Download test de alcohol, drogas y control de velocidad

CONTROL DE VELOCIDAD
CONTROL DE ALCOHOL
CONTROL DE DROGAS
DETECTOR DE METALES
SISTEMAS TERMALES DE
VIGILANCIA
ALCO-SENSOR ® V
Int o x i m e t e r s I n c .
CARACTERISTICAS TECNICAS
EL INSTRUMENTO
El nuevo y moderno equipo Alco-Sensor V es un peque€o equipo
de mano manejado por microprocesador de •ltima generacion. El
instrumento provee de un metodo simple y exacto para la determinaci‚n de la concentracion de alcohol. Adicionalmente permite
realizar analisis rapidos de screening disminuyendo en un 99%
el consumo de boquillas. El test pasivo permite realizar analisis
en sujetos que no presten colaboracion para realizar la prueba,
test en cadaveres y sustancias liquidas.
El Alco-Sensor V esta disponibles en 3 configuraciones:
1.- Solo el equipo (sin entrada de datos) con y sin impresora para
registrar los test realizados. En esta configuracion el instrumento
puede descargar periodicamente lso datos a una impresora o a
un computador para analisis estadistico. El resultado impreso incluye un espacion para que el fizcalizador y el sujeto puedan escribir sus datos.
2.- Con perifericos conectados el equipo. En esta configuracion,
el Alco-Sensor V a traves de un protocolo y al momento de realizar el test el equipo le dara prioridad al envio de los datos al periferico que este conectado. Dependiendo de lo que este conectado (teclado, lector magnetico, lector de codigo de barras u otro
compatible) la informcion puede ser ingresada manualmente. En
esta configuracion, mientras un test se esta imprimiendo tambien
se almacenara el dato para ser descargado en un computador.
Esto permite que una serie de instrumentos se puedan conectar
a una estacion de trabajo.
3.- Interface con un computador con un software que recoge los
datos del operador y del sujeto. En esta configuracion el software
maneja al Alco-Sensor V para llevar a cabo la garbacion de los
datos del instrumento. Esta configuracion ofrece el poder de pro
cesamiento del pc y la presicion del equipo Alco-Sensor V, esta
configuracion ofrece una amplia gama de entrada de datos y los
dispositivos de salida que se han desarrollado para el pc. Mientras Intoximeters ofrece un programa para la interfaz del pc con
el Alco-Sensor V, Intoximeters ha dise€ado el instrumento de manera que es posible que un tercer proveedor pueda desarrollar
otras soluciones.
CARACTERISTICAS UNICAS
El Alco-Sensor V fue dise€ado pensado en la seguridad del operador.
Forma: El Alco-Sensor V y su dise€o simetrico permite al operador controlar desde una posicion segura teniendo control absoluto
de la operacion. Puede realizar una prueba con una sola mano y
con la otra disponer de su arma o elemento de defensa ante cualquier situacion.
Dise€ado para una facil operacion y bajo cualquier condicion
de luz: El operador puede insertar la boquilla cuando hay poca
luz debido a que la base del equipo se encuentra iluminada. Su
pantalla iluminada y frontal permite ver los resultados de manera
muy comoda. En la pantalla se encuentra iluminada para que
el resultado sea de facil interpretacion.
ANALISIS
SENSOR
Esta celda de combustion electroquimica responde de manera
proporcional a la concentracion de aire con alcohol encontrada.
EXACTITUD Y PRESICION
El Alco-Sensor V cumple y supera las exigencias de la NHTSA
de los Estados Unidos para los dispositivos de alcoholemia que
realizan sus mediciones a traves del aliento para ser usados en
la fiscalizacion de los conductores.
ESPECIFICIDAD
La celda de combustion electroquimica solo responde especificamente a alcohol. No responde a otras sustancias del cuerpo
humano.
RANGO DE LA CELDA
El Alco-Sensor V detecta con exactitud los niveles a alcohol desde
0.00 a 5.00 gramos de alcohol por litro de sangre.
TEMPERATURA DE OPERACION
El Alco-Sensor V opera en ragos que van desde 0€C a 50€C
CERTIFICACION DE EMSIONES CE
El Alco-Sensor V esta dise•ado bajo la norma EMC de emisiones y
requerimientos de inmunidad.
CALIBRACION
El Alco-Sensor V es un equipo que por sus caracteristicas y dise•o
necesitan solo de una comprobacion de calibracion cada un a•o.
En el cado de que la comprobacion entregue un resultado distinto
usted debera solicitar una calibracion.
SITEMA DE TOMA DE MUESTRA
ALTERNATIVAS
El Alco-Sensor V esta dise•ado para tomar la ultima porcion de aire
de la profundidad de los pulmones del sujeto, una muestra pasiva del
sujeto, una muestra automatica o a sustancias. Puede tomar de modo
directo pruebas evidenciales o de screening ahorrando miles de boquillas al a•o.
COLECTOR DE MUESTRA
El Alco-Sensor V puede realizar dos tipos de test con el sistema de
colector siendo ellas manuales o automaticas utilizando el mismo colector miles de veces.
BOQUILLA DESECHABLE
El Alco-Sensor V tambien puede realizar dos tipos de test de manera
directa manual o automatica con una boquilla desechable especialmente dise•ada para pruebas 100% evidenciales. Cada vez que obtenga un resultado positivo con el colector de muestra usted debe realizar una muestra con boquilla desechable.
SITEMA DE TOMA DE MUESTRA
BOQUILLA DESECHABLE
Utiliza 4 pilas AA, estas alcanzan para mas de 1000 test
Tambien puede utilizar pilas recargables
PESO / TAMA€O / CONSTRUCCION
CARACTERISTICAS FISICAS
El analizador pesa solo 453 gramos.
Dimensiones 10 X 3.8 X 20 cm
MATERIAL
Policarbonato ABS de alta resistencia a los impactos
MEMORIA / COMUNICACIONES
ALMACENAMIENTO DE DATOS
Memoria para mas de 5000 test
PANTALLA
Pantalla de LCD iluminada de alta visibilidad
INTERFACE
Conexion mediante RS-232
ALMACENAMIENTO DE DATOS
Compatible con todos los formatos permitidos por Windows
OPCIONALES
- Corrector barmetrico para trabajaos en altura
- Comunicacion inalambrica
- Cd interactivo de entrenamiento
INTOXIMETERS INC
ALCOSENSOR V
EQUIPOS DE CONTROL DE ALCOHOL
CON MEMORIA PARA MÁS DE 5.000 REGISTROS
CONEXION A LA IMPRESORA POR BLUETOOTH
PARA TRANSFERENCIA DE DATOS
• 2 Copas para Control Pasivo
• 1 Rollo de papel termico
• 20 Boquillas
• Maletín de alta resistencia
• Certificado de calibración
Considerable Ahorro en el consumo de boquillas, sistema cualitativo y cuantitativo del sujeto.
FABRICACION: EE.UU.
TruCamTM
Bienvenido al futuro de la fotografía y videos digitales para el
control de velocidad
El equipo todo en uno más avanzado y compacto: fotografía, video e información, un radar laser
con cámara, nunca antes diseñado. El equipo TRUCAM no es un radar común. TRUCAM permite
al fiscalizador realizar el control e identificación de forma segura, el video y fotografía son
indiscutiblemente la mejor prueba al momento de enfrentar a un conductor desconfiado.
Olvídese de los equipos comunes.
Tarjeta SD
Velocidad y distancia en menos de un segundo
 TruSpeed ™ Core
 DBC/TBC (Distancia y tiempo entre autos)
Puerto USB 2.0
Gatillo
Video clip y captura de imagen
Batería y cargador
de 7.4V Li-ion
 Video sobre 35 cuadros por segundo
 2048 x1536 (3.1M) cada foto
 128 bit encriptado
Larga vida de la Batería
 7.4V 2600mAH Litio-ion polímero
 batería recargable (8 a 15 horas de operación)
Uso fácil - conexión rápida – memoria
 2.7" Pantalla táctil
 USB 2.0
 Software disponible en distintos lenguajes
 Sistema operativo en Linux
 Memoria SD
Lente de Cámara
de 75mm
Pantalla LCD y Pantalla
Táctil de 2.7” QVGA.
Puerto Serial
(RS-232) Opcional
- Sincronización del flash
en la noche
- Alimentación externa
- Serial RS-232
- Disparador remoto
- Funciones del
Supervisor
Botones de función con
código de colores:
Rojo, Verde, Azul y
Amarillo
Botón para cancelar
Botón de encendido (2
segundos o +)
Botón de encendido (10
segundos o + para apagar el
Linux *)
TruCamTM
TruCam También
Sobre un Trípode
Reproducción de Vídeo y Captura de Imagen en Movimiento
Test de drogas en Saliva
1
2
3
El examinado inserta la
lengüeta de paño en su boca y
la humedece con saliva, coloca
su lengua encima y abajo del
paño, y repite el movimiento
luego de retirar la lengua hacia
el fondo de la boca.
Coloque la tapa sobre la lengüeta de
paño y deje el casete sobre una
superficie plana.
Espera de 8 minutos para leer el
resultado.
Líneas rojas de cualquier
intensidad frente a los nombres de
las drogas, indican un resultado
negativo ( ausencia de droga)
A la primera mancha rosada
que aparezca en la ventana
del casette, retire el casette
de la boca del examinado.
La línea roja frente a “C”
(control) será la primera en
aparecer, confirmando que el
test funciona correctamente.
Si no aparece la línea de
control, el test es inválido y
debe ser desechado.
4
La ventana del tes mostrado en el
número 4, corresponde a un
ejemplo con 2 resultados
negativos ( marihuana y cocaína)
y 2 resultados positivos (opiáceas
y amfetaminas).
ORAL-VIEW
Saliva Multi-Drug of Abuse Test
One Step Assay
Rapid Visual Results
For Qualitative In Vitro Diagnostic Use
antibody binding sites between the drug in the sample and a drug-protein
conjugate immobilized on a porous membrane support.
During a test, the oral fluid migrates to the testing area of the membrane by
capillary action, mobilizing the colored antibody conjugates. Then the antibody
conjugates move along the membrane to the testing area. In the absence of the
drug or if the drug concentration is below the cutoff limit in the oral fluid, the
colored conjugates attach to the respective drug antigen immobilized in the test
line region, forming a burgundy-colored band (T line). When the drug is
present in the oral fluid, the drug compete for the limited antibody binding sites.
If the drug concentration is at or above the cutoff limit, the drug will saturate all
the binding sites of the antibody, preventing the attachment of the colored
conjugates to the antigen in the test line area of the membrane. Therefore the
colored line will not form.
INTENDED USE
The ORAL-VIEW
Saliva Multi-Drug of Abuse Test is a one-step rapid
qualitative immunoassay for screening potential abuse of one or more drugs in
human oral fluid at the following concentrations.
Abbreviation
AMP
BZD
COC
OPI
THC
Test
Amphetamine
Benzodiazepines
Cocaine
Morphine
Marijuana/Hashish
Cutoff
50 ng/ml
20 ng/ml
20 ng/ml
40 ng/ml
12 ng/ml
Detection Time
10 min – 72 hours
10 min – 72 hours
10 min – 24 hours
1 hour – 72 hours
1 hour – 14 hours
The control line (C line) serves as an internal quality control of the system. It
should always appear as a burgundy-colored band regardless of the presence of
the drug.
This test provides only a preliminary result. A more specific alternate chemical
method must be used in order to obtain a confirmed analytical result. Gas
Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid
Chromatography (HPLC) is the preferred confirmatory method. Clinical
consideration and professional judgment should be applied to any drug of abuse
test result, particularly when preliminary positive results are obtained.
REAGENTS AND MATERIALS SUPPLIED
1 Individually pouched multi-drug of abuse test device with cap
1 Package insert (Instructions for Use)
SUMMARY
MATERIALS REQUIRED BUT NOT PROVIDED
Amphetamine (AMP)
Timer
External positive and negative controls
Amphetamines are central nervous system stimulating drugs. They may induce
alertness, wakefulness, increased energy, reduced hunger and overall feeling of
well being. Overdose and extended usage of amphetamines may lead to
substance abuse, which may cause severe and/or permanent damage to the
human nervous system.
PRECAUTIONS
1.
2.
3.
4.
5.
Benzodiazepines (BZD)
Benzodiazepines, including Alprazolam, Diazepam, Lorazepam, Triazolam,
Chlordiazepoxide, Flurazepam and Temazepam are sedative, hypnotic and antianxiety drugs commonly being used as oral tranquilizers. Benzodiazepines have
a low potential for physical or psychological dependence. However, as with
other central nervous system stimulating drugs, they may induce drowsiness and
muscle relaxation. Chronic abuse of benzodiazepines may result in intoxication,
similar to drunken behavior. Overdose and extended usage of benzodiazepines
may lead to coma and possibly death. The members of the Benzodiazepine
family are absorbed at different rates and their effects may vary with the
absorption rate.
The instructions must be followed exactly to obtain accurate results.
Do not open the sealed pouch, unless ready to conduct the assay.
Do not use expired devices.
Do not moisten nitrocellulose membrane with samples.
Dispose of used device according to federal, state and local regulations.
STORAGE AND STABILITY
Store the product in the sealed pouch at room temperature 15-30 C (59 86°F). Each device may be used until the expiration date printed on the
label if it remains sealed in its foil pouch.
Do not freeze and / or expose this kit to temperatures over 30 C (86°F).
SPECIMEN COLLECTION AND TESTING
Cocaine (COC)
Cocaine is a nervous system stimulant that can be addictive. Physical effects of
cocaine use include constricted peripheral blood vessels, dilated pupils, and
increased body temperature, heart rate, and blood pressure. Some cocaine users
report feelings of restlessness, irritability, and anxiety, both while using and
between periods of use. High doses of cocaine and/or prolonged use can trigger
paranoia. Smoking crack cocaine can produce particularly aggressive paranoid
behavior in users (long-term effects). Prolonged cocaine snorting can result in
ulceration of the mucous membrane of the nose and can damage the nasal
septum enough to cause it to collapse. Cocaine-related deaths are often a result
of cardiac arrest or seizures followed by respiratory arrest.
Do not freeze and/or expose the kit
30°C
to temperatures over 30 C (86°F).
1.
2.
3.
Morphine (OPI)
15°C
Remove the test device from the sealed pouch and use it as soon as
possible.
Insert the collection pad end of the cassette into the subject’s mouth
holding the result window end of the cassette down.
Instruct the subject to move the collection pad from top to bottom of the
tongue and back again filling the collection pad with saliva. Do not pull
on or chew the collection pad.
When migration of saliva or any pink/burgundy color appears in the
test window, remove the cassette from the subject’s mouth
immediately and cover the collection pad end with the cap. Lay the device
flat. Total time from the start of the test to the appearance of the C line
depends on the saliva production and the viscosity of the saliva of the
individual.
Read results 5 to 7 minutes after the C line appears.
Morphine is a popular marketed drug (Serax) for treatment of moderate to
severe pain. It is also a common metabolite of opiates [morphine, codeine
(methyl-morphine), and heroin (semi-synthetic derivatives of morphine)]. The
opiates are administered by smoking, intravenous injection, intramuscular
injection or oral ingestion. Adverse or toxic effects of opiates usage include
pupillary constriction, constipation, urinary retention, nausea, vomiting,
hypothermia, drowsiness, dizziness, apathy, confusion, respiratory depression,
hypotension, cold and clammy skin, coma, and pulmonary edema. Death may
occur following an over-dosage.
4.
Marijuana (THC)
IMPORTANT: Do not read test results after seven (7) minutes following
appearance of C line. The T Line should always be interpreted independently of
the C Line. Do not compare color intensity of one test line to another.
5.
INTERPRETATION OF RESULTS
Tetrahydrocannabinols (THC, -9-THC) are the most active of the principle
constituents, as well as the major metabolites, of cannabinoids such as
marijuana and hashish. Cannabinoids have been used as central nervous system
depressants. Overdose and extended usage of cannabinoids may lead to
substance abuse, which may cause severe and/or permanent damage to the
human nervous system.
PRINCIPLE OF THE PROCEDURE
The ORAL-VIEW Saliva Multi-Drug of Abuse Test is a one-step lateral flow
chromatographic immunoassay based on the principle of competition for limited
33-4210 REV A 090808
C
T
C
T
Page 1
C
T
(+ )
(-)
PRELIMINARY
POSITIVE
NEGATIVE
C
T
INVALID
ORAL-VIEW
Saliva Multi-Drug of Abuse Test
Preliminary Positive:
COC
If a colored line appears in the control line region (C), but there is no line in the
test line region (T), the test indicates a positive result for that drug.
Note: Samples with preliminary positive results should be confirmed with a
more specific method before a positive determination is made.
Negative (<50%)
50%-- cutoff
Cutoff-150%
Positive (>150%)
Total
HPLC/MS
(ng/ml)
Negative:
OPI
A colored line in the control line region (C) and another line in the test line
region (T) indicate the corresponding drug is not present or the drug
concentration in the oral fluid specimen is below the designated cut-off level for
that specific drug.
Note: A very faint T line should be considered negative.
HPLC/MS
(ng/ml)
Invalid:
Negative (<50%)
50%-- cutoff
Cutoff-150%
Positive (>150%)
Total
THC
If no C line develops, the test is invalid. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for control line
failure. Review the procedure and repeat the test using a new test device. If the
problem persists, stop the test and contact your distributor.
HPLC/MS
(ng/ml)
QUALITY CONTROL
Negative (<50%)
50%-- cutoff
Cutoff-150%
Positive (>150%)
Total
Cutoff: 20ng/ml
Positive
Negative
0
30
0
10
8
2*
40
0
48
42
Cutoff: 40ng/ml
Positive
Negative
0
30
0
10
10
0
40
0
50
40
Cutoff: 12 ng/ml
Positive
Negative
0
30
0
10
8
2*
40
0
48
42
Total
30
10
10
40
90
Total
30
10
10
40
90
Total
30
10
10
40
90
Agreement
100%
100%
80%
100%
97.7%
Agreement
100%
100%
100%
100%
100%
Agreement
100%
100%
80%
100%
97.7%
* indicates discrepancy.
Built-in Control Features:
This test contains a built-in control feature, the C line. The presence of the C
line indicates that an adequate sample volume was used and that the reagents
migrated properly. If a C line does not form, the test is considered invalid. In
this case, review the whole procedure and repeat the testing with a new device.
Reproducibility:
Reproducibility of each test was determined by replicate assays of three product
development lots with four levels of samples: negative, 50% cutoff, 150%
cutoff, positive. A total of two hundred and sixteen devices were tested for
three consecutive days, six replicates per day. The results indicate over 97%
agreement with the replicates within each lot and for inter-lot variation.
External Quality Control:
It is recommended that positive and negative controls be tested as a good
laboratory practice to confirm the test procedure and to verify proper test
performance. Users should always follow the appropriate federal, state, and
local guidelines concerning the running of external quality controls.
Cross Reactivity:
The cross reactivity of the test was evaluated by spiking drug free samples with
structurally related compounds. Compounds producing positive response are
listed below:
LIMITATIONS
Drugs
AMP
This kit is for professional in vitro diagnostic use only.
Results obtained by this device provide only a preliminary qualitative analytical
test result. A more specific chemical method must be used in order to obtain a
confirmed analytical result.
This product is designed for testing human oral fluid only.
A negative result may not necessarily indicate a drug-free specimen. Drug may
be present in the specimen below the cut-off level of the test.
BZD
EXPECTED VALUES
This test is capable of detecting the specific drug and/or drug metabolite in
human oral fluid at or above its specific cutoff concentration indicated in the
intended use section on page 1.
COC
PERFORMANCE CHARACTERISTICS
OPI
Accuracy
A comparison study was performed at an Academy of Science. Ninety (90)
samples were blind labeled and tested for each analyte (drug or drug
metabolite). Each sample was tested with the multi-drug of abuse saliva device
and compared to HPLC/MS results. The test results are grouped into: below
50% cutoff (Negative), between 50% cutoff and cutoff, between cutoff and
150% cutoff and above 150% cutoff (Positive). Seven (7) discrepancies were
observed at the level between cutoff and 150% cutoff.
THC
Related compounds
d-Amphetamine
d-l-Amphetamine
p-hydroxymethamphetamine
L-methamphetamine
3,4-methylenedioxyamphetamine (MDA)
Diazepam
Oxazepam
Nitrazepam
Flurazepam
Clobazam
Bromazepam
Alprazolam
Lormetazepam
Cocaine
Benzoylecgonine hydrate
Codeine
Morphine 3- -D-glucuronide
Hydromorphine
Oxycodone
hydrocodon
Diacetylmorphine (Heroin)
(-)-11-nor-9-Carboxy-delta-9-THC
11-hydroxy-D-9-THC
11-nor-D-8-THC-9-COOH
Concentration (ng/ml)
50
100
20,000
50,000
100
20
20
20
5,000
30
20
20
20
20
30
40
100
180
3,000
100
100
12
300
12
Interference:
Overall, this device agrees with the results from the selected analytical method
at more than 95% for each analyte. The test results are tabulated as follows:
AMP
HPLC/MS
(ng/ml)
Negative (<50%)
50%-- cutoff
Cutoff-150%
Positive (>150%)
Total
BZD
HPLC/MS
(ng/ml)
Negative (<50%)
50%-- cutoff
Cutoff-150%
Positive (>150%)
Total
33-4210 REV A 090808
Cutoff: 50ng/ml
Positive
Negative
0
30
0
10
8
2*
40
0
48
42
Cutoff: 20ng/ml
Positive
Negative
0
30
0
10
9
1*
40
0
49
41
Total
30
10
10
40
90
Total
30
10
10
40
90
Each of the following commonly used analytes was evaluated in both drug free
saliva pools and pools spiked with the cutoff level of each analyte. The tables
below list the concentrations at which the common substances and analytes do
not interfere with the test results:
Agreement
Substances
Acetaminophen
Acetylsalicylic acid
Amitriptylin
Amobarbital
Ampicillin
Aspirine
Benzoic acid
Buprenorphine
Butabarbital
Butabital
Caffeine
Cortisone
100%
100%
80%
100%
97.7%
Agreement
100%
100%
90%
100%
98.8%
Page 2
Concentration
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
Substances
Isoxsuprine
MBDB
MDEA
MDMA
Meperidine
Methadone
Methadol
Methanol
Penicillin-G
Phenothiazine
Salicylic acid
EDDP
Concentration
100 g/ml
100 g/ml
10 g/ml
1 g/ml
1 g/ml
1000 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
100 g/ml
ORAL-VIEW
Substances
Ethanol
Hydroxy butyric acid
Concentration
100 g/ml
1000 g/ml
Imipramine
1 g/ml
Biological Analytes
Albumin
Bilirubin
Creatine
Glucose
Concentration
2,000 g/ml
100 g/ml
100 g/ml
200 g/ml
Saliva Multi-Drug of Abuse Test
Substances
Gentisic Acid
Ecgonine Methyl
Easter
Concentration
100 g/ml
10 g/ml
Biological Analytes
Hemoglobin
Uric acid
Vitamin C
(L-Ascorbic acid)
Concentration
100 g/ml
100 g/ml
100 g/ml
REFERENCES
A. Jenkins, B. Goldberger, On-Site Drug Testing, Humana Press, 2002
Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, 4th ED., Biomedical Publ., Davis,
CA; p713-715, 1995.
Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug
Testing Programs, Fed. Register. (69): 11970 (1988).
Wilson, John, Abused Drugs II, a Laboratory Pocket Guide., AACC Press. Washington, DC; 1994.
Gilman AG, Rall TW, Nies AS, Taylor P eds., Goodman and Gilman’s the Pharmacological Basis
of Therapeutics, 8th ed., New York, Pergamon Press, 1990.
Temperature limitation
Use by
YYYY-MM
Batch/Lot code
In vitro diagnostic
medical device
Manufacturer
Catalog number
Contains sufficient for < n >
tests
Consult instructions for
use
For IVD performance evaluation
only
Do not reuse
Caution, consult accompanying
documents
CE Mark
EC REP
ALFA SCIENTIFIC DESIGNS INC.
POWAY, CA 92064 – USA
MADE IN USA
REF 4210
33-4210 REV A 090808
Obelis s.a
Avenue de Tervueren, 34, Bte 44
B-1040 Brussels
Tel.: +32.2.732.59.54
Fax: +32.2.732.60.03
Email: [email protected]
Page 3