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System Operating Manual - MEQL - Med-E

1. 1 14 battery operation 1 15 sets and accessories 1 16 electrical artifacts 1 16 interconnecting of equipment 1 18 GUIDANCE ON COMPATIBILITY 1 18 FCC INFORMATION 1 19 US FCC 1 19 FCC interference 5 1 19 radio frequency exposure statement 1 20 Section 2 Principles of Operation 2 1 FEATURES zu ERR auno attack tna E dates 2 3 drug recognition ee 2 3 modes of delivery 2 3 programming hake EE A eu ste 2 3 Datteryz ca tb panne a Saba Retna boue aote ires 2 3 430 04685 004 ii For Systems With Hospira MedNet Software biomedical wo teen eg ue a ac RO RR Rep 2 4 EST 2 4 other features 2 4 ADMINISTRATION EQUIPMENT 2 5 Section 3 Equipment Description 3 1 FRONT PANEL s ries C tpe ee pate tae eC AR 3 2 VIAL CRADLE ASSEMBLE 3 3 REAR PANEL Deseo EA 3 4 OPERATING BUTTONS amp 3 5 Section 4 Basic Operation 4 1 OPERATING THE INFUS
2. 5 9 PCA CONTINUOUS MODE 5 13 PROTOCOLS 4d suu whee d see 5 18 DOSE LIMIT 4 23 px rer meagan dad a ated eq ien 5 21 programming the 4 or 1 hour dose limit 5 22 programming a limit 5 22 programming no dose limit 5 23 clearing or changing a dose limit 5 25 CLEARING THE HISTORY AND OR RX SETTINGS 5 27 USING REVIEW CONFIRMATION SCREENS 5 28 CHANGING SETTINGS DURING SETUP 5 29 stopping infusion 5 29 turning the infuser off 5 29 MAKING CHANGES AFTER SETUP 5 30 reviewing the current settings 5 30 changing settings 5 30 changing the CCA 5 32 CLEARING SHIFT TOTALS 5 33 CHANGING A VIAL 5 34 ADDING A SUPPLEMENTAL LOADING DOSE 5 36 CHECKING HISTORY amp SETTINGS 5 37 HISTORY AND EVENT LOG 5 38 Section 6 Advanced Programming with Hospira MedNet Software 6 1 GUIDED START UP USING HOSPIRA MEDNET TM SOFTWARE 6 1 SELEGT CGAY oe dob wis ached abe ns 6 7 UPDATING THE DRUG LIBRARY 6 8
3. s Min Mean PCA 5ml hr 0 mmHg Delivery Head 0 9 Saline 15 0 Maxima Minima of 3 Pumps 10 0 x 5 0 s 2 gt 0 0 e o o o 5 0 a 10 0 15 0 0 10 15 20 25 30 Observation Interval min e Max s Min Mean 430 04685 004 LifeCare PCA Infusion System PCA 5 100 mmHg Delivery Head 0 9 Saline 15 0 Maxima Minima of 3 Pumps 10 0 9 5 0 5 5 00 t 5 0 Li 8 10 0 4 a 15 0 20 0 T4 a 25 0 5 10 15 20 25 30 Observation Interval min s Min 4 Mean 5ml hr 100 mmHg Delivery Head 0 9 Saline Maxima Minima of 3 Pumps 20 0 15 0 10 0 x 5 0 wi 9 0 0 P a a 4 a a 5 0 10 0 a 15 0 5 10 15 20 25 30 Observation Interval e Min 4 Mean 20 ml hr 0 mmHg Delivery Head 0 9 Saline 15 0 Maxima Minima of 3 Pumps 0 10 0 5 0 E t 0 0 i i E a 5 0 a 10 0 15 0 5 10 15 20 25 30 Observation Interval min e s Min Mean 430 04685 004 NOTES Specifications 430 04685 004 LifeCare PCA Infusion System Section 10 Prescription Delivery Limits Prescription delivery limits f
4. display the option to clear CHANGE the total dose delivered CLEAR SHIFT DA NOTE CHANGE gt will only CHANGE display if Hospira MedNet Software was enabled Select gt to clear shift MORPHINE totals and return to the previous screen Or select No gt to return to previous screen NOTE Selecting Yes clears the PCA Summary data and total dose delivered but does not clear dose limit data Close and lock the door Place key in a secure location Press 4 to begin therapy Approximately 10 seconds after door is locked and 2 is pressed the DOOR LOCKED MESSAGE disappears 430 04685 004 5 33 Select Mode Changing a Vial 1 The alarm message EMPTY SYRINGE appears along with the statement REPLACE SYRINGE 2 Close the slide clamp on the PCA administration set NOTE The screen displays that the infuser is PAUSED 3 Remove the old vial by firmly grasping the glass vial on both sides and pulling straight out Load the new vial as shown MORPHINE PF before See Loading a Vial on WARNING page 4 5 DRUG and or CONCENTRATION If a change is detected from the previous vial or infused drug the WARNING DRUG AND OR CONCENTRATION CHANGE DETECTED SCREEN appears 5 Verify vial and Rx If vial and Rx is as intended select ConTINUE gt Available selections depend on the previous vial drug and concentration in the infuser verses the new vial 6 Select Yes when Purge is dis
5. e device is suitable for use in all establishments including domestic establishments If extended operation during power mains interruption is needed use battery power e Always manage the electromagnetic environment e The guidance included in this manual provides information needed to e Determine the device s suitability for use in the intended environment e Manage the electromagnetic environment to permit the device to perform as intended without disturbing other equipment 1 18 430 04685 004 LifeCare Infusion System Separate the device from all other electronic equipment If the device must be used near other electrical equipment monitor the equipment to ensure there is no electromagnetic interference Devices should not be used adjacent to or stacked with other equip ment If the device must be used adjacent to or stacked with other equipment monitor the devices to verify normal operation e USE ONLY components specifically labeled for use with the PCA Infusion System to help ensure the device operates as intended e f you suspect external RF sources or other equipment are influ encing device operation contact the Biomedical Engineering Department for additional guidelines concerning electromag netic immunity e Contact the Biomedical Engineering Department for additional information in the technical service manual concerning operat ing devices near RF sources FCC Information FCC
6. the programmed values may be changed by either entering the new value by using the numeric keypad and pressing ENTER or selecting the new setting using the appropriate SOFTKEY gt Once the appropriate parameters have been changed the REVIEW CONFIRMATION SCREEN will be presented again The clinician should review each setting to ensure agreement with the physician s order Once CONFIRM gt has been selected the clinician should close and lock the door Place the key in a secure location Upon locking the door the PCA Infuser is available if the mode is set on ONLY If mode is set for CONTINUOUS CONTINUOUS therapy will begin after pressing START PAUSE 430 04685 004 LifeCare PCA Infusion System Changing Settings During Setup During setup select PREVIOUS gt to return to the preceding display and enter the desired setting Each time PREVIOUS gt is selected the message display reverts to the previous setting until the first setting is displayed STOPPING INFUSION 1 Close slide clamp on the PCA Infuser administration set WARNING Always close slide clamp on the PCA administration set before removing or replacing the syringe and before discontinuing infusion 2 Unlock door Or press for Continuous Continuous NOTE If paused longer than two minutes without pressing an appropriate key the infuser alarm will sound TURNING THE INFUSER OFF 1 Close slide clam
7. Clause 50 102 Refer to this standard for detailed information Refer to the Example on page 9 6 to read a Trumpet Curve Graph The graphs following the Example plot flow rates at 30 second intervals for the first 2 hours and for the 96th hour of delivery The graph plots mean delivery rate error Average of 3 infusers for the 2nd hour and the 96th hour as a straight line The graph presents maximum and minimum average delivery rate error for this interval plotted by averaging delivery errors over intervals of 2 5 11 19 and 31 minutes Trumpet Curve EXAMPLE From the Trumpet Curve Graph sample that follows find the 5 minute interval A at the horizontal axis and read the corresponding points B and C on the vertical axis The values are approximately 2 8 and 0 5 This means that at the rate of 25 mL hr the average maximum flow rate fluctuation for any 5 minute time interval during the 2nd hour of operation was within the limits of 2 8 and 0 5 from the nominal rate The average delivery rate error over the entire 2nd hour was 1 6 D 9 6 430 04685 004 LifeCare PCA Infusion System For other time intervals look at other points at the horizontal axis and determine corresponding limits as above 25 ML HR 0 mm Hg DELIVERY HEAD START UP A 15 0 o Max Positive Error over 5 E 100 Minute Interval 2 8 f 5 096 0 0 7 2 Max Negative Error over 5 g 9 07
8. If the infuser is set in the PCA or PCA CONTINUOUS Mode the patient may request a bolus of analgesic during therapy by pressing the patient pendant button this causes the infuser to release the specified bolus of analgesic into the IV line After a Loading or Supplemental Loading Dose delivery the patient cannot receive any additional patient requested boluses until the lockout interval has elapsed assuming the dose limit has not been exceeded see Dose Limit on page 5 21 The alarm system sounds an audible alarm to alert the user of various conditions or a malfunction see Alarms and Messages on page 7 4 2 2 430 04685 004 LifeCare PCA Infusion System Features The following features are addressed in this section e Drug Recognition e Modes Of Delivery e Programming Battery e Biomedical e Options e Other Features DRUG RECOGNITION Barcode reader identifies drug name and concentration in the vial prefilled Hospira Abbott vials only e Bar code reader identifies the drug name and concentration of custom filled vials when appropriate pharmacy generated bar codes are used and Hospira MedNet Software is enabled MODES DELIVERY e PCA Only Continuous e PCA Continuous PROGRAMMING e Keypad with large numbers decimal point amp icons for easy use e Prompting alphanumeric display BATTERY 8V Battery e Battery for emergency backup and temporary portable operation approx 2 5 hrs
9. Minute Interval 0 5 10 0 Average Delivery Rate Error 1 6 15 0 0 5 10 15 20 25 30 Observation Interval minutes A trained professional can use the resulting graphs to select a infuser with the appropriate startup and flow characteristics to suit the clinical application NOTE As an example of how the trumpet curves may be used consider the maximum and minimum deviations at the 5 minute average interval The upper curve provides the maximum expected delivery rate error over a 5 minute interval the lower curve provides the minimum expected delivery rate error over a 5 minute interval An example would be Morphine administered at 5 mL mg At 5 minutes the average drug delivery error would be within the range of 2 8 and 0 5 of the expected nominal rate 430 04685 004 9 7 Specifications Trumpet Curves 0 1 ml hr 0 mmHg Delivery Head 0 9 Saline Maxima Minima of 3 Pumps 100 0 80 0 60 0 3 40 0 5 20 0 R E n n a 0 0 a z t 20 0 2 40 0 60 0 80 0 100 0 5 10 15 20 25 30 Observation Interval min e Max Min Mean PCA 1 ml hr 0 mmHg Delivery Head 0 9 Saline Maxima Minima of 3 Pumps 15 0 10 0 50 M a a 0 0 8 5 5 5 0 a 10 0 15 0 0 5 10 15 20 25 30 Observation Interval min e
10. PCA AVAILABLE Message 5 2 PCA bolus 5 17 PCA dose 2 2 5 17 PCA Infusion System 1 1 PCA LOCKOUT Message 5 8 PCA Mode 1 9 PCA Only 1 2 5 2 5 5 PCA Patient Pendant 3 8 PCA Set 1 9 PCA Vial 1 9 PCA CONTINUOUS 1 2 Pendant Fault Message 5 8 Prime 1 9 1 11 5 35 system 4 28 Print History 5 37 Softkey 5 39 printer connections 1 1 printouts 5 39 procedures 1 11 program values change 5 28 programmed therapy 1 10 programming features 1 1 Protocols 1 2 1 10 5 2 5 18 5 20 6 7 stored 5 2 purge 1 9 1 11 5 34 6 4 1 3 4 4 cycle 1 12 4 28 system 4 28 Purge Softkey 4 4 4 10 4 29 5 4 5 10 5 13 6 4 R Rear Panel equipment description 3 4 replace syringe message 5 34 Review Confirmation Screen 5 26 5 28 RF communications 1 17 Rule Set 1 9 Rx Rules 1 10 5 18 Rx Settings 1 10 5 safety 1 11 amp Exit Softkey 5 26 screen message alerts 5 2 Select CCA Screen 6 7 Select Delivery Mode 4 31 Screen 4 6 4 14 6 6 Select Mode Cont 5 14 PCA Only 5 4 Screen 4 30 self test 1 13 4 2 4 8 failures 4 16 set 4 4 4 11 4 29 5 5 5 10 5 14 6 4 Set List 1 15 settings 5 29 5 38 adjust system 5 4 5 9 5 13 SILENCE key 1 8 SILENCE VOLUME button 3 5 slack 1 12 4 28 5 35 soft limits 1 9 5 16 Softkeys 1 10 3 7 Standard Syringe 1 10 START PAUSE Button 3 6 5 3 START STOP Button 5 2 1 4 status messages 7 1 stopping infusion 5 29 Stored Protocols 1
11. Prime Manually removing air from the syringe and line Purge The process during which the pumping mechanism is run to remove air from the PCA set Rule Set A list of upper lower soft and or hard limits for delivery parameters Rule sets reside in the User Defined Drug Library and are associated with a specific vial within a CCA 430 04685 004 Descriptive Information TERMS DEFINITION Rx Settings The current programmed therapy Includes PCA Dose PCA Lockout Interval Continuous Rate Loading Dose and Dose Limit amount Soft Keys The five keys to the right of the device s LCD display Each key s function is dependent on the screen displayed data Stored Protocols Frequently used therapy settings stored in the infuser s memory Stored protocols can be recalled again making it unnecessary for the operator to program the same therapy settings each time they are needed Stored protocols are determined by the health care facility Standard Syringe A prefilled bar coded drug vial in which the infuser identifies the drug and concentration The drug and concentration are found in the Drug Library by using the bar code on the vial Standard syringes are also known as prefilled drug vials User defined Drug Library A drug library that contains hospital defined clinical care areas CCAs and rule sets created with Hospira MedNet Software Warning A
12. SOFT LIMIT OVERRIDE 6 10 HARD LIMIT VIOLATION 6 10 IMPORTANT SYMBOLS 6 11 no r le sets i3 ox este er ate 6 11 soft limit override 6 11 Wireless sone iva 6 12 AUTOPROGRAMMING 6 12 430 04685 004 iv For Systems With Hospira MedNet Software Section 7 Troubleshooting 7 1 STATUS MESSAGES sn doei ud Pup 7 1 INFUSER ALARM 7 2 SILENCING AN ALARM 7 3 ALARMS AND MESSAGES 7 4 INFUSER STALLING as bo oct La dae dus Gag ar 7 6 Section 8 Maintenance 8 1 INFUSER STORAGE 8 1 CLEANING AND SANITIZING 8 2 BATTERY MAINTENANCE 8 4 SERVICE cioe eo ed Eta a Aa ede ee eed 8 5 Section 9 Specifications 9 1 STORED OCCLUSION VOLUME 9 5 TIME FROM OCCLUSION TO ALARM 9 5 DELIVERY RATE ACCURACY 9 5 trumpet curves 9 6 example 5 LLL RES Lex LIS 9 6 TRUMPET CURVES suce ue Im ME 9 8 Section 10 Prescription Delivery Limits 1
13. Software is enabled and a upper hard or soft limit has been assigned for that CCA and drug then Dose entry is required and this screen will not be displayed NOTE The pre programmed Dose Limit is 1 or 4 hours The Hospira MedNet Software range is larger 1 4 6 or 12 hours For complete information on this feature see Dose Limit on page 5 21 430 04685 004 5 11 Select Mode 15 Select gt to verify No MORPHINE PF mg m Dose Limit selection CONFIRM NO DOSE LIMIT Select PREvious gt to return to the preceding screen PREVIOUS 16 Select gt to verify MORPHINE PF s mg m settings Or select CONTINUOUS PREVIOUS gt to return to the receding screen 9 CONT RATE mg h SO 17 Close and lock door Place uiu p key in a secure location CONFIRM 18 Press to begin therapy MORPHINE PF Approximately 10 seconds CONTINUOUS after door is locked and 2 is pressed the DOOR LOCKED Message disappears lt 2 mg O milligrams When the Dose Limit is TOTAL DELIVERED L CONT R lt O reached a message is do displayed that indicates the Dose Limit has been reached 5 12 430 04685 004 LifeCare PCA Infusion System PCA Continuous Mode For detailed startup information including vial insertion clearing settings purging and setting a Loading Dose see Loading a Vial on page 4 5 For information on adj
14. date with the Numbers ESET DATE WITH Buttons NUMBERS BUTTONS 01 15 05 The current setting for Date will flash NOTE Date must be entered in MM DD YY sequence 430 04685 004 4 25 Basic Operation 7 Select Nex again after changing to the desired date The CONFIRMATION CURRENT SCREEN appears Select SETTINGS CONFIRM to verify the changed settings 9 21 PM 01 15 05 8 Then select gt to exit the Change System Settings Menu and display the VIAL CONFIRMATION SCREEN if the vial is loaded properly 4 26 430 04685 004 LifeCare PCA Infusion System New Patient 1 The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less Select YES or NO NOTE If the infuser has been off for more than 4 hours the History and Rx settings are automatically cleared and the NEW PATIENT SCREEN is not shown If YES is selected the History and Rx settings are cleared If NO is selected the History and Rx settings are kept and a screen appears offering the option to CLEAR HISTORY CONTINUE 430 04685 004 BNEW PATIENT HISTORY AND RX SETTINGS CLEARED 4 27 Basic Operation Purging the System WARNING The patient must be disconnected from the PCA Infuser set before the purge cycle After the infuser is turned on and the self tests are complete the purge system prompt appears Confirm that the PCA Infuser set is disco
15. n mg _ milligram KC When the Dose Limit is reached a message is displayed that indicates the Dose Limit has been reached Protocols For detailed startup information including vial insertion clearing settings purging and setting a Loading Dose see Loading a Vial on page 4 5 For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 21 NOTE Protocols may be established by the hospital via Hospira MedNet Software or via Biomed Mode Hospira MedNet Software enabled devices allow for protocol programming from the Rx Rules application Only Protocols associated with the inserted drug vial will be available 1 Unlock door and press Q9 LIFECARE Button or load drug vial into SELF TEST cradle to power on the infuser Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen pa Hospira pa lt 5 18 430 04685 004 LifeCare PCA Infusion System 2 3 Select CONTINUE to advance to the next programming screen Select Yes or No at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less For more information see New Patient on page 4 27 Select CONFIRM gt to accept the inserted drug or remove the vial if it is not correct See New Patient on page 4 27 for more information Select either YEs gt or No to purge the system For more information
16. opening the door PCA Only loss of power reaching the dose limit emptying the vial ora malfunction alarm 430 04685 004 5 37 Select Mode 4 Continue to press D f TIME 8 04 PM DATE 07 15 05 for more information 12920191 such as DELIVERED ast one hour information if 10 min HOUR DOSE __ configured HOUR Er Last 24 Hour information if 2 di configured MORE PREVIOUS 4 Current settings Total drug delivered toward the dose limit Event Log The Event Log shows all events since the last Clear History Up to 400 events are shown D Press to return to the MAIN DELIVERY SCREEN 6 Close and lock the door Press startipause if in Continuous or PCA Continous mode History and Event Log The infuser stores data on therapy settings quantity and or number of doses delivered and has the capacity of recording up to 20 000 events The PCA Infuser displays a chronological record of 400 of the most recent events occurring during infusion by pressing the History Button These events include PCA doses requested the amount delivered the change of any settings the opening or closing of the security door start or stop of continuous infusion and alarm conditions For more information see Data Retention on page 4 20 5 38 430 04685 004 LifeCare PCA Infusion System Pressing the HISTORY Button displays this data on the LCD Pressing PRINT HISTORY gt gene
17. 10 syringe 1 12 change 1 12 4 28 custom 1 2 1 7 System Settings 4 21 5 4 4 4 10 4 28 T therapy settings 1 10 5 38 training infuser use 1 3 IV complication 1 3 PCA programming 1 3 units of measure 4 11 unpacking 1 11 Updating Drug Library 6 1 upper limits 1 9 User Defined Drug Library 1 9 1 10 5 2 5 3 5 21 6 1 V vial 1 12 5 2 barcoded 1 2 custom 1 7 1 9 4 8 6 1 custom filled 1 2 load drug 4 2 PCA 1 9 prefilled 1 2 1 9 1 10 6 1 removal 5 34 standard 1 9 sterile empty 1 2 1 7 Vial Confirmation Screen 4 26 Vial Cradle equipment description 3 3 vials prefilled 1 10 Warning 1 10 430 04685 004 LifeCare PCA Infusion System warning messages 1 4 Warning Drug and or Concentra tion Change Detected Screen 5 430 04685 004 1 5 Notes 430 04685 004 LifeCare PCA Infusion System Contact Information For customer service within the United States contact 1 877 9 HOSPIRA 1 877 946 7747 For technical assistance product return authorization and to order parts accessories or manuals within the United States contact Hospira Technical Support Operations 1 800 241 4002 To order parts using the online eCatalog download technical publications technical training courses and additional services visit the web site at WWW HOSPIRAPARTS COM After authorization ship prepaid product returns to this address HOSPIRA Technical Support Operations 755 Jarvis D
18. 5 39 HR LIMIT REACHED message 5 3 incompatibility 1 11 infuse 1 8 Loading Dose 6 6 infuser 5 29 cleaning 1 13 maintenance 1 13 sets 1 14 infusion rate 1 11 infusion therapy 1 9 injector 1 12 K keypad controls 1 1 L LCD 1 8 LED 1 8 3 7 Loading Dose 1 8 1 12 2 1 4 5 4 12 4 29 4 30 5 5 5 10 5 14 6 5 Deliver Later 5 10 displayed range 5 5 5 10 5 14 430 04685 004 LifeCare PCA Infusion System halt 5 36 infuse 4 6 4 13 4 31 mode 4 6 6 6 now 4 31 range 4 5 4 13 4 30 6 5 softkey 5 21 supplemental 2 2 5 21 5 36 Lockout Interval 1 8 1 9 2 2 5 2 5 3 value 5 6 Low Battery Alarm 1 15 Low Battery Message 4 16 22 Priming Volume PCA Set 2 lower limits 1 9 Main Delivery Screen 5 38 malfunction alarm 1 14 5 2 5 Medical Device Directive 93 42 EEC EN 55011 Class B 1 17 IEC EN 60601 1 2 2001 1 17 micrograms 4 12 Modes of Delivery CONTINUOUS 1 2 5 2 PCA ONLY 1 2 5 2 PCA CONTINUOUS 1 2 5 2 Muting Period 1 8 N New Patient Screen 4 3 4 9 4 17 4 27 5 4 5 9 5 13 5 27 6 3 Next Protocol Softkey 5 20 No Dose Limit 5 7 5 26 numeric buttons 3 6 Occlusion 1 8 Pressure 1 8 430 04685 004 ON OFF Button 3 5 6 2 one hour information 5 38 operating parameters 2 1 partial doses 5 2 Patient Pendant 1 1 1 3 1 9 1 12 3 8 4 15 5 2 patient pendant button 5 2 PCA 1 2 2 1 requested doses 5 39 PCA Cont 6 7 PCA Continuous 2 2 5 3 5 35 mode 1 12 5 21
19. Continuous or PCA 4 Continuous Mode 430 04685 004 5 35 Select Mode Adding a Supplemental Loading Dose 1 Unlock the door the infuser MORPHINE PF uu will pause 2 Select LOADING Dos M ERR NOTE CHANGE gt will only LOADING DOSE zn display if Hospira MedNet CHANGE Software has been enabled CLEAR SHIFT ZO CHANGE 3 Entera Loading Dose MORPHINE PF 1 mg mL within the displayed range MIREN PRESS 4 Then press 1139 ENTER BUTTON 2 5 mg milligrams 5 Press to infuse the MORPHINE PF loading dose APRESS NOTE The loading dose may be TO NFUSE O halted at any time by pressing Pe iG DOSE START PAUSE 6 Close and lock the door Place key in a secured place 5 36 430 04685 004 LifeCare PCA Infusion System Checking History amp Settings 1 To Check History or settings press D sutton 2 Press OF BUTTON to scroll through history Or fs select PRINT HISTORY to print if connected to printer PRESS HISTORY OR ENTER BUTTON TO SCROLL THROUGH HISTORY The Print History option does not appear when Hospira MedNet M Software is enabled 3 Press ww D 199 Burton MORPHINE PF a second time for more ict information When MORE is displayed amo more information is stored ees in infuser history RE PREVIOUS NOTE Partial boluses can be the result of interrupting delivery by pressing START STOP Count
20. ID STJ 20709 US FCC FEDERAL COMMUNICATIONS COMMISSION STATEMENT e This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause interference and 2 This device must accept any interference including that may cause undesired operation of this device FCC INTERFERENCE STATEMENT e This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installa tion This equipment generates uses and can radiate radio fre quency energy If not installed and used in accordance with the instructions it may cause harmful interference to radio commu nications However there is no guarantee that interference will 430 04685 004 1 19 Descriptive Information not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try and correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e ncrease the distance between the equipment and the receiver e Connect the equipment to an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an ex
21. Message appears only in the PCA ONLY or LOCKOUT PCA CONTINUOUS Mode The message remains until the lockout interval elapses and is displayed after a successful patient originated dose delivery 430 04685 004 7 1 Troubleshooting MESSAGE DEFINITION 4 1 LIMIT Message displayed if 4 or 1 hour dose limit REACHED has been selected and reached with security door locked without Hospira MedNet Software enabled Message displayed if 1 4 6 8 12 hour dose limit has been selected and reached with security door locked with Hospira MedNet M Software enabled PCA Message indicates patient can initiate a dose AVAILABLE in PCA ONLY or PCA CONTINUOUS Mode PCA ONLY Message displayed when infuser is in PCA ONLY Mode CONTINUOUS Message displayed when infuser is in CONTINUOUS Mode Message displayed when infuser is in PCA CONTINUOUS Mode INFUSER Message displayed when infuser is stopped PAUSED but door is locked Or if door is opened Infuser Alarm System During an Alarm condition the system performs the following actions e current display message is saved to the event log e flashing alarm message appears on the display See Alarms and Messages on page 7 4 e repetitive audible tone sounds with all MALFUNCTION alarms except PENDANT FAULT which is a single tone with continuous visual flashing The audible tone volume
22. NOT READ ALARM CHECK VIAL ALARM CHECK SYRINGE ALARM CHECK VIAL ALARM DOOR OPENED START INFUSION PCA STOP EMPTY SYRINGE ALARM USING A C USING BATTERY PCA DENIED PCA END PCA DENIED USING A C USING BATTERY PCA END PCA DENIED PCA DENIED PCA END PCA END USING A C PCA DENIED USING BATTERY USING A C USING BATTERY PCA END PCA DENIED PCA END PCA END PCA END PCA DENIED PCA END PCA DENIED PCA DENIED PCA DENIED PCA DENIED PCA END PCA DENIED Select Mode START INFUSION DOOR LOCKED CONFIRM 4 HR LIMIT 55 CONFIRM CONT RATE 1 CONFIRM PCA LOCKOUT 15 CONFIRM PCA DOSE 3 CONFIRM PCA CONT MODE MORPHINE PF SET 4 HR LIMIT SET CONT RATE SET PCA LOCKOUT SET PCA DOSE SET PCA CONT MODE RX SETTINGS RETAINED CONFIRM MORPHINE PF CHECK INJECTOR ALARM CHECK SYRINGE ALARM CHECK VIAL ALARM DOOR OPENED PCA STOP EMPTY SYRINGE ALARM PCA END PCA DENIED PCA DENIED PCA DENIED PCA DENIED PCA END PCA END PCA DENIED PCA PCA PCA PCA PCA PCA PCA PCA PCA DENIED START INFUSION LOAD DOSE END USING A C START LOADING DOSE DOOR LOCKED CONFIRM 4 HR LIMIT 55 CONFIRM CONT RATE 1 CONFIRM PCA LOCKOUT 15 CONFIRM PCA DOSE 3 CONFIRM PCA CONT MODE MORPHINE PF 1 SET 4 HR LIMIT 55 SET CONT RATE 1 SET LOCKOUT 15 SET PCA DOSE 3 SET PCA CONT MODE SET LOADING DOSE 5 PURGE CONFIRM MORPHINE PF i CHECK VIAL ALARM CHECK INJECTOR ALARM CHECK SYR
23. SULFATE HAS BEEN REPORTED 430 04685 004 4 3 Basic Operation If over delivery occurs during administration observe the patient carefully for signs of the following e Compression on spinal cord disorientation headache or transient neuralgia e Drug overdose The epidural space has 58 openings through which fluid can exit Pressure build up during administration is transient However if a large volume of fluid is administered over a short period the pressure will take longer to return to normal 4 4 430 04685 004 LifeCare PCA Infusion System Loading a Vial WARNING Failure to use compatible Hospira Abbott vial injector and Hospira Abbott PCA Infuser sets with integral anti siphon valve may cause an inaccurate dose delivery to the patient 1 Squeeze Cradle Release Mechanism together at the top of the holder and move to the uppermost position NOTE Always verify that the bar code reader window is clean before inserting vial 2 When inserting bottom of glass vial into middle black bracket ensure that the bar code label faces the bar code reader on the right side of the vial compartment CAUTION DO NOT POSITION VIAL INTO UPPER VIAL CLIP FIRST VIAL LIP MAY CRACK OR CHIP Insert bottom of glass vial into the middle black bracket Gently press upper end of glass vial into upper black bracket Squeeze the top of the Cradle Release Mechanism and move down until the vial injector snaps into
24. actions or inactions of the person performing such repair or service regardless of whether such person has been trained to perform such repair or service It is understood and acknowledged that any person other than an Hospira representative performing repair or service is not an authorized agent of Hospira C 2 430 04685 004 Numerics 24 Hour information 5 38 4 HR LIMIT 5 21 4 HR LIMIT REACHED Message 5 21 A AC power 1 2 indicator 3 7 Accuracy 1 6 alarm 1 8 system 2 2 Alert messages 1 4 Alpha Vial 4 9 analgesic 1 2 2 2 delivered 4 32 6 6 package 1 11 anesthetics 1 2 anti siphon valve 1 11 Autoprogramming 1 6 B bar code 1 10 drug vial 1 1 pharmacy generated 1 1 4 8 6 1 reader 1 1 1 13 battery 1 2 1 11 1 13 1 15 charge 4 16 fault 1 6 indicator 3 7 Biomed Mode 1 2 5 2 5 18 bolus 1 6 2 2 4 29 doses 1 9 partial 5 37 Button 1 6 CAUTION message 1 4 CCA 1 6 1 9 1 10 6 3 6 7 CE 1 6 Change CCA 5 32 1 1 Index Index Softkey 5 25 5 30 Change Rx Softkey 5 30 cleaning infuser 1 13 Clear Button 3 5 4 12 Clear History 5 38 Clear Shift Softkey 5 33 Clinical Care Area 1 6 CCA 6 7 clock 12 hour 4 25 24 hour 4 25 Confirm No Dose Limit Screen 5 22 5 23 Confirm Softkey 5 26 Confirmation Screen 4 26 5 35 Connectivity Engine 1 6 Continuous 1 2 1 6 2 2 5 3 5 35 infusion 5 3 mode 1 12 2 2 5 3 rate 5 11 5 16 CONTINUOUS ONLY 1 2 custom syringes 1 12 D DDL 1 7 5 21 DECIM
25. confusion with other infusion systems delivering concomitant intravenous formulations For epidural use administer only anesthetics analgesics approved for epidural administration as indicated or allowed by the drugs FDA approved labeling Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient If a patient access device is not indwelling prime and establish epidurally Confirm proper placement Attach recommended low priming volume infuser set without Y injection sites to patient access device CAUTION EPIDURAL ADMINISTRATION OF DRUGS BY PCA INFUSER AND OR CONTINUOUS MODES SHOULD BE LIMITED TO PERSONNEL FAMILIAR WITH ASSOCIATED TECHNIQUES AND PATIENT MANAGEMENT PROBLEMS PROPER EPIDURAL PLACEMENT OF THE CATHETER IS ESSENTIAL SINCE CATHETER MIGRATION COULD RESULT IN INTRAVASCULAR AND INTRATHECAL ADMINISTRATION FACILITIES PRACTICING CONTINUOUS EPIDURAL ADMINISTRATION MUST BE EQUIPPED WITH RESUSCITATIVE EQUIPMENT OXYGEN NALOXONE AND OTHER RESUSCITATIVE DRUGS ADEQUATE MONITORING EQUIPMENT IS RECOMMENDED FOR CONTINUOUS MONITORING OF THE PATIENT DURING EPIDURAL ADMINISTRATION PATIENTS MUST BE OBSERVED FOR SIDE EFFECTS FREQUENTLY IN A FULLY EQUIPPED AND STAFFED ENVIRONMENT FOR AT LEAST 24 HOURS FOLLOWING COMPLETION OF EPIDURAL DRUG ADMINISTRATION CAUTION DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE FREE MORPHINE
26. different sounds to differentiate between infusers in the Biomed Mode or by Hospira MedNet software 430 04685 004 7 3 Alarms and Messages MESSAGE MUTING TIMES POSSIBLE CAUSE Troubleshooting CORRECTIVE ACTION Bar code 1 minute Vial not loaded Position vial correctly Not Read properly Clean bar code reader window Check 1 minute Door locked Open the door Settings without Complete settings appropriate therapy settings Occlusion 1 minute Occlusion Open security door if detected closed Remove back pressure by squeezing and releasing the cradle release handles Identify and correct the cause of the occlusion Alarm will self correct Check None Syringe Vial Close Slide Clamp Syringe and Injector not Immediately properly loaded Properly insert syringe into holder assembly Check Vial None Injector Properly insert vial detected and into holder assembly vial not properly or removal of injector loaded Check None Vialis detected Properly insert Injector and injector not injector into holder properly loaded assembly or removal of vial 7 4 430 04685 004 LifeCare Infusion System MUTING POSSIBLE CORRECTIVE MESSAGE TIMES CAUSE ACTION Decimal N A Attempting to Press Clear and Point Not select the enter valid whole Allowed decimal point number button when programming in micrograms mcg Empty 15 Empty
27. dose requests in PCA Only and PCA CONTINUOUS Modes if the programmed PCA Lockout Interval has elapsed and resumes infusion at the continuous rate in the CONTINUOUS and PCA CONTINUOUS Modes NOTE Setting a new dose limit will not erase the previous dose history 430 04685 004 5 21 Select Mode PROGRAMMING THE 4 OR 1 Hour DOSE LIMIT The opportunity to program this feature is presented in two entry screens The first screen prompts the clinician to choose whether or not to set a Dose Limit Selecting No gt brings up the CONFIRM No DOSE LIMIT SCREEN Selecting Yes brings the DOSE LIMIT ENTER VALUE SCREEN This requires that the clinician enter a value within the displayed range NOTE If Hospira MedNet Software is enabled and a upper hard or soft limit for that CCA and drug has been assigned then a DOSE LIMIT entry is required PROGRAMMING A DOSE LIMIT 1 Select Yes at the Dose Limit MORPHINE PF 1 mg mL SELECTION SCREEN The display advances to the DOSE LIMIT ENTER VALUE SCREEN PREVIOUS 2 Enter the 4 Hour DOSE LIMIT value using the numeric TENE ENTER 4 HOUR keypad M DOSE LIMIT THEN PRESS NOTE Entry of zero forthe 4HR fj ENTER BUTTON Dose Limit using the numeric 0 1 80 mg keypad is NOT accepted by the 40m PCA Infuser see Programming milligrams No Dose Limit on page 5 23 Then press 1139 5 22 430 04685 004 LifeCare PCA Infusion System 3 Select gt to acce
28. environment where EMI or RFI levels are excessive RFI Electrical Leakage Risk current limits meets standard IEC EN UL 60601 1 Fuses 1 0 A 250 V Slow Blowing Lockout Interval 5 to 120 minutes in Range 1 minute increments Maximum Infusion 45 psig Pressure 430 04685 004 9 3 Overinfusion Occlusion Alarm Pressure Occlusion Bolus Volume Operating Temperature Power Cord Power Requirements Printer Port Recharge Self Discharge Storage Temperature Weight Specifications The maximum overinfusion under single fault conditions is 25 15 psig 5psig 2 mL for fully primed set max 5 to 40 C 10 90 relative humidity Hospital grade AC cord 10 ft long with transparent plug and retainer plate 105 130 Volts 57 63 Hz lt 50 W Maximum nondestruct voltage is 5 V After discharge to the LOW BATTERY operative limit the battery will recharge to at least 80 of its charge capacity in 16 hours provided it is plugged into rated AC power The infuser will operate on AC power in the event the battery is open or shorted 50 of charge retained for at least one month when unit is neither plugged in nor operating 20 to 60 C 10 90 relative humidity Approximately 10 lbs with battery 430 04685 004 LifeCare PCA Infusion System Stored Occlusion Volume DELIVERY Average Avera
29. for any field requiring numeric data The DECIMAL POINT Button is used for entering numbers with a decimal point An example would be 10 5 mg 3 6 430 04685 004 LifeCare PCA Infusion System XL Keys or Softkeys are touchkeys which are located to the right of the main display They perform a variety of functions correlating to the description displayed on the screen An example of a softkey in this manual is PCA ONLY Battery indicator illuminates continuously when infuser is running on battery power 4 AC mains power indicator illuminates when infuser is plugged into AC power DOSE DELIVERED 430 04685 004 LED displays the dose delivered When displaying dose delivery in micrograms a vertical walking stick appears on the right side of the display When displaying dose delivering in milligrams the walking stick appears on the left side of the display Equipment Description PCA Patient Pendant is used by the patient to deliver the drug upon the press of the button WARNING PATIENT PENDANT IS ONLY TO BE PRESSED BY THE PATIENT If the Patient Pendant is partially pressed a Pendant Fault Message will appear This can be corrected by releasing the button A PCA bolus will not be delivered during a Pendant Fault condition 430 04685 004 LifeCare PCA Infusion System Section 4 Basic Operation The following subjec
30. hours less PATIENT Select YES gt or NO gt gt is selected the History and Rx settings are kept If YES gt is selected the History and Rx settings are cleared D Select gt to accept MORPHINE PF 1 mg mL the inserted drug or 1 remove the vial if it is not correct BREMOVEVIAL lt lt IF NOT CORRECT n CONFIRM 6 Select the softkey next to the desired CCA example PACU SELECT CCA If only one CCA has been created that CCA becomes the default CCA and this screen is skipped If the desired CCA is not displayed select gt to view more options 430 04685 004 6 3 Advanced Programming with Hospira MedNet Software 7 Select either Yes or No to MORPHINE PF purge the system See Purging the System onpage 4 28 for more ff PURG information 8 ive is selected MORPHINE PF 1 mg mL disconnect the set from the patient and press and hold the gt Softkey DISCONNECT SET FROM While purging is occurring the word PURGING is displayed PREVIOUS NOTE Purging is recommended to remove system slack when a new vial is inserted The maximum volume delivered during a purge is 3 mL Upon release of the PuRGE gt MORPHING PF Softkey the display asks if 1mgmL the purge is complete M COMPLETES 9 Select Yes to continue or select No to purge again until complete 10 After purging is complet
31. not immerse the infuser in any fluids or cleaning solutions Some cleaning and sanitizing compounds may slowly degrade components made from some plastic materials Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage Do not use compounds contain ing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride Do not sterilize by heat steam ETO or radiation Do not place the PCA Infuser in service if it fails the self test Hospira will be responsible for the safety effect reliability and performance of this device only if adjustments modifications or repairs are performed by persons authorized by Hospira the 430 04685 004 1 13 Descriptive Information electrical setup at the point of use complies with appropriate local requirements and the device is used in accordance with the instructions for use identified in this operating manual e Hospital policies and guidelines must always be followed to ensure patient safety and to minimize the potential for patient hazards ALARMS This section presents alarm information e f the MALFUNCTION Alarm Message is seen and sounds press the ON OFF key to turn the infuser off Then turn the infuser back on If the malfunction alarm repeats remove the infuser from service EPIDURAL ADMINISTRATION This section contains epidural administration information e Recommended use of the epidural route is to provide anesthe
32. page 4 30 Lockout Interval Muting Period A programmed time interval specifying the minimum time that must pass after a loading dose or PCA dose bolus is administered this time interval specifies when the next PCA dose can begin infusing Bolus requests made during the lock out interval are denied The period between the silencing of an alarm by pressing the SILENCE key and the resumption of the alarm Occlusion A blockage in the PCA Infuser set that prevents the infuser from pumping fluid into the patient Possible causes of occlusions are kinked or plugged non patent IV tubing Occlusion The maximum pressure produced as a Pressure result of an occlusion in the PCA Infuser set 430 04685 004 LifeCare PCA Infusion System TERMS DEFINITION The infuser is turned on using either A C or battery power The infuser is not necessarily pumping when on Patient Pendant A hand held pendant connected to the infuser that allows the patient to request a PCA dose bolus by pressing a button PCA Mode Infusion therapy characterized by bolus doses administered on patient demand subject to a lockout interval and optionally a dose limit PCA Set Tubing connecting the PCA Vial to the patient PCA Vial Vial compatible with the infuser that is either prefilled with drug by Abbott or Hospira standard vial or filled by the hospital pharmacy custom vial
33. sia or analgesia for periods up to 96 hours e strongly recommended that the epidural infusion system be prominently identified as EPIDURAL Failure to identify the infu sion system as epidural could result in incorrect administration of intravenous rather than epidural formulations In addition failure to identify the epidural infusion system could result in confusion with other infusion systems delivering concomitant intravenous formulations e This device can be used to administer only those anesthetics analgesics approved for epidural administration as indicated or allowed by the drugs FDA approved labeling Epidural admin istration of drugs other than those indicated for epidural use could result in serious injury to the patient e For epidural administration the use of infuser sets without Y sites and epidural stickers indicating ongoing epidural adminis tration are recommended e Administration of drugs via the epidural route should be limited to personnel familiar with associated techniques and patient management problems Proper epidural placement of the cath eter is essential since catheter migration could result in intra vascular or intrathecal administration Facilities practicing epidural administration must be equipped with resuscitative equipment oxygen naloxone and other resuscitative drugs 1 14 430 04685 004 LifeCare Infusion System Adequate monitoring equipment is recommended for contin
34. the Default Drug Library Dose Limit periods on infusers with a User defined Drug Library may be defined as 1 4 6 or 12 hours 5 2 430 04685 004 LifeCare PCA Infusion System CONTINUOUS A programmed Continuous infusion is started by pressing the START PAUSE Button after the door is closed and locked The patient pendant is disabled in CONTINUOUS Mode Upon reaching the DOSE LIMIT if entered the infuser stops drug delivery and the designated HR LIMIT REACHED Message is displayed NOTE Dose Limit periods are specified as 1 and 4 hours on an infuser with the Default Drug Library Dose Limit periods on infusers with a User defined Drug Library may be defined as 1 4 6 or 12 hours NOTE In CONTINUOUS or PCA CONTINUOUS Mode The START PAUSE Button must be pressed within 30 seconds of locking the door or the infuser sounds an alarm PCA CONTINUOUS A programmed PCA Continuous infusion is started by pressing the START PAUSE Button after the door is closed and locked A patient initiated PCA dose may be administered using the patient pendant when the PCA AVAILABLE Message appears When the patient initiated dose is activated the PCA dose is delivered prior to the CONTINUOUS infusion rate After the PCA dose is completed the infuser enters the LOCKOUT nterval While in the lockout period the CONTINUOUS infusion remains in progress but the patient initiated dose cannot be activated If a Dose limit has been reached the i
35. the infuser that connected to the PC Port number is 8889 where the infuser will send the events to the PC Connect using TCP IP protocol a events Enter details for the host that you want to call Host address E 92 168 0 100 Port number 8883 Connect using Winsock B 4 430 04685 004 LifeCare PCA Infusion System 4 The Hyper Terminal program is ready to receive events sent from the infuser PCA events HyperTerminal 5 Printing to a PC e To print from the PCA Infuser complete the following steps e Press History touch switch to view the history on the display e Press Print HISTORY Softkey to print history log 430 04685 004 B 5 Network Printer Setup NOTES 430 04685 004 LifeCare PCA Infusion System Appendix C Warranty Subject to the terms and conditions herein Hospira Inc herein referred to as Hospira warrants that a the product shall conform to Hospira s standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase and b the replaceable battery shall be free from defects in material and workmanship under normal use and service for a period of 90 days after purchase Hospira makes no other warranties express or implied as to merchantability fitness for a particular purpose or any other matter Purchaser s exclusive remedy shall b
36. until a User defined Drug Library is installed and supersedes the DDL Dose Limit User programmable parameter specifying the maximum amount of drug that can be administered via PCA dose and continuous delivery in a programmable rolling time period consisting of discrete accumulation periods of 6 minutes NOTE Dose Limit periods are specified as 1 and 4 hours on an infuser with the DDL on infusers with a User defined Drug Library the dose limit periods can be defined as 1 4 6 or 12 hours Drug Library The process of moving the User defined Download Drug Library from the network server to the infuser Drug Library The process of moving the User defined Installation Drug Library from the CE to the infuser History Displays Rx Settings PCA Summary and the Event Log HospiraMedNet Network based application software used Software to upload event logs and download the user defined drug library to the infuser 430 04685 004 1 7 Descriptive Information TERMS DEFINITION Infusing The infuser is ON and a DELIVERY SCREEN 15 displayed The infusing mechanism may or may not be actually infusing at any given time LCD Liquid Crystal Display LED Light Emitting Diode Loading Dose An optional dose programmed during Setup before entering the program The loading dose can be administered at any time by the clinician during the programmed therapy For more information see Loading Dose on
37. will power off Or Select YEs gt to begin the installing the new drug library The Drug Library j j DRUG LIBRARY Installation Screen will flash the words Progress IN PROGRESS on the screen CAUTION WHEN A NEW DRUG LIBRARY IS INSTALLING ENSURE THE AC POWER CORD IS PLUGGED IN UNTIL THE PROCESS IS COMPLETE CAUTION THE INFUSER CANNOT COMMUNICATE VIA THE NETWORK IF THE Low BATTERY WARNING ALARM HAS SOUNDED 6 8 430 04685 004 LifeCare PCA Infusion System The infuser displays the DRUG LIBRARY INSTALL SUCCESSFUL SCREEN after the libray has been installed successfully The infuser will power off automatically If the Drug Library is not installed within 15 minutes or if it fails to install the Infuser displays the UNABLE TO INSTALL DRUG LIBRARY SCREEN and the infuser will power off automatically The previous library will be active when the infuser is re started 430 04685 004 DRUG LIBRARY INSTALL IN PROGRESS SHUTTING DOWN UNABLE TO INSTALL DRUG LIBRARY SHUTTING DOWN Advanced Programming with Hospira MedNet Software Soft Limit Override When entering parameters ifa soft MORPHINE PE limit is exceeded a soft limit override 1 mg mL screen is displayed 6 mg 1 Review display for the Ree m exceeded parameter LIM 2 Select CONFIRM to override the programmed soft limit or select change to correct the parameter All soft limit overrides made during progr
38. 0 1 Appendix A Generating Bar Code Labels Hospira MedNet Software Enabled 1 2 example of label layout amp sample A 3 label diagram A 4 430 04685 004 LifeCare PCA Infusion System Appendix B Network Printer Setup B 1 equipment needed B 1 Preparation e x Lr RD Rd RR eS B 1 procedure ER PR RUEDA m B 1 printing event history log B 2 DOWNLOADING LOGS 3 equipment needed B 3 preparatior ogi edie ER ele bis B 3 proced res wis e bates any baie eka eb eus B 3 Appendix C Warranty C 1 INGO outs ate ur M a meses 1 1 Contact Information Back Hospira Inc All Rights Reserved This document and the subject matter disclosed herein are proprietary information Hospira retains all the exclusive rights of dissemination reproduction manufacture and sale Any party using this document accepts it in confidence and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Hospira 430 04685 004 vi For Systems With Hospira MedNet Software NOTES vii 430 04685 004 LifeCare Infusion System Section 1 Descriptive Info
39. 430 04685 004 LifeCare PCA Infusion System 2 Select desired volume then SAVE amp EXIT The current setting flashes at this screen SAVE amp EXT CHANGING CONTRAST OF MAIN DISPLAY 1 Select CONTRAST 2 Select desired adjustment softkey repeatedly until contrast is optimized for viewing 3 Select SAVE amp gt SAVE amp EX 430 04685 004 4 23 Basic Operation CHANGING OR CONFIRMING TIME AND DATE WARNING Changing the date or time will clear all totals The current program will remain intact when the time date function is accessed Lockouts or limits in place when the time date is changed will remain in effect 1 Select Time DATE gt After selecting Time DATE gt a warning screen appears to indicate that changing the date or time will clear all totals TIME DATE CONTINUE 2 When the WARNING SCREEN appears select CONTINUE WARNING Set Time with number BATE OR TIME buttons using four digits ALL TODAS Enter hour as two digits 01 00 and minutes as two CONTINUE digits 01 07 PM PREVIOUS 4 24 430 04685 004 LifeCare PCA Infusion System Select AM PM to alternate between AM and PM NOTE Time may be displayed using the 12 or 24 hour clock The default setting is the 12 hour clock The clock selection option is available in the Biomed Mode D After changing the time select NExT gt to change the date 6 To change the date set the
40. 430 04685 004 2 3 Principles of Operation BIOMEDICAL RJ 45 Ethernet Connector Software is Field Upgradable Diagnostic Setup Options Alarm History Ability to Store Protocols for Hospira Abbott Prefilled Vials and Custom Sterile Empty Vials Nurse Call Relay Connector OPTIONS Infusion History OTHER FEATURES Prefilled and Sterile Empty Vials Wireless Antenna Autoprogramming Microprocessor Control Liquid Crystal Display LCD and Light Emitting Diode LED Display Panel Back Illumination Security Features 430 04685 004 LifeCare PCA Infusion System Administration Equipment The following sets may be used in any delivery mode The following sets are supplied sterile and are for single use only administration sets List 3559 List 6514 List 6516 List 6517 PCA Set Mini Bore with Integral Anti Siphon Valve SL 170 cm Approximate priming volume 2 3 mL For use in PCA mode via intravenous route PCA Extension Set with Backcheck Valve SL 25 cm Approximate priming volume 1 1 mL For use in conjunction with Set 6517 to convert from Continuous to PCA Mode via Intravenous route PCA Set Long Mini Bore with Integral Anti Siphon Valve SL 218 cm Approximate Priming Volume 2 6 mL For use in PCA Mode when extra length needed via Intravenous route PCA Continuous Infusion Set Mini Bore with Integral Anti Siphon Valve SL 203 cm Approximate Priming Volume 1 5 mL For use in Continu
41. A Infuser provides a LOW BATTERY warning at least 30 minutes prior to shutdown Casing High impact plastic 430 04685 004 9 1 Delivery Rate Dimensions Drug Concentration Settings Specifications See Section 10 Prescription Delivery Limits on page 10 1 Mode Delivery Rate PCA Mode Approximately 1 mL in 35 seconds CONTINUOUS Mode Variable from 0 1 x concentration mg hr or mcg hr to 20 x concentration mg hr or mcg hr Variable from 0 1 x concentration mg hr or mcg hr to 20 x concentration mg hr or mcg hr PCA dose mg Approximately 8 W 13 H 6 D excluding pole clamp protrusion and power cord storage See Section 10 Prescription Delivery Limits on page 10 1 430 04685 004 LifeCare PCA Infusion System Electrical Safety Meets IEC EN UL 60601 1 standards for Spec Description Class 1 AC mains supply equipment using protective earth Type CF Equipment providing a higher degree of electyric shock protection Drip Proof IPX1 The case is disinfectable and protected against dripping water Note Not to be used in the presence of flammable anesthesics Electromagnetic The LifeCare PCA is Interference designed to perform in the and Radio typical hospital Frequency environment Interference A qualified service technician should verify performance in any
42. AL POINT Button 3 6 Default Drug Library 1 7 5 21 Defined Drug Library 6 7 Deliver Later Option 4 6 4 14 4 31 Deliver Loading Dose Now Screen 4 5 4 13 6 5 Delivery 1 12 interruption 5 2 Mode Screen 5 5 5 10 Modes 5 21 Parameters 1 9 Screen 1 8 Door Locked Message 5 8 430 04685 004 Dose History 1 12 5 21 Dose Limit 1 7 1 9 1 12 2 1 5 2 5 3 5 16 5 21 5 22 new 5 21 pre programmed 5 11 Dose Limit Enter Value Screen 5 7 5 11 5 16 5 22 Dose Limit Periods 5 2 5 21 oe LIMIT REACHED State 5 Dose Limit Selection Screen 5 22 5 23 drug concentration 1 10 1 12 4 12 4 29 drug delivered display 4 28 drug identification 1 1 Drug Library 1 10 Download 1 7 Installation 1 7 E electromagnetic compatibility 1 electromagnetic interference 1 empty syringe message 5 34 ENTER Button 3 5 epidural 1 2 epidural infusion system 4 18 epidural route 1 14 2 2 epidural space 1 15 Ethernet cable 1 17 port 1 1 Event History HOUR BY HOUR 5 39 LAST 1 amp 24 HOUR 5 39 Event Log 1 7 5 38 Events recorded 4 17 EXIT Button 3 5 F FCC Rules 1 19 1 2 Index flow rate 1 12 4 28 Front Pannel equipment description 3 2 hard limit 1 9 5 16 History 1 7 HOUR BY HOUR 5 39 LAST 1 amp 24 HOUR 5 39 History and Rx settings 4 3 4 9 5 27 6 3 History and Rx Settings 4 9 History Button 3 6 5 38 History Printout 5 39 Hospira MedNet Software 1 1 1 2 5 2 5 7 5 11 5 16 5 18 5 22 HOUR BY HOUR history
43. CLEAR to zero the value Then enter a whole value within the displayed range 13 Then press Qu 14 Confirm the drug ALPHA VIAL 10 mcg mL concentration by selecting CONFIRM gt PREVIOUS 15 Set Loading Dose if ALPHA VIAL 10 mcg mL desired by selecting gt See Loading Dose on page 4 30 for more information ESET LOADING DOSE 4 16 430 04685 004 LifeCare PCA Infusion System 16 Entera Loading Dose within UT the displayed range Then MENTER s press Gaii IB THEN PRESS ENTER BUTTON 1 100 mcg 20 mcg micrograms 17 The DeLiver Dose Now SCREEN allows the option of delivering the loading dose LOADING DOSE now or after the programming is complete DELIVER LATER S 18 if YES gt was selected ALPHA VIAL 10 mcg mL press the Burro to infuse the programmed Loading TON Dose LOADING DOSE BPRESS START BUTTON TO INFUSE NOTE The loading dose mode is the only mode that the infuser will deliver with the door unlocked 430 04685 004 4 17 Basic Operation WARNING Always monitor the infuser when delivering medication with the door unlocked 19 If the DELIVER Later option is selected the screen advances to the SELECT DELIVERY MODE SCREEN ALPHA VIAL 20 The screen displays the ae amount of analgesic delivered as it infuses The PAUSE BUTTON bottom of the screen displays text confirming that the Loading Dose is being delivered Upon c
44. Changing Settings During Setup Making Changes After Setup Clearing Shift Totals Changing a Vial Adding a Supplemental Loading Dose Checking History amp Settings History and Event Log 430 04685 004 5 1 Select Mode Modes of Delivery The PCA Infuser delivers analgesia in one of three modes PCA ONLY CONTINUOUS e PCA CONTINUOUS PROTOCOLS Protocols for Hospira Abbott prefilled drug vials and sterile empty vials are created in the Biomed Mode or through the Hospira MedNet Software There are 10 stored protocols available without Hospira MedNet Software enabled or 90 stored protocols 5 per CCA available with Hospira MedNet Software enabled PCA ONLY A patient initiated dose may be administered using the patient pendant when the PCA AVAILABLE Message appears After completing the dose the infuser enters either the preset LOCKOUT Interval or the DOSE LIMIT REACHED State if a dose limit has been entered Further delivery is prohibited in both of these conditions Interrupting delivery by pressing START STOP opening the door loss of power reaching the dose limit emptying the vial or a malfunction alarm may result in partial doses The screen message alerts the user that the PCA Infuser is not available and a different audible tone occurs if the patient pendant button is pressed unless deactivated in Biomed Mode NOTE Dose Limit periods are specified as 1 and 4 hours on an infuser with
45. ER 4 2 intravenous pca infuser administration 4 2 epidural pca infuser administration 4 2 LOADING A VIALE rece ERU DUE Oa 4 5 GUIDED START UP FOR PREFILLED 5 4 6 GUIDED START UP FOR CUSTOM VIALS 4 12 GETTING STARTED eue Re puerta RR DR A 4 19 UNPACKING aro ester CR RUE eth UR a ents 4 19 connecting the patient pendant 4 19 system 15 4 19 data retention 4 20 ADJUSTING SETTINGS 4 21 changing alarm volume 4 22 changing contrast of main display 4 23 changing or confirming time and date 4 24 NEW PATIENT tar age ald s etre pra pon eran 4 27 PURGING THE SYSTEM 4 28 LOADING DOSE x vns yn Gates daca aha A aed acer 4 30 Section 5 Select Mode 5 1 MODES OF DELIVERY 0 0 nee eee 5 2 protocols sts deba baw Sele pete d a dv Ma d eat oe 5 2 cold cadum quA ERU RIF ANS 5 2 CONTINUOUS e ut E 5 3 0 eee 5 3 iii 430 04685 004 LifeCare PCA Infusion System PCA ONLY MODE ra suuu bates be SEE d eh ier Au 5 4 CONTINUOUS MODE
46. ERENCE TO A SECTION See Front Panel on FIGURE OR TABLE page 3 2 BRACKETED ALL KEYS OR BUTTONS ON THE ON OFF CAPS DEVICE ARE DISPLAYED IN BRACKETED ALL OR CAPS OR WITH A GRAPHIC ITALIC SMALLCAPS gt SOFTKEY OPTIONS PREVIOUS gt INITIAL CAPS LOWERCASE SCREEN DISPLAYS AND SELECT DELIVERY MODE DEVICE LABELS AS APPROPRIATE EMPHASIS SETS ARE SUPPLIED STERILE AND ARE FOR WARNINGS CAUTIONS AND NOTES Alert Messages used throughout this manual are described below Pay particular attention to these messages WARNING A Warning Message contains special safety emphasis and must be observed at all times Failure to observe a Warning Message is potentially life threatening CAUTION A CAUTION USUALLY APPEARS IN FRONT OF A PROCEDURE OR STATEMENT IT CONTAINS INFORMATION THAT COULD PREVENT IRREVERSIBLE PRODUCT DAMAGE OR HARDWARE FAILURE FAILURE TO OBSERVE A CAUTION COULD RESULT IN SERIOUS PATIENT OR USER INJURY NOTE A Note highlights information that helps explain a concept or procedure 1 4 430 04685 004 LifeCare Infusion System This symbol directs the user to consult accompanying documents NOTE Figures are rendered as graphic representations to approximate the actual product Therefore figures may not exactly reflect the product 430 04685 004 1 5 Descriptive Information Definitions General and Clinical TERMS DEFINITION Accuracy The de
47. IMIT Setting a specific Dose Limit will be selected for this PREVIOUS example If Hospira MedNet Software is enabled and a upper hard or soft limit has been assigned for that CCA and drug then a Dose entry is required and this screen will not be displayed NOTE The pre programmed Dose Limit is 1 or 4 hours The Hospira MedNet Software range is larger 1 4 6 or 12 hours For complete information on this feature see Dose Limit on page 5 21 5 16 430 04685 004 LifeCare PCA Infusion System 17 Enter the Dose Limit value MORPHINE PF using the numeric keypad the range is displayed on the screen 0 1 80 mg If the value is entered 40 mg milligrams incorrectly press to change value Then press Gu If programming changes need to be made select PREVIOUS to return to the preceding screen 18 Select gt to verify MORPHINE PF settings Or select PCASCONT DOSE PREVIOUS to return to the 2 mg LOCKOUT preceding screen min CONT FALE mg h ZSO 19 Close and lock door Place fumon Um lt key a secure location CONFIRM ely After locking the door the PREVIOUS PCA bolus is available for infusion The patient presses pendant to initiate PCA dose 430 04685 004 5 17 Select Mode 20 Press to begin therapy Approximately 10 seconds after door is locked and 2 8 is pressed the Door LOCKED Message disappears E
48. INGE ALARM 430 04685 004 LifeCare PCA Infusion System 08 19A BATTERY AVAILABLE 08 19A USING BATTERY 08 19A CHECK INJECTOR ALARM 08 19A POWER ON MAY 17 2005 08 18A POWER OFF MAY 17 2005 08 18A DOOR OPENED 08 18A CHECK SETTINGS ALARM 08 18A DOOR LOCKED 08 18A DOOR OPENED 08 18A CHECK SETTINGS ALARM 08 18A DOOR LOCKED 08 18A BATTERY AVAILABLE 08 17A POWER ON MAY 17 2005 08 17A USING BATTERY 08 13A USING BATTERY 08 13A POWER OFF MAY 17 2005 08 13A NEW PATIENT NOT SELECTED 08 12A USING A C 08 12A POWER ON MAY 17 2005 08 12A POWER OFF MAY 17 2005 08 11A CONFIRM MORPHINE PF 1 mg mL 08 11A NEW PATIENT NOT SELECTED 08 11A USING A C 08 11A POWER ON MAY 17 2005 08 11A POWER OFF MAY 17 2005 08 10A HISTORY CLEARED H e e e e e e ke e de e ede cde de e e e de de e de dee e de de de de e de He He He He de KEK VERIFIED BY 2H he e he e e de e e ehe ode ee e e hehe e e de che e eode e e e e de e he ke e ee ee de e e e e e de dede eee de e e e ee e ke ke k e k k k kk END OF RECORD Se e e ee e he e e ehe de de e e ke e hehe e ee he eee e ke he he ee e e ke e e ee 430 04685 004 NOTES Select Mode 430 04685 004 LifeCare PCA Infusion System Section 6 Advanced Programming with Hospira MedNet Software The following topics are addressed in this section Guided Start up Using Hospira MedNet Software Select CCA e Updating the Drug Library e Soft Limit Overr
49. IUM CHLORIDE CAUTION DO NOT STERILIZE BY HEAT STEAM ETHYLENE OXIDE ETO OR RADIATION APPLY DISINFECTANTS TO THE OUTSIDE SURFACE OF THE INFUSER ONLY USING ABRASIVE CLEANERS OR CLEANING SOLUTIONS NOT RECOMMENDED BY HOSPIRA MAY RESULT IN PRODUCT DAMAGE CAUTION AVOID INFUSER DAMAGE CLEANING SOLUTIONS SHOULD ONLY BE USED AS DIRECTED THE DISINFECTING PROPERTIES OF CLEANING SOLUTIONS VARY CONSULT THE MANUFACTURER FOR SPECIFIC INFORMATION CAUTION NEVER USE SHARP OBJECTS SUCH AS FINGERNAILS PAPER CLIPS OR NEEDLES TO CLEAN ANY PART OF THE PCA INFUSER Establish a routine weekly schedule for cleaning the infuser case front panel and patient pendant To clean proceed as follows Turn the PCA Infuser off with the ON OFF switch then disconnect from AC power 8 2 430 04685 004 LifeCare PCA Infusion System The exposed surfaces of the PCA Infuser may be cleaned with a lint free cloth dampened by one of the recommended cleaning solutions in the following list or mild nonabrasive soapy water Cleaning Solution Manufacturer Preparation Manu Klenz Calgon Vestal Per manufacturer s Laboratories recommendation Formula C Diversey Per manufacturer s Corporation recommendation Coverage VHBV Steris Corporation Permanufacturer s A division of recommendation Calgon Vestal Laboratories Sporicidin Sporicidin Per manufacturer s International recommendation Dispatch Caltech Industries Per manufac
50. MORPHINE PF 1 mg mL MDELIVER LOADING DOSE NOW DELIVER LATER S MORPHINE PF 1 mg mL SELECT DELIVERY MODE PCA ONLY CONT O CONTINUOUS PROTOCOLS b PREVIOUS 430 04685 004 LifeCare PCA Infusion System 13 Enter PCA dose value using MORPHINE PF 1 mg mL the keypad The value HENTER i i PCA DOSE range is displayed on the screen ENTER BUTTON If value is entered incorrectly press to change value 2mg milligrams Then press QU If programming changes need to be made select PREVIOUS to return to the preceding screen 14 Enter a Lockout Interval un PF value Value range is wEWiER LOCKOUT displayed on thescreen LOCKOUT M ENTER BUTTON If the value is entered 5 120 min 10 min incorrectly press to ines change the value 5 Then press QU If programming changes need to be made select PREVIOUS to return to the preceding screen 430 04685 004 5 15 Select Mode 15 Enter a Continuous Rate MORPHINE PF The value range is BENER displayed on screen BEN E ENTER BUTTON If the value is entered 0 1 20 mglhr mg incorrectly press change the value Then press GU If programming changes need to be made select PREVIOUS to return to the preceding screen 16 seta specific dose limit by MORPHINE PF selecting gt and advancing to the DOSE LIMIT ENTER VALUE SCREEN Or select No to choose No DOSE L
51. NNECT THE SET DURING THIS OPERATION 1 If Yes gt is selected MORPHINE PF disconnect the set from the DI CONNE T patient and press and hold f S EROM PRESS AND HOLD the PURGE gt Softkey N NOTE While purging is occurring the word PURGING will be displayed PREVIOUS NOTE Purging is recommended to remove system slack when a new vial is inserted The maximum volume delivered during a purge is 3 mL Upon release of the Purce gt MORPHINE PF Softkey the display asks if main the purge is complete M OU EETER 2 Select Yes to continue or select No to purge again until complete Reconnect set to patient 430 04685 004 4 29 Loading Dose Basic Operation After the drug concentration has been confirmed an optional loading dose may be programmed to provide an immediate bolus to the patient 1 Set Loading Dose if desired by selecting YES gt If No gt is selected the screen advances to the SELECT SCREEN See Modes of Delivery on page 5 2 for information on modes NOTE A supplemental loading dose can also be delivered after the programming sequence is complete and infusing by opening the door and selecting the LOADING DOSE gt key Enter a Loading Dose within the displayed range Then press 1132 4 30 MORPHINE PF 1 mg mL ESET LOADING DOSE MORPHINE PF 1 mg mL ENTER LOADING DOSE PRESS ENTER BUTTON 0 1 10 mg 2 mg millig
52. SE LIMIT 1 Unlock door to stop the MORPHINE PF mg m i PAUSED infuser T 2 Select CHANGE Ro mice ae NOTE CHANGE gt will only LOADING DOSE gt display if Hospira MedNet CHANGE Software has been enabled CLEAR SHIFT gt re CHANGE 3 Select NEXT gt to display MORPHINE PF 1 mg mL options SELECT SETTING TO CHANGE SAVE amp EXIT Select Dose MORPHINE PF 1 mg mL SELECT SETTING TO CHANGE LOCKOUT DOSE LIMIT e SAVE amp EXIT 430 04685 004 5 25 Set a specific dose limit by selecting YEs then advance to the DOSE LIMIT ENTER VALUE SCREEN Or select No to choose No DOSE LIMIT No Dose Limit will be selected for this example Select ConFiRM gt to verify the No Dose Limit selection Or select PREVIOUS to return to the preceding screen Press SAVE amp gt at the next screen This will bring up the REVIEW CONFIRMATION SCREEN Select Mode MORPHINE PF 1 mg mL PREVIOUS gt MORPHINE PF 1 mg mL CONFIRM NO DOSE LIMIT C PREVIOUS MORPHINE PF 1 mg mL SELECT SETTING TO CHANGE LOCKOUT DOSE LIMIT aD SAVE amp EXIT 430 04685 004 LifeCare PCA Infusion System 8 Press to accepta MORPHINE PF new program LOCKOUT 4 HOUR LIMIT NO CONFIRM PREVIOUS Clearing the History and or Rx Settings 1 To clear the HISTORY AND RX settings turn th
53. System Operating Manual For Use With List 20709 04 LIFECARE PGA W MedNet 430 04685 004 Rev 01 06 For Systems With Hospira MedNet Software Change History Title Description of Change Pages Affected 430 04685 001 Original Release All Rev 7 05 430 04685 002 Second Release All Rev 09 05 430 04685 003 Third Release All Rev 10 05 430 04685 003 Fourth Release All Rev 01 06 430 04685 004 Rev 01 06 i LifeCare PCA Infusion System Table of Contents Section 1 Descriptive Information 1 1 PRODUCT DESCRIPTION 1 1 INDICATIONS FOR USE 1 2 patient selection 1 3 user qualifications 1 3 CONTRAINDICATIONS FOR USE 1 3 CONVENTIONS ome Baden edere suche rer S eS 1 4 warnings cautions and notes 1 4 DEFINITIONS GENERAL AND CLINICAL 1 6 PRECAUTIONS AND WARNINGS 1 11 UNPACKING eect Sateen Gn 1 11 general Jet Pediat 1 11 programming eee 1 12 loading dose dose 1 12 Operation eser tp REN e EN EU 1 13 maintenance 1 13 alarms 5i e SU REN nen 1 14 epidural administration
54. The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less Select YES gt or NO gt BNEW gt 3 If NO is selected the History and Rx settings are kept 4 Ifthe YES gt option is selected the History and HISTORYAND Rx settings are cleared RX SETLINGS Select CONFIRM gt to confirm choice and continue A screen appears to confirm that History was cleared 430 04685 004 4 7 Select CoNFIRM to accept the inserted drug or remove the vial if it is not correct Select either YEs or No to purge the system See Purging the System on page 4 28 for more information If YES gt is selected disconnect the set from the patient and press and hold the PuRGE gt Softkey While purging is occurring the word PURGING is displayed NOTE Purging is recommended to remove system slack when a new vial is inserted The maximum volume delivered during a purge is 3 mL Basic Operation MORPHINE PF 1 mg mL CONFIRM 1 mami MORPHINE PF TO RX MORPHINE PF 1 mg mL PURGE PURGING RECOMMENDED MORPHINE PF 1 mg mL DISCONNECT SET FROM PREVIOUS 430 04685 004 LifeCare PCA Infusion System Upon release of the PURGE gt MORPHING DF Softkey the display asks if mg mL the purge is complete 8 Select Yes to continue or select No to purge again until complete 9 After purging is complete reconnect set to patient 10 set Loadi
55. amming are indicated on the INFUSION SCREEN with an appropriate upper or lower limit arrow See Important Symbols on page 6 11 for details Hard Limit Violation When entering parameters if a hard MORPHINE PE limit is exceeded a HARD LIMIT 1 VIOLATION SCREEN is displayed Hard limits cannot be overridden The only NOT way to continue is to select CHANGE gt to ALLOWED FOR change the parameter MED AND CCA 6 10 430 04685 004 LifeCare PCA Infusion System Important Symbols No RULE SETS MORPHINE PF The Cautionary Symbol N is displayed on the infusion screen to advise the user to program with caution because the established rule set does not have any milligrams soft or hard safety limits TOT L DELIVERED CONT RATE 1 mg hr PCA CONT PCA AVAILABLE NO 4 HR LIMIT SorT LIMIT OVERRIDE Th r nd lower MORPHINE e upper and lower Ve Soft Limit Override symbols PACU are displayed on the SGV ANAT infusion screen to inform e the user that one or more soft limits have been overridden CONT RATE 1 mg hr 430 04685 004 6 11 Advanced Programming with Hospira MedNet Software WIRELESS The Wireless Kp symbol is MORPHINE PF 1 mami displayed to inform the user PAGU that the PCA Infuser has an active connection to the wireless network The wireless icon is only displayed on the Waiting for Autoprogram SCREEN This symbol indicates that the PCA Infu
56. an s order programs the infuser with operating parameters which may include the following e Drug Dose and Concentration e Loading Dose e Delivery Mode Setting e PCA e CONTINUOUS e PCA CONTINUOUS PCA Dose e Lockout Interval e Continuous Rate 104 Hour Dose Limit factory setting 4 hour when using DDL e Protocols Hospital configured programs stored in the infuser Available operating parameters and their allowed ranges are determined based on the confirmed vial and the delivery mode selected The loading dose and dose limits are optional This programmed flexibility allows the physician to tailor an effective pain management program unique to each patient 430 04685 004 2 1 Principles of Operation The PCA Infuser may be programmed to deliver the following e doses PCA Mode e Continuous background infusion with no PCA doses permitted CONTINUOUS Mode e Continuous rate PCA doses PCA CONTINUOUS Mode Analgesic drugs may be delivered through the PCA Infuser intravenously by any of the three modes cited above In addition Preservative Free Morphine Sulfate Injection USP or other approved analgesic drugs can be administered epidurally through a recommended Low Priming Volume PCA Set without a Y adapter The epidural route may be used to provide analgesia by any of the three modes of infuser operation A lockout Interval controls the frequency that a patient may receive a PCA dose of analgesic
57. and will deliver at least 30 mL of solution The battery charges whenever the PCA Infuser is connected to AC mains power If the PCA Infuser is switched off a recharge takes approximately 16 hours The recharge takes longer if the PCA Infuser is turned on 8 4 430 04685 004 LifeCare PCA Infusion System As a general rule the more often the battery is partially discharged and recharged the sooner it will need to be replaced Consult a qualified Biomedical technician for battery replacement if necessary To maintain maximum battery charge and to prolong battery life connect the PCA Infuser to AC mains power whenever possible Service All servicing or adjustments to the PCA Infuser should be referred to qualified technical personnel A technical service manual may be ordered from the local Hospira sales office 430 04685 004 8 5 NOTES Maintenance 430 04685 004 LifeCare PCA Infusion System Section 9 Specifications Administration Sets Use only compatible Hospira Abbott PCA sets with Integral Anti Siphon Valve Atmospheric 0 10 000 feet 0 3 000m or equivalent Pressure pressure Battery One sealed lead acid rechargeable 8 V battery internal to device Accessible for ease of field replacement with color coded leads and polarized connector Battery Life A conditioned battery at full charge should operate for approximately 2 5 hours of continuous operation before a LOW BATTERY alarm The PC
58. e reconnect set to patient 6 4 430 04685 004 LifeCare PCA Infusion System 11 se Loading Dose if MORPHINE PF desired by selecting YES gt PACU See Loading Dose on page 4 30 for more information 12 Entera Loading Dose within MORPHINE PF 1 mg mL the displayed range LOADING DOSE THEN PRESS Then press ENTER BUTTON 0 1 10 mg 2 mg milligrams PREVIOUS 13 The DeLiver LoADING Dose Now MORPHINE PF SCREEN allows the option of PACU delivering the loading dose now or after the programming is complete DELIVER LOADING DOSE NOW 2 DELIVER LATER 430 04685 004 6 5 Advanced Programming with Hospira MedNet Software 14 it ves was selected press MORPHINE PF eo to infuse the programmed Loading 10 Dose LOADING DOSE d 55 START BUTTON TO INFUSE NOTE The LOADING DOSE Mode is the only mode that the infuser will deliver with the door PREVIOUS unlocked WARNING Always monitor the infuser when delivering medication with the door unlocked 15 it the DELIVER Later option is desired the screen advances to the SELECT DELIVERY MODE SCREEN See Modes of Delivery on page 5 2 for more information 16 The screen displays the MORPHINE PF amount of analgesic pes delivered as it infuses The PAUSE BUTTON bottom of the screen displays text confirming that the Loading Dose is being delivered Upon completion the red LED above the LCD displays the amou
59. e at Hospira s option the repair or replacement of the product In no event shall Hospira s liability arising out of any cause whatsoever whether such cause be based in contract negligence strict liability other tort or otherwise exceed the price of such product and in no event shall Hospira be liable for incidental consequential or special damages or losses or for lost business revenues or profits Warranty product returned to Hospira must be properly packaged and sent freight prepaid The foregoing warranty shall be void in the event the product has been misused damaged altered or used other than in accordance with product manuals so as in Hospira s judgment to affect its stability or reliability or in the event the serial number or lot number has been altered effaced or removed The foregoing warranty shall also be void in the event any person including the Purchaser performs or attempts to perform any major repair or other service on the product without having been trained by an authorized representative of Hospira and using Hospira documentation and approved spare parts For purposes of the preceding sentence major repair or other service means any repair or service other than the replacement 430 04685 004 C 1 Warranty of accessory items such as batteries and detachable mains power cords In providing any parts for repair or service of the product Hospira shall have no responsibility or liability for the
60. e infuser orr and on again to get to the PATIENT NEW PATIENT Screen 2 Press Yes gt and HISTORY AND RX settings are cleared NOTE The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less If off for more than 4 hours the HISTORY AND RX are automatically cleared and the NEW PATIENT SCREEN is not displayed 3 Select CoNriRM to accept MORPHINE PF the inserted drug or remove the vial if it is not correct CONFIRM 1 mami MORPHINE PF TORX 430 04685 004 5 27 Select Mode Using Review Confirmation Screens Prior to locking the infuser and removing the key a REVIEW CONFIRMATION SCREEN appears as shown below As determined by the programmed mode of delivery the screen displays the current settings for the applicable parameters including PCA Dose Lockout Interval Continuous Rate and Dose Limit 5 28 Clinicians should review each MORPHINE PF programmed parameter and ensure that the displayed program agrees with the physician s order 1 mg mL PCA CONT PCA DOSE LOCKOUT mg LOCKOUT i If all of the programmed parameters 10 AGREE with the physician s order m the clinician accepts the settings by selecting CONFIRM gt CONFIRM If one or more of the programmed PREVIOUS 4 parameters do not agree with the physician s order the clinician should select PREVIOUS gt until the incorrectly programmed parameter s is displayed Depending on the incorrect parameter s
61. for a sample history printout in the PCA CONTINUOUS Mode 430 04685 004 5 39 Select Mode Kc e e ce e de he e che e ede he he de e cde ce ce e ce KK KKK KKK HOSPIRA LifeCare PCA PATIENT RECORD e e e e ede e ede de e e e e e de ee e de ce de che e he e e e ee dece ce e KKK e e SERIAL NUMBER 00000143 SOFTWARE VERSION 5 00 PATIENT NAME DRUG ADMINISTERED PM 04 52 MAY 17 2005 MODE PCA CONTINUOUS SETTINGS MORPHINE PF CCA PCA DOSE PCA LOCKOUT CONTINUOUS RATE 4 HOUR LIMIT DELIVERED LOADING DOSE 4 HOUR DOSE TOTAL LAST 1 HOUR PCA COMPLETED PCA PARTIAL PCA DENIED LOADING DOSE TOTAL LAST 24 HOURS PCA COMPLETED PCA PARTIAL PCA DENIED LOADING DOSE TOTAL EVENT LOG 04 52P SET 4 HR LIMIT 04 52P SET CONT RATE 04 52P SET PCA LOCKOUT 04 52P SET PCA DOSE 04 52P SET PCA CONT MODE 04 52P RX SETTINGS RETAINED 04 52P CONFIRM MORPHINE PF 430 04685 004 LifeCare PCA Infusion System 430 04685 004 CHECK SYRINGE ALARM CHECK INJECTOR ALARM CHECK SYRINGE ALARM CHECK VIAL ALARM BAR CODE NOT READ ALARM CHECK VIAL ALARM BAR CODE NOT READ ALARM CHECK SYRINGE ALARM BAR CODE NOT READ ALARM CHECK SYRINGE ALARM CHECK VIAL ALARM DOOR OPENED CHECK SETTINGS ALARM DOOR LOCKED BAR CODE NOT READ ALARM CHECK VIAL ALARM CHECK SYRINGE ALARM CHECK VIAL ALARM BAR CODE NOT READ ALARM CHECK VIAL ALARM BAR CODE NOT READ ALARM CHECK VIAL ALARM BAR CODE
62. ge 0 1 mL hr 12 8 psig 0 92 mL 5 mL hr 12 6 psig 0 94 mL 20 mL hr 12 7 psig 0 96 mL Time from Occlusion to Alarm DELIVERY Jimmi OCCLUDE Average Average 0 1 mL hr 12 8 psig 12 hours 5 mL hr 12 6 psig 11 minutes 20 mL hr 12 7 psig 3 minutes Delivery Rate Accuracy Delivery accuracy is 5 at continuous delivery rates greater than 1 mL hr For accuracy data at other flow rates see the following typical trumpet curves The under delivery that may occur at rates less than 0 5 mL hr or bolus volumes less than 0 5 mL may be substantially greater than 5 and is due primarily to the variability of friction between the syringe plunger and barrel This under delivery may include periods of no delivery If multiple partial PCA doses are delivered the accumulated total reflected in the history totals may be more than the sum of the PCA doses logged in the event log This is due to the fact that only a portion of the next 0 1 mg or 1 mcg may have been delivered at the time any of the PCA doses were interrupted As 430 04685 004 9 5 Specifications these portions accumulate their combined total may account for 0 1 mg or 1 mcg TRUMPET CURVES The typical trumpet curve graphs following the example show representative maximum and minimum percent flow rate deviation from the programmed rate over time This information was developed in accordance with IEC 60601 2 24 1998 Sub
63. gree to which the instrument is capable of delivering the volume of analgesic drug that is displayed or targeted to be delivered Accuracy shall be specified as the maximum allowable delivery error from a targeted or displayed value see Section 9 Specifications on page 9 1 Autoprogramming Complete or partial program received from a bar code enabled Point of Care System requiring clinician confirmation prior to administration Battery Fault A battery that will not accept a full charge Bolus A fixed amount of drug delivered in a short amount of time A PCA dose Button A hard key on the front panel or on the patient pendant Clinical Care Area CCA An area of the hospital that authorized hospital staff is permited to use specific drugs The clinician selects a CCA after turning on the infuser The hospital may create from one to eighteen CCA s Connectivity A component of the infuser that controls Engine CE Ethernet and wireless communication between the network server and infuser Continuous Infusion program characterized by a constant fixed rate dose 430 04685 004 LifeCare PCA Infusion System TERMS DEFINITION Custom Syringe A bar coded Hospira Abbott sterile empty or Vial vial that is custom filled by a pharmacy Default Drug A pre programmed drug library embedded Library DDL in the infuser software The infuser uses the DDL
64. hernet Jack Printer Connector Univers al IV Pole Clamp with Dual LockTM NOTE Pole Clamp is locked when security door is closed and locked Unit cannot be removed from IV pole Battery and Fuse Cord Stabilizer Access Connector foot Door See pages 1 16 through 1 20 prior to interconnecting equipment 3 4 430 04685 004 LifeCare PCA Infusion System Operating Buttons amp Keys ON OFF The ON OFF Button controls the power of the PCA Infuser The CLEAR Button is used to clear an entry The ENTER Button is used to select and accept various screen options The EXIT Button is used to return to the main display from non programming screens e SILENCE Aa VOLUME 430 04685 004 The SILENCE VOLUME Button is used to temporarily silence an alarm while correcting a condition to temporarily silence an alarm while correcting a condition to temporarily mute the keypad for two minutes or to adjust alarm volume when the infuser is in run mode Equipment Description The START PAUSE Button is used to start or pause a e START continuous infusion or PCA PAUSE bolus The HISTORY Button is used to display parameter settings dose history review Rx and HISTORY review the event log It also provides access to the Print History Softkey Hospira Mednet Software not enabled The numeric Buttons are EXIT ENTER used to enter values
65. ician prescribed value that serves to limit the total dosage delivered in any 4 hour or 1 hour period This optional feature provides added safety that limits the total drug delivered in all delivery modes NOTE Dose limit periods are specified as 1 and 4 hours on a infuser using the Default Drug Library DDL on infusers using User Defined Drug Libraries created with the Hospira MedNet Software the dose limit periods are 1 4 6 or 12 hours There is a NO Dose Limit option as well with DDL and User Defined Drug Library The PCA Infuser is factory set to program a 4 hour dose limit For the purpose of simplifying this section examples will be written fora 4 hour dose limit program NOTE A supplemental Loading Dose may be delivered at any time during operation by opening the door and selecting the LOADING DOSE key When the sum of all doses PCA dose CONTINUOUS dose and any applicable loading or supplemental loading dose in a rolling 4 hour period equals or exceeds the 4 hour dose limit the patient s requests for PCA doses are denied and a 4 HR LIMIT REACHED Message appears In all modes the infuser stops delivery when the 4 hour dose limit is reached except during administration and delivery of a supplemental loading dose As the oldest dose either PCA dose CONTINUOUS dose ora supplemental loading dose ages out of the 4 hour dose record the 4 HR LIMIT REACHED Message disappears The infuser accepts patient initiated
66. ide e Hard Limit Violation e Important Symbols e Autoprogramming Guided Start up Using Hospira MedNet Software User Defined Drug Libraries are developed by hospital personnel in conjunction with the pharmacy using Hospira MedNet Software User Defined Drug Libraries allow hospitals to customize drugs in the library with preselected upper and lower delivery limits to ensure patient safety Hospira Abbott prefilled bar coded PCA Vials and custom vials with pharmacy generated bar codes may be used with the 430 04685 004 6 1 Advanced Programming with Hospira MedNet Software Hospira MedNet Software For instructions on how to produce pharmacy generated bar codes see Appendix A on page A 1 1 Press Burton load LIFECARE PCA drug vial into cradle to SELF TEST power infuser on See Loading a Vial on page 4 5 Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen This screen is followed by another screen displaying self test information that includes the following time date drug library software version and copyright data During the self test the infuser reads the bar code label 2 Select CONTINUE to advance LIFECARE PCA SELF TEST to the next screen Sel Teo SYSTEM SETTINGS CONTINUE 6 2 430 04685 004 LifeCare PCA Infusion System 3 New PATIENT SCREEN appears if the infuser has been off for 4
67. ine is not operating correctly or has loose or defective connections to its sensing electrodes these artifacts may be accentuated so as to simulate actual physiological signals To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some other source in the environment set the infusion device so that it is temporarily not delivering fluid Disappearance of the abnormality indicates that it was probably caused by the electronic noise generated by the infusion device Proper setup and maintenance of the monitoring equipment should eliminate the artifact Refer to the appropriate monitoring equipment system documentation for setup and maintenance instructions The PCA Infusion System is designed to operate normally in the presence of most encountered electromagnetic interference EMI conditions In the event of extreme levels of interference 430 04685 004 LifeCare Infusion System such as those encountered next to an electrosurgical generator it is possible that the normal operation of a sensor or microcom puter might be disrupted Even in this event the outcome would likely be a false alarm or detected system malfunction and would not result in a hazard to the patient or clinician e This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93 42 EEC EN 55011 Class B and IEC EN 60601 1 2 2001 These limits are designed to provide reaso
68. ira MedNet Software is enabled and the infuser stalls or suspends communication with an external devices such as the MMU for an inordinate amount of time discontinue use and send the infuser to the Biomed Department for restarting 430 04685 004 LifeCare PCA Infusion System Section 8 Maintenance The following topics are addressed in this section e infuser Storage e Cleaning and Sanitizing e Battery Maintenance e Service Infuser Storage To prolong the life of the Infuser observe the following storage precautions e Store away from excessive heat cold and humidity e Store the PCA Infuser connected to AC mains power e Switch off using the ON OFF key 430 04685 004 8 1 Maintenance Cleaning and Sanitizing Establish a routine infuser cleaning schedule to keep it contamination free CAUTION ALWAYS CHECK THAT THE BAR CODE READER WINDOW IS CLEAN BLOOD FINGERPRINTS CONDENSATION AND OTHER ELEMENTS MAY OBSTRUCT THE VIEW OF THE BAR CODE READER ELEMENTS ON THE WINDOW OTHER THAN SCRATCHES CAN BE CLEANED BY USING ONE OF THE RECOMMENDED CLEANING SOLUTIONS IN THIS SECTION CAUTION TO AVOID MECHANICAL OR ELECTRONIC DAMAGE DO NOT IMMERSE THE PCA INFUSER IN ANY FLUIDS OR CLEANING SOLUTIONS CAUTION SOME CLEANING AND SANITIZING COMPOUNDS MAY SLOWLY DEGRADE COMPONENTS MADE FROM SOME PLASTIC MATERIALS DO NOT USE COMPOUNDS CONTAINING COMBINATIONS OF ISOPROPYL ALCOHOL AND DIMETHYL BENZYL AMMON
69. irm that the power plug icon is illuminated on the front of the infuser 430 04685 004 4 19 Basic Operation To verify readiness for operation a systematic self testing of the processing delivery and safety systems is performed whenever the PCA Infuser is turned on CAUTION DO NOT PLACE THE PCA INFUSER IN SERVICE IF IT FAILS THE SYSTEM SELF TESTS NOTE If the quality of the earth grounding source is in doubt use battery power Self test failures are reported in the Malfunction Log as a Malfunction Condition If an alarm occurs during the Power On Self Test identify the alarm message then take corrective action see section Alarms and Messages on 7 4 Power the infuser ON If the alarm recurs remove the PCA Infuser from service and contact the hospital biomedical department or the local Hospira representative Unlock the door and press the ON OFF Button or insert the vial to turn the power on Check the screen display and listen for a beep that indicates the audio is working Wait for the self tests to complete If a vial was not previously inserted and the self test was successful put a vial with a fully primed set into the infuser NOTE When operating on battery power a LOW BATTERY Message displays to prompt for an AC power connection CAUTION DO NOT OPERATE THE PCA INFUSER WITH THE BATTERY REMOVED USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS ENSURE PROPER OPERATION To ensure a full
70. is adjustable to low medium or high by accessing system settings during self test 430 04685 004 LifeCare Infusion System at Start up It can also be accessed by pressing SILENCE VOLUME when infuser is in RUN Mode Select desired volume of alarm then press SAVE AND EXIT Softkey NOTE The infuser stops delivery when any of following alarms occur CHECK INJECTOR CHECK VIAL CHECK SYRINGE EMPTY SYRINGE OCCLUSION DEAD BATTERY or MALFUNCTION Silencing an Alarm To silence an alarm press the SILENCE key then follow the displayed messages All alarms except the MALFUNCTION CHECK VIAL CHECK INJECTOR and CHECK SYRINGE can be muted Clear the cause of the alarm if possible and press the START PAUSE key to resume operation for Continuous or PCA Continuous Modes The original display message will be restored NOTE If the MALFUNCTION alarm sounds press the ON OFF key to turn the infuser off Turn the infuser on If the malfunction repeats remove infuser from service Refer infuser to the hospital s technical support or contact Hospira Technical Support Operations NOTE In the event two or more alarms conditions simultaneously occur the alarm with shortest muting period will take priority and be displayed first If the alarm is muted and a second alarm condition occurs during the muting period an audible alarm signaling the new condition will immediately occur NOTE Alarm cadence can be configured for
71. ligrams is locked out TOTAL DELIVERED 2 If the Patient Pendant is partially pressed a Pendant Fault Message appears This is corrected by releasing the button When the Dose Limit is reached a message is displayed to indicate the Dose Limit has been reached NOTE A clinician may stop a PCA dose delivery in progress without unlocking the door by pressing the STOP PAUSE BUTTON 430 04685 004 LifeCare PCA Infusion System Continuous Mode For detailed startup information including vial insertion clearing settings purging and setting a Loading Dose see Loading a Vial on page 4 5 For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 21 1 Unlock door and press LIFECARE PCA Button or load drug vial into SELF TEST cradle to power on the infuser Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen Select CONTINUE to advance to the next programming screen Select Yes or No at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less See New Patient on page 4 27 for more information Select CONFIRM to accept the inserted drug or remove the vial if it is not correct See New Patient on page 4 27 for more information Select either YEs or No to purge the system See Purging the System on page 4 28 for more information 430 04685 004 5 9 Selec
72. ming changes need to be made select PREVIOUS to return to the preceding screen 430 04685 004 LifeCare PCA Infusion System 18 seta specific dose limit by MORPHINE PF selecting gt and advancing to the Dose Limit Enter Value SCREEN Or select No to choose No Dose Limit No Dose Limit will be PREVIOUS selected for this example If Hospira MedNet Software is enabled and upper hard or soft limit has been assigned for a that CCA and drug then a Dose entry is required and this screen will not be displayed NOTE See Dose Limit on page 5 21 1 or 4 hour for complete information about this feature 19 Select gt to verify the MORPHINE PF 1 mg mL No Dose selection CONFIRM NO DOSE LIMIT Select PREVIOUS to return to the preceding screen PREVIOUS 430 04685 004 Select Mode 20 Select gt to verify MORPHINE PF 21 settings Or select PCA DOSE PREVIOUS to return to the LOCKOUT preceding screen Close and lock door Place key in a secure location CONFIRM After locking the door the PREVIOUS PCA bolus is available for infusion Patient presses pendant to initiate PCA dose Approximately 10 seconds MORPHINE PF after the door is locked the p TOR Door Message disappears After delivering AO ee ie the PCA dose the PCA LOCKOUT Message appears 7 5 mg lt mo indicating the PCA Infuser milli 0 mil
73. n for reference The human readable label is on the right side of the vial and is not shown on this illustration Concentration Drug Name and 430 04685 004 A 3 Generating Barcode Labels LABEL DIAGRAM The label diagram below depicts the area where the bar code image must be placed within the dimensions shown The copy area length and width must be as specified 1 32 The center bar code includes 1 4 quiet zone on each side of the bar code The bar code and comodity number must be black on a white background White 129 32 w Background 1 8 1 8 Drug Copy Barcode 15 16 Atea 7 8 1 8 I 2 17 32 Concentration 01 0 030074 202904 9 A 4 430 04685 004 LifeCare PCA Infusion System The dimensions shown on the previous label diagram represent Hospira s recommendation for placement of the bar code and drug name concentration on a 3 x2 label The guidelines ensure the device s integral bar code reader will align correctly with the bar code on the PCA vial Your institution may choose to use a different format for placement of the drug name and concentration based on your specific hospital guidelines or size of the label However it is recommended that the system be validated before use 430 04685 004 A 5 Generating Barcode Labels NOTES 430 04685 004 LifeCare PCA I
74. n indication to advise the clinician of a possible dangerous condition 430 04685 004 LifeCare Infusion System Precautions and Warnings UNPACKING Product damage may occur unless proper care is exercised during the unpacking and setup process The battery may not be fully charged upon receipt GENERAL This section addresses general safety and operational procedures e Possible explosion hazard exists if used in the presence of flammable anesthetics WARNING Possible explosion hazard exists if the infuser is used in the presence of flammable anesthetics Potent analgesic medications are used with this device Refer to drug package insert for precautions and possible adverse reactions e Refer to analgesic package enclosure for possible incompatibil ity with fluid or drug being delivered through the IV line e Coupling together of more than one infuser into one patient may significantly affect the infusion rate of at least one of the infusers e Do not use sharp objects such as pens scissors or fingernails to press keys Such objects may damage keys and cause a malfunction e Arrange tubing cords and cables to minimize the risk of patient strangulation or entanglement Failure to use Hospira Abbott vials and Hospira Abbott PCA Infuser sets with the integral anti siphon valve may cause an inaccurate dose delivery to the patient e The system must be primed prior to purging Remove all ai
75. nable protection against harmful interference in a typical medical installation The equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity How ever there is no guarantee that interference will not occur a particular installation If this equipment causes harmful interfer ence with radio television or other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving device e Increase the separation between the equipment e Connect the equipment into an outlet on a circuit different from that to which the other device s is connected e Consult the manufacturer or field service technician for help e Portable and mobile RF communications equipment such as cellular telephones 2 way radios Bluetooth devices micro wave ovens in close proximity to this device may affect wire less and wired communications with the infusion pump and or the operation of the infusion pump Special precautions need to be exercised regarding EMC These include e Use of a shielded Ethernet cable CAT5 STP or better for plugging into the RJ45 Ethernet connector Using an unshielded Ethernet cable may result in increased emissions e Maintaining a minimum separation di
76. nformation PCA ONLY i CONT CONTINUOUS PROTOCOLS SD PREVIOUS 430 04685 004 4 11 Basic Operation Guided Start up for Custom Vials NOTE Custom vials without LIFECARE PCA pharmacy generated bar codes can only be used with the default drug library SELF TEST 1 Press sur or load drug vial into cradle to power on the infuser See Loading a Vial on page 4 5 Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen This screen is followed by another screen displaying self test information that includes the following time date drug library software version and copyright data During the self test the infuser reads the bar code label 2 Select CONTINUE to advance LIFECARE PCA SELF TEST to the next screen SELF TEST SYSTEM SETTINGS CONTINUED 4 12 430 04685 004 LifeCare PCA Infusion System 3 New PATIENT SCREEN appears if the infuser has been off for 4 hours less PATIENT Select YES gt or NO gt IfNO gt is selected the History and Rx settings are kept D if the YES option is selected the History and Rx settings are cleared Select CONFIRM gt to confirm choice and continue A screen appears to confirm that history was cleared HISTORY RX SETTINGS CLEARED NOTE An Alpha Vial is a type of sterile empty vial that can be customized by your hospital pharmac
77. nfuser stops all drug delivery NOTE Dose Limit periods are specified as 1 and 4 hours on an infuser with the Default Drug Library Dose Limit periods on infusers with a User defined Drug Library may be defined as 1 4 6 or 12 hours NOTE In CONTINUOUS or PCA CONTINUOUS Mode The START PAUSE Button must be pressed within 30 seconds of locking the door or the infuser sounds an alarm 430 04685 004 5 3 Select Mode PCA Only Mode For detailed startup information including vial insertion clearing settings purging and setting a Loading Dose see Loading a Vial on page 4 5 For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 21 1 Unlock door and press LIFECARE PCA Button or load drug vial into SELF TEST cradle to power on the infuser Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen Ka pa Hospira pw Select CONTINUE to advance to the next programming screen Select Yes or No at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less See New Patient on page 4 27 for more information Select CONFIRM to accept the inserted drug or remove the vial if itis not correct See New Patient on page 4 27 for more information Select either YEs or No to purge the system See Purging the System on page 4 28 for more information If gt is selected disco
78. nfusion System Appendix B Network Printer Setup This section provides information about the printing function EQUIPMENT NEEDED e infuser e Computer meeting the printer setup require ments e Network crossover cable PREPARATION e Connect the crossover cable between the printer network port and the computer Plug infuser amp printer into AC power Turn on the infuser and printer PROCEDURE 1 Identify the printer IP settings refer to printer operating instructions 2 Using the printer operating instructions configure the printer to match the infuser s printer network settings the IP address is 192 168 0 222 and subnet mask 255 255 0 0 3 Testthe installation Disconnect the crossover cable from the PC and connect it to the infuser Power up the infuser and print the history log 430 04685 004 B 1 Network Printer Setup PRINTING EVENT HISTORY LOG The history event log can be printed by connecting the infuser to a network ready printer Use the previous instruc tions to configure the printer WARNING Disconnect the infuser from the patient before connecting the infuser to a printer or computer To print from the PCA Infuser complete the following steps 1 2 o oo Load printer with paper Connect a network crossover cable between the printer and the infuser Plug infuser amp printer into AC power Turn on infuser and confirm drug and concentration Press History touch switch t
79. ng Dose if MORPHINE PF desired by selecting YES gt See Loading Dose on page 4 30 for more information 11 Entera Loading Dose within MORPHINE PF 1 mg mL the displayed range Then MENTER es press Gur ETHEN PRESS ENTER BUTTON 0 1 10 mg 2 mg milligrams PREVIOUS gt 430 04685 004 Basic Operation 12 The Loanne Dose Now MOPE INT PE SCREEN allows the option of BER oo delivering the loading dose NONE now or after the programming is complete DELIVER LATER S 13 it YES gt was selected MORPHINE PF 1 mg mL ress the Button to infuse impress START BUTTON the programmed Loading TO INFUSE 2m LOADING DOSE Dose NOTE The loading dose mode is the only mode that the infuser will deliver with the door unlocked WARNING Always monitor the infuser when delivering medication with the door unlocked 14 it the DELIVER Later option is selected the screen advances to the SELECT DELIVERY MODE SCREEN 4 10 430 04685 004 LifeCare PCA Infusion System 15 The screen displays the MORPHINE PF amount of analgesic delivered as it infuses The PAUSE BUTTON bottom of the screen displays text confirming that the Loading Dose is being delivered Upon completion O 1 9 milligrams lt the red LED above the LCD displays the amount LONG Bose delivered 16 The SELECT SCREEN MORPHINE PF appears See Modes of os Delivery on page 5 2 for more DELIVERY MODE i
80. nnect the set from the patient and press 4 hold the PURGE gt Softkey 430 04685 004 LifeCare PCA Infusion System 7 Select Yes to continue or select No gt to purge again until complete 8 Reconnect set to patient 9 set Loading Dose if desired by selecting YES See Loading Dose on page 4 30 for more information 10 Enter a Loading Dose within the displayed range 11 Then press QUID 12 select Yes to infuse the MORPHINE PF programmed Loading Dose Select DELIVER LATER to delay loading dose delivery BDELIVER LOADING DOSE NOW DELIVER 1 13 From the Select Delivery t Mode SCREEN select PCA eiter ONLY DELIVERY MODE PCA ONLY CONT CONTINUOUS PROTOCOLS PREVIOUS 430 04685 004 5 5 14 Enter the desired dose using the numeric keypad If the value is entered incorrectly press change value 15 Then press Gm If programming changes need to be made select PREVIOUS to return to the preceding screen 1 6 Enter a lockout Interval value The value range is displayed on the screen If the value is entered incorrectly press 3 change value 17 Then press QUID Select Mode MORPHINE PF 1 mg mL ENTER PCA DOSE PRESS ENTER BUTTON 2mg milligrams MORPHINE PF 1 mg mL HENTER LOCKOUT INTERVAL PRESS ENTER BUTTON 5 120 min 10 min minutes PREVIOUS gt If program
81. nnected from the patient s IV line before pressing YES gt to initiate the purge cycle To remove system slack when a new syringe is installed we recommend purging the infuser before beginning operation Press and hold the PURGE gt key The flow rate during purging is approximately 250 mL hr As soon as fluid is seen at the end of the administration set and no air remains in the set release the key After the PURGE gt key is released the purge cycle will stop and the infuser prompts you to respond if flow was seen If flow was not seen the cycle may be repeated until a total of 3 mL has been delivered NOTE The infuser only allows the user to purge if Manual Purge is enabled in Biomed Mode If it is disabled purging is not an option NOTE Prime the system before purging Remove all air from the syringe before loading it into the infuser NOTE Drug delivered during the purge cycle is not stored in system memory and will not be displayed CAUTION IN CONTINUOUS AND PCA ConrTINUOUS MODES IF A PURGE IS NOT PERFORMED AFTER A SYRINGE CHANGE THE INFUSER AUTOMATICALLY PERFORMS A SMALL SYSTEM COMPLIANCE STEP TO REMOVE SLACK WHEN START 15 PRESSED WITH THE DOOR LOCKED ALTHOUGH FLUID IS NOT NORMALLY DELIVERED TO THE PATIENT DURING THE COMPLIANCE STEP UNDER SOME CONDITIONS UP TO 0 3 ML OF FLUID MAY BE DELIVERED IF 0 3 ML OF FLUID REPRESENTS A 4 28 430 04685 004 LifeCare PCA Infusion System HAZARD TO THE PATIENT DISCO
82. nt delivered a5 Mmg lt miig O LOADING DOSE 6 6 430 04685 004 LifeCare PCA Infusion System 17 The SELECT MODE SCREEN MORPHINE 1 mg mL appears See Modes of s Delivery page 5 2 for more f DELIVERY MODE information ONLY CONT CONTINUOUS PROTOCOLS b PREVIOUS Select CCA The SELECT CCA SCREEN displays if a user defined drug library is installed SELECT CCA with more than one CCA Select the option appropriate for the patient If there is only one CCA this screen will not display NOTE The prior CCA flashes NOTE If the wrong is unintentionally chosen turn the Infuser off then on and select the correct CCA NOTE When using the Protocol feature be aware that the Protocol numbers are unique to each Clinical Care Area For example the protocol for Morphine PF 1mg mL concentration for PCA Cont delivery with a PCA dose of 1mg and continuous rate of 0 5mg may be assigned protocol No 1 in the Surgical CCA and No 6 in the Medical CCA 430 04685 004 6 7 Advanced Programming with Hospira MedNet Software Updating the Drug Library When the user presses OFF to shut the Infuser down if a new user defined NEW DRUG drug library is available for installation AVAILABLE the infuser will display the NEW DRUG LIBRARY AVAILABLE SCREEN 1 Select No gt to skip the installation and continue using the current library The infuser
83. o view the history on the display Press Print HISTORY Softkey to print history log NOTE After the infuser is turned on to initiate printing please allow 2 3 minutes for the infuser to complete start up before attempting to print the event log If the entire log is not successfully printed e g the header is missing reprint the log by pressing the Print HiSTORY gt Softkey B 2 430 04685 004 LifeCare PCA Infusion System Downloading Logs to a PC EQUIPMENT NEEDED e infuser e PC with Hyper Terminal program e Network crossover cable PREPARATION Connect the crossover cable between the computer and the infuser Turn on the infuser and the PC PROCEDURE 1 Create a Hyper Terminal connection Im Pogams Accessories d Communications gt HyperTerminal command Prompt Internet Connectic 4 Documents Microsoft office Y 4 NetMeeting Network and Dial u Bh 8 PrintMusic 2004 gt Phone Dialer A Search 8 Expert Software Paint shopProg 9 Help Y ue AJ 0 Framema windows Media Curgetaft Manual nse 430 04685 004 B 3 Network Printer Setup 2 Create a PCA Events connection setting Caneecthon DescHpl ka Mew Connection Enter mama ba the Hara 3 Establish the connection settings Host address is the IP address of
84. olicies and procedures for the following e Generating Bar Code Labels Applying Labels to Empty Sterile Vials e Filling Labeled Empty Sterile Vials Validating Correctly Filled and Labeled Vials Incorrect labels or filled vials may lead to significant and potentially fatal adverse events The following are general specifications for producing labels containing pharmacy generated bar codes for custom drugs These labels are adhered on the Hospira Abbott Sterile Empty Vials and should cover the entire existing Sterile Empty Vial bar code The proper placement of the pharmacy generated bar code label on the Sterile Empty Vial is shown in the Label Diagram on page 4 Correct placement of the pharmacy generated bar code on the Sterile Empty Vial helps ensure proper reading of the bar codes by the LifeCare PCA Infuser 430 04685 004 A 1 Generating Barcode Labels EQUIPMENT 1 Barcode thermal printer 300 DPI or higher 2 Barcode label software capable of producing labels ANSI X3 182 1990 EAN UCC Code 128 Code Set C numeric characters only ANSI Grade C or better 10 mil 0 010 inches pitch minimum Bar code height is 1 inch 18 Characters max 3 Opaque polyester labels non paper labels which are water and smudge resistant are recommended 430 04685 004 LifeCare PCA Infusion System EXAMPLE OF LABEL LAYOUT amp SAMPLE Example of a pharmacy generated bar code label on a PCA vial The plunger is show
85. ompletion kg EN EN 9 O the red LED above the INFUSING LCD displays the amount LOADING DOSE delivered The SELECT MODE SCREEN appears See Modes of 10 megimL Delivery on page 5 2 for more information PCA ONLY CONT CONTINUOUS lt PROTOCOLS 5 5 4 18 430 04685 004 LifeCare PCA Infusion System Getting Started This section details the PCA Infuser setup procedures UNPACKING Inspect the PCA Infuser packaging for possible shipping damage If damage is found contact the delivery company immediately Unpack the PCA Infuser carefully and inspect the PCA Infuser thoroughly for damage Retain the packing slip and save all packing material in case the PCA Infuser is damaged or fails the infuser self test and has to be returned to Hospira CAUTION CAREFULLY UNPACK AND SETUP THE PCA INFUSER TO AVOID PRODUCT DAMAGE DO NOT USE THE PCA INFUSER IF IT APPEARS DAMAGED IN ANY WAY THE BATTERY MAY NOT BE CHARGED UPON RECEIPT CAUTION IF THE PCA INFUSER APPEARS TO BE DAMAGED CONTACT HOSPIRA CONNECTING THE PATIENT PENDANT The Patient Pendant should be plugged into the unit prior to programming 1 Connect Patient Pendant plug into the back of unit opening labeled Patient Pendant 2 Tighten connector ring snugly to confirm proper attachment SYSTEM SELF TESTS Connect the AC power mains cord to an AC power receptacle then conf
86. on library an invalid barcode alarm will be activated D Scan the bar code on the infuser 6 Verify ALL parameters If changes are desired select CHG SETTINGS gt Otherwise if the Rx settings are correct select CONFIRM gt 7 Verify that the Loading Dose setting is correct To change the Loading Dose value select CHG SETTINGS gt Otherwise if the Loading Dose value is correct select CONFIRM gt 8 To deliver Loading Dose and begin the program select YES gt on the LOADING DOSE NOT GIVEN SCREEN 430 04685 004 6 13 Advanced Programming with Hospira MedNet Software cancel the Loading Dose and just start the program select CANCEL gt 9 Close and lock the door Press START to begin program WARNING The infuser cannot communicate via the network if the Low Battery Warning alarm has sounded 6 14 430 04685 004 LifeCare Infusion System Section 7 Troubleshooting The PCA Infuser is programmed to display status and alarm messages and to sound an audible tone for most alarm conditions These messages and alarm conditions are described in the following sections Status Messages Infuser Alarm System Silencing an Alarm Alarms and Messages Infuser Stalling Status Messages Displayed status messages are defined in the following table MESSAGE DEFINITION DOOR Message indicates the security door is closed LOCKED and locked It displays for 30 seconds and disappears PCA
87. or the loading dose PCA dose dose limit and continuous delivery rate parameters vary with the drug and concentration selected See Table 10 1 on page 10 2 and Table 10 2 on page 10 3 for listings of the lower and upper limits NOTE Drug and concentration selections are rounded up to the nearest tenth of a digit for mg mL values or to the nearest digit for mcg mL values Minimum delivery rate is 0 1 mL hr for concentrations between 0 1 and 1 mg mL 430 04685 004 10 1 15 Prescription Delivery 1 Grup ejqejrene sajes yonpoud yuauino ees 9 4 Jd UOIJesUBOU0D 2000 JO sanuiw 2 0 G si n00 0 gt sanjen yale jim dund 6666 lt senjeA 2 IM dung SJON IDH 16666 1 0666 008 1 007 1 002 1 081 001 1 0l aupada Sate 5 6666 50 00990 60 50 001 40 001 40 02 40 09 90 g auydio 918118 VO 00 08 10 0 0 00 OFFO auydio SIEI 9500 ay niq p ll d 34d syw pue 4 04 9192 430 04685 004 10 2 LifeCare PCA Infusion System 5 ejqejre e
88. ort periods of time when AC power is not available The vials are single use bar coded and prefilled with a prescription drug by Hospira Abbott or the vials are sterile and empty to be custom filled by the hospital pharmacy The Infuser offers the following modes of delivery e PCA ONLY e CONTINUOUS ONLY e PCA CONTINUOUS The PCA Infuser is able to store frequently used prescriptions called protocols The protocols are available for Hospira Abbott prefilled vials and custom syringes The protocols must be set up by a hospital designated authority in the Biomed Mode or through Hospira MedNet Software if enabled Indications for Use The LifeCare PCA Infusion System with Hospira MedNet Software is intended for accurate volumetric infusion of analgesic drugs by continuous or patient demanded intravenous administration It is intended for short term continuous less than 96 hours epidural administration of analgesic drugs WARNING For epidural use administer only anesthetics analgesics approved for epidural administration as indicated or allowed by the drugs FDA approved labeling Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient 1 2 430 04685 004 LifeCare PCA Infusion System PATIENT SELECTION Patients selected to use the PCA Infuser should be able to understand the relationship between pain and pushing the PCA Infuser patien
89. ous and PCA Continuous Modes via intravenous route For use in PCA Continuous and PCA Continuous modes via epidural route See the current product sales catalog for available drugs and sets 430 04685 004 2 5 Principles of Operation NOTES 430 04685 004 LifeCare PCA Infusion System Section 3 Equipment Description The following subjects are addressed in this section e Front Panel e Vial Cradle Assemble e Rear Panel e Operating Buttons 4 Keys 430 04685 004 Equipment Description Front Panel Vial Cradle Security Release Door Mechanism Holder LED Display Keypad Buttons wsronv ase AC Power Indicator Hospira PCA ri 53 EM 3 2 430 04685 004 LifeCare Infusion System Vial Cradle Assemble Wireless pr Antenna Cradle Release Mechanism f n e Vial Base i Bar code Reader Vial Cradle Window Clips vial bar gt code must face a Vial oe window witc Vial Top Vial Stopper E Cradle Clip Lower Vial Retainer md Middle Bracket Injector Injector Injector REGE Flange Vial etainer Plunger Injector Luer Lock _ 22 Sensor Fitment g Switch back of retainer 430 04685 004 3 3 Equipment Description Rear Panel Patient Ground Pendant Nurse Call Test Patient Jack Pendant Button Patient Pendant Cable Fastene Patient Pendant blue handle Et
90. p on PCA administration set 2 Unlock door Press Button 430 04685 004 5 29 Select Mode Making Changes After Setup REVIEWING THE CURRENT SETTINGS Settings may be reviewed while the infuser is running or stopped 1 Press OD Button twice 2 Press to return to main menu Or select PREVIOUS to return to the preceding display CHANGING SETTINGS 1 Unlock the door while the infuser is running The infuser will be paused Select CHANGE Rx gt to change individual settings NOTE CHANGE CCA gt only displays if Hospira MedNet Software has been enabled Select the desired field to change EXAMPLE PCA DOSE gt Or select NEXT gt to display more change options such as Lockout and Dose Limit NOTE If the mode of delivery is changed the display prompt for reprogramming uses the same steps outlined in the beginning of this section The value previously set for the PCA dose will flash MORPHINE PF 1 mg mL PAUSED CONT LOCK DOOR TO BEGIN LOADING CHANGE Ro CLEAR SHIFT O CHANGE CCA MORPHINE PF 1 mg mL SELECT SETTING TO CHANGE DOSE CONT RATE SAVE amp EXIP AR 430 04685 004 LifeCare PCA Infusion System 4 Enter the desired PCA dose MORPHINE PF using the numeric keypad ENTER The value range is I THEN PRESS displayed on the screen If ENTERBUTTON the value is entered incorrectly press 9 to change
91. perienced radio TV technician for help Changes or modifications not expressly approved by Hospira could void the user s authority to operate the equipment RADIO FREQUENCY EXPOSURE STATEMENT 1 20 The Wireless LAN radio device in the Connectivity Engine peripheral board with this infusion device has been evaluated and found compliant to the requirements of the following Radio Frequency exposure standards e Federal Communications Commission Bulletin 65 Edition 97 01 Supplement C Edition 01 01 Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields July 2001 e Industry Canada Evaluation Procedure for Mobile and Portable Radio Transmitters with respect to Health Canada s Safety Code 6 for Exposure of Humans to Radio Frequency Fields Radio Standards Specification RSS 102 Issue 1 Provisional September 1999 The radiated output power of this Wireless LAN device is far below the FCC radio frequency exposure limits The Wireless LAN device has been evaluated with one inch separation of human body from the antenna and found to be compliant with FCC RF exposure limits 430 04685 004 LifeCare PCA Infusion System Section 2 Principles of Operation The PCA Infuser is a portable infusion pump that allows a patient to self administer analgesia within programmed limits as well as providing continuous infusion of a desired drug Generally a clinician following a physici
92. played WARNING Disconnect the patient from the PCA set before the purge cycle f Atthis point 5 34 430 04685 004 LifeCare PCA Infusion System A Disconnect the set from the patient B Release the slide clamp on the PCA administration set C Select amp hold the PURGE gt key until fluid is seen at the end of the set and no air remains inside the set NOTE Purging is recommended to remove slack when a new vial is inserted The system must be primed before purging The maximum volume delivered during a purge is 3 mL NOTE The drug delivered during the purge cycle is NOT stored in system memory and will not be displayed CAUTION IN CONTINUOUS AND PCA CONTINUOUS MODES IF A PURGE IS NOT PERFORMED AFTER A SYRINGE CHANGE THE INFUSER AUTOMATICALLY PERFORMS A SMALL SYSTEM COMPLIANCE STEP TO REMOVE SLACK WHEN START IS PRESSED WITH DOORS LOCKED ALTHOUGH FLUID IS NOT NORMALLY DELIVERED TO THE PATIENT DURING THE COMPLIANCE STEP IT IS RECOMMENDED THAT THE SET BE DISCONNECTED FROM THE PATIENT DURING THIS OPERATION 8 Upon release of the PURGE gt Softkey the prompt asks if the purge is complete A Select YES to continue or select NO to purge again until complete B Reconnect the set to the patient C The CONFIRMATION Screen appears D Review the entered parameters and if they are correct select CONFIRM gt 9 Close and lock the door to begin infusion Press the 4 if the infuser is in the
93. pt MORPHINE PF he ch the chosen protoco PCA DOSE _____ 2 mg LOCKOUT _____ settings Or press PREVIOUS to return to the preceding min CONTRATE K 2 mglhr screen ee 4 HOUR 4 Close and lock the door CONFIRM ey Place key in a secure PREVIOUS location D Press to begin therapy Approximately 10 seconds after door is locked and 2 is pressed the DOOR LOCKED MESSAGE disappears PROGRAMMING No DOSE LIMIT 1 Select No at the Dose Limit MORPHINE PF 1 mg mL SELECTION SCREEN The display advances to the Confirm No Dose Limit SCREEN PREVIOUS 430 04685 004 5 23 Select Mode 2 Select CONFIRM to verify the MORPHINE PF 1 mg mL selection of the No Dose BECNEEM HO limit DOSE LIMIT NOTE When NO LIMIT has been programmed the message NO 4 HR LIMIT will be displayed after the door has been locked 5 3 gt to accept MORPHINE PF 1 mg mL PCA CONT the chosen protocol settings Or press PREVIOUS 2mg to return to the preceding LOCKOUT screen 2 ma hr mg 4 Close and the lock door CONFIRM GA Place key in a secure PREVIOUS location D Press to begin therapy Approximately 10 seconds after door is locked and 2 is pressed the DOOR LOCKED MESSAGE disappears 5 24 430 04685 004 LifeCare PCA Infusion System CLEARING OR CHANGING A DO
94. r from vial before placing it into the infuser 430 04685 004 1 11 Descriptive Information Always close the slide clamp on the PCA Infuser administration set before removing or the replacing syringe and before discon tinuing infusion Patient must be disconnected from the PCA Infuser set before the purge cycle Vial and injector must be securely locked into the infuser before beginning delivery PROGRAMMING This section presents known infuser programming cautions WARNING For custom syringes confirm that the displayed concentration mg mL or mcg mL exactly matches the concentration value and drug name on the syringe If they do not match under overdosage may result In the CONTINUOUS and PCA CONTINUOUS modes if a purge is not performed after a syringe change the infuser auto matically performs a small system compliance step to remove slack when the START PAUSE key is pressed with the door locked Although fluid is not normally delivered to the patient during the compliance step under some conditions up to 0 3 mL of fluid may be delivered If 0 3 mL of fluid represents a haz ard to the patient disconnect the set during this operation At flow rates less than 0 5 mL hr there may be a significant delay before flow is established if the system is not purged Selections are rounded up to the nearest tenth of a digit for mg mL values or to the nearest digit for mcg mL values LOADING DosE DOSE LIMITS This
95. rams 430 04685 004 LifeCare PCA Infusion System 4 The next screen offers the MORPHINE PF options of infusing the loading dose now later LOADING DOSE after programming is complete If DELIVER LOADING Dose Now is desired press the Yes gt Softkey to infuse DELIVER LATER the programmed Loading Dose D If the DELIVER LATER option is desired the screen advances to the SELECT DELIVERY MODE SCREEN See Modes of Delivery on page 5 2 for more information 6 if YES gt was selected MORPHINE PF 1 mg mL press the Buron to infuse the programmed Loading 0 Dose LOADING DOSE M PRESS START BUTTON TO INFUSE PREVIOUS 430 04685 004 4 31 Basic Operation The screen displays the amount of ed MORPHINE PF analgesic delivered as it infuses The 1 mg mL bottom of the screen displays text PRESS confirming that the Loading Dose is PAUSE BUTTON being delivered Upon completion the red LED above the LCD displays the amount delivered 0 5 mg After delivery is complete the SELECT MODE SCREEN appears See Modes of LOADING DOSE Delivery on page 5 2 lt lt milligrams a lt gt 4 32 430 04685 004 LifeCare PCA Infusion System Section 5 Select Mode This section addresses these topics Modes of Delivery PCA Only Mode Continuous Mode PCA Continuous Mode Protocols Dose Limit Clearing the History and or Rx Settings Using Review Confirmation Screens
96. rates a hard copy printout of the data When the infuser is configured with the HOUR BY HOUR history format the number of PCA injections partial doses and patient demands occurring in each one hour period during the last 24 hours may be displayed or printed Only the one hour periods with PCA activity are displayed and printed When the infuser is configured for the LAST 1 amp 24 HOUR history format PCA activity totals in the last hour and in the last 24 hours are displayed and printed NOTE The HOUR BY HOUR and the LAST 1 amp 24 HOUR history totals represent a dynamic summation of past delivery of drugs and events Data is accumulated in 10 minute time slots At any given time the last 10 minute time slot may represent anywhere from 0 to 10 minutes of data The hour and 24 hour periods are approximate only and may in fact represent as small as 50 minutes of data for the LAST HOUR total and 23 hours 50 minutes for the LAST 24 HOUR total NOTE PCA requested doses patient demands as recorded in the history display and event log may not reflect the total number of demands Maximum of 100 patient demands per 10 minute interval NOTE Events occurring while printing is in progress are stored in memory but not included in the current printout NOTE If the lithium battery the micro controller unit or the electronics assembly have been replaced the serial number will NOT display on printouts NOTE See the following pages
97. rive Morgan Hill CA 95037 NOTE Outside the U S contact your local Hospira sales office 430 04685 004 Contact Information CAUTION FEDERAL USA LAW RESTRICTS THIS INFUSER TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR OTHER LICENSED PRACTITIONER WARNING POSSIBLE EXPLOSION HAZARD EXISTS IF THE INFUSER IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS The PCA Infuser Hospira MedNet LifeShield and are trademarks of Hospira Teflon Formula C Manu Klenz Super Edisonite Coverage and Sporicidin are not trademarks of Hospira Equipment providing adequate degree of protection against electrical shock and suitable for application to patient Type CF Drip Proof IP X Medical Equipment Protected against dripping water Class 1 Mains supply equipment using protective earth The C and US indicators adjacent to the CSA Mark signify that the product has been evaluated to ETA 1 the applicable CSA and ANSI UL Standards for use in Canada and the U S respectively This US MCN 160992 indicator includes products eligible to bear the NRTL indicator NRTL i e National Recognized US Testing Laboratory is a designation granted by the U S Occupational Safety and Health Administration OSHA to laboratories which have been recognized to perform certification to U S Standards 430 04685 004
98. rmation The latest patient controlled analgesia PCA offered by Hospira LifeCare PCA Infusion System with Hospira MedNet Software allows clinicians to administer or patients to self administer analgesia safely and effectively within clinician programmed limits and or hospital defined medication limits The LifeCare PCA Infusion System is used in a wide range of clinical settings that includes but is not limited to the following MEDICAL LABOR DELIVERY POST BURN UNIT PARTUM SURGICAL OPERATING ROOM ONCOLOGY CRITICAL CARE UNITS POST ANESTHESIA CARE PEDIATRICS UNIT PACU Product Description The primary drug safety features of the LifeCare PCA Infuser device are the Hospira MedNet Software and the bar code reader that are designed to enhance patient safety and automate drug identification Other enhancements include new programming features and the ability to read pharmacy generated bar codes The PCA Infusion System includes a microprocessor based infusion device with keypad controls patient pendant a bar coded drug vial and a compatible administration set see Administration Equipment on page 2 5 for list of compatible sets The infuser has an Ethernet port for computer or printer connections 430 04685 004 1 1 Descriptive Information The software is field upgradeable It is intended to operate on AC power but an internal battery is provided to maintain operation for sh
99. sajes jonpoud yuana eas ei Adwa ejuejs AJS anjen uoneueouo 9 eynuiu Jo sanur Qz 0 si 3n0320 gt esou se jjam se 0 gt senjeA afou dung 6666 lt se se 6666 lt joefo m dung SeyoN 2 L L Xlorz ro xlozi rol 12 08 0 9Xloz rol 12 102 10 5x ero oxlorrol 009 1 sun 19 9 Xlorz ro xlozi rol 19108 10 020 12 102 00 oxlero oxlorrol 0910 sun apoo Jeg ejuejs oxloe rol 2 02 1 0 oxloero oxierol oxior ro 001 1 syun 9 108 10 oxloerol oxloecro oxiero oxior ro 0L L O syun 1 Adwa amaS XEUI UIUJ XEUI UIUI XEUI UIUI XEUI UIUJ XEUI UIUJ XEUI UIUI 1uysyun SIE a4 suun soq abuey wojsn9 2 2 2 nig siera uos syw esoq pue 2 0 10 3 430 04685 004 10 4 Prescription Delivery Limits NOTES 430 04685 004 LifeCare PCA Infusion System Appendix A Generating Bar Code Labels Hospira MedNet Software Enabled Hospira recommends that the hospital or pharmacy department develop clear p
100. section presents Loading Dose and Loading Dose information and cautions 1 12 The loading dose is always included in the total dose delivered Setting a new dose limit will not erase the previous dose history Always monitor the PCA Infuser when delivering medication with the door open Patient Pendant is only to be pressed by the intended patient 430 04685 004 LifeCare Infusion System WARNING Patient Pendant is only to be pressed by the patient OPERATION This section presents operational information and cautions Perform close assessment and monitoring of patients receiving potent analgesic medication for possible adverse reactions The PCA Infuser is not intended to be used for frequent long term portable operation Keep plugged into a properly grounded AC receptacle whenever possible and reserve battery power for temporary portable operation and emergency backup If the AC receptacle is in doubt use battery power MAINTENANCE This section addresses infuser maintenance Always confirm that the bar code reader window is clean Blood fingerprints condensation and other elements may obstruct the view of the bar code reader Elements on the win dow other than scratches can be cleaned by using one of the recommended cleaning solutions See Section 8 Maintenance on page 8 1 Window scratches cannot be wiped clean and will probably lead to window replacement To avoid mechanical or electrical damage do
101. see Purging the System on page 4 28 If gt is selected disconnect the set from the patient and press and hold the PURGE gt Select Yes to continue or select No to purge again until complete After purging reconnect set to patient Set Loading Dose if desired by selecting YEs gt For more information see Loading Dose on page 4 30 10 Enter a Loading Dose within the displayed range Then press 355535 430 04685 004 5 19 11 Press to infuse programmed Loading Dose Select DELIVER LATER gt to delay loading dose delivery From the SELECT DELIVERY MODE SCREEN select PROTOCOLS gt 12 Press to accept protocol or select NEXT PROTOCOL gt and PREVIOUS gt to view other stored protocols if available 13 Select ConFiru gt to accept the chosen protocol settings Or press PREVIOUS gt to return to the preceding screen 14 Close and lock the door Place key in a secure location Select Mode MORPHINE PF 1 mg mL ESELECT DELIVERY MODE PCA ONLY CONT O CONTINUOUS PROTOCOLS b PREVIOUS MORPHINE PF PRESS TO SELECT PCA DOSE LOCKOUT MORPHINE PF mg m PCASCONT PCA DOSE 2 mg LOCKOUT mg CONFIRM O PREVIOUS 4 15 Press to begin therapy Approximately 10 seconds after door is locked and 2 is pressed the DOOR LOCKED MESSAGE disappears 430 04685 004 LifeCare PCA Infusion System Dose Limit The dose limit is a phys
102. ser is connected to the wireless network It does not indicate if data is currently being sent or received The Waiting for Autoprogram Message will display on the screen Autoprogramming Autoprogramming is a new feature for Hospira PCA infusion pumps It can only be used if the feature has been installed in conjunction with your Hospital Information System HIS and Bar code Point of Care BPOC Unit It works by scanning bar code labels for the patient and infuser This information is then transferred to the infuser utilizing either its wireless antenna or shielded RJ 45 Ethernet connector The feature reduces the number of steps needed to program an infusion 6 12 430 04685 004 LifeCare PCA Infusion System NOTE If the physician s order for an autoprogram therapy exceeds the capabilities of the pump or is above a hospital defined hard drug limit the infusion parameters for autoprogramming will be rejected and the order needs to be rechecked The pump allows the clinician to change soft limits by changing the value when the SOFT LIMIT VIOLATION SCREEN appears 1 Power On the pump by pressing ON OFF 2 After the CCA has been selected the pump is ready for autoprogramming Scan the patient wristband to pull up the patient s task list on the BPOC system 4 Choose the desired IV task from the list on the BPOC unit NOTE If the scanned medication does not exist in the Hospira MedNet Software Rx Rules medicati
103. stance of 2 ft between the infusion pump system and portable mobile RF communica tions equipment e List Number 20709 is compliant to IEC EN 60601 1 2 2001 and have been tested and found to comply with EMC limits for 430 04685 004 1 17 Descriptive Information the Medical Device Directive 93 42 EEC EN 55011 Class B and IEC EN 60601 1 2 2001 For more information see Contact Information on back INTERCONNECTING OF EQUIPMENT Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC Standards e g IEC 60950 for data processing equipment and IEC 60601 1 for Medical Equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Any person who connects additional equipment to the signal input or output part configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system Standard IEC 60601 1 1 If in doubt consult the technical service department or your local representative Guidance on EMC Compatibility e There is a shared responsibility between manufacturers cus tomers and users to ensure that medical equipment and sys tems are designed and operated as intended Medical electrical equipment requires precautions regarding electromagnetic compatibility and must be installed and used according to the electromagnetic compatibility information provided in this manual
104. t Mode 6 If Yes is selected disconnect the set from the patient and press amp hold the PURGE gt Softkey 7 Select Yes to continue or select No gt to purge again until complete 8 After purging reconnect set to patient 9 set Loading Dose if desired by selecting YES See Loading Dose on page 4 30 for more information Enter a Loading Dose within the displayed range Then press 1132 10 Select ves to infuse the programmed Loading Dose Select DELIVER LATER gt LOADING DOSE to delay loading dose delivery DELIVER 11 From the Select Delivery MORPHINE PE Mode SCREEN select CONTINOUOUS gt penal DELIVERY MODE PCA ONLY CONT CONTINUOUS QD PROTOCOLS b PREVIOUS 5 10 430 04685 004 LifeCare PCA Infusion System 12 Enter a continuous rate MORPHINE PF using the keypad The HENTER i i CONT RATE value range is displayed fafo BRNE the screen ENTER BUTTON 0 5 100 mgt If value is entered 3 incorrectly press to change value 13 Then press Gm milligrams h If programming changes need to be made select PREVIOUS to return to the preceding screen 14 seta specific dose limit by MORPHINE PF 1 mg mL selecting YES and advancing to the Dose Limit Enter Value SCREEN Select No to choose No Dose Limit No Dose Limit will be PREVIOUS selected for this example If Hospira MedNet
105. t pendant for pain relief Patients selected for the use of the PCA Infuser should be able to physically self administer a PCA dose using the patient pendant WARNING Patient Pendant Is only to be pressed by the patient USER QUALIFICATIONS All clinicians should be appropriately trained to program the PCA Infuser prior to use The PCA Infuser is intended for use at the direction or under the supervision of licensed physicians or certified health care professionals Clinicians must be trained in infuser use administration of parenteral and epidural fluids and drugs and the prevention of related IV complications and precautions to prevent accidental infusion of air Training should emphasize the assessment and monitoring of patients receiving potent analgesic medications and the appropriate treatment for possible adverse reactions Contraindications For Use The PCA Infuser should not be used for patient controlled analgesia by patients who do not have the cognitive ability to understand the use of self administered pain medication nor have the physical capacity to operate the patient pendant if required Drugs not compatible with silicone rubber or PVC plastic or drugs not stable under infusion conditions should not be used with this system 430 04685 004 1 3 Descriptive Information Conventions This section describes the conventions used throughout this manual Convention Application Example ITALIC REF
106. tery operation is desired If quality earth grounding source is in doubt use battery power If the low battery alarm sounds connect to AC power immediately WARNING The infuser cannot communicate via the network if the Low Battery Warning alarm has sounded 430 04685 004 1 15 Descriptive Information SETS AND ACCESSORIES Use Hospira Abbott LifeCare PCA Set List 6517 whenever the infuser is in CONTINUOUS or PCA CONTINUOUS Modes When using PCA or PCA CONTINUOUS Mode another fluid line may be attached to the distal backcheck Y site Use Hos pira Abbott LifeCare PCA Infuser set List 3559 6516 or a combination of List 6514 and 6517 It is recommended that highly viscous solutions and drugs col loidal suspensions and emulsions should not be delivered through the inline backcheck valve of the PCA Infuser set Valve functionality may be compromised by the presence of residue Refer to vial and set package inserts for precautions and infor mation on proper handling ELECTRICAL ARTIFACTS This section addresses electrical artifacts and their remedies 1 16 Nonhazardous low level electrical potentials are commonly observed when fluids are administered using infusion devices These potentials are well within accepted safety standards but may create artifacts on voltage sensing equipment such as ECG EMG and EEG machines These artifacts vary at a rate that is associated with the infusion rate If the monitoring mach
107. the bottom bracket Select CONTINUE gt If vial bar code is not read by the infuser slowly rotate the vial and position with the bar code on the right until bar code has been read CAUTION VIAL AND INJECTOR MUST BE SECURELY LOCKED INTO THE INFUSER BEFORE BEGINNING DELIVERY 430 04685 004 WARNING Cracked vials may not show evidence of leakage until delivery pressure is applied NOTE If the device is OFF improper loading of syringe will turn the device ON and activate a non silenceable CHECK INJECTOR alarm within 30 seconds after CONTINUE gt is selected Proper loading engaging injector flange silences the alarm Guided Start up for Prefilled Vials NOTE If LifeCare PCA Infuser is Hospira MedNet enabled see Section 6 for Operation 1 Press Q9 Burton load LIFECARE PCA drug vial into cradle to SELF TEST power on the infuser See Loading a Vial on page 4 5 Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen This screen is followed by another screen displaying self test information that includes the following time date drug library software version and copyright data During the self test the infuser reads the bar code label 4 6 430 04685 004 LifeCare PCA Infusion System 2 Select CONTINUE to advance LIFECARE PCA SELF TEST to the next screen SYSTEM SETTINGS CONTINUE
108. ts are addressed in this section e Operating the PCA Infuser e Loading a Vial e Guided Start up for Prefilled Vials Guided Start up for Custom Vials Getting Started e Adjusting Settings New Patient e Purging the System e Loading Dose 430 04685 004 4 1 Basic Operation Operating the PCA Infuser The following topics are addressed in this section e Intravenous PCA Infuser Administration e Epidural PCA Infuser Administration INTRAVENOUS PCA INFUSER ADMINISTRATION 1 Connect the syringe to the set and manually prime set 2 Attach primary IV set line to recommended PCA Infuser set list 5 3559 6516 or 6517 attached to list 6514 via backcheck valve port Prime IV set and the lower portion of the PCA Infuser set and close the manual clamp on the IV set EPIDURAL PCA INFUSER ADMINISTRATION NOTE The administration of drugs is restricted to those analgesic drugs approved for continuous epidural administration Recommended use of the epidural route is for labor and delivery acute pain control or post operative analgesia for periods up to 96 hours 4 2 430 04685 004 LifeCare PCA Infusion System WARNING It is strongly recommended that the epidural infusion system be prominently identified as epidural Failure to identify it as epidural may result in incorrect administration of intravenous rather than epidural formulations In addition failure to identify the epidural infusion could result in
109. turer s recommendation Precise Caltech Industries Per manufacturer s recommendation Household bleach Various Per hospital procedures do not exceed one part bleach in ten parts water On a routine basis clean all of the elements behind the syringe door using cotton tipped swabs saturated with cleaning solution The door may be unlatched from the door handle to facilitate cleaning 430 04685 004 Maintenance WARNING Failure to clean infuser s outside surfaces after patient use may spread infection Please follow hospital infection protocols by cleaning the infuser for infection control No other routine maintenance is required the infuser has no other user serviceable parts All service must be carried out by Hospira qualified technical personnel A technical service manual may be ordered from Hospira Technical Service Battery Maintenance WARNING Disconnect the AC power cord from AC supply before removing the battery door CAUTION DO NOT OPERATE THE PCA INFUSER ON PATIENTS WITH THE BATTERY REMOVED USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS ENSURE PROPER OPERATION CAUTION THE LOW BATTERY ALARM SOUNDS CONNECT THE PCA INFUSER TO AC MAINS POWER IMMEDIATELY The PCA Infuser is battery powered for emergency backup and temporary portable operation A fully charged conditioned battery provides approximately 2 5 hours of continuous operation from start to low battery alarm
110. u ous monitoring of the patient during epidural administration Patients must be observed frequently for side effects in a fully equipped and staffed environment for at least 24 hours follow ing completion of drug administration by the epidural route CAUTION DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE FREE MORPHINE SULFATE HAS BEEN REPORTED The epidural space has 58 openings through which fluid can exit Pressure buildup during administration is transient How ever if a large volume of fluid is administered over a short time period the pressure will take longer to return to normal If over delivery occurs during administration observe the patient closely for signs of spinal cord compression disorientation headache transient neuralgias and drug overdose BATTERY OPERATION This section documents battery information WARNING Unplug the AC power cord before removing the battery door CAUTION WHEN THE PCA INFUSER IS CONNECTED TO A PATIENT DO NOT OPERATE THE PCA INFUSER WITH THE BATTERY REMOVED USE OF A PROPERLY MAINTAINED AND CHARGED BATTERY HELPS ENSURE PROPER OPERATION The battery may not be fully charged upon receipt Connect the PCA Infuser to AC power for at least 16 hours Use AC power whenever possible Connect to AC power during storage to ensure a fully charged battery during a power outage Always connect the infuser to a properly grounded receptacle unless bat
111. usting system settings such as contrast and volume see Adjusting Settings on page 4 21 1 Unlock door and press LIFECARE PCA Button or load drug vial into SELF TEST cradle to power on the infuser Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen lt lt pa Hospira 2 Select CONTINUE to advance to the next programming screen 3 Select Yes or No at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less See New Patient on page 4 27 for more information Select gt to accept the inserted drug or remove the vial if it is not correct See New Patient on page 4 27 for more information D Select either Yes or No to purge the system See Purging the System on page 4 28 for more information 6 If gt is selected disconnect the set from the patient and press amp hold the PURGE gt Softkey 430 04685 004 5 13 Select Mode 7 Select Yes to continue or select No gt to purge again until complete 8 Reconnect set to patient 9 set Loading Dose if desired by selecting Yes See Loading Dose on page 4 30 for more information 10 Enter a Loading Dose within the displayed range Then press 1139 11 Select ves to infuse the programmed Loading Dose Select DELIVER LATER gt to delay loading dose delivery 12 From the SELECT SCREEN select PCA gt
112. value 1 mg milligrams D Then press 0 If programming changes need to be made select PREvious gt to return to the preceding screen 6 ino settings require MORPHINE PF mg m change By SELECT SETTING selecting SAVE amp gt TO CHANGE CONT SAVE amp EXIT AP f Select gt to accept MORPHINE PF the new program PCA ONLY PCA DOSE 0 LOCKOUT NO CONFIRM PREVIOUS 430 04685 004 5 31 Select Mode CHANGING THE CCA 1 Unlock the door while the ME PF CARDIOLOGY infuser is running The ae infuser will pause CONT maa 2 Select CHANGE CCA gt to LOADING DOSE change the setting CHANGE RX NOTE CHANGE gt will only CLEAR SHIFT display if Hospira MedNet CHANGE Software has been enabled WARNING Changing the clears the RX settings 3 At the WARNING SCREEN select MORPHINE PF CONTINUE CARDIOLOGY WARNING CHANGING CCA WILL CLEAR THE RX SETTINGS CONTINUD PREVIOUS Select new CCA SELECT CCA 5 32 430 04685 004 LifeCare PCA Infusion System Clearing Shift Totals 1 2 Review 4 record shift totals using the gt Burro before clearing the shift totals Unlock the door while the MORPHINE PF mg m i 1 1 PAUSED pi p infuser will be paused TO BEGIN O Select CLEAR SHIFT gt tO LOADING
113. vial Press Silence to Syringe minutes detected silence the alarm Unlock and open the security door and squeeze and release handles in order to replace vial May turn infuser OFF while preparing new vial Door Open Door left open Close door and Lock or unlocked for more than 2 minutes Infuser 5 Infusion paused Press START PAUSE Paused minutes for more than 2 key again or unlock minutes door Low Battery 10 Battery life has Apply AC power minutes less than thirty failure to connect to minutes AC power may cause remaining and is battery damage currently operating on battery power Dead None Battery life has Apply AC power Battery expired 430 04685 004 7 5 Troubleshooting MUTING POSSIBLE CORRECTIVE MESSAGE TIMES CAUSE ACTION Pendant Visible Pendant not Secure pendant into Fault Flashing secured into port Occurs port Replace pendant or Faulty infuser Connection or Release pendant pendant button Partial Pendant Confirm use of PCA press Patient Pendant Using PCA Plus blue handle Patient Pendant white handle Pendant Visible Electrical Short Replace pendant Fault S Flashing in pendant Occurs Check PCA None Pressure inline Verify proper Infuser Set possible placement of injector to Relieve occlussion and Removal of vial and Pressure vial stiction or manual purge of vial and re insert vial Infuser Stalling If Hosp
114. y Other vials when available and used may be identified as Beta Gamma etc 6 Select Conrirm gt to accept ALPHA VIAL the D Mrd CONFIRM remove the vial if it is not VIAL TORK correct IF NOT CORRECT lt a 430 04685 004 4 13 Basic Operation 7 Select either Yes or No to purge the system See Purging the System on page 4 28 for more information 8 ive is selected disconnect the set from the patient and press and hold the PuncE Softkey While purging is occurring the word PURGING is displayed PREVIOUS NOTE Purging is recommended to remove system slack when a new vial is inserted The maximum volume delivered during a purge is 3mL 4 14 430 04685 004 LifeCare PCA Infusion System Upon release of the PURGE gt Softkey ETN the display asks if the purge is complete PURGE COMPLETE 9 Select gt to continue or select No gt to purge again until complete 10 After purging is complete reconnect set to patient 11 Select desired units of measure For the demonstration purposes Micrograms is selected 430 04685 004 4 15 Basic Operation 12 Enter desired drug concentration within the i CONCENTRATION displayed range En erp ENTER BUTTON NOTE Only whole numbers may 1 100 magi be entered when using 10 79 micrograms mcg If a decimal micrograms entry is attempted the display will inform the user that the decimal point is not allowed Press
115. y charged battery connect the PCA Infuser to AC power for a minimum of 16 hours while in the OFF DATA RETENTION Delivery program settings and programming option selections are retained in memory unless erased 4 20 430 04685 004 LifeCare PCA Infusion System The infuser will automatically erase the program and the history if infuser is off for more than 4 hours If the infuser is restarted after being off for 4 hour or less the NEW PATIENT SCREEN allows the Clinician to either keep the current program and history or erase the program and history The infuser has the capacity of recording up to 20 000 events The PCA Infuser displays up to 400 events by pressing the History Button Events recorded include opening or closing of the security door starting or stopping continuous infusion an alarm condition and so on All event descriptions are preceded with time of occurrence Adjusting Settings 1 Press Buron to power on UFECAREPCA the infuser Upon initial SELF TEST start up the self test begins It may take several seconds for the Hospira logo to appear on the screen 430 04685 004 4 21 Basic Operation 2 Select SYSTEM SETTINGS to LIFECARE PCA view the Change Settings SEL TEST Menu 3 Adjust settings by selecting the appropriate softkey CONTRAST TIME DATE CONTINUED CHANGING ALARM VOLUME 1 Select VoLume gt CONTRAST TIME DATE CONTINUE 4 22

System Operating Manual - MEQL - Med-E

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