1
2
4
3
5
6
7
8
9
10
12
11
14
15
16
17
18
P/N 504351-11 06-2018
19
13
Clearblue® Helpline
Monday-Friday 8:30 a.m. - 5:00 p.m. Eastern Time.
Toll-free. 1-800-321-3279
Please have the lot numbers from both the outer and inner packaging.
Calls are recorded for training and quality control.
www.clearblue.com
As prenatal care is very important for a baby’s health, we recommend that you
consult your doctor before trying to get pregnant.
Home ovulation test.
For in vitro diagnostic use.
Store at 36°-86°F (2°-30°C). Do not freeze.
Keep out of the reach of children.
Do not use if the foil wrapper containing
the Test Stick is damaged.
Do not use a Test Stick that has passed its
expiry date.
Do not reuse the Test Sticks.
These instructions are for SPD model
number 505121.
Clearblue® is a registered trademark of SPD Swiss
Precision Diagnostics GmbH.
Holder made in China. Packaged in the U.S.A.
Distributed by Procter & Gamble, Cincinnati, OH 45202.
© 2018 SPD Swiss Precision Diagnostics GmbH.
All rights reserved.
Pat. - see www.swissprecisiondiagnostics.com/patents
The US Surgeon General advises pregnant
women to abstain from alcohol consumption
as this may lead to harmful eects on the
baby such as Fetal Alcohol Syndrome
Disorders (FASD). More information is
available at www.surgeongeneral.gov
This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause
undesired operation.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between equipment and receiver.
• Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.
• Contact the dealer or an experienced radio/TV technician for help.
FURTHER INFORMATION
Disposing of your Digital Test Stick
• Once your result has been displayed, dispose
of the Test Stick with your normal household
waste. To do this, press the eject button on the
Test Holder. The Test Stick will automatically
be released. When you eject the Test Stick
you may notice one or two blue lines on the
Test Stick. These must be ignored; only refer
to the display on the Test Holder to determine
your results. The Test Stick is not reusable.
• Once you have used all the Test Sticks in the
pack you can dispose of the Test Holder in
your normal household waste. Remove all
batteries by separating the upper and lower
halves starting at the end nearest the display.
Remove all batteries from under the central
metal cover. Dispose of the batteries
according to the appropriate recycling
protocol. Caution: Do not disassemble,
recharge, or dispose of the batteries in fire. Do
not swallow. Keep away from children.
Dispose of the rest of the Holder according to
the appropriate recycling protocol for
electrical equipment. Do not dispose of
electrical equipment in fire
Using the Test Holder Again
• While doing a test the Test Holder may have
been splashed with some urine. Ensure that
you wipe it clean. A further test is not possible
while your result or any error symbols are on
the display. These will be displayed for 8
minutes (or 2 minutes if your display was blank
and you have just ejected the Test Stick). It is
important that you have not urinated for at
least 4 hours before doing a test. If you have
collected urine you can use the Test Holder
again as soon as the display is blank. When
you are ready to use the Test Holder again,
repeat the instructions from step 1 using a new
Test Stick.
QUESTIONS & ANSWERS
I do not know my usual cycle length or my cycle
length varies. How do I know when to start
testing?
If you don’t know your usual cycle length you are
advised to wait for at least one menstrual cycle,
and note the length of this cycle, before using
Clearblue® DIGITAL Ovulation Test. Once you
have determined your cycle length you can use
the instructions to work out when to start
testing.
If your cycle length varies by more than 3 days
then choose the shortest cycle you have had
over the last 6 months to work out when to start
testing. It is possible you may need to start a
new pack and use the new Test Holder and Test
Sticks to detect your LH surge.
Alternatively, if you wish to start testing without
knowing your cycle length, we recommend you
star t testing on day 10. (H owever, in this case it is
possible you may miss your LH surge because
you have started testing too late or you may
need to start a new pack to continue testing.)
(Refer to question 10).
My cycle length is outside of the range shown in
the table. How will I know when to start
testing?
If your cycle is 21 days or less , start testing on day
5. If your cycle is longer than 40 days, start
testing 17 days before you expect your next
period.
What time of the day should I carry out the test?
You may test any time of day, but you should test
at approximately the same time each day. You
should not have urinated for at least 4 hours
before testing.
Do I need to use all the tests?
No. You can stop testing when you detect your
LH surge, and save the remaining Test Sticks and
Test Holder to use next cycle if necessary.
Can I use the Test Holder with any other Test
Sticks?
You can only use Clearblue® DIGITAL Ovulation
Test Sticks with this Test Holder.
I have done a test, but the test ready symbol
has not started flashing. What does this mean?
The test has not been done correctly. An error
symbol will appear on the display within 10
minutes of testing. You should re-test with a new
Test Stick. For information on re-testing refer to
question 17 and ‘Using the Test Holder again’.
What if the Test Holder gets wet?
If the Test Holder gets wet you should wipe it
clean. Some splashing will not damage the Test
Holder, but if it becomes very wet it may be
damaged. If so, the display will either remain
blank or an error symbol will be displayed.
I have done a test, but no result has appeared
on the display. What does this mean?
Your result should appear on the display within
3 minutes of doing a test. If no result appears an
error symbol will appear on the display within
10 minutes. Refer to question 17.
How accurate is Clearblue® DIGITAL Ovulation
Test?
The Clearblue® DIGITAL Ovulation Test has
been shown in extensive laboratory trials to be
over 99% accurate in detecting the LH surge
prior to ovulation. The sensitivity of the
Clearblue® DIGITAL Ovulation Test is
40mIU/ml.
I’ve not yet detected my surge. What should
I do?
If your cycle length varies by more than 3 days
then it is possible that you may need to use
more tests to detect your LH surge. Some
women do not ovulate each cycle and
therefore will not see an LH surge in such
cycles. If you are concerned about your results
please see your doctor.
Can any medication or medical conditions
aect the result?
Always read the manufacturer’s instructions
for any medication that you are taking before
conducting a test.
Certain medical conditions and medications
can adversely aect the performance of the
test: for example if you are actually pregnant,
have recently been pregnant, have reached
menopause or have polycystic ovarian
syndrome you may get a misleading result. This
may also be true if you are taking fertility drugs
containing Luteinizing Hormone or human
Chorionic Gonadotrophin (such as Pregnyl®
and Profasi®)*. Please check with your doctor.
Clomiphene citrate (e.g., Clomid®**) does not
aect the tests, but may aect the length of
your cycle and, therefore, when you should be
testing. You may need to start a new pack and
use the new Test Holder and Test Sticks to
continue testing.
I’ve recently stopped using hormonal
contraception (e.g. the contraceptive pill).
Will this aect the results?
No, it will not aect your results. However your
natural hormone pattern is disrupted by
hormonal contraception and if you have
recently stopped using it your cycles can be
irregular and may take some time to stabilize.
You may wish to wait until you have had two
natural menstrual cycles, and note the length of
these cycles, before using Clearblue® DIGITAL
Ovulation Test.
Since it tells me when I am fertile, can I use
Clearblue® DIGITAL Ovulation Test as a
contraceptive?
No. Clearblue® DIGITAL Ovulation Test detects
the LH surge, which occurs only 24-36 hours
before ovulation. As sperm can survive for
several days, you might still become pregnant
if you made love before you detected your LH
surge.
I think I have become pregnant, what should I
do?
You can find out if you are pregnant up to 5 days
sooner than your missed period using a
Clearblue® Pregnancy Test. In laboratory testing
Clearblue® Pregnancy tests are more than 99%
accurate*** in detecting whether or not you are
pregnant when used from the day your period is
due. If you are pregnant you should see your
doctor who can advise what steps to take next.
The earlier you see your doctor, the better it is for
your own health.
I’ve used Clearblue® DIGITAL Ovulation Test for
several months and haven’t become pregnant.
Can I be sure of getting pregnant?
It can take many months to become pregnant.
There are many reasons why you may not
become pregnant even if you’ve been able to
make love at your most fertile time. If after
several months you’ve had no success, you
should consult your doctor.
ERROR MESSAGES
A flashing symbol (Error A)
has appeared on the display
What does this mean?
The Test Stick has been ejected too soon. If it is
not re-inserted quickly enough then a further
error symbol will appear on the display. Refer to
Question 17.
This symbol (Error B) has
appeared on the display.
What does it mean?
An error has occurred during testing. It may
be that
• Urine has been applied to the absorbent tip
before the Test Stick was inserted into the
Test Holder.
• The absorbent tip was not kept pointing
downward, or the test was not laid flat, after
urine was applied.
• Too much or too little urine was applied.
• The Test Stick was ejected too soon.
This symbol will be displayed for 8 minutes.
You should test again using a new Test Stick
taking care to follow the instructions. Refer to
‘Using the Test Holder again’.
This symbol (Error C) has
appeared on the display.
What does this mean?
The test has not performed as expected. This
may be because the instructions for use were
not followed. If you have unused Test Sticks in
the pack, do not use them with this Holder. You
will need to perform another test from a new
pack. Please follow the instructions for use
carefully.
The display has
remained blank.
What does this mean?
The test has not performed as expected. This
may be because the instructions for use were
not followed. If you have not applied urine to
the Test Stick eject it and start again. If the
Holder remains blank it will need to be
replaced.
LIMITS OF THE TEST
Certain medical conditions and medications
may or may not aect the reliability of this test
for predicting ovulation. These can include
pregnancy, post-partum, menopausal
symptoms, breast feeding, birth control pills,
some fertility medications and polycystic
ovarian syndrome (PCOS). Women with
medically diagnosed fertility problems should
ask their physicians if the product is suitable
for them.
* Pregnyl® is a registered trademark of Organon USA, Inc.
Profasi® is a registered trademark of Ares Trading S.A .
** Clomid® is a registered trademark of Merrell
Pharmaceuticals, Inc.
*** 99% accurate at detecting typical pregnancy hormone
levels. However, some pregnant women may not have
detectable amounts of the pregnancy hormone in their urine
on the first day of the missed period or may have
miscalculated the first day of their period.