Brainlab Buzz Navigation, Site Planning Manual

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1.4 Project-Specific Information
1.4.1 Overview
Project-Specific Information
This guide covers standard information and general specifications. As project requirements vary
from site to site, these specifications must be adapted accordingly. For the implementation of any
project, a detailed site planning phase by Brainlab is necessary.
Customer Responsibility
All structural preparations, such as reinforcement and/or strengthening for wall-mounted items,
ceilings, superstructures, or any related objects are the responsibility of the customer.
Technical Specifications
In the event of technical deviations from the specifications (related, for instance, to country-
specific codes and standards) planning and execution must be reworked in order to fulfill all
applicable regulations.
NOTE: The customer is responsible for notifying Brainlab of any necessary modifications that are
required to meet applicable local or country specific codes and regulations.
Medical Electrical Systems
Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (e.g., IEC 60950 for data processing equipment and
IEC60601-1 for medical equipment). Furthermore, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd
edition of IEC 60601-1, respectively). Anyone connecting additional equipment to medical
electrical equipment configures a medical system and is therefore responsible that the
system complies with the requirements for medical electrical systems. Please note that
local laws take priority over the above-mentioned requirements. If in doubt, consult your
local representative or the technical service department.
Safety Information
Read this guide thoroughly. Non-observance of the guidelines it contains may cause severe or
even fatal injury to the patient or user.
Do not use Buzz components after an abnormal impact, such as an earthquake or explosion.
Because of the possibility of fundamental structural damage to the building, a new structural
evaluation must be performed.
Buzz is only to be installed by trained and qualified personnel.
System components and accessory instrumentation comprise precise mechanical parts. Handle
them carefully.
Information about third-party products contained in this Brainlab site planning manual are for
guidance only - always refer to relevant vendor's site planning manual for up- to-date information.
Before patient treatment, review the plausibility of all information input to and output from the
system.
Only trained medical personnel may operate system components and accessory instrumentation.
MR Safety
Buzz has not been tested in an MR environment.
GENERAL INFORMATION
Site Planning Manual Rev. 1.1 Buzz Ver. 2.0 9