Frequently asked questions
1. Are your medical devices certified and compliant with industry regulations?
Regulatory Compliance:
Yes, all our products are manufactured under strict quality and manufacturing standards, including ISO 13485 and GMP. They are certified by major regulatory authorities such as CE (Conformité Européenne) and the U.S. FDA. Additionally, our products have been approved by local health authorities in regions including Japan, South Korea, Australia, and Taiwan. For more information, please contact us.
2. How can I place an order for your medical products?
Ordering Process:
Thank you for your interest in our products. You may place an order by completing the Demo Request Form or by contacting our customer support team or local distributor via email or phone. Our representatives will guide you through the ordering process. Product availability may vary by region. For further assistance, feel free to email us at info@flatmedical.com.
3. I am a clinician with an idea to address a clinical need. Can you support me?
Clinical Collaboration:
We actively collaborate with clinicians to turn practical ideas into innovative solutions. Every EpiFaith product originates from clinical input. We co-develop technologies with physicians, protect the innovations through patents, validate them through clinical studies, and bring them to market. Flat Medical was founded by physicians and engineers, and we believe that only through genuine collaboration can impactful solutions be realized and shared. We welcome new partnerships, especially in anesthesia, pain medicine, intensive care, emergency medicine, and vascular access.
Usage and Technique
1. What needles can be used with the EpiFaith Syringe?
Accessory Compatibility:
EpiFaith Syringe is compatible with multiple 14 through 22 gauge epidural needles and is available in two variants: Luer Slip or NRFit connector.
2. May I use EpiFaith Syringe with air or saline for epidural locating?
Compatibility with Epidural Locating Substances:
EpiFaith Syringe is compatible with both air and saline. For air, cover the color ring; for saline, ensure it is covered and consider further plunger advancement. Flat Medical does recommend saline to combat false positives more adequately.
3. What is the most important thing to remember when using EpiFaith?
Key Procedure Reminder:
Ensure positive pressure within the barrel by pushing the plunger until the color ring is covered—essential for all loss-of-resistance (LOR) techniques.
4. How deep should I push the plunger? What is the influence of the sensing pressure?
Plunger Depth and Pressure Sensing:
Adjust the plunger pressure based on technique and patient characteristics, considering factors like BMI, difficulty of locating traditional landmarks and the substance used (air or saline). Saline does combat false positives more adequately.
5. Should I keep pushing the plunger while advancing the needle?
The fixator maintains plunger position; no need to continuously push. This allows you to use both hands freely.
Training and User Experience
6. Is training required before using the EpiFaith Syringe?
Training Recommendations:
Although the operation is intuitive, training is recommended for new users to better understand the new technique and reduce false-positive rates.
7. May I use an EpiFaith Syringe if I am a healthcare provider with limited experience with the LOR technique?
User-Friendly for All Experience Levels:
EpiFaith Syringe's clear visual signal makes it suitable for healthcare providers with limited experience in the LOR technique, reducing the risk of accidental puncture.
Visual Indication vs. Manual Feedback:
EpiFaith Syringe is designed for visual indication; the clear visual signal replaces the manual feedback sensation.
Addressing Concerns and Challenges
8. What options do I have if the catheter cannot be inserted but I believe the needle tip has arrived at the epidural space?
Challenges with Catheter Insertion:
If catheter insertion is challenging, attach the syringe to the touhy once again, push the plunger again to confirm pressure, and carefully advance the needle, observing the EpiFaith’s Smart Signal’s movement. Once the Smart Signal is achieved, stop advancement and reinsert catheter.
9. Will false positives happen during the use of EpiFaith Syringe? What should I do to handle false-positive events?
Handling False-Positive Events:
Yes, false-positives may occur; to combat a false-positive push the plunger again after a signal. If the EpiFaith holds pressure continue forward. If the EpiFaith does not hold pressure you can verify needle placement with catheter placement or push the plunger once again. If it completely empties, you are in the epidural space.
10. What should I do if I encounter resistance while pushing the plunger?
Avoid Continuous Pushing:
The fixator maintains the plunger position; no need to continuously push. This allows you to use both hands freely.
Also:
Resolving Resistance Issues:
If you encounter resistance, pause and assess the situation.
Ensure the needle is properly positioned.
Consider adjusting the plunger pressure.
For persistent issues, consult the training materials or contact our support team.
11. Is there a risk of accidental dural puncture with EpiFaith Syringe?
Mitigating Dural Puncture Risks:
EpiFaith Syringe is engineered to minimize the risk of accidental dural puncture.
In unexpected events, it is advised to stop needle advancement and reassess.
12. How can I troubleshoot if I don't get a clear visual signal?
Troubleshooting Visual Signal:
If the visual signal is unclear, check the plunger position.
Ensure proper pressure and confirm needle placement.
For persistent issues, refer to the training materials or contact our support team.
Common Questions
1. What needles are compatible with EpiFaith CV?
Needle Compatibility:
We recommend using 18G needles. The compatible guidewire diameter range is 0.64–0.96 mm (0.025–0.038 inches). Using other needle types may alter pressure sensitivity due to variations in internal resistance.
2. Can EpiFaith CV be used with an Angiocath?
Compatibility with Angiocath:
Yes. Insert the Angiocath into the vessel first, then reconnect the device to confirm intravascular pressure before inserting the guidewire through the dedicated port.
3. Will the auto-aspiration function collapse the vessel?
Vessel Safety:
No. Each auto-aspiration draws only about 0.6–0.8 cc of blood. The small volume and controlled rate reduce the likelihood of vessel collapse compared to manual aspiration.
4. What if there is little or no blood reflux—can I still insert the guidewire?
Guidewire Insertion Criteria:
Guidewire insertion should only be attempted when there is smooth and continuous blood backflow. Minimal or absent reflux may indicate suboptimal needle placement.
5. Can EpiFaith CV detect high venous pressure?
Venous Pressure Indication:
Yes. The protrusion of the guidewire port indicates venous pressure above 30 mmHg. Full protrusion suggests pressure of approximately 50 mmHg, helping to identify elevated central venous pressure.
6. What if I forget whether I’ve pressed the trigger area?
Repressing the Trigger:
You may press the trigger area again. As long as the device is not full, it will continue generating negative pressure with each press.
7. Is it normal for there to be no backflow even if the needle is in the vessel?
Backflow Validation:
Yes. If manual aspiration works, EpiFaith CV will also produce backflow. Lack of reflux may indicate incorrect needle positioning.
8. Can I keep the trigger area pressed continuously?
Trigger Use Guidance:
Continuous pressing is not recommended. You may press multiple times for confirmation, but prolonged force may interfere with plunger movement.
9. What if backflow occurs but guidewire insertion is difficult?
Troubleshooting Guidewire Insertion:
Try adjusting the needle position slightly. The needle may have moved or only partially entered the vessel. Reconfirm with a trigger press and proceed if backflow is consistent.
10. Can the guidewire be inserted when the port is protruding?
Insertion Port Guidance:
Protrusion indicates pressure above 30 mmHg. In most cases, guidewire insertion should be avoided unless clinically justified. If the system detects arterial entry, it will restrict guidewire passage.
11. How many times can I use EpiFaith CV?
Device Reusability:
EpiFaith CV allows up to three auto-aspiration attempts. After each use, clear internal blood to avoid clotting. Do not use for prolonged or repeated procedures.
12. Can holding the device interfere with backflow observation?
Backflow Confirmation:
Yes, depending on hand positioning. In addition to visual indicators, plunger movement provides tactile feedback when blood enters the chamber.
13. Will EpiFaith CV be available in pre-bundled trays?
Tray Packaging Plans:
Currently, EpiFaith CV is offered as a standalone syringe. Pre-bundled tray sets are in development and will be announced through our distribution partners once available.