SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM

K121059 · Zimmer Medizinsystems GmbH · IMG · Aug 7, 2012 · Physical Medicine

Device Facts

• Record ID: K121059
• Device Name: SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
• Applicant: Zimmer Medizinsystems GmbH
• Product Code: IMG · Physical Medicine
• Decision Date: Aug 7, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module. The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV). The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles. At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms: Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated. The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.

Device Story

Soleoline is a prescription-only device family (Soleo Stim, Soleo Sono, Soleo SonoStim) for electrotherapy and ultrasound therapy. Used in clinical settings (hospitals, clinics, nursing homes) by licensed healthcare providers. Inputs include user-selected therapy parameters via a color touch-screen interface. The device generates electrical stimulation waveforms (e.g., Interferential, High Voltage, Microcurrent, Biphasic) and ultrasound energy (0.8MHz/2.4MHz). It features 120 storage bins for custom programs and a therapy menu for region-specific guidance. Outputs are delivered via ultrasound heads or stimulation electrodes. The device provides symptomatic pain relief, muscle spasm reduction, and improved circulation. Benefits include non-invasive management of chronic/acute pain and muscle rehabilitation. The system supports combination therapy, allowing simultaneous application of ultrasound and electrical stimulation.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by comparative technical specifications, validation documentation, and adherence to relevant safety standards (IEC/EN 60601-1, 60601-1-2, 60601-2-5, 60601-2-10).

Technological Characteristics

Molded PC-ABS plastic housing. Dual-channel electrotherapy (CC/CV) and dual-frequency ultrasound (0.8MHz/2.4MHz). Color LCD touch screen. Universal power supply (100-240VAC). Connectivity: Standalone. Software-controlled microprocessor. Compliant with IEC/EN 60601-1, 60601-1-2, 60601-2-5, 60601-2-10. Features automatic overload trip and patient override.

Indications for Use

Indicated for relief of pain, muscle spasms, and joint contractures (e.g., adhesive capsulitis, bursitis, myositis, soft tissue injuries, scar tissue). Electrotherapy indicated for relaxation of muscle spasm, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, maintaining/increasing range of motion, and symptomatic relief/management of chronic, intractable, post-traumatic, or post-surgical acute pain.

Regulatory Classification

Identification

An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.

Predicate Devices

• Vectra Genisys (K031077)
• Galva 5 M (K954411)
• Sono 5 (K952536)

Submission Summary (Full Text)

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#### (12/059 AGE | OF ID

Zimmer Medizinsysteme GmbH Junkersstraße 9 D-89231 Neu-Uim

Tel. [phone]

[e-mail] Fax 0731 / 9761-118

www.zimmer.de

AUG

## 5. 510(k) Summary

The following information is provided as required in 21CFR807.87 and the Guidance Document "Guidance Document for Powered Muscle Stimulators 510(k)s"

### a.) General

| 510(k) Submitter: | Zimmer MedizinSysteme GmbH<br>Junkersstrasse 9<br>D-89231 Neu-Ulm<br>Germany |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Mr. Armin Pétraschka<br>Project Manager<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Establishment Registration: | 8010720 |
| Submission Date: | January 13th, 2012 |
| Device Names: | |
| Device family name: | Soleoline |
| Trade Names: | Soleo Stim<br>Soleo Sono<br>Soleo SonoStim |
| Common Names: | Ultrasound and muscle stimulator<br>Powered muscle stimulator<br>Transcutaneous electrical nerve stimulator for pain relief<br>Ultrasonic diathermy |
| Regulation Numbers and Classification Names: | 21 CFR 890.5850 - Stimulator, Muscle, Powered<br>21 CFR 890.5300 - Ultrasonic diathermy<br>21 CFR 890.5860 - Ultrasound and muscle stimulator<br>21 CFR 882.5890 - Transcutaneous electrical nerve stimulator for pain relief |
| Classification: | Class II |
| Product Codes: | IPF, IMI, IMG, GZJ |
| Panel: | 89 - Physical Medicine<br>84 - Neurology |

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#### K121059 PAGE 2 OF IO

## b.) Predicate Devices

| 1-<br>Device:<br>Manufacturer:<br>510(k) number: | Vectra Genisys<br>CHATTANOOGA GROUP (Encore Medical)<br>4717 adams rd. P.O. Box 489<br>Hixson, Tennessee 37343-0489<br>K031077 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | |
| 2.<br>Device:<br>Manufacturer: | Galva 5 M<br>Zimmer MedizinSysteme GmbH (former Zimmer Elektromedizin GmbH) |
| | Junkersstrasse 9<br>89231 Neu-Ulm<br>Germany |
| 510(k) number: | K954411 |
| 3. | |
| Device: | Sono 5 |
| Manufacturer: | Zimmer MedizinSysteme GmbH |
| | Junkersstrasse 9 |
| | 89231 Neu-Ulm |
| 510(k) number: | Germany<br>K952536 |
| | |
| | |

## c.) Device Description

The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.

Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.

The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).

The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.

At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:

Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated

The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.

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K121059
PAGE 3 OF 10

## d.) Statement of indications for use

2.

The indications for use of the proposed device are the same as those for the predicate devices Ultrasound therapy:

- Relief of pain, muscle spasms and joint contractures 1.
- Relief of pain, muscle spasms and joint contractures that may be associated with: "
- · Adhesive capsulitis
- Bursitis with slight calcification o
- · Myositis
- Soft tissue injuries o
- Shortened tendons due to past injuries and scar tissues o
- 3. Relief of pain, muscle spasms and joint contractures resulting from:
- · Capsular tightness
- · Capsular scarring

#### Electrotherapy:

- 1. Relaxation of muscle spasm
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle re-education
- 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- ର. Maintaining or increasing range of motion
- 7. Symptomatic relief or management of chronic, intractable pain
- 8. Post-traumatic acute pain
- ு. Post-surgical acute pain

## e.) Comparison of Technological Characteristics

#### General:

| Feature | Zimmer Soleoline<br>(Soleo Sono,<br>Soleo Stim,<br>Soleo SonoStim) | Chattanooga Vectra<br>Genisys w/o EMG | Zimmer Galva 5 | Zimmer Sono 5 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Number of channels | 2 | 2/4 | 2 | - |
| Number of connections | 2 | 2 | 1 | - |
| Touch screen interface | + | - | - | - |
| Color LCD screen | + | + | - | - |
| Intended use | Ultrasound diathermy,<br>Powered muscle<br>stimulator,<br>Ultrasound and<br>muscle stimulator | Ultrasound and muscle<br>stimulator | Powered muscle<br>stimulator, | Ultrasound diathermy |
| Indications<br>electrotherapy | Relaxation of<br>muscle spasm<br>Prevention or<br>retardation of<br>disuse atrophy<br>Increasing local<br>blood circulation<br>Muscle re-<br>education<br>Immediate post-<br>surgical<br>stimulation of calf | Relaxation of<br>muscle spasm<br>Prevention or<br>retardation of<br>disuse atrophy<br>Increasing local<br>blood circulation<br>Muscle re-<br>education<br>Immediate post-<br>surgical<br>stimulation of calf | Relaxation of muscle<br>spasm<br>Prevention or<br>retardation of disuse<br>atrophy<br>Increasing local<br>blood circulation<br>Muscle re-education<br>Immediate post-<br>surgical stimulation<br>of calf muscles to<br>prevent thrombosis | - |

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# K121059
PASE 4 OF D

| | muscles to | muscles to | Maintaining or | | | | | | |
|----------------------------------------------------|--------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------------|--------------------|----|----|----|----|----|
| | prevent | prevent | increasing range of | | | | | | |
| | thrombosis | thrombosis | motion | | | | | | |
| | Maintaining or | Maintaining or | | | | | | | |
| | | | | | | | | | |
| | increasing range | increasing range | | | | | | | |
| | of motion | of motion | | | | | | | |
| | Symptomatic | Symptomatic | | | | | | | |
| | relief or | relief or | | | | | | | |
| | management of | management of | | | | | | | |
| | | | | | | | | | |
| | chronic, | chronic, | | | | | | | |
| | intractable pain | intractable pain | | | | | | | |
| | Post-traumatic | Post-traumatic | | | | | | | |
| | acute pain | acute pain | | | | | | | |
| | Post-surgical | Post-surgical | | | | | | | |
| | | | | | | | | | |
| | acute pain | acute pain | | | | | | | |
| Indications ultrasound | Relief of pain,<br> | Relief of pain,<br> | | Relief of pain | | | | | |
| therapy | muscle spasms | muscle spasms | | Muscle spasm | | | | | |
| | and joint | and joint | | Joint contractures | | | | | |
| | contractures | contractures | | | | | | | |
| | | | | | | | | | |
| | Relief of pain, | Relief of pain, | | | | | | | |
| | muscle spasms | muscle spasms | | | | | | | |
| | and joint | and joint | | | | | | | |
| | contractures that | contractures that | | | | | | | |
| | may be | may be | | | | | | | |
| | | | | | | | | | |
| | associated with: | associated with: | | | | | | | |
| | • Adhesive | • Adhesive | | | | | | | |
| | capsulitis | capsulitis | | | | | | | |
| | • Bursitis with | • Bursitis with | | | | | | | |
| | slight | slight | | | | | | | |
| | | | | | | | | | |
| | calcification | calcification | | | | | | | |
| | • Myositis | • Myositis | | | | | | | |
| | • Soft tissue | • Soft tissue | | | | | | | |
| | injuries | injuries | | | | | | | |
| | • Shortened | • Shortened | | | | | | | |
| | | | | | | | | | |
| | tendons due to | tendons due to | | | | | | | |
| | past injuries | past injuries | | | | | | | |
| | and scar | and scar | | | | | | | |
| | tissues | tissues | | | | | | | |
| | Relief of pain, | Relief of pain, | | | | | | | |
| | | | | | | | | | |
| | muscle spasms | muscle spasms | | | | | | | |
| | and joint | and joint • | | | | | | | |
| | contractures | contractures | | | | | | | |
| | resulting from: | resulting from: | | | | | | | |
| | • Capsular | • Capsular | | | | | | | |
| | | | | | | | | | |
| | tightness | tightness | | | | | | | |
| | • Capsular | • Capsular | | | | | | | |
| | scarring | scarring | | | | | | | |
| Prescriptive use | + | + | + | + | | | | | |
| | | | | | | | | | |
| Maximum adjustable therapy | Maximum adjustable therapy time [min] | 60 | 60 | 60 | 60 | 60 | 60 | 30 | 30 |
| Modifiable Waveform Parameters | + | + | + | - | | | | | |
| Power source(s) | Universal power supply:<br>100 - 240VAC, 50/60Hz | Onboard switchable power supply:<br>120/240VAC, 50/60Hz | 120 VAC, 60Hz | 120 VAC, 60Hz | | | | | |
| Method of Line Current Isolation | Fuse - Two 2,0A Time Lag | Fuse - Two 5.6A Time Lag | Decoupling by mains transformer, Fuses, Electrical overcurrent limiter | N/A | | | | | |
| Patient Leakage Current:<br>Normal condition | < 1mA | 69μΑ | < 1mA | < 1mA | | | | | |
| Patient Leakage Current:<br>Single fault condition | < 0.5mA | 31μΑ | < 0.5mA | < 0.5mA | | | | | |

Author: A. Petraschka
510 (k) Premarket Notification Soleoline

.

·

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# K121059
PAGE 5 OF ID

| Number of Output Modes | 8: Interferential,<br>Premodulated,<br>Monophasic, Medium<br>Frequency,<br>Asymmetrical<br>Biphasic, Symmetrical<br>Biphasic, High Volt,<br>Microcurrent | 10: Interferential,<br>Premodulated, VMS,<br>VMS Burst, Russian,<br>Asymmetrical<br>Biphasic, Symmetrical<br>Biphasic, High Volt,<br>Microcurrent, Direct<br>Current | 5: Diadynamic current,<br>Medium Frequency,<br>Monophasic, Biphasic<br>symmetric, High voltage | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Number of Output Channels | 2 | 2 & 4 channel units | 1 | - |
| Synchronous or Alternating | Both | Both | Synchronous | - |
| Method of Channel Isolation | LAN spacings<br>compliant with IEC<br>60601-1 isolation<br>requirements | LAN spacings<br>compliant with IEC<br>60601-1 isolation<br>requirements, and<br>protective software<br>isolation | - | - |
| Regulated Current or<br>Regulated Voltage? | Yes, both CC and CV | Yes, both CC and CV | Yes, both CC and CV | - |
| Software/Firmware/<br>Microprocessor Control? | + | + | + | + |
| Automatic Overload Trip? | + | + | + | + |
| Automatic No-load Trip? | - | - | - | - |
| Automatic Shut-Off? | + | + | + | + |
| Patient Override Control? | + | + | + | N/A |
| Indicator Display:<br>On/Off Status | + | + | + | + |
| Low Battery<br>Voltage/Current Level | N/A | N/A | N/A | N/A |
| Compliance with Voluntary<br>Standards? | Yes, IEC/EN 60601-1,<br>IEC/EN60601-1-2,<br>IEC/EN 60601-2-5,<br>IEC/EN 60601-2-10, | Yes, IEC/EN 60601-1,<br>IEC/EN60601-1-2,<br>IEC/EN 60601-2-5,<br>IEC/EN 60601-2-10, | Yes, IEC/EN 60601-1,<br>IEC/EN60601-1-2,<br>IEC/EN 60601-2-10, | Yes, IEC/EN 60601-1,<br>IEC/EN60601-1-2,<br>IEC/EN 60601-2-5 |
| Compliance with 21 CFR<br>898 | + | + | + | + |
| Dimensions (w x d x h)<br>[cm] | 32.2 x 23.4 x 13 | 28.9 x 32.4 x 22.2 | 45 x 32.5 x 14 | 3.25 x 4.5 x 1.4 |
| Weight<br>[kg] | 2.1 | 3.2 | 5.7 | 6.8 |
| Housing Materials and<br>Construction | Molded PC-ABS<br>plastic material with<br>screw assembly<br>construction | ABS/PC injection-<br>molded top and<br>bottom shells,<br>Thermo-Plastic<br>Elastomer (TPE)<br>partial overmolding on<br>top, Acryl lens, Top<br>and bottom are<br>secured together with<br>machine screws. | Bottom and front:<br>Polystyrene;<br>Cover: steel sheet;<br>Front panel: glass | Bottom and front:<br>Polystyrene;<br>Cover: steel sheet;<br>Front panel: glass |
| Surge Mode | Ramp up:0.5 - 60s<br>On Time:0 - 60s<br>Ramp down:0.2 - 5s | N/A | Ramp up:0.5 - 60s<br>On Time:0 - 60s<br>Ramp down:0.5s | - |
| Specifications | New Device | Vectra Genisys | Galva 5M | |
| Waveform | Monophasic | - | Biphasic symmetric | |
| Shape | Rectangular | - | Rectangular | |
| Maximum Output Voltage<br>(+/- 20 %) | 24.7V@500Ω<br>99.9V@2kΩ<br>180V@10kΩ | - | 25V@500Ω<br>100V@2kΩ<br>200V@10kΩ | |
| Maximum Output Current<br>(+/- 20 %) | 50mA@500Ω<br>50mA@2kΩ<br>12mA@10kΩ | - | 50mA@500Ω<br>50mA@2kΩ<br>20mA@10kΩ | |
| Pulse Width | 200μs – 1500μs | - | 200μs – 1500μs | |
| Frequency [Hz] | 0-1667 | - | 0-1667 | |
| Beat Frequency [Hz] | N/A | - | N/A | |
| Symmetrical Phases | No | - | No | |
| Phase Duration | 200μs – 1500μs | - | 200μs – 1500μs | |
| Net Charge | 75μC | - | 75μC | |
| Maximum Phase Charge | 75μC | - | 75μC | |
| Maximum Current Density [mA/cm²] | 3.9@500Ω | - | 3.9@500Ω | |
| Maximum Power Density [W/cm²] | 0.097@500Ω | - | 0.097@500Ω | |
| Burst Mode | N/A | - | N/A | |
| a. Pulses per burst [PPB] | N/A | - | N/A | |
| b. Bursts per second [BPS] | N/A | - | N/A | |
| c. Burst duration [BD] | N/A | - | N/A | |
| d. Duty Cycle | N/A | - | N/A | |
| ON Time | See surge mode point 28. | - | See surge mode point 28. | |
| OFF Time | See surge mode point 28. | - | See surge mode point 28. | |
| Additional Features | Polarity reversal: Selectable. positive, negative or alternating; switches after each minute | - | Polarity reversal: Selectable. positive, negative or alternating; switches after each minute | |

.

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## Output specifications:

.

#### Monophasic rectangular:

#### Microcurrent:

| Specifications | New Device | Vectra Genisys | Galva 5M |
|--------------------------------------|------------------------------------------|----------------------------------|----------|
| Waveform | Microcurrent, monophasic | Microcurrent, monophasic | - |
| Shape | Rectangular | Rectangular | - |
| Maximum Output Voltage<br>(+/- 20 %) | 0.49V@500Ω<br>1.98V@2kΩ<br>10.20V@10kΩ | 0.51V@500Ω<br>2V@2KΩ<br>10V@10kΩ | - |
| Maximum Output Current<br>(+/- 20%) | 0.98mA@500Ω<br>0.99mA@2kΩ<br>1.02mA@10kΩ | 1mA@500Ω<br>1mA@2KΩ<br>1mA@10kΩ | - |
| Pulse Width | 1ms-10000ms | 1ms-10000ms | - |
| Frequency [Hz] | 0.1-1000 | 0.1-1000 | - |
| Beat Frequency [Hz] | N/A | N/A | - |
| Symmetrical Phases | No | No | - |
| Phase Duration | 0.5ms-5000ms. | 0.5ms-5000ms | - |
| Net Charge | N/A (monophasic) | N/A (monophasic) | - |
| Maximum Phase Charge | 5000μC | 5000μC | - |
| Maximum Current Density<br>[mA/cm²] | 0.078@500Ω | 0.026@500Ω | - |
| Maximum Power Density<br>[W/cm²] | 0.4*10-4@500Ω | 0.1*10-4@500Ω | - |
| Burst Mode | N/A | N/A | - |
| a. Pulses per burst [PPB] | N/A | N/A | - |
| b. Bursts per second [BPS] | N/A | N/A | - |
| c. Burst duration [BD] | N/A | N/A | - |
| d. Duty Cycle | N/A | N/A | - |
| ON Time | See surge mode point 28. | N/A | - |

{6}------------------------------------------------

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|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Additional Features<br>Acres of Acres of Acres of Acres | N/A | A . Annual of all and and on Alle<br>Active And Charles<br>NIA | And Annon Charles Children Children | A 400-600-August |

·

.

| Symmetric biphasic rectanqular; | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |

| Specifications | New Device | Vectra Genisys | Galva 5M |
|----------------------------|---------------------------|------------------------------------------------------------------------------------------------|---------------------------|
| Waveform | Biphasic symmetric | Biphasic symmetric | Biphasic symmetric |
| Shape | Rectangular | Rectangular | Rectangular |
| Maximum Output Voltage | 40V@500Ω | 40V@500Ω | 25V@500Ω |
| (+/-20 %) | 146V@2kΩ | 158V@2kΩ | 100V@2kΩ |
| | 150V@10kΩ | 200V@10kΩ | 200V@10kΩ |
| Maximum Output Current | 80mA@500Ω | 80mA@500Ω | 50mA@500Ω |
| (+/-20 %) | 73mA@2kΩ | 79mA@2kΩ | 50mA@2kΩ |
| | 15mA@10kΩ | 20mA@10kΩ | 20mA@10kΩ |
| Pulse Width | 100μs -1000μs | 20μs-1000μs | 100μs-1500μs |
| Frequency [Hz] | 0-1667 | 1-250 | 0-1667 |
| Beat Frequency [Hz] | N/A | N/A | N/A |
| Symmetrical Phases | Yes | Yes | Yes |
| Phase Duration | 50μs-500μs | 10μs-500μs | 50μs-750μs |
| Net Charge | 0 (symmetric) | 0 (symmetric) | 0 (symmetric) |
| Maximum Phase Charge | 80μC | 80μC | 75μC |
| Maximum Current Density | 6.25@500Ω | 2.08@500Ω | 3.9@500Ω |
| [mA/cm²] | | | |
| Maximum Power Density | 0.25@500Ω | 0.083@500Ω | 0.097@500Ω |
| [W/cm²] | | | |
| Burst Mode | | | N/A |
| a. Pulses per burst (PPB) | 5-100 | 7 | N/A |
| b. Bursts per second (BPS) | 1-200 | 1 - 10 | N/A |
| c. Burst duration (BD) | 0.7-0.028s | 0.7 - 0.028s | N/A |
| d. Duty Cycle | 1 - 0.0042 | 0.7 - 0.28 | N/A |
| ON Time | See surge mode point 28. | See additional features | See surge mode point 28. |
| OFF Time | See surge mode point 28. | See additional features | See surge mode point 28. |
| Additional Features | See definition surge mode | Cycle times of 4/4, 4/8, 7/7, 5/5,<br>4/12, 10/10, 10/20, 10/30, 10/50,<br>continuous (On/Off) | See definition surge mode |
| | | | |

#### Asymmetric biphasic rectanqular:

・ー

| Specifications | New Device | Vectra Genisys | Galva 5M |
|--------------------------------------|-----------------------------------------|----------------------------------------------|----------|
| Waveform | Biphasic symmetric | Biphasic symmetric | - |
| Shape | Rectangular | Rectangular | - |
| Maximum Output Voltage<br>(+/- 20 %) | 48V@500Ω<br>104V@2kΩ<br>153V@10kΩ | 55V@500Ω<br>197V@2kΩ<br>200V@10kΩ | - |
| Maximum Output Current<br>(+/- 20 %) | 100mA@500Ω<br>52mA@2kΩ<br>15mA@10kΩ | 110mA@500Ω<br>99mA@2kΩ<br>20mA@10kΩ | - |
| Pulse Width | 20µs-1000µs | 20µs-1000µs | - |
| Frequency [Hz] | 1-331 | 1-250 | - |
| Beat Frequency [Hz] | N/A | N/A | - |
| Symmetrical Phases | No | No | - |
| Phase Duration | 20µs-1000µs positive<br>2000µs negative | 20µs-1000µs positive<br>80µs-4000µs negative | - |
| Net Charge | 0 (symmetric) | 0 (symmetric) | - |
| Maximum Phase Charge | 100µC | 110µC | - |
| Maximum Current Density<br>[mA/cm²] | 6.25@500Ω | 2.86@500Ω | - |
| Maximum Power Density<br>[W/cm²] | 0.25@500Ω | 0.157@500Ω | - |
| Burst Mode | | | |
| a. Pulses per burst [PPB] | 7 | 7 | - |
| b. Bursts per second [BPS] | 1 - 10 | 1 - 10 | - |
| c. Burst duration [BD] | 0.7 - 0.028s | 0.7 - 0.028s | - |
| d. Duty Cycle | 0.7 - 0.0028 | 0.7 - 0.28 | - |
| ON Time | See surge mode point 28 | See additional features | - |

.

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#### K121059 PAGE 8 OF ID

| OFF Time | See surge mode point 28. | See additional features | - |
|---------------------|---------------------------|-------------------------------------------------------------------------------------------|---|
| Additional Features | See definition surge mode | Cycle times of 4/4, 4/8, 7/7, 5/5, 4/12, 10/10, 10/20, 10/30, 10/50, continuous (On/Off); | - |

| High Voltage: | | | |
|-----------------------------------|------------------------------------------------------------------|----------------|------------------------------------------------------------------|
| Specifications | New Device | Vectra Genisys | Galva 5M |
| Waveform | High Voltage, monophasic symmetric | - | High Voltage, monophasic symmetric |
| Shape | Rectangular | - | Rectangular |
| Maximum Output Voltage (+/- 20 %) | 122V@500Ω<br>180V@2kΩ<br>180V@10kΩ | - | 125V@500Ω<br>200V@2kΩ<br>200V@10kΩ |
| Maximum Output Current (+/- 20 %) | 250mA@500Ω<br>75mA@2kΩ<br>15mA@10kΩ | - | 250mA@500Ω<br>100mA@2kΩ<br>20mA@10kΩ |
| Pulse Width | 10μs-100μs | - | 10μs-100μs |
| Frequency [Hz] | 0-1961 | - | 0-1961 |
| Beat Frequency [Hz] | N/A | - | N/A |
| Symmetrical Phases | No | - | No |
| Phase Duration | 10μs-100μs | - | 10μs-100μs |
| Net Charge | 25μC | - | 25μC |
| Maximum Phase Charge | 25μC | - | 25μC. |
| Maximum Current Density [mA/cm²] | 19.5@500Ω | - | 19.5@500Ω |
| Maximum Power Density [W/cm²] | 2.44@500Ω | - | 2.44@500Ω |
| Burst Mode | N/A | - | N/A |
| a. Pulses per burst [PPB] | N/A | - | N/A |
| b. Bursts per second [BPS] | N/A | - | N/A |
| c. Burst duration [BD] | N/A | - | N/A |
| d. Duty Cycle | N/A | - | N/A |
| ON Time | See surge mode point 28. | - | See surge mode point 28. |
| OFF Time | See surge mode point 28. | - | See surge mode point 28. |
| Additional Features | Polarity reversal: Selectable. positive, negative or alternating | - | Polarity reversal: Selectable. positive, negative or alternating |

| Specifications | New Device | Vectra Genisys | Galva 5M |
|--------------------------------------|-------------------------------------|-------------------------------------|--------------------------------------|
| Waveform | Medium Frequency | Medium Frequency | Medium Frequency |
| Shape | Sinusoidal, unmodulated | Sinusoidal, unmodulated | Sinusoidal, unmodulated |
| Maximum Output Voltage<br>(+/- 20 %) | 50V@500Ω<br>157V@2kΩ<br>153V@10kΩ | 52V@500Ω<br>188V@2kΩ<br>200V@10kΩ | 60V@500Ω<br>206V@2kΩ<br>200V@10kΩ |
| Maximum Output Current<br>(+/- 20 %) | 99mA@500Ω<br>77mA@2kΩ<br>15 mA@10kΩ | 104mA@500Ω<br>94mA@2kΩ<br>20mA@10kΩ | 120mA@500Ω<br>100mA@2kΩ<br>20mA@10kΩ |
| Pulse Width | N/A | N/A | N/A |
| Frequency [Hz] | 2000-8000 | 2000-10000 | 5000 |
| Beat Frequency [Hz] | N/A | N/A | N/A |
| Symmetrical Phases | Yes | Yes | Yes |
| Phase Duration | N/A | N/A | N/A |
| Net Charge | 0 (symmetric) | 0 (symmetric) | 0 (symmetric) |
| Maximum Phase Charge | 15.9μC | 16.6μC | 7.64μC |
| Maximum Current Density<br>[mA/cm²] | 4.38@500Ω | 2.6@500Ω | 9.4@500Ω |
| Maximum Power D…