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SIGMA, LLC

711 Park Avenue

Medina, New York 14103

v 800 356 3454

f 585 798 3909

www.sigmapumps.com

s p e c t r u m

Operator’s

Manual

35700ABB & 35700BAX

Содержание sigmaspectrum 35700ABB

Страница 1: ...SIGMA LLC 711 Park Avenue Medina New York 14103 v 800 356 3454 f 585 798 3909 www sigmapumps com s p e c t r u m Operator s Manual 35700ABB 35700BAX...

Страница 2: ...ii 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...

Страница 3: ...Cleaning the Power Adaptor 12 Connecting the Power Adaptor 12 Removing the Power Adaptor 12 Charging the Battery 13 Configuring User Options 13 User Options 13 The User Options menu has three categor...

Страница 4: ...ram 38 Clearing an individual step 38 Cyclic TPN Mode 39 Titrating 39 Delayed Start 42 Stopping Cancelling the Delay Timer 42 Changing the Delay Timer 42 Values Differ 42 Pump Operation 43 Operating T...

Страница 5: ...Sets 55 SIGMA Y Type Blood Sets 55 Compatible Hospira IV Sets 56 Compatible Hospira IV Sets WARNINGS 58 Compatible Baxter IV Sets 59 Compatible Baxter IV Sets WARNINGS 61 Accessories 62 Tandem Carrie...

Страница 6: ...ions 83 Immunity ESD transient burst voltage disparity magnetic 84 Immunity Conducted and Radiated 86 Immunity Separation Distances 88 APPENDIX F Low Very Low Battery Tutorial 89 Low Battery Tutorial...

Страница 7: ...such as but not limited to hospitals outpatient care areas homecare and ambulatory care services The SIGMA Spectrum and SIGMA Spectrum with Master Drug Library has not been tested or approved for use...

Страница 8: ...sting even when SIGMA personnel assist in training processes WARNING Confirm Safe Operation at Start and Thereafter Confirm safe accurate pump operation at start and periodically thereafter by Observe...

Страница 9: ...iggyback operation see Secondary Infusion Note Upstream occlusion detection is only effective for occlusions present immediately after the start of the pump s run operation Upstream occlusions caused...

Страница 10: ...rer s IV Set Type This label is located on the top of the pump and indicates the specific type of IV tubing that the pump has been calibrated for The use of other manufacturer s brands or type tubing...

Страница 11: ...e or ETO sterilize pumps CAUTION Be Cautious Near RF Sources The Spectrum pump meets the electromagnetic compatibility EMC requirements as specified in the International Electrotechnical Commission s...

Страница 12: ...sed above the Spectrum pump Small bore catheters or needles may cause excessive backpressure at elevated flow rates Size the catheters according to expected flow rate and fluid viscosity CAUTION Follo...

Страница 13: ...r each drug entry MDL Transfer The MDL Transfer is the process by which information in the library is communi cated to the pump There are two methods Transfer from a wireless network connection to a p...

Страница 14: ...ion 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 tery Module P N 35083 Figure 6 Back Vie...

Страница 15: ...urrent IEC 60417 5031 Recyclable dispose of properly ISO 7000 1135 This is a representation of the Direction of Flow not to scale This label appears behind the door of the pump It is intended to assis...

Страница 16: ...02 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 7 Pum...

Страница 17: ...y tab pull the tab straight out from the Battery Pack mounting cavity Figure 9 Battery Tab Save all packaging materials for reuse This is advised in the event product repair or war ranty replacement i...

Страница 18: ...e Power Adaptor The Protector is compatible with the cleaners mentioned in this Operators manual For the methods of cleaning and compatible cleaners that can be used on the A C Power Adaptor with Prot...

Страница 19: ...wered 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 Refer to APPENDIX G Icons section beginning...

Страница 20: ...30 minutes the alert shall not be generated regardless of the setting Down Stream Pressure Limit Pressure levels are selectable from three levels LOW 6 psi 4 psi MEDIUM 13 psi 6 psi and HIGH 19 psi 9...

Страница 21: ...ion 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 re...

Страница 22: ...n is not selectable and appears in grey text in the dis play Infusion Information The infusion information screen identifies the infusion specific pri mary and secondary bag parameters that are not ot...

Страница 23: ...usion Using the Drug Error Prevention DEP Mode 1 Power on the pump 2 Load the IV set 3 Select your care area 4 Select a drug 5 Select a concentration 6 Select primary or secondary bag 7 Enter and OK a...

Страница 24: ...is running 3 Press the REVIEW PROGRAM softkey 4 Press the PROGRAM SECONDARY softkey 5 Select the drug for the secondary infusion 6 Push OK to select confirm the secondary bag 7 Enter all required valu...

Страница 25: ...ntainers and prime IV sets a Position roller clamps below the pump b Position slide clamp near the keyhole at the top of the pump c Invert bags that need to be mixed rather than shaking them NOTE Warm...

Страница 26: ...closed or by partially opening the roller clamp to achieve gravity flow NOTE When changing IV sets or containers always keep the roller clamp fully closed except when following standard gravity set pr...

Страница 27: ...man errors Keys Used to Program and Operate the Pump Key Description ARROWS Press to advance cursors and select alternate choices BACK Press to go back to the previous screen BASIC Press to acesses th...

Страница 28: ...Press to view the setup screen without stopping the pump REVIEW PRIMARY REVIEW SECONDARY Press to to view and edit values in the setup screen REVIEW PROGRAM Press to display the setup screen when pum...

Страница 29: ...row buttons to select VIEW INFORMATION and press OK 3 Use the arrow buttons to select Library Information and press OK The Library Information screen displays the current active drug library informati...

Страница 30: ...mp Using the Drug Error Prevention Mode 1 Press the ON OFF button to turn the pump on 2 Use the arrow keys to select the care area nursing area and press OK Care Areas ICU Oncology Anesthesia Labor an...

Страница 31: ...and later drug modifers are a feature that can be enabled in the MDL Scroll to the desired modifier and press OK NOTE If a modifier is selected an icon will display next to the drug name on the pump r...

Страница 32: ...the primary or secondary bag and press OK NOTE The bag selection prompt does not appear if the selected drug has been specifically assigned to the primary or secondary bag or as a multi step infusion...

Страница 33: ...prop erly push the YES softkey NOTE Confirmation that drops are flowing is required for software versions 6 01 00 and later Version 5 02 03 and earlier versions Version 6 01 00 and later Soft dose rat...

Страница 34: ...ose rates and press OK 6 If a dose rate is chosen enter drug concentration and diluent mL values 7 Enter the dose or flow rate value and press OK 8 Enter the VTBI Volume To Be Infused in mL and press...

Страница 35: ...d press OK 8 Confirm the computed infusion time 9 Confirm the Volume Given mL value or press CLEAR to erase it NOTE VTBI counts down to zero while volume given counts from zero up 10 Press RUN to begi...

Страница 36: ...DEP select the drug from the MDL NOTE The drug must be pharmacy hospital approved for delivery as a secondary line a Using the keypad type the drug s first two letters and press OK All drugs beginning...

Страница 37: ...ndary VTBI should equal secondary bag volume NOTE A watermark indicator is displayed behind the parameter data to help distinguish the secondary 2 setup screen from the primary 1 setup screen This wat...

Страница 38: ...s OK to confirm secondary line is clamped 14 Upon completion of the secondary infusion and once the transition is made to the primary infusion a one bag icon shall replace the two bag icon on the run...

Страница 39: ...avoid infusing residual amounts of the secondary container at primary flow rates be sure to properly set the secondary VTBI value Secondary VTBI should equal secondary bag volume NOTE A watermark ind...

Страница 40: ...he two bag icon on the run screen NOTE Upon completion of the secondary infusion the clamp on the secondary set should be closed to prevent any remaining fluid in the secondary bag being delivered at...

Страница 41: ...to the Primary infusion upon completion of the Secondary infusion Amount Time infusions Secondary callback operates in the same manner as for contin uous secondary infusions with the addition of a Li...

Страница 42: ...n rate is automatic Programming a Bolus This feature is only available when using software versions 6 01 00 and later A Bolus is a large IV dose of a drug given all at once at the start of treatment w...

Страница 43: ...primary or secondary bag press the RAMP MULT STEP softkey to enter the Manual Programming Mode Ramp softkey for software version 5 02 03 and earlier Multi Step softkey for software version 6 02 00 an...

Страница 44: ...gram step indicator This indicator displays the current program step in the Step x of y format where x is the current step being delivered and y is the total number of programmed steps 11 Check the fl...

Страница 45: ...ew display screen with main rate VTBI prog time ramp up time main step time taper down time and volume given mL 8 Press RUN to start infusion 9 Check the flow and confirm that all clamps are open ther...

Страница 46: ...ose press DOSE softkey 3 To titrate rate mL hr press mL hr softkey 4 Observing the displayed hard and soft dose or mL hr flow rate limits enter a new dose or mL hr flow rate 5 Press OK If soft limits...

Страница 47: ...earlier To titrate flow rates without stopping the pump not available in Program Modes 1 Press the TITRATE softkey 2 Observing the displayed hard and soft rate limits enter a new flow rate 3 Press eit...

Страница 48: ...delay is running it may be stopped or cancelled To stop the delay press the STOP key The display updates to DELAY STOPPED and the delay timer is paused and no longer flashes To cancel the delay press...

Страница 49: ...the door with thumb pressure over both door hooks which is at the top of the door and the bottom of the door Open the slide clamp by pulling it straight up while holding the tubing around it down Use...

Страница 50: ...in standby press the HOLD softkey When standby is activated the In Standby message is displayed in a flashing format NOTE If the delay period is set to infinite the time value in the display will be...

Страница 51: ...ad allows certain alarm conditions to be silenced and cleared while in the Keypad Lock mode The code must be re entered to unlock the keypad If the keypad is unlocked while reviewing the setup data an...

Страница 52: ...for clearing the alarm Figure 13 Example Alarms Messages BATTERY DEPLETED Change battery or plug in AC cord and restart pump PUMP WILL NOT RUN AIR IN LINE Press OK then RUN silence To advance air for...

Страница 53: ...Y site or re prime the set Audio May be silenced for 2 minutes by depressing any key Low medium and high volume levels may be selected in the User Options Alarm Settingsscreen Battery Missing Battery...

Страница 54: ...amp Closed Open slide clamp and push RUN or unload set Line Flush Complete The line flush VTBI has counted down to zero mL the pupmp is running at a KVO rate of 1 mL hr Press STOP to halt the KVO rate...

Страница 55: ...may choose to suspend the alarm until the next STOP key press After YES is pressed to check flow the operator may select to suspend the upstream occlusion alarm temporarily on the Occlusion Alarm scr...

Страница 56: ...cclusions When a downstream occlusion alarm occurs pressure and a small volume of 0 98 mL of fluid the bolus builds up between the pump and the point of occlusion When it might be harmful to infuse th...

Страница 57: ...ery If the battery level drops below the low battery level the message changes to Very Low Battery and begins to flash The back light also dims to reduce battery usage Figure 15 Very Low Battery Alarm...

Страница 58: ...low the Very Low Battery level the message changes to Battery Depleted Figure 16 Battery Depleted Alarm The pump will stop running If the pump is not plugged in within 3 minutes the pump will shut its...

Страница 59: ...c tions using appropriate dilution ratio Disinfectants should remain on the pump s surface in an even but not dripping film for the recommended contact time for the compatible cleaning agents 4 Open t...

Страница 60: ...cleaning of hard non porous surfaces such as sinks counter tops and stainless steel Do not use abrasive cleaners Storing the Pump Connect the AC power adaptor to the pump and supply source power to c...

Страница 61: ...Bags to catheters Set description NOTE IV Sets are Latex Free Figure 18 Y Type Blood Set Cat No 99021 Pump Calibration Hospira Length 99 overall 15 PVC pumping section DEHP free vented drip chamber 6...

Страница 62: ...ck valve 3 CLAVE Y sites and OL2 7 100 12574 48 LS Primary Set Convertible Pin OL 100 20778 48 LS Primary Set with backcheck valve Yellow Key Slide Clamp 2 CLAVE Y Sites OL2 5 100 20793 48 LS Primary...

Страница 63: ...e Clamp 4 CLAVE Ports OL4 5 167 w Extension 150 mL Burette Set Micro 60 Drop mL 11398 20 LS Microdrip Filter SoluSet 150 x 60 PP site on burette capped port PP Y Site OL1 4 7 100 11964 02 LS Filter So...

Страница 64: ...ccuracy 4 Burettes with closed vents or shutoff valves will cause upstream occlusions that may not be detected by the infusion pump 5 Yellow Key Slide Clamp sets are only compatible with Spectrum soft...

Страница 65: ...k Y Site 2 ea with luer lock adapter backcheck valve2 89 2C6537s CONTINU FLO Solution Set Interlink Y Site 3 ea with luer lock adapter backcheck valve2 110 2C8515s CONTINU FLO Solution Set Clearlink Y...

Страница 66: ...ER LOCK ADAPTER BALL VALVE DRIP CHAMBER1 4 5 117 2C7562s 150 ML BURETTE INTERLINK Y SITE 3 EA WITH VALVELESS BURETTE1 4 7 115 2C7564s 150 ML BURETTE INTERLINK Y SITE 2 EA WITH DRIP CHAMBER FILTER VALV...

Страница 67: ...rate accuracy 4 Burettes with closed vents or shutoff valves will cause upstream occlusions that may not be detected by the infusion pump 5 Ball Valve operation may not be detected as an alarm conditi...

Страница 68: ...attachment of carrier is desired 3 Pump Carriers Cat No 55093 Holds 3 pumps Stainless upright tubes and aluminum plate UL CSA four outlet power strip for multi pole plug in 1 cord from IV pole to wal...

Страница 69: ...kwise To maintain IV pole stability never exceed 210 cm 83 from floor to IV pole top and limit bag volume at this extended height to 1 liter 1000 cc A C Power Adaptor Protector SIGMA Part Number P N 4...

Страница 70: ...n the adaptor can be rotated clockwise or counterclockwise in 90 increments by pressing the lever located on the arm The pump can be offset by the length of the arm by rotating the arm in clockwise or...

Страница 71: ...ts pump configurations for maximum rate VTBI patient weight and occlusion level Each drug entry includes the care area drug name concentration dose rate mode bolus mode starting dose rate soft able to...

Страница 72: ...out IV pole clamp 6 3 H x 4 2 W x 2 5 D With IV pole clamp 6 3 H x 6 4 W x 4 7 D Weight With Standard Battery Without IV pole clamp 25 5 oz 1 0 oz With IV pole clamp 33 5 oz 1 0 oz With Wireless Batte...

Страница 73: ...TE Clock is set to GMT Logging Memory AC Power Adaptor low 24 hr memory of all set up screens except for multi stepand cyclic modes that are maintained permanently Separate pump history log and drug e...

Страница 74: ...t backlight settings 16 hr recharge time Charging occurs if AC Power Adaptor is plugged in whether pump is ON or OFF Wireless Battery Module 802 11b g Lithium Ion 1800 mA h 7 4V nominal SIGMA Part Num...

Страница 75: ...Wireless Battery Module Operating temperature 60 to 80 F 15 6 to 26 7 C 20 to 90 relative humidity non condensing Storage Temperature With Standard Battery Storage temperature 4 to 120 F 20 to 49 C 1...

Страница 76: ...double confirmation it will not run with a hard dose rate exceeded rates must be reset within hard limits Downstream Occlusion automatic restart occurs after the downstream occlusion is cleared Actua...

Страница 77: ...rt Number 35162 Standard IEEE 802 11b g Transmit Power 12 dBm typical Wireless Security WEP Wired Equivalent Privacy Encryption 64 128 bit RC4 WPA WPA2 802 11i Encryption TKIP CCMP AES WPA PSK 802 1X...

Страница 78: ...infusion Back pressure equivalent to 300 mmHg may reduce the flow rate causing a deviation in accuracy by 9 Negative back pres sure of 100 mmHg may increase flow rate causing a deviation in accuracy o...

Страница 79: ...od 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 ove...

Страница 80: ...74 APPENDIX B Flow Rate Accuracy SIGMA Manual Number 41018 Revision AR Trumpet Curve 2nd Hour Set Rate 25 mL hr Error of Flow Observation Window min...

Страница 81: ...75 SIGMA Manual Number 41018 Revision AR Typical of intermediate rate last Hr Flow Accuracy Flow Rate Graph Last Hour Set Rate 25 mL hr Flow Rate mL hr Qi Time min...

Страница 82: ...cs Specific flow profiles are helpful in determining the correct clini cal application for the infusion pump Data is presented as requested by the applicable standards and represents the typical flow...

Страница 83: ...77 SIGMA Manual Number 41018 Revision AR Typical of minimum rate start up flow rate Startup Graph First Two Hours Set Rate 5 mL hr Flow Rate mL hr Qi Time min...

Страница 84: ...78 APPENDIX B Flow Rate Accuracy SIGMA Manual Number 41018 Revision AR Typical of minimum rate 2nd Hr Trumpet Graph Trumpet Curve 2nd Hour Set Rate 5 mL hr Error of Flow Observation Window min...

Страница 85: ...79 SIGMA Manual Number 41018 Revision AR Typical of minimum rate last Hr Flow Accuracy Flow Rate Graph Last Hour Set Rate 5 mL hr Flow Rate mL hr Qi Time min...

Страница 86: ...r 41018 Revision AR 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 Trumpet Curve Last Hour Se...

Страница 87: ...mat In either mode the time is entered in minutes and seconds min sec Limits are placed on the mini mum and maximum amount of time for the bolus delivery The limit constraints are contained within the...

Страница 88: ...bolus volume generated as a result of operation at 25 mL hr and reaching the maxi mum downstream occlusion alarm threshold is 0 8mL CAUTION Specifications for Downstream Occlusion detection times and...

Страница 89: ...ld assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Spectrum uses RF energy only for its internal function...

Страница 90: ...typical commercial or hospital environ ment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode Not applicable Supply power quality should be that of a typical commercia...

Страница 91: ...r is it intended to be used in this manner 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 su...

Страница 92: ...0 V m Portable and mobile RF communications equipment should be used no closer to any part of the Spectrum including cables than the recommended separation distance calculated from the equation applic...

Страница 93: ...ght into patient areas For this reason an additional factor of 3K is used in calculating the recommended separation distance for trans mitters in these frequency ranges c Field strength from fixed tra...

Страница 94: ...bands 150 kHz to 80 MHz in ISM bands 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 12 23 0 1 0 38 0 38 0 38 73 1 1 2 1 2 1 2 2 3 10 3 8 3 8 3 8 7 3 100 12 12 12 23 For transmitters rated at ma...

Страница 95: ...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 Low Battery Tutorial When the Low B...

Страница 96: ...90 APPENDIX F Low 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...

Страница 97: ...75 charged Battery is 100 charged Battery is installed and the AC adaptor is connected Alternates between one of the battery levels above Battery is depleted Red battery Wireless Battery Module Icons...

Страница 98: ...off Battery charger is determining the current status of the installed battery Black battery Initializing The dot will circle the tower Events are not sent to the net work host Red background Searchin...

Страница 99: ...in the upper left corner above the power icon of the display whenever the lock code has been entered to enable the keypad lock feature This icon shall be displayed next to any configuration option men...

Страница 100: ...e is displayed 4 1 2Enter patient weight kg or BSA if required 4 1 3Enter duration of infusion Press OK 4 1 4Dose if weight based is displayed 4 1 5Infusion rate mL hr is calculated and displayed 4 1...

Страница 101: ...on rate mL hr is calculated and displayed 4 3 8Press RUN to start the infusion 4 3 9Check the flow and confirm that all clamps are open there are no kinks in tubing and drops are flowing If everything...

Страница 102: ...he same as the last displayed mL hr rate Software versions 6 04 and later A maximum flush volume between 1 100 mL can be entered in the MDL for each drug 1 At primary or secondary infusion complete ra...

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