DVT Care CA5 Personal Circulation Assistant User Guide
Contents
1. equipment can affect the operation of this device PURPOSE OF DEVICE The purpose of the CA5 personal circulation assistant is to aid in the prevention of Deep Vein Thrombosis DVT by helping to stimulate blood flow in the legs This is accomplished by the electronically controlled pump unit delivering a set amount of air to the leg cuffs that in turn compress the calf s to aid blood flow out of the lower extremities This pump unit will inflate to a specified pressure set by the user or healthcare provider and deflate once that pressures is reached Cycles are repeated until the unit is turned off Cycle times can only be adjusted by a healthcare provider Internal rechargeable batteries allow the system to be completely portable thus preventing many interruptions in treatment INTENDED USES The DVTCare CAS is intended to be a portable system used only by the discretion of a prescribing medical doctor Its intended use is primarily to help prevent the onset of DVT in patients by stimulating blood flow in the legs simulating muscle contractions Because of its portability a medical doctor may prescribe this device for DVT prophylaxis in persons traveling or expecting to be stationary for long periods of time greater than 4 hours The DVTCare CA5 can also under the control and supervision of physicians and qualifying healthcare professionals be used for the treatment of leg ulcers edema and stasis dermatitis caused by chronic v2. 2 IEC 60601 TEST LEVEL 6 kV contact 8 kV air COMPLIANCE LEVEL 6 kV contact 8 kV air EMC ENVIRONMENT GUIDANCE Floors should be wood concrete or ceramic tilt If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 5 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge 1EC61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the DVTCare CA5 requires continued operation during power mains interruptions it is recommended that the DVTCare be powered from an uninterruptible power
3. Instructions for use my Ny wll DVTCare CA5 Life Without Limitations PLEASE FILL IN FOR FUTURE REFERENCE Date purchased Serial Number General Warnes re Ee AA ARA Ach gehen ee dane CCEA ES 4 PURDOSE ODE coccion dot AS hh ica ds ete dhe tA 4 InteridedsU ses art ai A Eeer 4 DeSeriptiOn or Devices rece sucacented eras sata casacas Se 5 Se UBA COS a os 5 Donning the Single Double Mode Garments 00 0 occ 6 EE 6 ODE Aline are e EE EEN 6 Explanation of DULLOM funcions caia daba aaa 7 Explanation of LED EIER ss hws ds siti a Gude es 7 EE Ee E EE Lat 7 User Ee ELE 8 Environmental Conditions A ae NEE E per at wales di arcada 8 TOD ESOO UA EE ti daca cd Gece Me oe ae tle HRA Rs 9 Ta Here ENEE 9 EE EE SE her 9 Cleaning and Disinfecing EE teens 10 Technical Data DVTCare Model CA 10 General Technical Data Ee ts Ae Roe ROTM AC 11 DAN e a od e 12 Uer EE 12 DISPO EECH 12 DVTCare CA5 Electromagnetic Compatibility oooooooooomooooom o 13 GENERAL WARNINGS WARNING Electric shock hazard Do not remove cover WARNING Do not attempt to service the pump control unit for any reason Contact Provider for instructions see front cover and or Provider documentation for contact information WARNING If pulsations or throbbing occur the cuff is wrapped too tight Loosen immediately WARNING Stop using device if swelling occurs consult physician WARNING Device to b
4. e used only by the patient prescribed and only for its intended use WARNING Ensure the pump control unit is turned off and unplugged from the power mains wall outlet prior to and while cleaning or disinfecting WARNING Equipment not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE WARNING Long time direct contact of the cuffs to the skin may cause some skin irritation especially in those with sensitive skin skin diseases or conditions like allergies or skin rashes Consult your doctor if you have any questions regarding your tolerance for the cuffs or if irritation occurs WARNING The cuffs are single use devices One patient may use a cuff multiple times but a single cuff may not be shared between patients WARNING Not MR Compatible Follow Magnetic Resonance Suite safety precautions Remove control unit before entering any MR magnetic zone CAUTION Do not immerse in any liquid for any reason CAUTION Do not operate device in a wet environment CAUTION Allow cuffs to warm to room temperature if exposed to temperatures below 5 C CAUTION Do not subject the unit to shocks such as dropping the pump unit CAUTION Contains no serviceable parts Contact provider for service back cover CAUTION Do not place any items in an autoclave CAUTION This unit needs to be installed according to information provided in EMC sec 38 CAUTION Portable and mobile RF communications
5. enous insufficiency in the legs Additional use under strict control and monitoring of a physician is for the possible enhancement of blood circulation in the legs of patients with arterial ulcers or diabetic ulcers Furthermore physicians may choose to use the DVTCare CA5 for diminishing post operative pain and swelling and for reducing wound healing time on the leg or foot DESCRIPTION OF DEVICE Pressure Decrease Button Power Button Pressure Increase ON OFF Button Mode Selection Button ERR E Pressure Display Single Leg Indicator Double Leg Indicator Charging Indicator Air Outlets Power Supply Adapter Jack Leg Air Tube We Supply po ZE adapter Plug po Cord J SET UP INSTRUCTIONS NOTE The DVTCare CA5 requires EMC precautions and needs to be installed and put into service according the EMC information provided on pages 13 15 NOTE Portable and mobile radio frequency communications can affect the DVTCare CAS For future reference enter the date of purchase and unit Serial Number found on the rear label of each pump unit in the spaces provided on back cover SM Remove items from packaging and plastic bags if present WD Make sure all of the pieces listed on page 5 are readily available Inspect all components for damage If any parts appear damaged or are inoperable contact Provider Customer Service back cover Uncoil the tubing attached to the cuff s App
6. es and has ceased cycling Remove kinks and or restrictions from tubing Orient Cuff fitting inside of calf above the ankle If bladder is full unplug from unit momentarily to allow deflation and reconnect Power unit down and restart Intermittent Blink Beep Control unit detected low pressure Inspect fittings at pump tubing and garment for loose fittings or leaks Allow unit to continue to cycle Steady Blink Beep Control unit detected low pressure for 10 cycles and has ceased cycling Inspect fittings at pump tubing and garment for loose fittings or leaks Power unit down and restart Battery is low Connect to wall supply Pump needs to be reset Power off and restart if condition persists contact Provider If problems persist contact your equipment provider as per back cover CONTRAINDICATIONS The DVTCare CA5 should not be used to treat the following conditions e The DVTCare CA5 system should not be used on patients with suspected confirmed active or untreated Deep Vein Thrombosis or thrombophlebitis e The DVTCare CA5 should not be used on patients with peripheral ischemic vascular disease or severe peripheral arteriosclerosis pulmonary edema congestive heart failure or active infection except at the discretion and under strict supervision of a medical doctor e The DVTCare CA5 is not recommended for use on a leg where the cuff would interfere with the following co
7. ey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 0 A 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 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 measure field strength in the location in which the DVTCare CA5 is used exceeds the applicable RF compliance level above the DVTCare CA5 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocation the DVTCare CAS zk Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 14 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE DVTCARE CAS IEC60601 1 2 TABLE 206 The DVTCare CAS is intended for use in the electromagnetic environment in an electromagnetic environment in which radiated RF disturbances are contr
8. hed and hard to read DO NOT place cuff or carry pouch in dryer as the bladder could melt Hand wash exterior of cuff and carry pouch using a soft cloth moistened with soapy water or 70 isopropyl alcohol and let air dry To ensure product is completely dry prior to use leave unit in the off condition and disconnected from power wall outlet for 30 minutes after cleaning or disinfecting TECHNICAL DATA DVTCARE MODEL CAN Electro Magnetic Compatibility Data on pages 13 15 below This symbol designates the degree of protection against electrical shock as being a AN Refer to user manual for further instructions type BF applied part o S ss He This unit is an electromechanical device that includes printed circuit boards and rechargeable batteries Do not discard in landfill Consult local state federal and country requirements for proper disposal instructions Designates Class ll medical electrical equipment Alternating Current Direct Current Fragile This end up Temperature Limits Keep away from rain GENERAL TECHNICAL DATA NOTE The DVTCare CA5 requires EMC precautions and needs to be installed and put into service according the EMC information provided on pages 13 15 THIS DEVICE IS NOT PROTECTED AGAINST INGRESS OF WATER ordinary protection IPX 0 Size Weight Power Power Supply Input Output Battery Run Time 5 9x 3 9x1 6 inches 15x10 x4 centimeters 15 ounces 0 50 kg T
9. his device is internally powered and operates under continuous loading This device is not protected by a protective earth ground Equipment not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE MPS 12 001 or DVT67119 110 240V 50 60Hz 0 5A 12VDC 1 25 A NOTE This power supply is not approved for hospital oxygen rich use Single leg mode 16 hours Double leg mode 8 hours Recharge time 3 5 hours Approximate number of charges 500 Cycles Based on default settings NOTE Recharge batteries using only the power supply supplied with this system Batteries are best cycled a minimum of once every 60 days to sustain 500 cycle life NOTE This unit is provided with rechargeable batteries that are not customer replaceable Return to provider for service see back cover DEFAULT SETTINGS D CEA SINGLE LEG MODE DOUBLE LEG MODE Hold Time 2 secs 2 secs Cycle Time 60 secs 60 secs ADJUSTMENT RANGE SINGLE LEG MODE DOUBLE LEG MODE Pressure adjustment 20 50 mmHg 20 50 mmHg Cycle Time 60 75 secs 60 75 secs The Healthcare Provider can adjust pressure range from 20 65 mmHg if so prescribed TOLERANCES Pressure 4mmHg Cycle Time 1 second Displayed battery charge 0 1V DISPOSAL This unit is an electromechanical device that includes printed circuit boards and rechargeable batteries DO NOT discard in landfill Consult
10. inking charge is complete Light is off when not connected to wall power supply EXPLANATION OF DIAGNOSTIC FUNCTION e Diagnostic Routine automatically runs at startup and every 30 minutes You will hear three short clicks and buzzes as part of the internal diagnostic routine USER MAINTENANCE WARNING DO NOT attempt to service the pump control unit for any reason Inspect the unit and components for any damage that may have occurred during shipping or general handling prior to each use ie cut cord split air tubes cracked plastic housing torn cuff etc Refer to Description of Device page 4 for description of all components Do not attempt to connect the wall supply if any damage is noticed Avoid subjecting the unit to shocks such as dropping the pump unit Notify provider for immediate replacement of any kinked or damaged tubes Do not handle the leg cuffs with any sharp objects If bladder is punctured do not repair Roll cuff for storage transportation avoid folding or creasing the bladder Battery is not replaceable return unit to provider This device is not protected by a protective earth ground ENVIRONMENTAL CONDITIONS DO NOT expose device to direct sunlight DO NOT operate the pump if it has been stored in freezing conditions Allow cuffs to warm to room temperature if exposed to temperatures below 5 C 41 F DO NOT unroll or don the leg cuff in below freezing temperatures 0 C 32 F as damage to the a
11. ir bladder can occur making it unable to hold pressure DO NOT expose device to a direct heat source with temperatures exceeding 50 C 122 F for extended periods of time Transport temperature and relative humidity Temperature Range 20 C 4 F to 60 C 140 F Relative Humidity 30 to 75 Keep Dry Normal Operating Conditions Temperature Range 10 C 50 F to 40 C 104 F Relative Humidity 30 to 75 Keep dry TROUBLESHOOTING PROBLEM Air tube outlet connector will not fit in port SOLUTION Ensure press tab on fittings is depressed Unit will not turn on Battery charge is too low Connect unit to a wall supply for a fresh charge and turn on Cannot feel pressure on leg s e Fitting on garment is compressed and must be oriented toward inside of calf above the ankle Garment is not wrapped secured tightly to site Air tubes are not connected or kinked Bladder is damaged and leaks e Ensure correct mode is selected Pressure is too high on leg e Verify settings are as prescribed by physician e Decrease pressure setting contact physician Intermittent Blink Beep Control unit detected high pressure Remove kinks and or restrictions from tubing Orient Cuff fitting inside of calf above the ankle If bladder is full unplug from unit momentarily to allow deflation and reconnect Allow unit to continue to cycle Steady Blink Beep Control unit detected high pressure for 10 Cycl
12. l P instructions for entering the Healthcare provider access code to adjust the upper pressure limit and access the reset function 9 To maximize performance during extended operation connect AC adapter while in use 10 To remove cuff pull securing straps and unwrap from leg 11 To disconnect the air tube from pump unit depress thumb tab on pump unit while pulling the tube away NOTE If this system does not inflate or has other malfunctions consult your Healthcare Provider immediately for a replacement and for further directions EXPLANATION OF BUTTON FUNCTIONS e Power Depress and hold for sec to turn unit on Depress and hold for 2 sec to turn unit off e Up Arrow Depress briefly to increase pressure by ImmHg Depress and hold to increase pressure in 3mmHg increments e Down Arrow Depress briefly to decrease pressure by ImmHg Depress and hold to decrease pressure by 3mmHg increments e Mode Depress briefly to change between single leg and double leg mode Confirm garment connections to single leg fitting when in single leg mode EXPLANATION OF LED INDICATORS The DVTCare CA5 has 2 operational modes single leg and dual leg e Single leg mode Indicates unit is operating in single leg mode e Double leg mode Indicates unit is operating in double leg mode e Charge status When power supply is connected to wall supply and unit and charge light is blinking unit is charging If charge light is on and not bl
13. local state federal and country requirements for proper disposal instructions Cuffs may be discarded in US landfill DVTCARE CA5 ELECTROMAGNETIC COMPATIBILITY GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS IEC60601 1 2 TABLE 201 The DVTCare CAS is intended for use in the electromagnetic environment specified below The customer or the user of the DVTCare CA5 should assure that it is used in such an environment EMISSIONS TEST RF emissions CISPR 11 COMPLIANCE Group 1 EMC ENVIRONMENT GUIDANCE The DVTCare CA5 uses RF energy for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Class B Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies The DVTCare CAS is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that that supplies buildings used for domestic purposes GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS IEC60601 1 2 TABLE 202 The DVTCare CAS is intended for use in the electromagnetic environment specified below The customer or the user of the DVTCare CA5 should assure that it is used in such an environment IMMUNITY TEST Electrostatic discharge ESD IEC 61000 4
14. ly Leg Garments to leg calf see below Route tubing under clothing or in a manner to prevent a tripping hazard and to avoid kinks Ensure metal thumb tabs on the pump units air outlets are depressed to allow the air tube connector to engage Insert pump in pouch and align the outlets with access holes in the pouch and connect air tube s to pump air outlets Secure carry case as desired using the strap or belt loop provided GEI W DONNING THE SINGLE DOUBLE MODE GARMENTS Securing Tab Air Tube Fitting Pa Inside of Leg 1 Ensure that the securing tab is on the inside of the garment relative to leg 2 Place the garment so the tube and elbow fitting are on the inside of the calf above the ankle 3 Wrap the garment around your calf so that it is a snug fit 4 Adjust as necessary WARNING If pulsations or throbbing occur the cuff is wrapped too tightly Loosen immediately WARNING If HI error occurs ensure that tubing is not kinked and elbow fitting is on interior of calf above the ankle AC ADAPTER Insert the supplied power supply plug into the adapter jack in the pump and connect the power supply adapter to a 100 240V wall socket To maximize performance during extended operation connect AC adapter while in use Full charge is approximately 8 2 volts NOTE Use power supply provided e Part MPS 12 001 or DVT67119 e Input 110 240V 50 60Hz 0 5A e Output 12V 2221 25 A NOTE To isolate unit un
15. nditions vein ligation gangrene dermatitis open wounds a recent skin graft massive edema or extreme deformity of the leg e Patients with peripheral neuropathy or who are insensitive to pain or for whom increased venous or lymphatic return is undesirable should not use this device STORAGE e Store in a dry location between 10 C 50 F and 40 C 104 F 309 75 relative humidity e DO NOT expose to heat exceeding 65 C 149 F e DO NOT Store items in direct sunlight e Ensure zipper covers of the carry pouch storage bags are firmly closed to prevent dust and damage e Roll cuff and do not fold as folding will decrease the life of your product e Connect unit to charger for recharge no less than 6 hours every 60 days to preserve integrity of internal batteries CLEANING AND DISINFECTING NOTE WARNING CAUTION CAUTION CAUTION Inspect the DVTCare unit and follow the cleaning and disinfecting procedures prior to each use Device must be turned off and disconnected from the wall outlet prior to and while cleaning or disinfecting Contains no serviceable parts Contact equipment provider for service DO NOT place any items in an autoclave DO NOT immerse pump unit in any liquid for any reason Clean the outer surface of the pump unit using a soft cloth moistened with 70 isopropyl alcohol or soapy water DO NOT use bleach on any item DO NOT use abrasive or volatile cleaners display could become scratc
16. olled The customer or the user of the DVTCare CA5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the DVTCare CA5 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 35vP d 70VP 100 00 12 00 3 50 7 00 For transmitters rated at a maximum output power not listed above the recommended separation distance of 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 NOTE The use of accessories transducers and cables other than those specified with the exception of transducers and cables sold by the manufacturer of the DVTCare CA5 as replacement parts for internal components may result in increased emissions or decreased immunity of the DVTCare CA5 NOTE The DVTCare CA5
17. plug from AC adapter power supply OPERATING INSTRUCTIONS 1 After following the set up instructions on page 5 ensure leg cuffs are wrapped firmly around legs as indicated 2 To turn the system on press the power button for a second 3 The system will self diagnose and display either battery voltage or AC if plugged in followed by the current pressure setting If battery voltage is below 6 9 plug in power supply prior to use Whenever possible operate unit with power supply connected 4 The Charge status shows blinking when unit is being charged and on when unit is fully charged Ifthe unit will not power on connect the wall supply to charge battery Unit may be used while plugged into wall outlet e ve GHD o E 5 Set pressure by using the 4 and y buttons to either increase WAS mode or decrease the set pressure Pressure adjustments can be SL made at any time during the cycle Press an arrow key for DVT lt CA CARE ImmHg increments and hold the arrow key to scroll in ra 3mmHg increments 6 Press the Mode button to change between single and nal Circulation Assista double leg modes D P 7 While in Double Leg mode only one leg cuff fills at a time Bo 4 E The leg bladders vent immediately after filling and continue E pl to vent until the next cycle Dr s ARE cree 0 8 Healthcare providers please reference supplementa
18. should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the DVTCare CA5 should be observed to verify normal operation in the configuration in which it will be used 15 Ossur Americas 27051 Towne Centre Drive Foothill Ranch CA 92610 USA Tel 1 949 382 3883 Tel 1 800 233 6263 Fax 1 800 831 3160 ossurusa ossur com Ossur Canada 2150 6900 Graybar Road Richmond BC V6W OAS Canada Tel 1 604 241 8152 Fax 1 866 441 3880 Ossur Europe Ekkersrijt 4106 4114 P O Box 120 5690 AC Son en Breugel The Netherlands Tel 800 3539 3668 Tel 31 499 462840 Fax 31 499 462841 info europe ossur com Ossur Deutschland GmbH Augustinusstrasse 11A 50226 Frechen Deutschland Tel 49 0 2234 6039 102 Fax 49 0 2234 6039 101 info deutschland ossur com Ossur Head Office WW Grj thals 5 110 Reykjavik Iceland Tel 354 515 1300 Fax 354 515 1366 mail ossur com www ossur com Ossur Nordic P O Box 67 75103 Uppsala Sweden Tel 46 1818 2200 Fax 46 1818 2218 info ossur com Ossur Iberia S A Calle Cal ndula 93 Miniparc Ill Edificio E Despacho M18 28109 El Soto de la Moraleja Alcobendas Madrid Espa a Tel 00 800 3539 3668 Fax 00 800 3539 3299 orders spain ossur com Ossur UK Unit No 1 S Park Hamilton Road Stockport SK1 2AE UK Tel 44 0 8450 065 065 Fax 44 0 161 475 6321 ossuruk ossur com Copyright Os
19. supply or battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level 13 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS FOR NON LIFE SUPPORT EQUIPMENT IEC60601 1 2 TABLE 204 The DVTCare CAS is intended for use in the electromagnetic environment specified below The customer or the user of the DVTCare CA5 should assure that it is used in such an environment IEC 60601 TEST LEVEL IMMUNITY TEST Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 KHz to 80 KHz 3V m 80 MHz to 2 5 GHz COMPLIANCE LEVEL EMC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the DVTCare CAS 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 35 VP 80MHz to 800 MHz d 70 VP 800MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surv
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