Yes, all our syringes for epidural and central venous catheterization are manufactured in accordance with strict quality standards, including ISO 13485 and GMP. They have been certified by regulatory authorities, including CE (Conformité Européene) and FDA (U.S. Food and Drug Administration), and comply with relevant industry guidelines, ensuring safety and efficacy. Our products have been approved by some countries’ local authorities (e.g. Japan, Australia, Taiwan, etc.) Please contact us for more detail.

Thank you for your interest in our medical devices, including the EpiFaith syringes. To place an order, please reach out to our customer support team directly via Trial Request Form or contact our local support through email/phone. Our dedicated representatives will be happy to assist you with your order requirements and guide you through the process. For more info, click “Contact Us”

We look forward to providing our device to everyone. However, the provision is dependent on geographical region. Please contact us for more information, or reach out to info@flatmedical.com

We suggest new users be trained with a simple teaching video. Although the operation of EpiFaith is intuitive, prior training before use would be beneficial. We provide a teaching video to simplify the training process. See all our Training Videos in our Youtube.

The products you see on our website were all from clinicians. We work with colleagues around the world to identify the problems in their clinical practice, and build the solutions together with protected patent filings. Then we conduct the studies and bring the products to the market together. The company is founded by clinicians and engineers, we trust that only with true partnership, the ideas can be implemented into real-world practices, and the profits should be shared with all the stakeholders along the process. We majorly focus on product ideas in anesthesia, pain management, intensive care, emergency medicine, and vascular access. Feel free to leave us a message to start the conversation!

We look forward to providing this novel device to everyone. However, the provision is dependent on geographical region. Reach out to your local support to get more information or fill out our Trial Request Form, for further information, Please contact us for more information.

EpiFaith - Syringe is produced by a professional medical device manufacture in Taiwan. The factory is certified by both ISO13485:2016 and the Taiwanese government. It strictly follows the rules of medical device good manufacturing practice, GMP.

It is important that the plunger is pushed until the color ring is covered. This ensures the establishment of positive pressure within the barrel, which is essential for all loss-of-resistance, LOR, techniques. EpiFaith Syringe is similar to traditional low-friction syringes in that it doesn't provide a signal of LOR (loss of resistance) if the plunger isn't pushed forward to create a positive pressure. However, EpiFaith Syringe differs in that the plunger only needs to be pushed once, and the presence of a fixator helps to maintain the pressure by keeping the plunger in place. This allows you to use both hands to control the needle and have continuous and real-time detection of LOR.

Certainly, the EpiFaith-Syringe utilizes the continuous LOR technique and is compatible with both air and saline. If using air, we recommend pushing the plunger until the color ring is just covered to begin LOR detection, as demonstrated in Figure 1. This will prevent overpressure and potential air leakage through the needle passage, resulting in a lower false-positive rate.

Yes, sure. EpiFaith is based on the continuous LOR technique and is compatible with both air and saline. The sensing mechanism is fully actuated if the color ring is covered. As a result, no matter air or saline is used, make sure the color ring is covered before advancing the needle. If saline is used, it is would be better to advance the plunger further. Check Question 4 for further details.

The pressure inside the barrel increases when the relative distance between the black piston rubber and the plunger, blue or yellow, decreases. Therefore, if saline is used, a faster response of the visual indicating signal can be induced by pushing the plunger further to cover most of the white region of the rubber shaft, as shown in Figure 2. However, the above is not recommended if air is used or if the procedure is performed on a patient with high BMI. In these situations, it is suggested that a lower pressure is used to avoid the false-positive signals. Overall, the pressure used should be determined by considering the technique of the operator and characteristics of the patient.

No, your hands are free now! After the plunger is pushed once, the fixator (a black rubber ring) will help maintain the position of the plunger. It allows the operator to place both hands on the needle or even operate other instruments simultaneously. For example, using one hand to hold an ultrasound probe.

EpiFaith - Syringe is compatible with 16–18-guage epidural needles. Two variants of EpiFaith, with either a Luer Slip or NRFit connector, are available.

We suggest new users to be trained with a simple teaching video. Although the operating of any EpiFaith product is intuitive, prior training before use would be beneficial. We provide a teaching video to simplify the training process. In the video, besides the step-by-step demo of using EpiFaith, an explanation of the principle of EpiFaith, suggestions of methods to reduce false-positive rates, and the processes to cope with false positive events are provided as well. Watching this video will improve the ease and efficacy of your initial procedures. - Product Design: https://youtu.be/FqiUeNCZPwo?feature=shared - Product Demo (Training) : https://youtu.be/uTQ_Hal9VCY?feature=shared - Product Demo (Full): https://youtu.be/EYoTa6CqGpU?feature=shared - EpiFaith - Syringe : Use on Real paitient (no re-direction made) : https://youtu.be/GzPbagcV-gM?feature=shared - EpiFaith - Syringe Use on Real paitient (re-direction made): https://youtu.be/ln4ofq5CDgo?feature=shared

EpiFaith is based on continuous LOR technique; thus, slight leakage of the contained air or saline before arriving at the epidural space is possible. The kind of slight leakage leads to slow and slight movement of the piston. Comparing with rapid movement of LOR, this slow and slight movement is identifiable. Please note: as described in the instruction for use, the appearance of the color ring is the final warning signal. The needle must be stopped from advancing further to avoid accidental dural puncture when the color ring is not covered. If you think the slight movement may result in confusion, the following can help to eliminate or decrease the movement inside the soft tissue layer. A. Use a low pressure to detect the LOR, which means pushing the plunger to cover the color ring only. B. Use saline rather than air for pressure sensing. C. Begin pressure sensing after the needle tip arrives at the ligament flavum.

EpiFaith - Syringe is designed for visual indicating. Therefore, the physical feedback felt on the finger has been transferred and replaced by a visual signal. We understand that experienced users may feel uncertain if the syringe plunger cannot provide physical manual feedbacks, but the use of EpiFaith does not lead to conflicts with previous experience. We encourage you to try EpiFaith to understand its differences and similarities from traditional devices, and you will realize the benefit provided by the clear visual signal.

With EpiFaith - Syringe, the subjective and unclear physical feedback on the hand is replaced by an objective visual signal, which is user-friendly and provides the following benefits in training: A. The visual signal can be seen by everyone in view of the device. It brings clear understanding to the signal that leads to stopping the needle from advancing or other operation processes. B. EpiFaith - Syringe allows the user to use both hands to control the needle and focus on identifying the route, so the speed of needle advancement would be well controlled and reduce the risk of accidental puncture of the epidural space. C. EpiFaith - Syringe provides continuous real-time pressure sensing. Accidental puncture related to non-sensing period of intermittent technique would be eliminated.

EpiFaith cannot completely eliminate the occurrence of false-positives. Due to tissue characteristics, the contained air or saline may be injected when the needle tip enters a fake cavity or particular soft tissue inducing a false signal. Therefore, it is recommended that the plunger to be pushed again after the signal occurs. If the color ring cannot be recovered, it means the volume of the cavity is big enough. An attempt of catheter insertion should be made to check whether the needle has been anchored in the correct region. If the color ring is covered again, the needle can be slowly advanced until the visual signal appears. (Note: although the movement resulting from false-positives and the epidural space is different, we suggest the use the above mentioned process to identify whether it is a false-positive or not.)

In this situation, we suggest you to attach the syringe and push the plunger again to confirm the signal. Observe the moving speed of the piston rubber and carefully advance the needle. When the needle opening completely enters the epidural space, the moving speed will increase due to the lower flow resistance. Here’s the results of the action. If the protruding distance of the needle from the ligament flavum is insufficient, it may not allow the catheter to pass the needle opening even if the needle tip has arrived. In fact, because the LOR-related devices must provide a warning, either via hand feedback or visual signal, when the epidural space is reached, this issue is mostly related to the needle design and user habits rather than the technique itself. Therefore, training would reduce the occurrence of this problem.

EpiFaith - Syringe is now CE marked, so it’s available in Europe. The USA FDA 510(k) clearance is expected to come in early 2019.

This depends on your geographical region. Reach out to your local support or Please contact us for more information.

Currently, we offer a single syringe without other accessories. The all-in-one epidural tray will be available in 2023. In some of territories, our local distribution partners offer pre-bundled trays. Please contact us for more information.

The unit package of EpiFaith - Syringe is 50 pcs per case. Please contact us if you require further information regarding the MPQ.

The unit package of EpiFaith - CV is 25 pcs per case. Please contact us if you require further information regarding the MPQ.