Important Legal Disclosure: Transcutaneous Electrical Nerve Stimulation (TENS) Unit
Please read this disclosure carefully before using any Transcutaneous Electrical Nerve Stimulation (TENS) unit.
By using this TENS unit, you acknowledge and agree to the terms and conditions outlined in this disclosure. If you do not agree with these terms, do not use the TENS unit.
- Not Medical Advice
This TENS unit is intended for personal use as a pain management device. The information provided with this unit, including any instructions, guides, or promotional materials, is for informational purposes only and does not constitute medical advice. It is not a substitute for professional medical diagnosis, treatment, or advice from a qualified healthcare provider. Always consult with a physician or other qualified healthcare provider before using this TENS unit, especially if you have any pre-existing medical conditions, have a pacemaker, or have any other health concerns.
- User Responsibility
You are solely responsible for your use of this TENS unit and for any consequences that may arise from its use. It is your responsibility to:
- Consult a Healthcare Professional: Seek professional medical advice before using this device.
- Read and Understand Instructions: Thoroughly read and understand all instructions, warnings, and contraindications provided with the TENS unit before operation.
- Follow Instructions: Use the TENS unit strictly in accordance with the provided instructions. Do not deviate from recommended settings, placement, or duration of use.
- Monitor Your Body: Pay close attention to your body’s response during and after TENS unit use. Discontinue use immediately if you experience any discomfort, pain, skin irritation, or adverse reactions, and consult a healthcare professional.
- Proper Maintenance: Ensure the TENS unit is properly maintained and stored according to the manufacturer’s guidelines.
- Potential Risks and Side Effects:
While TENS units are generally considered safe when used as directed, there are potential risks and side effects, including but not limited to:
- Skin irritation, redness, or burns at the electrode sites.
- Allergic reactions to electrode pads or gel.
- Muscle soreness or twitching.
- Interference with electronic medical devices (e.g., pacemakers, defibrillators).
- Aggravation of existing medical conditions.
This list is not exhaustive. If you have any concerns about potential risks, consult your healthcare provider.
- Contraindications
Do not use this TENS unit if you:
- Have a pacemaker, implanted defibrillator, or other implanted electronic devices.
- Have epilepsy or a history of seizures.
- Have heart disease or a history of cardiac issues.
- Have cancer, especially in the area of application.
- Have skin lesions, open wounds, or areas of infection where electrodes would be placed.
This list is not exhaustive. Consult your healthcare provider for a complete list of contraindications relevant to your individual health.
- Limitation of Liability
Tens for labor and its affiliates, distributors, and retailers shall not be liable for any direct, indirect, incidental, special, consequential, or punitive damages, including but not limited to personal injury, property damage, or economic loss, arising from or in connection with the use or misuse of this TENS unit. This limitation of liability applies even if Tens for labor has been advised of the possibility of such damages.
- No Warranty
This TENS unit is provided “as is” without any warranties, express or implied, including but not limited to implied warranties of merchantability, fitness for a particular purpose, or non-infringement. Tens for labor does not warrant that the TENS unit will meet your specific requirements or that its operation will be uninterrupted or error-free.
- Indemnification
By using this TENS unit, you agree to indemnify, defend, and hold harmless Tens for labor and its officers, directors, employees, agents, and affiliates from and against any and all claims, liabilities, damages, losses, costs, expenses, or fees (including reasonable attorneys’ fees) arising from your use or misuse of the TENS unit, your violation of this disclosure, or your violation of any rights of another.
- Governing Law
This disclosure shall be governed by and construed in accordance with the laws of United States of America, without regard to its conflict of law principles.
- Severability
If any provision of this disclosure is found to be invalid or unenforceable, the remaining provisions shall remain in full force and effect.
- Acknowledgment
By using this TENS unit, you acknowledge that you have read, understood, and agree to be bound by the terms and conditions of this legal disclosure.
physician or other qualified healthcare provider before using this TENS unit, especially if you have any pre-existing medical conditions, are pregnant, have a pacemaker, or have any other health concerns.
- User Responsibility
You are solely responsible for your use of this TENS unit and for any consequences that may arise from its use. It is your responsibility to:
- Consult a Healthcare Professional: Seek professional medical advice before using this device.
- Read and Understand Instructions: Thoroughly read and understand all instructions, warnings, and contraindications provided with the TENS unit before operation.
- Follow Instructions: Use the TENS unit strictly in accordance with the provided instructions. Do not deviate from recommended settings, placement, or duration of use.
- Monitor Your Body: Pay close attention to your body’s response during and after TENS unit use. Discontinue use immediately if you experience any discomfort, pain, skin irritation, or adverse reactions, and consult a healthcare professional.
- Proper Maintenance: Ensure the TENS unit is properly maintained and stored according to the manufacturer’s guidelines.
- Potential Risks and Side Effects
While TENS units are generally considered safe when used as directed, there are potential risks and side effects, including but not limited to:
- Skin irritation, redness, or burns at the electrode sites.
- Allergic reactions to electrode pads or gel.
- Muscle soreness or twitching.
- Dizziness or lightheadedness.
- Interference with electronic medical devices (e.g., pacemakers, defibrillators).
- Aggravation of existing medical conditions.
This list is not exhaustive. If you have any concerns about potential risks, consult your healthcare provider.
- Contraindications
Do not use this TENS unit if you:
- Have a pacemaker, implanted defibrillator, or other implanted electronic devices.
- Are pregnant or suspect you may be pregnant.
- Have epilepsy or a history of seizures.
- Have heart disease or a history of cardiac issues.
- Have cancer, especially in the area of application.
- Have skin lesions, open wounds, or areas of infection where electrodes would be placed.
- Are operating machinery or driving a vehicle.
This list is not exhaustive. Consult your healthcare provider for a complete list of contraindications relevant to your individual health.
- Limitation of Liability
Tens for Labor and its affiliates, distributors, and retailers shall not be liable for any direct, indirect, incidental, special, consequential, or punitive damages, including but not limited to personal injury, property damage, or economic loss, arising from or in connection with the use or misuse of this TENS unit. This limitation of liability applies even if Tens for Labor has been advised of the possibility of such damages.
- No Warranty
This TENS unit is provided “as is” without any warranties, express or implied, including but not limited to implied warranties of merchantability, fitness for a particular purpose, or non-infringement. Tens for Labor does not warrant that the TENS unit will meet your specific requirements or that its operation will be uninterrupted or error-free.
- Indemnification
By using this TENS unit, you agree to indemnify, defend, and hold harmless Tens for Labor and its officers, directors, employees, agents, and affiliates from and against any and all claims, liabilities, damages, losses, costs, expenses, or fees (including reasonable attorneys’ fees) arising from your use or misuse of the TENS unit, your violation of this disclosure, or your violation of any rights of another.
- Governing Law
This disclosure shall be governed by and construed in accordance with the laws of Kentucky, United States of America, without regard to its conflict of law principles.
- Severability
If any provision of this disclosure is found to be invalid or unenforceable, the remaining provisions shall remain in full force and effect.
- Acknowledgment
By using this TENS unit, you acknowledge that you have read, understood, and agree to be bound by the terms and conditions of this legal disclosure.
Tens For Labor
www.tensforlabor.com
2/14/2024
Manufacturer’s Product Liability Notice – August 2024
Manufacturer: Body Clock
We confirm that as legal manufacturer for our TENS and EMS medical devices and all of their accessories e.g. electrodes, we have undertaken rigorous testing (e.g.,biocompatibility, electrical safety, usability), which have been reviewed/audited by our Notified Body SGS before issuing Certification.
Certification and/or a copy of a Body Clock issued signed Declaration of Conformity, are legal documents required to legitimately register and place these medical devices on to the market, although additional local regulatory requirements may also apply.
If any of our medical devices are used in combination with other medical devices such as electrodes, sourced from alternative suppliers or if the information supplied with our medical devices (our user manual / Instructions for Use (IFU)) are amended, then these are not covered by our Certification nor our Declarations of Conformity. Accessories obtained from other suppliers have not been assessed and not only would their use make our warranty null and void, but they would not be covered under our Public Liability Insurance. You would need to obtain your own insurance for those other medical devices.
If you choose to supply alternative accessories including medical devices, or alternative information with our medical devices (the user manual / IFU) or own brand any medical devices or accessories, this can only be achieved by you taking on full legal manufacturer responsibility yourself. This means commissioning your own testing, creation of full technical documentation,
obtaining appropriate regulatory approvals and registrations (including with your own Notified Body) BEFORE placing your device on the market. Failure to do so, renders the product you are seeking to market, illegal.
The warranty supplied with our medical devices protects against manufacturer’s defects, providing that the recommended accessories and most current manual / IFU are used (Please Note: these can both be purchased directly from us or an approved local distributor only).
In addition, we do not give permission for anyone to copy our IFUs or to use excerpts to create their own IFUs.