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9 .3

  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

CISPR 11

Group 1

The ACTitouch System uses RF energy only 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

Class B

The ACTitouch System is suitable for use in all 

establishments including domestic and those directly 

connected to the public low-voltage power supply 

network that supplies buildings used for domestic 

purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Complies

Summary of Contents for Actitouch

Page 1: ...USER GUIDE ACTITOUCH SYSTEM Adaptive Compression Therapy...

Page 2: ...uted Operation in Sustained Compression Mode 13 5 7 Intermittent Pneumatic Compression Mode 13 5 8 Switching Off the ACTitouch System 15 5 9 Removing the ACTitouch System 16 Chapter 6 Wound Dressings...

Page 3: ...6 435 3948 Before first use ensure that the following ACTitouch System components are accessible Compression Sleeve Power Adapter Charger Control Unit Undersocks Three 3 socks included User Guide Not...

Page 4: ...ay from the skin and has padding in key areas to provide additional comfort 4 The Power Adapter Charger is used to power the device directly or to charge the battery for ambulatory use The device has...

Page 5: ...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...

Page 6: ...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...

Page 7: ...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 contro...

Page 8: ...ould 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...

Page 9: ...ouch Control Unit Status indicator ON OFF button MUTE or PAUSE button Liquid crystal display LCD Charging port ACTitouch Compression Sleeve Outer Face Up Control unit release handle Control unit relea...

Page 10: ...it is correctly connected Plug the supplied Power Adapter Charger into the charging port on the control unit If this is done correctly and the battery was low the control unit status indicator will f...

Page 11: ...it 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 con...

Page 12: ...e 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 r...

Page 13: ...oot 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 strap 1 over the top of the foot an...

Page 14: ...e sleeve too loosely may result in the unit switching off 5 5 Switching On the ACTitouch System in Sustained Compression Mode IMPORTANT If footwear is to be worn during the treatment session it is adv...

Page 15: ...or paused 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 IMPORTANT...

Page 16: ...ained 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 heal...

Page 17: ...n 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...

Page 18: ...Dressings CHAPTER 6 The ACTitouch System should be used in conjunction with an appropriate wound dressing as recommended by your clinician Apply the dressing to the wound before applying the ACTitouc...

Page 19: ...infecting 7 1 1 Cleaning the ACTitouch Undersock IMPORTANT The ACTitouch Undersock is intended for single patient use only It is recommended that the ACTitouch Undersock be replaced after a maximum of...

Page 20: ...infect the ACTitouch Compression Sleeve between patient use or if there are visible biological contaminants or visible stains the following steps are recommended 1 Clean any visible blood or body flui...

Page 21: ...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 pri...

Page 22: ...ten 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 f...

Page 23: ...ressing 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 Compress...

Page 24: ...ssing 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 Compressio...

Page 25: ...948 8 1 Limited Warranty for Home Use Tactile Medical provides a warranty for the ACTitouch System The ACTitouch control unit sleeve and power adapter are warranted to be free from defects in material...

Page 26: ...re 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 serv...

Page 27: ...iddle Calf 5 mmHg Upper Calf 5 mmHg Sustained Compression 40 40 30 20 Intermittent Pneumatic Compression 50 50 45 40 Equipment Classifications and Standards The ACTitouch System is tested to complies...

Page 28: ...chanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 43MH Manufactured after August 2005 Do not dispose of this product special collection only EU only Recycle 9 2 Device Label T...

Page 29: ...27 Customer Service Toll Free 866 435 3948 Tactile Medical Minneapolis Minnesota 55413 Rx Only 500234 000 00 MADE IN TAIWAN 500233 000 01...

Page 30: ...gnetic 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 e...

Page 31: ...er supply lines 2 kV for power supply lines Mains power quality should be that of a typical domestic commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV...

Page 32: ...smitters as determined by an electromagnetic site survey A should be less than the compliance level in each frequency range B Interference may occur in the vicinity of equipment marked with the follow...

Page 33: ...ower of transmitterW Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1...

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Page 36: ...oll free Telephone 866 435 3948 U S only Fax 612 355 5101 Toll free Fax 866 435 3949 U S only Hours of Operation Monday Friday 7 a m to 7 p m CT Email info tactilemedical com www tactilemedical com AC...

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