Vanadis Extract 提取剂盒包说明书

3221-0010
Vanadis Extract® Bind and Wash kit
Instructions for use.
Manufacturer:
Wallac Oy,
Mustionkatu 6, FI-20750 Turku, Finland
Phone: +358 2 2678 111
FOR IN VITRO DIAGNOSTIC USE
SYMBOLS
Symbol Symbol Title
and Reference
Number Symbol Source /
Standard Title and
Number
Description
In vitro diagnostic medical device No. 5.5.1 ISO 15223, Medical
Devices - Symbols to
be used with medical
device labels, labeling
and information to be
supplied
Indicates a medical device
that is intended to be used as
an in vitro diagnostic medical
device.
Batch code No. 5.1.5 ISO 15223, Medical
Devices - Symbols to
be used with medical
device labels, labeling
and information to be
supplied
Indicates the manufacturer’s
batch code so that the batch
or lot can be identified.
Packing number Not applicable Not applicable
Catalogue number No. 5.1.6 ISO 15223, Medical
Devices - Symbols to
be used with medical
device labels, labeling
and information to be
supplied
Indicates the manufacturer’s
catalogue number so that the
medical device can be
identified.
Use-by date No. 5.1.4 ISO 15223, Medical
Devices - Symbols to
be used with medical
device labels, labeling
and information to be
supplied
Indicates the date after which
the medical device is not to
be used.
Temperature limit No. 5.3.7 ISO 15223, Medical
Devices - Symbols to
be used with medical
device labels, labeling
and information to be
supplied
Indicates the temperature
limits to which the medical
device can be safely
exposed.
Consult instructions for use
No. 5.4.3 ISO 15223, Medical
Devices – Symbols to
be used with medical
device labels, labeling
and information to be
supplied
Indicates the need for the
user to consult the
instructions for use.
Symbol Symbol Title
and Reference
Number Symbol Source /
Standard Title and
Number
Description
Manufacturer No. 5.1.1 ISO 15223, Medical
Devices – Symbols to
be used with medical
device labels, labeling
and information to be
supplied
Indicates the medical device
manufacturer, as defined in
EU Regulations 2017/745
and 2017/746.
GHS02 Not applicable Not applicable
GHS05 Not applicable Not applicable GHS07 Not applicable Not applicable This way up IATA (International Air
Transport Association)
Not applicable
Fragile, handle
with care
EN ISO15223 Not applicable Keep dry EN ISO15223 Not applicable
Recyclable RESY Organization für
Wertstoffentsorgung
GmbH
Not applicable
TABLE OF CONTENTS
SYMBOLS (2)
INTENDED PURPOSE (5)
KIT CONTENTS (5)
Reagents (5)
WARNINGS AND PRECAUTIONS (6)
PRODUCT USE (7)
WARRANTY (7)
Vanadis Extract® Bind and Wash kit 3221-0010 INTENDED PURPOSE
The Vanadis Extract ® Bind and Wash kit is an accessory for Vanadis extraction kits to be used for extraction of cell-free DNA from maternal plasma with automated Vanadis instrumentation for in vitro diagnostic use. The kit is to be used by trained laboratory personnel.
KIT CONTENTS
The kit consists of three packages, 2 x P1 and P2. Store the kit at +19 to +25 °C.
The expiry date of the unopened kit is stated on the outer label. Do not use any component beyond the expiry date.
The kit contains following items:
Component Quantity
Binding Buffer 2 bottles, 640 mL
Wash Solution 2 bottles, 750 mL
Lot-specific quality control certificate 3 pcs
Reagents
2 x Package P1
Component Stability and storage
Binding Buffer Store at +19 to +25 °C until expiry date stated on the
bottle label. Once opened, stable for 30 days at +19 to
+25 °C.
DANGER
Ready-for-use aqueous buffer solution containing isopropanol and guanidinium thiocyanate (30–40%).
Vanadis Extract is a registered trademark of PerkinElmer, Inc.
Binding Buffer contains guanidinium thiocyanate and isopropanol:
H225 Highly flammable liquid and vapour.
H314 Causes severe skin burns and eye damage.
H336 May cause drowsiness or dizziness.
H412 Harmful to aquatic life with long lasting effects.
P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P310 Immediately call a POISON CENTER/doctor.
P405 Store locked up.
P501 Dispose of contents/container in accordance with local regulations.
EUH032 Contact with acids liberates very toxic gas.
Package P2
Component Stability and storage
Wash Solution Store at +19 to +25 °C until expiry date stated on the
bottle label. Once opened, stable for 30 days at +19 to
+25 °C.
DANGER
Ready-for-use aqueous buffer solution containing ethanol (70 %).
Wash Solution contains ethanol:
H225 Highly flammable liquid and vapour.
P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
P403+P235 Store in a well-ventilated place. Keep cool.
P501 Dispose of contents/container in accordance with local regulations.
WARNINGS AND PRECAUTIONS
This kit should only be used by trained laboratory personnel.
Binding Buffer contains guanidinium thiocyanate and isopropanol and is highly flammable liquid and vapor. It causes severe skin burns and eye damage and may cause drowsiness or dizziness. It is harmful to aquatic life with long lasting effects. See specific precautions from the section “KIT CONTENTS”.
Wash Solution contains ethanol and is highly flammable liquid and vapor. See specific precautions from the section “KIT CONTENTS”.
To avoid injuries when working with the kit components, always wear safety glasses, disposable gloves, and protective clothing.
All the reagents may be irritating.
Disposal of all waste should be in accordance with local regulations.
For a patient/user/third party in the European Union and in countries with an identical regulatory regime (IVDR; EU 2017/746/EU); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. The contact information for the manufacturer of this device to report a serious incident is stated on the cover page of these instructions for use.
PRODUCT USE
For further information on how to use the reagents, please refer to 3220-0010 Vanadis Extract Reagent kit insert and Vanadis Extract Manual.
WARRANTY
The performance data presented here were obtained using the assay procedure indicated. Any change or modification of the procedure not recommended by the manufacturer may affect the results, in which event Wallac Oy and its affiliates disclaim all warranties expressed, implied or statutory including the implied warranty of merchantability and fitness for use.
Wallac Oy, its affiliates and its authorized distributors, in such event, shall not be liable for damages indirect or consequential.
Patent: see /patentinfo
Copyright © 2020-2022, PerkinElmer, Inc. All rights reserved.
Changes are highlighted and/or indicated with a vertical line.
Last revision March 23, 2022。