RESEARCH INSTRUMENTS LTD 670854 ユーザーズマニュアル

Section 2

Introduction

Research Instruments Ltd

SECTION 2 - INTRODUCTION TO RI WITNESS™

Intended Use

For RI Witness™ heated work areas only.
Toidentifyandtrackhumansamplesthroughtheassistedreproduction(AR)cycleandwhererequired,

to maintain sample temperature.
Contraindications: Therearenocontraindicationsassociatedwiththeuseofthisdevice.

Medical Device Component

Theheatedplate(andtemperaturecontrol)componentsofthissystemareclassifiedasaclass

IImedicaldeviceinaccordancewithArticle9,AnnexIX,rule9oftheDirectives93/42/EEC&

2007/47/EC,ieit‘administersorexchangesenergy’toorfromthehumanbody.Inrespect

oftheRIWitness™system,energyisemittedintheformofheat,toorfromtheARsample.

Thereisnodirectpatientcontact.

Applicable indications for use are subject to the regulations of the country into which the device is sold.

Availability of RI Witness™ for clinical use is dependent on the regulatory approval status of RI Witness™

within the country the device is intended to be sold into.

Part Number

Description

6-70-801

Sit on Top Heated Work Area Assembly

6-70-801/C

Sit on Top Heated Work Area Assembly with Card Reader

6-70-801/T

Sit on Top Heated Work Area Assembly with Test Tube Reader

6-70-801/TC

Sit on Top Heated Work Area Assembly with Card and Test Tube Reader

6-70-802

FlushFittedHeatedWorkArea1ChannelAssembly

6-70-802/C

FlushFittedHeatedWorkArea1ChannelAssemblywithCardReader

6-70-802/T

FlushFittedHeatedWorkArea1ChannelAssemblywithTestTubeReader

6-70-802/TC

FlushFittedHeatedWorkArea1ChannelAssemblywithCardandTestTubeReader

6-70-803

Slim Heated Work Area Assembly

6-70-803/C

Slim Heated Work Area Assembly with Card Reader

6-70-803/T

Slim Heated Work Area Assembly with Test Tube Reader

6-70-803/TC

Slim Heated Work Area Assembly with Card and Test Tube Reader

6-70-804

FlushFittedHeatedWorkArea2ChannelAssembly

6-70-804/C

FlushFittedHeatedWorkArea2ChannelAssemblywithCardReader

6-70-804/T

FlushFittedHeatedWorkArea2ChannelAssemblywithTestTubeReader

6-70-804/TC

FlushFittedHeatedWorkArea2ChannelAssemblywithCardandTestTubeReader

Applicable Part Numbers