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.

The auto-aspiration mechanism of the device is identical to manual negative pressure. Through testing, it has been confirmed that if manual aspiration produces backflow, EpiFaith CV will also generate automatic backflow.

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

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.

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.

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

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.

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 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 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.)

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.

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.

To ensure accurate pressure measurements and correct placement of the guidewire, the compatible range for guidewires is restricted to 0.64 to 0.96 mm (0.025 to 0.038 inches), with the recommended needle size being 18G. The use of alternative needles may impact pressure readings due to differences in needle tube resistance.

If an Angiocath is utilized, please insert the catheter into the blood vessel before reconnecting the device to verify intravascular pressure. Subsequently, insert the guidewire through the insertion hole.

No, it will not. The automatic suction is only about 0.6 to 0.8 cc per try. Compared to manual aspiration, the small volume of blood and the restriction actually help reduce the risk of vessel collapsing.

When the needle tip is fully within the vessel, the device will smoothly aspirate blood. Therefore, we do not recommend inserting guidewire in situations where backflow is not smooth or only a small amount of blood is aspirated.

The protrusion of the insertion hole indicates blood pressure exceeding 30 mmHg, and it fully protrudes at a pressure of 50 mmHg. Therefore, it can be used to identify patients with high venous pressure.

You can simply press the trigger area again. As long as the trigger area is pressed, the device will generate negative pressure unless it is already full.

The auto-aspiration mechanism of the device is identical to manual negative pressure. Through testing, it has been confirmed that if manual aspiration produces backflow, EpiFaith CV will also generate automatic backflow.

It is not recommended. You can press the trigger area multiple times for reconfirmation at any time, but please avoid forcefully holding down the trigger area to prevent hindering the movement of the plunger.

It is recommended to remove the guidewire and adjust the needle tip before attempting guidewire reinsertion. --ž It could be due to the needle tip shifting away from the vessel. To prevent this, we suggest pressing the trigger area again for reconfirmation before placing the guidewire. If backflow remains smooth, proceed to insert the guidewire to minimize the likelihood of this situation. ž-- Another possibility is that the needle tip is only partially inside the blood vessel. Try slightly moving the needle forward or backward before proceeding with guidewire placement.

The protrusion of the guidewire insertion hole indicates blood pressure exceeding 30 mmHg. In normal cases, guidewire placement is not recommended, but the decision remains at the discretion of the physician. However, if the device determines that it is in an artery and the blood has filled the device, the device will restrict the passage of the guidewire.

The EpiFaith CV features three instances of auto-aspiration, activated by pressing the trigger area. If the procedure cannot be completed within these three uses, the device can be reused after removing blood from the device. However, it is important to note that blood clotting can affect the EpiFaith CV's functionality, so multiple uses or prolonged single operations should be avoided to prevent blood clotting.

This is related to hand gestures. Additionally, the device can be assessed not only through visual observation for backflow but also through tactile feedback. When blood enters the syringe, the plunger moves backward, allowing confirmation of backflow through the sensation of the plunger movement.

Currently, EpiFaith CV is CE-marked for Europe and has received FDA approval for the US market. For information on availability and regulatory status in other regions, please contact our regulatory affairs department.

EpiFaith CV is produced in a facility certified by ISO13485:2016 and the Taiwanese government, adhering to medical device good manufacturing practices (GMP). For specific certifications in your region, please contact our regulatory team.

Currently offered as a single syringe without accessories, plans for an all-in-one epidural tray are in development. Details will be communicated to our distributors once available.