Cooper Surgical RI Witness 6-70-854, Быстрый старт

Страница: 3 / 9

Section 3
3
Safety Warnings Research Instruments Ltd
3
Section 2
Introduction
2
Research Instruments Ltd
2
SECTION 2 - INTRODUCTION TO RI WITNESS
Indication for Use for RI Witness System
To identify and track human samples, using RFID technology, through the assisted reproduction
(AR) cycle, including cryopreservation.
Contraindication:
This device is not intended to be exposed to known sources of electromagnetic interference
(EMI) with medical devices such as diathermy, CT, MRI, RFID (except other RI Witness RFID
components) and electromagnetic security systems, e.g. metal detectors and electronic article
surveillance systems.
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.
Applicable Part Numbers
Related Documents
6-70-121UM RI Witness WorkArea Software Manual
6-70-122UM RI Witness Manager Software Manual
Compatibility
RI Witness is used in conjunction with the following:
•
Essential medical devices, e.g. dishes and tubes, maybe AR or non-AR specific.
• Non-essential medical devices, e.g. safety cabinets, incubators, micromanipulators, lasers.
• Non medical devices (general laboratory equipment), e.g. work benches, microscopes, PCs.
This device has RFID reader capability. If it is the intention that it be employed in a clinical lab, we
recommend its use alongside other medical devices and that the performance of these medical
devices be monitored for potential effects of EMI disturbances, and reported when appropriate.
Installation
Installations of the RI Witness Sperm Preparation Reader should be carried out by a RI technician
or other RI authorised personnel. Incorrect installation could result in overall poor performance.
Part Number Description
6-70-854 RI Witness Sperm Preparation Reader
SECTION 3 - SAFETY WARNINGS
DO NOT disassemble or modify any part of the RI Witness Sperm Preparation Reader,
or substitute any component for any other. Doing so may result in damage to samples.
This voids the warranty and/or service contract.
WARNING To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
ONLY use the power cable and power supply adaptor supplied with the system.The
cable to the power supply is the ‘disconnect device’ for this equipment. To remove
all electrical power from this product, disconnect the power cable from the electrical
outlet. Equipment should be positioned so as to allow easy access to the power
cable. The appliance coupler or mains plug is used as the disconnect and must
remain readily operable.
WARNING Not to be used in a patient environment.
The system should be operated by qualified and trained personnel only.
This symbol indicates cautionary text which should be followed to avoid injury to
users or damage to samples.
WARNING Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
WARNING
There are no replaceable parts supplied with this device. Should any
parts need to be replaced, contact RI or your distributor.
WARNING Use of accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
WARNING Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the Sperm Preparation Reader, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment
could result.