Patient Manual 18011 Mitchell South, Irvine, CA 92614 Call 800.266.6969 Fax 800.821.8012 www.vqorthocare.com customerservice@vqorthocare.com © 2010 VisionQuest Industries, Inc.
VQ OrthoCare is not liable for any misuse or misunderstanding of the SurgiStim4 product or Patient Manual. Please call your local representative if any additional assistance is required regarding this product and its operating instructions. Warranty VQ OrthoCare warrants the SurgiStim4 to be free from electrical circuit defects in workmanship and materials for a period of three (3) years upon delivery to the customer.
Table of Contents Letter to the Patient......................................................................2 System Components ...................................................................3 Precautions and Prescription Information ..............................4 Controls and Features .................................................................6 Accessories ....................................................................................8 Starting Your Treatment Sessions .....................
Letter to the Patient Your physician has selected the SurgiStim4 – a portable multi-modality device that provides Interferential, Neuromuscular, Pulsed Direct Current and High-Volt Pulsed Current Stimulation – as the most appropriate treatment for your needs. The SurgiStim4 electrical stimulator generates small pulses of current that are delivered through lead wires to stimulating electrodes* placed on your skin. These pulses pass through the skin and activate underlying nerves.
System Components The SurgiStim4 multi-modality stimulation system is operated with: A B C (1) (1) (1) (2) SurgiStim4 electrotherapy device package sterile electrodes lead wire non-rechargeable alkaline Power Packs The SurgiStim4 system also includes: D (1) (1) (5) (16) (10) F (1) G (1) H (1) E carrying case with removable shoulder pouch Patient Manual (this booklet) additional packages of non-sterile, reusable electrodes (depending on your doctor’s protocol) adhesive remover towelettes additional non
Precautions and Prescription Information CAUTION: Federal law restricts this device to sale by, or on the order of, a practitioner licensed by the law of the State in which he/she practices to use or order the use of this device. NOTE: Please read the following prescription information carefully before using the SurgiStim4. If you have any questions regarding this information, consult with your physician or therapist before proceeding.
• Electrodes should not be placed on the chest in such a configuration that would allow electrical current delivered by the device to flow through the chest because it might cause a cardiac arrhythmia. • Stimulation should not be applied transcerebrally. • Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc. • Stimulation should not be applied over, or in proximity to, cancerous lesions.
Controls and Features Pressing the button turns on the SurgiStim4 and performs a brief system test. Once the SurgiStim4 is turned on, pressing this button turns it off. The (P) button has three functions. It can be used to: • Proceed to the next step, according to directions on the screen • Go to the Protocol screen • Manually start a download when the SurgiStim4 is in the Cradle The (S) button has three functions.
Battery indicator A battery symbol in the upper left corner of the screen will display the battery status. When the battery is fully charged, the symbol displays as black. When the battery power is low, the symbol displays as white, and starts to flash and the device will beep once a minute. Replace the alkaline Power Packs as soon as possible. When battery power is sufficiently depleted, the device will shut off automatically.
Accessories Lead wire The lead wire connects the SurgiStim4 to the electrodes. When plugging the lead wire into the SurgiStim4, make sure it is pushed firmly into the socket, with the strain relief pointing toward the bottom of the SurgiStim4 (as shown). To remove the wire, grip the connector close to the socket and pull straight out. Power supply The SurgiStim4 can be operated with two non-rechargeable alkaline Power Packs, the AC Adapter, or by placing the SurgiStim4 in the Cradle.
AC Adapter If the alkaline Power Packs are in the SurgiStim4, the AC Adapter will bypass the Power Packs and provide power. The alkaline Power Packs are non-rechargeable. Use only the AC Adapter provided, because use of other products’ Adapters can damage the SurgiStim4. Press the (PAUSE) button to pause stimulation before connecting or disconnecting the AC Adapter. Press (PAUSE) to resume treatment.
Starting Your Treatment Sessions 1. Insert two alkaline Power Packs into the SurgiStim4. Make sure each is oriented according to the label on the Power Packs and the battery compartment, as the SurgiStim4 will only operate if the Power Packs are inserted correctly. To use external power instead, plug the AC Adapter into the SurgiStim4 or place the SurgiStim4 in the Cradle. [NOTE: If electrodes have been placed beneath a brace, cast or bandages by your healthcare professional, skip to step 5.] 2.
4. Gently remove the electrodes from the plastic liner. Place the electrodes on the sites prescribed by your physician or therapist and press them firmly onto the skin. Electrodes should be placed at least one inch away from each other. 5. Insert the lead wire into the SurgiStim4. For instructions, see page 8. 6. Turn the SurgiStim4 on by pressing the (ON/OFF) button. The serial number and compliance time will be displayed. After releasing the (ON/OFF) button, the SurgiStim4 will start its self-test.
Starting Your Treatment Sessions (continued) NOTE: The intensity levels of your treatments may have been preset by a technician following your surgery. If this is the case, when the SurgiStim4 is turned on you may be given the option to either use the saved amplitudes or cancel them. To use the saved amplitudes, press (P) to proceed. The SurgiStim4 will count down from 5 and begin treatment with the pre-set intensities.
Normal Running Screens These are the screens that appear during most of your treatment time, depending on the modality being used. Press the (+) or (–) button to change stimulation intensity. For your safety, the keypad locks after 30 seconds of inactivity. To unlock the keypad, press the (–) button and proceed to use the (+) button to increase intensity. At any time, you can press the (PAUSE) button to pause the treatment. Pressing the (PAUSE) button again will restart the treatment.
Normal Running Screens (continued) Before starting treatment, you have the option of returning to the protocol screen by pressing (P) and selecting another protocol. Once treatment has started, the (P) button does not return you to the protocol screen. [To choose another protocol after treatment has started, decrease the amplitude to 0 and press (P), or turn the device off, then on again.] Vectoring During an interferential (IF) treatment, the SurgiStim4 allows you to vector the stimulation.
Normal Running Screens NEUROMUSCULAR treatment screen If you are running a neuromuscular treatment, one of the following screens will be displayed: 1 NM 1 4mA 6mA 4mA 6mA Gray Black Gray Black (S) Ch Select (PAUSE) Pause (S) Ch Select (PAUSE) Pause 00:19:59 2 reps NM In the neuromuscular screen, there are two channels that may be set independently. They are represented by gray and black wires on your lead wire. Press the (S) button to move from one channel to another.
Normal Running Screens (continued) PULSED Direct Current treatment screen If you are running a pulsed DC treatment, the following screen will be displayed: X PDC 4mA 6mA Gray Black (PAUSE) Pause 00:39:59 HIGH-VOLT PULSED CURRENT treatment screen If you are running a high-volt treatment, the following screen will be displayed: 1 40V (PAUSE) Pause 00:39:59 16 HV
SLEEP screen Some protocols include a SLEEP segment. During this segment, the device does not provide stimulation, but the timer is counting down to the next treatment. This function is used if a clinician wants to create a protocol where the device treats for a specified amount of time, stops, then treats again, without the patient having to turn the device on and off. During the SLEEP segment, the screen will display the following: X SL SLEEP 00:29:59 After Completing Your Treatment Sessions 1.
Electrode Use and Care The SurgiStim4 will be applied post-surgically using single-use sterile electrodes. These should not be removed until you have seen your physician for a follow-up appointment or within 10 days, whichever occurs first. Reusable, self-adhering electrodes are included in the SurgiStim4 kit and can be used once the surgical electrodes have been removed and discarded. WARNING: This product should be used only under the direct supervision of a registered healthcare practitioner.
Replace the electrodes on the plastic liner in the resealable pouch provided. CAUTION: Never remove the electrode by pulling on the wire, as this can damage your electrode. CAUTION: Be careful when using the SurgiStim4 during sleep, as wires may tangle and become loose.
Cradle/Modem (continued) There are two indicator lights on the Cradle that will light up when the SurgiStim4 is placed in the Cradle. One shows the status of the modem: (red) The modem is currently active. The SurgiStim4 is not ready for use. (green) The modem is not active and the SurgiStim4 can be used. The other light (charge) shows the condition of the batteries: (red) Batteries needs to be replaced (alkaline Power Packs). (green) Power Packs have a good charge and are ready for use.
To manually download treatment information to the SurgiStim4: 1. Place the SurgiStim4 in the Cradle, making sure the Cradle is connected to a phone line and an AC Adapter. Turn the SurgiStim4 on. The following screens will be displayed: Do you want to download? (P) Proceed (S) Skip to treatment Connecting to VQ OrthoCare… Connected. Please wait while files are uploaded. Dialing XX:XX Sending Data Connection time: XX:XX 2. To download treatment information, press (P) to proceed.
Care and Maintenance CAUTION: Do not immerse the SurgiStim4 stimulator, lead wires, AC Adapter or batteries in water. Maintenance, care and cleaning of the SurgiStim4 is quick and easy when these instructions are followed: Case Clean the outside of the SurgiStim4 case as needed with a damp cloth and mild soap. Never immerse the SurgiStim4 or batteries in water, alcohol or other fluids since this could seriously damage the internal electronics.
Power Pack safety considerations Only use Power Packs provided by VQ OrthoCare. Never attempt to recharge alkaline Power Packs, as an explosion can occur. Do not short-circuit. A short circuit can severely damage the battery or cause it to explode. Avoid exposing the Power Packs to moisture or rain. Always keep the Power Packs away from fire or other sources of extreme heat. Never incinerate. Exposure of the Power Packs to extreme heat may result in an explosion.
Care and Maintenance (continued) The telephone company may make changes in its facilities, equipment, operations or procedures that could affect the operation of the equipment. If this occurs, the telephone company will provide sufficient advance notice for you to make any modifications necessary to maintain uninterrupted service. If you experience any difficulties with the Cradle/modem, please contact the VQ OrthoCare Patient Care Department at 800.452.7993 for repair or warranty information.
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Technical Data and Specifications Physical: Power source: Two (2) VQ OrthoCare non-rechargeable alkaline Power Packs. The SurgiStim4 can also be run with a VQ OrthoCare AC Adapter or in the Cradle provided. Size: 5.7” x 3.0” x 1.5” (14.5 x 7.6 x 3.8 cm) Weight: 12.8 oz. with alkaline Power Packs Lead wire length: 22.0” (55.88 cm) unstretched Electrodes: Normal – should be used with electrodes 2” x 2” or larger. The device will allow normal amplitudes as specified for each modality.
Interferential Stimulation: Pulse amplitude: 0 - 25V peak Pulse shape: With four (4) electrodes – symmetric, biphasic square wave With two (2) electrodes – symmetric, biphasic rectangular wave Pulse width: With four (4) electrodes – 125 μs per phase With two (2) electrodes – 5 μs to 125 μs per phase Output Configuration: Quadrapolar: Ch. 1 delivers a fixed-frequency carrier pulse train. Ch. 2 delivers a user-adjustable frequency that consists of the carrier frequency, plus a beat frequency.
Pulse coordination modes: Continuous: Stimulation is provided at the user-selected beat frequency. 1|1: After one second of stimulation, the beat frequency abruptly changes from 60% of user setting to 160% of user setting. One second later, the beat frequency abruptly changes back to 60% of user setting. The cycle then starts over. 6|6: After six seconds of stimulation, the beat frequency abruptly changes from 60% of user setting to 160% of user setting.
High-Volt Pulsed Current stimulation: Pulse amplitude: 0 - 330V peak Pulse shape: Twin peak, exponential spikes Pulse width: 5 μs per pulse @ 50% of maximum amplitude Pulse polarity: Selectable, positive or negative Pulse frequency: 1 - 120 Hz Ramp-up: 0 - 9 sec On time: 1 - 99 sec Ramp-down: 0 - 9 sec Off time: 0 - 99 sec Number of active electrodes: 1, 2 or 4 Frequency modulation: S1: S2: S3: 1 - 20 Hz over a 45-sec time frame 1 - 120 Hz over a 45-sec time frame 80 - 120 Hz over a 45-
Waveform Diagrams Figure 1 – HVPC stimulation This drawing shows the output waveform in the HVPC stimulation mode at maximum amplitude (330V). The waveform is shown with a purely resistive load of 500 ohms. The signal repeats at a period of time equal to the reciprocal of the rate. The rate for this waveform is 1Hz.
Figure 2 – Premodulated IF stimulation This drawing shows the output waveform in the single-channel premodulated IF stimulation mode at maximum amplitude (50mA). The waveform is shown with a purely resistive load of 500 ohms. The two signals created in two-channel mode are internally added together and output on a single channel.
Figure 3 – Two-channel IF stimulation This drawing shows the output waveform in the two-channel IF stimulation mode at maximum amplitude (50mA). The waveform is shown with a purely resistive load of 500 ohms. Ch. 1 is shown; Ch. 2 is identical except that the period is slightly less since the rate is slightly greater.
Figure 4 – Symmetrical biphasic NM stimulation This drawing shows the output waveform in the symmetrical biphasic NM stimulation mode at maximum amplitude (100mA). The waveform is shown with a purely resistive load of 500 ohms. The stimulation on each channel is the same. The signal on Ch. 1 occurs 180 degrees out-of-phase with Ch. 2. The signal repeats at a period of time equal to the reciprocal of the rate. The rate for this waveform is 1Hz.
Figure 5 – Asymmetrical biphasic NM stimulation This drawing shows the output waveform in the asymmetrical NM stimulation mode at maximum amplitude (100mA). The waveform is shown with a purely resistive load of 500 ohms. The stimulation on each channel is the same. The signal on Ch. 1 occurs 180 degrees out-of-phase with Ch. 2. The signal repeats at a period of time equal to the reciprocal of the rate. The rate for this waveform is 1Hz.
Figure 6—Pulsed Direct Current stimulation This drawing shows the 277 Hz output waveform in the pulsed direct current stimulation mode at maximum amplitude (100mA). The waveform is shown with a purely resistive load of 500 ohms. The stimulation on each channel is the same.
Figure 7—Pulsed Direct Current stimulation This drawing shows the 222 Hz output waveform in the pulsed direct current stimulation mode at maximum amplitude (100mA). The waveform is shown with a purely resistive load of 500 ohms. The stimulation on each channel is the same.
Troubleshooting: Problem Screen Displays: Your prescribed time for authorized use of this equipment is now complete. Screen Displays: Your prescribed time for authorized use will expire in X days. Device beeps and the screen says: Error! Check your lead wires and electrodes The device will not increase the intensity Solution Your device needs to download information to VQ OrthoCare for your physician. Place the device in the cradle, turn it on and press (P) to Proceed with a download.
Troubleshooting (continued): Problem Stimulation is weak, even at maximum intensity Screen Displays: A problem has been detected with your device. Device beeps and the screen says: Incomplete setup. Please set your intensity. Screen Displays: Warning. Incorrect power supply connected. Please use the AC Adapter provided by VQ OrthoCare for this device. Solution This is most likely due to low batteries. Replace Power Packs.
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VQ OrthoCare is not liable for any misuse or misunderstanding of the SurgiStim4 product or Patient Manual. Please call your local representative if any additional assistance is required regarding this product and its operating instructions. Warranty VQ OrthoCare warrants the SurgiStim4 to be free from electrical circuit defects in workmanship and materials for a period of three (3) years upon delivery to the customer.
Patient Manual 18011 Mitchell South, Irvine, CA 92614 Call 800.266.6969 Fax 800.821.8012 www.vqorthocare.com customerservice@vqorthocare.com © 2010 VisionQuest Industries, Inc.
