Hello everyone, myself Dr. Arfi, a third-year resident going to present my case series on a genetic disorder that is Jobert's syndrome. Aim of my paper will be to study a rare genetic disorder for its various clinical presentation to discuss its variable phenotypic presentation and radiological pattern and also to see if there is a correlation between severity of symptoms and the radiological findings. Introduction. Jobert's syndrome is a rare genetic heterogeneously inherited disorder named after Marie Jobert in 1969. It is characterized by brain stem and cerebellar malformation and multi-systemic affection involving nervous, ocular, gastrointestinal and urogenital system in varying proportion. It belongs to a primedicellular disease, primedicellular, which are, which are immotile celia, helps in receiving and transmitting signals. They play an important role in growth and function of the neuronal cells, skeleton, retina photoreceptors, kidney tubules and collecting ducts and also liver. Jobert's syndrome, here I would also like to discuss that celia related disorders are mainly categorized into motile celopathies such as catagener syndrome, which most of us are aware about and immotile celopathies that we might not have heard much about and these includes Jobert's syndrome, nephronyptasis, Beedle-Burtard syndrome and Meckel's syndrome. Jobert's syndrome and other immotile celopathies show pleotropy and overlapping phenotypes. The term Jobert's syndrome related disorder has been adopted to describe various pathological entities with the neuro radiological feature of mola to sign while involving other organs as well. Here in this presentation, we would discuss two cases in a family and both of them having similar complaints but with different severity. Family history revealed second-degree concern to universe marriage. No other prime members in the family were affected. My first case is a six-year-old child who was brought to OPD in the Department of Pediatrics, Jawaharlal Nehru Medical College for evaluation of developmental delay. According to her mother, she could not sit, stand or speak. However, there is spontaneous cry and smile. She also has gaze instability. There is no history of any abnormal facial-like movements. Further questioning to the patient's mother also revealed that she had weak cry since birth which rose the suspicion of some abnormality. NCCT head was also performed at the age of six months which came out to be normal. Currently, she has poor and delayed developmental milestones. She is not able to stand or sit on her own or with support. She was delivered by an uncomplicated caesarean at nine months of period for indication was laid for gestational age. She did not cry at the time of her birth. The postnatal history was negative for any prolonged admission at neonatal ICU. On examining the child, she appeared thin and fragile. She could not stand or sit. Mild facial dysmorphia was noted with a depressed nasal bridge and deepened orbital sockets. She is unable to follow command and does not follow her gaze on specific object. Ocular examination revealed bilateral horizontal pendulum stagmus without myopia. The cardiovascular examination was normal. A pulmonary examination revealed a prominent excretory visa without just in drawing. Examination finding of the cranial nerves were also normal. Motor examination revealed hypotonia with normal tendon reflexes. After examining the child, she was advised by the clinician to undergo MRI brain. As CT head at the age of six months came out to be normal and this is the MRI brain of the child where in the first two images, the axial and the coronal images, we can see that there is a genesis of the cerebellar vermice and there is deep and interpredicular fossa. For the curds at the level of midbrain and cerebellum shows thickened abnormally horizontally placed superior cerebellar peduncles giving the molar tooth sign. The appearance of the fourth ventricle gave the batwing appearance also called as umbrella sign. Here I would also like to discuss other signs such as buttock sign which is also described for jobbers syndrome and coronal image where there is a midline cleft scene separating the two cerebellar hemispheres due to absent cerebellar vermice. Other signs such as shepherd crook sign is also described in such vital views of the posterior fossa where the brain stem and ponds makes the shaft of the crook and abnormal superior cerebellar peduncles and cerebellar hemispheres make the arc of the crook. In my fifth image, sagittal T1-vitted image, there is thinning of the posterior body and spleenium of the corpus chelosum which was an additional finding. My second case is a three-year-old boy with the same symptoms and signs as his sister with different severity. He has developmental delay however less severe than his sister. He could sit or stand with support. He also had gaze abnormality. He could speak by syllables. No history of Cicerolec activity was there. Birth is to reveal that he was delivered by Cesarean at the age of nine months. Indication was caught around the neck with meconium aspiration. He weighed approximately 2.4 kg. He didn't cry immediately after birth and was on ventilator for 24 hours. Neurological examinations were normal. Rest of the findings were also normal. After his sister was diagnosed with jobbers syndrome and looking after his sign and symptoms, he was also advised MRI brain and it was very striking that the features were similar to his sister's sisters. Here in the first two images, we can see that there is a genesis of the cerebellar hemisphere. As we have seen in our first case, there is deep intubidumcular fossa. Molar tooth sign is also appreciated. However, umbrella sign was not seen. In the sagittal image, the corpus callosum appeared to be normal for his age. Coming to the discussion part, jobbers syndrome is a rare disorder of central nervous system with the incidence of one per one lakh children. Only few cases have been reported till now worldwide and by 2009, approximately 200 cases have been reported. Both sporadic and autosomal recessive pattern of inheritance has been described. Dr. Mary Jobert and co-workers in 1969 for the first time described four siblings with a texia, cognitive impairment, eye movement abnormalities, cerebellar vermice genesis, and episodic tachypnea in a French Canadian family. Marriott R in 1997 described this mid-brain hindbrain malformation on MRI as a result of hyperplasia of the midline cerebellar vermice resembling the cross-section of a molar tooth appearance, which is pathognomic for Jobert syndrome. In the same year, it was reported that there is association between Jobert syndrome and renal cystic disorders and liver fibrosis. But in our cases, it did not have any organ disorders and their ultrasonography and laboratory findings were normal. The first report and subsequent reports have been determined that Jobert syndrome has autosomal recessive inheritance and mutations in the eight ciliary basal body genes. So far, more than 30 causative genes have been found for the various subtypes of Jobert syndrome-related disorders. Backman Gekescu et al. reported TMEM67, C5ORF42, CC2D2A, CAP290, and AHI1 gene, which were more frequently found. The AHI1 gene, which is found in 10 to 15 percent of the patients, and CAP290 is found in 10 percent of the cases, and are the most common mutant gene related to Jobert syndrome-related disorders. AHI1 is abundant in brain and kidney and weakly expressed in the liver as well. The clinical features of Jobert syndrome-related disorders vary from being mild to severe, and it typically presents with the following features, such as abnormal popular findings, for example, nystagmus, strabismus, poses, hypotonia, and edexia, leading to gate abnormalities, respiratory dysregulation in the form of hyperepnea apnea episodes, which are usually present at the time of neonatal period and gradually diminishes, developmental retardation going to the abnormality of cerebellum and brainstem, and typical dysmorphic features such as hypertelurism, broad forehead, broad mouth with protrusion of tongue, or ptosis. The triad of Jobert syndrome includes hypotonia, developmental delay, and brainstem, cerebellum malformation, giving the molar tooth sign. Based on, as we have discussed, that imotile seropathies can involve multiple organs. So, based on the organ involved, Transisco etyl classified Jobert syndrome related disorders into six phenotypes. This includes pure Jobert syndrome with multiple organ involvement, Jobert syndrome with renal defect, Jobert syndrome with ocular defect, with ocular renal defects, Jobert syndrome with hepatic defects, and with orophatio-digital defects. The radiographic features include the molar tooth sign and the batwing configuration, which are the classical imaging findings. Severe hypogenesis to complete agenesis of the cerebellar hemisphere is characteristic. The superior cerebellar peduncles are thickened and have abnormal horizontal force. The lack of peduncular deputicization, which can be assessed by diffusion tensor imaging, often results in a superior vermin cleft. There can be distorted and superiorly pointing cerebellar white matter trap, especially in the posterior cerebellum. Other abnormalities could be inferior or abnormal inferior olivary nucleus, and a separate entoreal abnormalities include cortical dysplasia, corpus callosum abnormalities, as we have seen in our first case, heterotopic gray matter, and incafelocene. In coming to our case scenario, our first case was a six-year-old girl with severe developmental delay. In addition to molar tooth appearance, there was batwing appearance of the fourth ventricle with thinning of the corpus callosum. However, in our second case, with mild symptoms and malart tooth appearance, the corpus callosum appeared normal, and there was no batwing configuration. So, we have made a hypothesis that there is a possible correlation between severity of symptoms and radiological findings. However, there is limitation, as it is statistically insignificant. Further studies with more number of cases could be performed to prove this correlation statistically relevant. So, is the disease prenatally diagnosable? So, the answer is yes, it can be diagnosed with but with uncertainty. Diagnosis of Gerber syndrome is commonly made after birth. However, fewer cases of prenatal diagnosis by USG have been made, and they are more likely to be misdirected because of some nonspecific features that also manifest dandy woken malformation and cerebellum, cranioserebellum, cardiac syndrome, and many other diseases. Zool et al. in prenatal head sonography found absent for cerebellar vermice with fourth ventricle, communicating with the posterior fossa, molar tooth sign was also seen with enlarged fourth ventricle. Prenatal MRI in the same patient was done and molar tooth sign was seen with dilated cisterna magna and enlarged fourth ventricle. But the average age at diagnosis of Gerber syndrome is 33 months and therefore it should be considered a syndrome with varying phenotype, and it makes it difficult to diagnose the accurate subtype during the newborn period. However, we can get some clue for some abnormality in the brain. In highly suspected patients. Coming to the management part, in general, the prognosis of Gerber syndrome is poor. It largely depends on severity of different organ systems. Stylian et al. described variable course in these patients. Some patients die early in the infancy. Some have severe developmental handicaps and others survive with mild developmental delay. A five-year survival rate is 50% and death is usually due to defeating difficulties and respiratory infections. Treatment options are not readily available as this disease onset is during the ingestation period. Rehabilitation is the main state of management for these patients. Symptomatic and supportive therapy in the form of physiotherapy and speech therapy could help. Optimal management needs multidisciplinary approach, special consideration to respiratory and feeding disorders, cognitive and behavioral evaluation also could be helpful to these young children. Rehabilitation, therapy can improve disabilities of patients with Gerber syndrome. Gene analysis is the cornerstone of the disease. However, in our case, the poor financial status of the patient, genetic study could not be performed. Learned the genetic counseling and its prevention. Genetic counseling is important for its prevention as it is an autosomal recessive condition. The counseling should include that there is a recurrence rate of 25%. That is, there are 25% chances of having an affected child and 75% chances of having a phenotypically normal child, among which 50% will be carrier. And therefore, concern bonus marriage in the future among their children should be prohibited. So I would like to conclude my presentation with the following conclusion that Gerber syndrome is a rare disorder of central nervous system with variable clinical presentation. The classic imaging findings include molar tooth sign, which is pathognomic of Gerber syndrome and a batting configuration of the fourth ventricle, which could be seen both in CT and MRI. In our two cases, there's a positive correlation between severity of symptoms and neurological findings. However, many more studies need to be done to prove it statistically relevant. These are the references of my paper. Thank you.


Even when there's a chip shortage and supply and demand problem going on right now, jacking up the prices of PC parts sky high, you still went ahead and bought yourself a brand new PC. To be honest, good for you. So game time la ba? Well, there are a few things na you can first do to maximize and get the most out of your PC. This could also improve your PC's lifespan so you can enjoy it for much longer. I'm Rocky the Programmer and in this video, we're going to be talking about the five things you should first do to your brand new PC. Ang video na to ay handog ni CDKoffers.com. Maram kang mahanap na ibat-ibang uri ng software dito, may games, apps, activation codes or Windows 10, check out our video on CDKoffers in the video description. Mabilis, mura, and siyempre legit dito. Madalil ang mag-order, search for the software you need, add to cart, check out, dan ka sa payment options nila, wala pa isang minuto, finished. May legit working CDK ka na sa software na pinilimo. Gamitin ang aming promo code para makakuhapan ng extra 20% discount sa purchase mo. Kung naghanap ka ng mura, legit, and original software, check out CDKoffers.com. So for context lang, this guide is for when you've built your PC and every component works na and you can safely boot to Windows already. Although this video is generally for brand new PCs, you can still use some of the tips here for your existing or even laptops. Tip number one, create a comprehensive list of all the parts inside your PC.  List all the parts and the names ng parts, yung brand, yung exact na model niya, yung mga notable na specs like let's say may compatibilities, and also important din na ilagay mo yung date of purchase and also san mo siya na purchase so that you can check yung validity ng warrantismo. Sa kali lang naman yung karan ng problema. Listing it this way would also mean na alam mo kung ano yung na sa loob ng PC mo, and mas madali na siyang atrobo shoot later. Or if hindi ka naman magtotrobo shoot, it would save a lot of guesswork for the tech guys na tatanong mo para dun sa problema ng PC mo. Speaking of tech guys, make sure to check out yung ating official forum down below. Update Your Motherboard Bios Medyo mahirap, but this is a very important step. Yung firmware or yung Motherboard Bios, yun yung logical code that resides inside your motherboard that's in charge of yung pag-route ng data to the CPU, yung pag-supply ng power sa mga lahat ng components, kung anong speed yung ia-allow niya na patakbuhin yung ram mo, and marami pang ibang sobrang importante. Now obviously, yung mga manufacturer hindi naman sila mga kagawa ng code na perfecto agad in one go. Kaya naging exist yung mga update, yung mga patches na kailangan talaga nating i-download. Keeping your BIOS updated will ensure nang solid yung performance mo lagi, and mas stable siya that would also fix yung mga compatibility issues na nag-a-arise kapag kami mga bagong components na lumalabas, and most importantly, yun ding security. We'll go back to that later. The process is a bit involved, although hindi naman to guide, parang general na rin na kung anong a-expect mo, kailangan mong pumunta dun sa motherboard manufacturer website, and you're going to look for a BIOS section, tapos may file ka dun na ida-download. Titignan mo yung date kung yun may pinaka-updated, and isostormo yung file na yun sa isang thumb drive. Then, isasaksa ko yung thumb drive dun sa motherboard USB port, and when you go to the BIOS using yun delete key as your PC boots up, may kita mo dun, depende talaga sa brand-day. It's either update firmware, or easy flash, or flash BIOS, or update BIOS, or and so forth. Pero yun tool na yun, kadalasan, automatic na siya, once na ma-detect niya na yung firmware file, and laging isang warning lang na may malaking-malaking chance of breaking, or rendering your motherboard useless, kapag na interrupt ng whatsoever yung firmware installation. So either make sure na meron kang UPS, that's the best way to do it, or make sure mo lang na hindi mo mongulan kumikidlat para walang power interruptions habang nag-update ka ng firmware. Tip number three, update your software. So tungkol na naman to sa pag-update, pero nandung ka na sa loob ng OS ngayun. So you're going to update lahat ng pwede ng i-update. Pina ka obvious dito would be the GPU drivers, yung chipset drivers, and yung mga drivers nung mga components mo like yung Wi-Fi card, kung meron ka, mga LAN card, and yung mga let's say meron kang RGB controllers, kailangan up to date din sila. So to yan na sa GPU, kapag nag-update ka ng drivers nun, kadalasan, meron talagang na performance improvement, especially kapag kami mga bagong triple A games na lumalabas, kadalasan may kasabay din yan na Nvidia or AMD na nakalagay game ready card. So napapatch yung mga performance issues nung games na yun, and overall mas nagiging solid yung performance nung GPU mo, that also goes the same for yung chipset drivers ng motherboard mo. This is very important kasi yun yung link na OS to the BIOS, so dapat updated din yung chipset drivers na yun. Itong mga software updates na ito, makikita mo to dun sa website nung manufacturer mo. So tulad nung kumawa, GPU na sa Nvidia siya or AMD, and yung chipset drivers tulad nung sa BIOS na nandun din siya sa manufacturer's website ng motherboard mo. Probably the most important thing, keep your OS up to date. Ngayon parang meme na yung Windows updates na bigla na lang may surprise restart habang gumagawa ka ng thesis mo, bigla siya magda download ng 3GB na update habang merong kang ranked na match, pero this is very important kasi yung mga Windows updates, although parang nakakainis talaga yung update process, they address yung mga stability issues, yung mga weird na mga components na bigla na lang magahang, or bigla na lang nakakakorap yung OS mo, for example, kadalasan yung mga Windows updates yung nakakasol ng problems na yun. Most importantly din, is yung mga vulnerabilities and mga exploits na kailangan mo patch. We live in a digital age where kadalasan yung mga finances natin, like yung mga bank accounts, yung mga, or kung merong kang cryptocurrencies nakatay yung dun sa PC mo, or sa digital identity mo. Hackers are working day and night para ma-access yun, para makuha yung information mo, and yes, we mean you yung nanonood ngayon. We're going to show you an image of yung current na attacks right at this moment dun sa hardware sugar website. Sobrang damit di ba, kasi no one is accepted, so keep your OS up-to-date, keep your antivirus software up-to-date, and lahat ng components po, dapat up-to-date siya. So nakakatamatman or nakakahasel kasi yung dami-dami website, nakailangan puntahan, pero in reality, updates are good and patches mas nakakimprove talaga sila ng performance down the line. Tip number four is benchmark. I know most of you isn't like me na parang sobrang obsest na dun sa performance scores ng aking rig, but hear me out. Benchmarking your PC fresh out of the box will give you a basic idea of the fresh and yung normal lang operation ng PC mo. So you'd know kung ano yung FPS na you can expect while playing a game, ano yung temperatures na irreach mo while 100% load halimbawa yung rig mo, and so on. Ngayon sa benchmarking, you can use a combination of tools like Timespy, libre lang yung sustain for CPU and GPU performance, Cinebench for multi-threaded CPU performance, and then HW monitor para man monitor mo yung temps. Ngayon ang gagayon mo, once na masetap mo yung brand new PC mo, you're going to benchmark using yung tools na yun, and then you're going to save and record yung mga figures and scores na makukuhuha mo.  Like for example, like plus 10 degrees big lash na hotter, so that means na mayang something wrong with your cooling, for example, or alimbawa sa Timespy, gumaba yung GPU score mo, so that would mean either nago overheat yung GPU mo or mayang siguro error sa drivers niya, so you can troubleshoot it. Yung ibang games din, mayang build in a benchmark tools like yung Assassin's Creed Odyssey, CSGO, and actually kahit yung valorant mayang din, so you can use also those and record yung average na FPS mo, so that siguro 3 months or 6 months later, you can test it again and see if mayang bang nangyari na sa PC mo. So tip number 5, medyo controversial, pero consider overclocking your PC, siguro kahit yung ram lang. Now this comes down to personal preference and optional din talaga siya, and we do know yung great risk that comes with overclocking in general. Pero we've also come a long way na yung mga components ngayon, they're more or less designed to withstand heat and more voltage, kasi they're expected to be overclocked and part na yun ng PC ownership talaga. Gone are the days of frying your CPU dahil mayang kong maling nalagay na voltage or biglang mag overheat yung GPU mo dahil andami mo o clock na nabigay sa kanya, kadalasan mayang sila mga fail-safe sa loob. Actually mayang nangyari yung mga tools na ginawa para mas mapadali yung pag overclock natin like Ryzen Master for Ryzen CPUs and sometimes kahit yung mismo yung component mayroon siya mga either one click na OC button because they're expected talaga to be overclocked. And ayun nga components are designed talaga to be overclocked and you should take advantage of that. Now I understand if you're still iffy about it, pero at the very least overclock your ram kasi yung advertised na speeds ng ram makuamol ang siya by overclocking or yung pag-enable ng XMP. It's very simple lang naman just go to the BIOS and then enable yung XMP from there. For sure, gina gawanan namin yung by default, but you can also do it yourself. Anong tulad ng ram yung mga ibang monitors din, nagsasabi na 165 hertz yung kanilang refresh rates. Again, that's only reachable through overclocking monitor refresh rate. So you have to do that. Anong this is very addicting and it's really fun if you really want to do it. Pero if you want to go down this spiral, you have to do your homework. Search everything about your components kung papano sila yung overclock safely and ano yung mga mitigation steps para hindi na masira yung components mo if you do decide to overclock it. Sina sa jatala ganan namin ngayon na hindi magbigay ng guide para mag-overclock kasi ayaw naman namin maging liable kami dun sa pwedeng masira sa components nyo. But if you really want to do this, you can check out yung maraming maraming ng guides about overclocking, your specific component. And also remember, you're actually paying for the privilege of overclocking your components. Kasama siya dun sa research and development in yung overall na design ng components na yun kasi they have overclocking in mind.  So we hope na you found these tips helpful. If you like it, leave a like and make sure to subscribe if you haven't already. Also, you can visit our physical shop in Makati, Harvey Sugar, and also check out yung aming forum na pm.hwsugar.th. Thank you and see you next video. Thanks for watching, internet. to our top fans Christian Espinoza, John Ruben Ocha, ITX addict Ian Meru, Richard Ongkinko, Liam Magnaje, and Dom H. Maraming maraming salamat po.


Waterheating is the second largest energy user in your home, accounting for up to 20% of your monthly utility bill. So it pays to make smart choices in this area, like washing clothes in cold water, or setting your water heater's thermostat to a recommended 120 degrees. However, to save more energy on water heating, consider making the switch to a Marathon Electric Waterheater. Despite weight and durable, Marathon Waterheaters are among the most efficient models available, capable of providing a lifetime of energy savings and reliability. To learn more about the advantages of installing a Marathon Waterheater in your home, let's take a look at the technology of a conventional water heater, versus Marathon's unique energy saving features. Here's how a conventional water heater works. The tank is filled with cold water through the dip tube from your home's water supply lines. The water is then heated by a burner or heating element, which stays on until the water reaches the temperature set by your thermostat. As the water temperature increases, the hot water rises above the denser cold water to the top of the tank, where it exits the hot water heater's supply pipe, ready for household use. Conventional water heaters typically last 9 to 12 years, depending largely on the condition of the sacrificial anode rod, or sacrificial anode. A magnesium or aluminum rod suspended in the water heater tank to help prevent corrosion. When the sacrificial anode loses its effectiveness, water begins to rust the walls of a conventional steel water heater tank, resulting in a ruptured water heater and costly repairs from a flooded basement, attic, or garage. So how does a Marathon Waterheater differ from a conventional model? The most notable difference is that the Marathon Waterheater comes with a manufacturer's lifetime tank warranty. This no-leak promise is made possible by Marathon's unique superior construction, including a seamless, blow-molded polybutylene tank and a filament-wound fiberglass outer tank that allow a Marathon Waterheater to withstand years of plumbing pressure as well as the solvent nature of the water. Another key feature of a Marathon Waterheater is its higher efficiency rating. Marathon Waterheaters have 4 inches of insulating foam between the tank and the water heater jacket to help maintain water temperature and prevent heat loss. Trademarked in Virafoam, Marathon Insulation contains no ozone-depleting chemicals, making Marathon Waterheaters a smart choice for consumers interested in environmentally friendly energy saving options. So if you're in the market for a new water heater, consider a Marathon with its longer life, greater efficiency, lighter weight, and lifetime warranty. A Marathon Waterheater is designed to provide years of energy savings and peace of mind. Better yet, there's nothing to sacrifice, not an anode rod, your comfort, or your budget. Smart Energy, smart choices, brought to you by Georgia Power.


Never attack a powerful guy by my advice in business networking. Start out nice, nice, nice, nice, nice.  But don't start out mean. It goes against game theory. And here's what happens. Like attracts like. So the second you're an a**hole to start out with, all the a**holes congregate around you and all the good people scatter. So unless you're in prison, where you gotta act tough to start with, just chill. I don't know where this thing comes from, but I will tell you in business, if you wanna be broke, I mean broke, be an a**hole.  They're really not.


Hello, everyone. I'm Abhijit. I work as a back-end developer at Housing. I, alongside with my colleague Pranav, here to present about how we're using Erlang VM at Housing, what our experiences and learnings have been from the virtual machine. So I guess everyone here, I mean, they must be probably aware of the Erlang program language and the virtual machine. But still, just for sake, Erlang virtual machine, Erlang program language, they were both invented by Ericsson for designing distributed, scalable, and fault-oriented systems. So Erlang uses the Actor model to achieve concurrency. And the virtual machine has excellent in-built support for SMP scheduling. That means it can utilize multiple scores of a machine very efficiently. And it has been doing that since its inception. Erlang is an excellent language for programming distributed systems. So actors in Erlang, which are Erlang processes, can be scaled to multiple nodes, and they can act in the same way as they act in the same machine. I'll specifically talk about Elixir, which is a Ruby and Clojure-inspired syntax, and can be compiled directly upon the Erlang virtual machine. So I was talking about the Actor model. Basically, there are two types of model to achieve concurrency. One is the CSP paradigm, accommodating sequential processes, and one is the Actor model. Languages like Go, Haskell, they follow the CSP paradigm, but Erlang follows the Actor model. So in Actor model, what basically they do is they'll you can think of actors as objects, although that's completely untrue. But for, I mean, for programmers, for observational programmers, we have to think of it like that. It's not like that, basically. So each actor can communicate with any other actor. So you can think of actors like people who are not having a telephonic conversation or not having a face-to-face conversation, but communicating over emails, communicating over some kind of asynchronous messaging medium. So each actor, each actor in Erlang Virtual Machine has its own mailbox that mailbox receives messages from the other actors. And each actor has to read its mailbox and decide what to do after reading that message. So that's how it works. So you have multiple actors. They will dequeue their mailboxes. They will decide what to do. So yeah, I talked about this earlier. So actors in Erlang can be transparent upon note. That this means that the semantics of messaging between actors is remains the same in the same machine or across different machines. So if you want to say PID, process ID 1, messaging process ID 2, that remains the same for any distributed PID or in this local PID. If you have to think about the problems in which you have to send messages to an actor on a different machine, the semantics doesn't change. That makes this distribution dead simple. So this is a brief overview. So in the operating system, the Erlang Virtual Machine process will be a central process. It will have lots of actors, which are processes, lots and lots of actors it can have. Now what the Erlang scheduler will do is this will schedule those actors upon OS threads. So these are OS threads. And then it's the job of the OS scheduler to run these threads on the CPU. So basically, the scheduler, the same piece that I was talking about, so the scheduler has to be very fair in scheduling these processes upon OS threads. And that's what they have tried. That's what they have tried and successfully done. So we can exploit this feature of Erlang VM. Now what are the usage contexts for housing? So we all know that we have to build products very fast. So we are a Ruby on Rails stack, simple as that. But lately, many services written in Ruby on Rails started facing a lot of bottlenecks and a lot of scalability bottlenecks. So then we decided to chance upon several alternatives, maybe Go, maybe Haskell, maybe any other language. So the thing that we chose Elixir, so it is very similar to Ruby. And we thought that without taking much time, we could code our services in it and exploit the concurrency features of Erlang VM, thus making our entire web service architecture scalable. For interact, now we have lots of microservices at housing and these microservices have to communicate with each other. Now for communication, we could either use HTTP, but that is not a scalable pattern for communication. So asynchronous communication is best achieved by messaging queues, so we use RabbitMQ. So that in the RabbitMQ also has our language, is built upon our language machine and CouchDB is used for some use cases. We'll also talk about that. So this is like the code written Ruby, the code written Elixir. So you can just see how similar it all looks like. So the inventor of Elixir lang, Joseph Alim, he had this primary aim that writing Elixir should be as simple as writing in Ruby. That's what its aim is all about. So you see class becomes def module, def becomes def do, puts becomes IO puts. If you want to call any Erlang module function, you can just write column, the name of the Erlang module, the column name of a function of the, you have to call an arguments list. It's as simple as that. For lazy operations, you can use stream module for Ruby has an excellent inner module. If people, you know, you have program in Ruby, it's very simple, very intuitive. So the same way Elixir has also copied Ruby in that. So this is how one of our rewrite looks as. So this is, I'm talking about the main filter service. Now, first it was written in Ruby, how it looked like. Now it has been written in Elixir, how it looks like. I mean, the screen is not particularly otherwise, you'd agree that it's not that different. So here we are actually mutating objects. Mutating objects, this is like an object. We are mutating the hash of the object after every operation. But here we are not mutating. We are transforming the value of the function. So transforming piping to another operation, piping, piping. So Elixir has this concept called pipes where you can transform one value to the other. So you have to always keep in mind that Elixir, since it's an Erlang machine, it has the concept of immutable variables. So variables are not mutable. So you have to always keep transforming those variables to new variables. So what are the experiences of using Elixir? I mean, it has been an excellent choice, turned out to be an excellent choice for us because the ease of usability, given its ease of usability and productivity gains, yeah, it has turned out to be a great choice for us. Now, there's a problem with, I mean, people who have been coding in Erlang will agree that rebar was a big problem for making releases, builds, and generating all kinds of DevOps stuff in Erlang. So that has been perfectly solved by using Mix and EXRM. So that is not a problem. It's as intuitive as go, go build, or go run.  So in the same way, Mix aims to be as intuitive as that. So you can do mix depth.get, you can do mix test.compile, you can generate releases pretty intuitively. Test cases are very easy to implement, as easy as Ruby. So you just have to use EXUnit to use test cases. That is not a problem. The problem comes when you have to think about the problem in a functional way. So you can't think about classes and objects. Never, you can't. So you always have to think about, okay, this function, can it be done in a process? Can it not be done in a process? Or do I have to multiple process and use pipes? So you always have to think that way. So maybe sometimes we make mistakes in thinking that way. So that is a bit problematic. Until you get comfortable with the language. Also the library support is not maturing. I mean, it's maturing slowly. So we have had hands full sometimes to make it exist or work for us. So we have to code. You have to have a Redis connector or a Postgres connectors. They have some problems. So we have to go in the library itself. We have to code and make that thing work for us. So that was an issue of this. So the second context I was talking about, hello. RabbitMQ, so these are many services which want to send messages to lots of other services. So RabbitMQ is a standard message broker for multiplexing different messages to other services. So RabbitMQ, you almost obviously know about it, but still is a message queue which has any of the concepts of a publisher, consumer queue and an exchange. So publishers normally publish messages to exchange. Consumers listen messages from the queue and the exchange and the queues are bound by routing keys that is specified by the client itself. Now, we found topic exchanges to be pretty suitable for us because using topic exchanges, you can extend the flexibility of rejects pattern matching and then we can agree upon some conventions and then we can have generic publishers across all our services. So let's say you have a service A, let's say you have a model A and then you have an action of the model A and then you can, let's say, let's say you have a buy service in our system and okay, I'll speed it up. So, I mean, using routing convention topic exchanges, you can have generic publishers, that's my entire point. So generic publishers are pretty easily, you can embed it easily across the entire services. So, I mean, also I want to suggest about how some catches that you might fall upon when you're using the virtual machine. So always write tail because it functions. Never in our line, add as a list. So in the exit, add as a list. So list, link list are always inefficient. So always try to append on the head of link list rather than trying to merge it from the, trying to append it from the end. That's the basic, most basic point. Large files in Erlang are always reference counted. So Erlang has the concept of soft real time. So soft real time means that each process has a local heap, that heap gets cleaned after each processes dies.  So that Erlang, so by that Erlang can give you soft real time behavior. There's never stopped the world garbage collection but that can happen when you have large boundaries. Then Erlang starts sharing that boundaries across all the processes. So they would copy all the boundaries. So they have a central boundary and they can have a reference to that boundary. So those boundaries are always reference counted and reference counted.  Yeah, so some of our messages like polygons were pretty, pretty large. So we tried to compress them. We tried to make those messages small and fit that into the Erlang process architecture. And distribution is one thing. So if you have connected nodes, Erlang connected nodes, so you will try to ping one node with each other and try to establish a connection with each other. But always have this thing in mind that when anything breaks, so what is your failure? What is your fault or this mechanism? How do you want to start with a clean slate? So always those things are very important when you're having connected cloud of Erlang machines. So OTP gives excellent behaviors for achieving fault tolerance and you have to think about, you just have to think about how you can start with a clean slate. That's it, guys, yeah. Any questions? Hey, hey. Oh, yeah. Yeah. Hey, I have pins. Me? Yeah. I have two questions. Like one is like you are following up your asynchronous model in terms of factors and things like that, right? So any thoughts on transaction management that we're interested on that? So transactions are always implemented through a pipeline. So we have a kind of FSM, FSM, we make FSM for transactions. So even each part of, so we break transactions into events. So that, like you can model a transaction as state machine. So always after a failure of a transaction, you can go back to a state which you have clearly defined. So it provides excellent behavior. OTP has a FSM module, which is pretty easy to code in. Okay. And I wanted to know the thoughts on the choice of Erlang VM itself. Did you guys explore the choice of JVM probably with Scala and Akka for? Thing is that, yeah, we love Ruby.  It might be single thread and all that stuff, but I love the Ruby syntax. So I wanted to have some kind of syntax like that. So Elixir provides me that syntax. And most of the programs in housing love Ruby. So yeah, I mean, it's kind of stereotype. It's kind of preconceived notion. Yeah. Okay. Hello. Yeah. Just, I don't know, are we? Yeah. Here. Thank you for the excellent talk. I wanted to understand, like I'm curious to understand the tooling support. Tooling support. Yeah. How is it for Erlang? The tooling support was pretty good, but it was kind of unwieldy and obscure in Erlang. So if you have used rebar, if you have used, if you have used other Erlang.make, so you have to dig in quite deep to actually make, to actually do easy tooling. So with mix and EXRM, that is being done pretty easily. So Elixir has tried to solve that problem. And I believe that it has been solved to an extent. They are solving this problem, obviously. And is there any operating system constraint? Like, no, absolutely not. Okay. It has both windows. Yeah. Yeah. Yeah. So you said that you went to Elixir mainly because you had problems in scaling room. Yeah. So do you have some internal benchmark sort of approximate numbers? Yeah, we were. The thing is that we can always scale. So did you like first try things like event machine and do you have numbers to compare, say event machine based code versus Elixir? Yeah. Can you say it? Yeah. So I mean, with the same amount of Ruby instances, I mean, for the same amount of load, we are having a lot of Ruby instances around 10 or 11 for one of the service. And for when we installed, when we, I mean, it was hardly three to four days of coding Elixir and then it was, it dropped onto two or two. But you had, you were using event machine based code? No. In Ruby. So had you tried going to Ruby event machine? So yeah, event machine, no, I know, yeah. We didn't try.


Our investors use a host of different technical market gauges, and one of them is the Hindenburg Omen. Joining us now to explain is Mark Holbert of the Holbert Financial Digest. So, Mark, very simply, what is the Hindenburg Omen? Unfortunately, there's no simple answer. It's basically an index or an indicator that traces back, as far as I can tell, about 50 years. It was created in the 1970s. And it really builds on an indicator that Norm Fausback of the Institute for Econometric Research had created called the High-Low-Logic Index. And that remains the core of the Hindenburg Omen. But what followers of that High-Low-Logic Index did was add a whole host of additional indicators above and beyond what Fausback had introduced and put it all together in a package which is called the Hindenburg Omen. And I think that history is important because a lot of times what people do is they'll add indicator upon indicator together to retroactively make it fit the data better. And I think that's what's happened here. In fact, when I interviewed Norm Fausback about the Hindenburg Omen, this is several years ago now, but he referred to that mishmash of indicators that are all put together in the Hindenburg Omen. He called it a big pasta dish. It's just a conglomeration of lots of different things, and he doesn't think it has as much statistical validity even in theory. And of course, that's even before we start talking about his track record, which is also very checkered. But what kind of market insights do we get from the Hindenburg Omen? Well, if you look at the core of the High-Low-Logic Index, the theory behind it, as explained by Fausback, and this is all the way back to the 70s, and it remains a good indicator, though again it has had notable failures. But the logic behind that indicator is this, that when you have a market that is healthy, you're going to have a high number of new 52-week highs, but a relatively low number of new 52-week lows. And when you take, when both of those are at a relatively high level, that suggests that there's a lot of churning and distribution in the market and is a sign of not health or sickness, as you might say, in the market itself. And so that's what the indicator does. It simply looks at the lesser of new 52-week highs and 52-week lows, and then takes that number and the percentage of total issues traded. And when it goes above, different people look at different thresholds. It could be either two or three or four percent. And they usually look at it on a moving average basis because there's a lot of noise in the data. But basically, they're just looking to see if, in a bull market, if there's a lot of new 52-week lows, that has to suggest that the market isn't doing that well. All right. But now it has been triggered a few times in recent days. So from that, I mean, what are the odds of some sort of correction or pullback coming in the market this summer? I would say those odds are no greater than they would have been if the Hindenburg Omen had not triggered. You may recall that if you were looking at this indicator, no reason that we should because it's triggered so many times in recent months, but it was triggered before this last bout of triggers, I think it triggered most recently in December of last year. And here we have one of the strongest starts of the new year. So no indicator, of course, is perfect all the time. So pointing out that it's had a failure isn't in and of itself a reason not to pay any attention. But there have been so many failures of it over the years that I don't think it's tracker or prediction about a bear market is any better than you would if you simply flip the coin. And then you add on top of that, the concerns just theoretically, as Norm Fosback told me a several years ago, is that when you start adding it sort of in an ad hoc fashion, all these indicators on top of each other to try to retroactively fit the historical record, then you really are just engaging in data mining and are not involved in a very serious enterprise of trying to predict the future. All right, Mark Holbert, we appreciate you breaking all this down for us. Thanks for joining us. It's my pleasure. Thank you. All right, I'm Scott Gam and you're watching The Street.


Welcome to the English translation of why the Corten is not a medical product by Phil, live from the 336 KS Communication Congress in Leipzig. Your trendset is for this talk, Alutik and... Duckman. Thanks for allowing me to present something here, to give a talk here, or to say something about my person. I was announced as Phil, that's right. I've worked for over 10 years in the medical industry production, and I can understand if it is not very interesting for everyone, but I like it. I will bring a lot of examples. It means laws are very precise, and this will be a bit diluted with examples. Some things are extremely simplified, because I don't have enough time, don't take everything word by word, but just as in first approximation. More is not possible here due to the time. So first question, it's around who knows what cardio is, who has the one? Okay. Good. Ben, I'll briefly explain something about the hardware. The cardio, I still have a picture from the homepage. It is the standard organizations would say wearable, so you can wear it at your worst. You can use it at home, and mostly it has a lot of diodes, blinks, a rotation motor, so at the first glance it's not a medical product. What you can see at the picture is large metal pieces where you can measure ECGs, where it's the first point where it kind of looks like a medical product. So that's the first step where everyone has to go through. Your product is a medical device, is regulated via the European regulation and the medical device regulation, which is valid in a lot of the European Union. I want you to read the article two of the medical device is what you can see here. So it's a medical device or software that according to the producer has one or several of the following medical and purposes. The important purposes are for the ECG is that it has a purpose of diagnosis or surveillance or something similar. So it could be that similar sensors are in a different product, which where the producer says that the manufacturer says that it is not a medical device, for example in smartphones, and then the manufacturer has to look for what has to be done. So that answers the question how it is with the card here, you're great. So the purpose of the manufacturer regulates exactly this. So the purpose has to be in the manual, maybe you can find it on the web page, you can have an ECG here, nice, that's something which looks like it. And then there's like a long text which describes how you can do something with the data from the ECG. I did this, looked like this, and what's the purpose? I didn't find anything which was supposed to be for indication, nothing for measurements of ECGs, I don't know which diseases are supposed to be diagnosed or surveilled, I know anything about users or patients so it doesn't have a purpose, official purpose so it's not a medical device, that's my judgment. So let's look further. We could play the game and make part of the cardio to a medical device, easiest thing would be to make the program which shows the ECG to a medical device, medical device needed purpose and this could be the start of the purpose, so the ECG app, so piece of software is made into a medical device by describing how it works, what you can do with it, what is a medical reason for using it, in this case if there is a regular sinus rhythm, a sinusism, or if there is an atrial fibrelation present, this should be possible with the cardio, I have two electrodes, so medically speaking I have a cross section through the heart so I can illustrate, larger ECG has several electrodes which correspond to different cross sections, this is not possible with the cardio, second point is where is it supposed to be applied, so describing the environment, next point is who is supposed to use it and who is not supposed to use it, that's what this has to be answered by medical professionals and this is how you could write an official purpose for the ECG app, so to summarize function and indication, the patient group and the contraindication, this is an official purpose of the parts you need, so we have no purpose, so what next, so according to the purpose we can classify as a product according to a law, the classification rules are in the law, I always try to write down which article or annex has the rules, I'll show you now, the classifications are as follows, from a technical point of view it's not invasive so it's not this, it's not an invasive product, there are special rules but it is an active product and so rule 10 applies in this case, which is called diagnosis and surveillance, I want to show as an example the rule 10, so products of rule 10 are products of class 2, so then there are additional things which are applicable but not very interesting for the cardio and the red part here is an important part, control of vital body functions and if you are part of this category then you are class 2b which would apply to the cardio, so that's my opinion, now we have a purpose, now we have a classification and how to proceed, the classification determines how you can bring it into the market, the higher the classification the more you have to do, for example products of class 1, there's no risk, you don't have to do much like Band-Aid is class 1, every thermometer is a class 1 product, class 2a is more interesting, where's the risk in applications, for example dental implants, devices happening here, class 2b, a bit more can happen, where the products are more invasive, for example dialysis devices, endoscopes, condoms, perception and then class 3, that's a real thing that's implemented, it's hard, that's hard catheters, pacemakers, ADs with a significant risk that far exceeds class 2b, so we classify these and what do we have to do with this and I'm going to shine a light on what's supposed to happen here from left to right, so for every products we have to have a quality management system, products of class 1 can do it an easier way, but basically every single product has to have this, another thing every product has to have is technical documentation, in which you record what happened during development, every little thing, next step is not co-writing, the audit by a designated person, you don't have to do that for class 1, but you have to do that for all other classes, that designated person does not assume any risk, but this ensures that a neutral party is involved, for class 3 products there is a special product testing, there of course the ones with the highest risk, then there is the CE certificate and they basically tell you yes your product conforms to the CE regulations so you are allowed to put the logo on it, in the next step a unique device identifier needs to be attached to the product, it has to be registered, it has to be both on the product and on the packaging, last step is not co-writing again, last step is upkeep of this whole quality management system and all the processes, okay let's have a look at this example what you have to do for class 2 product, so a quality management system is required by law and industry has determined that the letter of the law is a bit difficult and can be interpreted, so that's not always that easy, so audits are expensive, so what happened? Norms, standards, standards have many good sites, there is less room for interpretation, they are a lot clearer than a law, they are internationally recognized, so if I go into one country I can use the same norm piece of paper in the next country and that overall makes for an easier audit which means cheaper, hence almost everyone uses the standard, then there's the expectation of standards, it's in the agreement and if I conform to certain parts of certain war norms I also conform to certain parts of some laws so it doesn't have to be checked for conformity with law, that's just automatic, I actually don't remember this slide that much, so a quick explanation what categories of standards are there, there's three main categories, there's general, that's often process standards, then there are standards for electronic technology and telecommunications, electronic technology means everything with a plug, telecommunications means everything that has a radio, in Germany there's three organizations that do this, that's the dean for general stuff, Dean Afia is a standard paper size and then there's DKE, VDE and Dean for the other two categories, Europe we have Ser, who do the general norms and electrical stuff and then we have Etsy for all the radio and telecom standards, internationally we have the ISO which does most of the process norms, the IEC which does the technical stuff and the ITU which works on worldwide telecom standards and let's take a look back to where we stopped, we stopped at the QM system, here's our first achievement, we have the ISO 3485 QM systems, so this is the first standard that is relevant for our medical product, roughly it looks like this, it's highly impressive, it's very large actually and the significant part of this is the business standards, you have your quality policy, you have to have a quality management handbook, there has to be an overview of the company, of the process in the company, what processes do you have, it's a top-down look, in the standard it says that the highest executive of the company has to have this as their job, the employees are not allowed to do this, it has to be the leadership of the company itself and this is subdivided and subdivided into smaller aspects and it goes down to various other documents, it can basically be everything, it's a hierarchical top-down system, in the QM systems a lot of things are very well defined so please look impressed, this is the sort of thing you find in a QM system, they basically want a process for every possible eventuality, if you want to do this yourself, don't be too impressed, the hot topic is risk-based, we looked at the most important things, did our assessments and now we're starting what's very critical, the designated persons know this, they have their guidance for it that they have to obey for the audits, you can get better bit by bit and there's development, the next standard is ISO 14971, it's a standard for risk management so I'll have to have a quick look or rather explain what kind of steps there are that you have to perform, the first step is what did I write down the edge cases, you have to determine what are the functions of the device, what risks are derived from these functions, though the standard says threats, threats are defined as a potential source of damage and these threats you have to, from the ones that can happen you can have go to risk situation, so the lamp at the ceiling can fall down but as long it's a hazard but as long as no one's underneath it, it's not a hazardous situation, only if people are close to it there is a hazardous situation, from this situation you have to go to risk, risk is defined to be the combination of probability of a hazardous situation happening and the resulting damage, these two values you can write down on a matrix and determine parts which are where you say it's completely unacceptable and other parts where you say it's why it's not acceptable but we'll leave it for now because the use of the product, the advantages of the product are more important and that's what's written down here, next step is the risk evaluation, where you say I've identified my risks, I moved from hazards to risk, I have my graph, how many risks do I have that are acceptable or unacceptable, this whole process is a risk evaluation, next step is risk control, where you want to have functions which reduce the risks, first one is modifying the design, where you change the product in such a way that it is not technically possible for the risk to occur for the ECG that's not really possible, it's a product something that creates a lot of heat, you can maybe change it, where you take induction instead of gas to reduce the risk of someone burning their finger, if that doesn't work you have to implement protections where you can move the probability but the risk still is there, the third possibility is to inform people or school people and at the end of risk control and more is not possible, next step is risk acceptance, you sum up all the risk and look at after minimizing the risk, is it acceptable, this is also the case, you write it down in the risk report and in the last step the last step, did what you write down work out or did you totally estimate something wrong or other new risks and this is also part of the process, next nor a standard that is applicable as i.e. 82 304 about health software, so let's look into this, the standards are from a time where no one could imagine that software is an independent medical device, basically all standards were written by people who were very much focused on hardware and mechanics so you will see a lot of V models or waterfall models and that's also how this norm starts, this is a lid because you forgot to classify software as a medical device, so now you say you've done everything for software, nice but don't ignore the whole environment where the software will live and so you have the system requirements then next step is the life cycle and determined in the ic 62 304 then you have to verify the system requirement and on top of that you have the validation and there these are two terms which have to be differentiated, verification is objective tests that certain steps are objectively verifiable, so for example you can put a ruler next to it and you say yeah that's inside the error tolerance and validation is defined that specified users, a specified product in this specified environment can use, people can use this product so you can very verify the product but people can't work with it because it's for example if it's too dark and people can't see anything that's here the standard adds a validation on top of the verification, additional you have some byproducts like some files which have to be created which comes in via the hardware products like the manual for the hardware or other stuff and there's also a last step where you have to keep up with and we have the next standard that we mentioned already is ic 62 304 that's pure software norm as standard it was developed in a time when people thought that software is always part of a medical software product but then there were medical products whose software was so bad that their own standard had to be invented a good example is the therac 25 a radiotherapy machine which didn't quite work and literally burned the patients on the table so much radiation was dumped into the body that the people ran away screaming and that's how this standard happened and standard starts at the beginning and says so you want to develop software okay but you have to plan it you can't just start developing but you have to think about what you want to do this starts with the software standards goes you have an architecture implementation verification the standard says plan all this in the beginning how the integration is supposed to happen and don't just start coding the next thing is the expectations at the software how do they have to look what do you have in their software architecture and the standard says i identifies or it identifies software systems so everything that has its own processor is on cpu dsp fpga is a software system you have to identify those break your software architecture down into a detailed design here software items and software units are mentioned so a software system breaks down into software items and software items break down into software units and that's the end of it the exact change in the definition between software item and unit is that with a software item the person making it says i can't take this apart any further if you go all the way down you end up an assembler you can do that but most manufacturers say yeah this library it's made of a lot of stuff and you can't really take it apart so they have the freedom to basically do what they think is right at this level the whole thing has to be implemented and the standard says you have to obey these things first you have to verify your design then you have to integrate your architecture just like you planned in the beginning then you have to verify the expectations and then the software is released here too we have certain things that are general that have to be done at every level then there's a software repair or patching so it says you have something on the market but what do you do when something doesn't work like it's supposed to there's software configuration which means what deliverables or what tools are you using is there a verging system is git happening is there's a branching workflow all this is defined here do you have an integration server if yes what do you do with it how do you update it how do you manage that all this has to be done and these processes are exactly for that then there's the process for solving problems in your software so what has to happen to change to changes what steps do those changes have to go through so let's have a look should actually ah yes nice and there's the next standard ic 6236x that's the one about as they say in german gebrauchstauglichkeit in english it's usability usability subdivides into in multiple parts the core thing is you can't sprinkle usability on top at the end but you have to keep the concept of mind from the beginning so there's a development process for this that starts in the beginning and at the end you have to evaluate it the standard talks about formative and summative formative is what you what happens during development and summative is what happens at the end then here too you have to look at the purpose so define the users define the environment what can be done with this thing how does this thing work so everything every single norm involves these factors in some way they at least have to be described then usability has to be specified in the simplest possible case this is more or less a style guide that says our product is constructed like this this is how you operate it we use this and that design this arrangement these design patterns and these have to then again be verified so best case i can use automated checks do these elements exist where they're supposed to be where we define they would be at the beginning or do the menus change like the design guide says they're supposed to just like everything has to be verified it has to be validated so i have to get real users and check if they can actually work with this stuff ideally during development so then we have iso 15223 this is about symbols and such this is one of the cheapest this is not an error just a thousand bucks the standard itself is a lot cheaper again but you just have to know where the symbols are supposed to go the nice thing about this one is that it is only for medical tech but the iso is so nice that the symbols in general can be viewed at their home page so you go to the iso page don't look for medtech but look for iso 7000 and then you can move through the iso home page and at the end you're going to land at the or the preview symbols which can be used here and you can click on them you'll get them in big you got them digital and you can just put them in the documents where they need to go that's actually kind of neat at the end i'd like to say that the purpose or the definition of purpose is the important bit of text a lot of stuff is determined here if you don't start with this keystone properly at the beginning you're gonna have immense problems as soon as external audits happen so in my case i said yeah cardio yeah nice awesome but it's just the software on the device if it was the whole thing then the whole hardware would be a medical product and we'd be in a whole another area we'd have to have the 6061 one standard and a lot of other regulations so reach rose vmv that's electro electromagnetic compatibility bio compatibility radio norms shake tests so yeah if you can avoid this that's a good thing and it's good thing for the maker of the product too exactly how it is represented development models because a lot of manufacturers are hardware manufacturers they only know this v model which is one of the most established models in the medical manufacture for me from a medical manufacturers there are a lot of companies who do this what turned out to be is that you still require usability but as soon as you have those you say we have our crumb project a process we are in a regular grid we are in a regulated market we can say that at the end of every spring there have to be concrete documents and during the process i can take documents from from the folder and can do design your verification and go up step by step and in an agile process i can go go through many these and that's what's happening usually in the industry and a lot of different things i also haven't seen a lot of different things things there that's what i just know the model is very important people don't know anything different what doesn't exist yet our standards for security and safety there are guidances the bsi is part of the standard of the committees of creating the standards it's a funny thing if i'm if i'm part of this i'm i'm called young because i reduce the average the the age average by 25 years um so they just don't think about the topics like this um there will probably be new two or three new standards less next year but at the moment there's nothing and the manufacturers don't really care about that now much at the moment the manufacturers and the the users uh fired a lot um manufacturers say oh yeah you have these great devices can a lot of do can do a lot of fancy thing in the networks and say to the user the the user has to take care of other security because the manufacturer said that's not my department we will not take care of that um we'll see how that turns out now we are done with the development so now is the noted body um comes in and does the audit first they want to see the documentation um depending how much they want to see depends on the classification next thing is the audit of the 13485 way and if you pass you get a certificate and then there's another certificate which by law allows you to put certain things on the market and you then declare the conformity that's very important in the EU there is no um there is no admission by the state um in in the US you go to the FDA and they admit your product or approve your product in Europe you do this yourself um this is written in the mdr nx4 um in nx1 it says um in nx4 it says do all this stuff written in nx1 which is like basic security um demands um in nx2 is technical documentation and in third step is surveillance of putting the process of putting on the market um a lot of manufacturers already have this but now it's also written in law then we can explain the conformity with a conformity explication which has to be a formal document with specific things in them what's the company where do you find it you have to have unique numbers with you have to name the product uniquely you have to have the risk class the noted body for products from the class to a to b and three and last thing is a date and this has to be signed so that's one of the few documents where you really have a formal uh heavily process if this is done that's great um then nx5 you get a c e um certificate which is exactly what it means uh means that you have declared to conformity that it is safe according to the noted body and the manufacturer and underneath you have the number of the noted body in this case zero one two three depending on where you go you might have a different number there so next step you have to register the udi is a unique device identifier this has to be not only on the product but also on the fabric um to to talk about this um which um which costs too much time but i want to talk about this very briefly there are two parts the udi di and the udi pi the di is static static part which identifies the device the the company this is a part that is more less static and then there's a second part which is dynamic um when was produced the lot number um until when is it usable um so this number depends on how much you want to put on the market or how much you how much you want to produce if you register the udi you manage to complete the development process and can go to the last step um the next step is chapter seven um surveillance and vigilance and these sort of topics upkeep means you have to renew the certificates they all come with the best buy date and i believe even the declaration of conformity has one and uh well let's have a look uh yeah it worked so you have to have continual uh audits uh the audits may be surprise audits uh you can as a maker of the device you can audit your the people you buy the parts from uh and you can be audited yourself there's a video from a french company that is both in the role of a device manufacturer and a component manufacturer they had about 20 audits in a year and uh well a noted body had a look at us the makers who we develop parts for okay and we basically just use the same piece of paper over and over these audits are a highly formal process and well usually you have a so-called front room backroom setting which means that there is one room where you go with the auditor and the auditor never leaves this room if the auditor wants to see something he asks what's the purpose of this thing and then just sort of digs through the paperwork backroom listens via skype or any other form of audio and will on demand if it's a paper based system literally stand next to the printer make copies that are marked as such and bring them to the front room and say here my dear auditor you wanted this let's see if you like it in digital systems this is a lot simpler but this is a typical setting and that you sort of disconnect these areas okay so these processes belong to the quality management system so you need one for market surveillance for product changes and for continuous improvement or for kappas corrective and preventive actions and yeah with that i'm actually done that was one whole product development and upkeep in very rough steps i got a podcast if there are any questions thank you so we have time for questions we have three microphones number one two and three please just go to one of them if you have questions and i'll point at you we haven't got anything from the internet yet something may be coming but microphone two hello with many slides you can replace the head a heading medical technology with automotive or aerospace technology it's basically the same the only way the standards are different is by the number but it's basically the same talk quality management risk management and so on is there something in medtech that deviates significantly from critical systems in other areas from the requirements not really every regulated part has certain things that have to be regulated what's special about medical devices is like appliance always kind of similarly constructed to for medical devices for the process this has to be has to work from and band aid up to devices implemented in your heart and representing this complexity is very difficult because no producer really finds himself or represented and that's a difficult part in for medical devices but the requirements are the same for all regulated areas okay just a short comment the whole thing about software that's sort of tacked on at the end as an afterthought and how the standards were written based on hardware it's their way in every area i know this is from aerospace technology where you rather change five hardware devices before you touch the software it's not that bad in medical for medical devices okay mic one please hey thank you um this all sounds quite complicated and for me the question emerges that what is the standard and what actually forces me to treat my device as a medical product where's the law where's the initiative that makes me not say yeah i'll just forget the certification it's too complicated the pragmatic answer to this question is if there are companies which compete with you they will sue you and what happened then that it will be come in front of court and then the the um someone appointed by the judge will do the the job and if it is obvious if it's if it's obvious um for some devices you can um if you it's supposed to be applied to a heart for a patient which is alive you can't really argue about it um you really should think about if um that you really don't aren't part of this classification otherwise you get the purpose report um really have to read the report um but uh i mentioned earlier where's the differential what's written what's different from pharmacology and okay mic two i have a small smartwatch here that has an ecg but in europe it's deactivated like from many other manufacturers we've just seen a well-defined process for doing this so why don't big companies like samsung or apple why aren't they able to do this sort of thing the apple watch is a great example it is at the moment in europe um a medical device not even the apple watch but they did the same trick they have they declared two apps as medical device one is the ecg app which has more or less the same purpose as we saw here and the other thing it is the app i think it was um detection if you if you fall um and those two things are medical devices and not more and for these two things you can find a purpose declaration and you can find the ce symbol and if you look at this you will see exactly what we saw here with number zero one two three where the tooth suit was part of the conformity um process meaning that it is at least plus two a product um and with the whole but it was a whole hardware apple set itself it does make sense the hardware so the main goal of the of the apple watch is not medical device everyone supposed to to develop for the apple watch they can't and don't want to control it and and so they said for these two parts we keep our our independence and only for these two things we have medical device status okay i was interested in why the hell this takes so long the apple watch took months to get certified that's right in this case apple is a u.s company they made the first application at the fda they knew exactly what they had to do and fda is a government organization was strict processes and it is easier to predict predict when they get the clearance from fda you have in europe you don't have this clear process you only have the guidelines and along which you can orient yourself the tooth suit can say oh well that's what the fda said but we have another standard here we find applicable so you have to you have to give us documents that you fulfill this and then apple has to live and the fda is not that much standard driven it's law driven and that's why i think apple it took longer for apple because they went look at the problem from a different mind that because they are american okay let's switch over to the internet yeah short question from the internet uh how much do those independent audience audits by uh name party cost it's like this and the producer looks for a noted body like for example europe a noted body from europe and they pay money to this body and this body performs the audits that's kind of an interest of conflict but the noted bodies um are very loudly saying that we get the money from the company but we can prove on paper that we follow the procedures and didn't just let any shit get through and there was some critique of some noted body but they were able to show that they showed that they did everything they possibly could but they can't but that they can't protect themselves against crimes okay mic one uh so uh in developing medical products a lot of documentation is generated is there any way for the patient or for the user of the document of the medical products to get their hands on this technical documentation no it's not possible we are at the moment at the moment so our changing at the moment we have an odd law the mdd which is still valid until may next year and afterwards the mdr is valid and afterwards there is a european database which is not completely public but partially at least um but the company say that's our business secret um that's the core of our company we can't just make this public the law says that certain things has to be in the manual that certain things have to be noted the uda or the certificates that's legislate um that has to be on the product but not the documentation um you could try to write a frame of information egg at the fda to get the documents but the fda will say if you do this once no one will ever come back to us um so no it's not possible to get the documents but only the the documents um for the users okay mic two yeah thanks for the talk and i've seen it very often that very small companies do algorithms to ctr mri images generate new images from that analyze them and say oh we're not a medical product we're just doing this for scientific purposes and then we're if you dear doctor use this data clinically then you're doing it for yourself because you're making the decision with the data you received from us is that legitimate in any way shape or form is this doable for small open source parks that want to do things with images that's gray area the manufacturer says this is only for clinical research this is only to test something and then you use it for something else the manufacturer will say the user is responsible if it's happening in a larger context the noted body or or a government organization will step in and stop it and then we'll go in front of court and then someone um appointed by the the court will write documentation another thing is that there is also software for example radiology um where this doesn't happen anymore um if a manufacturer just goes there and says you ever radiating um device and then takes the software from a small company and then looks where it has to shoot through the body that's not going to happen and with other cases uh possible but it's the question if that's happening though let's go over to number one uh yeah my question shorter follows this one how is standard adherence actually enforced so if doctors use the cardio on patients to surveil something or flower power enterprise some products whatever um use that stuff because it's cheaper who would realize this when how and where and what would be done about it i mean you can't do anything about it if someone uses the cardio like a medical product what can be done about this and who would get hit easiest way is to go by the farm that's uh um organization government organization germany responsible for a medical product where you can um complain and they'll take care of it and of course from time to time they have a lot of to do but that's the first um organization you have to contract so who would actually get punished a doctor uses cardio as a medical product without it actually being one will someone decide that cardio actually is a medical device and cardio whatever problem or would the doc have a problem um that's what a assessor has to um determine that's what comes out in front of court um if it's not a medical product and can't and detect and diagnose any illnesses which is according to my opinion true at the moment then the manufacturer will be liable because they used something the product which is not doesn't have the the um the the purpose um the device says you exactly when happens what um in this case the manufacturer is also um reliable but this doesn't happen for the cardio this all depends on the purpose of the device so you have to kind of guess what will be written in the report by an assessor got anything from the internet no well okay then we'll do mic one please hello if i understood it correctly then apple said that the apple watch is primarily not a medical device um it has other purposes than measuring vital parameters i don't know the product cardio personally but does the hardware have any other purpose except medical ish things oh okay so how did you get out of that bind because just from this talk it sounds like the thing is primarily for medical purposes okay i highlighted the medical part because that's where i'm expert in um the cardio on itself can apart from a thousand other things also create an ecg but can only visualize it not very well as schneider i'm sorry the thing can or should be used for much more than the ecg um where i'd say that people are supposed to write software it should be accessible should somehow connect with other cardio's and you should be you should write um create fancy things for the display you should um write the settings if you want to talk with other people or or not um it has to blink and that's where i start where i'd say the ecg is also part of it but it's also it's also just a toy it's not what the cardio is um supposed to be well i believe from the talk there it was only usable for this one thing but yeah that's a good answer thank you and we're going to continue with mic one good evening i have two smaller questions first one is uh could it happen that's something like google scholar pod med that docs use uh every day uh to make decisions about their patients could it be that that is a medical product by law and secondly the uh the difference between uh cat 2b and category three is a uh life threatening or very dangerous decision in software at least it looks like that to me in medicine it looks like patients can easily develop allergies to everyday medications penicillin for example and could die from those so how how is it that with that even banalities can have devastating effects in medicine and how that a small tiny product should essentially be built to the same standards as a robot who operates on my heart second question i can answer rather easily this has to do with the classification rules i only presented the rule 10 and for this product for each product you have you need to know the function the purpose and then you can go through the rules and they're just explained exactly if you have a product which has specific features if it has a specific invisibility uh then you land in specific categories other to show other rules here it would be very hard so it's kind of difficult um for the first question we have to meet uh in private um yeah we're talking about google or pub matter up to date um i don't really know what they do so i can't say much about it i'm sorry okay we're out of time and no more problems so thank you very much thank you


Item No. SCP-559 Object Class Euclid Special Containment Procedures SCP-559 is to be stored appropriately for any object it is taken to form of, with it as Secure Safe containing three other baked items inaccessible to those below Level 3 Security Clearance. Usage of SCP-559 is only to be done under the supervision of Level 4 or higher personnel with prior approval. Description As of the time of writing, SCP-559 is a round-vanilla birthday cake, however its powers have been observed to exist in other baked items like rolls, puffs, or cupcakes. Whichever item SCP-559 has subverted as manner is easily identified by the word's birthday time, marked out in green icing. Materials testing has returned its icing to be regular green icing with no unusual traits. When lit candles are placed into SCP-559, they cannot be extinguished by any means by someone who is not celebrating their birthday. However, they can be put out by people whose birthday falls on that day, termed birthdayers for convenience, upon which the subject will have their age changed to the equivalent of the number of candles in SCP-559. This effect lasts for 24 hours before the subject reverts to their original age. Testing has revealed several other properties. SCP-559 seems to regard anything burning as a candle, regardless of its size or orientation. Such sticks, fireworks, and even high explosives have been used, and when stuck into SCP-559, all were easily blown out by birthdayers. Tests have been conducted with a number of candles from 1 to over 900. Such a high age surprisingly brings about no directly related health problems, and the effects of existing health conditions, weak heart, asthma, etc., are reduced when aged in this manner. In fact, 87% of those who were aged to above 500 years old survived the full 24 hours, although were physically weakened and their age state is expected. When the 24 hours are up, the subject will mainly reverts to the original age, within a span of 20 microseconds, and retains full memory of the period where the age was altered. If SCP-559 is used in the above manner, or if a slice is cut from it, its current host item will lose its unique properties in green icing, and the nearest intact baked item will gain them instead. It has been observed that travel in this fashion over 25 km of sea, and this property just led to difficulties during location and retrieval of the object. Retrieval Log An item containing SCP-559 emerged from a bakery in ██████. It was bought by a family, and when used to celebrate an 82-year-old's birthday, 8 big candles and 2 small candles were placed on the cake. The act of blowing out the candles transformed the birthdayer into a 10-year-old, and the alarmed family contacted 9-1-1 as the first instinct. Routine monitoring of the 9-1-1 call centers alerted the Foundation to SCP-559's presence, and after making suitable negotiations with the family for secrecy, the spent cake was secured. However, after testing was done, it was realized that SCP-559 was still in the public domain, and this sparked a hunt for all baked goods similar to the original cake. It was eventually located after it took on the form of a puff pastry, the green icing betraying its unnatural properties and has since been secured. Addendum 559-01 Although we appreciate test subjects attempting to gather data for us, seeing as birthdays are only once a year, I would like to remind everyone that there should always be at least one fail-safe baked item nearby that contained 559 after usage. Recently, there was one usage that would have had no backup item. Fortunately, the staff canteen was serving cupcakes that day. Consider yourselves warned. Dr. Redge Dr. Redge Dr. Redge Dr. Redge Dr. Redge Dr. Redge