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Manual Reference
Ohio Medical Push-To-Set Intermittent Suction Unit (PTS-ISU) Service Manual, Adult/Pediatric/Neonatal, document 8700-0001-000 Rev. 17, July 2024; applicable PTS-ISU Instructions for Use.
Manufacturer Recommendation / AEM Status
Ohio Medical requires the pre-use checkout before use on each patient. If any item fails, remove the regulator from service for qualified repair.
After each patient use, clean and visually inspect the regulator, external high-flow suction filter, tubing/connections, overflow-protection floats, and perform pre-use checkout.
For scheduled maintenance, periodically inspect condition, test gauge accuracy, and perform pre-use checkout. The manufacturer gives no fixed calendar interval; determine it from inspection data, use, and environment. Service elastomers, O-rings, gaskets, diaphragms, and internal filters as needed. Perform full Service Checkout after repair.
This procedure uses the PTS-ISU manual. Confirm adult, pediatric, neonatal, analog, or digital configuration. Continuous-only Push-To-Set models require their applicable manual.
What This PM Procedure Covers
- Configuration, fittings, accessories, contamination, and condition.
- Filter, tubing, overflow protection, cleaning, and digital batteries.
- Mode selector, Push-To-Set function, gauge zero, and controls.
- Gauge accuracy, full vacuum, supply/patient leakage, and flow.
- Intermittent timing, regulation, build-up, and bleed-down.
- Return-to-service determination and CMMS documentation.
Required Tools and Equipment
- Regulated medical vacuum source: 500 +/- 10 mmHg, open flow at least 80 L/min.
- Supply vacuum gauge.
- Low-vacuum calibration gauge; analog testing requires 1% full-scale accuracy or better.
- 0-10 L/min and 0-50 L/min flowmeters.
- Bubble leak tester.
- 1500 mL suction canister with lid.
- Stopwatch, occlusion plug/clamp, and service-manual tubing/fittings.
- Water/mild detergent or approved cleaning solution.
- Two 2/3 AA, 3.6 V, 1.6 Ah lithium batteries when required for a digital gauge.
- Facility-required PPE.
Step-by-Step PM Procedure
1. Confirm Identification and Configuration
Action: Verify asset/serial/model, adult/pediatric/neonatal range, analog/digital gauge, intermittent capability, inlet adapter, patient fitting, filter, overflow device, canister arrangement, and history.
Expected outcome: Configuration and applicable limits are identified.
2. Remove, Isolate, and Decontaminate
Action: Remove from patient use and handle as potentially contaminated. Clean/disinfect before service. If aspirate entered the regulator, follow the facility contaminated-device process and do not return a contaminated unit to the manufacturer.
Expected outcome: Personnel can handle the device safely.
3. Inspect the Regulator and Accessories
Action: Inspect enclosure, faceplate, gauge/display, knob, selector, labels, ports, seals, tubing, filter, overflow device, float, and connections for damage, looseness, blockage, contamination, fluid intrusion, damaged threads, or incorrect connections. On digital units, confirm stable display and battery status.
Expected outcome: Components are intact, correctly connected, and ready for testing.
4. Clean the Exterior
Action: Wipe with water/mild detergent or a listed solution: 0.5% sodium hypochlorite, 70% isopropyl alcohol, 3% hydrogen peroxide, or full-strength ready-to-use Cavicide. Do not steam autoclave or liquid sterilize.
Expected outcome: The regulator is clean, dry, and undamaged.
5. Verify the Test Supply
Action: Confirm supply vacuum is 500 +/- 10 mmHg and open flow is at least 80 L/min, then connect to the adapter/probe port.
Expected outcome: Source conditions support valid tests.
6. Verify Controls and Gauge Zero
Action: With no suction, verify analog zero bracket/stop pin or digital 0. Exercise OFF, CONT, and INT. Push/rotate the knob through its range and confirm normal return and intended Push-To-Set action.
Expected outcome: Zero, selector, knob, and safety mechanism pass.
7. Perform the Push-To-Set Test
Action: Connect the 0-10 L/min flowmeter and select CONT. Hold the knob in and set adult 200 mmHg, pediatric 135 mmHg, or neonatal 100 mmHg. Leakage at the patient port must be no more than 1 L/min. Rotate while still pushed and confirm leakage remains no more than 1 L/min. Release and select OFF.
Expected outcome: Push-To-Set occlusion and leakage pass.
8. Test Gauge Accuracy and Full Vacuum
Action: In CONT, compare the calibration gauge at adult 40, 80, and 140 mmHg; pediatric/neonatal 40 and 80 mmHg.
- Adult analog: +/-10 mmHg.
- Pediatric/neonatal analog: +/-8 mmHg.
- Digital: +/-1% full range at 22 degrees C; no digital calibration required.
Adult only: at full clockwise, confirm at least 450 mmHg in CONT and FULL VAC indication; at least 400 mmHg in INT. Turn fully counter-clockwise and verify zero.
Expected outcome: Accuracy, zero return, and full-vacuum response pass.
9. Perform Leak Tests
Supply side: With the service-manual bubble setup at 500 mmHg and selector OFF, wait 20 seconds; allow no more than 6 bubbles in the next 10 seconds. Disconnect port B tubing from the regulator before venting port A.
Patient side: Increase at least one turn; allow no bubbles in 10 seconds. Turn fully counter-clockwise, select CONT, and again allow no bubbles in 10 seconds.
Expected outcome: Both leak tests pass.
10. Perform Continuous-Mode Flow Test
Action: Using the specified tubing and 0-50 L/min flowmeter, select CONT and set 100 +/- 5 mmHg. Verify flow exceeds 25 L/min for all models. Adult only: at full clockwise, verify flow exceeds 40 L/min.
Expected outcome: Flow exceeds the applicable minimum.
11. Verify Intermittent Flow and Timing
Action: Set adult 120 mmHg, pediatric 100 mmHg, or neonatal 80 mmHg. During ON, verify flow is 8 +/- 1 L/min. With patient port occluded, confirm the unit begins ON and measure 15 +/- 3 seconds ON and 8 +/- 3 seconds OFF. Adjust only through trained service; fully clockwise timing valves prevent cycling.
Expected outcome: Intermittent flow and timing meet factory settings.
12. Perform Regulation Test
Action: Set 100 mmHg and repeatedly open/close the patient port. With it occluded, verify return within adult analog +/-10 mmHg; pediatric/neonatal analog +/-8 mmHg; adult/pediatric digital +/-2 mmHg; neonatal digital +/-1 mmHg.
Expected outcome: Regulation meets the model-specific tolerance.
13. Verify Build-Up and Bleed-Down
Action: Connect a closed 1500 mL canister. In INT, use adult 120, pediatric 100, or neonatal 80 mmHg. Vacuum must reach preset within 5 seconds ON and fall to zero within 5 seconds OFF. In CONT at the same setting, switch OFF and verify zero within 10 seconds.
Expected outcome: Build-up and bleed-down times pass.
14. Inspect Service Items and Return to Service
Action: Based on use and environment, qualified service checks elastomers, O-rings, gaskets, diaphragms, and internal filters and services as needed. Repeat full Service Checkout after repair. Restore all fittings, filters, overflow protection, labels, and accessories.
Expected outcome: The regulator is complete, uncontaminated, and within specification.
Electrical Safety Testing
Electrical safety testing is not applicable to the pneumatic analog PTS-ISU. Digital versions use internal lithium batteries for the gauge; the reviewed manual does not prescribe mains electrical-safety testing. Inspect the display and battery compartment and follow facility policy for battery-powered equipment.
Pass / Fail Criteria
PM Pass Criteria
- Inspection, cleaning, filter, tubing, overflow protection, controls, and digital display pass.
- Gauge zero and applicable accuracy tolerance pass.
- Push-To-Set leakage is no more than 1 L/min.
- Supply leak is no more than 6 bubbles/10 seconds; patient tests show no bubbles/10 seconds.
- CONT flow exceeds 25 L/min; adult maximum exceeds 40 L/min.
- INT flow is 8 +/- 1 L/min; timing is 15 +/- 3 seconds ON and 8 +/- 3 seconds OFF.
- Regulation and build-up/bleed-down meet applicable limits.
- No unresolved contamination, damage, leak, or defect remains.
Remove From Service Criteria
- Any pre-use or Service Checkout item fails.
- Damage, contamination, blockage, incorrect connection, or overflow protection affects safety/performance.
- Push-To-Set, selector, knob, zero, display, accuracy, vacuum, leakage, flow, timing, regulation, build-up, or bleed-down fails.
- Aspirate contamination remains unresolved.
- Internal repair is needed or required supply conditions cannot be met.
Copy/Paste CMMS Work Order Procedure
Use the manufacturer service manual, facility policy, and approved AEM program to determine the final PM interval and return-to-service requirements.