Baxter SIGMA Spectrum

Asset Type

Infusion Pump

Manufacturer

Baxter

Model

SIGMA Spectrum

Manual Reference

Baxter Manual 41394, Revision A, July 2017, SIGMA Spectrum Infusion Pump with Master Drug Library Preventive Maintenance, Pump Operating Software Versions 6.02 and 6.05, Master Drug Library Version 6.

Manufacturer Recommendation / AEM Status

Baxter lists preventive maintenance for all pumps in service, any pump suspected of physical damage, being dropped, or fluid intrusion, and pumps requiring inspection, testing, performance evaluation, or service following a failed PM item.

Manufacturer-Listed PM Frequency

• Pump: Annually.
• Battery-capacity test: Only when a battery problem is suspected, such as reduced runtime.

Manufacturer-Listed Annual PM Activities

• Pump identification and software verification.
• Active drug-library verification.
• Network-connectivity verification when a Wireless Battery Module is installed.
• Pump and AC power-adapter inspection.
• Keypad test.
• Memory test.
• Downstream occlusion-sensor test.
• Upstream occlusion-sensor test.
• Flow-rate accuracy test.
• Air-detection test.

Baxter instructs the facility to record the PM findings and return any pump that fails an inspection, test, or performance evaluation to Baxter for service.

Manufacturer-Listed Parts and Test Accessories

• Preventive Maintenance Kit: P/N 42059.
• Alternate Test Set: P/N 99004.
• 38 cm / 15 in segment: P/N 99051-1.
• Three-way valve: P/N 55568.

The provided manual does not list a routine battery-replacement interval, calibration interval, or electrical-safety testing requirement.

If the facility performs this PM at a different interval or changes the listed activities, document the change under the facility’s approved AEM program, risk assessment, maintenance history, and applicable regulatory requirements.

What This PM Procedure Covers

• Pump identification and software verification.
• Drug-library and wireless-network verification.
• Visual inspection of the pump and AC power adapter.
• Keypad and memory testing.
• Upstream and downstream occlusion testing.
• Flow-rate accuracy verification.
• Air-in-line detection testing.
• Battery-capacity testing when indicated.

Required Tools and Equipment

• Baxter SIGMA Spectrum pump.
• Compatible new IV administration set without a backcheck valve.
• IV set matching the calibration label on the pump.
• Baxter PM Kit P/N 42059 or equivalent supported test components.
• Three-way valve P/N 55568.
• Vented or collapsible IV container, minimum 250 mL; 1000 mL recommended.
• Stable IV pole or test fixture.
• Pressure gauge with a minimum range of 207 kPa / 30 psi and accuracy of 0.5%.
• One hemostat.
• Collection cup or equivalent vessel.
• Saline, distilled water, or ISO Class III deionized water.

Gravimetric Testing Equipment

• Calibrated balance or scale.
• Minimum resolution: 0.1 g.
• Calibrated over 0–100 g.

Volumetric Testing Equipment

• 25 mL Class A graduated vessel.
• TC, “to contain,” construction.
• Resolution: 0.2 mL.

All measurement equipment should be traceably calibrated to NIST standards.

Do Not Use

• Tap water.
• IV sets with backcheck valves.
• IV sets with minidrip chambers.
• Previously pumped-on tubing.
• An incompatible administration-set brand or type.

Step-by-Step PM Procedure

1. Identify the Pump

Power on the pump and record:

• Pump serial number.
• Operating software version.
• Serial number shown on the display.
• Serial number printed on the bottom label.

Verify that the displayed and labeled serial numbers match.

Expected outcome: Identification information is present, legible, and consistent.

2. Verify the Active Drug Library

Record the active Drug Library BDL file name and date from the Power Status or User Options screen.

Verify the installed file against the facility’s current approved drug library through Pharmacy or the Master Drug Library Administrator.

Expected outcome: Pump and facility drug-library names and dates match.

A missing, outdated, or incorrect drug library must be corrected according to the operator manual and facility drug-library deployment process before clinical use.

3. Verify Network Connectivity

For pumps equipped with a Wireless Battery Module:

1. Enter Biomed Options.
2. Open Network Configuration.
3. View Network Status.
4. Confirm that the network configuration is installed.
5. Confirm connectivity, indicated by the appropriate wireless-status icon.

Expected outcome: The pump shows the expected network configuration and connectivity status.

Document “Not equipped” when no Wireless Battery Module is installed.

4. Inspect the Pump

Inspect for damage, contamination, heat damage, fluid intrusion, cracks, cuts, dents, or missing components.

Inspect:

• Pump casing.
• Display.
• Keypad.
• Keyhole.
• Pump door.
• IV-set tube channel.
• Pole clamp.
• Rear power/accessory connector.
• All external labels.

Confirm the tube channel is clean and dry.

Expected outcome: No damage, contamination, fluid intrusion, or unreadable labels are present.

5. Inspect the AC Power Adapter

Inspect:

• Adapter module.
• Power cord.
• Cord retainer.
• Six-pin connector when accessible.
• Bent prongs.
• Cuts or exposed wiring.
• Cracks or dents.
• Adapter labels.

Connect the adapter to a working receptacle and verify:

• The green adapter LED illuminates.
• The plug icon appears on the pump charging screen.

Expected outcome: The adapter is undamaged, properly labeled, and recognized by the pump.

A damaged adapter may be sent separately for service without the pump.

6. Perform the Keypad Test

Enter Basic Mode and verify keypad entry using the manufacturer procedure:

1. Enter 90.
2. Enter 5678.
3. Enter 1234.
4. Verify the display correctly registers each entry.
5. Verify the hard-limit message appears when RUN/STOP is pressed with an entry above the allowed value.
6. Clear the program and return to the Care Area screen.

Expected outcome: All keys, soft keys, decimal input, display fields, and prompts operate correctly.

Repeat once when a failure is suspected. Remove the pump from service if the failure repeats.

7. Perform the Memory Test

Program:

• Rate: 100 mL/hr.
• VTBI: 50 mL.

Power the pump off and back on. Select “No” when asked whether this is a new patient.

Verify that the programmed rate and VTBI were retained.

Expected outcome: Rate remains 100 mL/hr and VTBI remains 50 mL.

8. Prepare the Hydraulic Test Setup

Use a new compatible IV set. Configure the system as follows:

• Fill the drip chamber to the marked fill line.
• Maintain 610 ±51 mm / 24 ±2 inches from the top of the fluid level to the center of the pump.
• Keep the vertical distance from the center of the pump to the distal end of the IV set at no more than 304.8 mm / 12 inches.
• Keep the distal tubing outlet above the fluid level in the collection vessel.
• Use a collapsible or vented IV container.
• Fully prime the tubing and remove all air.
• Confirm the tube channel is clean and dry.
• Open the roller clamp.
• Confirm tubing above and below the pump is not occluded.

Avoid bright light directly over the pump keyhole because it may interfere with slide-clamp recognition.

Expected outcome: The test setup matches the manufacturer diagram and contains no air, occlusions, contamination, or incorrect tubing.

9. Test the Downstream Occlusion Sensor

Before testing:

• Set the downstream pressure limit to Medium.
• Verify Downstream Occlusion Auto Restart is On.

Program:

• Rate: 100 mL/hr.
• VTBI: 50 mL.

Connect the primed pressure gauge using the three-way valve.

Maintain approximately:

• 1.2 m / 48 ±0.5 inches of distal tubing between the pump and gauge.
• Gauge at the same height as the pump.

Start the infusion and record the pressure at which the downstream occlusion alarm occurs.

Pass range: 48–131 kPa / 7–19 psi.

Remove the pressure restriction and verify that the pump automatically restarts.

Expected outcome: The downstream occlusion alarm occurs within range and auto-restart functions after the occlusion is removed.

Repeat a failed test using a new unused IV set before declaring the pump failed.

10. Test the Upstream Occlusion Sensor

Program:

• Rate: 100 mL/hr.
• VTBI: 13.3 mL.

Clear the volume-given value.

Occlude the IV set with a hemostat approximately 30.2 cm / 12 inches above the pump, then start the infusion.

Expected outcome: The pump produces an upstream occlusion alarm before the infusion-complete message.

Remove the hemostat, acknowledge the alarm, and run the pump for approximately 5–10 seconds to normalize the tubing.

Repeat a failed test using a new unused IV set.

11. Test Flow-Rate Accuracy

Use either the volumetric or gravimetric method.

Program:

• Rate: 40 mL/hr.
• VTBI: 20 mL.
• Expected run time: 30 minutes.

Run the infusion until the infusion-complete alarm occurs. Immediately press RUN/STOP so KVO does not add fluid to the collection.

Volumetric Method

Read the collected volume at the bottom of the meniscus.

• Pass range: 19.0–21.0 mL.
• Nominal value: 20.0 mL ±5%.

Gravimetric Method

Determine the net collected fluid weight using the manual’s tare procedure.

• Pass range: 19.0–21.0 g.
• Nominal value: 20.0 g ±5%.

Expected outcome: Collected volume or weight falls within the listed range.

For a failed test:

1. Review the complete setup.
2. Install a new approved IV set.
3. Repeat the test.
4. Remove the pump from service if the failure repeats.

12. Test Air Detection

Program:

• Rate: 100 mL/hr.
• VTBI: 50 mL.

Start the infusion and introduce an air bubble at least 2.5 cm / 1 inch long upstream of the pump.

Expected outcome: The pump enters an Air In Line alarm.

Close the roller clamp before unloading the tubing. Remove the air, reload and prime the set, reopen the roller clamp, resume operation, and confirm the pump can return to normal operation.

Repeat a failed test with a new unused IV set.

13. Perform the Battery Capacity Test When Indicated

The battery-capacity test is not listed as a routine annual test. Perform it when shortened runtime or another battery problem is suspected.

Charge before testing:

• Standard Battery Module: Minimum 12 hours.
• Wireless Battery Module: Minimum 16 hours.

Verify the initial battery voltage is 8.0–8.3 V.

Run the manufacturer Battery Life Test at:

• Rate: 125 mL/hr.
• Backlight: Level 10.

Record start-to-dead runtime and low-to-dead runtime.

Used Standard Battery

• Start to dead: ≥6 hours.
• Low to dead: ≥31 minutes.

New Standard Battery, Less Than 30 Days Old

• Start to dead: ≥8 hours.
• Low to dead: ≥31 minutes.

Used Wireless Battery Module

• Start to dead: ≥3 hours.
• Low to dead: ≥31 minutes.

New Wireless Battery Module, Less Than 30 Days Old

• Start to dead: ≥4 hours.
• Low to dead: ≥31 minutes.

Expected outcome: Battery runtime meets the applicable criteria.

A battery below the listed threshold is reaching end of life and should be handled according to the service manual and facility battery-replacement process.

Electrical Safety Testing

The provided Baxter preventive-maintenance manual does not list an electrical-safety test, ground-resistance limit, or leakage-current limit as part of this PM.

Perform electrical-safety testing only when required by:

• Facility policy.
• The facility’s approved maintenance strategy.
• A separate Baxter service instruction.
• Post-repair testing requirements applicable to the work performed.

When facility policy includes electrical-safety testing, document:

Ground resistance measured in ohms, expected ≤ 0.5 Ω or facility/NFPA 99 criteria if different:
Result =

Touch/chassis leakage measured in microamps:
Facility limit used =
Result =
Pass / Fail =

Do not represent these limits as Baxter manufacturer-listed criteria unless supported by another applicable Baxter document.

Pass / Fail Criteria

PM Pass Criteria

The pump passes when:

• Identification and labeling are correct.
• The installed drug library matches the facility-approved version.
• Wireless connectivity is acceptable when equipped.
• The pump and AC power adapter are free of damage and fluid intrusion.
• All keypad inputs operate correctly.
• Memory retains 100 mL/hr and 50 mL.
• Downstream occlusion occurs at 48–131 kPa / 7–19 psi.
• Downstream auto-restart operates.
• The upstream occlusion alarm occurs before infusion complete.
• The flow-rate result is 19.0–21.0 mL or 19.0–21.0 g.
• The air-in-line alarm activates with the specified test bubble.
• Battery runtime meets the applicable criteria when tested.

Remove From Service Criteria

Remove the pump from service when:

• Physical damage, heat damage, fluid intrusion, or an unsafe connector condition is found.
• Identification labels are missing or serial numbers do not match.
• A keypad failure repeats.
• The memory test fails.
• An occlusion test fails when repeated with a new compatible IV set.
• Flow-rate accuracy remains outside tolerance after correcting the setup and repeating with a new IV set.
• Air detection fails when repeated with a new IV set.
• The pump fails any inspection, test, or performance evaluation.
• The pump cannot be confirmed safe and functional for clinical use.

The manufacturer directs facilities to return pumps that fail inspection or testing to Baxter for service.

Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.