NycoCard Reader II User Manual

Page 1
Introduction to NycoCard® READER II
The NycoCard®READER II is a small battery powered instrument, designed to measure all NycoCard
®
products. The coloured responses of the NycoCard
®
products are measured by spectral reflectance in three parts of the visible spectrum.
Description of NycoCard® READER II
The NycoCard®READER II kit consists of:
NycoCard
®
READER II 1 unit Battery charger 1 unit Batteries (rechargeable) 3 units
Calibration devices 10 units Pen tips 10 units Pen rings 10 units
Battery clips 3 units Pad1 unit Instruction manual 1 unit Warranty card 1 unit
The NycoCard
®
READER II consists of two units: the instrument box (1), which is the operational and calcu­lating unit, and the Reader pen (5), which is the mea­surement unit. The main components of the instrument box are the microprocessor, the LCD display (3) and the push buttons (2) for operation. The key elements of the Reader pen are the Light Emitting Diodes (LED’s) (11), a photodiode (12), a light/dark detector (10) and the functional design. A pen cable (4) connects these two units together. The penholder (8) is located to the right of the display on the instrument box. The pen is placed in the holder to protect it when not in use. In front of this holder, there is a lid (6), and on the rear side of the lid a white calibration device (9) is placed.
Basic theory
The Reader pen contains three pairs of LED’s: red, green and blue. Reflected light from the test sample is measured, relative to a white sample, by a light­sensitive photodiode circuit. When a specific test from the NycoCard
®
READER II test menu is chosen, the required LED’s illuminate the sample to be measured. The sample will reflect some of the light and give rise to a constant current in the photodiode, which will discharge a capacitor linearly from the voltage V
1
to
a lower voltage V
2
.When V2is reached, a signal is given to the microprocessor. The microprocessor measures the time (T) it takes to change the voltage from V
1
to V2.The intensity of reflected light (I) is then inversely proportional to T, and the microprocessor converts the time to a concentration value, which will then be displayed.
When the pen is placed over the sample and the pen sleeve is pushed down, the light/dark detector regis­ters that the environment has changed from light to dark and the measurement is automatically started. The sleeve will ensure that the pen is held stable in a vertical position, and that external light is excluded from the sample.
Adjusting This procedure compensates for the contribution of reflected light from the inside of the pen tip (14) and slight electrical current leakage in the electronic circuit. Adjusting is performed when the pen is placed in the penholder, i.e. in a dark chamber without any sample present. It is important to adjust the instrument each time the instrument is turned on and when the pen tip is replaced.
W
hite calibration White calibration adjusts for any differences in measuring conditions and variation of pen tips. The white calibration is performed on a special calibration device, which is stored under the lid, protected from light and dust. The NycoCard
®
READER II should be calibrated prior to each series of measurements (max 20 measurements per series) and prior to each single, sporadic measurement.
Installation and environment
Check that all components listed in the section Description of NycoCard
®
READER II are included in the package and that no components are damaged. Fill in the Instrument Warranty Card and send it back to your local distributor. Make sure that the instrument is acclimatised to room temperature before use. Recommended ambient temperature is 18 – 25°C and humidity must not be condensing. Ensure that the instrument is protected from dirt and direct sunlight.
Your NycoCard
®
READER II is supplied with 3 rechar­geable NiMH batteries (1.2 V) (16). Before using the new instrument the batteries should be charged for 18 hours. The connection plug of the battery charger (18) is inserted into the outlet (19) located at the rear side of the instrument box. The Reader pen has a modular plug (20). The NycoCard
®
READER II is equipped
with RS 232 port for PC-connection (21).
5
GB
A1 A2 A3 A4
Page 2
Using the instrument
Functions The instrument is operated by three push buttons:
To switch on the instrument and to screen the main menus and the sub menus.
To enter and activate the menu selected by the Select button.
To exit the current menu or function.
T
he menu
Four main menus are available for selection:
Main menu/Calibrate instructs the instrument to measure the White Calibration Device. Main menu/Enter test contains sub menus correspon­ding to each of the NycoCard
®
tests that are available.
Main menu/Options contains two sub menus:
- Enter language: To c hange the language on the display.
- New white:To measure a new value of white when a
message “Error Recalibrate” appears on the display. The white value will change with ageing, even if pen tips and calibration devices are replaced.
Main menu/Off followed by “ENTER” will turn off the instrument. Pressing QUIT and ENTER simultaneous­ly will also turn off the instrument, regardless of the position in the menu.
Operating procedure The following three steps must be performed before the result of a NycoCard
®
test is obtained:
1. Adjusting Make sure that the pen is placed in the penholder and turn the Reader on. The instrument automatically performs
“Adjusting”. Allow the Adjusting proce­dure to complete without touching the pen. A single beep will indicate that the Adjusting is completed correctly. A double beep will indicate errors in the Adjusting followed by the message “Adjust error”. (See troubleshooting).
2. White calibration
Press ENTER to activate the menu and
follow the instructions in the display.
When the message “Place pen…” is
displayed, lift the pen out of the holder
and place it on the White Calibration Device. Hold the pen steady until a single beep indicates that the cali­bration is finished.
3. Measuring a NycoCard
®
test The Reader pad (7) should always be used during measurements. The reque­sted NycoCard
®
test is chosen from Main
menu / Enter test and the instrument is
ready for the measurement. When the pen tip is placed into the test hole and the pen sleeve pushed down, the measurement will start. After a few seconds the test result will be displayed as a concentration value.
If the instrument is placed on stand-by for about 10 minutes, it will automatically switch-off. When the instrument is turned on again, the last measured value will automatically be displayed.
Maintenance
The Reader pen has two replaceable accessories, the pen tip (14) and the pen ring (13). These two parts will be in contact with the assay devices that are exposed to diluted blood/urine. The pen tip must be replaced if it is dirty, to reduce interference during measurements. Be careful not to touch the optics of the Reader pen. It is recommended that the pen tip and white calibra­tion device are inspected regularly. If the calibration device is damaged or dirty, it should be changed.
•Replacing the pen tip: to remove the pen tip, care­fully snap the tip off with your fingers. Replace the new pen tip.
•Replacing the pen ring: to remove the pen ring, hold the case shield with one hand and carefully wriggle the ring off with the other hand. Replace the new pen ring. Make sure it fits correctly.
•Replacing the calibration device: remove the device by simultaneously pressing the small handle down and the opposite side upwards. Place the new cali­bration device.
•Replacing the batteries: Step 1.
Use a screwdriver to open the battery lid (15).
Step 2. Remove the old batteries. It is recommen-
ded to use a small screwdriver when removing the battery clips (17).
Step 3. Replace the batteries with three new
batteries. Be sure that the batteries are inserted in the right direction.
Step 4. Replace the battery lid. New batteries
need to be charged before using the instrument.
6
Enter
Select
ON
Quit
Page 3
Warnings and precautions
IVD… For in vitro diagnostic use only.
• Do not interchange Reader pens between different instruments.
• Be aware that the pen tip and pen ring will be in contact with diluted blood/urine.
•Follow general laboratory precautions when hand­ling blood samples.
• Be certain that the outlet voltage has the same rating as the charger.
• Water or any other liquid should not be in contact with the instrument.
• Dispose the batteries according to manufacturer’s recommendations.
• Leaving batteries in the instrument for long intervals without charging can lead to spilling of electrolyte and damage the instrument.
• Measuring NycoCard
®
products without using the
pad may lead to wrong results.
7
Troubleshooting
The following conditions or problems may occur when using the NycoCard®READER II. If your problem still exists after corrective action is taken, please contact your local distributor.
Problem Possible cause Corrective action
“Battery low” appears on the 1. Batteries discharged. 1. Recharge the batteries. display.
2. Batteries improperly inserted 2. Reinsert batteries. into the battery holders.
3. One of the batteries has short- 3. Replace all batteries. circuited and is not recharging.
Display screen is blank or 1. Batteries discharged. (see other 1. Recharge the batteries. Check unreadable. causes under “Battery low”.) polarity and that the batteries are
of the correct type.
2. Sub-optimal viewing conditions. 2. Increase light level or change light Light too dim. position.
Display fades out during “Adjusting” 1. Batteries discharged. 1. Recharge batteries.
“Calibrate white/ ERROR! Recalibr.” 1. Calibration device used is dirty, 1. Replace calibration device and appears on the display. scratched or not totally white recalibrate.
2. Ageing of the instrument has 2. Measurement of new white value. changed the internal white value.
3. Pen tip is dirty or damaged. 3. Replace the pen tip. Recalibrate.
“Calibrate white Active. 1. Pen cable not properly inserted. 1. Check that the pen cable connector Wait...” persists on the display screen. plug is properly inserted into the
receptacle of the instrument. Recalibrate.
Program will not proceed from 1. Room light too strong or unit in 1. Reduce light/avoid sunlight on
device.
“Place pen” to “Active. Wait…” direct sunlight.
“Adjust ERROR” 1. Pen tip is dirty or damaged. 1. Replace Pen tip.
2. Humidity or temperature is too high.
Perform adjusting and white calibration.
“RAM ERROR” / “Test data error” 1. Contact your local distributor.
Page 4
Technical specifications
Instrument
Size, instrument box: 200x170x70 mm Size, Reader pen: L: 144 mm, D: 29.5 mm Weight: 540 g (incl. Reader pen and batteries) Display type: LCD, 2x16 characters Computer: Intel 80 C32 Memory capacity: Programme memory capacity: 64 Kbytes Test storage capacity: 2 Kbytes Power supply: Batteries, battery charger
Measuring conditions
Temperature range: 15-35°C
1)
(The recommended range is 18-25°C) Relative humidity: 0-90% Avoid direct sunlight or too dim light
1)
See special instructions for each NycoCard®test
Batteries
Rechargeable NiMH batteries only, size AA,
1.2 V, Recharge 8-18 hours
Battery charger
Mascot type 8311/0901 or equivalent Output: 9VDC/2.5 W Plug 3630+ (coaxial type): Polarity; pos. (+) in centre Length: 12.0 mm Inner diameter: 2.1 mm Outer diameter: 5.5 mm
Ordering information
Product Product no. Quantity
NycoCard
®
READER II 1113117 1 unit Calibration devices 1047782 1x10 units Pen tips 1047780 1x10 units Pen rings 1047781 1x10 units
8
A1 A2 A3
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