USER MANUAL (Instruction for Use) SW 2.9
Safety
Version 2.9.7 dated 2020-12-23 Page 13 of 75
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2 SAFETY
2.1 General Notes
The instructions given in this chapter are to be considered for proper and safe operation of the
Carriazo-Pendular.
The medical device was designed and manufactured in compliance with applicable legal
standards and further technical specifications. It is a state-of-the-art product and offers a high
level of safety.
This level of safety can only be maintained in practical use of the system when all required
measures are taken. It is the obligation of every system user to plan and supervise the
performance of these measures.
You will find relevant information in chapter 2.5 Manufacturer’s Responsibility and in chapter 2.6
Operator’s Responsibility.
IMPORTANT NOTE
Observe all safety regulations, notes and precautions in this User Manual to
ensure that the device is operated only in accordance with generally accepted
rules of technology and the relevant regulations for medical devices (refer to
chapter 2.2 Regulations for Medical Devices).
Observe any other instructions and requirements provided by the user
documentation of the different medical devices to ensure compatibility and safe
operation of the combination between devices.
For safety recommendations regarding electromagnetic compatibility (EMC) and
restrictions on the use of radio frequency (RF) equipment such as cellular phones,
refer to chapter 12 EMC Guidance and Manufacturer’s Declaration.
This is meant for the safety of the patients, for your own safety and for the
protection of the product from damage.
2.2 Regulations for Medical Devices
IMPORTANT NOTE
For safe use of the SCHWIND Carriazo-Pendular the operator must consider the
applicable, normative regulations and directives.
The most important regulations are:
1. Standard IEC 60601-1 Medical electrical equipment – Part 1: “General requirements for basic
safety and essential performance”
(Regulation valid worldwide)
2. Council Directives concerning Medical Devices MDD 93/42/EEC, as amended
(Regulation valid for EEC countries; please consider the valid national regulations)
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