Size Matters

As seen in
INDUSTRY
SECTOR
REPORTS
The RaySafe X2 from Unfors RaySafe
May 2013
Size Matters
New challenges are leading to smaller, cheaper
and easier-to-use biomedical test equipment
I
By Brendon Nafziger
f you showed the device to someone on the street, they
would probably mistake it for something they could
pick up at BestBuy. About 6 inches long and weighing
just over a pound, it has the elegant, slim curves and
shiny metallic facing of an Apple product, and the nofuss commitment to minimalism that characterizes modern
industrial design: only three buttons are visible, one of which
is the “home” button illustrated by the silhouette of a house
so familiar to owners of Android phones.
At a quick glance, it might look like a new kind of
tablet computer, the latest iteration of an iPad, but it’s not.
Its target audience is not everyday consumers, it does not
stream Netflix videos and is not cheap by home electronics
standards. Although the public will never use it, it does, in
its way, protect their health, and helps ensure doctors are
able to diagnose illnesses and save lives.
The device, called the RaySafe X2, is an X-ray quality
assurance tool, used by medical physicists, state health
department inspectors and imaging technicians to ensure
radiography machines in hospitals and clinics are working properly and emitting safe doses of ionizing radiation. And its sexy modern looks, developed by a Swedish
design firm, are no accident.
“Consumers have the same high expectations for the
devices they use at home and at work,” says Kelly Fitzgerald, a marketing executive with RaySafe, the Billdal,
Sweden-based company that sells the device and which
claims to be the largest X-ray quality assurance equipment
manufacturer by annual sales. “There is a convergence
between the personal and the professional in that nobody
wants to go to work and use a device that seems archaic in
its design and function.”
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INDUSTRY SECTOR REPORT: TEST EQUIPMENT
Simplicity and ease
Pronk Technologies' FlowTrax
approximately 80 percent of patient monitors and ECGs on
the market, Cadick says. It also tests 18 arrhythmia waveforms and half a dozen respiration waveforms.
This means 12-lead ECG carts are out, however, and
many hospitals will need more multi-functional devices
for annual preventive maintenance. But the PocketSIM
could really excel at spot checks, its designers say. If a
patient monitor is hooked up to a patient, and a nurse
sees noisy waveforms, a technician can quickly be called
in, carrying a PocketSIM, to check the monitor to see if it’s
working properly.
The low price is important for this function, as there
have to be enough PocketSIMs to go around. A typical
biomed shop might have 15 techs but only three patient
monitor simulators, the engineers say. They say they
priced theirs low enough that a CE manager could buy
one device for every one of their biomeds. The PocketSIM
retails for $300 dollars, while typical ECG simulators run
from $800 to almost $2,500, if they also offer non-invasive
blood pressure functions, Hafer says.
How did they make it cheaper? “A lot of Google
searching,” Cadick jokes. The engineers are choosing
the same path, oddly enough, that video game consolemakers have: using off-the-shelf parts. Sony and Microsoft
are both expected to release next-generation video game
consoles this year at lower prices than in the past, largely
because they’re mostly avoiding custom-built innards. “To
have your own custom tooling done, your cost of development goes up $10,000 or $15,000,” Cadick says.
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I MAY 2013
Cheap is good, but there’s no substitute for intuitive, simple
interfaces. The PocketSIM was originally designed with five
separate buttons, but after getting feedback from TriMedx
biomeds, the two engineers said they simplified it, so it can
now be operated with the push of a single button. X2, the
RaySafe-designed X-ray QA tool that was launched this
year, was also created for ease of use, the company says.
“Honestly, a biomed who has never done a radiology
reading before could walk into the room and get a reading,” RaySafe’s Fitzgerald says. “All they need to know is
how to push a button.”
The focus on simplicity informs most of the product’s
design, according to the company. The X2, which has a
10-hour battery life and can store about 10,000 exposures,
doesn’t need to be oriented in an X-ray beam to take a reading. Also, waveforms can be seen on the device’s built-in
display, so there’s no need to work off a laptop. For now, X2
only works with rad/fluoro, but future editions should be
able to do mammography and CT, Fitzgerald says.
With a push for efficiency also comes a need to reduce
downtime — something even testing equipment is subject
to. Every year, QA devices have to be sent back to RaySafe
for calibration. For the X2’s predecessor, the whole device
had to go, which meant biomeds couldn’t use it for the
seven to 10 business days it took to arrive, be recalibrated,
and sent back. “It’s kind of like you giving up your laptop
for seven to 10 days,” Fitzgerald says. “What am I going to
do with myself?”
How will CMS’ controversial PM
position affect the industry?
Last year, the Centers for Medicare and Medicaid
Services ruffled a few feathers in the biomed world.
The agency indicated that they were going to require
hospitals to follow a device manufacturers’ specified
preventive maintenance schedule rather than one developed by the hospital after consulting historical data.
Potentially, this new position meant some hospitals
would have to greatly increase the frequency of PMs,
putting a strain on budgets. But included in the original
suggestion was a rather worrisome request: that hospitals would not just have to follow a device maker’s PM
schedule, but also use whatever test equipment was
specified by the company. “It was panicking the industry, people were talking about the impact of that being
in the billions,” says Gregory Alkire, with Pronk Technologies Inc. The fear was that biomed shops would
have to swap out their current stock of tools with ones
approved by the manufacturers. But AAMI says CMS
dropped this by June 2012. Still, the new PM requirement, if it leads to more frequent maintenance checks,
could lead to more test equipment sales.
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Canary in the coalmine
RaySafe had a bit of a makeover last year. The company, formerly known as Unfors, adopted a new name and
a stylized canary as its new icon last spring as it tries
to position itself as a full-service radiation protection
manufacturer, releasing products to help technicians,
medical staff and patients. In addition to the new X2,
an X-ray QA tool, the company recently launched a dosimetry badge system, the i2, which tracks exposure for
interventionists. The system was initially released under
a two-year exclusive agreement with Philips, which sold
it under the DoseAware brand. In April 2012, however,
RaySafe released it on its own, and it’s now also sold by
GE and Siemens under the company’s i2 moniker.
On the patient side, RaySafe is also beta-testing
cloud-based software, S1, that collects and manages patient dose data. This will create visualization
maps of a patient’s dose history to inform referring
physicians and radiologists, Fitzgerald says, and also
allow optimization of exams. “This last piece of the
puzzle gives us the ability to provide a ‘RaySafe room’
to a hospital enabling everyone to [receive] the least
amount of dose [needed],” Fitzgerald says.
For the X2, RaySafe made a
change — now, only the detachable
sensor needs to be shipped back for
re-calibration, meaning the company
can keep several sensors on hand to
eliminate downtime. The sensors are
also much cheaper than full backup
kits, Fitzgerald says, as the X2 lists for
about $12,700.
The “biggest thorn” in their side
“Getting out of their car 10 years ago was miserable
because they had heavy pieces of equipment that had to be
dragged to an outlying clinic,” Alkire says of biomeds in
the past.
The company’s new 5.5-inch-long pump tester, called
FlowTrax, launched in wide release in March, though the
device has been out in a limited production run of about
60 units since last year. For the one pound device, Pronk,
like many other developers, aimed for multi-functionality,
in order to further lessen a biomed’s load: FlowTrax is an
IV pump analyzer, a full feature pressure meter, a temperature meter and a digital stopwatch.
Alkire says, as with most of their products, they spent
the first six months letting a few customers play around
with it. Then based on feedback, they made a few tweaks
– for instance, customers wanted to capture not only maximum, but minimum pressure. This means now everything
from “medair” vents in a patient room down to suction
pumps can be tested.
Accuracy and speed were other challenges. Pump
analyzers are hard to develop, because the flow pattern
varies between different models of infusion pumps, Alkire
explains. “So FlowTrax has to be able to take into account
‘pushes’ and ‘pauses’ of fluid that occur during the infusion in order to calculate an accurate flow rate in 3 minutes
or less,” he says.
“Getting out of their car 10 years ago was
miserable because they had heavy pieces of
equipment that had to be dragged to an outlying clinic,” Alkire says of biomeds in the past.
Portability is also essential for a new tool that aims to help
biomeds tackle a tricky mainstay of their work: the testing
of infusion devices.
“The IV testing that’s happening in the industry, it’s
probably the biggest thorn in everybody’s side,” says Greg
Alkire, with Pronk Technologies Inc.
The average 300- or 400-bed hospital has nearly 1,000
pumps that need to be tested once a year, Alkire says. In
general, hospitals either test all their IV pumps in one
month in a marathon preventive maintenance cram session, or they spread it out over the year, with possibly one
person in the biomed shop dedicated to testing pumps
every day over 12 months.
Usually, Alkire says, the pumps are schlepped down
to the biomed shop, but engineers can be called to spotcheck wonky equipment; and, with the increasing focus on
biomeds doing work outside their hospital, having pump
testers that are smaller, lighter and more durable has become increasingly important.
Automation is important, too, for ease of use. The
FlowTrax “primes” by itself, meaning it senses when the
fluid starts and stops, and tracks flow time automatically,
the company says. “It’s smart enough to know when the
fluid starts moving and knows when the fluid stops,”
Alkire explains.
The device costs $1,995. As with TriMedx, the company
says one of the determiners of the price was to keep it low
enough so a shop could buy one device for every biomed.
Of course, portable devices are prone to a hazard endemic
to their kind—dropping. Pump analyzers like FlowTrax are
especially vulnerable, as they contain glassware used to sense
fluid movement. But Alkire says the FlowTrax was built with
the occasional small fall in mind, and he drop tested it 53
times from a height of 3 feet without any harm. He says he
actually got a bit obsessed about this, and stayed up until 2
or 3 in the morning making a video of the test. Naturally, he
then set the video to Beethoven’s 5th symphony.
“We need to put it on YouTube,” he says.
Comments or feedback? Go online: dotmed.com/news/20821
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