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Home > Battery packs and medical devices don’t always make a great marriage

Battery packs and medical devices don’t always

make a great marriage
Riad Nakhleh, Palladium Energy
Created 2011-04-05 16:00
[1]

Battery packs and medical devices don’t always make a great

marriage [2]

April 05, 2011

By: Riad Nakhleh, Palladium Energy
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Find more content on: Components [4] Design [5] Feature [6] Integrated Circuits [7]
Standards/Regulations [8] Technology [9] Testing [10]
Find Qualified Medical Device Industry Suppliers at Qmed:
Batteries [11]

Safety and reliability head the priority list when designing battery packs into medical devices.

The healthcare industry has been trying to cut the electric cord since the 1950s when Earl Bakken and
Palmer Hermundslie invented the first transistorized cardiac pacemaker with an internal battery. Over
the ensuing decades, manufacturers have continued to introduce devices—hearing aids, digital
thermometers, defibrillators, nerve stimulators, suction pumps, ultrasound equipment, all manner of
surgical instruments, and even a new implantable heart-assist pump—that use internal batteries as a
power source.

Convenience, portability, and ease of use have fueled this market trend. But one of the biggest
challenges remains designing well-engineered battery packs. While improvements in battery technology
have created new opportunities for the introduction of smaller, lighter, smarter, and more portable
medical devices, design engineers who work on battery packs must balance many operational and
environmental needs to ensure that the power source is both reliable and safe.

Battery Power Requires Expertise

Over the last 20 years, the marketplace has increasingly favored the use of lithium-ion (LiIon) cells—for
good reasons. Most LiIon cells have a charge voltage three times greater than a nickel-cadmium (NiCd)
cell, which means that a single LiIon cell produces three times the voltage of a NiCd cell. When it comes
to performance, a LiIon battery provides nearly 10 times the energy density of a comparable sealed

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lead acid (SLA) battery. This makes LiIon an attractive alternative to lead-acid and even NiCd batteries,
especially when size and weight are key considerations.

Creating LiIon battery packs that are safe and reliable requires skill, specialized knowledge, and
experience. LiIon battery cells can be extremely safe to use in a range of applications, but assembling
multiple cells into a pack with sufficient power and run time to operate a device requires careful design
to deliver optimal performance. All battery packs, but especially LiIon packs, need to be part of a
properly designed system or they may rupture, ignite, or explode when exposed to high temperatures,
drops, or other abuses.

Improperly assembled or counterfeit battery cells also can be an issue. For example, a counterfeit cell
can be contaminated with small metallic particles that can cause a battery pack to short-circuit.
Detecting counterfeit cells can be extremely difficult; therefore it’s best to secure battery cells from a
reliable and traceable source. In this way, you can quickly track an issue if a problem is discovered after
a product is released.

If a cell in a LiIon battery pack does short, it can cause adjacent cells to overheat and lead to a
condition known as thermal runaway, in which the cell’s metallic lithium melts and catches fire,
generating temperatures hot enough to melt aluminum (1220°F). Thermal runaway prompted battery
recalls in 2006 and again in 2008, when consumers began reporting problems with the battery packs in
their Apple, Dell, HP, Toshiba, and Lenovo laptops. A similar battery pack problem affected 5.9 million
cell phones in 2006. The resulting recall cost the cell-phone maker $250 million in replacement battery
packs. But that wasn’t the complete picture. After the firm added in free battery replacement, shipping,
labor, sales loss, phone replacements, and other damages, the recall actually cost a whopping $429
million! In addition, the bad publicity pushed the company’s stock price to historic lows.

The chart reflects some serious battery recalls, which can have an enormous financial impact.

Safety is especially important in medical applications, because patients are often wearing (or implanted
with) a device with a battery pack. Even though the medical-device community is subject to rigorous
regulatory oversight, it has had issues with battery pack malfunctions and isolated recalls of implantable
and external defibrillators, instant thermometers, insulin pumps, and surgical instruments.
Improvements in technology and manufacturing processes have led to fewer incidents since 2006, but
continued vigilance and process improvement are necessary to ensure that this trend continues.

Make it safe and reliable

All electrical devices are subject to safety and reliability requirements. But how and where the device

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will be used are perhaps even more important considerations when dealing with a battery-powered
medical device. Will it be used in an oxygen-rich operating room, in a doctor’s office, or in an
ambulance? How long will the device run? Are hot-swappable battery packs required? What type of
battery-pack assembly is most cost-effective for the application?

When designing a battery pack, you should consider all these issues along with requirements for
voltage, accessibility, run time, charge time, and form factor. Each requirement has to be weighed and
considered to ensure that the battery system will deliver optimal performance under real-world
conditions.

For example, a battery pack can act as an ignition source under specific conditions if it isn’t designed
with non-sparking components. Similarly, there’s the potential for thermal runaways (at least with LiIon
batteries) if protection circuits aren’t included to mitigate power surges. Good engineering is even more
critical with some newer types of advanced batteries, such as those that use lithium iron phosphate
(LiFePO4) as a cathode material.

Specific types of protection devices include integrated circuits (ICs) for controlling battery cell voltage.
ICs prevent cells from over-charging or -discharging by controlling a cut-off switch and monitoring
voltage across the switch’s MOSFET structures. Well-designed battery packs also include a resettable
fuse (also known as a polymeric positive temperature coefficient device, or PPTC). Such safeguards
are essential for preventing surges or sags in voltage that could damage the medical device, its battery
pack, or both. Finally, an effective design also includes a thermistor that measures temperature and
shuts down the pack if it increases beyond a predetermined maximum.

All these protection strategies can be tied to a “smart battery” solution, or a microchip that
communicates with the battery pack and recharging source. The microchip can sense when a
recharging is needed, and during recharging it can protect the battery pack against overcharging. This
recharging management technology helps promote cell life and protects against adverse conditions like
thermal runaway. Simple onboard indicators can also tell users whether a device is ready for use or if it
requires recharging or maintenance.

Medical devices are subject to unique requirements, such as the need for sterilization after procedures,
which can affect the pack’s design. To ensure that a battery-powered device will remain safe and
reliable, its pack must be designed for repeated exposure to sterilization conditions. In the case of an
autoclave, this usually means treatment for a minimum of 20 minutes at a temperature of 266°F. These
kinds of high temperatures, moisture, and pressure conditions can stress the most robust piece of
electronic equipment.

Use industry guidelines

Battery packs don’t have to be approved by regulatory agencies such as the FDA, but packs for medical
devices should be independently tested and certified. Fortunately, there are many independent agency
certification programs to ensure LiIon battery pack performance and safety. These programs are
stringent and rigorous, and having their seal of approval provides users with added confidence that they
are implementing the safest battery packs possible.

Let’s now detail some of the more critical industry standards, guidelines, and certifications for ensuring
reliability. Underwriter Laboratories (UL) certifications such as UL 1642 and UL 2054 subject a device
with LiIon batteries to a variety of tests to evaluate its electrical, environmental, mechanical, and user-
replaceable performance. These two certifications apply to LiIon and nickel-based batteries rated at less
than 10 Amp-hours, but UL 2054 is a much broader standard and offers an end-product-level
certification or UL listing. The testing under this standard is divided into five main categories of
evaluation: electrical, mechanical, battery enclosure, fire exposure, and environmental.

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The International Electrotechnical Commission [12] (IEC) oversees a series of standards as part of IEC
60601. Testing and certification for medical devices are focused on demonstrating risk management. It
should be noted that this gives companies the option of following the IEC’s question-based approach or
a registration audit approach developed by the International Organization for Standardization (ISO). UL
60601 is the harmonized standard for IEC 60601 and provides another pathway to certification.

The Cellular Telecommunications Industry Association [13] (CTIA) has expanded the LiIon safety and
performance testing program to include the IEEE 1625 and IEEE 1725 programs. The uniqueness of
these two standards is that they look at the entire system (Host device, Battery, Charger, Cell and User)
for safe design.

The IEEE 1625 standard [14] was developed for mobile computing by manufacturers of rechargeable
lithium-ion or lithium-polymer cells, battery packs, battery and power management semiconductors, and
portable computing systems. It’s specific to batteries with LiIon cells in a multi-series configuration (for
example, two or more batteries in series), which can be used in wireless network devices. IEEE 1625
offers design methodologies to facilitate developing reliable and safe battery packs that still provide
desired features and functions. A designer uses these standards to determine critical operational
parameters over time and across different environmental conditions.

Gaining overall compliance requires conformance with each and every subsection of the standard. A
portable device can’t achieve compliance without consideration of all the related subsystems—including
the user. To achieve compliance, designers of a subsystem like a battery pack must thoroughly review
their designs individually and in conjunction with other subsystems to identify faults that could propagate
hazards. Once the designers ascertain that the subsystems all conform to their particular standard
requirements, they must conduct further analysis to assess the overall system compliance to ensure
that the design doesn’t allow two faults of any type to propagate a hazard.

The IEEE 1725 standard [15] establishes criteria for design analysis for qualification, quality, and
reliability of rechargeable LiIon and lithium-polymer batteries for cell-phone applications. This standard
covers the construction of the pack’s electrical and mechanical components, packaging of the
technology, and mechanisms for controlling cell-level charge and discharge, among other
considerations.

The purpose of this standard is to ensure reliable user experience and operation of batteries in single
series or 1S application in devices using wireless networks. No single piece (cell, battery, charger, or
phone) can be compliant alone—the combination of pieces must be compliant. Although these
standards and compliance to the standards are currently being used in U.S. by the cell phone carriers
(Verizon, AT&T, etc), they provide valuable guidelines for other battery applications.

The International Protection Rating (also known as the Ingress Protection Rating) defines how well an
enclosure excludes solids and liquids as defined in IEC 60529. Battery packs for medical devices
typically are designed for a rating of IP67. The first digit of this rating indicates that the battery pack
enclosure is dust-tight. The second digit indicates that the enclosure will remain watertight to a depth of
3.28 ft. North American enclosure rating systems are defined in National Electrical Manufacturers
Association (NEMA) 250, UL 50, UL 508, and Canadian Standards Association C22.2 No. 94. NEMA
addresses a wider range of product features than does the IP rating. This means an IP67 rating is
equivalent to NEMA 6, but NEMA 6 (which is more encompassing) may not be equivalent to IP67.

The ISO13485:2003 standard applies to medical devices and incorporates the FDA’s good
manufacturing practices. Companies with this certification have implemented a quality management
system that ISO has certified consistently meets customer and regulatory requirements for producing
medical devices and delivering related services.

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Third-party testing
Even if you don’t have an in-house lab, you can ensure compliance with industry guidelines by
consulting with an independent battery testing facility. Such a facility will meet CTIA battery certification
and UL 1642 and UL 2054 certifications requirements and be authorized to carry out the performance
tests noted previously.

Using this approach will enable you to validate that sourced batteries are legitimate and capable of
meeting your marketplace’s requirements. You can also ensure that the battery pack being developed
for your device meets all necessary performance, safety, and environmental requirements.

Battery power is growing

The popularity of battery-powered medical devices will increase as medical practitioners discover the
advantages of going cordless. Added flexibility means they can complete procedures more quickly
during routine visits while still providing the high-quality service patients want.

Device makers are presented with a unique market opportunity. But any cordless device, no matter how
groundbreaking, will be only as effective as the battery-pack system that powers it. Close attention to
system design and rigorous adherence to industry and government standards are essential at all
phases of product development.

About the author

Riad Nakhleh is the director of product solutions for Palladium Energy and leads the development of
innovative design engineering solutions for the company across a wide variety of verticals.

Author:
Riad Nakhleh, Palladium Energy
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