Transcript HumaMeter A1c Products

HumaMeter A1c
 Launch
 Marketing material
 Competition
Rev. 2
23.05.2013
About this presentation
• This presentation gives you valuable information
about the new HumaMeter A1c analyzer!
• Feel free to modify, translate or delete any part of
this presentation.
• For product features, key advantages and
benefits of HumaMeter A1c, please refer to the
separate HumaMeter A1c Product presentation!
• Use them to convince your customers of the
advantages of YOUR new product.
• Carefully read every slide and delete any unwanted
information before using them for your customers!
Revision: 01
Date: 12.07.2013
Page 2
Launch
Topics cover availability, scope of supply and registration.
Launch
• HumaMeter A1c and all reagents, accessories
etc are available now!
• Marketing and registration documents are also
available
• See Launch Mailing for the special Launch
Prices available!
• See Internet human.de (public and login areas):
HumaMeter A1c products are found under
Point of Care now (NOT Clinical Chemistry)!
Page 4
HumaMeter A1c Products
Necessary products:
•Analyser HumaMeter A1c
Product
Ref. No.
Software in English, French, Spanish, Russian;
Portuguese soon-to-come!
Includes:
HumaMeter A1c analyzer
16080
HumaMeter HbA1c reagent 16085/50
kit (50 test cartridges)
HumaMeter HbA1c Control 16086
Analyzer, User Manual (English, French, Spanish, Russian),
Barcode scanner, Power supply.
•Reagent and control
Additional products (optional, not necessary):
•Printer & printer paper
Page 5
Product
Ref. No.
Printer HumaMeter A1c
16081
Printer label rolls HumaMeter 16082
A1c (320 labels)
Marketing material
The slides provided in this section show the most important documents, flyers, etc. which you can
use for marketing and for product registration.
Human Website
Public:
•
News XX.XX.2013
Insert website screenshots
•
General product info
Login area:
•
Documents for download
•
Special section
“Marketing Materials HumaMeter A1c”
Page 7
Documents
Catalogue
Page 8
Documents
Regular Flyer
Page 9
Documents
Specifications & More Flyer
Page 10
Documents
User Manual (48 pages) and Leaflets (Reagent & Controls)
Page 11
Documents
Design Output (5 pages) & Verification reports (13 pages)
Page 12
Documents
Design Verification Report (23 pages)
Page 13
Competitive
advantages
Comparing of HumaMeter A1c and relevant competitors.
Competitor analysis I
HumaMeter A1c
CERTIFICATION
Axis Shield
Nycocard
NGSP and IFCC
certification
METHODOLOGY
TIME TO RESULT
MEASUREMENT
RANGE % A1C
SAMPLE VOLUME
IMPRECISION, CV
AT 7% A1C
SPECIMEN TYPE
Hemocue 501
(OEM of Clover)
NGSP certified
NGSP certified
Barcode calibration Barcode calibration
Boronate Affinity
Fluorescence
Quenching
<4 mins
Infopia Clover
Boronate Affinity
reflectance
3 mins
Boronate Affinity
Boronate Affinity
Inverse
Amperometry
5 mins
Inverse
Amperometry
5 mins
Boditech iCHROMA
Ceragem Labona
Check™
Ceragem CeraStat 2000
Bio-Rad IN2IT
NGSP certified
NGSP and IFCC
certification
NGSP certified
NGSP certified
Immunological
>12 mins
Boronate Affinity
with optical
reflectance
3 mins
Boronate Affinity
with optical
reflectance
3 mins
Chromato-graphy
10 mins
4 - 14%
10 ul
<4%
Boronate Affinity
4 - 15%
4 µl
4 - 15%
5 µl
4 - 14%
4 µl
4 - 14%
4 µl
4 - 15%
5 µl
4 - 15%
5 ul
HbA1c: 4 % - 15
%, Hemoglobin: 5 26 g/dL
5 ul
<3%
8.5%
<3%
<3%
<5%
2.8 - 3.8%
No info
Capillary
No
Capillary
No
Capillary
Yes
Capillary & venous Finger & venous
No
No
Capillary & venous Capillary & venous Capillary & venous
No
No
No
AFFECTED BY HB
VARIANTS*
REAGENT TYPE
Page 15
Cartridge:
Ready to use
Test disc:
Add reagents to
sample and disc
Cartridge:
Shake reagents
before taking
sample
Cartridge:
Lateral flow strip
Shake reagents
before taking
sample
Sample capillary Sample capillary
with hemolysis
with hemolysis
vials or step
vials or step
dropper, 2 liquid
dropper, 2 liquid
reagents, pipette, reagents, pipette,
cartridge
cartridge
Cartridge:
Ready to use
Competitor analysis II
MEMORY: PATIENT
& QUALITY
CONTROL
REAGENT
STORAGE
OPERATING
CONDITIONS
PATIENT/USER ID
PRINTER
POWER
QUALITY CONTROL
SELF-TEST
PC INTERFACE
Page 16
HumaMeter A1c
Axis Shield
Nycocard
Infopia Clover
Hemocue 501
(OEM of Clover)
7,000 P & QC
Last Patient
200 P
200 P
Boditech iCHROMA
Ceragem Labona Ceragem CeraCheck™
Stat 2000
300 results
1 year r shelf life
@ 2 - 8°C ;
therof 90 days at 2 - 8°C 90 days at
room temperature room temperature Room temperature Room temperature 2 - 8°C 20 months
18 - 30°C
Yes
18 - 30°C
No
17 - 32°C
Optional
17 - 32°C
Optional
10 - 40°C
No
External
No
External
External
External
AC or DC9
AC or DC9
300 results
Bio-Rad IN2IT
200 P & QC
2 - 8°C 30 days at
room temperature
2 - 8°C
20 - 25 °C;
20 - 25 °C;
Humidity:15 - 75% Humidity:15 - 75%
No
No (Patient ID
manual entry)
Integrated thermal Integrated thermal
printer
printer
18 - 30°C
No
External
AC
AC
battery
battery
AC or 12v battery
AC
AC
AC or 4 type AA
batteries
2 levels
2 levels
No
No
No
2 levels
2 levels
2 levels Must be
diluted
During start up
Optics check
before each test
Calibration check
Check cartridge
supplied
Check cartridge
supplied
Yes
Yes
Yes
Optics check
Serial port
Serial port, USB
port
Serial port, USB
port
None
Serial port, USB
port
USB port
Serial port
None
Competitor analysis III
HumaMeter A1c
DEVICE
CHARACTERISTICS
Axis Shield
Nycocard
DCCT reporting
only
Infopia Clover
Hemocue 501
(OEM of Clover)
Boditech iCHROMA
Dual reporting
Dual reporting
DCCT reporting
only
Multilingual
display
No
CE
Bio-Rad IN2IT
Reporting either
DCCT or IFCC,
touch screen
Reporting either
DCCT or IFCC
and Hb, touch
screen
Symbols and
codes used on
display
Hemoglobin
CE
CLIA waived
No
CLIA waived
No
CLIA waived
Requires multiple
pipette steps
Dual Reporting,
user selectable
units % DCCT,
mmol/mol IFCC,
% JDS, eAG
mg/dl and eAG
mmol/l
OTHER ANALYSIS
APPROVALS
Ceragem Labona Ceragem CeraCheck™
Stat 2000
CRP, D-Dimer,
Micro Albumin
510(k)
Blood glucose
PSA, D-dimer,
Optional module HS-CRP, TROP
510(k)
No
CE
MAXIMUM TIME
PERMITTED
AFTER BLOOD
COLLECTION
SIZE AND WEIGHT
7 minutes
30 seconds
95x205x135 mm 200x170x170mm 200x200x139mm 185x80x250mm
0.7kg
0.54kg
1.4kg
1.3kg
OEM of Clover
OTHER
Page 17
5 minute
178x195x77mm
0.73 kg
5 minute
10 seconds
10 seconds
178x195x77mm 140x100x145mm 140x100x145mm
0.73 kg
0.84kg
0.84 kg
Noisy in use
Insert cartridge
into machine then
insert reagent
Easy operation
pack with sample
Bulky cartridges
Noisy in use
(2 steps instead Reagents stable
take up lots of
Reagents stable
of
1)
fridge
space
at room
for 20 months Updated nycocard
Bulky cartridges
temperature for 1 Multi-step manual 1 cartridge must Multi step manual with multi-step Multi-step manual
take up lots of
month
process
be assembled
process
manual process
process
refrigerator space