Spotchem page 1 small

Specifications
Sample:
Measurement Wavelength:
Measurement Principle:
Processing Speed:
Minimum Sample Volume:
Simultaneous Measurement:
Reagent Reaction Temperature:
Light Source:
Calibration Method:
DataStorage Volume:
Display:
Built-in Printer:
External Output:
Power Supply:
Power Input:
Dimensions:
Weight:
Whole blood, serum, plasma
5 wavelengths (405, 550, 575, 610 and 820 nm)
Optical measurement of reflection intensity of reagent color reaction
48 samples per hour
250 ul whole blood, 100 ul serum
3 Single Reagent Strips and/or 1 multi Reagent Strip
98.6oF (37oC)
LED and interference filter
Calibration by magnetic card
100 tests
20 digits x 2 lines
36-character thermal printer (58 mm width)
RS-232C interface
AC 100-120 V, 220-240 V, 50/60 HZ (AC adapter method)
Max. 100 VA
Width 13.5” x Depth 8” x Height 6.5”
12 lbs
5182 W. 76th St.
Minneapolis, MN 55439 USA
TEL 877.538.8872
FAX 952.646.3110
www.arkrayusa.com
P/N 6331-00 REV 3/09
NP Intertrade Co., Ltd
Tel: ��-���-����, ���-���-����
���-���-����, ���-���-����, ���-���-����
www.npintertrade.com
Easy 3-step process simplifies
operation and staff training
Three Good Reasons to use
SPOTCHEM TM EZ for
On-the-Spot Chemistry Testing
1. Fast patient Care
- Same visit results in as little as 8 to 15 minutes
- Requires no spacial operating skills
- On board centrifuge
- Measures uo to 8 tests simultaneously
2. Easy Operation
- Fully automated with walk away operation
- No sample pre-treatment required
- Calibration in seconds with swipe of magnetic card
3. Versatile Testing
- Can run panels or single tests to test the way you
need to
- Test menu consists of 21 tests and 3 panels
- Lightweight and portable for easy transport
NP Intertrade Co., Ltd
Tel: ��-���-����, ���-���-����
���-���-����, ���-���-����, ���-���-����
www.npintertrade.com
RUN a panel,
run a single,
or combine
to meet
your needs
Step 1: Add sample and
insert centrifuge cup
Step 2: Place test strip
Step 3: Press start
and await results
SPOTCHEM TM EZ Test Menu
Diabetes Tests
Glucose*
Fructosamine
ALT*
AST*
General Chemistry Tests
Panel 1 (ALB, BUN, GLU, CRE, CAL)*
Panel 2 (ALP, T-BIL, ALT, TP)*
Albumin
ALP
Lipid Test
Amylase
Lipid Panel
BUN*
(HDL-C , T-Chol , Triglycerides) Calcium
Cholesterol*
CK
Triglycerides*
Creatinine*
HDL*
LDL*
GGT
Phosphorus
LDH
Magnesium
Total Bilirubin
Total Protein*
Uric Acid
* CLIA waived
Testing Procedure
Calibration Procedure
Calibrate once per box of test strips.
The SPOTCHEM™ EZ will not perform
an uncalibrated test.
Measurement:
Step 1
1. From the main menu, press the [3]
key to Calibrate.
2. Press the [1] key on the Main Menu to
measure.
• the calibration menu is displayed.
* The table cover opens, and the
STAND-BY screen is displayed.
Step 3
Step 4
3. The instrument will prompt to insert
a card. Insert card with stripe into
reader and slide to the right.
3. Press the [1] key for ID.
4. The instrument will then prompt to
swipe the same stripe again. Insert
card with the same stripe into
reader and slide to the right.
5. Remove centrifuge cover by pulling
backwards and upwards.
Step 7
5. The instrument will then prompt to
swipe another stripe on card. Insert
card with a different strip into reader
and slide to the right.
Step 5
6. The instrument will then prompt to
swipe the same stripe again. Insert
card with the same stripe into
reader and slide to the right.
Step 9
Step 8
10. Press [START] key to begin
measurement.
* The test name and lot
number is displayed.
7. Press the [STOP] key twice.
8. Place the tip in the Tip Hole.
9. Place the reagent strips on the
reagent table with pads facing the
rear of the instrument.
* Repeat this process with
remaining two stripes.
Calibration is successful!
6. Place the centrifuge cup with whole
blood in position on the indented
area of the silver tabs.
7. Replace centrifuge cover by
pushing cover slightly toward rear
of the instrument.
Step 6
Step 7
Steps 3 and
4
4. When "ID" screen appears, input ID
number and press [ENTER] key.
Step 6
Step 5
Step 2
1. Add whole blood to the line on the
centrifuge cup. Remove reagent strips
from refrigerator and allow to come to
room temperature for 10 minutes.
Calibration:
2. Press the [1] key for card calibration.
Step 1
Step 2
Step 10
* When the measurement is
completed, remove used strips
and centrifuge cup, and discard
them.
* SPOTCHEM™ EZ is ready to run
the next sample.
If the instrument fails to calibrate or there is trouble with the card
reader, please call ARKRAY Technical Services for assistance.
NP Intertrade Co., Ltd
Tel: ��-���-����, ���-���-����
���-���-����, ���-���-����, ���-���-����
www.npintertrade.com
SPOTCHEM™ EZ Technical Service 877.538.8872
For Troubleshooting and Common Errors,
please see the SPOTCHEM TM EZ Operator’s Manual.
LIMITATIONS OF PROCEDURE
• Assay whole blood samples immediately after collection and discard after use.
• Occasionally, air bubbles may adhere to the walls of the centrifuge cup. Aspiration of an
air bubble may affect measurement results. If air bubbles are observed, tap the centrifuge
cup to dislodge the bubble from the sample.
• Store strips in a refrigerator at 2°- 8°C (35.6°- 46.4°F). Improper storage may affect the
performance of the strip.
• Allow sealed reagent strips to come to room temperature for 10 minutes before use.
• Do not touch the reagent field of the reagent strip with your fingers.
• Do not reuse a reagent strip. These strips are designed to be used on a single sample
and then discarded.
• Reagent Calibration Cards are lot specific. Re-calibration is required with change of lot
numbers.
• Store Quality Control material according to manufacturer’s guidelines.
WARNINGS AND PRECAUTIONS
For in vitro diagnostic use only.
Exercise the normal precautions required for handling blood samples, containers, used reagent
strips, and pipette tips. Follow local regulations for disposal of biohazardous waste.
QUALITY CONTROL
Assayed Level 1 (HNC200) and Level 2 (HEC200) are recommended for daily quality control. Assay
the controls the same way as the patient samples. Following the instructions under the Test
Procedure Overview section in the package insert. More detailed instructions for quality control
may be found in the SPOTCHEM EZ manual. Two levels of controls should be assayed at least
once a day. Values obtained should fall within a specified range. If these values fall outside the
range and repetition excludes error, do not report results and the following steps should be taken:
1.
2.
3.
4.
Check instrument settings and light source
Check cleanliness of all equipment in use
Check expiration date of kit and controls
Contact ARKRAY Technical Services at 800.538.8872
QUICK
INSTRUCTION
GUIDE
MAINTENANCE REQUIREMENTS
Reference the Operator’s Manual for detailed instructions
Daily - Clean the tip waste case and centrifuge protective cover with soap and water
and dry thoroughly. Dust the reagent table.
This is a CLIA Waived test. A CLIA Certificate of Waiver is needed to perform testing in waived settings. Read the entire Quick
Weekly - Clean the black and white plates with a soft cloth. Clean the rubber plate
with a moistened cotton tip swab and wipe out stains or dust on the rubber plate.
Instruction Guide carefully before use. If a laboratory modifies the following test instructions including QC, the test will be
considered High Complexity and will no longer be considered CLIA Waived. This Quick Instruction Guide provides a brief
summary of the testing procedure. For more information, see the Package Insert and/or Operator’s Manual.
ARKRAY designs, manufactures, and markets IVD medical products.
5182 W. 76th St.
Minneapolis, MN 55439 USA
TEL 877.538.8872
FAX 952.646.3110
www.arkrayusa.com
© Copyright January 2009 ARKRAY USA, Inc.
SPOTCHEM is a Trademark of ARKRAY, Inc.
P/N 6331-00 REV 3/09
NP Intertrade Co., Ltd
Tel: ��-���-����, ���-���-����
���-���-����, ���-���-����, ���-���-����
www.npintertrade.com