SIGMA 8000, 8000 Plus and 8002 Plus Infusion Pump Operator`s
Contents
1. 0 f AA Options 60 OPT NO OPTION NAME INSTRUCTIONS DISPLAY In AUTOMATIC PROGRAMMING MODE also Called ramping tapering entry of a single VOLUME LIMIT ml and infusion TIME hrs results in the pump computing a 21 step ramp up 10 steps MAIN RATE 1 step and taper down 10 steps program The program ends with a PROG COMP program complete alarm and KVO rate The ramp and taper each take10 of total time leaving 80 of total time for the MAIN RATE The ramp and taper are broken into 10 steps each with the first ramp step RATE beginning at 50 of the MAIN RATE Each succeeding step results in a RATE increase eguivalent to 5 of the MAIN RATE The taper mirrors the ramp but with descending RATES See the graph on page29 for a programming example 60 PROGRAMMING AUTOMATIC 21 STEPS Not available on all models The pump may be programmed with or without an IV set loaded Program entries are maintained in permanent memory and may be cleared by pushing OPTIONS the desired OPT number and then pressing CLEAR or by using OPTION 95 Clear all Program Modes These actions cause a return to primary mode PRI MODE If a pump is turned off in the middle of a program and is left off for more than 60 min it will automatically reset to step 1 If itis turned back on in less than 60 mins it remains at the step in w2. No OPTION NAME INSTRUCTIONS DISPLAY OPTIONS 63 and 64 allow entry and storage in the pump s permanent memory of two different ramping tapering programs OPTIONS 63 and 64 require each step s RATE and VOLUME LIMIT to be entered individually Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 63 or 64 OPT 63 MANU PROG PUSH ENTR Push ENTER SET RT 1 RT1 0 63 PROGRAMMING Select the step 1 infusion RATE For example select 50 ml hr RT1 50 PUSH ENTR MANUAL Push ENTER SET VL1 VL1 0 64 Versions 1 8 2 Select the step 1 VOLUME LIMIT For example select 10 ml VL1 10 PUSH ENTR Eleven 11 steps are available Enter the desired values for each step OPT 63 OR 64 MANU PROG STEP being used 1 PUSH RUN After values for the desired number of steps up to 11 have been selected and ENTER pushed push run to begin the infusion Program entries are maintained in permanent memory and can only be cleared by pushing the OPTIONS key and entering the option number followed by pushing CLEAR or by using OPTION 95 Clear all Program Modes These actions cause a return to Primary Mode PRI MODE NOTE OPTIONS 60 64 may be used with the 8000 Aus 8002 Phu Drug Label ONLY feature 70 OCCLUSION PRESSURE psi Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 70 The occlusion alarm pressure may be adjusted from 2 to 15 psi in 1 psi increments 1 psi approxi
3. condition only gt 4 5 hrs to LOW BATTERY indication gt 30 min from LOW BATTERY to PLUG IN alarm Recharge time 18 hrs Dual Channel Type 12 volt battery pack consisting of 10 each 1 2V 4 5 amp hr rechargeable Nichol Metal Hydride NiMH batteries Operation for batteries in as new condition only gt 3 0 hrs to LOW BATTERY indication gt 30 min from LOW BATTERY to PLUG IN alarm Recharge time 18 hrs to 24 hrs 55 Rev J RS232 Communication Port Alarms air in line upstream and downstream occlusion improper IV set loading infusion complete low battery and plug in pump malfunctions close roller clamp before IV set removal from pump empty container with optional flow sensor PM Due notification Dimensions Single Channel 9 5 H x 6 5 W x 6 75 D 242mm x 165mm x 174 mm Dual Channel 10 25 H x 9 625 W x 7 375 D 26cm x 24 4cm x 18 7 cm Weight Single Channel 10 lbs 4 5 Kg Dual Channel 15 lbs 6 8 Kg Case material High impact plastic UL listed CSA certified LISTINGS CSA C and US to CSA Standard C22 2 No 125 M1984 Electromedical Equipment and UL Std No 544 Medical and Dental Equipment The C and US indicators adjacent to the CSA Mark signify that the product has been evaluated to the applicable CSA and ANSI UL Standards for use in the U S and Canada The US indicator means the product is eligible to bear the NRT
4. OS y Multi Pole GO Cat No 55027 Tandem Carrier Cat No 55030 Dual pump environment Holds 2 Sigma Model 8000 Pumps Stainless body Aluminum handle C Clamp jaw opening expands to 1 5 C Clamp knob comes off if semi permanent attachment of carrier is desired STO N M wheel for patient convenience Holds 3 pumps or 5 6 with optional adapters Adjustable height stainless steel pole 8 hook top UL CSA six outlet power strip for multi pole plug in one cord from IV pole to wall outlet Heavy duty 6 leg base with 3 soft rubber casters Patient support ring attached to rear of plate 1 Holds 2 8002 7 model pumps Same features as 55027 Optional plate P N 55029 can be purchased to convert your existing 55027 into a 55027 1 48 Rev J Sigma IV Sets Nitroglycerin Lipid Sets Connect IV containers to catheters Cat No Pump Calibration 99021 Abbott 99022 Baxter 99023 McGaw Pumping Section Set Description Length 99 overall 15 PVC pumping section DEPP free vented drip chamber 60 drops mL Polyethelene lined tubing Priming Volume 20mL Luer Lock Y Type Blood Sets Connect Blood and Saline Bags to catheters Set Description Cat No Pump Calibration 99031 Abbott 99032 Baxter 99033 McGaw Length 104 overall 15 PVC pumping section 200 Micron blood filter
5. amp Start Up SUMMARY Mount the pump to an IV pole Plug the pump in Using compatible IV sets prime the set and close the roller clamp Be sure the drug concentration and volume are as prescribed Load the IV set obtain two beeps at T occlusion loading at lever opening and at 4 occlusion loading Shut the lever and open the roller clamp Check for no drop flow Set RATE VOLUME LIMIT and push RUN Confirm all pump values are proper and confirm the drop rate approximates the mL hr rate Mount the pump to a standard IV pole holding the pump by its handle Do not hold the pump at its bottom or the pump may mount improperly Plug the pump into a grounded hospital grade AC receptacle Whenever possible plug the pump in to maintain full battery charge Use only the compatible IV sets specified on top of the pump or flow rate errors result Contact SIGMA for compatible set lists Prior to priming the IV set position the roller clamp so that it can be loaded into the CLAMP HOLDER Prime the IV set using standard gravity procedure and shut the roller clamp Be sure the IV container contains the prescribed fluid or drug drug concentration and volume Load the closed roller clamp into the CLAMP HOLDER This turns the pump on causes 8 s to display unlocks the lever for 10 seconds and allows the lever to be opened Characters other than 8 s indicate a display failure Discontinue pump use and have the pump serviced whene
6. ml h dose change continuous titration alarm tones alert the operator that a dose change has not occurred DOSE MODE The pump will continue to infuse at the original 50 mcg kg min dose rate set ugkm To titrate RATE push RATE Key RATE ml h flashes for ten seconds TITRATION Select new RATE New RATE ml h displays alternating with PUSH ENTR Push ENTER Infusion starts at new RATE ml h and recalculates dose Note If ENTER is not pushed to complete the rate change continuous titration alarm tones alert the operator that a rate change has not occurred The pump will continue to infuse at the original rate set DOSE MODE Follow the same operating instructions as OPTION OPT 51 DOSE ugkh 51 mcg kg hr 50 except enter mcg kg hr instead of ugkh mcg kg min Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 52 OPT 52 DOSE ug m PUSH ENTR Push ENTER SET DOSE 0 ug m DOSE MODE Select the DOSE in mcg min 0 1 9999 ug m For 50 ug m PUSH ENTR 52 mcg min example select 50 0 ug m ug m Push ENTER SET CONC 0 mg Select the amount of drug dissolved in the dosage container 0 1 9999 mg For example select 100 mg 100 mg PUSH ENTR Push ENTER SET CONC 0 ml Options 52 continued LC f AA OPT OPTION NO NAME INSTRUCTIONS DISPLAY Select the total volume of the dosage container 0 1 250 m PUSH ENTR 9999 ml For example select 250 ml DOSE Push ENTER
7. 7 5 ml hr DOSE ug m SET VOL VOL 0 52 MODE Select tne VOLUME LIMIT that portion of the dosage 250 VOL PUSH ENTR mcg min container that is to be infused 0 1 9999 ml For ug m example select 250 ml Push ENTER The computed ml hr RATE is displayed OPT 52 50 ug m 7 5 ml h IN STOP PUSH RUN Push RUN to start the infusion For additional tips on RATE ERR changing RATE reviewing all entries and clearing this option see NOTE under OPTION 50 Options 53 54 55 56 57 8c f AA OPT NO OPTION NAME INSTRUCTIONS DISPLAY ME ME pero DEE a mesial OPTSADOSE mg ss imeem cen O rs mo OPTSSDOSE moi EE ta r TE ae o TE RR 60 Auto Program Mode Example Option o e z E ill Din Oc oe 22 lt so Qs cao OL e ON 8 o E a x j
8. No see the next page Push Enter Enter all parameter values requested Push ENTER after each entry The next prompt will then appear The last prompt is PUSH RUN To review all entries repeatedly push ENTER To correct a mistaken entry push CLEAR To clear an entire option mode push OPTIONS and enter the option number Push CLEAR when the option number displays The pump must be in stop to clear any entry or an entire option To access other OPTION modes before starting the pump repeat steps 1 5 Note that NA not available displays when an operator selects an OPTION NO that is not in the pump s program selection 18 Rev J Options List No Option 10 Alarm Tone Loudness Adjustment 11 Keylock 12 Return to Primary Mode 20 Piggyback time min and vol limit 21 Piggyback rate and vol limit 30 Time primary time hrs and volume limit not available 20 Bolus Mode not available 40 Dose units hr un h 41 Dose units kg min unkm 42 Dose units kg hr unkh 43 Dose milliunits min mu m 44 Dose grams hr g h 50 Dose mcg kg min ugkm 51 Dose mcg kg hr ugkh 52 Dose mcg min ug m 53 Dose mcg hr ug h 54 Dose mg kg min mgkm 55 Dose mg kg hr mgkh 56 Dose mg min mg m 57 Dose mg hr mg h 60 Programming Automatic 21 steps 61 Programming Automatic Opt 60 or 62 taper step
9. SET VOL VOL 0 Select the VOLUME LIMIT that portion of the dosage 250 VOL PUSH ENTR container that is to be infused 0 1 9999 ml For example select 250 ml Push ENTER The computed ml hr RATE is displayed OPT 50 2 0 ugkm 6 0 ml h IN STOP PUSH RUN Push RUN to start the infusion Note ifthe values entered above are not within the pump s operating specifications ERR RATE or ERR ugkm displays Enter correct value as prompted ifthe values entered above do not result in a computed RATE ml h or dose within the pump s allowable range RATE or DOSE HIGH or LOW will display Follow prompts to enter new values To change the RATE ml h stop the pump and press the RATE key Select new rate and the dose will automatically be recalculated Push RUN To change any dose mode parameter stop the pump push ENTER until the parameter appears select the new value push ENTER push RUN All affected parameters will be recalculated To review all dose mode entries repeatedly push ENTER To clear this option push CLEAR while either PUSH RUN or OPT 50 displays Options 50 con d 51 52 9c f AA OPT OPTION NO NAME INSTRUCTIONS DISPLAY To titrate DOSE push ENTER DOSE flashes for ten seconds Select new dose New dose displays alternating with PUSH ENTR Push ENTER New DOSE is accepted Infusion starts at new dose and Note If ENTER is not pushed to complete the recalculates rate
10. SIGMA must be properly packaged and sent to SIGMA with postage and handling prepaid Severe Pump damage may result if SIGMA shipping cartons and inserts are not used Shipping cartons and inserts are available at no charge from SIGMA This limited warranty shall not apply to defective conditions or damage caused in whole or in part by negligence fluid spills dropped Pumps misuse abuse improper installation improper cleaning alteration or damage resulting from improper shipment to SIGMA If after inspection SIGMA is unable to identify a problem SIGMA reserves the right to invoice the purchaser for such an inspection THIS LIMITED WARRANTY IS THE SOLE AND ENTIRE WARRANTY PERTAINING TO THE PUMP AND IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES OF ANY NATURE WHATSOEVER WHETHER EXPRESS IMPLIED OR ARISING BY OPERATION OF LAW TRADE USAGE OR COURSE OF DEALING INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE ANY AFFIRMATION OF FACT OR PROMISE MADE BY SIGMA SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO THE AFFIRMATION OR PROMISE ANY DESCRIPTION OF THE PUMP IS FOR THE SOLE PURPOSE OF IDENTIFYING IT AND 57 Rev J SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO SUCH DESCRIPTION ANY SAMPLE OR MODEL IS FOR ILLUSTRATIVE PURPOSES ONLY AND SHALL NOT BE DEEMED TO CREATE AN EXPRESS WARRANTY THAT THE PUMP SHALL CONFORM TO T
11. feature disabled while a mode is currently set up with a drug label attached the label will be excluded from the running display Options 80 GE f AA OPT NO OPTION NAME INSTRUCTIONS DISPLAY EDIT If the operator accidentally enters the wrong label or answered NO to the DRUG LABL YES NO prompt when they really meant to press YES they may press the 1 key on the pump labeled EDIT If the operator presses the EDIT key and the pump is not running the pump shall display EDIT LABL DRUG LABEL lt drug name gt YES NO If the operator presses YES on the pump keypad the display shall show the ENABLE drug name that was incorrectly assigned and the operator may then navigate to the correct one using the DISABLE method described above If the operator presses NO at the EDIT LABL drug name VES NO 80 Available for display the pump will revert to the display shown prior to the EDIT key press ii lete V If the Drug Label feature is not enabled pressing the EDIT key shall do nothing If the Drug Label feature is with label only enabled the EDIT key is pressed while the pump is running STOP PUMP TO SET DRUG LABL shall software be displayed Labeling a Piggyback Infusion If the user has programmed a Piggyback Mode infusion to take place before the main infusion the pump will allow the user to assign separate Drug Labels to both the Piggyback and Main infusio
12. remove the case Refer servicing to qualified service personnel 2 Refer to the Service Manual for pump inspection and preventative maintenance procedures 3 When pump return to SIGMA is desired a Phone 1 800 356 3454 for repair authorization RA number A P O number for non warranty repairs is required b Ship pumps to SIGMA International at 711 Park Avenue Medina NY 14103 Return pumps in original boxes with original inserts to prevent damage during shipment c Include a problem description a contact person a phone number a return address and label the shipping box with the RA number 4 Required Maintenance and Frequency a Maintenance consists of routine cleaning and operations evaluation in accordance with the procedures described in the service manual It is recommended this evaluation be performed at least once every twelve 12 months 5 Battery Use and Maintenance a If a LOW BATT display is seen upon start the battery is insufficiently charged To recharge the battery plug the power cord into an outlet for 18 24 hours Recharging is automatic and occurs whenever the pump is plugged in whether stopped or operating b Ifleft idle for long periods of time 3 months or more the pump should be plugged into an AC outlet to recharge the battery c Batteries are maintenance free and should last 200 full discharge charge cycles 6 Protective Grounding a Do not operate the pump if the integrity o
13. the following example Dopamine is used and the pump s Drug Library has been programmed with two Dopamine concentrations 2 DRUG LABL YES NO displays Push YES to reverse a YES decision simply push NO 3 ENTR DRUG displays Push the DEF key once to pull up the D drugs Use the CLEAR NOW key to scroll to Dopamine to reverse an errant drug entry simply push another alpha key 4 DOPAMINE YES OR 4 displays Push YES 5 Since Dopamine is available in two concentrations 1 6 mg ml and 800 ug ml DRUG 1 of 2 DOPAMINE 1 6mgml DOSE ugkm mcg kg min YES NO displays Push YES to enter the 1 6 mgml concentration 8 Rev J 6 SET DOSE 0 ugkm displays Enter a dose rate The exceedable Soft Limits for Dopamine are 3 50 ugkm If 51 ugkm were entered DOSE HIGH DOSE LIMIT 50 ugkm OVER RIDE DOSE LIMIT 50 ugkm YES NO displays Push YES to enter 51 ugkm The pump will infuse with an override message displayed MAX DOSE OVER RIDE The unexceedable Hard Limits for Dopamine are 1 75 ugkm If 76 ugkm were entered it would not be accepted and DOSE HIGH DOSE LIMIT 50 ugkm SET DOSE O ugkm displays 7 Enter all other values the display asks for and push RUN to start the infusion 8 To titrate a dose rate without stopping the pump push ENTER select the new dose rate and push ENTER again Drug Label Mode 1 Drug labeling works in all modes of the pump 2 The Drug Label Mode applies to drugs and fluids where no rate limit
14. 0 psi 15 psi 1 ml hr lt 20 min lt 40 min lt 60 min 100 ml hr lt 15 sec lt 20 sec lt 30 sec Max Bolus 0 34 ml 0 6 ml 0 7 ml Ocelusion pressure 1s adjustable from 2 15 psi Mechanical occlusion pressure limit under fault conditions the maximum pumping pressure if the occlusion alarm is inoperative 55 psi Air Alarm detects air bubbles gt 1 inch long Safety Checks All safety related sensing systems are automatically checked for proper operation at power on and periodically thereafter Faults are identified by FIX codes In fault modes the pump will not operate 54 Rev J Type of Pump Volumetric Infusion Pump Operating Principle Linear Peristaltic Rated voltage and current Single Channel 105 135 VAC 0 2A 50 60 Hz fused T500Ma IEC 127 220 240 VAC 0 1 A 50 60 Hz fused T250Ma IEC 127 Dual Channel 105 135 VAC 0 3 A 50 60 Hz fused T500Ma IEC 127 220 240 VAC 0 15A 50 60 Hz fused T250Ma IEC 127 Ground resistance Single Channel lt 0 13 ohm Dual Channel lt 0 130hm Patient leakage lt 15 micro amp normal condition lt 50 micro amp single fault condition Operating conditions Relative humidity 30 90 non condensing Temperature 65 85 Atmospheric pressure 22 31 in Hg Battery Single Channel Type 12 volt battery pack consisting of 6 each 22 2V 2 5 amp hr rechargeable sealed lead acid batteries Operation for batteries in as new
15. 12 OPT 12 PRIM MODE PUSH ENTR Mode Push ENTER From PIG Mode PRIM MODE RATE X VOLX PUSH RUN From Dose Modes and Programming Modes PRIM MODE SET RATE RATE 0 SET VOL VOLO Options 20 Ic OPT OPTION NO NAME INSTRUCTIONS DISPLAY Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 20 OPT 20 PIG MODE PUSH ENTR Push ENTER SET PIG TIME O min Select the piggyback TIME in minutes from 1 1440 PIG TIME 30 min PUSH ENTR min For example select 30 min Push ENTER SET PIG VOL VOL O PIGGYBACK Select the piggyback VOLUME LIMIT from 0 1 VOL 50 PIG VOL PUSH ENTR 20 TIME MIN 9999 ml For example select 50 ml AND VOL Push ENTER CHEK PIG CLMP PUSH ENTR Ensure that the slide clamp on the piggyback line is open press ENTER OPT 20 PIG MODE IN STOP PUSH RUN Open all clamps and push RUN to start the infusion PIG RATE XXX PIG TIME XXXXMINS alternately display Or to clear all PIG MODE values push CLEAR when PUSH RUN or OPT 20 displays Note The piggyback instructions under OPT 21 below apply to OPT 20 also f AA CC f AA Options 21 OPT OPTION NO NAME INSTRUCTIONS DISPLAY Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 21 OPT 21 PIG MODE PUSH ENTR Push ENTER SET PIG RATE RATE 0 Select the piggyback RATE from 0 1 to 999 ml hr For example select 100
16. Allow the pump to reach a minimum of 65 F before subsequent operation This alarm will reset when the temperature goes above 40 F OPEN CLMP Open the roller clamp wheel OPEN CLMP OR PUSH OPEN Open the roller clamp s wheel or push the OPEN key to open the LEVER and unload the IV set OPEN LEV Open the LEVER to load or unload the IV set OPEN LEV FULLY Open the lever fully two beeps will occur A raspberry alarm sounds if the LEVER is not open fully OPEN LEV OR OPEN CLMP Open the lever to unload the IV set or open the roller clamp OVER RIDE 1 The existing soft rate limit may be exceeded by pushing the YES key 2 During RUN this display indicates the pump is infusing in an override condition PLUG IN The pump s battery is depleted Plug the pump in PM DUE Preventative Maintenance is due Send the pump to Biomed 15 Rev J PRI FLOW The Flow Sensor has detected drops in the primary drip chamber while the pump is infusing in the Piggyback Mode Correct the problem by preventing primary line flow while piggyback volume remains PROG COMP RATE KVO PUSH STOP The ramping tapering program is complete Push STOP to halt the KVO rate Turn the pump off or PUSH RUN to restart the program from RT 1 VL 1 step 1 PUSH RUN The pump is in stop Push RUN to resume the infusion RATE LMIT A RATE LIMIT for the fluid or drug in use has been exceeded RELOAD SET INTO JOCC Note The lever automat
17. Error Prevention software this list can be customized by each facility Drug Abbreviation Drug Abbreviation Abciximab Abci xima Cefotetan Cefo teta Acyclovir Acyc lovi Cefoxitin Cefo xiti Aldesleukin Alde sleu Ceftazidime Ceft azid Alfentanil Alfe ntan Ceftizoxime Ceft izox Alprostadil Alpr osta Ceftriaxone Ceft riax Alteplase rt Alte plse Cefuroxime Cefu roxi PA Amikacin Amik acin Central Line Cent ral Aminocaproic Amin ocap Chemotherapy Chem o Acid Aminophylline Amin ophy Cimetidine Cime tidi Amiodarone Amio daro Ciprofloxacin Cipr o Amphotericin B Amph oter Cisatracurium Cisa trac Ampicillin Ampi sulb Cisplatin Cisp lati sulbactum Amrione Amri one Cladribine Clad ribi Analgesic Anal gesi Clindamycin Clin damy Antibiotic Anti biot Colloids Coll oids Anticonvulsant Anti conv Cotrimoxazole Cotr imox Antidote Anti dote Crystalloid Crys tall Antiviral Anti vira Cyclophosphami Cycl opho de Argatroban Arga trob Cyclosporine Cycl ospo Arterial Arte rial Cytarabine Cyta rabi Ascorbic Acid Asco rbic Diltiazem Dilt iaze Atracurium Atra curi Diuretic Diur etic Azithromycin Azit hrom Dexmedetomidin Dexm edet e Aztreonam Aztr eona Dobutamine Dobu tami Bactrim Bact rim Docetaxel Doce taxe Bleomycin Bleo myci Dopamine Dopa mine Blood Products Bloo d Doxil Doxi Bretylium Bret yliu Doxorubicin Doxo rubi Bumetanide Bume tani Drotr
18. HE SAMPLE OR MODEL AND NO AFFIRMATION PROMISE DESCRIPTION SAMPLE OR MODEL SHALL BE DEEMED TO BE PART OF THE PURCHASE OF THE PUMP PURCHASER EXPRESSLY ACKNOWLEDGES THAT THIS LIMITED WARRANTY CONSTITUTES PURCHASER S SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO ANY CLAIM OF PURCHASER ARISING OR RESULTING DIRECTLY OR INDIRECTLY FROM THE USE OF THE PUMP IN NO EVENT SHALL SIGMA BE LIABLE HEREUNDER FOR AN AMOUNT WHICH EXCEEDS THE PURCHASE PRICE OF THE PUMP LESS A 100 USAGE FEE FOR EACH MONTH THE PURCHASER HAS HAD POSSESSION OF THE PUMP NO PERSON FIRM OR CORPORATION IS AUTHORIZED TO ASSUME FOR SIGMA ANY LIABILITY IN CONNECTION WITH THE SALE OF THE PUMP 58 Rev J
19. Keylock e Alarm Volume Occlusion Pressure Options 99 HE Maximum RATE or VOL LIMIT Settings MEMORY Biomedical Mode Entries Programming Modes Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 99 OPT 99 CLR ALL PUSH ENTR Push ENTER ALL CLR SET RATE Display Abbreviations Abbreviation Definition Abbreviation Definition ALRM Alarm m min minute s AUTO Automatic MIN Minimum BATT Battery ml milliliter s CHEK Check mmHg millimeters of mercury CHRG Charge mu milliunit s CLMP Clamp OCCL Occlusion CLR CLRD Clear cleared TOCC Upstream occlusion sensor upstream occlusion COMP Complete LOCC Downstream occlusion sensor downstream occlusion CONC Concentration OPT Option CUST Custom PIG Piggyback DISP Display POWR Power DLYD Delayed PRES Pressure ENTR Enter PRI Primary ERR Error PROG Program FULLY Fully PSI Pounds per square inch g gram s RE LOAD Reload h hr hrs hour s RE MOVE Remove RMVE INF Infusion RATE RT Rate JAMD Jammed STRT Start k kg kilogram TAPR Taper KVO Keep vein open TEMP Temperature LABL Label TOTL Total LEV Lever VL Volume LIMT Limit VOL Volume MANU Manual ug microgram s MAX Maximum un unit s Mg Milligram s 38 Rev J Drug Label Library Abbreviations Default drug label list available in the 8000 7 and 8002 Aas In 8000 Ps 8002 74 Drug
20. L indicator NRTL i e Nationally Recognized Testing Laboratory is a designation granted by the U S Occupational Safety and Health Administration OSHA to laboratories which have been recognized to perform certification to U S Standards 56 Rev J Limited Warranty SIGMA warrants to the original purchaser the SIGMA 8000 Infusion Pump hereinafter Pump to be free from defects in material and workmanship under normal use and service for one year from the date of shipment i e the invoice date SIGMA s obligation under this limited warrant shall be limited to repair or replacement of Pumps which upon SIGMA s examination are found defective in material or workmanship under normal use and within one year from the date of purchase by the original purchaser The repair or replacement of any Pump under this limited warranty shall not extend the term of this limited warranty beyond the original term as set forth in this paragraph All repairs qualifying under this limited warranty must be performed by qualified SIGMA trained service personnel In the event that any Pump is found to be defective during the aforesaid warranty period the purchaser shall notify SIGMA in writing of any claimed defect within thirty days after such claimed defect is discovered The Pump claimed to be defective must then be promptly delivered to SIGMA or its designated representative for inspection and repair or replacement if necessary Pumps returned to
21. Lower Y injection site Priming Volume 42mL Luer Lock amp je 1 pc Pumping Section I BEI EE I NOTE IV Sets are Latex Free 49 Rev J RS232 Pump to Computer Interface amp Staff Call The SIGMA 8000 is equipped with a serial port R5232 connector on its back panel 2 on the 8002 ws This connector is also used to connect the pump to staff call systems Since the systems pumps may be connected to vary widely users should consult with SIGMA s Service Department for specific instructions Users without sufficient electronics background and knowledge of both the SIGMA 8000 infusion pump and outside devices it may be connected to should never attempt such a connection To do otherwise can result in electrical damage to the pump Flow Sensor Drop Sensor The FLOW SENSOR detects drop flow in the IV set s drip chamber The sensor fits on the drip chamber and its cord plugs into the pump s serial output connector back panel When the sensor detects no drop flow the CLR T OCC EMPT BOTT clear upstream occlusion empty bottle alarm occurs Eliminating the cause of the alarm and pushing RUN causes the infusion to resume When using a Flow Sensor in the piggyback mode the Flow Sensor is placed on the primary set s drip chamber The pump will alarm PRI FLOW if drops are detected in the primary IV set s drip chamber before the PIG VOL LIMIT has
22. SIGMA 8000 8000 P4 and 8002 Pas Infusion Pump Operator s Manual Sigma International LLC 711 Park Avenue Medina New York 14103 585 798 3901 800 356 3454 585 798 3909 Fax PN 44001 Rev J Revised 8 2003 Table of Contents Introduction amp Intended Applications Views Loading Sets amp Start Up Start Up with Drug Error Prevention Unloading Sets Important Tips Alarm Clearing amp User Prompt Displays Option Modes Display Abbreviations Drug Label Library Abbreviations Cleaning amp Storing Servicing Cautions Accessories and SIGMA IV Sets RS232 Pump to Computer Interface amp Staff Call Flow Sensor Drop Sensor Specifications Limited Warranty Rev J Introduction amp Intended Applications INTRODUCTION This manual provides instruction for all Sigma 8000 infusion pumps the 8000 8000 7 and 8002 PA all referred to as the SIGMA 8000 INTENDED APPLICATIONS The SIGMA 8000 is intended for the following intravenous and epidural applications 1 Large and small volume parenterals 2 Neonatal 3 Homecare 4 Epidural Infusions 5 Blood Product Infusions STANDARD IV SET USE The SIGMA 8000 uses standard gravity IV sets The principle advantages of standard sets over captive sets are 1 Lowest possible cost 2 No need to change IV sets when patients move from one hospital area to another 3 Maximum IV set selection including needleless Each SIGMA 8000 is calibrated to use
23. a single brand of standard IV set either Abbott Baxter or B Braun McGaw Unlike other standard set pumps which cannot be recalibrated the SIGMA 8000 can be recalibrated to accommodate new IV set suppliers in the future Since the SIGMA 8000 is designed to use an IV set with a specific inner diameter and elasticity it will not operate safely and effectively with large diameter blood sets small diameter micro bore sets or stiff nitroglycerin sets However special SIGMA 8000 sets are available for blood lipid and nitroglycerin infusions These sets utilize a pump insert that is made from standard Abbott Baxter or B Braun McGaw IV tubing The SIGMA 8000 maintains 5 flow rate accuracy while using a single tubing section for 72 hours see Specifications for accuracy claims involving rates below 1 9 ml hr 2 Rev J SET BASED ANTI FREE FLOW PROTECTION The SIGMA 8000 requires the IV set s roller clamp be loaded into the pump and it locks the set in the pump preventing set removal until the roller clamp is closed This system prevents accidental free flow SIMPLE OPERATION The SIGMA 8000 1s very easy to use Simply follow the user prompts OPTION MODES All the SIMGA 8000 s special capabilities are accessed by means of its OPTION MODES which are listed on the left side of the pump CONCLUSION Thank you for taking the time to learn how to operate the SIGMA 8000 The SIGMA 8000 is a safe reliable time saving device that w
24. avulanate Tica clav Tirofiban Tiro fiba Tobramycin Tobr amyc Topotecan Topo teca TPN TPN Trastuzumab Tras tuzu Trovafloxacin Trov aflo Umbilical Arterial UAC Catheter Umbilical Venous UVC Catheter Urokinase Urok inas Vancomycin Vanc omyc Vasopressin Vaso pres Vecuronium Vecu roni Venofer Veno fer Verapamil Vera pami Vincristine Vinc rist Zoledronic Acid Zole dron 41 Rev J Cleaning amp Storing CLEANING 1 Turn the unit off and disconnect the power plug from the AC Power source before cleaning 2 Clean exterior surfaces with the pump in an upright position Apply cleaners with a dampened cloth per the manufacturers instruction and dilution ratios Disinfectants should remain on the pump surface in even but not dripping film for the manufacturers recommended contact time Wipe dry or air dry after completion of the contact time period before reusing the pump Dispose of all cleaning disinfectant materials per federal state and local regulations for infectious waste disposal 3 All elements in the IV SET CHANNEL should be cleaned on a routine basis with lint free foam tipped swab Chemtronics Foamtip 140 T M for example dampened with cleaning solution The CHANNEL should be thoroughly dried before reusing the pump Never use sharp objects such as pens pencils fingernails paper clips needles etc to clean the IV SET CHANNEL area DO NOT use abrasive cleaners or sprays sterilize b
25. delayed start was selected and the currently installed tubing has been pumped on the 9 pump motor will now position itself to maintain flow accuracy u DLAY STRT SET RATE RATE 0 DLAY 4 If Primary Mode was selected above when all set to run STRT PRI MODE IN STOP PUSH RUN Options 90 95 299 LS f AA lo OPTION NAME INSTRUCTIONS DISPLAY If Primary Mode was not selected above Enter option number for the Option Mode desired to run following the delay SET ORT CODE OPT 60 AUTO PROG PUSH ENTR Go thr ugh mod Setup example Option 60 entered DELAYED START If an infusion mode is set up prior to entering this option that i e DLAY STRT mode will become the delayed mode and you will not be asked EE NI POLA PROG STER 90 during the Delayed Start setup to select a mode Push RUN Not available on all RATE KVO DLAY STRT 1 5 hrs OPT 60 models If a KVO delay start selected pump runs at KVO rate AUTO PROG TA CAN DLAY STRT 1 5 hrs OPT 60 AUTO PROG Note Pushing STOP at any time during a delayed start or a KVO alarm delay pauses the timer To continue the delay push RUN Stop the pump IN STOP PUSH RUN a PECHA Push OPTIONS SET OPT CODE MODES Select 95 OPT 95 CLR PRGS PUSH ENTR Push ENTER PRGS CLRD SET RATE Note Use of this option enables the operator to clear all pump memory except the following items which must be cleared individually e
26. e desired drug name may be selected and placed in the display The menu shall display the first A drug upon entry The menu shall be designed with an interface similar to that of the telephone The keys 2 0 shall be utilized with each letter of the alphabet The first press of the numeric key would initiate a listing of the supported drug names starting with the first letter associated with that key So in this instance where the first A drug is in the display if the operator is delivering Colloids into the patient they would push the 2 key two times to bring up the alphabetical listing of the supported C drug names and then press CLEAR NO to scroll the list until COLL OIDS is observed Enter will select it and the pump shall proceed to the ready to run state If the operator happens to scroll past the drug they want a single press of the associated numeric key will place them back at the top of the list o f the current letter they are viewing For example if the operator is looking for Dobutamine and scrolls past it to Docetaxel they can just press the 3 again to put them back at Diltzern the first drug in the D list In another example if the operator wants to view the N drug name and presses the 6 key three times instead of the two putting them in the O list the software shall wrap around to the M labels on the fourth press and back to the N list on the fifth If Option 80 is entered and the drug label
27. ecogin Drot reco Calcium Calc gluc Enalapril Enal apri Gluconate Carboplatin Carb opla Epidural Epid ural Carmustine Carm usti Epinephrine Epin ephr Cefazolin Cefa zoli Eptifibatide Epti fiba Cefepime Cefe pime Erythromycin Eryt hrom Cefoperazone Cefo pera Esmolol Esmo lol Cefotaxime Cefo taxi Etomidate Etom idat 39 Rev J Drug Abbreviation Drug Abbreviation Etoposide Etop osid Meperedine Mepe redi Famotidine Famo tidi Mesna Mes na Femoral Femo ral Methohexital Meth ohex Fenoldopam Feno ldop Methotrexate Meth otre Fentanyl Fent anyl Methylprednisolo Meth pred ne Filgrastim Filg rast Metocloprimide Meto clop Fluconazole Fluc onaz Metoprolol Meto prol Fludarabine Flud arab Metronidazole Metr onid Flumazenil Flum azen Midazolam Mida zola Fosphenytoin Fosp heny Milrinone Milr inon Furosemide Furo semi Mivacurium Miva curi 5FU Five FU Morphine Morp phin Gemcitabine Gemc itab Muscle Relaxant Musc Rela Gentamicin Gent amic Nafcillin Nafc illi Heparin Hep arin Naloxone Nalo xone Hetastarch Heta star Nesiritide Nesi riti Hydrocortisone Hydr ocor Nicardipine Nica rdip Sod Succinate Hydromophone Hydr omop Nitroglycerin Nitr ogly Ibutilide Ibut ilid Nitroprusside Nitr opru Idarubicin Idar ubic Norepinephrine Nore pine Ifosfamide Ifos fami Octreotide Octr eoti Imipenem Imip Cila Ofloxacin Ofl
28. ept enter units kg min instead of mcg kg min unkm DOSE MODE E f 42 units kg hr unkh Follow the same operating instructions as OPTION 50 except enter units kg hr instead of mcg kg min DOSE MODE 43 milliunits min Follow the same operating instructions as OPTION 52 except enter milliunits min instead of mcg min mu m DOSE MODE a 7 44 grams hr g h Follow the same operating instructions as OPTION 52 except enter grams hr instead of mcg min Options 50 ST f AA OPT OPTION NO NAME INSTRUCTIONS DISPLAY Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT GODE Select 50 OPT 50 DOSE ugkm PUSH ENTR Push ENTER SET DOSE 0 ugkm Select the DOSE in meg kg min 0 1 to 9999 ugkm For 2 0 ugkm PUSH ENTR example select 2 0 ugkm Push ENTER SET CONC O mg Select the amount of drug dissolved in the dosage container 400 mg PUSH ENTR 0 1 9999 mg For example select 400 mg DOSE Push ENTER SET GONG 0 ml 50 MODE Select the total volume of the dosage container 0 1 9999 250 ml PUSH ENTR mcg kg min ml For example select 250 ml This and the former step ugkm establish the dosage concentration i e CONC Push ENTER SET kg 0 kg Select the patient s body weight in kg 0 1 999 kg Note 1 80 kg PUSH ENTR kg 2 2 lbs 1 Ib 0 454 kg For example select 80 kg Push ENTER The computed ml hr rate is displayed 6 0 ml hr DOSE ugkm
29. f the protective earth conductor is in doubt Have the pump serviced 43 Rev J 10 11 Cautions Operation of this pump is restricted to trained operators with a complete understanding of this operator s manual and standard IV therapy practices Retain this manual for future reference To reduce infusion errors 1t is strongly recommended that drug dose and rate infusion limits be entered by the pharmacist in the 8000 8002 Plas pumps equipped with drug error prevention software Servicing of this pump is restricted to qualified trained service personnel familiar with and who employ SIGMA factory authorized servicing calibration and testing procedures Use of other servicing procedures is prohibited The SIGMA 8000 pump is not intended to be a substitute for regular patient observation and evaluation Federal USA law restricts this device to sale by or on the order of a physician or other licensed practitioner Use only IV sets specified on the caution label on top of the pump or inaccurate flow rates malfunctions or false alarms may result Contact SIGMA for a complete list of compatible IV sets Visually inspect pump mechanism for presence of IV tubing or any other material prior to loading IV set into channel Shut the IV set s roller clamp before set removal or free flow can result Pull IV set taut no slack when loading the DOWNSTREAM OCCLUSION sensor Do not push the set up after loading or free flow can re
30. ght Then push RUN HIGH LOW RATE The pump was momentarily running at other than the rate selected If this alarm continues after pushing RUN discontinue pump use and have the pump serviced HIGH TEMP The internal pump temperature is above 150 F Allow the pump temperature to return to below 85 F before subsequent operation This alarm will reset when the temperature goes below 150 F INF COMP RATE KVO PUSH STOP INFUSION COMPLETE The volume to be infused has been delivered Push STOP to halt the KVO rate set a new VOL LIMIT and push RUN container overfill accounts for unexpected fluid residuals Be sure to set the VOL LIMIT to the value slightly under the volume of the IV container to prevent air from entering the IV set 14 Rev J IN STOP PUSH RUN The pump is stopped Push RUN to start the infusion KEY LOCK All keys are locked Key settings can be read but not changed To unlock keys push OPTIONS 11 LABL ONLY No dose rate limits are associated with the label being displayed LEV JAMD The LEVER is jammed Push the LEVER in then push the OPEN key LOAD Load the IV set or roller clamp into the area of the pump being indicated Prime the set prior to loading MAX DOSE The maximum allowable dose rate is displayed MIN DOSE The minimum allowable dose rate is displayed MODE CLRD The existing mode has been cleared LOW TEMP The internal pump temperature is below 40 F
31. hich it was turned off TIME OUT OPT 60 AUTO PROG STEP XX IN STOP PUSH RUN Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 60 OPT 60 AUTO PROG PUSH ENTR Push ENTER SET PROG VOL 0 Select the total VOLUME LIMIT in ml For example select 2000 ml VOL 2000 PUSH ENTR Push ENTER SET PROG 0 hrs Select the total infusion TIME in hrs For example select 10 hrs 10 hrs PUSH ENTR Push ENTER OPT 60 AUTO PROG STEP1 IN STOP PUSH RUN Push RUN to begin the infusion To review actual RATES and VOL LIMITS for each individual step repeatedly push the RATE or VOL LIMIT keys with pump stopped To exit OPTION 60 and immediately begin the taper steps simply enter OPTION 61 Options 61 62 Te f AA OPT NO OPTION NAME INSTRUCTIONS DISPLAY e OPTION 61 allows an immediate taper exit from OPTION 60 or 62 If the program is stopped in the ramp up PROGRAMMING steps 1 10 the taper will begin at the corresponding taper down step If the program is stopped while infusing AUTOMATIC in the main rate RT 11 the taper begins at step 12 and ends at step 21 61 Opt 60 or 62 Stop the pump IN STOP PUSH RUN taper steps only Push OPTIONS SET OPT CODE Select 61 OPT 61 AUT TAPR PUSH ENTR Push RUN to start the pump and begin the taper steps only OPTION 62 allows entry of customized ramp and taper s
32. ically unlocks for 10 seconds after a RELOAD SET display After 10 seconds push OPEN to unlock the lever One of the following conditions occurred Tubing is not loaded correctly into the downstream occlusion sensor no 2 beeps The lever was not opened fully during the downstream loading process no 2 beeps Tubing was overly stretched downward in the pumping channel as the lever was closed Pumped on tubing is loaded in the downstream occlusion sensor The IV set was left loaded in the turned off pump for more than 6 hours After reloading do not push the set up in the pumping channel Confirm tubing is not visible or looped out of the peristaltic pump area RMVE TUBE Load the roller clamp and open the lever to remove the set from the pump SET Enter the requested parameter SHUT CLMP Shut the roller clamp or free flow may result SHUT LEV Shut the LEVER completely TIME OUT The pump is in a program mode and has been stopped or turned off for 60 minutes or longer The pump has recycled to the first rate and volume step 16 Rev J YES or Push YES to enter the displayed drug or NO J to scroll through the list of drugs with the same first letter 17 Rev J Option Modes SUMMARY Push STOP Push the OPTIONS key Select the OPTION number see left side label Push ENTER Enter all required parameters and push RUN Push STOP Push the OPTIONS key Select the desired OPTION
33. ill serve you for many years Abbott Baxter and B Braun McGaw are registered trademarks Contact SIGMA for a complete list of compatible IV sets 3 Rev J AIR amp UPSTREA OCCLUSION SE OPEN ROLLER SENSOR ROLLER CLAMP H CLOSED RO CLAMP SENSO ON OFF CHARG RATE ML HR VOLUME LIMIT ML K IV SET CHANNE RUN STOP SILENCE LEVER LOCKING LABEL OPTIONS KEY LENTER KEY LEVER AIV Views FRONT VIEW 8000 Single Channel DISPLAY LED 7 5 A IAE x AC ON Nu TATA r g NDICATOR Y SIGMA NUMERICAL amp DECIMAL POINT V ame CHARGE EE lt Im fax 4516 4 SH SERER ENTER cusan r OPTIONS Yes f No Ael Ee EE CLEAR KEY O IT LE EY froma VOL E IN ak JIN d E P TOTAL VOLUME ML KEY Rev J REAR VIEW 8000 Single Channel CSA CERTIFICATION LABEL r J m 1 EN C A CALL CONNECTOR CONNECTOR FUSE HOLDER ELECTRICAL lies CAUTIONS SERIAL T NUMBER LABEL Rev J Loading Sets
34. infused The pump will alarm EMPT BOTT if the Flow Sensor does not detect drops in the primary set s drip chamber after switching to primary mode Since the FLOW SENSOR functions as a combination empty container upstream occlusion and air sensor plugging the sensor into the pump at the same time disables the air upstream occlusion sensor which can be particularly useful when infusing solutions that outgas Such solutions can cause microbubbles to adhere to tubing walls in large quantities which in turn result in nuisance air alarms While the in line AIR detector may alarm on such large quantities of microbubbles the FLOW SENSOR will not 50 Rev J DIRECTIONS FOR FLOW SENSOR USE 1 Connect the FLOW SENSOR S plug into the serial output connector on the back of the pump 2 Attach the FLOW SENSOR to the IV set s drip chamber with the sensor s arrow midway between the drop orifice and the drip chamber fluid level 3 Avoid nuisance alarms by filling the drip chamber no more than half full turning the sensor opening away from sunlight avoiding sensor shaking or tilting and using macro drop sets at flow rates above 200 ml hr Below 200 ml hr mini drop sets can be used Optional Flow Sensor 51 Rev J Specifications Applications 1 Large and small volume parenterals 2 Neonatal 3 Homecare Also intended for blood product infusions and for epidural applications V sets Compatible with standard gra
35. ion IV set based Option Modes Option Number Option Name 10 Alarm tone B 11 Key Lock B 12 Return to Primary Mode A 20 Series Piggyback Modes A 40 50 Series Dose Modes A 60 Series Program ramp taper Modes B 70 Series J Occlusion Pressure Modes selectable A or B 80 Series Drug Label 90 Delayed Start unless operating in conjunction with program mode 95 Clear all Program Modes N A 99 Clear all 6 hr Memory Settings N A Biomedical Modes B A indicates memory 1s retained for 6 hrs after power turn off after which time memory erases applicable to those options listed above and to primary RATE and VOLUME settings B indicates memory is retained indefinitely until the operator manually clears it Upstream Ocelusion Alarm Upstream ocelusion time to alarm 53 Rev J Distance Occlusion Above Pump RATE 6 inches 24 inches 5 ml hr lt 4 min lt 8 min 100 ml hr lt 30 sec lt 40 sec 999 ml hr lt 10 sec lt 10 sec Note Upstream occlusion detection is only effective for occlusions present immediately after the start of the pump s run operation Upstream occlusions caused by non vented IV sets used with non vented glass bottles or closed burette air vents cannot be detected because of the very slow building vacuums resulting from these situations Downstream occlusion alarm time With Occlusion 45 Inches Below Pump And Alarm Set to RATE 2 psi 1
36. l hr by using the numeric keys Set the VOLUME LIMIT in ml To avoid air entering the IV set the volume limit should not exceed the IV container s volume Push RUN to start the infusion Confirm all values are correct After each pump start and after all rate changes confirm the drop rate approximates the pump s mL hr RATE if they do not correspond discontinue pump use and send the pump for service A scrolling RATE display indicates the pump is infusing To titrate flow rates without stopping the pump push the RATE key select a new rate and push ENTER The rate will not change until ENTER is pushed push clear to erase a mistaken entry 7 Rev J Start Up with Drug Error Prevention Optional not available on all models SUMMARY DEP START UP Prime and load the IV set Open the roller clamp DRUG LABL YES NO Answer YES if infusing a drug or NO if no drug label is required NOTE If the DRUG LABL question does not appear turn it on by selecting OPTION 99 ENTR DRUG Push the desired alpha key scroll to the drug name and push YES Select the desired concentration Enter all parameters asked for and push RUN Use OPTION 99 to erase an errant drug mode entry NOTE DEP pumps include customized Drug Libraries that insure all drugs are infused within safe dose rate limits Drug Error Prevention DEP operates only in Primary mL hr and Dose Modes 1 Follow standard START UP steps 1 11 In
37. ll 1t in a second pump DO NOT remove the IV set by cutting or tearing the tubing Possible free flow may occur Infiltrations are not detected by the pump They must be observed and minimized by operators Dropped or damaged pumps should not be used and must be returned to Biomed to confirm calibration For accuracy complaints leave set loaded in pump and send pump with set to Biomed for evaluation Pumps should be tested for proper performance annually If the piggyback volume limit is less than the piggyback container s volume residual piggyback medication will run at the primary flow rate once the piggyback volume limit has been delivered During cleaning do not allow fluid to seep inside the pump through vent holes or severe damage may occur DANGER EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS RISOUE D EXPLOSION NE PAS EMPLOYER EN PRESENCE D ANESTHESIQUES INFLAMMABLES Electric shock hazard There are no user serviceable parts Do not open the case Refer servicing to qualified service personnel 45 Rev J 22 The following precautions are strongly recommended when using this pump for neonatal applications A bolus of approximately 0 1ml equivalent to 6 micro drops is delivered when an IV set is loaded into the pump if the set is connected to the patient s catheter To avoid this bolus load the set into the pump before connecting the set to the patient s catheter Use 60 drops 1ml IV se
38. mates 50 mmHg rss Push ENTER Note Pumps are factory set to 10 psi 500 mmHg 10psi If other than the displayed value is desired select the new value For example 9 psi 450 mmHg 9psi PUSH ENTR Push ENTER IN STOP PUSH RUN Push RUN to begin the infusion EE f AA Options 71 72 73 OPT NO OPTION NAME INSTRUCTIONS DISPLAY Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 71 The occlusion pressure may be adjusted from 100 to 750 mmHg in 50 mmHg increments Settings other than 50 mmHg OPT 71 OCCL mmHg PUSH ENTR 71 increments are rounded off by the pump Push ENTER Note Pumps are factory set to10 psi 500 mmHg 500 mmHg If other than the displayed value is desired select the new value For example 450 mmHg 9 psi ee Ods ja Push ENTER IN STOP PUSH RUN ALTERNATING Push OPTIONS PRESSURE SET OPT CODE 72 TREND Select 72 OPT 72 PRES DISP PUSH DISPLAY WITH Push ENTER ENTR Display ON or OFF RATE Turn this display off or on by pushing ENTER Push OPTIONS SET OPT CODE Select 73 OPT 73 PRES DISP PUSH ENTR Push ENTER Pressure displays for 30 sec PRESSURE TRENDING Options 72 and 73 30 SEC 1 to 8 arrows display to represent percentages of full scale gt gt gt gt gt gt gt gt 73 an 10 of scale 5096 of scale 100 of scale DISPLAY or 25mmHg whichever is greater The 8th arrow i e full
39. ml hr Push ENTER SET PIG VOL VOL 0 Select the piggyback VOLUME LIMIT from 0 1 to PIG VOL VOL 50 PUSH ENTR 9999 ml For example select50 ml Push ENTER CHEK PIG CLMP PUSH ENTR Ensure that the slide clamp on the piggyback line OPT 21 PIG MODE IN STOP PUSH RUN is open press ENTER PIGGYBACK Push RUN to start the infusion PIG RATE 100 PIG VOL 50 vol counts down to 0 21 RATE AND Or to clear all PIG MODE values push CLEAR PIG COMP VOL LIMIT when PUSH RUN or OPT 21 displays PRI RATE RATE XXX Note Use only compatible primary check valve sets and secondary piggyback sets Attach the piggyback container and set to the upper Y site of the primary check valve set Lower the primary container below the secondary container using the hanger provided with the secondary set Be sure a primary RATE and VOL LIMIT are entered If the piggyback volume limit is less than the piggyback container s volume residual piggyback medication will run at the primary flow rate once the piggyback volume limit is delivered Therefore safe practice dictates that the primary flow rate not be higher than the piggyback flow rate always follow physicians orders Assuming the PIG VOL LIMIT equals the piggyback container volume automatic gravity switchover to the primary container will coincide with the pump s switchover from piggyback to primary settings 4 tones optional When using a FLOW SENSOR while piggybacking place the sensor on the primary c
40. n Options 81 90 A OPTION NAME INSTRUCTIONS DISPLAY Stop the pump IN STOP PUSH RUN CLEAR DRUG Push OPTIONS SET OPT CODE 81 LABEL Select 81 OPT 81 CLR LABL PUSH ENTR Available for all Push Enter LABL CLRD Plus models IN STOP PUSH RUN Using this option to clear the drug label will also clear the Piggyback drug label if one is assigned Option 90 enables the operator to delay the start of an infusion with or without a KVO rate during the delay period and to delay the KVO alarm once the infusion has completed Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE EN Select 90 OPT 90 DLAY STRT PUSH ENTR Push ENTER SET DLAY STRT 0 hrs pius delayed start time in hours For example enter 1 5 hrs 4 5 hrs DLAY STRT PUSH ENTR DELAYED Push ENTER KVO ON YES NO RAE If KVO infusion is required during the delay push YES ENTER KVO YES PUSH ENTR 90 STRT If not required push NO CLEAR NO KVO PUSH ENTR Not available Push ENTER DLAY END KVO ALRM 0 hrs on all models Enter the KVO alarm delay time in hours For example enter 0 5 hrs 30 mins 0 5 hrs KVO ALRM PUSH ENTR If the infusion mode is not yet set up Push ENTER to accept PRI MODE YES NO setting If the pump is to run in Primary Mode push YES PRI YES PUSH ENTR If not push NO Push ENTER to accept the setting NA a Pe ENTR J NOTE If a non running
41. o xaci Cilastatin Infliximab Infl ixim Ondansetron Onda nset Inodilator Ino dila Oxacillin Oxac illi Insulin Insu lin Oxytocin Oxyt ocin Irinotecan Iron otec Paclitaxel Pacl itax Isoproterenol Isop rote Pamidronate Pami dron ltraconazole ltra cona Pancuronium Panc uron lvig lvig Pantoprazole Pant_opra Jugular Jugu lar Penicillin Peni cill Ketamine Keta mine Pentobarbital Pent obar Labetalol Labe talo Peripheral Peri pher Leucovorin Leuc ovor Phenylephrine Phen ylep Lidocaine Lido cain Phenytoin Phen ytoi Linezolid Line zoli Phytonadione Phyt onad Lipids Lip ids PICC PICC Lorazepam Lora zepa Piperacillin Pipe bact bactam Levofloxicin Levo flox Piperacillin Pipe raci Magnesium Magn esiu Plicamycin Plic amyc Infusion Mannitol Mann itol Potassium Pota sium Infusion 40 Rev J Drug Abbreviation Drug Abbreviation Potassium Pota phos Phosphate Procainamide Proc aina Propofol Prop ofol Prostaglandin E1 Pros tagl Quinolone Quin olon Ranitidine Rani tidi Remicade Remi cade Rituximab Ritu xima Rocu roni Rocuronium Sedative Seda tive Sodium Chloride NaCl 3 3 Sodium Sodi phos Phosphate Steroid Ster oid Streptokinase Stre ptok Subclavian Sub clav Subcutaneous Sub cuta Sufentanil Sufe ntan Synercid Syne rcid Tenecteplase Tene ctep Teniposide Teni posi Terbutaline Terb utal Theophylline Theo _phyl Ticar cl
42. ontainer s drip chamber If flow is detected in the primary container prior to the completion of the piggyback infusion Vol Limit the display is PRI FLOW NOTE OPTIONS 20 amp 21 may be used with the 8000 7 8002 Ps Drug Label ONLY Feature ET AA Dose Mode Abbreviations Dose Mode Option Description Display Abbreviation 40 units hr un h 41 units kg min unkm 42 units kg hr unkh 43 milliunits min mu m 44 grams hr g h 50 micrograms mcg kg min ugkm 91 micrograms mcg kg hr ugkh 92 micrograms mcg min ug m 99 micrograms mcg hr ug h 54 milligrams mg kg min mgkm 99 milligrams mg kg hr mgkh 96 milligrams mg min mg m 57 milligrams mg hr mg h NOTE The 8000 Aus 8002 As Drug Error Prevention Software may be used with the above dose modes Drug Error Prevention software is not available on all models VC f AY Options 40 41 42 43 44 NO OPTION NAME INSTRUCTIONS DISPLAY Note For the following OPTIONS 40 41 42 and 43 the CONC unit amount of drug dissolved in the dosage container may be set from 0 1 to 999 999 units 40 DOSE MODE Follow the same operating instructions as OPTION 52 except enter units hr instead of mcg min units hr un h DOSE MODE 41 units kg min Follow the same operating instructions as OPTION 50 exc
43. poles 46 Rev J 26 The SIGMA 8000 meets the electromagnetic compatibility EMC reguirements found in the International Electrotechnical Commission s IEC EN60601 1 2 1993 94 standard for emissions and immunity The Sigma Model 8002 7 meets the EMC requirements found in the IEC EN 60601 1 2 standards for emissions and immunity with the exception of Electrostatic Discharge ESD levels to 6kv contact and 9kv air discharge However it is good practice to keep the SIGMA 8000 8002 and all electronic instruments one meter away from other equipment such as hand held transmitters and cellular phones that may generate strong radio frequency interference RFI 27 WARNING SYMBOLS SN This symbol has been placed on the pump to indicate N potentially hazardous situations and the need for full user understanding before connecting This symbol is a Risk of Fire warning Replace the fuse as marked This symbol indicates the equipment s classification IEC Publication 878 02 03 Type BF Equipment This symbol identifies the potential equalization conductor N terminal IEC Publication 417 5021 Equipotentiality This symbol indicates possible electric shock SA1965 47 Rev J Accessories and SIGMA IV Sets Accessories Single Pole Cat No 86681 Adjustable height stainless steel pole Revolving 4 hook top leg base with 2 casters Stable 4 Support 55027
44. pumped on tubing in front of upstream or downstream occlusion sensors Keep the roller clamp on the same section of the IV set Keep the IV set channel clean and dry Fill the drip chamber halfway Remove air from IV bags and Y sites Invert do not shake bags when mixing solutions Warm IV solutions to room temperature before use Note The latter four points avoid microbubble creation 3 Ifthe roller clamp must be moved the set must be clamped shut first 4 To clear single parameters push STOP push the desired key and push CLEAR 5 For six hours after turn off the pump remembers all values entered Thereafter all values reset to zero except for all biomedical entries all programming mode entries the audio alarm level and the occlusion alarm level 6 To clear all parameter values enter OPTION 99 This will erase all entered data except for occlusion pressure levels audio alarm level program modes and biomedical mode entries To clear all program modes enter OPTION 95 11 Rev J 10 To silence the audio alarm for 2 minutes push the silence key To check patency push STOP close the roller clamp open the LEVER fully slowly open the roller clamp and check patency gravity flow indicates the IV line and catheter are patent SHUT CLMP will alarm and display To restart the pump shut the roller clamp reload the IV set in the downstream ocelusion sensor shut the LEVER open the roller clamp and p
45. s have been set up in the pump s Drug Library 3 To label a drug or fluid Push YES when DRUG LABL YES NO Displays and select the drug using the keypad The drug name and LABL ONLY displays 4 Use OPTION 99 to erase an errant drug label entry 9 Rev J Unloading Sets SUMMARY With power on shut the roller clamp Open the LEVER Pull the set out from the bottom of the pump towards the top Shut the LEVER and turn the pump off With power on and the roller clamp loaded shut the roller clamp The pump will stop automatically and the LEVER will unlock for 10 seconds If the LEVER is not opened within 10 seconds push the OPEN key to unlock it Open the LEVER fully If the LEVER will not open and LEV JAMD PUSH LEV PUSH OPEN displays push the LEVER in and push the OPEN key to release and open the LEVER To unload the IV set hold the set below the LEVER and pull it forward up and out Trying to unload the IV set by using the roller clamp or upstream tubing is difficult After set removal shut the LEVER and turn the pump off or reload the IV set if desired 10 Rev J Important Tips SUMMARY 1 Follow all prompts No pumped on tubing 1n sensors 2 3 OPT 99 clears all values 4 Have Biomed check dropped pumps before reuse Ra Follow prompts during IV set loading and to solve problems 2 To avoid nuisance alarms Use only compatible IV sets see the top of the pump Do not load previously
46. s only 62 Programming Automatic custom ramps 63 Programming Manual version 1 64 Programming Manual version 2 70 Occlusion Pressure psi 71 Occlusion Pressure mmHg 72 Occlusion Pressure Alternating Pressure Trending w Rate 73 Occlusion Pressure 30 second Pressure Trending 80 Drug Label 81 Clear Drug Label 90 Delayed Start 95 Clear all Program Modes 99 Clear all 6 hour Memory Settings Not available on all models Available for Plus models only 19 Rev J Options 10 11 12 0c AY OPT OPTION NO NAME INSTRUCTIONS DISPLAY Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 10 OPT 10 ALRM TONE PUSH ENTR Alarm Tone Push ENTER TONE 2 PUSH ENTR 10 Loudness Select 1 guiet to 3 loud if other than the Adjustment displayed loudness level is desired Push ENTER The audio will beep once at the ei p TONE 2 PUSH RUN Push RUN to start the infusion To enter KEYLOCK push OPTIONS SET OPT CODE Select 11 OPT 11 KEY LOCK To leave KEYLOCK push OPTIONS SET OPT CODE 11 Keylock Select 11 OPT 11 LOCK OFF Note The set must be loaded and parameters entered before entering KEYLOCK All parameters can be read but not changed The pump cannot be turned off The infusion can be stopped by closing the roller clamp Stop the pump IN STOP PUSH RUN Return To Push OPTIONS SET OPT CODE 12 Primary Select
47. scale represents the occlusion pressure limit For example if the occlusion pressure limit were 100 mmHg and4 arrows were displayed the pumping pressure is approximately 50 mmHg or 50 of full scale If that same pump went into occlusion alarm pumping pressure had reached 100 mmHg The 8th arrow never actually displays Rather if the pressure signal rises to that point CLR OCCL clear downstream occlusion displays Options 80 ve f ed pn OPTION NAME INSTRUCTIONS DISPLAY Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 80 OPT 80 DRUG LABL PUSH ENTR LABL ON YES NO or DRUG LABEL RE LABL OFF YES NO ENABLE Push CLEAR to change the status then push ENTER to 80 DISABLE select Available for Plus If an infusion is al models with label an infusion is already programmed the Drug Menu shall then be entered only software Otherwise once the infusion has been programmed DRUG LABL YES NO If YES ei p i A doa the Drug Menu shall be entered If the pump is ready to run NOS SE DE hte While the Drug Label feature is in use If the DRUG LABEL has been enabled in Option 80 the pump shall display DRUG LABL YES NO after the setup of any infusion has been completed If the label is not desired the NO key may be pressed to advance the IN STOP PUSH RUN display Otherwise the YES key must be pressed to enter the drug menu from which th
48. sensor will not fit most drip chambers on blood sets 3 T OCCLUSION Eliminate the cause of the upstream occlusion Push RUN Note Repeated pushes of RUN without eliminating the cause of the upstream occulsion will eventually prevent the RUN key from restarting the pump If this happens eliminate the occlusion cause 13 Rev J unload and reload the set from the T occ sensor and push RUN CLR TOCC EMPT BOTT The flow sensor is not detecting drops Correct the problem and push RUN CLR LOCC Eliminate the cause of the downstream occlusion positional IV closed clamp kinked tubing clogged filter or clotted catheter The pump restarts automatically DOSE COMP RATE KVO PUSH STOP The Dose is complete see INF COMP RATE KVO PUSH STOP DOSE LMIT A dose rate limit for the drug in use has been exceeded DRUG 1 OF 2 Select the desired drug concentration ERR ERROR The selected key value exceeds the allowable limit FIX Fix code numbers indicate pump malfunctions or improper set unloading Most fix codes may be corrected by Unloading the IV set checking the pump channel for cut or torn tubing remove it push OFF and push ON Have the pump serviced if the alarm continues FLOW SNSR Plug a FLOW SENSOR into the connector on the back of the pump and position the sensor properly on the IV set s drip chamber halfway between the drop orifice and the fluid level and turn its opening away from bright li
49. sult Confirm tubing is not visible or looped out of peristaltic pump area To create gravity flow with the IV set outside of the pump close the IV set s roller clamp remove the set from the pump and slowly open the roller clamp to achieve the desired drop rate Whenever the pump and set are connected to a patient especially at pump start after a rate change or following a set reload confirm that the drop rate approximates the pump s selected ml hr rate or send the pump for service 44 Rev J Also at every pump stop confirm there is no flow 12 13 14 15 16 17 18 19 20 21 At pump start and following any parameter change confirm that all pump entries RATE etc are properly set Be aware that accidental entry of wrong values may occur and must be guarded against Also never use pumps whose displays look garbled odd or pumps whose displays fail to show eight solid 8 s at power on send faulty pumps for service To avoid unauthorized tampering with and changing of pump parameters RATE etc it is recommended practice to always use KEYLOCK Option 11 In rare instances pump failures may result in the pump stopping with the IV set locked in the pump To resume the infusion close the roller clamp use a pen or similar sharp pointed object to push the LEVER LOCKING PIN up into the pump housing see the bottom of the LEVER open the LEVER remove the set from the defective pump and insta
50. teps The operator enters a total VOLUME LIMIT a total infusion TIME ramp time and taper time The pump computes 10 appropriate RAMP rates and volume limits which start at 50 of the MAIN RATE and ramp up in increments equivalent to 5 of the MAIN RATE The 10 RAMP steps are followed by step11 the MAIN RATE and MAIN VOLUME which is followed by TAPER steps 12 through 21 concluding in a PROGRAM COMPLETE alarm and KVO rate Stop the pump IN STOP PUSH RUN Push OPTIONS SET OPT CODE Select 62 OPT 62 CUST PROG PUSH ENTR PROGRAMMING Push ENTER SET PROG VOL 0 AUTOMATIC Select the total VOLUME LIMIT in ml For example select 2000 ml VOL 2000 PUSH ENTR 62 CUSTOM Push ENTER SET PROG O hrs RAMP Select the total infusion TIME in hrs For example select 10 hrs 10 hrs PUSH ENTR Pe modele on Push ENTER SET RAMP RAMP UP O hrs es the RAMP TIME in hrs For example select 0 5 hrs 30 0 5 hrs RAMP UP PUSH ENTR Push ENTER SET TAPR TAPR DOWN O hrs es the TAPER TIME in hrs For example select 0 5 hrs 80 0 5 hre TAPR DOWN PUSH ENTR Push ENTER OPT 62 CUSTPROG STEP1 PUSH RUN Push RUN to begin the infusion Program entries are maintained in permanent memory and can only be cleared by pushing the OPTIONS key and entering the option number followed by pushing CLEAR or by using OPTION 95 Clear all Program Modes These actions cause a return to primary mode PRI MODE Options 63 64 70 TE f AA OPT
51. ts Through biomedical option modes place upper limits on flow rate volume limit and ocelusion alarm pressure 23 If the pump remains off or is in a non running delayed start condition with an IV set loaded for extended periods of time reload a non pumped on set section into the pump to avoid initial flow rate errors 24 For EPIDURAL ADMINISTRATION The epidural administration of anesthetics is limited to short term less than 96 hours infusion with catheters specifically indicated for short term anesthetic epidural drug delivery For epidural administration of analgesics use only indwelling catheters specifically indicated for either short term less than 96 hours or long term 96 hours or greater analgesic epidural drug delivery To help in preventing accidental infusions of drugs that are not indicated for epidural use DO NOT USE administration sets that contain injection sites or other secondary connections ports Label the administration container and IV set EPIDURAL USE ONLY Clearly identify the infusion pump and IV set used for epidural administration Use the pump s KEYLOCK feature as required to assure patient safety WARNING Epidural administration of drugs other than those indicated for epidural use could result in serious patient injury 25 Do not mount pumps on IV poles that will allow the pump s case to impact the floor if the IV pole accidentally tips over see Accessories for safe SIGMA IV
52. ush RUN Note The IV set does not have to be removed from the entire pump only from the 4 OCC sensor Infiltrations cannot be detected by the pump They must be observed and minimized by operators Dropped damaged pumps and pumps with unusual displays must be checked by service personnel before being placed back in use Otherwise serious patient injury may result 12 Rev J Alarm Clearing amp User Prompt Displays BATT LOW 30 minutes of battery power remains Plug the pump in BATT CHRG E F The slash indicates the approximate amount of battery charge remaining E empty F full BATT ON The pump is running on battery The lit plug symbol denotes AC outlet operation CHEK CLMP Move the roller clamp to either the full open or closed position CLR AIR CLR T OCC PUSH RUN Note The upstream sensor detects both air in line and upstream occlusions The user must determine which problem is causing the alarm 1 LARGE BUBBLES Push RUN Each RUN key actuation advances 0 1 ml of fluid The pump will remain running when the air bubble moves below the air sensor Follow policy for removal of air 2 MICROBUBBLES Remove the IV set from the UPSTREAM SENSOR Tap the tubing driving all microbubbles upstream Reload the IV set into the UPSTREAM SENSOR Push RUN If nuisance alarms persist the air upstream occlusion sensor may be turned off by using a flow sensor drop sensor Note that the flow
53. ver unusual displays are observed Load the IV set into the UPSTREAM OCCLUSION AIR SENSOR T OCC and then let go of the set The tubing must snap into the sensor s two white teeth Two audio beeps occur to indicate the set is properly loaded After the T OCC sensor is loaded the LEVER unlocks for 10 seconds If the LEVER is not opened within 10 seconds push the OPEN key to 6 Rev J 10 11 12 13 14 15 unlock it Using one hand only open the LEVER keeping it fully opened until the IV set is loaded into the DOWNSTREAM OCCLUSION A OCC sensor Two beeps indicate the LEVER is in the proper full open position Conversely a raspberry alarm indicates the LEVER 1s not fully open which will require the OCC sensor to be reloaded Using one hand only and without touching the LEVER load the set into the L OCC sensor Two beeps indicate proper set loading The set should be taut in the pumping channel Do not push the tubing up It is important not to over stretch the tubing while loading the set into the pump or its sensors Shut the lever to lock the IV set channel Confirm no tubing 1s looping out of the pump channel or free flow can result Open the roller clamp and all other clamps center the roller wheel on the OPEN roller sensor Confirm no drop flow Immediately discontinue pump use and have the pump serviced if flow is observed when the pump is stopped with the roller clamp opened Set the RATE m
54. vity IV sets supplied by Abbott Baxter and B Braun all three names are registered trade marks and several other companies consult SIGMA for a complete list of compatible standard IV sets and syringes Accuracy When using IV bags or bottles flow rate accuracy is nominal 5 from 2 999 ml hr and 10 from 0 1 1 9 ml hr This is based upon Minus 100 mmHg maximum negative downstream pressure Plus 100 mmHg maximum positive downstream pressure With 72 hour usage of one section of an IV set while infusing a maximum of 9 liters 1 e 125 ml hr With the solution container 24 inches above the pumping mechanism Accuracy changes approximately 1 096 to 2 096 for each one foot of head height change Using the single standard IV set brand specified for the pump approved Abbott Baxter or B Braun sets Minimum 60 minutes sample volumes contact SIGMA for detailed trumpet curves Nominal temperature range from 68 F to 75 F Sets loaded taut with minimal stretch during loading excessive set stretching can cause 10 flow errors Note If these parameters are exceeded move to a fresh section of tubing to restore specified accuracy Flow Range 0 1 999 ml hr RATE with 0 1 ml hr increments from 0 1 99 9 ml hr and 1 0 ml hr increments above 100 ml hr 52 Rev J VTBI 0 1 9999 ml volume limit range KVO keep vein open rate is 1 ml hr or the selected rate whichever is lower Anti Free Flow Protect
55. y autoclaving or ETO gas immerse any part of the pump or allow cleaning fluids to seep inside the pump through vent holes back panel speaker holes back panel or the Lever hole bottom of the pump case Use of phenolic based cleaners or disinfectants may cause damage to the case and keypad The following cleaners and disinfectants may be used 70 to 90 ethyl or isopropyl alcohol in water 10 bleach water produces 0 55 Sodium Hypochlorite or a Sodium Hypochlorite cleaner disinfectant such as Dispatch by Caltech Industries Inc 1 800 234 7700 Cleaning FLOW SENSORS drop sensors Clean FLOW SENSOR and PUMP FLOW SENSOR CONNECTOR with a small amount of isopropyl alcohol and a cotton swab NOTES 1 Alcohols are flammable and should be used in well ventilated areas 2 The selection and use of disinfectants should be in accordance with hospital and user facility policies This listing is strictly provided to indicate pump material compatibility with cleaning and disinfectant agents STORING THE PUMP When storing the pump connect it to an AC line to ensure a full battery charge the next time it is used Do not store pumps in ways that might result in damage due to drops or from physical shocks Allow the pump to reach normal room temperature before operation Do not store in temperature above 110 F or below 35 F 42 Rev J Servicing 1 Caution Electric shock hazard There are no user servicable parts Do not
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