User Manual - MD Resource
Contents
1. Ifany cord or cable is frayed or damaged replace it immediately with another of the same type and rating as supplied by M D Resource Corp To clean the exterior of the K Pump follow the UL 60601 1 standard for use in a hospital environment See Cleaning the K Pump for more information K Pump Instructions For Use Warnings amp Symbols Warnings The information in the following table describes warnings that should be adhered to when operating the K Pump Description THIS SYMBOL INDICATES THE USE OF AUTHORIZED PRESCRIPTION DRUGS ONLY USE PROPER HOSPITAL GRADE POWER CORD ONLY a8 DANGER RISK OF EXPLOSION DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS A WARNING RISK OF ELECTRIC SHOCK DO NOT OPEN CASE REFER TO PROPER AUTHORIZED PERSONNEL FOR SERVICING SS ia a CREON Federal Law U S A restricts this device to sale by or on the order of a physician K Pump Instructions For Use ee eS Chapter 1 Getting Started This chapter contains information about properly unpacking and setting up your K Pump Unpacking the K Pump When the K Pump arrives check the shipping box for any apparent damages i e holes in the box or a crushed top Open the box and inspect each product Notes Inspect the K Pump for physical damage while unpacking Contact M D Resource Corp immediately if any physical damage is observed a Ifthe K Pump is for evaluation keep the shipping box These are needed to2. Custom Pls call for sizes pions Power Supply 115 003 a Rea cement Parts For Replacement Parts please contact M D Resource Corp to service or repair these parts Do not attempt to service or repair these items Refer to Page 7 Support amp Warranty to follow instructions on how to return the unit to M D Resource Corp a Warning Risk of Electric Shock Do not open case Appendix C EMC amp Other Interference Guidance and Manufacturer s Declaration Electromagnetic Emissions The K Pump is intended for use in the electromagnetic environment specified below The customer or the user of the K Pump should assure that it is used in such an environment The K Pump uses RF energy only for internal function Therefore RF emissions are very low and Group 1 f f are not likely to cause any interference in nearby electronic eguipment Guidance and Manufacturer s Declaration Electromagnetic Immunity The K Pump is intended for use in the electromagnetic environment specified below The customer or the user of the K Pump should assure that it is used in such an environment Use of accessories transducers power cords and cables other than those sold by Medical Device Resource Company may result in system failure increased EMC emissions and or decreased EMC immunity of the K Pump If used RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions K Pumps are suitable for use in all establishmen
3. To minimize trip hazard our recommended maximum length is three meters Use of accessories transducers and cables other than those sold by Medical Device Resource Company may result in system failure increased EMC emissions and or decreased EMC immunity of the K Pump Electromagnetic Interference This pump should not be used adjacent to or stacked on other equipment except as shown in the LS2 Aspirator pump user guide If it is used in a stacked configuration care should be taken to observe normal operation of system components Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put in service according to instructions and the EMC information included in Appendix C Portable and mobile radio frequency communication devices e g cell phones can affect medical equipment K Pump Instructions For Use Safety Information Safety Guidelines The K Pump is designed to ensure both the highest level of product quality and safety for the user To maintain both quality and safety follow the guidelines and instructions in this document a Use the K Pump only as intended a Refer all servicing and repairs to M D Resource Corp qualified personnel to maintain your warranty Any repairs or servicing performed by the customer voids the warranty a Store the K Pump within 10 32 degrees Celsius 50 90 degrees Fahrenheit Avoid prolonged exposure to direct sunlight
4. Pedal is depressed Contact M D Resource Wrong tubing in pumphead Corp to obtain proper tubing for the unit PUD BOSD eH ane Power Adapter not plugged into unit Appendix A Technical Specifications Electrical Specification Tn putin e as haat tated facts 100 240 VAC 1 6A MAX 50 60 Hz non user selectable Outpt s2h4 a wees eee 24V 2 1A Output Power 0605 50W MAX Speed Control 00 0000 1 Min to 10 Max 10 600 ml min Mechanical Specification Flow Rater rran onnee ea 10 600 ml min depending upon tubing selection and flow setting Panel Indicators Green LED Power On Safety Shock Protection 0 Class I Salt yin cs cechalercneansatedmesnadcneeseess Over speed protector manual safety cut off switch Environmental Conditions Operating Temperature 0 to 40 Celsius Operating Humidity 10 to 90 non condensing Storage Requirements Storage Temperature 10 to 32 Celsius Weight Limits amp Maximum Dimensions Dimensions iiaeeeaeo 6 1 2 L 9 1 2 W 7 1 2 H max Weisht 033s ht eae Approximately 5 0 Ibs without accessories Appendix B Parts amp Accessories Parts amp Accessories Part Number Sue Disposable 3 8 OD AutoFuse AFTD Tubing Optional Accessories Disposable 3 8 OD AutoFuse Tubing with Y bifurcation AF TDY
5. amp Warranty Information This chapter provides information regarding obtaining support if necessary from M D Resource Corp Support Warranty Should your K pump require repair contact M D Resource Corp to obtain an RMA Return Merchandise Authorization to return the unit to M D Resource Corp for servicing to maintain the product s warranty Any unit received without an RMA will be returned at the owner s expense See the warranty for more information or contact M D Resource Corp for questions related to service and or warranty coverage Medical Device Resource Corporation 5981 Graham Court Livermore Ca 94550 800 633 8423 Toll Free 510 732 9950 Customer Support 510 785 8182 Fax http www mdresource com 1 year limited warranty Chapter 7 Troubleshooting This chapter contains information about troubleshooting your K pump The following table describes some of the most common troubleshooting options for the K pump Possible Cause Possible Solution Tum Power Switch ON Power Adapter not plugged Plug Power Adapter into into wall outlet outlet Plug Power Adapter into Power Inlet Depress Foot Pedal Foot pedal cable not Foot Pedal s do not connected the Bulkhead Connectors activate the pump Foot pedal broken or torn Power Switch not ON Turn Power Switch ON Increase the speed by Fluid flow is too low turning the control knob Pump starts when Foot clock wise
6. 5 seconds 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur 95 dip in Ur for 5 seconds user of the Kpump requires continued operation during power mains interruptions it is recommended that the Kpump be powered from an uninterruptible power supply UPS Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Not applicable Kpumps are not Life Supporting Kpumps not affected by EMI in range from 150 kHz to 80 MHz or 80 MHz to 2 8 GHz Note Ur is the a c mains voltage prior to application of the test level Guidance and Manufacturer s Declaration Electromagnetic Immunity The K Pump is intended for use in the electromagnetic environment specified below The customer r the user of the K Pup should ensure that it is used in such an environment Electromagnetic IEC 60601 Test environment Immunity Test Level Compliance level guidance Portable and mobile RF communications equipment should be used no closer to any part of the K Pump and K Pump cabling than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance 0 MHz to lt 80 MHz 80 MHz to lt 800 MHz 800 MHz to 2 5 GHz Conducted RF 3 Vrms Where P is IEC61000 4 6 150 kHz to 80 MHz maximum output power rating of the transmitter Radiated RF 3
7. Table of Contents Disclaimer amp Contact Information soe oee noenee nennen LE Overview amp Intended UET aeia a a aee HH Safety Information a oeoo oee neeaae Warnings amp SVIMDOUS eniin aa Chapter 1 Getting Started erri ish Sen E E R RTR Chapter 2 Identifying the K Pump o oo ses noe ase neones Ponta Gk eseese see see sesser K Pump features onkeen E E E Ceara a Ea ACCESSOFIES TEQUITED ni sew ive Vicacied ace bo vin dcs Sen E EAEE detest Chapter 3 Connecting ACCESIOTIOS s s oossoo nesses sss oee sss oee see tes eresse see ee Chapter 4 Activating Deactivating the K PUMP 1 0 60 ee cev tee tee cee cee ees Chapter 5 Cleaning the K Pump wise ooo oeeoee noenee essnee nres RIANA Whe ideis ded K Pump Instructions For Use Chapter 6 Chapter 7 Appendix A Appendix B Appendix C Disclaimer Support amp Warranty Information s ses ccc cee cence cee cee cee cents Troubleshooting s set cee Nae dak esenee sesoses tss see isis aay ess reseso Technical specification o ses noe ans aae nes oeeo see sss oes ees see see eee Parts amp Accessorieslisting each Sio ets ase aes aes ore sesser ses ees eer EMC amp Other Interference n n nnsa ave aee sas nse oes es nas ans ove 10 LI 12 14 Medical Device Resource Corporation provides the following cautions to the reader of this manual a M D Resource Corp may change all or part of this manual w
8. V m in watt W according to IEC 61000 4 3 80 MHz to 2 5 GHz the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less that the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured field strength in the location in which the K Pump is used exceeds the applicable RF compliance level above the K Pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the pump Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m Recommended separation distances between portable and mobile RF communications equipment and the K Pump The K Pump is intended for use in an electr
9. enuine MD Resource parts Chapter 4 Activating the K Pump This chapter contains information about activating and deactivating your K Pump Activation 1 Turn the main Power Switch ON 2 Locate the Control Knob and rotate the speed to 3 setting 3 Depress the Foot Pedal to activate the K Pump The Foot Pedal controls the peristaltic pump when the main power switch is ON Note One or both pneumatic footswitches can be used to turn the pump on and off The footswitches may be operated in any sequence to activate or deactivate the pumping action Deactivation 1 Depress the Foot Pedal to deactivate the K Pump 2 Turn the main Power Switch OFF Chapter 5 Cleaning the K Pump This chapter provides information regarding the proper cleaning of your K Pump Cleaning the External Case 1 When cleaning your K Pump turn off the main Power Switch and then disconnect from the power source 2 Wipe down all external surface area with a cloth For dirt stains and or dried substances Remove by using any ammoniated cleaner Notes Use a short stiff bristled brush if the substances become ingrained in the case a For tough stains Remove with a solvent based cleaner a For minor scratches Remove by using white polishing compounds Notes Avoid spraying liquid in connection portals a8 Warning Risk of Explosion Do not use in the presence of flammable anesthetics Chapter 6 Support
10. ithout notice All rights are reserved Reproduction or duplication of all or part of this manual in any form is prohibited without the explicit written permission of M D Resource Corp a M D Resource Corp assumes no responsibility for damage or injury from use of the K Pump User s Guide not in accordance with the instructions provided in this manual Contact Information O v OVV Company Location Customer Support Orders Tech Support Fax Web Address Medical Device Resource Corporation 5981 Graham Court Livermore Ca 94550 800 633 8423 510 732 9950 510 785 8182 http www mdresource com K Pump Instructions For Use Overview amp Intended Use Document Overview This K Pump User s Guide provides information about using the K Pump infiltrator set up performing cleaning troubleshooting and obtaining support Product s Intended Use The K Pump is designed to infiltrate tumescent fluid into a patient during cosmetic or plastic surgery practices Electronic Accessories and Equipment Following is a list of approved electrical accessories for the K Pump Power Supply Power supply must be IEC 60601 1 1998 compliant 0 medical grade Input 100 240V 1 6a Max 50 60Hz Output 24V 2 1a 50W Max y Power Cord Any six foot hospital grade power cord Optionally if using with MD Resource LS system any one meter universal jumper cord v Air Switch Only use air switches supplied by MD Resource
11. ng to the IV Bag 8 Lastly insert the other end of the tubing to the Cannula a In the event of fluid dripping from the needle after the pump has been stopped we suggest Use a stopcock connector or trumpet valve type infiltration handle with infiltration needle attached Simply bend and kink the tubing when you do not want any flow Secure the pinch valve included on the tube set near the IV bag Connecting Optional Devices To LS2 Liposuction Aspirator 1 Perform Connecting Standard Accessories Steps to 3 Page 4 but instead of inserting one end of the Power Cord to the wall insert it into the LS2 socket 2 Obtain the LS2 Hospital Grade Universal Power Cord and insert one end to the LS2 and the other end to the wall Notes Refer to your LS2 User amp Technical Manual for further instructions on how to set up your aspirator To Tumescent Measuring Device TMD Perform Connecting Standard Accessories Steps 1 to 3 Page 4 2 Obtain the Conductor Cable and insert one end into the TMD and the other end into one of the Power Inlets of the K Pump Notes Refer to your TMD User Manual for further instruction on how to set up your tumescent measuring device a_ For safety only use specified parts supplied by M D Resource Corp Refer to Page 9 for Technical Specifications and Page 10 for Parts amp Accessories The K Pump uses a power adaptor to isolate itself from the mains For safe operation only use g
12. omagnetic environment in which radiated RF disturbances are controlled The customer r user of the K Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the K Pump as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter Meters output power of transmitter Watts 150 kHz to lt 80 MHz 80MHz to lt 800 MHz 800 MHz to 2 5 GHz a i I ac 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 rting of the transmitter in watts W according to the transmitter manufacturer ae ae a a ae 3 3 12 12 37 37 Ag 1 17 70 70 11 7 11 7 Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from structures objects and people
13. ories Devices This chapter contains information about properly routing accessories on your K Pump Connecting Standard Accessories 1 Position the posterior side of the K Pump in front of you 2 Obtain the Power Adapter and insert one end into any one of the Power Inlets See Figure 1 Page 2 Power Inlet Note The second Power Inlet is used for the optional Tumescent Measuring Device if purchased 3 Attach the Hospital Grade Power Cord to the Transformer and the other end to the wall 4 Lastly take the Foot Pedal and insert the tubing end into the Bulkhead Connectors See Figure 1 Page 2 Bulkhead Connector a For safety only use the specified parts supplied by M D Resource Corp Refer to Page 9 for Technical Specifications and Page 10 for Parts amp Accessories Connecting Optional Accessories Tubing to K Pump IV Bag and Cannula l Position the anterior side of the K Pump in front of you 2 Shift the Pumphead lever to the left This will enable the channel of the Pumphead to open and unlock 3 Obtain the sterile AutoFuse Tubing and locate its flexible portion Note This portion will be inserted into the channel of the pumphead 4 Starting from left to right carefully insert the tubing through the channel 5 Now shift the Lever to the right to close and lock the tubing in place Adjust the Clips accordingly located on the pumphead to stabilize the tubing Next insert the spiked end of the tubi
14. return the unit Removing the Product from the Shipping Box Remove the Styrofoam placed on top of the box Remove and set aside the K Pump User s Guide Do not discard Remove the accessories placed inside of the box Remove the K Pump and plastic protective cover from the product K Pump Instructions For Use Chapter 2 Identifying the K Pump This chapter contains information about identifying K Pump features and the accessories required to configure your device for use K Pump Features The following two illustrations Figure 1 were designed to help you to become familiar with the standard features of your K Pump ANTERIOR POSTERIOR Figure 1 K Pump unit anterior amp posterior position Accessories Required a Standard Accessories Supplied K Pump Instruction for Use Hospital Grade Power Cord Foot Pedal Power Adapter a Optional Accessories Supplied Disposable AutoFuse 3 8 OD Tubing Sterile Disposable AutoFuse Tubing with Y bifurcation Sterile Cannulae Custom made Please call for size shape tip and handles qa Optional Device s Used in Conjunction Tumescent Measuring Device LS2 Liposuction Aspirator To place an order for the accessories or the devices listed above contact M D Resource Corp at 510 732 9950 or call toll free 800 633 8423 Refer to Appendix B for further listings of parts amp accessories Chapter 3 Connecting Access
15. ts including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes TEC 61000 3 2 Voltage Fluctuations flicker emissions TEC 61000 3 3 adjacent to or stacked with other equipment all such equipment should be closely monitored to ensure normal operation IEC 60601 Electromagnetic Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrostatic Discharge ESD 6 kV contact 6 kV contact IEC61000 4 2 8 kV air Electrical fast transient burst 2 kV for power supply lines 2 kV for power supply lines IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines Surge 1 kV differential mode 1 kV differential mode IEC 61000 4 5 2 kV common mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for lt 5 Ur gt 95 dip in Ur for 0 5 cycle 0 5 cycle 8 kV air Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur 95 dip in Ur for
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