Hemo Control Analyzer

Point of care device providing

immediate, lab quality results for
hemoglobin and hematocrit from one
simple test
 Product features

Easy to use Practical and Fast and Accessories

Hemo Manager
portable accurate
Small sample size Stores up to Vials x 50
(ca. 8l) Compact size Results in 25-60 cuvettes
4,000 records;
Self-testing seconds 500 QC results
Step by step Single-packed
instructions, Integrated, Imprecision: Barcode cuvette option
backlit touch rechargeable CV <2% identification Control cuvettes
screen with battery (100 hrs) Soft-close included
Serial port for PC
adjustable Operating cuvette loader
Bluetooth Liquid controls
contrast temperature up minimises risk of
to 40C contamination QC lockout Cleaner
User selectable
language function
 Performing a test

Take a blood sample Insert cuvette into analyser Results in ca. 25 60 sec

Results in 3 easy steps

Performing a test
 Hemo Control devices

Hemo Control Hemo Control Manager

Basic analyzer version Preinstalled data management capability
Stores 4,000 test results with date Allows direct integration with LIS
and time Bi-directional interface
Data export only Configuration via LIS POC Manager or
Data transfer by cable Hemo Connect Software (EKF)
Barcode scanner included
Stores 4,000 patient results and
separately 500 QC results
Data transfer by cable or
integrated Bluetooth
New! Add pack DM for Hemo Control
Basic version of Hemo Control can be upgraded with Data Management
(DM) functions at a later point of time

Ideal for customers who are

Planning future connection of POC devices to LIS but have not yet decided
Connection to LIS postponed for budget reasons, option to split costs
Facing increasing demands for connectivity and want to keep options open

Unique feature in POC devices!

Only available for new release Hemo Control devices.
The Add pack DM upgrades a basic Hemo Control to the same functionality
as the Hemo Control Manager (except for the integrated Bluetooth module)
 Add pack DM for Hemo Control
Content:
Licence key
Barcode
scanner
3fold adapter
Barcode table
Manual
 How to install the Add pack DM
Once the end user has purchased the upgrade they can follow
this upgrade procedure:

- Go to www.ekfhemocontrol.com\addDM
- Access with User Name and Password
- Enter Licence Key and serial no. of device
- Print out generated barcode
- Connect scanner to device and scan code
- All DM functions are unlocked and set to optional input (basic configuration)
- Individual configuration of DM functions can be done either by LIS POC
Manager or Hemo Connect Software
 Data management functions
Hemo Control basic version

- Time and date

- Test result

Hemo Control with DM upgrade Lists can be send from LIS to device
or Lists canfunction
Each be sendcan
from
beLIS
setto
asdevice
compulsory,
Hemo Control Manager Each DM function
optional can be set as compulsory,
or in-active.
optional or in-active.

- Operator-ID - Test result

- Patient-ID - QC results and batch info
- Cuvette LOT - QC LOT, Level and Range
- QC scheme and lock-out function - Comments
- Time and date
 Public standard protocol
LIS2-A2 communication standard

Successor of the well known ASTM (E1381/E1394) standard

Common for small to mid size analyzers, easier to integrate than POCT-1A,
public protocol available from EKF
Bi-directional interface allows direct connection to third party software
Protocol is basis for interfacing with the customers LIS system via the existing
middleware or with other 3rd party software
EKF Hemo Connect and Hemo Connect light software continue to be available
for configuration and data export in case no direct connection to customer data
system is planned
 Data connections
USB
USB connector cable
port on PC
Hemo Control

LAN connector cable LAN port

Bluetooth
interface on PC

Hemo Control Manager

Bluetooth to LAN bridge
(u/d)
LAN port
 Accessories
BT printer MCP 1880
Small, lightweight
Communication via printer cable or Bluetooth
(HCM only)

Barcode scanner
Lightweight, flexible

3x adapter
To connect BC scanner and PC/LIS simultaneously
Alternatively connect barcode scanner and printer

Connection options to IT systems

USB connector cable, serial cable (HC + HCM)
BT dongle to PC (HCM only)
Options for serial-to-LAN and BT-to-LAN are under
investigation
 EKF nxt Microcuvette
Unique design minimises risk of air bubbles in the
sample:
A slot at the rear of the sample chamber allows
trapped air to escape
Round tip and wide opening for sample uptake
Users can hold the cuvette at any angle to the blood
droplet
Desiccant conveniently integrated in canister
Total shelf-life up to 24 months,
3 months after opening of canister
Package configuration 50 pcs per canister (4x50pcs)

Note: cuvettes are susceptible to humidity, only remove

cuvettes for direct use and close canister immediately after!
Capillary sampling
1. Hand must be warm and relaxed . Use
the middle or ring finger. The patient
should not be wearing a ring on the
finger.

2. Clean and dry

puncture site.

3. Gently massage the

finger towards the tip
4. Incision should be
done on the side of
the finger tip
 Capillary sampling
5. Discard the first 2- 3 drops

7. Wipe off the outside

6. Touch blood drop with the tip of the cuvette
of the cuvette. Blood drop must
fill the cuvette .
Fill completely in one continuous
process - do not refill!
 Capillary sampling
Blood flow in the fingertip

Incision
(Blood clot)

False high Normal blood flow

Correct

False low
3045 seconds

Pre-analysis is the key to accurate measurements

regardless of measuring system used!
 Method
Vanzettis azide methemogobin method
G. Vanzetti, An azide-methemoglobin method for hemoglobin determination in blood
Am. J. Lab. & Clin. Med. 67 (1966) 116

Advantages:
Azide methemoglobin is a stable coloured
complex
All Hb-variants* are converted
* except SulfHb (SHb)
Stable results within 10 min after sample uptake
into cuvette, shown in repetitive measurements
High accuracy and precision
 Method
1. Sodium desoxycholate dissolves the walls
of the red blood cells making hemoglobin
available for analysis in the sample.
2. Sodium nitrite oxidises Hemoglobin (Fe2+)
to Methhemoglobin (Fe3+)
3. Sodium azid ions and Methhemoglobin
form azide methemoglobin, a stable
coloured complex
4. This complex is then measured
photometrically at 570 nm
(and 880 nm for compensation of turbidity)
 Calibration
The International Committee for Standardization in Haematology (ICSH) was
founded in 1964 and given the task to develop recommendations for hemoglobin
measurements. Those recommendations were accepted in 1966 and published in
1967.
The CLSI (at that time NCCLS) converted these
recommendations into a formal standard named
NCCLS H15-A3.

Both, NCCLS and ICSH are describing the same

method.
Hemo Control is factory calibrated according NCCLS
H15-A3. (= Cyanmethemoglobin reference method)

NCCLS: National Committee for Clinical Laboratory Standards (USA)

CLSI: Clinical and Laboratory Standards Institute (since 2005)
 Analytical performance
Correlation with NCCLS H15-13 0.98
Imprecision: CV <2%
Measuring range: 0-25.6 g/dL (0-15.9 mmol/L)
Linearity:
0-20g/dL = +/- 0.3g/dL
>20g/dL = +/- 0.7g/dL
 Hematocrit
Hematocrit (Hct) is the volume of red blood cells within a sample
Hematocrit is an essential measurement in emergency and transfusion
medicine as well as in therapeutic blood dilution
Hematocrit readings also support the diagnosis of conditions such as
anemia and polycythemia

On Hemo Control the Hct value is derived

from the hemoglobin result using the factor
2,94.
Readings are only provided for normal
hemoglobin ranges i.e. 12 - 18 g/dL.
Abnormal values will not be reported.
 Control materials
Control cuvette

Included with each analyser

Physical standard to check
the optical unit
Using the control cuvettes provides
additional safety but means no
limitation of device function
Proctect of humidity > 85%
Avoid damage (e.g. scratches)
 Control materials
Control material (Hb-Con)

Liquid control made of bovine

hemolysate
1 ml dropper bottle, ready-to-use
Storage temperature (unopened)
2C 8C . Guaranteed shelf-life at
delivery: 6 months
Shelf-life after opening:
30 days at 2C 30C
Three levels available
(low, norm, high)
Cleaning procedure
Clean the optical unit once per month or if:
The displayed value of the control cuvette differs
from the value shown on the label
The error message intensity too low appears
Cleaning method
Open the cuvette holder until there is a noticeable
resistance
Press down the latch on the left-hand side of the
cuvette holder with the help of a pointed object
At the same time, pull the cuvette holder forward
Cleaning procedure
1. Insert the cleaner carefully into the opening of the
cuvette holder until you feel a smooth resistance.
2. Slightly push down on the cleaner and then push it
deeper into the opening. Use minimal force, only a
slight resistance should be felt.
3. Wipe the optical unit several times in order to clean
it. Remove the cleaner when complete.
4. If the cleaner is soiled repeat the cleaning process
with a new one.
5. To replace the cuvette holder push it into the
opening of the housing until it locks in place.
Cleaning procedure
1. The cuvette holder can be cleaned with
a mild soap solution. For disinfection,
products similar to those used for
surface disinfection can be used.
2. Wait at least 15 minutes until the
cuvette holder is dry befoe re-inserting
it into the photometer.
3. Clean the housing and touch screen
with a lint free cloth lightly dampened
with clean water, a mild soap solution
or products similar to those used for
surface disinfection.
 Evaluations
Report on the evaluation: Comparison with Swelab AC 910, Sysmex XE 2100,
Sysmex SE 9500, Sysmex SE 9000 = 4 study sites, parallel measurements on
Hemo Control and HemoCue B Photometer
Example:

For detailled information see

Report from the evaluation
2004 SKUP Report (Scandinavia)
Hemo_Control is quick and easy to use and well
suited for the Primary health care.
 Differentiation of
DiaSpect Tm vs Hemo Control
Feature Hemo Control DiaSpect Tm
Memory 4,000 patient results None
500 QC results (DM) > need to have PC
> Data can be transferred connected at test site to
online or retrospectively, save data
ideal for field use
Data management On-board External only
> IDs can be linked to > IDs can only be assigned
result onsite, QC lock-out in PC, requires software
solution, no QC lock-out
Interfaces Bi-directional with LIS or Send only
Hemo Connect
Summary on Hemo Control
Uses the most established technology
Highest degree of flexibility for
data management and connectivity
Maximum user comfort
Excellent product quality
Well suited for field and stationary use