AescuLink-remote treatment in real time

AescuLink is the innovative software solution that enables medical incidents to be handled from anywhere – from scheduled exams to life-threatening emergencies. Thanks to AescuLink, a tele-physician (or tele-emergency physician/TNA) can diagnose and transmit treatment instructions with the help of a helper on site. Time is of the essence in medical emergencies, so AescuLink performs all actions in real time to ensure that each patient receives the best possible treatment.

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AescuLink provides the tele-physician with all the necessary tools and information to provide successful remote treatment. With our solution, medical tasks such as history taking, physical examination, equipment diagnostics, diagnosis creation and treatment instructions can be completed quickly and efficiently. Through our multilateral audio-visual and textual connection between caregiver, patient and tele-physician, high quality voice and high definition video communication is available.

AescuLink also supports device diagnostics such as 12-lead ECG, electronic auscultation, pulmonary function testing, etc. through a variety of connected medical devices. Our solution enables the tele-physician to treat the patient as if he were directly in the doctor’s treatment room Discover the full range of AescuLink’s capabilities and how we can help you deliver healthcare to your patients on a secure basis..

AescuLink at a glance

AescuLink allows remote treatment at the highest level, providing the tele-physician with all the information needed in real time, especially information from medical devices. AescuLink can calculate additional medical information from raw data, allowing the tele-physician to gain deeper insights into the patient’s condition.

This is necessary for complex incidents.

For less complex incidents, GHC offers the RescueLink solution.. RescueLink is not a medical device due to its intended purpose and design. (see below)

AescuLink – Highlights

Use of AescuLink is legally compliant!

Whether telemedicine software must be approved as a medical device depends primarily on its purpose and design. The manufacturer defines the purpose of the software, but does not have full freedom in doing so. If the software qualifies as a medical device as defined in the Medical Device Regulation (MDR) Article 2 Definitions, the manufacturer cannot simply use it for another purpose. Conversely, he cannot simply declare a product that has no medical purpose as a medical device. At AescuLink, we have followed these regulations exactly and qualified and classified it accordingly.

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First, let’s look at an excerpt from our (intended use/intended purpose) document::

“The device is intended to be used when a medical incident occurs at remote locations, where limited medical personnel or medical expertise are available and medical data are required to make diagnosis …”

The AescuLink software thus qualifies for a medical device under MDR Article 2, paragraph 1. For further consideration, let’s look at the relevant facts of software design/its functionality.

Intended users: medical laypersons (non-clinical helpers), medical/clinical staff (authorized/licensed physician or authorized clinical staff).
Interpretation (design): a) Connection of further medical devices (without restriction: “The device acquires automatically medical data from medical modules, … Automatically acquired and manually entered medical data can be sent to the authorised personnel in order to obtain diagnosis and therapeutic instructions from the authorised personnel. Acquired medical data can be visualised on the graphic user interface GUI of the device” and b) remote control (“The authorised personnel can remotely control the device”)
Indication: as a supplement to (all) existing procedures, especially emergency medicine (“add-on on top of existing medical procedures, especially emergency procedures”)

The use of an emergency system by a layperson implies an increased risk, which was included in the risk management carried out in accordance with ISO 14971. The connection of medical devices and non-medical devices and thus the formation of a system according to Art 2(11) MDR is provided for in the design. AescuLink allows remote control of self and medical devices. This also carries higher risks and tighter integration with medical devices AescuLink not only displays the acquired data 1:1.. It calculates further information from raw data, which can be used for diganosis. A concise example is the “pulmonary function test” function of AescuLink. A spirometer is connected for this purpose. The spirometer provides the airflow as raw data.. From this one source, AescuLink calculates the metrics (e.g., FVC, FEV₁, FEV₁/FVC, FEF_25-75, and FEF₇₅) and compares these metrics to the table from GLI, giving the tele-physician the ability to validly assess the patient’s pulmonary functions.

Based on the intended purpose and design with the results of the risk analyses and clinical evaluation, we have qualified AescuLink as a medical device and classified it as Class IIb (see also the Declaration of Conformity available on this homepage). When operating AescuLink with other medical and non-medical devices, we subjected the system to the conformity assessment required by MDR as part of the AescuLink conformity assessment.

Our competent authority has audited AescuLink, particularly in qualification/classification, risk management and medical device connectivity.

Therefore, the use of AescuLink as a class IIb medical device is legally safe!

Source: iStock, kali9

Source: GHC

Use by medical laymen

One of the special features of AescuLink is that it is approved for use by a medical layperson. According to MDR Art 2, paragraph 38, “layperson means a person who does not have formal training in the relevant health care field or medical specialty”

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For the lay user, AescuLink offers a wide range of support:

Remote control of AescuLink and the medical devices – if they allow it – by the tele-physician to relieve the user.
Step-by-step guidance through procedures and the use of medical technology
Online guidance by the tele-physician in the case of bidirectional communication
Observing and, if necessary, correcting the procedure execution
and many more

This functionality is intended to relieve the user from operating the technology to the extent that he or she can fully concentrate on treating the patient. This helps to minimize the risks associated with the use of AescuLink by lay users and thus to be able to permit it. This serviceability was analyzed, evaluated and approved as part of the product approval process.

Thus, for example, a technician on an offshore wind platform, a chief mate on an ocean-going vessel, a nurse in a nursing home can use AescuLink without difficulty so that the tele-physician can treat a patient remotely.

Free choice with AescuLink thanks to platform technology

AescuLink provides a platform that can be designed according to the specific needs of the customer

AescuLink allows both operation in a cloud and use “on premisses” as a “legacy app”.
Mixed operation, where the patient unit is used as a web app and the tele-physician unit as a “legacy app”, is easily possible.
The patient unit can be equipped with different medical devices to enable a range of applications based on a single platform.
AescuLink is available on multiple hardware platforms. With AescuLink for smartphones, AescuLink contributes to increasing the mobility of users.

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For example, the following applications are in use:

You can find more information on the pages of the applications.

Source: GHC, iStock, bymuratdeniz

Source: GHC

Interruption-free telemedicine session!

Disconnections during a real-time telemedicine session often make remote treatment impossible. GHC researched and developed measures for implementation in the AescuLink solution to ensure the most uninterrupted telemedicine sessions possible. We follow two paths: measures internal to the software and measures in the network environment.

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The communication module of the AescuLink software implements algorithms for:

Data type dependent communication control:

As mentioned above, AescuLink provides the tele-physician with extensive information for use in remote treatment, e.g. communication audio/video, medical data in the form of real-time curves (ECG, plethysmogram, …), streamed audio (stethoscope), streamed video (ultrasound) or discrete values (heart rate, SPO2, blood pressure, …). These data have different and sometimes conflicting requirements from each other. For example, audio data requires very little bandwidth, but has very high requirements for completeness and uniformity of data streams. The video data requires very high amount of data and thus the corresponding bandwidth, but in return you can very well avoid data loss and poor uniformity.

Medical data must be transmitted in full, but have lower latency and uniformity requirements. Parameters representing the quality of a data transmission are: possible bandwidth, latency, packet loss and jitter. AescuLink controls the transmission by allocating the bandwidth, setting the transmission priority, adjusting the compression level and determining the buffering.

Limitation of consumption:

In a vehicle (ocean-going vessel, long-range aircraft, …), a satcom connection is usually available for all applications such as traffic control (AIS, ATC), weather forecasting, engine maintenance monitoring, management of maritime or air emergencies, or even remote treatment of medical emergencies with AescuLink. Here, AescuLink can limit its own consumption of network resources so that other applications significantly relevant to the operation of the vehicle can continue to work without interference.

Additional measures can be taken in the network environment to help ensure an uninterrupted telemedicine session.

Channel bundling: GHC deploys routers that perform “true” intelligent bundling of all currently available telecom technologies (LTE/5G, WiFi, Satcom, etc.), providing near 100% network coverage and uninterrupted remote treatment. If a channel fails, the remote treatment continues in such a way that the user is unaware of it. Data transmission is only slightly throttled.
Prioritization of telemedicine: In the network, telemedicine data can be passed through with higher priority than data from other applications, so that the telemedicine session runs without disruptions.

One-Touch ePCR Integration!

AescuLink and ePCR software such as ZOLL AmbulancePad are so tightly integrated that mission data is automatically exchanged. Switching between applications is done with just one click on the same system. This common solution eliminates the need for a separate device.

Source: gettyImages, franckreporter

Source: GHC

Free choice with AescuLink!

With AescuLink, you don’t need to worry about the interoperability of your medical equipment with the TNA solution. AescuLink can already control all common defis/ patient monitors. Adding another defibrillator or ventilator later is also not a problem, your investment is safe with AescuLink.

RescueLink at a glance

Although RescueLink is not a medical device, the development of RescueLink is compliant with ISO 13485 and therefore has the analogous quality of a medical device. The focus of RescueLink’s use is to clear less complex medical incidents with a tele-physician. This uses audio-visual-textual communication between patient/caregiver and tele-physician. If medical devices are to be integrated, the data from the medical devices are forwarded unprocessed to the tele-physician.

RescueLink

Source: GHC

Any questions? Feel free to get in touch.

To contact

AescuLink-remote treatment in real time

AescuLink at a glance

AescuLink – Highlights

Use of AescuLink is legally compliant!

Use by medical laymen

Free choice with AescuLink thanks to platform technology

Interruption-free telemedicine session!

One-Touch ePCR Integration!

Free choice with AescuLink!

RescueLink at a glance

RescueLink

Any questions? Feel free to get in touch.

GHC Global Health Care GmbH

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