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Guided Start-up Using Hospira MedNet Software

1. KC Hospira lt 2 Select SYSTEM SETTINGS gt to view the Change Settings Menu LifeCare PCA SELF TEST COMPLETE OK SYSTEM SETTINGS 3 Adjust settings by selecting the appropriate softkey CONTRAST ZO TIME DATE D CONTINUE 4 21 Basic Operation CHANGING ALARM VOLUME 1 Select VOLUME gt 2 Select desired volume then select SAVE amp EXIT The current setting flashes at this Screen SAVE amp EXIT 4 22 LifeCare PCA Infusion System CHANGING CONTRAST OF MAIN DISPLAY 1 Select CONTRAST 2 Select desired adjustment softkey repeatedly until contrast is optimized for viewing 3 Select SAVE amp EXIT gt SAVE amp EXIT 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 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 CONTRAST bh TIME DATE QD CONTINUE 2 When the WARNING SCREEN appears select CONTINUE gt WARNING 3 Set Time with number buttons CHANGING THE DATE OR TIME using four digits Enter hour as two digits 01 00 and minutes ALL TOTALS as two digits 01 07 PM CONTINU
2. 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 zero inch human body separation from the antenna and it was found to be compliant with FCC RF exposure limits 1 21 Descriptive Information NOTES 1 22 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 physician 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 e 1 or 4 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 2 1 Principles of Operation The PCA Infuser may be programmed to deliver the following e PCA doses Mode e Continuous background infusion with
3. 6 If no settings require MORPHING PF change confirm by 1 mg mL selecting SAVE amp EXIT BSELECT SETTING TO CHANGE PCA DOSED CONT RATED SAVE amp 7 Select CONFIRM gt to MORPHING PE accept the new program rz PCA hes LOCKOUT 4 HOUR LIMIT NO CONFIRM PREVIOUS 5 29 Select Mode Changing the CCA 1 Unlock the door while the MORPHINE PF infuser is running The infuser will pause CARDIRLOGY PCA CONT 2 Select CHANGE CCA gt to change BLOCK DOOR the setting TO BEGIN lt LOADING DOS Note CHANGE CCA gt will only CHANGE Ro display if Hospira MedNet CLEAR SHIFT bg Software has been enabled CHANGE CCA WARNING Changing the CCA clears the Rx settings 3 At the WARNING SCREEN select MORPHINE PF 1 mg mL CONTINUE gt C ARDIDIOGY WARNING CHANGING CCA WILL CLEAR THE RX SETTINGS K CONTINUE PREVIOUS 4 Select new CCA SELECT CCA 5 30 LifeCare PCA Infusion System Clearing Shift Totals 1 Review amp record shift totals using the s C BUTTON before clearing the shift totals 2 Unlock the door while the infuser is running The rri infuser will be paused pent UT 3 Select CLEAR SHIFT gt to ue d i display the option to clear K the total dose delivered LOADING DOSE CHANGE Note CHANGE will only CLEAR SHIFT S display if Hospira MedNet CHANGE Software was enabled 4 Select YES to
4. er a denas pia iet 2 4 BIOMEDICAL pi die ao e oig e 2 4 OPTIONS ees came A ERATES 2 4 OTHER FEATURES 2 4 ADMINISTRATION EQUIPMENT 2 5 SECTION 3 EQUIPMENT DESCRIPTION 3 1 FRONT PANEL cite a eee qa ncaa d 3 2 VIAL CRADLE ASSEMBLY 3 3 REAR PANEL 2522 ied dead BOs DS ae es e Ec 3 4 OPERATING BUTTONS amp 3 5 ATTACHING AN INFUSER TO AN IV POLE 3 9 REMOVING AN INFUSER FROM AN IV POLE 3 11 SECTION 4 BASIC OPERATION 4 1 OPERATING THE PCA INFUSER 4 2 INTRAVENOUS PCA INFUSER ADMINISTRATION 4 2 EPIDURAL PCA INFUSER ADMINISTRATION 4 2 LOADING A VIAL 4 4 GUIDED START UP FOR PREFILLED 5 4 6 GUIDED START UP FOR CUSTOM VIALS 4 11 GETTING STARTED 4 17 UNPACKING PEREAT 4 17 CONNECTING THE PATIENT PENDANT 4 17 SYSTEM SELF TESTS Susie Ghat 4 19 DATA RETENTION 4 20 ii LifeCare PCA Infusion System ADJUSTING SETTINGS 4 21 CHANGING ALARM VOLUME 4 22 CHANGING CONTRAST OF MAIN DISPLAY 4 23 CHANGING OR CONFIRMING T
5. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes these artifacts may be accentuated so as to simulate actual LifeCare PCA Infusion System 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 such as those encountered next to an electrosurgical generator it is possible that the normal operation of a sensor or microcomputer 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 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
6. 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 be 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 C 1 Warranty 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 of accessory items such as batte
7. 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 5 37 Select Mode Note Events occurring while printing is in progress are stored in memory but not included in the current printout Note Ifthe 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 for a sample history printout in the PCA CONTINUOUS mode 5 38 LifeCare
8. the vial if it is not correct CONFIRM 1 mami MORPHINE PF TO RX MORPHINE PF 1 mg mL 4 7 Select either YES gt or NO gt to purge the system See Purging the System on page 4 27 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 Upon release of the PURGE Softkey the display asks if the purge is complete Select YES to continue or select NO to purge again until complete After purging is complete reconnect Set to patient 4 8 Basic Operation MORPHINE PF 1 mg mL PURGE PURGING RECOMMENDED MORPHINE PF 1 mg mL DISCONNECT SET FROM PREVIOUS MORPHINE PF 1 mg mL PURGE COMPLETE LifeCare PCA Infusion System 10 Set Loading Dose if desired VTTTT by selecting YES gt See 1 mg mL Loading Dose on page 4 29 SET LOADING for more information DOSE 11 Enter a Loading Dose within MORPHINE PE the displayed range Then press 1 mg mL HENTER ENTERA LOADING DOSE WTHEN PRESS ENTER BUTTON 12 The DELIVER LOADING Dose NOW MORPHINE PF SCREEN allows the option of 1 mg mL delivering the loading dose DELIVER now or after the programming LOADING DOSE is complete NOW YES DELIVER LATE
9. 1 Descriptive Information The 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 BURN UNIT PARTUM SURGICAL OPERATING Room ONCOLOGY CRITICAL CARE UNITS Post ANESTHESIA PEDIATRICS CARE UNIT PACU Product Description The primary drug safety features of the LifeCare PCA Infuser device are the Hospira MedNet Software and the barcode 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 barcodes The PCA Infusion System includes a microprocessor based infusion device with keypad controls patient pendant a barcoded drug vial and a compatible administration set See Administration Equipment on page 2 5 for a list of compatible sets The infuser has an Ethernet port for computer or printer connections Descriptive Information The LifeCare PCA Infuser contains a Connectivity Engine module that provides wired Ethernet and wireless 802 11 a b g local area networking capabilities This allows the Hospira MedNet networ
10. 1 2 1 6 2 2 5 3 5 33 infusion 5 3 mode 1 11 2 2 5 3 rate 5 10 5 14 CONTINUOUS ONLY 1 2 custom syringes 1 11 D DDL 1 7 5 19 DECIMAL POINT button 3 6 Default Drug Library 1 7 5 19 Defined Drug Library 6 8 Deliver Later Option 4 10 4 16 4 30 6 6 Deliver Loading Dose Now Screen 4 9 4 15 6 5 Delivery 1 11 interruption 5 2 Modes 5 19 Parameters 1 9 Screen 1 7 Door Locked Message 5 7 Dose History 1 12 5 19 1 1 Dose Limit 1 7 1 8 1 12 2 1 5 2 5 3 5 14 5 19 5 20 new 5 19 pre programmed 5 10 5 15 Dose Limit Enter Value Screen 5 6 5 10 5 14 5 20 5 21 Dose Limit Periods 5 3 5 19 5 20 5 21 5 22 5 25 5 27 5 28 5 30 5 31 5 32 5 33 5 34 5 35 5 37 DOSE LIMIT REACHED State 5 2 Dose Limit Selection Screen 5 20 drug concentration 1 10 1 11 4 14 4 29 drug identification 1 1 Drug Library 1 10 Download 1 7 Installation 1 7 E electromagnetic compatibility 1 18 electromagnetic interference 1 17 empty syringe message 5 32 ENTER button 3 5 epidural 1 3 epidural infusion system 4 2 epidural route 1 14 2 2 epidural space 1 15 Ethernet cable 1 18 port 1 1 Event History HOUR BY HOUR 5 37 LAST 1 amp 24 HOUR 5 37 Event Log 1 7 5 36 Events recorded 4 20 EXIT button 3 5 1 2 Index F FCC Rules 1 flow rate 1 12 4 27 Front Panel equipment description 3 2 H hard limit 1 9 5 14 History 1 7 HOUR BY HOUR 5 37 LAST 1 amp 24 HOUR 5 37 History and Rx settings 4 7 4 12
11. 4 26 for more information Select either YES gt or NO gt to purge the system See Purging the System on page 4 27 for more information If YES gt is selected disconnect the set from the patient and press amp hold the PURGE gt Softkey Select YES gt to continue or select NO gt to purge again until complete Reconnect set to patient Set Loading Dose if desired by selecting YES gt See Loading Dose on page 4 29 for more information 5 4 LifeCare PCA Infusion System 10 Enter a Loading Dose within the displayed range 11 12 13 14 15 Then press Then press zs Select YES gt to infuse the programmed Loading Dose Select DELIVER LATER gt to delay loading dose delivery From the Select Delivery Mode SCREEN select PCA ONLY gt Enter the desired PCA dose using the numeric keypad If the value is entered incorrectly press O to change value Gi If programming changes need to be made select PREVIOUS gt to return to the preceding screen MORPHINE PF 1 mg mL IDELIVER LOADING DOSE DELIVER LATER S MORPHINE 1 mg mL SELECT DELIVERY MODE PCA ONLY Pca CONT O CONTINUOUS PROTOCOLS a gt PREVIOUS MORPHINE PF 1 mg mL HENTER PCA DOSE THEN PRESS ENTER BUTTON 0 1 5 mg 2 mg milligrams PREVIOUS 5 5 Select Mode 16 Enter a lockout Interval value aoe MORPHINE PF The value range is displayed 1 mg mL o
12. 5 25 6 3 History and Rx Settings 4 12 History Button 5 37 B 7 History button 3 6 History Printout 5 38 Hospira MedNet Software 1 1 1 2 5 2 5 6 5 10 5 14 5 16 5 20 HOUR BY HOUR history 5 37 HR LIMIT REACHED message 5 3 incompatibility 1 11 infuse 1 7 Loading Dose 6 6 infuser 5 27 cleaning 1 13 sets 1 14 infusion rate 1 11 infusion therapy 1 8 injector 1 11 K keypad controls 1 1 L LCD 1 7 LED 1 7 3 7 Loading Dose 1 8 1 12 2 1 4 9 4 15 4 29 5 4 5 9 5 12 6 5 displayed range 5 9 5 13 LifeCare PCA Infusion System halt 5 34 infuse 4 10 mode 4 10 6 6 now 4 29 range 4 9 4 15 4 29 6 5 softkey 5 19 supplemental 5 19 5 34 Lockout Interval 1 8 2 2 5 2 5 3 value 5 6 Low Battery Alarm 1 16 Low Battery Message 4 19 Low Priming Volume PCA Set 2 2 lower limits 1 9 M Main Delivery Screen 5 36 malfunction alarm 1 14 5 35 Medical Device Directive 93 42 EEC EN 55011 Class B 1 17 IEC EN 60601 1 2 2001 1 17 micrograms 4 14 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 7 4 12 4 20 4 26 5 4 5 25 6 3 Next Protocol Softkey 5 17 No Dose Limit 5 7 5 23 numeric buttons 3 6 Occlusion 1 8 Pressure 1 8 ON OFF button 3 5 one hour information 5 36 operating parameters 2 1 partial doses 5 2 Patient Pendant 1 1 1 3 1 4 1 5 1 8 1 10 1 11 1 12 1 15 3 8 5 2 patient pendant button 5 2
13. 6514 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 List 6516 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 List 6517 PCA Continuous Infusion Set Mini Bore with Integral Anti Siphon Valve SL 203 cm Approximate Priming Volume 1 5 mL For use in Continuous 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 Principles of Operation NOTES LifeCare PCA Infusion System Section 3 Equipment Description The following subjects are addressed in this section Front Panel Vial Cradle Assembly Rear Panel Operating Buttons amp Keys Attaching an Infuser to an IV Pole Removing an Infuser from an IV Pole 3 1 Equipment Description Front Panel Cradle Release Mechanism Holder Buttons HISTORY AC Power Indicator LIFECARE Injector Battery Power Indicator 3 2 LifeCare PCA Infusion System Vial Cradle Assembly Wireless Mechanism wee dida Upper Vial Retainer Vial Base Bar Code Reader Vial Window Cradle vial bar code Clips must face towar
14. 8 5 iv LifeCare PCA Infusion System SECTION 9 SPECIFICATIONS 9 1 WIRELESS LAN 9 5 STORED OCCLUSION VOLUME 9 5 TIME FROM OCCLUSION TO ALARM 9 6 DELIVERY RATE ACCURACY 9 6 TRUMPET CURVES 9 6 EXAMPLE wii Nd 9 7 TRUMPET CURVES 9 9 SECTION 10 PRESCRIPTION DELIVERY LIMITS 10 1 APPENDIX A GENERATING BAR CODE LABELS HOSPIRA MEDNET SOFTWARE ENABLED 1 EQUIPMENT NEEDED A 2 EXAMPLE OF LABEL LAYOUT amp A 3 LABEL DIAGRAM A 4 APPENDIX B NETWORK PRINTER SETUP B 1 EQUIPMENT NEEDED ebbe vs B 1 PREPARATION Sa Eire teh harried lee B 1 PROCEDURE S o esi s tbid cars db Bs OR Ad B 1 PRINTING EVENT HISTORY LOG B 2 DOWNLOADING LOGS B 3 EQUIPMENT NEEDED Y Mee pts B 3 PREPARATION are Y atau uo B 3 PROCEDURE 236 eem Vp x ES owe B 3 APPENDIX C WARRANTY acea con UR EN C 1 INDEX S ice x acad ae ace we ewe Oi 1 1 CONTACT INFORMATION D 1 vi For Systems With Hospira MedNet Software NOTES LifeCare PCA Infusion System Section
15. AVAILABLE is pressed the DOOR LOCKED 2mg Message disappears miligrama mc When the Dose Limit is reached a message is displayed that indicates the Dose Limit has been reached 5 15 Select Mode Protocols For detailed startup information including vial insertion clearing settings purging and setting a Loading Dose see Loading a Vial on page 4 4 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 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 2 Select CONTINUE gt to advance to the next programming screen 3 Select YES gt or NO gt at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less For more information see New Patient on page 4 26 4 Select CONFIRM gt to accept the inserted drug or remove the vial if it is not correct See New Patient on page 4 26 for more information 5 Select either YES gt or NO gt to purge the system For more information see Purgin
16. Door Open Door left open or unlocked for more than 2 minutes Close door and lock Infuser Paused 5 minutes Infusion paused for more than 2 minutes Press START PAUSE key again or unlock door Invalid Bar Code Custom Vials Disabled Replace Vial 1 minute Custom vial is disabled in Biomed mode Remove the device from service and send the device to Biomed to enable custom vial Invalid Bar Code Replace Vial 1 minute Medication concentration is not in the drug library Remove the device from service and send the device to Biomed to update the drug library LifeCare PCA Infusion System MESSAGE Low Battery MUTING TIMES 10 minutes POSSIBLE CAUSE Battery life has less than thirty minutes remaining and the infuser is currently operating on battery power CORRECTIVE ACTION Apply AC power Failure to connect to AC power may cause battery damage Dead Battery None Battery life has expired Apply AC power Pendant Fault O Visible flashing occurs Pendant not secured into port Faulty Connection or pendant Partial pendant press Using PCA Plus II patient pendant light gray pendant Secure pendant into port Replace pendant or infuser Release pendant button Confirm use of PCA patient pendant blue pendant Pendant Fault S Visible flashing occurs Electrical short in pendant Replace pe
17. 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 LifeCare PCA Infusion System START INFUSION DOOR LOCKED CONFIRM 4 HR LIMIT 55 CONFIRM CONT i 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 END PCA DENIED 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 SET 4 HR LIMIT SET CONT RATE SET PCA LOCKOUT SET PCA DOSE SET PCA CONT MODE SET LOADING DOSE PURGE CONFIRM MORPHINE PF CHECK VIAL ALARM CHECK INJECTOR ALARM CHECK SYRINGE ALARM 5 41 Select Mode 08 20A NEW PATIENT NOT SELECTED 08 19A BATTERY AVAILABLE 08 19A USING BATTERY 08 19A CHECK INJECTOR ALARM 08 19A POWER O
18. 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 Programs ccessories HyperTerminal gt Command Prompt Internet Connectic A NetMeeting Network and Dial u Phone Dialer E Paint Shop Pro 6 Y 1 Run Q shut Down tat Framems windows Flagstaff Manual inse Network Printer Setup 2 Create a PCA Events connection setting Coneecthon DescHpi in gi xi 789 Ente ber the 3 Establish the connection settings e Host address is the IP address of the infuser that connected to the PC e Port number is 8889 where the infuser will send the events to the PC e Connect using TCP IP protocol ze PCA events Enter details for the host that you want to call Host address E 92 168 0 100 Port number 8589 Connect using TCPAIP Winsock Cancel LifeCare PCA Infusion System 4 The Hyper Terminal program is ready to receive events sent from the infuser PCA events HyperTerminal Network Printer Setup 5 From the properties dialog box gt click the ASCII Setup button PCA printer Properties Connect To Settings Function arrow and ctrl keys act as Terminal keys O Windows keys Backsp
19. PCA Infusion System fe e e e de e dede de che cde e che KK KKK KKK KEK KR che e ce HOSPIRA LifeCare PCA PATIENT RECORD Se ke ee e ke e hee de de e e e ke e ee ke e de e che ce SERIAL NUMBER 000C 143 SOFTWARE VERSION 5 00U 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 SET 4 HR LIMIT SET CONT RATE SET PCA LOCKOUT SET PCA DOSE SET PCA CONT MODE RX SETTINGS RETAINED CONFIRM MORPHINE PF 5 39 5 40 Select Mode 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 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
20. a power outage Always connect the infuser to a properly grounded receptacle unless battery 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 Waming alarm has sounded SETS AND ACCESSORIES Use Hospira 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 Hospira LifeCare PCA Infuser set List 3559 6516 or a combination of List 6514 and 6517 It is recommended that highly viscous solutions and drugs colloidal 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 information 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
21. 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 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 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 4 2 LifeCare PCA Infusion System 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 a
22. monitoring equipment is recommended for continuous 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 following completion of drug administration by the epidural route CAUTION Delayed respiratory depression following continuous epidural administration of preservative free morphine sulfate has been reported e The epidural space has 58 openings through which fluid can exit Pressure buildup during administration is transient However 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 Whenthe Infuser is connected to a patient do not operate the Infuser with the battery removed Use of a properly maintained and charged battery helps ensure proper operation e battery may not be fully charged upon receipt Connect the PCA Infuser to AC power for at least 16 hours 1 15 Descriptive Information Use AC power whenever possible Connect to AC power during storage to ensure a fully charged battery during
23. no PCA doses permitted CONTINUOUS mode e Continuous rate and 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 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 19 The alarm system sounds an audible alarm to alert the user of various conditions or a malfunction see Alarms and Messages on page 7 5 2 2 LifeCare PCA Infusion System Features The following features are addressed in this section Drug Recognition Modes Of Delivery Programming Battery Biomedical Options Other Features DRUG RECOGNITION e Bar
24. on page 5 2 for more information SELECT DELIVERY MODE PCA ONLY PCA CONT SO CONTINUOUS PROTOCOLS PREVIOUS Advanced Programming with Hospira MedNet Software 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 CCA 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 5 mg may be assigned protocol No 1 in the Surgical CCA and No 6 in the Medical CCA 6 8 LifeCare PCA Infusion System 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 MERAY the infuser will display the NEW DRUG INSTALL NOW LIBRARY AVAILABLE screen 1 Select NO gt to skip the installation and continue using the current library The infuser will power off Or Select YES gt to begin the installing the new drug library The DRUG LIBRARY INSTALLATION Screen will DRUG LIBRARY flash the words IN PROGRESS IN PROGRESS
25. 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 ifthe LOW BATTERY WARNING alarm has sounded 6 9 Advanced Programming with Hospira MedNet Software The infuser displays the DRUG LIBRARY INSTALL SUCCESSFUL DRUG LIBRARY INSTALL screen after the library has IN PROGRESS been installed successfully The infuser will power off automatically SHUTTING DOWN 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 UNABLE TO INSTALL DRUG LIBRARY SHUTTING DOWN 6 10 LifeCare PCA Infusion System Soft Limit Override When entering parameters if a soft limit is exceeded a soft limit override do screen is displayed 6 mg 1 Review display for the IS OVER exceeded parameter 5 mg LIMIT 2 Select CONFIRM gt to override EEONEIRM the programmed soft limit or select CHANGE to correct the parameter All soft limit overrides made during programming are indicated on the INFUSION screen with an appropriate upper or lower limit arrow See Important Symbols on page 6 12 for details Hard Limit Violation When entering parameters if a hard Don m
26. settings are cleared 4 Select CONFIRM gt to accept the inserted drug or remove the vial if it is not correct 5 Select the softkey next to the desired CCA example PACU 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 NEXT gt to view more options BNEW PATIENT morPHINE PF 1 mg mL CONFIRM 1 MORPHINE BREMOVEVIAL IF NOT CORRECT SELECT 6 3 Advanced Programming with Hospira MedNet Software 6 Select either YES gt or NO gt to purge the system See Loading Vial on bu page 4 4 for more information PURGE PURGING RECOMMENDED 7 If YES gt is selected disconnect the set from the uc rra patient and press and hold E the PURGE Softkey While purging is occurring the word PURGING is displayed Note Purging is recommended to remove system slack when a new PREVIOUS i vial is inserted The maximum volume delivered during a purge is 3 mL Upon release of the PURGE i morPHINE PF Softkey the display asks if 1 mg mL PACU the purge is complete PURGE COMPLETE 8 Select YES gt to continue or select NO gt to purge again until complete 9 After purging is complete reconnect set to patient LifeCare PCA Infusion System 10 Set Loading Dose if desired by selecting YES gt mam See Loading Dose on page 4 29 ie for m
27. to the preceding screen 4 Close and lock the door Place key in a secure location 5 Press 4 to begin therapy Approximately 10 seconds after door is locked and 4 is pressed the DOOR LOCKED MESSAGE disappears PROGRAMMING No DOSE LiMIT 1 Select NO at the DOSE LIMIT SELECTION SCREEN The display advances to the Confirm NO DOSE LIMIT SCREEN 2 Select CONFIRM gt to verify the selection of the No Dose limit Note When NO LIMIT has been programmed the message No 4 HR LIMIT will be displayed after the door has been locked MORPHINE PF 1 mom PCA CONT PCA DOSE 2mg LOCKOUT min CONT RATE KC 2 mh ZSO 4 HOUR LIMIT 40 mo CONFIRM PREVIOUS MORPHINE PF 1 mg mL DOSE LIMIT PREVIOUS MORPHINE PF 1 mg mL CONFIRM NO DOSE LIMIT PREVIOUS 5 21 Select Mode 3 Select CONFIRM gt to accept MORPHINE PF the chosen protocol settings 1 mg mL Or press PREVIOUS to return to the preceding screen 2mg 4 Close and lock the door CONT RATES i i 2 mg hr Place key in a secure location EC 5 Press 4 to begin therapy CONFIR SO Approximately 10 seconds after PREVIOUS q door is locked and 4 is pressed the DOOR LOCKED MESSAGE disappears CLEARING OR CHANGING A DOSE LIMIT 1 Unlock door to stop the infuser MORPHINE PF 2 Select CHANGE RX gt PAUSED PCA CONT Note CHANGE CCA gt will only abii e ho display if Hospira Med
28. 5 35 Select Mode 4 Continue to press TIME 8 04 PM DATE 07 15 05 or 2 55 for more information S N 12920191 such as the following DELIVERED LOADING DOSE KC e Last one hour information 10 min i HOUR DOSE if configured HOUR ved e Last 24 hour information 2mg if configured PREVIOUS e Current settings e Total drug delivered toward the dose limit e Event Log The Event Log shows all events since the last Clear History Up to 400 events are shown 5 Press to return to the MAIN DELIVERY SCREEN 6 Close and lock the door Press START PAUSE if in Continuous or PCA Continuous mode 5 36 LifeCare PCA Infusion System 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 Pressing the HISTORY Button displays this data on the LCD Pressing PRINT HISTORY gt generates a hard copy printout of the data When the infuser is configured with the HOUR BY HOUR history
29. 601 1 standards for Description AC mains supply equipment using protective earth Type CF Equipment providing a higher degree of electric 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 Interference EMI and Radio Frequency Interference RFI Electrical Leakage Fuses Lockout Interval Range Maximum Infusion Pressure Maximum Overinfusion Occlusion Alarm Pressure The LifeCare PCA is designed to perform in the typical hospital environment A qualified service technician should verify performance in any environment where EMI or RFI levels are excessive Risk current limits meets standard IEC EN UL 60601 1 1 0 A 250 V Slow Blowing 5 to 120 minutes 1 minute increments 45 psig The maximum overinfusion under single fault conditions is 25 15 psig 5 psig Occlusion Bolus Volume Operating Temperature Power Cord Power Requirements Printer Port Recharge Self Discharge Storage Temperature Weight 9 4 Specifications 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
30. ACKING 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 the infuser is used in the presence of flammable anesthetics WARNING Possible explosion hazard exists if the infuser is used in the presence of flammable anesthetics e Potent analgesic medications are used with this device Refer to drug package insert for precautions and possible adverse reactions 1 10 LifeCare PCA Infusion System e Refer to analgesic package enclosure for possible incompatibility with fluid or drug being delivered through the IV line Coupling together of more than one infuser into one patient line 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 e Failure to use Hospira vials and Hospira PCA infuser sets with the integral anti siphon valve may cause an inaccurate dose delivery to the patient The system must be primed prior to purging Remove all air from the vial before placing it into the infuser e Always close the slide clamp on the PCA Infuser administration
31. C 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 fully charged battery connect the PCA Infuser to AC power for a minimum of 16 hours while in the OFF MODE 4 19 Basic Operation DATA RETENTION Delivery program settings and programming option selections are retained in memory unless erased 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 After 24 hours the data in the pump s short term memory must be cleared To clear the pump s memory see Clearing Shift Totals on page 5 31 4 20 LifeCare PCA Infusion System Adjusting Settings 1 Press BurroN to power LifeCare the infuser Upon initial start up SELF TEST the self test begins It may take several seconds for the Hospira logo to appear on the screen
32. CHANGING A VIAE 4 4 5 32 ADDING A SUPPLEMENTAL LOADING DOSE 5 34 CHECKING HISTORY amp SETTINGS 5 35 HISTORY AND EVENT LOG 5 37 iii For Systems With Hospira MedNet Software SECTION 6 ADVANCED PROGRAMMING WITH HOSPIRA MEDNET SOFTWARE 6 1 GUIDED START UP USING HOSPIRA MEDNET SOFTWARE 6 1 SELECT CGA ore s de ot DERE De EYE denen 6 8 UPDATING THE DRUG LIBRARY 6 9 SOFT LIMIT 6 11 HARD LIMIT VIOLATION 6 11 IMPORTANT SYMBOLS 6 12 RULE SETS lee eee eee 6 12 SOFT LIMIT OVERRIDE 6 12 WIRELESS Lc x eie A Relea a eee 6 13 AUTOPROGRAMMING 6 13 SECTION 7 TROUBLESHOOTING 7 1 STATUS MESSAGES 7 2 INFUSER ALARM 7 3 SILENCING AN ALARM 7 4 ALARMS AND MESSAGES 7 5 INFUSER STALLING 7 8 SECTION 8 MAINTENANCE 8 1 INFUSER STORAGE 8 1 CLEANING AND SANITIZING 8 2 BATTERY MAINTENANCE 8 4 SERVIGE ote PRA Buh a E B
33. CKOUT Interval 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 infuser 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 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 4 For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 21 4 5 Select CONTINUE gt to advance 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 to the next programming screen Select YES gt or NO gt at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less See New Patient on page 4 26 for more information Select CONFIRM gt to accept the inserted drug or remove the vial if it is not correct See New Patient on page
34. ED PREVIOUS 4 24 LifeCare PCA Infusion System 4 Select gt 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 5 After changing the time select NEXT gt to change the date 6 To change the date set the date with the Numbers Buttons ESET DATE WITH NUMBERS BUTTONS 01 15 05 The current setting for Date will flash Note Date must be entered in MM DD YY sequence 7 Select NEXT again after changing to the desired date The CONFIRMATION SCREEN appears cn Select CONFIRM to verify the TIME AND DATE SETTINGS changed settings 9 21 PM 01 15 05 8 Then select CONTINUE to exit the Change System Settings Menu and display the VIAL CONFIRMATION SCREEN if the vial is loaded properly 4 25 Basic Operation New Patient 1 The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less Select YES gt or No gt 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 2 If YES gt is selected the History and Rx settings are cleared gt HISTORY AND If NO gt is selected the History HISTORY AND and Rx settings are kept CLEARED and a screen appears offering the option to CLEAR HISTORY gt or CON
35. 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 CONFIRM gt to accept the MORPHINE PF inserted drug or remove the vial 1 mg mL if itis not correct CONFIRM 1 MORPHINE TO RX 5 25 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 26 Clinicians should review each MORPHINE PE rogrammed parameter and 1 mg mL pog PCASCONT ensure that the displayed program agrees with the physician s order 2mg If all of the programmed parameters AGREE with the 2 mgh SO physician s order the clinician E accepts the settings by selecting NL CONFIRM gt C PREVIOUS If one or more of the programmed 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 the programmed values may be changed by either entering the new value by using the numeric keypad and pres
36. Hospira sales office 8 6 NOTES Maintenance LifeCare PCA Infusion System Section 9 Specifications Administration Sets Use only compatible Hospira PCA sets with Integral Anti Siphon Valve Atmospheric 0 10 000 feet 0 3 000 m Pressure or equivalent 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 fully charged conditioned battery shall provide at least 3 hours of continuous operation from the Start of delivery at 5 mL hr to Dead Battery The PCA Infuser provides a low battery warning at least 30 minutes prior to shutdown Casing High impact plastic 9 1 Delivery Rate PCA mode Specifications See Section 10 Prescription Delivery Limits on page 10 1 Delivery Rate 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 PCA CONT mode Dimensions Drug Concentration Settings 9 2 Variable from 0 1 x concentration mg hr mcg hr to 20 x concentration mg hr or mcg hr PCA dose mg Approximately 8 W 13 6 D excluding pole clamp protrusion and power cord storage See Section 10 Prescription Delivery Limits on page 10 1 LifeCare PCA Infusion System Electrical Safety Specification Class 1 Meets IEC EN UL 60
37. IME AND DATE 4 24 NEWPATIENT tdt deest itecto a 4 26 PURGING THE SYSTEM 4 27 LOADING DOSE inky nee pe 4 29 SECTION 5 SELECT MODE 5 1 MODES OF DELIVERY 5 2 PROTOCOLS eieaa dr ded YD A ange 5 2 PCA ONLY dude UR hae a ee 5 2 CONTINUOUS eee 5 3 CONTINUOUS 5 3 PCA ONLY MODE seatanna uina aes ad ends 5 4 CONTINUOUS MODE 5 8 PCA CONTINUOUS MODE 5 12 PROTOCOLS s auis debt x e pda Rete ot qud 5 16 DOSE LMT Ua v afe varo 5 19 PROGRAMMING THE 4 OR 1 HOUR DOSE LIMIT 5 20 PROGRAMMING A DOSE LIMIT 5 20 PROGRAMMING NO DOSE LIMIT 5 21 CLEARING OR CHANGING A DOSE LIMIT 5 22 CLEARING THE HISTORY AND OR RX SETTINGS 5 25 USING REVIEW CONFIRMATION SCREENS 5 26 CHANGING SETTINGS DURING SETUP 5 27 STOPPING INFUSION 5 27 TURNING THE INFUSER OFF 5 27 MAKING CHANGES AFTER SETUP 5 28 REVIEWING THE CURRENT SETTINGS 5 28 CHANGING SETTINGS 5 28 CHANGING THE 5 30 CLEARING SHIFT TOTALS 5 31
38. N 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 11 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 e the de e e dee dece che de cde e de de k de e dece e k de e ee de e dede ke je he e je e de VERIFIED BY De ke ee ee e ee e k je ke ke e e dee e e e ce e e oe de he e ee e ee e e ke e e f fe e ehe ee ee cede e che ke e e e de de ke de e ehe de ke e k k k k END OF RECORD HRI e ee e e e he e e e de c e he e ke e e ke de de e de de e e de ee dee 5 42 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 Updating the Drug Library Soft Limit Override Hard Limit Violation Important Symbols Autoprogramming Guided Start up Using Hospira MedNet Software User Defined Drug Libraries are developed by hospital personnel in conjunction with the pha
39. NS 1t cok ok ee eh a 1 4 WARNINGS CAUTIONS AND NOTES 1 5 DEFINITIONS GENERAL AND CLINICAL 1 6 PRECAUTIONS AND WARNINGS 1 10 UNPACKING 1 10 GENERAL decade ats Re Ia 1 10 PROGRAMMING 1 11 LOADING DOSE DOSE LIMITS 1 12 OPERATION ER ERR cay ie 1 13 MAINTENANCE 1 13 ALARMS seti as Bae 1 14 EPIDURAL ADMINISTRATION 1 14 BATTERY OPERATION 1 15 SETS AND ACCESSORIES 1 16 ELECTRICAL ARTIFACTS 1 16 INTERCONNECTING OF EQUIPMENT 1 18 GUIDANCE ON EMC COMPATIBILITY 1 19 FCC INFORMATION 1 20 US FCC FEDERAL COMMUNICATIONS COMMISSION STATEMENT Ce oc 1 20 FCC INTERFERENCE STATEMENT 1 20 WIRELESS DEVICE CAUTION 1 21 RADIO FREQUENCY EXPOSURE STATEMENT 1 21 For Systems With Hospira MedNet Software SECTION 2 PRINCIPLES OF OPERATION 2 1 FEATURES A AN er Bid td Sh 2 3 DRUG RECOGNITION 2 3 MODES OF DELIVERY 2 3 PROGRAMMING 2 3 BATTERY ma
40. Net KC Software has been enabled LOADING DOSE i CHANGE CLEAR SHIFT gt CHANGE 3 Select NEXT gt to display more MORPHING DF change options 1 mg mL SELECT SETTING TO CHANGE PCA DOSE y CONT SAVE amp EXIT SD 5 22 LifeCare PCA Infusion System 4 Select DOSE LIMIT gt MORPHINE PF 1 mg mL SELECT SETTING TO CHANGE LOCKOUT DOSE LIMIT SAVE amp EXIT 5 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 MORPHINE PF No Dose Limit will be selected for this example PREVIOUS 6 Select CONFIRM gt to verify the MORPHINE PF No DOSE LIMIT selection Or 1 mg m select PREVIOUS to return to ICONFIRM NO DOSE LIMIT the preceding screen PREVIOUS 5 23 T Press SAVE amp EXIT at the next screen This will bring up the REVIEW CONFIRMATION SCREEN 8 Press CONFIRM gt to accept a new program 5 24 Select Mode MORPHINE PF 1 mg mL BSELECT SETTING TO CHANGE DOSE LIMIT gt SAVE amp EXIT AR MORPHINE PF 1 mg mL i PCA DOSE LOCKOUT 4 HOUR LIMIT NO cor MS O PREVIOUS LifeCare PCA Infusion System Clearing the History and or Rx Settings 1 To clear the HISTORY AND RX settings turn the infuser OFF and ON again to get to the gi NEW PATIENT SCREEN 2 Press YES and
41. Not Read MUTING TIMES 1 minute POSSIBLE CAUSE Vial not loaded properly CORRECTIVE ACTION Position vial correctly Clean bar code reader window Check Settings 1 minute Door locked without appropriate therapy settings Open the door Complete settings Occlusion 1 minute Occlusion detected Open security door if 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 Syringe Syringe Vial and Injector not properly loaded Close Slide Clamp Immediately Properly insert syringe into holder assembly Check Vial Injector detected and vial not properly loaded Properly insert vial into holder assembly or removal of injector Check Injector Vial is detected and injector not properly loaded Properly insert injector into holder assembly or removal of vial MESSAGE Decimal Point Not Allowed MUTING TIMES PossIBLE CAUSE Attempting to select the decimal point button when programming in micrograms mcg Troubleshooting CORRECTIVE ACTION Press CLEAR and enter valid whole number Empty Syringe 15 minutes Empty vial detected Press SILENCE to 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
42. PCA 1 2 2 1 PCA Cont 6 8 PCA Continuous 2 2 5 3 5 33 mode 1 11 5 19 PCA AVAILABLE Message 5 2 5 3 PCA bolus 5 15 PCA dose 2 2 PCA Infusion System 1 1 PCA LOCKOUT Message 5 7 PCA Mode 1 8 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 pole clamp 3 9 Prime 1 9 1 11 5 33 system 4 27 4 28 4 29 Print History 5 35 Softkey 5 37 B 7 printer connections 1 1 printouts 5 38 procedures 1 10 program values change 5 26 programmed therapy 1 9 programming features 1 1 Protocols 1 2 1 9 5 2 5 16 6 8 stored 5 2 purge 1 9 1 11 5 32 6 4 complete 4 8 cycle 4 27 I 3 system 4 27 Purge Softkey 4 8 5 12 6 4 R Rear Panel equipment description 3 4 removing an infuser from an IV pole 3 11 replace syringe message 5 32 Review Confirmation Screen 5 24 5 26 RF communications 1 17 Rule Set 1 9 Rx Rules 1 10 5 16 Rx Settings 1 9 5 safety 1 10 Save amp Exit Softkey 5 24 5 29 screen message alerts 5 2 Select CCA Screen 6 8 Select Delivery Mode Screen 4 10 4 16 6 6 6 8 Select Mode PCA Cont 5 13 PCA Only 5 4 Screen 4 29 self test 4 6 4 11 failures 4 19 set 4 8 4 13 4 28 5 4 6 4 Set List 1 16 settings 5 27 5 36 adjust system 5 4 5 8 5 12 SILENCE key 1 8 SILENCE VOLUME button 3 5 slack 1 11 4 27 5 33 soft limits 1 9 5 14 Softkeys 1 9 3 7 Standard Syringe 1 10 START PAUSE Button 5 2 5 3 5 8 START PAUSE b
43. Preparation Per manufacturer s recommendation Diversey Corporation Per manufacturer s recommendation Coverage HBV Steris Corporation A division of Calgon Vestal Laboratories Per manufacturer s recommendation TM Sporicidin Sporicidin International Per manufacturer s recommendation Dispatch Caltech Industries Per manufacturer 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 8 3 Maintenance 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 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 U
44. R 4 9 Basic Operation 13 If YES gt was selected press MORPHINE PE 1 mg mL the 4 BurroN to anes the programmed Loading Dose START BUTTON TO INFUSE Note The loading dose mode 2mg is the only mode that the infuser LOADING DOSE will deliver with the door unlocked WARNING Always monitor the infuser when delivering medication with the door unlocked 14 If the DELIVER LATER option is selected the screen advances to the SELECT DELIVERY MODE SCREEN 15 The screen displays the amount ae MORPHINE PF of analgesic delivered as it infuses 1 mg mL The bottom of the screen displays text confirming that the Loading PAUSE BUTTON Dose is being delivered Upon TO STOP completion the red LED above the LCD displays the amount 1 mg delivered milligrams INFUSIN 16 The SELECT MODE SCREEN MORPHINE PE appears See Modes of Delivery on 1 mg mL page 5 2 for more information BMSELECT DELIVERY MODE PCA ONLY Pca coot O CONTINUOUS PROTOCOLS S PREVIOUS 4 10 LifeCare PCA Infusion System Guided Start up for Custom Vials Note Custom vials without pharmacy generated bar codes can only be used with the default drug library 1 Press BuTTON or load drug vial into cradle to power on the infuser See Loading a Vial on page 4 4 Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen Lif
45. START 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 hazard to the patient disconnect the set during this operation 4 27 Basic Operation 1 If YES gt is selected disconnect MORPHINE PE the set from the patient and press 1 mg mL gt DISCONNECT and hold the PURGE gt Softkey RISCONNE Note While purging is occurring the word PURGING will be displayed PRESS AND HOLD PURGEKEY _ 9 Note Purging is recommended to remove system slack when a new vial is inserted The maximum volume delivered during a purge is mL PREVIOUS Upon release of the PURGE MORPHINE PF Softkey the display asks 1 mg mL if the purge is complete PURGE COMPLETE 2 Select YES gt to continue or select No gt to purge again until complete Reconnect set to patient 4 28 LifeCare PCA Infusion System Loading Dose 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 MORPHINE PE 1 mg mL by selecting YES gt mg m SET LOADING DOSE If NO is selected the screen advances to the SELECT MODE SCREEN See Modes of Delivery on page 5 2 for information on modes Note A supplemental loading dose can also be delivered after the pro
46. System n Operating f y Manual For Use With List 20709 04 LIFECARE PGA 430 04685 008 2014 02 For Systems With Hospira MedNet Software Change History 430 04685 007 A Rev 10 10 430 04685 008 A 2013 08 Seventh Release Eighth Release Update the LifeCare PCA logo change the registered trademark to a trademark 7 Remove references to Abbott vials Specification that the patient pendant is to be used only with the LifeCare PCA3 Infusion System or LifeCare PCA Infusion System for use with Hospira MedNet software Caution about the pole clamp Instructions on how to use the pole clamp Instruction to clear data stored in the short term memory in the PCA infuser 430 04685 008 B 2013 10 Eighth Release Update throughout with grammatical and formatting changes to align with approved design inputs 430 04685 008 C 2014 02 Eighth Release Add Caution regarding the cradle release mechanism Add Caution for proper cleaning of the bar code reader window LifeCare PCA Infusion System Contents SECTION 1 DESCRIPTIVE INFORMATION 1 1 PRODUCT DESCRIPTION 1 1 INDICATIONS FOR USE 1 2 PATIENT SELECTION 4 5 seu lier bee mens 1 3 USER QUALIFICATIONS 1 3 CONTRAINDICATIONS FOR USE 1 4 CONVENTIO
47. T SETTINGS Settings may be reviewed while the infuser is running or stopped 1 Press ww D 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 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 5 28 MORPHINE PF 1 mg mL PAUSED PCA CONT BLOCK DOOR TO BEGIN LOADING DOSE gt CHANGE CLEAR SHFP O CHANGE CCA MORPHINE PF 1 mg mL BSELECT SETTING TO CHANGE Pca Doso O CONT RATE SAVE amp EXIT LifeCare PCA Infusion System 4 Enter the desired PCA dose MORPHINE PE using the numeric keypad 1 mg mL The value range is displayed ENTER PCA DOSE on the screen If the value is THEN PRES 5 ENTER BUTTON entered incorrectly press O to change value jii milligrams 5 Then press If programming changes need to be made select PREVIOUS gt to return to the preceding screen
48. TINUE gt 4 26 LifeCare PCA Infusion System 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 disconnected 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 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
49. 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 installation This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with the instructions it may cause harmful interference to radio communications However there is no guarantee that interference will 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 Reorient or relocate the receiving antenna Increase the distance between the equipment and the receiver Connect the equipment to an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help e Changes or modifications not expressly appr
50. ace key sends Ctl H Del Space Ctri H Emulation ANSIW v Terminal Setup Telnet terminal ID VT100 Backscroll buffer lines 500 C Play sound when connecting or disconnecting Input Translation ASCII Setup LifeCare PCA Infusion System 6 Check the Append line feeds to the incoming line ends box ASCII Setup ASCII Sending C Send line ends with line feeds C Echo typed characters locally Line delay 0 milliseconds Character delay milliseconds ASCII Receiving Append line feeds to incoming line ends C Force incoming data to 7 bit ASCII Wrap lines that exceed terminal width 7 Printing to a PC Cancel 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 Network Printer Setup NOTES 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
51. alarm will be activated 5 Scan the barcode on the infuser 6 Verify all parameters If changes are desired select CHG SETTINGS gt 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 If the Loading Dose value is correct select CONFIRM gt 8 To deliver the Loading Dose and begin the program select YES gt on the LOADING DOSE NOT GIVEN screen To cancel the Loading Dose and just start the program select CANCEL gt 9 Close and lock the door Press START to begin the program WARNING The infuser cannot communicate via the network if the Low Battery Warning alarm has sounded 6 14 LifeCare PCA 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 7 1 Troubleshooting Status Messages Displayed status messages are defined in the following table MESSAGE DEFINITION DOOR LOCKED Message indicates the security door is closed and locked It displays for 30 seconds and disappears PCA LOCKOUT Message appears only in the PCA ONLY or PCA CONTINUOUS mode The message remains until the l
52. ar code reader window while cleaning 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 ammonium chloride CAUTION 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 To 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 LifeCare PCA Infusion System 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 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 Manu Klenz Manufacturer Calgon Vestal Laboratories
53. ay loading dose delivery From the SELECT MODE SCREEN select PCA CONT gt Enter PCA dose value using the keypad The value range is displayed on the screen If value is entered incorrectly press O to change the value Then press 31159 If programming changes need to be made select PREVIOUS to return to the preceding screen MORPHINE PF 1 mg mL IDELIVER LOADING DOSE DELIVER LATER S MORPHINE 1 mg mL BSELECT DELIVERY MODE PCA ONLY Pca CONT O CONTINUOUS PROTOCOLS PREVIOUS MORPHINE PF 1 mg mL HENTER PCA DOSE THEN PRESS ENTER BUTTON 99 0 1 5 mg 2 mg milligrams PREVIOUS 5 13 14 15 16 Enter a Lockout Interval value Value range is displayed on the screen If the value is entered incorrectly press O to change the value Then press 52 11 55 If programming changes need to be made select PREVIOUS to return to the preceding screen Enter a Continuous Rate The value range is displayed on the screen If the value is entered incorrectly press Q to change the value Then press 31152 If programming changes need to be made select PREVIOUS to return to the preceding screen Set a specific dose limit by selecting YES and advancing to the DOSE LIMIT ENTER VALUE SCREEN Select NO to choose No DOSE LIMIT Setting a specific Dose Limit will be selected for this example If Hospira MedNet Softwar
54. cal Hospira sales office 430 04685 008 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 HAZARD EXISTS IF THE INFUSER IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS The PCA Infuser Hospira MedNet LifeShield and E L I are trademarks of Hospira Teflon Formula C Manu Klenz Super Edisonite Coverage and Sporicidin are not trademarks of Hospira Type CF IPX1 Class 1 UL 60601 1 CSA 601 1 MCN 160992 US C 430 04685 008 Provides adequate degree of protection against electrical shock and suitable for application to patient Protected against dripping water Mains supply equipment using protective earth The C and US indicators adjacent to the CSA Mark signify that the product has been evaluated to the applicable CSA and ANSI UL Standards for use in Canada and the U S respectively This US indicator includes products eligible to bear the NRTL indicator NRTL National Recognized 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
55. center bar code includes 1 4 quiet zone on each side of the bar code The bar code and commodity number must be black on a white background White 1 29 32 m Background 1 8 1 8 Drug Copy Barcod 1 5 16 1 8 Drug Concentration 01 0 030074 202904 9 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 Generating Barcode Labels NOTES LifeCare PCA Infusion System Appendix B Network Printer Setup This section provides information about the printing function EQUIPMENT NEEDED e nfuser e Computer meeting the printer setup requirements e Network crossover cable PREPARATION e Connect the crossover cable between the printer network port and the computer e Plug infuser amp printer into AC power e Turn on the infuser and printer PROCEDURE 1 Identify the printer IP settings refer to printer operating instructi
56. cg mL ESET LOADING DOSE ALPHA VIAL 10 mcg mL ENTER LOADING DOSE ETHEN PRESS ENTER BUTTON 1 100 mcg 20 mcg micrograms ALPHA VIAL 10 mcg mL BDELIVER LOADING DOSE NOW DELIVER LATER S 4 15 18 If YES was selected press the 42 Button to infuse the programmed Loading 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 19 If the DELIVER LATER option is selected the screen advances to the SELECT DELIVERY MODE SCREEN 20 The screen displays the amount of analgesic delivered as it infuses The bottom of the screen displays text confirming that the Loading Dose is being delivered Upon completion the red LED above the LCD displays the amount delivered The SELECT MODE SCREEN appears See Modes of Delivery on page 5 2 for more information 4 16 Basic Operation ALPHA VIAL 10 mcg mL BPRESS START BUTTON TO INFUSE 20 mc LOADING DOSE ALPHA VIAL 10 mcg mL PRESS PAUSE BUTTON TO STOP micrograms INFUSING LOADING DOSE ALPHA VIAL 10 mcg mL SELECT DELIVERY MODE PCA ONLY PCA CONT n CONTINUOUS PROTOCOLS aD PREVIOUS LifeCare PCA Infusion System Getting Started This section details the PCA Infuser setup procedures UNPACKING Inspect the PCA Infuser packaging for possible shippin
57. clear shift totals MORPHINE PF and return to the previous screen 1 mg mL CLEAR SHIFT TOTALS Or select NO gt to return to previous screen Note Selecting YES gt clears the PCA Summary data and total dose delivered including the 24 hour totals The dose limit data is not cleared 5 Close and lock the door Place key in a secure location 6 Press 4 to begin therapy Approximately 10 seconds after door is locked and 4 is pressed the DOOR LOCKED MESSAGE disappears 5 31 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 4 Load the new vial as shown before MORPHINE PF See Loading a Vial on page 4 4 1 mg mL WARNING Ifa change is detected from DRUG andior the previous vial or infused drug the WARNING DRUG AND NE OR CONCENTRATION CHANGE REMOVE VIAL IF INCORRECT 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 gt when Purge is displayed WARNING Disconnect the patient from the PCA set before the purge cycle 7 At this point A Disc
58. code reader identifies drug name and concentration in the vial prefilled Hospira vials only e Barcode 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 OF DELIVERY PCA Only e Continuous e PCA Continuous PROGRAMMING Keypad with large numbers decimal point amp icons for easy use e Prompting alphanumeric display 2 3 Principles of Operation BATTERY 8 V Battery Battery for emergency backup and temporary portable operation approx 3 hrs BIOMEDICAL RJ 45 Ethernet Connector Software is Field Upgradable Diagnostic Setup Options Alarm History Ability to Store Protocols for Hospira Prefilled Vials and Custom Sterile Empty Vials Nurse Call Relay Connector OPTIONS Infusion History OTHER FEATURES 2 4 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 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 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 List
59. ctly reflect the product Descriptive Information Definitions General and Clinical Accuracy DEFINITION The degree 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 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 permitted 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 Engine CE A component of the infuser that controls Ethernet and wireless communication between the network server and infuser Continuous Infusion program characterized by a constant fixed rate dose Custom Syringe or Vial 1 6 A barcoded Hospira sterile empty vial that is custom filled by a pharmacy LifeCare PCA Infusion System DEFINITION Default Drug Library A pre programmed drug librar
60. d 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 LifeCare PCA Infusion System Attaching an Infuser to an IV Pole CAUTION To prevent personal injury or product damage do not use tools to tighten the pole clamp To attach an infuser to an IV pole proceed as follows 1 Ensure that the infuser is unplugged and that the security door is unlocked Grasp the infuser by the handle then place the IV pole inside the infuser s pole clamp Support the infuser with one hand and use your other hand to turn the pole clamp knob clockwise Secure the infuser against the IV pole and tighten the clamp Make sure that there is no gap between the pole and the infuser clamp o e NO GAP INFUSER J CLAMP POLE age POLE Press down and pull up on the infuser to confirm that it is clamped tightly to the IV pole with no vertical or rotational slippage If the infuser is not clamped tightly realign the pole clamp and turn the knob CAUTION Do not use tools to tighten the pole clamp Equipment Description Note Locking the security door will lock the pole clamp and the pole clamp knob so that the infuser cannot be removed witho
61. d window Vial Sensor Switch Top Vial Vial Stopper Cradle Clip Vial Lip Lower Vial Retainer Middle Bracket Injector Injector Flange Injector Flange Retainer Vial Plunger Injector Sensor Switch Back of Retainer Luer Lock Fitment 3 3 Equipment Description Rear Panel Patient G Pendant Nurse Call ag Jack Jack i Patient Pendant Cable Fastener Patient Pendant Ethernet Jack Printer Connector a Pole Clamp with Dual Lock gt Patient Pendant Button AC Power Cord Battery and Fuse Stabilizer Access Door Foot Note The pole clamp is locked when the security door is closed and locked The infuser cannot be removed from an IV pole without a key See pages 1 17 through 1 22 prior to interconnecting equipment 3 4 LifeCare PCA Infusion System Operating Buttons amp Keys 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 SILENCE VOLUME 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 r
62. 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 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 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 LO
63. dministration 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 sulfate has been reported 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 Basic Operation Loading a Vial 4 4 WARNING Failure to use compatible Hospira vial injector and Hospira 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 CAUTION Grasp the cradle release mechanism and squeeze completely Continu
64. e is enabled and a upper hard or soft limit has been assigned for that CCA and drug then a DOSE LIMIT entry is required and this screen will not be displayed 5 14 Select Mode MORPHINE PF 1 mg mL ENTER LOCKOUT INTERVAL THEN PRESS ENTER BUTTON medi 5 120 min 10 minutes PREVIOUS MORPHINE PF 1 mg mL HENTER CONT RATE THEN PRESS ENTER BUTTON 0 1 20 mg hr mg milligrams T PREVIOUS LifeCare PCA Infusion System 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 19 17 Enter the Dose Limit value using MORPHINEPE the numeric keypad the range is 1 mg mL displayed on the screen If the value is entered incorrectly press O to change value 40m Then press sis If programming changes need to be made select PREVIOUS gt to return to the preceding screen 18 Select CONFIRM gt to verify MORPHINE PF settings Or select PREVIOUS gt Bd mm to return to the preceding PCA DOSE screen 2 mg LOCKOUT 19 Close and lock door Place key in a secure location After locking the door the PCA bolus is available for CONFIRM gt infusion The patient presses PREVIOUS pendant to initiate PCA dose i MORPHINE PF 20 Press 4 to begin therapy E a Approximately 10 seconds PCA CONT after door is locked and 42 PCA
65. e 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 9 8 LifeCare PCA Infusion System Trumpet Curves Percent Error E 8 Percent Error 90 0 1 ml hr 0 mmHg Delivery Head 0 9 Saline Maxima Minima of 3 Pumps 15 20 Observation Interval min PCA 1 0 mmHg Delivery Head 0 9 Saline Maxima Minima of 3 Pumps 16 20 Observation Interval min 5 mhr 0 mmHg Delivery Head 0 9 Saline Maxima Minima of 3 Pumps 15 20 Observation Interval min Percent Error E P Percent Error 9 10 Specifications PCA 5 100 mmHg Delivery Head 0 9 Saline Maxima Minima of 3 Pumps 16 20 Observation Interval min 5 ml hr 100 mmHg Delivery Head 0 9 Saline Maxima inima of 3 Pumps 16 20 Observation Interval min 20 0 mmHg Delivery Head 0 9 Saline MaximaMinima of 3 Pumps 15 20 Observation Interval min LifeCare PCA Infusion System Section 10 Prescription Delivery Limits Prescription delivery limits for 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 for listings of the lower and upper limits Note Dr
66. e to squeeze the release mechanism during movement of the cradle A grinding sound should not be audible and the release mechanism should slide freely to prevent damage Note Always verify that the bar code reader window is clean before inserting vial LifeCare PCA Infusion System 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 3 Insert bottom of glass vial into the middle black bracket 4 Gently press upper end of glass vial into upper black bracket 5 Squeeze the top of the Cradle Release Mechanism and move down until the vial injector snaps into the bottom bracket CAUTION Grasp the cradle release mechanism and squeeze completely Continue to squeeze the release mechanism during movement of the cradle A grinding sound should not be audible and the release mechanism should slide freely to prevent damage 6 Select CONTINUE gt 7 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 WARNING Cracked vials may not show evidence of leakage until delivery pressure is applied Note If the device is OFF improper loading of syrin
67. eCare PCA SELF TEST 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 gt to advance to the next screen LifeCare PCA SELF TEST COMPLETE OK SYSTEM 5 ETTINGS SO CONTINUE 4 11 Basic Operation 3 The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less BNEW PATIENT Select YES gt or No gt 4 If NO is selected the History and Rx settings are kept 5 If the YES option is selected the History and Rx settings are cleared Select CONFIRM gt HISTORY AND to confirm choice and continue CLEARED A screen appears to confirm that history was cleared Note Alpha Vial is a type of sterile empty vial that can be customized by your hospital pharmacy Other vials when available and used may be identified as Beta Gamma etc 6 Select CONFIRM gt to accept ETNA the inserted drug or remove the vial if it is not correct 4 12 LifeCare PCA Infusion System 7 Select either YES gt or NO gt to purge the system See Purging the System on page 4 27 for more information 8 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 t
68. er is locked out MORPHINE PF 1 mg mL CONFIRM NO DOSE LIMIT PREVIOUS MORPHINE PF Bu ms PCA cm LOCKOUT MEE PF 5 7 Select Mode 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 Continuous Mode For detailed startup information including vial insertion clearing settings purging and setting a Loading Dose see Loading a Vial on page 4 4 For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 21 1 Unlock door and press 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 2 Select CONTINUE gt to advance to the next programming screen 3 Select YES gt or NO gt at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less See New Patient on page 4 26 for more information 4 Select CONFIRM gt to accept the inserted drug or remove the vial if it is not correct See New Patient on page 4 26 for more information 5 8 LifeCare PCA Infusion System 5 Select ei
69. ettings purging and setting a Loading Dose see Loading a Vial on page 4 4 For information on adjusting system settings such as contrast and volume see Adjusting Settings on page 4 21 5 8 9 Select CONTINUE gt to advance 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 to the next programming screen Select YES gt or NO gt at the NEW PATIENT SCREEN if the infuser has been OFF 4 hours or less See New Patient on page 4 26 for more information Select CONFIRM gt to accept the inserted drug or remove the vial if it is not correct See New Patient on page 4 26 for more information Select either YES gt or NO gt to purge the system See Purging the System on page 4 27 for more information If YES is selected disconnect the set from the patient and press amp hold the PURGE Softkey Select YES to continue or select NO to purge again until complete Reconnect set to patient Set Loading Dose if desired by selecting YES See Loading Dose on page 4 29 for more information 5 12 LifeCare PCA Infusion System 10 Enter a Loading Dose within the displayed range 11 12 13 Then press 211735 Select YES gt to infuse the programmed Loading Dose Select DELIVER LATER gt to del
70. fuser accepts patient initiated 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 5 19 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 gt brings up 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 an 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 gt at the DOSE LIMIT MORPHINE SELECTION SCREEN The display advances to the DOSE LIMIT ENTER VALUE SCREEN 2 Enter the 4 HOUR DOSE LIMIT MORPHINE PF value using the numeric 1 mg mL keypad Note Entry of zero for the 4 HR Dose Limit using the numeric keypad is NOT accepted by the 40m PCA Infuser see Programming No milligrams Dose Limit on page 5 21 Then press 91155 5 20 LifeCare PCA Infusion System 3 Select CONFIRM gt to accept the chosen protocol settings Or press PREVIOUS gt to return
71. g 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 WARNING Before connecting the patient pendant to the unit check the condition of the patient pendant cord for damage andconfirm that the connector is not bent When removing the patient pendant cord from the unit firmly grasp the connector and pull straight out DO NOT USE IF DAMAGED CAUTION Do not bend the patient pendant cord near the patient pendant or connector jack at an angle of 90 or greater 4 17 Basic Operation CAUTION Use only the LifeCare PCA patient pendant blue pendant The PCA Plus patient pendant light gray pendant will not work with this device Note The patient pendant is for use with LifeCare PCA3 pumps or LifeCare PCA pumps with Hospira MedNet Software ONLY The patient pendant should be plugged into the unit prior to programming 1 Connect the patient pendant plug into the back of the device opening
72. g the System on page 4 27 5 16 LifeCare PCA Infusion System 6 If YES gt is selected disconnect the set from the patient and press and hold the PURGE gt 7 Select YES gt 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 gt For more information see Loading Dose on page 4 29 10 Enter a Loading Dose within the displayed range Then press 11 Press to infuse MORPHINE PF 1 mg mL programmed Loading Dose Select DELIVER LATER gt to DELIVERY MODE delay loading dose delivery From the SELECT DELIVERY MODE SCREEN select PCA CONT PROTOCOLS gt CONTINUOUS gt PROTOCOLS S O PREVIOUS 12 Press to accept MORPHINE PF protocol or select NEXT PRESS ENTER PROTOCOL gt and PREVIOUS gt to view other stored protocols if available 10 O lt NO NEXT PROTOCOLS 9 PREVIOUS 5 17 Select Mode 13 Select CONFIRM gt to accept MORPHINE the chosen protocol settings Bd mm Or press PREVIOUS to return to the preceding screen 2mg 14 Close and lock the door CONT RATES i 2 mg hr Place key in a secure mm location 40 mg 3409 CONFIRM 15 Press 4 to begin therapy PREVIOUS q Approximately 10 seconds after door is locked and 4 is pressed the DOOR LOCKED MESSAGE disappears 5 18 LifeCare PCA Infusion System Dose L
73. ge 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 4 5 Basic Operation Guided Start up for Prefilled Vials Note IfLifeCare PCA Infuser is Hospira MedNet enabled see Section 6 for Operation 1 Press BUTTON or load drug vial into cradle to power on the infuser See Loading a Vial on page 4 4 Upon initial start up the self test begins It may take several seconds for the Hospira logo to appear on the screen LifeCare PCA SELF TEST This screen is followed by another screen displaying self test information that includes the following time date software version drug library and copyright data During the self test the infuser reads the bar code label LifeCare PCA 2 Select CONTINUE gt to advance pene to the next screen COMPLETE OK SYSTEM SETTINGS CONTINUE O 4 6 LifeCare PCA Infusion System The NEW PATIENT SCREEN appears if the infuser has been off for 4 hours or less Select YES gt or gt AT 3 If NO gt is selected the History and Rx settings are kept 4 If the YES option is selected the History and Rx settings are cleared Select CONFIRM gt to confirm choice HISTORY AND and continue A screen appears to RSET TINGS confirm that History was cleared 5 Select CONFIRM gt to accept the inserted drug or remove
74. gramming sequence is complete and infusing by opening the door and selecting the MORPHINE PF LOADING DOSE gt key 1 mg mL T HENTER 2 Enter a Loading Dose within LOADING DOSE 1 IBTHEN PRESS the displayed range 3 Then press 111115 8 PREVIOUS 4 The next screen offers the options MORPHINE Pr of infusing the loading dose now 1 mg mL or later after programming DELIVER is complete If DELIVER LOADING LOADING DOSE DosE NOW is desired press NOW the YES Softkey to infuse the programmed Loading Dose DELIVER LATER gt a 4 29 Basic Operation 5 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 If YES was selected press the 4 BUTTON to infuse the programmed Loading Dose The screen displays the amount of analgesic delivered as it infuses The bottom of the screen displays text confirming that the Loading Dose is being delivered Upon completion the red LED above the LCD displays the amount delivered MORPHINE PF 1 mg mL PRESS START BUTTON TO INFUSE 2mg LOADING DOSE MORPHINE PF 1 mg mL PRESS PAUSE BUTTON TO STOP 9 9 mg milligrams INFUSING After delivery is complete the SELECT MODE SCREEN appears See Modes of Delivery on page 5 2 LOADING DOSE 4 30 LifeCare PCA Infusion System Section 5 Select Mode This section addresses the following top
75. ics 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 Changing Settings During Setup Making Changes After Setup Changing the CCA Clearing Shift Totals Changing a Vial e Adding a Supplemental Loading Dose Checking History amp Settings History and Event Log Select Mode Modes of Delivery The PCA Infuser delivers analgesia in one of three modes PCA ONLY CONTINUOUS PCA CONTINUOUS PROTOCOLS Protocols for Hospira 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 nterval 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
76. imit The dose limit is a physician 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 for a 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 gt 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 in
77. ions for producing labels containing pharmacy generated bar codes for custom drugs These labels are adhered on the Hospira 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 A 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 Generating Barcode Labels EQUIPMENT NEEDED 1 Bar code thermal printer 300 DPI or higher 2 code 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 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 shown for reference The human readable label is on the right side of the vial and is not shown on this illustration Drug Name and Concentration 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
78. 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 7 3 Troubleshooting 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 Ifthe 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 different sounds to differentiate between infusers in the Biomed Mode or by Hospira MedNet software 7 4 LifeCare PCA Infusion System Alarms and Messages MESSAGE Barcode
79. jury to the patient PATIENT SELECTION Patients selected to use the PCA Infuser should be able to understand the relationship between pain and pushing the PCA Infuser patient 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 Descriptive Information 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
80. ked application software to download drug libraries to the infuser and enable the auto programming feature The infuser is intended to operate on AC power but an internal battery is provided to maintain operation for short periods of time when AC power is not available The vials are single use barcoded and prefilled with a prescription drug by Hospira or the vials are sterile and empty to be custom filled by the hospital pharmacy The PCA infuser offers the following modes of delivery PCA ONLY CONTINUOUS ONLY PCA CONTINUOUS The PCA Infuser is able to store frequently used prescriptions called protocols The protocols are available for Hospira 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 LifeCare PCA Infusion System 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 in
81. labeled Patient Pendant 2 Tighten the connector ring snugly to confirm proper attachment 4 18 LifeCare PCA Infusion System SYSTEM SELF TESTS Connect the AC power mains cord to an AC power receptacle then confirm that the power plug icon is illuminated on the front of the infuser 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 page 7 5 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 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 A
82. ll probably lead to window replacement To avoid mechanical or electrical damage do 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 containing 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 1 13 Descriptive Information e 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 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 inf
83. m dung SeyoN 9 L L x ovz ro xlozi ro 2 oxIoerol 9 xloz rol oxterol ox or rol 0094 spun 9 9 Xlorz ro xlozi ro oxlozrol oxlocFol oxteyol oxfor rol 0910 syun Bui Q NP N epoo Jeg pojelouan Aoeuueud Jern Adwa S oxloe rol oxloerol oxloero oxierol oxior ro 001 1 syun oxloe ro 2 0 0 oxloecrol oxierol 3x lorro 01 10 Janpayy Adwa ejuejs XEUI UIUI XEUI UIUI Tuysyun asog uojsn guru esoqg vod 2 siera uos syw esoq pue 01 10 3 Prescription Delivery Limits NOTES 10 4 LifeCare PCA Infusion System Appendix A Generating Bar Code Labels Hospira MedNet Software Enabled Hospira recommends that the hospital or pharmacy department develop clear policies and procedures for the following e Generating Bar Code Labels e Applying Labels to Empty Sterile Vials e Filling Labeled Empty Sterile Vials e Validating Correctly Filled and Labeled Vials Incorrect labels or filled vials may lead to significant and potentially fatal adverse events The following are general specificat
84. more information See Loading Dose on page 4 29 Lockout Interval 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 Muting Period 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 Pressure The maximum pressure produced as a result of an occlusion in the PCA Infuser set 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 1 8 LifeCare PCA Infusion System DEFINITION PCA Set Tubing connecting the PCA Vial to the patient PCA Vial Vial compatible with the infuser that is either prefilled with drug by Hospira standard vial or filled by the hospital pharmacy custom vial Manually removing air from the
85. n the screen If the value BENTER LOCKOUT is entered incorrectly press Q INTERVAL to change value THEN PRESS ENTER BUTTON 17 Then press 39 5 120 min 10 min minutes If programming changes need PREVIOUS i to be made select PREVIOUS to return to the preceding screen 18 Set a specific dose limit by MORPHNETPE selecting YES and advancing 1 mg mL to the Dose Limit Enter Value ESET A DOSE SCREEN Select NO gt to choose No Dose Limit No Dose Limit will be selected for this example PREVIOUS If Hospira MedNet Software is enabled and a upper hard or soft limit has been assigned for that CCA and drug then a DOSE LIMIT entry is required and this screen will not be displayed Note See Dose Limit on page 5 19 1 or 4 hour for complete information about this feature 5 6 LifeCare PCA Infusion System 19 20 21 Select CONFIRM gt to verify the No DOSE LIMIT selection Select PREVIOUS gt to return to the preceding screen Select CONFIRM to verify settings Or select PREVIOUS gt to return to the preceding screen Close and lock door Place key in a secure location After locking the door the PCA bolus is available for infusion Patient presses pendant to initiate PCA dose Approximately 10 seconds after the door is locked the DOOR LOCKED Message disappears After delivering the PCA dose the PCA LOCKOUT Message appears indicating the PCA Infus
86. ndant Check PCA Infuser Set to Relieve Pressure None Pressure in line Possible occlusion and vial stiction Verify proper placement of injector Remove vial and or manual purge vial and re insert vial Troubleshooting Infuser Stalling If Hospira MedNet Software is enabled and the infuser stalls or suspends communication with an external device such as the MMU for an inordinate amount of time discontinue use and send the infuser to the Biomed Department for restarting 7 8 LifeCare PCA Infusion System Section 8 Maintenance The following topics are addressed in this section Infuser Storage Cleaning and Sanitizing Battery Maintenance Service Infuser Storage To prolong the life of the PCA Infuser observe the following storage precautions Store away from excessive heat cold and humidity Store the PCA Infuser connected to AC mains power Switch off using the ON OFF key 8 1 Maintenance Cleaning and Sanitizing Establish a routine infuser cleaning schedule to keep it contamination free 8 2 CAUTION For proper functioning of the bar code reader keep the bar code reader window clean For cleaning use recommended CleanTex CT 811 OpticPad Optic Surface Cleaner or a soft lint free cloth moistened with a streak free optical glass cleaner To avoid fluid ingress do not spray fluids or cleaning solutions on the bar code reader window Gently wipe the b
87. nfuser MORPHINE will pause 1 mg mL CONT 2 Select LOADING DOSE gt BLOCK DOOR TO BEGIN Note CHANGE will only displays if Hospira MedNet LOADING DOSE Software has been enabled CHANGE Ro CLEAR SHIFT gt gt CHANGE 3 Enter a Loading Dose MORPHINE PF within the displayed range 1 mg mL HENTER 4 Then press 97195 ENTER BUTTON 0 1 10 mg 2 5 mg milligrams MORPHINE PF 5 Press 4 to infuse the E loading dose PRESS START BUTTON TO INFUSE Note The loading dose may be 25m halted atany time by pressing START LOADING DOSE PAUSE 6 Close and lock the door Place key in a secured location 5 34 LifeCare PCA Infusion System Checking History amp Settings 1 To Check History or settings press uso D BUTTON 2 Press H D sutton to scroll through history Or select PRINT HISTORY gt to print if connected to printer The Print History option does not appear when Hospira MedNet Software is enabled 3 Press n D or EWI Burton MORPHINE PF a second time for more information When MORE is displayed more information is stored in infuser history CONT mg hr 4 HOUR E NO Note Partial boluses can be the result of interrupting delivery by pressing START STOP PCA Count opening the door PCA Only loss of power reaching the dose limit emptying the vial or a malfunction alarm
88. ng sent or received The WAITING FOR AUTO PROGRAM message will display on the screen Autoprogramming Autoprogramming is a new feature for Hospira PCA infusion systems 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 Note Ifthe physician s order for an autoprogram therapy exceeds the capabilities ofthe 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 6 13 Advanced Programming with Hospira MedNet Software 1 Press ON OFF to power on the infuser 2 After the CCA has been selected the infuser is ready for autoprogramming 3 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 medication library or if the custom drug is disabled in Biomed mode an invalid barcode
89. o 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 Softkey the display asks if the purge is complete 9 Select YES gt to continue or select No gt to purge again until complete 10 After purging is complete reconnect set to patient PURGE PURGING RECOMMENDED PREVIOUS ALPHA VIAL PURGE COMPLETE 4 13 11 Select desired units of measure For demonstration purposes MICROGRAMS is selected 12 Enter desired drug concentration within the displayed range Note Only whole numbers may be entered when using micrograms mcg If a decimal entry is attempted the display will inform the user that the decimal point is not allowed Press CLEAR to zero the value then enter a whole value within the displayed range 13 Then press 3135 14 Confirm the drug concentration by selecting CONFIRM gt 4 14 Basic Operation ENTER BUTTON 1 100 mcg mL 10 7 micrograms mL PREVIOUS ALPHA VIAL 10 mcg mL CONFIRM PREVIOUS LifeCare PCA Infusion System 15 Set Loading Dose if desired by selecting YES gt See Loading Dose on page 4 29 for more information 16 Enter a Loading Dose within the displayed range Then press Gui 17 The DELIVER LOADING Dose Now SCREEN allows the option of delivering the loading dose now or after the programming is complete ALPHA VIAL 10 m
90. ockout interval elapses and is displayed after a successful patient originated dose delivery 4 1 HR LIMIT REACHED Message displayed if 4 or 1 hour dose limit 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 Software enabled PCA AVAILABLE Message indicates patient can initiate a dose 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 PCA CONT Message displayed when infuser is in PCA CONTINUOUS Mode INFUSER PAUSED Message displayed when infuser is stopped but door is locked Or if door is opened LifeCare PCA Infusion System Infuser Alarm System During an Alarm condition the system performs the following actions The current display message is saved to the event log A flashing alarm message appears on the display See Alarms and Messages on page 7 5 A repetitive audible tone sounds with all MALFUNCTION alarms except PENDANT FAULT which is a single tone with continuous visual flashing The audible tone volume is adjustable to low medium or high by accessing system settings during self test at Start up It can also be accessed by pressing SILENCE VOLUME when infuser
91. onnect 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 5 32 LifeCare PCA Infusion System 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 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 BurroN if the infuser is in the Continuous or PCA Continuous Mode 5 33 Select Mode Adding a Supplemental Loading Dose 1 Unlock the door the i
92. ons 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 Test the installation Disconnect the crossover cable from the PC and connect it to the infuser Power up the infuser and print the history log 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 instructions 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 Load printer with paper 2 Connect a network crossover cable between the printer and the infuser 3 Plug infuser amp printer into AC power 4 Turn on infuser and confirm drug and concentration 5 Press HISTORY touch switch to view the history on the display 6 Press PRINT HISTORY gt Softkey to print history log NOTE After the infuser is turned on to initiate printing please allow 2 to 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 Softkey LifeCare PCA Infusion System Downloading Logs to a PC EQUIPMENT NEEDED e infuser e PC with Hyper Terminal program e
93. orPHINE PF limit is exceeded a HARD LIMIT 1 mg mL VIOLATION screen is displayed Hard limits cannot be overridden The only way to continue is to select CHANGE FOR to change the parameter MED AND CCA MAX ALLOWED 6 11 Advanced Programming with Hospira MedNet Software Important Symbols No RULE SETS The Cautionary symbol A is displayed on the infusion screen to advise the user to program with caution because the established rule set does not have any soft or hard safety limits SOFT LIMIT OVERRIDE The Upper and Lower Soft Limit Override symbols are displayed on the infusion screen to inform the user that one or more soft limits have been overridden 6 12 morPHINE PF 1 mg mL PACU PCA CONT PCA AVAILABLE NO 4 HR LIMIT 40 mg K 0 mg milligrams TOTAL DELIVERED CONT RATE imo ww morPHINE 5 mg mL PACU PCA CONT PCA AVAILABLE NO 4 HR LIMIT 40 mg 4 m milligrams TOTAL DELIVERED 99 CONT RATE img Ww LifeCare PCA Infusion System WIRELESS Ko morPHINE PF The Wireless A symbol is 1 paml displayed to inform the user that the PCA Infuser has an active connection to the WAITING FOR AUTO PROGRAM wireless network The wireless icon is only displayed on the WAITING FOR AUTO PROGRAM screen This symbol indicates that the PCA Infuser is connected to the wireless network It does not indicate if data is currently bei
94. ore information ESET LOADING morPHINE PF 1 L DOSE 11 Enter a Loading Dose within morPHINE PF the displayed range un HENTER Then press 911193 LOADING DOSE THEN PRESS ENTER BUTTON 12 The DELIVER LOADING Dose NOW morPHINE PF SCREEN allows the option of 1 snail delivering the loading dose now or after the IDELIVER programming is complete LOADING DOSE NOW kd YES DELIVER LATERM 6 5 13 14 Advanced Programming with Hospira MedNet Software If YES gt was selected press morPHINE PF 4 to infuse the 1 mL programmed Loading PRESS Dose START BUTTON TO INFUSE Note The LOADING DOSE Mode e mg LOADING DOSE 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 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 15 6 6 The screen displays the amount of analgesic 1 mg mL delivered as it infuses The bottom of the screen displays text confirming that the Loading Dose is being delivered Upon completion the red LED above the LCD displays the amount delivered BPRESS PAUSE BUTTON TO STOP mg milligrams INFUSING LOADING DOSE LifeCare PCA Infusion System 15 The SELECT DELIVERY MODE screen ET appears See Modes of Delivery 1 mg mL
95. ormation e Recommended use of the epidural route is to provide anesthesia or analgesia for periods up to 96 hours e tis strongly recommended that the epidural infusion system be prominently identified as EPIDURAL Failure to identify the infusion 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 administration 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 administration are recommended 1 14 LifeCare PCA Infusion System 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 catheter is essential since catheter migration could result in intravascular or intrathecal administration e Facilities practicing epidural administration must be equipped with resuscitative equipment oxygen naloxone and other resuscitative drugs Adequate
96. otal 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 Do not bend the patient pendant cord at an angle of 90 or greater Use only the LifeCare PCA Patient Pendant blue pendant The PCA Plus II Patient Pendant light gray pendant will not work with this device WARNING Patient Pendant is only to be pressed by the patient LifeCare PCA Infusion System 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 the device 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 barcode reader window is clean Blood fingerprints condensation and other elements may obstruct the view of the barcode reader Elements on the window other than scratches can be cleaned by using one of the recommended cleaning solutions See Cleaning and Sanitizing on page 8 2 Window scratches cannot be wiped clean and wi
97. oved by Hospira could void the user s authority to operate the equipment 1 20 LifeCare PCA Infusion System WIRELESS DEVICE CAUTION The wireless 802 11 a b g device usage in the 5150 5250 MHz band is limited to indoor use to reduce potential for harmful interference to co channel mobile satellite systems In the 5250 5350 MHz and 5650 5850 MHz frequency bands high power radars are allocated as primary users and these radars could cause interference and or damage to LE LAN devices Operation is subject to the following two conditions 1 the wireless device may not cause interference and 2 the wireless device must accept any interference including interference that may cause undesired operation of the wireless device RADIO FREQUENCY EXPOSURE STATEMENT 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 OET 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
98. ph 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 For other time intervals look at other points at the horizontal axis and determine corresponding limits as above e 15 096 EI 25 ML HR 0 mm Hg DELIVERY HEAD START UP Max Positive Error over 5 Minute Interval 2 8 5 0 0 0 Max Negative Error over 5 e Minute Interval 0 5 PERCENT ERROR 96 10 0 Average Delivery Rate Error 1 6 15 0 7 0 5 10 15 20 25 30 Observation Interval minutes 9 7 Specifications A trained professional can use the resulting graphs to select an 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 exampl
99. reasonable 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 However there is no guarantee that interference will not occur in a particular installation If this equipment causes harmful interference 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 1 17 Descriptive Information e Portable and mobile RF communications equipment such as cellular telephones 2 way radios Bluetooth devices microwave ovens in close proximity to this device may affect wireless and wired communications with the infusion pump and or the operation of the infusion pump Special precautions need to be exercised regarding EMC These precautions 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 emis
100. ries 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 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 LifeCare PCA Infusion System Numerics 24 Hour information 5 36 4 HR LIMIT 5 19 4 HR LIMIT REACHED Message 5 19 A AC power 1 2 indicator 3 7 Accuracy 1 6 alarm 1 8 System 2 2 Alpha Vial 4 12 analgesic 1 3 delivered 4 30 6 6 package 1 11 anesthetics 1 3 anti siphon valve 1 11 attaching an infuser to an IV pole 3 9 Autoprogramming 1 6 B bar code 1 10 drug vial 1 1 pharmacy generated 1 1 4 11 6 1 reader 1 1 1 13 battery 1 2 1 10 1 13 charge 4 19 fault 1 6 indicator 3 7 Biomed Mode 1 2 5 2 5 16 bolus 1 6 2 2 4 29 doses 1 8 partial 5 35 Button 1 6 C CCA 1 6 1 9 1 10 6 3 6 8 CE 1 6 Change CCA Index Softkey 5 28 Change Rx Softkey 5 28 cleaning infuser 1 13 Cleaning solutions 8 3 Clear Button 4 14 Clear button 3 5 Clear Shift Softkey 5 31 Clinical Care Area 1 6 CCA 6 8 clock 12 hour 4 25 24 hour 4 25 Confirm No Dose Limit Screen 5 20 Confirm Softkey 5 23 Confirmation Screen 4 25 5 33 Connectivity Engine 1 6 Continuous
101. rmacy 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 6 1 Advanced Programming with Hospira MedNet Software Only Hospira prefilled PCA vials with bar codes and custom vials with pharmacy generated bar codes may be used with the Hospira MedNet Software Only bar codes entered into the User Defined Drug Library are recognized by the infuser For instructions on how to produce pharmacy generated bar codes see Appendix A on page 1 1 Press BUTTON or load LifeCare PCA drug vial into cradle to SELF TEST power infuser ON See Loading a Vial on page 4 4 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 gt to advance LifeCare PCA to the next screen SELF TEST COMPLETE O OK SYSTEM SETTINGS CONTINUE 6 2 LifeCare PCA Infusion System 3 The NEW PATIENT SCREEN appears if the infuser has been off for four hours or less Select YES gt or NO gt If NO gt is selected the History and Rx settings are kept If YES gt is selected the History and Rx
102. rmation provided in this manual The device is suitable for use in all establishments including domestic establishments If extended operation during power mains interruption is needed use battery power Always manage the electromagnetic environment The guidance included in this manual provides the following 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 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 equipment If the device must be used adjacent to or stacked with other equipment monitor the devices to verify normal operation USE ONLY components specifically labeled for use with the PCA Infusion System to help ensure the device operates as intended If you suspect external RF sources or other equipment are influencing device operation contact the Biomedical Engineering Department for additional guidelines concerning electromagnetic immunity Contact the Biomedical Engineering Department for additional information in the technical service manual concerning operating devices near RF sources 1 19 Descriptive Information FCC Information FE
103. se of a properly maintained and charged battery helps ensure proper operation CAUTION Ifthe 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 If the batteries are to be stored for more than 6 months they should be charged to prevent damage sulfation to the batteries during low charge conditions When the battery is first put into use or has been out of use for one or more months it will not have full capacity The battery will need conditioning Condition a battery for optimal performance by fully charging and discharging the battery three times A fully charged conditioned battery shall provide at least 3 hours of continuous operation from the Start of delivery at 5 mL hr to Dead Battery 8 4 LifeCare PCA Infusion System 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 To maintain maximum battery charge and to prolong battery life connect the PCA Infuser to AC mains power whenever possible Consult a qualified Biomedical technician for battery replacement if necessary 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
104. set before removing or the replacing syringe and before discontinuing infusion e Patient must be disconnected from the PCA Infuser set before the purge cycle e 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 1 11 Descriptive Information In the 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 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 hazard 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 section presents Loading Dose and Loading Dose information and cautions 1 12 The loading dose is always included in the t
105. signed for that CCA and drug then a DOSE LIMIT entry is required and this screen will not be displayed Select Mode MORPHINE PF 1 mg mL ENTER CONT RATE ETHEN PRESS ENTER BUTTON 0 5 100 mg hr mg milligrams PREVIOUS gt MORPHINE PF 1 mg mL ESET A DOSE LIMIT PREVIOUS 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 19 5 10 LifeCare PCA Infusion System 15 16 17 18 Select CONFIRM to verify No Dose Limit selection Select PREVIOUS to return to the preceding screen Select CONFIRM to verify settings Or select PREVIOUS to return to the preceding Screen Close and lock door Place key in a secure location Press 4 to begin therapy Approximately 10 seconds after door is locked and 4 is pressed the DOOR LOCKED Message disappears When the Dose Limit is reached a message is displayed that indicates the Dose Limit has been reached MORPHINE PF 1 mg mL ICONFIRM NO DOSE LIMIT CONFIRM PREVIOUS MORPHINE PF 1 mam CONTINUOUS mm E corm O PREVIOUS MORPHINE PF 1 CONTINUOUS X milli 2 mg DELIVERED KC TOTAL eee CONT RA 5 11 Select Mode PCA Continuous Mode For detailed startup information including vial insertion clearing s
106. sing 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 PCA ONLY If mode is set for PCA CONTINUOUS or CONTINUOUS therapy will begin after pressing START PAUSE LifeCare PCA Infusion System Changing Settings During Setup During setup select PREVIOUS 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 3 Or press 4 for Continuous or PCA 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 clamp on PCA administration set 2 Unlock door 3 Press Button 5 27 Select Mode Making Changes After Setup REVIEWING THE CURREN
107. sions e Maintaining a minimum separation distance of 2 75 ft between the infusion pump system and portable mobile RF communications equipment e List Number 20709 is compliant to IEC EN 60601 1 2 2001 and has been tested and found to comply with EMC limits for 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 1 18 LifeCare PCA Infusion System Guidance on EMC Compatibility There is a shared responsibility between manufacturers customers and users to ensure that medical equipment and systems 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 info
108. syringe and line 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 Rx Settings The current programmed therapy Includes PCA Dose PCA Lockout Interval Continuous Rate Loading Dose and Dose Limit amount Softkeys 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 1 9 Descriptive Information DEFINITION 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 A drug library that contains hospital defined Library clinical care areas CCAs and rule sets created with Hospira MedNet Software Warning An indication to advise the clinician of a possible dangerous condition Precautions and Warnings UNP
109. 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 10 165 with battery LifeCare PCA Infusion System Wireless LAN Module Device Name Hospira MedNet 802 11 a b g Wireless Upgrade Module Standards IEEE802 11a b g Transmit Power 802 11 b g 17 dBm 802 11 a 16 dBm Antenna Integrated surface mount antenna Certifications FCC Part 15 247 15 407 IC RSS 210 RSS 102 FCC ID STJ 80411396001 IC 5627A 80411396 Model CUSTOM DWL AG132 Stored Occlusion Volume DELIVERY PRESSURE STORED LIMIT VOLUME Average Average 0 1 mL hr 12 8 psig 5 mL hr 12 6 psig 20 mL hr 12 7 psig 9 5 Specifications Time from Occlusion to Alarm DELIVERY PRESSURE TIME TO RATE LIMIT 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 substantiall
110. ther YES gt or NO gt to purge the system See Purging the System on page 4 27 for more information If YES gt is selected disconnect the set from the patient and press amp hold the PURGE gt Softkey Select YES gt to continue or select NO gt to purge again until complete After purging reconnect set to patient Set Loading Dose if desired by selecting YES gt See Loading Dose on page 4 29 for more information Enter a Loading Dose within the displayed range Then press 10 Select YES gt to infuse the MORPHINE programmed Loading Dose 1 mg mL Select DELIVER LATER gt to delay DELIVER loading dose delivery LOADING DOSE 11 From the Select Delivery Mode NOW YES DELIVER LATER SCREEN select CONTINUOUS UE SELECT DELIVERY MODE PCA ONLY PCA CONT CONTINUOUS PROTOCOLS S PREVIOUS 5 9 12 13 14 Enter a continuous rate using the keypad The value range is displayed on the screen If value is entered incorrectly press to change value Then press 911553 If programming changes need to be made select PREVIOUS to return to the preceding screen Set a specific dose limit by selecting YES and advancing to the Dose Limit Enter Value SCREEN Select NO to choose No Dose Limit No Dose Limit will be selected for this example If Hospira MedNet Software is enabled and a upper hard or soft limit has been as
111. ug 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 10 1 ts IMI Prescription Delivery L Grup Hojeyeo sejes jonpoud zuana ees 959 Jd 2 2009 sjueuJeJou QZ o1 G si eue 3n090 p o gt sanjen oala dung 6 666 lt senjeA 129 9 jim dund 584004 IDH 666 6666 008 1 00 1 00 1 0S 001 1 01 euipuedejy m 666650 00 60 00 0 600 001 90 99 90 08 60 8 auydio dd eying 0rc LO 0ct FO 08 0 0 0 0 0 9 0 00 auydio 9500 yurpug WIT AYO gung Bey 300 9500 3U0 sje A p ll 4 1d syw pue vd 1 0L 2199 10 2 LifeCare PCA Infusion System sajes jonpoud eas ei Adwa ejuejs AJS enjeA 9 Jo sanu QZ 0 51 30320 gt esou se se gt sanea yoalen 6666 lt 9504 se se 6666 lt senje joefo
112. un mode 3 5 Equipment Description e START 2 PAUSE The START PAUSE Button is used to start or pause a continuous infusion or PCA bolus HISTORY The HISTORY Button is used to display parameter settings dose history review Rx and review the event log It also provides access to the Print History Softkey Hospira MedNet Software not enabled 0 0 The numeric Buttons are used to enter values 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 LifeCare PCA Infusion System 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 gt Battery indicator illuminates continuously when infuser is running on battery power AC mains power indicator illuminates when infuser is plugged into AC power DOSE DELIVERED 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 3 8 PCA Patient Pendant is use
113. ut a key 3 10 LifeCare PCA Infusion System Removing an Infuser from an IV Pole To remove an infuser from an IV pole proceed as follows 1 Ensure that the tubing and PCA administration set is disconnected from the patient 2 Verify that the security door is unlocked 3 Ensure that the infuser is unplugged Grasp the infuser by the handle and turn the pole clamp knob counterclockwise 4 With the pole clamp retracted remove the infuser from the pole 3 11 Equipment Description NOTES 3 12 LifeCare PCA Infusion System Section 4 Basic Operation The following subjects are addressed in this section Operating the PCA Infuser Loading Vial Guided Startup for Prefilled Vials Guided Startup for Custom Vials Getting Started Adjusting Settings New Patient Purging the System Loading Dose 4 1 Basic Operation Operating the PCA Infuser The following subjects are addressed in this section Intravenous PCA Infuser Administration 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 s 3559 6516 or 6517 attached to list 6514 via backcheck valve port 3 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
114. utton 3 6 status messages 7 2 stopping infusion 5 27 1 4 Index Stored Protocols 1 9 syringe 1 11 change 1 11 4 27 custom 1 2 1 6 System Settings 4 21 system slack 4 8 4 13 4 27 6 4 therapy settings 1 9 5 37 training infuser use 1 3 IV complication 1 3 PCA programming 1 3 troubleshooting 7 1 U units of measure 4 14 unpacking 1 10 Updating Drug Library 6 1 upper limits 1 9 User Defined Drug Library 1 9 1 10 5 2 5 3 5 19 V vial 1 11 5 2 barcoded 1 2 custom 1 6 1 9 4 11 6 1 custom filled 1 2 load drug 4 6 PCA 1 9 prefilled 1 2 1 9 1 10 6 1 removal 5 32 standard 1 9 sterile empty 1 2 1 6 Vial Confirmation Screen 4 25 4 26 Vial Cradle equipment description 3 3 vials prefilled 1 10 Warning 1 10 LifeCare PCA Infusion System warning messages 1 5 Warning Drug and or Concentration Change Detected Screen 5 32 1 5 Notes 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 Note Outside the U S contact your lo
115. with this system Conventions This section describes the conventions used throughout this manual CONVENTION ITALIC APPLICATION REFERENCE TO A SECTION FIGURE OR TABLE EXAMPLE See Front Panel on page 3 2 BRACKETED ALL CAPS KEYS OR BUTTONS ON THE DEVICE ARE DISPLAYED IN BRACKETED ALL CAPS OR WITH A GRAPHIC ON OFF OR ITALIC SMALL CAPS gt SOFTKEY OPTIONS PREVIOUS gt INITIAL CAPS LOWERCASE SCREEN DISPLAYS AND DEVICE LABELS AS APPROPRIATE SELECT DELIVERY MODE EMPHASIS SETS ARE SUPPLIED STERILE AND ARE FOR LifeCare PCA Infusion System 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 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 exa
116. y embedded DDL in the infuser software The infuser uses the DDL 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 Download The process of moving the User defined 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 Hospira MedNet Network based application software used Software to upload event logs and download the user defined drug library to the infuser Infusing The infuser is ON and a DELIVERY SCREEN is displayed The infusing mechanism may or may not be actually infusing at any given time LCD Liquid Crystal Display LED Light Emitting Diode 1 7 Descriptive Information DEFINITION Loading Dose An optional dose programmed during Setup before entering the program The loading dose can be administered atany time by the clinician during the programmed therapy For
117. y 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 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 Clause 50 102 Refer to this standard for detailed information 9 6 LifeCare PCA Infusion System Refer to the Example on page 9 7 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 Gra

Guided Start-up Using Hospira MedNet Software

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