Sigma sigmaspectrum 35700ABB Operator's Manual
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Sigma sigmaspectrum 35700ABB Operator's Manual

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s p e c t r u m
Operator's
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 Operator’s 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 41018 Revision AR ©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 ........1...
  • Page 4 SIGMA Manual Number 41018 Revision AR Programming the Pump ......... . 21 Keys Used to Program and Operate the Pump .
  • Page 5 SIGMA Nitroglycerin/Lipid Sets ........
  • Page 6 SIGMA Manual Number 41018 Revision AR Effect of Back Pressure ..........72 Flow Profile .

  • Page 7: Introduction And Safety

    INTRODUCTION AND SAFETY Intended Device Use The SIGMA Spectrum and SIGMA 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. ...

  • Page 8: Conventions

    Operation is Limited to Trained and Tested Operators WARNING: SIGMA Spectrum operation is strictly limited to trained operators whose competency in safe Spectrum operation and in safe IV therapy practices has been tested and proven. Pump owners have sole responsibility for operator training and testing even when SIGMA personnel assist in training processes.
  • Page 9 SIGMA Manual Number 41018 Revision AR WARNING: Prevent Inaccuracy The following can cause flow rate inaccuracies and must be avoided: Incompatible brand IV sets and compatible brand IV sets with unusually large or small diameters or unusually stiff materials. Operating temperatures outside of 60-90°F for Standard Battery and 60-80°F for Wireless Battery Module.
  • Page 10 SIGMA Manual Number 41018 Revision AR WARNING: Do Not Allow Uncontrolled Gravity Flow To open the pump door, the IV set’s slide clamp must first be closed (thus providing “set-based anti-free flow” protection). Do not open the slide clamp when the door is open or during and after IV set unloading. This can cause dangerous, uncontrolled free flow to occur.
  • Page 11 CAUTION: Confirm Audio Operation When pressing the ON key and all other keys, confirm that an audio beep is heard. If sound cannot be heard, discontinue use of the pump and return to SIGMA for service. Confirm Display Operation CAUTION: Regularly observe the pump’s display.
  • Page 12 SIGMA Manual Number 41018 Revision AR CAUTION: Accuracy Refer to trumpet curves for flow rate accuracy as a function of short infusion durations. The upstream occlusion detector may not detect partially occluded tubing. Always check to ensure the IV set’s clamp is not closed above the Spectrum pump.

  • Page 13: System Components

    Transfer from a wireless network connection to a pump using a wireless battery module Transfer from a PC via infrared to a pump SIGMA Spectrum Infusion Pump - The pump and the interface for programming the pump. Standard Gravity IV Sets - Compatible IV sets with slide clamp used for the door opening.

  • Page 14: Spectrum Pump Illustrations

    SIGMA Manual Number 41018 Revision AR Spectrum Pump Illustrations Figure 3. Front View - Door Open Figure 4. Back View- With Standard Battery (P/N 35724) Figure 5. Back View- With 802.11b Wireless Bat- Figure 6. Back View- With 802.11b/g Wireless...

  • Page 15: Hardware Labeling

    SIGMA Manual Number 41018 Revision AR Hardware Labeling The following is a description of the labels and symbols that appear on the Spectrum pump Attention, consult ACCOMPANYING DOCUMENTS (ISO 7010-W001) CLASS II EQUIPMENT (IEC 60417-5172) TYPE BF APPLIED PART (IEC 60417-5333)

  • Page 16: Battery Compatability

    SIGMA Manual Number 41018 Revision AR BATT ER Y COMPAT ABILITY 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.

  • Page 17: Setting Up The Pump

    SETTING UP THE PUMP Unpack the Pump The SIGMA Spectrum is packaged to provide protection during transportation and storage. When you unpack the pump, remove the Spectrum from the protective anti-static bag, remove the protect- ing foam end caps, and discard the desiccant package.

  • Page 18: Power Adaptor Protector

    Align the arrow on the power adaptor cord with the arrow on the connector identified as the external power adaptor connection (on the back of the SIGMA Spectrum pump). Insert the power adaptor module into the appropriate powered outlet receptacle.

  • Page 19: Charging The Battery

    Charging the Battery When the SIGMA Spectrum is connected to the AC Power Adaptor and the adaptor is plugged into a powered outlet receptacle, the pump’s Standard Battery Pack or Wireless Battery Module will be charged to full capacity. It is not necessary to turn the pump on.

  • Page 20: The User Options Menu Has Three Categories

    SIGMA Manual Number 41018 Revision AR Press the OPTIONS softkey. Select User Options from the options list and press OK. Software version 6.03.01 and later From the Care Area selection screen: Press the OPTIONS softkey. Select User Options from the menu and press ok.
  • Page 21 SIGMA Manual Number 41018 Revision AR ‘New Patient?’ Prompt – When the pump is turned on and programmed infusion data exists in memory, a screen is displayed asking the operator if the intended use for the pump is for a New Patient. Answering YES to this prompt clears the existing infusion data, answering NO retains the data and allows the operator to resume the infusion.

  • Page 22: View Information

    CPLD build SmartBatt Charger build Network Module build Serial number – The serial number assigned by SIGMA for tracking and device history. Tube type – the name of the IV tube set manufacturer that the device is calibrated for use with.

  • Page 23: Operational Overview

    SIGMA Manual Number 41018 Revision AR OPERATIONAL OVERVIEW The following sections provide a high-level overview of how to setup, program, and operate the Spectrum pump. For detailed instructions, refer to these sections: “Preparing the Pump and IV Sets” section, beginning on page 19 “Programming the Pump”...

  • Page 24: Secondary Infusions

    SIGMA Manual Number 41018 Revision AR Secondary Infusions Lower the primary bag at least 20" below the secondary bag. Stop the pump if it is running. Press the REVIEW/PROGRAM softkey. Press the PROGRAM SECONDARY softkey. Select the drug for the secondary infusion.

  • Page 25: Preparing The Pump And Iv Sets

    Select only IV sets made by the manufacturer listed on top of the pump. IV sets must be of standard stiffness and diameter. Performance can not be achieved using stiff, large, or small diameter tubing. Contact SIGMA for compatible standard IV set lists and for special SIGMA blood, nitroglycerin and lipid sets.

  • Page 26: Unloading An Iv Set

    SIGMA Manual Number 41018 Revision AR c. Push the tubing into loading point #2 and then loading points #3 and #4. The tubing is properly loaded when the screen displays a green bar and a check mark. Close the door by pressing the upper and lower corners near the door hooks.

  • Page 27: Programming The Pump

    Revision AR PR OGRAMMING THE PUMP The SIGMA Spectrum Pump provides two main options for controlling infusions: Drug Error Prevention (DEP) Mode - This mode uses predetermined dosing information stored in the Master Drug Library to control the dose, rate, volume, time and other infusion parameters for specific drugs.
  • Page 28 SIGMA Manual Number 41018 Revision AR Description LETTERS Press numeric keys once, twice, or three times to select corresponding letters. MULTI-STEP Press to access the Multi-Step Programming Mode. Press to confirm entries and advance cursors. ON/OFF Press to turn the pump on or off.

  • Page 29: Activating A Drug Library

    SIGMA Manual Number 41018 Revision AR Activating a Drug Library The pump must be on and in the idle state (not running) for the new drug library to be loaded auto- matically to the pump. The pump screen displays the status bar as the library is being installed. A confirmation screen will be displayed when the download is complete.

  • Page 30: Programming The Pump Using The Drug Error Prevention Mode

    SIGMA Manual Number 41018 Revision AR Programming the Pump Using the Drug Error Prevention Mode Press the ON/OFF button to turn the pump on. Use the arrow keys to select the care area (nursing area) and press OK. Select Care Area...
  • Page 31 SIGMA Manual Number 41018 Revision AR Select the drug from the MDL: a. Using the keypad, type the drug's first two letters and press OK. All drugs beginning with those two letters will appear. Press the key repeatedly to cycle through letters.
  • Page 32 SIGMA Manual Number 41018 Revision AR Select the correct drug concentration (if more than one is offered) and press OK. Cursor to the desired drug and press OK. DOPamine 800 mg/250 mL 400 mg/250 mL Once a concentration is selected, a dialog appears prompting confirmation of the selected drug concentration.
  • Page 33 SIGMA Manual Number 41018 Revision AR You may receive a popup error if you exceed the dose rate limits defined in the MDL for the drug. Version 5.02.03 and earlier versions Version 6.01.00 and later Soft dose rate limits may be exceeded by...

  • Page 34: Programming The Pump Using The Basic Mode

    SIGMA Manual Number 41018 Revision AR The run screens appears indicating that the infusion is running. DOPamine* mcg/kg/min bolus review options titrate Programming the Pump Using the Basic Mode Software version 6.01.00 and later Press the ON/OFF button to turn the pump on.

  • Page 35: Setting Up A Secondary Infusion

    SIGMA Manual Number 41018 Revision AR 13. Review or reprogram the primary infusion as needed: Running Press the REVIEW softkey to view infusion information and clear volume given mL. Stopped Press REVIEW/PROGRAM softkey to display setup screen and change any value.
  • Page 36 SIGMA Manual Number 41018 Revision AR When you have finished programming the pump for the primary infusion and before you run the infusion, press PROGRAM SECNDRY softkey to begin programming the second- ary bag. General Care IV Normal Saline 0.9%...
  • Page 37 SIGMA Manual Number 41018 Revision AR b. Use the arrow keys to scroll to the desired drug and press OK. General Care Cursor to the desired SECONDARY drug and press OK POTASSIUM chloride Potassium PHOSPHATE Press OK to select secondary bag or use the arrow softkeys to change to primary bag.
  • Page 38 SIGMA Manual Number 41018 Revision AR NO – Hang secondary bag above primary bag, confirm secondary clamp is open and flow from the secondary container, then press the YES or NO softkey. • YES – Secondary infuses as programmed until completion with auto- matic transition to primary.
  • Page 39 SIGMA Manual Number 41018 Revision AR a. Using the keypad, type the drug's first two letters and press OK. All drugs beginning with those two letters will appear. b. Use the arrow keys to scroll to the desired drug and press OK.

  • Page 40: Returning To The Primary Mode While Infusing In A Secondary Mode

    SIGMA Manual Number 41018 Revision AR Check Flow confirmation is displayed. If the secondary rate is above 300 mL/hr, a dialog box appears prompting observation of the primary drip chamber. If drops are seen, the primary line should be clamped closed. Press YES in this dialog box if a clamp is being applied to the primary line.

  • Page 41: Secondary Callback - Assigned To A Secondary Drug In The Mdl

    SIGMA Manual Number 41018 Revision AR Secondary Callback – Assigned to a Secondary Drug in the MDL Secondary Callback is a feature that causes the pump to drop to the KVO Rate (1 mL/hr or the cur- rent infusion rate, whichever is less) at the completion of the Secondary Infusion and sound an audio alarm to call the clinician back.

  • Page 42: Programming A Bolus

    SIGMA Manual Number 41018 Revision AR A loading dose icon (syringe) is displayed next to the “Primary or Secondary Bag” line on a completed setup screen. After all infusion values are entered, a loading dose dialog box displays:“Do you want to...

  • Page 43: Manual /Multi-Step Programming

    SIGMA Manual Number 41018 Revision AR Manual /Multi-Step Programming The Manual (RAMP/Multi-Step) Programming Mode allows the pump to be programmed with up to 10 individual infusion steps using either the Drug Error Prevention or Basic Programming Opera- tions. Drugs are eligible for use in the Manual Programming Mode, provided that the selected drug has not been specifically assigned to either the primary or secondary bag as identified in the pump’s...

  • Page 44: Clearing The Entire Multi-Step Program

    SIGMA Manual Number 41018 Revision AR View the setup data for any programmed step by moving the highlight (using the up arrow softkey) to the step indicator bar located at the top of the setup screen and then using the left and right arrow softkeys to move from step to step.

  • Page 45: Cyclic Tpn Mode

    SIGMA Manual Number 41018 Revision AR Cyclic TPN Mode This feature is only available when using software versions 6.02.00 and later. The cyclic TPN mode is designed to deliver TPN in an automatic ramp up, main rate and taper down program. The infusion schedule is calculated with the rates and volumes for 10 ramp steps up occupying 10% of the total infusion time, 10 taper down steps occupying another 10% and the main rate accounting for the remaining 80% of the infusion time.
  • Page 46 SIGMA Manual Number 41018 Revision AR Software version 6.01.00 and later: To titrate flow rates and VTBI without stopping the pump: Press the TITRATE softkey. DOPamine* mcg/kg/min bolus review options titrate To titrate dose, press DOSE softkey. To titrate rate mL/hr, press mL/hr softkey.
  • Page 47 SIGMA Manual Number 41018 Revision AR Software version 5.02.03 and earlier To titrate flow rates without stopping the pump (not available in Program Modes): Press the TITRATE softkey. DOPamine* mcg/kg/min bolus review options titrate Observing the displayed hard and soft rate limits, enter a new flow rate.

  • Page 48: Delayed Start

    SIGMA Manual Number 41018 Revision AR Delayed Start This feature is only available when using software version 5.02.03 and earlier. The start of any programmed infusion can be delayed by up to 12 hours. On the infusion set up screen, enter any value between one minute and twelve hours (00:01 to 12:00, hr:min) on the delay time parameter and press OK.

  • Page 49: Pump Operation

    SIGMA Manual Number 41018 Revision AR PUMP OPER ATION Operating Tips Follow all prompts on the pump screen. Always press OK to confirm entries and changes. Follow all prompts on screen to clear alarms. Be sure to load sets properly.

  • Page 50: Placing The Pump On Standby (Hold Mode)

    SIGMA Manual Number 41018 Revision AR Placing the Pump on Standby (Hold Mode) You can place the pump in a standby state to prevent the occurrence of the Inactivity Alarm (see “Alarms” section, beginning on page 46) for the period of time specified in the User Settings / Alarm Settings menu option.

  • Page 51: Manually Locking The Keypad

    SIGMA Manual Number 41018 Revision AR Manually locking the keypad To lock the keypad, enter the code 429 (“K”, “E”, “Y”). NOTE: 429 is the default keypad lock code. Refer to the Library Configurations section in the MDL User Manual (P/N 41020) to change the keypad lock code.

  • Page 52: Alarms

    SIGMA Manual Number 41018 Revision AR ALARMS The Spectrum Pump has a number of alarms that appear when specific conditions exist. These alarms are annunciated with a tone and an alarm message is displayed on the pump screen. The mes- sage states the reason for the alarm and contains prompts for clearing the alarm.

  • Page 53: Silencing An Alarm

    SIGMA Manual Number 41018 Revision AR Silencing an Alarm To silence the audio tone for an alarm, press the SILENCE softkey or any key on the keypad. This stops the tone from annunciating for 2 minutes. If the alarm has not been cleared after 2 minutes, the alarm tone will resume.
  • Page 54 SIGMA Manual Number 41018 Revision AR Alarm Action Downstream Occlusion Eliminate a closed clamp, kinked tube, positional catheter, clotted catheter, clogged IV filter or other sources of occlusion below the pump. Downstream Pressure Limit – The downstream pressure limit differs from care area default Reset Setting (set in Master Drug Library).

  • Page 55: Preventing Nuisance Alarms

    SIGMA Manual Number 41018 Revision AR Alarm Action Upstream Occlusion If a drug has been checked as an Effervescent Drug in the MDL Suspension (Drug Configurations / Upstream Occlusion Alarm), once flow has been confirmed (check flow display), if the operator considers the occlusion alarm to be a nuisance, they may choose to suspend the alarm until the next STOP key press.

  • Page 56: Managing Bolus Before Occlusion (Downstream) Release

    Follow prompts and HELP (operating software 6.02.00 and earlier) screens. Use only compatible IV sets as labeled and identified on the SIGMA pump. Keep the tubing channel clean and dry. Avoid empty IV containers by properly setting VTBI values.

  • Page 57: Very Low Battery

    SIGMA Manual Number 41018 Revision AR Figure 14. Low Battery Alarm BATTERY Plug into wall outlet Push OK to dismiss for 5 minutes PUMP IS RUNNING help If the pump is not plugged in or the alarm is not acknowledged after 2 minutes, the alarm volume increases and the troubleshooting tutorial automatically begins.

  • Page 58: Battery Depleted

    SIGMA Manual Number 41018 Revision AR Battery Depleted If the battery level drops below the Very Low Battery level, the message changes to Battery Depleted. Figure 16. Battery Depleted Alarm BATTERY DEPLETED PUMP WILL NOT RUN Change battery or plug in AC cord and restart pump The pump will stop running.

  • Page 59: Cleaning And Storage

    SIGMA Manual Number 41018 Revision AR CLEANING AND ST ORAGE The SIGMA Spectrum should be cleaned and disinfected for each patient use according to facility protocol. Compatible Cleaners Refer to DOC 11318 for complete listing 10% solution of bleach and water Up to 90% Isopropyl alcohol Caltech Industries Dispatch®...

  • Page 60: Storing The Pump

    Refer to Specifications section of this manual for recommended storage temperature and humidity. Servicing the Pump CAUTION: Electric shock hazard. Refer servicing to SIGMA trained and qualified service personnel. Refer to the Service Manual for inspection and maintenance procedures. Cleaning and Storage...

  • Page 61: Compatible Iv Sets

    SIGMA Manual Number 41018 Revision AR COMPATIBLE IV SETS SIGMA Nitroglycerin/Lipid Sets Connect IV containers to catheters. Set description: Cat No. 99021 Pump Calibration Length: 99” overall Hospira 15” PVC pumping section DEHP free vented drip chamber (60 drops/mL) Polyethylene lined tubing...

  • Page 62: Compatible Hospira Iv Sets

    Revision AR Compatible Hospira IV Sets The following is a partial listing of the Hospira IV sets compatible with the SIGMA Spectrum pumps that have been calibrated for use with Hospira nominal size 0.100" I.D. Series IV set tubing. Please consult DOC 11181 for a full listing of compatible sets.
  • Page 63 SIGMA Manual Number 41018 Revision AR 12453-48 LS Microdrip Primary Set, 1 CLAVE Y-site & OL , 100” 20779-48 1, 2, LS Microdrip Primary Set with backcheck valve, Yellow Key Slide Clamp, 2 CLAVE Y-Sites, & OL , 100” Primary Filter Set Micro (60 Drops/mL) 20801-48 LS Primary Microdrip Filter Set with backcheck valve, Yellow Key Slide Clamp, 2 CLAVE Y-Sites, &...

  • Page 64: Compatible Hospira Iv Sets - Warnings

    SIGMA Manual Number 41018 Revision AR All sets use roller clamps referenced to as CAIR® clamp. All sets (except the Blood sets) use convert- ible pins. LS = LifeShield®, OL = Option-Lok®, PP= Prepierced, CAIR®, CLAVE®, Option-Lok®, LifeShield®, Microdrip® SoluSet® are all registered names / trademarks associated with Hospira (Abbott Laboratories).

  • Page 65: Compatible Baxter Iv Sets

    Revision AR Compatible Baxter IV Sets The following is a partial listing of the Baxter IV Sets compatible with the SIGMA Model Spectrum pumps that have been calibrated for Baxter “S” I.V. set tubing. Please consult DOC 11182 for a full listing of compatible sets.
  • Page 66 SIGMA Manual Number 41018 Revision AR PRIMARY FILTER SET MACRO (10 DROPS/mL) 2C6571s CONTINU-FLO SOLUTION SET, 0.22 MICRON FILTER, INTERLINK Y-SITE (2 EA) WITH LUER 2, 3, LOCK ADAPTER, BACKCHECK VALVE 105” 2C8571s CONTINU-FLO SOLUTION SET, 0.22 MICRON FILTER, CLEARLINK Y-SITE (2 EA) WITH LUER...

  • Page 67: Compatible Baxter Iv Sets - Warnings

    6. Rigid polyethylene lined tubing, as is often used in nitroglycerine sets, may produce as much as 10 PSI downstream occlusion pressure above the lower limit of the SIGMA Spectrum Pump specification. 7. Some Sets contain two or more slide clamps. Only the slide clamp on the pumping section or on the section with the main roller clamp should be used for pumping operation and clamp detection.

  • Page 68: Accessories

    SIGMA Manual Number 41018 Revision AR ACCESSORIES Tandem Carrier Cat No. 55092NS Holds 2 Spectrum pumps Stainless upright tubes and aluminum plate C-clamp jaw opening expands to 1.5” C-clamp knob comes off if semi-permanent attachment of carrier is desired 3 Pump Carriers Cat No.

  • Page 69: Multi-Pole

    < 1 liter (1000 cc). A.C. Power Adaptor Protector SIGMA Part Number (P/N) 45742 Snaps on the adaptor side of A.C. Power Adaptor Handle on the Protector helps for easy insertion...

  • Page 70: Double Rotating Pole Clamp Assembly

    SIGMA Manual Number 41018 Revision AR Double Rotating Pole Clamp Assembly SIGMA Part Number (P/N) 35743 The double rotating feature of Double Rotating Pole Clamp enables the pump to be offset on left or right side of the single (standard) IV pole diam- eters ranging from 0.75”...

  • Page 71: Appendix A - Specifications

    SIGMA Manual Number 41018 Revision AR APPENDIX A - SPECIFICATIONS Drug Error Prevention “A” pump Includes Drug Library Prevents wrong dose rate mode and dose rate “C” pump Includes Drug Library Prevents wrong dose rate mode and dose rate Includes Wireless Battery Module for wireless communication...
  • Page 72 SIGMA Manual Number 41018 Revision AR IrDA® Serial Infrared Physical Layer Link Specification v1.4(IrPHY), IrDA Serial Infrared Link Access Protocol v1.1 (IrLAP) and IrDA Serial Infrared Link Management Protocol v1.1 (IrLMP), IrDA Tiny TP v1.1 Wireless – 802.11b, 802.11g EIA-RS-232 levels for Asynchronous Transmit/Receive only (RS232)
  • Page 73 Output: 9V-DC/800mA, short circuit protected cord length 3.0 m (~ 9.75 feet) Use only SIGMA part number 35714 or equivalent The SIGMA Spectrum Infusion Pump is classified according to Medical Electrical Equipment standards as: Class II Equipment Type BF Applied Part...
  • Page 74 Revision AR Specification Description Battery Power and Capacity Standard Battery Lithium Ion, 1800 mA/h, 7.4V nominal. SIGMA Part Number, 35724 Capacity 8hrs (at 125 mL/hr at the highest backlight settings) 12 hr. recharge time Charging occurs if AC Power Adaptor is plugged in whether pump is ON or OFF Wireless Battery Module (802.11b)
  • Page 75 SIGMA Manual Number 41018 Revision AR Specification Description Operational Conditions With Standard Battery Operating temperature: 60 to 90°F (15.6 to 32.2° C), 20 to 90% relative humidity non-condensing With Wireless Battery Module Operating temperature: 60 to 80°F (15.6 to 26.7° C),...
  • Page 76 SIGMA Manual Number 41018 Revision AR Specification Description Alarms and Alerts Air-In-Line: dual beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass. Detects air bubbles > 1” (» 125µL Hospira, » 140µL Baxter), will alarm if > 1 mL* of air in 15 min., <...
  • Page 77 Revision AR Specification Description Anti-Free-Flow System Set based, utilizing IV set slide clamp. Wireless Network Interface Wireless Battery Module (802.11b), SIGMA Part Number 35083 Standard: IEEE 802.11b Transmit power: 16 dBm typical Wireless Battery Module (802.11b/g), SIGMA Part Number 35162 Standard: IEEE 802.11b/g...

  • Page 78: Appendix B - Flow Rate Accuracy

    Baxter IV Sets. Flow Profile The SIGMA Spectrum Infusion pump has the following start-up flow rate accuracy curve shape asso- ciated with stability through time. These graphs represent the variation in flow rate that is recorded from the time the infusion is started to the end of a two hour period. The graph is intended to give a picture of the “general stability”...
  • Page 79 The percent variation of mean flow rate accuracy over a specific observation period may be quanti- fied with the use of a trumpet graph. Using the rationale for development of a statistical trumpet graph as defined in IEC 60601-2-24, a presentation of the SIGMA Spectrum mean flow over a spe- cific measurement interval is provided.
  • Page 80 SIGMA Manual Number 41018 Revision AR Trumpet Curve, 2nd Hour Set Rate 25 mL/hr Observation Window (min) APPENDIX B - Flow Rate Accuracy...
  • Page 81 SIGMA Manual Number 41018 Revision AR Flow Rate Graph, Last Hour Set Rate 25 mL/hr Time (min) Typical of intermediate rate last* Hr Flow Accuracy...
  • Page 82 (.5mL/hr) and inter- mediate rate (25 mL/hr) for the SIGMA Spectrum. NOTE: The SIGMA Spectrum is best classified as a “Volumetric Infusion Pump” as defined by the applicable standards. Reference IEC 60601-2-24 and AAMI ID26:1998, Medical electrical equipment –...
  • Page 83 SIGMA Manual Number 41018 Revision AR Startup Graph, First Two Hours Set Rate .5 mL/hr Time (min) Typical of minimum rate start-up, flow rate...
  • Page 84 SIGMA Manual Number 41018 Revision AR Trumpet Curve, 2nd Hour Set Rate .5 mL/hr Observation Window (min) Typical of minimum rate 2nd Hr, Trumpet Graph APPENDIX B - Flow Rate Accuracy...
  • Page 85 SIGMA Manual Number 41018 Revision AR Flow Rate Graph, Last Hour Set Rate .5 mL/hr Time (min) Typical of minimum rate last* Hr Flow Accuracy...
  • Page 86 SIGMA Manual Number 41018 Revision AR Trumpet Curve, Last Hour Set Rate .5 mL/hr Observation Window (min) Typical of minimum rate last* Hr, Trumpet NOTE: For Hospira calibration the last hour is the 72nd hour. For Baxter calibration the last hour is the 96th hour.

  • Page 87: Appendix C - Bolus Accuracy

    Revision AR APPENDIX C - 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 utilize 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 88: Appendix D - Downstream Occlusion

    The analytical related conditions are: A distance of 48” from the point of the downstream occlusion to the SIGMA Spectrum’s Downstream Occlusion sensor (approximately the distance from the IV administration set’s exit from the pumping channel to the point of occlusion).

  • Page 89: Appendix E - Electromagnetic Compatibility

    Guidance and manufacturer ’s declaration – electromagnetic emissions The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment speci- fied below. The customer or user of the Spectrum should assure that it is used in such an environment.

  • Page 90: Immunity - Esd, Transient/Burst, Voltage Disparity, Magnetic

    Guidance and manufacturer ’s declaration – electromagnetic immunity The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment specified below. The customer or user of the Spectrum should assure that it is used in such an environment.
  • Page 91 Strong magnetic fields (those beyond the level tested) may cause the device to operate improperly. Do not expose the SIGMA Spectrum to strong magnetic fields such as is common with MRI equipment. Doing so may cause injury to the patient...

  • Page 92: Immunity - Conducted And Radiated

    Guidance and manufacturer ’s declaration – electromagnetic immunity The SIGMA Model Spectrum Infusion pump is intended for use in the electromagnetic environment specified below. The customer or user of the Spectrum should assure that it is used in such an environment.
  • Page 93 SIGMA Manual Number 41018 Revision AR Note 1 At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

  • Page 94: Immunity - Separation Distances

    RF communications equipment and the Spectrum The SIGMA Model Spectrum is intended for use in an electromagnetic environment in which the RD dis- turbances are controlled. The customer or user of the Spectrum can help prevent electromagnetic inter-...

  • Page 95: Appendix F - Low / Very Low Battery Tutorial

    SIGMA Manual Number 41018 Revision AR APPENDIX F - LOW / VER Y LOW BAT- TER Y TUT ORIAL The Low Battery and Very Low Battery Tutorials provide step-by-step confirmation that the external power supply is connected to the wall outlet, the power light is illuminated, and the power cord is properly connected to the Spectrum.

  • Page 96: Very Low Battery Tutorial

    SIGMA Manual Number 41018 Revision AR Very Low Battery Tutorial When the Very Low Battery Alarm activates, the following tutorial appears. APPENDIX F - Low / Very Low Battery Tutorial...

  • Page 97: Appendix G - Icons

    SIGMA Manual Number 41018 Revision AR APPENDIX G - ICONS Power Icons These icons are visible in the upper left corner of the pump display. Battery is 25% charged Battery is 50% charged Battery is 75% charged Battery is 100% charged Battery is installed and the AC adaptor is connected.

  • Page 98: Wireless Icons

    SIGMA Manual Number 41018 Revision AR Battery Error. This will alternate with a battery code number if communication to the battery is functional. If communication to the battery is not functional the icon will be displayed without a battery code number. Refer to the Service Manual for a description of the error code.

  • Page 99: General Icons

    SIGMA Manual Number 41018 Revision AR The figure below shows the key lock and battery icon (upper left) and the network connection (upper right) icon. Figure 19. Icon Displays Alert Bar Setup and Run screens General Icons The following icons are displayed on various screens in the Spectrum: The “keypad lock”...

  • Page 100: Appendix H - Amount / Time

    SIGMA Manual Number 41018 Revision AR APPENDIX H - AMOUNT / T IME Drug Amount / Time Infusion This feature is only available when using MDL version 6.3.0 and later (not available in Basic or Multi-Step delivery modes). Follow all set up, set loading/unloading and operation instructions in this manual.

  • Page 101: Priming Volume Adjustment For Primary Amount / Time Infusions Only

    SIGMA Manual Number 41018 Revision AR 4.2.9Check the flow and confirm that all clamps are open, there are no kinks in tub- ing, and drops are flowing. If everything is flowing properly, press the YES soft- key. 4.2.10Press REVIEW softkey to display infusion status while running.

  • Page 102: Flush

    SIGMA Manual Number 41018 Revision AR Flush This feature is only available when using MDL versions 6.3.0 and later. Can be delivered in drug amount/time infusion modes (as selected in the Master Drug Library) and is not available in continuous modes.

This manual is also suitable for:

Sigmaspectrum 35700bax

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