Sys Stim 240 Instruction Manual Rev G Jan 2013

Mettler Electronics Corp. - Rev.G_01/08/13

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Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Table of Contents Section

Title

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Introduction Introduction to the Sys*Stim 240 Introduction to this Manual Safety Precautions Caution Shipping Damage Package Contents Limited Warranty Symbol Glossary and List of Abbreviations Symbol Glossary Control descriptions Laser and Cluster Applicators – Controls, Output aperture and Indicators List of Abbreviations Installation Installation Instructions A Brief Operational Overview of the Sys*Stim 240 Optional setting EMC Guidance Operating Instructions A Note About Electrodes General Operating Instructions Quick Set-up for Electrical Stimulation Set-up for Light Therapy Using Preset Programs Saving a Treatment Protocol Interferential (IFC, 4-Pole) Procedure Premodulated (IFC, 2-Pole) Procedure Medium Frequency (Russian) Procedure Biphasic Procedure High Volt Procedure Microcurrent Procedure TENS, Symmetrical Biphasic Procedure TENS, Asymmetrical Biphasic Procedure DC Low Amplitude Procedure Using the pencil electrode Combination Therapy Setup Procedure Indications, Contraindications, Precautions and Adverse Reactions Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms Additional Indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms Indications for DC (Direct Current) Mode The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:

1.1 1.2 1.3 1.4 1.5 1.6 1.7 2 2.1 2.2 2.3 2.4 3 3.1 3.2 3.3 3.4 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17 5 5.1 5.2 5.3 5.4

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5.5 5.6 5.7 5.8 5.9 5.10 6 6.1 6.2 6.3 7 8 8.1 8.2 8.3 8.4 9 9.1 9.2

Contraindications for Neuromuscular Electrical Stimulation Contraindications for Laser Light Therapy Warnings for Neuromuscular Electrical Stimulation Precautions for Laser Light Therapy Precautions for Neuromuscular Electrical Stimulation Side Effects/Adverse Reactions for Neuromuscular Electrical Stimulation Maintenance and Troubleshooting Cleaning the Sys*Stim 240 Routine Maintenance Troubleshooting the Sys*Stim 240 References

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Specifications General Specifications Waveform Specifications Optional Laser Performance Optional Applicator Specifications Accessories Ordering Information Sys*Stim 240 Accessories

61 61 62 65 65 67 67 67

List of Figures No. Title 1.1 2.1 2.2 2.3 3.1 3.2 3.3 3.4 3.5 3.6 4.1 4.2 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 4

Sys*Stim 240 Sys*Stim 240-Control Panel and Display Laser Applicator Label Descriptions-Top Laser Applicator Label Descriptions-Bottom Sys*Stim 240, Bottom View Showing battery door Sys*Stim 240, Bottom View-Installing the battery Sys*Stim 240, Back View Showing the On/Off Switch and Power Cord and Patient Safety Cable Connections Sys*Stim 240, Side View Showing the Electrode Cable Connection Sys*Stim 240, Side View Showing the Installation of the Applicator Holder Sys*Stim 240, Front View Showing the Laser or Cluster Cable Connector Touch Controls and Display Electrode Sizes and Current Density Interferential (IFC, 4-Pole) Waveform Premodulated (IFC, 2-Pole) Waveform Medium Frequency (Russian) Waveform Biphasic Waveform High Volt Waveform Microcurrent Waveform TENS, Sym. Waveform TENS, Asym. Waveform

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Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Section 1: Introduction 1.1 Introduction to the Sys*Stim 240

Thank you for purchasing the Sys*Stim 240 two-channel neuromuscular stimulator with optional light therapy capability. The technically advanced Sys*Stim 240 provides Interferential (4 pole), Premodulated (2 pole), Medium Frequency (Russian), Biphasic, High Volt Pulsed Galvanic, Microcurrent, TENS-Asymmetrical Biphasic, TENS-Symmetrical Biphasic and Galvanic (Continuous DC) waveforms. In addition the Sys*Stim 240 offers an optional laser or cluster applicator for light therapy. New touch-sensitive technology has been used to make starting a treatment easy. The highresolution color display allows you to monitor all treatment parameters continuously. The patented M Wheel™ provides easy navigation through all of the menus.

Figure 1.1- Sys*Stim 240 Treatment protocols complete with electrode placement guidance, allow you to quickly program treatment parameters for your patients. There is even space to save your own special treatment protocols for each waveform and for light therapy. The Sys*Stim 240 has an optional battery pack so that you can take either electrical stimulation or light therapy to your patient. A carrying case is also available which holds the units and all the accessories necessary for therapy on the road. The Sys*Stim 240 has been certified by Intertek Testing Services to meet the requirements for ETL Listing per the following standards:  UL 60601-1 Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety.  CSA C22.2.601.1 M90 Medical Electrical Equipment – Part 1 General Requirements for Safety  IEC / EN 60601-1 Standard for Safety Medical Electrical Equipment, Part 1: General Requirements for Safety  IEC / EN 60601-2-10 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators 5

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 IEC / EN 60601-2-22 Medical Electrical Equipment – Part 2-22: Particular Requirements for Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment  IEC / EN 60825-1 Safety of Laser Products Part 1: Equipment Classification and Requirement  IEC / EN 62471 Photobiological Safety of Lamps and Lamp Systems In addition, the Sys*Stim 240 also meets the following standards for radio frequency emissions and immunity:  IEC / EN 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for safety-Collateral Standard Electromagnetic Compatibility Requirements and Test  FCC 47 CFR, FCC Sub Part 18 Industrial, Scientific and Medical (ISM) Equipment Mettler Electronics Corp. has been certified by VTT Expert Services LTD to be compliant with EN ISO 13485:2003 and MDD 93/42/EEC Annex II requirements. In addition, Mettler is certified by DQS Medizinprodukte GMBH to be compliant with ISO 13485:2003 (CMDCAS) Canadian Medical Device requirements.

1.2 Introduction to This Manual Read the contents of this manual before treating patients with the Sys*Stim 240. This manual has been written to assist you with the safe operation of the Sys*Stim 240. It is intended for use by the owners and operators of the Sys*Stim 240. The goal of this manual is to direct the correct operation and maintenance of this unit. The specifications and instructions presented in this manual are in effect at the time of its publication. These instructions may be updated at any time at the discretion of the manufacturer.  The operating manual is required for safe use of the unit. If you lend or transfer the unit to another party such as a facility, be sure to provide this manual with the unit.  Carefully read the Safety Precautions before operating the unit. Follow the precautions given.  To prevent injury to the operator or patient or property damage, the manual uses the following terms and symbols to represent varying levels of danger. Make sure you understand what these symbols mean before reading the manual. Improper handling may result in a high risk of death or serious injury. Improper handling may result in a risk of death or serious injury. Improper handling may result in injury or property damage. Calls attention to Danger, Warning, or Caution items This particular symbol means "Electric Shock Hazard." Indicates an action to be avoided. This particular symbol means: "Do Not Disassemble."

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Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Indicates a mandatory action. This particular symbol means "Remove the plug from the power outlet."

1.3 Safety Precautions The Sys*Stim 240 operates with high voltages. Qualified biomedical technicians with training in neuromuscular stimulator and light therapy service should perform servicing of the Sys*Stim 240 or it should be returned directly to the factory. To maximize safety during use, the unit should be plugged into a grounded wall outlet. General safety guidelines for medical electronic equipment should be followed. Service may be obtained from the manufacturer by sending the Sys*Stim 240 in its original shipping container to Mettler Electronics Corp., 1333 South Claudina Street, Anaheim, CA 92805, ATTN: Service Department. (Telephone toll free: (800) 854–9305, Alternate telephone number: 1 (714) 533–2221) NOTE: All warranty repairs must be performed by Mettler Electronics Corp. or by a service facility authorized by Mettler Electronics to perform warranty repair work. A service manual for the Sys*Stim 240 is available from Mettler Electronics Corp. for a nominal charge.

1.4 Caution Rx only. Federal law restricts the sale of this device to, or on the order of a physician, dentist, veterinarian or any other practitioner licensed by law of the state in which he practices. The electric energy delivered by this device may possibly be lethal. Treatment should be administered only under the direct supervision of a health care professional. The stimulus delivered by this device may be sufficient to cause electrocution. Electrical current above 25 µC must not flow through the thorax because it may cause a cardiac arrhythmia. If you choose to use either the optional cluster or laser applicator, use the protective glasses on both you and your patient to prevent eye exposure to infrared light.

1.5 Shipping Damage Your new Sys*Stim 240 is shipped complete in one carton. Upon receipt, please inspect the carton and the unit for visible and hidden damage. If you discover any damage, hold all shipping materials, including the carton, and call the shipping agent who delivered the unit. They are responsible for all damage in transit; therefore, all claims should be filed directly with them. The factory will not be responsible for any damage in shipment, nor allow any adjustments unless proper formal claim has been filed by the receiver against the carrier. The carton in which your new Sys*Stim 240 was received is specially designed to protect the unit during shipping. Please retain all shipping materials in the event that you will need to return your unit for servicing. NOTE: All warranty repairs are to be performed by Mettler Electronics Corp. or an authorized Mettler Electronics warranty repair center.

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1.6 Package Contents Your new Sys*Stim 240 comes complete with all the necessary components to perform neuromuscular electrical stimulation. Below is a list of items that are included in the shipping carton. 1. Sys*Stim 240 2. Two electrode cable sets, (ME 2260) 3. One package V Trodes, 2" diameter (ME 2702) 4. One package V Trodes, 2.75" diameter )ME2703) 5. Two pin to banana adapters, (ME 2027) 6. One patient safety switch, (ME 2403) 7. Detachable U.L. listed, hospital–grade line cord (ME 7293) 8. Instruction Manual on a CD ROM

1.7 Limited Warranty The Sys*Stim 240 neuromuscular electrical stimulation with optional light therapy is warranted against defects in materials and workmanship for a period of two years from date of purchase. The Sys*Stim 240 cluster and laser applicators are warranted against defects in materials and workmanship for a period of one year from date of purchase. The battery is warranted against defects in materials and workmanship for a period of 90 days from date of purchase. During the applicable warranty period Mettler Electronics Corp. will, at its discretion, either repair or replace the Product without charge for these types of defects. For service under this warranty, the Product must be returned by the buyer within the applicable warranty period to Mettler Electronics Corp. Shipping charges to Mettler Electronics Corp. under this warranty must be paid by the buyer. The buyer must also include a copy of the sales receipt or other proof of the date of purchase. If the Product is returned without proof of the date of purchase, it will be serviced as an out–of–warranty product at Mettler Electronics Corp.'s prevailing service rates. Alteration, misuse, or neglect of the Product voids this warranty. Except as specifically set forth above, Mettler Electronics Corp. makes no warranties, express or implied, including without limitation any implied warranty of merchantability or fitness for a particular purpose, with respect to the Product. If any implied warranties apply as a matter of law, they are limited in duration to one year. Mettler Electronics Corp. shall not be liable for any indirect, special, consequential or incidental damages resulting from any defect in or use of the Product. Any legal action brought by the buyer relating to this warranty must be commenced within one year from the date any claim arises and must be brought only in the state or federal courts located in Orange County, California. Some states do not allow limitations on how long an implied warranty lasts, or the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusions may not apply to the buyer. This warranty gives the buyer specific legal rights, and the buyer may also have other rights which vary from state to state.

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Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Section 2-Symbol Glossary, Control Descriptions and List of Abbreviations 2.1 Symbol Glossary Stop all treatments selector

Start or pause a treatment

Enter control used to select an item.

Channel one selector

Channel two selector

Light (laser) therapy selector

Information selector

Interferential (4-pole) symbol

Select a preset protocol

Medium Frequency (Russian)

Biphasic

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High Volt Pulsed Galvanic

Microcurrent

TENS-Symmetrical Biphasic

TENS-Asymmetrical Biphasic

Galvanic (Continuous DC)

Amplitude Modulation (Vector, Surge and Reciprocation)

Pulse width and frequency

Frequency Modulation

Polarity functions

Time

Output intensity

Laser applicator in use

Cluster applicator in use

No light therapy applicator installed

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Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Enter passcode

Begin or forward (not selected)

Begin or forward (selected)

Back (not selected)

Back (selected)

Time in status bar Output in status bar Pencil electrode function active Battery status Device plugged in and running on mains power supply. Info options

System check being conducted

AC power Attention, consult instruction manual. Warning symbol indicates that the device emits laser energy and that proper precautions listed in this manual need to be taken. Type BF Equipment-Class I

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Mains On. Mains Off. Fuse rating symbol Patient safety switch symbol

Recycle the rechargeable lithium ion battery.

Rechargeable lithium ion battery, dispose of separately from other trash. UL Recognized Component Mark Tested to comply with FCC standards CE mark on battery

ETL and C–ETL Listed

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Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

2.2 Control Descriptions

Figure 2.1- Sys*Stim 240, control panel and display 1. 2. 3. 4. 5. 6. 7. 8. 9.

Back-lit LCD display Stop all treatments button Channel 1 selector button Enter button Light (Laser) selector button Information selector button Channel 2 selector button M Wheel™ rotary control dial Start / Pause treatment button

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2.3 Laser and Cluster Applicators – Controls, Output aperture and Indicators 1

2 3

4

5

6

Figure 2.2- Laser Applicator Label Descriptions-Top 1. Laser Output Aperture 2. Aperture Warning Label 3. Laser On Indicator

4. “Laser Activate” Capacitance Switch 5. Increase Output Energy (repeat dosage) 6. Decrease Output Energy

Laser Warning Labels The laser applicator has four warning labels; two of these labels are visible on figure 2.2. These two labels are the international Laser Hazard symbol which is located on the “Laser Activate” capacitance switch pad, and the other is the yellow Laser Aperture label which has an arrow pointing to the laser aperture at the front of the laser applicator. The two other labels are shown in figure 2.3 below.

1

2

Figure 2.3-Laser Applicator Label Descriptions-Bottom 1. Laser Aperture Label

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2. Explanatory Label

Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Laser On Indicator The green Laser On indicator illuminates when the laser is lasing. When the laser beam is turned off after the treatment time has elapsed, the Laser On indicator will turn off. Note: When the Sys*Stim 240 turned on, the Green Indicator will flash momentarily and you will hear a brief beep, this is normal and is provided as a start-up lamp test. Please Note: When there is a problem with the laser applicator, the Laser On indicator will glow an amber color. The blue LEDs will not be illuminated, but it is possible that the laser diode will be active and therefore eye protection is still warranted. If the amber indicator light comes on and stays on when the capacitive switch is activated, return the laser applicator for service. Laser Activate Capacitance Switch The “Laser Activate” capacitance switch is located on the handle section of the laser applicator membrane. The capacitance switch works by measuring the practitioner's body capacitance across a sensing ‘Pad’. The ‘Pad’ is a rectangular shaped area and has the words “Laser Activate” on it. By placing a finger or thumb over the ‘Pad’, the capacitance is increased and the switch is activated. The advantage is that it requires no force to actuate, and therefore reduces the strain a practitioner may experience holding down a mechanical switch for possibly long periods of time. Increase/Decrease Output Energy Keys The two membrane keys on the handle section of the applicator are used to increase or decrease the dosage energy. During the laser treatment, these keys are locked out so that the dosage cannot be accidentally increased.

2.4 List of Abbreviations AM CC CV FM Hz J J/cm² LCD

- - - - - - - -

Amplitude Modulation (intensity is changed over time) Constant Current Constant Voltage Frequency Modulation (frequency is changed over time) Hertz (pulses per second) Joules Joules per square centimeter Liquid crystal display

A mA

- -

Microampere (1 x 10-6 ampere) Milliampere (1 x 10-3 ampere)

s ms mm:ss bps pps s Ser. No. V AC

- - - - - - - - -

Microsecond (1 x 10-6 second) Millisecond (1 x 10-3 second) Minutes and seconds in timer Bursts per second Pulses per second Seconds Serial Number Volts Alternating Current

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Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Section 3-Installation 3.1 Installation Instructions 1. When installing the unit, pay attention to the following:  Install the unit beyond the reach of possible water splashes.  Install the unit where it will not be adversely affected by atmospheric pressure, temperature, humidity, sunlight, dust, ventilation, salt air, sulfur, or other such harmful substances.  Protect the unit against instability, vibration, or impact (including during transportation).  Do not leave the unit in locations with combustible airborne materials such as combustible anesthetic gases mixed with oxygen, nitrogen suboxide and air, or combustible disinfecting agents or cleaning agents mixed with air.  Do not install the unit where chemical products are stored or where gases may be emitted. 2. The Sys*Stim 240 may be susceptible to interference originating from shortwave diathermy units operating in close proximity to it. Avoid operating the Sys*Stim 240 adjacent to and simultaneously with operating shortwave devices. 3. If you have chosen the optional battery pack, install the battery as seen in Figures 3.1 and 3.2. 4. To install the optional battery first remove the power cord. Then, remove the screws located on the back panel of the Sys*Stim 240 on either side of the specification label using a Phillips screw driver, Figure 3.1. 5. Place the battery into the compartment as shown in Figure 3.2. Turn the unit upside down while installing the battery. 6. Close the battery compartment lid and reattach it by tightening the Phillips head screws. 7. Connect the line cord to the back of the Sys*Stim 240. (See Figure 3.3) 8. Plug the line cord into a grounded wall outlet that is rated at 100-240 VAC 50/60 Hz. Your mains power supply must match the voltage requirements listed on the serial number label of your device. Do not connect the Sys*Stim 240 to a power supply rated differently than that described above. 9. The line cord comes equipped with a standard 3–prong plug. This plug provides grounding for the Sys*Stim 240. Do not defeat its purpose by using 3–to–2 prong adapters or any other means of attaching to a wall outlet. 10. If the optional battery is installed, it will begin charging as soon as the line cord is plugged into the wall and the Sys*Stim 240 is turned on using the switch on the back of the unit. The charging status will be displayed on the display. Full charging takes up to four hours. The unit may be used while it is charging. 11. Plug the electrode cables (ME 2260) into the electrode cable connections as seen in Figure 3.4. 12. If you have chosen to purchase either the optional laser or cluster kit, then install the applicator holders in Figure 3.5 on the side of the unit using the Phillips head screws included with the holders. Plug in the applicator into the front of the device as seen in Figure 3.6 and insert into the holder on the side of the unit. When using either the cluster or the laser 17

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applicator, you must wear the protective glasses and instruct your patient to wear the glasses during treatment to prevent exposing the eyes to infrared energy. 13. Finally, plug the patient safety cable into the back of the unit as shown in Figure 3.3. 14. Once you have verified proper functioning of your Sys*Stim 240, using the instructions in Section 4, please go online to www.mettlerelectronics.com to register your product. 15. The optional battery pack may only be used in the Sys*Stim 240 or Sonicator 740. Do not attempt to use other batteries than Mettler part number ME7401. The batter is a lithium ion battery. Additional precautions for handling the optional battery include: • Do not store the Sys*Stim 240 for long periods with the battery installed. • Keep the Sys*Stim 240 plugged into the mains to assure full battery charge when needed. • Do not ship the Sys*Stim 240 with the battery installed. • Avoid shorting the battery • Do not immerse in water. • Do not disassemble or deform the battery • Do not expose the battery to fire. • Do not dispose of the battery in fire. • Avoid excessive physical shock or vibration. • Keep out of the reach of children. • Never use a battery that appears to have suffered abuse. • Lithium ion batteries are recyclable. • Regulations for disposal vary for different countries. Dispose of in accordance with local regulations. • Batteries are shipped with between 30% and 50% rated capacity and this provides a minimum of 90 days shelf life when stored at 25°C. If the temperature exceeds 25°C over this time then the shelf life will be reduced and provisions should be made to recharge the battery periodically. • In order to prevent parasitic drain on the battery, the electronics will go into a shutdown mode at 2.4±0.08V/parallel-cell-group. If this should happen, the battery pack will require an initial low charge to activate the electronics prior to the implementation of the normal charge. Any SMBus version 1.0, or higher, compatible charger is capable of providing this initial pre-charge.

Figure 3.1- Sys*Stim 240, Bottom View Showing battery door 18

Sys*Stim 240 Instruction Manual - Rev.G_01/08/13

Figure 3.2- Sys*Stim 240, Bottom View- Installing the battery

Figure 3.3- Sys*Stim 240, Back View Showing the On/Off Switch and Power Cord and Patient Safety Cable Connections

Figure 3.4- Sys*Stim 240, Side View Showing the Electrode Cable Connection

Figure 3.5- Sys*Stim 240, Side View Showing the Installation of the Applicator Holder 19

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Figure 3.6- Sys*Stim 240, Front View Showing the Laser or Cluster Cable Connector

3.2 A Brief Operational Overview of the Sys*Stim 240

The Sys*Stim 240 has touch sensitive controls that include the patented M Wheel which is used to scroll through menu selections and increase or decrease treatment time, stimulation intensity or laser dosage. Below are listed some of the other features of the product. 1. Each menu item is color coded so that the clinician can determine

the status of a particular menu item. A white background denotes an item that can be selected. A yellow background shows where the curser is. A dark blue background indicates that you have selected the item and now you can change its value. If a menu item is grayed out, it cannot be selected or edited. 2. Press either the Channel 1 or Channel 2 key to go to the Electrical

Stimulation screen. 3. Press the Laser key to go to the Light Therapy screen.

4. Press the Info key to go to the Information menu.

5. Use the M Wheel to move through menu options or

increase/decrease parameter values. Sliding your finger clockwise will move the cursor down or increase parameter values. Sliding you finger counterclockwise will move the cursor up or decrease parameter values.

6. Press the enter key to select a menu item.

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