Акку-Чек Перформа Нано: Chapter 6: Technical Information

Chapter 6: Technical Information: Акку-Чек Перформа Нано

Chapter 6: Technical Information

Product Limitations

Please read the literature packaged with your test strips to nd the latest information

on product speci cations and limitations.

Speci cations

Blood volume 0.6 μL

Sample type Fresh whole blood

Measuring time Refer to your test strip package insert for more information

Measuring range 0.6 to 33.3 mmol/L (10 to 600 mg/dL)

Test strip storage conditions Refer to your test strip package insert for more information

Meter storage conditions Temperature: -25 °C to 70 °C

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System operating conditions Refer to your test strip package insert for more information

Relative humidity operating range Refer to your test strip package insert for more information

Memory capacity 500 results with time and date

Automatic power off 2 minutes

Power supply Two 3-volt lithium batteries (type 2032)

Display LCD

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Dimensions 69 x 43 x 20 mm (LWH)

Weight Approx. 40 g (with batteries)

Construction Hand-held

Protection class III

Meter type The Accu-Chek Performa Nano Meter is suitable for

continuous operation

Control solution storage conditions 2 °C to 32 °C

Electromagnetic Compatibility

This meter meets the electromagnetic immunity requirements as per EN ISO 15197

Annex A. The chosen basis for electrostatic discharge immunity testing was basic

standard IEC 61000-4-2. In addition, it meets the electromagnetic emissions

requirements as per EN 61326. Its electromagnetic emission is thus low. Interference

from other electrically driven equipment is not to be anticipated.

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Performance Analysis

The performance data for the Accu-Chek Performa Nano System (Accu-Chek

Performa Nano Meter with Accu-Chek Performa Test Strips) were obtained using

capillary blood from diabetic patients (method comparison, accuracy), venous blood

(repeatability), and control solution (reproducibility). The system is calibrated with

venous blood containing various levels of glucose. The reference values are obtained

using the hexokinase method. For method comparison, the results were compared

with results obtained using the hexokinase method with deproteinization (automatic

analyzer). The hexokinase method is traceable to an NIST standard.

The Accu-Chek Performa Nano System meets the EN ISO 15197 requirements.

Measuring Principle

Refer to your test strip package insert for more information.

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Product Safety Information

Strong electromagnetic fields may interfere with the proper operation

of the meter. Do not use this meter close to sources of strong

electromagnetic radiation.

To avoid electrostatic discharge, do not use the meter in a very dry

environment, especially one in which synthetic materials are present.

Disposing of Your Meter

During blood glucose measurement the meter itself may come into

contact with blood. Used meters therefore carry a risk of infection.

Please dispose of your used meter, after removing the batteries,

according to the regulations applicable in your country. For

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information about correct disposal please contact your local council

and authority.

The meter falls outside the scope of the European Directive

2002/96/EC – Directive on waste electrical and electronic equipment

(WEEE).

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Explanation of Symbols

You may encounter the following symbols on packaging, on the type plate, and in the

instructions for your Accu-Chek Performa Nano Meter, shown here with their meaning.

Consult the instructions for use

Caution (refer to accompanying documents). Please refer to

safety-related notes in the manual accompanying this instrument.

Store at

Manufacturer

Catalogue number

For in vitro diagnostic use

This product ful lls the requirements of Directive 98/79/EC on in vitro

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diagnostic medical devices.

3V type 2032

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Guarantee

The statutory provisions on rights in consumer goods sales in the country of purchase

shall apply.

Additional Supplies

The following supplies and accessories are available from your authorized Roche

Diabetes Healthcare Center, pharmacies or your medical/surgical supply dealer:

Test Strips

Accu-Chek Performa Test Strips

Control Solutions

Accu-Chek Performa Control Solutions

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Information for Healthcare Professionals

Healthcare Professionals: Follow the infection control procedures

appropriate for your facility.

A drop of fresh, whole blood is required to perform a blood glucose test. Fresh

venous, capillary, arterial, or neonatal blood may be used. Caution should be taken to

clear arterial lines before blood is drawn. Caution should be exercised in the

interpretation of neonate blood glucose values below 2.8 mmol/L (50 mg/dL). Refer to

your test strip package insert for additional healthcare professional information.

Decisions about whether to recommend alternative site testing (AST) should take into

account the motivation and knowledge level of the patient and his or her ability to

understand the considerations relative to diabetes and AST. If you are considering

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recommending AST for your patients, you need to understand that there is a potential

for a signi cant difference between ngertip/palm and alternative site blood glucose

test results. The difference in capillary bed concentration and blood perfusion

throughout the body can lead to sample site-to-site differences in blood glucose

results. These physiological effects vary between individuals and can vary within a

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single individual based upon his or her behavior and relative physical condition. Our

studies involving alternative site testing of adults with diabetes show that most

persons will nd their glucose level changes more quickly in the ngers’/palms’

blood than the alternative sites’ blood.* This is especially important when glucose

levels are falling or rising rapidly. If your patient is used to making treatment

decisions based upon ngertip/palm readings, he or she should consider the delay, or

lag-time, affecting the results obtained from an alternative site.

* Data on le.

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Index

alarm clock function,

control test, acceptable

high blood glucose, 26

setting, 40

range, 56

hyperglycemia, 26

alternative site testing,

control test, performing, 53

hypo indicator, setting,

19, 79

control test, results, 57

45–47

appetite, increased, 26

control test results,

hypoglycemia, 26

batteries, changing, 59

understanding, 57

low blood glucose, 26

batteries, installing, 59

control test, unacceptable

maintenance, meter, 62

range, 57

batteries, type, 60, 73, 77

marking test results, 17–18

display check, 62

beeper, setting, 34

memory, meter, 27–29

error messages, 69–72

blood glucose, testing, 13

numbness, 26

expiry date, 11, 52

blurred vision, 26

post-meal marker 17–18,

fatigue, 26

button, on/off/set, 7, 8

28–29

81

frequent urination, 26

code chip, 8, 9

post-meal reminder 17–18,

general marker, 17–18

30, 37–39

computer, connecting your

meter to, 48

guarantee, 78

pre-meal marker 17–18,

28–29

control solution, 52

healthcare professionals, 79

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product limitations, 73

product specifications, 73

rapid heartbeat, 26

screen messages, 63–72

settings, meter, 30

supplies, 78

sweating, 26

symbols, 77

technical information, 73

test results, unusual, 24

test strips, Accu-Chek

Performa, 8, 11

thirst, increased, 26

82

time and date, setting, 31

tingling, 26

trembling, 26

troubleshooting, 62–72

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This le may not print or view at 100%.

Die lines and color breaks do not print.

1

Roche USA – 44702

DE

V4/1 – 05106508001(01) – Schwarz

Roche USA – 44702

®

Unabhängig davon, ob das Accu-Chek

Performa Nano Messgerät Ihr erstes

V4/2 – 05106508001(01) – Cyan

Blutzuckermessgerät ist oder ob Sie schon längere Zeit eines verwenden, nehmen

Roche USA – 44702

V4/3 – 05106508001(01) – Magenta

Sie sich bitte die Zeit und lesen Sie die Gebrauchsanweisung sorgfältig durch, bevor

Roche USA – 44702

Sie Ihr neues Messgerät in Betrieb nehmen. Um es richtig und verlässlich verwenden

V4/4 – 05106508001(01) – Yellow

zu können, müssen Sie verstehen, wie es bedient wird, was die Anzeigen im Display

bedeuten und alle seine Funktionen kennen.

Falls Sie Fragen haben, kontaktieren Sie bitte eine unserer

Kundendienstvertretungen. Eine Adressliste nden Sie am Ende dieser

Gebrauchsanweisung.

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®

Das Accu-Chek

Performa Nano System

2

Ihr neues Accu-Chek Performa Nano Messgerät dient zur quantitativen Messung des

Blutzuckerwertes unter Verwendung von Accu-Chek Performa Teststreifen.

Zur Selbstanwendung geeignet.

Das Accu-Chek Performa Nano Messgerät kann sowohl von Patienten zur Messung

ihrer eigenen Blutzuckerwerte als auch für Blutzuckermessungen durch

medizinisches Fachpersonal eingesetzt werden.

Zum System gehören (einige Artikel sind möglicherweise separat erhältlich):

Accu-Chek Performa Nano Messgerät mit Batterien

Accu-Chek Performa Teststreifen und Code-Chip

Accu-Chek Performa Kontrolllösung

Alle Gegenstände, die mit menschlichem Blut in Kontakt kommen

können, stellen eine potentielle Infektionsquelle dar (siehe: Clinical

and Laboratory Standards Institute: Protection of Laboratory Workers

from Occupationally Acquired Infections; Approved Guideline – Third

Edition; CLSI document M29-A3, 2005).

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Warum regelmäßige Blutzuckermessungen so

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wichtig sind

Regelmäßige Blutzuckermessungen können Ihnen dabei helfen, Ihren Diabetes im

Alltag besser zu kontrollieren. Dabei wollen wir Ihnen das Messen so einfach wie

möglich machen.

Wichtige Hinweise zu Ihrem neuen Messgerät

Ihr neues Messgerät ist für die Messung von frischen Vollblutproben (z. B. Blut aus

der Fingerbeere oder dem Unterarm) konzipiert. Die Messung erfolgt außerhalb des

Körpers (In-vitro-Methode). Das Messgerät sollte nicht für die Diabetes-Diagnose

eingesetzt werden.

Verwenden Sie ausschließlich Accu-Chek Performa Teststreifen. Andere

Teststreifen verfälschen die Messwerte.

Im Messgerät sind Uhrzeit und Datum bereits voreingestellt. Die Uhrzeit müssen

Sie gegebenenfalls an Ihre lokale Zeitzone anpassen.

Wenn Sie die Anweisungen in der Gebrauchsanweisung befolgen und dennoch

unter Symptomen leiden, die nicht mit Ihren Messwerten übereinstimmen oder

wenn Sie Fragen haben, konsultieren Sie Ihren Arzt oder Diabetesberater.

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4

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Inhalt

5

Kapitel 1: Ihr neues System kennen lernen .................................................. 7

Das Accu-Chek Performa Nano Messgerät ..................................................................... 7

Codieren des Messgerätes ............................................................................................. 9

Zur Verwendung des Accu-Chek Performa Nano Systems ............................................ 11

Kapitel 2: Blutzuckermessung ................................................................... 13

Durchführen einer Blutzuckermessung ........................................................................ 13

Markieren von Messwerten und Einstellen der Erinnerung nach einer Mahlzeit............ 17

Blutzuckermessung an alternativen Körperstellen (AST) ............................................... 19

Ungewöhnliche Messwerte .......................................................................................... 24

Symptome für Über- oder Unterzuckerung ................................................................... 26

Kapitel 3: Speicherfunktionen, Einstellungen und Messwertübertragung .... 27

Messwertspeicher ........................................................................................................ 27

Abrufen der gespeicherten Messwerte ......................................................................... 28

Geräteeinstellungen ..................................................................................................... 30

Einstellen von Uhrzeit und Datum ................................................................................ 31

Ein- und Ausschalten des Signaltons ........................................................................... 34

Einstellen der Zeit für die Erinnerung nach einer Mahlzeit ............................................ 37

Einstellen der Testerinnerung ....................................................................................... 40

Einstellen der Hypoglykämie-Hinweis-Funktion ............................................................ 45

Direkte Übertragung der Daten auf einen Computer oder Handheld unter Verwendung

einer Spezialsoftware und eines Infrarot-Adapterkabels ............................................... 48

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Kapitel 4: Funktionskontrollen ................................................................... 51

6

Warum sind Funktionskontrollen wichtig? .................................................................... 51

Hinweise zu den Kontrolllösungen ................................................................................ 52

Durchführen einer Funktionskontrolle........................................................................... 53

Wie interpretiert man Ergebnisse von Funktionskontrollen, die außerhalb des

zulässigen Bereichs liegen? ......................................................................................... 57

Kapitel 5: Wartung und Fehlerbeseitigung.................................................. 59

Wechseln der Batterien ................................................................................................ 59

Reinigen des Messgerätes ........................................................................................... 61

Wartung und Fehlerbeseitigung.................................................................................... 62

Gerätemeldungen und Fehlerbeseitigung ..................................................................... 63

Kapitel 6: Technische Informationen .......................................................... 73

Produktbeschränkungen .............................................................................................. 73

Gerätedaten ................................................................................................................. 73

Sicherheitshinweise ..................................................................................................... 76

Messgerät entsorgen ................................................................................................... 76

Gewährleistung ............................................................................................................ 77

Verbrauchsmaterialien ................................................................................................. 78

Informationen für medizinisches Fachpersonal ............................................................. 79

Stichwortverzeichnis .................................................................................................... 81

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