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Table 8: Guidance and Manufacturer’s Declaration –  

Electromagnetic Immunity (continued)

The Entre system is intended for use in the electromagnetic environment specified 
below . The customer or the user of the Entre should assure that it is used in such an 
environment .

Immunity  

Test

IEC 60601  

Test Level

Compliance 

Level

Electromagnetic

Environment – Guidance

Conducted  
RF IEC  
61000-4-6

Radiated  
RF IEC  
61000-4-3

3 Vrms 
150 kHz to 
80 MHz

3 V/m 
80 MHz to 
2,5 GHz

[V1] 3 Vrms

[E1] 3 V/m

Portable and mobile RF communications 
equipment should be used no closer to any 
part of the PD08-U system, including cables, 
than the recommended separation distance 
calculated from the equation applicable to 
the frequency of the transmitter .

Recommended separation distance:

d = [ 3,5/V1]  √P

d = [ 3,5/E1 ]  √P  80 MHz to 800 MHz

d = [ 7/E1]  √P  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 meters (m) .

Field strengths from fixed 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:

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 measured field strength in the location in which the Entre system is used exceeds 
the applicable RF compliance level above, the PD08-U system should be observed to verify normal operation . If 
abnormal performance is observed additional measures may be necessary, such as re-orienting or relocating the 
Entre system .
† Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m .

Summary of Contents for ENTRE PD08-U

Page 1: ...M O D E L P D 0 8 U U S E R G U I D E User Guide...

Page 2: ...eating the Upper Extremity 10 Chapter 3 Controller Unit Set Up 11 3 1 Setting Up the Controller Unit 11 3 2 Connecting the Hose to the Controller Unit 12 Chapter 4 Garment Application 15 4 1 Applying...

Page 3: ...7 1 Limited Warranty and Service for Home Use 28 7 2 Limited Warranty and Service for Facility Use 29 7 3 Return Policy 29 7 4 Equipment Lifetime 29 Chapter 8 Technical Information 30 8 1 Technical In...

Page 4: ...ou manage your condition improve your health and allow you to enjoy a better quality of life This guide provides the information needed to set up and use your Entre system 1 1 How to Contact Tactile M...

Page 5: ...ent Use this product only at the settings prescribed by your healthcare provider Do NOT Dispose With General Household Waste Tactile Medical complies with the Waste Electric and Electronic Equipment D...

Page 6: ...t attempt to service the controller unit Such attempts could result in injury or damage to the product and will void any warranty Do not disassemble the controller unit Unplug the controller unit when...

Page 7: ...on openings on the back or the sides of the controller unit Keep the ventilation openings free of debris such as lint and hair Never operate the controller unit on a soft surface such as a bed couch o...

Page 8: ...ent but not yet in remission Any circumstance where increased lymphatic or venous return is undesirable 1 5 Unpacking Instructions When your Entre system arrives it is important that you carefully unp...

Page 9: ...y is ordered Extender provided only if ordered Upper Extremity Treatment The garments and device accessory needed for upper extremity treatment may include the following Arm garment Y connector provid...

Page 10: ...ose connector which is attached to the garment Depending on the prescription from your physician a Y connector can be added to allow two garments to be used at the same time The device applies differe...

Page 11: ...treatment you will receive a Y connector accessory 2 2 Adjustable Pressure Levels Your healthcare provider will determine what pressure setting s are appropriate for you The Entre controller unit all...

Page 12: ...tinuous motion Full Leg Treatment This option provides full leg treatment in a distal to proximal foot to top of thigh direction via the sequential inflation of the 8 chambers Treatment time 60 minute...

Page 13: ...emity Full Arm Treatment This option provides full arm treatment in a distal to proximal hand to top of biceps direction via the sequential inflation of the 8 chambers Treatment time 60 minutes Figure...

Page 14: ...surface near an electrical outlet Position the device so you have easy access to the plug 2 Plug the supplied power adapter into the power adapter inlet on the back of the controller unit Then plug th...

Page 15: ...must be connected to the controller unit prior to connecting your garments NOTE Both garments must be connected to the Y connector Figure 3 2 a Hose Connector BOTTOM Tab Connector Collar Arrowed Latch...

Page 16: ...row is facing up Figure 3 2 b Figure 3 2 b Connecting the Hose to the Controller Unit 2 Align the arrowed latch with the notch on the controller unit port 3 Reposition your hand so your thumb and fing...

Page 17: ...onnected Two clicks will be heard one for the top and one for the bottom latch Figure 3 2 d Figure 3 2 d Properly Connecting the Latches 5 If using the Y connector ensure the Y connector is attached t...

Page 18: ...clothing example scrubs stockinette If skin irritation develops consult with your doctor Lymph fluid is moved through the vessels in the skin It is important to avoid wearing anything during therapy t...

Page 19: ...le Black pull string to zipper 1 Petite Black pull string to zipper 2 Small Teal pull string to zipper 1 Medium Teal pull string to zipper 2 Large NOTE If you are using an extender position it so the...

Page 20: ...tment Figure 4 1 b Figure 4 1 b Fully Applied Full Leg or Half Leg Garment 4 2 Applying the Arm Garment Garment Preparation 1 Once the garment is connected to the controller unit unfold and place the...

Page 21: ...l string to zipper 2 Small Teal pull string to zipper 1 Medium Teal pull string to zipper 2 Large 3 Zip the garment up completely Garment Application 4 Slide your arm into the garment NOTE If the sugg...

Page 22: ...to be modified from one treatment to the next 1 Turn the controller unit ON Turn on the controller unit by pressing the ON OFF button located on the front panel Figure 5 1 a The ON OFF button and PRE...

Page 23: ...in a chair or bend your affected limb s during the therapy session 3 Elevate the affected limb s on a pillow just above your hips 4 Check your pressure setting to ensure you have selected the correct...

Page 24: ...ug the device This will cause the internal valves to close and the garment s will not deflate properly 5 5 Storing the Entre System To store the Entre system follow the steps outlined below 1 Unplug t...

Page 25: ...ector are to be cleaned as needed using a damp cloth and mild household cleaner 1 Unplug the power adapter from the electrical outlet 2 Wipe all accessible surfaces including the power adapter 3 After...

Page 26: ...pray or similar disinfectant compliant with OSHA s Bloodborne Pathogen Standard 29 CFR 1910 1030 and or registered with EPA To disinfect the PD08 U system including garments controller or accessories...

Page 27: ...able disconnect the garment from the controller unit and then reconnect again Power up the device by pressing the ON OFF button Restart the therapy session by pressing the START PAUSE button Ensure t...

Page 28: ...troller unit and then reconnect again Power up the device by pressing the ON OFF button Restart the therapy session by pressing the START PAUSE button 2 Please call Customer Service if unable to resol...

Page 29: ...per and lower connector latches are engaged 5 If the chambers still do not fill turn the machine off detach the connectors and turn the machine ON again 6 Feel for air coming out of the controller uni...

Page 30: ...s not function 1 Power down the device Power up the device by pressing the ON OFF button 2 Please call Customer Service toll free for instructions The controller unit makes an abnormal noise 1 Stop th...

Page 31: ...ts regarding suitability for use or performance of the Entre system shall be deemed to be a warranty or representation by Tactile Medical for any purpose nor give rise to any liability or obligation o...

Page 32: ...vince or country 7 2 Limited Warranty and Service for Facility Use Contact Tactile Medical for information regarding the service agreements available to facilities 7 3 Return Policy Returns are not ac...

Page 33: ...ural rubber latex Therapy Programs 1 Chambers 8 Mode of Operation Continuous Calibration Recalibration not required Electromagnetic Interference EMI Electromagnetic Compatibility EMC The Entre system...

Page 34: ...ve 2002 95 EC Table 7 Guidance and Manufacturer s Declaration Electromagnetic Emissions The Entre system is intended for use in the electromagnetic environment specified below The customer or the user...

Page 35: ...typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line 2 kV line to earth Voltage dips short interruptions and voltage variations on powe...

Page 36: ...rom fixed 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 wi...

Page 37: ...ce facing away from you at eye level at a distance that maximizes character clarity generally 20 inches 50 cm to 40 inches 100 cm with an illumination of 500 lx minimum Call Tactile Medical Customer S...

Page 38: ...35 This page has intentionally been left blank...

Page 39: ...36 Customer Service Toll Free 833 382 2845 833 3TACTILE This page has intentionally been left blank...

Page 40: ...s MN 55416 USA T 612 355 5100 F 612 355 5101 Customer Service Toll Free Tel 833 382 2845 833 3TACTILE Toll Free Fax 866 435 3949 Hours 7 a m to 7 p m CT Monday Friday tactilemedical com For Additional...

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