Field Safety Notice FSN: Automatic program/profile modes can cause “unwanted acceleration”

FSN Field Safety Notice
08 Sep 2023
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Warning! Automatic program / profile modes on treadmills without instruction can cause “unwanted acceleration”

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Dear customers, distributors, field service engineers and manufacturers,

A potential risk for patients and/or subjects on a controlled treadmill may arise, if the instruction has not been performed in a sufficient way and if patients or subjects are left alone without understanding proper operation of the treadmills.
Especially if modern motor powered and computerized treadmills have also automatic program and profile modes or cardio mode control or remote control via interface.

Users need to be instructed and need to understand, that in an automatic mode the treadmill will start and stop automatically and will change speed and elevation automatically based on the defined test or program profile. Below see some examples of such tests and profiles.

h/p/cosmos has been informed about some accidents (some of them with injuries) which occurred when operators, patients or subjects have not been instructed properly or when they have been left alone on treadmills without supervision.

Also almost all modern cars and road vehicles have advanced driver-assistance systems such as Automatic Speed Control or Adaptive Cruise Control (ACC) where for example the car will maintain, increase or decrease the speed automatically in order to the maintain a safe distance from vehicles ahead.
See also https://en.wikipedia.org/wiki/Adaptive_cruise_control

In such cases drivers also need to be instructed and need to understand, that the car will not slow down anymore if the foot was removed from the accelerator pedal (accel pedal). The car only slows down when the Automatic Speed Control or Adaptive Cruise Control (ACC) was deactivated or when the brake pedal was pressed by the driver.

Same situation applies for modern treadmills.

The treadmill belt will start and/or stop, increase speed and/or elevation based on the activated profile, program or test mode or commands received via interface in remote control mode. In case there was no sufficient instruction and/or warning, treadmill users may start and activate such profiles, programs or test modes without realizing the functionality and the consequences.
The emergency stop buttons and normal stop buttons will still work on treadmills and can stop the belt immediately.

However, we have heard about cases and accidents, that patients and subjects have been left alone on treadmills and they have been caught by surprise due to the automatic functions and acceleration of the treadmill which then caused panic to the patient/subject.
Due to the panic in some cases they did not press the emergency button and fell on the treadmill which caused serious injuries.

The risks of wrong handling or misuse of a device due to lack of instruction, fluctuation of personnel or misunderstandings can vary depending on the intended location of the device.

For treadmills as medical devices the operator of the treadmill is never the patient but the professional medical staff, therapist or medical doctor. So the sufficient instruction to the operator is limited to a relatively small group of users.

But for example in commercial fitness centers the operator of a fitness treadmill is usually the subject after getting the instructions from the trainer. However, professional trainer staff and supervisors still have to be available also in fitness centers. So there may be hundreds or more operators to be instructed in the operation of a motorized treadmill, including how to perform the emergency dismount. See also instruction based on treadmill standard EN 957-6.

Therefore please allow to repeat the obligatory and necessary steps and risk mitigation and risk control:

  1. perform sufficient instruction to users and operators in operation of treadmill, point out and obey all warnings.
    For this utilize the installation, commissioning and instruction protocol form cos15228-05_en_de:
  2. teach and practice the emergency dismount on treadmills as described on the operation manual
  3. supervise the operation of the treadmill as described in the operation manual IFU instructions for use and never leave children or patients alone on treadmills
  4. temporarily lock and deactivate the automatic program and profile modes or cardio mode control if not needed and activate them only on demand. MCU5: With option 41 ... 44 the modes (manual, profile, cardio, test) can be locked.
  5. secure treadmill against unauthorized operation. MCU5: See “option 40“ in chapter 5.11 “Optional settings User Options
  6. utilize safety arch [cos10170xx] with harness, chest belt as fall prevention device for any application where falling might cause an unacceptable risk

For any questions and/or support and/or PMS observations on that please send an eMail to safety@hpcosmos.com

 

Check also www.coscom.org and h/p/cosmos website:
https://www.hpcosmos.com/en/safety
https://www.hpcosmos.com/en/contact-support/media-downloads/manuals

Deactivation/Activation of automatic program/profile modes