Electro-Therapeutic Modalities for Pain Management - MTRs - 10-23-20251.docx
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- 36C79126Q0004
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This document is a Minimum Technical Requirements (MTR) attachment for Electro-Therapeutic Modalities for Pain Management (ETMPM) that establishes specifications for four primary device categories and accessories being procured by the Department of Veterans Affairs.
The first category covers Transcutaneous Electrical Nerve Stimulation (TENS) Units and includes 13 specific requirements such as dual independent channel output, biphasic waveform, adjustable pulse width and frequency, rechargeable batteries with charger, digital display with backlighting, FDA 510(k) clearance, and one-year minimum warranty. The unit must include four connecting lead wires, four 2x2 self-adhesive reusable electrodes, belt clip, storage pouch, English instruction manual, and visible serial numbers. The second category specifies four types of electrode pad accessories (CLINs 0002-0005) in varying sizes and materials, all latex-free with reusable adhesive gel and provided in packages of at least four units. The third category addresses Interferential Current (IFC) devices with 21 requirements including medium frequency carrier wave, dual independent channels, multiple operational modes, portable design with rechargeable capability, body part-specific modes with pictures, FDA 510(k) clearance, and one-year warranty. The fourth category covers Short Wave Diathermy Thermal units requiring FDA 510(k) clearance (Class II, prescription-only), operation on federally regulated radio frequencies (13.56 MHz, 27.12 MHz, or 40.68 MHz), power output of 250-800 watts in continuous mode, biocompatible skin-contact components, IEC 60601-1 compliance, and clinical testing documentation. The fifth category (CLIN 0008) specifies FDA-cleared neuromodulation devices including Cefaly, Nerivio, Gammacore, MiniTMS, and Relivion, requiring rechargeable capability, no subscription requirement, multiple operational modes, digital displays, and comprehensive safety and contraindication documentation. All devices must be new (not refurbished), support multiple daily uses, include product manuals in English, and have visible serial numbers and barcodes.
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ATTACHMENT ( )
ELECTRO-THERAPEUTIC MODALITIES for PAIN MANAGEMENT (ETMPM)
MINIMUM TECHNICAL REQUIREMENTS
1. TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT AND ACCESSORIES (CLIN 0001):
1. Unit must be new and not refurbished.
2. Multiple uses per day/reusable
3. Unit must have a digital display feature indicating battery level, intensity level (shall duration time and shall pad contact).
4. Unit must have Dual Independent Channel Output.
5. Unit shall use a Biphasic wave form.
6. Unit must have a minimum of two modes: a continuous and a timer feature for programmed duration of treatment.
7. Unit must have Adjustable Pulse Width and Frequency.
8. Unit must include a visual display with back lighting.
9. Unit must include 2 sets of 2 connecting Lead Wires (e.g. 2 connecting Lead Wires Per Set – Total 4) in the device package.
10. Unit must include a package of Four (4 total) “2x2” self-adhesive, reusable electrodes.
11. Unit must include Rechargeable Batteries.
12. Unit must include a Battery Charger.
13. Unit must include a belt clip.
14. Unit must include a secure storage pouch or case large enough to store device and the device accessories.
15. Unit must include Product Instruction Manual in English.
16. Unit must be FDA 510(k) market clearance.
17. Unit must have a visible serial number.
18. Unit package must have a visible serial number and bar code.
19. Must have minimum of one (1) year warranty.
2. ACCESSORIES
TENS ELECTRODES (CLIN 0002):
Electrode pads must be:
1. 2 in. diameter (square or circular).
2. Flexible non-porous material.
3. Reusable adhesive gel to allow for multiple use.
4. Latex free.
5. Provided in a package of a minimum of 4 electrodes.
TENS ELECTRODES (CLIN 0003):
Electrode pads must be:
1. 2 in. x 4 in. diameter (rectangular or oval).
2. Flexible non-porous material.
3. Reusable adhesive gel to allow for multiple use.
4. Latex free.
TENS ELECTRODES/HYPOALLERGENIC (CLIN 0004):
Electrode pads must be:
1. 2 in. x 2 in. diameter (rectangular or oval).
2. Flexible non-porous material.
3. Reusable adhesive gel to allow for multiple use.
4. Latex Free, hypoallergenic.
5. Provided in a package of a minimum of 4 electrodes.
TENS ELECTRODES/HYPOALLERGENIC (CLIN 0005):
Electrode pads must be:
1. 2 in. x 4 in. diameter (rectangular or oval).
2. Flexible non-porous material.
3. Reusable adhesive gel to allow for multiple use.
4. Latex Free, hypoallergenic.
3. - INTERFERENTIAL CURRENT – IFC (CLIN 0006):
1. Unit must be new and not refurbished.
2. Multiple uses per day/reusable
3. Unit must have a digital display feature indicating battery level, intensity level (shall duration time and shall pad contact).
4. Unit must have Dual Independent Channel Output.
5. Unit must use a carrier wave of medium frequency.
6. Unit must have multiple modes: a continuous and a timer feature for programed duration of treatment.
7. Unit must have Adjustable treatment frequencies.
8. Unit must include a visual display with back lighting.
9. Unit must include 2 sets of 2 connecting Lead Wires (e.g. 2 connecting Lead Wires Per Set – Total 4) in the device package.
10. Unit must include a package of Four (4 total) “2x2” self-adhesive, reusable electrodes.
11. Unit must have rechargeable capability.
12. Unit must include a charging apparatus.
13. Unit must be portable.
14. Unit must include a secure storage pouch or case large enough to store device and the device accessories.
15. Unit must include Product Instruction Manual in English.
16. Unit must be FDA 510(k) market clearance.
17. Unit must have a visible serial number.
18. Unit package must have a visible serial number and bar code.
19. Must have minimum of one (1) year warranty.
20. Unit shall have specific body part mode with picture.
21. Size parameters.
4. SHORT WAVE DIATHERMY - THERMAL (CLIN 0007):
1. Unit must be new
2. Multiple uses per day/reusable
3. Unit must have a digital display feature indicating battery level, intensity level (shall duration time and shall pad contact).
4. Unit must include a visual display with back lighting.
5. Unit must have Dual Independent Channel Output. Industry standard
6. MODE?
7. Frequency Range 10 to 100MHz (most common pulsed frequency is between 13.56 and 27.12)
8. Unit must include 2 sets of 2 connecting Lead Wires (e.g. 2 connecting Lead Wires Per Set – Total 4) in the device package. Industry standard for channels.
9. Unit must include Rechargeable Batteries. Industry standard for power capabilities.
10. Unit must include a Battery Charger. Charging capability
11. Unit must include a secure storage pouch or case large enough to store device and the device accessories.
12. Unit must include Product Instruction Manual in English.
13. Unit must be FDA 510(k) market clearance. FDA Class II, shortwave diathermy medical device available by prescription only and must be for Pain management.
14. Unit must have a visible serial number.
15. Unit package must have a visible serial number and bar code.
16. Must have minimum of one (1) year warranty.
17. Pads – industry standard
A. Device must be compliant with IEC 60601-1 and related collateral standards, like IEC 60601-1-2 for medical electrical equipment and ensuring the device.
B. Facility must designate specific clearance area around the unit to prevent Electromagnetic Interference per Industry standard (at least 3 meters (10 feet)).
C. Device's power output power must be controllable and maintained at therapeutic levels that can increase tissue temperature to 40–45°C without causing burns or irreparable cell damage.
· Continuous mode: For thermal effects, devices may deliver 250 to 800 watts.
· Pulsed mode: For nonthermal effects, a pulsed waveform is used, with specifications defined for peak output power, pulse width, and pulse frequency.
D. for #7 Must operate on specific, federally regulated radio frequencies. In the United States this is limited to 13.56MHz, 27.12 MHz, and 40.68 MHz. (Of note 27.12 MHz is the most common).
E. Electrodes and Applicators: Device must provide specific accessories that have been show to work as intended under expected conditions. Electrodes are typically separated from the skin with felt pads (industry standard) to prevent burns.
F. Any components of the device that come into contact with patient’s skin must be demonstrated to be biocompatible.
G. For #12 The device must come with clear warnings and operating instructions in English covering
a. Potential side effects, i.e. burns
b. Proper placement of electrodes and the use of insulation
c. Appropriate dosage and treatment times
H. Provide a summary of clinical testing to demonstrate the device’s effectiveness for its intended use, such as pain management. For example, nonthermal SWT devices require documentation to support their use in the treatment of postoperative pain and edema.
5. NEUROMODULATION (CLIN 0008):
1. FDA cleared
a. Cefaly (migraine) Trigeminal
b. Nerivio (migraine) TENS
c. Gammacore (migraine, cluster headache, hemicrania continua, paroxysmal hemicrania) Vagus
d. MiniTMS (migraine) TMS
e. Relivion (migraine) Trigeminal and ONS
2. NOT INCLUDING IMPLANTABLES/EXTERNAL APPLICATIONS
3. Multiple uses per day/reusable
4. Unit must not require a subscription to function as intended
5. Unit must be new
6. Unit must have a digital display feature indicating battery level, intensity level (shall duration time and shall pad contact).
7. Unit must have a minimum two modes: a continuous and a timer feature for programmed duration of treatment.
8. Unit must have Adjustable Pulse Width and Frequency.
9. Unit must include a visual display with back lighting.
10. Unit must include 2 sets of 2 connecting Lead Wires (e.g. 2 connecting Lead Wires Per Set – Total 4) in the device package.
11. Unit must include a package of Four (4 total) “2x2” self-adhesive, reusable electrodes.
12. Unit must include Rechargeable Batteries or the device itself is rechargeable.
13. Unit must include a Battery Charger.
14. Unit must include a belt clip.
15. Unit must include a secure storage pouch or case large enough to store device and the device accessories.
16. Unit must include Product Instruction Manual in English.
17. Unit must have a visible serial number.
18. Unit package must have a visible serial number and bar code.
19. Must have minimum of one (1) year warranty.
20. Provide defined contraindications and safety documentation. Specific indications of use, application instructions
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