DVT User Manual - Advanced Medical Solutions
Contents
1. Customer Service See Service Provider Documentation Document 1012 rev 13 7 14 10 Copyright 2010 Michigan Medical Innovations CA5 USER MANUAL TAEA of Contents General Warnings Environmental Conditions Purpose of Device EE Troubleshooting Intended Uses 3 Contraindications T Description of Device Storage Some ooo a S Teint LA aC taper 6 age EL Owaingiwemis S Manufactured by Michigan Medical Innovations 481 Pettis Ave NE Ada Michigan 49301 USA www michmedical com Please Fill in for Future Reference Date Purchased Serial Number General Warnings WARNING Electric shock hazard Do not remove cover WARNING Do not attempt to service the pump control unit for any reason Contact DVTCare for replacement instructions page 56 WARNING If pulsations or throbbing occur the cuff is wrapped too tight Loosen immediately WARNING Stop using device if swelling occurs consult physician Page 2 WARNING Device to be 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 Leg cuffs are not to be used in direct contact with the skin CAUTION Do not immerse in any liquid for any reason CAUTION Do not operat2. 40 C 104 F 30 75 relative humidity e Transport temperature and relative humidity Temperature Range 20 C 4 F to 60 C 140 F Relative Humidity 30 tp 75 Keep Dry e Normal Operating Conditions Temperature Range 10 C 50 F to 40 C 104 F Relative Humidity 30 0 75 Trouble Shooting Air tube outlet connector will not fit in port Make sure the metal thumb latch is pressed until it clicks such that the tube connector will enter the air outlet fitting Batter charge is too low Connect unit to a wall supply for a fresh charge and turn on Cannot feel pressure on leg s Cuff is not wrapped tightly enough Air tubes are not connected Bladder is damaged and will not hold air Tube is damaged Ensure Double Leg mode is selected when using both cuffs Verify settings are correct as prescribed by physician Decrease pressure setting Contact physician mla Controt unit detected nigh Remove any kinks from line Be sure all tubes pressure are not tangled or constricted Start pump again LOMB Pressure cuff is under inflated Make sure tubing is properly connected Listen and look for air leaks Pressure is too high on leg Pump will not operate Battery charge is low Connect charger Battery pack has expired Contact DVTCare rl Pump will not operate Contact DVTCare for return information If problems persist contact your equipment provider as per page 1 Page 7 Contraindication
3. Return to provider for service see page 1 Default Settings Pressure SOmmHg Tolerances Hold Time 1 second Pressure Cycle Time 60 seconds Cycle Time Displayed battery charge Feature Adjustment Range Recharge Time Pressure 20 65 mmHg Single leg run time Hold Time Not adjustable Dounie de omine Cycle Time 60 75 seconds Explanation of button functions 1 Power Depress and hold to turn unit on Depress and hold to turn unit off 2 Up Arrow 4 mmHg second 0 1 V 3 4 hours 17 hours 8 hours Depress briefly to increase pressure by ImmHg Depress and hold to increase pressure by SmmHg increments 3 Down Arrow Depress briefly to decrease pressure by 1mmHg Depress and hold to decrease pressure by SmmHg increments 4 Mode Depress briefly to change from single leg mode to double leg mode and vice versa Confirm garment connections to single leg fitting when in single leg mode and garment connections to both fittings when in double leg mode Page 10 Explanation of LED indicators 1 Single leg mode Indicates unit is operating in single leg mode 2 Double leg mode Indicates unit is operating in double leg mode 3 Charge status If charge light is on unit is charging If charge light is off charging while connected to power supply and plugged into wall power supply charge is complete Disposal This unit is an electromechanical device that includes printed circuit boards and rechargeable batterie
4. pressure If battery voltage is below 5 8 connect the power supply prior to use Any error codes will be displayed as well see page 7 If the unit will not 1 power on connect the wall supply to charge battery Unit may be used while plugged into wall outlet 4 Set pressure by using the 7 and Y buttons to either increase or decrease the set pressure 5 Press the Mode button to change between single and double leg m n modes ie a 6 While in Double Leg mode only one leg cuff fills at a time The rr ro leg bladders vent immediately after filling and continue to vent Bee ORG until the next cycle 7 Healthcare providers please reference supplemental instructions for entering the Health care provider access code to adjust the upper pressure limit and access the reset function 8 Pressure adjustments can be made at any time during the cycle by pressing the or Y arrow keys Each press will change the pressure in 1mmHg increments Press and hold either key for 1 second to scroll in 5mmHg increments 9 To turn off the pump unit depress and hold the power button for approximately 2 seconds 10 To maximize performance during extended operation connect AC adapter while in use 11 To remove cuff pull securing straps and unwrap from leg 12 To disconnect the air tube from pump unit depress thumb tab on pump unit while pulling the tube away User Maintenance WARNING Do not attempt to service the
5. UTION Contains no serviceable parts Contact equipment provider for service CAUTION Do not place any items in an autoclave CAUTION 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 soapy water or 70 isopropyl alcohol Do not use bleach on any item Do not use abrasive or volatile cleaners display could become scratched 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 Note Inspect unit and follow the cleaning and disinfecting procedures prior to each use Page 8 Technical Data DVT Care Model CA5 Electro Magnetic Compatibility Data available at www michmedical com caS5emcdata Refer to user manual for further instructions This symbol designates the degree of protection against electrical shock as being a type BF applied part 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 The use of accessories transducers and cables other than tho
6. d Uses The DVTcare CAS is intended to be an easy to use portable system that is prescribed by healthcare professionals to help prevent the onset of DVT in patients by stimulating blood flow in the legs simulating muscle contractions Furthermore the unit can be used as an aid in the prophylaxis for DVT by persons traveling or those expecting to be stationary for long periods of time greater than 4 hours The designed portability allows patients to wear the unit during many hospital stay related activities such as physical therapy sessions wheel chair transportation cafeteria sittings and during general mobility throughout the facility This device can also be used by patients to aid in the prevention of DVT enhance blood circulation diminish post operative pain and swelling reduce wound healing time and aid in the treatment and healing of stasis dermatitis venous stasis ulcers arterial and diabetic leg ulcers chronic venous insufficiency and reduction of edema in the lower limbs Page 3 Description of Device Pressure Decrease Power Button ON OFF Button Pressure Increase Mode Selection Button Button marr 7 Pressure Display a Single Leg Indicator Double Leg Indicator Charging Indicator Air Outlets Leg Cuff Power Supply Power Cord Adapter Jack Air Tube N Power Supply Connector Power Supply Adapter Plug Default Settings f Mode P
7. e 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 page 2 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 equipment can affect the A 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 health care provider and deflate once that pressures is reached Cycles are repeated until the unit is turned off In addition to having single and double leg modes the CAS also incorporates adjustable cycle times adjusted by healthcare providor to accommodate a wide range of treatment profiles The hold and 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 Intende
8. onning the Leg Cuffs 1 Make sure that the securing Velcro is on the inside of the sleeve relative to your leg 2 Place the cuff so the middle of the bladder outline is against Ts the back of your calf with the air tube fitting facing out 3 Wrap the cuff 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 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 The batter charge LED will illuminate while charging battery and remain turn off when charge is complete It will not be illuminated if the charger is not connected To maximize performance during extended operation connect AC adapter while in use Full charge is approximately 7 0 volts f Guide Strap NOTE Use power supply provided ITE FJ SW1280c029 Input 110 240V 50 60Hz 0 5A Output 12V 1 2A NOTE To isolate unit unplug from AC adapter power supply Page 5 Operating Instructions 1 After following the set up instructions on page 5 ensure leg cuffs are firmly around legs as indicated on page 5 wrapped 2 To turn the system on press and hold the power button for 2 oj Lt n fa seconds re for 3 The system will self diagnose and the display will show the N I Va ts Assistant CAL remaining battery voltage followed by the current set
9. 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 pg 5 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 Page 6 Environmental Conditions Do not expose device to direct sunlight Do not operate pump below 0 C 32 F Do not expose to heat exceeding 65 C 149 F 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 e Do not unroll or don the leg cuff in below freezing temperatures 0 C 32 F as damage to the air bladder can occur making it unable to hold pressure e Do not expose device to a direct heat source with temperatures exceeding 50 C 122 F for extended periods of time e Store in a dry location between 10 C 50 F and
10. ressure Set Point 50 mmHg Pressure Limit 50 mmHg Pressure Adjustment 20 50 Range mmHg Hold Time 1 1 second _ Cycle Time Page 4 Set Up Instructions NOTE The DVTCare CA5 requires EMC precautions and needs to be installed and put into service according the EMC information provided at www michmedical com ca5emcdata CD NOTE Portable and mobile radio frequency communications can affect the DVTCare CA5 1 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 page 2 2 Remove items from packaging and plastic bags if present Make sure all of the pieces listed on page 4 are readily available 4 Inspect all components for damage If any parts appear damaged or are inoperable contact Provider Customer Service page 1 5 Uncoil the tubing attached to the cuff s 6 Apply garments to leg calf see Donning Leg Cuffs on page 6 route tubing under clothing or in a manner to prevent a tripping hazard and to avoid kinking 7 Ensure metal thumb tabs on the pump units air outlets are D n depressed to allow the air tube connector to engage NS 8 Insert pump in pouch and align the pump air outlets with the two access holes in the pouch 9 Connect air tube s to pump air outlets by routing them through the carry pouch air access holes 10 Secure carry case as desired using the strap or belt loop provided sel D
11. s The DVTCare CA5 should not be used to treat the following conditions Persons with suspected active or untreated deep vein thrombosis ischemic vascular disease severe arteriosclerosis pulmonary edema congestive heart failure thrombophlebitis or an active infection It is not recommended for use on a leg where cuffs would interfere with the following conditions vein ligation gangrene dermatitis open wounds a recent skin graft massive edema or extreme deformity of the leg Not for use with patients with neuropathy Do not use on extremities that are insensitive to pain Do not use where increased venous or lymphatic return is undesirable Leg cuffs are not to be used in direct contact with skin Storage Store in a dry location between 10 C 50 F and 40 C 104 F 30 75 relative humidity Do not expose to heat exceeding 65 C 149 F Do not store items in direct sunlight Ensure zipper covers of the carry pouch storage bags are firmly closed to prevent dust and damage Roll cuff and do not fold as folding will decrease the life of your product Connect unit to charger for recharge no less than 6 hours every 30 days to preserve integrity of internal batteries Cleaning and Disinfecting Note Inspect the DVTCare unit and follow the cleaning and disinfecting procedures prior to each use WARNING Device must be turned off and disconnected from the wall outlet prior to and while cleaning or disinfecting CA
12. s Do not discard in landfill Consult local state federal and country requirements for proper disposal instructions Cuffs may be discarded in US landfills Index A E S Assistance Environment 7 Set Up 6 AC Adapter 5 Error Codes 7 Single Leg 6 B H Starting 6 Battery 10 H1 7 Storage 8 C L T Cautions 5 Lb 7 Troubleshooting 7 Cleaning 8 LO 7 Turning Off 6 Contraindications 8 amp 8 M W Cuffs Using 5 Maintenance 8 Warnings 2 3 Customer Service 2 Mode 6 Wrapping 5 D O Default Settings 10 Operating 6 Description 4 P Disposal 11 Phone Numbers 1 Double Leg 6 Pressure Adjust 6 Page 11 See Service Provider Documentation for Service and Technical Support Information Page 12
13. se specified may result in increased emissions or decreased immunity of the DVTCare CAS Designates Class II medical electrical equipment The cuffs are single use devices One patient may use a cuff multiple times but a single cuff may not be shared between patients Alternating Current e Direct Current Fragile This end up Temperature Limits Keep away from rain A General Technical Data Continued Size 5 9 x 3 9 x 1 6 inches 15 x 10 x 4 centemeters Weight 1 1 Ibs 0 50 kg This device is not protected against the ingress of water ordinary protection IPXO Equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Page 9 Power This device is internally powered and operates under continuous loading This device is not protected by a protective earth ground Power Supply ITE FJ SW1280c029 Input 110 240V 50 60Hz 0 5A Output 12VDC 1 2 A NOTE This power supply is not approved for hospital oxygen rich use Battery Single leg mode run time 17 hours Double leg mode run time 8 hours Recharge time 3 4 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 and are not replaceable
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