BMW C 650 Latest Updates
The BMW C650 is a mark of the exquisite with its new updates. The bike now comes with a more dynamic design that is detailed, keeping the futuristic approach in mind. The bike has been revamped across its body and showcases a new exhaust that adds to its dynamic appearance besides its new instrument dial design. Available across two variants in the Philippines, the C 650 is available in a Sport and GT trim. As the name suggests, the Sport variant picks up on a sporty appearance while the GT is engineered for touring. The lineup is powered by a liquid-cooled parallel engine, generating a healthy 58 hp of power besides 63 Nm of peak torque.
BMW C 650 Pros & Cons
Get the better insights of BMW C 650, Read our expert opinion and helps to buy or not
Things We Like in BMW C 650
Great road presence
Comfortable ride quality
Things We Don't Like in BMW C 650
Design starting to show its age
Too big to maneuver for amateur riders
BMW C 650 Colors and Images
BMW C 650 Review
BMW C 650 Overview
The flagship scooter from BMW Motorrad, the C 650, is a globally acclaimed maxi-scooter, popularly known for its excellent touring credentials and massive road presence it offers. In the Philippines, the BMW C 650 is available in the global-spec form and is being offered in three different paint shades – Ocean Blue Matt, Black Storm, and Light White.
BMW C 650 Design
The BMW C 650 has got a tremendous road presence – there are no two ways about it. However, the original design of it is in existence in the global market for quite some time now, which is reflecting on its appeal. In front of other contemporary scooters in the same price range, the BMW C 650 looks slightly old, with a couple of crucial modern-day features missing from it.
The BMW C 650 looks quite bulky when viewed head-on, with a massive dual headlamp setup mounted just in the center of the front apron. The headlamp misses out on LED treatment as well as daytime running LEDs, which make it look a bit old school in appearance. The apron of the BMW C 650 has wide side extension panels as well as lower side panels. At the top of the headlamps, the fairing of the scooter has got a huge fully adjustable and transparent windscreen mounted on it. The fairing mounted rear view mirrors are electrically adjustable and also come integrated with LED turn indicators in them.
The side profile of the BMW C 650 looks quite muscular, with the overall design having a slightly curvy approach to it. Just like in any other conventional maxi-scooter, the BMW C 650 gets a split floorboard theme, with wide foot spaces and underbody panels working together to give it a beefy appeal. The rear side body panels with their rounded design as well as the large stepped seat further accentuate its gargantuan appeal even more.
The rear side body panels of the BMW C 650 GT work in making the rear profile of the scooter look really appealing and massive. The split pillion grab rails mounted at the back of the pillion seat look huge and along with the large LED tail lamp cluster, make it look muscular here as well. There is a twin-port exhaust system mounted on the right side of the scooter, which shows its sporty side too.
The instrument console, with its part digital theme and analog tachometer, looks purposeful but a bit old school in today’s day and age. The clip-on handlebars as well as huge under-seat storage space make the BMW C 650 GT a very practical scooter to live with.
BMW C 650 Ride & Handling
The BMW C 650 GT is highly regarded for its touring credentials, the majority of the credits for which goes to the great and comfortable suspension setup – 40mm upside-down hydraulic telescopic forks at the front and a single-sided swingarm at the back. The maxi-scooter is equipped with a good braking setup too – 270mm dual discs at the front and a single 270mm disc at the rear.
BMW C 650 Engine & Fuel Consumption
Powering the BMW C 650 is a large four-stroke, inline twin, water-cooled, fuel-injected, 647cc engine, which is one of the largest engines for a production-spec scooter in the world. Mated to a V-belt automatic gearbox, the engine belts out a maximum power output of 60 PS and a maximum torque output of 63 Nm.
BMW C 650 Braking & Safety
The BMW C 650 gets quite an impressive list of safety features for a scooter, the major inclusions of which are a dual-channel ABS, hazard lights, integrated ignition and steering lock, electronic immobilizer, electronic stability control, and side-view assist.
BMW C 650 Verdict
The BMW C 650, with its gargantuan appeal, is alone enough to create a strong impression of a great mile muncher, something which is helped by a very comfortable ride quality and ergonomic setup. While it misses some of the modern-day cool features, it still feels premium for the impeccable fit and finishes as well as top quality parts being used.
BMW C 650 ReviewsBMW C 650 Reviews
A maxi-scooter with unmatched taste
In my opinion, the BMW C650 is indeed a scooter with an unmatched taste. The scooter is designed to provide the user’s convenienc...
melvin Saturday Nov 21, 2020 07:11:58
Hyper cruiser scooter like never before
BMW is off to a fine presence in the Philippines market. I did not think I would say this but scooters with high capacity engines...
Ejay Monday Oct 19, 2020 15:40:45


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Second Official Teaser of Lady GaGa's 'Alejandro' Music Video
Another sneak peek to Lady GaGa's highly-anticipated music video for her single "Alejandro" is put out. It contains similar scenes, featured on the first teaser which was revealed on "Larry King Live", with new additional footage intercepted in between.
Directed by Steven Klein, the music video has "homoerotic military theme" and is going to be premiered on June 7. GaGa told Larry King earlier this week, "It is a celebration of my love and appreciation for the gay community, my admiration of their bravery, their love for one another and their courage in their relationships."
In further statement, she explained, "I can speak for myself in that my admiration comes from an incredibly steadfast and joyful courage and bravery they have for one another and their community. To be gay and live openly in this society requires tremendous strength. ... I admire it and envy it in some ways. It's something that, as a woman, I don't always wholeheartedly possess."
More Lady GaGa News
- Pixar's Video Reveals Mind-Blowing Hidden Easter Eggs Throughout Their Movies
- Olivia Munn Reportedly Causes a Rift in Aaron Rodgers' Family
- Watch Fifth Harmony and Blake Shelton's Performances at 2017 People's Choice Awards
- Taryn Manning Is Not Leaving 'Orange Is the New Black', Despite Report
- Zayn Malik Shows Off New 'Love' Tattoo Amid Gigi Hadid Engagement Rumors
- Jennifer Lopez Spotted Cozying Up to Drake on Another Date
- Is Jared Leto Returning as Joker in New DC Movie?
- Listen to Big Sean's New Moody Track 'Halfway Off the Balcony'

domain: entertainment


text: The DStv Delicious International Food & Music Festival, a music festival for food lovers and the food festival for music lovers launched 7 years ago. They took the entertainment and culinary world by storm on its debut in Johannesburg in October 2013. Headlining the music was Jamiroquai supported by a host of top South African artists. UK celebrity chefs Aldo Zilli, Ed Baines, and John Burton Race displayed their signature dishes at their own pop-up restaurants. The last three iterations of the event were held at the revamped Kyalami Grand Prix circuit where 40 000 visitors indulged in the best food and music Johannesburg had to offer.

domain: artistic


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MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announced that Laurent Nguyen, Chief Executive Officer, is scheduled to present at the 18th Annual Rodman & Renshaw Global Investment Conference, being held on September 11-13, 2016 at The Lotte New York Palace Hotel in New York City.
Dr. Nguyen will provide an overview of the company’s upcoming clinical and operational plans during a live presentation. Details of the presentation are as follows:
Date: Monday, September 12, 2016
Time: 11:15 AM EST
Room: Louis (4th Floor)
Investors attending the conference who would like to schedule a one-on-one meeting with Sensorion’s management may do so by contacting their Rodman & Renshaw representatives, or Chris Nardo at The Ruth Group at firstname.lastname@example.org.
The presentation will also be webcast live. To access the webcast, please visit the Company’s website at www.sensorion.com. The webcast replay will remain available for 90 days following the live presentation.
Spun off from Inserm (the French institute of health and medical research) in 2009, Sensorion is a biotech company that specializes in the treatment of pathologies of the inner ear such as acute vertigo, tinnitus and hearing loss. The Company has substantial pharmaceutical R&D experience and a comprehensive technological platform for developing easy-to-take (notably orally) first-in-class drug candidates for treating hearing loss and the symptoms of vertigo or tinnitus, for preventing complications associated with progressive lesions in the inner ear and for preventing the toxicity of chemotherapy in the inner ear. Based in Montpellier, southern France, Sensorion receives financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative.
For more information: www.sensorion-pharma.com
ISIN code: FR0012596468

domain: medical


BONFIGLIOLI is introducing new ranges of planetary speed variators for control of industrial power transmissions in rugged environments and where maximum durability and simple operation are required.
Bonfiglioli's VBG and VBA series of mechanical variators are suitable for variable speed applications such as pumping or mixing and in environments such as exposed weather, hazardous chemical and for very dusty or high humidity conditions.
To service these applications, Bonfiglioli's expanded range of mechanical variators offers stepless speed reductions down to 6.5:1, with the ratio simply altered by means of an externally mounted handle.
The Bonfiglioli VBG series of variators are of cast iron construction and include seven sizes ranging from 0.2 kW to 11 kW in capacity.
The VBA series, which offers three sizes in the 0.12 - 1.5kW power range, has aluminium housing and external fins that ensure effective heat dispersion during operation.
Features of both series include:
· Space-saving planetary gears and high-efficiency rolling races that are machined to very high tolerances so that smooth, quiet running is guaranteed.
· Gearing systems made from special steel that run submerged in lubricant, which means that wear is virtually non-existent.
· The ability to be used in applications where overloads are likely to occur.
· Availability in a broad range of designs, suiting any type of support.
Unlike many modern variable speed drives, the VB series is actually a torque increaser. This allows the system designer confidence in that the required torque will be delivered though the entire speed range.
Bonfiglioli also offers a differential style unit with the VBG range. This unit allows operation down to 0rpm whilst maintaining full torque and offers substantial savings when compared to closed loop ac or field wound dc drives.
An input adaptor is available to fit the mechanical variators to standard IEC motors of the B5 type.
All Bonfiglioli variators support a wide range of optional accessories, such as gravity speed indicators, servo controls, proximity sensors, digital scanners and encoders. These accessories further enhance the versatility of the variators and enable use in more applications. Bonfiglioli Transmission 02 8748 4400.


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Wilmington, Delaware: Textile Fibers Department Patent Division. E.I. Du Pont de Nemours & Company, 1952.
Softcover. First edition revised and enlarged from a manuscript prepared by Roy Soukup. Quarto. 205pp. Illustrated from photographs. Green pebble-grain cloth over flexible boards. Slight smudges on the cloth, else near fine. Combination history and yearbook, with photographs of the various employees. *OCLC* locates three copies.

domain: library


text:
You know when you think you've come up with a truly great idea? An idea no one else in the world has ever had. Like when I was about 8 and my sister and I started putting honey on cheddar cheese. We thought we were the first people ever to have come up with that idea. (It was quite a shock to me when I first saw honey served on a cheese and charcuterie plate, seriously)
I feel a little like that today. I thought I was the first person on the planet to come up with the idea to put pesto on their popcorn. Pesto plus popcorn, I mean, it does seem a little strange, right?
Turns out that somebody beat me to that idea. A whole lot of people beat me to that idea. There are 1,350,000 different results for pesto popcorn on Google. If this were a race, I would have seriously lost.
Luckily it's not a race. And if you haven't already joined the pesto popcorn fan club, you should. Do you love pesto? Silly question, I know. Do you love popcorn? Another silly question, I know. Then you're going to love pesto popcorn.
It's nothing but cheesy, basil-y, popcorn-y goodness. Welcome to the club!
If you love this recipe as much as we do, let us know with a 5-star rating!
- 2 tablespoons cooking oil
- 1 cup popcorn kernels
- 2 tablespoons pesto
- 2 ounces grated parmesan cheese
- Sea salt, to taste
- Heat the oil in a pot over medium-high heat. Add the popcorn kernels so they cover the bottom of the pot in a single layer.2 tablespoons cooking oil, 1 cup popcorn kernels
- When the popcorn starts to pop, lift the pot just barely off of the element and shake it back and forth until the corn stops popping. Remove the pot from the heat and pour the popcorn into a large bowl.
- Toss the popcorn to coat with pesto and parmesan cheese. Season to taste with sea salt.2 tablespoons pesto, 2 ounces grated parmesan cheese, Sea salt

domain: food


text:
Contemporary art and literary criticism broadened from the high seriousness of Landfall from 1947 to 1971 or the opacity of the theoretically driven little magazines of the 1980s: AND and Antic (1986–90). Since the 1990s scholarly criticism of New Zealand art and literature has become securely established in universities. In the 2000s academics and critics, including Leonard Bell and Roger Blackley for visual arts, and Mark Williams, Jane Stafford, Alex Calder and Lydia Wevers for literature, paid new attention to the long-neglected colonial period. Beyond the universities Ian Wedde and Martin Edmond have continued to push the range of contemporary art and literary criticism.
The tradition of literary and artistic biography, exemplified by Anthony Alpers’ Life of Katherine Mansfield (1954) and E. H. McCormick’s work on painter Frances Hodgkins, led to a rich critical outpouring from the 1980s. Biographies of Frank Sargeson, Janet Frame, Colin McCahon, C. F. Goldie, Bill Pearson, R. A. K. Mason and Robin Hyde shaped the arguments about art and literary movements.
Historical and international comparisons
Terry Sturm’s Oxford history of New Zealand literature in English (first published in 1991, with a second edition in 1998) redressed the neglect of local literature in the universities. It allowed New Zealanders to see the full historical range and development of their literature, including the colonial period and popular writing.
Conversely, through the efforts of Petar Vuletic, Michael Dunn and Tony Green, the work of abstract New Zealand artists was, without embarrassment, examined in relation to their international influences.
At the centre
In an influential 1992 essay ‘Maori: at the centre, on the margins’, Rangihiroa Panoho acknowledged past cultural ‘borrowings’ by both Māori and Pākehā, but asserted ‘In the cultural sphere – the arts – it is now essential for Maori to resume control, re-establish boundaries for appropriation and move taha Maori (things Maori) back to the centre.’1
Māori perspectives have become influential in art criticism. Rangihiroa Panoho’s critique of Pākehā artists’ use and misuse of Māori motifs, ‘Maori: at the centre, on the margins’, (1992), ignited an appropriation debate that resonates still.
Art criticism in print
Notable for its longevity is the well-illustrated Art New Zealand (founded in 1976). Although rarely edgy or radical, it provides accessible insights into the art world, and it was there that critics such as William McAloon and Ed Hanfling cut their teeth.
Numerous lavishly illustrated guides to traditional and contemporary art are published, and there is a substantial market for intelligent critical and explanatory books on art, such as those by of Justin Paton, Gregory O’Brien and Damian Skinner. Exhibitions remain a key driver of publications and art criticism.
Online art criticism
At the beginning of the 2000s the internet became a significant medium for visual arts criticism, a space to voice opinions that did not otherwise find a place in ‘official’ channels. Artbash had its moment (albeit as much for venting and ranting as for considered criticism). John Hurrell's EyeContact, Natural Selection and The Lumière Reader provided forums for new and diverse writers to emerge. On The Lumière Reader in 2013 Thomasin Sleigh considered how the ‘stuttering conversation of art criticism in New Zealand’ should proceed, concluding that it might best do so by actively and critically continuing to disagree with itself.2


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VG Lacquer Stripe Placemat
Unexpected and decidedly modern, these placemats are a striking addition to the table. High gloss lacquer is paired with sleek curvilinear stripes and rendered in intriguing color combinations.
Dimensions: 18″ x 14″
Materials: Lacquer and surface-friendly rubber feet
Care Instructions: Wipe clean with a damp cloth

domain: design


Home Tags Netflix
Attention HGTV fans, especially those of us still missing “Million Dollar Decorators” (me!): Netflix just released Season 1 of “The World’s Most Extraordinary Homes.”That...
We’re expected snowmageddon this weekend (maybe) or at least a return to February. Perfect timing for a deep dive into the creative processes of eight visionary designers. The new eight-part documentary series, “Abstract: The Art of Design,” now streaming on Netflix, is good stuff.


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RPOA is classified into type 1 and type 2 in terms of the absence or presence of bony destruction [6, 7]. Karayiannis et al  described another classification system on the basis of the time interval and rate of bone loss (type 1, rapid; type 2, moderate; and type 3, delayed). The patterns of disease progression varied in our study. It is difficult to recognize transition from type 1 to type 2 RPOA due to the lack of clinical signs and proper serial imaging.
Our RPOA diagnostic criteria exclude hip dysplasia from the major components of criteria because dysplasia is difficult to be differentiated from RPOA at the early stage of chondrolysis and the late stage of bony destruction . Thus, our diagnostic criteria emphasize the importance to rule out dysplasia from the standard definitions . Our criteria include both initial imaging and progression assessments. When the hip is still grossly intact, a higher Tonnis angle and lower pelvic tilt parameter predict the development RPOA in the future and differentiate this condition from dysplasia  and osteonecrosis . It is in line with our results and the existing literature.
Subsequent imaging provides evidence to assess the rate of cartilage and bony destruction. In our study, new radiological findings were found and were in concordance with the proposed pathophysiology of bony destruction and supero-lateral wear. Changes in leg length discrepancy, acetabular volumetric widening, femoral head destruction, Tonnis angle and lateral subluxation progression, all demonstrated statistically significant differences between RPOA group and non-RPOA groups in our study. However, these parameters have not been described in the existing literature. Both superior bone loss and widening contribute to acetabular bone deficit, and femoral head destruction reduces autograft available for acetabular reconstruction.
Dysplastic hips showed a similar rate of length shortening, volumetric widening and head destruction. The two conditions can be distinguished clinically in light of younger-age onset, initial radiographic films showing a higher Tonnis angle of more than 10 degrees, and lower Wiberg angle of less than 25 degrees in the dysplastic group. In the AVN group, although early head destruction is common, the condition can present with head flattening and paradoxical joint widening, unlike RPOA, which manifests as early joint space obliteration.
Until now, the etiology of RPOA has not been well understood. The proposed mechanisms include idiopathic chondrolysis, subchondral-insufficiency fracture, labrum inversion or immunological reaction with activation of osteoclasts . Recently, some surgeons proposed that the abnormal anatomical and morphological factors might underlie rapid progressive antero-superior and supero-lateral wear , including increased Tonnis angle, Wiberg angle, acetabular extrusion index , and abnormal pelvic tilt . As opposed to decreased dysplasia parameters in elderly osteoarthritis , an abnormally high Tonnis angle may constitute a different mechanism, leading to rapidly progressive osteoarthritis. On the sagittal plane, pelvic tilt has also been proposed as a potential causative mechanistic factor . With an abnormal posterior pelvic tilt secondary to degenerative lumbar kyphosis, bone destruction commenced in the anterior portion of the femoral head in all type 2 patients . This consequence leads to wear in the antero-superior portion of the acetabulum, in coincidence with the description by Thompson et al  and Karayiannis et al . This finding has intraoperative significance, since a large antero-superior gap will be anticipated during acetabular reaming. The acquired deformity of Tonnis angle and lateral subluxation progression may further decrease hip conformity and containment, aggravating lateral edge wear and resulting in acetabular and head destruction. This may explain why the subsequent bony loss is usually rapidly progressive. Our postulation also explains the observation that bony destruction in RPOA is usually supero-lateral as well as supero-anterior .
Our study has limitations. First, the patients were recruited only in the Southeast Asian population, and the results may not be generalized to other populations. Second, the retrospective nature and small sample size might result in confounding bias. Third, the intervals of subsequent imaging and the waiting time to operation varied widely due to rapid clinical progression and the patient’s choice for operation. We couldn't obtain the images of different patients at exactly the same time intervals. Fourth, we only included the patients on the fast-track hip replacement list with complete imaging sequences, possibly resulting in selection bias. Fifth, most patients with RPOA underwent an operation early, but some OA patients may be put on further observation. This led to shorter follow-up duration in the former group. Sixth, the bony landmarks may be destructed due to RPOA, increasing measurement variations compared to non-RPOA conditions. Seventh, it might be difficult to measure the Wiberg angle due to gross head destruction and the loss of head center. Finally, volumetric acetabular width was only estimated based on 2-dimensional length instead of 3-dimensional volumetric measurement, which may not reflect the entire situation of acetabular erosion.

domain: literature


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Country superstar Tim McGraw is just one of the celebs performing in a special concert for military members and families on Veterans Day on Nov. 10.
"It’s not every day we put on a show for 15,000 servicemen and women!” Tim tells Closer of his upcoming Veterans Day salute to the troops. “We’ll probably have a different sense of pride that night because of those guys.”
And it's a must-see show! “We're definitely gonna have fun,” Tim adds about the concert on Jacksonville, Fla.'s U.S Naval Station Mayport, which can be seen Nov. 10 at 8:45 p.m. ET at timmcgraw.com. “They give so much for us.”
Tim is no stranger to supporting our veterans. Last year, he helped launch the HomeFront program, which has awarded more than 70 mortgage-free homes to wounded warriors. This year, he will present another one to a deserving recipient during the special show.
“Having family members in the military definitely inspires me to do what I can,” the singer, 46, reveals, tipping his hat to anyone brave enough to enlist .
“I’ve seen firsthand what it’s like for families when someone is away and making that sacrifice. The whole family makes a sacrifice, so the least we can do is help give them a safe, comfortable place to live when they need that upon returning.”

domain: news


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Preview of the short film “U.H.T” by Guillaume Senez
The preview of the short film U.H.T by Guillaume Senez will take place on june 1st at 20:00 at Rits in Brussels.
To be at the screening, send us an email at email@example.com.
Only few tickets available.
Please complete this application form to purchase your DVD.
Once your order received, we will contact you as soon as possible to treat it.


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David began writing music at the age of 9 and been writing ever since, producing music in many styles and different forms. David's music was described, by Chicago Lyric Opera singer Christine Steyer, as "immediately accessible, while maintaining immense depth, beautiful melodic writing, and incredible sophistication".
David has composed around 200 works in many different forms including sonatas, concerti, a symphony, an oratorio, several string quartets, dozens of songs, and many instrumental works.
Christopher John Campion is the frontman of the New York City alt-pop combo Knockout Drops and a singer-songwriter-raconteur known, most notably, for his rollicking off-Broadway music-monologue-multimedia piece, Escape From Bellevue and his critically acclaimed memoir that followed on Gotham/Penguin Books. In 2016 he released the full length solo album, Watch The Gap, touring and opening shows for M.Ward and Violent Femmes. His most recent records include; the solo EP Split Milk(October 2017) and the just released, Otto Otto, a batch of Campion penned songs made with the atomic and funky “Faces-esque” rock-n-roll band Mad Staggers. He is currently out playing area shows....


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This is not headline news anymore, yet it screams to be said over and over.
West Virginia can’t shoot the basketball.
They prove that game after game after game unless something freakish happens, like Kevin Noreen stepping outside and making the 3-point shots the guards can’t make.
This time they proved it against a team that really doesn’t have any business beating them, a Duquesne team that lost much of its talent and ran off its coach, a fellow we all know down West Virginia’s way named Ron Everhart.
Well, even Everhart knowing the Dukes, even teaming that with a Hall of Fame coach in Bob Huggins, doesn’t help if no one can put the ball in the basket, the Mountaineers scoring all of 20 second-half points in blowing a 15-point lead and losing, 60-56, their fourth loss in eight games.
Oh, yes, ahead on Saturday?
Just John Beilein’s undefeated and No. 3 ranked Michigan team.
Now there are any number of ways to look at what transpired here at the Consol Energy Center. You could say that WVU didn’t play defense in the second half, letting the Dukes hit 53.6 percent of their shots ... but that wouldn’t be right.
See, it was hard for them to miss as they were grabbing rebounds — outrebounding WVU, 54-39 — and running down the court on fast break, scoring 18 of their points off breaks.
What would be right though would be to point out that WVU shot 28.1 percent from the field in the second half, 33.3 percent for the game.
They shoot the way the WVU football team plays defense.
Jabarie Hinds has become the poster child for it, going 1 for 7 shooting this time and now having hit 22 of 65 shots for the season, just barely better than 33.3 percent ... which, no matter how you slice it, is unacceptable.
When breaking down the game, Coach Bob Huggins eventually arrived at one point.
“They made their shots. We didn’t,” he said.
It isn’t that they are trying. In fact, they might be trying too hard, but the more they miss, the more the opposition packs people inside around Deniz Kilicli and renders him useless, and there is only one way to fix that and that’s to make some jump shots.
“If not, they are just going to stand in there,” Huggins said.
Kilicli is tiring of it, in part because the way he is being played is making him look bad ... or is it the way he’s playing doing that?
It’s hard to tell, but Huggins did note that “we got a guy playing 33 minutes and he got one defensive rebound ... and he’s the biggest guy on the floor.”
Kilicli was the only one to fit that description.
“The last two games they have put everyone in the paint and they will keep doing it until we make some shots,” he said.
The first half was ugly basketball but WVU did use its defense to shut down the Duquesne shooters and to get some transition baskets, making it look as if it didn’t matter if they were sharp from the outside.
At halftime they led, 36-23, and guards Juwan Staten and Gary Browne each hade 10 ponts, Brown even hitting two of the three 3s WVU would score in the first half.
Then came the second half. Staten scored three points, Browne none. WVU had only one 2, that from Matt Humphrey who saw 14 minutes of playing time and couldn’t quite understand what happened.
“We got complacent,” he theorized. “We were up 13, 15, whatever it was, you don’t lose games like that ... not in college basketball.”
But WVU lost this one.
“We didn’t get back in transition. We didn’t rebound,” Humphrey said. “That’s not how we play. That’s a recipe to lose.”
But that’s just what was being cooked up on the court before 6,244 fans, most of them West Virginia fans who well may have saved the day by coming up early to Christmas shop.
Duquesne simply began hitting shots and you could see their confidence soar. This was a team that went 0-of-8 on 3s in the first half who canned 3 of 11 in the second half, a team that sliced into that 13-point halftime deficit until it was 53-53, then took the lead on a pair of transition layups by Errick Colter.
West Virginia could never get the lead back.
It came down to one final chance, down by 3, four seconds left and Browne at the free throw line.
He missed the first, then intentionally tried to miss the second, as if he had to, the shot being so far off it didn’t hit the rim and went over to Duquesne, which made one final free throw to ice it at 60-57.
Email Bob Hertzel at firstname.lastname@example.org or follow him on Twitter @bhertzel.
This is not headline news anymore, yet it screams to be said over and over.
- Bob Herzel
HERTZEL COLUMN: There are no sick days for athletes
So you wake up on a Monday morning and it’s cold outside; a couple of inches of snow have fallen. That’s bad enough, but then as you roll out of bed and put your feet on the cold floor, you realize you head is aching and your back hurts and you’ve got the sniffles and then …
Huggins implores Mountaineers to play to their strengths
Bob Huggins’ message to his West Virginia University team coming out of its disappointing 80-71 loss at Missouri that never really was as close as the final score indicates was a simple one – do what you do.
“We come out and we have too many guys playing out of character and doing things they can’t do instead of doing things they can do,” he said immediately after addressing his team on Thursday night in Columbia, Mo.
WVU women win seventh straight
Unlike the West Virginia University women’s basketball team she plays for, Asya Bussie draws a crowd every time she steps onto the Coliseum court.
The crowd, unfortunately, isn’t fellow WVU students or paying customers.
Dreadful shooting costs WVU in 70-61 loss to Missouri
West Virginia University couldn’t get out of Columbia, Mo., fast enough Thursday night, but the predicted snow/ice/cold storm had far less to do with it than the storm the Missouri Tigers brewed up for them.
HERTZEL COLUMN: Days later Iron Bowl finish still shocking
In reality, Shelly Poe had thought she’d seen it all but she had no idea what was awaiting her.
There she was, down on the sideline, caught up in a thrilling renewal of the Auburn-Alabama rivalry, the score tied and regulation seemingly over when Alabama coach Nick Saban, a one-time West Virginia neighbor of hers, so to speak, got one second put on the clock.
Mountaineers square off with similar Missouri team
If Bob Huggins took a mirror and held it up to the Missouri team that West Virginia University plays tonight in Columbia, Mo., he would get back a reflection of his own team.
Luck announces Holgorsen will be retained for 2014
West Virginia athletic director Oliver Luck put an end to the speculation about the future of head football coach Dana Holgorsen on Tuesday, announcing that he and his staff would be retained for 2014 despite a second consecutive disappointing season.
HERTZEL COLUMN: Like it or not, Holgorsen is coming back
Like it or not, it appears that Dana Holgorsen and his staff will be back to coach the West Virginia football team next year, looking down the throat of an angry Alabama football team to open the season.
WVU women overwhelm Coppin State
West Virginia’s women’s basketball team, ignited by Christal Caldwell and Taylor Palmer, turned on the juice after a lackadaisical first half and scored 56 second-half points to bury a game against an overmatched Coppin State team. The 88-56 win gave coach Mike Carey his 250th victory as Mountaineer coach.
Mountaineers make quick work of Greyhounds
A day before West Virginia was to play what seemed to be a dangerous Loyola of Maryland basketball team at the Coliseum, coach Bob Huggins talked for some time in depth about shortcomings his team had been displaying and about how they would have to overcome them to become a good team.
- More Bob Herzel Headlines
- HERTZEL COLUMN: There are no sick days for athletes


Please save the date:
Virtual Annual Staff Service Awards Ceremony
Wednesday, December 2, 2020, 11:30 a.m. – 1:00 p.m.
Join us for a celebration of service! The Department of Human Resources cordially invites you to show your support for your colleagues' years of service and special awards with the State of Maryland and the University of Maryland, Baltimore County.
Mark your calendars for this fun event that has something for everyone! Please visit the Service Awards page for details.


Archive | May 2018
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Surge in West Ham season ticket renewals
West Ham have seen a recent surge in Season Ticket renewals before Friday’s 5pm deadline.
Mystery names on Pellegrini’s transfer list
Claret and Hugh have learnt that the majority of Pellegrini’s transfer targets are not in the public domain and most have not been linked in reports by the media. Many of targets previously linked under David Moyes are now out of the window with the notable exception of Ryan Fredericks.
West Ham transfer latest update
Ryan Fredericks is not quite the done deal some media reports are suggesting today. The 25-year-old free agent remains in Las Vegas celebrating Fulham’s promotion to the Premier League.
Ginger Pele offered new chance
Tony Pulis has reportedly contacted James Collins over his availability to join him at Middlesborough.
West Ham partner with Airline
West Ham have announced an agreement with EVA Air as the Club’s first ever Official Airline Partner.
Arnautovic and Mourinho break silence
Marko Arnautovic has responded to the rumours that Jose Mourinho is interested in bringing him to Manchester United.
Ryan Fredericks up close and personal
Ryan Fredericks is primarily a right-back, but he can also play in the right and left midfield positions as well as on the left side of defence. Born in Hammersmith Fredericks is a graduate of Spurs’ youth academy, but he made just four appearances for Spurs’ first team before he signed a permanent deal with Bristol City in 2015 after loan spells with Brentford, Millwall and Middlesbrough.
Hammers ‘targets’ all linked to same agent
West Ham are keen on Manchester United keeper Sam Johnstone who was left shattered after missing out with Aston Villa in the Championship play off final.
West Ham chasing Chelsea Brazilian winger target
West Ham have joined the race to sign Lazio winger Felipe Anderson, according to Sky Sports.


A lot of our photographs are from our fishermen customers. Having photos of our customers using our gear is a great connection for everyone. Some of the most striking and technically challenging photos are the work of fisherman/photographer Jimmy Phillips. His work has been featured in many trade magazines and on the American Albacore website. We wish to extend our thanks to Jimmy and the rest of the crew for the cool photos. He can be reached online at Jimephtography.com or at 415-317-7437.
Ken and Linda


Kareena Kapoor and Saif Ali Khan are being cautious about teaming up for the big screen.
Their last two outings, 'Agent Vinod' (2012) and 'Kurbaan' (2009), proved disastrous.
So, the couple want to be fully convinced before giving their nod to any filmmaker who wants to pair them up on screen.
Buzz is that Saif was offered a negative role in a film opposite Bebo. And guess what?
His character had to beat her black and blue. Now the Nawab could not bring himself to raise his hand on his begum even on screen. He outrightly refused the role.
Photos: Katrina Kaif, Shamita Shetty at Mumbai airport
Photos: Varun Dhawan, Alia Bhatt promote 'Badri...' on 'Dil Hai Hindustani'
In pictures: 15 facts about kissing that will surprise you
Photos: Shahid Kapoor and Mira Rajput at cafe in Bandra
Photos: Deepika Padukone, Neha Dhupia and Soha Ali Khan at event


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Business continuity and protecting the BoP during COVID-19
While businesses are faced with many challenges during pandemic, inclusive business models are more resilient to crises as they already navigate challenging markets and are successful in difficult conditions. However, as the COVID-19 pandemic continues, many such initiatives are struggling with business continuity and have the added challenge of engaging low-income populations as part of their business activities.
During this time some of Business Call to Action (BCtA) members have adapted their businesses while others are looking at what will happen post-COVID and how to best continue engaging low-income populations in their value chain.
In Uganda, BCtA member AFRIpads not only employs low-income populations, but their customers are low-income women and girls dependant on the reusable menstrual kits the company sells across Africa.
“It is essential for our manufacturing to continue to ensure this uniquely gendered need of women and girls can be met,” said co-founder Sophia Grinvalds, as access to menstrual products decreases and cost of purchasing them increases, yet the need to manage periods with dignity is very much there.
During the initial phase of the pandemic the company enforced guidelines set out by the Ministry of Health of Uganda in the workplace and provided information for employees in local languages to ensure they could protect their families and community.
However, an overnight lockdown and the ruling that essential factory workers had to live on-site to continue work shut the AFRIpads factory down for two weeks.
Almost 90 percent of the company’s 200 workers are low-income women and vulnerable to risk and interruptions of businesses during the pandemic. “We have to be able to preserve the livelihood of our team… we had to be creative and needed to pivot and respond,” said Grinvalds, who understands the challenges of having workers from the bottom of the pyramid (BoP) who are dependent on employment with limited savings and safety nets to fall back on during emergencies.
As a solution, the team was able to set up temporary housing for factory workers and after two weeks workers returned.
“The reality is these are challenging times for small and medium companies, especially those with a strong social impact focus to their work,” said the co-founder. “There is a huge amount of flexibility and empathy needed in how we respond to this crisis, the situation is changing for everyone on a daily basis.”
Like AFRIpads, Indian waste processing company Saahas Zero Waste undertook initiatives to ensure the safety of their workers, including providing PPE, awareness on hygiene standards at home and “social distancing” protocols at work.
While lockdowns are making it difficult for daily wage earners and low-income workers to make ends meet, Saahas Zero Waste’s employees had certain safety nets.
“We are taking ample steps to safeguard the interests of our waste workers. Thanks to a formal approach in waste management, Saahas Zero Waste is able to support our field staff in these difficult times,” said Arun Murugesh, Regional Director of Saahas Zero Waste.
Looking ahead after COVID-19 there may be opportunities to transform the waste management industry in India, where much of the sector is made up of informal labourers. Many of these waste workers operate without health and safety standards and vulnerable people living at the BoP are exploited by the informal sector.
“At Saahas Zero Waste we observed that formal full-time employment ensures a stable workforce. As factories slowly ramp-up their workforce, we encourage them to incentivising returning workers with full-time employment. A strategic formalization of end-to-end waste management supply chain will make it robust and reliable,” said Murugesh.
The company is also making use of relief plansannounced on taxation and loan repayments to keep business going during uncertain times and continue engaging with low-income communities.


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The kidnapper is their maths teacher, a man named Gary Soneji. As Cross gets pulled deeper into the strange world of the kidnapper, it becomes clear he is not what he seems…
If I ever needed a case solving then Alex Cross is the man you would want on the job.
One of the things I particularly like about JP's books are the short chapters, it makes it so easy to say 'just one more, just one more' before you know it you have devoured half the book. I have just re read this in little over a day.
It's scary when I think the first time I read this is over 20 years ago, (published in 1993) can you believe that. so it was certainly due a re read. And although I could remember a little of what happened, it was great getting to Know Alex all over again, and the fantastic characters of Sampson and Nana Mama.
Once you get into the story you are left wanting more and more, you are drawn into the story and each chapter leaves you needing to read the next one.
I remember hating Gary Soneji, an evil kidnapper, and second time around I hated him twice as much.
James Patterson is well known for his Alex Cross Series, but I also love his Michael Bennett Series, and The Womans Murder Club Series. All books well worth reading and if you haven't yet read a JP book, well this little lot would certainly keep you going for quite some time.


Latest Kennametal Inc. Stories
New Beyond™ grades from Kennametal are delivering higher productivity for turning tough alloys, both in higher speeds and feeds (faster turnaround time) and longer tool life (more parts per
Word of the Day
- Monstrous in size or character; huge; prodigious; monstrously perverse, savage, cruel, etc.
The word 'immane' comes from the Latin word 'immanis', 'enormous'.


While not the best reviewed holiday film in recent years, the timely release of Fred Claus last November proved to be a solid outing for Warner Bros. The film pulled in a little over $70 million domestically and will no doubt reap even more in home video sales this holiday season. Although definitely not the best holiday film to be made, it is one of the more unique outings with its quirky tale of Santa’s older brother and the life he’s had over the years.
This is the story you’ve never heard before, a hilarious and heartwarming comedy about Fred Claus, Santa’s brother – and complete opposite. After growing up in saintly Nick’s shadow, Fred becomes a grouch who’s lost his belief in Christmas. Then, one magical December, Fred flies north (first class via reindeer) to find brother Nick is in trouble: a scheming efficiency expert is out to shut down Christmas forever! Expect fun by the sleighful as Fred helps save Christmas and rediscovers the gift of family. Join Vince Vaughn, Paul Giamatti, Miranda Richardson, Rachel Weisz, Kathy Bates, Kevin Spacey and more in a yuletide treat to enjoy for years to come.
The above description, plastered across the DVD and Blu-ray rear jackets for this film, is a tad bit inaccurate. Fred’s appearance in the North Pole is anything but friendly and the true intentions of the “efficiency expert” are not even revealed until a while into the film. It’s a bit of a stretch to call this film a coming together of brothers so much as a study of sibling rivalry. On top of that the film is plagued with tiny little nuances that don’t quite work, but all the while I couldn’t help but try my best to overlook the flaws as I was really enjoying watching this film, as flawed as it was.
Obviously the biggest flaw is the “efficiency expert”, played by Kevin Spacey. Exactly who is he working for and how does he have the authority to shut down Santa Claus? It’s incredibly vague and we only get the smallest sense that they’re some kind of agency in charge of all of the holiday’s, as passing references to the Tooth Fairy and Easter Bunny are made, and it’s altogether a very vague and underdeveloped plot point that runs throughout the entirety of the film. Although it’s a major detail that sat in the back of my head while watching the film, it was again something I just pushed aside for the greater good.
What made me want to like this movie was how it started out. It set up a genuinely believable scenario for which Santa Claus would not also exist but also a believable plot that would work in an older brother. I was more excited about the films originality than I was about the clichés and plot holes that were plaguing it and more than anything that fueled my desire to enjoy this film. It had the makings of a genuinely good and entertaining family film and every time I would make a note of something that seemed off, I opted to ignore it as best as I could.
Particularly enjoyable to me was the banter between Fred and Nick, who had a genuinely believable bout of sibling rivalry between the two. Although Fred was the older of the two, he certainly looked younger than Nick, which is another discrepancy I’ll freely avoid. I also found the interactions with Fred and his mother and father to be wholly believable and, really when it comes down to it, it’s the family elements of the film that really kept my attention for this film. I was rather shocked at its run time (five minutes shy of two hours) when starting it, but the film honestly flew by. Not once did I feel it drag in pacing and the run time never got in the way of my enjoyment of it.
What did admittedly irk me was the films constant switching between tones. At one point it felt like an adult Christmas comedy (in subject matter) and then it would switch into something out of Jingle All the Way. The film kept up this constant switching in tones up until the very end and that was perhaps the most aggravating. The other annoying aspects of the film were the elf CGI; Willie (John Michael Higgins) looked absolutely horrid in some of the environments, as did Ludicrous. They simply didn’t mesh well with the other non-CGI elements and why they couldn’t have done it ala Lord of the Rings I don’t know. Whatever the case was, it was highly distracting at times, especially since not all of the elves were CGI. On top of that were the sound effects in the film, which got to be a bit too much, especially the first round of them; they came out of nowhere and I had to wonder if I was really hearing what I was hearing.
Oddities aside, the film really is enjoyable to watch, as long as you are able to push the annoyances to the sidelines like I did. If I were feeling overly critical towards films like I am some days (luckily I’d spent the morning reviewing comedies, so I was already in a pretty lightened mood) I’d probably tear into this film for being a wildly uneven story that makes up stupid plot points for its own benefit and completely screws with the viewers head when it comes to deciding what age group it wants to go after, but it being the season of giving, I’m going to be a bit more lenient on this film. It’s certainly the most original Christmas film I’ve seen in a long time and based on that element alone I’m going to Recommend it. There’s no reason a family less critical than I wouldn’t have an absolute blast watching this one, so put it on your list or give it a rental—either way it’s a solid holiday film that gets major points for originality (and quite the star studded cast).
Fred Claus arrives on Blu-ray in a three-disc edition (one Blu-ray disc, one digital copy and one DVD-ROM game, i.e., the usual Warner Bros. fair). The set is in a standard three-disc Elite Blu-ray case, complete with an embossed/foil reflective/glitter laden o-ring cover. The interior of the case includes the three discs (be sure to give your set a shake; mine arrived with the middle tray broken and upon opening the set I got an array of blue plastic confetti pieces flying up at me) as well as inserts for the digital copy and notes to keep your firmware up-to-date. There is also an instruction manual for the DVD game. As a general note, the DVD game is really for children only, so unless you have a great desire to absolutely waste your time, and don’t bother putting the disc into your PC or DVD player.
Video for this film arrives in a VC-1 encoded 1080p 2.4:1 transfer that is a bit of a baffler to me. On one hand it can look exceptionally great, with plenty of detail and the North Pole coming to life in a sea of lights and at other times I’m either put off by the compression or grain level. In fact, in the opening shot of the film in the woods, I was confused as to whether or not it was even compression showing up or just a very light grain level. It paused me to check the bitrate on the transfer, but it was sporting an average of 27mbps and a maximum of 29mbps, so I don’t know what was going on with it…just my eyes going overly sensitive, I guess. The more I watched the film, however, I became more inclined to think it was just the grain, which really was some of the most finely diced grain I’ve seen on a print in my life. Thankfully there is little DNR present, although it’s obvious when it’s been applied as there is a bit of an overly smooth haze to the picture.
For the audio we once again get a DD5.1 mix. Yup, Warner has again decided to bless us with a compressed and generic DD5.1 track that we get on the standard DVD release. What exactly is the point of the Blu-ray format if they’re going to pull this type of crap with the audio portion of the release? This isn’t a film that demands a TrueHD 5.1 track, but it’s the very least they could do if they’re putting out a 1080p transfer. I mean I wouldn’t even be so upset about this, but they pulled this crap on Speed Racer too and that was a film that really deserved to be heard in a lossless mix. Granted everything sounds clean and clear here so I don’t really know what we’d be missing if we had a lossless track, but it’s more the principal of it than anything. If you have a format like Blu-ray, then why squander its disc space with lossy audio tracks? Also included are French, Spanish, Japanese and Portuguese DD5.1 tracks and English, French, Spanish, Chinese, Japanese, Korean and Portuguese subtitles.
Moving onto the extras we have a Commentary with director David Dobkin which is worth a listen, although the lack of Vaughn or Giamatti on the track is a bit disappointing. The remaining extras are either a tongue-in-cheek type piece, such as the Pause for Claus: Elves Tell All (9:00) bit that is…I don’t really know why they even made this extra to be honest. It’s almost too cutesy that its wholly unbelievable and you can feel everyone making fun of the whole idea of an extra like this. Sibling Rivarly (9:27) focuses on the element of the film that will click the most with individuals and we get to hear from Vaughn, Stephen Baldwin, Roger Clinton and Frank Stallone (all of whom made up one of the most memorable sequences in the film).
Meet the Other Clause (13:05) acts as a making-of for this film and Ludachrismas – Music Video (1:37) wraps up the high-definition extras on the disc. Those wondering what the Ludachrismas song sounds like…it’s annoying. It sounds like every other song the man has put out and I make no apologies about being so blunt. I literally just listened to another one of his songs a few hours before watching this film and I honestly could not tell the difference. Granted rap just isn’t my forte, but…blargh.
The remaining extras, a series of Vince and Paul Fireside Chats (4:11) and a wealth of Deleted Scenes (25:30), are in standard definition. I’m surprised there were such a large number of deleted scenes for this film. None were particularly wonderful and if they’d been left in the film would’ve been near two and a half hours long; I’m more surprised there was this much material shot for the film than anything.
That ends the array of extras (unless you count the digital copy and DVD game), which really isn’t bad for a film of this nature. The commentary more than makes up for any in-depth extras on the construction of this film and the short making-of and Sibling Rivalry pieces are well worth checking out if you enjoyed the film. Like the film this one comes Recommended.
Fred Claus is now available on DVD and Blu-ray.


Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use
For questions regarding this document contact Richard Felten at 301-796-6392 by email at email@example.com.
U.S. Department of Health and Human Services
General Surgery Devices Branch
Written comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 1735 to identify the guidance you are requesting.
Table of Contents
- Device Description
Photograph or Drawing of the Device
Comparison to the Predicate Device
- Risks to Health
- Bench Testing
- Software Validation
- Clinical Testing
- Electromagnetic Compatibility (EMC)
- Electrical and Mechanical Safety Performance Testing
Device User Manual
Directions for Use
Indications for Use
Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use
This guidance document was developed as a special control guidance to support the classification of the low level laser system for aesthetic use into class II (special controls). The device is intended to apply low level laser energy to the body to achieve temporary changes in physical appearance. This guidance document is issued in conjunction with a Federal Register notice announcing the classification of the low level laser system for aesthetic use.
Following the effective date of the final rule, manufacturers of devices within this generic type of device will need to address the issues covered in the special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. These recommendations are in addition to the requirements that low level laser systems must also meet under 21 CFR 1040, Performance Standards for Light-Emitting Products.1
FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the low level laser system for aesthetic use. Therefore, a manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug & Cosmetic Act (the FD&C Act), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with the low level laser system for aesthetic use, including those identified in this guidance, and (3) obtain a substantial equivalence determination from FDA prior to marketing the device.
This special control guidance document identifies the classification regulation and product code for the low level laser system for aesthetic use (refer to Section 3. Scope). Other sections of this guidance document list the risks to health FDA has identified and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these low level laser systems and lead to a timely 510(k) review. This document supplements other FDA documents regarding the specific content requirements of a premarket notification submission. You should also refer to 21 CFR 807.87, the guidance, Format for Traditional and Abbreviated 510(k)s2 and the section of CDRH’s Device Advice, How to Prepare a 510(k) Submission.3
The scope of this document is limited to the following class II device (product code OLI) described below.
21 CFR 878.5400 Low Level Laser Systems for Aesthetic Use
Identification. A low level laser system for aesthetic use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
Classification. Class II (special controls). The special controls are: The FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See 21 CFR 878.1(e) for availability of this guidance document.
We recommend you identify your device using regulation and product code described in Section 3. Scope and include the following:
We recommend you identify all components, system software, and accessories within the scope of the 510(k).
We recommend you provide a photograph or drawing of the device. We also recommend you provide a functional block diagram (including all accessories).
We recommend you explain how your device and the predicate are similar, with respect to indications for use and technological characteristics.
In the table below, FDA has identified the risks to health generally associated with the use of the low level laser system for aesthetic use addressed in this document. The measures recommended to mitigate these identified risks are given in this guidance document, as also shown in the table below. You should also conduct a risk analysis before submitting your premarket notification to identify any other risks specific to your device. We recommend the premarket notification describe the risk analysis method and include the results. If you elect to use an alternative approach to address a particular risk identified in this guidance document, or you have identified risks additional to those in the guidance, you should provide sufficient detail to support the approach you have used to address that risk.
|Identified risk||Recommended mitigation measures|
|Ocular Injury||Section 6. Bench Testing
Section 7. Software Validation
Section 8. Clinical Testing
Section 12. Labeling
|Electrical Shock||Section 11. Electrical and Mechanical Safety Performance Testing (IEC 60601-1)
Section 12. Labeling
|Unintended Cell Damage||Section 6. Bench Testing
Section 7. Software Validation
Section 8. Clinical Testing
Section 9. Biocompatibility
Section 10. Electromagnetic Compatibility (IEC 60601-1-2)
Section 12. Labeling
|Use Error||Section 12. Labeling|
We recommend that preclinical testing be performed to demonstrate that the low level laser system for aesthetic use meets all design specification and performance requirements. In regard to laser power and performance, laser power measurements should be conducted and should demonstrate that the laser output power, specifically that reaching the target site, is predictable. Testing should accurately characterize the output beam profile and establish that the laser energy is delivered and concentrated in the desired target location. Testing should demonstrate the accuracy of the method for targeting the region of interest and, if applicable, for monitoring the progress or result of treatment.
Testing should be performed to assess the probability of system failure, the means by which system failure can be mitigated, and the means by which system failure is apparent to the user. The overall system should be tested to ensure proper performance to design specifications and to assess the failure modes and probabilities. Bench testing may also be used to assess the likelihood that the conditions of use may affect system performance.
We recommend that you submit the information for software-controlled devices described in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.4 The kind of information we recommend you submit is determined by the “level of concern,” which is related to risks associated with software failure. The level of concern for a device may be minor, moderate, or major. FDA believes that the software used to operate a low level laser for aesthetic use presents a “moderate level of concern” as described in the Software Guidance because a failure or latent design flaw could directly result in minor injury to the patient or operator.
In addition, we recommend that the development of the control software follow IEC 60601-1-4: Medical electrical equipment – Part 1-4; “General Requirements for Safety; Collateral Standard: Programmable electrical medical devices” or equivalent methods.
FDA may recommend that you collect clinical data for a low level laser system for aesthetic use with any of the following:
- indications for use dissimilar from a legally marketed system of the same type;
- designs dissimilar from designs previously cleared under a premarket notification; or
- new technology, i.e., technology different from that used in legally marketed low level laser systems for aesthetic use.
FDA will consider alternatives to clinical testing when the proposed alternatives are supported by an adequate scientific rationale. Also note that, as with any premarket notification, any new intended uses or technology differences that raise new types of safety or effectiveness questions may be grounds for finding your device not substantially equivalent (NSE).
If a clinical study is needed, we recommend that you evaluate the safety and effectiveness of the particular low level laser system for aesthetic use demonstrating its ability to achieve the desired aesthetic results in a significant portion of the target population when used for the proposed indications for use and under the proposed conditions of use, including adequate direction for use and warnings against unsafe use that appear in the labeling. We suggest that you use any clinical studies that are conducted to confirm the safety of the device that was established through bench testing.
If a clinical study is needed to demonstrate substantial equivalence, i.e., conducted prior to obtaining a 510(k) clearance of the device, the study must be conducted under the Investigational Device Exemptions (IDE) regulation, 21 CFR Part 812.5 In addition the sponsors of such trials must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).
We recommend that you evaluate the biocompatibility of the device as described in the International Organization for Standardization (ISO) standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for intermittent external contact with intact external body surfaces. If identical materials and identical material processing are used in a predicate device with the same type and duration of patient contact, you may identify the predicate device in lieu of performing biocompatibility testing.
We recommend that you demonstrate the EMC of the device by performing EMC testing as described in the following FDA-recognized standard or equivalent method.
- IEC 60601-1-2 (Second Edition, 2001) Medical Electrical Equipment – Part 1: General Requirements for Safety; Electromagnetic compatibility – Requirements and Tests
We recommend that you demonstrate the electrical and mechanical safety of the device by performing electrical and mechanical safety testing as described in the following FDA-recognized standard or equivalent method.
- IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
The premarket notification must include labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). The following suggestions are aimed at assisting you in preparing the labeling that satisfies the requirements of 21 CFR Part 801.6
We recommend that you provide a user manual with the device. The user manual should include descriptions of:
- the device and all accessories
- how the device interconnects with other components or accessories
- all features, functions, output modalities, and specifications
- all user-accessible controls
- indicators, markings, and/or labels on the device which provide information regarding the function or meaning of each control, display output jack, etc.
- illustrations of the device and accessories
- summary of clinical testing
As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate directions for lay use. Labeling must, however, include adequate information for practitioner use of the device, including indications, effects, routes, methods, frequency and duration of administration and any relevant hazards, contraindications, side effects and precautions. (21 CFR 801.109(d)).
The indication for use should give the specific indication for use for which the device is being granted marketing permission and include the statement that the device is a low level laser system for aesthetic use.
We recommend that the indications for use be included in the user manual.
We recommend that you advise users with open wounds or lesions, active implantables (e.g., pacemakers or defibrillators), or metallic implants not to use the device in these areas.
We recommend that storage conditions be included in the user manual.
We recommend that you describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur.
The warning section should also include an appropriate warning if there is reasonable evidence of an association of a serious hazard with the use of the device. A causal relationship need not have been proved.
We believe a warning is appropriate when the device is commonly used for a disease or condition for which there is a lack of valid scientific evidence of effectiveness for that disease or condition and such usage is associated with a serious risk or hazard.
The precaution section of labeling should include information regarding any special care to be exercised by the practitioner and/or patient for the safe and effective use of the device, for example:
- We recommend that this section indicate or emphasize any need for protective eye wear during use.
- We recommend that this section identify any laboratory tests or other evaluations that may be helpful in following the patient’s response in identifying adverse reactions and, if appropriate, specify the frequency of such tests or evaluations before, during and after use of the device.
- We recommend that this section identify any precautions to help prevent electrical shock, such as any need for specific device placement, appropriate electrical wiring needs, reminders to periodically check device wiring and accessories for damage, and avoidance of use of the device in environments where electrical shock is possible.
1 These devices must comply with 21 CFR 1040.10, Laser products, and 21 CFR 1040.11, Specific purpose laser products.
5 For additional information regarding clinical trial requirements, see Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, available at: http://www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinicalTrials/GuidancesInformationSheetsandNotices/default.htm
6 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.


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This green machine mimics clouds to provide clean drinking water, and is powered by biomass
A technology developed by Skywater Alliance won the $1.75 Water Abundance XPrize, a competition launched by the United Nations to encourage engineers to harness technology that could provide clean drinking water to millions of people.
The device, which looks like a shipping container, mimics the way clouds are formed to generate clean, drinking water. It contains a power system that sucks in warm air so that it can mingle with the cold air inside, causing condensation to form. The resulting water droplets are then collected into a water tank that can be dispensed through a tap.
In order to generate the amount of electricity necessary for the system, the technology can be powered by biomass, such as twigs, branches, or dead trees.
Since some disaster-stricken areas may not have access to biomass, the Skywater device can also be adapted to solar power and wind energy power systems as well.


Post Published: March 12, 2019
An Irish aid worker was among 157 people on board an airline that crashed minutes after take-off from the Ethiopian capital yesterday.
The Ethiopian Airlines flight to Nairobi reported difficulties during its ascent and the captain issued a distress call shortly before contact was lost at 8.44am. The aircraft crashed about 40 miles from Addis Ababa near the town of Bishoftu with 149 passengers and eight crew on board. There were no survivors. Witnesses reported an intense fire after it came down […]


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oembed rumble video here Ever since Blue Apron came onto the scene, meal delivery services are all the rage nowadays. . There are so lots of options to choose from: Plated, HelloFresh, Blue Apron, and even. Developed with the house cook with no time to grocery store in mind, provides your pre-selected meal plan to your door weekly with pre-measured active ingredients.
So why did I cancel my plan after the very first week? That’s an excellent question. My HelloFresh evaluation is that this service simply isn’t the ideal one for me, despite the fact that I can see why some individuals like it. To start, I must inform you a bit about me. I’m a house cook with minimal time to run to the supermarket, residing in a studio apartment with an even smaller kitchen area, and I make dinner simply about every night.
In reality, making new recipes weekly (a minimum of one!) is a concern for me as the Managing Editor of Wide Open Eats. After all, if I’m not attempting new things in the house, especially after a long work day, then how will I understand what to really advise? So that’s our set-up in your home.
When you log onto HelloFresh, you choose the meals you wish to use ahead of time. The choices aren’t endless, and in truth, there are just enough to make you feel like you have a choice without being overwhelmed. I selected 3 suppers with various kinds of meat to cover all my bases.
The first box I chose was Tex-Mex Tilapia. Not imagined: Tilapia. . Shannon Ratliff I was most ecstatic about this meal, and it didn’t dissatisfy. The tastes were spot-on, zesty and crispy all around, and the accompanying dish cards were simple to follow. The packaged, fresh ingredients (shown above) were simple to read and the meal kit directions were easy.
This HelloFresh meal gave way more couscous than I anticipated, and overall my review for this particular HelloFresh meal was that I was pleased with the meal choice I made from the other meal choices. The part sizes were large, but not excessive. I could clear my plate quickly, which is rare, however my partner was reaching for a treat only an hour later on.
The Juicy Lucy Burger was on the menu next, with supplied Brioche buns and directions for a Tomato Onion Jam that will stay in my dish rotation permanently – . A Juicy Lucy is a popular hamburger and is packed with cheese inside rather of a piece on top (although I would have liked that, too).
Regrettably, we simply could not wait while we were making supper, and so the Arugula Salad isn’t envisioned since we consumed it in about 6 minutes over the range as the burgers prepared (). By this 2nd home-cooked meal, I was almost ready to come around to HelloFresh and turn over to the dark side of meal membership services.
Opening the refrigerator to see a different meal in the classic HelloFresh brown paper bag, cooking had actually lost its appeal late in the week (). Still, I laid it out on the counter and persevered in spite of the truth that all I wished to do was pan-fry some chicken, peppers, and onions for a quick meal of.
The Pineapple Salsa, like the Tomato Onion Jam, was an advanced dish than I think of the majority of us whip up when we make pork chops or hamburgers, so it was nice to make something beyond my comfort zone with that recipe. This was, by far, my boyfriend’s preferred meal.
No, he was shoveling it in his mouth and caring every second of it. Praising the well balanced meals we had actually eaten that week, he wanted to understand why my HelloFresh review wasn’t that passionate. I believe HelloFresh is worth it for big families, particularly when food delivery is much simpler than filling the kids into the automobile to head to the supermarket.
I likewise appreciate that the quantity of packaging isn’t frustrating. For very first time meal package users, there are factors to try the service, including the capability to customize to particular dietary restrictions (though not particular allerigies) and a good variety of vegetarian choices. And if you wish to track your dietary details, all that is offered on their site.
In spite of all that, here are three reasons that I’m not offered yet – . I hadn’t realized the pleasure I took in finding brand-new dishes to try, even if it’s simply one weekly. The structure of HelloFresh implies it’s created for fairly senseless cooking; you merely pick your meals through the timeless strategy and you don’t require to think of them anymore.
Despite the absence of food pictures on my own (I loathe pulling out the phone throughout dinner), I take pride in my cooking and laugh it off when I fail. With the pre-packaged components particularly, I felt restricted to remain on track. Naturally, this part of my HelloFresh evaluation wouldn’t necessarily be a problem for others.
While this is excellent for not overindulging, there were no leftovers at all. One of the ways we try to conserve money throughout the week is to take leftovers for lunch. While that suggests I’m making a much bigger supper regularly, it likewise indicates that those lunches will keep us complete at work for a minimum of two days after.
I was also in the kitchen a lot longer whipping up those lunches whereas, on a typical night, supper clean-up and lunch-packing takes place simultaneously. For our, this just didn’t fit. In hindsight, we could have changed from the traditional box for 2 individuals to the household plan box, however I still think I ‘d be purchasing lunches.
I would make each of these recipes once again, however the issue is that I just wasn’t excited by them. Perhaps it was since I understood I ‘d be writing this evaluation after, however each brown paper bag of HelloFresh ingredients loomed in the refrigerator and made me feel as though I had a due date to keep.
I have actually been practicing instinctive cooking for the last 6 months approximately, and my cooking has improved by leaps and bounds. That confidence I felt in the kitchen area didn’t translate over to cooking with HelloFresh. So while this is definitely a quality service, my evaluation is that HelloFresh simply didn’t suit my lifestyle.
HelloFresh is a meal kit delivery service that uses weekly deliveries of recipes and groceries that enable you to facilitate and appealing meals at house – . The service is a terrific way to minimize the concern of meal planning and grocery shopping. It is a good choice if you delight in cooking and do not desire your meals premade but do not have much time for meal prep.
However, it might not be the best fit for those with unique dietary needs. This article reviews how HelloFresh works and how it compares to other meal package delivery services. Each week, HelloFresh ships you a box of active ingredients in addition to recipes that assist you cook your own meals.


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Puppets are a great tool everyone can use to stretch their imagination. Puppets can be made using any supplies you like. You can experiment with socks, gloves, household packages, and just about anything else. Design your own puppet crafts and then submit it
to be included here. If you make any of these crafts, make sure you send in a photo
to be included in this collection. You can also get your crafts published
. If you want to be one of the first to know when new craft projects are posted, take a few moments to sign up for the Family Crafts Newsletter
and you can also chat about crafts with others in the Family Crafts Forum
Learn how you can make an assortment of finger puppets that look like cute bugs. Of course, you can also make scary looking bugs or ugly bugs if you like.
You can recycle a cd, a paper plate, and a sock to create fun and unique flower puppets.
Follow these directions and you can craft a duck finger puppet using an empty film container or pill bottle.
Grab a paper plate, some gray paper, and some gray paint and you can make one of these cute elephant face puppets.
This tutorial shows you how to craft a lion out of pom-poms and chenille stems. Make a cute lion finger puppet and then you can try making different animals.
Like the duck finger puppet above, this person finger puppet is made using a pill bottle or film container.
This video shows you how to make a miniature puppet theater out of a picture frame.
This how-to video will teach you how to turn an ordinary doll or stuffed animal into a fancy marionette.
Learn how to make a large puppet theater out of a cardboard box by watching this craft video.
A visitor named Julie shares some suggestions for a variety of puppets using paper lunch bags.

domain: hobby


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The Original Pair
The waistband on these shorts would give and move when I moved (or when I ate). My other pair of jean shorts did not...the waistband was seriously restrictive. Yes, If I lose weight, I'd have no problem with them, but it's too hot to wait until I lose 10 pounds to make them too big again.
I'm not really posting a tutorial for this because I want to do it again with something else to perfect the process. But I'll show you a few of the steps I took to give you an idea...
I took the waistband off
I cut off and kept the button and button hole
I pinned them back on so I could get a measurement for the rest of the waistband.
I could have used the left over pieces of the waistband, but I wanted to go by the size of the shorts, not the waistband, which was slightly smaller (hence the reason they were restrictive).
I then sewed the new comfy fabric and a piece of elastic to the button and button hole fabric.
Then I pinned and sewed the newly created waistband into place. It's not exactly pretty...the sewing machine was giving me problems.


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The pickup also hit part of a gas meter, causing a leak. Five homes were evacuated until the gas could be turned off.
"It sheared off the gas meter which exposed the pipe in the ground and it was leaking natural gas until the power company came and turned it off," said Lt. Steve Cupid with the Precinct 4 Constable's Office.
No one in any of the homes was hurt.
One witness told deputy constables a group of around four or five young males ran from the truck after the accident. Investigators are asking for anyone who has information on the driver of the truck or any occupants to contact them.
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Sci. Aging Knowl. Environ., 8 February 2006
Mucking With Metabolism
Inability to repair DNA damage in mitochondria could foster metabolic syndrome
Abstract: In some family businesses, one heir will strike out in a new direction, rejecting his or her expected fate. Similarly, a protein whose kin protect animals from cancer instead seems to guard mice against a metabolic disruption. The results show that flawed DNA repair could contribute to a condition called metabolic syndrome, and they support a link between the condition and mitochondria.
Citation: M. Beckman, Mucking With Metabolism. Sci. Aging Knowl. Environ. 2006 (5), nf6 (2006).
Science of Aging Knowledge Environment. ISSN 1539-6150


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The vertebral column is a series of articulated bones known as vertebrae which act as the axis of the body in organisms known as vertebrates. Also known as the spine, the vertebral column is a critical part of the anatomy, serving a number of important functions. In humans, there are some unique features in the vertebral column which are designed to facilitate upright walking. The design of the human pelvis is also very different from that of other animals, reflecting the upright orientation of the body.
Some people are surprised to learn that the number of bones in the vertebral column actually varies, depending on the person. The number is usually between 32 and 34, with several of those bones being fused. The coccyx and sacrum at the base of the vertebral column, for example, are made of groups of bones which have fused together.
At the top of the vertebral column, one finds a special vertebra known as the “atlas.” The atlas supports the skull, with the name being a reference to the mythological figure Atlas, who managed to support the weight of the world. Below the atlas, one finds the cervical or neck vertebrae, followed by the thoracic vertebrae in the midback, and the lumbar vertebrae in the lower spine. Between each pair of vertebrae is a thick, tough, slightly giving layer of material called a disc. The discs articulate the joints, allowing for some flexibility, and they also act as shock absorbers for the spine.
One important function of the vertebral column is to protect the spinal cord, a key component of the central nervous system. The spinal cord consists of a cluster of nerve fibers wrapped in several layers of tough material which act as a sheath. The vertebrae provide further protection from impact, pinching, and other potential sources of trauma.
In the case of the thoracic vertebrae, the spinal column also provides a point of attachment for bones, specifically the ribs. Together, the thoracic vertebrae, ribs, and sternum create a hard protective case of bone to shelter vital organs. Known as the rib cage, the design shelters the heart and lungs from potential trauma.
A number of medical issues can involve the vertebral column, including fractures, scoliosis, kyphosis, slipped discs, herniated discs, hairline cracks, and degenerative diseases such as arthritis. Treatments for these conditions vary, and can include the use of surgery, medications, and physical therapy.


Amidst a bustling hackathon in a lavish Silicon Valley mansion, a surprise speaker took the stage. This unassuming individual, dressed in a casual attire, captivated the audience of AI enthusiasts with his compelling story. Revealing that he was there to buy time for the event’s main speaker, he humbly acknowledged the collective genius of those around him.
Sergey Brin, co-founder of Google, confided in the room filled with AI startup founders, investors, and researchers, shedding light on his unexpected return to the forefront of technology. Brin, renowned for his brilliance in the realms of tech and AI, recognized the formidable competition present within the crowd.
While the details of Brin’s involvement in Google’s latest ventures were initially shrouded in secrecy, his recent revelations emphasize his fascination with generative AI. This groundbreaking technology has the potential to reshape various industries, paving the way for unprecedented advances in creativity and problem-solving.
Generative AI, a branch of artificial intelligence, focuses on enabling machines to produce original and innovative content. Using algorithms and vast amounts of data, generative AI systems can generate text, images, music, and even entire works of art. This capacity for creative output holds immense promise for industries such as entertainment, design, and advertising.
Brin’s return to Google signifies his belief in the transformative power of generative AI. By immersing himself in the trenches once again, he is poised to drive the development and implementation of this cutting-edge technology. His presence serves as a testament to Google’s commitment to pushing the boundaries of innovation.
What is generative AI?
Generative AI refers to a branch of artificial intelligence that focuses on enabling machines to generate original and innovative content, such as text, images, music, and art.
How does generative AI work?
Generative AI systems use algorithms and vast amounts of data to generate creative output. By analyzing patterns and learning from existing content, these systems can produce new and unique creations.
Which industries can benefit from generative AI?
Generative AI has the potential to revolutionize industries such as entertainment, design, advertising, and more. It can enhance creativity, streamline content creation processes, and drive innovation in various fields.
What does Sergey Brin’s return to Google signify?
Sergey Brin’s return to Google demonstrates his strong belief in the transformative power of generative AI. By immersing himself in the development and implementation of this technology, he aims to push the boundaries of innovation and drive progress in the field.


Maple Ridge Welding has been serving clients with their welding and metal fabrication needs all over Ohio since 2012.
We specialize in structural HSS and plate fabrication, as well as misc steel fabrication for construction contractors and many other clients.
Maple Ridge Welding has developed a relationship with a network of local suppliers, and always purchases materials locally. We only buy steel, equipment, and consumables made in the USA. We believe in helping other locally owned businesses, by always purchasing locally, we are doing our part to save on transportation costs, and fuel consumption. We are happy to pass this savings onto our customers.
Maintaining an excellent working relationship with our suppliers and our customers has allowed Maple Ridge Welding to grow quickly year after year. Buying materials locally and keeping overhead to a minimum allows us to pass this savings on to clients, while still maintaining the prices, quality of work, and grade A materials our customers deserve, and expect.
Today, we are working to become the most customer focused welding and steel fabrication companies in Ohio.
Always using local suppliers, and always buying American produced steel and equipment.