ICU Medical 16026 Symbiq One Channel Infusion System User Manual mds PHXopsmanual
Hospira, Inc. Symbiq One Channel Infusion System mds PHXopsmanual
Contents
- 1. User Manual Part 2
- 2. User Manual Part 1
- 3. User Manual Part 3
User Manual Part 2
Intermittent Therapy Chapter 7: Advanced Therapies • BSA OR press Calculate to manually calculate BSA (if available) Figure 92: Intermittent Programming Screen 10. Press Enter to accept the dose. The rate is automatically calculated and appears in the rate field. Figure 93: Intermittent Dose Calculation Screen 11. Press VTBI field (Volume to be infused) and enter the amount of fluid to be delivered. Time is automatically calculated. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 99 Chapter 7: Advanced Therapies Intermittent Therapy Note: Entering two of the three programming parameters (Rate, VTBI, or Time) automatically calculates the third. 11 13 Figure 94: Intermittent Programming Screen 12. Press Enter to accept VTBI. 13. To enter Time—if required—press time field. Select hours (hh) or minutes (mm). Enter time period using numeric keypad. Press Enter. Figure 95: Time Numeric Keypad 14. When finished entering parameters on the Intermittent Programming screen, press Next to display the Confirm Intermittent screen. Program-level buttons have the following functions: 100 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Intermittent Therapy Chapter 7: Advanced Therapies Clear restores default field values for current screen Setup displays the Intermittent Setup screen Clear All deletes entire program Back displays the Intermittent Setup screen Press Setup to advance screen to access Clear All. Clear All deletes entire Intermittent program. Note: User may enter KVO rate for continuous delivery between Intermittent cycles. See “Chapter 8: Program Options” for more detail. 15. Review the therapy parameters, and then press Start Intermittent. ICU 0 mL/hr 0 mL Bolus Program Advanced Piggyback CONFIRM INTERMITTENT (with KVO) Ceftriaxone [1 grams / 50 mL] Number of Deliveries: Time Between Start of Deliveries: 00:30 hh:mm Dose: Rate: VTBI: Time: 2.5 mcg / kg / min 0.6 mL/ hr 0.1 mL 00:10 hh:mm Start Intermittent Press Start to begin Infusion. Advanced button to edit program. Mode Settings Logs Lock Alarm 09:21 AM Figure 96: Confirm Intermittent Screen SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 101 Chapter 7: Advanced Therapies Intermittent Therapy 16. The therapy begins and the Delivering screen displays with DELIVERING INTERMITTENT Delivery X of Y (where Y is the total number of programmed intervals) on the status line. To stop the therapy, press Stop Program. ICU 0.6 mL / hr 0.1 mL Ceftriaxone Bolus Program Advanced Piggyback DELIVERING INTERMITTENT 1 of 2 Ceftriaxone [ 1 grams / 250 mL] Dose: Rate: Time Remaining: 2.5 mcg/kg/min 0.6 mL / hr 00:10 hh:mm VTBI: Volume Infused: Stop Intermittent 0.1 mL 0 mL Press Stop to end infusion. Advanced button to view current program. Mode Settings Logs Alarm Lock 03:38 PM Figure 97: Delivering Intermittent Screen X of Y Note: Between phases of an Intermittent therapy, WAITING FOR INTERMITTENT X of Y displays on the status line. Each additional phase of an Intermittent therapy updates the status line with DELIVERING INTERMITTENT / X of Y. Between phases of delivery, medication continues to infuse at KVO rate. ICU ICU 1 mL / hr 0 mL Ceftriaxone Ceftriaxone Bolus Program Advanced Piggyback WAITING FOR INTERMITTENT 2 of 2 Ceftriaxone KVO: Time Remaining VTBI: Volume Infused Stop Intermittent Dose: Rate: Time Remaining 1 mL / hr 00:20 hh:mm 0 mL 0.1 mL VTBI: Volume Infused Stop Intermittent Settings Program Advanced Piggyback [ 1 grams / 50 mL] Press Stop to end infusion. Advanced button to view current program. Mode Bolus DELIVERING INTERMITTENT 2 of 2 Ceftriaxone [ 1 grams / 50 mL] 03:38 PM 0.6 mL / hr 0.1 mL Logs Lock Alarm 2.5 mcg/kg/min 0.6 mL / hr 00:10 hh:mm 0.1 mL 0.4 mL Press Stop to end infusion. Advanced button to view current program. Mode Settings Logs Lock Alarm 03:38 PM Figure 98: Waiting for Intermittent X of Y screen; Delivering Intermittent X of Y screen 102 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Intermittent Therapy Chapter 7: Advanced Therapies 17. When the Intermittent program completes and the VTBI is delivered, COMPLETED INTERMITTENT displays on the status line of the Delivering screen. ICU 1 mL / hr 0 mL Ceftriaxone Bolus Program Advanced Piggyback COMPLETED INTERMITTENT Ceftriaxone [ 1 grams / 50 mL] KVO: Time Remaining VTBI: Volume Infused Stop Intermittent 1 mL / hr 00:00 hh:mm 0 mL 0.5 mL Press Stop to end infusion. Advanced button to view current program. Mode Settings Logs Lock Alarm 03:38 PM Figure 99: Completed Intermittent Screen SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 103 Chapter 7: Advanced Therapies Intermittent Therapy NOTES: 104 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options Options allows the selection of additional functions and alarms while infuser is stopped. Options button is available from any therapy programming screen. Press Options to access Options selection menu. Press up or down arrows on scroll bar to view available options. Press selectable fields to change an option. The following options may be changed by the user: Deliver at End of Infusion Press Deliver at End of Infusion and select None, KVO, or Continue Rate. • Select KVO to change to KVO rate at end of infusion. • Select Continue Rate to deliver programmed therapy rate at end of infusion. • Select None for no delivery at end of infusion. Press Done to accept change and exit Options menu. Figure 100: Options Menu screen KVO Rate Press KVO Rate and enter rate using numeric keypad. Press Done to accept change and exit Options menu. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 105 Chapter 8: Program Options Power Priming a Set Power priming may be used to prime or remove air from an administration set. In general, the time required to power prime an administration set is: • 60 seconds for a 72" microbore set Note: Refer to the SYMBIQ™ administration sets labels for information regarding use with different flow rates. • 3 minutes for a 72" macrobore set WARNING: Always prime the administration set to remove air from the cassette, tubing, and injection sites prior to connecting to the patient. Always disconnect the administration set from the patient prior to priming or purging. To power prime a cassette: 1. In the programming screen, fill in infusion information. When completed, press Options to display the Options screen. ICU 0 mL/hr 0 mL Bolus Program Advanced Piggyback Infusion DOPamine [ 400 mg / 250 mL] Dose Dose Calculation Rate mL/hr VTBI mL Time --:-- Clear hh:mm Cancel Titration Options Next Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue. Mode Settings Logs Lock Alarm 01:15 PM Figure 101: Programming Screen 106 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options 2. On the Options screen, press Select Amount under the Power Prime label. ICU 0 mL / hr 0 mL Program Bolus Power Prime Deliver at End of Infusion Advanced Piggyback Select Amount KVO mL/hr KVO Rate Delayed Start --:-- hh:mm Yes Standby Alarm Options Done Options Press button or field to select option to change. Done to return to previous screen when finished. Mode Settings Lock Logs Alarm 04:34 PM Figure 102: Options Screen 3. The Disconnect Tubing system message activates reminding you to ensure the administration set is disconnected from the patient. Press OK to display the Power Prime screen. ICU 0 mL / hr 0 mL Bolus Program Advanced Piggyback Power Prime Ensure tubing is not connected to the patient. Disconnect Tubing Ensure tubing is disconnected from patient before proceeding. OK Press OK to acknowledge. Mode Settings Logs Lock Alarm 08:33 AM Figure 103: Disconnect Tubing System Message 4. On the Power Prime screen, select one of these three priming options: • Prime 1 mL • Prime 3 mL • Prime 5 mL SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 107 Chapter 8: Program Options Note: The power prime rate is 250 mL/hour. ICU Program Bolus Piggyback Advanced Power Prime Ensure tubing is not connected to the patient. Prime 3 mL Prime 1 mL Cancel Prime 5 mL Options Press button to select amount to prime. Cancel to return to Options screen. Mode Settings Logs Lock Alarm 10:28 AM Figure 104: Power Prime Screen 5. The Power Prime Progress screen displays showing the cumulative amount of fluid primed measured in mL. To cancel priming, press Cancel. ICU Program Bolus Advanced Piggyback Power Prime Ensure tubing is not connected to the patient. Total Amount Primed 2 mL Cancel Options Press button to select amount to prime. Cancel to return to Options screen. Mode Settings Logs Lock Alarm 10:33 AM Figure 105: Power Prime Progress Screen Note: 50 mL is the maximum total primed value allowed. If primed to 50 mL, the priming will stop and the total primed will display for 5 seconds. The Infuser will then return to the Options screen. When priming finishes, press Cancel to return to the Options screen. See Figure 102: "Options Screen" on page 107. Priming is complete when a steady drip of fluid is observed at the end of 108 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options administration set. Repeat Power Prime as often as necessary to obtain steady drip at end of tubing. 6. On the Options screen, press Done to return to the Programming screen. The power priming process is complete; continue entering program parameters as desired. Note: If an occlusion occurs during power priming, priming stops and the infuser reverts to the Power Prime screen. Clear the occlusion and select one of the three power prime options to restart priming. Delayed Start You can delay the start of a programmed therapy (from one minute up to 12 hours) with the Delayed Start programming option. If allowed for the current program and enabled in the selected CCA, Delayed Start is available for all therapies. Once a therapy is started on a channel, Delayed Start is not available on that channel. You cannot select Delayed Start for a channel with an active alarm until the alarm is cleared. To program a delayed start: 1. Press the Delayed Start field. Use numeric keypad to enter time period. Press Done to accept change and exit Options menu. Figure 106: Options Screen 2. Press Next on the programming screen to display the Confirm Delayed Start screen. 3. Review the program parameters. Press the Press Here to Confirmand Start Countdown for Delayed Start button to display the Confirm Program screen. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 109 Chapter 8: Program Options 4. The infuser starts therapy when the delayed start countdown reaches zero. 5. Press Delayed Start to start the therapy before the delayed start time elapses. ICU 0 mL/hr 0 mL Bolus Program Piggyback Advanced CONFIRM DELAYED START DOPamine [400 mg/ 250 mL] 5 mcg / kg / min 13.1 mL/ hr 103 mL 08:00 hh:mm Dose: Rate: VTBI: Time: Delayed Start Press Program to edit program. Delayed Start button to begin countdown. Mode Settings Logs Lock Alarm 09:21 AM Figure 107: Delayed Start Confirmation Screen Standby Mode You can place the SYMBIQ™ Infusion System in Standby mode for up to 24 continuous hours before starting a programmed therapy. Standby is not available for Intermittent. Standby can be selected anytime after programming a therapy except when infusing. You can also place the infuser in Standby mode without a cassette loaded if enabled in the defined device settings in the Drug Library. If the infuser has been in Standby mode for 24 hours, all program settings are cleared, a message box displays confirming settings have been cleared. 110 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options To place an infuser in Standby mode: 1. Press the Standby field to display the Standby drop-down list. ICU 0 mL / hr 0 mL Program Bolus Power Prime Piggyback Advanced Select Amount Deliver at End of Infusion KVO KVO Rate Delayed Start --:-- mL/hr hh:mm Yes Standby Alarm Options Done Options Press button or field to select option to change. Done to return to previous screen when finished. Mode Settings Alarm Lock Logs 04:34 PM Figure 108: Options Screen 2. Press Yes to place the infuser in Standby mode or No to remove the infuser from Standby mode. ICU 0 mL 0 mL Bolus Program Power Prime Select Amount Deliver at End of Infusion KVO Yes No KVO Rate Delayed Start Piggyback Advanced hh:mm --:-- Standby No Alarm Options Cancel Select Yes to activate standby and hold program for later start. No to deactivate standby. Cancel for no change. Mode Settings Logs Lock Alarm 03:01 PM Figure 109: Standby Drop-Down List SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 111 Chapter 8: Program Options 3. Press Done to accept changes and return to the Programming screen. ICU 0 mL / hr 0 mL Program Bolus Power Prime Deliver at End of Infusion Advanced Piggyback Select Amount KVO KVO Rate Delayed Start --:-- mL/hr hh:mm Yes Standby Alarm Options Done Options Press button or field to select option to change. Done to return to previous screen when finished. Mode Settings Logs Lock Alarm 04:34 PM Figure 110: Options Screen 4. Press Next to display the Confirm Standby screen. 5. Review the program parameters. Press the Standby button to initiate Standby. 6. Press Cancel Standby to return to the Confirmation screen. 7. Press Start to begin infusion. Alarm Options Distal Occlusion To select the Distal Occlusion alarm: 1. 112 Use the vertical scroll bar to scroll down to the Alarm Options section, and then press the Distal Occlusion field. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options Note: The unit of measure is either psi or mmHg as configured in the Drug Library from the facility’s respective CCA. Figure 111: Options Screen 2. Select the desired distal occlusion setting. ICU 0mL/hr 0mL Program Bolus Advanced Piggyback of Infusion 6 psi KVO Rate Delayed Start 6.5 psi Options Standby 7 psi Options Alarm Options Options 7.5 psi Distal Occlusion Options Cancel Options 8 psi 8.5 psi Press button to select occlusion pressure setting at which alarm will sound. Cancel for no change. Mode Settings Logs Lock Alarm 03:02 PM Figure 112: Distal Occlusion Setting Drop-Down List SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 113 Chapter 8: Program Options 3. Press Yes to change the distal occlusion setting. Press No to return to the psi settings list without saving changes. Figure 113: Change Distal Occlusion Setting Message Box 4. Press Done to return to the Programming screen. Figure 114: Options Screen Proximal Occlusion To select the Proximal Occlusion alarm: 1. 114 From any programming screen, press Options to display the Options screen. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options 1. Use the vertical scroll bar to scroll down to the Alarm Options section, and then press the Proximal Occlusion field. Figure 115: Options Screen 2. Select Solution Container or Syringe. Figure 116: Proximal Occlusion Setting Drop-Down List SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 115 Chapter 8: Program Options 3. Press Yes to change the proximal occlusion setting. Press No to return to the proximal occlusion settings list without saving changes. Figure 117: Change Proximal Occlusion Setting Message Box 4. 116 Press Done to return to the Programming screen. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options Infusion Complete Callback To select the Infusion Complete Callback alarm: 1. Use the vertical scroll bar to scroll down to the Alarm Options section, and press the Infusion Complete Callback field. Figure 118: Options Screen 2. Select Yes or No. ICU 0mL/hr 0mL Program Bolus Advanced Piggyback Standby Alarm Options Distal Occlusion Yes 7 psi No Proximal Occlusion Syringe Infusion Complete Callback Cancel Yes Done Options Select Yes to be notified when each step is completed. Cancel for no change. Mode Settings Logs Lock Alarm 10:09 AM Figure 119: Infusion Complete Callback Drop-Down List SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 117 Chapter 8: Program Options 3. Press Yes to change the Infusion Complete Callback setting. Press No to return to the Infusion Complete Callback settings list without saving changes. Figure 120: Change Infusion Complete Callback Message Box 4. Press Done to return to the Programming screen. Note: If selecting the Infusion Complete Callback alarm for a Multistep therapy, the alarm activates at the end of each step in the therapy. Air-In-Line To select the Air-In-Line alarm setting: 1. Use the vertical scroll bar to scroll down to the Alarm Options section. Press the Air-In-Line field to display the Air-In-Line settings list. Figure 121: Options Screen 118 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options 2. Select the desired air-in-line setting. Figure 122: Air-In-Line Sensitivity Drop-Down List 3. Press Yes to accept the air-in-line setting. Press No to return to the mcL settings list without saving changes. Figure 123: Change Air Sensitivity Setting Message Box 4. Press Done to return to the Programming screen. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 119 Chapter 8: Program Options Nearing End Of Infusion To select the Nearing End Of Infusion alarm: 1. Use the vertical scroll bar to scroll down to the Alarm Options section. Press the Nearing End Of Infusion field to display the selection list. Note: A medium urgency alarm sounds until silenced. Figure 124: Options Screen 2. Select the desired setting. Figure 125: Nearing End of Infusion Alarm Setting Drop-Down List 120 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 8: Program Options 3. Press Yes to change the Nearing End of Infusion setting. Press No to return to the settings list without saving changes. Figure 126: Change Nearing End of Infusion Setting Message Box 4. Press Done to return to the Programming screen. Figure 127: Options Screen SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 121 Chapter 8: Program Options NOTES: 122 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 9: Bolus Overview This chapter describes how to program bolus deliveries and select program options for a therapy. Bolus Use Bolus to program a delivery from a primary or secondary container. Only medications designated by facility may be delivered by bolus. Bolus is only available with Basic and Multistep therapies. Note: In Bolus from a primary container is confirmed without an underlying primary therapy confirmed, a primary therapy cannot be entered until the Bolus delivery is complete. If primary container is selected, the VTBI delivered is subtracted from the underlying primary therapy (Basic) VTBI. Note: Bolus may not be selected if a Piggback or Advanced therapy has been entered. To program a Bolus: 1. Press Bolus to display the Bolus Setup screen. Figure 128: Bolus Setup Screens 2. Press Select infusion field to select medication and concentration (if necessary). 3. Press Deliver From and select Primary Container (if available) or Secondary Container. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 123 Chapter 9: Bolus Overview 4. Press When Bolus Completes and select either Resume Primary Infusion or Stop Infusion press Next to display the Bolus Programming screen. Note: Press Bolus Calculation and enter Bolus medication amount using numeric keypad (enter patient weight, height, and BSA, if required). VTBI will be calculated. Press Enter to accept Bolus amount.Press Time and enter time period using numeric keypad. Rate will be calculated. (Entering rate will calculate time period.) Press Enter to accept time period.The lowest displayed time increment is 1 minute. Infusion is delivered in the calculated time. 5. Press Next to display the confirm Bolus screen. Note: If delivering a bolus from a secondary container, pressing Next activates the Secondary Container system message. 6. Review the program parameters. Press Start Bolus to begin infusion. Figure 129: Confirm Bolus Screen 124 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Overview 7. Chapter 9: Bolus The Delivering Bolus screen displays; to stop the therapy, press Stop Bolus. ICU 100 mL / hr 49.9 mL Heparin Program Bolus Advanced Piggyback DELIVERING BOLUS Heparin [ 25,000 units / 250 mL] Dose: 5000 units 100 mL / hr Rate: Time Remaining 24.6 mL VTBI: Volume Infused: 49.9 mL 0.1 mL Stop Program Press Stop to end infusion. Bolus button to view program. Program parameters may be changed after stopping. Mode Settings Logs Lock Alarm 02:30 PM Figure 130: Delivering Bolus Screen SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 125 Chapter 9: Bolus Overview NOTES: 126 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 10: Alarm and System Messages Alarm There are three types of alarms: invalid keypress, operational and malfunction. • Invalid Keypress—an alert tone that sounds when an invalid entry is touched; for example, a double keypress. • Operational alarms—active based on program options selection or when other delivery issues occur. • Malfunction alarms—activate when mechanical or software issues occur that require the infuser be removed from service and examined by authorized service personnel (Biomed). Operational alarm conditions are defined as low, medium, and high urgencies. All Malfunction alarms are high urgency. If an alarm occurs in Delivery mode, or if a malfunction occurs, the Nurse Call relay activates to notify clinicians at remote locations (e.g., centralized nurse stations) of an alarm condition. During an active alarm, an alarm tab displays on the screen until the alarm is resolved and/or cleared. Malfunction alarms remain active until the infuser is powered off. Pressing the alarm tab displays additional information for assistance in resolving the alarm. For more information on alarm messages, causes, and remedies, see “Appendix B: Alarm Messages and Troubleshooting” on page 171. Alarm Urgency The SYMBIQ™ Infusion System has four distinct levels of alarms outlined in Table 10. Each alarm level includes an alarm message, a distinct audible tone, and a detailed troubleshooting tab. The troubleshooting tab contains a full description of the alarm condition and suggested remedies or checklists to assist in resolving the root cause of the alarm. Multiple, simultaneous alarms display in order from highest to lowest priority. During an alarm, the channel LEDs and bag icons take on the alarm’s color treatment and flashing behavior. Table 10: Alarm Conditions and Criteria Alarm Urgency Alarm Sound Alarm Tab Color Channel LED Color Criteria for Alarm Immediate Single sound of three notes N/A N/A Invalid press or double-key effect occurs Low Single twonote melody Solid yellow Solid yellow if alarm is deliveryrelated Condition which does not require immediate attention or resolution. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 127 Chapter 10: Alarm and System Messages Alarm Table 10: Alarm Conditions and Criteria (Continued) Alarm Urgency Alarm Sound Medium High Alarm Tab Color Channel LED Color Criteria for Alarm Repeating two- Flashing note melody yellow Flashing yellow if alarm is deliveryrelated Condition which, if not resolved promptly, could result in an escalation to a Warning alarm. Repeating 10note melody Flashing red if alarm is deliveryrelated Condition which disrupts a therapy and/or requires immediate attention. Flashing red Alarm Appearance If an alarm occurs while the Near Viewing screen is active, a Near Viewing Alarm overlay like the one shown in Figure 131 displays. This alarm overlay contains information about the alarm name, the reason for the alarm, a suggested remedy for the alarm, and elapsed time of the alarm (if enabled). ICU Lidocaine Bolus Program Advanced Piggyback STOPPED PROGRAM DOPamine [400 mg / 250 mL] Dose 5 mcg / kg / min 13.1 mL/ hr Rate: Repeat? Time Remaining: 08:00 hh:mm VTBI Volume Infused 105 mL 0 mL Start Program AIR-IN-LINE Infusion stopped. Remove air from line. Restart infusion. Check air sensitivity setting if alarm persists. Press here to minimize all alarms 00:00:09 Figure 131: Near Viewing Alarm Overlay A Far Viewing Alarm overlay is shown in Figure 132. The Far Viewing Alarm overlay displays the alarm name and elapsed time of the alarm. Touching Far Viewing Alarm overlay displays Near Viewing Alarm. 128 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Alarm Chapter 10: Alarm and System Messages A device-level alarm is not associated with a channel, e.g., a Low Battery alarm, displays with a center tab as shown in Figure 132. An alarm associated with the infuser displays with a center tab, because it is not associated with a channel. ICU ICU 13.1 mL / hr 24.6 mL 13.1 mL / hr 96.1 mL DOPamine DOPamine Bolus Program Piggyback Advanced DOPamine DELIVERING PROGRAM [400 mg / 250 mL] DOPamine Rate [ 400mg / 250 mL] Dose: 13.1 mL / hr 24.6 mL 00:04 hh:mm 0.4 mL 13. 96. mL / hr VTBI hh:mm Time Stop Program 5 mcg / kg / min Rate: VTBI: Time: Volume infused: mL LOW BATTERY Less than 5 minutes of battery life remaining at current rate. Connect pump to A/C power. Press here to minimize 00:00:00 LOW BATTERY Press here for more information 00:00:00 Figure 132: Near and Far Viewing Device-Level Alarm Overlay Minimized Alarm Tabs Active alarms may be minimized when acknowledged by the user. This occurs when the user presses the detailed alarm message tab. In this circumstance, the infuser level alarm button changes to the respective alarm color. To restore an alarm overlay to full size, press the alarm button. Mode Settings Logs Lock Alarm 08:45 AM Figure 133: Low Battery Alarm button Alarm Silencing Audible alarms can be silenced for a two-minute interval. Pressing the SILENCE button silences the alarm and Nurse Call Relay (if enabled) for two minutes without affecting the touchscreen alarm message. Pressing SILENCE during a two-minute silence period resets the alarm silence period Note: All operational alarms may be silenced except the Depleted Battery alarm and the Power Loss alarm. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 129 Chapter 10: Alarm and System Messages Alarm If a new alarm occurs during an alarm silence period, an audible alarm sounds and a message displays on the touchscreen for the highest priority active alarm. To silence an audible alarm: 1. Press and release the SILENCE button on the top of the infuser. Figure 134: Infuser SILENCE Button Multiple Alarms Should multiple alarms occur, the highest priority alarm features both audible and visual priority. The SYMBIQ™ Infusion System can display up to six active alarms simultaneously by layering the alarm overlays from highest priority (i.e., the top or visible tab) to lowest priority. Pressing the alarm tab of a lower-priority alarm will display the associated alarm overlay. 130 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) System Messages Chapter 10: Alarm and System Messages If more than one alarm occurs, resolving or minimizing the highest-priority alarm overlay displays the next highest alarm overlay. ICU 0 mL/hr 0 mL Program Bolus Advanced Piggyback Infusion DOPamine [400 mg / 250 mL] Dose 5 mcg / kg / min Rate 13.1 mL / hr (Calculated) VTBI 103 Time (Calculated) 07:51 Clear Options mL hh:mm Cancel Titration Next CHECK CASSETTE Cassette Improperly installed or missing. Reinstall cassette. Contact Biomed if problem persists. Press here to minimize 00:00:00 Figure 135: Infuser Screen with Multiple Alarm Tabs System Messages System messages provide feedback about infuser status when powered on and when input requires confirmation. System messages also provide feedback when programming a therapy. For example, violating either a hospital defined rule set or a field range activates a system message alerting you to the problem. The Invalid Key Press tone sounds whenever a system message activates. Until acknowledged, system messages display while the infuser operates in violation of a defined rule set or field range limit. Types of system messages include: • Information or decision point messages • Outside of Soft Limits • Outside of Hard Limits • Invalid Entry For more information on system messages, causes, and remedies, see “Appendix A: System Messages and Troubleshooting” on page 161. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 131 Chapter 10: Alarm and System Messages System Messages Exceeded Soft Limits The Outside of Soft Limits system message activates when selected medication values exceed Drug Library-defined soft limits but do not exceed hard limits. ICU Program Bolus Advanced Piggyback Infusion DOPamine [ 400 mg / 250 mL] OUTSIDE LIMITS (Programmed Value) 5 mg/kg/hr 10 30 50 Override 70 Edit Press Override to bypass Limit. Press Edit to re-enter value. Mode Settings Logs Lock Alarm 04:34 PM Figure 136: Soft Limit Outside of Limits System Message When an attempt is made to enter a program value that exceeds the predefined soft limits, the event is recorded to both the Event Log and the Rule Set Override Log. To address a soft alert: 1. To change an exceeded limits medication value, press Edit, change the medication value, and then press Enter. 2. 132 If allowed by facility pressing Override will take user to the next programming step. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) System Messages Chapter 10: Alarm and System Messages Note: When a program is delivering Outside of Soft Limits, an Exceeded Soft Limit icon appears. ICU Bolus Program Advanced Piggyback DELIVERING PROGRAM Ampicillin ( 2 grams/ 100 mL) Dose Rate VTBI: Time: Volume Infused: Stop Program 100 mL / hr 100 mL/hr 99:9 mL 01.00 hh:mm 0.1 mL Press Stop to end infusion. Program button to edit program. Mode Settings Logs Lock Alarm 09:21 AM Figure 137: Delivering Screen with Exceeded Lower Soft Limit Icon Exceeded Hard Limits The Outside of Hard Limits system message activates when a medication value exceeds a hard limit for that medication. A Outside of Hard Limits message screen for a value that exceeds a lower hard limit is shown in Figure 138. ICU Figure 138: Outside of Hard Limits System Message SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 133 Chapter 10: Alarm and System Messages System Messages When entering a program value that exceeds the hard limit, the event is recorded to both the Event Log and the Rule Set Override Log. To override a hard limit: A hard limit may be overridden with proper authorization if enabled by hospital policy. A passcode is then required. The user may enter a passcode to override a Hard Limit. Press the Override button to display the passcode system message. ICU Figure 139: Override Code Screen 134 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) System Messages Chapter 10: Alarm and System Messages If no valid override passcode is defined for the current CCA, the Invalid Passcode system message activates. ICU Figure 140: Delivery Screen with Exceeded Upper Hard Limit Icon Invalid Entry Entering a value that exceeds infuser system limits, e.g., 1100 mL/hr, activates the Invalid Entry system message (Figure 141). For example, entering a patient weight of 1000 kgs in the Patient Weight field when the acceptable patient weight range is between 1 and 999 kgs activates the Invalid Entry system message. Pressing Clear on the Invalid Entry system message, and then entering a valid value in an active field removes the Invalid Entry system message from the touchscreen. Pressing Cancel on the SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 135 Chapter 10: Alarm and System Messages System Messages Invalid Entry system message closes the numeric keypad without saving changes. Invalid Entry are recorded to the Event Log. ICU Figure 141: Invalid Entry System Message 136 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 11: Stored Data The SYMBIQ™ Infusion System collects and stores data which is available for on-screen viewing. Types of data stored by the infuser and viewable in Clinical mode are: • Patient Information—Last Name, First Name, ID, Weight, Height, BSA (Body Surface Area), Caregiver ID, and CCA (Clinical Care Area, if defined for a hospital or institution) • Program Totals—medication name and concentration, number of boluses, bolus volume infused, bolus medication amount infused (if applicable), primary volume infused, primary medication amount infused (if applicable), total volume infused, and total medication amount infused • Shift Totals—date and time shift totals were cleared, combined total volume infused for all medications, and medication information for medications infused including: number of boluses bolus volume infused bolus medication amount infused (if applicable) primary volume infused primary medication amount infused (if applicable) total volume infused total medication amount infused (if applicable) • Logs—three types of logs are available for viewing: - Event Log—programming data, limit overrides, out-of-limit attempts, changes to settings, warnings, alarms, malfunctions, and power events - Alarm Log—malfunction and operational alarms - Rule Set Alert Override Log—all out-of-limit alerts, and overrides • Current Program—parameters of current or most recent program including medication name and concentration, dose, rate, VTBI, duration of therapy, and alarm settings • Default Drug Library (DDL)—factory-installed drug library with at least 99 medications and the manufacturer’s recommended default units of measure and concentration SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 137 Chapter 11: Stored Data Patient Information Patient Information Use the Patient Information screen shown in Figure 142 to enter patient name and ID (if required by your facility), Weight, Height, BSA, and Caregiver ID. ICU 0 mL/hr 0 mL CCA ICU Caregiver ID GREEN PATIENT INFO Last Name SMITH First Name PAT ID 976543 Weight Height 80 BSA (Calculated) 180 cm Calculate Clear Patient Information Height and Data Done Refer to Manual during use. Press fields to enter patient information if desired. Done to continue. Mode Settings Logs Lock Alarm 01:54 PM Figure 142: Patient Information Screen The Patient Information button at the top of the touchscreen displays on all subsequent programming and delivery screens. This button contains the CCA name, patient name, and patient ID. The Patient Information button only displays patient information if configured to do so in the selected CCA. Clinical Care Areas Using Hospira MedNet® Service Suite (MMS), your hospital or institution can define up to 40 different CCAs. Each CCA can have up to 400 medications to choose from including “Other Drug.” Note: Selection of a CCA is required. All other fields are optional. When you select a CCA, the infuser uses that CCA’s configuration and medication definition settings for all subsequent therapies until a different CCA is selected. When CCAs have been downloaded to the infuser, you must either confirm the current CCA or select a new one each time the infuser is powered on. Changing CCAs You can change a CCA any time the infuser is powered on. When you change a CCA, the Change CCA system message activates requiring confirmation. The Change CCA system message only 138 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Patient Information Chapter 11: Stored Data activates when you change a previously selected CCA; it does not activate when you initially select a CCA. After confirming the CCA change, press Done on the Patient Information screen to return to the prior screen and update Patient Information button display, if necessary. While a primary infusion is delivering under the old CCA rule sets, any secondary infusions (bolus or piggyback) programmed on the same line also deliver under the old CCA rule sets. To enter information in the Patient Information screen: 1. On the Patient Information screen, press the CCA field to select a CCA: Figure 143: Patient Information Screen • select the desired CCA from the CCA selection list Note: If no CCAs have been downloaded to the infuser, the default CCA selection will be No CCA. If one or more CCAs have been downloaded to the infuser, the default CCA field will be Select CCA. 2. The facility may restrict access to a CCA by requiring a passcode. In this case, enter the CCA Access passcode on the Enter Code dialog box, if required. Figure 144: Enter Code Dialog Box for CCA Access SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 139 Chapter 11: Stored Data Patient Information Note: Entering an invalid passcode three consecutive times activates the Invalid Passcode system message for each attempt. Entering an invalid passcode a fourth time closes the Enter Code dialog box and displays the Patient Information screen without changing the CCA. 3. Press the BSA field to enter the patient’s BSA (Body Surface Area) after entering patient weight and height. Note: To calculate the BSA, enter patient’s weight and height. Press Calculate. The Calculate button is only available if both weight and height values are entered. 4. Press the Caregiver ID field. Use the touchscreen keypad to enter an ID up to 15 characters long, and then press Enter. 5. On the Patient Information screen, press Done to display the Basic Program screen or press Clear to remove all patient values entered. ICU ICU 0 mL/hr 0 mL CCA ICU Caregiver ID GREEN PATIENT INFO Last Name SMITH First Name PAT ID 976543 Bolus Height 80 BSA (Calculated) 180 cm Calculate Clear Patient Information Height and Data Done Refer to Manual during use. Press fields to enter patient information if desired. Done to continue. Mode 01:54 PM Settings Logs Program Infusion Dose Weight 0 mL/hr 0 mL Lock Alarm Advanced Select Infusion Dose Calculation Rate mL/hr VTBI mL Time --:-- Clear Piggyback Options hh:mm Cancel Titration Next Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to contine. Mode Settings Logs Lock Alarm 02:27 PM Figure 145: Patient Information and Basic Programming Screens Note: Pressing Clear Patient Information and Data button clears current patient information, shift totals, program totals, the current program, and all logs visible in Clinical mode. If no keys are pressed for 30 seconds, the Patient Information screen reverts to the screen from which it was accessed. Any values changed by pressing Enter on the Patient Information screen are retained. Note: Clear Patient Information and Data button only displays if Infuser is not in Delivery Mode and a CCA has been selected. 140 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) To display Program Totals Chapter 11: Stored Data To display Program Totals The Program Totals screen shown in Figure 146 contains program totals for these items: • Medication name/medication concentration • Number of boluses infused • Bolus volume infused • Bolus medication amount infused (if applicable) • Primary volume infused • Primary medication amount infused (if applicable) • Total volume infused • Total medication amount infused All volume infused totals and medication amount infused totals include volumes delivered during KVO and Auto KVO deliveries. ICU Logs: Program Totals Ceftriaxone [1 grams / 50mL] Primary Infused Volume Drug 1.1 mL 0 grams Boluses Infused Number Volume Drug Tota Infusedl Volume Drug 0 mL 0 grams 1.1 mL 0 grams Exit Press arrows to scroll to other entries. Press Exit to return to prior screen. Press Exit to return to previous screen. Mode Settings Logs Lock Alarm 04:34 PM Figure 146: Program Totals Screen Clearing Program Totals Entering new patient information on the Patient Information screen resets program totals to zero. The following actions also reset program totals to zero: • pressing Clear All on the first programming screen of a therapy • changing a medication on an existing program screen The cleared Program Totals values are logged to the Event Log. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 141 Chapter 11: Stored Data Shift Totals Data WARNING: Accuracy of medication amounts recorded in the logs are dependent on the fill accuracy of IV container and amount discarded during priming. To view the Program Totals Log: 1. Press Logs at the bottom of the touchscreen to display the Logs menu screen. Figure 147: Logs Menu Screen 2. From the Logs menu screen, press Program Totals. See Figure 146. 3. On the Logs: Program Totals screen, press the scroll bar on the right of the touchscreen to scroll through the log. 4. Press Exit to return to the Logs menu screen. Note: If no keys are pressed for two consecutive minutes, the Logs menu screen reverts to the screen from which the Logs button was selected. Shift Totals Data The Shift Totals screen shown in Figure 148 displays the following: • Date and time shift totals were cleared • Combined total volume infused during a shift • Medications infused during a shift All volume infused totals and medication amount infused totals include volumes delivered during KVO and Auto KVO deliveries. 142 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Shift Totals Data Chapter 11: Stored Data ICU Logs: Shift Totals Shift Cleared Date & Time Mar 17, 2006 10:33 AM Infuser Shift Totals (All Programs) Volume Infused 1.1 mL Exit Clear Press arrows to scroll to other entries. Press Exit to return to prior screen. Press Clear Shift Totals button to delete all shift information. Exit to return to previous screen. Mode Settings Logs Lock Alarm 04:34 PM Figure 148: Shift Totals Screen Clearing Shift Totals Entering new patient information on the Patient Information screen clears shift totals and causes the infuser to: • update the shift cleared date and time to the current date and time • log the cleared values to the Event Log • reset values to zero To clear the Shift Total Logs: 1. Press Logs at the bottom of the touchscreen to display the Logs menu screen. 2. From the Logs menu screen, press Shift Totals to display the Logs Shift Totals screen. 3. On the Logs Shift Totals screen, press the scroll bar on the right of the touchscreen to scroll through the log. 4. Press Clear to display the Clear Totals message box. Press Yes to clear the shift totals or press No to return to the Logs Shift Totals Screen. 5. On the Logs Shift Totals screen, press Exit to return to the Logs menu screen. Note: If no keys are pressed for two consecutive minutes, the Logs menu screen reverts to the previous screen. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 143 Chapter 11: Stored Data Event Log Event Log The Event Log records infuser events including infusion programs, limit overrides, out-of-limit alerts, changes to settings, power events, and operational alarms, and malfunctions. Figure 149 illustrates the Event Log screen. The infuser stores up to 8,000 entries in the Event Log. Figure 149: Event Log Screen Entering new patient information on the Patient Information screen clears the Event Log viewable in Clinical mode. To view the Event Log: 1. Press Logs at the bottom of the touchscreen to display the Logs menu screen. 2. From the Logs menu screen, press Logs, and then press Event Log to display the Event Log screen. 3. On the Event Log screen, press the vertical scroll bar on the right of the touchscreen to scroll through the log. Note: The most recent event recorded displays as the top entry in the Event Log. 4. To scroll to the first record of the log, press Beginning of Log. Press End of Log to scroll to the last record of the log. 5. On the Event Log screen, press Exit to return to the Logs menu screen. Note: If no keys are pressed for two consecutive minutes, the Logs menu screen reverts to the screen from which the Logs button was selected. 144 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Alarm Log Chapter 11: Stored Data Alarm Log The Alarm Log (Figure 150) is a filtered view of the Event Log. Every operational alarm, and malfunction is recorded in the Alarm Log. Each entry includes the associated time, date, and description of the alarm event. Figure 150: Alarm Log Screen Entering new patient information on the Patient Information screen clears the Alarm Log viewable in Clinical mode. To view the Alarm Log: 1. Press Logs at the bottom of the touchscreen to display the Logs menu screen. 2. From the Logs menu screen, press Logs, and then press Alarm Log to display the Alarm Log screen. 3. On the Alarm Log screen, press the vertical scroll bar on the right of the touchscreen to scroll through the log. Note: The most recent alarm recorded displays as the first entry in the Alarm Log. 4. To scroll to the first record of the log, press Beginning of Log. Press End of Log to scroll to the last record of the log. 5. On the Alarm Log screen, press Exit to return to the Logs menu screen. Note: If no keys are pressed for two consecutive minutes, the Logs menu screen reverts to the screen from which the Logs button was selected. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 145 Chapter 11: Stored Data Rule Set Alert Override Log Rule Set Alert Override Log Attempts to override CCA Rule Sets are recorded to the Rule Set Alert Override Log. Out-of-limit alerts, and rule set overrides are recorded and stored as illustrated in Figure 151. The infuser stores up to 1,000 entries in the Rule Set Alert Override Log. ICU Rule Set Alert/Overide Log: 1 of 40 Drug Library: 1234567891234567889 Patient: ID: 1234567890 Height: 100 cm Weight: 40 kg BSA: 6.333 m2 11:35:23 PM Dec 30, 2003 CCA: Med/Sur Infuser: 1234567890 Caregiver:1234567890 Dose Upper Hard Limit Alert Without Override Channel A - Variable Time Phase 2 Lidocaine [25 mg/100 mL] Limit: 5000 mg/kg/hr Attempted: 6000 mg/kg/hr Confirmed: 4000 mg/kg/hr Beginning of Log Exit End of Log Press arrows to scroll to other entries. Press Exit to return to prior screen. of Log and End of Log buttons to jump. Press Beginning Exit to return to previous screen. Mode Settings Logs Lock Alarm 04:34 PM Figure 151: Rule Set Alert Override Log Screen Anytime new patient information is entered on the Patient Information screen, the Rule Set Alert Override Log viewable in Clinical mode is cleared. To view the Rule Set Alert Override Log: 1. Press Logs at the bottom of the touchscreen to display the Logs menu screen. 2. From the Logs menu screen, press Logs, and then press Rule Set Override Log to display the Rule Set Alert Override Log screen. 3. On the Rule Set Alert Override Log screen, press the vertical scroll bar on the right of the touchscreen to scroll through the log. Note: The most recent rule set alert override event recorded displays as the first entry in the Rule Set Alert Override Log. 4. To scroll to the first record of the log, press Beginning of Log. Press End of Log to scroll to the last record of the log. 5. On the Rule Set Alert Override Log screen, press Exit to return to the Logs menu screen. Note: If no keys are pressed for two consecutive minutes, the Logs menu screen reverts to the screen from which the Logs button was selected. 146 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Current Program Chapter 11: Stored Data Current Program Select Current Program to view information about the current program including dose, rate, volume, time, VTBI, volume infused, and program options. To view the Current Program Log: 1. Press Logs at the bottom of the touchscreen to display the Logs menu screen. 2. From the Logs menu screen, press Current Program to display the Logs Current Program screen. 3. On the Logs Current Program screen, press the vertical scroll bar at the top of the touchscreen to scroll through the log. Note: Not all Current Program logs have a vertical scroll bar. Only therapies with either multiple steps or phases will have additional screens to scroll through. 4. On the Logs Current Program screen, press Exit to return to the Logs menu screen. Note: If no keys are pressed for two consecutive minutes, the Logs menu screen reverts to the previous screen. Default Drug Library The SYMBIQ™ Infusion System has a factory-installed Default Drug Library (DDL) used to program therapies. The DDL is set up as a single CCA drug library and uses the defined CCA defaults for all medication settings. To help differentiate sound-alike or look-alike medication names, the DDL uses TALL-man lettering (Figure 152). Infusion Fluid Only Dose Carboplatin Rate Cyclosporine VTBI DOBUTamine Time Docelaxel Cancel DOPamine Figure 152: Infusion Field Drop-Down List with DDL Medication Names The DDL is active and available for use until a new drug library is downloaded to the infuser using Hospira MedNet® Service Suite (MMS). Once a new drug library is successfully downloaded, it replaces the DDL as the active drug library. Medications in the DDL have neither hard limits nor soft limits. Hard limits and soft limits are specified by each facility using Hospira MedNet® Service Suite (MMS). For a list of medications available in the DDL, see “Appendix E: Default Drug Library (DDL)” on page 187. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 147 Chapter 11: Stored Data Default Drug Library High-Risk Medications Your hospital or institution can designate certain medications as high-risk medications. High-risk medications display on the infuser touchscreen highlighted in yellow as shown in Figure 153. ICU Figure 153: Far Viewing Delivery Screen with High-Risk Medication Infusing Table 11 describes other touchscreen elements that display high-risk medications highlighted in yellow. Table 11: Touchscreen Elements with High-Risk Medications Highlighted Element Highlighted Near Viewing Delivery screen with high-risk medication infusing Touchscreen Location ICU Infusion field displaying a high-risk medication 148 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Using the Hospira MedNet® Service Suite (MMS) Chapter 11: Stored Data Table 11: Touchscreen Elements with High-Risk Medications Highlighted Element Highlighted Touchscreen Location High-risk medication in Infusion Selection dropdown list Confirmation screen ICU 0 mL/hr 0 mL DOPamine Bolus Program Advanced Piggyback CONFIRM PROGRAM DOPamine [400 mg/ 250 mL] 5 mcg / kg / min 13.1 mL/ hr 103 mL 08:00 hh:mm Dose: Rate: VTBI: Time: Start Titration Press Start to begin infusion. Program button to edit program. Mode Settings Logs Lock Alarm 09:21 AM Using the Hospira MedNet® Service Suite (MMS) The Hospira MedNet® Service Suite (MMS) assists with the reduction of medication errors by associating a hospital's predefined dosing limits, both soft and hard limits with each medication. A value—programmed outside the rule sets determined by a facility—triggers an Outside Limits message along with a visual graph indicting the predefined values for the selected medication. Rule sets are applied to medications found in all Therapy listings; Program, Piggyback, Advance and Bolus. To ensure the predefined dosing limits are meeting clinical requirements, the SYMBIQ™ Infuser records the programmed information in the Event Log and Rule Set Override log. Up to 1000 events are stored allowing for continuous monitoring of dosing parameters, availability of medications, and to service as a clinical education tool. The Soft Outside of Limits message notifies the user when a selected medication value is outside the predefined Soft Limit value. (See Figure 136 on page 132.) The user can reprogram or accept the limit. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 149 Chapter 11: Stored Data Using the Hospira MedNet® Service Suite (MMS) Programming a Soft Outside limits Message If the values enter result in either a higher or lower than the pre-defined limits, an alarm tone will sound and a pop-up OUTSIDE LIMITS is displayed. (figure 71 using dopamine as drug) Press Edit to return to programming screen and re-enter programmed value and proceed with programming If the clinical decision is to bypass the limit message, press Override and proceed with programming. When finished programming verify the programmed information on the Confirm Program screen and press Start to begin the infusion. The icons will appear in the tab on the top left corner of the screen indicating the value is either lower or higher than the pre-defined rule set. Figure 154: Upper and Lower Soft Limit icons Programming a Hard Limit Outside Limits Message The Hard Outside Limits message notifies the user when the selected value exceeds the predefined value. An alarm will sound and a pop-up Outside Message appears. A facility hard limit cannot be overridden. Press Edit to return to programming screen and re-enter programmed value and proceed with programming. Note: Based on a facilities policy selected CCA's may be able to override a hard limit if a valid pass code is entered. 150 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 12: Cleaning, Maintenance, and Storage This chapter describes how to clean, store, and service the SYMBIQ™ Infusion System. This chapter also describes battery maintenance and battery disposal. Cleaning the Infuser To ensure the SYMBIQ™ Infusion System functions properly, practice the cleaning guidelines in this chapter. Establish a routine weekly schedule for cleaning the infuser. Before cleaning the infuser you should: • Power down the infuser using the ON/OFF button • Disconnect the infuser from AC (mains) power The exposed surfaces of the SYMBIQ™ Infusion System may be cleaned with a lint-free cloth moistened with one of the cleaning solutions recommended in Table 12 or with mild, nonabrasive soapy water. Use a small, non-abrasive brush to aid in cleaning the cassette carriage. Table 12: Cleaning Solutions for use on the SYMBIQ™ Infusion System Cleaning Solution Manufacturer Preparation CoverageTM HBV Steris Corporation, a division of Calgon Vestal Laboratories Per manufacturer's recommendation Dispatch® Caltech Industries Per manufacturer's recommendation Precise® Caltech Industries Per manufacturer's recommendation Household liquid bleach (5.25 sodium hypochlorite) Various manufacturers Use per hospital procedures; do not exceed one part bleach to ten parts water Manu-Klenz® Calgon Vestal Laboratories Per manufacturer's recommendation Sani-Wipes PDI, the healthcare division of Nice-Pak Per manufacturer’s recommendations SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 151 Chapter 12: Cleaning, Maintenance, and Storage Battery Maintenance Cleaning Cautions Avoid damaging the SYMBIQ™ Infusion System by following these cleaning cautions: CAUTION: To avoid mechanical or electronic damage, DO NOT immerse the SYMBIQ™ Infusion System in fluids or cleaning solutions. DO NOT spray cleaning solutions in or near infuser openings. DO NOT allow cleaning solutions to saturate the air-in-line detectors or enter the infuser when cleaning the air-in-line detectors. USE ONLY the recommended cleaning solutions and follow the manufacturer’s recommendations. Using cleaning solutions not recommended by Hospira may result in product damage. The disinfecting properties of cleaning solutions vary; consult the manufacturer for specific information. DO NOT use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride. NEVER use sharp objects such as fingernails, paper clips, or needles to clean any part of the infuser. DO NOT sterilize by heat, steam, ethylene oxide (ETO), or radiation. Battery Maintenance CAUTION: Before connecting a patient to the infuser, ensure the infuser has a fully charged battery installed for continuous infuser operation. The SYMBIQ™ Infusion System is designed to use battery power for emergency backup and temporary portable operation. A one-channel infuser with a fully charged battery provides at least four hours of operation at 100 ml/hr with the LCD backlighting set to Power Saving mode. The battery recharges whenever the infuser is connected to AC (mains) power. With the infuser powered off and connected to an AC power source, the battery takes four hours to recharge. Battery recharge takes longer if the infuser is powered on. In general, the more often the battery is partially discharged and then recharged, the sooner it will need to be replaced. Consult a qualified biomedical technician for battery replacement if necessary. Note: Disconnect AC power line prior to opening unit or changing battery. To maintain maximum battery charge and to prolong battery life, connect the infuser to AC (mains) power whenever possible. Battery Disposal Do not discard the infuser’s used lithium ion battery pack with regular trash. Instead, dispose of it in an environmentally sound and approved manner. Contact your local waste management 152 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Storage Chapter 12: Cleaning, Maintenance, and Storage company for information on environmentally sound ways of collecting, disposing, and recycling used batteries. Storage To prolong the life of the SYMBIQ™ Infusion System, take the following storage precautions: • Store away from excessive heat (more than 60º C), cold (less than -20º C), and humidity (outside 10% to 90% range) • Store connected to AC (mains) power Infuser Maintenance and Service All maintenance, service, or adjustments to the SYMBIQ™ Infusion System should be referred to qualified technical personnel. A technical service manual may be ordered from your local Hospira sales representative. Product Handling and Disposal Do not discard the infuser’s administration set with regular trash. Instead, follow hospital procedures for disposing and handling of infuser’s administration set. Please comply with local disposal and recycling regulations as appropriate for disposable batteries, rechargeable battery packs, medical electronic components and infusion sets. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 153 Chapter 12: Cleaning, Maintenance, and Storage Product Handling and Disposal NOTES: 154 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 13: Product Specifications Physical Specifications One-channel infuser dimensions: Width: 9.9 inches Height: 10.2 inches Depth: 8.6 inches Depth with Pole Clamp: 13.0 inches Weight: 10.7 pounds Casing: High-impact plastic Electrical Specifications Power frequency: Between 47 Hz and 63 Hz Fuses: T1.6A/250VAC AC power rating: 100-240 VAC, 100 VA MAX, Power cord: Hospital-grade AC cord approximately 10 feet in length with a hospital-grade plug at one end Rear infuser AC power outlet: Located on the back of the infuser; accommodates one additional SYMBIQ™ Infusion System only Electrical safety: The SYMBIQ™ Infuser has been assessed and complies with the following standards: • • • • UL 60601-1 CSA C22.2 No.601.1 IEC/EN 60601-1-2 (2001) IEC/EN 60601-2-24 (1998) Battery Specifications Battery: Rechargeable lithium ion 10.8 volts Battery life for a one-channel infuser: With a fully charged battery, a one-channel infuser will operate for at least 4 hours at 100 mL/hour with the LCD backlight set to Power Saving mode Battery gauge: Located on the infuser screen, the gauge indicates the amount of battery life remaining Battery recharge: Recharging a depleted battery requires 4 hours or less when infuser is off Battery automatically recharges while infuser operates on AC power External Interfaces External communication ports: 1 Ethernet port 1 Nurse callback port Nurse callback jack: Standard 1/4 inch phone jack Nurse call relay: Industry standard type 1 Form C Reed relay SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 155 Chapter 13: Product Specifications Wireless Connectivity Transceiver band: 2.4GHz ISM band Wireless certification: FCC Part 15 Class B compliant Communications standard: IEEE 802.11b Input Device/Keypad Off-screen: Off-screen buttons including LOAD/EJECT, On/Off, SILENCE, Emergency Stop Touchscreen keypad: Thin film transistor (TFT) touchscreen keys LCD Display Display size: 8.4 inch diagonal color display Viewable angles: Minimum side angle: 45º ± 5º Vertical angle: 60º ± 5º Display adjustments: User-adjustable brightness control and Power Saving mode Computer-controlled backlight brightness level LED Display External power LED: Indicates when infuser is on AC power and when charging the battery Infuser Alarms Channel LED: LED color indicates infuser alarm states: Solid red—Malfunction alarm Flashing red—High urgency Flashing yellow—Medium urgency Solid yellow—Low urgency Solid red—Latched alarm Infuser Alarms Alarm tones: Initial alarm tone (except Latched alarm) sounds at a user-defined level. Alarm tone reverts to maximum level if no user action is taken within time configured for the CCA. Audible Tones Audible tone range is minimum of 45 dB(A) to a maximum of 65 dB(A) or more Safety Features Power-on diagnostics: Checks all critical infuser components and data at power-on; any component failure is reported and logged as a Malfunction alarm Background diagnostics: Checks and monitors all critical infuser components and data while powered-on; any component failure is reported and logged as a Malfunction alarm. Component failure during an infusion stops delivery on the appropriate channel. Memory Protection Non-volatile memory: 156 Stores data and logs for at least one year after power is removed from the infuser SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Chapter 13: Product Specifications Date and Time Settings Time of day clock: Displays time of day in either 12-hour or 24hour formats Temperature Parameters Ambient Operating temperature range: 5°C to 40°C Storage temperature range: 20°C to 60°C Relative humidity: Operational range of 10% to 90% noncondensing Barometric pressure range: Operational range from 0 to 10,000 feet Surface temperature: Maximum of 50° C Occlusion Settings Distal occlusion: User specified range in either psi (from 1 to 15 in increments of 0.5) or mmHg (from 50 to 775 in increments of 25) Proximal occlusion: -5 psi/250 mmHg Air sensitivity settings: User-specified bubble size threshold levels: • 50 mcL • 100 mcL • 150 mcL • 250 mcL • 500 mcL Single bubble automatic threshold of 250 mcL. Cumulative bubble automatic threshold setting of < 1mL/15 minutes. Delivery Rate Delivery range: Between 1.1 to 1000 mL/hr KVO Specification KVO rate: Between 0.1 and 20 mL/hr programmed in 0.1 mL increments; default is 1.0 mL/hr Hemolysis Blood and blood products: During the pumping of red blood cells, the increase in 5 hemolysis shall be less than 1%. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 157 Chapter 13: Product Specifications Flow Rate Accuracy Flow Rate Accuracy Flow rate accuracy represents the infuser’s fluid delivery performance under these conditions: Table 13: Standard Environmental Conditions and Specifications Condition Specification Ambient and fluid temperature: 22° C + 5° C Back pressure: + or -1 psig Filling head height: 18 inches of water (+ 4 inches) IV fluid: Sterile water or D25W. Delivery rate range: 0.1 to 1000 mL/hr Administration set condition: No air trapped in tubing The flow rate accuracy of the SYMBIQ™ Infusion System is + 5% for all rates greater than 1.0 mL/hr with 95% confidence. For rates less than or equal to 1.0 mL/hr, the flow rate accuracy is + 10% with 95% confidence. WARNING: Rate accuracy can be affected by variations of fluid viscosity, fluid temperature, head height, back pressure or any combination of these. Additional factors that can have an influence are administration set configuration and use duration. Flow Continuity At low flow rates (between 0.1 and 1.0 mL/hr) with microbore tubing, the no-flow period does not exceed 20 seconds and the bolus volume released does not exceed 2 microliters. Trumpet Curves Trumpet curve graphs 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. Trumpet curve graphs plot flow rates at 30 second intervals for the first 2 hours and for the 96th hour of delivery. The graphs plot the mean delivery rate error (average of 3 infusers) for the 2nd hour and the 96th hour as a straight line. The graph also presents maximum and minimum average delivery rate errors for this interval by plotting average delivery errors over intervals of 2, 5, 11, 19, and 31 minutes. 158 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Trumpet Curves Chapter 13: Product Specifications Sample Trumpet Curve On the trumpet curve graph sample shown in Figure 155, 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 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 to determine the corresponding limits. Figure 155: Sample Trumpet Curve A trained professional can use the resulting graphs to select an infuser with the appropriate startup and flow characteristics to suit the clinical application. To illustrate how trumpet curves are 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. Take for example Dopamine administered at 5 mcg/kg/ min. At 5 minutes, the average medication delivery error would be within the range of +2.8% and -0.5% of the expected nominal rate. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 159 Chapter 13: Product Specifications Trumpet Curves NOTES: 160 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix A: System Messages and Troubleshooting Appendix A outlines system messages generated by the SYMBIQ™ Infusion System, the cause of the message, how the message text displays, steps to remedy the condition, and message logging. On-Screen Text System Message Message Cause Steps to Remedy Battery Depleted Battery Depleted Powering on an Infuser with a battery not having sufficient charge to power the device if AC power is disconnected. Press OK to acknowledge. Delivery Will Start When Bolus/ Piggyback Completes Pressing Start for a Basic or Advanced therapy while a bolus or piggyback delivery is in progress for that channel. If bolus, setting to resume primary when complete. Press OK to acknowledge. Delivery Can Be Started When Bolus Completes Pressing Start on the primary confirmation screen or Stop Mode screen while a bolus is infusing that is set to stop when infusion complete. Press OK to acknowledge. BSA Calculated Value Out of Range (invalid value based on updated Height, Weight or pressing Calculate button) The user changes the Height or Weight value on the Patient Information screen after the BSA value has been calculated and the new calculated BSA value is an invalid value. Press to acknowledge. Check height and weight entries No Power if A/C Fails. Bolus In Progress (Bolus) Piggyback In Progress (Piggyback) Delivery will start when Bolus delivery is complete. (Bolus) Delivery will start when Piggyback delivery is complete. (Piggyback) Bolus In Progress Primary infusion can be started by clinician when bolus completes. BSA Out of Range Calculated BSA is Out of Range. BSA value has been cleared. OR The user changes the Height or Weight value on the Dose Calculation or Bolus Amount widget after the BSA value has been calculated, and the Dosing Units include m2 and the new calculated BSA value is an invalid value. OR The user presses the Calculate button on the Patient Information Screen or Dose Calculation Widget, and the calculated BSA value is an invalid value Calculated Rate Out of Range The calculated rate is outside the accepted range. Verify program parameters. Calculated Rate Out of Range The user enters a parameter on the Dose Calc Complex Pop-up that results in a calculated rate outside of the acceptable range. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Press OK to acknowledge. 161 Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Calculated VTBI Out of Range Calculated VTBI Out of Range The user enters a parameter on the Dose Calc Complex Pop-up that results in a calculated VTBI outside of the acceptable range. Press OK to acknowledge. Standby when Delayed Start is Selected Selecting Standby when Delayed Start is already programmed. Press Continue to cancel the Delayed Start and program Standby. Delayed Start when Standby is Selected Selecting Delayed Start option when Standby already programmed. Cassette Eject Not Allowed Pressing LOAD/EJECT when the associated channel is delivering an infusion in Clinical Mode. The calculated VTBI is outside the accepted range. Verify program parameters. Cancel Delayed Start? Programming Standby will cancel the Delayed Start. Cancel Standby? Programming a Delayed Start will cancel Standby. Cassette Eject Not Allowed (Clinical Mode): Channel delivery or power priming must be stopped or Delayed Start must be canceled before cassette can be ejected. Press Cancel to maintain current Delayed Start setting. Press Cancel to maintain current Standby setting. OR Pressing LOAD/EJECT while the associated channel is running an infusion test or a calibration in Biomed or Service Mode. (Biomed and Service Mode): Procedure must complete before cassette can be ejected. Press Continue to cancel Standby and program a delayed start. OR Pressing Load/Eject button while the associated channel is power priming (mechanism is moving). (Clinical Mode - Delivery Mode) Press Stop to stop delivery. Load/ Eject to eject the cassette after delivery is stopped. (Clinical Mode - Power Priming) Press Cancel to stop power priming. Load/Eject to eject the cassette after power priming is stopped." (Clinical Mode - Delayed Start) Cancel OR Pressing Load/Eject button while the associated channel is in Delayed Start. CASSETTE REQUIRED A cassette must be loaded to program this channel. Load cassette and press OK to continue. CASSETTE REQUIRED A cassette must be loaded to start this channel. Load or check cassette and press OK to continue. Change Air Sensitivity Setting? Change Channel Air Sensitivity setting from to ? 162 Casette Required Programming screen is displaying, the ability to program without a cassette is configured off, the cassette for the associated channel is missing or improperly installed, and the user touches a program parameter field. Press Load/Eject button and insert cassette. Verify Cassette The confirmation screen is displaying, the ability to program without a cassette is configured on or off, the cassette for the associated channel is missing or improperly installed, and the user presses the Start button. Press Load/Eject button and insert cassette. Change Air Sensitivity Setting Selecting an Air-In-Line Sensitivity setting that differs from the current setting and then exiting the screen for that setting. Press Yes to continue with new setting. Press No to continue with previous setting. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Change CCA? Change CCA Changing the current CCA by selecting a CCA from the CCA Selection drop-down list. Press Yes to change CCA. Change CCA from to ? Changing the CCA will clear any partially programmed channels. Change Distal Occlusion Setting? Change Channel Distal Occlusion setting from to ? Change Proximal Occlusion Setting? Change Channel Proximal Occlusion setting from to ? Check BSA Change to height/weight may affect BSA. Check BSA value. Check BSA BSA will be recalculated using the BSA formula. New BSA is . Cleaning Lock Active. (if no cassette doors are open): Press Cleaning Lock button on the back of the Infuser to unlock. Press No to retain current CCA. Note: Once a CCA has been selected (i.e., the CCA field is displaying a CCA name, not "Select CCA"), this message will display each time a CCA is selected from the drop-down list. Change Distal Occlusion Setting Selecting a Distal Occlusion setting that differs from the current setting and then exiting the screen for that setting. Press Yes to continue with new setting. Change Proximal Occlusion Setting Selecting a Proximal Occlusion setting that differs from the current setting and then exiting the screen for that setting. Press Yes to continue with new setting. Check BSA Entered Value Changing height or weight values after the BSA value has been entered. Press OK to acknowledge. BSA Calculated Value Affected (Valid value) Changing height or weight values after the BSA value has been calculated and the new calculated BSA is a valid value. Press OK to acknowledge. Cleaning Lock Active Activating the Cleaning Lock. Cleaning Lock will automatically deactivate from activation. Clear All Settings and Data Pressing Clear Patient Information and Data button on the Patient Information screen. Press Cancel to exit without clearing. Clear Program Pressing Clear All on the first programming screen of an advanced therapy or Clear on the Basic Program programming screen. Press Continue to clear all programmed values and proceed. Press No to continue with previous setting. Press No to continue with previous setting. (if one or more cassette doors are open): Ensure tubing is disconnected from patient before proceeding. Press Cleaning Lock button on the back of the Infuser to unlock. Clear All Settings and Data? Clearing the current patient information will also clear the CCA, caregiver ID, shift totals, program totals, medication amount totals, current program and logs. Clear Program? Continuing will result in loss of current program information. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Press Confirm to clear all settings and data. Press Cancel to return to current program. 163 Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Delete Information? Delete Information Pressing Clear Shift Totals on the Shift Totals Screen in Clinical Mode Press Yes to delete information. Delete Information to be deleted text: OR Shift Totals Screen: Shift Totals Pressing Clear All on the Service: Logs Menu Screen in Service Mode Service Logs Menu Screen: contents of all logs Disconnect Tubing Ensure tubing is disconnected from patient before proceeding. Door open. Unable to power down. One or more cassette doors are open. Close door(s) and press the On/Off button again. Medication Duplication is already in use. Exceeds VTBI Bolus volume exceeds Volume Remaining in primary delivery. Press No to cancel. Ensure Tubing is Disconnected from Patient Pressing Power Prime on the Program Options screen. Press OK to acknowledge. Unable to Power Down With Door Open Pressing Power hard key when at least one cassette carriage is not closed (cassette present) or not in storage (cassette not present). Press OK to acknowledge. Medication Name Duplication Selecting the same medication (excluding “Other Drug”) for more than one program. Press Continue to complete program with duplicate Medication Name. Note: this applies to a bolus from secondary or piggyback dose. Bolus from primary, by default, uses the same medication. Press Cancel to Clear Duplicate Medication. Pressing Start Bolus after programming a bolus from the primary container on a channel with an underlying primary delivery already confirmed and the bolus VTBI exceeds the primary delivery VTBI. Enter valid value or clear Bolus program and increase primary VTBI. Exceeds VTBI Press Force Shutdown to powerdown with the door open. OR Pressing Enter on any screen on the Bolus Primary Container Programming screen that causes the Bolus VTBI to be greater than the remaining primary VTBI on a channel with an underlying primary delivery already confirmed. Note: Values on the programming screen will not change - user will have to modify the parameter they want to correct the situation before proceeding. Infuser is initializing Start may be pressed when initialization is complete. Invalid Titration One or more limit has been exceeded. 164 Infuser Initializing Pressing the Start button while the Infuser is initializing. Press OK to acknowledge. Invalid Titration Pressing Start Titration for an infusion in progress and one or more limits (system or Hard/Soft) are exceeded. Press OK to return to programming screen and resolve before continuing. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Malfunction Malfunction Occurred The Infuser is powered on after a malfunction occurred during the last power up which may not display. Press OK to acknowledge. Multiple CCAs Programming one or more channels under the current CCA and pressing Yes on the Change CCA system message when no CCA passcode is required Therapies in progress will continue operating under the prior CCA rule sets. New therapies will operate under the new CCA rule sets. Press OK to acknowledge. A malfunction occurred that might not have displayed. See the logs for additional information. All patient and therapy information has been cleared. Contact Biomed. Multiple CCAs OR Programming one or more channels under the current CCA and pressing Enter on the CCA Access Passcode Pop-up after entering a valid CCA access code Multiple CCAs Channel is operating under rule set until program in progress is complete. Old CCA Reminder Pressing any Program level button to change the current program on a channel while that channel is operating under an old CCA after a CCA change. Press OK to acknowledge. Note: If the Advanced button is pressed and the Advanced therapy screen appears the Old CCA Reminder system message will not appear until the Advanced therapy is selected. No battery is detected when the Infuser is powered on. Press OK to acknowledge. No Dose/Amount or Rate Limits No Dose/ Amount or There are no rule sets applied to Rate Limits the Dose, Bolus Amount or Rate Informational values. A 3-D tab has been pressed and a No Dose/Amount or Rate Limits condition exists. Press OK to acknowledge. No Primary Program A piggyback auto-program is scanned for a channel that does not have a confirmed primary program. Press Yes to accept program and deliver as a primary infusion. No Backup Battery In the event of A/C power loss, infusion will stop. Do you want to infuse this piggyback as a primary IV? No Battery Backup (detected at Power On) No Primary Program Note: System Message will display over screen displaying when auto-program was initiated. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Press No to reject the autoprogram. Enter a primary infusion. Rescan piggyback after primary is programmed 165 Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Operation Test Due Operation Test Due The infuser is powered down, “Operation Test Notify When Test is Due” device setting is set to Yes and the “Reminder Test is Due” setting is reached. Press OK to acknowledge. Return Infuser to Biomed for Operation Test as soon as possible. Note: Activation of the Operation Test Due System Message will be based on the current Date of the Infuser. Note: Once the “Reminder Test is Due” setting has been reached, this system message will display each time the Infuser is powered down until the Operation Test is completely run. Outside Limits (Information will vary.) Outside of Hard Limits Pressing Enter on a Numeric Entry Keypad causes an entered or calculated value on the current programming screen to be outside of a user-specified hard limit and at least one override passcode has been defined for the current CCA. Press Override to bypass Limit. Press Edit to re-enter value. Note: For Lower VTBI limit checking, the Infuser must add the current Volume Infused value with the newly entered/calculated VTBI value and compare that total against the Lower VTBI limit to determine whether or not the lower limit has been violated. Outside Limits (Information will vary.) Outside of Soft Limits Pressing Enter on a Numeric Entry Keypad causes an entered or calculated value on the current programming screen to be outside of a user-specified soft limit, but that value does not violate a hard limit. Press Override to bypass Limit. Press Edit to re-enter value. Note: For Lower VTBI limit checking, the Infuser must add the current Volume Infused value with the newly entered/calculated VTBI value and compare that total against the Lower VTBI limit to determine whether or not the lower limit has been violated. Outside Limits (Information will vary.) Note: If the value that exceeds the hard limit is a calculated value, the Hard Limit Outside of Limits System Message shall be displayed with "(Calculated Value)" instead of "(Programmed Value)". 166 Outside of Hard Limits Informational Pressing a 3-D touchscreen tab when an Outside of Hard Limits condition exists. Press OK to acknowledge. OR Exceeding a hard limit but no hard limit override passcodes are defined. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Outside Limits Outside of Soft Limits Informational Pressing a 3-D touchscreen tab when an Outside of Soft Limits condition exists. Press OK to acknowledge. Hard Limit Override Pressing Override on the Outside of Hard Limits system message. Enter override code by pressing number buttons and then press Enter. (Information will vary.) Note: If value that exceeds soft limit is a calculated value, Soft Limit Outside of Limits System Message shall be displayed with instead of . Outside of Limits Enter Bypass Code. Cancel to exit. Patient Parameter Change A Program BSA, Height, and/or Weight differs from its corresponding Master value and there is no impact on a currently programmed rate value due to the change: One or more patient program values (BSA, Height, Weight) differ from Master value(s). Patient Parameter Change (Clinical Mode): Infuser cannot be powered down while one or more channels are in Delivery Mode. Stop Delivery on all channels to power down. (Biomed and Service Mode): Procedure must complete before infuser can be powered off. (During Drug Library Transfer from CE to the Infuser): Infuser cannot be powered down while a drug library transfer is in progress. Infuser will power down automatically upon completion. Press Continue to change value(s). Press Cancel to keep previous value(s). OR Changing the program-specific height, weight, and/or BSA values on the Dose Calculation Complex screen so that a previously programmed rate value is affected and then attempting to leave the Dose Calculation Complex screen. A Program BSA, Height, and/or Weight change impacts a currently programmed rate (regardless of relation to corresponding Master value): One or more patient program values (BSA, Height, Weight) have been changed from their previous value(s). Rate and Time parameters have been recalculated. Power Off Unavailable Changing the program-specific height, weight, and/or BSA values on the Dose Calculation Complex screen so one or more differs from the associated Master value(s), and then attempting to leave the Dose Calculation Complex screen. OR Programming one or more channels using program-specific height, weight, and/or BSA values, changing the associated Master value(s), and then attempting to leave the Patient Information screen. Power Off Unavailable Attempting to turn the Infuser off while in one or more channels are in Delivery mode in Clinical Mode. Press OK to acknowledge. (Biomed and Service Mode) None OR Attempting to turn the Infuser off while it is running an infusion test or a calibration. OR Cycling power during a drug library transfer from CE to Infuser. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 167 Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Program Data Will Be Deleted Program Data Will Be Deleted Reducing the number of steps in a Multistep program, and the deleted steps contain programmed data. Press Continue to proceed with change and clear associated program data. Accessing a Programming Mode in the Stop Mode screen after the End of Infusion Alarm has occurred (whether or not the alarm overlay was touched) and the program is operating under the old CCA after a CCA change Press OK to acknowledge. Program Data in eliminated steps will be lost. Program is Being Cleared Programs on Channel will now operate within the rule set. Program is Being Cleared Press Cancel to undo change. OR Accessing a Programming Mode for the first time, for a program: • after a power cycle less than 5 hours • occurring after End of Infusion alarm (whether or not the alarm overlay was touched) • not cleared at power on, and • operating under old CCA after a CCA change OR A pending CCA is invoked for a channel. Recondition Battery Battery needs servicing. Contact Biomed. Resume Primary Selected. Any remaining volume in secondary container will deliver at primary rate. Secondary on Hang Secondary container higher than Primary container. Open Secondary slide clamp. Recondition Battery Infuser battery needs reconditioning (Conditioning Cycle Request detected at power on). Press OK to acknowledge. Resume Primary after Secondary Programming a bolus from secondary and setting When Bolus Completes to Resume Primary. Press OK to acknowledge. Secondary Confirmation Pressing Next on the Piggyback or Bolus Programming Screen to access the Confirmation Screen. Press OK to acknowledge. Transfer Drug Library? Pressing On/Off when the Infuser is in Clinical mode and a library is ready to be transferred from the CE to the Infuser. Press Yes to begin Drug Library transfer. Pressing Next on the second program screen of a 3-part Interchannel Sequence where the third delivery is on the same channel as the first delivery. Press Yes to automatically enter values used in first program screen. Note: This pop-up displays over the Confirmation Screen. Transfer Drug Library? A new drug library is ready to be transferred to the Infuser. Transfer may take up to 5 minutes. Use Same Program for Channel? Press Yes to use the same program values that were used for the first delivery in this sequence. 168 Use First Program Parameters Press No to power off without transferring the Drug Library. Press No to enter new values. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix A: System Messages and Troubleshooting On-Screen Text System Message Message Cause Steps to Remedy Values out of Range Height/ Weight/BSA Out of Range Invoking a CCA that results in the current Master patient Weight, Height and/or BSA being out of range. Press OK to acknowledge. Multistep Values Out of Range In a Multistep program, pressing the Enter button on a Height, Weight or BSA field numeric entry widget or pressing the Calculate button on the Dose Calculation Complex screen and the resulting value causes at least one value in steps 1 or above to go out of range. Press Continue to accept new value and clear all steps. Press Cancel to continue with current program. Patient out of allowed range in the new CCA and have been cleared Values out of Range The changed value has caused one or more values to go out of range. If you continue, all steps will be cleared. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 169 Appendix A: System Messages and Troubleshooting NOTES: 170 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix B: Alarm Messages and Troubleshooting Appendix B outlines alarm messages generated by the SYMBIQ™ Infusion System, the cause of the alarm, how the alarm text displays, steps to remedy the alarm, the alarm urgency, and alarm logging. On-Screen Text Alarm Alarm Cause Message Steps to Remedy Alarm Urgency ACCUMULATED AIR-INLINE Air-in-Line Restart the infusion to clear the alarm. High ANALYSIS: Infusion stopped. REMEDY: Remove air from line. Restart infusion. Check air sensitivity setting if alarm persists. OR ACTION: Press here to minimize all alarms. AIR-IN-LINE Air-in-Line ANALYSIS: Infusion stopped. REMEDY: Remove air from line. Restart infusion. Check air sensitivity setting if alarm persists. PIGGYBACK COMPLETE (Piggyback) ANALYSIS: Unable to resume primary infusion. REMEDY: Enter or Start delivery. ACTION: Press here to clear alarm. Infusion Complete (No Primary) Clear the current program to clear the alarm. Press the alarm window to minimize the alarm. An amount of accumulated air over 15 minutes exceeds the 15 minute threshold. Note: If both thresholds are violated at the same time, the single-bubble messages will display. Press the 1 mL, 3 mL, or 5 mL button on the Power Prime Screen to clear the alarm. An amount of air, greater than or equal to the current air sensitivity setting, is detected in the line distal to the cassette while the device is infusing. Restart the infusion to clear the alarm. OR ACTION: Press here to minimize all alarms. BOLUS COMPLETE (Bolus) An amount of air, greater than or equal to the current air sensitivity setting, is detected in the line distal to the cassette while the device is infusing. High Clear the current program to clear the alarm. Press the alarm window to minimize the alarm. An amount of accumulated air over 15 minutes exceeds the 15 minute threshold. Note: If both thresholds are violated at the same time, the single-bubble messages will display. Press the 1 mL, 3 mL, or 5 mL button on the Power Prime Screen to clear the alarm. A Bolus is set to Resume Primary or a Piggyback is programmed and there is no primary programmed when the Piggyback or Bolus completes. Press alarm window to clear the alarm. Medium Clear associated program to clear the alarm. Confirm a new piggyback dose to clear a Piggyback Infusion Complete (No Primary) alarm. Confirm a new bolus dose to clear a Bolus Infusion Complete (No Primary) alarm. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 171 Appendix B: Alarm Messages and Troubleshooting On-Screen Text Alarm Alarm Cause Message Steps to Remedy Alarm Urgency BOLUS COMPLETE (Bolus) Infusion Complete Press alarm window to clear the alarm. Medium PIGGYBACK COMPLETE (Piggyback) STEP COMPLETE (Multistep) ANALYSIS: Stop Infusion or Callback requested by caregiver. OR Callback Option is set to Yes because Stop Infusion during Bolus programming was selected. REMEDY: None ACTION: Press here to clear alarm. CALLBACK Setting the Infusion Complete Callback Option for Piggyback, Bolus or Multistep, and the Piggyback, Bolus or any Multistep step 1 through n-1, respectively, completes. Callback ANALYSIS: Waiting for user input. REMEDY: None ACTION: Press here to clear alarm. The Infuser has been waiting for a user keypress on a popup for more than the time configured for the current CCA, or the DDL, if being used. OR The Infuser has been waiting for a user keypress on the Patient Information screen with no CCA selected for 2 minutes ± 2 seconds. Clear associated program to clear the alarm. Confirm a new piggyback dose to clear a Piggyback Infusion Complete alarm. Confirm a new bolus dose to clear a Bolus Infusion Complete alarm. Activate Multistep Step n Infusion Complete alarm to clear a Multistep n-1 Infusion Complete alarm. Press alarm window to clear alarm for that channel. Medium Note: Any key press in an active area of the touchscreen will reset the Callback Alarm timers (channel and device). OR One or more channels are Active and waiting for input. OR One or more channels are Idle and waiting for input. OR All channels on a device are idle. CHECK CASSETTE ANALYSIS: Alarm occurred in Delivery Mode—Infusion stopped. Alarm occurred outside of Delivery Mode —Cassette improperly installed or missing. REMEDY: Reinstall cassette. Contact Biomed if problem persists. ACTION: Press here to minimize all alarms Check Cassette Attempt to access the channel’s Delivery mode and determine the channel’s cassette is improperly installed or missing. Properly install the cassette to clear the alarm. OR Press the alarm window to minimize the alarm. Attempt to load cassette and the linear pixel array indicates there is a problem. Close the cassette door with no cassette present to clear the alarm. Infuser in Delivery mode: High Infuser not in Delivery mode: Medium OR Find that the sensors indicate the cassette is improperly loaded while the infuser is in Delivery mode. OR Manually eject the cassette. 172 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix B: Alarm Messages and Troubleshooting On-Screen Text Alarm Alarm Cause Message Steps to Remedy Alarm Urgency CHECK FLOWSTOP Check Flowstop Cassette problem bit is set (door is closed with high pressure indicating possible debris present) Open the door to clear the alarm. High The distal pressure is greater than the selected pressure level and the channel is in Delivery mode. If distal pressure becomes less than 50% of the selected pressure level for three seconds within 60 seconds of detection, alarm auto-clears and becomes latched, Distal Alarm AutoClears counter increments by 1, and delivery resumes—if the channel has not exceeded the allowed number of auto clears. ANALYSIS: Cassette flowstop may not be closed. REMEDY: Close clamp, open door, and ensure flowstop is closed. Replace set if problem persists. Press the alarm window to minimize the alarm. ACTION: Press here to minimize all alarms. DISTAL OCCLUSION ANALYSIS: Active Alarm— Delivery stopped. Latched Alarm—Delivery was interrupted during distal occlusion. REMEDY: Active Alarm— Clear occlusion below pump. Restart delivery. If not priming, check occlusion sensitivity setting if alarm persists. Distal Occlusion OR The distal pressure is greater than 10 psi and the Infuser is power priming. High Stop Mode—Pressing Start clears the alarm. Latched Alarm—None ACTION: Active Alarm— Press here to minimize all alarms. Note: If Occlusion still exists, a new instance of the alarm will activate. Latched Alarm —Press here to clear alarm. Priming—Press Cancel, 1 mL, 3 mL or 5 mL button on Power Prime screen to clear the alarm. Press the active alarm window to minimize the alarm. Press the latched alarm window to clear the alarm. Change the Distal Occlusion threshold setting to a new threshold greater than the current measured pressure to clear the alarm. EMERGENCY STOP ANALYSIS: Emergency Stop button pressed. Infusion(s) stopped. Emergency Emergency Stop off-screen Stop button has been activated during infusion. Press alarm window to clear alarm. High REMEDY: None ACTION: Press here to clear alarm. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 173 Appendix B: Alarm Messages and Troubleshooting On-Screen Text Alarm Alarm Cause Message Steps to Remedy Alarm Urgency END OF INFUSION (KVO) (KVO is delivering) END OF INFUSION (KVO is not delivering) End of Infusion Press alarm window to clear alarm. Medium Press the alarm window to clear the alarm for that channel. Medium Infuser detects AC power to clear the alarm. 30 minutes: Low Onset of a higher-priority Low Battery alarm clears a lower-priority Low Battery alarm. 15 minutes: Medium Basic Program - Programmed VTBI delivery completes. OR Multistep/Intermittent—Last Step/Dose delivery completes. ANALYSIS: KVO is delivering—Infusion Complete. KVO in progress. KVO is not delivering— Infusion Complete. No KVO. REMEDY: Clear or edit current program. ACTION: Press here to clear alarm. INTERMITTENT CALLBACK Intermittent Callback ANALYSIS: Selected callback time has been reached. REMEDY: None ACTION: Press here to clear alarm. The selected callback time before an Intermittent Dose is less than or equal to the programmed Time Between Start of Deliveries and the callback time is reached for any dose (regardless of whether the Infuser is in Programming Mode, Delivery Mode or Stop Mode). OR The selected callback time before an Intermittent Dose is greater than the programmed Time Between Start of Deliveries and any dose but the last dose begins delivery. OR Whether a callback time or Off is selected for the Intermittent Callback option, the Infuser is in Stop or Programming mode and the start time for the next dose is reached. LOW BATTERY ANALYSIS: Less than <30, 15, 5> minutes of battery life remaining at current rate. REMEDY: Connect pump to AC power. ACTION: Press here to minimize all alarms. Low Battery The battery has <= 30 minutes but > 15 minutes of delivery left at the current infusion rate and battery power is the last power source. OR The battery has <= 15 minutes but > 5 minutes of delivery left at the current infusion rate and battery power is the last power source. OR The battery has <= 5 minutes of delivery left at the current infusion rate and battery power is the last power source. 174 5 minutes: High Change the delivery so the delivery time is greater than the alarm threshold (e.g., stop one of the channels or reduce the rate) to clear the alarm. Press the alarm window to minimize the alarm. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix B: Alarm Messages and Troubleshooting On-Screen Text Alarm Alarm Cause Message NEARING END OF INFUSION Nearing End of Infusion ANALYSIS: Infusion almost complete. REMEDY: None. ACTION: Press here to clear alarm. The total time remaining on a primary infusion transitions from being greater than the user-defined Nearing End of Infusion alarm setting to being less than or equal to that setting. OR A bolus or piggyback delivery completes and the Infuser transitions back to a primary infusion that has a total time remaining which is less than or equal to the user-defined Nearing End of Infusion alarm setting. OR Steps to Remedy Alarm Urgency Press alarm window to clear the alarm. Low Press Start after titrating the associated program to clear the alarm. Change the Nearing End of Infusion alarm setting so a Nearing End of Infusion condition no longer exists clears the alarm when Done is pressed on the Options screen. Activate an End of Infusion alarm for a channel to clear an active Nearing End of Infusion alarm for the same channel. The total time remaining on a primary infusion is less than the Nearing End of Infusion setting on a therapy start or restart. Note: Once a Nearing End of Infusion alarm has been cleared, it will only recur if one of these triggers occurs again. NEW DRUG LIBRARY ANALYSIS: New library available. Accepting library will clear current patient, programs and totals. REMEDY: When safe, power off Infuser to accept. ACTION: Press here to minimize. New Drug Library None (no message can be displayed). Depleted Battery None (no message can be displayed). The Infuser is currently powered on and a library is ready in the CE for transfer to the infuser. OR Successfully transfer the library to the Infuser to clear the alarm. Low Press the alarm window to minimize the alarm. At power on, a library is ready in the CE to transfer to the Infuser. Power Loss A depleted battery is detected and the infuser is operating on battery power. Restore AC power to clear alarm. The Infuser is powered by AC only and the power level drops below the level required to operate the Infuser. Restore AC power to clear alarm. High Replace battery to clear alarm. High Replace battery to clear alarm. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 175 Appendix B: Alarm Messages and Troubleshooting On-Screen Text Alarm Alarm Cause Message Steps to Remedy Alarm Urgency PROXIMAL OCCLUSION Proximal Occlusion If proximal pressure becomes greater than 50% of the selected pressure level within 60 seconds of detection, alarm auto-clears and becomes latched, Proximal Alarm Auto-Clear counter increments by 1, and delivery resumes—if the channel has not exceeded the allowed number of auto clears. High ANALYSIS: Delivery stopped. REMEDY: Active alarm— Clear occlusion above pump. Restart delivery. If not priming, check occlusion sensitivity setting if alarm persists. The proximal pressure is less than or equal to the selected pressure level and the channel is in Delivery mode. OR The proximal pressure is less than --7 psi and the channel is power priming. Latched alarm—None ACTION: Active alarm— Press here to minimize all alarms. Stop Mode—press Start to clear the alarm. Latched alarm—Press here to clear alarm. Note: If Occlusion still exists, a new instance of the alarm will activate. Priming—Press Cancel, 1 mL, 3 mL or 5 mL button on Power Prime screen to clear the alarm. Change the Proximal Occlusion threshold setting for the affected channel to a new threshold less than the current measured pressure to clear the alarm. RECURRING OCCLUSION ANALYSIS: CCA-defined number of recurring Proximal Occlusion alarms has been reached. Recurring Proximal Occlusion The CCA-defined number of auto-reset Proximal Occlusion alarms for the program has been reached. Press alarm window to clear the alarm. Low Recurring Distal Occlusion The CCA-defined number of auto-reset Distal Occlusion alarms for the program has been reached. Press alarm window to clear the alarm. Low Reinitializing System The device detects the flash memory is not formatted. Touch alarm overlay body to minimize the alarm. High REMEDY: Check occlusion sensitivity. ACTION: Press here to clear alarm. RECURRING OCCLUSION ANALYSIS: CCA-defined number of recurring Distal Occlusion alarms has been reached. REMEDY: Check occlusion sensitivity. ACTION: Press here to clear alarm. REINTIALIZING SYSTEM OR The device forces the formatting of the flash due to a software download. 176 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix B: Alarm Messages and Troubleshooting On-Screen Text Alarm Alarm Cause Message Steps to Remedy Alarm Urgency RESTART REQUIRED Restart Required The flash memory has completed formatting. Touch alarm overlay body to minimize the alarm. High Service Battery Battery shorted Low OR Replace Battery to clear alarm. SMBus error/Battery Communication error Press alarm window to minimize the alarm. ANALYSIS: The infuser needs to be restarted. REMEDY: Please restart the infuser. ACTION: Press here to minimize SERVICE BATTERY ANALYSIS: Battery should be replaced. No battery back-up. In the event of AC power loss, infusion will stop. OR REMEDY: Replace battery soon. Battery open ACTION: Press here to minimize all alarms. Battery missing OR OR Battery will not charge OR Battery under-voltage OR Battery Service warning SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 177 Appendix B: Alarm Messages and Troubleshooting NOTES: 178 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix C: Accessories, Administration Sets, and Components Appendix C outlines the list number and description of accessories, administration sets, and components available for use with the SYMBIQ™ Infusion System. List Number Item Description 2006-04-01 Standard I.V. Pole 11249-04-01 Heavy Duty I.V. Pole 11868-04-01 PlumXL3M I.V. Minipole 11986-04-48 Vented Syringe Adapter 16000-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 106 Inch, Piggyback with Backcheck Valve, 2 CLAVE Ports, Distal Microbore Tubing and OPTION-LOK, Microdrip, Non-DEHP 16001-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 105 Inch with CLAVE Port and OPTION-LOK 16002-04-01 LATEX-FREE SYMBIQ™ Pump Set, Yellow Striped Tubing, Convertible Pin, 108.5 Inch with Distal Microbore tubing and OPTION-LOK 16003-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump 150mL Burette Set, Convertible Pin, 129 Inch with 3 CLAVE Ports, 0.2 Micron Filter and OPTION-LOK, Soluset, Non-DEHP 16004-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump 50mL Burette Set, Convertible Pin, 104 Inch with 3 CLAVE Ports, Distal Microbore Tubing and OPTION-LOK, Microdrip Soluset, Non-DEHP 16005-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 104.5 Inch with CLAVE Port and OPTION-LOK, Non-DEHP 16006-04-01 LifeShield LATEX-FREE HEMA SYMBIQ™ Pump Blood Set, Nonvented, 110 Inch with 210 Micron Filter, CLAVE Port and OPTION-LOK 16007-04-01 LifeShield LATEX-FREE Hemoset SYMBIQ™ Pump 100mL Burette Set, Nonvented, 104 Inch with CLAVE Port, 170 Micron Filter and OPTIONLOK, non-DEHP 16008-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 106 Inch, Piggyback with Backcheck Valve, 2 CLAVE Ports and OPTIONLOK 16009-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump 50mL Burette Set, Convertible Pin, 100 Inch with 2 CLAVE Ports, 0.2 Micron Filter, Distal Microbore Tubing and OPTION-LOK, Microdrip Soluset, Non-DEHP 16010-04-01 LATEX-FREE SYMBIQ™ Nitroglycerin Pump Set, Convertible Pin, 108.5 Inch with Polyethylene-Lined Tubing and OPTION-LOK 16011-04-01 LifeShield LATEX-FREE SYMBIQ™ Nutritional Pump Set, Convertible Pin, 103.5 Inch with 1.2 Micron Filter, CLAVE Port and OPTION-LOK, Non-DEHP SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 179 Appendix C: Accessories, Administration Sets, and 180 List Number Item Description 16012-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 106 Inch, Piggyback with Backcheck Valve, 2 CLAVE Ports, Distal microbore segment and OPTION-LOK 16013-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 104.5 Inch, Piggyback with Polyethylene-Lined Tubing, Backcheck Valve, 2 CLAVE Ports, 0.2 Micron Filter and OPTION-LOK 16014-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump 150mL Burette Set, Convertible Pin, 124.5 Inch with 3 CLAVE Ports, Distal Microbore Tubing and OPTION-LOK, Microdrip Soluset, Non-DEHP 16015-04-01 Latex-Free SYMBIQ™ Pump Enteral Set, 99 Inch with 40 mm Screw Cap, Non-DEHP 16017-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump 150mL Burette Set, Convertible Pin, 115 Inch with 3 CLAVE Ports and OPTION-LOK, Soluset, Non-DEHP 16018-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump 150mL Burette Set, Convertible Pin, 138 Inch with 4 CLAVE Ports, 0.2 Micron Filter, Distal Microbore Tubing and OPTION-LOK, Microdrip Soluset, Non-DEHP 16019-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 105.5 Inch, Piggyback with Backcheck Valve, 2 CLAVE Ports and OPTIONLOK, Non-DEHP 16020-04-01 LifeShield LATEX-FREE HEMA SYMBIQ™ Pump Y-Type Blood Set, Nonvented, 121.5 Inch with 210 Micron Filter, CLAVE Port and OPTIONLOK 16021-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 106 Inch, Piggyback with Backcheck Valve, 3 CLAVE Ports and OPTIONLOK, Non-DEHP 16022-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 104.5 Inch, Piggyback with Backcheck Valve, 2 CLAVE Ports, 0.2 Micron Filter and OPTION-LOK, Non-DEHP 16023-04-01 LifeShield LATEX-FREE SYMBIQ™ Syringe Microbore Pump Set, 83 Inch with Syringe Holder, 2 CLAVE Ports and OPTION-LOK, Non-DEHP 16024-04-01 LifeShield LATEX-FREE SYMBIQ™ Pump Set, Convertible Pin, 105 Inch, Orange Polyethylene-Lined Light Resistant Tubing, CLAVE Port, Distal Microbore Tubing and OPTION-LOK 16025-04-01 LATEX-FREE SYMBIQ™ Nitroglycerin Pump Set, Convertible Pin, 108 Inch with Polyethylene-Lined Tubing and OPTION-LOK, Microdrip N/A SYMBIQ™ Tips Cards N/A SYMBIQ™ System Operating Manual SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix D: Glossary Term Definition AC Alternating Current. active screen A selected programming screen or a programming screen in use. administration set The sterile, disposable assembly with flexible tubing that connects to a source fluid container for input to the cassette carriage and to some output device for administration to the patient. air sensitivity The amount of air detected in which the Air-In-Line alarm activates. air-eliminating filter Used to reduce the risk of infusing air. air-in-line Air in the fluid path. Air-In-Line alarm Alarm that occurs if sensors detect the present measured amount of air in the fluid path. alarm Visual and/or audible warning from an infuser indicating a condition requiring attention, e.g., Air-In-Line alarm. alarm analysis message Basic descriptions of the cause of the alarm displayed on the infuser touchscreen. alarm auto-reset condition Condition under which an alarm clears without user intervention. alarm base message Short description of an alarm that appears on the infuser touchscreen. alarm remedy message Helpful hints and suggestions for fixing an alarm condition that display on the infuser touchscreen. alarm system response Any special action other than the alarm annunciation that must be taken in response to an alarm. alarm urgency/priority Level of alarm related to an LED/alarm tab color and behavior. There are three priorities—low, medium, and high. allowed range The minimum and maximum allowable values for a therapy. audible alarm An alarm that can be heard. backcheck valve Prevents fluid from backing up in part of an administration set. backpressure Resistance to fluid flow on the distal or output portion of the administration set, usually expressed in PSIG. backup power source An alternate source of power should the main power source fail. Biomed mode The non-delivery or service mode of infuser operation that allows authorized personnel, typically institution technicians (Biomeds), access to delivery parameter limits and display default settings. bolus A single, uninterrupted, discrete volume of fluid delivered over a discrete period of time. BSA Body Surface Area, a value calculated by the infuser. BSA=0.007184 x Height (cm)0.725 x Weight (kg)0.425. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 181 Appendix D: Glossary Term Definition callback alarm An alarm indicating additional action is required before an infuser can continue its program. cancel To stop or nullify a previously intended action. cassette A Hospira cassette that contains the actual pumping chamber with inlet and outlet valves and a flow stop. It also contains access ports to diaphragms for proximal and distal line pressure sensing. cassette carriage The cassette is loaded in the infuser via an automatic door. cassette loaded A cassette placed in the carriage and the carriage is closed. Caution: A caution appears in front of a procedure or statement. It contains information that could prevent irreversible product damage or hardware failure. Neglecting to pay attention to a caution could result in serious patient or user injury. Caution (medium alarm urgency) An alarm which requires prompt user response, and if not responded to promptly, could result in an escalation of the alarm to the Warning urgency. change a program Adjust the values/selections of the current program. clamp (noun) Device used to restrict flow in the line. clamp (verb) To block off or restrict flow in the line. clear history A function that clears the log files on an infuser. Clinical Care Area (CCA) A subset of a drug library for use in an area or patient population of the hospital, as defined by an authorized user. A CCA can have up to 400 specific medications plus “Fluid Only” and “Other Drug.” The hospital may create up to 40 CCAs and 16,000 specific medications in a drug library. clinical mode General use mode where an infuser can be programmed and medication can be delivered. clock type There are two clock types available: 12-hour and 24-hour. cold boot When the power is first applied to the infuser processor. It occurs when an infuser is off and the AC power is applied, or during battery operation when On/Off is pressed. concentration Consists of medication amount (in nanograms, micrograms [mcg], milligrams [mg], grams, milliequivalents [mEq], units [USP Units]), or diluent (volume in milliliters [mL]). continue rate An option used to provide fluid delivery at the current fluid delivery rate when the VTBI reaches zero. contraindications Conditions under which an infuser should not be used. Default Drug Library (DDL) A drug library with at least 99 medications including the manufacturer’s package insert recommended default units of measure and default unit of concentration. Also includes “Fluid Only” and “Other Drug.” Delivery mode The operational mode during which fluid delivery occurs. delivery rate The speed at which the fluid is delivered, e.g., 125 mL/hr. delivery type Method of infusing: Multistep, Basic therapies, Intermittent, Bolus. diluent (volume) or amount The volume of fluid used with the diluent unit (e.g., 250 mL). 182 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix D: Glossary Term Definition distal In relation to the casette, this refers to the tubing leaving the cassette going to the patient. distal end End closest to patient. distal occlusion Blockage between the infuser and the patient. dose frequency The rate or interval in which medication is given. dose limit An optional restriction of fluid deliveries. dose rate Delivery rate times medication concentration. dose/dose amount A specified volume or amount of medication. dosing units Dose Rate units that may be selected; for example, mcg/kg/min, mcg/kg/hr, mcg/min, mcg/hr, mg/min, mg/hr, mg/kg/hr, units/min, units/hr, grams/hr, ng/ kg/min, units/kg/hr, mUn/min, mEq/hr. download Transfer of data from a computer to an infuser. drip chamber Apparatus for visualizing/monitoring fluid flow in the administration set. drop-down box An element of the infuser touchscreen. Pressing the down arrow of this element displays additional items. drug library A customized library containing medication entries available for use with the SYMBIQ™ Infusion System. Medication entries include the Medication Name/Medication Amount/Medication Unit/Diluent Amount/Diluent Unit/ Dosing units, Medication class, and Hard/Soft Limits. duration Period of time used to deliver a VTBI at an existing delivery rate or as set by the user. Ethylene Oxide (ETO) Method of sterilization. Event Log A record that indicates what and when a specific event occurred. The Event Log includes but is not limited to programming, limit overrides, out-of-limits attempts, setting changes, warnings, alarms, malfunctions, and power events. external power source Any external power source like an AC mains. FHH Filling Head Height. The gravity-induced proximal line pressure due to fluid height in source container above the distal line output level. flow rate The resulting rate of fluid flow (see delivery rate and dose rate). flow stop A device on the administration set cassette that toggles to start and stop fluid flow through the tube. hard limit The upper and/or lower dose limits for the selected medication and selected CCA that cannot be overridden. Defined by the hospital for each medication in its drug library. The hard limits for a particular medication may vary across different CCAs. Help Text area Area on the touchscreen that provides context-sensitive information during programming steps and alarm conditions. HIS Hospital Information System. hospital formulary Proprietary list of all medications used by the hospital. inactive screen A programming screen that has been programmed but is not currently selected. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 183 Appendix D: Glossary Term Definition infuser settings Adjustable settings, e.g., distal occlusion pressure limits, air sensor sensitivity, real-time clock, and audible alarm volume. intermittent To give a specified dose amount of medication at regular intervals, e.g., every 4 hours. isopropyl alcohol A disinfectant not to be used to clean the SYMBIQ™ Infusion System. I.V. pole A pole that an infusion bag and an infuser are attached to. JCAHO The Joint Commission on Accreditation of Healthcare Organizations. key Buttons on the keypad or touchscreen. KVO (Keep Vein Open) Minimal delivery rate intended to provide sufficient fluid flow to prevent or reduce the potential for clotting at the IV infusion site. The KVO rate is the lesser of 1 mL/hr or the actual delivery rate. LED Light-Emitting Diode. low flow continuity Infusion of fluids and drugs at very low rates malfunction Alarm indication that a software or hardware failure has occurred (e.g., motor over-current.) These conditions usually require repair. medication amount The mass or quantity of the medication premixed with a diluent to express the concentration for the channel being programmed. minimized alarm An active alarm that has been acknowledged and is accessible by touching the alarm tab. mL/hr only A type of delivery expressed as volume divided by hour. non-vented administration sets For use with flexible containers. Not recommended for use with glass containers that are not vented by some other means. occlusion Blockage, may be caused by a kink in administration set tubing. off-screen key A key located on the infuser casing. Options button Button that provides access to the Options menu. override The user acknowledges a hard or soft limit violation prompt, and then proceeds with a program containing a parameter that falls outside the hospital-defined hard or soft limits. PAV Pressure Activated Valve. parenteral Any route other than the GI tract by which drugs, nutrients, or other solutions may enter the body for example IV, IM, or subcutaneously piercing pin Sharp plastic pin on an administration set that pierces the container. piggyback Infusion option that allows the delivery of a secondary container on the same channel. pole clamp Device used to connect an infuser to an I.V. pole. power LED Indicates an infuser is powered by AC mains when LED lit continuously. Indicates an infuser is powered by batteries when LED is off. power priming Used to prime or remove air from an administration set found in Options menu. Power Saving mode Low power state utilized when no keys have been pressed for a specified time period. 184 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix D: Glossary Term Definition power sources Energy source an infuser draws power from like rechargeable batteries or AC mains. power off (verb) Turning off infuser allow the internal processors to shut off. pressure The measured fluid pressure for the proximal line or the distal line when a fully primed administration set is loaded into an infuser with the cassette carriage closed. prime To remove all air from the cassette, tubing, and injection site prior to connecting the infuser to the patient. program (noun) A set of coded instructions for delivering fluids. program (verb) Defining or entering coded instructions for delivering fluids. programmable ranges The minimum and maximum allowable values for a therapy. programming mode Operational mode during which therapy parameters are selected. proximal In relation to the cassette, it refers to the tubing entering the cassette coming from the container. proximal occlusion Blockage between an infuser and the fluid container. psi Pounds per square inch. purge Clear out or purge air from the tubing. Same as prime. PVC plastic Polyvinyl Chloride plastic. rate The infusion speed expressed in mL/hr. rate titration Changing the rate while an infuser is infusing. remote access Connecting to an infuser using a computer via wireless connectivity. rounding Process of making a fractional amount displayed on the screen. rule sets User-defined rules relating to the drug library including minimum and maximum dose, maximum rate and maximum VTBI for each medication, and maximum patient weight. secondary container A container connected to the primary line to infuse additional fluid or medication used in piggyback. Service mode The mode accessible only to Hospira personnel. settings Parameters such as program settings, infuser settings, or configuration settings. set up (verb) To make an infuser ready for use. shift totals Totals for a shift. silence the alarm To silence an infuser alarm in 2 minute intervals, press SILENCE. slide clamp An apparatus in an administration set that can be opened or closed to restrict or allow fluid delivery. soft limit The upper and lower dose limits for the selected medication and selected CCA. Soft limits can be overridden. Defined by the hospital for each medication in its drug library, the soft limits for a particular medication may vary across CCAs. If a given medication has a hard limit, its soft limits, if any, must equal or fall within its hard limits. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 185 Appendix D: Glossary Term Definition standard conditions Conditions the defined infuser accuracy. standby A delivery program state that resembles a delayed start of 24 hours for a channel in all respects except a status display of Standby instead of Delayed. stop mode Operating mode an infuser enters when the programmed therapy is complete, and during certain alarm conditions. Stop Program button Stops an infusion. stop time A specific time to stop a program. subcutaneous A route of delivery just beneath the dermal skin layer. syringe A device for withdrawing, injecting, or instilling fluids. system message— advisory A visual message indicating infuser status. system message— prompt While entering a program, a visual warning that informs the user of the violation of a hospital-defined rule set or a field range, e.g., a dose limit for a specific medication. system setup The process of preparing an infuser for use. TALL-Man lettering TALL-Man lettering uses upper case letters to help differentiate sound-alike or look-alike medication names. Default Drug Library medication names are displayed in TALL-Man lettering where appropriate. therapy A type of program that can be entered into an infuser. Available therapies include Basic Program,Taper, Multistep, Intermittent, and Interchannel Sequencing. touchscreen key Any key rendered on the touchscreen to facilitate interaction with an infuser. units A medication amount (without a quantity of mass referent) adopted as the USP standard of measure for use in a concentration. unlock No cleaning or program locks are active. volume totals Section of event history that stores volumes delivered from either the fluid container or a specified time. VTBI Volume To Be Infused. 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. Warning (high alarm urgency) An alarm condition which requires immediate operator response. For example, an infusion delivery disruption or a severely low battery. weight The parameter entry required with dosing units that include kg. weight dosed A type of therapy that uses a calculated dose amount based on the patient’s weight. y-sites A port on the administration set tubing to inject medications via a syringe. 186 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Appendix E: Default Drug Library (DDL) Medication Name Medication Name Medication Name Fluid Only DOXOrubicin Morphine Other Drug Epinephrine Nafcillin Abciximab Epoprostenol Naloxone Acyclovir Eptifibatide NitroGLYCERIN Albumin Erythromycin NitroPRUSSIDE Aldesleukin Esmolol Norepinephrine Alfentanil Etomidate Ofloxacin Alteplase (rt-PA) Etoposide Ondansetron Amikacin Famotidine Other Drug Aminocaproic acid Fentanyl Oxacillin Aminophylline Fluconazole Oxytocin Amiodarone Fluid Only Paclitaxel Amphotericin B Flumazenil Pancuronium Ampicillin-sublactam Fluorouracil Pantoprazole Atracurium Furosemide Penicillin Azithromycin Gatifloxacin Pentobarbital Bleomycin Gentamicin Phenylephrine Bretylium Heparin Piperacillin-bactam Carboplatin Hetastarch/NaCl Potassium Infusion Cefazolin Hextend Procainamide Cefepime Hydromorphone Propofol CefoPERAZONE Ifosfamide Ranitidine CefoTAXIME Imipenem Cilastatin STREPTOkinase CefoTETAN Immune Globulin IV Teniposide CefoXITIN Insulin Theophylline CeftAZIDime Isoproterenol HCl Ticar-clavulanate CeftIZOXime Labetalol Tirofiban Ceftriaxone Lepirudin Tobramycin Cefuroxime Leucovorin UROkinase Cimetidine Levofloxacin Vancomycin Ciprofloxacin Lidocaine Vecuronium Cisplatin Lorazepam Verapamil Clindamycin Magnesium Infusion VinCRIStine Co-trimoxazole Mannitol Cyclophosphamide Mesna Cyclosporine MethoHEXITAL Cytarabine MethoTREXATE Dexmedetomidine HCl Methylprednisolone Diltiazem Metoclopramide DOBUTamine Metronidazole Docetaxel Midazolam DOPamine Milrinone SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 187 Appendix E: Default Drug Library (DDL) NOTES: 188 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Index AC power 33 Active button 16 administration sets general information 54 loading 62 non-blood sets 57 preparing 55 with syringe holder 60 advanced therapies overview 87 Air-In-Line 118 alarm 118 alarm Air-In-Line 118 conditions and criteria (table) 127 Distal Occlusion 112 Infusion Complete Callback 117 log 145 messages 127 minimized tabs 129 multiple 130 Nearing End of Infusion 120 Proximal Occlusion 114 silence audible 130 silencing 129 touchscreen appearance 128 urgency 127 alarm messages 127 alarm tab End of Infusion (figure) 80 Nearing End of Infusion (figure) 80 backcheck valve 59, 83 bar vertical hot scroll 17 vertical short scroll 17 Basic program programming 71 screen 78 Basic therapy end of infusion 80 overview 71 Battery Indicator icons 36 battery power 36 Biomed Mode 47 Bolus 123 bolus clinician-activated, programming icon 18 Bolus Delivery unintended 11 Bolus Setup screen 123 button Active 16 Depressed 16 drop-down list field 17 Emergency Stop 42 end-of-list indicator 17 horizontal navigation arrow 17 on infuser body 16 patient information 17 Selected 16 SILENCE 130 Start Multistep 93 Start Program 45 touchscreen 16 Unavailable 16 123 calculated field value screen 45 calculated values 45 Cassette Eject Lever (figure) 68 Cautions administration sets 9 battery operation 10 cleaning 11 general 8 CCA 138 access passcode (figure) 73 changing 138 list (figure) 72 channel LED 35 color and conditions 36 channel level feature 24 availability 24 screen 24 Clinical Care Area see CCA Clinical Modes Delivery 41 Power 33 Programming 40 Stop 42 Clinician-Activated Bolus programming 123 Current Program log view 147 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 189 Index Default Drug Library (DDL) delayed start programming 109 Depressed button 16 disposal product 153 Distal Occlusion 112 alarm 112 document conventions 7 137, 147, 187 electrical artifacts 12 Emergency Stop button 42 end-of-list indicator 17 features channel level 23, 24 device level 23, 26 infuser 23 program level 23, 25 flow continuity 158 flow rate accuracy 158 standard specifications (table) 158 fluid container compatibility 56 glossary 181 grasping infuser (figure) 51 hard limit override 134 high-risk medications 148 I.V. pole attach to infuser 49, 50 clamp knob (figure) 51 clamp screw (figure) 50 detaching infusers from 51 infuser acceptable configurations (figure) 49 configurations 49 pole clamp (figure) 50 Rapid Travel Release button (figure) 52 removing infuser 53 icon basic program 18 Battery Indicator 36 bolus 18 190 Exceeded Upper Hard Limit 135 Exceeded Upper Soft Limit 133 infusion running drip 18 Intermittent therapy 18 Multistep therapy 18 piggyback 18 infuser acceptable configurations I.V. pole (figure) 49 buttons 16 features 23 front view and touchscreen 15 grasping (figure) 51 I.V. pole attach 50 configurations 49 overview 15 power on 33 SILENCE button 130 Standby mode 111 Infuser Basic Operations 33 infuser cassettes emergency eject 67 power priming 106 removing 66 infuser layout bottom 22 front 15 rear 20 infuser specifications (table) 155 audible tones 156 battery 155 date, time settings 157 delivery rate 157 electrical 155 external interfaces 155 infuser alarms 156 input device, keypad 156 KVO 157 LCD display 156 LED display 156 memory protection 156 occlusion settings 157 physical 155 safety features 156 temperature parameters 157 wireless connectivity 156 Infusion Complete Callback 117 alarm 117 intended audience 7 intended use 7 Intermittent therapy 95 icon 18 programming 95 Invalid Entry 135 system message 46 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Index system message (figure) 136 invalid value handling 45 hard limit 134 keypad Intermittent Time Numeric 100 label Sterile Parts and Pathways 54 list numbers accessories 179 administration sets 179 loading administration sets 62 logs Alarm Log 137, 145 Event Log 137, 144 Rule Set Alert Override Log 137, 146 maintenance battery 152 battery disposal 152 cleaning solutions 151 cleaning the infuser 151 medication concentration, specifying messages alarm 127 system 127 minimized alarm tabs 129 multiple alarm tabs (figure) 131 Multistep Setup screen 88 Multistep therapy icon 18 programming, part II 87 Nearing End of Infusion 120 Nearing End of Infusion alarm New Patient dialog box 35 non-blood sets administration sets 57 Number of Steps drop-down list (figure) 88 numeric keypad Time touchscreen 77 Outside of Hard Limits 133 system message 133 override 76 patient information 138 patient information button 17 performance trumpet curves 158 piggyback preparing for secondary delivery piggyback icon 18 Piggyback infusion how to program 85 pole clamp placing I.V. pole (figure) 50 power AC 33 battery 36 power LED 38 priming sets 106 product disposal 153 program (Basic) 71 Program Lock 29 activate 30 Enter Code dialog box activating 31 program options 83, 105 alarm settings 112 Delayed Start 109 Standby Mode 110 program totals accessing screen 141 clearing 141 view log 142 programming delayed start 109 Proximal Occlusion 114 alarm 114 59 120 Rapid Travel Release button (figure) Rule Set Alert Override Log 146 view 146 52 screen Advanced Therapy Selection 87, 95 Alarm Log 145 Basic Program 74 Basic program, filled 78 Basic programming 75, 140 Bolus Setup 123 calculated field value 45 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 191 Index channel LED location 35 channel level feature 24 Completed Intermittent 103 Completed Multistep 94 Concentration drop-down list 76 Confirm Bolus 124 Confirm Program 78 Delivering Bolus 125 Delivering Intermittent X of Y 102 Delivering Multistep 94 Delivering Program 85 device level features 26 Disconnect Tubing system message 107 Dose Calculation 77 End of Infusion, alarm tab 80 Enter Code dialog box activating 31 unlocking 32 Event Log 144 Exceeded Upper Hard Limit icon 135 Exceeded Upper Soft Limit icon 133 Far Viewing Delivery 42, 148 Far Viewing device-level alarm tab 129 High-Risk Medication Infusing 148 infuser bottom view and layout 22 rear view and layout 20 startup 34 Infusion Field Drop-Down List 147 Infusion Selection drop-down list 75 Intermittent Callback 98 Intermittent Dose Calculation 99 Intermittent Programming 99, 100 Intermittent Setup 1 of 2 96 Intermittent Setup 2 of 2 98 multiple alarm tabs 131 Multistep 1 of X 89 Multistep 1 of X programming 90 Multistep 2 of X Programming 91 Multistep Programming 92 Multistep scroll bar 93 Multistep Setup 88, 89 Multistep Summary 92 Near Viewing Alarm tab 128 Near Viewing Delivery 41 Near Viewing device-level alarm tab 129 Nearing End of Infusion alarm tab 80 No Battery system message 38 On/Off button 34 Options Standby field 111, 112 Patient Information 72, 74, 138, 140 Piggyback Programming 85 power LED location 38 Power Prime 108 Power Prime Progress 108 power priming options 192 infuser cassettes 107 program level features 25 Program Lock 30 activated 31 deactivated 32 Program Totals 141 programming power prime cassette 106 Rule Set Alert Override Log 146 Settings 27, 29 Brightness 28 Date & Time 29 Sound Volume 27 Stop Mode Alarm State 43 Manual Stop 43 Time touchscreen 77 touchscreen front view 15 Waiting for Intermittent X of Y 102 Selected button 16 sets power priming 106 settings button sound volume settings 27 shift totals clearing 143 view logs 143 shift totals data 142 SILENCE button 130 sound volume settings settings button 27 specifications see infuser specifications Standby Drop-Down list 111 Standby mode place infuser in 111 Start Program button 45 Sterile Parts and Pathways label 54 Stop infuser Emergency Stop button 44 Stop Program button 44 stored data 137 stored information current program 137, 147 logs 137 patient data 137 program totals 137 shift totals 137, 142 storing the infuser 153 supplemental deliveries 83 syringe holder administration sets 60 system message 131 Invalid Entry 46, 135 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Index Invalid Entry (figure) 136 Outside of Hard Limits 133 Soft Limit Outside of Limits 132 Soft Limit Outside of Limits (figure) system messages 127 tab minimized alarm 129 multiple alarm 131 Time touchscreen 77 titrate infusion 81 titration 105 touchscreen button 16 front view 15 icons 17 symbols 17 troubleshooting alarm messages 171 system messages 161 132 Unavailable button 16 value rounding 46 VTBI piggyback VTBI 84 wireless communication workflow Basic program 71 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 22 193 Index 194 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) SYMBIQ™ Infusion System License & Warranty Subject to the terms and conditions herein, Hospira, herein referred to as Hospira, warrants that (a) the product shall conform to Hospira's standard specifications and be free from defects in material and workmanship under normal use and service for a period of one year after purchase, and (b) the replaceable battery shall be free from defects in material and workmanship under normal use and service for a period of 90 days after purchase. Hospira makes no other warranties, express or implied, as to merchantability, fitness for a particular purpose, or any other matter. Purchaser's exclusive remedy shall 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. 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, “repair or other service” means any repair or service other than the replacement of accessory items such as batteries and detachable mains power cords. In providing any parts for repair or service of the product, Hospira shall have no responsibility or liability for the 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 a Hospira representative performing repair or service is not an authorized agent of Hospira. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 195 SYMBIQ™ Infusion System License & Warranty NOTES: 196 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) Hospira, SYMBIQ™ and Hospira MedNet® MedNet Service Suite are registered trademarks of Hospira. The process of downloading a customized drug library to an infuser is covered by U. S. Patent Numbers 5681285. Other patents pending. The SYMBIQ™ Infusion System uses components and technologies protected by U. S. Patent Numbers 6,497,680, 5,989,222, 5,186,779, 5,745,378, 5,586,868, 5,462,256, and 5,191,795. WARNING: Possible explosion hazard exists if used in the presence of flammable anesthetics. The SYMBIQ™ Infusion System is Wide Fidelity (WiFi) enabled and complies with the IEEE 802.11b communications standard. The SYMBIQ™ Infusion System provides an adequate degree of protection against electrical shock and is suitable for application to a patient. Protected against dripping water. The SYMBIQ™ Infusion System complies with ul60601-1 with respect to Protective Earthing (ground). Copyright 2006 All Rights Reserved Hospira North Chicago, Illinois 60045 www.hospira.com This document and the subject matter disclosed herein are proprietary information. Hospira retains all the exclusive rights of dissemination, reproduction, manufacture, and sale. Any party using this document accepts it in confidence, and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Hospira. SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06) 197 198 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06)
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