Any equipment used in the front line of surgical or medical applications must meet the stringent requirements and industry standards of this demanding sector.

Steatite has decades of experience in designing, prototyping and manufacturing batteries for use in healthcare settings, and our capabilities in this area are extensive.

What are the common requirements for medical batteries?

The paramount requirement in supplying battery packs for medical applications is reliability. Batteries must run continuously, often for lengthy procedures, without experiencing overheating or variation in discharge performance.

Battery packs must meet rigorous safety standards to prevent any risks of fire, explosions, or leakage of hazardous substances. A BMS (Battery Management System) should be incorporated to provide built-in protection mechanisms, such as protection against overcharge, over-discharge and short-circuiting.

Being able to easily monitor the battery’s state of charge is also essential. Some devices even require a certain threshold capacity before they are operable at all, to ensure that they don’t require changing or charging at a critical point of surgery.

Almost all batteries for use in the medical sector will need to comply with IEC 62133 or its regional equivalent. This is an international standard for the safety of rechargeable batteries, and is a cornerstone for obtaining approval for devices from the UK Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and other global regulatory bodies.

Our proven expertise

We have several customers in the medical sector who have specified a range of parameters for their power requirements, so we have various tried-and-tested battery designs for this industry.

Examples of existing Steatite battery systems

Patient monitoring systems

We currently supply a battery consisting of 2S3P 18650 cells for a ruggedised ambulatory patient monitoring system, capable of recording and transmitting patient data from first responders directly to A&E departments and receiving hospitals.

The cell selection enables the monitor to perform across the widest operational environments while maintaining and communicating critical patient data. The lithium-ion 7.4V 10.2Ah battery is built and tested to the highest tolerances using free issue plastics maintaining the IP66 rating for the device and its UN certification. It also includes a TI fuel gauge and state of charge LED indicators.

Hand-held surgical power

For another customer, our team has developed power packs for battery-operated tools for bone surgery to deliver consistent, reliable power within a highly-regulated medical environment. The range includes both Nickel-Metal Hydride (NiMh), Lithium Ion and Lithium Ferro Phosphate (LiFePO4) batteries. NiMh cells offer good power delivery, tolerate a wide operating temperature, and can be less complex than lithium alternatives. Where runtime and comfort are important, our Lithium based options improve overall energy density including battery capacity-to-weight ratio by around 25% and an increase in delivered power of up to 20%.

Battery-powered ventilators

Another medical customer approached us about providing batteries for its range of portable ventilators. The result was a new rechargeable battery solution that is the sole source of energy for the equipment, including one internal and one external battery, all thoroughly tested and compliant to medical standards.

Powered air-purifying respirators (PAPRs)

For these devices, we have designed batteries with bespoke mechanical enclosures fit for respiratory protection in harsh and critical environments, which may be helmet integrated or body worn. We’ve engineered solutions using both NiMH cells, which are recommended for hazardous areas, and Li-ion cells where space, weight, run time and whole life costs are important.

Portable microwave devices

Our battery design skills have also been put to good use for a compact and portable device in the fight against cancer. Our team was involved right from the beginning of a new project and helped guide the manufacturer through the cell selection process, battery design, prototype development, testing and final production. We also designed the electronics for the custom-built charging station.

One stipulation for this project was that the customer requested all our electronics to establish a handshaking protocol in order to operate, meaning that batteries couldn’t be replaced at a later date with alternative models which may not have been tested to the correct medical standards.

Mobile ultrasound

In the veterinary  sector, where adaptability to diverse weather conditions and limited space are the norm, handheld devices are essential tools.

Partnering with IMV, the leaders in veterinary imaging, we supply cutting-edge battery technology that powers their reliable handheld porcine ultrasound devices. This collaboration yields several thousand units annually, demonstrating both companies’ commitment to powering innovation. Together with IMV, we’ve engineered a robust and enclosed power solution, specially designed for monitoring lively piglets in challenging environments. This collaboration showcases our dedication to delivering advanced, reliable, and versatile solutions for the veterinary industry.

Medical carts and UPSs

Another customer in the medical sector has benefitted from our lead acid battery provision for medical carts. These provide an uninterruptible power supply (UPS) to provide automated backup power in the event of battery or mains failure. Therefore, it goes without saying that reliability is absolutely critical.

Why choose Steatite?

Our large portfolio of customers in the medical sector prove that we are trusted to deliver reliable and efficient battery solutions to this industry. Many of our designs are already certified to IEC 62133 or UL 62133 and these designs can be quickly customised by our expert team to fit the space, power and performance requirements of a huge range of medical devices and scenarios.

In addition to our proficiency in power, we have further capabilities across the business and can combine solutions beyond just batteries.

For example, we offer a wide selection of computers and panel PCs specifically for medical applications. Many of these are certified to EN60601 and incorporate IP rated enclosures to allow for thorough cleaning, plus the transmission of viruses and bacteria is prevented by anti-microbial housing.

Our imaging business unit, Active Silicon, is a leading provider of imaging products for surgical microscopy, ophthalmology, patient positioning systems and other medical devices. Embedded vision systems support computer vision assisted surgery, frame grabbers enhance image acquisition for digital slide scanners and autofocus-zoom cameras capture and transmit HD video for real-time viewing and training purposes.

If you’re involved with designing and manufacturing medical devices, contact our team to discuss your requirements and see what proven products we can offer or modify to meet your exact needs.

Transporting lithium metal and lithium ion batteries means adhering to international regulations. These cover stringent testing, package and storage requirements to ensure the safe containment and carriage of all lithium-ion cells and batteries.

Our battery team has thorough knowledge of the safest and fastest way to transport lithium cells and batteries over land, sea and air. We’ve compiled some FAQs to support you with your transportation queries, but get in touch directly for door-to-door expert assistance.

Why are there rules in place for storing and transporting lithium batteries?

Lithium batteries, under certain conditions, can disassemble rapidly, leading to the risk of fire which can be particularly difficult to extinguish. Should this happen in storage or transit, it poses a risk to life which transport companies must mitigate. Regulations are in place to minimize the chance of a fire breaking out.

Who makes the rules?

Transporting lithium batteries via air is regulated by the global trade association for airlines, the International Air Transport Association (IATA), and the UN specialised agency, the International Civil Aviation Organisation (ICAO) within their Technical Instructions for the Safe Transport of Dangerous Goods by Air document.

Sending lithium batteries via sea is overseen by the UN specialised agency, the International Maritime Organisation (IMO), according to their International Maritime Dangerous Goods Code (IMDG).

When transporting lithium batteries via road within Europe, carriers must adhere to the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), set by the United Nations Economic Commission for Europe (UNECE).

For rail transport, the Intergovernmental Organisation for International Carriage by Rail (OTIF) has its Regulations concerning the International Carriage of Dangerous Goods by Rail (RID).

It’s important to note that local or national regulations take priority over UN instructions and must be legally adhered to over and above the standards set by UN bodies.

Which UN Regulations need to be met?

UN 3090 comprises the United Nations regulations covering Lithium metal batteries (shipped by themselves).

UN 3091 comprises the United Nations regulations covering Lithium metal batteries contained in equipment or packed separately with a piece of equipment.

UN 3480 comprises the United Nations regulations covering Lithium-ion batteries (shipped by themselves).

UN 3481 comprises the United Nations regulations covering Lithium-ion batteries contained in equipment or packed separately with a piece of equipment.

Is there a difference in transporting lithium cells and lithium batteries?

To clarify, a lithium cell is a single unit consisting of a positive and negative electrode that exhibits a voltage differential across the two terminals. A battery is a collection of cells which are electronically connected. Both batteries and cells are subject to the same transportation regulations under the Dangerous Goods Act.

How should lithium batteries be packed for transport?

Cells and batteries must be packaged so that they can’t come into contact with conductive material which may result in a short circuit leading to disassembly. Devices should therefore be wrapped individually in rigid, strong non-conductive packaging unless the device itself provides comparable protection.

It’s also advisable to ensure that any switches on devices are covered or secured so the device can’t be accidentally switched on during travel.

What labelling and documentation is required?

Packaging containing lithium cells or batteries must display all of the relevant markings, see the example below. The border of the mark must have red diagonal hatchings with a minimum width of 5mm. The symbol (group of batteries, one damaged and emitting flame, above the UN number for lithium ion or lithium metal batteries or cells) must be black on white or a suitable contrasting background.

The mark must be in the form of a rectangle or a square with minimum dimensions of 100mm x 100mm. See reference to the relevant shipping method required for full details.

IATA does not require a material safety data sheet (MSDS or SDS), or the UN 38.3 test data report as part of the required documentation requirements when offering lithium batteries for transport.

What else do I need to know?

When shipping Section IB lithium cells and batteries, it’s important to know that Dangerous Goods Training will be required. This is because all elements of the Dangerous Goods Regulations apply to these cells and batteries (exceptions are listed in Section IB). “IB” must be added next to the packing instruction number “965”.

I’m confused, who can help me?

The transportation of lithium cells and batteries is complex, but at Steatite we have the expertise and necessary authorisation to transport lithium batteries both nationally and internationally. Our battery specialists are always on hand to guide you through your engineering and logistical requirements.

Contact the team for help.

Designing and manufacturing superior custom batteries

Steatite has extensive experience of manufacturing custom battery packs and we’ve just added extra capability to our remit.

Our engineers have been successfully spot welding and arc welding packs for a number of years. Spot welding is suitable for the vast majority of our cells, where parts are up to 3mm in thickness. The process does not require excessive heat and the energy delivered to the spot can be carefully controlled to produce reliable welds. Our semi-automated production lines are tailored specifically to create the optimum bond for specific cells and applications, and regularly adapted for changing requirements.

We’ve recently installed an Asterion wire bonder, manufactured by K&S and provided by Inseto to add wire bonding to our inhouse capabilities.

Compared to traditional methods of interconnecting, wire bonding enables manufacturers to offer custom battery packs with high discharge capabilities and reduced assembly time (in a shorter lead time) which meet even higher levels of reliability and safety. Wire bonding helps to prolong cell life and improve battery performance as a result of lower resistance.

Steatite specialises in creating custom batteries which often need to be built in a particular size and shape for unusual housings, and wire bonding allows us the flexibility to place cells in tailored positions and still maintain strong and dependable connections.

What is wire bonding?

Wire bonding is an interconnect technology used to bond integrated circuits, semiconductors and other electronic devices. The process is used by high quality battery manufacturers for the production of Lithium-ion battery pack assembly.

There are three different types of wire bonding: ball bonding, suitable for small wires only; wedge bonding, suitable for small and wide diameter wires; and compliant bonding.

In addition, different wire bonding techniques can be used:

• Thermocompression (wedge: ball) bonding is the original technique, dating back to 1957. This method requires high force and high temperature – around 300°C – but is
viewed as reliable and robust.

• Ultrasonic (wedge: wedge) bonding relies on pressure and vibrational energy and so is carried out at lower temperatures (around 25°C) and is the most common technique for
Aluminium wires.

• Thermosonic (ball: wedge) bonding is the most prevalent method of wire bonding and is conducted at temperatures between 100°C and 240° High pressures are not required
as the bond is formed through ultrasonic energy.

Gold was originally the material of choice for wire bonding technology but Aluminium has now become increasingly widespread due to its good electrical performance and lower cost. Copper wire is another option and is favoured by some manufacturers due to its inherent stability and similarly low cost.

Steatite’s wire bonder

The Asterion model is a rotary head ultrasonic wedge bonder featuring a graphical bond head setup, advanced bond process diagnostics, integrated pull test & loop control with an optional configurable bond head, segmented bonding, extensive logging capabilities, and advanced vision for component alignment.

This model was selected due to the larger bondable area: the 300 x 300mm working area and 0.1μ resolution is ideal for ultrasonic bonding of large wires and ribbons to batteries. The low operating temperature means that components are less likely to be damaged during the process, making the resultant battery packs robust and reliable. Creating new wires is simple and intuitive using the windows-based graphical user interface.

Pull testing capability was also particularly important in the selection process to ensure every pack which leaves our manufacturing site is as robust as possible. The process involves positioning a hook underneath the wire and pulling either until the bond breaks (destructive testing) or a pre-defined force is reached (non-destructive testing).

The location of the wire bond on the bond pad is, of course, extremely important for a secure bond, and we are confident that the Asterion bonder maintains excellent control of bond positioning.

Build, test and test some more

To ensure that Steatite battery packs are correctly and safely bonded, they are tested to comply with several standards, including MIL-STD-883. This military-grade standard stipulates the following mechanical tests for electronics:

• Internal visual.

• Destructive bond pull test.

• Non-destructive bond pull test.

• Ball bond shear test.

• Constant acceleration.

• Random vibration.

• Mechanical shock.

• Stabilisation bake.

• Moisture resistance.

Our engineers also have the capability to design and build bespoke test equipment to analyse, program and test many of the custom battery packs that we design and manufacture. For our more advanced batteries that are designed to operate in high temperature environments, we also have a large thermal test chamber.

Additionally, our battery test facility houses a large selection of power supplies and electronic loads to enable automated emulation of customer applications to aid with testing suitability and projected lifetime of battery packs, often before the final application design is completed.

Power failure is not an option in many of the critical applications we manufacture batteries for. With our best-in-class wire bonding facilities and stringent test capability, customers can be assured that our battery packs will deliver consistent power throughout the lifecycle of the pack.

Expert battery engineering

We will now be able to deliver wire bonded battery packs to customers covering a range of applications including medical, industrial, oceanographic, transport and energy.

We know that every cell that leaves our factory having been wire bonded is safe, reliable and robust. This is in addition, of course, to our traditionally bonded battery packs which have been tried and tested over decades.

See more of what we do and how we can support your standard or custom battery pack requirements: https://custompower.co.uk/