BeneCheck Meter Kit Meter (Front Side & Back Side) / BeneCheck Messgerät
Messgerät (Vorderseite & Rückseite) / Kit Medidor BeneCheck Medidor (Parte delantera y
parte trasera) / Kit de l’Appareil BeneCheck Appareil (Face Avant et Face Arrière)
Serial Number Sticker
Seriennummer
Pegatina de número de serie
Vignette du Numéro de Série
Battery
Batterie
Batería
Pile
Battery Lid
Batterieabdeckung
Tapa de batería
Couvercle de la pile
Meter Label
Messgeräteetikett
Etiqueta de medidor
Étiquette de l’Appareil
LCD Screen
LCD-Display
Pantalla LCD
Écran LCD
Right “S” Button
Rechte S-Taste
Botón “S” Derecha
Bouton “S” droit
Left “M” Button
Linke M-Taste
Botón “M” Izquierda
Bouton “M” gauche
Test Port
Test-Port
Puerto de análisis
Orice de Test
Ejection Button
Auswurftaste
Botón de expulsión
Bouton d’Éjection
Alert Tones: • Normal Alert: a short “beep”
• Warning Alert: 3 short “beeps”
• Turning On/ Off: a long “beep”
Alarmtöne: • Normaler Alarm: ein kurzer “Piep”
• Warnalarm: 3 kurze “Piepser”
• An-/Ausschalten: ein langer “Piep”
Tonos de alerta: • Alerta normal: un pitido corto
• Alerta de advertencia: 3 pitidos cortos
• Encender/ Apagar: un pitido largo
Tonalités d’Alerte : • Alerte Normale: un “bip” court
• Alerte de Mise en Garde: 3 “bips” courts
• Marche/ Arrêt: un “bip” long
LCD Screen Display: Information and test result display
LCD-Displayanzeige: Anzeige von Informationen und Testergebnissen
Visualización de pantalla LCD: Visualización de información y resultados de prueba
Afchage de l’Écran LCD: Afchage de l’information et du résultat de test
①
②
③
④
⑤
⑥
⑦
⑧
⑨
⑩
⑪
Result Area / Messergebnisse/ Zona de resultado/
Zone du Résultat
Low Battery / Schwache Batterie / Batería baja /
Batterie Faible
Temperature Icon / Temperatursymbol / Icono de
temperatura / Icône de Température
Average (GLU) / Durchschnitt (GLU) / Media (GLU) /
Moyenne (GLU)
Unit Icon / Einheitssymbol / Icono de unidad / Icône
d’Unité
System Check, Data upload successful /
Systemüberprüfung, Daten-Upload war erfolgreich
/ Control del sistema, Subida de datos correcta
/ Vérication du Système, Téléchargement des
données réussi
Strip Loading Icon / Streifenbeladungssymbol /
Icono de tira cargando / Icône de Chargement de la
Bandelette
Blood Loading Icon / Blutentnahmesymbol / Icono
de sangre cargando / Icône de Chargement du San
Bluetooth on / Bluetooth an / Bluetooth activado /
Bluetooth activé
Test Mode Icon / Testmodussymbol / Icono de modo
de prueba / Icône de Mode de Test
Memory Mode Icon /Speichermodussymbol / Icono
de modo de memoria / Icône de Mode Mémoire
Code Number Icon / Codenummersymbol / Icono de
código numérico / Icône de Numéro de Code
Test Strip / Teststreifen / Tira reactiva / Bandelette de Test:
GLU (GDH-FAD)- Glucose / Glucose / Glucosa / Glucose
CHOL- Total Cholesterol / Gesamtcholesterin / Colesterol Total / Cholestérol Total
UA- Uric Acid / Harnsäure / Ácido úrico / Acide urique
Electronic Contact Bars
Elektronische Kontaktleisten
Rodillos de contacto electrónicos
Barres de Contact Electroniques
Sample Inlet
Probeneinlass
Entrada de muestra
Entrée de l’échantillon
Code Strip: Contact Bar
Code-Streifen: Kontaktleiste
Código de tira: Rodillo de contacto
Bandelette de Code: Barre de Contact
Test Mode
Testmodus
Modo de prueba
Mode de Test
Code
Code
Código
Code
UA
CHOL
7142
Labelling and Information / Etikettierung und Informationen / Etiquetado e información/
Etiquetage et Information
•
Caution, consult accompanying documents
•
Vorsicht, Begleitdokumente lesen
•
Cuidado, consulte los documentos adjuntos
•
Attention, consulter les documents joints
• Do not re-use • Nicht wiederverwenden
• No reutilizar • Ne pas réutiliser
• Keep dry • Trocken halten
• Mantener seco • Garder au sec
• Operation temperature limitation
• Temperaturbegrenzung Arbeitsbereich
•
Límite de temperatura de funcionamiento
•
Température de Fonctionnement Limitée
•
In-vitro diagnostic • In-Vitro-Diagnostik
• Diagnóstico in vitro •
Diagnostic In-vitro
• Lot number • Chargennummer
• Número de lote • Numéro de lot
• CE certication • CE Zertikat
• Certicado CE • Certication CE
•
Read instructions • Anweisungen lesen
•
Leer instrucciones • Lire les instructions
• Storage & Transportation Condition
• Temperaturbegrenzung Lagerung und Transport
•
Condiciones de almacenamiento y transporte
• Condition de Transport et de Stockage
• Use by • Verwenden bis
• Fecha de caducidad • Utiliser avant
•
EU Representative
• EU Repräsentant
• Representante UE •
Représenté dans l’UE
• Date of Manufacture • Herstellungsdatum
• Fecha de fabricación • Date de fabrication
• Manufactured by • Hersteller
• Fabricado por • Fabriqué par
• Keep away from sunlight
• Vom Sonnenlicht fernhalten
• Mantener alejado de la luz solar
• Conserver à l’abri de la lumière
Operation
90%
10%
Storage &
Transportation
• Serial number • Seriennummer
• Número de serie • Numéro de série’
•
Storage & Transportation Relative Humidity
•
Lagerung & Transport Relative Luftfeuchtigkeit
• Humedad relativa de almacenamiento y transporte
•
Humidité Relative pour le Transport et le Stockage
Storage &
Transportation
4
•
Comply with WEEE Directive 2012/19/EU
•
Entspricht der WEEE Richtlinie 2012/19/EU
•
Eento con la Directiva WEEE 2012/09/EU
•
Conforme à la Directive DEEE 2012/19/EU
EN
Chapter 1 Introduction ................................................................................. 1
Chapter 2 Setting the Meter
2.1 Installing/ Replacing the Batteries ...................................................... 2
2.2 Set the Date and Time .................................................................... 2
2.3 Code the Meter................................................................................ 2
Chapter 3 How to Perform a Test
3.1 Perform the Test ........................................................................... 3-5
3.2 Alternate Site Testing (AST) .......................................................... 5-6
Chapter 4 Meter Memory Function ................................................................ 7
Chapter 5 Control Solution Test .................................................................... 8
Chapter 6 Transmission Function ................................................................ 9
Chapter 7 Care and Maintenance
7.1 Storing Your Meter and Strip ............................................................10
7.2 Cleaning and Caring for Your Meter ...................................................10
Chapter 8 Error Message and Trouble Shooting .......................................11-12
Chapter 9 Specication ................................................................................13
1
Chapter 1
Introduction
Introduction
Please read carefully before using meter kit, and consult healthcare professional before
making any important medical decision. Please contact your local customer service for further
assistance with the product.
Normal Environmental Conditions
This meter designed under the following conditions:
• Indoor use • Overvoltage category II • Pollution degree 2
Electromagnetic Compatibility
This meter meets the electromagnetic compatibility, emission, and immunity, and the
requirements of IEC 61326-2-6, ISO 18113-5 and IEC 61010-1.
Intended Use
• In vitro diagnostic use only.
• Do not inhale or swallow
• Measuring blood glucose in fresh capillary whole blood from ngertip, palm, or forearm/
venous blood /arterial blood.
• Measuring total cholesterol/ uric acid in fresh capillary whole blood from ngertip.
• The meter can be used by laypersons or healthcare professionals.
Principles of the Examination Method
• Electrochemical biosensor technology.
The meter is plasma-calibrated by reference instruments, which are traceable to the following
standard reference materials and methods.
Test Standard Method
Glucose NIST SRM 917 Glucose Dehydrogenase
Total Cholesterol NIST SRM 911 Abell ⁄ Kendall
Uric Acid NIST SRM 913 Uricase ⁄ UV
2
2.1 Installing/ Replacing the Batteries
This meter uses AAA battery * 2. Please remove the plastic tab under the battery before
using. Note: Dispose the batteries according to your local environmental regulations.
2.2 Set the Date and Time
Press “S” Button (3 secs)→One “Beep” Sound→Setting Mode→Turn Off
Automatically after Setting
• Setting order: Year/ Month/ Date/ Hour/ Minute
• Press “M” button to advance one unit, “S” button to enter next setting.
Note: Correct setting is important while managing your health records.
2.3 Code the Meter (Total Cholesterol/ Uric Acid)
• Code your meter when you rst use it or open a new vial of strips.
• Make sure the meter is off before you insert the code strip.
Chapter 2
Setting the Meter
1 2 3
AAA
AAA
3
• Make sure the codes on screen, code strip, and strip vial label are the same.
Note: With Auto Strip Recognition function, once you code your meter, the meter will switch
to the test mode automatically when you insert a strip.
Materials you need to perform a test:
BeneCheck Meter/ BeneCheck Test Strip/ Lancing Device/ Lancets/ Tissue or Cotton Ball with
75% Ethanol or Disinfection Wipes
3.1 Perform the Test
• Wash and clean your hands with disinfection wipes, and make sure your hands are dry
before testing.
Chapter 3
How to Perform a Test
2
Insert lancet
rmly.
Remove and save
the protective
cap.
Recap lancing
device and adjust
penetration depth.
Take a strip and
close the vial
immediately.
Insert the strip.
1 2 3 4 5
Operation
Test Strip
Control Range
7142
1
C
H
O
L
7
1
4
2
Test Strip
7142
Operation
Storage &
Transportation
Storage &
Transportation
90%
10%
109-164 mg/dL
6.1-9.1 mmol/L
G1303190
2016/01
7142
C
H
O
L
7
1
4
2
3
C
H
O
L
7
1
4
2
4
10
Note: Insufcient ll up of blood sample could lead to inaccurate or failed test result.
Do not rell the test strip.
Glucose/ Uric Acid/
Total Cholesterol
Fill up ok
Fill up FAILED
GLU UA CHOL
0.8
6 7 8 9
Make sure the
code number is
correct.
Pull the sliding
barrel till it clicks.
Press the release
button to sample.
Wipe off rst drop
of blood and start
sampling.
Result will show
after countdown.
Then eject
the used strip
to biohazard
container.
11 13 14 15
Pierce used
lancet into
protective cap.
Discard used lancet
to biohazard
container.
Recap lancing
device and
storage.
Note: Please refer to Lancing Device Instructions for
detail procedure.
Touch the blood
sample with strip.
The meter
will turn off
automatically.
12
7
1
4
2
5
Note:
• Please nish the test within 3 minutes or the meter will turn off automatically.
• The meter will not turn on if you insert the wrong end or wrong side of strip.
• Marked open date on new open strip vial, do not use expired strip.
• Dropping, bumping or other violent impact will damage the meter or cause malfunction.
• Do not use the meter in an environment with possible magnetic, electromagnetic, and
radioactive interferences.
3.2 Alternate Site Testing (AST)
You can test your glucose from ngertip, palm or forearm. Taking blood from palm or forearm
could reduce the pain, but the glucose level changes faster. These differences may cause
wrong medical decision.
Note: Please consult healthcare professional before AST sampling.
Suitable timing to acquire blood sample from alternate sites:
• Routinely before meal.
• Prior or 2 hours after meal/ short-acting or rapid-acting insulin analogue/ exercise.
Warning:
● Please follow local regulations to discard used test strips and lancets.
● Used test strips, lancets and any other material that has been in contact
with blood should be treated as potential biohazards.
● If user has infectious disease, the used test materials could be sources of
infection.
● Lancets cannot be reused.
● Always use certied lancets to ensure safety.
● Keep the system away from children and pets.
6
DO NOT test from alternate sites:
• During or less than 2 hours after meal/ short-acting or rapid-acting insulin analogue/ exercise.
• When you think your glucose level is low or unaware of your low blood glucose condition.
• When you are examined for hypoglycemia or hyperglycemia.
• Your AST test result does not match your health condition.
• When you are ill, or you are operating machinery or driving a car.
Sampling from an Alternative Site:
1.Repeat the steps 1-7 in Chapter 3.1.(Replace the lacing device tip with adjustable AST tip.)
2.Hold the lancing device against sampling site, and press the release button.
Keep holding the lancing device against sampling site until sufcient sample formed.
3.Then repeat steps 10-15 in Chapter 3.1.
Note:
• Sampling from ngertip if your AST test result does not match your health condition.
• Repeat puncturing the same spot may cause soreness and calluses.
• Do not squeeze the site excessively. It may take longer for sufcient blood sample to form.
• Do not use smeared blood sample, please acquire new blood sample.
• If you continue failing in getting enough blood samples, please try to get lancets in lower
gauge or sample from ngertip instead.
Palm sampling
• No visible veins.
• Away from deep palm prints.
Forearm sampling
• Away from bones, visible
veins and hair.
7
• Glucose - 360 results, capable in counting 7-, 14-, 21- and 28- days average
• Total Cholesterol - 50 results
• Uric Acid - 50 results
The latest test result will replace the oldest when the records exceed maximum memory
capacity. The memories start record from M1 to M360 or M1 to M50, include test results and
control solution test results.
Note: The control results are not included in the average.
Directions for Checking Memories:
No Test Strip in the Meter→Press “M” Button (3 secs)→A Short “Beep”→Enter
the Memory Mode→Full Display on Screen→Press “M” Button to Switch Mode
(GLUC/ CHOL/ UA)→Press “S” Button to Conrm→Press “S” Button for Next Test
Record/ Press “M” Button for Previous Record→Press “M” Button (3 secs) to Turn
Off
• In GLU memory mode, it will display 7-, 14-, 21-, 28- days average rst.
• Once you enter one memory mode, you cannot switch. You need to turn off the meter
(Press “M” button for 3 seconds) and enter the memory mode again.
Memory Records are shown as follows:
Chapter 4
Meter Memory Function
7-, 14-, 21-, 28days average
Test Record
Blink Blink
Control Record
8
Control solution is used to check the performance of the kit.
The meter kit should be check:
• When the meter and strip do not work properly.
• When the test result is unusual or inconsistent.
Control solution range is shown as follow:
Please check your strip vial label for exact range.
Perform a Control Test:
Insert an Unused Strip→Make Sure the Code Number is Correct (Total Cholesterol/
Uric Acid)→Press “M” Button (3 secs)→Enter Control Solution Mode (Shown CL
on Screen)→Shake the Control Solution Well→Discard First Three Drops→Put
One Drop onto a Clean Surface→ Touch the Control Solution with Strip Sample
Inlet→Test Result Display after Count Down→Compare the Result with the Range
Listed on Test Strip Vial
Note:
• Do not reuse the test strip.
• Marked open date on new open control solution.
• Do not use the meter if the control test is out of range.
• If the control test keeps result wrongly, please contact an authorized distributor.
• Control solutions are not included. Please contact an authorized distributor for purchasing.
Chapter 5
Control Solution Test
98-164 mg/dL
5.4-9.1 mmol/L
EA13120901
Control Range LV1
2017-01
Test Strip
142
Operation
Storage &
Transportation
Storage &
Transportation
90%
10%
98-164 mg/dL
5.4-9.1 mmol/L
G1303190
2017/01
EA13120901
2017-01
9
Chapter 6
Transmission Function
The meter provides Bluetooth transmission function. It can transmit test results to connected
device wirelessly via Bluetooth.
The screen show " " means Bluetooth transmission function is working.
• The meter with Bluetooth 4.0 can apply to IOS, Android 2.3.3 and above.
• The meter complies with IEC 60601-1-2 and the relevant EMC (electromagnetic
compatibility) and RF (radio transmission) requirements regulated by US Federal
Communications Commission. The purpose of these requirements is to ensure that meter
does not affect or being affected by other devices during operation.
• The meter and the transmission function may be interfered while other device is operating
nearby. Ex: mobile phone, wireless internet, etc.
• If the transmission has been interfered. Please keep the meter away from the source of
interference or turn off the interfering device.
• Please make sure the meter and the receiving device are placed within a reasonable
distance (less than ve meters) during transmission via Bluetooth.
• Please do not share the meter with other people if you are using Bluetooth transmission
function. The test results from other people will also transmit to the receiving device, and it
will inuence your test record.
• The Bluetooth transmission function may not work on certain types of mobile phone due to
the compatibility of Android systems.
• Frequency range: 2402 – 2480MHz. RF power: 3 dBm @ room temperature Typical.
10
7.1 Storing Your Meter and Strip
Meter:
• Avoid bump or violent behavior.
• Do not use in extremely dry environment. It may cause static discharges.
• Do not use under electromagnetic radiation, ex: electrical equipment.
• Do not disassemble the meter for any reason.
• No modication of this equipment is allowed.
• Keep meter clean by wiping the exterior appearance with tissues or lint-free cloth.
• Do not expose the meter under lint, dust, sunlight, heat or humid environment.
Strip:
• Do not store in high humidity environment, or expose directly to sunlight.
• Do not freeze or refrigerate the meter and strips.
• Keep your hand dry and clean while handing the strips and performing the test.
• Do not bend, cut or fold the strips.
7.2 Cleaning and Caring for Your Meter
Please use soft cloth slightly damp with one of the following solution to clean meter surface.
• 75% alcohol
• Super Sani-Cloth disposable wipes
• Mild dishwashing liquid with water
• 10% household bleach solution and 90% water
Note:
• Do not allow any other wet cloth or liquid.
• Do not allow any liquid run in or around the test port and battery cover.
• Make sure the meter is completely dry before use.
• Protection impairment if used in a manner not specied by the manufacturer.
Chapter 7
Care and Maintenance
11
• Incorrect meter
operating temperature.
Repeat the test after meter return to operating
temperature. If the problem persists, please
contact local distributor for service.
Chapter 8
Error Message and Trouble Shooting
Message Cause Solution
• Problem with code strip.
• Problem with test strip.
• Insert strip improperly.
Repeat the coding procedure (Chapter 2.3) and
insert the strip again. If the problem persists,
please contact local distributor for service.
• Low battery. Replace with new battery.
• Problem with code strip
or meter.
• Insert code strip
improperly.
Repeat the coding procedure (Chapter 2.3).
If the problem persists, please contact local
distributor for service.
• Used strip.
• Damped strip.
Follow Chapter 3.1 and repeat the test with
a new strip. If the problem persists, please
contact local distributor for service.
12
• Test incomplete due to
removing the strip during
measuring.
Follow Chapter 3.1 and repeat the test with a
new strip. Do not remove the strip before the
test is completed.
• Improper code strip. Repeat the coding procedure (Chapter 2.3).
If the problem persists, please contact local
distributor for service.
• Test result is higher than
the range listed on
Chapter 9.
Follow Chapter 3.1 and repeat the test with
the same strip. If the problem persists,
please contact local distributor for service.
• Test result is lower than
the range listed on
Chapter 9.
Follow Chapter 3.1 and repeat the test with
the same strip. If the problem persists,
please contact local distributor for service.
• Sample volume not
enough.
Repeat the test with a new strip, and make
sure the sample volume is enough. If the
problem persists, please contact local
distributor for service.
13
Chapter 9
Specication
Note:
• Please refer to the strip insert for accuracy, precision, limitation, and other important
information.
Test Sample Fresh Capillary Whole Blood
Measuring Time GLU:5 seconds; CHOL: 26 seconds; UA: 15 seconds
Measuring Range GLU: 20-600 mg/dL (1.1-33.3 mmol/L);
CHOL: 100-400 mg/dL (2.59-10.35 mmol/L );
UA: 3-20 mg/dL (0.18-1.19 mmol/L )
Sample Volume GLU: 0.7 µL; CHOL: 0.8 μL; UA: 1 μL
Storage & Transportation
Condition
4-30˚C (39-86˚F)
Operation Temperature 10-40˚C (50-104˚F)
Storage & Transportation
Relative Humidity
10-90%
Memory 460 Test Results (GLU: 360 ; CHOL: 50 ; UA: 50)
Battery Type AAA battery * 2
Battery Life Approximately 1,000 tests
Dimensions 95*60*20mm
Weight 71g (with battery)
Altitude 10,000 feet (3048 m)
Expected Service Life 5 years
Transmission Function Bluetooth 4.0
Contents of the Kit (please check the meter outer box for exact detail)
• BeneCheck Supreme Multi-Monitoring Meter (BX-M00D) (with AAA battery * 2)
• User’s Manual
• Quick Guide
• Pouch
• Lancing Device
Optional
(not included in the standard kit package, please contact your local distributor for
ordering)
• BeneCheck Supreme Glucose Test Strips (BK-SG1)(with Insert)
• BeneCheck Supreme Total Cholesterol Test Strips (BK-SC2)(with code card & Insert)
• BeneCheck Supreme Uric Acid Test Strips (BK-SU1)(with code card & Insert)
• BeneCheck III Glucose Control Solution
• BeneCheck II Total Cholesterol Control Solution
• BeneCheck Uric Acid Control Solution
• Lancets (Please refer to package for manufacture information.)
Note:
After purchasing, if the contents are damaged, please contact authorized distributor
immediately.
Electromagnetic Compatibility
This meter meets the electrostatic discharge immunity testing was basic standard IEC6100-4-2.
In addition, the meter meets the electromagnetic emissions requirements as per EN61326.
The purpose of these requirements is to ensure that meter does not affect or being affected
by other devices during operation.
Warning:
● Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally. The BeneCheck Multi-Monitoring Meter may provide a
description or list of equipment with which the BeneCheck Multi-Monitoring
Meter has been tested in a stacked or adjacent conguration.
● Use of accessories, transducers and cables other than those specied or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
● Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the BeneCheck Multi-Monitoring Meter, including cables specied
by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
FCC Statement:
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 off 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 the equipment and receiver.
● Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
● Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
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