contents entering the cod-ing or chip into the glucose meter, the meter will be calibrated to that...

ContentsAbout Fia .................. 4

Diabetes care system ... 5

Product series ............ 6

Our technology

Coding (DCS) ........... 9

POCT meter ............ 10

Single foil strip ........ 11

QM strip ................ 11

Strip enzymes ......... 12

OEM/ODM service ....... 14

Spec comparison ........ 15

Product advantage ...... 16

Meter list ................. 17

4 | Fia Biomed GmbH Fia Biomed GmbH | 5

Fia Biomed GmbH is a Germany based company dedicated in blood glucose measurement technology. Its internation-al team has more than 20 years experi-ence in the technologies like electronic, mechanism, medical engineering, elec-trochemistry, printing…etc.

Fia’s philosophy in technology has only one: Reliability!

We make everything possible to measure the glucose as close as possible to the real value.

We make the variance of variable test re-sults from different time as little as pos-sible.

The American Diabetes Association, ap-proximately 18,3% (8,6 million) of Ameri-cans age 60 and older have diabetes. In 2008 there are 24 million people with diabetes in the United States alone, plus other 57 million people are estimated to have pre-diabetes, there are 81 million people, or 26% of the whole population in the United States, are affected by dia-betes. In Europe, only in the countries of Germany, France, Italy, Spain and UK , together there are diabetes number ap-proximately 24 million as well, similar to the whole Unites States, not to mention the rest of the world where there are so many more diabetes.

In light of the relevancy to so many lives, Fia senses the responsibility to develop a reliable product to comfort the diabe-tes’s glucose measurement issue.

Without against the philosophy, Fia de-signs the product to meet the require-ments from the diabetes.

Design Philosophy

Cost effective: to let the diabetes pay less while enjoy the high accuracy of the products.

Less painful: to let the diabetes free from fear of glucose measurement.

Comfort: to design with the features to let the users feel more comfortable and more protected.

Handy: to design the products to let the diabetes to use anywhere and anytime.

Professional: to design the products not only for home, but also for hospital.

About Fiaglucose monitoring system

Blood glucose testing, showing the size of blood drop required by modern meters.

Blood glucose monitoring is a way of testing the concentration of glucose in the blood (glycemia). Particularly impor-tant in the care of diabetes mellitus, a blood glucose test is performed by pierc-ing the skin (typically, on the finger) to draw blood, then applying the blood to a chemically active disposable ‘test-strip’. Different manufacturers use different technology, but most systems measure an electrical characteristic, and use this to determine the glucose level in the blood.

Healthcare professionals advise patients with diabetes on the appropriate moni-toring regime for their condition. Most people with Type 2 diabetes test at least once per day. Diabetics who use insulin (all Type 1 diabetes and many Type 2s) usually test their blood sugar more often (3 to 10 times per day), both to assess the effectiveness of their prior insulin dose and to help determine their next in-sulin dose.

blood glucose meter

A blood glucose meter is an electronic device for decoding the blood glucose level sensed from the test strip. A rela-tively small drop of blood is placed on a disposable test strip which interfaces with a digital meter. Within several sec-onds, the level of blood glucose will be shown on the digital display.

blood glucose Test Strip

The blood glucose test strip use biologi-cal chemical material to sense the glu-cose level in the blood sampled from patients.

It reflects the level of the glucose by spe-ficied electric current through the chemi-cal interaction between the enzyme on strip and the glucose in blood. For ex-ample: 1 μA electric current sensed from the strips might represents 100 mg/dL. The graph of liner relationship depends on the formula used by different manu-facturer.

Diabetes care system


The core concepts of the design of the products are cost effective, less painful, com-fortable, and handy to use for personal health care.

Fia has also professional meters to make rapid and accurate mass measurement in hospital and meet all conditions and requirements in hospital.

Product series

Meter for personal care:

Fia ‘s products are the fruit of more than 20 years experience in product design. We focus not only in accuracy of the test results, but also the features and lay-out to make the use more comfortable. There are many different designs for dif-ferent kinds of comfort usage. The com-mon is they are all reliable.

glucoFia™ Salut Digital Code Strip (DCS) 150 Test Results Memory Capillary whole blood 0.25μL / 5 seconds Measuring: 20-600 mg/dL Operation Range: 10 ℃ - 40 ℃ HCT Range: 25% - 65% PC Download Function Blood Glucose Monitoring Software (PC)

POCT Meter for hospital:

This device has a barcode scanner to identify patient’s personal data as well nurse’s. It guarantees the data accuracy from the first step to data transmission to hospital server. No writing, neither typing is needed. Automatic, accurate and reliable for data processing.

It adapts the GDH-FAD technology which makes the test strips to react to no other sugars than glucose. This technology is widely recognized to be reliable. It is well thought for hospital’s intensive care since it has many features to care the nurses’ operation need on rapidity, effi-ciency and security.

Glucose Test Strips:

GDH-DS4-A ; 1.5μL / 8 seconds

GOD-DS4-A ; 1.5μL / 8 seconds

GOD-DS4-B ; 1.5μL / 8 seconds

GOD-XF4-A ; 0.25μL / 5 seconds

The strips are manufactured in a very stable condition. The technology is Glucose Oxidase(GOD), or Glucose Dehydrogenase(GDH). Both technology can distinguish glucose from other sugars, not like Pyrroloquinoline Quinine(GDH-PQQ) who cannot.

Fia’s strips can absorb from the top or middle of the strips.

Fia’s strips are packed in vials or foils.

Control Solution:

An in-house technology to test the func-tionality of the meter whenever an user wants to test. There are two kinds, high and low, to test whether the meter is working properly in high and low glucose level.

Product series


Lancing Device:

Fia designs the lancing device to make the pain as little as possible when taking the blood for test. the adoption of AST is from this philosophy. Alternative Site Testing(AST) is a technology allowing the lancing device to take the blood from anywhere of the body.

Standard Twist Lancet:

glucoFia™ Twist Lancet 30G (0.3 X 4mm) Fine gauge, tri-bevel tip for virtually

painless sampling. Consistent depth penetration. Universal lancet which fits most of the

lancing devices.

Product seriesCoding (Digital Code Strip)

Since test strips may vary from batch to batch, some models require the user to manually enter in a code found on the vial of test strips or on a chip that comes with the test strip. By entering the cod-ing or chip into the glucose meter, the meter will be calibrated to that batch of test strips. However, if this process is carried out incorrectly, the meter read-ing can be up to 4 mmol/L (72 mg/dL) inaccurate. The implications of an incor-rectly coded meter can be serious for pa-tients actively managing their diabetes. This may place patients at increased risk of hypoglycemia.

We use the Digital Code Strip (DCS) sys-tem. It simplifies the coding process and allows users to code our glucometer in one step. By using Digital Code Strip, coding our meter becomes very easy and yet the accuracy is ultimately retained.

The outlook of the patented Digital Code Strip is highly recognizable, so it can pre-vent people from copying your test strips and at the same time protect your prof-its. All in all, please try our CS meter series and you will fall in love with the simplicity that our DCS system would of-fer.

01

Set Mem

Acacia

01

Set Mem

Acacia

Our technology


POCT meter for hospital

Point-of-care Testing:

Our blood glucose care solution is a com-pact system, includes a server and sever-al portable devices. The portable device integrating glucose meter, scanner and LAN transmitter to do patient ID scanning (by Barcode system), glucose measuring, result transmitting to server, and data fil-ing, all in one and anywhere in hospital.

In addition to its efficiency in glucose measuring and data processing, it is also accurate, and easy to use.

We offer the whole solution to hospi-tal. This system has already implied in Chang-Gung Memorial Hospital located in Taiwan for two years, gaining positive feedback from nurses and professional care agency.

* GDH-FAD Glucose Strip - Capillary, venous, arterial

* Barcode Scanner - User ID / Patient ID

* Total QC* LAN (Work with LIS & HIS)

- LIS: Laboratory Information System - HIS: Hospital Information System - WS: Work Station - NS: Nurse Station

Our technologySingle Foil Packet Strip

Generally, the blood glucose test strip is very easy to be affected with wet envi-ronment after the vial is opened. Moreo-ver, the end-user might get a wrong test result through these expired test strip and cause serious medical care issue.

Since we use patented technology to pack our test strip in a single foil packet, the test strip will be well-protected by the foil.

With our patented Single Foil Packet Strip, our end-user is possible to store their test strips conveniently and safety. This also keep the accuracy of test re-sults, preventing the fatal self-diagnostic mistake.om copying your test strips and at the same time protect your profits.

QM Technology

Quarter Microliter - 0.25μL

Our QM strip requires the smallest sam-ple volume in the world.

Real AST - Real Alternative Sites Testing: patients can adopt their blood sample from any sites of body, not only from fin-gertips.

Target on patients suffering from Type I Diabetes, with the QM and AST Technol-ogy, the patients can easily adopt their blood sample without pain.

These two innovated technologies bring glucose meters industry into another new century.

Our technology

6 9 4 2 7 4 1 6 0 0 1 39


glucose test strips enzyme

We are using GDH-FAD and GOD-FAD En-zymes for our Strips.

Those two methodologies can distinguish between glucose and other sugars. Cer-tain non-glucose sugars, including mal-tose, xylose, and galactose, can be found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product.

When these non-glucose sugars are pre-sented in the patient's blood, using a GDH-PQQ (Pyrrolo-quinoline quinine) test strip, which can not distinguish between glucose and other sugars, will produce an elevated glucose result which may sug-gest the need for clinical action. This can lead to inappropriate dosing and adminis-tration of insulin, potentially resulting in hypoglycemia, coma, and death.

FDA notice (GDH-PQQ)

There are several enzyme systems for the blood glucose testing in current market, HMD uses GOD-FAD & GDH-FAD currently. Roche uses GDH-PQQ for their product, only indicating out the potential risk in caution. This fatal risk of misuse in GDH-PQQ strips is continually monitored by FDA for many years actually, the root cause of that concernment is because GDH-PQQ enzyme have relative activity to some other sugar. If patients are tak-ing drug products or therapies that con-tain certain non-glucose sugars, such as maltose, galactose and xylose, these sug-ars will produce a falsely elevated glu-cose result while using a GDH-PQQ test strip. Patients might give themselves too much insulin under the falsely elevated result, which could result in dangerously low blood glucose and cause fatal condi-

tion like hypoglycemia, coma, or even death.

D-glucoseMaltose

Maltotriose

Maltotetraose

D-Galactose

D-mannoseD-xyl

ose

D-trehalose

D-arabinose0

20

40

60

80

100

120

The specificity of GDH-FAD and GDH-PQQ

Rela

tive

activ

ity (%

)

GDH-FAD GDH-PQQ

This Figure were illustrated depends on data of the enzyme producer by our RD. We can tell that GDH-FAD has better spe-cificity to D-glucose than GDH-PQQ.

Our technologyenzyme system of Fia

We use GOD-FAD & GDH-FAD for our prod-ucts.

The difference between theses two en-zymes were O2 concentration. Since the blood samples used in hospital might in-cludes different type of bloods. GDH-FAD is especially a better choice to be used in professional health care facilities.

For the Home Care Market, GOD-FAD is fine for the end-user since they generally using the lancing device to take blood sample (Capillary whole blood) which has few Oxygen from finger tip.

Both methodologies are not affected by the presence of non-glucose sugars.

GDH-DS4-A ; 1.5μL / 8 seconds

GOD-DS4-A ; 1.5μL / 8 seconds

GOD-XF4-A ; 0.25μL / 5 seconds

0 100 200 300 400 500-20

-10

0

10

20

The Bias of GDH-FAD and GOD-FAD in venous blood testing

Bias

(%)

Glucose (mg/dL)-Roche Hitachi 717 Chemistry Analyzer

GDH-FAD GOD-FAD

40 50 60 70 80 90 100

80

90

100

110

The effect of oxygen concentration on blood glucose testing by glucose strips using GDH-FAD and GOD-FAD

Rela

tive

activ

ity (%

)

Oxygen concentration (%)

GDH-FAD GOD-FAD

Our technology


We have accumulated a lot of expertise in OEM and ODM tasks.

OEM

If you wish to distribute our products with your own brand, you can discuss with us as OEM customer. Our team will tell you how to establish your own brand, like logo, packaging, CE certificates or FDA certificates application, …etc. We shall let you know the investment you need to spend if you like to do with your own brand.

Based on our experience, from agree-ment signing to the start of production will take around 2 months, with CE ap-proval included.

ODM

If you wish to design a new product and use the technology of FIA in your prod-ucts, you can come to talk to us as ODM customer.

You give us your design, then we make the prototype for your approval, then we begin the mass production for you.

Or you can even tell us about your idea, we can realize your idea into a real prod-uct design.

We shall help you on CE and FDA applica-tion to let you get the certificates.

Should you have an ambitious plan for international market, you can consider OEM/ODM. Contact us with the following form. Our OEM/ODM specialist will con-tact you.

Contact Information

Fia Biomed GmbHwww.fia-biomed.de

TEL: +49 (0) 25 72 60 98 9 31 ~ 39FAX: +49 (0) 25 72 60 98 9 40

Rheinerstrasse 172,D-48282 Emsdetten, GERMANY

For General Information, please contact [email protected]

For Customer or Technical Support, please contact [email protected]

For Product Inquiry, please contact [email protected]

OEM / ODM services

Spec

com

pari

son

Auto Shut Off

(minutes)

Battery Type

Battery Life

AST

Memory Capacity

Operating Temp. (F)

Result Range

(mg/dL)

Sample Size

(microliter)

Test Time (s)

Backlit Display

Coding Method

WarrantyACCU-CHEK

Com

pact

Plu

s1

- 5

AAA

1000

Te

sts

Yes

500

50 -

104

10 -

600

1.5

5Ye

sTe

st D

rum

Life

tim

e

Aviv

a2

CR20

3220

00

Test

sYe

s50

043

- 1

1110

- 6

000.

65

No

Code

Key

Life

tim

e

Com

pact

1 -

5AA

A50

0 Te

sts

Yes

100

50 -

104

10 -

600

1.5

8N

oTe

st D

rum

Life

tim

e

Adva

ntag

e1

- 5

CR20

3210

00

Test

sN

o48

057

- 1

0410

- 6

000.

426

No

Code

Key

Life

tim

e

J&J

Ult

raM

ini

2CR

2032

6-12

m

onth

sYe

s50

043

- 1

1120

- 6

001.

05

No

Butt

on3

Year

s

Ult

ra2

2CR

2032

6-12

m

onth

sYe

s50

043

- 1

1120

- 6

001.

05

Yes

Butt

on3

Year

s

Ult

raSm

art

1 -

3AA

A6-

12

mon

ths

Yes

3000

43 -

111

20 -

600

1.0

5Ye

sBu

tton

3 Ye

ars

Ult

raLi

nk2

AAA

240

Test

sYe

s50

043

- 1

1120

- 6

001.

05

No

Butt

on3

Year

s

Abott

Lite

2CR

2032

500

Test

sYe

s40

040

- 1

0420

- 5

000.

35

Yes

No

Codi

ngLi

feti

me

Free

dom

Lit

e2

CR20

3210

00

Test

sYe

s40

040

- 1

0420

- 5

000.

35

No

No

Codi

ngLi

feti

me

Prec

isio

n Xt

ra2

CR20

3210

00

Test

sYe

s45

050

- 1

2220

- 50

00.

65

Yes

Calib

rato

rLi

feti

me

Bayer

Cont

our

1CR

2032

1000

Te

sts

Yes

480

41 -

113

10 -

600

0.6

5N

oN

o Co

ding

™5

Year

s

Cont

our

TS3

CR20

32Ye

s25

041

- 1

1310

- 6

000.

68

No

No

Codi

ng™

5 Ye

ars

Bree

ze 2

3CR

2032

Yes

420

50 -

113

20 -

600

1.0

5N

oN

o Co

ding

™5

Year

s

FIA

CS m

eter

3CR

2032

1000

Te

sts

No

150

50 -

104

20 -

600

1.5

8N

oD

CS5

Year

sQ

M m

eter

3CR

2032

Yes

150

50 -

104

20 -

600

0.25

5N

oD

CS5

Year

s


GOD-FAD and GDH-FAD Enzymes

For the most competitive point of our product compared with ACCU-CHEK is that we use GOD-FAD and GDH-FAD En-zymes which are not affected by the presence of non-glucose sugers. As FDA notices: strips that use GDH-PQQ will react with certain non-glucose sugars, including maltose, galactose and xylose, and produce a falsely high (elevated) re-sult.

If a diabetic patient then takes too much insulin because of this falsely high result, it could lead to abnormally low blood sugar (hypoglycemia), coma, or even death. In the glucose care area, reliabil-ity of product and the accuracy of test result is the most concernment not only for manufacturer but our end-users.

Coding Method

Since test strips may vary from batch to batch, some models require the user to enter in a code found on the vial of test strips or on a chip that comes with the test strip by buttons. This operation process might cause risk of miscoding or incorrect coding. Without sacrificing the accuracy, our test result keeps less than 20% tolerance by using our patented DCS (Digital Code Strip) technology. Our DCS method is easier to use Abbott or One Touch by only one insertion action. The DCS of proper code of the strip is at-tached in every single vial, which could decrease the risk of incorrect coding.

Production Line

All our meter and strips are all made in Taiwan. By fully in-house manufacturing, we keep the quality highly stable and qualified.

Product Selling Point

- Price & Quality

The price to end-user of our meter is al-most 1/3 compared to ROCHE. More over, we also provide economics price for our distributor. With the better price and quality, our products are very competi-tive in the market.

- DCS Technology

Code the meter easily without sacrificing the accuracy.

- Complete Glucose Care Solution

We have complete Glucose Care Solu-tion not only for Home Care Series but POCT (Point-of-care Testing) for profes-sional hospital & health care facilities. Our hospital blood glucose care solution is a compact system, includes a server and several portable devices. The port-able device integrating glucose meter, scanner and LAN transmitter to do pa-tient ID scanning (by Barcode system), glucose measuring, result transmitting to server, and data filing, all in one and anywhere in hospital. In addition to its efficiency in glucose measuring and data processing, it is also accurate, and easy to use. This system has already implied in Chang-Gung Memorial Hospital located in Taiwan for two years, gaining positive feedback from nurses and professional care agency.

Product advantageglucoFia™ Primera

glucoFia™ Acacia

glucoFia™ Linda

glucoFia™ Precisa

Meter list


glucoFia™ Bona - Strip Ejection Function

glucoFia™ Salut - Strip Ejection Function

glucoFia™ Mora - Strip Ejection Function

glucoFia™ Venecia - Speaking Meter

Meter listglucoFia™ Naomi - Speaking Meter

glucoFia™ Karina

glucoFia™ Sabrina - Strip Ejection Function

glucoFia™ Silvia - Strip Ejection Function

Meter list

20 | Fia Biomed GmbH

glucoFia™ Yolanda

glucoFia™ Lola

glucoFia™ Uno (POCT meter for hospital)

Meter list

Fia Biomed GmbHwww.fia-biomed.de

[email protected] [email protected]

+49 (0) 25 72 60 98 9 31 ~ 39 +49 (0) 25 72 60 98 9 40

Rheinerstrasse 172,D-48282 Emsdetten, GERMANY

contents entering the cod-ing or chip into the glucose meter, the meter will be calibrated to that...

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