Charging ahead with medical devices

~ Hi-tech medical equipment goes portable with new energy-dense battery ~

Independent battery design, development and manufacturing expert Accutronics has launched a new smart battery that fulfils the needs of manufacturers of high powered medical devices. The CMX series packs a punch - offering high energy density along with high power discharge. Medical OEMs (Original Equipment Manufacturers) can now produce innovative portable devices without compromising on safety and reliability in life-critical applications.

The medical market is a challenging environment, and understandably so. With people's lives on the line it is essential that medical practitioners can rely on their equipment to perform under pressure. The rise in the use of portable devices such as acute ventilators, anaesthesia workstations and intra-oral scanners over the last twelve months has left many medical OEMs struggling to keep pace in the market.

“Part of our branded Entellion range, the CMX meets stringent regulations, demanding development schedules and innovation aims, whilst minimising unit costs," explained Neil Oliver, technical marketing manager at Accutronics.

The battery is available in three versions, using eight, twelve or sixteen '18650' sized cells, with continuous discharge rates of up to 300W. Two voltage platforms are used; 28.8V, which operates between 20.0V and 33.6V and 14.4V, which operates between 10.0V and 16.8V.

Smart features of the CMX series include active and passive protection circuits that prevent over-temperature, over and under-voltage, overload and short circuit.

Forming an essential part of its medical device operation, smart power management means the battery only requests charge when needed and shuts down when not being used. Accurate fuel gauging is possible to 1% through an LCD display, further enhancing reliability.

The new battery complies with the relevant transport regulation, which exists to eliminate the risk of explosion associated with the transport of such energy dense cargo. The CMX series complies with transportation (UN 38.3) and safety (UL2054 2nd ed. and IEC61233:2012) as well as electromagnetic compatibility (EMC) regulations (CE and FCC).

The range charges between zero and +40 degrees, discharges between -10 and +50 degrees and can be stored between -20 and +60 degrees. This results in 500 cycles of 80% minimum rated capacity.

Hospitals can now perform routine power management checks without having to remove the medical device from service using the smart charger that accompanies the CMX battery. A single charger can be used for different sized batteries, because the two devices automatically communicate exact voltage requirements.

For customer convenience, two chargers are available to accompany the CMX series, an internal single channel charger and an external dual bay desktop charger, which can also be used for battery calibration.

Whether batteries or chargers, the Entellion range is made to be customised. Options include product labelling and case colours, software setup and SHA-1 algorithmic security, which prevents counterfeit batteries being used under fraudulent warranty claims.

Trends in Medical Technology 2015

Medical technology (MedTech) is one of the world’s fastest growing industries and the latest and most exciting innovations are currently being explored at COMPAMED, the international medical trade show running from 12-14 November in Dusseldorf, Germany. 

By Michele Windsor

We launched our latest smart-battery range at the trade show, providing a versatile solution to the demand for portable medical devices. Here, we explore a few of the latest trends, live from COMPAMED, for the next generation of medical devices.

1. Power and energy requirements on the rise for portable battery-powered MedTech devices
The last decade has borne witness to rapid innovation in the medical market. Devices have become smaller and as a result, smarter and more intricate components are increasingly in demand. However, there is now an increased demand for mobile technology used in hospitals and in the field, including acute ventilators, portable anaesthesia workstations and intra-oral scanners.

2015 will see a trend for portable, battery-powered medical devices delivering high power discharge from batteries with high energy densities used in mobile hospital setups and emergency services use.


2. Security in MedTech is a concern for OEMs' brands and reputations
Copycat batteries are now available at the click of a button. These, often grey market and sometimes outright illegally produced, knockoffs are now spreading via improved logistics and global supply chain networks. The problem is that copycat batteries often mimic big name brands but lack the certification, testing and even vital circuitry that protects lithium-ion (Li-ion) batteries from unpredictable failure, overheating and potentially exploding.

Battery original equipment manufacturers (OEMs) as well as consumer brands including Nokia and Kodak have already taken action to protect their lucrative aftermarket from reputational damage by introducing security measures such as hologram labels and traceable invisible ink markings on devices.

2015 will see companies push further into securing their products. Accutronics has already made headway into improved security by making available a hardware-embedded software algorithm (SHA-1) which can identify and isolate fake batteries, stopping them from being used in critical-care devices. This also provides better batch traceability and deters fraudulent warranty claims.

3. Western OEMs competing to win market share of premium MedTech in Asia
Until now, the western world has dominated medical technology, with the majority of intellectual property belonging to European and North American companies. Lately there has been a power shift in the MedTech industry and the Asian market, specifically China, is booming, with growth expected to continue over the next few years.

Thanks to a growing Chinese middle class there are hundreds of millions of new patients, creating a significant demand for high tech devices such as pacemakers, defibrillators and insulin pumps.

2015 will see the trend for European and North American MedTech OEMs begin to establish a more permanent presence in Asian and Far Eastern economies to secure and win market share of the premium industry sector.

4. Fringe technologies will start to be used in MedTech
Having already gained traction in the consumer electronics sector, wireless, or inductive charging, to give it its full name, will begin trials in many MedTech devices in 2015. One of the vulnerable areas of rechargeable medical devices to date has been the connection made between the charging port and the mains AC power supply. This can be a source of ingress for dust and water as well as being a haven for bacterial growth.

2015 will see more medical OEMs explore the use of inductive charging to improve device IP (ingress protection) ratings. Introducing fully enclosed and waterproof designs will make it possible to sterilise devices in high pressure hospital autoclaves. The resultant lack of user-serviceable parts will further elongate device lifecycles by the implementation of a return-to-base repair strategy being adopted widely.

5. Anti-microbial surfaces provide an extra line of defence against superbugs
A World Health Organisation report released in April 2014 states that, "this serious threat is no longer a prediction for the future; it is happening right now in every region of the world and has the potential to affect anyone, of any age, in any country. Antibiotic resistance–when bacteria change so antibiotics no longer work in people who need them to treat infections–is now a major threat to public health."

2015 will see OEMs begin to widely consider the role of antimicrobial polymers and coatings for use in device mouldings, casings and on touchable surfaces to minimise the spread of superbugs such as MRSA and other multidrug resistant (MDR) microorganisms.

Visitors to COMPAMED can view and discuss Accutronics' new product range in Hall 8b Stand F30. We look forward to seeing you.

Trust me, I'm a medical device

There is a growing debate surrounding the rise in mobile medical devices. The concern is that the increased reliance on electronic devices to monitor and treat our health becomes dangerous if those very devices become unsafe or unreliable to use. Here, we explore the security and safety of batteries used in our critical medical equipment going forward. 

Medical devices are moving from the once fixed sanctuaries of hospital wards and wandering out into our portable world. The abundance of WiFi, the interconnectivity of electronics and remote information exchange has given rise to the increased portability of the critical devices that monitor our health and provide doctors and paramedics with the tools necessary in delivering flexible and customisable treatment.

However, this rise in portability has created numerous security challenges. The US Food and Drug Administration (FDA) last month pushed for improved cyber security when it issued guidelines aimed at helping medical device manufacturers manage cyber security risks as well as "maintain medical device functionality and safety".

The guidelines will decrease the number of incidents of medical devices being hacked, putting the life of patients in jeopardy. Controversies, such as the one reported by former US Vice President Dick Cheney who, fearing assassination, told doctors to turn off the wireless functionality of his pacemaker after it was found that it could be wirelessly hacked, will be avoided.

However, the problem of security is not limited to the wireless capability of devices. A lack of hardware based encryption has already caused widespread concern over the reliability of batteries used in such equipment.

The fact that portable medical devices have to be designed to operate without mains electricity/AC power access necessitates the use of reliable and safe backup-power management systems. Devices such as acute ventilators, portable anaesthesia workstations and intra-oral scanners all need continuous and safe power to protect patient health.

Battery counterfeiting is a problem faced by the medical industry on a scale never before witnessed in the sector. The ready availability of grey market, untested copycat batteries using inferior components means that many life-critical devices used in our hospitals and medical establishments are becoming unreliable and unsafe to use.

Here at Accutronics, we've worked hard to tackle this problem and will be launching a new CMX series of smart batteries and chargers this November. The new range incorporates some innovative features that include SHA-1 hardware encryption, to prevent fake batteries being used with the host device, active and passive protection circuits, accurate fuel gauging, smart charge control and device-to-host communication.

The new batteries can be transported, stored and used safely, without overcharging, over discharging, overloading and short-circuiting. Thermal sensing on the battery triggers alarms if it is too hot; removing it from the circuit if the operating temperature exceeds safe levels.

Smart power management is what makes the CMX range stand out. Whereas other dumb systems that use a fixed-voltage cut off to prevent over-discharge, the intelligent system in the CMX maximises runtime per discharge cycle by telling the host device when to shut down based on highly accurate remaining-capacity prediction.

Visitors to COMPAMED can find out more about how the CMX range will revolutionise the mobile medical market at Accutronics' product launch press conference. The event will be held at 3pm on the 12th of November, 2014 in room 801a off hall 8b at COMPAMED. If you're interested in attending, you can register for free by calling 01785 225416 today.

If you’re unable to make it to Compamed we will also be launching and displaying the new CMX series at ELECTRONICA in Munich between 11th & 14th November in Hall B2 Stand Booth 454.

High-five for high-power

Tackling the rise in demand for portable medical devices delivering high-rate power discharge, battery specialist Accutronics will be launching a new CMX range on 12 November, 2014 at COMPAMED, the international medical trade show held in Dusseldorf, Germany. In anticipation of the launch, we explore the world of portable power.

Speed is of the essence in life-critical applications. Usually, ambulance crews will transport heart-attack patients to the hospital's emergency ward as soon as possible. However, a leading UK Accident & Emergency doctor recently called for patients to be treated by paramedics until their heart starts beating or they die.

Writing in the British Medical Journal, Dr Benger says that it, "may be actively harmful" to rush cardiac arrest patients to hospital. Because there is only a short time-window of around 50 minutes before permanent brain damage sets in, it is vital that treatment is provided quickly and effectively.

The last few years have seen an increased demand in mobile technology used in hospitals and in the field. Specialised stroke emergency mobile (STEMO) ambulances fitted with portable CT scanners cut the alarm-to-treatment period to just 25 minutes. Acute ventilators, portable anaesthesia workstations and intra-oral scanners are other examples of medical equipment breaking free from the traditional mains power supply.

However, the challenge with these devices is the high-rate power delivery required to operate reliably. The recent Ebola outbreak in West Africa has highlighted the challenge of transporting patients from one part of the world to another. Medical equipment used in the transport of patients must be capable of operating with limited resource for electricity, water and compressed gas.

On September 4, 2014, in response to the Ebola outbreak, the World Health Organisation (WHO) issued guidelines for medical equipment donated for use in the field. The guidelines reinforce the necessity for devices to use high-quality backup power, with current stabilisation, surge protection and uninterrupted power supplies to protect against blackouts and unsustainable mains power.

To overcome these problems, here at Accutronics we've developed a new CMX smart-battery range specifically for high-power applications. Capable of accurate fuel gauging, built to international regulatory standards (IEC62133, UL2054) and offering device-to-host communication for continuous swappable power, the new range will be especially useful in the increasingly dynamic nature of modern hospital care.

Visitors to COMPAMED can find out more about how the CMX range will revolutionise the mobile medical market at Accutronics' product launch press conference. The event will be held at 3pm on the 12th of November, 2014 in room 801a off hall 8b at COMPAMED. Alternatively you can view and discuss the new product range in Hall 8b Stand F30 where Accutronics will be exhibiting. If you're interested in attending, you can register for free by calling 01785 225416 today.

If you’re unable to make it to COMPAMED, we will also be launching and displaying the new CMX series at ELECTRONICA in Munich between 11th and 14th November in Hall B2 Stand Booth 454.

Rechargeable Batteries for Medical Devices

Portable medical devices have benefitted hugely from various advanced technologies which were initially developed for consumer electronic devices such as notebook computers and smart phones, when coupled with these enabling technologies they are being developed faster, made easier to use, and now perform more reliably than ever before.

One continuing complaint from consumers is ‘battery life’. If the battery in your notebook computer runs out while you are writing a report it is annoying, if the battery fuel gauge on your smartphone jumps instantly from 25% to 0% and then shuts off while you are on the train home then it can be frustrating – but in either case no real harm is done. However if a doctor in a hospital is transporting a patient connected to a battery powered portable ventilator or, similarly a paramedic is working on a patient in the street using a battery powered aspirator, then the batteries used to power the portable medical equipment must be completely reliable or patient care could be at risk.  These batteries must work each and every time and never let the medical professional, or their patients down when they need them most.

 

 

Regulatory Framework

Until recently the regulatory framework surrounding the use of batteries in medical devices was poor. There was little or no regulation regarding testing requirements for batteries and it was down to the OEM (original equipment manufacturer) and the battery integrator to work out an agreed quality, safety and performance standard for the battery.

Today, the medical device standard IEC60601-1 (3^rd edition) requires that most battery powered medical devices have their batteries (and the cells within them) tested to IEC62133, which has the catchy title of “Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications”. In addition, Lithium ion batteries (and the cells within them) must be tested to ensure they are safe for transport, and of course, the relevant electromagnetic compatibility standards must be met to allow for CE marking.

Of course, the long arm approach of purchasing a product that has met the relevant regulatory standards does not alone ensure a reliable and safe product.  The device OEM has the responsibility of selecting and partnering with a battery integrator who has a proven track record in the development and manufacture of batteries for medical devices – ones that are also certified to ISO13485 demonstrate they have the correct quality management procedures in place and will furthermore strive for the continuous improvements required for the medical device industry.

 

The need for a professional battery Integrator

A good battery integrator will advise the OEM on the correct battery chemistry to use.  Most OEM customers would simply specify ‘Lithium Ion’ because of its high gravimetric and volumetric energy density, but few realise the term is actually a catch-all for a wide number of different cells types that encompass different cell chemistries, cell manufacturing techniques and physical form factors. Selecting the wrong cell type can be very costly indeed and can result in poor performance, customer dissatisfaction or even product recall.

 

The Smart Battery

Understanding how much runtime remains is vital for users of portable medical devices. If a medical professional cannot rely on the battery fuel gauge then they lose confidence in their ability to use the device away from the AC supply and suffer from runtime anxiety – the worry that they cannot complete their task before the battery energy is depleted.

A good battery integrator will gain a deep understanding of how the medical device will be used and design an electronic fuel gauge system into the battery which constantly tracks the charge, rest and discharge activity. These electronic systems factor-in the prevailing environmental conditions and even the age of the battery to provide a runtime prediction which can be as accurate as ±1%. This runtime prediction is automatically communicated to the device which then displays it in a format the user can easily understand – the battery will even communicate warnings when runtime becomes critical so the user can take action and charge the battery or replace it with another.

As safety is paramount, a battery integrator will include active protection circuitry into the design. These protection circuits monitor the voltage of each cell in the battery and prevent its charge or discharge if one or more cells is in an over-charge or over-discharge condition. The battery is also protected against over temperature conditions or if discharge currents exceed predetermined levels. Industry best practise dictates that secondary over-charge protection is included when designing Lithium Ion batteries to prevent them from becoming unsafe should both the charger and active protection fail. Secondary over-charge protection activates a non-resettable fuse, permanently preventing further operation.

 

Conclusion

The market for portable medical devices is growing rapidly and the increased regulation surrounding the batteries that power them can only help to ensure the devices are safer and more reliable than in the past.

Battery integrators continue to play an important part in providing OEMs with the best battery technology available which allows medical professionals to take their equipment and skills closer to their patients where they can make a real difference - after all, the outcome for the patient is what matters most.

Neil Oliver
Technical Marketing Manager

Sichere CMX-Serie bald verfügbar

~ Akkuhersteller sorgt auf medizinischem Markt für Aufsehen ~

Der in Großbritannien ansässige Akkuhersteller Accutronics wird im Herbst dieses Jahres mit der Einführung seiner neuen Akkuserie auf der COMPAMED in Düsseldorf im medizinischen Bereich neue Impulse setzen. Die CMX-Serie wird bei einer Pressekonferenz auf der COMAPMED, der internationalen Fachmesse für medizinische Hightech-Lösungen, am 12. November 2014 um 15:00 Uhr in Raum 801b bei Messehalle 8b, präsentiert.

Auf dem sich schnell verändernden medizinischen Markt stehen Entwicklungen wie Portabilität und Einsatz von Geräten ohne Netzstrom durch Ärzte und Notdienste derzeit im Mittelpunkt.

Die COMPAMED, die führenden Fachmesse der medizinischen Branche, ist der passende Ort für die Einführung der CMX-Serie. In zwei Messehallen mit insgesamt 10.000 m² Standfläche werden 700 Aussteller aus 40 Ländern vertreten sein. Die Veranstaltung deckt das komplette Spektrum von medizinischen Produkten ab, von Design und Entwicklung bis hin zur Herstellung und Wartung. Besucher können auf der Messe mit Produktionsleitern, Ingenieuren, Konstrukteuren, Forschungsmitarbeitern und führenden Persönlichkeiten aus der Branche zusammentreffen.

Accutronics stellt in Haupthalle 8b auf Stand F30 aus. Das in Großbritannien ansässige Unternehmen spezialisiert sich auf Entwurf, Entwicklung und Herstellung von intelligenten Akkus für Branchen wie Medizin, Verteidigung, Industrie sowie den Markt der portablen Handheld-Geräte.

„So viel sei verraten: Die neue CMX-Serie vereint hohe Spannung, hohe Leistung und intelligente Akkufunktionen in einem Paket, das über die strengen behördlichen Anforderungen hinausgeht, die an für medizinische Geräte bestimmte Akkus gestellt werden,“ erklärte Rob Phillips, Managing Director von Accutronics. „Der Markt der medizinischen Geräte verzeichnet zurzeit ein rasantes Wachstum und die CMX-Serie bietet enorme Möglichkeiten für OEMs, die Geräte für lebenskritische Anwendungen entwickeln.“

Die Einführung wird bei Erstausrüstern (OEMs) im medizinischen Bereich auf großes Interesse stoßen. Accutronics hat in der Vergangenheit bereits ähnlich innovative neue Produkte für diesen Markt präsentiert. Hierzu gehörten u. a. ein kreditkartengroßer Akku für portable medizinische Handheld-Geräte und ein Multi-Akkusystem zur Stromversorgung von medizinischen Gerätewagen. Alle Produkte sind Teil zur anpassbaren Entellion-Serie, die auch algorithmenbasierte Sicherheitsfunktionen bietet, um die Verwendung unautorisierter Nachahmer-Akkus zu verhindern.

FAA approves lithium-ion batteries for A350 Airbus aircraft

Excellent news from Airbus  - they have approval from the FAA to use Lithium Ion batteries on their A350 aircraft. There was concern that the incidents experienced by Boeing would forever prevent Airbus from moving forward with the modernisation of their aircraft battery platforms.

 

The weight and power advantages of Lithium ion batteries in aircraft are so huge compared with traditional Nickel based technologies that this is the only sensible way forward. It looks like Airbus have learnt the lessons from Boeing and can always revert back to Nickel Cadmium if they really have to - but I don't see that being a problem if they have they have done their homework...

Read the article in ESP here...

Neil Oliver