natus Quantum 10-10 Скачать руководство пользователя

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Glossary of Symbols:

Symbol

Standard

Reference

Standard Title

Symbol Title

Explanation

Not applicable Not applicable

An indication of
Medical Device

This product is a medical device.

21 CFR Part
801.109(b)(1)

Labeling-Prescription
devices

Prescription only

Indicates that the product is
authorized for sale by or on the
order of a licensed healthcare
practitioner.

ISO 15223-1
Symbol 5.4.5
(Reference
Annex B for
the general
prohibition
symbol)

Medical devices

—

Symbols to be used with
medical device labels,
labelling and information
to be supplied

Not made with natural
rubber latex

Indicates that the medical device is
not made with natural rubber latex.

2012/19/EU

Waste Electrical and
Electronic Equipment
(WEEE)

Disposal at end of
operating life
instructions

Indicates that electrical and
electronic equipment waste should
not be discarded together with
unseparated waste but must be
collected separately.

ISO 15223-1
Symbol 5.1.1

Medical devices

—

Symbols to be used with
medical device labels,
labelling and information
to be supplied

Manufacturer

Indicates the medical device
manufacturer.

ISO 15223-1
Symbol 5.1.2

Medical devices

—

Symbols to be used with
medical device labels,
labelling and information
to be supplied

Authorized
representative in the
European Community

Indicates the Authorized
representative in the European
Community.

ISO 15223-1
Symbol 5.1.3

Medical devices

—

Symbols to be used with
medical device labels,
labelling and information
to be supplied

Date of manufacture

Indicates the date when the
medical device was manufactured.

ISO 15223-1
Symbol 5.1.7

Medical devices

—

Symbols to be used with
medical device labels,
labelling and information
to be supplied

Serial number

Indicates the manufacturer's serial
number so that a specific medical
device can be identified.

ISO 15223-1
Symbol 5.1.6

Medical devices

—

Symbols to be used with
medical device labels,
labelling and information
to be supplied

Catalogue number

Indicates the manufacturer’s
catalogue number so that the
medical device can be identified.

ISO 15223-1
Symbol 5.4.3
Annex A
#A.15

Medical devices

—

Symbols to be used with
medical device labels,
labelling and information
to be supplied

Consult instructions for
use

Indicates an instruction to consult
an electronic instructions for use
(eIFU).

Содержание Quantum 10-10

Страница 1: ...rademarks or registered trademarks owned licensed to promoted or distributed by Natus Medical Incorporated its subsidiaries or affiliates CaviWipes is a trademark of Metrex Research LLC Sani Cloth is a registered trademark of PDI Inc Description The Natus Quantum 10 10 10 20 Pin Box is a passive inbox replacing standard touch proof connector pin boxes on a Quantum Breakout Box It provides convenie...

Страница 2: ...onments such as hospital rooms epilepsy monitoring units Sleep labs intensive care units and operating rooms It can be used with patients of all ages but is not designed for fetal use Clinical Benefits This Natus Quantum 10 10 10 20 Pin Box provides easier connection of the electrodes during preparation of routine studies using the 10 10 10 20 scheme The 10 10 10 20 Pin Box replaces the standard p...

Страница 3: ...odule into position 3 Create or select a Quantum montage that uses the 10 10 or 10 20 labels Please refer to the NeuroWorks or SleepWorks user manuals for additional information on how to create or select the montage 4 Ensure the 10 10 10 20 Pin Box is enabled in the NeuroWorks SleepWorks software by selecting Edit Settings Acquisition tab Note Additional Breakout Boxes can be added for additional...

Страница 4: ... of the Quantum User and Service Manual to learn more about connectors on the Breakout Box Cleaning Instructions 1 Clean with a commercial wipe such as CaviWipesTM or Sani Cloth to remove visible soil 2 Wipe the article using a lint free cloth and air dry 3 The cleaning procedure must be in accordance with your local facility s guidelines The user operator shall clean the device after every use ...

Страница 5: ...ray liquid onto the device Misaligned connector pins may lead to damage of system components at power on Refer to the Natus Quantum User and Service Manual for connection diagrams CAUTION Device dropped or damaged in transit or use may lead to loss of function Inspect the device before each use and do not use if damaged Unauthorized modification or servicing could lead to loss of device safety fun...

Страница 6: ... the obligation for take back and recycling to the end user unless other arrangements have been made Please contact us for details on the collection and recovery systems available to you in your region at natus com Electrical and electronic equipment EEE contains materials components and substances that may be hazardous and present a risk to human health and the environment when WEEE is not handle...

Страница 7: ... https neuro natus com neuro support Search for Natus Quantum 10 10 10 20 Pin Box IFU refer to the Product Part Number and choose the version for your local language for the instructions to use The files can be printed saved or searched using Adobe Reader A copy of Adobe Reader can be downloaded directly from Adobe Systems www adobe com ...

Страница 8: ...pplied Manufacturer Indicates the medical device manufacturer ISO 15223 1 Symbol 5 1 2 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Authorized representative in the European Community Indicates the Authorized representative in the European Community ISO 15223 1 Symbol 5 1 3 Medical devices Symbols to be used with medical device labels label...

Страница 9: ...electrical equipment Part 1 General requirements for basic safety and Essential performance General warning sign Indicates a hazard of potential personal injury to patient or operator MDR 2017 745 EU Medical Device Regulation CE marking Signifies European technical conformity ISO 15223 1 Symbol 5 3 7 Medical devices Symbols to be used with medical device labels labelling and information to be supp...

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