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HAEMATOLOGY ANALYSER (Sysmex XQ320), 110-240V, 50-60Hz

https://unicat.msf.org/cat/product/89751
STD ELAEHAAE10-

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CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
W0202010101 - Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
UN3091
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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HAEMATOLOGY ANALYSER (Sysmex XQ-320)

The XQ-320 replaces the XP-300 starting from 2023. The XQ-320 uses the same reagents and solutions as the XP-300 but spare parts are different for both models.

Definition

Sysmex XQ-320 is an automated haematology analyser allowing analysis of the main clinical parameters associated to haematology, including, total and differential (3-part) white blood count, platelets and haemoglobin.

Specifications

Parameters: haemoglobin measurements, white cell, red cell and platelet counts, red cell indices: 20 parameters

- WBC- NEUT%
- RBC- LYM#
- HGB- MXD#
- HCT- NEUT#
- MCV- RDW-SD
- MCH- RDW-CV
- MCHC- PDW
- PLT- MPV
- LYM%- P-LCR
- MXD%- PCT
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Quality standards

  • EN IEC 61010-1, 2010, edition 3, +2019 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
  • EN IEC 61010-2-081, 2020, edition 3, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
  • EN IEC 61010-2-101, 2022, edition 3, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

Components

Haematology ananlyser (apparatus)

  • open cap analyser incl. 2D barcode reader
  • Power cable, IFU and CELLPACK spout kit (83400116)
  • Wireless Keyboard (international Layout)
  • Single sheet certificate
  • PRE-INSTALLATION SERVICE (which is not a product)

Technical specifications

  • Standalone device
  • All parameters using the same reagents (see related articles below)
  • Measurement principle: Impedance measurement (WBC, RBC/PLT)
    non-cyanide haemoglobin detection method (HGB)
  • Analysis mode: whole blood (WB) mode and pre-dilution (PD) mode
  • Aspiration volume: 16 μL in whole blood mode, 65 μL in pre-diluted mode
  • Throughput: approx. 70 tests/h (WB mode), 60 tests/h (PD mode)
  • Time to result: <1 minute
  • Operating temperature: 10 to 40 °C
  • Operating humidity: 20-85%
  • Fully automated and standardised measurement
    • Automated background check analysis to avoid carryover
    • Auto dispense function for standardised PD measurement
  • Interface: RS-232C, VGA, 2x Ethernet (RJ45), 4x USB
  • Operating system: Embedded Microsoft ® Windows 10 with McAfee Security
  • Power supply: AC 100 to 240 V (50/60 Hz)

Dimensions

Dimensions: 365 x 440 x 450 mm

Weight: 22 kg

Transport Dangerous Goods

  • UN3091: Lithium metal batteries contained in equipment
  • Class: 9
  • Packing instructions: 970 Section II
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
  • Not regulated for transport by sea
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Supplied with the Article

  • CELLPACK 10L
  • CELLCLEAN
  • STROMATOLYSER-WH 3X500ML

Instructions for use

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

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Precautions for Use

  • Air conditioning is necessary. Dust-free environment.
  • Installation to be done by authorised Sysmex distributor.
  • Secure all electrical devices in the laboratory‌ with a UPS double conversion (see related articles below). To define the best sizing of the UPS, contact your biomedical or energy referent.

Maintenance

A maintenance contract is mandatory. Six-monthly maintenance to be performed by authorised Sysmex distributor.

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