Stryker Smart Pump Preventative Maintenance Procedure Scope This maintenance procedure provides the basic testing and inspection criteria necessary for an annual performance and/or check-in evaluation of the Stryker Smart Pump Single-Channel (5920-010-000) and Dual Channel (5920-011-000) tourniquets. This check is also recommended if the unit is suspected of not operating properly. For general information and trouble-shooting guidance, please consult your Smart Pump Instructions for Use (IFU) - 5920-010-700 or 5920-011-700, respectively. If the device being tested is an older revision of the Smart Pump (serial numbers 215xxx or 216xxx and model number SP21.1 on the product label), the steps in italics shall be omitted. If the device fails testing at any point, DO NOT attempt to repair the device. If you require service, please contact your Stryker Sales Representative, or call Stryker Customer Service at 1-800-253-3210. Outside the US, please contact your nearest Stryker subsidiary. Required Equipment 1 Calibrated Dwyer 477A or Love Controls HM28D3H10000 manometer 1-2 cuffs (Ideally 15 or 24 size) 1 T-connection 3/16 tubing (uncoiled) 1 Smart Pump Printer Sections A. Visual check and Power-up tests B. Functional tests C. Settings check Appendix A. Data Sheet A. Visual checks and Power-up tests 1. Visual Checks a. Ensure the overall appearance is free of cosmetic defects which are to the extent where they could reasonably be expected to impact performance or compromise integrity. Example: Superficial scratches or blemishes should be acceptable, gouges are typically not acceptable. b. Verify all the screws are tightened. 1 www.stryker.com
c. Verify the seam between the front and rear enclosure pieces is even. d. Verify that both cuff couplings are aligned in the hex shaped feature on the enclosure plastic, with the metal tab facing outward (away from the center of the product). e. Check for loose parts inside that rattle when the unit is shaken lightly. 2. Power-up Test a. Plug the device into an AC power outlet. Verify the front panel AC power LED (~) is illuminated. b. Verify the battery charge LED is either blinking yellow or lit green (skip to next step if Older Pump). c. Press the power button. Observe the LCD and verify that all the characters and numerics light up during start-up. d. Remove the AC power. The ALARM MUTE button should blink red and the LCD should indicate noac. Press the ALARM MUTE button to clear the alarm the button should switch to a steady green color. e. Keeping the AC power removed, power the unit off. The ALARM MUTE button should blink red and the LCD should indicate noac. Press the ALARM MUTE button to cancel the alarm the button should switch to a steady green color. B. Functional Tests 1. Smart Pump Pressure Reading Check a. Connect the unit to AC power and power the device on. b. Zero the calibrated Dwyer 477A or Love Controls HM28D3H10000 manometer. Record which manometer is being used on the data sheet. Attach the manometer, T connection, fill-lines and two test cuffs (or one if applicable) to the Smart Pump as shown in the Figure below. The cuff(s) should be left uncoiled. 2 www.stryker.com
c. 100 mmhg CHECK i. Set the pressure to 100 mmhg (SET/SAVE, adjust, SET/SAVE again). Press the INFLATE button and allow the pressure to stabilize (approximately 5 seconds). ii. The unit pressure display should be within the following range. Record the pressure setting and the manometer reading on the data sheet. Dwyer 477A Love Controls HM28D3H10000 Low 96.5 97.5 High 103.5 102.5 d. 200 mmhg CHECK i. Set the pressure to 200 mmhg. Press the INFLATE button and allow the pressure to stabilize (approximately 5 seconds). ii. The unit pressure display should be within the following range. Record the pressure setting and the manometer reading on the data sheet. 3 www.stryker.com
Dwyer 477A Love Controls HM28D3H10000 Low 196.5 197.5 High 203.5 202.5 e. 475 mmhg CHECK i. Remove AC power and cancel the noac alarm as needed. ii. Set the pressure to 475 mmhg. Press the INFLATE button and allow the pressure to stabilize (approximately 5 seconds). iii. The unit pressure display should be within the following range. Record the pressure setting and the manometer reading on the data sheet. Dwyer 477A Love Controls HM28D3H10000 Low 466.5 467.5 High 483.5 482.5 f. Press Deflate. The unit should deflate. g. Repeat steps B.1.c through B.1.f for the second Cuff if applicable. 2. Printing Check (skip to section C if Older Pump) a. Connect a printer to the Smart Pump using the Printer Cable. With the printer connected and turned on, press the Print button. Two labels should print, indicating that each cuff has been operated at the following pressures: i. 100 ii. 200 iii. 475 b. Verify that the serial number, date, time and recorded information are correct on both labels. Affix these two labels to the data sheet. 3. Pneumatic Check (skip to section C if older Pump) a. Turn the Smart Pump off and back on. Ensure the pump is plugged in to AC power. b. Adjust the Cuff 1 (and Cuff 2) pressures to 475 mmhg. c. Clear and start a calibrated timepiece. d. After at least 2 minutes have elapsed, print the Smart Pump s Service History Label by performing the following procedure: i. Press and hold Cuff 1 s TIME INCREASE and PRESSURE INCREASE buttons simultaneously for at least 2 seconds (until a faint beep is heard). ii. Perform the above step 3 times in a row; the label printer will print out the Smart Pump Assembly s Service History Record Label. e. Stop, clear, and start the calibrated timepiece. f. After at least 5 minutes have elapsed, stop the calibrated timepiece, and print the Smart Pump s Service History Label (as described in Step (d)). 4 www.stryker.com
C. Settings Check g. Write the time shown on the calibrated timepiece on the data sheet. h. Record the number of pump cycles printed after the 2 minutes have elapsed on the data sheet and also record the number of pump cycles printed after the 5 minutes have elapsed. i. Take the subtraction difference between the 5 minute result and the 2 minute result, and record this value on the data sheet. j. Ensure that the value in the Total row is less than 10. Include the printout with the data sheet. 1. Ensure the Smart Pump is on AC power. Push each of the buttons, verifying that each button is operational by noting an audio tone each time a button is pressed. 2. Set Default Settings to 60 minutes and 250 mmhg, or as your facility prefers. a. Press the SET/SAVE button. b. Press the TIME INCREASE or DECREASE buttons to increase or decrease the time value, respectively. Press the PRESSURE INCREASE or DECREASE buttons to increase or decrease the pressure value, respectively. c. After the desired values are selected, press the DEFAULT DISPLAY button to save. 3. Verify that the date and time are accurate, or adjust as necessary. Note that the pump has a real-time clock that does not adjust for daylight savings time changes automatically. a. To access date and time settings, press and hold the SET/SAVE button and the Cuff 1 TIME INCREASE button simultaneously for four seconds. b. Press the TIME INCREASE or DECREASE buttons of Cuff 1 to set the hour value. Press the SET/SAVE button to save the new value. Keep repeating this procedure to set the Minute, Month, Day, and then Year values. 4. Press the IVRA button and ensure that the graphic toggles between the locked and unlocked modes. Leave the IVRA lock in the unlocked condition, or as your facility prefers. 5. Verify the speaker volume is at the maximum setting, or as your facility prefers. Change speaker volume by holding the ALARM MUTE button and pressing the TIME INCREASE or DECREASE buttons of Cuff 1 to increase or decrease, respectively, the alarm volume to a desired level. 6. Verify that the unit is in non-blinking mode by simultaneously pressing and releasing the ALARM MUTE and DEFAULT DISPLAY buttons. The numerics on both sides should blink at the same time. If they do not, change the setting by simultaneously pressing and releasing the Alarm and Default Display buttons again. 5 www.stryker.com
Appendix A: Data Sheet Please keep for your Records Technician/Signature: Date: Visual Checks Power-up Tests Manometer Used 100 mmhg Test 200 mmhg Test 475 mmhg Test Printing Pneumatic Time Pump cycles 2 min Pump cycles 5 min Difference Settings 6 www.stryker.com