User Manual - Stryker Restep
Contents
1. 30 dip in UT for 25 cycles for 25 cycles lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in UT for 5 sec for 5 sec Power frequency Power frequency magnetic 50 60 Hz fields should be at levels magnetic field characteristic of a typical location in a typical commercial or hospital IEC 61000 4 8 environment NOTE UT is the a c mains voltage prior to application of the test level Guidance and manutachurere declaration electromagnetic immunity This device is intended for use in the electromagnetic environment specified below The customer or the user of this device should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic environment guidance test test level level Portable and mobile RF communications equipment Should be used no closer to any part of this device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 VP d 1 2 VP 80 MHz to 800 MHz Conducted 3 Vrms a 61000 46 80 MHz SC Where P is the maximum output power rating of the 3 V m transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Radiated RF 3 V m IEC 61000 80 MHz to 4 3 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should b2. before the battery is charged or the pump is used This will ensure that the pump and battery life is not affected e Please contact your Stryker Sustainability Solutions representative for appropriate disposal method RETURNS Any equipment failing to work properly should be returned to Stryker Sustainability Solutions Prior to return please contact Stryker Sustainability Solutions at 888 763 8803 for the best method of return SPECIFICATIONS Item Specifications Pump Kit PUMPKIT Pump RSP101 Leg Garments RCG10 Thigh Garments RTG30 Bariatric Calf Garments RBG60 Foot Garments RFG210 Classification Class Il E IPXO NO AP APG Type BF Mode of Operation Continuous Internally powered portable Item RSP159 Type TWM15 09 UN 585L ASC TRUMPower Input AC 100 240 Vac 50 60 Hz 0 5 0 3 A Output DC 9V 1 67 A Adapter Item RSP164 Type VEP15US09 XA0436B XP Power Input AC 100 240 Vac 50 60 Hz 0 5 A Output DC 9V 1 40 A Battery Protection PTC Overcurrent Protection Device 2 5 LPM Leg Calf Bariatric Thigh 40 mmHg Pressure Range Foot 80mmHg Cycle Time 12 seconds inflate 48 seconds deflate per garment Dimensions Pump 7 0 x 4 1 x 2 75 18 cm x 10 5 cm x 7 cm Pump with battery cover RSP167 1 4 Ibs 640 g Pump with battery cover bed bracket RSP163 1 5 Ibs 700 g Adapter RSP159 0 5 Ibs 215g Adapter RSP164 0 6 Ibs 255g Temperature Operat
3. take 16 48 hours the system may be used while recharging discharging a fully charged nominal battery via battery only operation may take 8 hours Overall battery life etfectiveness is maintained by continuous full charging and discharging cycling routines e Charge the battery when the battery capacity Is low This will be indicated when the red LOW BATTERY light is solid accompanied by a constant audible alarm when the pump is under battery only operations e While charging the battery the BATTERY CHARGE light green will be blinking When the battery Is fully charged an audible double beep is presented once and the BATTERY CHARGE light green will be lit constantly e While pump is not being used and idle the power adapter should be connected to the pump to insure a charged battery during its next use If the pump was left idle without being charged It is recommended that the pump be charged until the BATTERY CHARGE light emits a constant green light prior to utilization without a power adapter e t is normal for the battery to get warm during charging and while in use AN CAUTION e Use only the provided manufacturer approved battery included in the package Replacement Item Number RSP152 e Disconnect the adapter from the pump before unplugging the adapter from the AC outlet Disconnection in reverse order may cause damage to the pump e Use only the provided manufacturer approved power adapter included in the package DO NOT U
4. the TYPE key to select either LEG GARMENTS default or FOOT GARMENTS 4 Mode Selection Key MODE selection key is inactivated after 60 seconds of initially powering on the pump Press the MODE key to select dual garment default or SINGLE GARMENT 5 Mute Key Press the Mute Key to silence the audible alarm If the mute key Is enabled alarm silenced it will disable alarm reactivated automatically after 3 minutes 6 Battery Status Indication gt BATTERY CHARGE light solid green battery fully charged state reached gt BATTERY CHARGE light flashing green battery charging gt LOW BATTERY light solid red with constant audible alarm pump has vented and powered down to a suspended safe mode low battery charge required gt LOW BATTERY light flashing red no audible alarm bad battery cannot reach fully charged State in 48 hours pump is on suspended mode and requires all power sources to be removed AC power adapter and battery in order to reset 7 Alarm Indication HIGH PRESSURE light solid red with beeping audible alarm garment not deflating HIGH PRESSURE light solid red with constant audible alarm high pressure kinked tubing LOW PRESSURE light solid yellow with constant audible alarm no garment LOW PRESSURE light solid yellow with beeping audible alarm low pressure 8 Garment Type Indication LEG GARMENT light calf bariatric calf and thigh garments in use FOOT GARMENT light foot garments in
5. the alarm still continues after garment change there may be an internal pump fault indicating the pump may need servicing Remove pump from service and contact your Stryker Sustainability Solutions representative DO NOT CONTINUE TO USE CRITICAL LOW BATTERY This alarm will sound during battery only pump operation when the battery is near depletion The following actions will be initiated by the pump when this alarm is activated gt A solid tone audible alarm will begin and continue for 10 minutes This alarm cannot be disengaged by pressing the MUTE button The garments will be vented immediately The pump operations will be suspended for 10 minutes lf the User connects the AC Adapter Power Supply to the pump within 10 minutes of alarm initiation the pump will automatically resume operations POWER button press is not required and begin charging the battery gt lf the AC Adapter Power Supply is not connected to the pump after 10 minutes of alarm initiation the pump will completely power off and will not power on until the AC Adapter Power Supply is connected to the pump vv viv gt Ifthe interval between achieving full battery charge to a critical low battery alarm begins to be noticeably shorter over time battery operation run time the battery pack may require a replacement gt If anew replacement battery is observed to have a short battery operation run time there may be an internal pump fault indicating the pump may nee
6. the pump when it is hanging from the footboard or bedrail as this may result in a fracture of the bracket housing gt Place the equipment in a location where it will not be susceptible to impact forces from other equipment or personnel gt Pump hooks are designed for bed attachment only gt Itis not recommended that pumps or Bed Brackets RSP166 if applicable are permanently fastened or tied to objects gt Only the pump and garment combinations provided by Stryker Sustainability Solutions should be used The correct function of the product cannot be guaranteed if the incorrect pump garment combinations are used gt Regularly check the system while in use assuring pump operation and garment fit gt Keep the pump away from sources of liquids and do not immerse in water gt Switch off the electrical supply to the pump by removing the power supply from the power outlet and the pump before cleaning and inspection gt Do not use cleaning solutions that are known to damage plastics gt Do not autoclave any parts of the system gt Ensure the system Is clean and dry prior to storage GENERAL The Restep system has been tested and certified for the following standards UL 60601 1 CAN CSAC22 2 No 601 1 EN60601 1 IEC 60601 1 IEC 60601 1 2 The power adapter has been tested by the manufacturer and certified for the following standards UL 60601 1 CAN CSA C22 2 No 601 1 EN 60601 1 Symbols Read through all instructions
7. this time the LOW PRESSURE alarm may activate If after a few cycles this alarm does not reset please refer to the trouble shooting guide To end pump operation press POWER button again When the pump is powered down during an inflation cycle the Garment TYPE light will flash while the valves open and drain the pressure from the garment This ensures the system is left in a safe deflated mode for the patient NOTE You may change the TYPE or MODE settings only within the first 60 seconds of the initial Power button press after 60 seconds TYPE and MODE selection keys are inactivated It is NOT recommended to change garments after initial setup while pump is in use The pump should be turned off during a garment change to avoid unnecessary alarm disturbance to the patient Garment TYPE selection The user may select between the LEG GARMENTS type or FOOT GARMENTS type by pressing the Type Selection Key Press this key until the desired type is illuminated by the garment type indicator LED LEG This is the default setting for calf bariatric calf and or thigh garments The operating inflated pressure is 40mmHg and the compression delivered is considered a uniform type compression The LEG GARMENT light will flash during initial setup of the pump and then will be lit constantly during use FOOT Select this button for foot garment use The operating inflated pressure is 830mmHg and the compression delivered is considered a uniform type
8. tubing Tubing may become a trip hazard during ambulation if the shoulder strap is not used to secure excess tubing Thigh Garments The thigh garments may be used on either leg Unfold the garment s and position the inflatable center bladder directly behind the patient s calf and rear of the thigh with the square shaped cut out directly behind the patient s knee The outlet tube on the garment should not be in direct contact with the patient s skin SNUGLY wrap the thigh garment s around the patient s leg and thigh and secure the hook tabs onto the loop material Repeat for the other leg or store the unused garment and tube for later use Attach the garment s to the tube set by pushing in the silver latch on the female tube connector and inserting the male garment connector firmly into the tube connector until a click is heard NOTE Ensure the pump is held firmly onto the bed frame while used in bed During ambulation or transportation ensure that the pump is secured Rotate the outlet tube on the garment to eliminate kinks in the tubing Tubing may become a trip hazard during ambulation if the shoulder strap is not used to secure excess tubing Foot Garments The foot garments may be used on either foot Unfold the garment s and position the inflatable center bladder directly below the arch of the patient s foot The outlet tube should be adjusted so it is parallel with the patient s toes NOTE Do not use calf garments a
9. MENT gt gt During inflation verify a manometer reading of at least 7ommdHg It may take up to three 3 cycles to achieve this pressure while the garment inflates and fits its shape to the solid object Inflation will happen in multiple segments Verify the manometer reading falls below 20mmHg during deflation Press the POWER button to turn off the pump Allow for the pump to completely shutoff Testing using Pump Bottom Outlet Port gt gt Ensure battery RSP152 is installed in pump Pump will not operate without battery in place Plug the Power Adapter RSP159 or RSP164 into a wall outlet Insert the power adapter output into the pump adapter inlet located at the top of the pump Make sure calf garment RCG10 is deflated then wrap the calf garment snugly around a solid object and secure the hook tabs Attach the garment to a 6 tube and the other end of 6 tube to the end of the modified tube set Connect the modified tube set to the bottom outlet port of the pump Press the POWER button to turn on the pump and immediately press the MODE selection key to select SINGLE GARMENT During inflation verify a manometer reading of at least 35mmdHg It may take up to three 3 cycles to achieve this pressure while the garment inflates and fits its shape to the solid object Inflation will happen in multiple segments Verify the manometer reading falls below 20mmHg during deflation Press the POWER button to turn off the
10. MS 0c cccccccseeesseseeeseeeeeeeeeeseseveseeeueeaeeeuaeaveseeaueeaeenaeanenss 14 PUTTAR BI AE 14 OV D TE 14 FITC AL OY TT E 15 BADDATTER rnr tree rte rere err rre reper terete ere eer cere rere rer ee ere tere 15 TROUBLESHOOTING uo cccccecsceceeeeeeeeeeeeseeeseeeeeaeeeeeeveseeeueeaeeeaeeeueueveueeaueeaeeneeananss 16 GLEANING estes se 17 PREVENTIVE MAINTENANCE 00 0 0 cece eccceeceeeeeseseeeseeeeeeeeeeeeseeeseveueeeeeaeeeneeeneneeaeeany 18 HANDLING AND GSIORAGE cc cccccccccecsceceeeeeeueeeseseeeseeeueeaeeeaeeeueveeeueeaueeaaeeuaeaeenenaneeany 22 IN ese sr 22 SPECIFICATIONS 0 0 oc eccccccccccccecscecececeeueeeeeeueceeeseeeueeeceeeeeaueuaeaueeaueeueeuaeauaceeeueeaueeaeenaeanenss 23 EMC GUIDANCE AND DECLARATIONG rnrn rnrn rnrn rnrn rnnr nnan n nanana 24 27 INTRODUCTION This manual should be used for the initial set up of the Restep system and for reference purposes Clinical Indications for use The primary application of the Restep system is for the prevention of Deep Vein Thrombosis DVT due to the presence of risk factors for thrombus formation during orthopedic trauma neurology urologic critical care general medicine obstetrics and general surgery gt This system should be used when prescribed by a physician gt Garments should be removed regularly to inspect the skin gt Patients with diabetes or vascular disease require frequent skin assessment gt When appropriate patients should be instructed in
11. Reste j A e A NOTE Garments are purchased and supplied separately pest oi 43506 _ _ Calf Garments Thigh Garments up to 20 up to 26 Item Number RCG10 Item Number RTG30 Calf garments are supplied in pairs Thigh Garments are supplied in pairs Bariatric Calf Garments Foot Garments 20 26 universal size Item Number RBG60 Item Number RFG210 Bariatric Garments are supplied in pairs Foot garments are supplied in single units SYSTEM INSTALLATION Battery installation eme Unscrew the battery cover then Push the connectors firmly onto Fit the battery into the compartment connect the battery male connector the female connector to secure Make sure that nothing gets in the to the female connector inside the the battery wires within the way of the battery cover battery compartment Ensure the battery compartment correct orientation of the connector Slide the battery cover RSP167 or Secure the battery cover RSP167 or Attach the shoulder strap to the pump RSP163 close Make sure it snaps RSP163 with the screw if needed for ambulation firmly into position NOTE The pump will not operate without a battery in place Charging the battery Plug the adapter into a The adapter inlet is located Insert the adapter output wall AC outlet at the top of the pump into the adapter inlet Charging the battery continued NOTE e In a nominal battery charging may
12. SE any other power adapters with the Restep system Replacement Item Number RSP164 Using the bed bracket RSP163 eu 6er E K i 8 j The pump may be attached to a bed frame with the supplied embedded bed bracket Unfold the bed bracket arms and place the hooks over the bed footboard or another convenient place where it can be easily seen and heard Using the bed bracket RSP166 The pump may be attached to a bed frame with the bed bracket Insert the pump into the bed bracket Hang the black mounting arm of the bed bracket over the bed footboard or another convenient place where It can be easily seen and heard GARMENT USE Secure the pump at the foot of the bed or in place of use The pump connectors are located at the top left of the pump Attach the 6 ft or 10 5 ft tube set to the pump by pushing in the silver latch on the female pump connector and then inserting the male tube connector into the pump connector until a click is heard Calf Garments The calf garments may be used on either leg Unfold the garment s and position the inflatable center bladder directly behind the patient s calf The outlet tube on the garment should not be in direct contact with the patient s skin SNUGLY wrap the calf garment s around the patient s leg and secure the hook tabs onto the loop material Repeat for the other leg or store the unused garment and tube for later use Attach the garment s to the tube se
13. T allow excess cleaning solution on control panel of pump or inside accessories damage may occur Garments gt Garments are single patient use and should be collected for reprocessing after each patient use gt Stryker Sustainability Solutions provides a full reprocessing service for used garments PREVENTIVE MAINTENANCE General gt The Restep system should be inspected and tested by a qualified biomedical service technician annually as part of Preventive Maintenance to ensure proper operation of the pump and garment system Inspection and testing will verify that the buttons speaker lights compressors transducers and solenoids function properly Visually inspect power adapter for abrasions bent pins damaged cables and excessive wear Make sure the garment tubes are correctly connected and ensure they are not kinked broken or damaged Visually inspect battery for signs of damage vveve y Replace battery annually to ensure optimal performance of the pump NOTE 1 Battery Item Number RSP152 is available from Stryker Sustainability Solutions NOTE 2 DO NOT disassemble the pump housing as this will void the warranty If the pump is not operating prop erly contact your Stryker Sustainability Solutions representative NOTE 3 Restep Pump inspection and testing may take approximately 15 minutes to execute Materials Needed 1 x Calibrated Manometer Minimum Accuracy of at least 1 of full scale and Maximum Press
14. any source of such mixture leaking especially patient s airway or anesthesia machines Pump Back Label E N Medical Equipment Air Pump Input DC 9V 1 4A IPX0 No AP APG Adapter RSP159 RSP164 Battery NiMH 6V 1800 2200mAH Manufactured For Stryker Sustainability Solutions Tempe AZ Made in China Model RSP101 I MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH IEC EN UL CSA 60601 1 L i E http restep stryker com Tal RONLY TD10929 Rev E Se e UN 6 HAZARD INFORMATION All Stryker Sustainability Solutions manufactured products are intended as medical devices in medical environments Where a product meets IEC 60601 1 it is under the principle that 1 It is a more rigorous standard than other standards that could be adopted 2 It provides the most appropriate safety level for subjects and operators Meeting IEC 60601 1 Is in no way to be interpreted to mean that product safety is guaranteed in all circumstances of operation For example when any electrical device is used specific parts of the device are subject to voltage If safety warnings are not followed hazards to personnel and property may potentially result Personal injury and damage to property may also potentially occur The following safety rules should be followed 1 DO NOT roll beds stretchers or other equipment over the AC Adapter Power Supply cord 2 DO NOT
15. apter Power Supply is disconnected Battery Pack Is removed and replaced with a new Battery Pack Any attempt to power on the pump without executing the steps above will result in an audible double beep upon POWER button press The double beep indicates that the pump has been locked in a power down mode TROUBLESHOOTING Problems Solutions e Check if the battery charge is too low plug in the power adapter to charge the battery The Battery Charging light should flash e f the Battery Charging light does not flash ensure there is power to the socket you have used or try another socket e Press Power Switch and see if the pump works correctly If it does the system may be used If pump does not operate when power switch is pressed and an audible alarm is The pump present ensure a functional battery is properly installed doesn t work lf the pump only works while plugged into a power source replace the existing battery with a fully charged battery After charging turn the pump on and see if it works properly lf the pump does not work correctly after these initial troubleshooting steps remove pump from service and contact your Stryker Sustainability Solutions representative for immediate assistance It is not recommended for the user to open the enclosure and try to repair anything inside the pump Check if the garment connection tubes are properly connected to the pump and the tube set Allow the pump to operate for f
16. attempt to repair broken AC Adapter Power Supply casings or cords 3 DO NOT attempt to open or repair pumps Although the Restep DVT Pump System is designed to be a low voltage device hazard information review and good operational practice as described in this section should be applied SYSTEM COMPONENTS A complete system should contain the following components If any of the following items are missing or damaged please contact your Stryker Sustainability Solutions representative for immediate assistance Item Number PUMPKIT includes the following items d A P j RSP159 Pump Battery 12 Power Adapter Item Number RSP101 Item Number RSP152 Item Number RSP159 or RSP164 a N d N r of XM J Battery Cover Battery Cover Bed Bracket 6 Tube Set Item Number RSP167 Item Number RSP163 Item Number RSP154 KC D Carrying Strap Item Number RSP160 lt A Accessories E N Sat LV XS Bi Bed Bracket 10 5 Tube Set Extension 3 Prong Plug Extension Item Number RSP166 Item Number RSP161 Item Number RSP162 Garments All Restep DVT garments have a single center inflating bladder and adjustable straps with hook tab attachments The garment tube inlet to the garment should be rotated to the most comfortable position for the tube set depending on where the pump is placed d
17. before use Symbols used on this product are as below gt NOTES Type BF Indicates some tips or some information users should be aware of o Class Il equipment bg Caution amp Warning statements Ta Consult instructions for use gt CAUTION Q Single patient use only do not reuse Indicates correct operation or maintenance _ procedures to prevent damage to or destruction ga Manufacturer of the equipment or other property Part Number gt WARNING l Calls attention to a potential hazard that requires SN Serial Number correct procedures or practices in order to Rony CAUTION US Federal Law restricts this device prevent personal injury to sale by or on the order of a physician EMC Warning This product complies with the requirements of applicable EMC standards The use of accessories not specified by the manufacturer may result in increased emissions by or decreased immunity of the equipment affecting its performance There is a possibility of electromagnetic interference with other devices When there is suspicion of possible EMC interference to the pump it is recommended to shut down the electrical devices nearby one by one to locate the possible interference source Consult an expert if you are not sure how to solve the interference problem WARNING The equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Keep the pump and adapter at least one foot away from
18. c environment specified below The customer or the user of this device should assure that it is used in such an environment Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete discharge ESD 8 kV air 8 kV air or ceramic tile If floors are IEC 61000 4 2 covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that transient burst Supply lines Supply lines of a typical commercial or hospital environment IEC 61000 4 4 1 kV for input 1 kV for input output output lines lines Surge 1 kV line s to 1 kV line s to line s Mains power quality should be that IEC 61000 4 5 line s of a typical commercial or hospital 2 kV line s to earth environment 2 kV line s to earth Interruptions and lt 5 UT lt 5 UT Mains power quality should be voltage variations gt 95 dip in UT gt 95 dip in UT that of a typical commercial or on power supply for 0 5 cycle for 0 5 cycle hospital environment If the user input lines of the device requires continued 40 UT 40 UT operation during power mains IEC 61000 4 11 60 dip in UT 60 dip in UT interruptions it is recommended for 5 cycles for 5 cycles that this device be powered from an uninterruptible power supply or 70 UT 70 UT a battery 30 dip in UT
19. compression The FOOT GARMENT light will be lit constantly when selected Note Ensure the garments on the patient and the garment TYPE selection are the same Do not mix leg and foot garments on the same patient If desired a calf and thigh garment may be used simultaneously Garment MODE selection The two modes available are DUAL GARMENT mode and SINGLE GARMENT mode All garments can be used in either mode Press this key until the desired mode is illuminated by the mode indicator LED DUAL GARMENTS This is the default setting for the pump Each garment inflates for 12 seconds and then deflates for 48 seconds per cycle Inflation alternates between the two garments during each cycle One garment will inflate and then deflate and 30 seconds later the second garment will inflate and then deflate SINGLE GARMENT Press the MODE key once to select the SINGLE GARMENT mode Only one garment is used on the patient either extremity This garment inflates for 12 seconds and then deflates for 48 seconds per cycle Note It does not matter which extremity the garment Is placed on or which connector Is used The pump will detect this during its first inflation cycles and compensate accordingly Mute When an alarm occurs the pump will give the appropriate audible tone to inform the user of the alarm and light the appropriate ALARM light The user may silence the audible tone by pressing the MUTE key WARNINGS AND ALARMS HIGH PRESSURE This ala
20. d servicing Remove pump from service and contact your Stryker Sustainability Solutions representative DO NOT CONTINUE TO USE BAD BATTERY This alarm is presented when a battery does not complete charging while connected to the AC Adapter Power Supply after 48 hours The alarm is an indicator that the battery pack may have a fault or has reached its limit to properly maintain useful charge Remove pump from service and contact your Stryker Sustainability Solutions representative DO NOT CONTINUE TO USE The following actions will be initiated by the pump when this alarm is activated gt Ifthe alarm condition initiates while the pump is powered on and operating then the LOW BATTERY LED will begin flashing e The flashing LED cannot be disengaged by a MUTE button press e The pump will vent garments and power off e Once the pump is powered off the LED will continue to flash and the pump cannot be powered on again until AC Adapter Power Supply is disconnected Battery Pack is removed and replaced with a new Battery Pack Any attempt to power on the pump without executing the steps above will result in an audible double beep upon POWER button press indicating that the pump has been locked in a power down mode gt lf this alarm condition initiates while pump is not operating but being charged by the AC Adapter Power Supply then the LOW BATTERY LED will begin flashing e The pump cannot be powered on until AC Ad
21. directly on the surface of the pump DO NOT use a Hypocarbonate or phenol based cleaning solutions as these may cause damage to the enclosure Allow the solution to work for 10 minutes or in accordance with the time stated by the cleaning product used gt After the pump is thoroughly cleaned and dried switch the pump ON and test system function Unplug the pump and store It in an appropriate place Accessories gt Check for damage before cleaning gt DO NOT immerse or soak the accessories gt Clean with a soft cloth dampened with water and a mild disinfectant and or detergent Excess fluid should be avoided gt Spray cleaning solution on a piece of cloth and clean the accessory with a cloth Allow surface to thoroughly dry after cleaning DO NOT spray any cleaning solution directly on any accessory DO NOT use a Hypocarbonate or phenol based cleaning solution as these may cause damage DO NOT use a Ethanolamine based cleaning solution for the Bed Bracket RSP166 Allow the solution to work for 10 minutes or in accordance with the time stated by the cleaning product used gt After the accessory Is thoroughly cleaned and dried test function v v v 4 gt Store in appropriate place NOTE DO NOT IMMERSE PUMP OR ACCESSORIES IN WATER DO NOT USE a Hypocarbonate or phenol based cleaning solutions as those may cause damage DO NOT USE a Ethanolamine based cleaning solution for the Bed Bracket RSP166 A CAUTION DO NO
22. e less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol e NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electromagnetic interference by maintainin
23. g a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 VP d 1 2 VP d 2 3 VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTES The information presented in this brochure is intended to demonstrate a Stryker product Always refer to the package insert product label and or user instructions before using any Stryker product Products may not be available in all markets Product availability is subject to the regulatory or medical practices that govern individual markets Please contact your Stryker representative if you have questions about the availability of Stryker products in your area St
24. ion 10 to 35 C 50 F to 95 F Storage 15 to 50 C 5 F to 122 F Environment Requirements Humidity Operation 20 to 80 non condensing Storage 10 to 90 non condensing Safety Standards UL60601 C22 2 No 601 1 EN60601 1 IEC60601 1 Garments are made from laminated Polyester Polyurethane Garments are Latex free Garments bladders are PVC free Garments are Single Patient Use only EMC GUIDANCE AND DECLARATIONS The following EMC Guidance and Declarations refer to the Restep DVT system Guidance and manufacturer s declaration electromagnetic emissions This device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment RF emissions Group 1 This device uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B This device is suitable for use in all CISPR 11 establishments including domestic establishments and those directly connected to Harmonie emiccione Class A the public low voltage power supply network that EC 61000 3 2 Supplies buildings used for domestic purposes Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Guidance and manutachurere declaration electromagnetic immunity This device is intended for use in the electromagneti
25. ive 5 cycles after switching the pump on Re arrange the tubes if they are kinked Check that the garments are wrapped snugly around the extremity If not reapply the garments Verify correct garment type and garment mode has been selected for the garment used on the patient HIGH LOW Pressure Alarm Ensure there are no splits or tears in the garments If present replace the garments Replace the garments with new garments if alarm persists Switch pump on and allow pump to operate for five 5 cycles If alarm persists remove from service The initial alarm will continue until manually muted reset The alarm will not activate until another alarm event occurs lf the pump does not work correctly after these initial troubleshooting steps remove pump from service and contact your Stryker Sustainability Solutions representative for immediate assistance CLEANING This section describes the procedures to clean the Restep system after patient use Cleaning should be In accordance with existing hospital guidelines Pump gt Check for external damage before cleaning gt DO NOT immerse or soak the pump gt Clean with a soft cloth dampened with water and a mild disinfectant and or detergent Excess fluid should be avoided gt Spray cleaning solution on a piece of cloth and clean the faceplate and the pump with the cloth Allow surface to thoroughly dry after cleaning gt DO NOT spray any cleaning solution
26. nd foot garments on the same patient at the same time Snugly wrap the garment s around the patient s foot and secure the hook tabs Wrap the ankle straps around the back of the ankle and on top of the foot Repeat for the other foot or store the unused garment and tube for later use Attach the garment s to the tube set by pushing in the silver latch on the female tube connector and inserting the male garment connector firmly into the tube connector until a click is heard NOTE e Foot garments should be removed prior to patient ambulation or transportation e See online IFU for full details http restep stryker com SYSTEM CONTROLS Front control panel The functions of the Restep system pump are described below 1 SEET Reep 6 1 Power Switch Se Deg 2 Alarm Graphic 3 Garment Type Selection Key 2 N eege 4 Mode Selection Key ALARM 5 Mute Key 3 Pi i mg S 6 Battery Status Indication 7 Alarm Indication HIGH LOW Pressure 4 gy mon aet 8 Garment Type Indication S 9 Mode Indication 9 amp EE 10 10 Alarm Mute Indication stryker Sustainability Solutions 1 Power Switch Press the Power Switch to turn the power ON OFF and to start stop the pump 2 Alarm Graphic This is NOT a key This graphic highlights the function of the HIGH LOW pressure alarm indicators 3 Garment Type Selection Key TYPE selection key is inactivated after 60 seconds of initially powering on the pump Press
27. pump Allow the pump to completely shut off Disconnect calf garment from 6 tube Make sure foot garment RFG210 is deflated then wrap the foot garment snugly around a solid object and secure the hook tabs Attach the garment to a 6 tube which is attached to the end of the modified tube set Connect the modified tube set to the bottom outlet port of the pump Press the POWER button to turn on the pump and immediately press the TYPE selection key to select FOOT GARMENTS Then press the MODE selection key to select SINGLE GARMENT During inflation verify a manometer reading of at least 7ommdHg It may take up to three 3 cycles to achieve this pressure while the garment inflates and fits its shape to the solid object Inflation will happen in multiple segments Verify the manometer reading falls below 20mmHg during deflation Press the POWER button to turn off the pump Allow for the pump to completely shutoff HANDLING AND STORAGE Environmental Operating Conditions Temperature range 50 F to 95 F 10 C to 35 C Relative humidity 20 to 80 non condensing Atmospheric pressure 00hPa to 1060 hPa Environmental Storage and Shipping Conditions Temperature range 5 F to 122 F 15 C to 50 C Relative humidity 10 to 90 non condensing Atmospheric pressure 500 hPa to 1060 hPa NOTE e f the pump has been stored in a cold place it is recommended that the pump be allowed to reach normal operating temperature
28. rm may sound if a blockage exists between the pump and garment connections gt Check connectors between the garments and pump If there is a disconnection reconnect it gt Ensure that the tube set is not kinked bent and or blocked If present reposition the tubes to clear the blockage gt Ensure the garment is wrapped snugly around the extremity as required If not refit the garment gt Ifthe alarm continues there may be an internal pump fault indicating the pump may need servicing Remove pump from service and contact your Stryker Sustainability Solutions representative DO NOT CONTINUE TO USE LOW PRESSURE This alarm may sound when a garment is new and is first applied to the patient Allow the system to stabilize the pressure within the garment for five 5 cycles and check that the alarm has ceased lf the alarm persists check for air leakage between the pump and the garment connections lf the alarm persists gt Ensure that garments are fully connected to the pump garment ports e Check for air leakage between the pump and the garment connections e f there is a disconnection reconnect tt e f air hose presents a leak replace the hose gt Ensure there are no splits or tears in the garments Ensure correct garment type and garment mode has been selected gt Ensure the garment is wrapped snugly around the extremity as required If not refit the garment as required lf the alarm continues change garments lf
29. ryker Corporation or its divisions or other corporate affiliated entities own use or have applied for the following trademarks or service marks Restep All other trademarks are trademarks of their respective owners or holders Restep Restep af MANUFACTURED FOR stryker Sustainability Solutions 1810 West Drake Drive Tempe Arizona 85283 888 888 3433 restep stryker com RM801005H Printed in the USA
30. stryker Sustainability Solutions Deep Vein Thrombosis DVT System User Manual TABLE OF CONTENTS INTRODUCTION i ee diaadina saina diadi dira didadiaadi ai dinadisedia daanin 2 Ginie ande anon Tor E 2 Conine te EEN 2 ELLS eege 3 EI EE 3 le 3 Notes Cautions and Warning SEHR sccccecccce cece eceeeececeenccevccoueueesesuccexcvevsceueseuseseceexexeuecters 4 EMC Warning sssesssessnserrnnsrrnerrnnnrrnnnrrnnnnnnnnrunanutnnntna nten n nunan u nannu Nan K ER ANEEAAEERANEEREEEEA KEER AEEEA EEEE E EEn 4 azard MOn E e a EEEE E EEE EEE EE EE E EEE E EA EE E AET 4 SYSTEM COMPONENTS innnan annann aranna nnen ennen 5 Pump Kit Accessories ccceccecccecceeeeeceeceseneeeeeeeeeeeeeeeeeeeeeeaeeaeeueeeaeeeeeaeeneueeeeeeeaeeueeneneeeeaeeaennennass 5 C EEN 6 SYSTEM INSTALLATION WEEN 7 selar a AE O E H R I ee isesusacvenitosiaeasseaisboianasseniibaianaiseaiiaianasonitoasnnosonismasunnisoniieasennisen tesserae 7 SIS NG BCCI AC E 8 GARMENT USE ee 9 KEREN 9 Balance Gall Gal E 10 d EE 10 Foot Garments ccccccccceccsecececececeeeeeeeeeeueceeeceeeueeaeeeueeeueceeeceeaueeaueeuacaeeceeaueeaueeueeaueueeaneeaneeneeens 11 SYSTEM CONTROLS eet 11 Beigl dei BET 11 12 PUMP COPE ee 13 SWVIEC e OUTIL OF ANG ee 13 Garment YPE Selec del Senne eeee ee enrol ere ee eee ne ee ee ee ee 13 Garment MODE selection ssssssessessessssnssrssrsernnrnnnnnnrrnnnnninnin nktan antann annen AERA EEEEEEEREE EAER A AEAEE EEEn 14 ee 14 WARNINGS AND ALAR
31. t Attach the male to male connector to outlet ports of the pump gt Press the POWER button to turn on the pump and immediately press the MODE selection key to select SINGLE GARMENT and the Garment TYPE selection key to select FOOT GARMENTS The FOOT GARMENTS light green and SINGLE GARMENT light green should illuminate gt Within approximately 60 seconds the HIGH PRESSURE light red should illuminate with a constant audible alarm gt Turn off the pump by pressing the POWER button Allow pump to completely shut off Compressor Transducer and Solenoid Verification Testing gt A manometer and a modified tube set are required to verify that the compressors transducers and solenoids are functioning properly gt To create a modified tube set the following materials are necessary one 6 Tube Set RSP154 and one 1 8 plastic barbed tee connector NOTE The Plastic Barbed Tee Connector can be purchased at a local hardware store or online The modified tube set can be made as shown below Cut tube 3 from male connector end Cut 3 piece of tubing Cut tube 3 from female connector end Gather all components as illustrated Modified tube set is made by Attach garment 6 tube modified tube connecting the three pieces together set manometer and pump using plastic barbed tee connector Testing using Pump Top Outlet Port gt gt Ensure battery RSP152 is installed in pump Pump will no
32. t by pushing in the silver latch on the female tube connector and inserting the male garment connector firmly into the tube connector until a click is heard NOTE Ensure the pump is held firmly onto the bed frame while used in bed During ambulation or transportation ensure that the pump is secured Rotate the outlet tube on the garment to eliminate kinks in the tubing Tubing may become a trip hazard during ambulation if the shoulder strap is not used to secure excess tubing Bariatric Calf Garments The bariatric calf garments are specially shaped to conform better to the bariatric patient s lower legs The bariatric calf garments may be used on either leg Unfold the garment s and position the inflatable center bladder directly behind the patient s calf The outlet tube on the garment should not be in direct contact with the patient s skin SNUGLY wrap the bariatric calf garment s around the patient s leg and secure the hook tabs onto the loop material Repeat for the other leg or store the unused garment and tube for later use Attach the garment s to the tube set by pushing in the silver latch on the female tube connector and inserting the male garment connector firmly into the tube connector until a click is heard NOTE Ensure the pump is held firmly onto the bed frame while used in bed During ambulation or transportation ensure that the pump is secured Rotate the outlet tube on the garment to eliminate kinks in the
33. t operate without battery in place Plug the Power Adapter RSP159 or RSP164 into a wall outlet Insert the power adapter output into the pump adapter inlet located at the top of the pump Make sure calf garment RCG10 is deflated then wrap the calf garment snugly around a solid object and secure the hook tabs Attach the garment to a 6 tube and the other end of 6 tube to the end of the modified tube set Connect the modified tube set to the top outlet port of the pump Press the POWER button to turn on the pump and immediately press the MODE selection key to select SINGLE GARMENT During inflation verify a manometer reading of at least 35mmHg It may take up to three 3 cycles to achieve this pressure while the garment inflates and fits its shape to the solid object Inflation will happen in multiple segments Verify the manometer reading falls below 20mmHg during deflation Press the POWER button to turn off the pump Allow the pump to completely shut off Disconnect calf garment from 6 tube Make sure foot garment RFG210 is deflated then wrap the foot garment snugly around a solid object and secure the hook tabs Attach the garment to a 6 tube which is attached to the end of the modified tube set Connect the modified tube set to the top outlet port of the pump Press the POWER button to turn on the pump and immediately press the TYPE selection key to select FOOT GARMENTS Then press the MODE selection key to select SINGLE GAR
34. the proper use of the system and any problems should be reported to the nursing staff gt The garments should be applied to the patient prior to the induction of anesthesia gt Ifthe garment cannot be applied to the operative limb during surgery it may be applied to the limb once the patient reaches the recovery room For a non surgical patient the system Should be applied as soon as the risk of DVT is identified gt The system should be used continuously until the person is fully ambulatory The therapy can continue with leg garments for people with limited mobility Contraindications The Restep system should NOT be used in the following conditions gt gt Severe arteriosclerosis or active infection Suspected or known acute DVT Severe congestive heart failure or any condition where increased fluid to the heart may be detrimental Existing pulmonary edema Local skin or tissue conditions in which the garments would interfere lf in doubt refer to the patient s physician before using device A CAUTION US Federal law restricts this device to sale by or on the order of a physician Precautions gt gt Do not drop the power adapter or pump as It may result in damage to the components potentially affecting functional performance Remove pump and Bed Bracket RSP166 if applicable from the footboard or bedrail prior to moving the bed to prevent impact damage during transportation gt Do not lean on
35. ure at least 200mmHg 2 x 6 Tube Set RSP154 1 x Calf Garments RCG10 1 x Foot Garments RFG210 1 x 1 8 Plastic Barbed Tee Connector Light Button and Speaker Verification Testing gt Ensure battery RSP152 is installed in pump Pump will not operate without battery in place gt Plug the Power Adapter RSP159 or RSP164 into a wall outlet Insert the power adapter output into the pump adapter inlet located at the top of the pump gt Without connecting garments turn on the pump by pressing the POWER button The BATTERY CHARGE light green and the LEG GARMENTS light green should illuminate within 5 seconds Within approximately 60 seconds the LOW PRESSURE light yellow should illuminate with a constant audible alarm emitting from the speaker gt Press the MUTE key and the MUTE light yellow should illuminate and silence the audible alarm Turn off the pump by pressing the POWER button Allow pump to completely shut off gt A male to male connector is necessary to test the HIGH PRESSURE light To assemble the male to male connector one 6 Tube Set RSP154 is necessary The male to male connector can be made as shown below M Locate a 6 Tube Set RSP154 Cut tube 6 from male end Remove male connector from the other 6 Tube in set a lt a Gather male connector and 6 tubing Insert male connector into 6 tubing Attach male to male connector to outlet ports of pump g
36. use The default setting is LEG garment mode Press this key to select FOOT garments 9 Mode Indication The SINGLE GARMENT light is lit when selected for any single garment including the foot garment 10 Mute Indication The MUTE light yellow is lit when the MUTE mode is enabled This function will disable after 3 minutes of activation to allow the user to hear future audible alarms PUMP OPERATION Switching the pump on and off Light Indicators while pump Is off gt No light pump off and not connected to power gt BATTERY CHARGE light flashing green battery charging gt BATTERY CHARGE light solid green battery charged To start pump operation press the POWER button once and wait The pump will undergo a software auto check for a few seconds During this time the LEG GARMENT light may flash After the auto check is completed the LEG GARMENT light will be lit constantly NOTE When the POWER button is pressed Restep pumps using Software PSoC Version 2 3 will also produce an audible beep and the BATTERY CHARGE and LOW BATTERY lights will flash simultaneously A label indicating Software PSoC Version 2 3 can be found on the back of the pump if applicable Please be patient and do not press the POWER button again or you may turn the pump off The pump will now begin its normal operation cycle Allow the pump to run for several cycles to allow the garments to inflate and fit their shape to the patient s extremity During
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