Wireless foot switches for the control of medical devices are gaining acceptance and growing in popularity — prompting OEMs to design medical equipment for use with a wireless foot switch or to accept a wireless foot switch as a pre-sale or post-sale option.
Such designs introduce two new elements into the design of the medical device. The first set of design considerations revolve around the use of wireless foot controls. The second set of design considerations involves the associated wireless receiver located on or in the medical device itself.
Foot Control Design Considerations
Wireless Protocol Selection
Today’s technologies present the OEM with an array of wireless protocols from which to choose. A sampling includes ZigBee®, BlueTooth®, Infrared, WLAN, and customized protocols designed expressly for medical applications.
Key selection factors may include: compatibility with the assessed risk in the application, power consumption and power management, response time, inherent safety and reliability, and cost. Low-risk applications, such as a medical camera capturing reference images, may be adequately addressed with a unidirectional protocol such as Infrared. Alternatively a higher-risk application, such as a laser-based surgical instrument or a high-frequency surgical generator, may be better addressed with a bidirectional protocol. The latter may offer better noise immunity, greater encryption possibilities (for “pairing” the foot control with a specific piece of equipment), and the ability to verify the integrity of the communications link in real time.
The type of batteries to power the foot control will typically be determined by: required operating voltage of the foot control electronics, space constraints to accommodate the required cell(s), frequency of recharging or battery replacement (typically influenced by the wireless protocol selected), the power consumption during a typical procedure, and the number of procedures per day.
Required Operating Voltage/Space Constraints
Most wireless solutions will require at least 3.6 volts to operate the electronics. Thus the battery chemistry selection will gate the number of cells required, and (hence) the space requirements. More cells may require a larger access door for replacement — with attendant moisture sealing requirements.
Battery Replacement/Recharging Techniques
Regardless of the type of batteries used, ease-of-replacement may be an important design consideration — especially if done in the field by the user. In applications requiring frequent replacement, fast access without the need for tools may be a design objective. Depending upon the application, maintaining the sealing integrity of the battery compartment may also be important.
Where secondary batteries are chosen, the method of recharging may also be a major design variable. Current techniques include use of a medical-grade, plug-in wall recharger; conductive recharging in a charging cradle or docking station; inductive recharging; or simply replacing the discharged battery with a fully-charged cell from a charging station on the host system.
Wireless Receiver Design Considerations
OEMs have two options for locating the wireless receiver module: externally (on or attached to the host system) or internally (integrated within the medical device console).
Whether designed as an optional addon accessory or as an element of a new product, an externally mounted receiver requires the electronics to be housed in a rugged package that can be conveniently attached to the medical device. Here the designer must consider:
- A location that does not interfere with foot control (transmitter) and receiver communications
- The method for mounting the receiver to the host device, e.g. docking pocket, magnetic latch, hard mounting with screws, et al).
- Providing power from the host system through the receiver connector (typically via a pin on the host systems’ receiver input connector).
An internally located receiver can consist of a PCB assembly that is mated to the host system electronics, or a bracketed unit that can be quickly installed. Here the designer must consider:
- Space constraints that may affect the dimensional requirements for an internally located receiver.
- Whether to integrate the receiver electronics with the host electronics during initial production or whether to have the receiver electronics as a discrete device to be connected to the host electronics during final system assembly.
- If a discrete device, how power will be supplied to these electronics. Internally located receiver modules generally cost less, as they typically do not need a housing, mounting hardware, or a cable (from the receiver housing to the foot switch input connector or the mating female connector).
Receiver Signal Protocols
Medical device designers have several protocol choices when interfacing the receiver to the host system. The receiver can present the control signals (and other transmitted data, such as battery charge status, number of recharge cycles experienced, foot switch identification information, et al.) to the host device.
The received data can be presented to the host electronics in a wide variety of protocol formats. These include, but are not limited to, Serial RS232, I2C, USB, or simply as discrete contact closures and/or analog voltage or current for variable controlled functions such as speed, power, et al. Close collaboration with the foot switch supplier will result in an optimal interface that is easy to integrate.
Unlike cabled foot switches, which are “tethered” and hence dedicated to controlling the medical device to which they are connected, wireless units (theoretically) have the ability to control any device with the required receiver electronics. Therefore it is essential that the wireless foot switch communicates with, and controls, only the specific device with and for whom its use is intended.
The acceptance and use of wireless foot switches has been greatly accelerated by the development of safe, reliable techniques for “pairing” the transmitter (foot control) and its receiver.
“Pairing”, or the marriage of a foot control to a specific mate, can be achieved in a number of ways. Current techniques include:
- Introducing a foot control to its intended mate over a dedicated IR channel used expressly for establishing a mated pair. This typically involves actuating the foot control in the presence of its mate, in so doing establishing a handshaking protocol in which the receiver accepts and stores the unique identity of the foot control (e.g. model, number, serial number, et al). Following this handshaking, the receiver will recognize commands solely from its “paired” mate.
- Introducing a foot control to its intended mate over its wireless RF link. This typically is accomplished by placing the receiver in a “pairing mode” during which time one or more control functions are actuated on the foot control and the units are subsequently paired.
- Using a “pairing cable.” Here the pairing is achieved by plugging the foot control into the receiver system, during which time the first actuation of the foot switch enables the pairing process. Once paired, the cable can be stored for later use to pair a different/replacement foot control — or for use as a back-up cable to allow the foot switch to be used in a hardwired (non-wireless) mode.
For most applications, pairing is limited to one foot control for one receiver. However, for selected applications it is possible to pair two like foot controls to a single medical device — for example, where two surgeons on opposite sides of the operating table are involved in the same procedure. Here, programming will typically recognize only one foot switch at a time — ignoring any signals from its paired mate until permitted to do so by the system’s program.
The diversity of pairing techniques allows for a great deal of flexibility in the use of a population of like foot controls in the same facility, with consideration for ease-of-field replacement and without compromising system safety.
This technology was done by Steute Meditech, Ridgefield, CT. For more information, Click Here