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Stryker SmartPump Rx, Instructions For Use Manual

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Stryker SmartPump Rx Instructions For Use Manual Download Page 2

 

 

ii 

Table of Contents

 

  

P

AGE

 

User/Patient Safety 

5

 

Indications 5

 

Contraindications 6

 

Possible Adverse Effects 

6

 

Precautions for Use 

7

 

Environment and Placement 

7

 

1 Introduction 

8

 

System Overview 

8

 

Features 9

 

Convenient Preparation 

9

 

Ease of Operation 

9

 

Continuous, Real-time Monitoring 

9

 

Accessory Information* 

9

 

Power Options 

10

 

AC Power 

10

 

Internal Battery 

10

 

Low Battery Power Alarms 

11

 

Maintaining Internal Battery Charge 

11

 

2 Control Panel and Display 

12

 

Control Buttons 

13

 

Display Screen 

15

 

Display Indicators 

16

 

Status Indicators 

16

 

Alarm Indicators 

16

 

Summary of Contents for SmartPump Rx

Page 1: ...6 6 475 228 6 605 103 Additional US and foreign patents pending Software Version 1 3x 2007 04 5920 011 700 Rev www stryker com SmartPump Tourniquet System Dual Channel Tourniquet Pump REF 5920 011 000 Instructions For Use ...

Page 2: ...System Overview 8 Features 9 Convenient Preparation 9 Ease of Operation 9 Continuous Real time Monitoring 9 Accessory Information 9 Power Options 10 AC Power 10 Internal Battery 10 Low Battery Power Alarms 11 Maintaining Internal Battery Charge 11 2 Control Panel and Display 12 Control Buttons 13 Display Screen 15 Display Indicators 16 Status Indicators 16 Alarm Indicators 16 ...

Page 3: ...n the SmartPump 22 Setting Timer and Target Pressure 23 Time Display Format 24 Alarm Volume Adjustment 24 Default Display Viewing Preferences 24 Setting Time and Date 26 Cuff Inflation 28 Intravenous Regional Anesthesia IVRA Lock 28 To Inflate a Cuff 28 Cuff Pressure Gauge 29 Monitor Time and Pressure 29 Cuff Deflation 33 Tourniquet Report Printer 34 Bier Block Procedure 35 Responding to Alarms an...

Page 4: ...iv 5 Cleaning and Maintenance 39 Cleaning Recommendations 39 Periodic Maintenance 40 Annual Maintenance Checklist 43 6 Service Code Summary 46 7 Specifications 47 ...

Page 5: ... Only personnel trained and or authorized by Stryker may perform adjustments modifications or repairs to this equipment The SmartPump must be used maintained and cleaned in accordance with these Instructions For Use Indications A tourniquet is indicated when it is necessary to reduce blood flow and or when greater visualization of the operating field is imperative or desired It is designed to temp...

Page 6: ...tion Severe scar tissue in cuff zone Mellitus Open leg fractures Post traumatic lengthy reconstruction Severe crushing injuries Elbow surgery associated with excessive swelling Severe hypertension Skin grafts in which bleeding must be readily distinguished Presence of sickle cell disease or clotting disorder All final decisions regarding use of a tourniquet are the responsibility of the attending ...

Page 7: ...et guidelines and training programs developed by the Association of periOperative Registered Nurses AORN provide valuable references and resources to establish and update guidelines The AORN Recommended Practices for Use of The Pneumatic Tourniquet is available online Originally published in the AORN Journal and revised in December 1998 it is included in the AORN 2000 Standards Recommended Practic...

Page 8: ...re and time settings are displayed controlled and monitored independently The SmartPump uses single port cuffs The built in serial interface port supports its optional Stryker Tourniquet Report Printer and enables Clinical Information System CIS connectivity The two channels are identified on the SmartPump s display as Cuff 1 and Cuff 2 The cuff connection ports are identified similarly Cuff 1 may...

Page 9: ...automatically and tests the pneumatic pressure display battery and processor systems The SmartPump will alert the user via alarms indicators and the display of error codes to assist in troubleshooting Ease of Operation The procedure timer and cuff target pressure may be set using simple intuitive steps Control buttons are clearly identified Inflation is initiated by pressing the Inflate button Def...

Page 10: ...ill return to green the no AC indicator will remain illuminated and the battery symbol will indicate the amount of battery charge NOTE If at initial start up there is no AC present and the Alarm Indicator Mute button is not pressed within 30 seconds the SmartPump will return to its OFF standby mode automatically This feature prevents the SmartPump from unintentionally being used in a back up batte...

Page 11: ...tatus as follows Battery Charging Symbol The segments of this symbol illuminates sequentially and repetitively while the internal battery is being charged This occurs when the SmartPump is connected to an AC power source Once the internal battery is fully charged all of the segments are lit Battery Power Symbol The segments of the battery power symbol are lit to indicate the level of battery charg...

Page 12: ... Deflation and Default Display Cuff pressure and elapsed cuff time are displayed in real time LCD Display Screen Time display User Selectable Minutes or Hours and Minutes Pressure display mmHg IVRA Lock Alarm Indicator Mute button Default Display button On Off standby AC and Battery Indicators Cuff 1 Cuff 2 Fill line Fill line Connector Connector Serial Interface Port not shown Cuff Control Button...

Page 13: ...ng the Set Save button press these buttons to increase or decrease the inflation time for the selected cuff Each button press changes the time value in 5 minute increments 1 minute increments within the 1 to 15 minute time range The numeric display changes accordingly PRESSURE PRESSURE Increase Decrease located below the Set Save button After pressing Set Save button press these buttons to increas...

Page 14: ...ional elapsed cuff time DEFAULT DISPLAY At the end of a procedure and after deflation has occurred press the Default Display button to clear and reset the SmartPump to its default time and pressure settings The Default Display button is also used to set new default time and pressure settings for preferred practice settings See Changing Default Time and Pressure Settings ALARM INDICATOR MUTE BUTTON...

Page 15: ...attery Charge Indicator Actual Cuff Pressure 220 mmHg Pressure Gauge Indicating cuff at target pressure System Ready Indicator IVRA Lock Status Unlocked Inflation Timer Indicating elapsed time 50 minutes Time displayed in hours and minutes format Active Cuff Cuff 1 Ready Cuff Cuff 2 Default Settings Time 1 hour Pressure 250 mmHg ...

Page 16: ...Deflation Indicates corresponding cuff is deflating or deflated Alarm Indicators Service Required When the SmartPump detects a condition that requires service a service code with a wrench is displayed on the LCD and an audible alarm will occur Note the code and call Stryker for assistance 1 800 253 3210 Caution When an alarm is detected the Alert triangle is displayed and either the time or pressu...

Page 17: ...ay result in user patient injury 1 Assemble roll stand See instructions for use supplied with roll stand 2 Gently lower the SmartPump onto the roll stand pole Adjust the height of the SmartPump using the adjustment knob to facilitate access to the display and controls 3 Tighten the knob to secure the SmartPump to the roll stand pole Roll Stand Pole Cuff 2 ...

Page 18: ...wer on and self test The self test checks the pneumatic system pressure display battery and processors Self test errors are reported via service codes on the LCD display See Service Code Summary section Upon successful completion of the system self test including battery charge level voltage test the Ready indicator appears in the center of the display The Battery Charging indicator on the bottom ...

Page 19: ...uff time alarm is preset at the factory for one hour This means that if unchanged the time setting for the Cuff is one hour The Timer s alert will sound the Alarm Indicator Mute button will flash red and the corresponding time display will flash when the preset total elapsed inflated cuff time has been reached NOTE The SmartPump does NOT automatically deflate the cuff when the target time is reach...

Page 20: ...lay changes accordingly 4 To change the default pressure use the increase or decrease buttons Each press adjusts the pressure in 5 mmHg increments numeric pressure values change accordingly 5 When the desired values are displayed press the Default Display button to store the new values as the new default settings The display stops blinking and the double beep indicates the new values have been sto...

Page 21: ...mb 5 Connect cuff to fill line connector 6 When ready press the Inflate button 7 Monitor cuff time and pressure during the procedure 8 Manage Timer and Pressure as necessary 9 Deflate the cuff and disconnect the cuff from fill line connector WARNING At the end of a procedure as soon as the tourniquet pressure is released remove the cuff sleeve and other underlying materials as the slightest impeda...

Page 22: ... bottom of the display If the displayed Time and Cuff Pressure settings are acceptable proceed with the cuff inflation by pressing the Inflate button If the self test fails the following occurs The Alarm Indicator Mute Button flashes red and the audible alarm sounds Press the Alarm Indicator Mute Button to mute the unit WARNING indicators will appear on both sides of the display and a wrench icon ...

Page 23: ... Time and Pressure values will blink 3 To change the set Time use the increase or decrease buttons Each press adjusts the time in 5 minute increments 1 minute increments in the 1 to 15 minute time range The numeric time display changes accordingly 4 To change the set Pressure use the increase or decrease buttons Each button press adjusts the pressure in 5 mmHg increments displayed numeric values c...

Page 24: ...started If it is currently displaying H MM hours and minutes it will automatically shift to Minutes and vice versa A Time Display format change remains in effect permanently until changed again Alarm Volume Adjustment While pressing the Alarm Indicator Mute Button press either the or buttons on the top left of the SmartPump to increase or decrease the alarm volume to a desired level Alarm volume m...

Page 25: ...n the ready mode no cuffs inflated press and hold the Alarm Indicator Mute button then press the Default Display button See figure A 2 The display will cycle twice blinking one side then the other This confirms the selection of minimization In this mode when either cuff is inflated the unused cuff s default settings will be minimized See figure B 3 When in the Default Display Minimization Mode min...

Page 26: ...dy mode without an inflated cuff It is not possible to change the Time or Date if a procedure is underway Button Explanation 1 Confirm the SmartPump is in the ready mode 2 Simultaneously press and hold Set Save and Time buttons on the left side of the SmartPump for four seconds Release both buttons The current time value HH MM 24 hour format will appear in the bottom left corner of the LCD with th...

Page 27: ...th the month blinking i e 12 December 12 06 7 Set the month Use the left side time increase or decrease buttons to set the month 8 Press Set Save to save the new month setting The current calendar date will blink i e the date is the 6th 12 06 9 Set calendar date Use the left side time increase or decrease buttons to set the date 10 Press Set Save to save the new date setting The current calendar y...

Page 28: ...ocked state the icon changes to a locked padlock See images below The IVRA lock unlock button is below the LCD on the right If when attempting to deflate the second cuff with the IVRA Lock enabled the SmartPump will produce an audible error beep and the IVRA padlock will blink To Inflate a Cuff Press the Inflate button on the selected side The selected cuff is inflated to the target pressure The S...

Page 29: ...monitor the elapsed procedure time and the inflation pressure of the cuff s in use Time and or pressure settings may be changed during a procedure Immediately after changing the setting s and pressing the Set Save button the SmartPump adjusts the time and or pressure to the new setting s See Setting Timer and Cuff Pressure Inflation Time H MM format Indicating elapsed inflation time of 17 minutes ...

Page 30: ...n the Alarm Indicator Mute button is pressed the audible chime is silenced for 15 minutes However the time value on the LCD display will continue to blink once per second When the target time is reached do one of the following Deflate the cuff by pressing the Deflate button for 1 5 seconds and if necessary re inflate the cuff Press the Alarm Indicator Mute button to mute the alarm for 15 minutes T...

Page 31: ... Cuff pressure changes within normal operating parameters and pressure compensation thresholds may be caused by a Limb extension and contraction b Initial cuff conformity and tissue compression c A leaking damaged reusable cuff leaking cuff O ring loose Luer connector or fill line leak Intraoperative limb manipulation may cause the cuff to induce a momentarily minor high and or low pressure fluctu...

Page 32: ...ng cuff pressure value s The SmartPump will continue to adjust pressure to the set target pressure while the audible alarm is muted In a muted state the pressure values continue to blink If automatic pressure adjustments do not resolve the low or high pressure conditions within one second the following occurs The cuff pressure audible alarm sounds once a second Low pressure alarms are muted for 30...

Page 33: ...utomatically prior to cuff removal WARNING At the end of a procedure as soon as the tourniquet cuff pressure is released remove the cuff sleeve and other underlying materials The slightest impedance of venous return may lead to congestion and pooling of blood in the operative field Failure to comply may result in patient injury The total elapsed cuff time remains displayed Prior to pressing the De...

Page 34: ...a is saved to a non volatile memory that will preserve the data even if the SmartPump is turned off AC power is removed or the internal battery is fully discharged Each time the SmartPump starts a new procedure the previous procedure is fully erased and new data is accumulated Procedure summary data is preserved until either of the following events happen which will cause the last procedure s summ...

Page 35: ...utton The IVRA padlock icon will change to the locked position 1 Begin the procedure by sequencing the inflation and deflation of the Bier block cuffs according to your institution s standard practice 2 When the procedure is completed unlock the IVRA Lock to deflate the remaining Bier cuff or 3 Reduce the cuff pressure in stages Follow standard Set Save pressure adjustment steps See Setting Timer ...

Page 36: ...or replacing a leaking cuff b adding time to the procedure Timer c charging a low battery or d connecting the SmartPump to an AC power source Service Codes The Alarm Indicator Mute button flashes red An audible alarm sounds The associated graphic or numeric will flash When the target procedure time has been reached the time display blinks Once the alarm is muted the audible Alarm indicator is illu...

Page 37: ... and cuffs are leak free SINGLE TOURNIQUET CUFF During the initial inflation if the tourniquet cuff cannot reach or maintain target cuff pressure discontinue use After inflation if cuff pressure is at risk and or tourniquet pump alarms cannot be resolved 1 Clamp off the inflated cuff s fill line and remove it from the fill line connector of the SmartPump 2 Press the Deflate button on the failed si...

Page 38: ... maintain target pressure prior to anesthetic injection discontinue use of the cuff If prior to deflation of the primary cuff the second cuff cannot reach or maintain target pressure do the following 1 Clamp off the primary cuff to retain pressure and disconnect the fill line This action will cause the SmartPump to alarm 2 Connect the second cuff s fill line to the fill line connector of the prima...

Page 39: ...comply may result in product damage DO NOT allow water detergent or any liquid to enter any button opening or electrical connector Failure to comply may result in product damage DO NOT use abrasive materials Failure to comply may result in product damage like scratching the LCD window 1 Wipe the exterior surfaces with a soft cloth moistened with a mild detergent to clean the SmartPump 2 Wipe the e...

Page 40: ... and the fill line for damage such as cracks abrasion or a damaged O ring on the fill line connector DO NOT use the equipment if damage is apparent 2 Clean the SmartPump See the Cleaning Recommendations 3 Plug the SmartPump into AC power Verify that the green AC power light on the front panel is lit 4 Verify the internal battery charge light is either blinking yellow fast charge mode solid yellow ...

Page 41: ...ing the internal battery for power The Alarm Indicator Mute button should flash red and the no AC message should appear on the lower left of the LCD Press the Alarm Indicator Mute button to cause the Alarm Indicator Mute button to stay solid green color 10 Change the Time setting to 15 minutes Press Set Save button to save this new time setting 11 Connect a 10 foot fill line to the SmartPump Conne...

Page 42: ...he alarm should cancel and the Alarm Indicator Mute button should be illuminate green 22 Press the Deflate button to deflate the cuff 23 Press the Inflate button The cuff should re inflate to 350 mmHg for this test sequence 24 Momentarily disconnect the fill line from the SmartPump The alarm should sound and the Alarm Indicator Mute button should flash red indicating a low pressure pneumatic leak ...

Page 43: ...ATORS AC indicator light ON when AC power present battery charge indicator shows battery charge status AC POWER ERROR no AC error message when AC power removed AC POWER FAIL AT START UP Unit will alarm at start up with no AC power LCD message and Alarm Indicator Mute button red no audible tones Alarm may be cancelled LCD message no AC remains PRESSURE CALIBRATION VERIFICATION 100 mmHg 4 mmHg Cuff ...

Page 44: ...Alarm Indicator Mute button flashes red blinking time indicator TIMER RESET Increasing the timer value will reset the timer alarm to the normal state Timer alarm reset indicated by audible alarm stops Alarm Indicator Mute button is solid green time indicator stops blinking DEFLATE OPERATION INTERRUPTION cuff re inflates to prior setting 350 mmHg if deflation interrupted and deflates fully if defla...

Page 45: ...T DISPLAY Default Display settings TIME 1 00 PRES 250 mmHg upon selection of default display your institution may use different Default Display settings BATTERY CHARGED battery fully charged Printed Label from Tourniquet Report Printer ...

Page 46: ...onvolatile memory for the FP processor has failed a memory test FP FILES CORRUPT 34 The nonvolatile memory storing the FP code has failed a memory test A NONVOLATILE MEMORY ERROR 35 The nonvolatile memory for the A code has failed a memory test B NONVOLATILE MEMORY ERROR 36 The nonvolatile memory for the B code has failed a memory test HARDWARE FAULT 37 An internal hardware fault was detected POWE...

Page 47: ...wer 120 VAC 10A hospital grade receptacle AC Input Input voltage range 100 240 VAC Frequency 50 60 Hz AC fuses 3 15A 250V Power requirements 1 5 A 120 VAC Internal DC Supply Module Output voltage 15 VDC 1 150 mV pk pk ripple Output current 4A maximum Output power 60 W maximum Overload protection short circuit 110 150 auto recovery Over voltage protection 115 130 of rated output voltage Internal Ba...

Page 48: ...increments Quick Connect Hose Couplings CPC PMC1602 or equivalent Environment Operation Storage and Transportation Temperature Relative Humidity Atmospheric Pressure Optional Printer Tray Tray size 8 25 inch width x 7 5 inch depth 21 cm x 19 cm Tray load capacity 5 lbs 2 3 kgs maximum load capacity Pole Basket and Stand Pole adjustable height from 46 inch to 56 inch 117cm to 142cm Base weighted ba...

Page 49: ... s are connected consult the manufacturer or field service technician for help Only Stryker printer and shielded serial cable may be connected to the equipment s serial port Usage of accessories or cables other than those sold by Stryker may result in increased RF emissions or decreased RF immunity of the equipment Guidance and manufacturer s declaration electromagnetic emissions The Dual Channel ...

Page 50: ...on application to the frequency of the transmitter Recommended separation distance d 1 67 P d 1 67 P 80 MHz to 800 Mhz d 2 33 P 800 MHz to 2 5 Ghz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Interference may occur in the vicinity of equipment marked with the following sym...

Page 51: ...de 1 kV for input output lines 0 5 1 kV differential mode 0 5 1 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 cycles 95 Reduct...

Page 52: ...communications equipment transmitters and the Dual Channel SmartPump as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 04 0 07 0 1 0 37 0 11 0 22 1 1 17 0 35 0 70 10 3 70 1 11 2 21 100 11 ...

Page 53: ...Specifications 53 ...

Page 54: ...Specifications 54 ...

Page 55: ...Specifications 55 ...

Page 56: ...Stryker Instruments 4100 E Milham Kalamazoo MI USA 49001 1 269 323 7700 1 800 253 3210 2007 04 5920 011 700 Rev www stryker com ...

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