System Operating Manual
222 Pages
Preview
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TM
For use with the SYMBIQTM One-Channel Infuser TM and SYMBIQ Two-Channel Infuser
Hospira, Inc., Lake Forest, IL 60045 430-11348-01 (F, 2012-08)
TM
System Operating Manual For use with the following list numbers with software version 3.13: 16026-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94 16027-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94
The SYMBIQTM Infusion System is designed for use by healthcare professionals. The Hospira Customer Support Hotline is available 24 hours a day (in the USA). 1-800-241-4002 To order additional copies of this manual, call 1-877-946-7747. www.hospira.com
430-11348-011 (F, 2012-08)
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Contents CHAPTER 1: INTRODUCTION... 5 Default Drug Library... 5 Drug Library... 6 Conventions... 6 Front View... 7 Rear View... 8 Underside View... 9 Infuser Buttons... 10 Touchscreen Icons, Buttons, and Symbols...11 Wireless Communication... 14 FCC... 14 Electromagnetic Compatibility... 15 Wireless Device Usage... 15 Battery Power Indicators... 16
CHAPTER 2: GENERAL SETUP AND OPERATION... 19 Infuser Configurations on an IV Pole... 19 Attaching Infusers to an IV Pole... 21 Detaching Connected Infusers... 26 Administration Sets... 27 Preparing Administration Sets... 29 Power On... 34 Loading and Removing an Administration Set... 36 Emergency Stop... 41 Ejecting a Cassette in an Emergency... 42 Power Off... 42
CHAPTER 3: PROGRAMMING... 43 Programming a Basic Therapy... 43 Distal Pressure Trend... 56 Titrating an Infusion... 58 Changing Time... 61 End of Infusion... 64 Programming a Piggyback Delivery... 66 Programming a Bolus Delivery... 73 Programming Advanced Therapies... 83 Multistep Therapy... 83 Intermittent Therapy... 90 Delayed Start... 96 Specifying Infusion and/or Concentration... 98
SYMBIQ System Operating Manual
Contents
CHAPTER 4: CHANGING CCAS, DEVICE LEVEL SETTINGS, AND OPTIONS... 101 Changing CCAs... 101 Device Level Buttons... 104 Mode... 104 Settings... 105 Logs...110 Standby...117 Program Lock...119 Programming Options... 121 Power Prime... 121 Deliver at End of Infusion... 125 Alarm Options... 125 High-Risk Medications... 135
CHAPTER 5: ALARMS AND SYSTEM MESSAGES... 137 Alarms... 137 Silencing an Alarm... 138 Alarm Appearance... 139 Minimizing Alarm Tabs... 140 Multiple Alarms... 141 Nearing End of Infusion Alarm... 142 End of Infusion Alarm... 143 System Messages... 145 Outside Soft Limits... 145 Outside Hard Limits... 147 Invalid Value Entered... 149 Battery Alarms... 150
CHAPTER 6: DRUG LIBRARY UPDATE... 151 Drug Library Acceptance... 153
CHAPTER 7: AUTO-PROGRAMMING... 155 CHAPTER 8: CLEANING, MAINTENANCE, AND STORAGE... 161 Cleaning... 161 Cleaning Lock... 162 Battery Maintenance... 163 Battery Power... 163 Battery Disposal... 164 Storage... 164 Infuser Maintenance and Service... 164 Product Handling and Disposal... 164
CHAPTER 9: SPECIFICATIONS... 165 Trumpet Curves... 172 Sample Trumpet Curve... 172 Wireless LAN Module... 179
SYMBIQ System Operating Manual
Contents
APPENDIX A: SYSTEM MESSAGES AND TROUBLESHOOTING... 181 APPENDIX B: ALARM MESSAGES AND TROUBLESHOOTING... 191 APPENDIX C: DEFAULT DRUG LIBRARY (DDL)... 199 APPENDIX D: ACCESSORIES AND ADMINISTRATION SETS... 201 APPENDIX E: CONFIGURATION SETTINGS... 203 APPENDIX F: UNITS OF MEASURE... 211 WARRANTY... 213 INDEX... 215
SYMBIQ System Operating Manual
Contents
NOTES:
SYMBIQ System Operating Manual
Chapter 1: Introduction The Hospira SYMBIQTM Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The system can communicate, wired or wirelessly, over the hospital’s network infrastructure with Hospital Information Systems (HIS) through Hospira MedNetTM server software. All data entry and validation of infusion parameters are performed by a trained healthcare professional according to a physician’s orders. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas outside the hospital, under the supervision of a healthcare provider. Infusers are available in one-channel or two-channel configurations, and may be connected to configure a three-channel or four-channel system. The connecting mechanism is designed to allow a maximum of one additional infuser to be connected to the right of the infuser mounted on the IV pole. The infusion system is powered by either AC power or the integrated rechargeable battery. The SYMBIQ delivers Basic, Bolus, Piggyback, or the Advanced therapies of Multistep and Intermittent. Training should emphasize preventing IV related complications including appropriate precautions to prevent accidental infusion of air. Use the SYMBIQ according to established hospital or institution guidelines, policies, and procedures. WARNING: Do not use the infuser in an MRI environment or strong magnetic field. Serious injury or damage to equipment may result. CAUTION: Federal (USA) law restricts this device to sale by or on the order of physicians or other licensed health practitioners.
Note: Refer to medication labeling for infusion guidelines.
Default Drug Library CAUTION: Some of the drugs in the Default Drug Library (DDL) may also be administered using plastic syringes via the vented syringe adapter system in combination with the Symbiq Infusion System. Review the package insert for the specific drug information or consult with Pharmacy to ensure syringe compatibility with the drug as well as drug stability.
The SYMBIQ has a factory-installed Default Drug Library (DDL) used to program therapies. The DDL is set up as a single Clinical Care Area (CCA) drug library and uses the defined CCA defaults for all medication settings. The DDL uses TALL-man lettering to help differentiate sound-alike or look-alike medication names. The DDL is active and available for use until a new drug library is downloaded to the infuser with Hospira MedNet software. Once a new drug library is successfully downloaded, it replaces the DDL as the active drug library.
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Chapter 1: Introduction
Conventions
For a list of medications, see Appendix C. For a list of default configurations, see Appendix E. Medications in the DDL have neither hard limits nor soft limits. Hard limits and soft limits are specified by each facility using Hospira MedNet software. Contact an authorized Hospira representative for more information regarding Hospira MedNet Software.
Drug Library Hospira MedNet software provides hospitals and other healthcare facilities with the ability to build a drug library based on hospital-defined best practices. The customized drug library is downloaded into the infuser by authorized hospital personnel. Hospital personnel determines and selects medications, concentration, units of measure, dose, and dose limits available for use with the infuser in the selected CCA. Drug libraries can define up to 40 different CCAs, and can have up to 400 medications per CCA chosen by the healthcare facility. When a CCA is selected, the infuser uses that CCA’s configuration and medication definition settings for programming for all therapies until a different CCA is selected.
Conventions The conventions listed in Table 1-1 are used throughout this manual. Table 1-1. Conventions Convention
Application
Example
Italic
Reference to a section, table, figure, publication, or website
See Figure 1-1
Bold
Emphasis
The Check Cassette alarm activates.
Arial Narrow Bold
Button name
Press the Enter button.
SMALL CAPS Bold
Screen name
The STARTUP screen displays.
Throughout this manual, the following conventions are used to call attention to warnings, cautions, notes, and tips: WARNING: A warning message contains special safety emphasis and must be observed at all times. Failure to observe a warning message is potentially life threatening. CAUTION: A caution appears in front of a procedure or statement. It contains information that could prevent product damage or hardware failure. Failure to observe a caution could result in patient or user injury.
Note: A Note highlights information that helps explain a concept or procedure. Figures and graphics are rendered as representations to approximate the actual product, and may not exactly reflect the product.
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SYMBIQ System Operating Manual
Front View
Chapter 1: Introduction
Front View Figure 1-1 shows the front view and touchscreen of the one-channel and two-channel device.
Figure 1-1: Front Views
#
Feature
#
1
Distal Tubing Guide
7
On/Off Button
13 Help/Status Text Area
2
Cassette Carriage
8
SILENCE Button
14 Battery/AC Power Indicator
3
Cassette Loader Housing
9
Emergency Stop Button
15 Cassette LOAD/EJECT Button
4
Channel Identifier Tab
10 CCA/Patient Information Button
16 Channel Identifier Tab
5
Proximal Tubing Guide
11
17 Cassette Carriage
6
Cassette LOAD/EJECT Button
12 Programming Screen
SYMBIQ System Operating Manual
Feature
Channel-Level Therapy Buttons
#
Feature
7
Chapter 1: Introduction
Rear View
Rear View Figure 1-2 shows the rear view of the two-channel infusion system.
Figure 1-2: Rear View
#
8
Feature
#
Feature
#
Feature Locking Mechanism
1
Quick Release Button
6
Proximal Tubing Guide
11
2
IV Pole
7
Carrying Handle
12 Pole Clamp Knob
3
Black Release Lever
8
Purple Release Lever
13 AC Power Cord
4
Cleaning Lock
9
AC Power Cord Retainer Strap
14 Battery Compartment
5
Ethernet Port
10 Nurse Callback Jack
SYMBIQ System Operating Manual
Underside View
Chapter 1: Introduction
Underside View Figure 1-3 shows the underside view of the device.
Figure 1-3: Underside View #
Feature
#
Feature
1
Battery Compartment
4
Pole Clamp Assembly
2
Cassette Eject Lever (Emergency Use Only)
5
Cassette Eject Lever (Emergency Use Only)
3
Distal Tubing Guide
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Chapter 1: Introduction
Infuser Buttons
Infuser Buttons Table 1-2 describes infuser buttons and their functions. Table 1-2. Infuser Buttons Infuser Button
Function
Appearance
LOAD/EJECT
Opens and closes the cassette carriage
On/Off
Turns power on and off
SILENCE
Silences an alarm for a specified period of time, usually two minutes
Emergency Stop
Stops all channels Generates high urgency alarm
Cleaning Lock Label located on the rear of the infuser
Label points to the button which activates and deactivates the touchscreen
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SYMBIQ System Operating Manual
Touchscreen Icons, Buttons, and Symbols
Chapter 1: Introduction
Touchscreen Icons, Buttons, and Symbols Table 1-3 illustrates and describes user interface touchscreen components that provide information about infusion state and status. Table 1-3. Touchscreen Icons, Buttons, and Symbols Icon/Symbol
Description
Waiting icons Displayed when a keypress requires processing time
Horizontal navigation arrow buttons
Vertical short scroll bar Up and down arrows scroll a list by one item
Vertical hot scroll bar White interior arrows scroll a list by one item Each yellow arrow increases the scrolling increment by one item more than the previous arrow
Dropdown List field
End-of-List indicator for dropdown lists
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Chapter 1: Introduction
Touchscreen Icons, Buttons, and Symbols Table 1-3. Touchscreen Icons, Buttons, and Symbols
Icon/Symbol
Description CCA/Patient Information button The Patient Information at the top of the screen displays on all screens, and identifies the selected CCA Select the Patient Information button to display Patient name, Patient ID, and Caregiver ID
Infusion Running Drip icon Alternates between the three drip icons as illustrated
Basic Therapy icon
Multistep Therapy icon
Intermittent Therapy icon
Piggyback icon
Bolus icon
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Touchscreen Icons, Buttons, and Symbols
Chapter 1: Introduction
Table 1-3. Touchscreen Icons, Buttons, and Symbols Icon/Symbol
Description
Upper Hard Limit icon Displays on a channel tab when an upper hard limit is overridden and the program is confirmed on that channel
Lower Hard Limit icon Displays on a channel tab when a lower hard limit is overridden and the program is confirmed on that channel
Upper Soft Limit icon Displays on a channel tab when an upper soft limit is overridden and the program is confirmed on that channel
Lower Soft Limit icon Displays on a channel tab when a lower soft limit is overridden and the program is 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
Touchscreen Buttons SYMBIQ utilizes a touchscreen that accommodates a keypress whether users are wearing wet, dry, or no gloves. The infuser sounds an audible valid key tone when a button is pressed. Note: A triple-beep audible tone will sound when making entries that are considered to be invalid keypresses. The appearance of touchscreen buttons varies depending on their status. A touchscreen button is either active or unavailable, and will appear as shaded (see Figure 1-4).
Active Touchscreen Button
Unavailable Touchscreen Button
Figure 1-4: Touchscreen Button Appearance
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Chapter 1: Introduction
Wireless Communication
Device Level Buttons and Status Bar The device level buttons and status bar are located at the bottom of the touchscreen and display the following user-adjustable device buttons: Mode, Settings, Logs, Standby, Lock, and Alarm icons (see Figure 1-5). Time, WiFi-Enabled, and Battery Status icons are displayed below the device level buttons.
Figure 1-5: Device Level Buttons and Status Bar
Wireless Communication The SYMBIQ supports wireless communication via an internal wireless communications module and antennae. Use the infuser’s wired or wireless connectivity options to communicate with server-based networks or hospital local area networks. The Wireless Connection Available icon is displayed on the touchscreen when the device is receiving a wireless signal (see Figure 1-5). The infuser will connect to the network if a wireless network access point is recognized. Wireless communication to an infuser is direct rather than indirect through another infuser.
FCC This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. If not installed and used in accordance with the instructions, the infusion system may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. To determine if the infusion system does cause harmful interference to radio or television reception, turn the infuser off and on. The user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving antenna - Increase the distance between the infusion system and the receiver - Connect the infusion system to an outlet on a different circuit from the circuit to which the receiver is connected - Consult the dealer or an experienced radio/TV technician for help Changes or modifications not expressly approved by Hospira could void the user's authority to operate the infusion system.
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SYMBIQ System Operating Manual
Wireless Communication
Chapter 1: Introduction
Electromagnetic Compatibility The equipment has been tested and found to comply with electromagnetic compatibility (EMC) limits in accordance with IEC/EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. CAUTION: Portable and mobile RF communications equipment, such as cellular telephones, two-way radios, Bluetooth® devices, and microwave ovens in close proximity to the infusion system may affect wireless and wired communications and degrade performance of the system. Operation of the infuser under such conditions should be avoided.
There is a shared responsibility between manufacturers, customers, and users to assure that medical equipment and systems are designed and operated as intended. Medical electrical equipment requires special precautions regarding electromagnetic compatibility. The electromagnetic environment should be managed to permit the infusion system to perform as intended without disturbing other equipment. The infusion system should not be used adjacent to or stacked with other equipment. If the device must be used adjacent to or stacked with other equipment, monitor the equipment to assure there is no electromagnetic interference, and verify normal infuser operation. Use of a shielded Ethernet cable (CAT5 STP or better) for plugging into the Ethernet connector is required. Using an unshielded Ethernet cable may result in increased emissions.
Wireless Device Usage The wireless 802.11 a/b/g device usage in the 5150-5250 MHz band is limited to indoor use to reduce potential for harmful interference to co-channel mobile satellite systems. In the 5250-5350 MHz and 5650-5850 MHz frequency bands, high power radars are allocated as primary users and these radars could cause interference and/or damage to LE-LAN devices. Operation is subject to the following two conditions: (1) the wireless device may not cause interference, and (2) the wireless device must accept any interference, including interference that may cause undesired operation of the wireless device.
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Chapter 1: Introduction
Battery Power Indicators
Battery Power Indicators Table 1-4 describes the battery indicator icons and the associated battery life, power level, and alarm state for each indicator icon. When the infuser is connected to an AC power source, the battery indicator icon shows the current battery charge level. The battery indicator icon is displayed below the device level buttons (see Figure 1-5). Table 1-4. Battery Indicator Icons Battery Indicator Icon
Alarm State
Power Level
Battery indicators when the infuser is operating on battery power
16
Full 76%-100%
None
Three-Fourths 51%-75%
None
Half 50% Battery is at half capacity, until the activation of the 30 minute Low Battery Alarm when the infuser is operating on battery power
None
30 minutes
Low
15 minutes
Medium
5 minutes Depleted Battery Alarm occurs Plug in the AC power cord immediately Infuser is about to shut down
High
Empty A flashing battery indicator will alternate between the two battery icons
High
SYMBIQ System Operating Manual
Battery Power Indicators
Chapter 1: Introduction Table 1-4. Battery Indicator Icons
Battery Indicator Icon
Power Level
Alarm State
Charging Battery indicators when the infuser is operating on AC power
SYMBIQ System Operating Manual
AC Power Infuser is using AC power only Battery charged to 90% or more capacity
None
Charging Capacity at 75% or greater but less than 90% capacity
None
Charging Capacity at 50% or greater but less than 75% capacity
None
Charging Capacity at 25% or greater but less than 50% capacity
None
Infuser is powered on and no battery above the Depleted Battery threshold is detected
None
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