BMC Oratect HM 15 User manual

Drugs of Abuse
Methamphetamines (ME) 50 ng/mL
Marijuana (TH) 40 ng/mL
Cocaine (CO) 20 ng/mL
Amphetamines (AM) 50 ng/mL
Opiates (OP) 40 ng/mL
PPhencyclidine (PC) 10 ng/mL
www.brananmedical.com
®
Made in USA
US Patent: 6248598
®
• Two test strip configurations of 6 drugs
• Rapid collection and testing in one step
• Results in 5 minutes
• User-friendly and non-invasive
• Avoids cross gender observation
• Reduces sample adulteration or contamination
•
• Includes transport tube for confirmation testing
FDA 510K CLEARED

Oratect®Reference Guide
Branan Medical Corporation Oratect®
140 Technology, Bldg. 400, Irvine CA 92618 Rev: B, 05/2012
1-866-INTECT-7 or 949-598-7166 MKT-041
[email protected]
Test
Windows
Test
Windows
The Oratect® Oral Fluid Drug Screen Device is a simple one-step test for the detection of drugs of abuse in oral fluid.
Oratect® Procedures -- Refer to package insert for detailed instructions and technical information.
1. Remove the blue cap by holding
the sides and pulling gently. This
will expose the collection pad.
Make sure there is a blue line
present in each window area
indicating an unused device.
2. Open mouth and gently rub the
collection pad inside mouth against
cheek in a circular motion several
(approximately 15-20) times. Make
sure to keep head level.
3. Gently rub the collection pad
against the opposite cheek in
circular motion several
(approximately 15-20) times.
4. Gently rub the collection pad on
top of the tongue several
(approximately 15-20) times. Do
not chew, suck, bite or bend the
collection pad.
5. Rub the collection pad underneath
the tongue several (approximately
15-20) times.
6. Place the collection pad underneath
the tongue for approximately 30
seconds to collect saliva. Instruct the
donor to hold the device in place with
hand. Sufficient amount of saliva
collected is indicated by the flow
of the blue lines. Repeat steps 2-6
until blue lines flow.
7. Remove from mouth as soon as
blue lines flow at both of the test
windows. Re-cap the device.
8. Lay the device on a flat surface
and read results in 5 minutes
after removing the device from
mouth. See Package Insert.
Interpreting Oratect®Test Results
Invalid Result
When no colored band appears in the
CONTROL (C) region, the test is
invalid even if there is a band in the
test region. Repeat the test with a new
device.
Example Interpretation:
ME:
Invalid
TH:
Invalid
CO:
Invalid
AM:
Invalid
OP:
Invalid
PC:
Invalid
Negative Result
For each test, two colored bands should
be observed:
One in the CONTROL (C) region
One in the specific TEST region
The color of the test band may be
slightly darker or lighter than the control
band. Any visible band
that can be seen is a
negative result.
Example Interpretation:
ME:
Negative
TH:
Negative
CO:
Negative
AM:
Negative
OP:
Negative
PC:
Negative
Presumptive Positive Result
A colored band at the CONTROL (C)
region should be observed. When
there is no colored band at the specific
TEST region, the test is presumptive
positive for that particular drug.
Example Interpretation:
ME:
Presumptive
Positive
TH:
Negative
CO:
Negative
AM:
Negative
OP:
Negative
PC:
Negative
Blue
Lines