System Operating Manual For List Number 16026-04 (One-Channel Infuser) AC PO W E R STOP L OAD / EJECT On / Off Emer op y St genc ICU A 13.1 mL / hr 103 mL DOPamine DOPamine [ 400 mg / 250 mL ] Rate 13.1 mL / hr VTBI 103 mL Press Tab A to display Near Viewing Delivery screen. Mode Settings Logs Lock Alarm 09:57 AM The SYMBIQ™ Infusion System is designed for use by health care professionals.
SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06)
C o n t e n ts WHAT IS IN THIS BOOK 5 CHAPTER 1: INTRODUCTION 7 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Document Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents Delivery Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Stop Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General Programming Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calculated Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Invalid Value Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents CHAPTER 9: BOLUS 123 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 CHAPTER 10: ALARM AND SYSTEM MESSAGES Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarm Urgency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents APPENDIX A: SYSTEM MESSAGES AND TROUBLESHOOTING 161 APPENDIX B: ALARM MESSAGES AND TROUBLESHOOTING 171 APPENDIX C: ACCESSORIES, ADMINISTRATION SETS, AND COMPONENTS 179 4 APPENDIX D: GLOSSARY 181 APPENDIX E: DEFAULT DRUG LIBRARY (DDL) 187 INDEX 189 SYMBIQ™ INFUSION SYSTEM LICENSE & WARRANTY 195 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06)
What is in this book Table 1 outlines the chapters and chapter contents of this manual. Table 1: SYMBIQ™ Infusion System Operating Manual Contents Chapter/Section Chapter Contents Chapter 1 Introduction, warnings, and cautions. Chapter 2 Infuser layout, features, and touchscreen icons and symbols. Chapter 3 Clinical modes including Power, Programming, Delivery, and Stop. Chapter 4 Attaching infusers to an I.V. pole, administration sets, and fluid container compatibility.
What is in this book NOTES: 6 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06)
Chapter 1: Introduction The SYMBIQ™ Infusion System is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The SYMBIQ™ Infusion System is available as a one-channel system.
Chapter 1: Introduction Warnings and Cautions Warnings and Cautions The SYMBIQ™ Infusion System is designed and manufactured to be safe, reliable, and easy to use. This section describes possible hazards and explains how to prevent these hazards. Warnings • When infusing at low delivery rates (5.0 mL/hr or less), use microbore sets to reduce the amount of the fluid bolus that may be delivered when a distal line occlusion is released.
Warnings and Cautions Chapter 1: Introduction • To prevent product damage, use proper care during unpacking and installation. DO NOT use a SYMBIQ™ Infusion System if it appears damaged in any way.
Chapter 1: Introduction Warnings and Cautions • Before using a CLAVE® connector, ensure administration set and fluid compatibility. Do not use needles to access the CLAVE® connector. • To help prevent fluid flow, close ALL slide clamps before removing the cassette from the infuser. • In vitro studies suggest packed red blood cells with unusually high hematocrit be diluted with blood-compatible fluids like 0.9% sodium chloride injection to decrease hemolysis and increase flow rate.
Warnings and Cautions Chapter 1: Introduction • Before connecting a patient to the infuser, ensure the infuser has a fully charged battery installed for continuous infuser operation. • If the low-battery alarm activates, connect the infuser to AC power immediately. • Use AC power as the primary power source whenever possible. Before use, inspect the AC cord to check for defects. Connect to AC power during storage to ensure a fully charged battery for emergencies.
Chapter 1: Introduction Warnings and Cautions this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures: - Reorient or relocate the receiving antenna. - Increase the distance between the equipment and the receiver. - Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
Warnings and Cautions Chapter 1: Introduction • The SYMBIQ™ Infusion System is designed to operate around normally encountered electromagnetic interference (EMI) conditions. If extreme levels of interference like that produced by an electrosurgical generator are encountered, normal operation of a sensor or microcomputer might be disrupted. • This equipment has been tested and found to comply with EMC/EMI limits in accordance with IEC/EN 60601-1-2 (2001).
Chapter 1: Introduction Warnings and Cautions NOTES: 14 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06)
Chapter 2: Infuser Overview Chapter 2 describes the SYMBIQ™ Infusion System layout (front, rear, and bottom), infuser buttons and touchscreen buttons, touchscreen icons and symbols, and the features that control the infuser. Many features of the SYMBIQ infuser system are configurable through the Hospira MedNet® software. For details on facility-defined configuration, contact the facility software administrator.
Chapter 2: Infuser Overview Infuser Layout—Front Infuser Buttons Buttons on the infuser casing function in the following manner: • LOAD/EJECT—opens and closes the cassette carriage • On/Off—turns power on and off • SILENCE—silences a silenceable alarm for a specified period of time, usually two minutes • Emergency Stop—stops all channels, generates high urgency alarm • Cleaning Lock (located on the rear of the infuser)—activates and deactivates the touchscreen Touchscreen Buttons The SYMBIQ™ Infusion Sys
Infuser Layout—Front Chapter 2: Infuser Overview Touchscreen Icons and Symbols Table 4 describes and illustrates the various touchscreen icons and symbols.
Chapter 2: Infuser Overview Infuser Layout—Front Table 4: Touchscreen Icons and Symbols On-Screen Item Description On-Screen Item Illustration Infusion running drip icon Basic program icon Multistep therapy icon Intermittent therapy icon Piggyback icon Bolus icon Upper hard limit icon (displays on a channel tab when an upper hard limit is overridden, and the program confirmed on that channel) Lower hard limit icon (displays on a channel tab when a lower hard limit is overridden, and the program c
Infuser Layout—Front Chapter 2: Infuser Overview Table 4: Touchscreen Icons and Symbols On-Screen Item Description On-Screen Item Illustration Lower soft limit icon (displays on a channel tab when a lower soft limit is overridden, and the program confirmed on that channel) No rule set icon (displays on a channel tab when a medication with no defined dose or dose rate limits is selected on a channel) Device Status Bar has two rows.
Chapter 2: Infuser Overview Infuser Layout—Rear Infuser Layout—Rear Figure 2 depicts the rear layout of the SYMBIQ™ Infusion System. 3 4 5 6 7 2 8 9 10 1 11 Figure 2: Rear View and Layout of the SYMBIQ™ Infusion System Table 5 outlines features on the rear of the infuser that correspond to the numbers in Figure 2 above.
Infuser Layout—Rear Chapter 2: Infuser Overview Rear Infuser AC Power Outlet The rear infuser AC power outlet on the back of the SYMBIQ™ Infusion System is specifically designed to accommodate one additional SYMBIQ™ Infuser. Never connect more than one additional infuser to the primary infuser connected to an AC power outlet; connecting any additional infusers may cause an electrical safety hazard. Before use, inspect the AC cord to check for defects.
Chapter 2: Infuser Overview Infuser Layout—Underside Wireless Communication The Wireless Connection Available icon is displayed when the device is receiving a wireless signal. The infuser will connect to the network if a wireless network access point is recognized. The SYMBIQ™ Infusion System supports wireless communication via an internal wireless communications module and antennae.
Infuser Features Chapter 2: Infuser Overview Table 6 outlines features on the bottom of the infuser that correspond to the numbers in Figure 6 above. Table 6: Item Number and Corresponding Feature Graphic # Feature Graphic # Feature 1 Battery compartment access door 3 Distal tubing guide 2 Cassette eject lever (EMERGENCY USE ONLY) 4 Pole Clamp Infuser Features The SYMBIQ™ Infusion System has three levels of features: • Channel Level—accessed by buttons on the infuser touchscreen.
Chapter 2: Infuser Overview Infuser Features Channel Level Features Channel level features are accessed via buttons across the top of the touchscreen as depicted in Figure 7. The default channel level screen is the Basic Program screen. ICU A 0mL/hr 0mL Bolus Program 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 mL hh:mm Cancel Titration Options Next Press fields to edit.
Infuser Features Chapter 2: Infuser Overview Program Level Features Options Program level features are accessed on the programming screen shown in Figure 8. ICU A 0 mL / hr 0 mL Bolus Program Power Prime Deliver at End of Infusion Advanced Select Amount KVO 1 mL/hr --:-- hh:mm KVO Rate Delayed Start Standby Piggyback Program Level Features Yes Alarm Options Done Options Press button or field to select option to change. Done to return to previous screen when finished.
Chapter 2: Infuser Overview Infuser Features Device Level Features Device level features are accessed via buttons across the bottom of the infuser touchscreen (Figure 9). ICU A 0mL/hr 0mL Bolus Program 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 mL hh:mm Cancel Titration Options Next Press fields to edit. Clear to delete all entries. Options to edit program settings.
Infuser Features Chapter 2: Infuser Overview • Time mode—time mode settings To access sound volume settings: 1. From any infuser screen, locate and press Settings to display the Settings screen. Mode Settings Logs Lock Alarm 08:45 AM Figure 10: Settings button 2. On the Settings screen, press Sound Volume to display the Settings Sound Volume screen. Figure 11: Settings Screen 3. On the Settings Sound Volume screen, press the Key Press Volume and Alarm Volume buttons to adjust volume levels.
Chapter 2: Infuser Overview Infuser Features - Medium Urgency—press button for audible Medium Urgency alarm tone at the current level - High Urgency—press button for audible High Urgency alarm tone at the current level 5. Cancel—displays the Settings Menu screen without saving changes 6. On the Settings screen, press Exit to return to the screen from which the Settings screen was accessed.
Infuser Features 3. Chapter 2: Infuser Overview Press the Time Format field to specify 12-hour or 24-hour clock formats. Select the desired time format button on the drop-down list. Settings: Date & Time Month Mar Day 03 Year 2003 Time Format 12 Hour PM Time 04:34 PM 3 4 Cancel Save Figure 14: Settings Date & Time Screen 4. When finished adjusting settings on the Settings Date & Time screen, press Save. Press Cancel to return to the Settings Menu screen without saving changes. 5.
Chapter 2: Infuser Overview Infuser Features You cannot start or stop a therapy while the program lock is active using on-screen buttons. However, pressing Stop Program on the touchscreen or pressing Emergency Stop does not deactivate the program lock.
Infuser Features 2. Chapter 2: Infuser Overview On the Enter Code dialog box, use the touchscreen keypad to key in a valid passcode, and then press Enter. Press Cancel to return to the previous screen. ICU A 13.1 mL / hr 24.6 mL DOPamine Bolus Program Piggyback Advanced DELIVERING PROGRAM DOPamine [400 mg / 250 mL] Enter Code Activating the program lock will prohibit the user from changing program-related settings.
Chapter 2: Infuser Overview 2. Infuser Features On the Enter Code dialog box, use the touchscreen keypad to key in a valid passcode, and then press Enter. Press Cancel to return to the previous screen. ICU A 13.1 mL / hr 24.6 mL DOPamine Bolus Program Piggyback Advanced DELIVERING PROGRAM DOPamine [400 mg / 250 mL] Enter Code Unlocking the Infuser will allow the user to change program-related settings.
Chapter 3: Infuser Operations Chapter 3 describes the Infuser Basic Operations of the SYMBIQ™ Infusion System. This includes a discussion of power on, power down, programming a therapy, and delivering a therapy. Infuser Operations Overview The infuser has four basic operations divided into four segments: power on, program, deliver and stop.
Chapter 3: Infuser Operations 2. Power Modes Press and hold the On/Off button for one second, and then release. AC PO W E R STOP L OAD / EJECT On / Off p c rgen Eme to yS Figure 21: On/Off Button 3. At power on, the Startup screen displays during diagnostic self-tests. SYMBIQ TM Infusion System Software Version XXX Drug Library Version 0.01 Medical Center Thursday February 20, 2006 02:19 AM Copyright Hospira, Inc.
Power Modes Chapter 3: Infuser Operations Selecting No in the New Patient field and pressing Continue retains stored patient and program information and displays the Startup screen. The Startup screen shows infuser status and provides access to view both patient and program information. Selecting Yes in the New Patient field and pressing Continue clears stored patient and program information and displays a blank Patient Information screen.
Chapter 3: Infuser Operations Power Modes Table 7 outlines channel LED color and the conditions under which the channel LEDs illuminate. During an alarm state, the color and flashing characteristics of both the channel LED and channel alarm tab are the same. Table 7: Channel LED Color and Conditions Channel LED Color Conditions Solid Green While in Delivery mode and delivery has not been interrupted.
Power Modes Chapter 3: Infuser Operations Table 8: Battery Indicator Icons (Continued) Battery Indicator Icon Power Level Alarm State Half (50%) Note: This indicator displays when the battery is at half capacity—until the activation of the 30-min.
Chapter 3: Infuser Operations Power Modes Do not use a SYMBIQ™ Infusion System without a properly functioning battery installed. If no battery is detected at power on, the No Battery system message activates (Figure 26). In this case, remove the infuser from service until a properly functioning battery can be installed. ICU A 0mL/hr 0mL Bolus Program Advanced Piggyback Infusion DOPamine [400 mg / 250 mL] Dose 5 mcg / kg / min Rate mL / hr 13.
Power Modes Chapter 3: Infuser Operations Turning touchscreen away from direct sunlight improves visibility. Any infuser alarm state or pressing the touchscreen restores brightness to normal levels. Power Off When power is removed from the infuser, it enters Power Down mode. During a normal power down, all critical data is saved to the appropriate logs, the current program and all user-configured settings are retained, and, if open, the cassette carriage closes.
Chapter 3: Infuser Operations Programming Mode Programming Mode Programming mode is used to program infusion therapies. Therapies and supplemental deliveries available in programming mode include: • Bolus • Program (Basic) • Advanced • Piggyback Program (Basic) From this screen, you can access these features: • Patient Information Button—displays patient information • Channel Tab—displays the channel screen.
Delivery Mode Chapter 3: Infuser Operations Delivery Mode Two types of screens display during Delivery mode—Near Viewing and Far Viewing. A Near Viewing Delivery screen is shown in Figure 28. ICU A 13.1 mL / hr 24.6 mL DOPamine Bolus Program Advanced Piggyback DELIVERING PROGRAM DOPamine [ 400 mg / 250 mL] Dose: 5 mcg / kg / min Rate: VTBI: Time: Volume infused: Stop Program 13.1 mL / hr 24.6 mL 00:04 hh:mm 0.4 mL A Press Stop to end infusion. Program button to edit program.
Chapter 3: Infuser Operations Stop Mode the Far Viewing Delivery screen, VTBI values display with one decimal place for values less than 100. For values greater than or equal to 100, values display with no decimal. ICU A 13.1 mL / hr 96.1 mL DOPamine DOPamine [400 mg / 250 mL] Rate 13.1 1 96. mL / hr VTBI mL Press Tab A to display Near Viewing Delivery screen.
Stop Mode Chapter 3: Infuser Operations 3. An active alarm state will stop the infusion. 4. When a programmed VTBI completes and there is no KVO. 5. A bolus is complete and Stop Infusion has been selected on the bolus setup screen. When a delivery is manually stopped (by pressing Stop Program) and the VTBI has not completely delivered, the Stop mode screen shows STOPPED across the banner as in Figure 31. A DOPamine ICU 13.
Chapter 3: Infuser Operations Stop Mode While in Stop mode, you can: • access the current programmed therapy • access the lock/unlock functionality • access programming mode to start a new program or change a current program • start a programmed therapy or continue the current therapy • select a new CCA • update patient information Note: The Stop Mode Screen shall only display the Dose label and value if a dose is programmed. To stop the infuser using the touchscreen Stop Program button: 1.
General Programming Guidelines 3. Chapter 3: Infuser Operations Press Start Program on the touchscreen to resume the therapy. A ICU 13.1 mL / hr 105 mL DOPamine Program Bolus Advanced Piggyback STOPPED PROGRAM DOPamine [400 mg / 250 mL] Dose 5 mcg / kg / min 1 13. mL / hr Rate: Repeat? Time Remaining: 08:00 hh:mm VTBI Volume Infused 105 mL 0 mL Start Program A Press Start to resume infusion. Program button to view or edit program. Press here to clear alarm.
Chapter 3: Infuser Operations General Programming Guidelines • activates the Invalid Entry system message • sounds the Invalid Key tone • replaces the value with three dashes (“---”) There are two types of value limits for a field; maximum field length and maximum field amount. For fields with defined maximum lengths, entering a four-character value in a field with a threecharacter limit exceeds the length limit for that field and activates the Invalid Entry system message.
Biomed Mode Chapter 3: Infuser Operations Biomed Mode Biomed mode is used to perform calibrations and diagnostic tests on the SYMBIQ™ Infusion System. In Biomed mode, a trained and qualified biomedical technician can restore the infuser’s default factory settings and default drug library, configure device settings, and clear all logs and viewable data. CAUTION: Only qualified biomedical technicians should access the infuser’s Biomed mode. Note: Biomed mode is password protected.
Chapter 3: Infuser Operations Biomed Mode NOTES: 48 SYMBIQ™ Infusion System Operating Manual 430-10599-001 (MDS DRAFT 04/06)
