Sigma 8000, 8000 plus, 8002 plus User manual
SIGMA
8000, 8000 Plus
Plus and 8002 Plus
PlusPlus
Plus
PlusPlus
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 & Intended Applications 2
Views 4
Loading Sets & Start Up 6
Start-Up with Drug Error Prevention 8
Unloading Sets 10
Important Tips 11
Alarm Clearing & User Prompt Displays 13
Option Modes 18
Display Abbreviations 38
Drug Label Library Abbreviations 39
Cleaning & Storing 42
Servicing 43
Cautions 44
Accessories and SIGMA IV Sets 48
RS232 (Pump to Computer Interface) & Staff Call 50
Flow Sensor (Drop Sensor) 50
Specifications 52
Limited Warranty 57
1 Rev.J
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).
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 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.
3 Rev.J
Views
FRONT VIEW – 8000 Single Channel
4 Rev.J
REAR VIEW – 8000 Single Channel
5 Rev.J
Loading Sets & Start Up
mL/hr rate.
SUMMARY:
1. Mount the pump to an IV pole.
2. Plug the pump in.
3. Using compatible IV sets, prime the set and close the roller clamp.
4. Be sure the drug, concentration and volume are as prescribed.
5. Load the IV set (obtain two beeps at ↑ occlusion loading, at lever
opening, and at ↓ occlusion loading).
6. Shut the lever and open the roller clamp. Check for no drop flow.
7. Set RATE, VOLUME LIMIT and push RUN. Confirm all pump
values are proper and confirm the drop rate approximates the
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 Rev.J
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).
7 Rev.J
Start-Up with Drug Error Prevention
(Optional – not available on all models)
SUMMARY – DEP START-UP:
1. Prime and load the IV set. Open the roller clamp.
2. 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).
3. ENTR DRUG – Push the desired alpha key, scroll to the drug name,
and push YES.
4. Select the desired concentration.
5. Enter all parameters asked for and push RUN.
6. 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 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.
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/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.
9 Rev.J
Unloading Sets
SUMMARY:
1. With power on, shut the roller clamp.
2. Open the LEVER.
3. Pull the set out from the bottom of the pump towards the top.
4. 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).
10 Rev.J
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
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.
11 Rev.J
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.
12 Rev.J
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.
- 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 Rev.J
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 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. 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/↓↓↓↓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 Rev.J
* YES or ↓↓↓↓: Push YES to enter the displayed drug or NO (↓) to scroll
through the list of drugs with the same first letter.
17 Rev.J
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