User`s Manual BluFlex DVT Prophylaxis System
Contents
1. It is recommended that the following guidelines be used whenever the system is being stored or transported to another location V Temperature limitations 5 C 60 C v Relative humidity 30 75 Control Unit 1 Check power cord and plug for abrasions and excessive wear 1 INSTRUCTIONS FOR USE p Control SMI 420 435 Rev B STER IL 2 Plug in the unit and verify airflow from the hose connection ports Gu 3 Place in a dry storage area when not in use Product Description The BluFlex DVT Prophylaxis System is a non invasive intermittent pneumatic compression system that aids in prevention and reduction in incidence of deep vein thrombosis DVT a potentially life threatening condition which can lead to pulmonary embolism The system consists of a pump and soft pliable compression single patient use garments for leg or foot compression The pump supplies compression on a pre set inflation pressure of 40mmHg for calf and thigh compression and 80mmHg for foot compression Pressure in the garments is transferred to the extremities augmenting venous blood flow thus reducing stasis This process also stimulates fibrinolysis further reducing the risk of early clot formation Please note It is NOT RECOMMENDED that patients with following symptoms use this product without consulting a physician Caution Contraindications for use The use of the BluFlex DVT Prophylaxis System is NOT RECOMMENDED in the following co2. THIGH GARMENTS for approximately 3seconds until LEG is displayed If the pump is in operation on Dual Garments Therapy and you want to change to Single Garment Therapy disconnect one of the hoses from the pump and press SINGLE GARMENT The pump will start initialization process for 10 seconds and the Single Garment Therapy will begin If the pump is in operation on Single Garment Therapy and you want to change to Dual Garment Therapy attach the second hose and garment and press SINGLE GARMENT The pump will directly start the Dual Garment Therapy INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL 13 TIMER To activate the TIMER switch the pump and timing will commence The TIMER reflects HOURS of compression If compression is interrupted i e the patient is removed from therapy and the pump is switched off at the power switch the timer will suspend timing until the patient is reconnected to therapy and therapy is continued 14 RESETTING TIMER to reset the timer press RESET TIMER for 5 seconds and it will reset Always reset timer prior to new therapy to ensure correct time is measured 15 Disconnect Device Switch the device off disconnect from power supply and remove garments from the patient Note Ensure that there are no kinks in the tubing and the connectors are properly locked Never apply or remove the garments while inflated as this may damage to the garments The parts and o
3. electrical supply to the pump and disconnect the power cord from the main supply before cleaning and inspection Caution v Do not use phenol based cleaning solutions v Switch off the electrical supply to the pump and disconnect the power cord from the main supply before cleaning and inspection Garment Cleaning After patient use save garments for reprocessing and place in designated collection containers Periodic Maintenance WARNING Make sure the unit has been removed from the mains power supply by removing the mains power supply from the socket CAUTION Static Sensitive Devices Electrostatic discharge can seriously damage the control and power supply PCB assemblies No daily maintenance is required Aside from routine cleaning and disinfecting routine checks and optional annual preventative maintenance only authorized technical personnel should service equipment If the tamper proof seal on the bottom of the pump is compromised customer will be charged a user damage fee 1 Routine Checks a Inspect the control unit for external damage to case controls and connections b Inspect power cord for damage c Test all controls INSTRUCTIONS FOR USE gt Control SMI 420 435 Rev B STERIL lt 2 Annual Preventive Maintenance Preventive maintenance can be carried out every 12 months Check a Case is free from debris b Electrical connections are secure and completely insulated c Tubes are completely
4. in nearby electronic equipment RF emissions Class B The BluFlex DVT Prophylaxis System is suitable CISPR 11 for use in all establishments including domestic establishments and those directly Harmonic emissions Class A connected to the public low voltage power EN 61000 3 2 supply network that supplies buildings used for domestic purposes Voltage fluctuations Complies flicker emissions EN 61000 3 3 12 INSTRUCTIONS FOR USE gt Control SMI 420 435 Rev B Article Il STERIL lt Guidance and manufacturer s declaration electromagnetic immunity The BluFlex DVT Prophylaxis System is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment Immunity test EN 60601 Compliance level Electromagnetic environment test level guidance Electrostatic ESD EN 61000 4 2 Electrical fast transient burst EN 61000 4 4 Surge EN 61000 4 5 interruptions and voltage variations on power supply input lines EN 61000 4 11 Power frequency 50 60 Hz magnetic field EN 61000 4 8 discharge 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 UT gt 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 lt 5 UT gt 95 dip
5. pushed on and are free from kinks d Wiring is intact e Air is alternating f Outlet tubes and snap lock connectors are secured and fitted correctly Qualitative Check Qualitative Tasks ma o eessen 2 Vem L 2 p me j aa x AC Plug Receptacles Iban aa Quantitative Check a Pressure for Foot is 75 100mmHg 120V 60Hz Pressure for Calf Thigh is 35 55mmHg 120V _ 60Hz Can alternate One Garment or Two Garments 12 sec inflation 48 sec Deflation restA__B_ Possible air leak from tubing connection or compressor oad T pump displays the high pressure alarm code Possible kinked tubing Possible incorrect 2 7 The pump displays garment error code GE garment configuration INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL lt Pressure Settings and Testing Pre set inflation pressure settings are as follows Calf and Thigh 40 mmHg nominal Foot 80 mmHg nominal If needed pressure verification testing can be done as follows Setup equipment as shown below making sure there are no kinks in the tubing Use mercury pressure gauge Garments have to be wrapped on objects which have Leg or Foot shapes Reference garment application instructions for more details Pressure Garments Tubing DVT Pump Pressure Gauge Factory Testing Each pump s functionality has been factory tested The tamper proof seal at the bottom of t
6. DVT Prophylaxis where increased venous or lymphatic return is not desired The BluFlex DVT Prophylaxis System could be contraindicated and should not be used by persons with known or suspected deep vein thrombosis pulmonary oedema congestive heart failure severe arteriosclerosis thrombophlebitis or active infection Do not use on persons with painful and sensitive extremities where the garment will interfere with gangrenous limbs on persons with vein ligation or recent skin grafts or extreme deformity of the leg Note If you are unsure of any contraindications please refer to the patient s physician before using the BluFlex DVT Prophylaxis system Tubing Set Compatibility The garments connect to the Pump via the Tubing Sets provided with the Pump The following is the recommendation but the caregiver can still select the tubing type based on the situation Note Do not connect multiple Tubing Sets together Item I Item 4 Recommendation Replacement tubing 60 Replacement tubing 120 610L INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STER IL Cleaning The pump The casing of the pump is manufactured from ABS plastic If soiled it can be wiped down with a sodium hypochlorite solution to dilution of 1000ppm or any EPA approved hospital grade disinfector The control unit face should also be cleaned weekly or as often as hospital protocol requires using a damp soft cloth and mild detergent Switch off the
7. INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL lt User s Manual BluFlex DVT Prophylaxis System Distributed By SIERILA ED lt PART OF THE FAMILY OF COMPANIES INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STER IL Warning Connect the Master Control unit to a proper power source Do not use the pump in the presence of uncontained flammable liquids or gasses Keep the pump and garment away from sources of liquid and open flames Keep the pump and garment away from sharp objects oN N Caution Product should be used in accordance with hospital policy 1 The control unit should only be repaired by an authorized distributor 2 Do not drop the control unit store it in direct sunlight or extreme cold conditions Safety These usage and safety guidelines are IMPORTANT Please follow them carefully General Use 1 Carefully unpack the contents of the pump package 2 Connect the master control unit to a proper power source 3 Do not use or store your pump any of the listed environments Y Do not drop the control unit or store it in direct sunlight or extreme cold conditions V Do not use the pump in the presence of uncontained flammable liquids or gasses v Keep the pump and garments away from sources of liquid and open flames V Keep the garments away from sharp objects V Keep the pump and garments away from heating devices Storage Environment Specification
8. ailure Pressure is greater than Check air hose connections set pressure after two e Turn the pump off and restart inflations Garment Error Garment is not Connect garments to pump connected to pump and restart during start up Ensure garments are fully Garments are not fully deflated before restarting deflated during each pump restart Undo kinks from air The initialization failed hoses garments and restart due to possible kinks pump from air hoses garments Electrical malfunction INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL e e lt li Garment Application Instructions BluFlex DVT Prophylaxis System Garments are 100 Latex FREE Instructions for use 1 Plug the BluFlex DVT Prophylaxis control unit into a suitable electrical outlet 2 Connect Air hoses to the pump 3 Connect Garments to the air hose A click confirms proper connection 4 Place the garments on the patient ensuring that male Velcro does not contact the patient s skin Use only foot or only calf thigh for dual garment therapy don t mix foot with calf thigh garment 5 Ensure a snug fit Place two fingers around the back of the garment to ensure the garment is not too tight Routinely inspect the patient s feet for proper circulation once compression commences 6 TURN THE PUMP ON the power indicator light will illuminate A beep sound confirms operation Contraindications amp Cautions Do not use the BluFlex
9. ce 660TB Foot Garments Standard Up to US men s size 13 690F Large Over US men s size 13 690FL Extension tubing INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL 17 INSTRUCTIONS FOR USE gt Control SMI 420 435 Rev B STERIL Symbols Used k European Conformance Type BF Applied Part Operating Instructions l Manufacture Date of Manufacture Batch Code Ex YYMMDDXX B w Serial Number A C 18 INSTRUCTIONS FOR USE Ah Control SMI 420 435 Rev B STERIL Distributed by a STERILMED lt PART OF THE Johsmonalfeturon L FAMILY OF COMPANIES AL300269 V1 01 lt 11400 73 Ave North Maple Grove MN 55369 888 541 0078 763 488 3350 fax www sterilmed com
10. dios 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 BluFlex DVT Prophylaxis System is used exceeds the applicable RF compliance level above the BluFlex DVT Prophylaxis System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the BluFlex DVT Prophylaxis System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 14 INSTRUCTIONS FOR USE p Control SMI 420 435 Rev B STERIL Recommended separation distances between portable and mobile RF communications equipment and the BluFlex DVT Prophylaxis System The BluFlex DVT Prophylaxis System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the BluFlex DVT Prophylaxis System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the BluFlex DVT Prophylaxis System as recommended below according to the maximum output power of the communications equipment Rated maximum output power of Separation distance to frequency of transmitter trans
11. ect orientation Garments are labelled to indicate correct positioning When correctly positioned secure with the tabs Garments should fit securely but not tightly around the patient s extremity Repeat the procedure for the other limb If only one garment is used disconnect one of the hoses from the pump Air tubing is required to connect garment s to the pump Attach the garments to the air tubing using the white snap lock connectors Each tube has a male end connector at one end and a female end connector at the other The female end large white connector will fit to the male end small white connector that is on the garment Make certain that a click sound is heard to ensure a solid connection Attach the other end s of the air tubing male end to the large white female connector s on the pump Make certain that a click is heard with each snap lock connection If you need to disconnect the tubing press the silver tab on large white female connector and pull apart Press the on off switch to turn pump on Pump will start initialization process for approximately 10 seconds Pump will automatically detect Single Dual garment s during initialization process The pump is set to default to Dual Calf Thigh garments To switch to Foot Therapy while pump is in operation press FOOT button for approximately 3 seconds until FT is displayed To switch back to Calf Thigh Therapy while the pump is in operation press CALF
12. ed below The customer or the user of the BluFlex DVT Prophylaxis System should assure that it is used in such an environment Immunity test EN 60601 test level Electromagnetic environment guidance level Portable and mobile RF communications equipment should be used no closer to any part of the BluFlex DVT Prophylaxis System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 d 1 2 80 MHz to 800 MHz Conducted RF 3 Vrms d 12 800 MHz to 2 5 GHz EN 61000 4 6 150 kHz to 80 MHz 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 Radiated RF 3 V m distance in metres m EN 61000 4 3 80 MHz to 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol gt 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 ra
13. he pump designates when the pump was last tested If the seal is compromised your service warranty will be voided and you will be charged a user damage fee Double Insulation Although the BluFlex pump is classified as an IEC Class 1 Device the pump is of double insulation design and the design has been approved by safety testing report issued by TUV INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL lt A Waste Disposal This Product has been supplied from an environmentally aware manufacturer that complies with the WEEE This product may contain substances that could be harmful to the environment if disposed of in places landfills that are not appropriate according the legislation Please be environmentally responsible and recycle this product through your recycling facility at its end of life INSTRUCTIONS FOR USE p Control SMI 420 435 Rev B STER IL lt Article I Guidance and manufacturer s declaration electromagnetic emissions The BluFlex DVT Prophylaxis System is intended for use in the electromagnetic environment specified below The customer or the user of the system should assure that it is used in such an environment naa Emissionstest i Compliance Electromagnetic environment guidance RF emissions Group 1 The BluFlex DVT Prophylaxis System uses RF CISPR 11 energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference
14. in UT for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 UT gt 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 lt 5 UT gt 95 dip in UT for 5 sec NOTE UT is the a c mains voltage prior to application of the test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 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 Main power quality should be that of a typical commercial or hospital environment If the user of the BluFlex DVT Prophylaxis System requires continued operation during power mains interruptions it is recommended that the BluFlex DVT Prophylaxis System be powered from an uninterruptible power supply ora battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 13 INSTRUCTIONS FOR USE p Control SMI 420 435 Rev B STERIL lt Article Ill Guidance and manufacturer s declaration electromagnetic immunity The BluFlex DVT Prophylaxis System is intended for use in the electromagnetic environment specifi
15. mitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 s d 1 2 w d 2 3 w For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres 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 15 INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL lt Technical Data The Control Unit Model Name Sie 84 5 x 1 x 19 5 cm Weight 3 1 Kg Foot 75 100 mmHg Class I Type BF Classificati Somers Not AP or AGP type Operation Humidity 30 75 Operation Temperature 15 35 C Applied Part Garment and Air Hose Garments are designed for use with the BluFlex DVT Prophylaxis System Controller Calf Garments Small Up to 14 calf circumference 640CS Medium Up to 18 calf circumference 640CM Large Up to 24 calf circumference 640CL Bariatric Up to 32 calf circumference 640CB Thigh Garments Medium Up to 29 thigh circumference 660TM Large Up to 36 thigh circumference 660TL Bariatric Up to 42 thigh circumferen
16. nditions 1 Severe congestive cardiac failure 2 Severe arteriosclerosis or other ischaemic vascular disease 3 Extreme deformity of the limbs 4 Known or suspected deep vein thrombosis 5 Known or suspected Pulmonary Embolism 6 Any local condition in which the garments would interfere i e Gangrene Dermatitis Untreated or infected wounds Recent skin grafts INSTRUCTIONS FOR USE me Control SMI 420 435 Rev B STERILMED BluFlex DVT Prophylaxis System Power Switch Control Panel Air Outlet Control Unit Features Power Single Garment Light Mode Timer in Hours Display Alarm Light Pressure Setting for Prssure Setting for Foot at 80mmHg Call Thigh at40mmH8 INSTRUCTIONS FOR USE gt Control SMI 420 435 Rev B STERIL Ti Operating Instructions To operate the BluFlex DVT Prophylaxis System the following steps should be followed Please read this instruction manual in its entirety before setting up 1 2 10 11 12 Plug pump into an appropriate electrical outlet DO NOT SWITCH ON Position the pump on flat surface or suspend the pump at the foot of the bed using the swing out hooks Place garment s on the legs or feet ensure the male Velcro does not touch the patient s skin Use only foot or only calf thigh for dual garment therapy don t mix foot with calf thigh garment Snugly wrap garment making sure the inflatable bladder is in the corr
17. r accessories supplied are specifically designed for use with the BluFlex DVT Prophylaxis System control unit Use of other products in conjunction with the system is not recommended AN Caution Indicator Lights Green Illuminated to indicate power on Amber Flashing indicates a fault has been detected An audible alarm will follow after 5 minutes visual alarm Blue Flashing indicates initialization in process Upper display window will show INT Blue LED Display Upper display illuminated to indicate when Calf Thigh LEG or FOOT Ft is activated Lower display illuminated to indicate pressure being delivered and alarm signals of low pressure LO high pressure HI garment error GE and fault F redirect for service Indication of therapy time in hours from last reset INSTRUCTIONS FOR USE Control SMI 420 435 Rev B STERIL Alarm Codes lt Indicates the error information for BluFlex DVT Prophylaxis System these include LO HI GE and F LO Low Pressure Leg pressure is less than Check garment application is 40mmHg or Foot not too loose or too tight pressure is less than Check for air leaks from air 80mmHg after 2 hoses garments Replace if consecutive cycles faulty Air hose is disconnected If hose is disconnected from garment connect hose to garment Turn the pump off and restart High Pressure Air hose is kinked Check air hoses garments for kinks Undo kinks and restart pump System F
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