Operation Manual

Fully Automated
Nucleic Acid Extractor
Nexor 32M

Version: V1.0
Revised on: Dec. 2020
©Yantai Addcare Bio-Tech Co.,Ltd.

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 Statement
The copyright of this manual is reserved by Yantai Addcare
Bio-Tech Co.,Ltd. This manual is provided along with the
equipment as instructions, duplicate and reprography whole or any
part of this manual are strictly prohibited prior to signing any
written agreement.
We have tried to ensure all texts and figures are accurate
while compiling this manual, but imperfection is inevitable.
Therefore, Yantai Addcare Bio-Tech Co.,Ltd. assumes no
responsibility for any fault or injury caused by applying the
information in this manual. Yantai Addcare Bio-Tech Co.,Ltd.
reserves the rights of integrating the latest research and
development achievements and improving with new components
and new techniques at any time. And this manual is unconditionally
subject to modification on the basis of technical improvement
without prior notification.
Yantai Addcare Bio-Tech Co.,Ltd. assumes no responsibility
for any injury caused by using this product beyond its intended
purposes or operating by incapable personnel.

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Contents

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1 Overview ......................................................................................4
1.1 About manual.......................................................................4
1.2 Introduction to instrument ....................................................5
1.3 Intended use ........................................................................5
1.4 Structural composition .........................................................5
1.5 Operating principles.............................................................7
1.6 Technical indicators .............................................................7
1.6.1 Technical data of instrument .......................................7
1.6.2 Specification of instrument ..........................................8
1.7 Safety ..................................................................................8
1.7.1 Symbols ......................................................................8
1.7.2 Warnings and precautions ..........................................9
1.7.3 Electric safety ............................................................11
1.7.4 Emergency and corrective measures ........................11
1.8 Electro-magnetic compatibility (EMC) ...............................12
1.9 Service life .........................................................................12
2 Installation & Commissioning .....................................................14
2.1 Packaging of instrument ....................................................14
2.1.1 Packaging & pictorial marking for handling of goods 14
2.1.2 Instructions of packaging, shipment and storage ......15
2.1.3 Packing list ................................................................16
2.1.4 Instrument labeling and external markings ...............17
2.1.5 Package removal ......................................................18
2.2 Installation .........................................................................18
2.2.1 Installation requirements ...........................................18
2.2.2 Spatial and power requirements ...............................19
2.2.3 Environmental requirements .....................................19
2.2.4 Installation of equipment ...........................................20
3 Software Overview .....................................................................22
3.1 Main interface ...................................................................22
3.2 System tools ......................................................................23
3.2.1 Introduction to functions of parameters .....................24
3.2.2 Introduction to component console ...........................25
3.3 Method editing ...................................................................25
3.3.1 Adding .......................................................................26
3.4 Run program......................................................................27
3.5 Beginning test ....................................................................28
4 Maintenance, Servicing & Verification........................................28
4.1 Cleaning & sterilizing maintenance ...................................28
4.2 Verification .........................................................................30
4.3 Disposal of instrument .......................................................30
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 4.4 Training ..............................................................................30
4.5 Disposal of wastes after using the product ........................31
5 Safety risks and prevention........................................................32
5.1 Electrical hazards ..............................................................32
5.2 Mechanical safety ..............................................................33
5.3 Fire safety ..........................................................................34
5.4 Bio-hazards .......................................................................34
6. Troubleshooting ........................................................................34
7 Maintenance Service .................................................................35
7.1 Quality statement...............................................................35
7.2 Warranty instructions .........................................................36
7.3 Warranty limits ...................................................................37
7.4 Product recall.....................................................................38
8 Product and Manufacturer Information ......................................40

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1 Overview

Nucleic acid test has been widely applied in blood sampling

and supplying as well as by medical or clinical institutions. As a
carrier of genetic information, nucleic acids are crucial bio-
informatic molecules and major research objects in molecular
biology such that extraction of nucleic acids is the most important
and fundamental operation among experimental techniques for
molecular biology. Extraction is a process in which nucleic acids in
samples are released into lysed systems.
Our company has developed fully automated equipment that is
able to extract nucleic acids.
Product Name: Fully Automated Nucleic Acid Extractor
Model: Nexor 32M
This manual, containing crucial information and precautions
on use of the equipment and the manual, must be read through
before applying the fully automated nucleic acid extractor
(hereinafter referred to as the extractor).

1.1 About manual

The instruction manual for this product is elaborately compiled

by professionals under organization of Yantai Addcare Bio-Tech
Co.,Ltd. on the basis of the Regulation on the Supervision and
Administration of Medical Devices and pursuant to the Provisions
on the Administration of Instructions for Use and Labels of Medical
Devices.
IMPORTANT NOTICE — Key information about
successful operation or product using.
Provided to the user together with the product, this manual
covers the basic safety and effectiveness information about the
fully automated nucleic acid extractor, and intends for guiding
installation, adjustment, operation, maintenance and servicing as a
technical document.

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1.2 Introduction to instrument

The fully automated nucleic acid extractor finishes sample

nucleic acid extraction, whose functions include lysis, magnetic
collection, binding, rinsing, eluting and magnetic bead removal.
The product adopts modular design for each functional
assembly and open design for the worktop layout. Highly
automated; the system is integrally designed and operated on
Chinese-English bilingual interfaces. Improved precision and
stability; high-precision sensors and motors are employed for
measuring and controlling, thus the motion is precisely controlled.

1.3 Intended use

The fully automated nucleic acid extractor is intended for

extracting and purifying nucleic acids from clinical samples.
As clinically applied to test labs of hospitals, blood banks,
CDC and inspection & quarantine bureaus, this instrument shall be
operated by lab professionals who have accepted training on lab
techniques, learned this manual and can skillfully use the moving
parts within the machine.
Contraindications: None

1.4 Structural composition

The fully automated nucleic acid extractor consists of

mechanical part and electrical part.

Primary structural composition:

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1 Display Module 2 Magnetic Bar holder 3 Magnetic Bush unit
unit
4 Extraction unit 5 Shell module

1 Display Module — operating device software module.

2 Magnetic Bar holder unit — it’s main function is to absorb and discard
magnetism with magnetic rod sleeve.
3 Magnetic Bush unit — The main function is mixing, with magnetic rod
transfer beads.
4 Extraction unit — The main function is to move the deep hole plate to the
designated position for use, for the experiment on the deep hole plate heating
use.
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5 Shell module —appearance of equipment.

1.5 Operating principles

The fully automated nucleic acid extractor extracts nucleic

acids of samples with the ancillary nucleic acid extracting reagents
in the principle of magnetic beads adsorption and automatically
finishes purification by utilizing the encapsulated ancillary
reagents.

1.6 Technical indicators

1.6.1 Technical data of instrument

Major technical indicators are listed below

Item Technical requirements

Environme
Temp. 10 °C~30 °C, RH≤80%
nt
Power
source
Oper AC 200-240 V; 50/60 Hz
requiremen
ating
ts
condi
tions Baro.
86 kPa~106 kPa
Pressure
Altitude ≤2000 m
Plug Meeting local national standard system
Sample
Capable of processing 1 to 32 samples/run
size
Extraction
Para 20 ul-1000 ul
amount
meter
s Te m p e r a t u r e i s s e t a t 6 5 ° C , t h e
Temp. temperature value is within ±1°C of the set
control value, and the fluctuation is not greater
than 1°C
Magnetic Used for magnetic attraction of the
rods magnetic beads
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 Workt Finishing magnetic attraction with
Magnet set
op magnetic rods
Deep-well
plate 2 positions of 96-cavity deep-well plate
position

1.6.2 Specification of instrument

Overall dimension of the nucleic acid extractor: L(W)*W(D)*H:

423*420*420, unit: mm.
Weight：25kg.

1.7 Safety

1.7.1 Symbols

In this manual, symbols are taken as visual signals for conveying

information of vital characteristics.
Symbols Title Description

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 This symbol indicates violating the
operation guide or procedure may
result in physical injury or even
death and may also damage the
instrument. The document should
Caution
be consulted in any circumstances
with this symbol in order to make
clear the nature of the potential
hazard as well as all necessary
measures to be taken.

Caution, hot This symbol indicates the surface of

surface the instrument may be very hot.

This symbol indicates keeping alert

Biological
while using potentially contagious
hazards
substances.
C a u t i o n , This symbol indicates there may be
possibility of electric shock hazard in the
e l e c t r i c operation process and it should
shock keep alert.
This symbol indicates there may be
B e w a r e o f hand pinching hazard in the
pinch points operation process and it should
keep alert.
This symbol is used to indicate the
Beware of
possibility of ultraviolet light
ultraviolet
exposure during the operation and
light
caution should be exercised.

1.7.2 Warnings and precautions

As there are moving parts and bio-chemical hazards, this

instrument can only be operated by trained and skilled personnel
with protective tools, otherwise it may cause injury to the
operators.
When operating the instrument, the operators should wear

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protective equipment against UV radiation.

The following safety information about instrument

installation and operation must be carefully read and observed.
Please ensure this safety information is available for each user.
Operation requirements
This instrument belongs to automated
electrical equipment. Personal injury
may be caused if the user fails to use
this instrument in accordance with the
instructions in this manual.
● Avoid pinching hand when opening
or closing the operation window.
● The housing MUST NOT be
opened when power source is
connected. The operation window
MUST NOT be opened during
operation.
● In order to prevent the danger
caused by moving of the
mechanical parts, DO NOT reach
any part of body into the instrument
when it is running.
● This instrument is fully automated
IVD equipment. Please take
protective measures such as
wearing gloves in the whole
operation process.
● The extraction rack is a potential
source of contamination such that
the user should wear medical
rubber gloves to clean and sterilize
in order to avoid biohazards.
● Please consult relevant sections for
details of cleaning and sterilization.
● Electrical parts with this indication
MUST NOT be touched with hands
or tools when power source is
connected.

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 ● Pay attention to avoid pinching
hand when opening and closing the
equipment gate.
● Do not open the door when the UV
lamp is in operation. It may cause
damage to skin and eyes.

1.7.3 Electric safety

The baseplate/housing of the instrument

Protective should be safely grounded via earth wires.
Conductor Breaking of any grounding circuits, no
terminal matter inside or outside the instrument, will
cause danger.

In order to prevent the danger of electric

shock, please choose qualified power
source (e.g. 200-240V wire 3-phase
grounding receptacle) for the instrument.
In no case should the user try refitting or
destructing the safety devices of the
instrument.
In case the power cord is fractured, worn or
broken, please contact local engineer to
Caution
replace at once.
The back panel MUST NOT be opened
when it is energized.
The operator MUST NOT open the back
panel by itself, and the engineer should
disconnect the power source before
opening the panel and pay attention to the
live parts with indication of “CAUTION,
ELECTRIC SHOCK”.

1.7.4 Emergency and corrective measures

In order to prevent personal injury or damage of machine,

please timely disconnect the power source when this instrument

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occurs with danger or mechanical fault.

1.8 Electro-magnetic compatibility (EMC)

This equipment may be subjected to various kinds of

electromagnetic disturbance. These kinds of disturbance are
conducted via power source, measure or control cables, or
radiated in environment. And this equipment MUST NOT be used
beside intense radiation sources such as non-shielded RF
sources, otherwise normal functioning of the equipment may be
interfered.
a) As professional IVD equipment, this instrument conforms to
the radiation and anti-interference requirements set forth in IEC
61326.
b) This equipment is designed and tested as per type A
equipment in IEC/CISPR 11. This equipment may cause radio
disturbance, so protective measures should be taken in the
ambiance of household.
c) The user is suggested evaluating the electromagnetic
environment around the instrument before using the equipment.

1. The manufacturer is responsible to provide the EMC

information to the user.
2. The user is responsible to guarantee the EMC environment
to enable the equipment to function normally.

1.9 Service life

According to accelerated aging test, the normal service life of

this product is equivalent to 10-plus years. In view of some
unpredictable factors, the service life is fixed as 10 years. When
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the service life ends, the product can be continued to use subject
to maintenance and confirmation of the manufacturer.
This product should not be used at intervals longer than 3
months since it is electrical equipment, otherwise not using for a
long term may cause electrical faults which lead to equipment
damage. In case of not using for a long term, the product should
be turned on and initialized at least once per month.
The user will be accountable for any electrical fault as a result
of not using for a long term and failing to observe the
manufacturer’s stipulations.

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2 Installation & Commissioning

2.1 Packaging of instrument

2.1.1 Packaging & pictorial marking for handling of goods

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 Symbol Description Explanation

Indicating the package should be upright

Upward
during handling.

Fragile,
Indicating the package contains fragile
handle with
care articles and should be handled with care.

Keep dry Indicating the package should be kept dry.

Indicating the package should not be rolled

Do not roll
during handling.

Indicating the range of temperature in

which the package should be kept.
Temperature
limitation
This instrument should be stored and
handled at temperature between
-40°C~55°C.

This instrument should be stored and

Humidity
limitation
handled at relative humidity not greater
than 85%.

Atmospheric This instrument should be stored and

pressure handled under barometric pressure 85
limitation kPa~106 kPa.

2.1.2 Instructions of packaging, shipment and storage

Packaging: Three-layer packaging is employed for the main

unit, of which the outer layer is carton for equipment packaging,
marking and protection; the intermediate layer is polyfoam
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(polystyrene) wrapping for collision protection and buffering; the
inner layer is overall stretch film or plastic bag wrapping for water,
damp and dust proofing.
Shipment: the packaged equipment will be shipped according
to the requirements of order contracts, and it should be kept away
from intense collision, drenching and exposing to direct sunlight
during shipment.
For relocating the equipment that has been installed and
commissioned by the manufacturer, please contact the
manufacturer to relocate and re-commission before using.
Storage: the packaged equipment should be stored in such an
environment that the temperature is -40°C~55°C, the relative
humidity is not greater than 85%, the barometric pressure is 85
kPa~106 kPa, and well-ventilated without corrosive gases.

2.1.3 Packing list

Note: Please check the damages occurred in shipment at the

time of delivery, and report all the apparent damages to the local
after-sales engineer.
Qty Assembly
1 Main unit and accessories, control software
1 Power cord
1 Operation Manual
1 Certificate of Quality
1 Packing List
10 Nucleic acid extraction sleeve
6 96-cavity deep-well plate

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2.1.4 Instrument labeling and external markings

A label shall indicate the product name, model, power

connection conditions, input power, product number, production
date and shelf life, name of the manufacturer’s name, residence,
contact information, production address, etc.
Marker Explanation

Power switch,
1 indicates OFF;
2 indicates ON.

In vitro diagnostic medical device

Alternating current

Authorized Representative In The European Community

Consult Instructions for Use

Date of manufacture

Manufacturer

Serial number

CE Mark

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2.1.5 Package removal

Open the outer packing carton, take out the instrument,

remove the foam, open the packing plastic bag and take out the
stuffing in the equipment.
Please check the packing list.

2.2 Installation

2.2.1 Installation requirements

The instrument should be uprightly placed on a horizontal

plane.
The instrument should be away from equipment with intense
shocking or high electromagnetic radiation.
The instrument is provided with qualified power cord, which
shouldn’t be replaced at will.
The instrument shouldn’t be exposed to direct bright light such
as sunlight.
Installation of the instrument should be in the charge of the
manufacturer’s technical engineer.
After installation, the waste materials placed at the specified
position inside the equipment shall be put on a specified refuse
bag.

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2.2.2 Spatial and power requirements

Floor Level floor

Power connection conditions: AC 200-240 V; 50/60

Hz; typical transient overvoltage power appeared on
power grid is category II and; rated pollution class 2 is
applicable.
In order to prevent electric shock hazard that may be
caused by electric leakage, the external power source
should be grounded.
Electric
power
The instrument is not provided with UPS, but suitable
UPS could be adopted according to local condition of
electric supply, for which the user may consult local
engineer.
The power outlet for the instrument should be local
national standard 10A outlet with ground protection,
and its position should be within 2 meters from the
power inlet of the instrument.

Power Nexor 32M：300VA

There is no other special requirement than the

following:
Ventilati 1. Do not block the air inlets. The horizontal spacing
on between the air inlets and surrounding walls or
other obstacles should not be less than 5cm.
2. Putting articles at the air inlets of fans is prohibited.
An operation space of 50cm should be kept in the front
of the instrument for ensuring convenient and safe
Pass operations.
ways A space of 20cm should be kept on the right of the
instrument for turning off the power switch easily.
Putting articles in the power switch area is prohibited.

2.2.3 Environmental requirements

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Environmental conditions for normal running:
The instrument should be used indoors;
Power source: AC 200-240 V; 50/60 Hz;
Ambient temp.: 10°C~30°C;
RH: ≤80%;
Barometric pressure: 86 kPa~106 kPa;
Altitude≤2000m;
Keep away from sources of intense electromagnetic interference;
Avoid exposing to direct bright light;
Provide an environment with favorable ground connection;
There is no apparent indoor mechanical vibration.
Do not place the equipment in a position that the
equipment is hard to be disconnected. The installation position
should be stable. For relocating the equipment, it has to be done
by professional engineer and calibrated before using.

2.2.4 Installation of equipment

As a precise medical device, this instrument should be

installed by professionals for ensuring safety and effectiveness.
Please assist in supervising the installation process. When in
doubt, please contact the manufacturer (see the section of
production information for details)
Instructions of instrument ports:
Power Power inlet. It is used for input of electric
source power.

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 Installation process:
Inspect the completeness of the external package (whether it’s
broken, caught in the rain, tilted/inverted, or buckled under
Delivery strain etc.) and sign on logistical delivery receipts. Should the
outer packaging be incomplete, please refuse to sign in and
contact local sales rep or engineer.
The installation engineer of the manufacturer is responsible for
safely handling the instrument to the specified location.
Note:
1. The installation engineer has to pre-evaluate the
environmental conditions for installation and confirm the
Transfer
feasibility.
2. Observe the precautions on instrument handling, and it
should not be tilted, inverted or handled roughly, etc.
3. It strictly forbids handling the instrument by removing its fixing
devices.
1. Adjust and fix the horizontal position of the instrument.
2. Remove the devices for fixing the moving parts inside the
instrument.
3. Connect the accessories and the power source. See the
following figure for connecting method:

Installati
on

4. Calibrate the position parameters, technical parameters and

functional requirements of each part.
5. Simulate the test running process and confirm the instrument
running status.

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 1. Check the items against the packing list, and sign the
equipment handover list.
2. Both parties carry out inspection & acceptance according to
Inspecti
the expected test plan, and fill out the installation acceptance
on &
report / technical service report after acceptance.
accepta
3. The installation engineer should train the operators on SOP,
nce
instrument maintenance, alarms and troubleshooting.
4. The operators should be assessed on-site after training and
issued with certificates after passing the assessment.

3 Software Overview

3.1 Main interface

The following figure is the main interface display upon booting:

Functions
1. UV - it mainly controls on/off of the UV lamp
2. Program running (Run) - it’s mainly for selecting test method
and running programs.
3. Program edit (Edit) - it’s mainly for adding edit for new methods.
4. System tools (Tools) - it’s mainly for setting component
coordinates and operating individual component, etc.

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3.2 System tools

System tools comprise of component parameters, component

control, language, system settings, and about.

Component parameters (Param.) – it is mainly for setting the limits

and running speed of components.
Component control (Control) - it is mainly for individually controlling
the operation module of each component.
Language - it is mainly for switching between Chinese and English
languages
System settings (Setting) - it is mainly for setting brightness of
display, time and on/off of buzzer.
About - display software version information.

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3.2.1 Introduction to functions of parameters

Component parameters mainly include:

Tip comb limit: the distance that the tip comb reaches to the
bottom of the deep-well plate.
Rod synchronization: the distance that the magnetic rod reach
to the bottom of the tip comb.
Magnet set speed: running speed of the magnet set Z.
Attract speed: running speed of Z at the time of magnetic
attraction.
Rack speed: heating plate lifting speed.
Mix speed (high, medium, low): mixing speed.
Slot 1, 6: only the coordinates of slot 1 and 6 need to be
adjusted when adjusting slot coordinates. Angle is taken as unit for
adjusting.
Pre-heat tem.: setting temperature

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3.2.2 Introduction to component console

Component control includes target moving positions of

components, deep-well plate, tip comb, turning on/off UV lamp,
ventilating fan. Specified heating temperature. Mixing oscillation
function.
Note: After coordinate z of the magnetic rod, the tip comb and the
magnet set move downwards when carrying out component
control, it has to make the components rise by initializing before
moving the coordinates of the baffle and the carousel. Otherwise, it
may cause collision.

3.3 Method editing

Program editing

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1 Add - click for adding new methods
2 Delete - click for deleting methods
3 Edit – for editing and modifying existing methods

3.3.1 Adding

When clicking “Add”, the interface will be as below.

After entering “Program Name”, click the lower “Add” to add steps.
Note: “Save” should be clicked after adding all steps.

When clicking “Add”, the following interface will display. Just enter
corresponding parameters.
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Note: the name has to be entered manually. The unit of time is second.

3.4 Run program

When clicking “Run”, the interface will be as below.

The program names are on the left side of the interface, and the
running steps of the selected test are on the right side. When
selecting “OK”, the interface will display as below. Test name and
the current step are displayed.

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3.5 Beginning test

Overview of running status: click “Run” — select test method

and confirm — equipment initialization (please close the bin gate in
ahead of this status) — prompt placing deep-well plate after
initialization, and place corresponding deep-well plate according to
the prompt. The last piece of deep-well plate is magnet set
assembly (deep-well plate + magnet set).
Note: please close the bin gate each time after the deep-well plate
is placed. Otherwise it will not run. The equipment will run normally
when the deep-well plate meets the conditions.

4 Maintenance, Servicing & Verification

Since the day of equipment installation, the company will

provide maintenance service that is free for the first time and one
time of free calibration. For details, please call the After-sales
Service Department.

4.1 Cleaning & sterilizing maintenance

● Cleaning:
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 Be careful not to splash liquid onto the external surface, the
worktop and the inside of the instrument.
The instrument can be wiped with soft clean wet gauze or
tissue.
The acrylic housing and the worktop can be further wiped with
95% alcohol or special detergent for instrument.
Mechanical dead corners such as metal plate slits can be
dusted with a soft brush.
● Sterilization:
The following areas should be sterilized on a regular basis as
there are potential bio-hazards:
The test tube rack, the test tube slot, the manipulator, the
centrifuge and the waste bin.
Ways of sterilization: key positions and dead corners should
be treated with 75% medicinal alcohol; components with
higher potential bio-hazard such as waste bin should be
removed and soaked in special disinfectant for regular
sterilization.
● Maintenance:
◇ Daily maintenance items:
1. The worktop should be timely cleaned each day after tests
are finished.
2. Inspect whether the extracting modules and the extracting
rack run stably.
3. Timely dispose abnormal conditions in running.
◇ Weekly maintenance items:
1. Inspect whether the extracting modules and the extracting
rack move flexibly.
2. Inspect whether the extracting modules and the extracting
rack run stably.
3. Clean the dirt on the extracting rack.
4. Timely clean the dirt inside the instrument.
◇ Monthly maintenance items:
1. Each guide rail and bearing should be lubricated.
2. When left unused for a prolonged period, the equipment
should be turned on once per month.
3. Inspect whether the positions of the extracting module and
the extracting rack are precise, and timely adjust if there is
deviation.
4. Check whether the moving parts move smoothly. If not, they
should be timely adjusted.
◇ Guide to annual maintenance:

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 No. Modules Items to be confirmed in maintenance

Measure the grounding wire of power supply.

1 Power If there is no grounding, BE SURE to rectify in
source time.
2 Inspect the power port
3 Wipe and clean the exterior of the equipment
4 Comple Wipe and clean the worktop
te
machin Timely replace the magnetic rod holder or the
5
e tip comb holder if it’s broken
6 Inspect fixing screw

4.2 Verification

After initial setting, the nucleic acid extractor should be

calibrated by professionally trained engineer of Yantai Addcare
Bio-Tech Co.,Ltd., and then calibration will be carried out as per
the time interval stipulated in service agreement.
There will be positional deviation in case of long term running,
and then the instrument should be calibrated. Normally, the time
interval of calibration is one year.
Calibration content
Each positional coordinate of the nucleic acid extractor;
Primary technical Indicators

4.3 Disposal of instrument

The instrument should be properly disposed pursuant to local

Measures for Administration of Medical Wastes when its service
life is over and it is confirmed not serviceable any longer by the
engineer.

4.4 Training

According to requirements of installation and use, the user

can dispatch operating staffs to accept training on installation,
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operation and maintenance at Yantai Addcare Bio-Tech Co.,Ltd.

4.5 Disposal of wastes after using the product

Large amount of wastes will be produced after using the fully

automated sample pipette, which have higher bio-hazard and must
be uniformly disposed pursuant to the Measures for Administration
of Medical Waste.
Waste disposal procedure:
1. The operator should classify the medical wastes in
accordance with the Classified Catalogue of Medical Waste;
2. According to classification, the medical wastes should be
respectively placed into special packaging bags or containers that
conform to Standard of packaging bags, containers and warning
symbols specific to medical waste.
3. The operators should check the packaging bags or
containers carefully before holding the medical wastes and ensure
they are intact without leakage or other defects;
4. When the packaging bags or the containers are filled up to
3/4, they should be sealed up firmly and tightly with effective
method.
5. The outer surface of each bag or container holding medical
wastes should be marked with warning sign and attached a label in
local. The label should contain medical waste producing unit,
production date and classification;
6. Infectious wastes, pathologic wastes and traumatic wastes
within the bags or the containers should not be taken out at will;
7. Regular medical waste handlers handle the medical wastes
that have been packaged by classification from their producing site
to the temporary storage room along the specified route on a daily
basis. In the handling process, it should prevent the medical
wastes from getting out or leaking and prevent direct body contact
with such wastes. Each day after handling operation, the handling
tools should be timely cleaned and sterilized.
8. Regular medical waste handlers should weigh and register
the medical wastes at the producing sites on a daily basis. The
registered content includes source, type, weight, time of handing
over, finial destination and operator;
9. The medical wastes in the temporary storage room should
be handed over by regular staff to special personnel appointed by
County Bureau of Health and County Bureau of Environmental

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Protection. The storage time should not exceed 2 days and the
Hazardous Waste Transfer Sheet should be filled out;
10. After the medical wastes have been handed over, regular
staffs should timely clean and sterilize the temporary storage site
and facilities.
The medical wastes are generally disposed through the
aforementioned process. If the user of the fully automated sample
pipette has special requirements on waste disposal, it has to be
carried out in accordance with the user’s method of waste
disposal.

5 Safety risks and prevention

5.1 Electrical hazards

Operators must not open the instrument housing at will so as to

prevent the built-in high voltage modules or the moving parts from
jeopardizing the operator’s safety. Please disconnect the power
supply and unplug the power cord before cleaning or sterilizing the
instrument. When the instrument is running or malfunctions, please
DO NOT reach your hand into the instrument. In case of abnormal
conditions, please make sure to disconnect the power source at
first.
When the equipment is in normal conditions or with single
fault, it should be kept electric shock proof, and the accessible
parts should not be hazardously live. When it is hard to keep the
following parts both from accessible and from hazardously live, the
operators will be allowed to perform simple maintenance while
these parts are hazardously live after training, but they must not be
touched during normal use:
a) The parts that are predetermined to be replaced by the
operators, such as batteries, could be hazardously live when they
are replaced or under other operations, so they can be touched
only with tools and should be marked with CAUTION.
b) Locking or thread fastening measuring terminals, including tool-
less demountable terminals.
In order to prevent personnel injury, untrained operators should
not disassemble electrical and mechanical parts at will.
Preventing flame from spreading from the inside of the
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equipment to the outside
When the equipment is in normal conditions or with single
fault, the flame should not spread to the outside of the equipment.
When the equipment is in normal conditions or with single
fault, the flammable fluids that are filled in the equipment or used
together with the equipment should not cause spread of flame; the
ignition sources within the equipment should be reduced or
eliminated; in case of fire, the flame should be controlled within the
equipment.
The following structural requirements should be met:
a) The flammability rating of the insulating conductors should be
equivalent to or better than FV-1 as stipulated in IEC 60707. The
flammability rating of the insulating materials for the connectors
and the installation components should be equivalent to or better
than FV-2 as stipulated in IEC 60707.
b) The housing should meet the following requirements:
1) The bottom of the housing should be free of openings, or
mounted with conforming baffles within the specified range, or
made of metallic materials. The openings should meet
requirements or metal separation nets are used.
2) The housing and all baffles or fireproof plates should be made
of metals (except magnesium), or made of non-metallic materials
whose flammability rating is equivalent to or better than FV-1 as
stipulated in IEC 60707.
3) The housing and all baffles or fireproof plates should be with
adequate rigidity.

5.2 Mechanical safety

When the equipment is in normal conditions or with single

fault, operations should not affect mechanical safety. There should
be no chance for the moving parts to squeeze, cut or pierce any
part of the operator’s body, or seriously pinching the operator’s
skin.
Do not use easily accessible moving parts that are apparently
supposed to be used for processing external parts or materials.
Equipment that is not fixed on structural part of building before
operation and equipment components should be physically stable
while normal functioning.

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5.3 Fire safety

Fire regulation in regard of this medical field must be strictly

established, observed and implemented, and fire extinguishers for
electrical and non-electrical fire must be equipped. The operators
should know about fire extinguishers and other fire facilities and be
trained. In case of fire, be sure to disconnect the power supply at
first so as to prevent secondary injury caused by electric shock.

5.4 Bio-hazards

Bio-hazards normally refer to potential threatening to ecological

environment and body health caused by development and
application of modern biological technology as well as a series of
effective prevention and control measures thereupon.
The operators should abide by relevant stipulations and
requirements on laboratory bio-safety and dispose wastes
following the instruction. As the sample testing devices are bio-
hazardous, the operators should pay close attention to their safety.
Be sure DO NOT smoke, eat or drink when using the machine. At
the time of testing, necessary safety protection should be taken,
such as wearing protective suits, gloves and other protective
articles according to laboratory regulations.
Note:
DO NOT splash devastating liquid onto the instrument. In
case of splashing carelessly, it should be cleaned up in time.

6. Troubleshooting
Troubles Cause analysis Solution

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A certain It indicates 1. First determine whether the
motor doesn’t there is no motor malfunctions. For
move. When it problem in preliminary determination, it
is commanded communication can measure whether A+A-,
to move to a between the B+B- are close circuit.
position by main control 2. Inspect whether there is
software, the board and the open circuit on the main control
motor doesn’t computer since board.
respond, but the software 3. Inspect whether the power
the software doesn’t report supply of the main control
doesn’t report error board is normal.
error 4. Replace the damaged main
control board and test.
When the The main Replace zero-position switch
software is control board and test.
initialized, the always receives
parts always commands of
stop after zero-position
moving switch
forward once.
A certain There is 1. Inspect whether there are
motor vibrates mechanical mechanical obstacles on the
and abnormal obstacles or guide rail when such part runs.
sound given phase loss 2. Measure the motor line A
out when it after removing the mechanical
runs. obstacles
Whether +A- or B+B- is open
circuit.
A certain The motor 1. The main control board is
motor runs direction open circuit.
only to one signals are 2. The main control board is
direction abnormal broken.

7 Maintenance Service
7.1 Quality statement

1. The company has established perfect quality management

systems on product R&D and production, and ensures they are

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effectively implemented.
2. This product has been registered pursuant to Measures for
Administration of Medical Device Registration and obtained
medical device registration certificate.
3. This product conforms to performance indexes and test
methods required by compulsory national/industrial standards for
medical devices and product technology.
4. This product is manufactured strictly pursuant to the Quality
Management Specification for Production of Medical Devices,
ISO13485 Medical Device Quality Management System, and it has
obtained medical device production license and registration
certificate.
5. This product is manufactured by professional technical
staffs with top-end production equipment in workshops with
adequate scale and good environmental conditions.
6. The quality inspection organization for this product is
staffed with regular inspectors and equipped with specialized
inspection equipment. All processes from raw materials to finished
products are subject to strict and perfect inspection systems.
7. We have a mighty after-sales service team and professional
technical service capability for this product.

7.2 Warranty instructions

The warranty period is 1 year, which starts from the day of

signing for acceptance and expires on the day following the day of
acceptance in the next year.
All equipment within the warranty period enjoys the following
service:
1. The scope of warranty includes equipment installation and
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commissioning as well as free repair, maintenance, technical
support and consulting service for troubles occurred during normal
use of the equipment within the warranty period.
2. Free replacement of damaged parts and guarantee that no
used or repaired parts will be employed for replacement.
3. Solve any problem of the software system occurred in
normal using conditions.
4. The user can solve any troubles via free technical support
telephone call or the company’s website.
5. Software upgrading service is provided free of charge.
6. For user’s any trouble encountered while using, other than
those caused by the equipment, we will assist the user in
analyzing the causes and provide solutions.
7. Service record card or “technical service report” should be
filled out for all service, which should be signed and sealed by the
user and submitted to the After-sales Service Department of
Addcare for putting on record within one month.
8. The company will appoint responsible persons to visit the
user and collect the feedback on a regular basis for understanding
all kinds of problem of the equipment and the service quality.
Upon expiration of the warranty period, the company will
provide paid repair and maintenance service.
With regard to the accessories and the consumables, the
company undertakes free warranty for materials and quality only at
the time of delivery.

7.3 Warranty limits

This company is not responsible for providing warranty

service in regard to the faults caused by the following reasons:
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 1. This equipment is not operated in accordance with user’s
manual or the training content;
2. This equipment is not maintained regularly and/or
correctly;
3. Maintenance, repair or upgrade of this equipment was
done by user itself or unauthorized representatives.
4. The equipment uses parts or fittings other than the
original ones provided by the company, except the liquid
containers.
5. The equipment or any part therein is modified without
written authorization of the company.
6. There is no original package when the product is
returned to the company.
Yantai Addcare Bio-Tech Co.,Ltd. reserves the right of
rejecting the products used with microbiological or radioactive
materials or any other materials that are deemed hazardous to the
staffs of Yantai Addcare Bio-Tech Co.,Ltd. And this kind of products
should be properly sterilized and marked.
Yantai Addcare Bio-Tech Co.,Ltd. will try our best to provide
prompt and satisfactory service.

7.4 Product recall

When a medical device dealer or a user finds the medical

device that it deals or uses is defective, it should immediately
suspend dealing or using and timely inform the medical device
manufacturer or supplier.
Yantai Addcare Bio-Tech Co.,Ltd. has established complete
quality management system and adverse event control system for
medical device for collecting and recording quality issues and
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adverse event information in regard of the medical device. The
collected information will be analyzed for investigating and
evaluating possible defects of the medical device.
The medical device should be recalled in case it is confirmed
defective on the basis of the medical device manufacturer’s
investigation and evaluation.

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8 Product and Manufacturer
Information

Product name: Fully Automated Nucleic Acid Extractor

Model: Nexor 32M
Name of the manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Address of the manufacturer: No.7, Hanjiang Road, Development
Zone, Yantai, Shandong, 264006, P.R.China
Contact telephone number of the manufacturer: +86-535-6958579
Manufacturer's website: www.addcare.cn
Manufacturer's E-mail: [email protected]
Postal code: 264006
Shelf life: 10 years
Production date: See the instrument label

Name of EU Authorized Representative: Lepu Medical (Europe)

Cooperatief U.A.
Address of EU Authorized Representative: Abe Lenstra Boulevard
36, 8448 JB, Heerenveen, The Netherlands

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