HemoPoint
®
H2
Hemoglobin Photometer
User’s Guide
The copyright of this document is protected! Copying and
distribution to third parties only by written permission of
Stanbio Laboratory.
Stanbio Laboratory
1261 North Main Street
Boerne, Texas 78006 U.S.A.
Tel: (830) 249-0772
Fax: (830) 249-0851
e-mail: stanbio@stanbio.com
HemoPoint®H2 Photometer manufactured in Germany for:
Stanbio Laboratory, Boerne, Texas U.S.A.
Revised: 10. May 2010
Software-Version: From 2.04.0
Subject to modifications.
0. Table of contents
0. TABLE OF CONTENTS .................................................. 1
1. IMPORTANT INFORMATION ......................................... 5
1.1 WELCOME! .................................................................... 5
1.2 EXPLANATION OF THE GRAPHIC SYMBOLS ........................ 5
1.3 SAFETY NOTES .............................................................. 5
2. INTENDED USE .............................................................. 8
3. SET UP ............................................................................ 9
3.1 UNPACKING THE PHOTOMETER ....................................... 9
3.2 SETTING UP THE PHOTOMETER ..................................... 10
3.3 SWITCHING THE PHOTOMETER ON AND OFF ................... 11
3.3.1 Using for the first time ........................................... 11
3.3.2 To operate using the power adaptor ..................... 12
3.3.3 Battery operation ................................................... 14
3.3.4 Stand-by mode ...................................................... 14
3.3.5 Displays and symbols in the ready mode ............. 15
4. SAMPLING AND TESTING PROCEDURE .................. 16
Table of contents
4.1 TAKING A SAMPLE ........................................................ 16
4.1.1 Notes on using the microcuvette ........................... 16
4.1.2 Taking a sample of capillary blood........................ 17
4.1.3 Taking a sample of venous or arterial blood ......... 21
4.2 PERFORMING THE TEST ................................................ 23
4.3 QUALITY CONTROL ....................................................... 28
4.3.1 AutoCheck ............................................................. 28
4.3.2 Blank reading ........................................................ 28
4.3.3 External quality control .......................................... 28
5. FURTHER FUNCTIONS ................................................ 30
5.1 TOUCHSCREEN ............................................................ 30
5.1.1 General.................................................................. 30
5.1.2 Meaning of the buttons / Navigation ..................... 31
5.2 MEMORY (DATA STORAGE) ........................................... 31
5.2.1 Displaying results from memory ............................ 31
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Table of contents
5.3 MENU FUNCTIONS ........................................................ 34
5.4 STANDARD PRINT MODE................................................ 41
5.5 EXPANDED PRINT MODE................................................ 42
5.6 CONNECTING ACCESSORIES ......................................... 44
Printing out results ................................................ 33
5.2.2
5.2.3 Deleting the stored test data ................................. 33
5.3.1 Information about the photometer ......................... 35
5.3.2 Setting the date ..................................................... 36
5.3.3 Setting the time ..................................................... 37
5.3.4 Setting the units..................................................... 37
5.3.5 Hgb mode and limits ............................................. 38
5.3.6 Setting the display contrast ................................... 38
5.3.7 Settings ................................................................. 39
5.3.7.1 Setting the language ............................................ 39
5.3.7.2 Setting date format ............................................... 39
5.3.7.3 Setting time format ............................................... 40
5.3.7.4 Setting the power frequency ................................. 40
5.3.8 Menu options ......................................................... 40
5.3.8.1 Hematocrit mode .................................................. 40
5.3.8.2 Setting the print mode .......................................... 41
5.4.1 Header (Example) ................................................. 41
5.4.2 Hgb limit mode (On), Hematocrit (On) .................. 42
5.5.1 Header (Example) ................................................. 42
5.5.2 Hgb limit mode (On), Hematocrit (On) .................. 42
5.5.2.1 Setting the tone signal .......................................... 43
5.5.2.2 Setting the backlight mode ................................... 43
5.5.2.3 Setting the stand-by time ...................................... 43
5.5.2.4 The service menu ................................................. 44
5.5.3 Information on contacting us ................................. 44
5.6.1 Connecting a printer .............................................. 45
5.6.1.1 Connecting the printer cable ................................ 45
6. MAINTENANCE ............................................................ 47
6.1 CLEANING AND DISINFECTION OF THE INSTRUMENT ........ 47
6.1.1 Housing and touchscreen ..................................... 47
6.1.2 Cuvette holder ....................................................... 47
6.1.3 Optical unit ............................................................ 48
6.1.4 Power adaptor ....................................................... 49
6.2 CHARGING AND CARE OF THE BATTERY.......................... 49
6.2.1 Charging procedure .............................................. 50
6.2.2 Charging time ........................................................ 50
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6.2.3
Self discharge ....................................................... 51
6.3 REPAIRS...................................................................... 51
6.4 PROPER DISPOSAL ....................................................... 51
7. TROUBLESHOOTING .................................................. 52
7.1 PROBLEM SOLVING....................................................... 52
7.2 RESETTING OF THE PHOTOMETER ................................. 57
8. TECHNICAL DATA....................................................... 58
8.1 HEMOPOINT®H2 PHOTOMETER ...................................... 58
8.2 N•X•T MICROCUVETTE .................................................. 59
9. REFERENCE RANGE ................................................... 60
9.1 NORMAL RANGE ........................................................... 60
9.2 UNDERSTANDING YOUR RESULT .................................... 60
10. APPENDIX ...................................................................... 61
10.1 REPLACEMENT PARTS AND CONSUMER MATERIALS ........ 61
10.2 FURTHER INFORMATION................................................ 62
11. INDEX ........................................................................ 63
Table of contents
3
HemoPoint
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H2 User’s Guide
Important information
1. Important information
1.1 Welcome!
Congratulations on purchasing the HemoPoint
testing system. Before you begin using your new HemoPoint
system we strongly recommend you read this manual completely,
with particular attention to the following section with its
introductory explanations and safety notes.
1.2 Explanation of the graphic symbols
The DANGER symbol!
This symbol warns of situations or actions that could
DANGER!
WARNING!
lead to serious damage to the health of the user or a
patient.
The WARNING symbol!
This symbol warns about incorrect handling that
could cause measuring errors or damage to the
instrument or any accessories used.
®
H2 hemoglobin
®
H2
The TIP symbol!
Alongside this symbol we provide useful additional
TIP
information about the current matter.
1.3 Safety notes
It is essential that you read the following notes, in order to avoid
risks to persons and damage to the photometer and other
equipment. Stanbio Laboratory does not accept responsibility for
damage arising from non-observance of the following notes.
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H2 User’s Guide
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Important information
Follow the user’s guide!
Each time the photometer is used, precise knowledge and
attention to these operating instructions is required. Only use the
WARNING!
HemoPoint
Section 2.
Danger of fatal electric shock!
Under no circumstances should you open the AC power
DANGER!
Never use a mechanically damaged AC power adaptor –
The AC power adaptor is not waterproof. Therefore, never
Only use the AC power adaptor in a socket that has been
Check that the AC voltage and frequency printed on the AC power
adaptor label match your electrical socket and whether the shape
WARNING!
and configuration of the plug contacts are compatible for this
connection.
®
H2 system for the purpose which will be described in
adaptor. There are no elements inside which require
servicing or maintenance.
live connections might be exposed.
let liquids come into contact with it. A lightly dampened
cloth, however, can be used to clean it when
disconnected. Please see the notes on care in Section 6.
properly installed.
DANGER!
WARNING!
WARNING!
6
Not to be used in areas where there is a risk of explosion!
The instrument is not approved for use in areas where there is a
risk of explosion.
Keep the photometer away from liquids!
The photometer is not waterproof. Fluids entering the instrument
could destroy the electrical and optical components in the
photometer. A lightly dampened cloth, however, can be used for
cleaning. Please see the notes on care in Section 6.
Allow the instrument to reach room temperature!
Particularly on changing from a cold into a warm environment (i.e.
after storage or transport) condensation can form inside and on
the outside of the instrument. Wait an appropriate time (approx. 1
HemoPoint
®
H2 User’s Guide
Important information
hour), before you connect to the main power supply or switch on
the instrument.
Only use original equipment!
Only attach equipment that is expressly approved for use with the
®
HemoPoint
H2. Stanbio does not guarantee the function of the
instrument when other equipment is used.
Never open the photometer!
There are no parts in the photometer that require customer
maintenance. Repairs can only be carried out by Stanbio
Laboratory personnel. Further notes on maintenance can be
found in Section 6.
Do not force the cuvette holder!
The cuvette holder is very important for the quality of testing.
Therefore mechanical force on the holder should be avoided and
only the designated microcuvettes should be used. For cleaning
purposes the cuvette holder can be removed from the photometer
after a mechanical locking device is released. Notes on this can
be found in Section 6.
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Intended use
2. Intended use
®
The HemoPoint
determination of hemoglobin (Hgb) in whole blood of adults,
infants, and children in a professional point-of-care setting. It
consists of a dedicated photometer and individual, single-use
microcuvettes filled with reagents.
Using the microcuvette, a small amount of arterial, venous or
capillary blood is taken up by capillary action. The filled cuvette is
inserted into the HemoPoint
by the chemical reaction in the cuvette is measured, and the Hgb
value is displayed. The microcuvettes are intended to be used
only once and must be disposed after use as potentially infectious
waste, in accordance with the current regulations applicable to
your establishment.
The HemoPoint
practices and in clinical laboratories to assist in medical
diagnostic investigations. In addition it can be used in emergency
and intensive care units and in medical facilities such as blood
banks. This test system has been approved for use in
laboratories with Waived status as defined in 452 CFR
493.15(c)(a).
STANBIO LABORATORY, LP DISCLAIMS ALL EXPRESS AND
IMPLIED WARRANTIES OF THE MERCHANTABILITY AND
FITNESS PERTAINING TO THIS PRODUCT WHICH ARE NOT
EXPRESSLY DETAILED IN THIS PACKAGING INFORMATION
OR A WRITTEN AGREEMENT BETWEEN THE BUYER AND
SELLER OF THIS PRODUCT.
STANBIO LABORATORY, LP MAINTAINS THAT THIS
PRODUCT CONFORMS TO THE INFORMATION CONTAINED
IN THIS INSERT. PURCHASER MUST DETERMINE THE
SUITABILITY OF THE PRODUCT FOR THEIR PARTICULAR
USE. USE ONLY IN ACCORDANCE WITH LABELING
INSTRUCTIONS.
H2 system is intended for the quantitative
®
H2 photometer, the color produced
®
H2 system is designed for use in medical
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H2 User’s Guide
3. Set up
3.1 Unpacking the photometer
Before you set up the HemoPoint
all the items are present and undamaged (see Illustration 1).
®
H2 photometer, first check that
Set up
Illustration 1: (1) HemoPoint
®
H2 photometer and (1) AC power adaptor.
Materials provided
®
• One (1) HemoPoint
H2 Photometer
• One (1) AC power adaptor
• One (1) User’s Guide
• One (1) Quick Reference Guide
• One (1) Warranty Registration Card
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H2 User’s Guide
Set up
WARNING!
Additional materials required but not provided
• Latex Gloves
• Sampling devices for capillary blood collection
• Biohazardous waste container
• Alcohol swabs and gauze for cleaning puncture site
®
• HemoPoint
• HemoPoint
• HemoPoint
H2 n•x•t Microcuvettes
®
H2 Hemoglobin Controls (optional)
®
H2 Optics Cleaner
®
Why Register your HemoPoint
H2?
Returning the completed Warranty Registration Card will activate
your warranty and allow Stanbio to provide you with the latest
product updates and improvements.
Even easier – Go to www.stanbio.com/warranty.php and
®
register your HemoPoint
H2 online!
What is your voltage?
Check that the AC voltage and frequency printed on the AC
adaptor label match your electrical socket and whether the shape
of the plug is compatible for this connection. If not, do not connect
the photometer to the electrical socket under any circumstances.
Contact Stanbio Laboratory in this case.
10
3.2 Setting up the photometer
Select a suitable place for setting up the photometer, according to
the following criteria:
Avoid direct sunlight
Avoid strong electromagnetic fields
Avoid direct influence from ionizing radiation
Avoid rapid temperature fluctuations (keep away from
heaters, open windows, ventilators, fans or airconditioning, etc.)
Avoid wet areas (i.e. wash basins)
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H2 User’s Guide
Place the photometer on a level counter adjacent to a power
socket. Make sure there is enough room for the cuvette holder to
be freely accessible.
Set up
Illustration 2: Setting up the photometer.
3.3 Switching the photometer on and off
3.3.1 Using for the first time
Allow the photometer to reach room temperature!
Changing from a cold to a warm environment (i.e. after storage or
transport), condensation can form both on the inside and the
outside of the photometer. Wait at least 1 hour, before you
connect the photometer to a power supply.
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H2 User’s Guide
WARNING!
11
Set up
TIP
As the built-in battery has not yet been charged, the photometer
must first be connected to the power adaptor (supplied) and
plugged into an electrical socket until the battery is completely
charged.
This procedure is necessary in order for the capacity of the
battery to be checked and the charge indicator to function
correctly. Further information on this can be found in Section 6.2
“Charging and care of the battery”.
3.3.2 To operate using the power adaptor
Use the power adaptor to operate the photometer, noting the
following steps when connecting the power adaptor:
1. Insert the small round plug on the connecting cable of the
power adaptor into the appropriate socket (6VDC) at the
back of the photometer.
Illustration 3: Connecting the power adaptor.
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H2 User’s Guide
2. Next, insert the power adaptor plug into an appropriate
electrical socket. The photometer itself does not have a
power On/Off switch.
Please be patient after plugging the photometer into the electrical
socket. It may be 4 or 5 seconds before anything appears on the
display. This does not indicate a fault but is related to various
initialization steps within the photometer. Following this
initialization phase, the display illuminates and a welcome screen
appears briefly, after which the instrument is ready to operate.
Illustration 4: Welcome display screen.
Set up
TIP
Illustration 5: Display in ready mode (Open Holder).
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Set up
TIP
TIP
The individual symbols and their meanings are explained in
Section 3.3.5 “Displays and symbols in the ready mode“.
Now you can either start your testing, view results in the memory,
or carry out adjustments in the Menu.
You can find tips on this in Sections 4 “Sampling and testing
procedure”, 5.2 “Memory (data storage) and 5.3 “Menu
functions”.
If the photometer is not in use for some time, it switches into the
energy-saving, Stand-by mode (see Section 3.3.4 “Stand-by
mode”).
3.3.3 Battery operation
®
The HemoPoint
H2 photometer automatically switches to battery
operation when you unplug the power adaptor from the electrical
socket, or from the instrument (assuming, of course, that the
battery is sufficiently charged).
When the battery is fully charged it will operate for a period of at
least 100 hours.
TIP
WARNING!
14
Tips on charging the battery and battery maintenance can be
found in Section 6.2 “Charging and care of the battery”.
To avoid problems while testing during battery operation, also
note the tips in Section 3.2 “Setting up the photometer”.
3.3.4 Stand-by mode
The photometer does not have a separate On/Off-switch. It is
designed so that it automatically switches to the Stand-by mode
when you are not operating the instrument for a certain time
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H2 User’s Guide
(approximately 5 minutes). The display will go blank in the Standby mode.
This elapsed time can be changed in Section 5.5.2.3 “Setting the
Stand-by time”.
The Stand-by mode reduces power usage to a minimum.
There are (3) three ways of switching the instrument ON again:
Touch the Touchscreen
Open or close the cuvette holder
Plug the photometer into an electrical power supply
3.3.5 Displays and symbols in the ready mode
Set up
TIP
Illustration 6: Display in ready mode (Open Holder).
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15
Sampling and testing procedure
4. Sampling and testing procedure
4.1 Taking a sample
4.1.1 Notes on using the microcuvette
Illustration 7: n•x•t microcuvette
optical eye
16
The microcuvette is the most sensitive component in the
®
HemoPoint
H2 system. It is therefore necessary to handle the
cuvette carefully, paying particular attention to the following
conditions:
1. Each microcuvette can only be used once!
The microcuvette is designed for single use. The cuvette is
coated during manufacturing with all the reagents necessary for
determining the hemoglobin concentration in the blood sample.
As soon as the blood is taken into the cuvette, a reaction occurs
(within 1 minute).
2. The microcuvette is sensitive to moisture!
The microcuvette will absorb moisture therefore the cuvettes are
supplied in a special airtight container that contains a drying
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H2 User’s Guide
Sampling and testing procedure
agent. This drying agent assures that any moisture is readily
absorbed during storage.
Pay attention to the following notes, to preserve the integrity of
the cuvettes:
Store the cuvettes only in the original container and at
room temperature (59-86°F / 15-30°C).
Only remove one cuvette at a time from the container and
then immediately close the lid. Make sure that the lid is
completely closed by pressing it down as far as it will go.
WARNING!
The cuvette shelf life is reduced once the lid is opened. See the
®
HemoPoint
H2 cuvette container label for additional information.
Please make a note of the date of opening on the container label.
3. The microcuvette is a precision optical component!
®
The microcuvette is analyzed optically in the HemoPoint
H2
photometer. The measured absorption is proportional to the
hemoglobin concentration. The light from the light source should
penetrate through the sample to the photo detector with the least
possible influence from the cuvette. Therefore it is important not
to touch the optical eye of the cuvette with fingers or sharp
objects (see Illustration 7).
4. The microcuvette is only designed for in-vitro testing!
5. The reagents that coat the inner walls of the cuvette are
harmful and must not be swallowed.
4.1.2 Taking a sample of capillary blood
1. Take out a microcuvette from the original container and
immediately close the lid.
Please note Section 4.1.1 “Notes on using the microcuvette”.
WARNING!
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Sampling and testing procedure
Illustration 8: Preparing to take a blood sample.
2. Make sure that your patient is sitting comfortably. There
should be good blood circulation in the hand from which
you wish to take blood, i.e. it should be warm and
relaxed.
If in doubt, the hands can be warmed in warm water.
TIP
Illustration 9: Stimulating the circulation.
3. Lightly massage the fingers, in order to stimulate the
circulation.
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Warning, risk of infection!
Please wear suitable protective gloves!
Sampling and testing procedure
DANGER!
Only use the middle or ring finger. The patient should not
wearing a ring on the finger used for sampling.
Illustration 10: Disinfecting the puncture site.
4. Disinfect the puncture site and allow to dry.
be
TIP
Illustration 11: Sticking the finger.
5. Press lightly on the fingertip and puncture with a suitable
sampling device on the side of the fingertip.
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Sampling and testing procedure
Sticking the fingertip on the side is less painful and the blood flow
is better. To ensure to have a spontaneous flow of blood use a
TIP
sampling device with a proper depth size (2.25 mm).
Illustration 12: Blotting the first drop of blood.
6. Blot away the first drop of blood then, if necessary, press
gently once again to get a drop of blood which is large
enough to fill the cuvette completely. Avoid “milking”. (For
additional information about obtaining a capillary blood
sample, read the latest CLSI guideline. Order information
may be found at www.clsi.org.)
Illustration 13: Filling the cuvette.
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H2 User’s Guide
Sampling and testing procedure
7. Hold the center
of the cuvette in the middle of the drop of
blood and wait until the cuvette is filled completely. DO
NOT fill from the side as this could create air bubbles in
the cuvette optic window and result in an erroneous
result.
Ensure that the cuvette cavity is completely filled and free of air
bubbles. DO NOT try and top-off cuvette if not filled completely.
Repeat the process with a new drop of blood and a new cuvette.
Illustration 14: Removing excess blood.
8. In order to avoid contamination of the cuvette holder,
remove excess blood from the outside of the cuvette by
carefully wiping off with a gauze or lint-free tissue.
WARNING!
Please note, do not remove any blood from the cuvette cavity.
DO NOT try and top-off cuvette if not filled completely. Repeat the
process with a new drop of blood and a new cuvette.
The cuvette sample can now be tested immediately or within 10
minutes. DO NOT read cuvette after 10 minutes. For further
steps, please read Section 4.2 “Performing the test”.
4.1.3 Taking a sample of venous or arterial blood
®
The HemoPoint
H2 photometer can be used for determination of
hemoglobin in venous or arterial blood samples if the blood
collection date is not longer than 24 hours and the sample was
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H2 User’s Guide
WARNING!
21
Sampling and testing procedure
stored refrigerated (2-8°C). Prepare the sample for testing as
follows:
1. Remove sample tube from the refrigerator and bring it to
room temperature (15-30°C).
2. Mix the sample well (i.e. by a mechanical rotator or by
inverting by hand).
3. Take out a microcuvette from the container and
immediately close the lid.
Please note Section 4.1.1 “Notes on using the microcuvette”.
WARNING!
4. Pipette a sufficient drop of blood on a non-absorbent
material (i.e. plastic film).
5. Hold the center
blood and wait until the cuvette is filled completely (see
Illustration 15). DO NOT fill from the side as this could
create air bubbles in the cuvette optic window and result
in an erroneous result.
of the cuvette in the middle of the drop of
Illustration 15: Taking a sample of venous or arterial blood.
Ensure that the cuvette cavity is completely filled and free of air
bubbles. DO NOT try and top-off cuvette if not filled completely.
WARNING!
Repeat the process with a new drop of blood and a new cuvette.
6. In order to avoid contamination of the cuvette holder,
remove excess blood from the outside of the cuvette by
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H2 User’s Guide
Sampling and testing procedure
carefully wiping off with a gauze or lint-free tissue (see
Illustration 14).
Please note, do not remove any blood from the cuvette cavity.
DO NOT try and top-off cuvette if not filled completely. Repeat the
process with a new drop of blood and a new cuvette.
The cuvette sample can now be tested immediately or within 10
minutes. DO NOT read cuvette after 10 minutes. For further
steps, please read Section 4.2 “Performing the test”.
4.2 Performing the test
(“Hgb limit” mode ON with the “Hematocrit” mode ON)
WARNING!
Illustration 16: Opening the cuvette holder.
1. Open the cuvette holder completely.
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Sampling and testing procedure
Illustration 17: Display “Add Cuvette”.
The instrument will check the optical performance of the
measuring system. This process takes approx. 1 – 2 seconds.
TIP
Release the cuvette holder and do not touch it again until the
process is finished and an audible signal (beep) occurs.
2. If you have the “Hgb limit” mode activated and set the
normal range for each patient type (see Section 5.3.5
“Hgb mode and limits”), the display will show the “Patient
type” buttons that can be selected before testing occurs.
Select the patient type by touching the appropriate
button. If you select “NO”, then no patient range will be
displayed or printed with the result.
Illustration 18: Display to select “Patient Type”.
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H2 User’s Guide
Sampling and testing procedure
In case you wish to change or cancel the selected patient type,
simply touch the “Patient Type” button and make another
selection.
Illustration 19: Display after a patient type (male) is chosen.
Illustration 20: Inserting the cuvette.
3. Insert the appropriate patient microcuvette (example,
Male) into the cuvette holder as shown in Illustration 20,
making sure the microcuvette is properly inserted into the
holder.
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Sampling and testing procedure
4. Push gently
automatically. DO NOT force!
5. Testing of the cuvette begins automatically (see
Illustration 21).
Ensure the cuvette holder closes completely, otherwise the
cuvette will not be positioned correctly in the photometer and this
WARNING!
will cause an incorrect result.
Illustration 21: Display during the testing cycle.
The testing time varies according to the hemoglobin
concentration and can take between 10 – 60 seconds.
TIP
on the cuvette holder and it will close
Patient Types: M … Male, F ... Female, C ... Child
Symbols for exceeding Hgb-limits: H … Result above upper limit threshold
L … Result below lower limit threshold
Illustration 22: Display showing the test result.
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Sampling and testing procedure
6. Read the test result.
You can now make a note of the result(s). Pressing the OK button
is not absolutely necessary. It merely produces a confirmation of
the result, while the photometer changes to the ready mode
display. Opening the cuvette holder will start a new testing cycle.
The hemoglobin result is displayed with the selected patient type
and may be marked with an (H) High or (L) Low if the result falls
outside the selected patient normal range. An estimated
Hematocrit result will be displayed if the “Hct mode” is activated
(see Section 5.3.8.1 Hematocrit mode). The measured result(s)
is stored and can be recalled later from the memory (data
storage) which can hold up to 4000 patient results (see Section
5.2.1 “Displaying results from memory”).
If you have connected a printer, the current test result will be
printed out immediately. Further information about connecting a
printer can be found in Section 5.6.1 “Connecting a printer”.
If you prefer the display to show the result in another type of unit,
you can change it as described in Section 5.3.4 “Setting the
units”.
TIP
7. Open the cuvette holder, take out the used cuvette and
dispose properly (see Section 6.4 “Proper disposal”).
Keep the cuvette holder closed when photometer is not in
use.
When the holder is opened, a new testing cycle is started and the
photometer checks the optical performance of the measuring
system and automatically becomes ready for a new cuvette to be
inserted.
If you do not want to perform another test, simply close the
cuvette holder again. The test cycle will be cancelled.
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TIP
27
Sampling and testing procedure
4.3 Quality control
4.3.1 AutoCheck
The HemoPoint
photometers optic system every time the cuvette holder is
opened. If regulatory quality control checks are required, the
quality control check should be performed using Stanbio liquid
controls.
4.3.2 Blank reading
All the optical and mechanical components involved with the
measuring cycle are carefully manufactured with extremely small
tolerances. This is essential for the proper function of the
photometer.
Always carry out a blank reading whenever you have removed
the cuvette holder (i.e., cleaning, replacing with a new cuvette
holder).
A blank reading can be performed as follows:
1. Open the cuvette holder completely.
®
H2 AutoCheck performs an internal check of the
TIP
28
The text in the display reads “Add Cuvette”.
2. Close the cuvette holder, without inserting a cuvette.
In this case the photometer does not start testing. After approx. 2
– 3 seconds the display will read “Open Holder”. If the instrument
TIP
does not show “Open Holder”, there is possibly a malfunction.
Please consult Section 7 “Troubleshooting”.
4.3.3 External quality control
If additional quality control is required by local or other
regulations, external control material may be used. For this
HemoPoint
®
H2 User’s Guide
Sampling and testing procedure
purpose, we recommend the use of Stanbio HemoPoint
®
H2
Hemoglobin Controls.
Instructions for ordering can be found in Section 10.1
“Replacement parts and consumer materials”.
There are a variety of hemoglobin controls on the market today.
®
Stanbio only recommends the use of the HemoPoint
H2
Hemoglobin Controls, since we cannot guarantee the
®
compatibility of other brands of controls on the HemoPoint
H2
system.
Thoroughly mix the controls before use (see the control package
insert for directions).
Compare the values obtained with the controls against the stated
reference values. If the Hgb result falls outside the range of the
controls, there is evidently a problem. Please consult Section 7
“Troubleshooting” in this regard.
TIP
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®
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29
Further functions
5. Further functions
5.1 Touchscreen
5.1.1 General
The photometer has been equipped with a touchscreen. The
touch sensitive surface is divided into various individual
segments. According to the current operating mode, these
segments can be defined as operating buttons.
Illustration 23: Divided touchscreen.
WARNING!
30
The buttons in the lower part of the display are enlarged to allow
easy operation. As can be seen in Illustration 23, the sensitive
area of these buttons extends into the middle of the display, so it
is not difficult to operate them.
A touchscreen is a delicate electronic component. Therefore
please note the following instructions:
Only touch the touchscreen lightly with fingertips.
Avoid sharp objects such as ball-point pens, fingernails,
etc.
Only clean the touchscreen with a soft cloth that is
lightly dampened with water or a mild cleaning solution.
Follow the instructions given in Section 6.1 “Cleaning
and disinfection of the instrument”.
HemoPoint
®
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5.1.2 Meaning of the buttons / Navigation
Further functions
Function
Software button, calls up appropriate
function such as Memory or Menu.
“UP” button, selects the next higher listed
item or increases the numerical value.
“DOWN” button, selects the next lower listed
item or decreases the numerical value.
ESC
OK
Function
“ESC” button, leaves the menu screen or
rejects changes.
“OK” button, selects the next lower menu
screen or confirms a selection.
Shows a button that is inactive.
5.2 Memory (data storage)
The instrument is equipped with data storage, which can store up
to 4000 results.
5.2.1 Displaying results from memory
Access to the data storage is possible only if the photometer is in
the ready mode (Open Holder).
Illustration 24: Display screen, ready mode (Open Holder).
Memory
Press this button to display the test data.
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31
Further functions
You will see the following screen display, for example:
Illustration 25: Display screen, data storage.
The entry displayed is the most recent result.
Press this button to display preceding
results until you reach the first entry on
the list.
Press this button to display successive
results, until you reach the last entry on
the list.
32
ESC
Press this button (Escape) to leave the
memory (data storage).
Press this button to select the menu
“Options”. In this menu you will find
Options
additional functions for printing and for
deleting results.
Further information in this regard can be
found in Sections 5.2.2 and 5.2.3.
If correlation is activated (see Section 5.3.1 “Information about
the photometer”) you may see - - - or +++ symbols at any
positions in the data storage. This indicates that the real results
cannot be shown with the current settings of the correlation
function, because they exceed the testing range.
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®
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Further functions
If the estimated Hematocrit mode has been activated the
hematocrit result will be displayed as well (see Section 5.3.8.1
“Hematocrit mode”).
5.2.2 Printing out results
In order to print out from memory (data storage) you must have a
printer connected. Instructions for this can be found in Section
5.4 “Standard print mode” and Section 5.5 “Expanded print
mode”.
You can print out results as follows:
From the memory (data storage) display, press the
button
Options
.
Select the entry “Print” using the buttons.
Confirm the selection with
results, otherwise press
OK
ESC
, to print out the
, in order not to
print.
Printing out the results can take a few seconds. Following
printing, the photometer changes back again to display the
memory (data storage).
TIP
5.2.3 Deleting the stored test data
With this function the entire data storage (all results) is deleted.
To delete the data storage, proceed as follows:
From the memory (data storage) display, press the
button
Options
.
Select the entry “Delete” using the buttons.
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®
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33
Further functions
TIP
Confirm the selection with
data storage, otherwise press
OK
, to delete the
ESC
, in order
not to delete.
After deleting, the instrument changes back again to display
memory (data storage) – “Empty”.
5.3 Menu functions
The photometer has various possible settings that can be
accessed through the menu function.
Access to the menu is possible only if the photometer is in the
ready mode.
Illustration 26: Display screen, ready mode.
34
Menu
Press this button to access the Menu.
You will see the following screen display:
Illustration 27: Display screen, Menu.
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®
H2 User’s Guide
Further functions
Press this button to scroll up to desired
menu entry.
Press this button to scroll down to desired
menu entry.
ESC
Press this button to select the next higher
menu level, or to leave the menu.
Press this button to select the next lower
OK
menu level, to adjust settings, or to
display information.
5.3.1 Information about the photometer
Information about the photometer and the status of various
components can be found under the menu item “Info”.
You can scroll up or down with the arrow
buttons.
OK
With this button you can leave the
information display again.
The following information is displayed:
- Test Count -
Total: Total number of tests performed on this instrument
Today: Number of tests performed today
Battery: Number of tests performed using battery power
- Battery -
Remaining battery charge
- Memory -
Pat: Number of new test results / number of test results
- Serial No. -
Serial number of the photometer
- Model No. -
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®
H2 User’s Guide
35
Further functions
Correlation function to conform the output of results with different
devices and/or methods.
The correlation can only be enabled by authorized personnel on
special request. Contact Stanbio Laboratory’s Technical Service
Department for additional information.
5.3.2 Setting the date
The function of setting the current date can be found under
“Menu”, sub-menu “Date”. Setting the date is important for the
correct relationships of the results from the memory (data
storage) or for printing out the results.
Model number of the photometer
y = m * x + n
m … correlation factor
n … offset
if m = 1 and n = 0 (factory defaults) the function
is not active
The current S
- Version -
Software Version
Electronic hardware
Mechanical hardware
- Adaptation -
- SPN -
ervice Process Number, needed by Servicing
36
The format to enter the date depends on the date format setting
(see Section 5.3.7.2 “Setting date format”).
The arrow buttons increase or decrease
the numerical value in each case.
ESC
Press this button to reject the entry and to
leave the adjustment.
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®
H2 User’s Guide
Further functions
Press this button to confirm the current
setting and to access the next entry. After
OK
entering the last value, the settings are
stored and you leave the adjustment
menu.
5.3.3 Setting the time
The function of setting the photometer to the current time can be
found under “Menu”, sub-menu “Time”. Setting the time is
important for the correct relationships of the results from the
memory (data storage) or for printing out the results.
The format to enter the time depends on the time format setting
(see Section 5.3.7.3 “Setting time format”).
The functions of the individual buttons can be found in Section
5.3.2 “Setting the date”.
5.3.4 Setting the units
The function of setting the units can be found under “Menu”, submenu “Unit”. This gives you the ability to set the test unit for the
hemoglobin value you wish to use. This setting influences all test
displays, including the results in the memory (data storage) and
the printer.
Illustration 28: Display screen, Unit
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®
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37
Further functions
You can select the following units:
mmol/L
g/dL (default)
g/L
Select the appropriate entry using the
arrow buttons.
TIP
ESC
OK
Press this button to reject the selection.
Press this button to confirm the selection.
5.3.5 Hgb mode and limits
The function of enabling the Hgb mode and setting the limits can
be found under “Menu”, sub-menu “Hgb limits”. This gives you
the ability to enable or disable the Hgb mode and to set the
normal range limits of each patient group. This setting influences
all test displays, including the results in the memory (data
storage) and the printer.
Limits can be set for the following groups of patients:
Adult Male - (13 – 18 g/dL) default
Adult Female - (11– 16 g/dL) default
Child - (11 – 16 g/dL) default
Limits can be set within 5 – 25.5 g/dL (0.31 – 15.81 mmol/L).
While the “Hgb limits” mode is activated, the lower limits must
show different values than the upper limits of all groups of
patient. Otherwise the “Hgb-limits” mode will be inactive.
5.3.6 Setting the display contrast
The LCD display contrast is strongly dependent for technical
reasons on the environmental temperature. You can set the
contrast by entering “Menu”, sub-menu, “Contrast”. Default
setting is “3”. Higher numbers will darken the screen.
38
HemoPoint
®
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Further functions
Please be very careful when setting the contrast. At certain
temperatures you can no longer read anything on the display
under certain conditions with some contrast settings. Should
you accidentally store these settings by pressing the OK button,
the instrument must be reset. You can read about this in Section
7 “Troubleshooting”.
The function of the individual keys can be found in Section 5.3.2
“Setting the date”.
5.3.7 Settings
In this menu some general format settings can be found.
5.3.7.1 Setting the language
The HemoPoint
®
H2 photometer supports various languages. The
function of setting the language can be found under “Menu”, submenu “Settings”, sub-menu “Language”. This gives you the
ability to set the photometer to the language you wish to use.
The following languages are supported:
German
English (default)
Spanish
WARNING!
The function of the individual keys can be found in Section 5.3.4
“Setting the units”.
5.3.7.2 Setting date format
Under the “Menu”, sub-menu “Settings”, sub-menu “Date
Format” the output format of the date can be set. This affects the
output of data record in the memory (data storage) and the
printout of the results.
The following settings are supported:
DD.MM.YY (Day.Month.Year)
MM/DD/YY (Month/Day/Year) (default)
DD/MM/YY (Day/Month/Year)
YY-MM-DD (Year-Month-Day)
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®
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39
Further functions
5.3.7.3 Setting time format
Under “Menu”, sub-menu “Settings”, sub-menu “Time Format”
the output format of the time can be set. This affects the output
of data records in the memory (data storage) and the printout of
the results. The following settings are supported:
5.3.7.4 Setting the power frequency
Under “Menu”, sub-menu “Settings”, sub-menu “Frequency” the
frequency of the electrical current can be set. In the United
States 60 Hz is the norm. The following settings are supported:
The function of the individual keys can be found in Section 5.3.4
“Setting the units”.
5.3.8 Menu options
To keep the main menu clear, all functions that are used less
frequently have been placed under the menu item “Options”.
12 hours (default)
24 hours
50 Hz
60 Hz (default)
WARNING!
40
5.3.8.1 Hematocrit mode
Display of an estimated hematocrit value can be activated in
“Menu”, sub-menu “Options”, sub-menu “Hematocrit”. The
hematocrit value will be calculated using the formula Hct=F x
Hgb [g/dL], with F= 2.94. A true hematocrit test is not determined
with this system.
The use of this formula is allowed only within the normal
hemoglobin range, means from 12.0 g/dL (7.44 mmol/L) – 18.0
g/dL (11.16 mmol/L). If the Hgb result is outside this range then
the estimated hematocrit result will not be calculated and “N/A”
will appear.
HemoPoint
®
H2 User’s Guide
5.3.8.2 Setting the print mode
Further functions
To print-out test result(s) and result(s) from the memory (data
®
storage), the HemoPoint
H2 supports different print modes:
Off
Standard-Print Mode
Expanded-Print Mode (default)
Under “Menu”, sub-menu “Options”, sub-menu “Print Mode” the
mode of print can be set.
In standard-print mode you will get a simple and compact
printout of the results from the memory (data storage) including
all available information in list form.
In the expanded-print mode you have the possibility to separate
single records and to assign them to patient records.
5.4 Standard print mode
5.4.1 Header (Example)
Stanbio Laboratory
www.stanbio.com
Version…: X.XX.x
Serial No.: 3008-09-0001
Cust.Service: (866) 782-6246
Tech.Service: (800) 531-5535
Hgb Limits:
Male…..: 13-18 g/dL
Female.: 11-16 g/dL
Child….: 11-16 g/dL
Printed one time a day, after changing the print mode or after
changing the date.
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®
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41
Further functions
5.4.2 Hgb limit mode (On), Hematocrit (On)
5.5 Expanded print mode
5.5.1 Header (Example)
No. Date Time Hgb Hct
--------------------------------------------------------------
1. 01/01/09 12:03pm 15.0 g/dL F 45%
2. 01/01/09 12:03pm 13.2 g/dL F 40%
Stanbio Laboratory
www.stanbio.com
Version…: X.XX.x
Serial No.: 3008-09-0001
Cust.Service: (866) 782-6246
Tech.Service: (800) 531-5535
42
Printed one time a day, after changing the print mode or after
changing the date.
5.5.2 Hgb limit mode (On), Hematocrit (On)
Pat. No. 01 ____________________(Female)
Date.....…....: 03/25/09
Time.....…...: 10:45am
Hgb.........….: 11.9 g/dL (11.0-16.0 g/dL)
Hct.......…....: 45%
HemoPoint
®
H2 User’s Guide
Further functions
5.5.2.1 Setting the tone signal
Under “Menu”, sub-menu “Options”, sub-menu “Tone” the signal
can be switched ON or OFF. This adjustment affects the button
signals as well as the signals that sound at the end of the current
test.
5.5.2.2 Setting the backlight mode
Under “Menu”, sub-menu “Options”, sub-menu “Backlight” the
backlight can be switched ON or OFF when under battery
operation. If turned ON the backlight is temporarily switched on
for all entries and actions. Under electrical power operation the
backlight is always on.
: The backlight consumes power from the battery, and
Note
therefore shortens the operation time of the instrument under
battery operation.
5.5.2.3 Setting the stand-by time
®
The HemoPoint
H2 is equipped with integrated energy
management. If the photometer is not used for a certain time, it
switches into the stand-by mode (see Section 3.3.4 “Stand-by
mode”). Under this menu, you can set the number of minutes the
photometer will remain active (ON), after which the instrument
will switch off.
Under “Menu”, sub-menu “Options”, sub-menu “Stand-by” the
stand-by time can be set according to your preference. Use the
appropriate arrow key to either increase or decrease the standby time (in increments of 1 minute).
Illustration 29: Display screen, Stand-by.
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®
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43
Further functions
5.5.2.4 The service menu
Under “Menu”, sub-menu “Options”, sub-menu “Service”, this
menu item is intended for an authorized Stanbio technical
service representative only.
5.5.3 Information on contacting us
Information on how to contact Stanbio if you need further help or
if you wish to place an order is found under “Menu”, sub-menu
“Contact”. This information can also be found in Section 10.2
“Further information”.
5.6 Connecting accessories
The HemoPoint
interface at the back of the instrument.
®
H2 photometer is equipped with a serial
Illustration 30: Interface socket.
Only instruments specifically intended for the purpose should be
connected to this interface socket, using the appropriate
WARNING!
connecting cable. To avoid short circuits, keep sharp metallic
objects away from the sockets.
44
HemoPoint
®
H2 User’s Guide
Further functions
5.6.1 Connecting a printer
The HemoPoint
®
H2 photometer supports the connection of a
Seiko Model No. DPU-414 serial printer.
The DPU-414 can be ordered through an authorized Stanbio
Laboratory distributor.
With the use of a printer you can print each patient’s test result
immediately or print patient result(s) from memory (data storage)
later (see Section 5.2.2 “Printing out results”).
Illustration 31: DPU-414 printer.
5.6.1.1 Connecting the printer cable
To connect the printer to the HemoPoint
®
H2 a special printer
cable is needed which is included with each printer if sold for use
®
with the HemoPoint
H2 or may be purchased separately from an
authorized Stanbio Laboratory distributor.
Please only use the cable intended for this purpose, otherwise
both the photometer and the printer may be seriously damaged.
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®
H2 User’s Guide
WARNING!
45
Further functions
The printer cable is equipped at one end with a 9-pin serial plug
to connect with the printer and at the other end with a 7 pole mini
–DIN plug to connect to the interface socket of the HemoPoint
H2 (see Illustration 32, Connecting the Seiko DPU-414 printer).
Illustration 32: Connecting the Seiko DPU-414 printer.
®
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HemoPoint
®
H2 User’s Guide
6. Maintenance
6.1 Cleaning and disinfection of the instrument
6.1.1 Housing and touchscreen
It is essential to follow the instructions in Section 1.3 “Safety
notes”. Disconnect the power adaptor from the electrical
connection before proceeding.
Cleaning the housing and touchscreen is best accomplished with
a lint-free cloth, lightly dampened with clean water. For more
stubborn soiling, a mild soap solution may be used. For
disinfection, standard solutions can be used for surface
disinfection provided they do not
The housing is equipped with a high-quality lacquered surface.
Please do not use any harsh cleaning agent or solvent otherwise
the surface can be damaged and the photometer will look
unsightly.
contain alcohol or other solvent.
Maintenance
WARNING!
WARNING!
Before cleaning the touchscreen, open the cuvette holder.
6.1.2 Cuvette holder
The cuvette holder can be removed from the instrument for
cleaning. Proceed as follows:
Disconnect the power adaptor from the electrical
connection before proceeding.
Open the cuvette holder until you feel a resistance and
the holder will not extend further.
Press down the silver pin on the left-hand side (bottom)
of the cuvette holder with a ball-point pen and draw the
cuvette holder forward at the same time.
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®
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TIP
47
Maintenance
WARNING!
Illustration 33: Removing the cuvette holder.
The cuvette holder can now be cleaned with a mild soap solution.
For disinfection, standard solvent-free preparations can be used.
To replace the cuvette holder, simply push it in the correct
position into the opening in the housing until it engages.
Please wait until the cuvette holder is completely dry before
replacing it. Do not use any cleaning agent for cleaning the
cuvette holder that could leave scratches on its surface.
6.1.3 Optical unit
The optical unit is situated inside the photometer and has no
direct contact with the cuvette therefore no routine cleaning is
needed. Cleaning the optical unit can become necessary if the
measured maximum light intensity of the photometric light source
no longer achieves the appropriate level required for testing. The
optical unit should be cleaned when the following error message
is displayed: Dirty Optics – Use Optics Cleaner (see
Illustration 34, Display screen, Measurement Error).
48
HemoPoint
®
H2 User’s Guide
Illustration 34: Display screen, Measurement Error.
Maintenance
®
For cleaning the optical unit the use of a special HemoPoint
H2
optics cleaner is recommended. The Optics Cleaner can be
obtained through an authorized Stanbio distributor. Please follow
the instructions for use that can be found in the package insert
that comes with the Cleaner or go online to www.stanbio.com
®
Tech Support, “Routine Cleaning of the HemoPoint
H2” for step-
by-step instructions.
Cleaning the optical unit is a delicate operation inside the
instrument. Please do not use any cleaning agents other than
original Stanbio Optics Cleaner.
6.1.4 Power adaptor
Care! Danger of fatal electric shock!
It is essential to follow the instructions in Section 1.3 “Safety
notes”. Disconnect the power adaptor from the electrical
connection before proceeding.
The power adaptor can be cleaned and disinfected in the same
way as the instrument housing (see Section 6.1.1 “Housing and
touchscreen”).
WARNING!
DANGER!
6.2 Charging and care of the battery
The HemoPoint
etal Hydride) battery. The capacity of the battery is calculated
M
on the basis of being sufficient for 100 hours of measuring
®
H2 photometer is equipped with a NiMH (Nickel
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®
H2 User’s Guide
49
Maintenance
TIP
operation. As with many other components, the battery will lose
capacity over time. Frequent partial discharging and re-charging
accelerates this process. By observing a few “golden rules” you
can considerably influence the life span of the battery:
6.2.1 Charging procedure
To maintain the battery’s full capacity, the battery should always
be discharged as completely as possible before being recharged
again.
The instrument is designed so that the battery will immediately
recharge when it is connected to the power adaptor.
To conserve the battery capacity, from time to time leave the
instrument in battery operation mode until it is almost fully
discharged.
TIP
50
Illustration 35: Display screen when battery is discharged.
6.2.2 Charging time
The battery charging time depends on the charge remaining and
can be fully charged in 9 hours.
If you recharge it overnight, the battery will be fully charged and
ready for use.
After recharging, it is not necessary to disconnect the photometer
from the electrical connection. Overcharging the battery is
impossible.
HemoPoint
®
H2 User’s Guide
6.2.3 Self discharge
Self-discharging is a typical property of batteries. Even when you
are not using the instrument, the battery slowly discharges and
later reaches the deeply discharged phase, which can damage
the battery.
IMPORTANT! Fully charge the battery at least once a month.
6.3 Repairs
Care! Danger of fatal electric shock!
It is essential to follow the instructions in Section 1.3 “Safety
notes”.
If your instrument does not function as expected, i.e. if the
measured results are not credible, or you are getting incorrect
reports from the instrument, try to solve the problem initially with
the aid of Section 7 “Troubleshooting”.
If you require assistance, contact Stanbio’s technical service
department (see Section 10.2 “Further information”).
6.4 Proper disposal
It is the responsibility of the user to arrange proper disposal of the
individual components.
The microcuvettes and containers for potentially
infectious solutions (Hemolysate, control bloods, etc.)
must be disposed of in accordance with the regulations in
force in your establishment.
The HemoPoint
accessories must be disposed of according to the
regulations for the disposal of electronic components,
after removing the battery.
The battery must be disposed of according to the
regulations for the disposal of old batteries.
®
H2 photometer and electronic
Maintenance
TIP
DANGER!
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®
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51
Troubleshooting
7. Troubleshooting
Before you call Stanbio’s technical service department or send
the instrument in for repair, please try to define or solve the
problem with the help of this section.
Care! Danger of fatal electric shock!
It is essential to follow the instructions in Section 1.3 “Safety
DANGER!
notes”.
7.1 Problem solving
No display, no response to entries
Battery is empty Power the instrument with the power adaptor;
Battery is defective Instrument can only be operated when
Software does not
respond
Battery problems
Error message:
"Defective battery"
No battery symbol
displayed
The battery operation
time is too short. The
instrument switches off
without previous
warning.
allow the battery to recharge completely.
powered with the power adaptor.
Perform a reset of the instrument (see Section
7.2 “Resetting of the photometer”).
A battery problem was found.
Following this message the battery is switched
off. The instrument can only be operated when
powered with the power adaptor.
->Contact Stanbio Technical Support.
The battery has been switched off by the
instrument. The instrument can only be
powered with the power adaptor.
->Contact Stanbio Technical Support.
- Always leave the instrument connected to the
power adaptor until the charging process has
been completed.
- The battery has deteriorated and should be
replaced.
->Contact Stanbio Technical Support.
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Troubleshooting
Power adaptor problems
No plug symbol
displayed
- Power adaptor not powered from the
electrical source.
- Instrument plug not connected.
- Wrong power adaptor.
- Defective power adaptor.
->Contact Stanbio Technical Support.
Error message
“Wrong power supply"
Disconnect the wrong adaptor immediately
and connect with the correct Stanbio adaptor.
Error message
"User error, voltage too
When operated with the power adaptor:
- Wrong power adaptor connected.
low"
Problems with QC measurements and sample measurements
Test results are not
realistic.
Control blood test
result is out of range.
- Defective or superimposed microcuvette.
- Air bubbles in the microcuvette.
- Sampling error (see Section 4.1 “Taking a
sample”)
- Wrong or unsuitable control blood. Incorrect
control level.
- Cuvette holder not properly engaged; replace
cuvette holder (see Section 6.1.2 “Cuvette
holder”).
- Dirty Optical unit; clean optical unit (see
Section 6.1.3 “Optical unit”).
- Cuvette is not correctly positioned into the
cuvette holder.
®
- The HemoPoint
H2 must be only used with
Stanbio Hemoglobin n•x•t microcuvettes.
Error and information messages
Information message
"Temp. too high"
Information message
"Temp. too low”
- Ambient temperature is too high. Operate the
instrument within the correct temperature
range.
- Ambient temperature is too low. Operate the
instrument within the correct temperature
range.
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®
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Troubleshooting
Information message
"Low battery"
Error message
"Measured value too
high"
Error message
"Dirty Optics – Use
Optics Cleaner"
Error message
"Memory is full"
System error
Error message
"CRC ROM"
"CRC RAM"
"CRC EEProm"
Error message
"Defective electronics"
- Low battery operation time. Power the
instrument from the power adaptor to recharge
the battery.
- If the battery is not recharged, the instrument
will switch off after a while.
- Wrong or unsuitable sample material (see
Section 8 “Technical data”).
- Wrong sampling (see Section 4.1 “Taking a
sample”).
- Defective or superimposed microcuvette.
- Dirty Optical unit; clean unit (see Section
6.1.3 “Optical unit”).
- Cuvette holder not properly opened or closed;
repeat testing procedure.
- Cuvette holder not properly engaged; replace
cuvette holder (see Section 6.1.2 “Cuvette
holder”).
- Ambient temperature too high.
- Defective optical unit -> Contact Stanbio
Technical Support.
-At least 4,000 test values have been stored.
->Delete memory.
- Internal problem of instrument; operation not
possible.
->Contact Stanbio Technical Support.
- Microcuvette in the closed cuvette holder
when the instrument is switched on; remove
cuvette.
- Dirty Optical unit; clean unit (see Section
6.1.3 “Optical unit”).
- Internal problem of instrument; operation not
possible.
->Contact Stanbio Technical Support.
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HemoPoint
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H2 User’s Guide
Troubleshooting
Display screen is hard to read.
Display contrast setting
is unsuitable.
Reset the display contrast (see Section 5.3.6 “
Setting the display contrast”).
Instrument will not switch on.
Battery is discharged. Plug in the power adaptor.
Software does not
respond.
Instrument does not
react when connected
to the power adaptor.
Carry out a “Reset” (see Section 7.2 “Resetting
of the photometer”).
Check the connections and that all plug
contacts are correctly seated.
Instrument switches off too quickly or too slowly.
Stand-by time is
unsuitable.
Reset the stand-by time
(see Section 5.5.2.3 “Setting the stand-by
time”).
Instrument does not react to opening or closing the cuvette holder.
Battery is discharged
Connect the power adaptor.
(Display shows
nothing).
Software does not
react.
Carry out a “Reset”
(see Section 7.2 “Resetting of the
photometer”).
Background illumination does not work.
Power adaptor is not
Connect the power adaptor.
connected.
Backlight illumination is
not turned on under the
Turn the backlight mode on (see Section
5.5.2.2 “Setting the backlight mode”).
battery backlight mode.
Tone Signal does not work, or does not work properly.
Tone signal is set
incorrectly.
Adjust the tone signal
(see Section 5.5.2.1 “Setting the tone signal”).
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®
H2 User’s Guide
55
Troubleshooting
Display texts are not shown in your language.
Language is set
incorrectly.
Time displayed is incorrect.
Time is set incorrectly. Reset the time
Date shown in the printout or data storage is incorrect or will not
be displayed as expected.
Date setting is
incorrect.
Date format is set
incorrectly.
Time shown in the printout or data storage is incorrect or will not
be displayed as expected.
Time is set incorrectly. Reset the time
Time format is set
incorrectly.
Set your language
(see Section 5.3.7.1 “Setting the language”).
(see Section 5.3.3 “Setting the time”).
Reset the date
(see Section 5.3.2 “Setting the date”).
Set the date format
(see Section 5.3.7.2 “Setting date format”).
(see Section 5.3.3 “Setting the time”).
Set the time format
(see Section 5.3.7.3 “Setting time format”).
56
Incorrect units are shown.
Setting of units is
incorrect.
Set the units of measurement
(see Section 5.3.4 “Setting the units”).
Printer does not print.
Incorrect type of
printer.
Connect to a DPU-414 printer
(see Section 5.6.1 “Connecting a printer”).
Printer not “online”. Switch the printer to online mode (see
operating instructions for the printer).
Incorrect, or incorrectly
connected, printer
cable.
Use an original printer cable from Stanbio or
check that the plug contacts are correctly
seated
(see Section 5.6.1.1 “Connecting the printer
cable”).
HemoPoint
®
H2 User’s Guide
Troubleshooting
7.2 Resetting of the photometer
The “Reset” serves to transfer the photometer to its default
settings, without changing user-specific settings significantly. The
settings for contrast, date and time are lost.
The reset button can be found on the underside of the
photometer.
Reset button
Illustration 36: Location of the reset button.
To reset the photometer, simply press the button using a narrow
object such as a ballpoint pen or paperclip.
Illustration 37: Confirmation display, Reset
HemoPoint
®
H2 User’s Guide
57
Technical data
8. Technical data
8.1 HemoPoint
Measuring
procedure
Source
Dominant
wavelength of
source
Spectral half value
width of the source
Receiver
Measuring range
Sample material
Sample carrier
Sample size
Linearity
Measuring time
Memory (data
storage)
Dimensions
(LxWxH)
®
H2 photometer
Optical absorption photometry.
Dual-Color-LED 570 / 880 nm
st
wavelength: 570 ± 5 nm
1
nd
2
wavelength: 880 ± 10 nm
st
wavelength: 15 ± 3 nm
1
nd
wavelength: 50 nm
2
Photodiode 350 – 820 nm
0 – 25.6 g/dL
Venous, arterial, or capillary human blood.
Stanbio n•x•t Microcuvette.
8 μL
0- 20.0 g/dL ± 0.3 g/dL
>20.0 g/dL ± 0.7 g/dL
Dependent on concentration, 10 – 60s.
Up to 4000 results, including date and
time.
6.25 in. x 6.5 in. x 2.5 in.
58
HemoPoint
®
H2 User’s Guide
Weight 1.3 lbs.
Power supply
AC Power adaptor:
Input: 100- 250 V AC / 50-60Hz
Output: 6 VDC
Integrated battery:
Voltage: 2.4 V
Capacity: 1500 mAh
(ca. 100 h operation time)
Power
maximal: 3 W
typically: 1.2 W
minimal: 30 mW
Interface
Printer (RS 232 C)
Environmental
Room temperature (15 – 30°C)
temperature
8.2 n•x•t Microcuvette
Technical data
Type
Volume in the
cuvette cavity
Reagents
Material
Storage
Dimensions
(LxWxH)
Microcuvette, coated with reagents for
determining the hemoglobin value in
venous, arterial, or capillary blood.
8 μL
Sodium desoxycholate, sodium nitrite,
sodium azide, non-reactive additives.
Polystyrene
Room temperature (15 – 30°C), dry
storage in the original containers.
1.5 in. x 1.0 in. x 0.125 in.
HemoPoint
®
H2 User’s Guide
59
Reference range
9. Reference range
9.1 Normal range
Different blood hemoglobin values have been reported in the
literature
Adult Males: 13.0 – 18.0 g/dL
Adult Females: 11.0 – 16.0 g/dL
Children (2 yrs to teenage): 11.0 – 16.0 g/dL
Infants (post-natal) 10.0 – 14.0 g/dL
The highest Hgb concentrations are usually measured in neonates.
Due to the wide range of conditions (dietary, geographical, smoking,
exercise, recumbency, etc.), which affect reference values, it is
recommended that each laboratory establish its own expected ranges.
9.2 Understanding your result
Hemoglobin is the oxygen–carrying pigment and main component
of red blood cells. Low hemoglobin levels may indicate anemia,
recent hemorrhage or fluid retention. Elevated hemoglobin levels
may indicate hemoconcentration from polycythemia or
dehydration.
1. Fandek N, Moreau D, Newell KC, Ofner A, eds. Clinical Laboratory Tests –
2. Demott Wayne R, Tilzer Lowell L, Hematology. In: Jacobs DS, Demott WR,
3. Wallach J. eds. Interpretation of Diagnostic Tests – A Synopsis of Laboratory
4. Painter Pennell C, Cope June Y, Smith Jane L, Appendix. In: burtis CA,
(1,2,3,4)
.
Values and Implications. 2
328pp.
Finley PR, Horvat RT, Kasten jr BL, Tilzer LL, eds. Laboratory Test Handbook.
Hudson: Lexi-Comp, 1992: 517-626.
Medicine, 4
Ashwood ER, eds. Tietz Textbook of Clinical Chemistry. Philadelphia: WB
Saunders, 1994: 2161 – 2217.
th
ed. Boston/Toronto: Little Brown and Co. 1986: 6pp.
nd
ed. Springhouse: Springhouse Corporation, 1955:
60
HemoPoint
®
H2 User’s Guide
10. Appendix
10.1 Replacement parts and consumer materials
Appendix
Catalog No. Description Ordering
3015-100
3015-200
3060-601
3065-601
3050-003
G3250-001
3150-001
3175-001
3172-001
3180-005
3030-001
3040-001
G3000-001
3190-001
3071E-001
ver.02
HemoPoint
2 Containers @ 50 cuvettes each (100 tests)
HemoPoint
4 Containers @ 50 cuvettes each (200 tests)
HemoPoint
Set of 6 dropper bottles: 2 x Hgb control-low,
2 x Hgb control-normal, 2 x Hgb control-high
HemoPoint
Set of 6 dropper bottles: 3 x Hgb control-low,
3 x Hgb control-high
HemoPoint
For cleaning the optical unit
Printer, DPU-414
Thermal printer with power adaptor and
interface cable
Printer, Power Adaptor
Printer, Battery Pack
Rechargable battery pack for DPU-414 printer
Printer, Cable
For connecting the DPU-414 to the
HemoPoint
Printer, Thermal Paper
Suitable for DPU-414, Set consists of 5 rolls
HemoPoint
Power Adaptor
HemoPoint
Carrying Case, Plastic
for HemoPoint®H2 photometer, power
adaptor, microcuvettes
User’s Guide - English
for HemoPoint®H2 photometer
®
H2 n•x•t Microcuvettes
®
H2 n•x•t Microcuvettes
®
H2 Tri-level Hgb Controls
®
H2 Bi-level Hgb Controls
®
H2 Optics Cleaner
®
H2 photometer
®
H2 Cuvette Holder
®
for the HemoPoint
H2 Photometer
3 pcs.
®
H2
1 pack
1 kit
1 kit
1 set
1 set
1 pc.
1 pc.
1 pc.
1 pc.
1 set
1 pc.
1 pc.
1 pc.
1 pc.
HemoPoint
®
H2 User’s Guide
61
Appendix
10.2 Further information
If you have any questions over and above this user’s guide, we
would be pleased to help. Here is all the important contact
information:
Main address: Stanbio Laboratory
1261 North Main Street
Boerne, Texas 78006
U.S.A.
Telephone: (830) 249-0772 / (866)782-6246
Fax: (830) 249-0851
Technical
Support:
e-Mail: stanbio@stanbio.com
Internet: www.stanbio.com
(800) 531-5535
62
HemoPoint
®
H2 User’s Guide
11. Index
Index
A
accessories · 5, 44, 51
air bubbles · 21, 22, 53
B
backlight · 43
battery · 12, 14, 35, 49, 50, 51,
52, 54, 59
battery operation · 14
blank reading · 28
C
charging · 49
charging procedure · 50
charging time · 50
cleaning and disinfection of the
instrument · 47
concentration · 16, 17, 26, 58,
60
cuvette holder · 7, 11, 15, 21,
22, 23, 26, 27, 28, 47, 48, 55
E
environmental temperature · 59
H
hematocrit · 40
I
intended use · 8
interface · 44, 59
K
keys
buttons · 31, 36, 38
L
language · 39, 56
linearity · 58
D
data storage · 31, 58
date · 36, 39, 56
display contrast · 38, 55
disposal · 51
HemoPoint
M
maintenance · 47
measuring procedure · 58
measuring range · 58
measuring time · 26, 58
menu functions · 34
microcuvette · 16, 58, 59
moisture · 16
®
H2 User’s Guide
63
Index
N
navigation · 31
O
optical eye · 16
P
print mode · 41
printer · 27, 45, 56
connecting cable · 45
DPU-414 · 45
puncture site · 19
Q
quality control · 28
R
reference range · 60
repairs · 51
reset button · 57
results
displaying · 31
printing · 33
S
safety notes · 5, 47, 49, 51, 52
sample carrier · 58
sample material · 58
sample size · 58
sampling procedure · 16
self discharge · 51
service menu · 44
set up · 9
stand-by · 14, 43
storage · 59
symbols · 15, 26, 32
danger symbol · 5
tip symbol · 5
warning symbol · 5
T
testing cycle · 26, 27
testing procedure · 16
time · 37, 40, 56
tone signal · 43
touchscreen · 30, 47
troubleshooting · 52
U
units · 37, 38, 56
64
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®
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®
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