Sigma Spectrum 35700BAX & 35700ABB Service Manual Rev AA

SIGMA Manual Number 41019 Revision AA

©2010 Copyright SIGMA, LLC 711 Park Avenue Medina, New York 14103 v 800 356 3454 f 585 798 3909 www.sigmapumps.com

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SIGMA Manual Number 41019 Revision AA

TABLE OF CONTENTS Introduction and Safety... 1 Intended Device Use... 1 Related Documents... 1 Listings & Certifications... 2 Contacting SIGMA Technical Support... 2 Conventions... 3 Summary of Warnings and Cautions... 3

Design and Theory of Operation... 5 Case... 5 Front Case Assembly... 5 Rear Case Assembly... 5

Battery Pack... 5 Pole Clamp... 7 Double Rotating Pole Clamp Assembly (Accessory)... 7 Tubing Channel/Pump Door... 7 Set Slide Clamp Sensor... 7 Processing Architecture... 7 Pumping Mechanism... 8 Physical Method... 8 Operation... 8 Pumping Mechanism Assembly... 8

Motor... 8 Motor Drive... 8

Motor and Gear Drive... 9 Fluid Temperature... 9 Upstream Sensors... 9 Optical Tube Sensor... 9 Proximal Occlusion Detection... 9 Air Sensor... 10

Downstream Sensors... 10 Set Loading... 10 Distal Occlusion Detection... 10

Audible Alarm Device and System... 11 Electronic Components... 11 AC Power Adaptor / Charger... 11 Display... 12 I/O Board... 12 Processor Board... 12 Flex Circuits... 12 Keypad... 13 Power Connector... 13

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SIGMA Manual Number 41019 Revision AA

Pump Specifications...14 Applications... 14 Administration Set... 14 Performance... 14 Effect of Fluid Container Height... 14 Bolus Accuracy... 14 Technical... 15

Configuration Options... 16 BioMed Options...16 Sensor Configuration... 17 Calibration Menu... 17 Pump Settings... 18 Pump Testing... 19 Update Software... 19 Network Configuration... 19

Wireless Networking... 21 Network Configuration

...21

Network Status... 21 Transfer Network Status... 22 Network Settings... 23 TCP/IP Settings –... 24 Wireless Settings... 24

Network Interface Information...25

Service and Maintenance... 26 Required Maintenance and Frequency...26 SIGMA Spectrum Cleaning...26 Compatible Cleaners... 26 Cleaning the Pump... 26

Battery Removal and Replacement...28 Wireless Module Battery Cell Removal and Replacement... 28 Battery Disposal... 30

Returning Equipment...30

Preventive Maintenance... 31 Preventive Maintenance Schedule...31 Equipment Required...31 Visual Inspection... 32 Determine Software Version and Serial Number... 32 Keypad Test... 32 Upstream (Proximal) Occlusion Sensor Test... 33 Downstream (Distal) Occlusion Sensor Test*... 33

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Air Detection Test*... 34 Memory Test... 35 Recommended Flow Rate Accuracy Test*... 35 AC Power Adaptor Safety Analysis... 36 Battery Capacity Test... 37 Pass criteria for a used battery... 38 Pass criteria after installation of a new battery... 38

Preventive Maintenance Check Sheet... 39

Troubleshooting... 40 Battery Charger Error Code Descriptions... 40 System Error Code Descriptions... 41

Logging... 48 Downloading the History Log... 48 Equipment List... 48 Procedure... 48

Appendix A: Technical Drawings... 51

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SIGMA Manual Number 41019 Revision AA

INTRODUCTION AND SAFETY

Intended Device Use The Spectrum and Spectrum with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products, antibiotics, nutritional fluids and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The Spectrum is intended to be used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library are suitable for many user facility applications such as, but not limited to, hospitals, outpatient care areas, homecare and ambulatory care services. The Spectrum and Spectrum with Master Drug Library are intended to reduce operator interaction through automated programming, thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician's directive.

Related Documents The following documents also pertain to the Spectrum and Spectrum with Master Drug Library: ■ ■

1

Operator’s Manual P/N 41018 MDL User Manual P/N 41020

Introduction and Safety

SIGMA Manual Number 41019 Revision AA

Listings & Certifications Standard

Version

Description

UL 60601-1

2003

UL Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety First Edition

CAN/CSA C22.2 NO 601.1-M90

1990

Medical Electrical Equipment – Part 1: General Requirements for Safety General Instruction No 1: with UL60601-1 Supplement I

IEC 60601-2-24

1998–2002

Medical Electrical Equipment – Part 2 –24: Particular Requirements for Safety of Infusion Pumps and Controllers First Edition

EN 60601-1

1990

Medical Electrical Equipment Part 1: General Requirements for Safety Includes Amendments + A1(93) + A2(95)

FCC Section 15C

N/A

FCC approved wireless transmitter/receiver module

ID: MCQ-50M879

(wireless battery module only – SIGMA P/N 35083) FCC Section 15C

N/A

ID: MCQ-50M1538

FCC approved wireless transmitter/receiver module (wireless battery module only – SIGMA P/N 35162)

See the SIGMA Spectrum Operator’s Manual (P/N 41018) for specific flow rate accuracy (trumpet curve) information and electromagnetic compatibility compliance levels. NRTL – Intertek Testing Services NA Inc. Reference Control Number 3063464

Contacting SIGMA Technical Support Contact SIGMA, LLC for all service information at: Telephone:1-800-356-3454 Email: [email protected]

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SIGMA Manual Number 41019 Revision AA

Conventions

WARNING:

CAUTION:

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate personal injury or property damage. This word is used to also alert against unsafe practices.

NOTE: Additional information to clarify or strengthen wording.

Summary of Warnings and Cautions

WARNING: - THIS EQUIPMENT IS NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR OXYGEN OR NITROUS OXIDE. - LITHIUM BATTERY (SIGMA P/N 55075) (LOCATION: BT1 ON PCBA P/N 60087) DANGER OF EXPLOSION IF THE BATTERY IS INCORRECTLY REPLACED. REPLACE ONLY WITH THE SAME OR EQUIVALENT TYPE RECOMMENDED BY SIGMA. REFERENCE THIS MANUAL FOR DISPOSAL INSTRUCTIONS. - DO NOT SHORT CIRCUIT THE BATTERY TERMINALS, DISASSEMBLE OR MODIFY BATTERY PACKS. - DO NOT DISPOSED OF BATTERIES OR BATTERY PACKS IN FIRE. - ANY PUMP THAT HAS BEEN DROPPED OR IS OTHERWISE VISIBLY DAMAGED MUST NOT BE USED. Discontinue use immediately and refer to a qualified Service Technician for inspection and repair prior to further use. - USE ONLY IV ADMINISTRATION SETS THAT ARE LISTED ON SIGMA COMPATIBLE SET LISTING (see Operator’s Manual for listing). Use of any other sets may result in malfunction or inaccurate delivery. - DO NOT USE IF ROOM OR PUMP TEMPERATURE IS BELOW 15°C (60°F) OR ABOVE 32°C (90°F).

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Introduction and Safety

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CAUTION: - Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed practitioner. - Operate only on the AC line voltage for which the AC power adaptor is marked. - The AC power adaptor should be plugged in during storage to maintain proper battery charge level. - Disconnect from AC power source and remove the battery pack prior to servicing this pump. - Routine cleaning and periodic maintenance is needed to assure that the pump remains safe and functional. Refer to “Service and Maintenance” on page 26, and “Preventive Maintenance” on page 31. - Clean up solution spills as soon as possible using a damp cloth or sponge. Dry thoroughly before use. Keep the upstream and downstream sensors’ tube channels clean and dry at all times during pump operation. Do not use hard or sharp objects to clean sensor tube channel areas. Failure to comply with this requirement may cause the pump to fail. Refer to “Service and Maintenance” on page 26. - Static sensitive electronics used in SIGMA infusion pumps may be damaged by electrostatic discharge. Service technicians must follow proper ESD procedures when working on pumps. Refer to MIL-STD1686 for protective handling procedures. - Do not use a pen or any other sharp object to actuate the keyboard switches. Replace torn or punctured membranes immediately, to assure solutions won't internally damage the membrane switch and prevent proper operation of the SIGMA Spectrum. (Replacement should only be performed by authorized personnel). - Use only filter sets that are specifically listed in the Operator's Manual for use with Spectrum pumps. NOTE: For a list of serviceable parts, contact SIGMA.

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SIGMA Manual Number 41019 Revision AA

DESIGN AND THEOR Y OF OPER ATION

Case SIGMA Spectrum consists of two case halves: front and rear case assemblies. Front Case Assembly The front case assembly is comprised of the following primary components: ■ ■ ■

Front case Display Two circuit boards

The circuit boards of this assembly are fastened with four hex standoffs and four Phillips machine screws. Rear Case Assembly The rear case assembly consists of the following primary components: ■ ■ ■ ■

Rear case Back flex circuit Power connector Speaker

The back flex circuit is adhered to the rear case. The power connector is assembled to the rear case.

Battery Pack The SIGMA Spectrum employs a removable lithium ion 7.2V battery pack. This assembly consists of the battery cells, contact pins and the two plastic case halves. The battery pack uses both cell and battery pack protection to guard against short-circuit, over voltage and over current conditions. The battery terminals are slightly recessed to minimize the possibility that the terminals may be shorted on a conductive surface. The battery pack is labeled to identify it and provide handling / disposal information as necessary for user safety. There are three battery types: ■ ■ ■

P/N 35724 - standard battery P/N 35083 - 802.11b wireless module P/N 35162 - 802.11g wireless module.

The standard battery (P/N 35724) and 802.11b wireless module (P/N 35083) are compatible with all SIGMA Spectrum pumps. The 802.11g wireless module (P/N 35162) is only compatible with wireless G compatible pumps. Wireless G compatible pumps are identified by the letter G preceding the serial number on the pump (see Figure 1.). Pumps that do NOT have a letter G preceding the serial number (see Figure 2.) are not compatible with the 802.11g wireless module (P/N 35162).

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Design and Theory of Operation

SIGMA Manual Number 41019 Revision AA

Figure 1. Serial Number for Pump Compatible with the 802.11b/g Wireless Battery Module (P/N 35162)

Figure 2. Serial Number for Pump NOT Compatible with the 802.11b/g Wireless Battery Module (P/N 35162)

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Pole Clamp The pole clamp assembly (SIGMA P/N 35712) is attached to the rear of the pump. A thumbscrew is used to lock the pole clamp assembly to the SIGMA Spectrum pump. The pole clamp assembly is comprised of an anodized aluminum C-clamp and a slide mount receptacle bracket. The bracket is attached to the C-clamp with two 1/4-20 x 5/8” Phillips machine screws.

Double Rotating Pole Clamp Assembly (Accessory) The Double Rotating Pole Clamp Assembly (SIGMA P/N 35743) is an accessory to the Spectrum infusion pump. The double rotating feature of the Double Rotating Pole Clamp enables the pump to be offset on the left or right side of the single (standard) IV pole. The clamp can also be clamped to hospital bedside rail diameters ranging from 0.75” to 1.25”. Refer to the cleaning section of this manual for compatible cleaners. Refer to the installation manual (SIGMA P/N 41092) on how to install the clamp on the pump. The dimension of the clamp is less than 7.0” long X2.5” wide. The weight of the clamp is less than 1.2 lbs. CAUTION:

Always operate the pump in vertical direction with the key hole at the top of the pump.

Tubing Channel/Pump Door The tubing channel consists of ■ ■ ■

Proximal air/occlusion sensor Pump valves and fingers Downstream tubing guide

These components are designed to facilitate in the proper loading of the IV tube.

Set Slide Clamp Sensor A reflective slide clamp sensor is employed to determine whether a closed slide clamp is present in the keyhole. If a slide clamp is present in the keyhole, the sensor LED light source illuminates and detects the presence of the clamp. The sensor component alerts the user that a closed slide clamp is present in the keyhole when the user presses the RUN/STOP key.

Processing Architecture The SIGMA Spectrum employs three computational processors. ■

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Two of the three processors, “Sharp” (Processor Board – 60087) and “PIC” (I/O Board – 60091), form a diverse checked redundancy scheme and perform all of the safety critical computations. The scheme is diverse because they are different processor types manufac-

Design and Theory of Operation

SIGMA Manual Number 41019 Revision AA

■

tured by separate, independent manufacturers. Likewise, these processors use different software compilers and math libraries, which yields additional independence. This processor pair uses a master/slave checked redundancy scheme where safety critical computations are computed by the master processor and checked by the slave processor. If either processor’s check calculation does not match its own computation or if a fault condition is detected, the processor can independently fail the system to a safe state, which includes an audible alarm. The third processor is used to charge the battery (Backflex – 35149), interface to the barcode scanner, and pass asynchronous data through the rear case connector.

Pumping Mechanism Physical Method The SIGMA Spectrum uses a linear peristaltic motion to pump the fluid. That is, the tubing is repeatedly squeezed to create fluid pressure and thereby flow of fluid. Operation There are two phases of the pumping cycle: ■ ■

Fill phase Pumping phase

The fill phase allows the tubing to be filled from the proximal or “upstream” end of the pump. The second phase of the cycle is the pumping phase. The pump consists of two valves, one of which occludes the administration set tubing at all times. The proximal valve occludes the tubing during the pumping phase of the cycle. Similarly, the distal valve occludes the tubing during the fill phase of the cycle. There are two “fingers” whose function is to squeeze fluid towards the distal end of the pump, thereby creating fluid pressure and fluid flow during the pumping phase of the cycle. During the fill phase of the cycle, the fingers are in a position that allows maximum volume of fluid to fill the tubing proximal to the distal valve. Pumping Mechanism Assembly This assembly is comprised of a cast aluminum chassis and doorplate assembly. The motor, cams, pumping fingers, upstream sensor and downstream sensor are also part of this assembly. All components are fastened with standard, Phillips and socket head machine screws.

Motor The motor is connected to the I/O Board (60091) through a 10-conductor, 1 mm pitch flex circuit. Motor Drive The motor drive circuitry will only allow the motor to run in a clockwise direction, which creates fluid flow from the proximal end of the pump to the distal end of the pump. Both the PIC and Sharp processors have the ability to independently remove power from the motor through independent hardware switches, thereby halting the pump in the event that single fault condition is detected. There are two mechanisms for detecting rotation of the motor. The first rotation sensing mechanism is the two-channel encoder, which can sense motor angular velocity as well as rotation direction. The second rotation sensing mechanism is the once-per-revolution hall effect sensor. These two sensing

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SIGMA Manual Number 41019 Revision AA

mechanisms eliminate the possibility of incorrect sensing motor velocity after a detectable single fault condition.

Motor and Gear Drive SIGMA Spectrum employs a 16 mm DC motor, encoder and planetary gearbox. The output shaft of the gearbox is coupled to the pump drive camshaft by two identical gears, thereby creating a 1:1 drive ratio between the camshaft and output of the gearbox. Motor speed is controlled by a closedloop pulse width modulation (PWM) drive system that derives its power directly from the battery or 9VDC source when the AC power adapter is connected.

Fluid Temperature Physical properties of administration set tubing are subject to the effects of fluid temperature. In general, colder temperatures can cause negative flow rate errors in an uncompensated system. Similarly, hotter temperatures can cause positive flow rate errors in an uncompensated system. The SIGMA Spectrum employs a temperature compensation system to maintain flow rate accuracy over the operating temperature range of the device. Approximate fluid temperature is measured by two negative temperature coefficient thermistors, one proximal to the pumping mechanism and one distal to the pumping mechanism. The proximal sensor is housed by the upstream sensor assembly. The distal sensor is located in the lower tubing guide, just below the distal occlusion sensor. Both sensors are calibrated at the factory, and are used to check each other for single fault failure conditions. The output of both thermistors are filtered and fed to A/D converters for processing by Spectrum processors for compensating pump motor speed to maintain flow rate accuracy.

Upstream Sensors Optical Tube Sensor The optical tube sensor consists of a light emitting diode (LED) emitting infrared light and a phototransistor. The LED and phototransistor are located at the bottom of the ultrasonic sensor housings, facing opposite to each other. This position is marked as load point 2 and is indicated in red color next to the “direction of flow” label inside the pump door. The optical tube sensor detects that an IV set is loaded at load point 2 to assist in proper loading of the IV set into the pump. It must recognize the presence or absence of the IV tube. The sensor is activated only when the door is open. If the IV tube is properly placed in the space between the LED and phototransistor, the infrared light is diffracted and the phototransistor outputs a high voltage. If there is no IV tube present, the phototransistor receives continuous infrared light and a low voltage is output. The software monitors the output voltage and displays a green bar with a check mark to indicate a properly loaded tube or a red bar with loading instructions when there is no tube or if the tube is improperly placed in the sensor. This sensor is calibrated through a biomed option. Proximal Occlusion Detection The proximal occlusion sensor consists of two pairs of ultrasonic transmitters and receivers. A “pusher” connected to the door assembly assures that a constant force is exerted to push the administration set tubing against the sensor housing. The transmitted ultrasonic signal is a constant wave

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Design and Theory of Operation

SIGMA Manual Number 41019 Revision AA

(CW) signal centered at a nominal 293 KHz. This signal is generated by exciting a piezoelectric crystal near its natural resonant frequency. The ultrasonic signal propagates from the sensor housing laterally through the administration set tubing. The ultrasonic receiver is a piezoelectric crystal matched in frequency to the transmitter. The differential output of the receiver is amplified, envelope detected, and filtered before being presented to a 12-bit A/D converter where it is converted to a 12bit digital word. Three samples are taken for each pump revolution. The digital words are processed by the SIGMA Spectrum processor and fed into a detection algorithm. The detection algorithm compares successive samples and looks for a trend of decreasing signal amplitude caused by a reduction in pressure against the sensor housing. If the trend continues through a predetermined threshold over a predetermined unit of time, a proximal occlusion is declared and a visual and audible alarm is presented to the user. Air Sensor The air detector uses the same sensor hardware as described in the Proximal Occlusion Detection section. The air detection algorithm uses an “air” threshold that is set by a calibration routine at the factory. If the signal amplitudes received by both sets of ultrasonic receivers are below the air threshold, an air alarm is declared and a visual and audible alarm is presented to the user. The SIGMA Spectrum air sensor is designed to detect air bubbles greater than 1 inch of tubing (125–150 µl depending on tubing calibration).

Downstream Sensors Set Loading The downstream sensor consists of a channel piezoelectric bridge force transducer and is located between loading points 3 and 4 inside the pump door. This sensor has two basic functions. The first is to acknowledge an IV administration set as being installed at load points 3 and 4. Acknowledgement is identified on the display with a third green bar and check mark. The second function is to detect distal occlusions. Distal Occlusion Detection The distal occlusion sensor uses a piezoelectric bridge force transducer. A pusher connected to the door assembly assures that a constant force is exerted to push the administration set tubing against the sensor housing. The detection algorithm compares successive samples and looks for a trend of increasing/decreasing signal amplitude caused by a increase/reduction in pressure against the sensor housing. Four samples are taken for each pump revolution. The differential output of the force transducer is amplified, envelope detected, and filtered before being presented to a 12-bit A/D converter where it is converted to a 12-bit digital word. The digital words are processed by the SIGMA Spectrum processor and fed into a detection algorithm. The detection algorithm compares the received signal levels to thresholds set by the user selected occlusion alarm trip points. If the received signal exceeds the trip points, a distal occlusion alarm is declared and a visual and audible alarm is presented to the user.

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Audible Alarm Device and System The audible alarm device is a 1-inch moving coil speaker. The speaker is driven by two separate audio paths, one by the Sharp and one by the PIC. Either the Sharp or PIC can independently sound an audio alarm tone if an alarm occurs or a fault is detected.

Electronic Components AC Power Adaptor / Charger The SIGMA Spectrum infusion pump uses an AC power adaptor capable of providing 9 VDC. The power adaptor connects to Spectrum via a positive locking connector, which will reduce the possibility of accidental disconnection. When the AC power adaptor is plugged into an AC receptacle, the lithium ion battery pack will be charged. Normal charger operation occurs as follows: If the battery requires charging, the Spectrum battery charger will initially maintain the battery at a constant current of approximately 250 mA (400 mA if pump is non-wireless or wireless is turned off). After the battery voltage reaches a nominal charge of 8.3 volts, the charger maintains this voltage until the charging current supplied to the battery is less than 60 mA. The battery charge cycle is completed and will terminate. There are three mechanisms employed to prevent overcharging of the battery: ■ ■ ■

The charging microcontroller’s ability to monitor and control voltage and current applied to the battery. A current clamp circuit is employed to prevent charge currents that would cause charge circuit overheating. Battery pack protection circuits within the battery pack itself prevent overheating and over charging.

The adaptor side of the AC power adaptor is equipped with a Protector (P/N 45742). The Protector is a plastic enclosure which snaps onto the adaptor. The purpose of the Protector is to protect the adaptor from damage during use in a hospital environment. The AC power adaptor with the Protector can be used on wall outlet and pole mount power strip receptacles. The Protector comes installed with the pump. The Protector cannot be removed from the adaptor once it is installed. The Protector can be ordered separately as an accessory for installing on an old AC power adaptor. A separate instruction bulletin on how to install the Protector is sent along with the Protector. The Protector is compatible with the cleaners mentioned in this Service Manual. Refer to “SIGMA Spectrum Cleaning” on page 26 of this Service manual for cleaning methods and compatible cleaners that can be used on the Protector. CAUTION:

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IMPROPER REMOVAL MAY DAMAGE THE AC POWER ADAPTOR. Remove the AC power adaptor by grabbing the handle of the Protector and pulling it back off the receptacle. Do not pull the cord to unplug the Adaptor from the receptacle. Improper twisting or pulling of the connector or cord may damage the AC power adaptor.

Design and Theory of Operation

SIGMA Manual Number 41019 Revision AA

Display Spectrum uses a highly reflective thin film transistor (HRTFT) liquid crystal display containing: ■ ■ ■ ■

240 X 320 pixels (240 x270 are active) Color HRTFT - 16 out of a palette of 262,144 possible colors 0.2235 mm X 0.2235 mm dot pitch Illumination by side mounted LEDs and diffuser.

The display employs front lighting using six white LEDs. Brightness of the LED front light is controlled by a constant current source implemented on the 60091 I/O Board. The display can be easily viewed while mounted to an IV pole, with viewing distances up to 15 feet and a minimum viewing angle of ±30 degrees from a line perpendicular to the display plane. The display has two flex circuit connections: The first 50-conductor flex circuit carries digital display and control data as well as power for the display. The second 5-conductor display flex circuit carries power for the back light. Both of these flex circuits connect to 0.5 mm flex circuit connectors on the I/O Board. I/O Board This 10-layer, 100% surface-mount component circuit board distributes input and output (I/O) from all sensors (except the ultrasonic air detector) through flex circuit connections that will be discussed in detail below. The I/O board also receives the keypad, motor and display flex circuit signals. The I/ O board hosts A/D converters and discrete I/O to interface to the Spectrum sensors. Processor Board This 10-layer, 100% surface mount component circuit board distributes input and output (I/O) from the ultrasonic air detector through a 40-pin flex circuit connection (detailed below). Additionally, the processor board hosts the Sharp processor, which controls the HRTFT display, and performs most of the primary computations for Spectrum. The processor board also hosts the real-time clock (RTC) chip and lithium back-up battery for the RTC, Flash and static RAM memory. Flex Circuits ■

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■

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Ultrasonic Flex - This flex circuit provides connections to two pairs of ultrasonic piezoelectric crystals (receive and transmit) as well as the secondary tube temperature thermistor. The Ultrasonic Flex is connected to the processor board (60087) through a 0.5 mm pitch, 40conductor, right angle flex connector. Upper Aux Flex - This flex circuit provides connections to the upper door latch and link discrete signals, once per revolution hall effect sensor, and slide clamp sensor signals. The upper aux flex is connected to the I/O board (60091) through a 0.5 mm pitch, 30-conductor, vertical flex connector. Lower Aux Flex - This flex circuit provides connections to the lower door latch and link discrete signals. The lower aux flex is connected to the I/O board (60091) through a 0.5 mm pitch, 10-conductor, vertical flex connector. Force Sensor Flex - This flex circuit provides connections to the distal force sensor and the primary tube temperature thermistor. The force sensor flex is connected to the I/O board (60091) through a 0.5 mm pitch, 10-conductor, vertical flex connector. Backflex - This flex is connected to the I/O board (60091) through a 0.5 mm pitch, 30conductor, vertical flex connector. The backflex provides the following functions:

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■ System power supply control and fuse – A 2.5 Amp surface-mount primary power fuse is mounted on this flex circuit. Additionally, four dual battery contacts are also on this flex circuit. ■ High-Speed UART Interface / MUX – A digital MUX allows either a smart battery interface that includes an UART, or traditional “dumb” battery connections (battery type ID resistor and battery thermistor). ■ Battery System Charge Control – An Atmel 8-bit microcontroller is hosted on the backflex. One function of this processor is to control battery charging. ■ Audio Output – The backflex provides connections to a 1-inch moving coil speaker that is used during audio alarms. ■ Temperature Monitor – A temperature sensing thermistor is hosted on the backflex, which provides internal case temperature to the Spectrum processors. ■ Advanced Battery Removal Detector – A magnetic reed relay is housed on the backflex, and provides an early or advanced battery disconnection warning to the Spectrum processors. Keypad The keypad consists of 19 user-actuated keys. Keys 1–9 also have alpha designations A–Z (in groups of 3 starting at the 1 key, with the exception that the 9 key has alpha designation “YZ”), a “0” key, a decimal point, 4 soft keys, a RUN/STOP key, and an ON/OFF key. The keypad is constructed of polyester dome keypad material with a circuit layer and adhesive layer. The keypad is edge sealed to prevent fluid intrusion between the layers of the keypad. The keypad is connected to the I/O board through a 10-conductor 1-mm pitch flex circuit. The following is a detailed description of the keys: ■ ■ ■ ■ ■

■

ON /OFF: Powers up the pump. OK: This key accepts the information currently shown on the pump display and advances the pump program to the next screen. SETUP: This key is used to access the Care Area Selection screen. RUN/STOP: This key signals the request to Start or Stop infusions. Soft keys: Four multi-function keys. Can be used in conjunction with the display to perform any software programmable function including but not limited to Bolus operations, navigation arrows, help screens etc. Alphanumeric 1-9: These keys may be used to enter numeric sequences including real numbers with decimal point. Alphabetic strings may also be entered using the alphabetic groupings of characters found on these keys.

The infrared interface (Infrared Data Association) utilizes the IrDA protocol that can connect to personal computers and personal digital assistants (PDAs) that employ the IrDA standard. This digital interface can transmit and receive data at rates of up to 115 thousand bits per second (115Kbs). The IrDA interface is accessible through the SIGMA Spectrum keypad that is located on the front case assembly. The IrDA port operates at distances of up to 3 meters assuming a direct line of sight within a 15-degree conic section. Power Connector The power connector serves two functions: ■ ■

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External power input Asynchronous data interface

Design and Theory of Operation

SIGMA Manual Number 41019 Revision AA

Pump Specifications Applications ■ ■

Large and small volume parenterals Neonatal

Administration Set Compatible with standard gravity IV sets supplied by Baxter® and Hospira® and several other companies. (Visit www.sigmapumps.com for a full listing).

Performance Downstream occlusion time to alarm for occlusion pressures adjusted to LOW (6 psi), MEDIUM (13 psi), and HIGH (19 psi)1:

Rate

Low (6 psi)

Medium (13 psi)

High (19 psi)

5 mL/hr

<5 min.

<10 min.

<20 min

100 mL/hr

<15 sec.

<20 sec.

<40 sec.

Max. Bolus

0.25 mL

0.50 mL

0.80 mL

All safety related sensing systems are automatically checked for proper operation periodically during setup and pump running conditions. Faults are identified by SYSTEM ERROR codes. See the Specifications section of the Operator’s Manual for additional specifications. Effect of Fluid Container Height2 The performance of the infusion pump will be influenced by the forces of gravity on the fluid being administered to the patient. When a fluid container is positioned above or below the patient’s administration site, pressure forces associated with the fluid’s head-height (distance measured from the center of the pumping mechanism to the top of the fluid in the source container) will cause deviations in the nominal specification for device flow rate accuracy. The nominal head-height used for the flow rate and the graphical presentation is 24” (61 cm). For example, the deviation from the nominal flow rate accuracy from +24” to -20” (-51 cm) head-height has an influence of a possible -4% in flow rate accuracy when the flow rate is set to 25 mL/hr. Bolus Accuracy The SIGMA Spectrum IV pump may have an optional bolus mode of operation. This feature allows the user to perform a BOLUS SETUP action. To use this feature the pump must be programmed with either a specific rate or a specific amount to be delivered in a certain amount of time.

1.With Occlusion 45 inches below the pump and alarm set to LOW, MEDIUM or HIGH. 2.Liquid container must be a vented or collapsible bag.

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If the pump is currently operating in mL/hr delivery mode, the bolus rate value is entered in mL/hr and the volume is entered in milliliter (mL). If the pump is operating in a non-mL/hr delivery mode (for example mcg/kg/min), the bolus amount would be entered in mcg/kg however the ML/HR soft key may be pressed in the setup screen to enter the bolus information in mL/hr format. In either mode, the time is entered in minutes and seconds (min:sec). Limits are placed on the minimum and maximum amount of time for the bolus delivery. The limit constraints are contained within the software of the Spectrum pump and are necessary to control the maximum or minimum flow rate of the bolus infusion. The accuracy of the bolus volume is dependent upon the resultant flow rate that is obtained from the calculation of volume to be delivered in the time requested. For example, if the maximum bolus volume is 300 mL, the maximum flow rate is obtained with a bolus time of 18:02 (min:sec) or a flow rate of approximately 999 mL/hr. Using this maximum bolus volume, and delivering the volume in the shortest amount of time, the mean value of 302 mL ±5% may be expected. Whereas using a minimum bolus volume (.5 mL), and delivering the volume in a reasonably short amount of time (1 minute), the mean value of .52 mL ±16% may be expected. Technical ■ ■ ■ ■

Type of pump - volumetric infusion pump. Operating principle - linear peristaltic Patient leakage: <15 micro amps, normal condition; <50 micro amps, single fault condition. Battery type: 7.2-volt battery pack consisting of (2) 3.6V/1.8 Ampere-hr rechargeable lithium ion, or 7.2-volt battery pack consisting of (2) 3.7V/1.75 Ampere-hr rechargeable lithium ion. ■ Alarms: ■ Air-In-Line ■ Downstream Occlusion ■ Upstream Occlusion ■ Door Open, Door Not Latched ■ Low and Depleted Battery ■ AC Applied / Removed ■ Battery Not Detected ■ Infusion Complete ■ Secondary Complete ■ Secondary Delivery ■ Primary Delivery ■ User Inactivity ■ Unload Set Caution ■ System Errors ■ Incomplete Titration Entry ■ Slide Clamp Closed NOTE: For additional technical specifications, refer to the SIGMA Spectrum Operator’s Manual.

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Design and Theory of Operation