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 fi nd the latest information
on product specifi cations and limitations.
Specifi 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
76
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 fulfi lls the requirements of Directive 98/79/EC on in vitro
77
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
79
recommending AST for your patients, you need to understand that there is a potential
for a signifi cant difference between fi 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 fi nd their glucose level changes more quickly in the fi 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 fi ngertip/palm readings, he or she should consider the delay, or
lag-time, affecting the results obtained from an alternative site.
* Data on fi 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 fi 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 fi 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
3
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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Оглавление
- Chapter 1: Understanding Your New System
- Chapter 2: Testing Your Blood Glucose
- Chapter 4: Control Testing
- Chapter 5: Maintenance and Troubleshooting
- Chapter 6: Technical Information
- Kapitel 1: Ihr neues System kennen lernen
- Kapitel 2: Blutzuckermessung
- Kapitel 3: Speicherfunktionen, Einstellungen und Messwertübertragung
- Kapitel 4: Funktionskontrollen
- Kapitel 5: Wartung und Fehlerbeseitigung
- Kapitel 6: Technische Informationen
- Kapitola 1: Základní informace o novém systému
- Kapitola 2: Měření krevní glukózy
- Kapitola 4: Kontrolní měření
- Kapitola 5: Údržba a řešení potíží
- Kapitola 6: Technické informace
- Глава 1: Знакомство с Вашей новой системой
- Глава 2: Проведение измерения уровня глюкозы крови
- Глава 4: Контрольные измерения
- Глава 5: Техобслуживание, поиск и устранение неисправностей
- Глава 6: Техническая информация