Technical Service Manual
135 Pages
Preview
Page 1
TM
INFUSION SYSTEM
For use with list numbers 16026-04 and 16027-04
Technical Service Manual
Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045 430-11023-010 (B, 2013-04)
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SYMBIQ Infusion System
Technical Service Manual
Contents Section 1 INTRODUCTION... 1.1 SCOPE... 1.2 CONVENTIONS... 1.3 ACRONYMS AND ABBREVIATIONS . . 1.4 USER QUALIFICATION... 1.5 ARTIFACTS... 1.6 ELECTROMAGNETIC COMPATIBILITY . 1.7 FCC... 1.8 INFUSION SYSTEM INSTALLATION . . 1.8.1 UNPACKING... 1.8.2 INSPECTION... 1.8.3 INSTALLATION... 1.9 BIOMED MODE...
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1-1 1-1 1-2 1-3 1-4 1-4 1-5 1-5 1-5 1-6 1-6 1-6 1-7
Section 2 WARRANTY .
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2-1
SYSTEM OPERATING MANUAL
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3-1
THEORY OF OPERATION... 4.1 SYSTEM ARCHITECTURE... 4.1.1 USER INTERFACE CONTROLLER... 4.1.2 PUMP MECHANISM CONTROLLER . . . 4.1.3 POWER SYSTEM CONTROLLER... 4.1.4 COMMUNICATION ENGINE... 4.1.5 CONTROL AREA NETWORK... 4.2 DISPLAY SUBSYSTEM... 4.2.1 LCD AND TOUCHSCREEN... 4.3 MECHANICAL SYSTEM... 4.3.1 CONNECTOLOGY... 4.3.1.1 MODULARITY... 4.3.1.2 COMMUNICATION... 4.3.1.3 TRANSPORT... 4.3.1.4 MINIPOLE ATTACHMENT . . . 4.3.2 POLE CLAMP ASSEMBLY... 4.3.3 CASSETTE LOADER... 4.3.3.1 CASSETTE LOADER ACTUATOR . 4.3.3.2 REAR CARRIAGE ASSEMBLY . . 4.3.3.3 RELEASE PLATE... 4.3.3.4 EMERGENCY MANUAL RELEASE . 4.3.3.5 SIDE PLATES... 4.3.3.6 FRONT FASCIA... 4.3.3.7 CASSETTE CARRIAGE... 4.3.3.8 AIR SENSORS AND ACTUATOR . 4.3.3.9 PUMPING MECHANISM... 4.3.3.10 NORMAL OPERATION...
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4-1 4-1 4-2 4-2 4-2 4-3 4-3 4-3 4-3 4-4 4-4 4-5 4-6 4-6 4-6 4-6 4-7 4-7 4-7 4-7 4-8 4-8 4-8 4-8 4-8 4-8 4-9
Section 3 Section 4
Technical Service Manual
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SYMBIQ Infusion System
CONTENTS
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4-9 4-10 4-10 4-10 4-10 4-11 4-11 4-11 4-11
MAINTENANCE AND SERVICE TESTS... 5.1 ROUTINE MAINTENANCE... 5.1.1 CLEANING AND SANITIZING... 5.1.1.1 CLEANING LOCK... 5.2 SETTING THE DATE AND TIME... 5.3 PERFORMANCE VERIFICATION TEST... 5.3.1 EQUIPMENT REQUIRED... 5.3.2 INSPECTION... 5.3.3 TEST SETUP... 5.3.4 PSC POWER TEST... 5.3.5 TEMPERATURE TEST... 5.3.6 HARD KEYS TEST (ONE-CHANNEL)... 5.3.7 HARD KEYS TEST (TWO-CHANNEL)... 5.3.8 LCD BACKLIGHT TEST... 5.3.9 LCD TEST... 5.3.10 TOUCHSCREEN TEST... 5.3.11 LED TEST (ONE-CHANNEL)... 5.3.12 LED TEST (TWO-CHANNEL)... 5.3.13 AUDIBLE TONE TEST... 5.3.14 NURSE CALL RELAY TEST... 5.3.15 CASSETTE LOADING MECHANISM TEST (ONE-CHANNEL) . 5.3.16 CASSETTE LOADING MECHANISM TEST (TWO-CHANNEL) . 5.3.17 AIR SENSOR TEST (ONE-CHANNEL)... 5.3.18 AIR SENSOR TEST (TWO-CHANNEL)... 5.3.19 PRESSURE SENSOR TEST (ONE-CHANNEL)... 5.3.20 PRESSURE SENSOR TEST (TWO-CHANNEL)... 5.3.21 VOLUME ACCURACY TEST (ONE-CHANNEL)... 5.3.22 VOLUME ACCURACY TEST (TWO-CHANNEL)... 5.3.23 COIN CELL BATTERY PACK TEST... 5.3.24 ELECTRICAL SAFETY TEST... 5.4 PERIODIC MAINTENANCE INSPECTION... 5.5 BATTERY OVERVIEW...
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5-1 5-1 5-1 5-2 5-3 5-4 5-4 5-5 5-5 5-7 5-7 5-8 5-8 5-9 5-9 5-9 5-10 5-10 5-11 5-11 5-12 5-12 5-13 5-13 5-14 5-14 5-15 5-17 5-18 5-19 5-20 5-20
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6-1 6-1 6-1 6-2 6-10 6-15 6-16 6-17 6-18 6-19
4.4
4.3.4 FREE FLOW MITIGATION . . 4.3.5 OFF-SCREEN KEYS... 4.3.6 SENSOR INTERFACE... 4.3.7 LINEAR PIXEL ARRAY . . . CASSETTE SYSTEM... 4.4.1 BODY AND TOP... 4.4.2 DIAPHRAGM... 4.4.3 FLOWSTOP... 4.4.4 INCOMPATIBILITY COLLAR .
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Section 5
Section 6 TROUBLESHOOTING... 6.1 TECHNICAL ASSISTANCE... 6.2 MALFUNCTION CODES AND ALARM MESSAGES 6.2.1 MALFUNCTION CODES... 6.2.2 ALARM MESSAGES... 6.2.2.1 CHECK CASSETTE ALARM . . . 6.2.2.2 INITIAL INFUSER TURN-ON . . 6.2.2.3 BATTERY RECONDITIONING . . 6.2.2.4 BOOT TO POLO - BLUE SCREEN . 6.3 TROUBLESHOOTING PROCEDURES...
SYMBIQ Infusion System
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Technical Service Manual
CONTENTS
Section 7 REPLACEABLE PARTS AND REPAIRS... 7.1 REPLACEABLE PARTS... 7.2 REPLACEMENT PROCEDURES... 7.2.1 SAFETY AND EQUIPMENT PRECAUTIONS... 7.2.2 REQUIRED TOOLS AND MATERIALS... 7.2.3 BATTERY ASSEMBLY REPLACEMENT... 7.2.4 RUBBER FOOT PAD REPLACEMENT... 7.2.5 AC POWER CORD, RETAINER, AND VELCRO STRAP REPLACEMENT... 7.2.6 HANDLE REPLACEMENT... 7.2.7 ETHERNET CONNECTOR COVER REPLACEMENT . . 7.2.8 POLE CLAMP ASSEMBLY REPLACEMENT... 7.2.8.1 CLEANING THE POLE CLAMP... 7.2.9 CONNECTOLOGY ASSEMBLY REPLACEMENT . . . 7.2.10 FILLER PLATE REPLACEMENT... 7.2.11 CE ASSEMBLY REPLACEMENT... 7.2.12 PSC REPLACEMENT... 7.2.13 POWER SUPPLY BOARD REPLACEMENT... 7.2.13.1 FUSE REPLACEMENT... 7.2.14 COIN CELL BATTERY PACK REPLACEMENT... 7.2.15 INFUSER MECHANISM REPLACEMENT... 7.2.15.1 INDICATOR WINDOW REPLACEMENT . . 7.2.16 FRONT BEZEL REPLACEMENT... 7.2.16.1 SWITCH MEMBRANE REPLACEMENT . . . 7.2.16.2 LOWER BUMPER REPLACEMENT... 7.2.17 REAR BEZEL REPLACEMENT... 7.2.17.1 UPPER BUMPER REPLACEMENT... 7.2.18 BACK ASSEMBLY REPLACEMENT... 7.2.18.1 AC POWER CONNECTOR REPLACEMENT . 7.2.18.2 FAN ASSEMBLY REPLACEMENT... 7.2.19 UIC REPLACEMENT... 7.2.19.1 SPEAKER REPLACEMENT...
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7-1 7-1 7-1 7-1 7-2 7-2 7-4
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. 7-4 . 7-6 . 7-7 . 7-9 . 7-12 . 7-13 . 7-15 . 7-17 . 7-18 . 7-19 . 7-20 . 7-20 . 7-21 . 7-23 . 7-24 . 7-25 . 7-27 . 7-27 . 7-29 . 7-29 . 7-31 . 7-31 . 7-32 . 7-34
Section 8 SPECIFICATIONS .
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8-1
9-1
Section 9 DRAWINGS .
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Appendix .
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. A-1
Index .
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Technical Service Manual
iii
I-1
SYMBIQ Infusion System
TABLES
Figures Figure 4-1. Figure 4-2. Figure 4-3. Figure 5-1. Figure 5-2. Figure 5-3. Figure 5-4. Figure 5-5. Figure 5-6. Figure 5-7. Figure 6-1. Figure 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure 7-6. Figure 7-7. Figure 7-8. Figure 7-9. Figure 7-10. Figure 7-11. Figure 7-12. Figure 7-13. Figure 7-14. Figure 7-15. Figure 7-16. Figure 7-17. Figure 7-18. Figure 7-19. Figure 7-20. Figure 7-21. Figure 7-22. Figure 9-1. Figure 9-2. Figure 9-3. Figure 9-4.
System Controllers... Connectology Features... T-Slot and T-Profile Features... Date & Time Screen... Self Test Screen... Volume Accuracy Test Setup (One-Channel) Reading the Meniscus... Front Views... Rear View... Underside View... Blue Screen with Service Required Window Battery Assembly and Rubber Foot Pads . . AC Power Cord, Retainer, and Velcro Strap . Handle Replacement (One-Channel) . . . Ethernet Connector Cover... Applying Grease to Surfaces... Removal and Installation Positions... Pole Clamp Positions and Connectology . . Pole Clamp Assembly... Connectology Assembly... Filler Plate and Boards... CE Assembly Replacement... PSC Replacement... Power Supply Board Replacement... Coin Cell Battery Pack... Infuser Mechanism Replacement... Infuser Indicator Windows... Front Bezel Replacement... Switch Membrane... Rear Bezel Replacement... Back Assembly with Fan and AC Connector UIC Replacement... Speaker Replacement... Illustrated Parts Breakdown... Infuser Assembly... Front and Rear Bezels... CE Assembly, PSC, and Power Supply . .
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4-1 4-4 4-5 5-4 5-6 5-16 5-16 5-21 5-22 5-23 6-18 7-3 7-5 7-6 7-8 7-9 7-10 7-11 7-12 7-14 7-16 7-17 7-18 7-19 7-21 7-22 7-23 7-25 7-26 7-28 7-30 7-33 7-34 9-5 9-9 9-11 9-13
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. 1-2 . 5-2 . 5-7 . 5-7 . 5-19 . 6-2 . 6-10 . 6-19 . 9-1 . 9-1
Tables Table 1-1. Table 5-1. Table 5-2. Table 5-3. Table 5-4. Table 6-1. Table 6-2. Table 6-3. Table 9-1. Table 9-2.
Conventions... Cleaning Solutions... PSC Power Test... Temperature Test... Electrical Safety Measurements . Malfunction Codes... Alarm Messages... Troubleshooting with the PVT . Drawings... IPB for the Infuser...
SYMBIQ Infusion System
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Technical Service Manual
Section 1
INTRODUCTION The Hospira SYMBIQ™ 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 MedNet™ server software. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to 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. The infusion system is powered by either AC power or the integrated rechargeable battery, and delivers Basic, Bolus, Piggyback, or Advanced therapies of Multistep and Intermittent. Infusers are available in one-channel or two-channel configurations, and may be connected to configure a three-channel or four-channel system. The SYMBIQ administration set is designed specifically for use with the SYMBIQ infusion system, assuring the correct administration set will be used with the correct device. The device contains a Communication Engine (CE) module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. Hospira MedNet software is designed to allow a facility to customize and download a drug library for use with the infusion system (see the Hospira MedNet Software User Guide).
1.1
SCOPE This manual is organized into the following sections: ❏
Section 1 Introduction
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Section 2 Warranty
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Section 3 System Operating Manual
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Section 4 Theory of Operation
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Section 5 Maintenance and Service Tests
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Section 6 Troubleshooting
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Section 7 Replaceable Parts and Repairs
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Section 8 Specifications
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Section 9 Drawings
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Appendices
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Index
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Technical Service Bulletins
Technical Service Manual
1-1
SYMBIQ Infusion System
SECTION 1 INTRODUCTION
If a problem in device operation cannot be resolved using the information in this manual, contact Hospira (see Section 6.1). Specific instructions for operating the device are contained in the SYMBIQ System
Operating Manual. The terms “infusion system”, “infuser”, and “device” are used interchangeably throughout the manual. Figures are rendered as graphic representations to approximate actual product. Therefore, figures may not exactly reflect the product. Screen representations are examples only, and do not necessarily reflect the most current configuration.
1.2
CONVENTIONS The conventions listed in Table 1-1 are used throughout this manual. Table 1-1. Convention
Conventions
Application
Example
Italic
Reference to a section, figure, table, publication, or website
(see Section 6.1)
Red Bold
Warnings and Cautions
CAUTION: Use proper ESD grounding techniques when handling components.
Bold
References to keys, buttons, icons, screens, and displayed messages
Press Start.
Throughout this manual, warnings, cautions, and notes are used to emphasize important information as follows: WARNING: A WARNING CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MAY RESULT IN PATIENT INJURY AND BE LIFE-THREATENING. CAUTION: A CAUTION usually appears in front of a procedure or statement. It contains information that could prevent hardware failure, irreversible damage to equipment, or loss of data.
d Note: A note highlights information that helps explain a concept or procedure. Indicates International Electrotechnical Commission (IEC) compliance.
SYMBIQ Infusion System
1-2
Technical Service Manual
1.3
ACRONYMS AND ABBREVIATIONS
1.3
ACRONYMS AND ABBREVIATIONS Acronyms and abbreviations used in this manual are as follows: A Ampere AC Alternating current ADC Analog-to-digital converter CAN Controller area network CCA Clinical care area CE Communication engine CPU Central processing unit DC Direct current DDL Default drug library ECG Electrocardiogram EEG Electroencephalogram EEPROM Electrically erasable programmable read-only memory EMC Electromagnetic compatibility EMG Electromyogram EMI Electromagnetic interference ESD Electrostatic discharge ETO Ethylene oxide hr Hour Hz Hertz I/O Input/output IPB Illustrated parts breakdown IV Intravenous KB Kilobyte Kg Kilogram KVO Keep vein open LCD Liquid crystal display LED Light emitting diode LPA Linear pixel array mA Milliampere MB Megabyte mcg Microgram mg Milligram mL Milliliter mL/hr Milliliter per hour ng Nanogram NVRAM Non-volatile random access memory
Technical Service Manual
1-3
SYMBIQ Infusion System
SECTION 1 INTRODUCTION
PMC Pump mechanism controller PSC Power supply controller PVT Performance verification test PWA Printed wiring assembly RAM Random access memory TFT Thin film transistor UIC User interface controller V Volt VAC Volts AC VDC Volts DC VTBI Volume to be infused
1.4
USER QUALIFICATION The infusion system is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of the infusion system and the administration of parenteral and enteral fluids and drugs, and whole blood or red blood cell components. Training should emphasize preventing related IV complications, including appropriate precautions to prevent accidental infusion of air. The epidural route can be used to provide anesthesia or analgesia.
1.5
ARTIFACTS Nonhazardous, low-level electrical potentials are commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infuser instead of some other source in the environment, set the device so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by electronic noise generated by the infuser. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring system documentation for setup and maintenance instructions.
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Technical Service Manual
1.6
ELECTROMAGNETIC COMPATIBILITY
1.6
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 (see the SYMBIQ System Operating Manual). 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.
1.7
FCC The device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference. The wireless LAN device in the CE has been evaluated and found to be compliant with the requirements of FCC radio frequency exposure standards.
1.8
INFUSION SYSTEM INSTALLATION CAUTION: Infusion system damage may occur unless proper care is exercised during product unpacking and installation. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (i.e., IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-2. Any person who connects additional equipment to the signal input or output part is configuring a medical system, and is therefore responsible for assuring that the system complies with the requirements of IEC 60601-1-2. If in doubt, contact Hospira.
Technical Service Manual
1-5
SYMBIQ Infusion System
SECTION 1 INTRODUCTION
1.8.1
UNPACKING Inspect the shipping container as detailed in Section 1.8.2. Use care when unpacking the infusion system. Retain the packing slip and save all packing material in the event it is necessary to return the infuser to the factory. Verify the shipping container contains a copy of the SYMBIQ System Operating Manual.
1.8.2
INSPECTION Inspect the shipping container for damage. Should any damage be found, contact the delivering carrier immediately. CAUTION: Inspect the infuser for evidence of damage. Do not use the device if it appears to be damaged. Should damage be found, contact Hospira. Inspect the infusion system periodically for signs of defects such as worn accessories, broken connections, or damaged cable assemblies. Also inspect the infuser after repair or during cleaning. Replace any damaged or defective external parts.
1.8.3
INSTALLATION WARNING: TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.
Note: Do not place the infuser in service if the battery is not fully charged. To make certain the battery is fully charged, connect the infuser to AC power for four hours.
Note: When plugging the device into an AC power outlet, grasp the AC power
cord plug and use a forward motion into the socket. Do not use a sideways motion. When unplugging the device, grasp the AC power cord plug and pull straight out. Do not pull out using the power cord cable and do not pull out at an angle.
Note:. Do not operate the infuser without the power cord retainer (see Figure 7-2)
See Figure 5-5, Figure 5-6, and Figure 5-7 for front, rear, and underside views of the infuser. To install the infusion system, proceed as follows: 1. Plug the AC power cord into a grounded, hospital-grade 120 VAC, 50-60 Hz receptacle, and confirm the AC power indicator is illuminated. 2. Press and hold the On/Off button for a minimum of two seconds to turn on the infuser. The infuser will perform a self test (see Figure 5-2).
Note: Do not place the infuser in service if it fails the self test. 3. Verify the date and time. To set the date and time, see Section 5.2. If the infuser has a CE board installed and the Ethernet cable is not connected, the CE Installed icon will display in the device status information area. To adjust brightness and volume, see the SYMBIQ System Operating Manual.
SYMBIQ Infusion System
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Technical Service Manual
1.9
BIOMED MODE
1.9
BIOMED MODE CAUTION: Mode.
Only qualified Biomedical Technicians should access Biomed
In Biomed Mode, a trained and qualified Biomedical Technician can view device settings and logs, and configure and perform diagnostic tests. Biomed Mode is password protected (see Section 5.3.3).
Note: Do not switch to Biomed Mode with the door open. In Biomed Mode, the infuser allows the technician to perform the following: - View the current Biomed settings
- Upload logs and data to a CE
- View the serial number - Configure the operation test
- Reset a channel after a cassette was manually ejected
- Set the date and time
- Download new device software
In Biomed Mode, the infuser allows the technician to view the following logs: - Event Log
- Biomedical Log
- Alarm Log
- Run Time log
- Keystroke Log
- Malfunction Log
- Rule Set Alert/Override Log
- Battery Charge Log
Technical Service Manual
1-7
SYMBIQ Infusion System
SECTION 1 INTRODUCTION
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SYMBIQ Infusion System
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Technical Service Manual
Section 2
WARRANTY Subject to the terms and conditions herein, Hospira, Inc., hereinafter 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, and specifically disclaims the implied warranties of merchantability and fitness for a particular purpose. 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 or lot number has been altered, effaced, or removed. The foregoing warranty shall also be void in the event any person, including the Purchaser, performs or attempts to perform any major repair or other service on the product without having been trained by an authorized representative of Hospira and using Hospira documentation and approved spare parts. For purposes of the preceding sentence, "major repair or other service" means any repair or service other than the replacement of accessory items such as batteries and detachable AC 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.
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SECTION 2 WARRANTY
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Section 3
SYSTEM OPERATING MANUAL A copy of the system operating manual is included with every SYMBIQ infusion system. If a copy of the system operating manual is not available, contact Hospira (see Section 6.1).
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Section 4
THEORY OF OPERATION This section describes the theory of operation for the SYMBIQ infusion system. The theory of operation details the system architecture, display subsystem, mechanical system, and cassette system.
4.1
SYSTEM ARCHITECTURE The infuser is a multi-controller system comprised of the following components: - User Interface Controller (UIC) - Pump Mechanism Controller (PMC) - Power Supply Controller (PSC) - Communication Engine (CE) All communications between the UIC, PMC, and PSC are accomplished by a Control Area Network (CAN) (see Figure 4-1). The UIC also interfaces with the CE and connects to user interface components.
Figure 4-1.
System Controllers
The following sections describe the functionality of system controllers and user interfaces.
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SECTION 4 THEORY OF OPERATION
4.1.1
USER INTERFACE CONTROLLER The UIC contains a high-speed, 32-bit processor and a minimum of 32 MB Flash, 32 MB static RAM, and 256 KB of NVRAM. It provides the ability to interface to a liquid crystal display (LCD) and four-wire touchscreen. The UIC manages all user interface related functions, including the following: - System startup and shutdown
- Nurse call support
- Touchscreen and off screen key processing
- Drug library interface
- Text and graphics display
- System logs
- LCD backlight control
- Protocol and configuration storage, retrieval, and maintenance
- Key press and audible alarm tones
- Software download interface
- User interface navigation
4.1.2
PUMP MECHANISM CONTROLLER The PMC manages the pumping and sensing mechanisms as directed by the UIC, including the following:
- Fluid delivery
- Motor movement monitoring to detect overdelivery or underdelivery
- Air-in-line sensing
- Plunger position sensing
- Distal and proximal pressure sensing
- Plunger pressure sensing
- Cassette loader operation
- Sensor monitoring for safe operation The PMC controls an LED indicating delivery status, cassette loader status, or alarm status, and has a watchdog to independently stop delivery if a major PMC or CAN failure is detected.
4.1.3
POWER SYSTEM CONTROLLER The PSC manages power usage from external AC power or from the internal battery, controls an LED indicating the primary power source, and processes power on/off key presses. The PSC also supports an audible alarm that sounds if the UIC’s audible alarm has failed or a total loss of power occurs. The PSC manages power-related functions, including the following: - Power level sensing
- Battery temperature monitoring
- Switching between AC and battery power
- Cooling fan control
- Battery charging The PSC also functions as a system watchdog. It monitors CAN activity and sounds an alarm before shutting down the system if communication with the UIC fails.
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