ACTitouchTM - Tactile Medical
Contents
1. Time CHAPTER Warnings and Cautions i I Warnings Please read all of the information provided before use and ensure that all instructions are followed Electrical equipment may be hazardous if misused Do not open or take apart the ACTitouch Control Unit for any reason or the warranty will be voided There are no customer serviceable parts in this device Prior to use the patient should be fully assessed by a healthcare professional for treatment Suitability trained on the use of the device and advised on optimal wear time in each mode Failure to wear the device as recommended even for short periods may delay ulcer healing or may negatively impact treatment outcomes Use the ACTitouch Control Unit or ACTitouch Compression Sleeve only with the ACTitouch Undersock and Power Adapter Charger Do not use the ACTitouch System while wearing other compression products Treatment should be stopped if additional pain tingling or numbness of the limb occurs during or as a result of treatment The Undersock should not be placed in direct contact with an open wound It is recommended that this device be used in conjunction with an appropriate absorptive moisture retentive wound dressing applied before the ACTitouch System Caution should be taken when using the ACTitouch System on fragile skin Do not operate motor vehicles or other machinery while wearing the ACTitouch System Consult with your healthcare provide2. The Control Unit does 1 The Control Unit needs to not respond to buttons be charged 5 3 Charging the Device being pressed 2 The Control Unit has not been 2 Switch the Control Unit on Refer to switched on Chapter 5 5 Switching On the ACTitouch System in Sustained Compression Mode 3 The event log needs to be reset 3 Remove the Control Unit from the Compression Sleeve Reset the device by pressing and holding the MUTE button for ten 10 seconds The LCD will flash to indicate a successful event log reset and the unit will switch off The Control Unit may now be reinserted into the Compression Sleeve and used as normal D Please call customer service at toll free 1 866 435 3948 4 Device fault Customer service can be contacted at 1 866 435 3948 toll free between 8 00 am 5 00 pm CT Monday through Friday Problem Possible Cause Corrective Action The Control Unit will not operate in Intermittent Pneumatic Compression Mode 1 The Control Unit has not been securely inserted into the Compression Sleeve 2 The Power Adapter Charger is not securely connected to the charging port and an AC power outlet 3 The Control Unit has not been switched on 4 The event log needs to be reset 5 Device fault 1 Refer to Section 5 4 2 Inserting the Control Unit into the Compression Sleeve 2 Ensure the Power Adapter Charger is securely connected to the char
3. at the theater a MUTE button can be used to pause the pump See Section 5 6 Muted Operation in Sustained Compression Mode While muted the device will remain inflated to apply pressure to the leg but will no longer adjust the pressure e IMPORTANT The device will automatically reset to normal operation after two 2 hours of muted use 2 2 Intermittent Pneumatic Compression Mode When in Intermittent Pneumatic Compression Mode the device will perform cyclic inflation deflation sequences to preset gradient pressures To operate in this mode the Control Unit requires power from the Power Adapter Charger When the device is first plugged in and switched on it will initially inflate to a low pressure in each chamber Once the starting pressure is reached each chamber will inflate in sequence starting at the foot and working up toward the knee until all of the chambers reach the intended pressure levels All four 4 chambers will then deflate to the low pressure level This cycle of inflation and deflation will continue until the device is either unplugged from the Power Adapter Charger or after two 2 hours of use When the device is operating in Intermittent Pneumatic Compression Mode the patient should remain seated reclining or lying down Pressure Changes During Intermittent Pneumatic Compression Mode Chamber 1 Chamber2 Chamber3 Chamber 4 O Mo Pressure mmHg N N UN WN oO wm
4. regardless of whether LS the Compression Sleeve is to be applied to the right or left leg Place the arch of the foot over chamber 1 marked with an arrow on the Compression Sleeve with the toes pointing in the direction of the arrow 7 a se nadine Strap 7 l 5 rrr rere ATTE Strap J ankle strap Wrap strap 1 over the top of the foot and secure in place by wrapping strap 2 ankle strap around the ankle and placing over strap 1 Wrap strap 3 over the top of the foot and secure in place over straps 1 and 2 Gee Strap 3 The correctly applied foot section will appear as shown Once the foot section is fastened lift the leg section of the Compression Sleeve and drape over the leg with the Control Unit and ACTitouch logo positioned over the shin Wrap the loop fasteners around the back of the calf Fix the loop fasteners securely in place with the hook fasteners Ensure that fasteners are adjusted to give a close fit between the Compression Sleeve and the leg and foot The correctly applied ACTitouch System will appear as shown WARNING When applied the top of the Compression Sleeve should be at least 2 5cm below the crease of the knee when seated If this is not the case recheck the sizing and fit See Section 9 1 ACTitouch Compression Sleeve Sizing and Section 5 4 3 Applying the Compression Sleeve 5 IMPORTANT Always ensure that the Compression Sleeve is applied in the correct
5. 00 for the average number of hours the device has been used per day in Sustained Compression Mode and Intermittent Pneumatic Compression Mode and 001 for the number of days since the device was last reset CHAPTER 10 Technical Information The ACTitouch System is not made with natural rubber latex The ACTitouch System is tested to complies with the following equipment classifications and standards U S Medical Equipment Classification Class II Degree of Protection Against Electric Shock Class II Classification According to Directive 93 42 EEC IIA Safety UL60601 1 and CAN CSA C22 2 No 601 1 M90 Electromagnetic Compatibility EMC EN60601 1 2 Software EN60601 1 4 Internal Power Source Lithium lon Battery External PSU Input 100 240Vac 200mA 50 60H7 Class II External PSU Output 7 5Ndc 900MA Dimensions and Weights Component Size cm inches Weight kg Ibs Control Unit 18 7X6 9xX3 2 7 4 x 2 7 x 1 3 0 22 kg 0 49 Ibs Pressure Parameters Mode Foot Lower Calf Middle Calf Upper Calf 5 mmHg 5 mmHg 5 mmHg 5 mmHg Sustained Compression 40 40 30 20 Intermittent Pneumatic Compression 50 50 45 40 Operating Conditions Temperature Humidity Pressure Storage Conditions 10 C to 40 C 50 F to 104 F 0 to 75 RH 0 7 to 1 3 Bar 70 kPa to 130 kPa Store at room temperature Avoid excessive heat a
6. air pressure to ensure the correct level of compression is applied to the leg UN The Undersock is designed to draw perspiration and moisture away from the skin and has padding in key areas to provide additional comfort D The Power Adapter Charger is used to power the device directly or to charge the battery for ambulatory use The device has two 2 modes of operation Sustained Compression Mode and Intermittent Pneumatic Compression Mode 2 1 Sustained Compression Mode In this mode the device provides sustained graduated pneumatic compression to the leg at preset pressures while powered by its own rechargeable battery When it is first switched on the device gradually inflates starting at the foot and working up toward the knee Each chamber will stop inflating when the correct pressures are achieved and will hold these pressures until the device is turned off Every half hour the pressures are automatically checked and readjusted if necessary The patient may hear the pump running for a few seconds while the pressure is being checked In this mode the patient is free to move around and carry out normal activities See Chapter 3 Warnings and Cautions Pressure Changes During Sustained Compression Mode Chamber 1 Chamber2 Chamber3 Chamber 4 oO N N A O wm Pressure mmHg uw Time When operating in Sustained Compression Mode and absolute quiet is necessary e g
7. position with the Control Unit on the front of the leg over the shin Applying the sleeve too loosely may result in the unit switching off 5 5 Switching On the ACTitouch System in Sustained Compression Mode E IMPORTANT If footwear is to be worn during the treatment session it is advisable for the wearer to put on footwear prior to switching on the ACTitouch System Do not switch on the device in Sustained Compression Mode unless it is applied to the leg Ensure that the Control Unit is correctly inserted in the Compression Sleeve that the Compression Sleeve is correctly applied to the leg and that the Power Adapter Charger is not connected While seated press and hold the ON OFF button until the status indicator illuminates approximately two 2 seconds The ON OFF button can then be released The Compression Sleeve will now inflate It may take up to five 5 minutes to completely inflate the Compression Sleeve Remain seated during inflation To ensure a better fit pull up and support the Compression Sleeve in place while the chambers inflate The Control Unit is programmed to inflate the chambers of the Compression Sleeve to preset pressures When the correct pressures are reached the Control Unit will stop pumping When the Compression Sleeve is fully inflated the patient may stand up and resume normal activities See Chapter 3 Warnings and Cautions The MUTE button may be used in Sustained Compression Mode once the Com
8. the unit will switch off The Control Unit may now be reinserted into the Compression Sleeve and used as normal 2 Please call customer service at toll free 1 866 435 3948 Customer service can be contacted at 1 866 435 3948 toll free between 8 00 am 5 00 pm CT Monday through Friday Problem Possible Cause Corrective Action The Control Unit power 1 The Control Unit needs to 1 Charge the Control Unit Refer to Section 5 3 does not last a full day be charged Charging the Device 2 Device fault 2 Please call customer service at toll free 1 866 435 3948 There is a change 1 The Control Unit has not been securely 1 Refer to Section 5 4 2 Inserting the Control in performance of inserted into the Compression Sleeve Unit into the Compression Sleeve the device 2 Device fault 2 Please call customer service at toll free 1 866 435 3948 The device turns off 1 Automatic shutdown 1 Switch the Control Unit back on Refer to unexpectedly due to temporary event Section 5 5 Switching On the ACTitouch System in Sustained Compression Mode 2 The Control Unit needs to be charged 2 Charge the Control Unit Refer to Section 5 3 Charging the Device 3 Auto shutdown and lock out 3 Remove the Control Unit from the Compression Sleeve Reset the device by pressing and holding the MUTE button for ten 10 seconds The LCD will flash to indicate a successful event log reset and the un
9. to patients whose leg length B is less than 35cm Healthcare professionals should assess any potential interference between the peroneal nerve the back of the knee and the Compression Sleeve Step 3 Based on measurements A and B select the correct size of Compression Sleeve Circumference A Less than 22cm gt 32cm gt 48cm Greater than 22cm 32cm 48cm 60cm 60cm Less than Length 40cm n a 240 M240 L240 n a B and Dene n a S300 M300 L300 n a 9 2 ACTitouch Undersock Sizing Select the correct size of ACTitouch Undersock based on the patient s current shoe size Undersock Size Men Women S P Small Petite 4 to 6 2 5 to 7 2 M M Medium 7 to 9 2 8 to 10 2 L G Large 10 to 12 11 to 13 2 XL Extra Large 13 and over 14 and over 9 3 Compliance Monitoring The device is designed to record and display compliance data 9 3 1 Compliance Data Display Remove the Control Unit from the Compression Sleeve in order to read the compliance data a To remove the Control Unit simultaneously press down firmly on the two 2 release buttons and lift the Control Unit release handle By lifting the Control Unit release handle the Control Unit will eject approximately 1 2 inch from its fixed position The Control Unit may now be removed from the Control Unit housing by sliding it out To display the compliance data press the ON OFF bu
10. 1 Limited Warranty for Home Use 27 8 2 Obtaining Replacement Products and Service 28 8 3 Limited Warranty and Service for Facility Use n n anaana 28 CA PIENS ierenererssssnirrorres 28 8 5 Product Development and Quality Improvement 28 Chapter 9 Information for Clinicians 29 9 1 ACTitouch Compression Sleeve SIZING pa nck ss nvhaaaviawersd 29 9 2 ACTitouch Undersock Sizing 30 9 3 Compliance Monitoring 31 Chapter 10 Technical Information 33 10 1 SVD ONS ix onder eivesianmarddmne s 34 10 2 Electromagnetic Interference 36 CHAPTER Component List Before first use ensure that the following ACTitouch System components are accessible Compression Sleeve Power Adapter Charger PE E EE Control Unit E EE E E ETE Undersocks Three 3 socks included User s Guide Not shown CHAPTER Product Description The ACTitouch System applies pneumatic compression to the lower leg ankle and foot It consists of four 4 main parts _ The Compression Sleeve consists of four 4 chambers that inflate with air to apply pressure to the leg Its simple wrap around design with hook and loop fasteners means the Compression Sleeve can be fitted to many differently shaped legs and can be applied and removed with ease N The Control Unit fits into the Compression Sleeve during device use It monitors and adjusts the
11. 9 8 00 A M 5 00 P M CT www tactilesystems com ACTitouch and the ACTitouch logo are trademarks of Tactile Systems Technology Inc 2013 Tactile Systems Technology Inc All rights reserved D N 500220 000 00 Rev B 07 2013
12. ACTitouch ACT Adaptive Compression Therapy User s Guide YACTitouch Table of Contents Chapter 1 Component List 2 2 Chapter 2 Product Description 3 2 1 Sustained Compression Mode 4 2 2 Intermittent Pneumatic Compression Mode 5 Chapter 3 Warnings and Cautions 6 Bl Wamings rei darsndin osu erediens 6 3 2 Cautions caved saxdasecnueewnass 7 Chapter 4 Indications and Contraindications 8 4 1 Indications 0 0 00 00s 8 42 Contraindications 8 Chapter 5 Directions for Use 005 9 5 1 Functional Controls 9 52 TASS Eck pedade dnni 11 5 3 Charging the Device 11 5 4 Applying the ACTitouch System 12 5 5 Switching On the ACTitouch System in Sustained Compression Mode 16 5 6 Muted Operation in Sustained Compression Mode 16 5 7 Intermittent Pneumatic Compression Mode 17 5 8 Switching Off the ACTitouch System 18 5 9 Removing the ACTitouch System 18 Chapter 6 Wound Dressings 0 19 Chapter 7 Cleaning Care and Maintenance 20 7 1 Cleaning and Disinfecting 20 7 2 Storage and Handling 22 7 3 Maintenance and Service 22 TA WIGPOSEl inn daxedanssssesvddewexs 22 Chapter 8 Troubleshooting Guide 23 8
13. MPORTANT Do not switch the device into Intermittent Pneumatic Compression Mode unless the Compression Sleeve is applied to the leg 5 7 2 To Activate Intermittent Pneumatic Compression Mode from Off Apply the Compression Sleeve See Section 5 4 3 Applying the Compression Sleeve Plug the supplied Power Adapter Charger into the charging port on the Control Unit Ensure that the Power Adapter Charger is connected to an AC power outlet A green light will illuminate on the Power Adapter Charger if it is correctly connected to the power supply Press the ON OFF button for at least two 2 seconds Upon release of the ON OFF button Intermittent Pneumatic Compression Mode will be activated and the pump will start 5 8 Switching Off the ACTitouch System Ensure that the Power Adapter Charger is not attached to the charging port Press and hold the ON OFF button for at least two 2 seconds On release of the ON OFF button the device will now deflate all chambers and automatically switch itself off 5 IMPORTANT The ACTitouch System device may automatically switch off on rare occasions if prolonged high pressure is detected by the device This could occur if high pressure is applied externally to the sleeve This is a safety feature of the device which may be restarted in the normal way See Section 5 5 Switching On the ACTitouch System in Sustained Compression Mode If the device switches off repeatedly refer to Chapter 8 Troubleshooting Guid
14. RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol O NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflected from structures objects and people NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 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 ACTitouch device is used exceeds the applicable RF compliance level above the ACTitouch System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating ACTitouch System NOTE B Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Recommended separation distances between portable and mobile RF communications equipment and the ACTitouch System The device is intended for use in an electromagnetic environment in which ra
15. diated RF disturbances are controlled The customer or the user of the ACTitouch System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ACTitouch System as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power m of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz wW d 1 2VP d 1 2VP d 23VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12 1 2 23 10 3 8 3 8 73 100 12 12 23 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 6 Kian SYSTEMS TECHNOLOGY INC 1331 Tyler Street NE Suite 200 TEL 612 355 5100 TOLL FREE TEL 866 435 3948 Hours Monday through Friday Minneapolis Minnesota 55413 USA FAX 612 355 5101 TOLL FREE FAX 866 435 394
16. e 5 9 Removing the ACTitouch System To remove the device reverse the procedure outlined in Section 5 4 Applying the ACTitouch System If required clean the Compression Sleeve according to the cleaning instructions in Chapter 7 Cleaning Care and Maintenance Wash the Undersock according to the cleaning instructions in Chapter 7 Cleaning Care and Maintenance E IMPORTANT The patient should leave the Control Unit inserted into the Compression Sleeve at all times The battery can be charged without removing the Control Unit from the Compression Sleeve CHAPTER Wound Dressings It is recommended that the ACTitouch System is used in conjunction with an appropriate wound dressing as recommended by your clinician Apply the dressing to the wound before applying the ACTitouch Undersock Please follow the dressing manufacturer s instructions for use Appropriate tape or a light retention stocking may aid dressing retention The primary dressing over the ulcer should be changed when clinically indicated Typically dressings will require changing when they are moistened as can occur if your wound is leaking any fluid or if the dressing becomes wet after bathing or showering Remove the ACTitouch System prior to showering If you do not wish to change the dressing when showering cover the dressing with a waterproof outer layer CHAPTER Cleaning Care and Maintenance Please refer to Chapter 3 Warnings and Cautions Switch of
17. ensed healthcare professional 4 1 Indications The ACTitouch System provides graduated compression in both sustained and intermittent settings for use in Enhancing venous return Reducing venous leg ulcer healing time Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers Treatment of chronic venous insufficiency Reducing edema due to venous stasis Treatment of lymphedema 4 2 Contraindications The ACTitouch System is contraindicated if the patient has An Ankle Brachial Pressure Index of less than 0 8 Diagnosed or suspected acute Deep Vein Thrombosis DVT or pulmonary embolism Pulmonary edema Leg gangrene Acute thrombophlebitis Decompensated Congestive Cardiac Failure Severe arteriosclerosis or other ischemic vascular disease Diabetes in association with peripheral arterial disease Acute infections of the skin such as cellulitis Any lower limb malignancy CHAPTER Directions for Use The ACTitouch System should be worn as recommended and prescribed by the physician The usual prescribed duration of use will range from 10 to 14 hours per day including both Sustained Compression and Intermittent Pneumatic Compression Modes The device should be applied immediately upon waking and worn throughout the day The ACTitouch System should be removed for bathing or showering and when driving or operating machinery Reapply the device immediately after these activities The device sh
18. eve is not inflating or deflating as expected 1 The Control Unit has not been securely inserted into the Compression Sleeve 2 The Control Unit needs to be charged 3 The Control Unit has not been switched on 4 The MUTE button has been activated while operating in sustained mode 5 Device fault 1 Refer to Section 5 4 2 Inserting the Control Unit into the Compression Sleeve 2 Charge the Control Unit Refer to Section 5 3 Charging the Device 3 Switch the Control Unit on Refer to Section 5 5 Switching On the ACTitouch System in Sustained Compression Mode 4 Deactivate muted operation Refer to Section 5 6 Muted Operation in Sustained Compression Mode Operation 5 Please call customer service at toll free 1 866 435 3948 The Compression Sleeve is difficult to fasten securely 1 An incorrectly sized Compression Sleeve has been selected 2 The Compression Sleeve is already partially inflated prior to application to the limb 3 The Compression Sleeve hook or loop fastening areas have been contaminated with foreign bodies debris such as lint or hair 4 Device fault 1 Refer to Section 9 1 ACTitouch Compression Sleeve Sizing and verify the correct size sleeve has been selected 2 Switch the Control Unit on Prior to full inflation of the Compression Sleeve switch the Control Unit off again to evacuate any air present in the sleeve 3 Inspect the Compression Sleeve fa
19. f and disconnect the Power Adapter Charger before cleaning or disinfecting 7 1 Cleaning and Disinfecting 7 1 1 Cleaning the ACTitouch Undersock E IMPORTANT The ACTitouch Undersock is intended for single patient use only It is recommended that the ACTitouch Undersock be replaced after a maximum of 60 washes To purchase additional socks please contact Customer Service at 1 866 435 3948 Machine wash hot on a gentle cycle Air dry or tumble dry on a low temperature setting Do not iron Do not use chlorine based bleach Do not dry clean eO 7 1 2 Cleaning and Disinfecting the ACTitouch Compression Sleeve WARNING Switch off and disconnect the Power Adapter Charger before inspecting cleaning or disinfecting Failure to comply could result in electric shock To clean wipe down with a soft cloth dampened with mild soap and water Do not immerse in fluids Air dry thoroughly Do not machine wash Do not tumble dry Do not iron Do not dry clean EX The ACTitouch Compression Sleeve should be disinfected anytime there are biological contaminants or visible stains After cleaning wipe down with an isopropyl alcohol or water based antimicrobial wash with a soft cloth or pad Do not immerse in fluid Do not steam sterilize For device use in multi patient situations it is important to minimize cross contamination by disinfecting the ACTitouch system between patient
20. ging port and power supply A green light will illuminate on the Power Adapter Charger if it is correctly connected to an AC power outlet 3 Switch the Control Unit on Refer to Section 5 71 To Activate Intermittent Pneumatic Compression Mode from Sustained Compression Mode Operation and Section 5 72 To Activate Intermittent Pneumatic Compression Mode from Off 4 Remove the Control Unit from the Compression Sleeve Reset the device by pressing and holding the MUTE button for ten 10 seconds The LCD will flash to indicate a successful event log reset and the unit will switch off The Control Unit may now be reinserted into the Compression Sleeve and used as normal om Please call customer service at toll free 1 866 435 3948 The Compression Sleeve appears to be leaking air 1 The Control Unit has not been securely inserted into the Compression Sleeve 2 Device fault 1 Refer to Section 5 4 2 Inserting the Control Unit into the Compression Sleeve N If sleeve is damaged call customer service at toll free 1 866 435 3948 for replacement The device is frequently locking out 1 The event log needs to be reset 2 Multiple lockouts may be a device fault s Remove the Control Unit from the Compression Sleeve Reset the device by pressing and holding the MUTE button for ten 10 seconds The LCD will flash to indicate a successful event log reset and
21. henol based agents such as trichlorophenol TCP 1 2 Storage and Handling It is recommended that the ACTitouch System be stored at room temperature Avoid excessive heat and cold Do not store device in direct sunlight Ensure that the device is clean and dry prior to storage Reasonable care should be taken when handling and using the ACTitouch System Although the device has been designed for everyday use heavy impacts contact with sharp objects and rough handling should be avoided Do not immerse the device in fluid If either the Compression Sleeve or Control Unit become soaked with fluid or otherwise damaged do not use the device 7 3 Maintenance and Service The ACTitouch System is designed to be maintenance free routine service is not required A CAUTION Do not open or take apart the ACTitouch Control Unit for any reason There are no customer serviceable parts in the ACTitouch System 7 4 Disposal For disposal of any components of the ACTitouch System please follow local waste regulations or consult your local institutional waste management service or municipal waste authority CHAPTER Troubleshooting Guide The following table provides a troubleshooting guide for the ACTitouch System in the unlikely event of a malfunction Please refer to Section 8 2 Obtaining Replacement Products and Service for additional information Problem Possible Cause Corrective Action The Compression Sle
22. it will switch off The Control Unit may now be reinserted into the Compression Sleeve and used as normal as 4 Device fault Please call customer service at toll free 1 866 435 3948 Customer service can be contacted at 1 866 435 3948 toll free between 8 00 am 5 00 pm CT Monday through Friday 8 1 Limited Warranty for Home Use Tactile Systems Technology Inc TSTI provides a warranty for the ACTitouch System The ACTitouch Control Unit is warranted to be free from defects in material and workmanship for a period of one 1 year from the date of purchase The ACTitouch Compression Sleeve is warranted to be free from defects in material and workmanship for a period of three 3 months from the date of purchase All other accessories and supplies related to the use of the ACTitouch System are warranted to be free from defects in material and workmanship for their first use TSTI s sole obligation in the event of a breach of this warranty is expressly limited to the replacement of defective parts that cannot in the sole discretion of TSTI be repaired Replacement parts may be new or refurbished parts as solely determined by TSTI No representation or other affirmation of fact set forth in this agreement including but not limited to statements regarding suitability for use or performance of the ACTitouch System shall be deemed to be a warranty or representation by TSTI for any purpose nor give rise to any liabil
23. ity or obligation of TSTI EXCEPT FOR THE FOREGOING TST MAKES NO OTHER WARRANTY THE WARRANTIES SET FORTH HERE ARE IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED WHICH ARE HEREBY DISCLAIMED AND EXCLUDED BY THE MANUFACTURER INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE AND ALL OBLIGATIONS OR LIABILITIES ON THE PART OF TSTI FOR DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE USE REPAIR OR PERFORMANCE OF THE ACTITOUCH SYSTEM IN NO EVENT SHALL TSTI BE LIABLE FOR ANY SPECIAL DIRECT INDIRECT OR CONSEQUENTIAL DAMAGES Some states provinces or countries do not allow exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply This warranty is available only to the original user and is not transferable Repairs or alterations to the product not conducted by TSTI shall void these warranties These warranties do not cover failures due to improper or negligent use of the product These warranties provide specific legal rights there may be other available rights which may vary by state province or country 8 2 Obtaining Replacement Products and Service For information about replacement products and service contact customer service 1 866 435 3948 8 3 Limited Warranty and Service for Facility Use Contact Tactile Systems for information regarding the service agreements available to facilities 8 4 Patents The ACTito
24. n not standing This can be for One 1 session of two 2 hours OR Two 2 one hour 1 hour sessions Any session should be a minimum of 30 minutes It is recommended that the Intermittent Pneumatic Compression Mode be used late in the user s day when swelling would be the greatest and when the user Is less active and can sit recline or lie down To operate in Intermittent Pneumatic Compression Mode for longer than two 2 hours in succession the Intermittent Pneumatic Compression Mode may be re activated after the device automatically switches back into Sustained Compression Mode For advice on optimal wear time in Intermittent Pneumatic Compression Mode please consult a healthcare professional Failure to use the device as recommended may delay ulcer healing or may negatively impact treatment outcomes CAUTION Do not walk while the device is operating in Intermittent Pneumatic Compression Mode 5 7 1 To Activate Intermittent Pneumatic Compression Mode from Sustained Compression Mode Operation Plug the supplied Power Adapter Charger into the charging port on the Control Unit Ensure that the Power Adapter Charger is connected to an AC power outlet A green light will illuminate on the Power Adapter Charger if it is correctly connected to the power supply Press the ON OFF button for at least two 2 seconds Upon release of the ON OFF button Intermittent Pneumatic Compression Mode will be activated and the pump will start E I
25. nd cold 0 1 Symbols ON OFF button Class Il equipment Protection MUTE button Sustained Compression Mode Caution Friwo AC DC adaptor type cE FW7333M 08 Intermittent Pneumatic Compression Mode REF Manufacturer s part number Direct current Keep dry Avoid high humidity AC DC Adapter polarity center positive pi Operating temperature limits Type BF Applied part LOT Lot number MEDICAL EQUIPMENT with respect to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 43MH 2 2 y aS a Refer to User s Manual for Instructions for Use 43MH Manufactured after August 2005 Do not dispose of this product special collection only EU only Recycle X Hat SP hes TPA SUOIMUNAP JOGWUAS JO PIND SJas QDIAVP JNOA UO zey uey JUBAYIP ag Aew UOIDIdap aqe Aq JLIS 0 JOU Jaqe S9 0N 3 HWE L LO9 ON 80 NIEEEZMA EF Fono COD stoner O Y A E m 3 NSZ INIWdINDI TIAI Ome uporov X F 00 000 t 700S 34 juo XY 666666 LOV z LYSS BJos uuIy s jodeauuiy a onraooronnoai swausas amv IILIIIITIIIIIII TIITLIT UIRW J age Y SUIPEdY S NSSI JI BDIAJAS JAWOJSND SWAISAS L L WUNLWIUILU X OOS JO uoneuiunjji ue yum LUD 00L S9YUI Oy 0 w 09 sayu OZ jeJ u 8 Aye JapeJeUD SOZILWIXEL JU SIUEJSIP L Je JAS dAa ye NOA
26. ould be removed just prior to going to bed and recharged See Section 5 3 Charging the Device Consult with your healthcare provider about other compression options during sleep E IMPORTANT Failure to wear the device as recommended even for short periods may delay ulcer healing or may negatively impact treatment outcomes 5 1 Functional Controls ACTitouch Control Unit ENEA ALIETTE TELIT Status indicator PRA Charging DOM see tinirenrii tanii aieia T s E ON OFF button ex aa MUTE button Liquid crystal display LCD 0 cI ACTitouch Compression Sleeve Outer Face Up piion perereeenen Control Unit K N release buttons F L Leek his SORA SNR raii Control Unit release handle Leg section i REAA EARANN Foot section ee Chamber 4 upper calf aoo N Chamber 3 mid calf oE zan Chamber 2 ankle gaiter Strap 2 ankle strap Strap 3 oe Chamber 1 foot 5 2 First Use Remove all device components from the packaging and fully charge the device as indicated in Section 5 3 Charging the Device 5 n 3 Charging the Device Before each daily use the ACTitouch System should be fully charged It is recommended that the device be charged every night for a minimum of four 4 hours The Control Unit should remain inserted in the Compression Sleeve while charging Ensure that the Power Adapter Charger is connected to an AC power outlet A green light will illuminate on the Power Adapter Charge
27. pression Sleeve is fully inflated See Section 5 6 Muted Operation in Sustained Compression Mode for details 5 6 Muted Operation in Sustained Compression Mode To activate muted operation during Sustained Compression Mode press the MUTE button and hold for at least two 2 seconds Upon release of the MUTE button the Control Unit will make a subtle beep sound E IMPORTANT While muted the device will remain inflated to apply pressure to the leg but will no longer adjust the pressure To deactivate muted operation press the MUTE button again for at least two 2 seconds Upon release of the MUTE button the Control Unit will make a subtle beep sound The pump will now restart and if necessary readjust all chambers back to the correct pressures If muted operation is not manually deactivated then the device will automatically switch back to Sustained Compression Mode operation after two 2 hours 5 7 Intermittent Pneumatic Compression Mode In Intermittent Pneumatic Compression Mode the device will operate a cyclic pulsed inflation deflation sequence until either it is unplugged from the Power Adapter Charger or two 2 hours have elapsed at which point the device will switch back to Sustained Compression Mode operation It is recommended that the Intermittent Pneumatic Compression Mode be used for at least two 2 hours per day When using in Intermittent Pneumatic Compression Mode the user should be either seated or lying dow
28. r about compression options when not wearing the ACTitouch System Ensure the electrical supply to the device is switched off by disconnecting it from the Power Adapter Charger before cleaning or disinfecting The ACTitouch System should be removed before bathing or showering Reapply the device immediately afterward ensuring the skin is dried prior to application Do not walk with the Power Adapter Charger attached to the device JN 3 2 Cautions Regularly check the status indicator located at the top of the control unit while using ACTitouch The green light on the Control Unit indicates that appropriate compression is being applied to the limb A flashing red status light and periodic audible alarm indicates that battery power is low No light indicates the power is off Ensure that the device is clean and dry prior to storage Do not immerse the ACTitouch System in water or spill liquid on the Control Unit The device is not waterproof and exposure to liquid may damage the Control Unit or Compression Sleeve If the device becomes soaked with fluid discontinue use of the device Do not allow the Compression Sleeve to come into contact with sharp objects Do not expose the Undersock Compression Sleeve or Control Unit to excessive heat or open flames such as cigarettes portable heaters etc CHAPTER Indications and Contraindications Rx Only U S Federal law restricts this device to sale by or on the order of a lic
29. r when it is correctly connected Plug the supplied Power Adapter Charger into the charging port on the Control Unit If this is done correctly the green status indicator on the Control Unit will illuminate Charge the unit for a minimum of four 4 hours even if the status indicator on the Control Unit is showing green The status indicator flashes red when the battery charge is low Immediate charging is required The normal battery life between charges is sixteen 16 hours The device will be fully charged after four 4 hours Nightly charging is recommended If the Control Unit is stored unused for prolonged periods of time the Control Unit should be fully charged at least once every six 6 months This will ensure that a good battery life is maintained E IMPORTANT To ensure an adequate supply of power while wearing the device please ensure that you charge the device at the end of each day Charge whether the status indicator is showing green or flashing red Use only the Power Adapter Charger provided with your ACTitouch System for charging the Control Unit and for Intermittent Pneumatic Compression Mode operation The batteries are not user replaceable 5 4 Applying the ACTitouch System CAUTION The ACTitouch Undersock should not be placed in direct contact with an open wound It is recommended that this device be used in conjunction with an appropriate wound dressing before the device is applied See Chapter 6 Wound Dre
30. ronment lt 5 U lt 5 U gt 95 dip in U gt 95 dip in U for 5 sec for 5 sec Power frequency 50 60 Hz 3 A m 3 A m Power frequency magnetic magnetic field fields should be at levels IEC 61000 4 8 characteristic of a typical location in a typical domestic commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level Guidance and Manufacturer s Declaration Electromagnetic Immunity The ACTitouch System is intended for use in the electromagnetic environment specified below The customer or the user of the ACTitouch System should assure that it is used in such an environment Immunity test IEC 60601 test Compliance Electromagnetic environment guidance level level Portable and mobile RF communications equipment should be used no closer to any part of the ACTitouch System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 0 35 VP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 0 29 VP 80 MHz to 800 MHz IEC 61000 4 3 80MHz to 2 5GHz d 0 58 VP 800 MHz 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 metres m Field strengths from fixed
31. s usage To disinfect the ACTitouch system wipe down with an isopropyl alcohol or water based antimicrobial wash with a soft cloth or pad Do not immerse in fluid Do not steam sterilize 36 Do not clean or disinfect with household detergents abrasive cleaners scourers degreasers CS solvents bleach or phenol based agents such as trichlorophenol TCP 7 1 3 Cleaning and Disinfecting the ACTitouch Control Unit WARNING Switch off and disconnect the Power Adapter Charger before inspecting cleaning or disinfecting Failure to comply could result in electric shock To clean wipe down with a soft cloth dampened with mild soap and water Do not immerse in fluids Air dry thoroughly The ACTitouch Control Unit should be disinfected anytime there are biological contaminants or visible stains After cleaning wipe down with an isopropyl alcohol or water based antimicrobial wash with a soft cloth or pad Do not immerse in fluid Do not steam sterilize For device use in multi patient situations it is important to minimize cross contamination by disinfecting the ACTitouch system between patients usage To disinfect the ACTitouch system wipe down with an isopropyl alcohol or water based antimicrobial wash with a soft cloth or pad Do not immerse in fluid Do not steam sterilize 30 Do not clean or disinfect with household detergents abrasive cleaners scourers degreasers CS solvents bleach or p
32. ssings E IMPORTANT Patients are advised to apply the device before putting on clothing over the leg and foot 5 4 1 Applying the ACTitouch Undersock For correct positioning of the Undersock ensure that the word ACTitouch is positioned on the top of the foot and the padded areas are positioned over the shin and around the heel and ankle Apply the Undersock over the foot and then pull it up to just below the knee taking care not to displace any wound dressing 5 4 2 Inserting the Control Unit into the Compression Sleeve Slide the Control Unit into its housing on the Compression Sleeve until a click is felt and heard the Control Unit is then secured correctly within the sleeve Correct placement Verify the Control Unit is correctly assembled by checking to see if the blue markings are visible on the front of the Control Unit If they are visible the Control Unit is not fully secure Incorrect placement E IMPORTANT For correct functioning of the device ensure that the Control Unit is correctly inserted in the Compression Sleeve The patient should leave the Control Unit inserted into the Compression Sleeve at all times The battery can be charged without removing the Control Unit from the Compression Sleeve 5 4 3 Applying the Compression Sleeve Place the Compression Sleeve on the floor outer face downward so that the chambers can be seen with strap 2 ankle strap pointing toward the wearer
33. stening areas and remove any fluff or similar foreign bodies 4 Please call customer service at toll free 1 866 435 3948 Customer service can be contacted at 1 866 435 3948 toll free between 8 00 am 5 00 pm CT Monday through Friday Problem Possible Cause Corrective Action The Control Unit will not 1 The Control Unit has not been securely 1 Refer to Section 5 4 2 Inserting the Control operate in Sustained inserted into the Compression Sleeve Unit into the Compression Sleeve Compression Mode 2 The Control Unit needs to be charged 2 Charge the Control Unit Refer to Section 5 3 Charging the Device 3 The Control Unit has not been 3 Switch the Control Unit on Refer to switched on Section 5 5 Switching On the ACTitouch System in Sustained Compression Mode 4 The MUTE button has been activated 4 Deactivate muted operation Refer to Section 5 6 Muted Operation in Sustained Compression Mode Operation 5 The event log needs to be reset 5 Remove the Control Unit from the Compression Sleeve Reset the device by pressing and holding the MUTE button for ten 10 seconds The LCD will flash to indicate a successful event log reset and the unit will switch off The Control Unit may now be reinserted into the Compression Sleeve and used as normal a Please call customer service at toll free 1 866 435 3948 Charge the Control Unit Refer to Chapter 6 Device fault
34. tton until the status indicator illuminates approximately two 2 seconds and release The LCD alternates between displaying the following A 4 A i The average number of hours the device has been in use per day 24 hour ZH period in Sustained Compression Mode since the compliance data was last reset o gt A dash appears in the LCD next to the sustained compression icon as circled The average number of hours the device has been in use per day 24 hour period in Intermittent Pneumatic Compression Mode since the compliance data was last reset A dash appears in the LCD next to the Intermittent Pneumatic Compression icon as circled The number of days since the compliance data was last reset Three 3 digits appear as circled 9 3 2 Exiting from Compliance Display Should you not wish to reset the compliance data you may exit the compliance data display by pressing the ON OFF button for at least two 2 seconds Upon release of the ON OFF button the Control Unit will switch off 9 3 3 Compliance Data Reset After review the compliance data can be reset by pressing the ON OFF button and MUTE button simultaneously for at least five 5 seconds and then releasing The LCD screen will flash 00 to indicate a successful data reset and the unit will switch off The Control Unit may now be re inserted into the Compression Sleeve and used as normal Resetting the compliance data will reset the values as follows
35. uch System is protected by the following United States patents 7 741 966 7 909 786 7 947 003 8 075 507 D578 652 Additional patents pending 8 5 Product Development and Quality Improvement Tactile Systems Technology Inc reserves the right to modify product specifications as part of its continuing program of product development and quality improvement CHAPTER Information for Clinicians 9 1 ACTitouch Compression Sleeve Sizing E IMPORTANT For correct functioning of the ACTitouch System select the correct size of Compression Sleeve and Undersock When measuring do not pull the tape measure tightly Select the correct size of the ACTitouch Compression Sleeve based on the guidelines below Step 1 Measure the leg around the point of maximum calf circumference A parallel to the floor The patient should be either standing with weight distributed evenly on both legs or seated with feet resting lightly on the floor E IMPORTANT Do not use the ACTitouch System on patients whose calf circumference A is less than 22cm or greater than 60cm Step 2 While the patient is seated measure the leg length B vertically from the floor to the popliteal tendon which extends back from the knee along the back of the lower outer part of the thigh The seat should be adjusted so that the patient can sit with the lower legs vertical thighs horizontal and feet flat on the floor CAUTION Special attention should be given
36. w voltage IEC 61000 3 2 power supply network that supplies buildings Voltage fluctuations flicker Complies used for domestic purposes emissions IEC 61000 3 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The ACTitouch System is intended for use in the electromagnetic environment specified below The customer or the user of the ACTitouch System should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD 8 kV air 8 kV air concrete or ceramic tile IEC 61000 4 2 If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient 2 kV for power supply 2 kV for power supply Mains power quality should Burst lines lines be that of a typical domestic IEC 61000 4 4 Surge 1 kV differential mode 1 kV differential mode IEC 61000 4 5 2 kV common mode 2 kV for common mode Voltage dips short lt 5 U lt 5 U interruptions and voltage gt 95 dip in U gt 95 dip in U variations on power supply for 0 5 cycle for 0 5 cycle input lines IEC 61000 4 11 40 U 40 U 60 dip in U 60 dip in U for 5 cycles for 5 cycles 70 U 70 U 30 dip in U for 25 cycles 30 dip in U for 25 cycles commercial or hospital envi
37. woy Aeme SUDE yun O UOD y a2e d qe ay Ped o UP O NUOD INOA Jo yDeq y UO PUNO SI Jaqe adIAp OY Jeqe DVN l 0 2 Electromagnetic Interference This device has been tested and found to comply with the limits for medical devices in accordance with EN60601 1 2 2001 These limits are designed to provide reasonable protection to assure the safety of medical devices from interference from other electrical equipment and devices This equipment can be affected by radio frequency energy and if not installed and used in accordance with the instructions may cause interference to other devices in the vicinity There is no guarantee that interference will not occur in a particular installation Guidance and Manufacturer s Declaration Electromagnetic Emissions The ACTitouch System is intended for use in the electromagnetic environment specified below The customer or the user of the ACTitouch System should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The ACTitouch System uses RF energy only for CISPR 11 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The ACTitouch System is suitable for use in all CISPR 11 establishments including domestic and those Harmonic emissions Class A directly connected to the public lo
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