Sigma spectrum 35700ABB Service Manual
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Sigma spectrum 35700ABB Service Manual

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s p e c t r u m
Service
Manual
35700ABB & 35700BAX
SIGMA, LLC
711 Park Avenue
Medina, New York 14103
v 800 356 3454
f 585 798 3909
www.sigmapumps.com

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  • Page 1 Service Manual 35700ABB & 35700BAX SIGMA, LLC 711 Park Avenue Medina, New York 14103 v 800 356 3454 f 585 798 3909 www.sigmapumps.com...
  • Page 2 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...

  • Page 3: Table Of Contents

    Contacting SIGMA Technical Support ........2...
  • Page 4 SIGMA Spectrum Cleaning ........
  • Page 5 SIGMA Manual Number 41019 Revision AA Air Detection Test* ........... . 34 Memory Test .

  • Page 6: Introduction And Safety

    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.

  • Page 7: Listings & Certifications

    (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...

  • Page 8: Conventions

    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.
  • Page 9 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.

  • Page 10: Design And Theory Of Operation

    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.
  • Page 11 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)

  • Page 12: Pole Clamp

    Revision AA 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”...

  • Page 13: Pumping Mechanism

    Pumping Mechanism Physical Method The SIGMA Spectrum uses a linear peristaltic motion to pump the fluid. That is, the tubing is repeat- edly squeezed to create fluid pressure and thereby flow of fluid. Operation...

  • Page 14: Motor And Gear Drive

    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 closed- loop pulse width modulation (PWM) drive system that derives its power directly from the battery or 9VDC source when the AC power adapter is connected.

  • Page 15: Air Sensor

    If the signal amplitudes received by both sets of ultrasonic receivers are below the air thresh- old, 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).

  • Page 16: Audible Alarm Device And System

    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 possibil- ity of accidental disconnection. When the AC power adaptor is plugged into an AC receptacle, the lithium ion battery pack will be charged.

  • Page 17: Display

    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...

  • Page 18: Keypad

    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.

  • Page 19: Pump Specifications

    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.

  • Page 20: Technical

    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. Design and Theory of Operation...

  • Page 21: Configuration Options

    The Spectrum pump has two sets of configuration options: User Options Biomed Options NOTE: For a description of the User options, refer to the SIGMA Spectrum Operator’s Manual. BioMed Options Biomed Options allow the Biomedical Technician access to certain pump functions and settings. This section will describe the options available to the technician.

  • Page 22: Sensor Configuration

    The Calibration Menu provides access to sensor calibration data. There are 4 sensors in this menu and, the biomed personnel can access the sensor data in these menus. Calibration of the device shall be performed by technicians that have been NOTE: formally trained by SIGMA personnel on Spectrum calibration procedures ONLY. Sensor Calibration Upstream Sensor View Calibration Values - Provides a utility to view the Upstream Sensor calibration data that follows.

  • Page 23: Pump Settings

    SIGMA Manual Number 41019 Revision AA Red Hz Green Hz Blue Hz Optical Tube Sensor View Calibration Data - Provides a utility to view the Optical Tube Sensor calibration data. No Tube VDC Tube VDC Pump Calibration View flow calibration values - Allows the Biomedical Engineer/Technician to view flow cali- bration correction values applied during the flow rate calibration process.

  • Page 24: Pump Testing

    IP Addr - Displays the current IP address of the pump. SIGMA GW - Displays the IP address or DNS name of the network host, also known as the Sigma Gateway server.
  • Page 25 Sigma GW - (read-only, set via network configuration file) The IP address or DNS name of the network host, also known as the Sigma Gateway server. Either this item or ‘Mul- ticast’ may be set, but not both.

  • Page 26: Wireless Networking

    IP Addr – displays the current IP address of the pump. SIGMA GW – displays the IP address or DNS name of the network host, also known as the SIGMA Gateway server.

  • Page 27: Transfer Network Status

    # DHCP=1 DHCP enabled - IP, GATEWAY, NETMASK, and DNS must be blank DHCP=1 GATEWAY= NETMASK= DNS= # Leave either SIGMAGW or MULTICAST blank # SIGMAGW set to DNS name or IP address of SIGMA gateway server SIGMAGW=SIGMAPUMPGW # MULTICAST group default is 239.237.12.87 MULTICAST= # DEVICEID set to device alias Limited...

  • Page 28: Network Settings

    Multicast – (read-only, set via network configuration file) the IP address of the multicast group that the pump joins to learn the location of the host. Either this item or ‘SIGMA GW’ may be set, but not both.

  • Page 29: Tcp/Ip Settings

    SIGMA Manual Number 41019 Revision AA TCP/IP Settings – This option shows the TCP/IP settings of the pump’s network connection. If Dynamic Host Control Protocol (DHCP) is enabled, the current settings as configured by the DHCP server will be shown.

  • Page 30: Network Interface Information

    Contact SIGMA LLC for further information pertaining to suggested host requirements and/or details needed for network implementations.

  • Page 31: Service And Maintenance

    At power off, a due for inspection display will appear prior to pump shutdown. SIGMA Spectrum Cleaning The SIGMA Spectrum is portable and should be cleaned and disinfected for each patient use accord- ing to facility protocol. Compatible Cleaners...
  • Page 32 DO NOT use phenolic-based cleaners or disinfectants; extended use may cause damage to the keyboard, case and any other plastic component of the SIGMA Spectrum. DO NOT use spray or aerosol cleaners. A lint-free, foam-tipped swab (Chemtronics FoamtipTM or Qosmedix® precision foam tip for example) may be used in the tube channel.

  • Page 33: Battery Removal And Replacement

    Disconnect the AC power adaptor, and lay the pump on its front. Use a protective surface, such as plastic foam, to prevent damage to the keypad window. Remove the screw located in the upper right-hand corner of the SIGMA Spectrum battery (if equipped).
  • Page 34 SIGMA Manual Number 41019 Revision AA Using the TORX driver, remove and retain the four TORX head screws from the case. (Wireless modules purchased prior to 2008 may have five torx head screws on this side of the case). Turn the wireless battery module over so that the terminals are now towards the work sur- face and remove and retain the one remaining TORX head screw at the top of the antenna housing.

  • Page 35: Battery Disposal

    Package the pump in the original shipping container (replacement available upon request) and affix the RA number on the outside of the package. Ship pump, freight prepaid, by traceable means to: SIGMA LLC. SIGMA LLC will not be responsible for unauthorized returns or units damaged in shipment due to improper packing.

  • Page 36: Preventive Maintenance

    Revision AA PR EVENTIVE MAINT ENANCE To ensure that the SIGMA Spectrum IV pump is operating within the specified parameters set forth by SIGMA LLC, perform the preventive maintenance tests in this section according to the mainte- nance schedule below. After each operation in this procedure, record the results on a copy of the Pre- ventive Maintenance Check Sheet at the end of this section.

  • Page 37: Visual Inspection

    SIGMA Manual Number 41019 Revision AA Preventive Maintenance Tests CAUTION: All testing and evaluations require fluid and air temperature of 72°F ±2°F. NOTE: The brand of IV sets being tested must be compatible with the pump under test. The proper IV set calibration is listed on the label located on the top of the pump.

  • Page 38: Upstream (Proximal) Occlusion Sensor Test

    SIGMA Manual Number 41019 Revision AA Press the CLEAR soft key and enter “.” and “0” using the keypad and observe the Rate mL/ hr field to be “0.0” Press the CLEAR soft key, and press the key until the Volume Given field is highlighted.

  • Page 39: Air Detection Test

    SIGMA Manual Number 41019 Revision AA Verify that DS Occlusion Auto Restart is set for “on” and verify US/Air Alarm Confirm is set for “on”. Press the EXIT soft key two times to return to the OPTIONS screen. On the options screen, select User Options and press OK.

  • Page 40: Memory Test

    SIGMA Manual Number 41019 Revision AA For Mode select mL/hr and press OK. Set the Rate to 100mL/hr and press OK. Set VTBI mL to 50 mL and press OK. Press the RUN/STOP key. Pumps with v6.00.00 and later software versions will display the Check NOTE: Flow screen once the pump is started.

  • Page 41: Ac Power Adaptor Safety Analysis

    SIGMA LLC for re-calibration. AC Power Adaptor Safety Analysis Inspect the SIGMA P/N 35714 AC power adaptor for signs of abuse such as cracks in the housing or bent AC main prongs. Verify green LED is lit.

  • Page 42: Battery Capacity Test

    SIGMA Manual Number 41019 Revision AA Battery Capacity Test The storage capacity for the battery may be determined by running the Battery Capacity Test. Connect the pump to the AC power line for at least 12 hours prior to the test, to allow the battery to attain full charge.

  • Page 43: Pass Criteria For A Used Battery

    SIGMA Manual Number 41019 Revision AA Pass criteria for a used battery ≥6 hours from “Start to dead” and ≥31 minutes from “Low to dead”. NOTE: If a wireless battery module is installed, the pump used battery pass criteria is ≥3 hours from “Start to dead”...

  • Page 44: Preventive Maintenance Check Sheet

    SIGMA Manual Number 41019 Revision AA Preventive Maintenance Check Sheet Serial Number: ______________________ Date:______________________ Software Version:_________________________________ Control Number:_________________________________ Test Pass Fail Visual Inspection Keyboard Test Upstream (Proximal) Occlusion Sensor Test Air Detection Test Downstream (Distal) Occlusion Sensor Test ___________psi or ___________mm/hg...

  • Page 45: Troubleshooting

    At this time the replacement of this battery is not user-serviceable and the pump must be returned to SIGMA for battery replacement. Battery (Very) Low – Send Pump For Repair – This alert appears during a Low Battery alarm when, through a tutorial-based system of user prompts, it has been determined that the external power cord or supply is damaged and may need to be serviced or replaced.

  • Page 46: System Error Code Descriptions

    If the charge error repeats, return the pump to SIGMA for service. System Error Code Descriptions A series of error codes are generated by the software of the SIGMA Spectrum Infusion Pump, then displayed on the pump. The following error codes are intended to help the biomedical engineer to identify problems encountered during operation of the pump for assistance in repair of the product.
  • Page 47 SIGMA Manual Number 41019 Revision AA Displayed and Error History Log Description Code # Language Sensor disparity (fast) Motor is speeding up Motor without PWM Motor movement without PWM PWM MAX Max PWM for too many revs Bad Motor Msg Tag...
  • Page 48 SIGMA Manual Number 41019 Revision AA Displayed and Error History Log Description Code # Language Diag Task Starved Diagnostic task starved Set Mech task Starved Set mechanism task starved Unknown Tsk Checked In Unknown task checked in Network Task Starved...
  • Page 49 SIGMA Manual Number 41019 Revision AA Displayed and Error History Log Description Code # Language Latch Switch Error Hook switches do not agree Link Switch error (up) Upper link switch not activating Link Switch Error (low) Lower link switch not activating...
  • Page 50 SIGMA Manual Number 41019 Revision AA Displayed and Error History Log Description Code # Language 402-411 NVM write error: x (1- NVM write failed User NVM CRC Error NVM CRC check failed (user data) Cal NVM CRC Error NVM CRC check failed (cal data) Wrong NVM structure NVM version # doesn’t match...
  • Page 51 SIGMA Manual Number 41019 Revision AA Displayed and Error History Log Description Code # Language Bad drug lib CRC Drug library CRC failed Bad drug lib data Bad drug library data Invalid Drug Lib Version Bad drug library version Cannot read from RTC...
  • Page 52 SIGMA Manual Number 41019 Revision AA Displayed and Error History Log Description Code # Language Invalid PIC Version Wrong PIC version Invalid CPLD Version wrong CPLD version Invalid AVR Version Wrong AVR version Invalid Smart Battery Wrong smart battery version...

  • Page 53: Logging

    Infrared Data Association (IrDA) port using the Dump History Log option. NOTE: This procedure applies to the transfer of the history (event) log contents from a SIGMA Spectrum Infusion pump with V5.00.06 Operating Software to a PC via the IrDA port.
  • Page 54 SIGMA Manual Number 41019 Revision AA Transfer the history log using the pump-to-PC method: a. Position the pump near the PC such that the IrDA ports of both devices are in an unob- structed line-of-sight orientation with a distance of no greater than 3 feet between them.
  • Page 55 SIGMA Manual Number 41019 Revision AA Files that have the *.log extension may require selection of software to “Open with…”. Typically, Microsoft® Wordpad may be used to open even the longest history log files. b. Confirm that the file is readable.

  • Page 56: Appendix A: Technical Drawings

    SIGMA Manual Number 41019 Revision AA APPENDIX A: TECHNICAL DRAWINGS Figure 3Assembly, Spectrum Final 35700 Appendix A: Technical Drawings...
  • Page 57 SIGMA Manual Number 41019 Revision AA...
  • Page 58 SIGMA Manual Number 41019 Revision AA Figure 4. Assembly, Rear Case 35701 Appendix A: Technical Drawings...
  • Page 59 SIGMA Manual Number 41019 Revision AA Figure 5. Assembly, Key Hole 35709...
  • Page 60 SIGMA Manual Number 41019 Revision AA Item Part No. Description Quantity 95213 Screw, 0-42 x 3/8” thread Forming, SS 41021-1 Label, blue color sensor 41021 Label, red color sensor 50730-2 Keyhole extension - Baxter 50730 Keyhole extension - Hospira 45751...
  • Page 61 SIGMA Manual Number 41019 Revision AA Figure 6. Assembly, Pole Clamp 35712 Item No. Part No. Description Quanity 45727 Pole Side Adaptor 55041 C-Clamp 95204 Screw, 1/4-20 x 5/8", FHMS, SS 95064 Washer, 1/4” External Tooth Star, SS...
  • Page 62 SIGMA Manual Number 41019 Revision AA Figure 7. Assembly, Double Rotating Pole Clamp 35743 Item No. Part No. Description Quanity 45727 Pole Side Adaptor 95064 Lockwasher, 1/4 Countersink, SS 95204 Screw, 1/4-20 x 5/8” 55129 Double Rotating Pole Clamp 41093...
  • Page 63 SIGMA Manual Number 41019 Revision AA Figure 8. Assembly, 802.11b Wireless Battery Module 35083 Item No. Part No. Description Quanity 45737 Battery Case - Front 45739 Latch, Battery 95065 Spacer, Nylon 6/6, White...
  • Page 64 SIGMA Manual Number 41019 Revision AA Item No. Part No. Description Quanity 60128 Assembly, Wireless Flex 55095 Digi Module 55094 Antenna 55075-1 or Battery Pack 55075-2 95213 Screw, 0-42 x 3/8 SS Thread Forming 50738 Contact, Wireless Battery 55024-3 Magnet, Battery, 0.25 DIA x 0.031 THK...
  • Page 65 SIGMA Manual Number 41019 Revision AA Figure 9. Assembly, 802.11b/g Wireless Battery Module 35162 16 13 SEALANT TO BE APPLIED AROUND ENTIRE EDGE OF FRONT CASE INCLUDING BATTERY TERMINALS AND SCREW OPENINGS Item No. Part No. Description Quantity 45737 Battery Case - Front...
  • Page 66 SIGMA Manual Number 41019 Revision AA Item No. Part No. Description Quantity 95213 Screw, 0-42 x 3/8 SS Thread Forming 95222 S Screw, 0-42x 3/16, Thread Forming 95507 Spring, Compression 50738 Contact, Battery 55024-3 Magnet, Battery, 0.25 DIA x 0.031 THK 90058 Lubricant &...
  • Page 67 SIGMA Manual Number 41019 Revision AA Figure 10. Packaging Assembly 35716 BACK VIEW DISCARD PACKAGING FOAM, TOP AS RECEIVED FROM THE VENDOR Item No. Part No. Description Quantity 98009 Packing Box 98010 Packaging Foam, Bottom 98012 Anti-Static Bag 35700 Spectrum Final Assembly...
  • Page 68 SIGMA Manual Number 41019 Revision AA Item No. Part No. Description Quantity 98011-1 Packaging Foam, AC Power Adaptor Packing Tape 2" 41018 Operator’s Manual 41019 Service Manual 85088 Alcohol, Isopropyl 35724 Assembly, Battery 35083 Wireless Battery Module 35724 Li-Ion Battery Assembly...

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