KUKA LBR Med Medical Robot Integration Guide

KUKA LBR Med Medical Robot Integration Guide

Product positioning: Robot components rather than complete machines

Unlike LBR iiwa, which is aimed at the industrial field, KUKA LBR Med (models 7 R800 and 14 R820) is a special type of "Robot Component" - it is integrated by medical device manufacturers into fixed, permanently installed, or mobile medical devices and marketed as a medical device in the form of a complete system. The document clearly states that this user manual is intended for medical device manufacturers and cannot be directly handed over to end users as a user manual.

LBR Med undertakes two types of tasks in medical devices: tool guidance (including navigation) and action repetition. Typical applications include surgical navigation, biopsy positioning, and other scenarios. Its system composition includes: a robot body with built-in Inside Electrical Med media flange, KUKA Sunrise Cabinet Med controller (available in AC and DC versions), smartPAD teaching pendant (optional), connecting cables, and KUKA Sunrise. OS Med software.

A hard indicator that must be kept in mind is that the operating life of the robot system is 10000 operating hours. This value should be used as the basic input for the overall life design and service cycle planning of the machine.

Compliance Framework: CB Certification and Partial Completion of Machinery

LBR Med has been tested according to the CB Scheme and accompanied by a CB testing certificate to demonstrate compliance with the standards listed in the certificate. There are two red lines in the document that are particularly noteworthy for integration engineers:

Software version binding: Only software components with version numbers listed in the CB test report are compatible with each other and allowed to be installed together. Install software components that deviate from the report, and the CB test report will be invalidated.

Prohibition of modification: Any modification or adaptation of LBR Med and its components (including attachments) is not allowed, as modification will result in the invalidation of CB test certificates and compliance statements.

At the level of the Machinery Directive, LBR Med belongs to partially completed machinery (Appendix II B of 2006/42/EC), and can only be put into operation after being integrated into medical devices and meeting the requirements of the Medical Device Directive/Regulation through compliance assessment procedures. The "General Safety and Performance Requirements" in Appendix I of 2017/745/EU (MDR) are the responsibility of medical device manufacturers. The AC version of the controller comes with EMC and low voltage directive CE markings, while the DC version comes with EMC and RoHS directive CE markings.

List of Expected Uses and Prohibited Items

Among the abuse scenarios listed in the document, the following are directly related to the clinical environment and must be explicitly excluded in the risk assessment:

Non medical applications (such as industrial use)

During the operation of mobile medical equipment, the mobile device itself

Robots move simultaneously with their external axes (such as linear units)

Operating in an oxygen rich environment and near flammable materials (such as anesthetics)

Operating near MRT (magnetic resonance) equipment and strong magnetic fields

Used in conjunction with defibrillators (robots do not have defibrillator safety)

Robots used as Applied Parts

Connect the BF or CF type application parts defined in IEC 60601-1 directly to the robot without appropriate intermediate insulation

Power the application part through data cables (such as PoE)

Unmanned operation, operated by non-medical personnel/patients/third parties

The underlying reason for these limitations lies in the electrical and electromagnetic characteristics of LBR Med, and the insulation concept section below will provide the technical roots.

Technical parameter comparison and medical differentiation design

Parameter item LBR Med 7 R800 LBR Med 14 R820

Workspace volume 1.7 m ³ 1.8 m ³

Posture repeatability (ISO 9283) ± 0.1 mm ± 0.15 mm

Self weight approximately 25.5 kg, approximately 32.3 kg

Rated load 7 kg 14 kg

Maximum operating range 800 mm 820 mm

Protection level IP54 IP54

Maximum shaft torque A1/A2 176 Nm 320 Nm

Controller Sunrise Cabinet Med Sunrise Cabinet Med

Torque sensor measurement accuracy ± 2% ± 2%

Compared with the industrial version of IIWA, the medical version has three significant differences: firstly, the operating environment temperature has been narrowed to+5 ° C to 35 ° C (45 ° C for the industrial version), and the requirements for atmospheric pressure (500-1060 hPa) and maximum installation altitude of 3000 m have been increased; Secondly, the appearance is uniformly in traffic white (RAL 9016), which meets the visual standards of medical environments; Thirdly, the maximum length of the cable is only 7 meters (with five options of 1/1.8/2.3/3/7 meters and no extension allowed), which is much shorter than the industrial version's 15 meters.

The two Cartesian motion abilities are consistent: translational speed of 3.0 m/s, rotational speed of 400 °/s, and translational acceleration of 10 m/s ². The document specifically reminds that the maximum axial acceleration and acceleration given correspond to the rated load condition, and the actual allowable value may be higher under light load - in force control and trajectory planning, the measured constraints of the controller must be used as the standard.