User Guide Model AVACEN 100 · 2018-09-27 · 171208 AVACEN 100 User Guide 1 1. DESCRIPTION The AVACEN 100 is a Dry Heat Therapy FDA Class II Medical Device. It consists of a control

171208

User Guide Model AVACEN 100

Caution: Please read the entire user guide with care prior to using the device. AVACEN is a Registered Trademark of AVACEN, Inc.

Protected by one or more of the following U.S. patents: 8,679,170; 9,066,781; 9,192,509; 9,687,385; international equivalents. Other patents pending.

AVACEN Medical 9835 Carroll Centre Rd. #104

San Diego, CA 92126

(888) 4-AVACEN (888-428-2236) www.AVACEN.com

THE QUICK START GUIDE IS ON BACK COVER

171208

OK/Accept/ Confirm/ Select ✔

Display PanelON/OFF Silicone Seal for

Vacuum Chamber

Inflatable Cuff

Metal Heatpad

Pressure Holes

Power Supply Connector

Hand Positioning Tips: KEEP WRIST STRAIGHT AND IN THE CENTER OF THE CUFF!

POSITION WRISTIN MIDDLE OF CUFF

PARALLEL WITH CHAMBER

CORRECT

CORRECT

INCORRECT

INCORRECT

Power Plug

Up

Down

Left Right

AVACEN 100 Diagram

Vacuum Chamber Pins

Sanitary Mitt

Metal Heatpad

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Table of Contents 1. DESCRIPTION ....................................................................................................................... 1

2. UNPACKING THE UNIT ........................................................................................................ 1

3. NORMAL USE ...................................................................................................................... 1

4. INDICATIONS FOR USE ........................................................................................................ 1

5. CONTRA-INDICATIONS ........................................................................................................ 1

6. WARNINGS & PRECAUTIONS .............................................................................................. 2

7. IMPORTANT SAFETY INFORMATION ................................................................................... 3

8. CONTACT INFORMATION .................................................................................................... 4

9. EXPLANATION OF SYMBOLS ............................................................................................... 4

10. OPERATING INSTRUCTIONS (NORMAL MODE OPERATION) .............................................. 5

11. CUFF SEALING .................................................................................................................... 7

12. HAND PRESSURE INDICATOR (HPI) .................................................................................... 7

13. PAUSING A THERAPY SESSION ............................................................................................ 8

14. ADJUSTING THE THERAPY TIME .......................................................................................... 8

15. ADJUSTING THE THERAPY TEMPERATURE .......................................................................... 8

16. END OF THERAPY ................................................................................................................ 8

17. POWERING DOWN .............................................................................................................. 8

18. STANDBY MODE OPERATION .............................................................................................. 9

19. GAME MODE OPERATION ................................................................................................... 9

20. TROUBLESHOOTING AND FAQ .......................................................................................... 11

A. How long should treatment last? ...................................................................................... 11

B. How important is the placement of my hand? .................................................................. 11

C. Is it necessary to wear the AVACEN Mitt? ......................................................................... 11

D. Do I need a new a Mitt every time I have a treatment? ................................................... 11

E. Do I need to purchase the Mitts from AVACEN? ............................................................... 11

F. The AVACEN 100 powers down while the 'Sealing Cuff' message or 'Lost Vacuum Seal'

message is displayed ......................................................................................................... 12

G. "Rest Palm On Heatpad" message ..................................................................................... 12

H. "Calibration Failed" message ............................................................................................. 13

I. "System Error" Message .................................................................................................... 13

J. There is noise while the AVACEN 100 is running ............................................................... 13

K. The inflatable cuff is too tight ............................................................................................ 13

L. I keep getting a "Push Hand Down Slightly" or "Lift Hand Slightly" message ................... 14

M. The AVACEN 100 Heatpad is too hot ................................................................................. 14

N. The Display Panel Power LED does not illuminate after pushing the ON Button ............. 14

O. Checking the inflatable cuff for leaks ................................................................................ 14

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P. Excessive swelling of the hand ........................................................................................... 15

Q. Red or purple spots on the hand ........................................................................................ 15

R. Hand itches or tingles ......................................................................................................... 15

S. My hand is reddish-colored like it has been in hot water .................................................. 15

T. Sweating when using the AVACEN 100 .............................................................................. 15

U. Discomfort in wrist or forearm during use ......................................................................... 15

21. USER SETTINGS .................................................................................................................. 16

A. Language Selection ............................................................................................................. 16

B. Beep Tone Style .................................................................................................................. 16

C. Default Therapy Time ......................................................................................................... 16

D. Default Therapy Temperature ............................................................................................ 17

E. Display Error Messages ....................................................................................................... 17

F. Measure Hand Pad Force .................................................................................................... 17

G. Run Self-Sealing Test ........................................................................................................... 17

22. CLEANING ........................................................................................................................... 19

23. PERIODIC MAINTENANCE .................................................................................................. 19

Removing the Vacuum Chamber ............................................................................................... 19

Removing the Seal ..................................................................................................................... 20

Installing the Seal ....................................................................................................................... 20

Installing the Vacuum Chamber ................................................................................................ 21

24. EC DECLARATION OF CONFORMITY ................................................................................... 23

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions and Immunity.......... 24

171208 AVACEN 100 User Guide 1

1. DESCRIPTION The AVACEN 100 is a Dry Heat Therapy FDA Class II Medical Device. It consists of a control panel, metal Heatpad, and a Vacuum Chamber with an Inflatable Cuff. The vacuum pump and heat source are in the base of the unit. For proper function and to maintain sanitary conditions, the AVACEN 100 MUST be used with the supplied hand mitts. Extra hand mitts can be purchased at: https://avacen.com/parts/

2. UNPACKING THE UNIT The shipping box contains the AVACEN 100 unit, power cord, power supply, mitts, spare Vacuum Chamber "pins", and this user guide. Lift the top shipping foam piece out of the box. Then lift the AVACEN 100 out of the box with two hands. Keep the shipping box and foam in case the AVACEN 100 needs to be returned.

3. NORMAL USE The AVACEN 100 is designed to provide dry heat therapy. Treatment time and/or number of uses per day can be increased based on professional recommendations or absence of response to treatment. Proposed use is: 15 minutes first thing in the morning using the LEFT hand (hint: "Left is for day Light") and 15 minutes before bed using the RIGHT hand (hint: "Right is for Night") healthy hand condition permitting. Any level of major discomfort (after lowering Heat setting first) is not normal. If this happens, stop using the AVACEN 100 right away and report the problem to AVACEN Medical Customer Service at (888) 4-AVACEN (888-428-2236) or send an email to: [email protected]

4. INDICATIONS FOR USE United States: The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied. Outside the United States: The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; the temporary relief of widespread pain associated with fibromyalgia; muscular relaxation; and the temporary increase of microcirculation.

5. CONTRA-INDICATIONS Although there has been no issues reported, it is suggested that you contact a doctor before using the AVACEN 100 if you are under 18 years of age, are pregnant, or have a temperature higher than 99.5°F (37.5°C). Do not use the AVACEN 100 on a hand that has open sores or wounds.


6. WARNINGS & PRECAUTIONS WARNINGS are used to signal potential hazards which could lead to death or serious injury. PRECAUTIONS are used to warn the reader of potential hazardous situations. If not avoided, these hazards may result in minor or moderate injury to the user or patient or damage to the device or other property. Warnings

• This device IS NOT meant to provide ample heating where the internal body core temperature is falling uncontrollably, or is lower than 95°F (35°C). In these cases, GET MEDICAL ATTENTION FAST!

• Making changes to this device is not allowed. • Do not use the AVACEN 100 with other devices or accessories except as described in this

User Guide. • Choking Hazard - contains small parts. Keep out of reach of children. • Strangulation Hazard - contains a long power cord that may cause strangulation if used

improperly. Keep out of reach of small children.

Precautions • The following cautions are guidelines only and are not meant to replace a health care

professional’s advice. If any harmful effect occurs while using the product, stop use and contact your health care professional.

• Use with care. May cause serious burns. Do not use on over sensitive skin areas or in the presence of poor circulation.

• The unattended use of the AVACEN 100 by children or incapacitated persons may be dangerous.

• Do not use with liniment, salve or ointments - May cause skin irritation. • To prevent damage to the mitt and inflatable cuff: remove all jewelry (rings, bracelets,

watches) from the hand that will be used for therapy. • Do not use the AVACEN 100 on a hand that has open sores or wounds. Any level of major

discomfort (after lowering temperature first) is not normal. • Metal implants - pay attention for signs of any uncomfortable heat buildup in the

treatment area. If this occurs, stop using the device. • Stop using the AVACEN 100 right away and report any major discomfort problems to

AVACEN Medical customer support at (888) 4-AVACEN (888-428-2236) or email AVACEN Medical at [email protected]

• If the unit does not turn off when the On/Off Button is pressed, unplug the unit. • To remove your hand from the Vacuum Chamber at any time, release the air from the

inflatable cuff by pressing the Pressure Release Button on the underside of the Inflatable Cuff.

• Although there have been no issues reported, consult your healthcare professional before using the AVACEN 100 if you have any of the following:.

• Malignancy (A term for diseases in which abnormal cells divide without control and can invade nearby tissues) .

• Pregnancy. • Chronically hot or swollen joint in the hand, fingers, or wrist. • Circulatory diseases. • Recent acute joint injury in the hand, fingers, or wrist.


7. IMPORTANT SAFETY INFORMATION • Read the entire AVACEN 100 User Guide before using this device. • For continued protection against risk of fire and shock, use the hand unit only with the

provided power supply, AVACEN part number 50-100000. • Do not store the AVACEN 100 in direct sunlight. The AVACEN 100 should be stored in a clean,

well-ventilated area at room temperature. Keep out of reach of small children and pets. Optional carrying bags should be left open to allow ventilation.

• Do not use outdoors in the rain, snow, or under water. While the device is protected against vertically dripping water, it is not water resistant, and should not be used in wet areas.

• Pressing too hard on the heat pad can cause the AVACEN 100 to be ineffective. • The Power Supply Connector is the main power disconnect device for the AVACEN 100. If the

unit does not turn off when the On/Off Button is pressed or a malfunction is suspected, unplug the power supply or remove the power input from the unit.

• This device complies with Part 18 of the FCC Rules, as well as international electromagnetic compatibility requirements. Use is subject to these two conditions:. 1) This device may not cause harmful interference. 2) This device must accept any interference received, including interference that may cause undesired operation. These limits are designed to provide reasonable protection against harmful interference in a residential installation. However, there is no guarantee that interference will not occur in a particular installation. If this equipment causes problems with radio or TV reception, which can be checked by turning the equipment off and on, you are encouraged to try to correct the interference by one or more of the following measures:. • Reorient the receiving antenna. • Relocate the system with respect to the receiver. • Move the system away from the receiver. • Plug the system into a different outlet so that the system and the receiver are on different branch circuits.

Environmental Conditions Temperature Operating 50°F (10°C) to 104°F (40°C)

Storage 32°F (0°C) to 140°F (60°C) Relative Humidity

Operating 30 to 75% rH Storage 10 to 95% rH

Atmospheric Pressure

Operating 700 to 1060hPa Storage 500 to 1060hPa

AC Input Voltage 100-240V~, 50-60Hz Expected service life of equipment and accessories 5 years

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Set the therapy Time (10 – 30 minutes) on the Control Panel using the ▲ and ▼ buttons. Set the Temperature (High, Med, Low) by using the ◄ and ► buttons. OR, do nothing to accept the default of 15 minutes and High Temperature. These settings may be changed at any time during use. Press ✔ on the Control Panel to indicate Time and Temperature have been set or do nothing to accept default of 15 minutes and High Temperature. The Time and Temperature settings may be changed at any time during use. Note: For the most benefit the "High" setting is preferred. Select "Med" or "Low" only in the case of major discomfort. The Heatpad will feel hot during use. If a lower temperature is used, after several uses, return to the "High" mode to see if the discomfort has been reduced.

11. CUFF SEALING The "Sealing Cuff" message is displayed while the vacuum motor runs. The bar along the bottom shows the vacuum level; when the bar reaches the length of the Display Panel, the full vacuum has been achieved. IMPORTANT NOTE: The seal on the bottom of the Vacuum Chamber may have become dislodged during shipping and unpacking. If the seal is not properly in place, the Vacuum Chamber will not seal. Refer to the "Troubleshooting" section of this User Guide for simple ways to correct this issue.

12. HAND PRESSURE INDICATOR (HPI) When the unit seals properly, the top line of the display will show the remaining therapy time and the temperature level indicator. The bottom line of the display will show the Hand Pressure Indicator (HPI). The HPI shows if you have the right amount of hand pressure. You are in the optimal zone when the double column indicator is near the middle. Too much pressure will set off an alarm (beep) and display "Lift Hand Slightly". Too little pressure will set off an alarm (beep) and display "Push Hand Down Slightly". Keeping the HPI in the middle will ensure ideal function.

Set Time ▲ ▼ Set Temp ◄ ►

Time: 15:00 Temp: High ▇

Sealing Cuff ███████

Time/Temp:14:57▇ ██

Hand Pressure Indicator

Too Little Too Much

Lift Hand Slightly

Push Hand Down Slightly

Min Max


13. PAUSING A THERAPY SESSION PAUSE: If the ✔ button on the control panel is pressed during treatment, the timer and Vacuum motor are paused. Pressing ✔ again will cause the timer and Vacuum Chamber sealing process to resume.

14. ADJUSTING THE THERAPY TIME Pressing the ▲ button on the control panel while running will cause the therapy timer to increase in value and holding the ▲ button down will cause the timer to continue increasing until it reaches the initial set value. Pressing the ▼ button on the control panel while running will cause the therapy timer to decrease in value. Holding the ▼ button down will cause the timer to continue dropping until it reaches zero (00:00) Then the AVACEN 100 will shut off.

15. ADJUSTING THE THERAPY TEMPERATURE Pressing the ◄ or ► buttons during therapy will switch the Temperature setting from High to Medium to Low, and back to High again.

16. END OF THERAPY When the treatment time runs down to zero, the device will begin to shut down. The cuff will begin to deflate and the "Remove Hand Slowly" message is displayed. Remove your hand from the Vacuum Chamber. Remove the Mitt and discard or retain for your own use at a later time. Therapy is now complete. After a few seconds, the display will change to "Powering Down", and then the device will turn off.

17. POWERING DOWN If (i) the button is pressed the device will shut down by itself. The cuff will begin to deflate and the "Remove Hand Slowly" message is displayed. Remove your hand from the Vacuum Chamber. After a few seconds, the display will change to "Powering Down", and then the device will turn off. If there is a problem during operation, the device will display an error message. If it can not recover, the device will shut down. After powering down, the display will continue to show the error message.

Time/Temp:14:57▇ Paused

Remove Hand Slowly

Remove Hand Slowly

Powering Down

Powering Down

Unit Did Not Seal Properly

Calibration Failed

Unit Has Lost Vacuum Seal


18. STANDBY MODE OPERATION If the AVACEN 100 is turned ON, turn it off by pressing the

button on the control panel and wait for the green power light to turn off. If the AVACEN 100 is OFF or has just been turned OFF, hold down the ✔ button on the control panel and then press the POWER button. The Display will show "Entering Standby Mode". The Display will then show "Remove Jewelry From Hand", "Warming Heatpad Please Wait…", and after about three minutes, the "Place Mitt on Therapy Hand" and "Insert Hand Press ✔" message will be displayed. Use is the same as described in the "Normal Mode Operation" section of this manual. In the Standby Mode, at the end of a treatment, a "Remove Hand Slowly" message will be briefly displayed, and then the "Remaining In Standby Mode" message. In a few seconds, the startup message and the "Insert Hand" message will be displayed. The button can be pressed anytime to turn off Standby Mode and power down the AVACEN 100. The AVACEN 100 is now ready for the next user. The rest of the device functions are the same as described in the "Normal Mode Operation" section of this manual.

19. GAME MODE OPERATION To enter Game Mode, you must press the ▲ button when the "Insert Hand / Press ✔" message is being displayed (after the unit is warmed up). Pressing the ▲ button while warming up has no effect. This Game Mode setting will persist even if the power is turned off or the unit is powered down (and also in Standby). Game Mode is reset to OFF when the AVACEN 100 is unplugged. Pressing the DOWN button when the "Insert Hand / Press ✔" message is being displayed turns Game Mode OFF. Game Mode is used to encourage the user to maintain the proper amount of pressure on the Heatpad. The Hand Pressure Indicator (HPI) position on the bottom row of the Display Panel is used as the input for the game. The goal is to score the most points by keeping the HPI as close to the center of the screen as possible.

Entering Standby Mode

Remove Jewelry From Hand

Warming Heatpad Please Wait...

Place Mitt On Therapy Hand

Insert Hand Press ✔

Remove Hand Slowly

Remaining In Standby Mode

Insert Hand Press ✔

3000 14:57▇ ██

Hand Pressure Indicator (HPI)

Min OPTIMAL Max


An enlarged view of the bottom row of the Display Panel below shows the number of points that are awarded per second. The number of points earned is based on the position of the HPI. More points are scored by keeping the HPI in the center of the screen. If the "Lift Hand Slightly" message or the "Push Hand Down Slightly" message are displayed, the user will hear an audio beep, and 10,000 points are subtracted from the total score every second.

The highest number of points awarded is 60,000 points per minute. Therefore the user could accumulate as many as 1,200,000 points in a 20-minute therapy session (more or less points depending on the length of the session). A score of half the highest possible score (i.e. 600,000 for a 20-minute session) would indicate that the user did a very good job of keeping their hand properly seated on the heat pad. The final score can also be used as a gauge of proper hand position during unattended patient therapy sessions. The unit must be used for a minimum of 10 minutes in order to qualify for a high score.

At the end of the session the final score is shown, along with the current high score. If a new high score was earned, this will be shown. Pressing the ✔ button changes the display to show a random message. This message falls into one of three basic groups, that vary based on the average points per second that was scored by the user. If the average points per second is high, a "Great Job" message will be displayed. If the average points per second was in the middle (acceptable but not "high"), a "Good Job" message will be displayed. If the average number of points per second is low, a "Try Harder" message is displayed. These messages can be viewed at the end of the session (along with the final score) to see how well the user did at keeping their hand in the correct place on the hand pad during the therapy session.

"Great Job" messages:

"Major league performance! Wow" "Super! That's how it's done!"

"You got some serious skills!" "You did great!"

"Awesome Job!"

"Good Job" messages:

"Nice! beat this score next time!" "Well done, keep up the good work!"

"Next time get the high score!" "Steady hand - good job!"

"You did pretty good!"

"Try Harder" messages:

"I remember MY first time..." "Did you actually try?"

"Come on! Try harder!" "My grandma could do better!"

"Yay! You got the new low score!"

Pressing the ✔ button again causes the unit to turn off or go back into standby mode.

████████████████


20. TROUBLESHOOTING AND FAQ If you are having problems using the AVACEN 100, review this section to see if a solution is described. If you are still having trouble, call AVACEN Medical at (888) 4-AVACEN (888-428-2236) and select "Customer Service" or email: [email protected]. When you call, have your AVACEN 100 ready and make note of the device serial number (marked on the bottom of the device).

A. How long should treatment last? The AVACEN 100 is designed to comfortably and noninvasively provide dry heat therapy for a period between 10 and 30 minutes. For many conditions 15 minutes twice daily is sufficient. Treatment time and/or use frequency can be increased to accommodate professional recommendations or absence of response to treatment. The best times for treatment are in the early morning and prior to bed. Suggested use should be: 15 minutes first thing in the morning using the LEFT hand (reminder hint: "Left is for day Light") and 15 minutes before bed using the RIGHT hand (reminder hint: "Right is for Night"). Switching hands assumes both hands are equally healthy. If not, use the healthy hand only. Any level of major discomfort (after adjusting temperature) is not normal. Stop using the AVACEN 100 right away and report the problem to AVACEN at (888) 4-AVACEN (888-428-2236) and select "Customer Service" or email: [email protected].

B. How important is the placement of my hand? It is critical to make sure that the palm is completely inside the vacuum chamber and resting on the Metal Heatpad. The raised, egg-shaped portion of the Heatpad should be cupped in the center of the palm.

C. Is it necessary to wear the AVACEN Mitt? The AVACEN 100 design requires a special Mitt. Without this mitt, the AVACEN 100 may not seal properly. Using the mitt also provides a sanitary environment for multiple family members or clinic users. In addition, the Mitt keeps dirt and hand oils off of the critical metal Heatpad and from inside the vacuum chamber. This prolongs the efficiency and extends the useful life of the AVACEN 100.

D. Do I need a new a Mitt every time I have a treatment? No. As long as the Mitt appears to be in good repair and clean, the same person may use it for months.

E. Do I need to purchase the Mitts from AVACEN? The AVACEN 100 was developed and tested for FDA Clearance using a very specific Mitt material and design. We have priced the Mitts to be very affordable and therefore recommend that Mitts be purchased at https://avacen.com/parts/

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H. "Calibration Failed" message It is very important that the AVACEN 100 is placed on a level surface and your hand is NOT inside the Vacuum Chamber when you turn the device on. If your hand is inside the vacuum chamber (resting on the Heatpad) when the device is turned on, the onboard computer will not measure your hand pressure correctly. If you turn the device off (by mistake or on purpose), remove your hand from the Vacuum Chamber before turning the device back on again. To make sure that the device computes the proper weight of your hand against the Metal Heatpad it is important during the initial sealing and calibration process to apply slight pressure with your palm against the Heatpad. Without this base pressure, the onboard computer will not be able to properly manage the pressure of the palm against the Heatpad. At that point the "Calibration Failed" message will appear and the device will shut down. After the weight of the hand is measured during the calibration phase, the onboard computer monitors if there is too much or too little palm pressure against the Heatpad. This will be displayed on the Hand Pressure Indicator (HPI). After a number of uses, it will become much easier to judge the proper pressure of your palm against the Heatpad. If you are still having trouble, call AVACEN at (888) 4-AVACEN (888-428-2236) and select "Customer Service" or email: [email protected].

I. "System Error" Message The device is always checking and adjusting the temperature of the Heatpad. If for some reason it can not measure the Heatpad temperature, a warning message will be displayed. This can happen for a few reasons: (i) The device is very cold. - Turn off the device and allow it to warm to room temperature before turning on. (ii) The device has been stored somewhere very hot. - This may have damaged the device. Unplug the unit, then plug back in and try again. If the message is displayed a second time, call AVACEN at (888) 4-AVACEN (888-428-2236) and select "Customer Service" or email: [email protected].

J. There is noise while the AVACEN 100 is running There is an air pump inside the AVACEN 100 that runs during therapy. Some motor noise is normal, and the noise will vary as the AVACEN 100 adjusts the air pressure of the inflatable cuff and inside the vacuum chamber. This improves the comfort of the inflatable cuff.

K. The inflatable cuff is too tight The inflatable wrist bladder is designed to work on almost any size wrist and therefore it may feel tighter to some people than others. The first inflation exerts the most pressure to assure a proper seal every time. This highest pressure will only last for less than a minute. After that the pressure will relax to a more comfortable level. If the pressure does not relax there may be a vacuum leak. Refer to Item F: "The AVACEN 100 powers down while the 'Sealing Cuff' message or 'Lost Vacuum Seal' message is displayed" for solutions.

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Powering Down

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L. I keep getting a "Push Hand Down Slightly" or "Lift Hand Slightly" message

It is very important that the AVACEN 100 is placed on a level surface and your hand is NOT inside the Vacuum Chamber when you turn the device on. If your hand is inside the vacuum chamber (resting on the Heatpad) when the device is turned on, the onboard computer will not measure your hand pressure correctly. If you turn the device off (by mistake or on purpose), remove your hand from the Vacuum Chamber before turning the device back on again. To make sure that the device calculates the proper pressure of your hand against the Heatpad it is important that during the initial sealing and calibration process that you apply slight pressure with your palm against the Heatpad. Without this base pressure, the onboard computer will not be able to properly manage the pressure of the palm against the Heatpad and "Push Hand Down Slightly" or "Lift Hand Slightly" message will continue to appear along with a beeping sound. During treatment there is a chance the heel of your palm will be pushing too hard against the palm end of the Metal Heatpad (end nearest the wrist opening). This condition is not wanted and will cause the "Lift Hand Slightly" message to appear along with a beeping sound. At this point just retract your hand into the cuff to its original position and the alerts will stop. To make it easier to shift your hand, briefly press in the pressure release button on the bottom of the cuff to deflate the cuff slightly. One of the top features of the device is to monitor and display too much or too little pressure of the hand on the Metal Heatpad. Correct hand pressure on the Heatpad increases heat transfer. After the weight of the hand is calculated during the calibration phase, the onboard computer is responsible for monitoring the palm pressure. If there is too much or too little palm pressure against the Heatpad, it will be displayed on the Hand Pressure Indicator (HPI). After a number of uses, it will become much easier to judge the proper pressure of your palm against the Heatpad. If you are still having trouble, call AVACEN at (888) 4-AVACEN (888-428-2236) and select "Customer Service" or email: [email protected].

M. The AVACEN 100 Heatpad is too hot For the most benefit "High" is recommended. Select "Med" or "Low" only in the case of major discomfort. The Heatpad will feel hot during use. If a lower temperature is used, return to the "High" mode after several uses to determine if the discomfort has been reduced. If the heat does not recede to a more comfortable level RIGHT AWAY stop using the device and call AVACEN Medical at (888) 4-AVACEN (888-428-2236) and select "Customer Service" or email: [email protected]

N. The Display Panel Power LED does not illuminate after pushing the ON Button

Make sure that the power cord is plugged into the unit and the light on the Power Supply (black box between the device plug and wall plug) is on. If the light on the Power Supply is not on; check the ends of the power cord to make sure it is plugged into both the Power Supply and the wall plug. If the power Supply light is still not on, make sure that the wall plug is working properly. Do this by plugging in another device or lamp that you know works into the wall plug. If you are still having trouble, call AVACEN Medical at (888) 4-AVACEN (888-428-2236) and select "Customer Service" or email: [email protected].

O. Checking the inflatable cuff for leaks This test can be found in USER SETTINGS. Refer to section 21: "USER SETTINGS" in this Guide for details on starting the test.


P. Excessive swelling of the hand The AVACEN 100 is designed to comfortably and noninvasively provide dry heat therapy. Any level of major discomfort is not normal. Right away stop using the AVACEN 100 and report the problem to AVACEN Medical at (888) 4-AVACEN (888-428-2236) and select Customer Service.

Q. Red or purple spots on the hand Red or purple spots on the hand (usually the backside) after the first couple of AVACEN 100 uses can be caused by a minor hemorrhage (petechia). These spots are harmless and will likely vanish within a few days. Should they not disappear or if they are accompanied by any level of major discomfort; this is not normal. Right away stop using the AVACEN 100 and report the problem to AVACEN Medical at (888) 4-AVACEN (888-428-2236) and select Customer Service.

R. Hand itches or tingles It is common and normal for the hand to slightly itch or tingle during a treatment session as circulation in the hand increases. If this at any time becomes uncomfortable or painful, immediately stop the treatment session and call AVACEN Medical at (888) 4-AVACEN (888-428-2236) and select Customer Service.

S. My hand is reddish-colored like it has been in hot water This state is normal and you will likely see this on every treatment. It is due to the increased microcirculation (blood in the capillaries).

T. Sweating when using the AVACEN 100 The AVACEN 100 is designed to comfortably and noninvasively provide heat therapy. Mild sweating is not typical but seldom may occur and is not a serious indication. Any level of major discomfort pain is not normal. Right away stop using the AVACEN 100 and report the problem to AVACEN Medical at (888) 4-AVACEN (888-428-2236).

U. Discomfort in wrist or forearm during use Raise or lower forearm or adjust rear device feet to increase comfort.


21. USER SETTINGS There are some settings that can be made on the AVACEN 100 that will be stored. Even if power is removed, the settings are kept. The following User Settings can be made on the AVACEN 100:

• Language Selection • Beep Tone Style • Default Therapy Time • Default Therapy Temperature

In addition, there are some settings that can be used to help diagnose problems with the device:

• Display Error Messages • Measure Hand Pad Force • Run Self-Sealing Test

All of these features are accessed in the User Settings menu. To access User Settings, begin by turning the AVACEN 100 Off. Press and hold down the ▼ button while turning the device On with the button. The display will show "User Settings". Moving through the different User Settings is done using the front panel buttons: ◄ or ► Press to scroll back or forward through menu selections. ▲ or▼ Press to scroll up or down through menus and options. ✔ To store the selected setting. ◄ Go back to the previous (higher level) menu. After you are done making changes to any of the settings, press ◄ one or more times until the display shows "User Settings". Then press the button to return to normal operation. While in the "User Settings" menu, press ►, then press ▲ or▼ one or more times to go to the following menus:

A. Language Selection Messages can be displayed in multiple languages on some device versions. Press ► to enter this menu, then press ▲ or▼ to choose the desired language. Press ✔ to select the desired language. If this menu is not available, then your device only supports English.

B. Beep Tone Style There are two options, "Original" and "Low Tones". Press ► to enter this menu, then press ▲ or▼ to choose a style of Beep Tone. A sample of the tones will sound. Press ✔ to select the desired Beep Tones.

C. Default Therapy Time The default setting for therapy time is 15 minutes. At any time before the start of a therapy session, the therapy time may be changed from 15 minutes to 10, 20, 25, or 30 minutes. If you find that you a usually selecting a time other than 15 minutes for therapy, the default therapy

User Settings:

Change Display Language

Beep Tone Select

Default Therapy Time/Temp

Set Default Therapy Time


time can be changed. From the "Default Therapy Time/Temp" menu, press ► to get to the "Set Default Therapy Time" menu. Press ►again then press ▲ or▼ one or more times to choose a default therapy time setting. Press ✔ to store the setting. Now, whenever the device is turned on, the new default therapy time will be selected.

D. Default Therapy Temperature The default setting for therapy temperature is HIGH. This is the preferred setting for maximum benefit. At any thine during therapy the temperature setting can be changed by pressing the ▲ or▼ buttons. If you find that you are usually selecting the MEDUIM or LOW temperature setting, the default setting can be changed from HIGH to MEDIUM or LOW. From the "Default Therapy Time/Temp." menu, press ►, then press ▲ or▼ to get to the "Set Default Therapy Temp." menu. Press ► again then press ▲ or▼ one or more times to choose a default therapy temperature setting. Press ✔ to store the setting. Now, whenever the device is turned on, the new default therapy temperature will be selected.

E. Display Error Messages This menu stores information about errors when the device was last used. If you are talking to AVACEN Customer Support, they may ask you to go to this menu. From the "Display Last Error Message" menu, press ► to show the last error that was recorded.

F. Measure Hand Pad Force If you are talking to AVACEN Customer Support, they may ask you to go to this menu. In this menu you can see the amount of force that is being put on the hand pad by your hand. From the "Hand Force Measurement" menu, press ► to display a number that shows the amount of force that is being applied to the hand pad. The number will increase or decrease as more or less weight is applied to the hand pad.

G. Run Self-Sealing Test The AVACEN 100 can perform a self-test to check for air leaks. If you are talking to AVACEN Customer Support, they may ask you to go to this menu. This test may also be helpful when trying to see if there are any leaks in the inflatable cuff. • To access User Settings, begin by turning the AVACEN

100 Off. • Press and hold down the ▼ button while turning the

device On with the button. The display will show "User Settings".

• Press ► once, then the ▲ or▼button multiple times until the display shows "Sealing Test".

• Press ► and then ✔ to start the test.

Default Therapy Time/Temp.

Set Default Therapy Temp.

Display Last Error Message

Hand Force Measurement

Sealing Test

Start Test? Press ✔

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Guidance and Manufacturer’s Declaration: Electromagnetic Emissions and Immunity Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. This declaration applies to the model AVACEN 100. The device is intended for use in the electromagnetic environment specified. The customer or the user of the device should assure that it is used in such an environment. Electromagnetic Emissions Emissions test Compliance Electromagnetic environment – guidanceRF emissions CISPR 11

Group 1 The device 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 device is suitable for use in all establishments, including domestic establishments 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

The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. Electromagnetic Immunity Immunity test IEC 60601 test

level Compliance Level Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

± 2 kV for powersupply lines ± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

± 1 kV differentialmode ± 2 kV common mode

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

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the AVACEN 100 requires continued operation during power mains interruptions, it is recommended that the AVACEN 100 be powered from an uninterruptible power supply or a battery.

NOTE UT is the a.c. mains voltage prior to application of the test level.Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital 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

3 Vrms 3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the AVACEN 100, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 √P d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √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 metres (m). Field strengths from fixed RF transmitters, 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 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. 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 AVACEN 100 is used exceeds the applicable RF compliance level above, the AVACEN 100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AVACEN 100. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the AVACEN 100

The AVACEN 100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AVACEN 100 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AVACEN 100 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitterm

150 kHz to 80 MHzd = 1.2 √P

80 MHz to 800 MHzd = 1.2 √P

800 MHz to 2,5 GHzd = 2.3 √P

0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.3

10 3.8 3.8 7.3100 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.

AVACEN 100 Quick Start Guide 171208


Display PanelON/OFF Silicone Seal for

Vacuum Chamber

Inflatable Cuff

Metal Heatpad

Pressure Holes

Power Supply Connector

Hand Positioning Tips: KEEP WRIST STRAIGHT AND IN THE CENTER OF THE CUFF!

POSITION WRISTIN MIDDLE OF CUFF

PARALLEL WITH CHAMBER

CORRECT

CORRECT

INCORRECT

INCORRECT

Power Plug

Up

Down

Left Right

AVACEN 100 Diagram

Metal Heatpad

Sanitary Mitt

Vacuum Chamber Pins

171208 AVACEN 100 Quick Start Guide

AVACEN 100 Quick Start Guide

IMPORTANT: Please read The AVACEN 100 User Guide prior to use of this device! When you first unpack the device, run a Sealing Test to make sure that the device was not damaged during shipping. Refer to this User Guide, section 21.G "Run Self-Sealing Test" for details. To run the device normally, follow these instructions: 1. Connect the Power Cord to the hand unit & wall plug.

2. Press the On/Off Button on the left side of the Control Panel to turn Power Light on. 3. Follow the commands on Display Panel. Control buttons are as shown in the figure to the right. Notes:

a. Jewelry must be removed on treatment hand/wrist. b. If Time/Temp is not modified: "15 Min/High" will be automatically selected after 5 Seconds. c. If Temp is too hot: select a lower temp and work back to High over time.

Warnings: Contact a physician before using the AVACEN 100 if you are:

• Under 18 years of age • Are pregnant • Have a history of heart disease or blood circulation problems • Have a temperature higher than 99.5°F (37.5°C) • Have any other medical concerns

Do not use the AVACEN 100 on a hand that has open sores or wounds. Any level of major discomfort (after changing temperature) is not normal. Stop using the AVACEN 100 right away. Report the problem to AVACEN Customer Support at (888) 4-AVACEN (888-428-2236) or email AVACEN at [email protected] If the unit does not turn off when the On/Off Button is pressed, please unplug the unit.

IMPORTANT: Please read The AVACEN 100 User Guide prior to use of this device!


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Documents

User Guide Model AVACEN 100 · 2018-09-27 · 171208 AVACEN 100 User Guide 1 1. DESCRIPTION The AVACEN 100 is a Dry Heat Therapy FDA Class II Medical Device. It consists of a control