KUKA LBR Med Medical Robot Integration Guide

Absolute precision model installation constraint: The gravity direction during calibration must be consistent with that during operation - a deviation of ≤ 5 ° will only result in loss of pose accuracy, while a deviation greater than 5 ° will prevent the controller from starting properly. The W/A/B/C information on the label must be interpreted according to the KUKA agreement (ZYX intrinsic Euler angle) and must be entered in Sunrise. Wordbench.

The pre startup functional testing is consistent with the industrial version framework (emergency stop, enable switch, panic position, mode selection switch, safety output shutdown capability), but the panic position test requires holding down the panic position for 3 seconds. If smartPAD is configured as pluggable, at least one external emergency stop device that is always accessible must be installed. When starting incompletely, alternative risk minimization measures (safety fences, warning signs, main opening and closing locks, etc.) must be taken and recorded.

Maintenance cycle table:

Periodic tasks

Daily (before operation) visual inspection for damage and liquid leakage; Perform brake testing; Check the operational readiness status (controller error); cleaning robot

Replace all worn stickers within a maximum of 6 months; Check the fastening of the connectors; Check for cable damage; Check the tightness of the threaded connection

1 year inspection of emergency stop device availability; Measure leakage current and grounding conductor resistance; SmartPAD All Enable Switch Function Test

Periodic electrical testing must be carried out by the user in accordance with IEC 62353 and is limited to personnel who have received specialized training - this is the key point that distinguishes the medical version from the industrial version, which states' no maintenance required for intended use '.

The boundary between cleaning, disinfection, and sterilization

The cleaning specification in the medical environment is extremely strict: only wet cloth is allowed to wipe, and spray is strictly prohibited (spray may form combustible mixture or penetrate into the equipment); Cleaning agents are limited to 96% ethanol and medical wiping alcohol (undiluted); Disinfectants are limited to specified formulas such as phenolic derivatives (6% concentrated solution+94% water), aldehydes (undiluted or 12%+88% water), aldehydes+quaternary ammonium salts (10%+90% water), etc. Residual disinfectants and cleaning agents must be thoroughly removed to avoid contamination and infection risks for patients; Clean all parts that come into contact with the patient before each use.

An absolute ban: Robots are not allowed to sterilize. If the intended use requires direct operation in a sterile environment, medical device manufacturers must define corresponding measures (such as using appropriate Drape sterile covers), and the applicability of Drape must be included in the risk management assessment - it must not restrict the robot's mobility, affect the manual guidance mode (no additional external force generated after stretching), cause damage or displacement during movement, and not cause overheating.

List of Key Risk Management Points for Medical Device Manufacturers

The document appendix provides a fairly complete risk management framework, with the following core items that must be implemented item by item:

Liquid accumulation: There are gaps and open cavities on the structure of the robot that can accumulate liquid, and measures to prevent condensation and drainage need to be evaluated.

Application component determination: Evaluate whether non application parts that may come into contact with patients must meet the requirements of B/BF/CF according to clause 4.6 of IEC 60601-1.

Controller isolation: Patients are not allowed to touch the controller and a casing must be installed. Only maintenance personnel can use tools to open it.

Leakage current: Measure the leakage current of the whole machine according to the classification of application parts to ensure that it does not exceed the limit.

Vibration: Running vibration transmission may cause discomfort to patients and should be minimized.

Unexpected stop and fault stop behavior: If risk management allows, safety stop 1 should be prioritized over brake stop (safety stop 0) in emergency situations to avoid unnecessary wear and tear on the brake.

Single fault safety: Security configuration must be correctly configured in Sunrise. WGbench Med based on its own application risk management.

Alarm system: An alarm system that complies with IEC 60601-1-8 can be established based on LBR Med data.

PEMS network integration: Analyze three types of threats: data error flow (CRC/timestamp/packet counter, timing watchdog), network overload, and direct/indirect network access (complete isolation on the network side, system reinforcement, physical access protection), and record protective measures.

Clamping hazard: Assess the squeezing risk of operators at potential clamping points and configure corresponding safety functions.

Strong magnetic fields and implants: The electromagnetic fields generated by motors and magnets may cause dysfunction of implants such as pacemakers, and evaluation and measures must be taken.