gluco-comfort Blood glucose measuring systems BGM 105 / BGM 205 Operating manual Issued in 09/2008 REF: 590107 Manufactured for: Biocomfort Diagnostics GmbH & Co. KG Bernhaeuser Strasse 17 73765 Neuhausen a. d. F.
Contents: 1 Introduction 1.1 Intended Use 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 3 3.1 3.2 3.3 3.
Control elements Test strip Sample capillary Display elements 1 2 biocomfort Display On/Off button 1. Switch on device (measuring mode) 2. Switch off device 3. Confirm user selection 4 mem Set button 1. Switch on device (setting mode) 2. Selection button (next field) 3. Switch off device after the last field has been set Memory button: 1. Switch on device (memory mode) 2. Selection button (lower to higher value) 3. Select user 3 4 5 6 1 Number field for: blood glucose measurement, user no.
1.1 Intended Use The Biocomfort blood glucose measuring system is an in-vitro diagnostic device for the quantitative measurement in capillary whole blood. It is meant for the personal use at home and therefore supports the diabetes therapy. The system is not intended for professional use and the use on neonates. Dear User, We are pleased that you have decided in favour of the Biocomfort blood glucose measuring system. It will be a reliable aid for you in checking your blood glucose values.
You can check your momentary blood glucose level with high precision with the Biocomfort blood glucose measuring system. Only your doctor can determine whether your blood glucose levels are an indication of a diabetic illness requiring treatment, however. The blood glucose meter should not be used by critically ill patients (e. g. those with severe hypotension or shock, hyperglycaemichyperosmolar state, hypoxia, severe dehydration, diabetic ketoacidosis) because inaccurate results may occur.
Important information regarding the control solution: Please observe the separate user instructions for the test strips. Please observe the separate user instructions for the control solution. – The test strips could be damaged by effects of temperature and light. For this reason, they should be used immediately after being removed from the test strip container. – The test strips may not be used past the expiration date. The test strips can be used four months after the container has been opened.
Step 1: Please always switch off the device before exchanging the battery. Step 2: Pull the battery compartment cover (on the back side of the device) in the direction of the arrow and remove. Step 3: Remove any used battery. Step 4: Insert the 3V lithium cell with the writing facing up. Step 5: Replace the battery compartment cover and push it over the compartment until you hear the cover click into place.
SET button: If you press the SET button with the meter switched off, you will get into the settings menu. The year of the date is the first setting which can be made. You can tell which parameter can be set at any given time by its blinking. If you press SET again, you proceed to the next settable parameter. Pressing the SET button MEM button: By pressing the MEM button, you can change the currently blinking parameter until it takes on a value you desire.
Step 11: If you are finished making settings, you can exit the settings menu by pressing the On/Off button. Otherwise, continue making settings by pressing the SET button. Step 5: By pressing the SET button again, you activate the day display. Step 6: Keep pressing the MEM button until the correct day is displayed. Step 9: By pressing the SET button again, you activate the minute display. Step 10: Keep pressing the MEM button until the correct minute is displayed.
biocomfort To do this, the measured value memory must be enabled for the individual users. 2.6.1 Configuration of the model variant BGM205 This indicates whether the measured value memory for user 1 is enabled or blocked at this time. 2 Getting started mmol/L mg/dL gluco-comfort mem Step 3: If you are finished making settings, you can exit the settings menu by pressing the On/Off button. Otherwise, continue making settings by pressing the SET button. 2.
user “off” means: The measured value memory is blocked for user 1. user Step 2: To change the measured value memory state for user 1 from “off” to “on” or vice versa, press the MEM button. Step 3: After you have set the measured value memory to the status you wish, you can set the status for user 2 by pressing the SET button.
If there is a dash between the two “0”s, this means that the wireless connection is maintained. 22 2.8 Clearing the measured value memory The operation for clearing the measured value memory is the last item in the settings menu. Step 2: To switch between maintaining and resetting the wireless connection, press the MEM button. Step 3: If you are finished making settings, you can exit the settings menu by pressing the On/Off button. Otherwise, continue making settings by pressing the SET button.
24 code biocomfort gluco-comfort mem Step 2: As soon as the code number of the code chip appears on the meter display, you can remove the code chip from the test strip receptacle. Note: Keep the code chip in the test strip package until all test strips have been used up. Afterwards, you can dispose of the code chip along with the empty test strip package in your household garbage.
blinks on the display (see Section 3.5 “Use by multiple persons”). Note: Please observe the separate user instructions for the test strips. Step 3: With the device switched off, guide the test strip with the darker side facing up into the test strip receptacle in the direction of the arrow until you feel it click into place. Step 4: If the test strip is positioned correctly, the device switches on automatically.
Step 9: After the test strip has been properly positioned, the meter signals that it is ready for measuring with two short beeps. In addition, a drop symbol blinks on the display. 3.3 Getting a drop of blood for the blood glucose measurement Step 1: Remove the cap of the lancing device. Using the gluco-comfort lancing device LDV 105/LDV 205 allows you to get a blood sample gently, with almost no pain, and hygienically. Attention: To avoid infections, use a new lancet for every lancing.
Step 8: Hold the lancing device to the side of the finger pad and press the release button. Step 6: Massage the finger from which you’d like to get your sample for about three seconds (don’t squeeze) to increase the blood flow. lower lancing depth higher lancing depth Remark: The required lancing depth is different from person to person. In principle, it is to be assumed that you will get a larger drop of blood with a high lancing depth than you would with a low lancing depth.
Attention: 3 biocomfort biocomfort biocomfort biocomfort biocomfort mg/dL mg/dL gluco-comfort gluco-comfort mg/dL mg/dL ��g� ��g� ��g� lo� lo� gluco-comfort gluco-comfort mem mem mem mem Step 2: Once the measuring cell of the test strip is sufficiently filled with blood, the meter confirms this with a beep. The measurement starts automatically. Step 3: The blood glucose measurement takes ten seconds. There is a measuring time “countdown” on the display.
The blood glucose measurement can lead to false results: – when the haematocrit value of the patient is less than 20% or greater than 60%. – in patients with haemolytic blood – in patients who have icterus (jaundice) – in patients who have lip(id)aemia – when there is a change in the peripheral blood circulation – when coagulated blood is measured 34 – when the time span from getting the blood drop to measurement is too long. – in patients treated with specific drugs such as ...
4.1 Storing the measured values The Biocomfort blood glucose meter automatically saves the last 122 measured blood glucose measurements together with the date and time of measurement. If the memory is full, the oldest result is overwritten by the result of the next measurement. The measured values are retained in the measured value memory even when the battery is removed. 4.
mem� mem� day avg Remark: By repeatedly pressing the MEM button, the average values of the last 21 and then 28 days are displayed. Afterwards, all stored individual values can be viewed, from the second-tolast one to the oldest available measurement. Step 8: To exit memory mode, switch the device off again with the On/Off button. Once the end of the measured value memory has been reached, or if there are no other measured values available, the following is displayed: 38 5.
biocomfort mg/dL ctl gluco-comfort gluco-comfort Kontroll-LösungGCS101 12ml mem NormalzurEigenanwendg •vorderVerwendunggutsütteln •nichtzumVerzehrgeeignt •nichtverbrauchteKontrollngist30Tage nachAnbruchderAmpulverwerfen: •Anbruchdatum: BiocomfortDiagnosticsGm& Co.KG BernhäuserStraße17 D73765Neuhausena.d.
Your blood glucose meter does not require any maintenance. If needed, clean the outside of the switchedoff device with a soft cloth, if necessary, with a mild cleaning solution. If the meter is contaminated, it is to be disinfected with a suitable disinfectant in accordance with the specifications of the disinfectant manufacturer. Attention: Never submerge the meter in any liquid. 5.6 Storage Make sure that no dirt, dust, blood, control solution or water can get into the inside of the blood glucose meter.
Causes Measures Remarks 0 error Error cannot be identified. Switch off the device and restart. If this error message appears repeatedly, have the device checked by the manufacturer. 1 error 2 error 3 error 44 Internal function test failed. Segmentation fault Information on the code chip could not be read. Switch off the device and restart. If this error message appears repeatedly, have the device checked by the manufacturer. Switch off the device and restart.
Causes Measures Bad operating conditions: The ambient temperature is too low. Adapt the ambient temperature to the required operating conditions (see technical data). 10 error No test strip was inserted after starting the device. Repeat measurement. Due to a timeout error, the device interrupted the measurement. 11 error No blood or control solution was applied to the test strip. Repeat measurement. 14 error Test strip must be removed.
Causes Measures Remarks 23 error (BGM 105) The wireless connection could not be cut. Switch off the device and restart. Measurement cannot be carried out. 24 error (BGM 105) Communication error 32 error Function test of the system was not completed successfully. Switch off the device and restart. If this error message appears repeatedly, have the device checked by the manufacturer. error and blinking battery symbol Battery is almost completely used up.
Average values: Device type: Model: User management: Size: Serial no.: Measuring method: Blood glucose meter gluco-comfort BGM105/ gluco-comfort BGM205 Specified on the type plate (bottom of measuring device) Glucose is oxidised by a glucose dehydrogenase, amperometric biosensor Sample: fresh capillary blood Sample volume: < 2 µl Measuring range: 20 – 600 mg/dl (1.1 – 33.3 mmol/l) Measuring period: 10 seconds Coding: Code chip Measured value memory: Max.
EMC information The wireless module integrated in this device (BPM105 only) fulfills the regulations of EC directive 1999/5/EC (Radio and telecommunication terminal equipment, R&TTE). The requirements of the following standards are met: – ETSI EN 301 489-17 Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Electromagnetic Compatibility (EMC) Standard for Radio Equipment and Services; Part 17: Specific Conditions for 2,4 GHz Wideband Transmission Systems – EN 300328-2 V1.2.
Guidance and manufacturer’s declaration – electromagnetic emissions The BGM105/BGM205 is intended for use in the electromagnetic environment specified below. The customer or the user of the BPM105/BPM205 should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity The BGM105/BGM205 is intended for use in the electromagnetic environment specified below. The customer or the user of the BGM105/BGM205 should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the BPM105/BPM205 The BPM105/BPM205 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
On the device, packaging material and in the operating manual you will find the symbols shown below with the following meanings: SN Serial number 0197 Coding: SN: 0205280008 Device type: Year of production Week of production IVD 10ºC 40ºC In vitro diagnostics device Operating temperature at 10°C to 40°C Please follow the operating manual. REF 60 Article or order number Production number The device BGM105 contains an HF transmitter (wireless transmitter).
0197 The blood glucose meter, test strips and control solution are in vitro diagnostic supplies for personal use. The CE marking of this product confirms that the relevant requirements of the EC directive 98/79/ EC for these products are fulfilled. The blood glucose meter BGM105 contains an HF wireless module. The CE marking on the blood glucose meter confirms that the wireless module meets the relevant requirements of EC directive 1999/5/EC.
10 Limited Product Warranty Information This product is subject to the Biocomfort One-Year Limited Warranty separately included in this box and also available from Biocomfort or any authorized Biocomfort dealer or from Biocomfort’s website at http://www.biocomfort.com/support.
PURPOSES, WILL HAVE ANY BENEFICIAL EFFECT OR THE OPERATION OF THE SOFTWARE WILL BE ERROR FREE OR THAT THE CONTENTS OF THIS USER MANUAL ARE ERROR FREE. Some states may not allow a disclaimer of all warranties, express or implied, with respect to software. In that case, Biocomfort limited product warranty applicable to the hardware sold to you shall apply to the software except that Biocomfort disclaims all implied warranties to the maximum extend permissible by applicable law.
other legal or equitable theory, and you hereby irrevocably waive all claims to that effect. Excluded damages shall include, but not be limited to, product (re-)installation expenses, loss of anticipated benefits, profits, savings or revenue, loss of goodwill, business interruption damages, loss of time or use of the product, any third party claim, and injury to property, even if Biocomfort knew of the likelihood of such damage.
