The following symbols and designations are used in this document

to warn users of possible dangers.

Biohazard indicator
This is a safety warning indicating a risk of
being infected with biological contaminants.

Failure to prevent such occurrences will result

Danger
in death or severe injuries.

Failure to prevent such occurrences may

Warning
result in death or severe injuries.

Failure to prevent such occurrences may

Caution result in minor or moderate injuries, or loss
of/damage to property.

This is used to improve the work efficiency or

Note to provide additional information to help users
understand the contents more accurately.

Conventions for notation

Convention Description
[] The screen name, On-screen menu display and display
names of specific functions are contained within brackets.
Names of screen elements such as buttons, tabs, or keys
on the Operation Panel are contained within brackets.
Note: Supplemental information or restrictions are noted.
> This indicates a menu sequence.

1
Product Warranty
Thank you for purchasing Coapresta 2000.
The product warranty is provided by SEKISUI MEDICAL CO., LTD. (the manufacturer)
based on the specifications described in this document, and is valid only if the product is
used in accordance with this document. The following are the details of the warranty.

1) Warranty Period The warranty is valid for one year post-installation.

2) Warranty Region Please contact your local distributor.

3) Extent of Warranty In the event that a malfunction is caused by defects in materials or

workmanship during the Warranty Period, relevant repair or
replacement of parts (except for consumable items or their
equivalents) will be conducted at no charge to the purchaser.
Replacement of parts, however, may be done using equivalent
parts.
Especially in the case of PCs and printers, which undergo frequent
model updates in the market, the same models are less likely to be
used for replacement. Additionally, the following exclusions will
apply:

Exclusions (Disclaimer)
(1) Even during the Warranty Period, the warranty does not apply to
malfunctions as a result of:

1. Improper handling
2. Repair or modification performed by anyone other than SEKISUI
MEDICAL CO.,LTD. or its designees
3. Other causes not originating from the system
4. Use in harsh environments including high temperature and humidity,
corrosive gases, and excessive vibration
5. Fire, earthquake, and other natural disasters
6. Replacement or transportation after completion of installation
7. Use of hardware, software or auxiliary parts that are not supplied by
the manufacturer
8. Unauthorized installation of application software on the
accompanying computer
9. Computer viruses
10. Damage or defect of consumables or their equivalent parts
11. Damage or defect of out-of-warranty parts that are used beyond the
regular replacement period.

(2) Goods or items below are not covered by the warranty in any case.

1. Consumables or their equivalent parts

2. Diagnostic results based on measurements or data from this device,
or other secondary damages
3. Corruption or loss of data stored on this system's computer
4. Any damage or loss caused directly or indirectly by failure or use of
this system

2
Safety Precautions
Precautions for use of medical (in vitro diagnostic) electrical equipment in terms of safety
and risk prevention.
In order to ensure the long-term proper functioning of this system, please read and follow the
precautions below.*
1. Only experienced and trained personnel
should be allowed to operate this
instrument.
2. When installing the instrument, take the
following precautions into consideration.
(1) Do not place the instrument in a
location where it may be splashed
with water.
(2) Do not place the instrument in a
location where it is adversely affected
by air pressure, temperature,
humidity, ventilation, sunlight, dust,
or salt/sulfur containing air.
(3) Install the instrument in a stable
location to avoid inclination, vibration,
impact, etc. (these conditions should
also be applied during transportation
of the device).
(4) Do not place the instrument in a
location where chemicals are stored,
or where there are gas emissions.
(5) Use an appropriate power source
which supplies the correct frequency
and voltage, and ensure that current
tolerance (or power consumption) is
properly observed.
(6) When using an external emergency
power supply always keep an eye on
the discharge level and/or polarity.
(7) Ground the instrument properly.
3. Prior to use of the instrument, take the
following precautions into consideration.
(1) Inspect the switch connection,
polarity, dial settings, meters, and
verify that the instrument operates
properly.
(2) Verify that the instrument is securely
grounded.
3
(3) Verify that all the cords are correctly
connected and fully functional.
(4) Pay special attention when using the
instrument in conjunction with other
devices, as this may lead to a
misdiagnosis, or cause a dangerous
malfunction.
(5) When using an external power
supply to power the instrument, verify
their functionality.
4. During use of the instrument, take the
following precautions into consideration.
(1) Be careful not to spend more than
the required amount of time for
diagnosis and treatment.
(2) Always monitor the entire instrument
for any malfunction.
(3) If any abnormality is detected on the
instrument, appropriate action must
be taken, including aborting
operation of instrument to ensure the
patient's safety.
(4) Do not let patients touch the
instrument.
5. After use of the instrument, adhere to the
following precautions.
(1) Restore any operating parts such as
switches and dials to their initial
positions, then power off the
instrument.
(2) Do not unplug the cords by pulling on
them, or by using excessive force on
the cords.
(3) Storage area for the instrument
should meet the following
requirements.
I. It is not exposed to water splashes.
II. It is not subject to any adverse
effects from air pressure,
 temperature, humidity, ventilation,
sunlight, dust, or air containing salt
or sulfur.
III. A stable location is provided which
avoids inclines, vibrations, impacts,
etc (these conditions should also be
applied during transportation).
IV. It is not located where chemical
agents are stored or where gases
are emitted.
(4) Clean the accessories, cords,
electrodes, etc., and store them in an
organized manner.
(5) Make sure to clean the instrument to
prevent any inconvenience during
subsequent use.
6. If the instrument malfunctions, do not
engage in any repair attempt but call for
professional service.
7. Do not attempt any modification to the
instrument.
8. Maintenance
(1) Inspect the instrument and the parts
regularly.
(2) When you start reusing the
instrument after it has not been used
for an extended period of time, make
sure that the instrument is in safe
and normal operating condition
before use.
9. Other Notes
Always adhere to this operation manual
for safe and correct operations.

* This is printed in accordance with PAB Notification No. 495 of the Ministry of Health and
Welfare (June 1, 1972), and is intended for Medical Devices as well as In Vitro Diagnostic
Medical Devices).

4
 Avoiding infection

Biohazard

1. Always use protective wear such as gloves to avoid any direct contact with the
system and its parts. Beware of the risk of infection with pathogens. Waste liquids,
as well as parts that are in contact with waste liquids, are especially dangerous.
2. If you accidentally contaminate materials or surfaces, wash the affected area with
plenty of water and follow the applicable disinfection requirements in your
laboratory.
3. Always use protective wear such as gloves when handling samples. Should your
eyes or open skin injuries be exposed to a sample, rinse with plenty of water and
immediately seek medical attention to prevent infection.
4. Please be advised that control materials may contain pathogens. Exercise the
same precautions and always use protective wear such as gloves when you
perform quality control operations. Should your eyes or open skin injuries be
exposed to a sample, rinse with plenty of water and immediately seek medical
attention.
5. Waste liquids must be handled carefully to protect individuals from exposure. Wash
with disinfectant solution if spilled onto skin or clothes.
6. Disposal of used cuvettes in a cuvette waste container should be carried following
the instructions described in the "Disposal" section below. Used cuvettes may pose
a threat of infection and bacterial contamination.
7. Do not use damaged cuvette waste containers. These may pose a threat of
infection.
8. When testing is complete, wash your hands with disinfectant solution to prevent
infection

5
 General Precautions

Warning

1. Only trained personnel should be allowed to use the device.

2. This device is sample testing equipment intended for screening samples. Clinical
diagnosis should be determined by physicians based not only on the measurement
results from the device, but also on clinical symptoms and other test results.
3. Every effort has been made to indicate warnings for possible dangers, but please
ensure you assess any other risks independently.
4. If system malfunction occurs, only the supervisory staff should take the necessary
measures that are explicitly described in the manual, implement and communicate
with technical service.
5. If abnormal situations are detected including unusual odor or smoke, immediately
turn off the POWER switch and the MAIN POWER switch, remove the power plug
from the outlet, and request an inspection by the distributor. Do not continue using
the device as it may result in fire, electric shock, or injury.
6. Make sure the power cord is not damaged, subjected to a heavy load, or forcefully
pulled. The resulting short circuits or wire breaks may cause fire or electric shocks.
7. When spillage of water or reagents is suspected, turn off the MAIN POWER switch
located on the right side of the device to avoid risk of electric shock or fire.
8. When connecting peripheral equipment such as a PC or a conveyance system, turn
of the POWER switch first. Otherwise, electric shock or damage may occur.
9. When replacing a fuse, turn off the POWER and the MAIN POWER switch and
disconnect the power plug from the outlet. Otherwise, electric shock may occur.
10. Do not touch the electrical circuits inside the cover of the equipment. In particular,
touching them with wet hands may result in electric shock.
11. Only use fuses with the type and the rating specified for the system. Failure to do
so may result in malfunctions leading to fire.
12. Do not modify the device, as this may result in malfunctions. In addition, doing so
would render the device void of warranty.

6
 Caution

1. Be careful not to trip over the power cord or pull it unintentionally. Disconnecting the
power cord during operation may result in malfunction or corruption of
measurement data.
2. In case of a fire, immediately turn off the POWER and the MAIN POWER switch
and disconnect the power plug from the outlet.
3. When turning off the power of the device's PC, refrain from doing so while
accessing the hard disk or other memory device, as this may result in data
corruption.
4. Do not use a sharp tip (e.g., a ballpoint pen) to press the switch of the operation
panel as this may damage the switch.
5. The "Foreign Exchange and Foreign Trade Act" or the "US Export Administration
Regulations" may prevent you from transferring the device to certain locations. In
addition, failure or damage which arises while the device has been moved to a
different location may not be covered by the warranty.
6. Prolonged use of a keyboard can cause neurological disorders in the hands or
arms. Use preventive measures such as occupational safety and health standards.
7. When using alcohol for cleaning purposes, avoid exposure to flames, as there is a
risk of fire.

 Installation
Check the following prior to the installing the device:

Warning

1. Only insert the power plug into an outlet with the correct voltage.
2. Use a suitable socket (for the PC, the touch screen and the printer (always use a
separate power supply). If the system is not grounded there is a risk of an electrical
shock which may be fatal. The installation of a grounded electrical outlet should be
performed by a qualified electrician.

7
 Caution

1. Do not install the device in the following areas:

 Possible wet areas
 Areas with poor ventilation
 High altitude areas exceeding 2000m
 Areas where the device is adversely affected by high temperatures, high
humidity, dust, and direct sunlight
 Areas where strong vibrations and impacts can be expected
 Areas within the vicinity of a signal noise source, such as a centrifugal separator
 Storage areas for chemicals, or areas containing gas emissions
 Environments containing oxygen, hydrogen, or other flammable or conductive
gases
 Outdoors
 Locations that are not level (horizontal)
 Locations where there is no load bearing floor
 Locations where radiation can affect the device's proper functionality

2. The minimum clearance dimensions surrounding the system are as follows. Wider
clearance is needed at the sides, rear, and the front when performing maintenance
work.
 Both sides of the system: 20 cm each
 Back of the system: 15 cm

 Electro-magnetic compatibility

Caution

1. This device complies with electromagnetic compatibility requirements (IEC61326).

2. The device is designed to comply with the CISPR11 Class B standard so protection
against harmful interference is provided when installed. Do not use the system in
the vicinity of a source of strong electromagnetic radiation. Radiation can affect the
devices' proper functionality. Perform an electromagnetic assessment for the area
prior to installation.

8
 Handling of samples

Biohazard

1. Always use protective wear such as gloves when you handling samples. After work
is completed, wash your hands with disinfectant solution. Beware of the risk of
infection with pathogens.

Caution

1. Make sure that the lids of the sample vials are removed before the analysis is
started. Otherwise, the sample probe will be damaged.
2. Samples must be free of contaminants such as dust. If the sample Probe becomes
clogged, the data may be inaccurate.
3. Samples with high viscosity can clog the sample Probe or cause inadequate intake
of the sample and thus lead to incorrect measurements.
4. When making direct measurements, using the blood collection tube, verify that the
plasma volume is sufficient. If the plasma volume is not sufficient it needs to be
transferred to a sample cup. It is important to ensure that the sample contains no air
bubbles. If the sample needle becomes clogged with release agent or a clot, this
will lead to inaccurate data.
5. Do not leave the sample vessel open for long periods as evaporation of liquid
samples occurs leading inaccurate.
6. Samples with unusual color or samples from patients taking drugs such as
Warfarin, can produce inaccurate results.
7. To obtain accurate results, quality control materials must be tested and their results
must be within expected ranges.

 Handling of reagents and other hazardous materials

Please make sure you read and understand the instructions for use provided with
reagent, calibrator, quality control samples, deficient plasma, etc., and use these
materials accordingly. If you need safety information for those materials, contact the
manufacturer.

Biohazard

1. Always use protective wear such as gloves when you handling hazardous
materials. After work is completed, wash your hands with disinfectant solution.
Beware of the risk of infection with pathogens.

9
 Warning

1. The end user must fully validate any non Sekisui assay/kit prior to use.
2. Always use protective wear such as gloves when handling hazardous materials to
prevent direct skin exposure. Otherwise, irritation to eyes, skin and mucosa may
occur.
3. If your skin accidentally comes in contact with hazardous materials, wash the area
immediately with plenty of water.
4. If you get hazardous materials in your eyes, flush the eyes immediately with plenty
of water and seek immediate medical attention.
5. If you swallow hazardous materials, seek immediate medical attention.
6. When evaluating prothrombin time analysis, enter the exact ISI value assigned on
the label of the reagent or scanning the QR code when changing the reagent lot,
upgrading software, or modifying primary equipment, check the ISI value. Incorrect
ISI values will cause erroneous INR results.

Caution

1. Do not use any expired reagents or materials.

2. Make sure that the lid of the reagent bottle is removed. Otherwise, the reagent
probe may be damaged.
3. Keep reagents free from dust or bacterial contamination.
4. When handling reagents or other materials, take care to prevent errors such as
reconstitution errors, a long post- reconstitution elapsed time, and introduction of air
bubbles into the solution.
5. Handle reagents gently without introducing air bubbles into them. Do not shake
reagents.
6. In order to prevent degradation of the reagent after preparation, close the sample
and the reagent cover unless otherwise required.
7. Do not use a reagent immediately after its preparation / reconstitution.
8. Be careful not to spill any reagents. If a reagent is spilled, take note of the
information in the Safety Data Sheet.

10
 Concerning specified detergent
Use the following detergent concentration: concentration for cleaning the rinse water tank
should be two percent (2%), and concentration for other tanks and probes should be five
percent (5%).
Description Main Ingredients pH Example
Nonionic surfactant 12.1
New Alkali
Organic acids (at two percent)

Warning

1. To be used to in conjunction with the Safety Data Sheet.

2. Always use protective wear such as gloves and safety glasses when handling New
Alkali to prevent direct skin exposure. Otherwise, irritation to eyes, skin and mucosa
may occur.
 In case of contact with eyes, flush with clean running water for at least 15
minutes and immediately seek medical attention.
 In case of contact with skin, remove affected clothes immediately, wash the
exposed skin with soap and water, and seek medical attention.
 If inhaled, immediately move the individual to fresh air and keep them warm and
rested. If respiratory difficulty is exhibited, perform artificial respiration and seek
medical attention.
 If the detergent is swallowed, do not induce vomiting. Rinse out mouth and give
plenty of water to drink. Summon a doctor immediately. Never give anything by
mouth to an unconscious person.

Caution

1. Use the detergent in specified concentrations. Diluted detergent must be used

within two weeks.
2. Diluted detergent solution must be sealed in a container and stored in a cool, dry,
well-ventilated place out of direct sunlight.
3. Separate it from acidic or oxidizing substances, or organic peroxides.
4. Never mix different kinds of detergents, as doing so can produce toxic gases.

11
 Disposal

Caution

Disposal of waste liquid, consumables of the device, and the device itself must be carried
out in accordance with local regulations.

 Maintenance

Biohazard

When you performing maintenance work (e.g. inspection or repair), always use
protective wear such as gloves and wash hands with disinfectant solution at the end of
work. Beware of the risk of infection with pathogens.

Caution

1. The device maintenance and management is the responsibility of the customer, if

there is no separate contract/agreement.
2. When you powering on the device, confirm that no one is conducting maintenance
or inspection work. Otherwise, moving parts can come into contact with the
individual working, leading to damage or injury.
3. When performing maintenance work, to ensure the work is conducted safely, and to
protect the equipment, use only those tools designated for the work in question.
4. When you replace the light source lamp, wait for at least 30 minutes after it is
turned off. Confirm the bulb and the surrounding area is cooled enough before
starting replacement work to reduce any risk of burning.
5. When replacing the light source lamp, do not push the bulb forcefully. The bulb
could break, leading to injury.
6. When performing maintenance or inspection, read Chapter "10. Equipment
Maintenance" carefully, and adhere to all the precautions listed.

12
 Laser

Caution

The device itself is a Class 1 laser product, while the sample barcode reader is a Class 2
laser product. Do not look into the laser beam while using the device to avoid risk of
injury to your eyes. (Refer to appendix 4 and 5 for "Barcode Reader Specifications" for
laser radiation ranges)

 Data Backup

Caution

Data such as measurement results and parameters may become corrupt and unusable
due to a failure or incorrect operation of the device. Thus it is important to backup your
data on a regular basis.

 Computer viruses

Caution

The system is verified free from infection from computer viruses before shipping. The
customer should implement protective measures against computer viruses, as there is a
risk of infection via Internet, USB memory, or networks depending on usage and the
environment. Note: we will not be held responsible for any problems resulting from a
computer virus infection.

 Restriction on software installation

Caution

Do not install software that is not provided for use with the device. It can affect the proper
functioning of the device.

13
 Other Precautions

Caution

1. Power outages or lighting strikes can cause device failure or data (measurement
results and parameters) corruption. Thus, it is important to backup your data on a
regular basis.
2. Measurements must be made with the covers (top cover, front cover, reagent
cover, sample cover, etc.) in the closed position. Do not deliberately disable the
open/close sensors for these covers. Otherwise, the auto shutdown mechanism will
be compromised, leading to a contact accident. In addition, do not open the main
cover unless otherwise needed.
3. Sometimes, an open/close sensor erroneously detects closing of a cover even if it
is not properly closed. In such a case, the probe can be damaged. Therefore, check
the closed position of the covers routinely.
4. When opening the top cover, open it until it stops. Otherwise, the cover may close
itself unexpectedly, leading to injury.
5. Do not place any objects (including reagents or samples) on top of the device.
Spilling liquids such as blood or reagents, or inserting metals such as staples or
paper clips, into the device may cause a short circuit.
6. If the device will not in use for an extended period of time, water must be drained
out of the system. After it has been stored for an extended period of time, general
inspection must be carried out before use.

14
 Warning Do not look into beam.

Note: The shaded area shown in the diagram below is the radiation range of the laser
beam.
Note: See Appendix 5 for barcode specifications

15
Maintenance Checks

In order to ensure the safety and optimal performance of this device, maintenance
checks are required.
This manual contains specific details for performing maintenance checks on a daily and
regular basis. In addition, as part of a "service contract" periodic maintenance checks
can be offered by our specially trained service technicians.

16
Warning Labels

The device is marked with the following warning labels.

Read the warning labels carefully and adhere to the warnings.

Cuvette Waste Container

Found internally on the left
hand side.

17
18