Sigma 8000, 8000 plus and 8002 plus Operators Manual Rev J Aug 2003

Table of Contents Introduction & Intended Applications Views Loading Sets & Start Up Start-Up with Drug Error Prevention

2 4 6 8

Unloading Sets Important Tips

10 11

Alarm Clearing & User Prompt Displays

13

Option Modes

18

Display Abbreviations Drug Label Library Abbreviations Cleaning & Storing

38 39 42

Servicing

43

Cautions Accessories and SIGMA IV Sets RS232 (Pump to Computer Interface) & Staff Call Flow Sensor (Drop Sensor) Specifications

44 48 50 50 52

Limited Warranty

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Introduction & Intended Applications INTRODUCTION:

This manual provides instruction for all Sigma 8000 infusion pumps: the 8000, 8000 Plus and 8002 Plus (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 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).

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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 is 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 will serve you for many years. *Abbott, Baxter, and B. Braun McGaw are registered trademarks. Contact SIGMA for a complete list of compatible IV sets.

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Views FRONT VIEW – 8000 Single Channel

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REAR VIEW – 8000 Single Channel

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Loading Sets & Start Up SUMMARY: 1. 2. 3. 4. 5. 6. 7.

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 ↑ occlusion loading, at lever opening, and at ↓ 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.

1. 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. 2. Plug the pump into a grounded, hospital-grade AC receptacle. Whenever possible, plug the pump in to maintain full battery charge. 3. Use only the compatible IV sets specified on top of the pump (or flow rate errors result). Contact SIGMA for compatible set lists. 4. 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. 5. 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 whenever unusual displays are observed. 6. Load the IV set into the UPSTREAM OCCLUSION/AIR SENSOR (↑ 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. 7. After the ↑ 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

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unlock it. 8. Using one hand only, open the LEVER, keeping it fully opened until the IV set is loaded into the DOWNSTREAM OCCLUSION (↓ OCC) sensor. Two beeps indicate the LEVER is in the proper full open position. Conversely, a raspberry alarm indicates the LEVER is not fully open – which will require the ↓ OCC sensor to be reloaded. 9. Using one hand only and without touching the LEVER, load the set into the ↓ 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. 10. Shut the lever to lock the IV set channel. Confirm no tubing is looping out of the pump channel (or free flow can result). 11. 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. 12. Set the RATE (ml/hr) by using the numeric keys. 13. Set the VOLUME LIMIT (in ml). To avoid air entering the IV set, the volume limit should not exceed the IV container’s volume. 14. 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. 15. 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).

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Start-Up with Drug Error Prevention (Optional – not available on all models)

SUMMARY – DEP START-UP: 1. 2.

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.

3. 4. 5. 6.

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 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/NO/↓ key to scroll to Dopamine (to reverse an errant drug entry, simply push another alpha key). 4. DOPAMINE/YES? OR ↓ 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.

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6. SET DOSE / 0 ugkm displays. Enter a dose rate. -

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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/0 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 limits 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.

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Unloading Sets

SUMMARY: 1. 2. 3. 4.

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.

1. 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. 2. 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. 3. 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. 4. After set removal, shut the LEVER and turn the pump off (or reload the IV set, if desired).

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Important Tips SUMMARY:

1. Follow all prompts. 2. No pumped on tubing in sensors. 3. OPT 99 clears all values. 4. Have Biomed check dropped pumps before reuse reuse. 1. 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 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. If the 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.

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7. To silence the audio alarm for 2 minutes, push the silence key. 8. 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 occlusion sensor, shut the LEVER, open the roller clamp, and push RUN. Note: The IV set does not have to be removed from the entire pump, only from the ↓ OCC sensor. 9. Infiltrations cannot be detected by the pump. They must be observed and minimized by operators. 10. 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.

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Alarm Clearing & 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 ↑ 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 0.1ml 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.

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If nuisance alarms persist, the air/upstream occlusion sensor may be turned off by using a flow sensor (drop sensor). Note that the flow sensor will not fit most drip chambers on blood sets.

3. ↑ 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

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unload and reload the set from the ↑ occ sensor, and push RUN. *CLR ↑ OCC/EMPT BOTT: The flow sensor is not detecting drops. Correct the problem and push RUN. *CLR ↓ OCC: 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 light). 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

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* 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. 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

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* 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/↓ ↓OCC: Note: The lever automatically 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

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* YES or ↓: Push YES to enter the displayed drug or NO (↓) to scroll through the list of drugs with the same first letter.

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Option Modes SUMMARY: 1. 2. 3. 4. 5.

Push STOP. Push the OPTIONS key. Select the OPTION number (see left side label). Push ENTER. Enter all required parameters and push RUN.

1. Push STOP 2. Push the OPTIONS key. 3. Select the desired OPTION No. (see the next page) 4. Push Enter. 5. Enter all parameter values requested. Push ENTER after each entry. The next prompt will then appear. The last prompt is PUSH RUN. 6.

To review all entries, repeatedly push ENTER.

7.

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.

8.

To access other OPTION modes before starting the pump, repeat steps 1-5.

9.

Note that NA (not available) displays when an operator selects an OPTION NO. that is not in the pump’s program selection.

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Options List:

No. 10 11 12 20 21 *30 *35 40 41 42 43 44 50 51 52 53 54 55 56 57 *60 *61 *62 *63 *64 70 71 72

Option Alarm Tone Loudness Adjustment Keylock Return to Primary Mode Piggyback-time (min.) and vol. limit Piggyback-rate and vol. limit Time-primary time (hrs.) and volume limit (not available) Bolus Mode (not available) Dose-units/hr (un/h) Dose-units/kg/min (unkm) Dose-units/kg/hr (unkh) Dose-milliunits/min (mu/m) Dose-grams/hr (g/h) Dose-mcg/kg/min (ugkm) Dose-mcg/kg/hr (ugkh) Dose-mcg/min (ug/m) Dose-mcg/hr (ug/h) Dose-mg/kg/min (mgkm) Dose-mg/kg/hr (mgkh) Dose-mg/min (mg/m) Dose-mg/hr (mg/h) Programming-Automatic (21 steps) Programming-Automatic (Opt. 60 or 62, taper steps only) Programming-Automatic (custom ramps) Programming-Manual (version 1) Programming-Manual (version 2) Occlusion Pressure (psi) Occlusion Pressure (mmHg) 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

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