Glossary of Terms

Frequency: The number of times that the light wave oscillates per second (The number of periods of oscillations per second). hPa: Unit of pressure measurement (Atmospheric pressure). IEe 60825-1: "Safety of laser products - Part 1: Equipment classification, requirements and user's guide", an internationally recognized standard containing laser safety requirements. Infrared Radiation: Invisible electromagnetic radiation with wavelengths which lie within the range of 0.70 to 1000 micrometers (microns). This region is often broken up into IR-A, IR-B, and IR-C. LED: Light Emitting Diodes, used to generate infrared energy. Mw: Megawatt, units of measure for laser output power.

nm: The unit of measure for the length of the light wave (wavelength), which is defined as the shortest distance at which the wave pattern fully repeats itself, usually measured from crest to crest. The wavelength of light in the visible spectrum determines its color. Pulse Laser Power: Energy delivered by a laser in the form of a single or train of bursts (pulses). V dc: Direct current voltage.

.

Introduction
The PainNOTTMLaser RX is designed to lessen pain by using laser diode and light emitting diodes (LEDs) that generate infra-red energy in the form of low level light to deliver a therapeutic effect. It is important to emphasize that therapy with the PainNO'fTM Laser RX does not exclude other conventional medical treatment. It is recommended that you consult your health care professional before using this product if you have any questions or concerns.

Intended Use and Indications for Use
The PainNOTTMLaser RX is a non-invasive, infrared lamp device intended to provide topical heating. The PainNO'fTM Laser RX is intended to provide the following: • Temporary relief of muscle and joint pain, arthritis and muscle spasm • Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin • Temporarily relieving stiffness • Temporarily promoting relaxation of muscle tissue • Temporarily increasing local blood circulation

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Device Description

.,

The PainNO'fTM Laser RX is an over-the-counter, non-invasive pain therapy system that utilizes laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of other low-level laser systems currently in commercial distribution into one complete, compact system. The system weighs 1.0 pounds (0.300 kg). FigureI below shows the PainNO'fTM Laser RX. Figure 1- PainNOTTM Laser RX

Contraindications
• DO NOT USE the PainNO'fTM Laser RX if you have a pacemaker as it could interfere with the proper function of the pacemaker. • DO NOT USE the PainNO'fTM Laser RX in the vicinity of a pacemaker as it could interfere with the function of other people's pacemakers. • DO NOT USE the PainNO'fTM Laser RX if you are using a device that uses magnets as it could interfere with the proper function of the device . • DO NOT USE the PainNO'fTM Laser RX over sensitive skin areas or in the presence of poor circulation. The unattended use of the PainNO'fTM Laser RX by children or incapacitated persons may be dangerous . • Keep the PainNO'fTM Laser RX away from children. • DO NOT USE the PainNO'fTM Laser RX on children under 3. • During treatment, avoid direct exposure of the treated area to other intense light sources such as a UV sun lamp. Exposure to other high intensity light sources may cause excess heating and slight bums on the skin. Excessive use of the PainNO'fTM Laser RX will not result in bums, however use of the PainNOT™ Laser RX with other heat sources could cause slight bums on the skin.

2

------- ~~-.--..--------~----

Warnings
• DO NOT use the PainNOTTM Laser RX in or around, water. Contact with water could cause electric shock that can result in serious injury to you. • DO NOT look directly at the light source. The PainNOTTM Laser RX emits high intensity light. than 30 seconds) direct exposure of your eyes to the light emitted by the PainNOTTM Laser RX your vision. Direct or reflected radiation should be prevented from entering the eyes. Damage even with your eyes closed, therefore never point the laser at the eyes directly. Use the supplied when treating any area on the body. Prolonged (greater may cause damage to could possibly occur protective eyewear

• DO NOT point the laser directly at your eyes. Damage to your vision could possibly occur even with your eyes closed. Use the supplied protective eyewear especially when treating the facial area. • DO NOT allow the unit to contact broken skin. The device is not sterile and may cause infection if used on broken skin. If used on broken skin, infection may result and further medical attention may be needed. • DO NOT use PainNOTTM Laser RX if you are pregnant. • DO use only the medical grade switching power adapter supplied with your PainNOTTM Laser RX (see picture of power adapter in Figure 2). Do not use any other power supply as it may cause electric shock. • ALWAYS contact your medical doctor before using the PainNOTTM Laser RX or any other pain therapy system. Figure 2 - PainNOTTM Laser RX Power Adapter

CONNECT TO WALL

CONNECT' TO PAINNOT LASER RX
M

Precautions
Read these instructions, including all warnings before using the PainNOTJ"M Laser RX to ensure proper use of the device. • Use this device while following the safety precautions and operating instructions in this Operator's Manual. It is important to keep this manual handy. The Operator's Manual should be studied and reviewed periodically by users of PainNOTTM Laser RX. • The PainNOTTM Laser RX was designed and manufactured to ensure maximum safety of operation. device in strict compliance with the safety precautions and operating instructions in this manual. Maintain the

• The PainNOTTM Laser RX should be maintained and serviced only by BioTech Research personnel, or other qualified personnel approved in writing by BioTech Research. If you experience any problems with the unit, return it to Bio'Iech Research for a replacement. • Do not drop the PainNOTTM Laser RX as it could be damaged and will not function properly.

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Risks
by the than 30 vision, light

o

There is a risk of damage to your vision from prolonged exposure (longer than 30 seconds) to the light emitted PainNOTTM Laser RX. Damage to your vision could occur upon looking directly at the light source for longer seconds. Your vision could be damaged whether you looked at the light source with central vision or peripheral or possibly with your eyes closed. Damage to your vision can be prevented by avoiding looking directly at the source, wearing the supplied eyewear, and never pointing the laser directly at your eyes.

o

The PainNOTTM Laser RX is programmed to deliver a limited amount of energy to the skin, to protect against overheating that may cause discomfort. When the device is used as directed, the skin is heated only to temperatures of 104 - 113 OF (40-45 QC). Repeated treatments of a single part of the body or continuous treatment will not cause the skin to be overheated. However, to prevent discomfort, the PainNOTTM Laser RX should not be used on any area of your body that you are concerned may be overly sensitive to heat (i.e., on a sunburned area). There is a risk of excessive heating of the skin, and slight superficial burning, if the treated area is directly exposed to other intense light sources such as UV sun lamps. Buming your skin can be avoided by protecting treated areas from direct exposure to intense light sources. There is a risk of infection if the PainNOTTM Laser RX contacts broken skin. Infection can be avoided by using the unit on intact skin. The PainNOTTM Laser RX includes a magnet to focus the laser. These magnets can interfere with the function of other medical devices. Therefore, do not use the PainNOTTM Laser RX in the vicinity of any other medical devices including pacemakers. Do not use the PainNOTTM Laser RX is you are pregnant.

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Benefits
o

Use of the PainNOT™ Treatment

Laser RX makes it easy to administer

treatment at home. medicine.

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with the PainNOTTM Laser RX can be combined with treatment via conventional

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Most patients should expect to feel pain relief and/or muscle relaxation after 6 days of PainNOTTM Laser RX treatment. The first three days of treatment consists of 2 sessions of 15 minutes each per day. This is followed up by treatment of one session of 15 minutes per day for 3 days. However, some patients may feel a noticeable of stiff muscles after I day of treatment. reduction of pain immediately after their first treatment, and relaxation

o

Adverse Effects
o

The PainNOTTM Laser RX can cause damage to the eyes by looking directly at the light source for an extended period of time (greater than 30 seconds). The PainNOTTM Laser RX may interfere with pacemaker The magnets incorporated medical devices. function if used in the vicinity of a pacemaker.

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in the PainNOTTM Laser RX to focus the laser can interfere with the function of other

4

Overview of PainNO ...~'MLaser RX Treatment/ .... reatment Programs
The pain you are feeling can be divided into two areas, localized pain (shallow pain felt near the surface of your body or pain confined to one area) or radiating pain (for example pain radiating from your neck to the arm), which typically is internal (deep) pain felt along your nerves. Pain is defined as physical discomfort or suffering associated with a bodily disorder. Stiffness is defined as an area of the body that is inflexible or rigid and cannot be moved easily and/or without

pain.

When you are feeling pain that seems like minor muscle pain or a muscle spasm, identify the location of the pain and focus the PainNOTTM Laser RX beam directly on it. For joint paint arthritis, focus the beam on the joint-line area. (The joint-line area is the area where the two bones meet). The PainNOTTM Laser RX is supplied with three pre-programmed treatment programs that have been established to treat different conditions (see Table 1). A program is selected by pushing the Freq button. The duration of all of the treatment programs is 15 minutes per session. . Each program uses different pulse frequencies, as summarized in the table below. Variation of the pulse frequencies alters the depth of penetration of the laser light. Each site where pain and/or stiffness is experienced should be treated via either program 1 or 2 for two days (one day's treatment is defined as two IS-minute sessions), followed by program 3 on the third day. More detailed information section. regarding how to manage the treatment of your pain is provided in the Course of Treatment

Table 1 • Treatment Programs Program 5 Hz, Program 50 Hz, Program Variable Program

1

2

3

-Chronic Pain Syndrome Treatment

- Acute Pain Syndrome

-Ternporary relief of minor -Temporary relief of minor muscle and joint pain, muscle and joint pain, arthritis and muscle spasm arthritis and muscle spasm - deep pain - shallow pain -Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origins

-Treatrnent completion Relaxation of muscle tissue -Ternporary increase of local blood circulation -Relief of stiffness

Pulse frequency Program duration

5 Hz 15 minutes

50 Hz IS minutes

Variable 1 to -250 Hz 15 minutes

5

'-

Course of Treatment

,

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• An initial treatment cycle consists of up to two days treatment (one day's treatment is defined as two IS minute sessions) for either program I or 2, followed by one day of program 3. • Three-day treatment cycles can be repeated, by applying treatment once a day on each individual point for no more than 21 consecutive days. • Patients should expect to feel relief of pain and/or stiffness after 6 days of commencing treatment, although some patients begin to feel beneficial affects following the first treatment. • Upon completion of a full course (21 days) of the single treatment course, a further course can be undertaken after a 3day break. • Treatment should be continued until pain has stopped.

Operating Instructions-Programmed
1. Connect the PainNO'fTM Laser RX to the AC power Adapter.

Mode

The PainNO'fTM Laser RX operates using an internal battery that must be fully charged before each use with the AC power adapter (supplied). If the battery is charged, the cord does not need to be plugged into the wall power source. If the battery is not charged, the device can be used with the AC adapter plugged into the wall outlet. NOTE: DO NOT use the device in any capacity near or around water. 2. Charge the PainNO'fTM Laser RX for a minimum of 8 hours before initial use. 3. Press and hold the Start/Stop button until the PainNOTTMLaser RX turns on. 4. After the Battery light and the 5Hz light have turned green, PainNOTTMLaser RX is ready for use. 5. Select the treatment regimen for your type of pain using Table 1 in Section 10. 6. Use the Freq button to select the appropriate treatment program - Program I (5 Hz), Program 2 (50 Hz), or Program 3 (1-250 Hz) 7. Push the Start/Stop button to begin the treatment session of IS minutes. The Treatment light on the control panel will start flashing. 8. Hold the PainNOTTMLaser RX to the area being treated for the duration of the treatment session (15 minutes). 9. At the conclusion of the treatment, the Treatment light will switch off. Select another program via the Freq/Prograrn button, or push the Start/Stop button to repeat the treatment on another area of pain or stiffness. 10. To stop a treatment, push the Start/Stop button. II. To shut off the device, push and hold down the start/stop button. Release the start/stop button after the device beeps 3 times. The device will then shut off. 12. Attach the PainNOTTMLaser RX to the power adapter to charge for the next treatment session.

6

Alternative Methods for Delivering Treatment
• Where possible, treatment should be provided on bare skin. However, when necessary, treatment can be provided over clothing or over a clean, dry wound dressing. In these situations, clothing and dressings should be kept to a minimum thickness, as this can reduce the ability of the laser to penetraLe, as well as altering the distance between the emitter and the area being treated, which will change the penetration depth. • In general, the emitter should simply be held in the place in which the pain or discomfort is being felt. • In cases where the area of treatment is more general, then the emitter should still touch the skin, but should be moved (scanned) around the treatment area.

"

Monitoring Device Function
• If the PainNO'fTM Laser RX is operating properly, the patient will feel a gentle warming of the skin surface in the area

when receiving treatment.

• A green light on the panel of the emitter indicates that the device is turned on and the emitter is activated. • If the green light on the emitter does not illuminate when a treatment session is initiated, contact the dealer. • The emitter consists of eight LEDs and one laser diode (in the middle). When the emitter is activated, four of the LEDs light up (in red). • Do not look at the emitter head for longer than 30 seconds when checking device operation. Radiation from the other four LEDs and the laser diode are invisible to the eye. If the user does not see the red LEDs illuminate when treatment is initiated, contact the dealer.

Effect of Device Failure on Patient
If the PainNOTTMLaser RX fails prior to commencement of treatment, the emitter will not tum on and the equipment dealer should be contacted. If there is an equipment failure during the course of the treatment, the emitter will shut off. If the emitter does not shut off at the end of the treatment session, the user should position the unit so that the emitter cannot cause vision damage. The user should open the battery cover and remove the battery. Contact the equipment dealer as soon as possible for further instruction.

Lifetime of Device
The PainNO'fTM Laser RX laser will last for 10,000 hours of usage.

7

--~

Cart and Cleaning/Troubleshooting
• Wipe the PainNOTTMLaser RX with an alcohol swab or cotton moistened with 70% isopropyl alcohol before and after each use. • Use only a soft dry cloth to clean the body of the emitter (if necessary). Never use an abrasive cleanser or submerge the emitter in water or any other liquid. • Do not expose the PainNOT™ Laser RX to extreme temperatures, humidity, or direct sunlight. • Cleaning should only be done after making sure that the PainNOTTMLaser RX is not plugged into the power adapter. The cleaning solution could wet the power adapter, which will damage the unit. • Do not allow the emitter or the connecting port for the power adapter to become wet. The user should ensure that these components are dry prior to use of the PainNOTTMLaser RX. If the Emitter connector does become wet, please contact the manufacturer for instructions on how to continue use of the PainNOTTMLaser RX. • Do not expose the PainNOT™ Laser RX to extreme temperatures, humidity, or direct sunlight. Store at room temperature. The PainNOTTMLaser RX may not operate properly if it is exposed to extreme conditions. • One of the design features of the PainNOTTMLaser RX is that there is no maintenance required by the user, other than keeping the products clean and stored in the proper environment, as described above. All repair and/or service to the PainNOTTMLaser RX must be done by the manufacturer. Any opening or disassembly of the Emitter immediately voids the warranty of the PainNOTTMLaser RX. • If all 3 program lights are illuminated, this means that the device is damaged and should not be used [or treatment. Contact BioTech Research. Repair should only be made by the manufacturer or authorized service center. Please contact BioTech Research at 1-800-895-0008 should you have any questions or experience any problems with the PainNOTTM Laser RX.

Technical Information
Average Power: Laser radiation: 0.4-7.S mW Infrared radiation: 30-90 mW Red LEDs: 2-10 mW Infrared Laser radiation: 90S nm Infrared radiation: 87S nm RED radiation: 660nm Pulse laser Power: 2SW Medical Grade Switching Power Adapter (supplied) Input: 100-204 V SO/60 Hz, 0.SS-03A Output: 13.SV max 1.3A

Wavelength of:

Power Source:

Class IIequipment Applied Part Type Laser class 1M (IEC 60825-1) Supply ratings: Mode of operation: 13.S Vdc; max. 0.7A Continuous Operation

*Equipment is not suitable for use in the presence of a flammable anaesthetic mixture of air or with oxygen or nitrous oxide. Operating environment: lonc to 40nc (sonF to 104nF) 700-1060 hPa Storage environment: Humidity: Dimensions: Weight: -20nc to sonc (4!lFto 122nF) 700-1060 hPa IS-9S% RH 14cm x Scm x Scm 300g
8

GUARANTEE
This product carries a 60-day satisfaction guarantee. If you are not totally satisfied, your purchase price will be refunded if you return your PainNO'fTM Laser RX within sixty (60) days. No questions asked. In the event you need to return your PainNOTTM Laser RX, it must be returned in the original packaging damage to unit during shipping. to avoid

ONE YEAR LIMITED WARRANTY
Bio'Iech Research warrants that the PainNOTTM Laser RX is free of defects in materials and workmanship from the date of purchase. This warranty is valid only in accordance with the conditions set forth below. for one year " or institutional

1. This warranty applies to consumer
setting.

use only and is void when the product is used in a commercial

2. This warranty extends only to the original consumer purchaser and is not transferable. This warranty is void if the product has been subject to accident, misuse, abuse, improper maintenance of unauthorized repair or modification. 3. This limited warranty is the only written or express warranty given by BioTech Research. If BioTech Research cannot lawfully disclaim any implied warranties of fitness for a particular purpose then such warranties are limited in duration to the duration of this warranty. Some states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. 4. Repair or replacement of the product (or, if repair or replacement is not feasible, a refund of the purchase price) is the exclusive remedy of the consumer under this warranty. BioTech Research shall not be liable for any incidental , or consequential damages for breach of this warranty or any implied warranty on this product. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. 5. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state.

For more information, or for assistance, please call or write: BioTech Research 7800 Whipple Ave NW Canton, OH 44767 1-800-895-0008

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~lngredkHds ••••••••••••••••••••••••• Menthol .................... 5% ... Topk:8I Methyl Salicylate ...•..•.•...• 2.68% • Topical Borneo Camphor ...•........• 2.68% .. Topical Camphor, Thymol ............ 1% .... Topical DIphenhydramIne Hydrochloride •• 0.68% .• Topical CapsIcum extract •..•.••••••• 0.25% .• Topical P~ Analgesic Analgesic Analgesic . Analgesic Analgesic
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Uses For temporary relief 01minor aches & painS 01muscles & joints associated wHh: - arthritis _ simple backache _ strains - sprains _ bruises
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7800 Whipple Ave. N.W.•

N. Canton, Ohio 44720 • (330) 494·5504 • FAX (330) 497·6847

PIO NUMBER MUST APPEAR ON ALL CARTONS AND INVOICES P/ONUMBER PAGE

PURCHASE ORDER

ORDER IS SUBJECT 1"0 THE TEAMS, CONDITIOI~S AND INSTRUCTIONS ON THE FACE AND REVERSE SIDE HEREOF. ACCEPTANCE OF l"HIS PURCHASE ORDER CONSTITUTES YOUR CONSENT TO BE BOUND BY THE T;:RMS, CONDITIONS AND INSTRUCTIONS HEREOF.

nils PURCHASE

P/O DATE

CHANGE!CANCEL

(Ship to the above address unless specified below.)

ORDERED FROM

SHIP TO

ORDER TYPE

BUYER

ACKNOW· CONFIRM LEDGE

TERMS

F.O.B.

SHIP VIA

COUPPD

LINE NUMBER

QUANTITY ORDERED BLANKET TYPE

u/M

ITEM NUMBER! DESCRIPTIONINOTES

YOUR ITEM NUMBER

PRICEIUNITIM

REQUESTED DELIVERY DATE

CHANGE! . CANCEL

NOTES

RECEIVING HOURS· 8:00 A.M. TO 4:00 P.M. NO RECEIVING WILL BE ACCEPTED AFTER 4:00 P.M.

SWlrez corp. Ind. Inc.
North Canton. OH 3/4.24/08 _I'lL ., Exhibit #~pgj_or.J!!,_

Ordered By VENDOR

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1F·IICIIR1'1D4A

• HandyRx Laser • MQ2007

Operators Manual

Table of Contents
Section Page

.1. 2.
3.

Glossary of Terms 2 Introduction

Intended Use and Indications for Use 3 4. Device DescriQtion 3 5. Contraindications 3 6. Warnings

2

7. 8. 9.

Precautions RiskslBenefits Adverse Effects

4
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Suarez Corp. Ind. Inc. North Canton, OH
3/4-24/08 Exhibit H

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.l.!l Overview of HandyRx Treatmentffreatment Programs

lL Course of Treatment
8 12. Operating Instructions-Programmed Mode 9 u_,_ Alternative Methods for Delivering Treatment 10 14. Monitoring Device Function 10 ~ Effect of Device Failure on Patient
11

7

16. Lifetime of Device
11

17. Care and Cleaningffroubleshooting 11 ~ Technical Infonnation 12 19. HandyRx Warranty
13

20. DistributorlRetail Outlet Infonnation 13

Suarez COl}!. Ind. Inc. North Canton. OH
3/4-24108 BJL

Exhibit #_ll_pg_k__or~

HANDYRX LASER MQ2007 OPERATORS MANUAL

1.

Glossary of Terms Frequency: The number of times that the light wave oscillates per second (The number of periods of oscillations per second). hPa: Unit of pressure measurement (Atmospheric pressure) lEe 60825-1: "Safety of laser products - Part 1:Equipment classification, requirements and user's guide", an internationally recognized standard containing laser safety requirements Infrared radiation: Invisible electromagnetic radiation with wavelengths which lie within the range of 0.70 to 1000 micrometers (microns). This region is often broken up into IR-A, IR-B, and IR-C. LED: Light emitting diodes, used to generate infra-red energy Mw: Megawatt, units of measure for laser output power !!!!!:. The unit of measure for the length of the light wave (wavelength), which is defined as the shortest distance at which the wave pattern fully repeats itself, usually measured from crest to crest. The wavelength oflight in the visible spectrum determines its color. Pulse laser power: Energy delivered by a laser in the form of a single or train of bursts (pulses). V dc: Direct current voltage

2.

Introduction The HandyRx MQ2007 Laser Therapy Device is designed to lessen pain by using laser diode and light emitting diodes (LEDs) that generate infra-red energy in the form of low level light to deliver a therapeutic effect. It is important to emphasize that therapy with the HandyRx MQ2007 does not exclude other conventional medical treatment.

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Suarez Corp. Ind. Inc. North Canton. OH 314-24/08 BIl Exhibit IIJ::LpJL3...or1i_

3.

Intended Use and Indications for Use The HandyRx MQ2007 Laser Therapy Device is a non-invasive, infrared device lamp intended to provide topical heating. The HandyRx Laser MQ2007 is intended to provide the following:

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Temporary relief of muscle and joint pain, arthritis and muscle spasm, Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, Relieving stiffness, Promoting relaxation of muscle tissue, Temporarily increasing local blood circulation.

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~ 4.

Device Description The HandyRx MQ2007 is an over-the-counter, non-invasive pain therapy system that utilizes laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of other low-level laser systems currently in commercial distribution into one complete, compact system. The system weighs 1.0 pounds (0.300 kg). Figure 1 below shows the HandyRx MQ2007.

Figure 1 ~HandyRx MQ2007

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5.

Contraindications 1 DO NOT USE the HandyRx MQ2007 if you have a pacemaker as it could interfere with the proper function of the pacemaker. 2 3 DO NOT USE the HandyRx MQ2007 in the vicinity of a pacemaker as it could interfere with the function of other people's pacemakers. DO NOT USE the HandyRx MQ2007 if you are using a device that uses magnets as it could interfere with the proper function of the device.

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DO NOT USE the HandyRx MQ2007 over sensitive skin areas or in the presence of poor circulation. The unattended use of the HandyRx MQ2007 by children or incapacitated persons may be dangerous.

5 6 7

Keep the HandyRx MQ2007 away from children. DO NOT USE the HandyRx MQ2007 on children under 3. During treatment, avoid direct exposure of the treated area to other intense light sources such as a UV sun lamp. Exposure to other high intensity light sources may cause excess heating and slight burns on the skin. Excessive use of the HandyRx MQ2007 will not result in burns; however use of the HandyRx MQ2007 with other heat sources could cause slight burns on the skin.

6.

Warnings 8 9 DO NOT use the HandyRx MQ2007 in, or around, water. Contact with water could cause electric shock that can result in serious injury to you. DO NOT look directly at the light source. The HandyRx MQ2007 emits high intensity light. Prolonged (greater than 30 seconds) direct exposure of your eyes to the light emitted by the HandyRx MQ2007 may cause damage to your vision. Direct or reflected radiation should be prevented from entering the eyes. Damage could possibly occur even with your eyes closed, therefore never point the laser at the eyes directly. Use the supplied protective eyewear when treating any area on the body. 10 DO NOT point the laser directly at your eyes. Damage to your vision could possibly occur even with your eyes closed. Use the supplied protective eyewear especially when treating the facial area. 11 DO NOT allow the unit to contact broken skin. The device is not sterile and may cause infection if used on broken skin. If used on broken skin, infection may result and further medical attention may be needed. 12 DO NOT use HandyRx MQ2007 to treat the abdominal area if you are pregnant in order to avoid potential injury to the developing fetus. 13 DO use only the medical grade switching power adaptor supplied with your HandyRx MQ2007 (see picture of power adaptor in Figure 2). Do not use any other power supply as it may cause electric shock.

Suarez Corp. Ind. Inc. North Canton. OH 3/4.24/08 Bll . III Exhibit 1#1:1...ps.£_or_t.:I....

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Precautions Read these instructions, including all warnings before using the HandyRx MQ2007 to ensure proper use of the device. 14 Use this device while following the safety precautions and operating instructions in this Operator's Manual. It is important to keep this manual handy. The Operators Manual should be studied and reviewed periodically by users of HandyRx MQ2007. 15 The HandyRx Laser MQ2007 was designed and manufactured to ensure maximum safety of operation. Maintain the device in strict compliance with the safety precautions and operating instructions in this manual. 16 The HandyRx MQ2007 should be maintained and serviced only by Medical Quant Limited personnel, or other qualified personnel approved in writing by Medical Quant Limited. 17 Do not drop the HandyRx MQ2007 as it could be damaged and will not function properly.

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Suarez Corp. Ind. Inc. North Canlon. OH
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8.

RiskslBenefits Risks 18 There is a risk of damage to your vision from prolonged exposure (longer than 30 secondsjto the light emitted by the HandyRx 2007. Damage to your vision could occur upon looking directly at the light source for longer than 30 seconds. Your vision could be damaged whether you looked at the light source with central vision or peripheral vision, or possibly with your eyes closed. Damage to your vision can be prevented by avoiding looking directly at the light source, wearing the supplied eyewear, and never pointing the laser directly at your eyes. 19 The HandyRx 2007 is programmed to deliver a limited amount of energy to the skin, to protect against overheating that may cause discomfort. When the device is used as directed, the skin is heated only to temperatures of 104 - 113 OF (40-45 °C). Repeated treatments of a single part of the body or continuous treatment will not cause the skin to be overheated. However, to prevent discomfort, the HandyRx 2007 should not be used on any area of your body that you are concerned may be overly sensitive to heat (i.e., on a sunburned area) .. 20 There is a risk of excessive heating of the skin, and slight superficial burning, if the treated area is directly exposed to other intense light sources such as UV sun lamps. Burning your skin can be avoided by protecting treated areas from direct exposure to intense light sources. 21 There is a risk of infection if the HandyRx 2007 contacts broken skin. Infection can be avoided by using the unit on intact skin. 22 The HandyRx 2007 includes a magnet to focus the laser. These magnets can interfere with the function of other medical devices. Therefore do not use the HandyRx 2007 in the vicinity of any other medical devices. Benefits 23 Use of the HandyRx MQ2007 makes it easy to administer treatment at home. 24 Treatment with the HandyRx MQ2007 can be combined with treatment via conventional medicine. 25 Most patients should expect to feel pain relief and/or muscle relaxation after 6 days ofHandyRx MQ2007 treatment (one day's treatment consists of2 sessions of 15 minutes each). The first three days treatment consists of2 sessions of 15 minutes each per day. This is followed up by treatment of one session of 15 minutes per day for 3 days. 26 However, some patients may feel a noticeable reduction of pain immediately

Suarez Corp. Ind. Inc. North Canton. OH 3/4-24108 BJ L Exhibit #.z2_pv:J_orfl

11

after their first treatment, and relaxation of stiff muscles after 1 day of treatment.

.2:..

Adverse Effects
27 The HandyRx MQ2007 can cause damage to the eyes by looking directly at the light source for an extended period of time (greater than 30 seconds). 28 The HandyRx MQ2007 may interfere with pacemaker function if used in the vicinity of a pacemaker. 29 The magnets incorporated in the HandyRx 2007 to focus the laser can interfere with the function of other medical devices.

10. Overview of HandyRx TreatmenttI'reatment

Programs

The pain you are feeling can be divided into two areas, localized pain (shallow pain felt near the surface of your body or pain confined to one area) or radiating pain (for example pain radiating from your neck to the arm), which typically is internal (deep) pain felt along your nerves. Pain is defined as physical discomfort or suffering associated with a bodily disorder. Stiffness is defined as an area of the body that is inflexible or rigid and cannot be moved easily and/or without pain. When you are feeling pain that seems like minor muscle pain or a muscle spasm, identify the location of the pain and focus the HandyRx MQ2007 beam directly on it. For joint pain! arthritis, focus the beam on the joint-line area. (The joint-line area is the area where the two bones meet). The HandyRx MQ2007 is supplied with three pre-programmed treatment programs that have been established to treat different conditions (see Table 1). A program is selected by pushing the Freq button. The duration of all of the treatment programs is

15 minutes per session.

Each program uses different pulse frequencies, as summarized in the table below. Variation of the pulse frequencies alters the depth of penetration of the laser light. Each site where pain and/or stiffness is experienced should be treated via either program 1 or 2 for two days (one day's treatment is defined as two IS-minute sessions), followed by program 3 on the third day. More detailed information regarding how to manage the treatment of your pain is provided in Section 12, Duration of Treatment.

Suarez Corp. Ind. Inc. North Canton, OH
3/4-24/08 BJl E"hibitII z_-, Pg_j_of_jj_

Table 1 - Treatment Programs
Program 5Hz, Program 1 • Chronic Pain Syndrome • Temporary relief of minor muscle and joint pain, arthritis and muscle spasmdeep pain • Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origins 5Hz 15 minutes 50Hz, Program 2 • Acute Pain Syndrome • Temporary relief of minor muscle and joint pain, arthritis and muscle spasm - shallow pain Variable Program 3 • Treatment completion Relaxation of muscle tissue. • Temporary increase oflocal blood circulation. • Relief of stiffuess

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Treatment

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Pulse frequency Program duration

50Hz 15 minutes

Variable I to 250 Hz 15 minutes

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11. Course of Treatment 30 An initial treatment cycle consists of up to two days treatment (one day's treatment is defined as two 15 minute sessions) for either program 1 or 2, followed by one day of program 3. 31 Three-day treatment cycles can be repeated, by applying treatment once a day on each individual point for no more than 21 consecutive days. 32 Patients should expect to feel relief of pain and/or stiffuess after 6 days of commencing treatment, although some patients begin to feel beneficial affects following the first treatment 33 Upon completion ofa full course (21 days) of the single treatment course, a further course can be undertaken after a 3-day break. 34 Treatment should be continued until pain has stopped.

Suarez Corp. Ind. Inc. North Canton, OH
3/4-24/08

Exhibit# 2-7 Pg_j_or

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12. Operating Instructions-Programmed
12.1

Mode

Connect the HandyRx MQ2007 to the AC power Adaptor. The HandyRx MQ2007 operates using an internal battery that must be fully charged before each use with the AC power adaptor (supplied). If the battery is charged, the cord does not need to be plugged into the wall power source. If the battery is not charged, the device can be used with the AC adaptor plugged into the wall outlet.

NOTE: DO NOT use the device while connected to the AC power adaptor near or around water.
12.2 12.3 12.4 Charge the HandyRx MQ2007 for a minimum of 8 hours before initial use. Press and hold the Start/Stop button until the HandyRx MQ2007 turns on. After the Battery light and the 5Hz light have turned green, HandyRx is ready for use. 12.5 Select the treatment regimen for your type of pain using Table 1 above in Section 10. 12.6 Use the Freq button to select the appropriate treatment program (program 1 (5 Hz), Program 2 (SO Hz), or Program 3 (1-250 Hz» 12.7 Push the Start/Stop button to begin the treatment session of 15 minutes. The Treatment light on the control panel will start flashing. Hold the HandyRx MQ2007 to the area being treated for the duration of the treatment session (15 minutes). At the conclusion of the treatment, the Treatment light will switch off. Select

12.8

12.9

another program via the FreqlProgram button, or push the Start/Stop button to repeat the treatment on another area of pain or stiffhess. 12.10 To stop a treatment, push the Start/Stop button. 12.11 To shut off the device, push and hold down the start/stop button. Release the start/stop button after the device beeps 3 times. The device will then shut off." 12.12 Attach the HandyRx MQ2007 to the power adapter to charge for the next treatment session.
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13. Alternative Methods for Delivering Treatment 35 Where possible, treatment should be provided on bare skin. However, when necessary treatment can be provided over clothing or over a clean, dry wound dressing. In these situations, clothing and dressings should be kept to a minimum thickness, as this can reduce the ability of the laser to penetrate, as well as altering the distance between the emitter and the area being treated, which will change the penetration depth. 36 In general, the emitter should simply be held in the place in which the pain or discomfort is being felt. 37 In cases where the area of treatment is more general, then the emitter should still touch the skin, but should be moved (scanned) around the treatment area. 14. Monitoring Device Function 38 If the HandyRx MQ2007 is operating properly, the patient will feel a gentle warming of the skin surface in the area when receiving treatment. 39 A green light on the panel of the emitter indicates that the device is turned on and the emitter is activated 40 If the green light on the emitter does not illuminate when a treatment session is initiated, contact the dealer. 41 The emitter consists of eight LEDs and one laser diode (in the middle). When the emitter is activated, four of the LEDs light up (in red). 42 Do not look at the emitter head for longer than 30 seconds when checking device operation. Radiation from the other four LEDs and the laser diode are invisible to the eye. If the user does not see the red LEDs illuminate when treatment is initiated, contact the dealer.

Suarez Corp. Ind. Inc. North Canton. OH
3/4·24/08 Exhibit #

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15. Effect of Device Failure on Patient If the HandyRx MQ2007 fails prior to commencement of treatment, the emitter will not turn on and the equipment dealer should be contacted. If there is an equipment failure during the course of the treatment, the emitter will shut off. If the emitter does not shut off at the end of the treatment session, the user should position the unit so that the emitter cannot cause vision damage. The user should open the battery cover and remove the battery. Contact the equipment dealer as soon as possible for further instruction. 16. Lifetime of Device The HandyRx MQ2007 laser will last for 10,000 hours of usage. 17. Care and CleaninglTroubleshooting 43 Wipe the HandyRx MQ2007 with an alcohol swab or cotton moistened with 70% isopropyl alcohol before and after each use. 44 Use only ~ soft dry cloth to clean the body of the emitter (if necessary). Never use an abrasive cleanser or submerge the emitter in water or any other liquid. 45 Do not expose the HandyRx MQ2007 to extreme temperatures, humidity, or direct sunlight. 46 Cleaning should only be done after making sure that the HandyRx MQ2007 is not plugged into the power adaptor. The cleaning solution could wet the power adaptor, which will damage the unit. 47 Do not allow the emitter or the connecting port for the power adaptor to become wet. The user should ensure that these components are dry prior to use of the HandyRx MQ2007. If the Emitter connector does become wet, please contact the manufacturer for instructions on how to continue use of the HandyRx MQ2007. 48 Do not expose the HandyRx MQ2000 to extreme temperatures, humidity, or direct sunlight. Store at room temperature. The HandyRx MQ2007 may not operate properly if it is exposed to extreme conditions. 49 One of the design features of the HandyRx MQ200 is that there is no maintenance required by the user, other than keeping the products clean and stored in the proper environment, as described above. All repair and/or service to the HandyRx MQ2007 must be done by the manufacturer. Any opening or disassembly of the Emitter immediately voids the warranty of the HandyRx MQ2007. 50 If all 3 program lights are illuminated, this means that the device is damaged and

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Suarez Corp. Ind. Inc. North Canton, OH
3/4-24/08 BJL Exhibit lIJ!1_pgJ1..orJ.!l_

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should not be used for treatment. the manufacturer

Contact the dealer*. Repair should be made by

or authorized service center.

*To contact Service Department Call 1-800-373-0955 Please contact your closest HandyRx dealer should you experience any other problem. Please call *TOLL FREE NUMBER if you have any questions or problems with HandyRx MQ2007. *The toll free number will be inserted prior to commercial distribution.

18. Technical Information Average power:
Laser radiation: 0.4-7.5 m W Infrared radiation: 30-90 m W Red LEDs: 2-10 mW Infrared Laser radiation: 905 nm Infrared radiation: 875 nm RED radiation: 660nm Pulse laser Power: 25W Medical Grade Switching Power Adaptor (supplied) Input: 100-204 V 50/60 Hz, 0.55-03A Output: 13.SV max 1.3A

Wavelength of:

Power Source:

Class n equipment Applied Part Type Laser class 1M (lEe 60825-1) Supply ratings: 13.5 Vdc; max. 0.7A Mode of operation: Continuous Operation *Equipment is not suitable/or use in the presence 0/ ajlammable anaesthetic mixture 0/ air or with oxygen or nitrous oxide. Operating environment: Storage environmeat: Humidity: Dimensions: Weight:
10°C to 400C (SO°F to 104°F) 700-1060 hPa -20°C to SOOC(4°F to 122°F) 700-1060 hPa 15-9S% RH 14cm x Scm x Scm 300g

Suarez Corp. Ind. Inc. North Canton, OH 3/4-24/08 BlL .• J Exhibit 1# 1"1 Ps1l.orJ.+__

19. HandyRx Warranty Medical Quant Limited guarantees that HandyRx will operate in the manner described in this manual for a period of 12 months from the date of purchase, when used and maintained in accordance with the instructions herein. Defects or damage due to misuse or abuse are not covered by this warranty. Please bring this warranty with the HandyRx in the event of a complaint. Medical Quant Limited shall not be liable in any manner in respect of bodily injury and/or property damage arising from the use of the HandyRx where such use is not in strict compliance with the instructions and safety precautions contained in the HandiRx Operating Manual, including all supplements thereto, in all product labels, and according to the terms of warranty and safety of this equipment, nor if any changes unauthorized by Medical Quant Limited are made to the HandyRx.

20. DistributorlRetall Outlet Information
Distributor Information: [LOGO AND CONTACT INFORMATION FOR DISTRIBUTOR TO BE SUPPLIED HERE] Retail Outlet Information: [LOGO AND CONTACT INFORMATION FOR DISTRIBUTOR TO BE SUPPLIED HERE] Date of Purchase:

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Sua",z Corp. Ind. Inc.

North Canton. OH
3/4-24/08 BJL

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3/4-24/08 BJL

___________________________

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Exhibilll.1,i_piLof_1._

R.4.ITUNG, rU:rUND WRONG CUSTOr"lER NUI"IBER, REfUND ..... RETURNED DUE TO-DR-'S ADVICE, REFUND - .. SKR RETURNED DUE TO SIDE AFFECTS, REFUND R RETURNED DUE TO DYES IN PRODUCT, REFUND GFT SENDING f"lERCHANDIS£ TO SI(I1Sf'Y CUSTOI'1ER {manager approval) IFR INVOICE FULFIUJvlENT RETURN, R!:FUND CTS CALL TAG WAS SENT TO PICK UP MERCHANDISE CTR tvTERCHANDl5E WP.S RECEIVtD AFrEiR CALL TAG WAS SENT ~TR \N

EDE_NPURE HEATI;B DISPO'S
TRE TRF NAA CDS CDR t-'lLS fvTLR EBR THERIIIJOSTATNOr WORIONG, ru:SHIP 1'HERr'~OSTAT Nor WORKING, REFUND NOT AS ADVERTISED, REFUND COSMETIC DAMAGEr RESHIP COSMmc (>At~AGE,REFUND UNIT MEI.TING, RESHIP UNiT fVjELllNG, REFIJND ELECTRIC BILL TOO Hl{;~f, REFUND

PQSJCARDS
ALS SPD BOq PRO AUDIT POSTCARDSENT WHEN cosr POSTCARDSENT TO,CUST Sl"AnNG POSTCARDSENT TOCUST STATING POSTCARDSENT 1'0 C.1J5T STATING MAS NOT RECEIVED ORDER (wIthin 3{1 daY5) DATE THE ORDeR WAS SHTPPED ORDER IS OUT OF STOCK ORDER IS PROCESSING (use when order 15 not

pending in doc Inquiry)

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3/4-24/08 BJL Exhibit N~pdof

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