading dose volume delivered is automatically added to the Total Volume Delivered TVD as well as the Programmed Volume Delivered PVD or Programmed Dose Delivere...

Page 74: ...bleshoot the alarm condition 2 Press É 3 To continue the loading dose from where it left off delivering only what was remaining press Yes Press No to cancel the remainder of the loading dose and begin the main infusion CONTINUE SAME LOAD BOLUS 5 mg kg DELIVERED 4 0040 mL REMAINING 05 07 MM SS 80 0800 MG TOTAL BOLUS 200 MG RATE 70 2 mL hr YES NO OCCLUSION CHECK INFUSION LINE Aminocaproic Acid Drip ...

Page 75: ...ence the alarm Loading Dose delivery continues at the reduced rate The pump continues to monitor the infusion and may reduce the rate multiple times only the first alarm produces an audible tone if the first alarm is silenced additional rate reductions will not cause an audible tone to sound however the amber yellow LED and the alarm message will display and can be cleared by pressing í If the rat...

Page 76: ...es To alter the rate press No press á to stop the normal infusion then enter the Options menu to reprogram the Loading Dose this method restarts the infusion from the beginning so you may need to manually subtract any loading dose delivered prior to the cancellation from the amount programmed If Recall Last Settings is used when É is pressed the Begin Loading Dose Delivery screen appears with the ...

Page 77: ...olume limit is found in the Options menu which can be accessed from the Begin Infusion screen 1 With the pump stopped press Options 2 Use the number key to select Volume Limit 3 Use the number keys to set the volume limit then press Enter Note Volume is limited to 500 mL regardless of syringe size in use as some infusions may require multiple syringes OPTIONS CLEAR TOTALS PRESS KEY TO BEGIN INFUSI...

Page 78: ...e 58 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death 6 Press É to begin infusion The infusion will automatically stop when it reaches the preset volume limit OPTIONS CLEAR ...

Page 79: ...also be programmed as part of the drug program using PharmGuard Toolbox 2 Note The setting of KVO rates should be based on a physician s order or the facility s policies and procedures for rate determination Enable Disable KVO Rate KVO rate can be enabled or disabled through custom pump configuration using PharmGuard Toolbox 2 Programming KVO rate 1 With the pump stopped press Options 2 Use the nu...

Page 80: ...reaches the programmed volume limit rather than stopping delivery the pump automatically begins delivery at the KVO rate or continues at the current rate if less than the KVO rate and triggers an alarm 8 KVO delivery automatically stops when the pump calculates the syringe is empty or if á is pressed When the pump automatically stops keep vein open infusion it sounds a syringe empty alarm Stop KVO...

Page 81: ...VD 0 000 mL BOLUS 2 5 mL V LIMIT 50 mL KVO RATE 0 6 mL hr RATE 3 5 mL hr Enable Disable Standby The Standby option can be enabled disabled through custom configuration using PharmGuard Toolbox 2 Programming standby 1 When the pump is paused at the Begin Infusion screen press Options 2 Use the number keys to choose Standby 3 Set the Standby time in hours minutes The maximum Standby setting is 24 ho...

Page 82: ...s a reminder to begin the infusion WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in serious injury or death ...

Page 83: ...r by setting Delayed Start to zero 5 If this is a new infusion prior to connecting to the patient press è to initiate the priming sequence page 58 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause inappropriate delivery which can result in s...

Page 84: ...rrect press Enter to accept the setting and go to the Begin Infusion screen 4 If this is a new infusion prior to connecting to the patient press è to initiate the priming sequence page 58 WARNING Confirm All Settings Before starting any delivery always confirm the accuracy of all infusion values to the original order Programming the pump at a delivery rate other than that prescribed will cause ina...

Page 85: ...arm sounds a Medium priority alarm at the time interval programmed The Periodic Callback Alarm can be discontinued at any time by changing the Periodic Callback Alarm time to zero OPTIONS CLEAR TOTALS PERIODIC CALLBACK SILENCE ALARM TO CONTINUE CHG RATE MAIN MENU PVD 14 251 mL BOLUS 2 5 mL V LIMIT 50 mL KVO RATE 0 6 mL hr RATE 3 5 mL hr N ...

Page 86: ...PTIONS CLEAR TOTALS PRESS KEY TO BEGIN INFUSION CHG DOSE MAIN MENU CONC 1 5 mg mL PDD 0 mcg WEIGHT 5 kg DOSE 20 mg TIME 02 00 00 TIME REMAINING 02 00 00 RATE 6 67 mL hr PVD Program Volume Delivered indicates Volume is currently selected PDD Program Dose Delivered indicates Dose is currently selected Change to Dose Change to Volume When delivering a drug program or infusion containing a concentrati...

Page 87: ...ose Override Occl Limit You may have to press More to see this option 3 The highlight shows the pump s current default setting Use the number keys to choose the desired occlusion setting then press Enter see the table on page 93 for more information about occlusion settings PRESS THE NUMBER TO SELECT THE PROGRAM OPTION MORE 1 STANDBY 5 DELAYED START 2 VOLUME LIMIT 6 LOADING DOSE 3 OVERRIDE OCCL LI...

Page 88: ...y have to press More to see this option 3 The highlight shows the pump s current default setting Use the number keys to choose the desired alarm loudness setting then press Enter To determine which setting meets the needs for the infusion use the number key to choose a loudness level then press Test PRESS THE NUMBER TO SELECT THE PROGRAM OPTION MORE 1 STANDBY 5 DELAYED START 2 VOLUME LIMIT 6 LOADI...

Page 89: ...NE 3 DISABLE VOL EMPTY TONE Disable enable near empty alarm tone The pump may be configured to have an alarm sound to indicate when a syringe is nearly empty Alarm triggering is calculated based on the syringe size used and the volume initially calculated see page 102 for an explanation of this alarm Use this option to enable or disable this feature for this infusion 1 With the pump running or sto...

Page 90: ... this infusion 1 With the pump running or stopped press Options 2 Use the number keys to choose Disable Vol Empty Tone or Enable Vol Empty Tone only one of the above will be displayed depending on whether the Empty Alarm feature is currently active or not You may have to press More to see this option PRESS THE NUMBER TO SELECT THE PROGRAM OPTION BEGINNING 1 DISABLE FLOWSENTRY 2 DISABLE NEAR EMPTY ...

Page 91: ...an infusion setup and progressing all the way through the setup levels the pump pauses at the Begin Infusion screen 1 Program an infusion 2 Verify all values are correct 3 Press É 4 The pump begins the infusion OPTIONS CLEAR TOTALS PRESS KEY TO BEGIN INFUSION CONC 250 mcg mL PVD 0 00 mL WEIGHT 5 KG DOSE 1 MCG KG MIN RATE 1 2 mL hr CHG DOSE MAIN MENU WARNING Confirm All Settings Before starting any...

Page 92: ...livery mode 1 If there is an active alarm first silence it Then press á 2 The infusing indicators turn off and the pump pauses Restart the infusion or change settings and restart Or turn the pump off OPTIONS CLEAR TOTALS TIME UNTIL START OF INFUSION 00 59 50 CHG RATE MAIN MENU PVD 0 000 mL BOLUS 2 5 mL V LIMIT 50 mL KVO RATE 0 6 mL hr RATE 3 5 mL hr NO CONTINUE SAME INFUSION YES PVD 0 000 mL BOLUS...

Page 93: ...press No the pump will return to the Begin Infusion screen To begin the flush setup press Yes 3 Remove the syringe at the end of the infusion when prompted and replace with the flush syringe Use the number key to select the syringe model 4 Load the syringe onto the pump verify the correct size is shown then press Enter 5 Use the number keys to enter the desired amount of flushing infusate then pre...

Page 94: ...24 mL hr YES PVD 4 151 mL NO FLUSH VOLUME 1 5 mL FLUSHED 0 151 mL TIME 00 03 45 REMAINING 00 03 21 RATE 24 mL hr CANCEL OCCLUSION CHECK INFUSION LINE Continuing an interrupted flush infusion Should a High Priority alarm occur during flush infusion delivery or if á is pressed to interrupt a flush infusion delivery will stop Either continue the flush from where it left off restart a new flush or can...

Page 95: ...ress Enter 6 The pump requires confirmation that the flush be delivered at the same rate as the previous infusion To deliver at the same rate press Yes the pump will then automatically calculate the delivery time To deliver at a different rate press No 7 If No was pressed the Flush Time screen appears Use the number keys to select the delivery time then press Enter OPTIONS CLEAR TVD INFUSION COMPL...

Page 96: ...l If flush delivery is cancelled or should an alarm interrupt flush delivery it can be restarted by pressing Flush or if finished press Main Menu or Quick Library to exit 10 When the flush infusion has been delivered delivery stops and the pump alarms Press í to silence the alarm then press Main Menu PRESS CANCEL TO STOP FLUSH DELIVERY FLUSH VOLUME 1 5 mL FLUSHED 0 02 mL TIME 00 04 30 REMAINING 00...

Page 97: ...table are only approximations This is because syringe friction affects the actual pressure level Occlusion limit default is set up using PharmGuard Toolbox 2 which was completed by the person responsible for custom Configuration before the pumps were delivered to a work area Override the default Occlusion limit for a particular infusion from the Options menu if that option is enabled The pump take...

Page 98: ... the following table Syringe Size FlowSentry maximum infusion rate 60 mL 20 mL hr 50 mL 20 mL hr 35 mL 12 mL hr 30 mL 10 mL hr 20 mL 6 6 mL hr 12 mL 3 3 mL hr 10 mL 3 3 mL hr 6 mL 1 65 mL hr 5 mL 1 65 mL hr 3 mL 1 mL hr If FlowSentry pressure monitoring is disabled the bar graph is still shown however none of the icons or will appear on screen Post occlusion bolus reduction With large syringes flu...

Page 99: ...E 3 6 mL hr CHG DOSE OPTIONS CLEAR TVD DOBUTAMINE 0 5 mg mL PICU Changing rate during delivery The infusion rate can be changed during any delivery session except when using Intermittent delivery modes 1 From any delivery screen press CHG Rate or CHG Dose 2 The Enter Rate screen appears Infusion does not stop The current setting continues to be delivered until the new rate is entered Note the curr...

Page 100: ... entry does not change until Enter is pressed Exit without changing the rate by pressing â 3 When the desired new rate is displayed press Enter to accept the new setting 4 The pump is paused at the Begin Infusion screen When ready to restart the infusion press É OPTIONS CLEAR TOTALS PRESS TO BEGIN INFUSION PVD 0 429 mL BOLUS 2 5 mL V LIMIT 60 mL KVO RATE 0 6 mL hr RATE 3 5 mL hr CHG RATE MAIN MENU...

Page 101: ...on only PVD PDD is automatically cleared when the infusion ends and the pump is returned to the Main menu and can be cleared by pressing Clear Totals This display totals the boluses loading dose and normal delivery volumes Priming volume Which should never be delivered to the patient does not accumulate on this display Program volume or dose delivered Appears on screen while the pump is paused and...

Page 102: ... DOSE 2 5 MCG KG MIN RATE 3 5 mL hr CHG DOSE MAIN MENU NO CLEAR TOTAL VOLUME DELIVERED YES With the pump delivering 1 From any run screen press Clear TVD 2 Confirmation is required to clear the Total Volume delivered Press Yes to clear total volume delivered only Or press No to exit without clearing The program volume or dose delivered is cleared automatically whenever the pump s delivery mode is ...

Page 103: ...ks the front panel 1 Press Lock to lock the front panel controls The Lock indicator on the front panel lights 2 If any front panel keys other than Unlock are pressed a Pump is Locked message appears on screen 3 Press the Unlock softkey to unlock the front panel If an Unlock Passcode has been set a prompt to supply the passcode before the front panel will unlock is displayed BACKSPACE ENTER ENTER U...

Page 104: ...lt is displayed on the pump due to the fact that the only method for ending the alarm is to turn the pump off High priority A high priority alarm is initiated by any condition that halts an ongoing infusion High priority alarms are signaled with a flashing red indicator a viewing screen backlight that oscillates between bright and dim and a repeating audible signal Press í to return the viewing sc...

Page 105: ... to interaction with the pump Note The audio part of the limit priority alarm is tied to Key Click loudness which is set in PharmGuard Toolbox 2 If key click loudness is set to Off there will be no audible tone accompanying limit priority alarms visual advisory messages will still appear in the display The volume will otherwise sound at the loudness level selected for key clicks Level 2 quietest L...

Page 106: ...some other alarm LOCK N CONC 1 2 mg mL PVD 13 81 mL WEIGHT 50 KG BOLUS DOSE 20 MCG KG MIN RATE 50 mL hr CHG DOSE OPTIONS CLEAR TVD SYRINGE NEAR EMPTY Press ANY key to silence the alarm for another 30 seconds Go to the Begin Infusion screen There the alarm silence interval is one to two minutes depending on the configuration Use the Standby option to prevent the User Callback alarm while paused at ...

Page 107: ...sscode will appear If this screen appears immediately remove pump from service for inspection repair by a trained biomedical service technician 1 Press í to clear the alarm tone message 2 Unload the syringe 3 If the infusion is complete either turn the pump off or prepare for another infusion If the infusion is not complete prepare and load another syringe and return to the Select the Profile scre...

Page 108: ...ed the clutch is not properly engaged the syringe in use is overfilled causing the syringe plunger to reposition itself once the plunger driver begins moving forward or there is a problem with the pump hardware Press í and check the plunger lever and ensure the lever moves freely and is capturing the syringe plunger Always use the Prime feature when loading a new syringe If the alarm persists remo...

Page 109: ...n where no alarms sound or turn off the pump Input Out of Range Greater Than Max Value Limit The value entered is greater than the maximum allowed for the item Please try a lower value Input Out of Range Less Than Min Value Limit The value entered is less than the minimum allowed for the item Please try a higher value Invalid Entry Limit There is a problem with the drug program selected and the pu...

Page 110: ...t clear the occlusion alarm there may be a problem with the pump that requires repair by a trained biomedical technician Outside Range Limit Silence Alarm to Continue Medium The entered rate is outside of the Drug Program soft limits Press í to continue You may then choose to override the range limit or change the value entered Periodic Callback Silence Alarm to Continue Medium Press í User progra...

Page 111: ...volume limit then set a KVO rate Syringe Does Not Match Entry Limit The drug program indicates a specific syringe and the syringe in use is different Verify the correct drug program and syringe are being used Syringe Empty High Press í The syringe is now empty Either Prepare and load another syringe Return to the Select the Profile screen where no alarms sound Turn the pump off Syringe Empty Stop ...

Page 112: ...ut Medium The internal battery is not working The pump may be used on AC power on a conditional basis As soon as possible remove pump from service for repair by a trained biomedical technician System Advisory Battery Not Charging Low The internal battery is not charging The pump may be used on AC power on a conditional basis As soon as possible remove pump from service for repair by a trained biom...

Page 113: ...ufficient charge in the super capacitor This problem can occur when a new Main PCB is installed or when a pump battery is totally dead Plug the pump into AC power for at least two minutes then turn the pump off then back on If the alarm persists when the pump is turned back on immediately remove pump from service for repair by a trained biomedical technician System Failure xx xx xx System Fault Wh...

Page 114: ...System Advisory xx Data Corrupted Low Infusion will continue using backup copy of xx data where xx represents variable text indicating the specific data that is corrupted As soon as possible remove pump from service for testing and checkout by a trained biomedical service technician ...

Page 115: ...AC is disconnected while the pump is turned on the pump automatically begins drawing power from the internal battery Attaching the power cord 1 Connect the AC power cord to the connector port on the pump 2 Drop cord clip over the top of the connector to prevent accidentally unplugging pump WARNING Shock Hazard The only means of removing AC power is to disconnect the AC power cord While the AC powe...

Page 116: ...ge the battery When the Battery Low message displays plug the pump into a power outlet for recharging The battery indicator remains on continuously when charging If the pump IS plugged into an outlet and fails to charge the battery or the pump has been storedforlongerthantwomonths without charging contact Service Repair for information on how to test and or service the battery When you can run on ...

Page 117: ...lder pumps may use poleclamp catalog number 3000RPC which is no longer available The 100 degree anchor bracket attaches the pump to a pole at a slight forward angle making the display and keypad easier to view when pumps are attached to a pole in certain circumstances for instance high on a pole Align the poleclamp for mounting on any vertical or horizontal pole bed rail or similar solid structure...

Page 118: ...p until the retainer lock button audibly clicks into place 2 Pull the round lock button at the top of the clamp assembly up and rotate the clamp to the desired angle The poleclamp can be rotated so the pump is horizontal vertical or at a 45 angle to either side of vertical 3 To remove the poleclamp from the pump pull the release lever toward the pump and slide the poleclamp off the pump ...

Page 119: ... of electrostatic charge and how and why to discharge one s body to earth or to bond oneself by means of a wrist strap to earth prior to making a connection Use of cables WARNINGS Use of cables other than as listed below may result in increased EMC emissions or decreased immunity of the pump Use of the listed cables with equipment other than those specified may result in increased EMC emissions or...

Page 120: ...y collateral standard usability EN 60601 2 24 1998 Medical Electrical Equipment Part 2 Particular requirements for safety of infusion pumps and controllers EN 475 1995 Medical Devices Electrically generated alarm signals UL 60601 1 2006 Medical Electrical Equipment Part 1 General Requirements for Safety US Deviations to IEC 60601 1 CAN CSA C22 2 No 601 1 M90 1990 Medical Electrical Equipment Part ...

Page 121: ...cal electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirements and tests Parent Standard Applies to section IEC EN 61000 4 2 Electrostatic Discharge Immunity test CISPR 11 2009 A1 2010 Industrial scientific and medical ISM radio frequency equipment electromagnetic disturbance characteristics limits and methods of measurement Amendme...

Page 122: ...and are not likely to cause any interference in nearby electronic equipment RF emissions RF emissions CISPR 11 Class A The Medfusion Syringe Pump Model 3500 V6 is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not Applicable Vol...

Page 123: ... 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Uт 95 dip in Uт for 0 5 cycle 40 Uт 60 dip in Uт for 5 cycles 70 Uт 30 dip in Uт for 25 cycles 5 Uт 95 dip in Uт for 5 sec 5 Uт 95 dip ...

Page 124: ... î 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 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 to 40 70 ...

Page 125: ... 1 2 1 2 2 3 10 3 7 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the sepa...

Page 126: ...nd alerts table starting on page 104 Time to occlusion alarm Very High 50 psi testing performed using B D 1 mL syringe High and Very Low testing performed using B D 20 mL syringe syringes meet the requirements of the ISO 7886 2 standard Flow Rate mL hr Syringe Mfg Size Occlusion Setting Max time to occlusion Start up hr min sec 1 minimum B D 1 mL Very High 50 psi 00 10 00 B D 20 mL High 16 psi 00 ...

Page 127: ...nges specified to meet the ISO 7886 2 standard syringe accuracy may be expected to meet the 2 requirement WARNING Ensure that the 2 accuracy specification is taken into account when programming the pump and or filling a syringe If accuracy is of prime concern use only syringes that meet the 2 requirement of the ISO 7886 2 Standard Failure to do so may result in medication in the syringe becoming d...

Page 128: ... Max mL hr whichever is lower see page 133 Maximum Bolus Rate for further explanation Infusion rate range 0 01 mL hr to 1130 mL hr in increments of 0 01 0 1 mL hr depending on syringe size rate Refer to syringe tables on page 129 for Minimum Recommended Rate Bolus volume range Volume is limited to the maximum fill volume of the current syringe size and minimum volume is 1 600th the syringe size No...

Page 129: ...PharmGuard Toolbox 2 Version 3 or higher Medfusion Standard Configuration catalog number 67 2460 current version Medfusion Standard Syringes catalog number 67 2459 current version Lockbox with Keys 22 1000 51 Infrared RS232 Converter Box 3000RS232 not RoHS Restriction of Hazardous Substances compliant and being phased out contact Smiths Medical for availability Infrared USB Connector 22 1060 51 Ro...

Page 130: ... a continuous two tone audible alarm and stop all drug delivery Data Used in Calculations Critical data failure Calculations on data used in some way to control the Safety Features Safety Features and Fault Detection Hardware Safety Features A watchdog circuit made up of a separate microcontroller with a dedicated timer alarm speaker and power supply monitors the main microprocessor and associated...

Page 131: ...ware will display a system fault screen turn on a continuous two tone audible alarm and stop all drug delivery Timer Data Registers Time base BGND time of day clock POST time of day clock timeout The data in the Real Time Clock is checked at regular intervals If the data is not reasonable the software will turn on a continuous two tone audible alarm and stop all drug delivery ...

Page 132: ...x B Braun 5 10 20 and 50 mL Luer Lock BB Perfusor B Braun 20 and 50 mL Luer Lock The critical volume maximum which could be infused in the event of a single point failure is 1 100th of the syringe size by volume PharmGuard Supported Syringes PSS Series 2 In order to offer customers a wide range of available syringe manufacturers and sizes Smiths Medical has available PharmGuard Supported Syringes ...

Page 133: ... Size Min Rate Max Rate Minimum volume to infuse Minimum recommended rate mL mL hr mL hr mL mL hr FlowSentry disabled FlowSentry enabled B D Becton Dickinson Tuberculin SlipTip 1 0 01 29 0 0016 0 033 N A Luer Lok 1 0 01 29 0 0016 0 033 N A 3 0 01 98 0 005 0 1 0 03 5 0 03 191 0 0083 0 17 0 05 10 0 05 277 0 0166 0 33 0 1 20 0 1 483 0 0333 0 67 0 2 30 0 1 622 0 05 1 0 3 60 0 1 944 0 1 2 0 6 Monoject ...

Page 134: ... set with the smallest diameter tubing available that does not result in excessive back pressure at the desired flow rate Consider priming loading bolus and flush rates when selecting an infusion set Per the US Food and Drug Administration the 28 syringes available as the general configuration for the Medfusion Model 3500 pump V6 were tested for stability with Morphine Sulfate Dopamine and Floxuri...

Page 135: ...oft User Defined Intermittent Volume Time Volume Hard and Soft User Defined Time Hard and Soft User Defined Time Between Starts Hard and Soft User Defined Dose Time Concentration Hard and Soft User Defined Dose Hard and Soft User Defined Time Hard and Soft User Defines Dose Kg Time Concentration Hard and Soft User Defined Body Weight Configurable User Defined Dose Hard and Soft User Defined Time H...

Page 136: ...d User Defined Configuration options A pump s Alarm Setup Auto Prompts Limits Occlusion Detection settings and many miscellaneous properties can be customized within the PharmGuard Toolbox 2 software These properties define the limits imposed by a pump and the general operational behavior of a pump The following is a list of user configurable settings that are available Each of these settings is c...

Page 137: ... Select from two values Enabled or disabled Flush Time Defines if a user will be prompted to enter a flush time when programming a flush infusion Select from two values Enabled or disabled Maximum Flush Volume Defines the maximum flush volume in mL allowed by the pump during a flush infusion Maximum flush volume is a numeric value from the minimum volume for the syringe to the fill volume of the s...

Page 138: ...access the Profile Profile Passcodes can be any numeric code in the range of 1000 to 9999 If set to none no passcode is required to access the Profile Program Display Defines if the pump will display the delivered Program Dose or the delivered Program Volume Select from two values Volume or Dose Quick Library Defines the Library Category that will be used as the Quick Library Syringe 1mL Support D...

Page 139: ... to enter a Keep Vein Open KVO rate This value cannot be set or changed while an infusion is running Loading Dose Defines if a pump user will be able to enter a Loading Dose during infusion setup Override Alarm Loudness Defines if a pump user will be able to change the loudness level of a pump s alarm during an infusion Override Occlusion Limit Defines if a pump user will be able to override the p...

Page 140: ...w typical performance of the pump system in two ways 1 A flow versus time graph during the stabilization period start up curves 2 The accuracy of fluid delivery of particular time periods or observation windows is measured trumpet curves The start up curve displays flow rate continuously from the start of the infusion The curve visually represents flow rate uniformity Trumpet curves are derived fr...

Page 141: ...immediately following startup Flow rate immediately following startup 0 2 5 5 7 5 10 0 10 20 30 40 50 60 70 80 90 100 110 120 time Min flow ml h Trumpet curves over T2 period Minimum rate 1 mL hr 2 5 11 19 31 10 0 7 5 5 0 2 5 0 0 2 5 5 0 7 5 10 0 T min 1 47 Trumpet Curve Epmax Epmin Error of Flow Intermediate rate 5 mL hr 2 5 11 19 31 10 0 7 5 5 0 2 5 0 0 2 5 5 0 7 5 10 0 T min Trumpet Curve Epmax...

Page 142: ...c magnetic field MR Image Distortion No MR imaging interference was observed when tested with the Medfusion Model 3500 pump V6 at 8 feet from the isocenter of a 1 5T 64 MHz Siemens Magnetom Symphony MR system Siemens Software VA35A SP2 under the following conditions battery only no AC cord back of the pump facing the MRI isocenter full body receiver coil most sensitive using standard spin echo and...

Page 143: ...ater proof NEVER spray cleaning or other fluids directly into openings on the bottom of the pump Not Waterproof The pump is not certified water proof Never immerse the pump in water or other fluids Avoid wiping or spraying the barrel clamp rod and syringe plunger driver rod see page 8 as they are coated with a light layer of grease refer pump to service personnel if these parts require cleaning Av...

Page 144: ...ld always disconnect the AC power cord before servicing the pump Dropped or Damaged Pumps Never use a dropped or obviously damaged pump Withdraw it from service until a trained biomedical technician can test it Periodic maintenance Trained biomedical service personnel should test the pump at least yearly to ensure continued safe operation This testing should be performed at least yearly or wheneve...

Page 145: ...61 Outside the U S 1 614 210 7300 2 When calling any of these numbers please have the following ready Model name number of pump Pump serial number Purchase date if pump is within warranty period Description of problem in as much detail as possible 3 The service representative may talk you through to a solution if possible Component parts such as the internal battery can be ordered from Smiths Medi...

Page 146: ...turning items to Smiths Medical This is required before shipment according to United States Occupational Safety Health Administration OSHA regulations 3 Package the infusion pump carefully for shipment 4 Smiths Medical will not accept returns for service without the assigned RA number clearly printed on the shipping package Mark the RA number clearly on the outside of the shipping package used to ...

Page 147: ...uipment 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 RE...

Page 148: ...affected which includes use of service replacement parts not supplied by Smiths Medical or its authorized agents including the battery pack 3 misused or 4 damaged by negligence or accident Misuse includes but is not limited to use not in compliance with the Operator s Manual or use with non approved accessories Removal or damage to the Pump s serial number will invalidate this warranty D Limitatio...

Page 149: ... 43 E ECMO Extracorporeal Membrane Oxygenation 7 Electromagnetic Compliance EMC 115 Explosion risk warning 1 F FlowSentry rapid occlusion detection 6 93 Flush feature 89 133 G General Use Diagram 22 H Hard limits 13 18 131 Hardware related Software Safety Features 126 hyperbaric chamber use warning 1 I Intermittent volume time 54 K Keep Vein Open KVO rate 75 Keypad 9 buttons or keys 10 Indicators ...

Page 150: ...107 Recall last settings 56 Restarting a bolus dose 64 Restarting a loading dose 70 S Self tests 25 Service 140 Soft limits 13 18 131 Software Safety Features 126 Data Handling Software Safety Features 126 Hardware related Software Safety Features 126 Standard libraries 14 Using 15 Standby 77 88 Starting an infusion 87 from pause 87 from standby delayed start 88 Stopping an infusion 88 Stopping de...

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Page 152: ...www smiths medical com Medfusion PharmGuard FlowSentry Medfusion design mark and Smiths Medical design mark are trademarks of Smiths Medical The symbol indicates the trademark is registered in the U S Patent and Trademark Office and certain other countries All other names and marks mentioned are the trade names trademarks or service marks of their respective owners 2014 Smiths Medical All rights r...

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