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150908

User Guide Model AVACEN 100

Caution: Thoroughly read all instructions prior to operating 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, international equivalents. Other patents pending.

AVACEN, Inc.

7920 Silverton Ave. Suite L

San Diego, CA 92126

(888) 4‐AVACEN (888‐428‐2236)

www.AVACEN.com

THE QUICK START GUIDE IS ON BACK COVER

150908

150908

Table of Contents

1. DESCRIPTION ........................................................................................................................... 3

2. UNPACKING THE UNIT ............................................................................................................ 3

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

4. INDICATION FOR USE .............................................................................................................. 3

5. CONTRA‐INDICATIONS ............................................................................................................ 3

6. WARNINGS & PRECAUTIONS .................................................................................................. 4

7. IMPORTANT SAFETY INFORMATION ....................................................................................... 5

8. CONTACT INFORMATION ........................................................................................................ 6

9. EXPLANATION OF SYMBOLS .................................................................................................... 7

10. OPERATING INSTRUCTIONS (NORMAL MODE OPERATION) ............................................... 8

11. CUFF SEALING .................................................................................................................... 10

12. Hand Pressure Indicator (HPI) ........................................................................................... 11

13. Pausing a Therapy Session ................................................................................................. 11

14. Adjusting the Therapy Time ............................................................................................... 11

15. Adjusting the Therapy Temperature ................................................................................. 11

16. POWERING DOWN ............................................................................................................. 12

17. END OF THERAPY ............................................................................................................... 12

18. STANDBY MODE OPERATION ............................................................................................. 13

19. GAME MODE OPERATION .................................................................................................. 14

20. TROUBLESHOOTING AND FAQ ........................................................................................... 16

A. How long should treatment last? ...................................................................................... 16

B. How important is the placement of my hand? .................................................................. 16

C. Is it necessary to wear the AVACEN Sanitary Mitt? ........................................................... 16

D. Do I need a new a Sanitary Mitt every time I have a treatment? ..................................... 16

E. Do I need to purchase the Sanitary Mitts from AVACEN? ................................................. 17

F. The AVACEN 100 powers down while the 'Sealing Cuff' message is displayed ................ 17

G. “Rest Palm On Heatpad” message ..................................................................................... 18

H. “Calibration Failed” message ............................................................................................. 18

I. I keep getting a “Unit Has Lost Vacuum Seal” message after therapy has begun. .......... 18

J. There is noise while the AVACEN 100 is running ............................................................... 19

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Table of Contents (continued)

K. The inflatable cuff is too tight ............................................................................................. 19

L. I keep getting a “Push Hand Down Slightly” or “Lift Hand Slightly” message ................... 19

M. The AVACEN 100 Heatpad is too hot .................................................................................. 20

N. The Display Panel Power LED does not illuminate after pushing ON Button ..................... 20

O. The wrist seal inflatable cuff is damaged ........................................................................... 20

P. Excessive swelling of the hand ........................................................................................... 20

Q. Red or purple spots on the hand ........................................................................................ 21

R. Sweating when using the AVACEN 100 .............................................................................. 21

S. Discomfort in wrist or forearm during use ......................................................................... 21

21. CLEANING ............................................................................................................................ 22

22. PERIODIC MAINTENANCE ................................................................................................... 23

23. DECLARATION OF CONFORMITY ......................................................................................... 25

24. WARRANTY PROGRAMS ..................................................................................................... 26

150908 AVACEN 100 User Guide 1


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

AVACEN 100 Diagram


1. DESCRIPTION

The AVACEN 100 is a Dry Heat Therapy FDA Class II Medical Device. The AVACEN 100 consists of a control panel, temperature‐controlled raised thermal transfer pad (Metal Heatpad), and a Vacuum Chamber with an integrated Inflatable Cuff. The vacuum pump and heat source are located in the base of the unit. For proper functioning and to maintain sanitary conditions, the AVACEN 100 MUST be used with the provided hand mitts. Additional hand mitts can be purchased at https://avacen.com/parts/

2. UNPACKING THE UNIT

Please remove the tape applied to the blue plastic vacuum chamber. Also remove the bubble wrap inside the vacuum chamber by lifting out the vacuum chamber and removing the packing material – refer to the PERIODIC MAINTENANCE section of this manual.

3. NORMAL USE

The AVACEN 100 is designed to comfortably and noninvasively provide dry heat therapy. Treatment time and/or use frequency can be increased to accommodate professional recommendations or absence of response to treatment. Suggested use is: 20 minutes first thing in the morning using the LEFT hand (reminder hint: “Left is for day Light”) and 20 minutes before bed using the RIGHT hand (reminder hint: “Right is for Night”) healthy hand condition permitting. Any level of significant discomfort (after lowering temperature first) is not normal. Immediately stop using the AVACEN 100 and report the problem to AVACEN Customer Service at (888) 4‐AVACEN (888‐428‐2236) or send an email to: [email protected].

4. INDICATION FOR USE

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.

5. CONTRA‐INDICATIONS

Contact a physician 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 a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.

Warnings This device IS NOT intended to provide adequate heating where the internal body core

temperature is falling uncontrollably, or lower than 95F (35C). In these cases, GET IMMEDIATE MEDICAL ATTENTION!

Use carefully. 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 significant discomfort (after lowering temperature first) is not normal.

Modification of this equipment is not allowed.

Do not use the AVACEN 100 with equipment or accessories other than 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 cautionary notes are a guideline only and not intended to replace a health

care professional’s advice. Should any negative reaction to the product use occur, discontinue use and contact your health care professional.

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


Precautions (continued) Metal implants ‐ pay attention for signs of any uncomfortable heat buildup in the

treatment area. If this occurs discontinue use.

Immediately stop using the AVACEN 100 and report any significant discomfort problems to AVACEN customer support at (888) 4‐AVACEN (888‐428‐2236) or email AVACEN at [email protected]

Read the AVACEN 100 User Guide completely prior to use of this device.

If the unit does not turn off when the On/Off Button is pressed, please unplug the unit.

7. IMPORTANT SAFETY INFORMATION

For continued protection against risk of fire and shock, use the hand unit only with the provided power supply, CINCON model TR60M12.

Do not store the AVACEN 100 in direct sunlight. The AVACEN 100 should be stored in a clean, well‐ventilated area at room temperature. Optional carrying bags should be left open to allow ventilation.

Do not use outdoors in the rain, snow, or underwater.

Pressing too hard on the raised transfer pad can cause the AVACEN 100 to be ineffective.

Read all instructions thoroughly before using the AVACEN 100.

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, either 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. Operation is subject to the following 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 interference with radio or television reception, which can be determined 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 50F (10°C) to 104F (40°C) Storage 32F (0°C) to 140F (60°C)

Relative Humidity

Operating 30 to 75% rH

Storage 10 to 95% rH

Atmospheric Pressure

Operating 700 to 1060hPa

Storage 500 to 1060hPa

8. CONTACT INFORMATION

Manufacturer: AVACEN, Inc.

7920 Silverton Ave. Suite L San Diego, CA 92126

Phone: (888) 4‐AVACEN (888‐428‐2236)

web: AVACEN.com Email: [email protected]

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10. OPERATING INSTRUCTIONS (NORMAL MODE OPERATION)

Connect the Power Supply Connector into the Power Supply Plug, located on the right side panel towards the lower back corner. Plug the AC power cord end from the external power supply cord into an appropriate power source (wall plug): 100‐240V~, 50‐60Hz. International use: Care should be taken to ensure that you have the appropriate cord and plug configuration adapter for the country in which the AVACEN 100 is to be operated. Power‐on the AVACEN 100 by pressing the button on the left side of the control panel. The Display Panel will show a brief welcome message and then will show reminder messages: “Remove Jewelry from Hand” (to prevent damaging the Mitt and cuff membrane), and “Place Mitt on Therapy Hand”, followed by a “Warming Heatpad Please Wait…” message. Note: If multiple users will be using the AVACEN 100, the device can be put into “Standby” mode so that the Heatpad stays warm in‐between uses and the device does not shut down. For details on this operating mode, refer to the section of this manual below titled “Standby Mode Operation”. Wait about 3 minutes for the Ready light to turn from Orange to Green (“A” on the Control Panel in the figure to the right). While waiting remove all jewelry (rings, bracelets, watches) from the hand and wrist that will be used for therapy. OPTIONAL: While the unit is warming up (or at any other time), the rear feet on the bottom of the AVACEN 100 can be adjusted to ensure maximum comfort while using the device. Turn the feet counterclockwise to extend the feet; turn clockwise to retract the feet. This allows the user's elbow to rest on a table or other supporting surface without excessive bending at the wrist. Therapies will run from 10 to 30 minutes (user selectable), so it is recommended to adjust the feet before use.


Place therapy hand in the Sanitary Mitt. All 4 fingers should be placed in the body of the mitt and the thumb should be placed in the right or left thumb cavity of the mitt. Important: Leave 1/2 inch in top of mitt free when placing hand inside. When the Heatpad has warmed up, the Display Panel will change to “Insert Hand, Press Accept“ and a “beep“ will sound. Hold down the Pressure Release Button located on the bottom of the cuff while SLOWLY inserting the hand (with Sanitary Mitt applied) into the Inflatable Cuff. Continue to hold button down until hand is completely inserted (see below pictures).

Position the heel of the palm (where the palm ends and the wrist begins) on the Front Base of the Metal Heatpad. For maximum effectiveness, keep all four fingers resting on the Rear Base of the Metal Heatpad. NOTE: It is critical to make sure that the heel of the palm is completely inside the vacuum chamber and touching the Front Base of the Metal Heatpad even though the finger tips may extend beyond the Rear Base of the Heatpad. If the fingertips extend over the end of the Heatpad, try to bend your fingertips slightly to maintain contact with the Heatpad. Press “Accept” button ( on the Control Panel) to indicate that your hand is inserted into the Sanitary Mitt and Inflatable Cuff, and is properly positioned on the


Metal Heatpad. Set the therapy Time (10 – 30 minutes) on the Control Panel using the ▲ and ▼ buttons, and the Temperature (High, Med, Low) by using the ◄ and ► buttons OR do nothing to accept the default of 20 minutes and High Temperature. These settings may be changed at any time during use. Press “Accept” ( on the Control Panel) to indicate Time and Temperature have been set or do nothing to accept default of 20 minutes and High Temperature. The Time and Temperature settings may be changed at any time during use. Note: For maximum benefit the “High” setting is recommended. Select “Med” or “Low” only in the case of significant discomfort. The Heatpad will feel hot during use. If a lower temperature is used, after several uses, return to the “High” mode to determine 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 indicates the vacuum level; when the bar reaches the length of the Display Panel, maximum vacuum has been achieved.

As the Vacuum Chamber begins to pull downward, push your free hand against the Vacuum Chamber top to speed up the vacuum process. As soon as an initial seal is created it is no longer necessary to keep your hand on the top of the Vacuum Chamber. IMPORTANT NOTE: A new Vacuum Chamber and seal will need a few uses to properly set the seal. Therefore with a new AVACEN 100, it is important to push down on the top of the Vacuum Chamber to ensure a good initial seal.


12. Hand Pressure Indicator (HPI)

When the unit seals properly, the top line of the display will show the remaining therapy time and temperature (H,M,L). The bottom line of the display will show the Hand Pressure Indicator (HPI). The HPI shows if you are applying the optimal 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 audio alarm (beep) and display “Lift Hand Slightly”. Too little pressure will set off an audio alarm (beep) and display “Push Hand Down Slightly”. Maintaining the dual column indicator in the middle will ensure ideal operation.

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. TIP: Press the button quickly, do not hold the button down.

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 initial set value. Pressing the ▼ button on the control panel while running will cause the therapy timer to decrease in value and holding the ▼ button down will cause the timer to continue decreasing until it reaches zero (00:00) at which point 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. POWERING DOWN

When: (i) the selected treatment time runs down or; (ii) the button is pressed or; (iii) the Initial Sealing process fails or; (iv) unit has lost vacuum for 60 seconds, a “Powering Down” message is displayed.

17. END OF THERAPY

Push and hold the Pressure Release Button on the bottom of the Inflatable Cuff. Remove your hand from the Vacuum Chamber. Remove the Sanitary Mitt and discard or retain for your own personal use at a later time. Therapy is now complete.


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 extinguish. If the AVACEN 100 is OFF or has just been turned OFF, while holding down the ACCEPT button on the control panel, press the POWER button. Screen will say “Entering Standby Mode”. The Display Panel will say “Remove Jewelry From Hand”, “Place Glove on Therapy Hand”, “Warming Heatpad Please Wait…”, and after about three minutes, the “Insert Hand Press Accept” message will be displayed. Operation is the same as described in the “Normal Mode Operation” section of this manual. In the Standby Mode of operation, at the end of a treatment, a “Remaining In Standby Mode” message will be briefly displayed again, followed by the startup message and the “Insert Hand” message. The button can be pressed anytime to deactivate Standby Mode and power down the AVACEN 100. The patient can now press the Pressure Release Button at the bottom of the cuff and remove their hand. The AVACEN 100 is now ready for the next patient. The rest of the operating 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 Accept" 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), but Game Mode is reset to OFF when the AVACEN 100 is unplugged. Pressing the DOWN button when the “Insert Hand / Press Accept” message is being displayed turns Game Mode OFF. Game Mode is used to encourage the user to maintain the most efficient 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 accumulate the maximum number of points by keeping the HPI as close to the center of the screen as possible.

An enlarged view of the bottom row of the Display Panel is shown below, showing the number of points that are awarded per second. The number of points awarded is based on the position of the HPI. More points are accumulated 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 maximum 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 maximum 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 positioned on the heat pad. The final score can also be used as an indicator of


proper hand positioning 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 therapy session the final score is displayed, along with the high score. If a new

high score was achieved, this will be displayed. Pressing the "Accept" button ( on the Control

Panel) advances the display to a show a randomized message that falls into one of three basic

categories, depending on the average points per second that was accumulated 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 moderate (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 therapy session (along with the final score) to

determine how well the user did at keeping their hand properly positioned 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 "Accept" button again ( on the Control Panel) causes the unit to turn off or go back

into standby mode.


20. TROUBLESHOOTING AND FAQ

If you are having problems with the operation of the AVACEN 100, review this section to see if a solution is described. If you are still having trouble, call AVACEN at (888) 4‐AVACEN (888‐428‐2236) and select “Customer Service” or email: [email protected].

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 20 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: 20 minutes first thing in the morning using the LEFT hand (reminder hint: “Left is for day Light”) and 20 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 significant discomfort (after adjusting temperature) is not normal. Immediately stop using the AVACEN 100 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 heel of the palm is completely inside the vacuum chamber and touching the Front Base of the Metal Heatpad (edge closest to sealing cuff/hand opening) even though the finger tips may extend beyond the Rear Base of the Heatpad. If the fingertips extend over the end of the Heatpad, try to bend your fingertips slightly to maintain contact with the Heatpad.

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

The AVACEN 100 design requires a special Sanitary 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 Sanitary Mitt keeps dirt and hand oils off of the critical metal Heat pad 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 Sanitary 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 multiple times.


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

The AVACEN 100 was developed and tested using a very specific Sanitary Mitt material and configuration. We have priced the Mitts to be very affordable and therefore recommend that replacements be purchased at https://avacen.com/parts/

F. The AVACEN 100 powers down while the 'Sealing Cuff' message is displayed

If the AVACEN 100 is not able to reach the appropriate vacuum level after 60 seconds, the “Unit Did Not Seal Properly” message is displayed and the unit will

automatically Power Down. This can occur if: (i) the Inflatable Cuff is not properly sealed at the wrist or; (ii) a Sanitary Mitt is not being used or; (iii) the end of the Sanitary Mitt does not extend beyond the sealed cuff or; (iv) there is debris underneath the seal on the bottom of the Vacuum Chamber or; (v) the Pressure Release Button is not fully disengaged or; (vi) the Vacuum Chamber is not properly positioned. (vii) the user's hand is not properly positioned: It is critical to make sure that the heel of the palm (where the palm connects to the wrist) is completely inside the vacuum chamber and touching the Front Base of the Metal Heatpad (closest to opening) even though the finger tips may extend beyond the Rear Base of the Heatpad. Check for the above problems, restart the unit and begin again confirming that the Vacuum Chamber is properly positioned by pushing your free hand against the top of the Vacuum Chamber while it is sealing. If you are still having trouble, call AVACEN at (888) 4‐AVACEN (888‐428‐2236) and select “Customer Service” or email: [email protected]. If it happens again check that: 1. the end of the Sanitary Mitt extends outside the Inflatable Cuff; 2. the Vacuum Chamber is properly positioned; 3. there is nothing under the AVACEN 100 that is pushing in the Pressure Relief Button located under the Inflatable Cuff; 4. your wrist is straight into the cuff and not at an angle (See optional AVACEN Forearm Support Pad); 5. the inflatable wrist bladder has no holes or tears. If your skin is very dry, put a small amount of hand lotion on your wrist and rub it in to improve sealing. If you are still having trouble, call AVACEN at (888) 4‐AVACEN (888‐428‐2236) and select “Customer Service” or email: [email protected].


G. “Rest Palm On Heatpad” message

To make sure the device calculates the proper weight of your hand against the Metal 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 microprocessor will not be able to properly manage the pressure of the palm against the Heatpad and “Rest Palm On Heatpad” message will continue to appear for 30 seconds and the AVACEN 100 will power down. This situation is common for most people on the first several uses of the AVACEN 100. One of the important innovations in this device is the ability to monitor and display too much or too little pressure of the hand on the Metal Heatpad to maximize heat transfer. After the weight of the hand is calculated during the calibration phase, the onboard microprocessor is responsible for monitoring if there is too much or too little palm pressure against the Heatpad, which 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].

H. “Calibration Failed” message

To make sure that the device calculates the proper weight of your hand against the Metal 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 microprocessor will not be able to properly manage the pressure of the palm against the Heatpad and “Calibration Failed” message will continue to appear. This situation is common for most people on the first several uses of the AVACEN 100. One of the important innovations in this device is the ability to monitor and display too much or too little pressure of the hand on the Metal Heatpad to maximize heat transfer. After the weight of the hand is calculated during the calibration phase, the onboard microprocessor is responsible for monitoring if there is too much or too little palm pressure against the Heatpad, which 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. I keep getting a “Unit Has Lost Vacuum Seal” message after therapy has begun.

1. Adjust your position so that your wrist is straight into the cuff and not at an angle (See optional AVACEN Forearm Support Pad). 2. Check that the end of the Sanitary Mitt extends outside the Inflatable Cuff. 3.Make sure there is nothing under the AVACEN 100 that is pushing in the pressure relief button located under the Inflatable Cuff.


4. Turn the unit off and inspect the inflatable wrist bladder for any holes or slashes. If you are still having trouble, 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 100 that operates during therapy. Some motor noise is normal, and the noise will vary as the 100 regulates 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 initial inflation exerts maximum pressure to assure a proper seal every time. This maximum pressure will only last for less than a minute. After that the pressure will recede to a more comfortable level similar to the experience of using a blood pressure cuff. If the pressure does not recede to a more comfortable level IMMEDIATELY stop using the device and call AVACEN at (888) 4‐AVACEN (888‐428‐2236) and select “Customer Service” or email: [email protected].

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

During treatment it is common to involuntarily feed your hand into the vacuum chamber a little bit at a time to the point where at between 10 and 15 minutes into treatment, the heel of your palm will be pushing against the Front Base of the Metal Heatpad nearest the opening. This is an undesirable condition which will cause the “Lift Hand Slightly” message to appear accompanied by a beeping sound. At this point simply retract your hand into the cuff to its original position and the alerts will abate. To make it easier to reposition your hand, momentarily press in the pressure release button on the bottom of the cuff to deflate the cuff slightly. To make sure that the device calculates the proper weight 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 microprocessor 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 accompanied by a beeping sound. This situation is common for most people on the first several uses of the AVACEN 100. One of the important innovations in this device is the ability to monitor and display too much or too little pressure of the hand on the Metal Heatpad to maximize heat transfer. After the weight of the


hand is calculated during the calibration phase, the onboard microprocessor is responsible for monitoring if there is too much or too little palm pressure against the Heatpad, which 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 maximum benefit “High” is recommended. Select “Med” or “Low” only in the case of significant discomfort. The Heatpad will feel hot during use. If a lower temperature is used, after several uses, return to the “High” mode to determine if the discomfort has been reduced. If the heat does not recede to a more comfortable level IMMEDIATELY stop using the device and call AVACEN 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 ON Button

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

O. The wrist seal inflatable cuff is damaged

Replacements can be purchased at https://avacen.com/parts/

P. Excessive swelling of the hand

The AVACEN 100 is designed to comfortably and noninvasively provide dry heat therapy. Any level of significant discomfort is not normal. Immediately stop using the AVACEN 100 and report the problem to AVACEN 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 (broken capillary blood vessels). These spots are harmless and usually disappear within a few days. Should they not disappear or if they are accompanied by any level of significant discomfort; this is not normal. Immediately stop using the AVACEN 100 and report the problem to AVACEN at (888) 4‐AVACEN (888‐428‐2236) and select Customer Service.

R. Sweating when using the AVACEN 100

The AVACEN 100 is designed to comfortably and noninvasively provide heat therapy. Any level of significant discomfort is not normal. Immediately stop using the AVACEN 100 and report the problem to AVACEN at (888) 4‐AVACEN (888‐428‐2236).

S. Discomfort in wrist or forearm during use

Elevate or lower forearm or adjust rear device feet to maximize comfort. Optional: Order AVACEN Forearm Support Pad at https://avacen.com/parts/


21. CLEANING

The outside surfaces of the AVACEN 100 can be wiped down with a damp cloth or a disinfectant hand wipe. Do not use any abrasive cleaners or gel sanitizers as damage to the enclosure may result. Cleaning the inside of the Vacuum Chamber is not needed between uses as long as clean Sanitary Mitts are used. If it is necessary to disinfect the Vacuum Chamber, remove the Vacuum Chamber (see section 22) and use a disinfectant hand wipe on the inside and outside surfaces. The seal on the bottom of the Vacuum Chamber can be removed and washed with mild soap and water. Allow the seal to dry before putting it back on the Vacuum Chamber. Do not use any lubricants on the seal or the sealing surface: doing so will degrade performance. The seal works best when it is clean and slightly "tacky" so that it seals well to the AVACEN 100. The seal on the bottom side of the Vacuum Chamber is made from a superior grade of silicone rubber. It is designed to provide over ten years of service when used daily. If the seal gets dirty, it can be removed and cleaned in mild soapy water. To remove and install the seal, follow the instructions below. Seal Removal: Lift the Vacuum Chamber vertically away from the AVACEN 100. It is not necessary to remove the air line from the fitting on the Inflatable Cuff. Remove the seal from the Vacuum Chamber by gently peeling the seal away from the Vacuum Chamber. Seal Installation: The seal has a groove on one side all the way around (highlighted in yellow in the photo). The bottom of the Vacuum Chamber fits into this groove. Note that the side of the seal with the groove in it has a lower area on one end (identified by the red arrow in the photo). This is the end that fits onto the cuff end of the Vacuum Chamber (the lower area fits under the cuff). Turn the seal so that the lower part is under the cuff, and fit the groove in the seal onto the bottom of the Vacuum Chamber.


Seal Installation (continued): Make sure that the seal is properly seated on the Vacuum Chamber by pushing the seal onto the Vacuum Chamber (only minimal force is needed). When properly seated on the Vacuum Chamber, the bottom surface of the seal will be flat.

22. PERIODIC MAINTENANCE

After a while, the Inflatable Cuff on the Vacuum Chamber may appear excessively stretched out. This is acceptable as long as the Inflatable Cuff continues to seal properly, and does not apply excessive pressure to the wrist. If the Inflatable Cuff is excessively worn out or gets torn, it must be replaced. A "Refresh Kit" consisting of a replacement Vacuum Chamber / Inflatable Cuff assembly is

available. The Refresh Kit can be purchased at https://avacen.com/parts/

To remove the Vacuum Chamber, lift the Inflatable Cuff end of the Vacuum Chamber and remove the air pressure line from the fitting at the front ‐ underside of the Vacuum Chamber.


Lift the Vacuum Chamber up and out. The Seal on the

bottom of the Vacuum Chamber will come out with the

Vacuum Chamber.

Installation of the Vacuum Chamber is opposite of removal. For removal and installation of the

seal that is on the bottom of the Vacuum Chamber, refer to section 21. Ensure that the pressure

line is re‐connected to the inflatable cuff, and that the pressure line is slid back into the opening

inside the base of the AVACEN 100 so that it is not kinked or obstructed. It is not necessary to

force the Vacuum Chamber back into position; it should go together easily.


23. DECLARATION OF CONFORMITY

We, AVACEN, INC. declare under our sole responsibility that the model AVACEN 100 and supplied accessories are in conformity with the following standards or other normative documents:

ANSI/AAMI ES60601‐1:2005 ‐ Medical electrical equipment ‐ Part 1: General requirements for basic safety and essential performance (IEC 60601‐1:2005, MOD.) AAMI ANSI IEC 60601‐1‐2:2007, Medical electrical equipment ‐ Part 1‐2: General requirements for basic safety and essential performance ‐ Collateral standard: Electromagnetic compatibility ‐ Requirements and tests (Edition 3) ISO 10993‐1: 2009, Biological evaluation of medical devices ‐ Part 1: Evaluation and testing within a risk management process. ISO 10993‐5: 2009, Biological evaluation of medical devices ‐Part 5: Tests for in vitro cytotoxicity. ISO 10993‐10: 2009, Biological evaluation of medical devices ‐ Part 10: Tests for irritation and skin sensitization.

© 2013, 2015 AVACEN, Inc. All rights reserved.


24. WARRANTY PROGRAMS

Consumer Warranty

AVACEN warrants to the initial purchaser (“Purchaser”) that each new AVACEN 100 (“Product”) purchased directly from AVACEN or an authorized AVACEN distributor will be free from defects in materials and workmanship under normal use for a period of 12 months from the date of its initial shipment to the Purchaser, or such Extended Warranty period purchased by Purchaser, from the date of initial shipment (“Warranty”). Repair or replacement of products (or parts thereof) under this Warranty does not extend the Warranty period. Products that are not new are subject to separate warranties expressly provided in connection with the sale of such products.

The obligations of AVACEN under this Warranty shall be limited to repair or replacement (at AVACEN’s option) of any product (or part thereof) under Warranty that AVACEN reasonably determines to be covered by this Warranty and to be defective in workmanship or materials. AVACEN shall determine whether to repair or replace products and parts covered by this Warranty. All products or parts replaced shall become AVACEN’s property. In the course of Warranty service, AVACEN may, but shall not be required to, make engineering improvements to the warranted products or parts.

Prior to shipping your AVACEN 100 for repair under this Warranty Purchaser MUST call AVACEN at (888) 4-AVACEN (888-428-2236) and select “Customer Service” or email: [email protected] to obtain a Return Authorization Number (RAN). REPAIR RETURNS WILL NOT BE ACCEPTED WITHOUT A RAN.

Products shipped to AVACEN by the Purchaser under this Warranty shall be suitably packaged to protect the product. If the Purchaser ships a product to AVACEN in unsuitable packaging, any physical damage in the product upon receipt by AVACEN (and not previously reported) will be presumed to have occurred in transit and will be the responsibility of the Purchaser. Risk of loss or damage during shipment under this Warranty shall be borne by the party shipping the product.

This Warranty shall be invalid if the warranted products (or parts thereof) have been subject to misuse, neglect, or accident; have been damaged by causes external to the warranted product; have been affixed to any nonstandard accessory attachment; have had the serial number removed or made illegible; is used for rental, military or commercial purposes; or have been disassembled, modified, serviced, or reassembled by anyone other than AVACEN, unless authorized by AVACEN.

AVACEN will not be responsible for the effect on safety, reliability, and performance of the product if:

a) assembly, extensions, readjustments, modifications, or repairs are carried out by anyone other than AVACEN or persons authorized to perform repair service on AVACEN’s behalf; or b) the electrical installation does not comply with the requirements of the applicable national and international standards, including requirements of the IEC; or c) the product is not used in accordance with AVACEN’s instructions for use.

THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT MAY BE ISSUED BY AVACEN, IS THE SOLE AND EXCLUSIVE WARRANTY AS TO AVACEN PRODUCTS, AND EXTENDS ONLY TO THE PURCHASER AND IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. AVACEN SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL, OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE (INCLUDING WITHOUT LIMITATION LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING FROM THE SALE, INABILITY TO SELL, USE, OR LOSS OF USE OF ANY PRODUCT.

DISCLAIMER OF WARRANTIES

AVACEN 100 devices are used in extremely variable environments, ancillary equipment connections and physical conditions. The devices may fail to function for a variety of causes, including but not limited to the physical condition of the person or the failure of the device or ancillary equipment by breakage. In addition, despite the exercise of all due care in the design, component selection, manufacture and testing prior to sale, the devices can be damaged, before, during or after use by improper handling or other intervening acts. Consequentially, no Warranty is made that failure or cessation of the function.


Commercial Warranty

AVACEN warrants to the initial purchaser (“Purchaser”) that each new AVACEN 100 (“Product”) purchased directly from AVACEN or an authorized AVACEN distributor will be free from defects in materials and workmanship under normal use for a period of 12 months from the date of its initial shipment to the Purchaser, or such Extended Warranty period purchased by Purchaser, from the date of initial shipment (“Warranty”). Repair or replacement of products (or parts thereof) under this Warranty does not extend the Warranty period. Products that are not new are subject to separate warranties expressly provided in connection with the sale of such products.

The obligations of AVACEN under this Warranty shall be limited to overnight replacement of any Defective Product (or part thereof) under Warranty that Purchaser reasonably determines to be covered by this Warranty to be defective in workmanship or materials.

Under this Warranty Purchaser MUST request a Replacement Product by calling AVACEN at (888) 4-AVACEN (888-428-2236) and select “Customer Service” or email: [email protected].

Upon receipt by Purchaser of the Replacement Product, Purchaser shall, within 3 business days, ship the Defective Product back to AVACEN using the prepaid return shipping label included with the Replacement Product.

Products shipped to AVACEN by the Purchaser under this Warranty shall be suitably packaged to protect the product. If the Purchaser ships a product to AVACEN in unsuitable packaging, any physical damage in the product upon receipt by AVACEN (and not previously reported) will be presumed to have occurred in transit and will be the responsibility of the Purchaser. Risk of loss or damage during shipment under this Warranty shall be borne by the party shipping the product.

This Warranty shall be invalid if the warranted products (or parts thereof) have been subject to misuse, neglect, or accident; have been damaged by causes external to the warranted product; have been affixed to any nonstandard accessory attachment; have had the serial number removed or made illegible; or have been disassembled, modified, serviced, or reassembled by anyone other than AVACEN, unless authorized by AVACEN.

Purchaser agrees to indemnify AVACEN for all costs to necessary to correct any damage to the returned Defective Product not covered by this warranty including, but not limited to, those identified as invalidating this warranty.

AVACEN will not be responsible for the effect on safety, reliability, and performance of the product if:

a) assembly, extensions, readjustments, modifications, or repairs are carried out by anyone other than AVACEN or persons authorized to perform repair service on AVACEN’s behalf; or b) the electrical installation does not comply with the requirements of the applicable national and international standards, including requirements of the IEC; or c) the product is not used in accordance with AVACEN’s instructions for use.

THIS WARRANTY, TOGETHER WITH ANY OTHER EXPRESS WRITTEN WARRANTY THAT MAY BE ISSUED BY AVACEN, IS THE SOLE AND EXCLUSIVE WARRANTY AS TO AVACEN PRODUCTS, AND EXTENDS ONLY TO THE PURCHASER AND IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. AVACEN SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL, OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE (INCLUDING WITHOUT LIMITATION LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING FROM THE SALE, INABILITY TO SELL, USE, OR LOSS OF USE OF ANY PRODUCT.

DISCLAIMER OF WARRANTIES

AVACEN 100 devices are used in extremely variable environments, ancillary equipment connections and physical conditions. The devices may fail to function for a variety of causes, including but not limited to the physical condition of the person or the failure of the device or ancillary equipment by breakage. In addition, despite the exercise of all due care in the design, component selection, manufacture and testing prior to sale, the devices can be damaged, before, during or after use by improper handling or other intervening acts. Consequentially, no Warranty is made that failure or cessation of the function.

AVACEN 100 Quick Start Guide 150908

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

150908 AVACEN 100 Quick Start Guide

AVACEN 100 Quick Start Guide

IMPORTANT: Please read The AVACEN 100 User Guide prior to use of this device! 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 instructions on Display Panel. Control buttons are as shown in the figure to the right. Notes:

a. “Cuff Sealing” may be accelerated by using free hand to press down on hand chamber top. b. Jewelry must be removed on treatment hand/wrist. c. Inserting/Removing Hand: HOLD DOWN Pressure Release Button on the underside of the Cuff. d. If Time/Temp is not modified: “20 Min/High” will be automatically selected after 5 Seconds. e. If Temperature is too hot: select a lower temperature 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, blood circulation problems, have a temperature higher than 99.5°F (37.5°C), or have any other medical concerns.

Do not use the AVACEN 100 on a hand that has open sores or wounds. Any level of significant discomfort (after adjusting temperature) is not normal. Immediately stop using the AVACEN 100 and 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!

Documents

User Guide Model AVACEN · P. Excessive swelling of the hand ... This device may not cause harmful interference. ... tch shbuttons