Woodley Insight User manual

HCT Meter
Instruction Manual
Woodley Equipment Company Ltd
Old Station Park Buildings,
St. John Street
Horwich,Bolton
BL6 7NY,UK
Tel: [phone]
Fax: [phone]
www.woodleyequipment.com

Contents
Chapter One: Introduction …1
Chapter Two: Technical Specifications …2
Chapter Three: Principal of Operation …3
Chapter Four: Blood Sample Collection …4
Chapter Five: Note …5
Chapter Six:Appearance and Function …7
Chapter Seven: Settings …8
Chapter Eight: Operation …14
Chapter Nine: Trouble-shooting …18
Chapter Ten: Maintenance …20
Chapter Eleven: Symbols …21

Chapter One: Introduction
InSight HCT Meter is designed for use only
with InSight HCT Test Strips from Woodley
Equipment Co Ltd, for the measurement of
haematocrit and total haemoglobin in capillary and
venous whole blood.
Kit Contents
•InSight HCT Meter
•InSight HCT Test Strips (10)
•InSight HCT Code Cards –Cat , Dogand
Horse
•Lancets (10)
•Lancing Device
•Instruction Manual
•CR2032 Batteries (2)
•Carry Case
1

Chapter Two: Technical Specifications
Parameter: Haematocrit and Haemoglobin
in fresh whole blood
Measuring Principle: Optical reflectance
Strip: InSight HCT Test Strips
Display: LCD
Weight: <58g (Battery included)
Outer dimension: 102mm×50mm×19mm
Power: DC 6V (Two CR2032 Battery)
Operating Temp: 15 ~30℃;
RH ≤80% non-condensing
Ultimate Temp: -20 ~55℃;
RH <90%non-condensing
Others: Internal trouble check and
display
Chapter Three: Principal of Operation
The InSight HCT meter utilises optical reflectance
for determination of the total haemoglobin
and calculated haematocrit (HCT). The test strip is
inserted into the meter and abackground blank
reading is automatically determined. Adrop of
whole blood is applied to the test spot on the strip.
Blood immediately disperses within the membrane,
contacts the reagent, then reacts. The meter’s optical
detector automatically measures the change in
membrane reflectance. The intensity of reflectance
is inversely proportional to the haemoglobin
concentration. The meter calculates and displays the
total haemoglobin concentration in gram/deciliter
(g/dL) in 30 seconds based on amathematical
conversion and calculates the haematocrit result
reporting HCT as apercentage (%).
23

Chapter Four: Blood Sample Collection
1. Fresh capillary or EDTA-anticoagulated venous
whole blood may be used.
2. If an EDTA-treated sample is refrigerated,
allow it to be at room temperature prior to use.
EDTA-treated blood samples should be mixed
using end to end inversions at least 8times prior
to use, and shouldbe tested within 24 hours.
3. For fresh venous whole blood samples, collect
approximately 0.1mL into an anticoagulant-free
plasticsyringe.
Chapter Five: Note
1. InSight HCT Meter is designed for use only
with InSight HCT Test Strips from Woodley
Equipment Co Ltd. Prior to inserting test strips,
readthe Manual carefully and input the Code
Card in to the meter.
2. Insufficient blood sample volume and
inadequate mixing of EDTA-treated samples
willaffect results.
3. As all diagnostic tests, test results should be
evaluated according to the specific patient’s
condition.Any results demonstrating the
inconsistency with the patient’s clinical status
shouldbe repeated or supplemented with
additional test data.
4. In order to test the heamatocrit accurately,
please use and maintain the meter correctly.
Reviewthis manual prior to the first use of the
meter.
5. While the test is in progress, do not disturb or
move the meter or strip or press any keys.
45

6. Strong electromagnetic waves will interfere
with the meter. Keep adistance of 2meters
between the meter and amicrowave oven.
7. High temperatures and humidity will affect
the meter.
8. Operating Temperature 15℃-30℃.
9. Avoid any liquid from permeating the meter.
Chapter Six: Appearance and function
1. Appearance:
The meter is composed of keys, LCD, circuit
board, optical system, strip holder, cover and battery
LCD
Warning:
1.Blood plasma and serum should not be
used as samples. Inaccurate results will report
if using arterial blood.
2.Anticoagulants other than EDTAare NOT
recommended for use, such as sodium citrate
and heparin.
Power switch
▲ key
Test port
2. Function:
HCT
Hg b
Strip insert
Data port
Code slot
▼ key
Power switch: Meter on and confirm key
(turning meter off is confirmation)
▲
key :up
▼
key :down
Strip holder: hold strips
SET key: set function (under the strip holder,
refer to Chapter Seven)
67

Chapter Seven: Settings
1. Setting Meter Options
Prior to the first use of the InSight HCT Meter,
the user must enter the following settings:
•Time and date format.
•Current time and date.
2. Enter Settings
Step 1: Lift the test strip holder off the meter.
Step 2: Turn the meter on by pressing the Power
switch key. Wait until the meter displays the Lot Code,
time and date.
The meter can now be customised for time and
date format, current time and date.
3. Selecting Time and Date Format:
The user can select to display the time and date
in 12-hourAM/PM time clock with mm/dd date
format or in a24-hour time clock with dd/mm
dateformat.
Note: The date format only contains day and
month, not year.
Step 1: Press the SET key once the date and
time will display. Press and hold the SET key again
until the time and date flash.
8
Step 2: Press the ▲or ▼key to select date
format.
Step 3: Pressing the SET key to enter the
current time and date. If entering current time and
date is not required, and then turn the meter off to
accept the selected time and date format.
Note: Once accepted, the time and date format
will be changed for all stored test results.
HCT
Hgb
SET KEY
9

4. Entering Current Time and Date
The user must enter the current time and date for
correct stamping of test results. If proceeding from
Select Time and Date Format instructions above, go
directly to Step 2. Otherwise, start from Step 1.
Step 1: Press and hold the SET key until the time
and date flash. Press the SET key again.
Step 2: The hour (withAM/PM if 12 hr format
selected) will flash. Press the ▲or ▼ key to enter
the hour. Press the SET key to accept.
Step 3: The minute will now flash. Press the ▲or
▼key to enter the minute. Press the SET key to
accept.
Step 4: The first date selection will flash (mm or
dd). Press the ▲or ▼key to enter the first date
selection. Press the SET key to accept.
Step 5: The second date selection will flash (dd or
mm). Press the ▲or ▼key to enter the second date
selection. Press the SET key to accept.
10
Step 6: Turn the meter off to accept the
entering time and date.
Note: Once accepted, the reporting units will
be changed for all stored test results.Once the
selection of meter settings has been completed,
replace the strip holder onto meter.
5. Saving Test Results
InSight HCT Meter automatically stores 250
test results with adate and time stamp. Upon
storage of more than 250 test results, the oldest test
result is automatically erased. Test results are stored
in ascending chronological order: The first test
result displaying (sequence 001) is the newest test
result, and the last test result displaying (up to
sequence 250) is the oldest test result. Atest result
is stored automatically when the meter shuts off
(either by pressing the key or automatic shut off
after two minutes of inactivity).
11

6. Viewing Saved Test Results
Step 1: Turn the meter on by pressing the
Power switch key. Wait until the meter displays the
Lot Code, time and date. Press the ▲key to
display the test result and its sequence number (a
flashing MEM will display to the lower left of the
test result). After releasing the key, the test result
with its time and date and aflashing MEM will
display.
Step 2: Continue pressing the ▲or ▼key to
scroll through test results.
Step 3: Turn meter off to exit the memory.
7. Deleting Test Results
Test results can be deleted using two methods:
deleting the recent results by CLE or deleting all
result by CLA.
Deletetherecentresults:
Step3:ContinuepressingSETkeytillCLE
flashes. Release SET key, the last result will
display. To delete this result, keep holding SET key
and the result will flash and then be deleted.
Delete all results:
Step 4: Press SET key one more time, CLA
will display. Hold pressing SET key, CLA flashes,
Release SET key,ALL will display. Continue
pressing SET key, all the results will be changed
into MEM.
After completing all steps, turn off the meter
and cover the strip holder.
Note: If you want to exit CLE without
deleting test results, you can shut off the meter
directly.
User could turn the meter off to stop deleting
test results before MEM displays.
Step 1: Lift the strip holder, turn the meter on.
Wait until the meter displays the Lot Code, time
and date.
Step 2: Press SET key twice, CLE displays.
12 13

Chapter Eight: Operation
1. Turn the meter on
Press the Power switch key to turn the meter on.
The meter automatically monitors its internal circuitry
and components during abrief self-check. The meter
is ready when the test strip prompt, Lot Code and
time/date are displayed.
Note: To conserve the battery power, the meter
will automatically shut off after 2minutes of inactivity.
If this happens, turn the meter on again.
2. Input Lot Code Strip
Change the numbers as follows:
1) Press the Power switch to turn the meter off
2) Insert code card provided with the strips
correctly into the Code slot. Press the Power switch
to turn the meter on, the meter will read the code
automatically and display the code on the screen.After
reading the code, the meter will automatically turn off.
3) Remove the code card. Turn the meter on
again, check the code matches then accept atest.
3. Prepare Sample
Clean the sample area with alcohol and wipe
dry with asterile gauze pad. Obtain fresh capillary
or EDTAanticoagulated whole blood sample.
4. Prepare the Test Strip
Take atest strip from its container. Examine the
test strip. Do not use if there are tears, wrinkles or
debris. Do not touchthe test spot membrane. Reseal
remaining test stripsin the original container.
5. Insert the Test Strip
Insert the test strip into the strip holder with the
notched end in first and the hole facing up. The
notched end on the top of the strip should no longer
be visible when the test strip is inserted correctly.
6. Prepare the Meter for Sample Application
The meter will automatically perform a
background blank reading. It will display aflashing
prompt to indicate that it is ready to test asample.
The meter will allow 2minutes for application of the
blood sample
14 15

7. Apply Blood Sample to the Test Strip
Immediately apply adrop of blood to the test
strip by touching the hanging blood drop to the test
spot, ensure the blood drop is large enough to
completely cover the test spot. Acapillary transfer
tube may also be used to transfer the blood sample
to the test strip.
NOTE:
•Use adrop of whole blood (refer to the
instruction of Strips for detail)
•Do not use astrip to touch blood, prior to
being inserted in the meter. Apply only a
hangingblood to the test spot.
•Do not touch the test spot membrane.
•Donot apply asuperfluous amount of
blood.
•Each test strip is for single use only.
8. Read Result
The blood sample will migrate and the meter
will automatically begin the test. During the test, do
not disturb or move the meter or strip, or press any
meter keys.
The test result will be displayed in less than 30
seconds.
Once the test is completed, remove the test
strip and check if the test strip spot is completely
covered by the blood. If not completely covered
then an inaccurate result may report.
After the test is finished, the meter will
automatically shut off after 2minutes of inactivity,
or can be turned off manually by pressing the
Power switch key. The test result will be stored
automatically with date and time.
9. Disposal
Discard the used test strip into clinic waste
16 17

18
Chapter Nine: Trouble-shooting
19
Error Code
Possible Cause
Correction
E0, E1
Hardware or software
error
Turn off and on. If the
error still exists, please
contact your local
distributor.
Meter used in bright
sunlight
Bright sunlight disturbs
meters optical system.
Turn off and on. Repeat
test with new test strip.
E2
Temperature out of
range
Allow meter to adjust to
15 to 30oC. Turn off and
on. Repeat test with new
test strip.
Removing the strip
before testing
Do not remove test strip
until the test is complete.
Turn off and on. Repeat
test with new test strip.
Insufficient sample
volume
Remove the test strip and
turn meter off. Turn on
and repeat test with new
strip. Confirm the blood
sample size is sufficient.
Strip is damaged
Remove the test strip and
turn meter off. Turn on
and repeat test with new
strip. Confirm there are
not tears, wrinkles or
debris.
Incorrect blood sample
Do not use incorrect blood
samples, such as plasma.
Repeat test with the
correct blood sample: fresh
capillary or EDTA-
anticoagulated whole
blood.
E4
Damaged strip
inserted
Remove the test strip and
turn meter off. Turn on
and repeat test with new
strip. Confirm there are
no tears, wrinkles or
debris.
Optical detector
needs cleaning
Remove strip holder
and clean lenses.
Optical detector
does not read the
background
blank
Donotapplybloodsampleuntilthethe
backgroundblankreadingiscomplete.
Optical detector is
clogged
Check the Optical detector,
ensure it isn’t covered by blood.
Ifblocked, remove the
strip holder and clean it.
Refer to the Manual.
UsedStrip
Inserted
Remove the test
strip and turnmeter off. Turn on
and repeat test with anew test
strip.
Insertedstrip
error
Review Insert Strip instructions.
Remove the test
strip and turnmeter off. Turn on
and repeat test with anew test
strip.
Meter
immediately
shuts off once
turned on or
during the
testing process
Replace battery
Replace battery referring to the
Manual.
Stripmoved
duringthetest
The meter will turn off
automatically in 4seconds if
the test strip is moved. Repeat
test with new atest strip.

Chapter Ten: Maintenance
1. Routine maintenance and cleaning
Cleaning must be completed if excess blood is
applied. Lift up the strip holder, so that it can be
removed and cleaned. Wipe away blood or hair left
on the holder or meter using gauze with disinfectant
(10% bleach dilution or, 0.6% hypochlorite
solution).
If there is superfluous blood on the optical
detector, clean it using acotton bud with detergent.
Wipe the strip holder and optical detector
completely using alint free tissue or lens cloth.
Avoid any liquid permeating the meter.
Do not wipe the surface of optical detector
with any polished or corrosive detergent to avoid
the damage of meter and optical detector.
2. Battery replacement
Open the battery cover, take the battery out and
replace with two new CR2032 batteries with
cathodes facing down and close the cover.
Chapter Eleven: Symbols
Caution! Refer to accompanying documents
Biological Hazard!
Serial number
Direct current
CR2032 Use CR2032 as power supply
Manufacturer
Recovery
Protect from heat and radioactive sources
20 21