Required documentation · Web viewStability of the device is guaranteed even if not powered?...

FES-ARM-LEG-EXO-WHL

Protocol to review devices: FES-ARM-LEG-EXO-WHLThis protocol contains relevant safety paragraphs for FES bikes and systems (FES), arm prostheses (ARM), leg prostheses (LEG), exoskeletons (EXO) and wheelchairs (WHL) that are intended to be used at a CYBATHLON event.

Document version number V_2018-02-23Applicable to the following CYBATHLON Events (Name, Date and Location)

CYBATHLON 2020, May 2/3, 2020, Kloten, Switzerland

This protocol serves as the checklist for the examination of device safety (TecCheck) before a CYBATHLON event. This protocol has to be completed by the team manager of the registered team and is then reviewed by the CYBATHLON technical examiners. CYBATHLON technical examiners are matter experts assigned by the organizer to review the provided device documentation.

This checklist is based on requirements and guidelines provided by ISO13482-2014 (Robots and robotic devices – Safety requirements for personal care robots) and by ISO22523-2011 (External limb prostheses and external orthoses – Requirements and test methods).

Only members of the CYBATHLON organising team and the involved CYBATHLON technical examiners have access to the data and documents that are relevant for the TecCheck. Device documentation is reviewed independently by a minimum of two technical examiners. The examiners must sign the examiner’s agreement before having access to the team’s data and documentation.

Once the review is completed by the examiners, the result will be shared with the team manager.

The teams registered for a CYBATHLON event must provide complete safety documentation in order to be eligible for participation.

Instructions to the team managerUse this protocol to check if the documentation on the safety of your device is complete. Please add a reference to each paragraph that refers to the respective document (incl. page number/section) where the item is described (see examples below). Please send us the completed protocol as a word-file.

Team nameDevice nameDevice brand (if applicable)Team manager / corresponding person nameTeam manager / corresponding person email

CYBATHLON_TecCheck_Protocol_FES_ARM_LEG_EXO_WHL V_2018-02-23 of 18Copyright © 2018 ETH Zurich / CYBATHLON

Instructions to the examinerPlease fill in, sign, scan and send the examiner’s agreement to [email protected] (Lukas Jaeger). It is critical to be objective and constructive in the examination and to give clear and helpful feedback to the teams. Please make your revision comments in the empty box right under the corresponding item that is being checked. It is also important that critical items that need to be checked again onsite, i.e. at the event location, are noted. Please mark these items with “Onsite: …”. Please share with the head of discipline any item that was found to be missing in this protocol during examination.

Examiner nameExaminer emailPlace and date


mailto:[email protected]

Required documentationThe following documentation is required and must be provided by the teams (as applicable for the respective discipline):

All devices Video of the device showing functionality during CYBATHLON race task execution or execution of a

comparable task (see most recent version of the CYBATHLON Races & Rules ). Photos of the device

In addition, please complete the following pages 6 to 18 as applicable and sign on the last page (page 18).

Please note that all items in the checklist on pages 6 to 10 have to be on status ‘OK’ in order to be eligible for the onsite TecCheck prior to the event. If any item is ‘NOT OK’ on pages 6 to 10, the teams will be asked to rework the item and to resubmit the documentation.

For commercial devices Declaration of Conformity (DoC) Technical documentation (e.g. manual; design, usage of the product) Records of how the product conforms to relevant European standards European Community type-examination certificates (if applicable) Confirmation that the device(s) will be used at the event according to the specified standards (as intended).

Otherwise the completed Risk Management File is required.

I, the team manager of team _____________________________ (insert team/company name) confirm that neither ourselves nor any commissioned third persons have modified the certified device or any of its components and will only use the device at the CYBATHLON races or on the CYBATHLON racetracks as intended (as declared in the certification):

Team manager namePlace and date

Signature

Please sign, scan and send us this signature page (in addition to the complete protocol as a Word file).

For prototypes or commercial devices that are adapted or used outside the scope of their certification. (In case the device is used outside the scope of its certification, the Risk Management File should be completed only for the tasks that are outside the scope of the product certification.)

Risk Management File (please sign) Information about batteries (usage, charging, temperature, etc.) Residual risks relevant to power failure or shutdown Maintenance instructions Start-up and restarting instructions Continuous usage instructions

The head of discipline checks if the team has provided the documentation that is required to carry out the examination.


Checklist

The team confirms that it has checked and implemented the following points in their device:

Electrostatic discharge (ESD) protectionESD protection is sufficient (IEC 61000-4-2 gives additional guidance).

Electromagnetic interference (EMI) protection Hazards like loss of safety function due to external EMI or an unsafe robot state induced by external EMI are prevented.

Protection against noise > 85 dBThe level of acoustic noise emitted by the robot is sufficiently low that no special protective equipment needs to be worn (for reference values see, ISO 3740, ISO 11200, ISO/TS 15666, ISO 15667).

Vibrations between 0,5 Hz and 80 Hz and between 0,1 Hz and 0,5 Hz are avoidedThe pilot is protected from vibrations between 0,5 Hz and 80 Hz which can cause problems for health, comfort, and perception, and from vibration between 0,1 Hz to 0,5 Hz which can cause motion sickness.

No exposure to extreme temperaturesThe user is sufficiently protected from extreme temperatures, i.e. beyond normal temperatures (surface temperatures between 10°C and 43°C are normally not considered extreme).

The robot does start-up in safe modeThe robot does not perform any hazardous action immediately upon start-up (internal control tests exist and are working, protective stop if any of the initial tests fails).

Speed and force are limited in safe modeThe robot starts in a state of restricted speed and force and in a manual mode that does not use autonomous control mechanisms

The robot stays in safe mode until manually changedWhen the robot is fully functional, continuous operation of the device can only be initiated through a mode change of the pilot.

Maximum voltage does not exceed 50VAccording to EN 60601, devices that are operated at voltage levels less than 50V are considered as safe. If a device is operated at a higher voltages, it must be ensured that no hazards can be caused by the energy source (e.g. sufficient insulation is existent), and an additional risk management document related to the power supply must be shared with the CYBATHLON organising team.


Example - How to fill out this TecCheck Protocol

Team: The team participating at the CYBATHLON needs to fill in this cell.Examiner: The CYBATHLON examiner of the device fills in this cell.

Status (for use by examiner)

Item Description OK NOT OK N/A

Example 1 Electrostatic discharge (ESD) protection is sufficient?ESD protection is sufficient (IEC 61000-4-2 gives additional guidance). X

Team Ref.: Please fill in a reference to your documentation where this item is treated:SuperDeviceSafetyDocumentation.pdf / page [chapter / section]

Examiner If a requirement is met, please mark “OK”. The item does not require further attention.

Example 2 Device can be heard when operated?Hazards due to lack of awareness - lack of noise, if the robot operates silently (noise level < 50 dB), there is some sort of indication (acoustic, visual) when the robot is active.

X

Team Ref.: See above.Examiner Examiner: If a requirement is NOT met and needs further attention

mark “NOT OK” and note in this field what has to be improved in order to be eligible for the onsite check at the event.


Please complete the checklist from this point forward

1) General Safety Measures



1.1. Device can be heard when operated?Hazards due to lack of awareness - lack of noise, if the robot operates silently (noise level < 50 dB), there is some sort of indication (acoustic, visual) when the robot is active.

TeamExaminer1.2. No exposure to harmful substances/materials?

Contact with harmful substances/ leakage or fluid emissions from the robot (e.g. hydraulic fluid) is avoided; no materials that might cause allergies should be used at a surface which comes into contact with human skin (e.g. nickel, chromium, certain types of rubber).

TeamExaminer1.3. Emergency stops can be identified and reached easily?

Emergency stops can be easily reached by the pilot, and by a person that is monitoring the robot during its application; if not reachable by a person in the vicinity, then there must be a second emergency stop that can be reached easily.

TeamExaminer1.4. No loose wires and cables?

No loose wires that could touch a person (open leads) or could be a potential snag hazard for the pilot or any other person in the vicinity of the robot. All cables must be routed closely to the robot or within the robot and must be properly secured (cables ties, clamps, etc.).

TeamExaminer1.5. Uncontrolled release of stored energy does not lead to an unsafe device

state?Uncontrolled release of stored energy cannot lead to hazards. This applies when the robot is operating as well as when the robot is switched off (e.g. mechanical end-stops exist or similar safety features exist).

TeamExaminer1.6. Moving/rotating components cannot be touched?

The robot does not expose moving or rotating components such as motor shafts, gears, drive belts, wheels, tracks or linkages.

TeamExaminer1.7. No potential snag hazards?

There are no components that could potentially become a snag hazard.TeamExaminer1.8. Peripheral components cannot be lost?

If crutches, canes or similar assistive tools are a functional part of the robotic device, it must be assured that these parts are attached to either the robot or the pilot, so that they cannot be lost during operation.

TeamExaminer1.9. Safety equipment does not impose any restrictions?

The use of required safety equipment such as helmet does not restrict the user (range of motion, field of view) during operation.




TeamExaminer1.10. Is it safe to touch/interfere with the device during operation?

The device provides features or is built in a way, so that surrounding safety personal can safely interfere and touch the device in case of emergency (e.g. to prevent it from falling down the stairs without hurting themselves).

TeamExaminer

2) Requirements Related to Energy Storage and Electric Components



2.1. Battery state is displayed?Battery state is indicated to avoid deeply discharged batteries or overloaded batteries (e.g. due to back electromotive force (back EMF) or while regular charging), especially for Lithium Polymer, Lithium-ion (Lithium Cobalt Oxide (LiCoO2), Lithium Manganese Oxide (LiMn2O4), Lithium Nickel Manganese Cobalt Oxide (LiNiMnCoO2 or NMC), Lithium Iron Phosphate (LiFePO4), Lithium Nickel Cobalt Aluminum Oxide (LiNiCoAlO2), and Lithium Titanate (Li4Ti5O12)).

TeamExaminer2.2. Batteries are stored securely?

Batteries are properly secured, cannot move in their casing and are protected from potential impacts and collisions.

TeamExaminer2.3. Batteries do not touch the pilot?

Battery casing is not in direct contact with the pilot or any other person.TeamExaminer2.4. Live battery terminals cannot be touched?

Contact with live battery terminals is not possible.TeamExaminer2.5. Electric components are covered/insulated sufficiently?

All electric components are sufficiently covered/insulated so that electric shocks or burnings are avoided (harmful contact with high electrical energy sources and live components). Any exposed person is protected from direct or indirect contact with live parts of the robot.

TeamExaminer2.6. Energy sources are covered/isolated sufficiently?

Any other potentially hazardous energy sources (e.g. mechanical, hydraulic, pneumatic, chemical and thermal) are isolated and cannot cause crushing, cutting, trapping, burning or injection.

TeamExaminer2.7. Energy sources can be identified easily?

All hazardous energy sources are clearly identified/labeled, and the isolators are capable of being locked or are firmly connected, and thus are not removable.

Team




Examiner2.8. Heat dissipating components cannot be touched?

Heat dissipating components are fully covered or protective guards are used (protection against high temperature due to heat dissipation e.g. electric motors).

TeamExaminer2.9. Splash water protection is implemented?

Splashing water/ spray water cannot lead to an unsafe device state in any case.TeamExaminer

3) Requirements Related to Start-up and Shut-down



9.1. Power failure does not cause a potentially dangerous state?Power failure or unintended shutdown and subsequent re-application of power does not lead to unacceptable risk in terms of robot stability.

TeamExaminer

4) Requirements Related to the Robots Shape



4.1. Stability of the device is guaranteed even if not powered?Hazards due to robot motion (while not traveling) causing mechanical instability (overturning, falling, excessive leaning) are avoided – stability is guaranteed in every posture even if the robot is not powered; if that is not achievable, then there must be an appropriate safety feature that prevents any harm to the pilot and any other nearby person in case of an unexpected power shutdown.

TeamExaminer4.2. Travel of the device does not cause hazards?

It is ensured that the device does not cause any hazardous rollovers, runaways, or drops-off its parts during travel in its specified operating environments.

TeamExaminer4.3. Safe embarkation/disembarkation is ensured?

The device is sufficiently stable to ensure safe pilot embarkation/disembarkation.TeamExaminer4.4. Collisions do not cause an unsafe state of the device?

Safety-related objects are protected from hazardous movements after or during a collision; a collision cannot cause instability

TeamExaminer4.5. Mounting/attachment equipment is ergonomic?




Straps, cuffs or similar mounting/attachment equipment are designed not to cause injuries, e.g. cutting or abrasion.

TeamExaminer4.6. No sharp edges and points?

Sharp edges and points are avoided in the design of the device, or sufficient cushioning or protective guards are used.

TeamExaminer4.7. Insertion of any part of the human body is prevented?

Holes or gaps in the accessible part of the robot are designed so that the insertion of any part of the human body is prevented.

TeamExaminer4.8. Moving parts and detachments do not cause injuries?

Crushing, trapping, pinching, cutting, severing and abrasion due to moving parts and detachments/dropping parts are avoided.

TeamExaminer4.9. The device’s design is ergonomic?

Stress, posture and usage hazards are avoided during robot operation and it is ensured that the user body size assumptions are correct.

TeamExaminer4.10. The field of view is not limited?

The robot does not limit the field of view or visibility of the pilot during operation.TeamExaminer4.11. All components are connected properly?

All parts of the robots need to be connected in a safe way that forces during normal operation are not able to cause any hazardous damage, break them apart or cause instability. Instability can be reached by immoderate physical material extension or reduction, cracks in the electrical wheelchair materials, imprecisely tightened screws or other inadequate attached connecting material.

TeamExaminer


5) Pilot-Device Interaction



5.1. Is the pilot able to control the device and attempt to solve the tasks safely?Video of the device showing functionality during CYBATHLON race task execution (see most recent version of the CYBATHLON Races & Rules ).Tasks that cannot be executed safely will be blocked in the race. (Please indicate in the corresponding section 6) below which task(s) in your discipline you are not going to attempt.)

TeamExaminer

Teams can add additional comments at the end of Section 6) (page 17)

Examiners can add additional comments and/or add additional items that must be checked at the end of Section 6) (page 17) in case they are specific to the device under examination and if they can only be checked onsite.


6) Onsite ChecklistThe following items must be checked by the examiner at the onsite TecCheck. Only once all items are ‘OK’, the device is accredited to start in the event.

Standard items pertaining to all disciplines at onsite check



6.1. Device can be heard when operatedExaminer

6.2. Emergency stops can be identified and reached easilyExaminer

6.3. No loose wires and cablesExaminer

6.4. Moving/rotating components cannot be touchedExaminer

6.5. No potential snag hazardsExaminer

6.6. Peripheral components cannot be lostExaminer

6.7. Safety equipment does not impose any restrictionsExaminer

6.8. Energy sources are sufficiently protected from possible impactsExaminer

6.9. Electric components are covered/insulated sufficientlyExaminer

6.10. Energy sources can be identified easilyExaminer

6.11. Power failure does not cause a potentially dangerous state (test emergency procedure)

Examiner6.12. Device restart does not cause a potentially dangerous state (test restarting

the device after power-off)Examiner

6.13. Safe pilot embarkation/disembarkation is ensuredExaminer

6.14. No sharp edges and pointsExaminer

6.15. Insertion of any part of the human body is preventedExaminer


FES – FES Bike and Systems: Discipline specific items at onsite checkThe following paragraphs are specific to this discipline and only the applicable sections must be answered accordingly.



FES.1. Hazardous levels of voltage and current are avoided?

Any damage to muscle or tissue due to exaggerated electrical current (80mA) or voltage (500V) has to be prevented (according to IEC standard 60201-1 and 60201-210). The applied FES stimulation can be adjusted by the athletes during the run.

TeamExaminerFES.2. The bike is not actuated?

The cycling device is not actuated and must be able to turn with a radius of approx. 13 m.

TeamExaminerFES.3. The electrodes cannot injure the user?

Electrodes must be safe. Implanted electrodes must be stable for at least 6 months and free of complications (e.g. infections) prior to the competition.

TeamExaminer


ARM – Powered Arm Prosthesis: Discipline specific items at onsite checkThe following paragraphs are specific to this discipline and only the applicable sections must be answered accordingly.



ARM.1. Can the socket be attached reliably?

The socket is completely fixed to the stump, i.e. without vibrations/oscillations/residual room, and allows the correct and stable positioning of the prosthetic joints with the pilot’s body.

TeamExaminer


LEG – Powered Leg Prosthesis: Discipline specific items at onsite checkThe following paragraphs are specific to this discipline and only the applicable sections must be answered accordingly.



LEG.1. Is the device properly adjusted to the pilot?

The device’s joints are designed in a way that parts of the human body cannot be injured when the joint is moved as intended by the manufacturer (e.g. restricting the joint limits inherently).

TeamExaminerLEG.2. Is the prosthesis aligned with the opposite leg?

It is assured that the robot’s joints are aligned with the missing biological joints (conformity to the human anatomy) – the pilot’s anthropometric data is provided, so that the examiner can take measurements of the robot’s joints and verify conformity directly. Additionally, the range of motion matches the ROM of the correspondent human joints.

TeamExaminerLEG.3. Can the socket be attached reliably?

The socket is completely fixed to the stump, i.e. without vibrations/oscillations/residual room, and allows the correct and stable positioning and alginment of the prosthetic joints with the pilot’s body.

TeamExaminerLEG.4. Can the foot module be attached reliably?

The foot is completely fixed to the prosthesis, i.e. without vibrations/oscillations/residual room, and allows the correct and stable positioning of the prosthetic joints w.r.t. the pilot’s body.

TeamExaminerLEG.5. The use of the prosthesis cannot cause hazardous situations?

The pilot is able to fully control the leg prosthesis during level ground walking, stair ascent/descent and slope ascent/descent without external support (e.g. crutches, canes).

TeamExaminerLEG.6. Is the weight of the pilot inside the range of weights allowed for safe use of

the prosthesis?

The team has to provide information on the maximum weight allowed for the pilot to use the prosthesis. The weight of the pilot has to be below the maximum weight for safety reasons (e.g., avoid overheating of the motor).

TeamExaminerLEG.7. Is the pilot able to control the device and attempt to solve the tasks safely?

Team and examiner should cross out the tasks that will NOT be attempted in the race. (Tasks are numbered in order of appearance on the track.). The crossed out tasks will then be blocked accordingly on the racetrack by CYBATHLON staff.

Task 1 Task 2 Task 3 Task 4 Task 5 Task 6

TeamExaminer


EXO - Powered Exoskeleton: Discipline specific items at onsite checkThe following paragraphs are specific to this discipline and only the applicable sections must be answered accordingly.



EXO.1. The exoskeleton does not exceed the natural range of motion?The robot’s joints are designed in a way that parts of the pilot’s body cannot be injured when the joint is moved as intended by the manufacturer (e.g. restricting the joint limits inherently).

TeamExaminerEXO.2. Is the exoskeleton properly adjusted to the pilot?

It is assured that the pilot’s biological joints are aligned with the robot’s joints (as intended by the manufacturer), in a way that no harmful/unintended forces are created at the biological joints – the pilot’s anthropometric data is provided, so that the examiner can take measurements of the robot’s joints and verify conformity as intended by the manufacturer directly.

TeamExaminerEXO.3. The device’s weight is less than maximum weight (75kg)?

The device’s weight does not exceed the maximum allowed weight (75 kg excluding the pilot) of the robot as specified by the official CYBATHLON rules.

TeamExaminerEXO.4. Is the pilot able to control the device and attempt to solve the tasks safely?



TeamExaminer


WHL - Powered Wheelchair: Discipline specific items at onsite checkThe following paragraphs are specific to this discipline and only the applicable sections must be answered accordingly.



WHL.1. Can the wheelchair be used by its intended pilot?The powered wheelchair needs to be operable by the pilot: functioning test of patient and pilot together.

TeamExaminerWHL.2. The wheelchair does not fall over on inclined surfaces?

The wheelchair including the pilot has to stand on a ramp with the maximal inclination as specified by the official CYBATHLON rules in 8 directions forward/backward, sideward (left, right side facing up the hill), and all 4 diagonals without falling over.

TeamExaminerWHL.3. The operation of the wheelchair does not cause any hazardous situation?

The wheelchair needs to be demonstrated for its function on stairs and ramps without provoking dangerous situations like falling over. Test stairs upward and downward. Test ramp upward and downward.

TeamExaminerWHL.4. The device’s weight is less than maximum weight (200kg)?

The device’s weight does not exceed the maximum allowed weight (200 kg excluding the pilot) of the wheelchair as specified by the official CYBATHLON rules.

TeamExaminerWHL.5. Is the pilot able to control the device and attempt to solve the tasks safely?



TeamExaminer


Special items to examine onsite (i.e. due to special features of the device under review or cases not covered under standard items above)


Item Description OK NOT OK

Examiner

Examiner

Examiner

Examiner

Examiner

Additional comments by the team

Additional comments by the examiner


7) Signature page

I, the team manager of team ________________________ (insert team/company name) confirm that the above-mentioned safety-relevant items were implemented and tested to the best of our knowledge to ensure safe operation of the device at the CYBATHLON races or on the CYBATHLON racetracks:

I, the team manager, confirm that the content of this form is true and complete.

Team manager namePlace and dateSignature

Please sign, scan and send us this signature page (in addition to the complete protocol as a Word file).

Required documentationPlease make sure to provide the following documentation together with this protocol.

All devices attached Video of the device showing functionality during CYBATHLON race task execution or

execution of a comparable task (see most recent version of the CYBATHLON Races & Rules ).

Photos of the device

Commercial devices Declaration of Conformity (DoC) Technical documentation (e.g. manual; design, usage of the product) Records of how the product conforms to relevant European standards European Community type-examination certificates (if applicable) Confirmation that the device(s) will be used at the event according to the specified

standards (as intended). Otherwise the Risk Management File is required.Please do not forget to sign, scan and send pages 3 and 18 (in addition to the completed protocol as a Word file).

Prototypes or commercial devices that are adapted or used outside the scope of their certification

Risk Management File (please sign) Information about batteries (usage, charging, temperature, etc.) Residual risks relevant to power failure or shutdown Maintenance instructions Start-up and restarting instructions Continuous usage instructions

Please do not forget to sign, scan and send page 18 (in addition to the completed protocol as a Word file).


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