MADE IN JAPAN

Automated Clinical Analyzer

Improved user-friendly interface and test efficiency

The latest model of Biolis series meeting various needs of clinical laboratory tests

1Compact & Easy Operability & Excellent Function

Brand new user interface• Intuitive screen layout with a sense of unity• Item parameter in one screen relieving the bother of page feedingUpgraded operability• Various touch panel operation (swipe-to-select / drag & drop ) contributing tobetter facility of operation• Enlarged touch buttons for reducing operation errors

Upgraded throughput• 270 tests/hour (maximum 450 tests/hour with ISE )Hemolysis of whole blood sample for HbA1c• Automatic process on board contributing to the test efficiency

Automatic sample clot detection• Automatic detection & clean-up of sample probe clots (such as fibrin)

Crash prevention• Prevent reagent & sample probes from crash during operation for safety

Automatic startup and shutdown• Stress-free operation by cutting waiting time

Ethernet connections• Ethernet connections between machine and operation PC for higher-speed andmore stable communication

2

Main unit arrangement
Cuvette washing systemReaction tray
Lamp (Easy replacement）

Sample probe

ISE sample
inletReagent probe

Reagent tray
(24-item tray)

Individual probes are used
for 1st and 2nd reagents toavoid carry-over

36-item tray available
as an option

Sample tray

Up to 30 patient samples on board forboth sample cup and primary tube

Installation■ Conditions■ The space required for installation

unit:mm

Item
Dimensions andWeight
Power supply
Power consumption
GroundingDescription

320

Analyzer
W800×D670×H555(mm) Approx. 95Kg
AC 100/115/220/230V、50/60Hz
Voltage ﬂuctuation less than 10%670Analyzer

600VA
Earth resistance of ground terminal should beless than 100ΩAmbient temperature

15~30℃

Humidity

45~85% (No condensation)

Water consumption

Max 3.8 l / hour

Waste liquid

Separate drainage (low and high density waste)

500

800

500

1800

※At least 1000mm upper space required.

3

Specifications
Analysis

SystemDiscrete single line random access multi-test analysis

Throughput

270 tests/hour, 450 tests/hour including ISE, 90tests/hour for HbA1c only

Number of test items on board
Analysis method

End point, Rate, ISE
8 kinds (linear , spline, etc)

Calibration curve
Sample kind

Sample container

Serum, Plasma, Blood cell, Urine, Dialisys, CSF (ISE not available for CSF and Blood cell)
Sample cups , primary tube (5, 7, 10ml)

boardstandard and blank sample)

Number of samples on

Sample36+3 (ISE) or 24+3(ISE)

Sample tray mode
(software tray)

Software tray (30 positions for patient sample, and 45 positions for
Selectable modes for patient sample, calibration and QC

Sample dispensing volume

2.0 〜 25.0μｌ（0.1μｌ step）

STAT

available during measurement (step between samples by priority)

Dilution ratio
Reagent tray

0.5 〜 100 times

Reagent dispensing volume
Reagent storage
Reagent volume check

36 items or 24 items (removable)
72 (36 items) or 48 (24 items)
36 items : 13, 25, 40 ml
24 items : 20, 40, 60 ml
R1 : 140 〜 300μl(1μｌ step）, R2 : 20 〜 260μl(1μｌ step）
24 hours cooling
Level sensing or count down

Reaction

Cuvette material
Reaction volume
Reaction time
Reaction temperature
Optical measurements
Optical source
Optical range
Cuvette washing
Reaction waste collection
Pure water consumption

Plastics (semi-disposable)
140μl 〜 400μl
approx 10 min. (1st reaction 5 min., 2nd reaction 5 min.)37±0.1℃
Fixed 13 wavelengths（340 〜 800nm)
Tungsten halogen lamp
OD 0 〜 2.5
Auto washing with heated water and 2 kinds of washing solutions
Reaction waste stored in a dedicated tank
Maximum 3.8ℓ /hour

Interface

Operation
OSReaction monitor
Quality control
OutputPersonal computer
Windows 10
Optical absorbance graphic display
Current, Daily and Cumulative QC. Westgard algorithms
Ethernet connection

OptionISE module
Sample barcode reader, Reagent barcode reader

Number of bottles on board

Reagent

Bottle size

※Speciﬁcations are subject to change without notice.

Test Items List
Clinicalchemistry

LD(LDH)
ChE
Cys-C
IP
GLU
L-FABP*PL

AST(GOT)
AMY
TG
Mg
HbA1c
T-BIL
*SIA

ALT(GPT)
P-AMY
T-CHO
Ca
1,5-AG
D-BIL
*Fer

ALP
LAP
HDL-C
FeGA
TTT
*Li

γ-GTP
CRE
LDL-C
UIBC
μTP
ZTT

CK(CPK)
UA
TP
Zn
μALB
NH3

CK-MB
BUN
ALB
Cu
IRI
*NEFA

Coagulation

*ATⅢ

*FDP

*D-dimer

Immuno-assay

CRP
*IgE

RF
MMP-3

TPAb

RPR

*IgG

*IgA

*IgM

TDM

VCM
CBZABKDIGTPM
HALMTX
PB

EVER
PHT

TACR
THEO

BRP
VPAISENaKCl* Above includes test items under veriﬁcation.

4

User Interface

5

Run monitor screen

Journal screen

Monitor measurement info by cycles

View sample ordered time and result out-put time

Order screen

QC graph screen

Easy to select test items by swiping the touch screen

Current,daily,and cumulative QC

Auto startup & shutdown screen

Result screen

Auto maintenance available before shutdown

Show current day test results(Separate printer needed for output)

Air pressure mixing systemDOWN

Our original system for mixing the sample
and reagent using air pressure alone.
PRESSURE

SUCTION

UPAIR

Reaction cuvette

SAMPLE• Specially developed toutilize air pressure mixingsystem• The material is water
repellent plastic(Semi-disposable)

REAGENTREPEAT

Advantages of Air Pressure Mixing• No carry-over because a stirrer is not used
• No water consumption for stirrer washing• No dilution of the reaction solution by washing water from the stirrer

HbA1c sample preparation and measurement
Cuvette1

Centrifugedsample

Cuvette2

HbA1c(%) is calculated
from hemoglobin andA1c results.

Aspirating
the redblood cell.

Dispensing the red blood cell
into the hemolyzing reagent
and mixing them.

Hemoglobin (Hb) is measured by R1.
A1c is measured by R2.
In the case of Enzymatic method

ISE module (OPTION)
Side view

ISE is Direct Method
Throughput is 450 tests/hour including ISE
ISE module is equipped with Biolis 30i
Easy to replace electrodes

Consumables for ISE module
Calibrators
Cleaning solution
Electrode (Na, K, Cl, Ref)

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International Marketing Division
28F KYOBASHI EDOGRAND, 2-2-1 Kyobashi, Chuo-ku, Tokyo, 104-0031 Japan
Tel: +81-3-6841-8703 Fax: +81-3-6841-8704
Headquarters & R&D Center
1-14-21, Higashitoyoda, Hino, Tokyo, 191-0052 Japan
Tel: +81-42-587-7777 Fax: +81-42-587-7781
URL http://www.tb-medisys.co.jp/english/

USCISO13485: 2016

Ver.1.2’18.NOV. 2,000