KUKA LBR Med Medical Robot Integration Guide

Surface temperature and IEC 60601-1 Table 23

This is a key data unique to the medical version: after using a 50-150 µ m transparent anti-static polyethylene sterile cover and running continuously for seven hours at an ambient temperature of 30 ° C, the surface temperatures of each PDS (electric drive system) cover plate were measured to be PDS1=39.0 ° C, PDS2=47.5 ° C, PDS3=49.1 ° C, PDS4=48.7 ° C, and then the values remained constant. The ambient temperature and the highest surface temperature can be seen as a linear relationship. When the ambient temperature does not exceed 28 ° C, it meets the requirements of Table 23 of IEC 60601-1 for the highest surface temperature; Manufacturers must verify compliance through continuous or intermittent operation testing for complete machine applications exceeding 28 ° C.

Media Inside Electrical Med and 1 MOPP Insulation Concept

The media flange is the core interface integrated by LBR Med, weighing 262 g, and the hole position complies with DIN ISO 9409-1-50-7-M6. Robots can only operate with this media flange. It provides two power supplies (maximum 48 V DC/8 A via X651, maximum 48 V DC/5 A via X76), analog signal and CAT5 data interface, and internal connectors. The maximum number of insertions and removals of the Tool Connector is 100 times, and the minimum bending radius of the outgoing cable is 5.85 mm.

The insulation concept is the safety core of the entire electrical design. The document assumes that the external environment of the robot is pollution level 2 (it can operate in a pollution level 3 environment under IP54), and the insulation achieved is designed according to 1 MOPP (Patient Protection Measures). The key rules include:

Insulated paths 1-10 are located inside the robot and media flange, with the second layer of protection provided by PE;

The insulation paths 11-14 are located inside the tool connector, and the second MOPP must be achieved by the medical device manufacturer by properly integrating the tool connector into the customer's tool - this is the manufacturer's non transferable responsibility;

The shielding layers of CTR1 and CTR2 must not be connected to PE or grounded enclosures, otherwise the achieved quantity of 1 MOPP will not meet the requirements;

The CTR3 shielding layer between the controller casing and the media flange casing has been internally connected to the flange casing;

The exposed cable end must be insulated, otherwise it may cause short circuit and damage to the media flange;

IP54 cannot be maintained without connecting all connecting cables, and appropriate sealing measures must be implemented between the flange and the tool.

This set of rules explains the root cause of the "BF/CF application section prohibits direct connection" in the previous abuse list: the robot body only meets the requirements of the B-type application section.

Stop distance data and braking testing mechanism

The document provides STOP 0 data according to Appendix B of DIN EN ISO 10218-1. Taking LBR Med 14 R820 as an example, the results of the traditional four axis assessment method (100% extension, 100% POV, maximum load) are: A1 axis 5.742 °/0.188 s, A2 axis 5.998 °/0.200 s, A3 axis 9.323 °/0.198 s, A4 axis 3.162 °/0.092 s.

The medical version has added seven axis flange space stop distance data, which has more clinical reference value: when STOP 0 is triggered from rest, the maximum stop distance of the entire machine flange is only 0.152 mm (A2 axis dominant, 13.9 ms); When moving at 400.0 mm/s, the complete machine stops at a distance of 22.05 mm (133.8 ms); When moving at 598.0 mm/s, it is 41.80 mm (144.8 ms). For surgical scenes with limited space, this millimeter level data directly determines the setting of the protected space.

Special reminder: The STOP 0 data for axes 1-2 are measured values. To avoid risks, it is recommended to multiply the stopping distance and time results by a safety factor of 2.0. Brake wear is related to the number of STOP 0 triggers, and it is recommended to check the stopping distance at least once a year.

The medical version has a qualitative difference in brake testing: the brake test cannot be turned off by the system integrator, and the system enforces periodic brake testing. If not executed, the system will shut down. The document also states that the brake is only applied as a safety measure in the event of a malfunction, and the system will provide a warning message in advance to indicate torque decay before reaching the minimum allowable holding torque - medical device manufacturers must include the time occupation of periodic brake testing in application development.

Installation, startup, and daily operation and maintenance

Installation specification: Both models should use 4 M10x30-8.8 hexagon socket bolts (torque 45 Nm) uniformly, and tighten them in diagonal sequence in multiple stages. After running for 100 hours, tighten them again. The positioning holes are Ø 6 H7 with two depths of 15mm, and the fastening threads are M10x1.5 with four depths of 20mm. We recommend Misumi LANAN6-P6-B5-L5 (cylindrical) and LANDN6-P6-B5-L5 (flat side) positioning pins. The bending radius of the fixed cable laying shall not be less than 45 mm, and an additional 4 mm ² grounding conductor (M4 ring cable terminal) shall be laid according to DIN EN 60204 requirements to achieve low resistance equipotential connection, in order to meet the EMC level of Group 1 of Class B in EN 55011.