The scope of products

The flow cytometer belongs to the blood analysis system in the Class II 6840 clinical  test  analysis  instrument  according  to  the  "Medical  Device  Classification Catalogue".

ZS-AE7S flow cytometer produced by Biosino can analyze the biochemical and biophysical characteristics on the surface or inside of the membrane of single cell or other particles quantitatively. ZS-AE7S flow cytometry is used to analyze the multi parameter of cells and particles by FSC,SSC, and fluorescence signals excited by 488nm laser and analyzed by five fluorescence channels (FL1, FL2 etc).

This instrument is used for in vitro testing.

Texas Red® is a registered trademark of Molecular Probes, Inc;

CyTM is a registered trademark of Amersham Biosciences Corp.

Identification Description

The following table lists the symbols used in this manual:

Safety and Restrictions

The ZS–AE7S flow cytometer is limited to operate by professional inspectors, doctors or laboratory technicians trained by Biosino.

Biosino is responsible for the installation and maintenance. The safety, reliability and performance of the instrument shall be responsible only when all the conditions are met as below:

1 All operations involve assembling, expansion, readjustment, improvement and repair are carried out by Biosino or its authorized personnel;

 2 All parts and accessories (including reagents and consumables) that need to be replaced during maintenance are original or approved by Biosino.

3 The electrical part of the relevant equipment room complies with the national standards and the requirements of this instruction manual;

4 Instrument operation is carried out in accordance with these instruction;

5 The operator should finish the training of Biosino and pass the examination.

Safety and Restrictions

The ZS–AE7S flow cytometer is limited to operate by professional inspectors, doctors or laboratory technicians trained by Biosino.

Biosino is responsible for the installation and maintenance. The safety, reliability and performance of the instrument shall be responsible only when all the conditions are met as below:

1. All operations involve assembling, expansion, readjustment, improvement and repair are carried out by Biosino or its authorized personnel;

2. All parts and accessories (including reagents and consumables) that need to be replaced during maintenance are original or approved by Biosino.

3. The electrical part of the relevant equipment room complies with the national standards and the requirements of this instruction manual;

4. Instrument operation is carried out in accordance with these instruction;

5. The operator should finish the training of Biosino and pass the examination.

The  ZS–AE7S  flow  cytometer  is  user  friendly  with  safety  protection.  Please operate and maintain the instrument strickly with the instructions in the manual.

Please  ensure  that  this  safety  information  is  accessable  at  any  time.  If the instrument is operated under violation of the instructions, the safety protection of the instrument may be not working.

Laser safety

The laser emits strong electromagnetic radiation. Human eye directly or indirectly exposed to  laser  radiation  can  burn the  cornea  and the  retina, which  can  cause blindness. Laser radiation can also cause irreversible damage to human skin.

This  instrument contains a laser, which  is classified as Class  1 laser product (embedded laser product). This is according to the category described in Appendix

C.3 of GB 7247. 1-2012.

   To avoid exposure to  laser radiation  hazards,  be sure to follow the

following guidelines:

    Adjust or remove the hood of the optical system will cause laser radiation hazard.

It is forbidden for the user to remove the hood of the optical system. It is forbidden to adjust the knob or repair the instrument in the place with laser radiation mark.

    Any adjustment or calibration of the instrument in violation of the instructions will

cause harmful laser radiation hazard;

    When operating the instrument, users must close all the doors on the instrument.

Biosafety

 All biological samples and materials in contact with them are likely to

transmit potential fatal diseases. To avoid exposure to biological hazards, operators must follow the guidelines as below:

ZS-AE7S Flow Cytometer Instruction Manual                                        

      All  biological  samples  and  materials  must  be  strictly  treated  as  infectious materials and reasonable precautions should be taken in order to dispose of the waste in accordance with local relevant guidelines;

      Do not touch the samples or waste liquid directly by hand. Do not blow the tubette with your mouth. Please wear work clothes and gloves when operating. Wear protective glasses if necessary.

      Please wear gloves for protection ，when manually handling the sample.                   

    Please  carefully  use  reagents  like  sheath  solution, cleaning  solution  and shutdown solution which may damage the skin.  In case of accidental contact, please rinse with plenty of water immediately.

     Please dispose waste liquid in accordance with local regulations. When handling the  waste  liquid,  be  sure  to  wear  proper  clothes  and  other  facilities.Wear protective glasses if necessary.

      Empty the waste bottle at the end of the daily operation.

Electrical Safety

    To  prevent  electrical  safety  incidents  and to  protect the  instrument, please follow the guidelines as below:

    The power cord must be connected to the instrument under the suitable voltage condition; any high voltage which above the limit will damage the instrument.

    The power cord must be connected to a three-hole socket with ground protection;     If liquid leaks inside of the instrument, please turn off the power immediately, and clean the  liquid  uptime, do  not turn on the  power before all  liquid  is cleaned properly. (make sure vapor is also gone)

     Electromagnetic compatibility

     The equipment complies with the emission and immunity requirements specified in the electromagnetic compatibility part of GB/T 18268.

ZS-AE7S Flow Cytometer Instruction Manual：                                       

   The equipment is designed and tested according to the Class A equipment in GB4824. In a domestic environment, this device may cause radio interference and protective measures may be required.

    Evaluate the electromagnetic environment before the equipment is used.                  

    This instrument should not be located close to or stacked with other equipment. Ifit must be located close to or stacked, it has to be able to operate properly in the environment.

    In a dry environment, it can cause damaging electrostatic discharges, resulting inerroneous test results.

    Do not use this device near strong radiation sources (such as unshielded RFsources) as this may interfere with proper operation of the device.

    *See “Appendix D Electromagnetic Compatibility Requirements for Equipment”for details.

Safe use

    In order to ensure the safety, please follow the guidelines as below:     Do not touch any moving parts while the system is working;

    Do not put your fingers or hands on any moving/open parts, which may pinch your fingers;

    The mechanical moving part of the automatic sampling module may pinch your fingers. Please close the cover of the automatic sampling module before testing. Please do not open the cover during the test;

    Do  not  stack  any  heavy  objects  on  the  instrument,  which  may  damage  the instrument.

    The system has the function of automatically saving test data on the computer hard disk,  but the  computer  hard disk  may  be  broken,  if so the data will  be missing.  Please  backup  the  analysis  data  to  other  mobile  storage  devices periodically to make sure the data is saved with copy.

ZS-AE7S Flow Cytometer Instruction Manual

Limit

  It is forbidden to use flammable or explosive liquids or reagents on the ZS-AE7S flow cytometer.

  Do not use expired reagents or consumables.

  Biosino provides software and computer for ZS-AE7S flow cytometer. It is the responsibility of the user to ensure that all software installed on this computer or a mobile  storage  device  connected  to  this  computer  does  not  carry  virus.  If  this computer is used for network connection or other purposes, it is the user responsibility to install and maintain effective virus protection software. Biosino does not guarantee that the virus  protection software will  not  be  infected after  installation of antivirus software, nor will it bear any responsibility related to the user's failure to install and maintain the virus protection software.