Medisana GlucoDock Instruction Manual Download Page 56

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6 Miscellaneous

6.6 Technical specifications

Product name

GlucoDock

blood glucose

measuring module

Runs on

: Apple devices

- iPhone 3G, 3GS, 4G
- iPod touch 2nd, 3rd, 4th generation
- iPad, iPad 2

Operating system

: Apple iOS 3.0 or higher

Power supply

: via the connected Apple device

Measuring method : Electrochemical biosensor

technology

Measuring range

: 20 - 600 mg/dL (1,1 - 33,3 mmol/L)

Measuring time

: approx. 5 seconds

Memory

: depends on memory of the

connected Apple device

Calibration

: Plasma

Operating

: Temperature 10 °C - 40 °C

conditions

(50 °F - 104 °F),
maximum relative humidity 90 %

Storage/transport

: Temperature 2 °C - 30 °C

conditions

(35,6 °F - 86 °F),
maximum relative humidity 90 %

Blood sample
volumes

: 0,6 µl

Sample material

: Fresh blood from the finger tip,

palm of the hand or lower arm
(capillary whole blood)

Haemotocrit value

: 30 - 55 % (Htc)

Dimensions

: approx. 40×62×10 mm ( L x W x H )

Weight

: approx. 14 g

Article number

: 79306

EAN number

: 40 15588 79306 6 (black)

Summary of Contents for GlucoDock

Page 1: ... de mesure de glycémie Mode d emploi A lire attentivement s v p IT Modulo di misurazione della glicemia Istruzioni per l uso Da leggere con attenzione ES Módulo de medición del nivel de glucosa en sangre Instrucciones de manejo Por favor lea con cuidado NL Bloedglucose meetmodule Gebruiksaanwijzing A u b zorgvuldig lezen GlucoDock Art 79306 ...

Page 2: ...started 19 GB 5 Operation 23 GB 6 Miscellaneous 50 GB 7 Warranty 55 GB IT Istruzioni per l uso Descrizione del sistema 2 IT Indice 3 IT 1 Spiegazione dei simboli 5 IT 2 Norme di sicurezza 7 IT 3 Informazioni interessanti 16 IT 4 Messa in funzione 19 IT 5 Modalità d impiego 23 IT 6 Varie 50 IT 7 Garanzia 55 IT NL Gebruiksaanwijzing Beschrijving van het systeem 2 NL Inhoudsopgave 3 NL 1 Verklaring v...

Page 3: ... GlucoDock auf einen Blick Vue d ensemble de GlucoDock GlucoDock de un vistazo GlucoDock at a glance Breve panoramica di GlucoDock GlucoDock in een oogopslag ...

Page 4: ...on slot for test strips Test strip Front Test strip Back Contact electrode Insert in the direction of the arrow Grip holder Reaction cell Blood sample area absorbent slot Capillary Lancing device clamp Lancing device Slider switch for ejecting lancet on the back Trigger button Protective cap can be removed with can be replaced by the AST cap Cap end adjustable 2 GB ...

Page 5: ...lied and packaging 16 3 2 Special features of the MEDISANA GlucoDock 17 4 Getting started 4 1 Installing the VitaDock app software 19 4 2 Settings 20 5 Operation 5 1 Using the control solution 23 5 1 1 Why do I need to perform a test with control solution 23 5 1 2 Performing a test with control solution 23 5 1 3 Evaluating a test result with control solution 26 5 2 Preparing and performing a blood...

Page 6: ... 2 10 Unusual test results 41 5 2 11 Symptoms of high or low blood glucose 42 5 2 12 Comparing your test result to laboratory results 43 5 2 13 Calling up test results 44 5 2 14 Blood glucose data export 47 5 2 15 Adding further user profiles 48 5 2 16 Deleting user profiles 49 6 Miscellaneous 6 1 Error messages 50 6 2 Care and maintenance 51 6 3 Guidelines Standards 52 6 4 Disposal 53 6 5 Accesso...

Page 7: ...ervance of these instructions can result in serious injury or damage to the device WARNING These warning notes must be observed to prevent any injury to the user CAUTION These notes must be observed to prevent any damage to the device NOTE These notes give you useful additional information on the installation and operation Lot number Catalogue number Serial number Manufacturer Date of manufacture ...

Page 8: ...o the requirements of the EU guidelines 98 79 for in vitro diagnostic devices and bears the CE marking conformance label CE 0483 Biohazard Do not re use Use by Storage temperature limitation Sterilisation by means of radiation lancets Contains sufficient for n tests Control solution Protect from sunlight Protect from moisture n ...

Page 9: ...2 1 Important considerations Proper use This system is intended for taking an adult s blood glucose test from the finger tip alter natively from the ball of the hand or lower arm It should be used together with Apple iOS 3 0 or higher devices iPhone 3G 3GS 4G iPod touch 2nd 3rd 4th generation iPad iPad 2 Contraindication The system is not suitable for diagnosing diabetes for children younger than ...

Page 10: ...ren must be supervised to ensure that they do not play with the device Do not use this blood glucose measuring device to test seriously ill patients Do not operate the device in the vicinity of high frequency transmitters e g microwave and short wave transmitters Do not use the device if it is not working correctly if it has been dropped or has fallen into water or has been damaged Protect the mod...

Page 11: ...om a blood glucose test system for self monitoring does not replace a professional test performed in a laboratory Do not change any treatments as a result of your blood glucose reading without first consulting your doctor The measuring system is intended for external use only in vitro Only use fresh capillary whole blood from the finger tips for the test Your monitor only requires one small drop o...

Page 12: ...dings If patients are undergoing an oxygen therapy the readings could be incorrect If the proportion of red blood cells haemotocrit level is very high over 55 or very low under 30 this could distort the test results Lipaemic effects cholesterol value of up to 500 mg dL and blood glycerides of up to 3 000 mg dL do not affect the readings However readings at higher values can affect the blood glucos...

Page 13: ... with the household rubbish make sure you wrap them first to avoid harming or infecting other people Medical staff or others who use this monitor on more than one patient must be aware that all products or objects which come into contact with human blood must be dealt with as if they are capable of spreading viral diseases even after cleaning Never use a lancet or the lancing device on more than o...

Page 14: ... dust Use the test strip within three minutes of remo ving it from the container The test strip is intended to be used only once Do not use it again Write the opening date on the label of the container when you open it for the first time Observe the expiry date The test strips can be used for approx three months after opening the container or until the expiry date whichever comes first Do not use ...

Page 15: ...inhaled or swallowed This could also lead to skin and eye irritations 2 4 Instructions on how to use the control solution Only use MEDISANA control solution Only use GlucoDock test strips with the MEDISANA control solution Write the opening date on the label of the container The control solution can be used for approx three months after opening the container or until the expiry date whichever come...

Page 16: ...l solution back in the container Close the container carefully after every use 2 5 Information about the software Make sure that your Apple device is running on the latest operating system For information about software updates see the instructions for your Apple device Make sure that your VitaDock software app is updated at regular intervals For information about app updates see the instructions ...

Page 17: ...pply unit or a charging device to hand Make sure that there is always enough memory available to back up the reading data on your Apple device If you receive a call or a text message during a reading the reading is cancelled for safety reasons If you want to prevent your reading from being cancelled we recommend switching your iPhone to flight mode ...

Page 18: ...your GlucoDock blood glucose measuring system for a very long time we recommend that you read the following information on the use and care of the device carefully 3 1 Items supplied and packaging Please check first of all that the device is complete and is not damaged in any way In case of doubt do not use the appliance and contact your supplier or your service centre The following parts are incl...

Page 19: ...larly and anywhere you choose The lancing device can be set to the sensitivity of your skin Always consult your doctor about your test results and treatment This measuring system is intended for actively testing a person s blood glucose at home It is not suitable for diagnosing diabetes or for testing the blood glucose of newborn babies Your blood glucose measuring system GlucoDock from MEDISANA c...

Page 20: ...lood for the test preferably from the finger tips or the ball of the hand or lower arm The monitor measures the blood glucose level very precisely The VitaDock software app transfers the data generated by the GlucoDock module to the connected Apple device The VitaDock app allows users to save display and analyse measurement data You can also transmit the measurement data to other people via e mail...

Page 21: ...Dock CardioDock and TargetScale software is only fully functioning if the relevant modules or scales are used To operate your new GlucoDock blood glucose measuring module for iPod touch iPhone and iPad you have to install the free VitaDock app You can download it from Apple s app store and then install it To download the software you need an Apple ID with an e mail address and password as well as ...

Page 22: ...ersonal data You can create a total of 4 user profiles in the VitaDock app In the first user profile you can enter your personal data Pressing on a text field opens a keyboard field with which you can edit your data You have the option of activating a unique password for each user using the VitaDock app To do this touch the Password text field and specify a password You are asked to enter it twice...

Page 23: ...icon Choose Unit of measure mg dL or mmol L Enter the target blood glucose range specified by your doctor Enter the names of the insulin Insulin 1 Insulin 2 Insulin 3 When you touch the text field e g Insulin 1 a keyboard field opens that you can use to edit your insulin further information on page 35 Your entries are saved in the current user profile ...

Page 24: ...GlucoDock display Masthead New reading see page 32 Result of last reading see page 34 Gluco statistics see page 44 Gluco log book see page 46 30 day overview see page 46 Entering the carbohydrate quantity see page 35 Entering the insulin quantity see page 35 Masthead display When a VitaDock module is connected the module s serial number appears in the masthead The serial numbers of all the modules...

Page 25: ... a new container of test strips You suspect the monitor or test strips might not be working properly The monitor has been dropped You have repeated a test and the results are still lower or higher than you expected You are practicing the test procedure 5 1 2 Performing a test with control solution WARNING Before you perform a test with control solution read section 2 on Safety instructions p 7 15 ...

Page 26: ...sert the GlucoDockblood glucose measuring module in the slot on the Apple device Select your user profile 2 The system prompts you to insert a test strip 3 Insert a test strip in the direction shown by the arrow into the slot on the GlucoDock module 4 Activate function field Control solution mode 5 Unscrew the cap of the container for the solution and wipe the tip with a clean cloth ...

Page 27: ...ple area of the test strip capillary on the drop Make sure that the test strip s capillary is completely filled 8 The device starts a reading After about 5 seconds the test result of the reading with the control solution appears 9 Before removing the test strip see whether the test result is within the range specified on the test strip container Sample values Normal 104 140 mg dL 5 8 7 8 mmol L 5 ...

Page 28: ...ted Make sure that you compare the test result with the correct range If the control test result lies within the range indicated on the test strip container then the test strips the GlucoDock module and your mobile device are working accurately NOTE If you save test results with the control solution they are included in your regular measuring data To prevent this select control solution mode If th...

Page 29: ... steps of the test procedure properly Remedy Repeat the test with a test strip that has been stored correctly The test strips are damp Replace the test strip Repeat the test as described in section 5 1 2 If problems persist get in touch with the service centre Use new control solution to check the performance of the measuring system Repeat the control test using strips and solution that have been ...

Page 30: ...e appropriate direction until the arrow is pointing to the number for the lancing depth you want Set the appropriate lancing depth as described on p 30 5 2 2 Inserting the lancets into the lancing device Before using the lancing device you need to insert a lancet WARNING Before performing a blood glucose test and before using the lancing device make sure you read section 2 on the safety instructio...

Page 31: ...lockwise direction and then remove it 3 Insert the lancet all the way into the cup without twisting it in the lancing device 4 Twist off the protective end of the lancet carefully Retain the protective end until you dispose of the lancet 5 Replace the cap on the lancing device and tighten by turning it in an anti clockwise direction not too tight ...

Page 32: ...lous skin 7 Set the lancing device by extending it until it clicks into place If it does not click it is probably already in position from when you inserted the lancet The lancing device is ready to use Do not lance your finger before the measuring module and the test strips are ready to use 8 Place the lancing device to one side until the test is complete ...

Page 33: ...t they are capable of spreading infection Dispose of the lancets so that there is no risk of injury or infection to other people 5 2 3 Identifying the blood glucose value with blood from the finger tip WARNING Before performing a blood glucose test and before using the lancing device and the blood glucose test strips make sure you read section 2 on the safety instructions carefully pages 7 15 Note...

Page 34: ... and enter the password if necessary The VitaDock app starts automatically in blood glucose measuring mode b Manual start Start the VitaDock app Select the user profile and enter the password if necessary The VitaDock universe appears Touch the GlucoDock application and tap on the New icon The New reading Step 1 window opens You are prompted to connect the GlucoDock module or enter the value manua...

Page 35: ... at the side and press the trigger button Then remove the lancing device from your finger 4 Draw a drop of blood approx 0 6 µl by gently massaging the area Make sure that the blood droplet does not smudge 5 Place the drop onto the transparent blood sample area capillary on the end of the test strip 6 Do not get any blood on the top of the test strip Make sure not to place too little blood in the b...

Page 36: ...gh red colour values above the target range specified by the doctor Display low blue colour values below the target range specified by the doctor Touch the field Add comment to open the entry field for comments about the reading 9 Optional comments Activity infirm rest normal activity sport measurement before or after a meal Mood Notes Comments are displayed in the statistics and in the log book ...

Page 37: ...input field for meals Touch the digits to enter your carbohydrate quantity in grammes Save your entry The meals overview is on page 45 Insulin Tapping the icon Insulin opens the input field Touch the digits to enter your insulin quantity Editing the insulin type is on page 21 Save your entry The insulin overview is on page 45 ...

Page 38: ...ter inserting the lancet put the transparent AST cap on the lancing device instead of the protective cap and tighten Note that the AST cap is not intended to be used for a blood sample from the finger tip The only other alter native parts of the body that are suitable for testing with this device are the ball of the hand and the lower arm 5 Operation 36 GB WARNING The readings from a finger tip bl...

Page 39: ...ch the way you feel You think your blood glucose value is high The blood glucose values you take at regular intervals differ frequently Only take blood samples from the finger tip When you are ill When you are hypoglycaemic because blood samples from the finger tip can measure changes to the blood glucose level more quickly than from other parts of the body After physical exercise Two hours or les...

Page 40: ... set are only intended for cleaning the surface of the skin if there is no opportunity to wash your hands Remove the pad and clean the intended pricking point Wait a few seconds until the alcohol has completely evaporated from the skin to avoid causing incorrect readings Throw the pad away immediately after use WARNING The alcohol pads are for external use only Avoid contact with eyes lips and muc...

Page 41: ...e the circulation 2 Hold the lancing device against the lancing spot for a few seconds and then press the trigger button 3 Wait until a blood drop forms under the AST cap with a diameter of approx 1 4 mm 4 Remove the lancing device from the skin carefully and proceed in the same way as for the normal protective cap see 5 2 3 Identifying the blood glucose value with blood from the finger tip page 3...

Page 42: ... lancet holder and carefully eject the lancet 2 Dispose of the used lancets properly see warning below WARNING Lancets are intended to be used only once Used test strips and lancets are considered hazardous biological non biodegradable waste Dispose of them taking into account that they are capable of spreading infection Dispose of the lancets so that there is no risk of injury or infection to oth...

Page 43: ...ith diabetes consult your doctor about the range of blood glucose level valid for you 5 2 10 Unusual test results If your test result is not what you expected proceed as follows 1 Perform a control test see section 5 1 2 Performing a test with control solution page 23 onwards 2 Repeat the blood glucose test see section 5 2 3 Identifying the blood glucose value with blood from the finger tip page 3...

Page 44: ...s of high or low blood glucose To understand test results and make the right decision if the results seem unusual it can be useful to be familiar with the symptoms of high and low blood glucose The most frequent symptoms are For hyperglycaemia i e over 240 mg dL 13 3 mmol L Symptoms Signs of tiredness increased appetite or thirst frequent passing of water vomiting headaches generally feeling unwel...

Page 45: ...ol L and you show symptoms of low blood glucose consult your doctor without delay If the result does not match how you feel follow the steps described in 5 2 9 Unusual test results page 41 5 2 12 Comparing your test result to laboratory results The question of how you can compare the blood glucose level of the measuring system with tests performed in the laboratory is frequently asked Your blood g...

Page 46: ...ogy in the laboratory is different from your measuring system and that blood glucose monitors for using at home generally produce slightly different results To ensure the accuracy and precision of such important information read the instructions included with the blood glucose test strips 5 2 13 Calling up test results You can access the test results for the selected user profile at any time witho...

Page 47: ... 3 6 month 1 year or overall Total The overview of all the measurements is displayed By sliding the display to the left you can display the overviews Mood Activity Insulin and Meals Insulin Display Insulin overview Insulin 1 white circle Insulin 2 green dot Insulin 3 white dot Meals Meals overview with carbohydrate quantities ...

Page 48: ...he active user profile Tap the arrows to page through the log book 30 day overview Tapping the icon opens the overview of test results for the last 30 days of the active user profile The number of good high and low test results in a month is shown 5 Operation 46 GB ...

Page 49: ...h iPad manual When the GlucoDock display is shown touch the icon and slide the display to Global settings Tapping the icons takes you directly to the programme Touch the Report icon to display the monthly reports Tap the arrows to reach the previous or next month Slide the display up or down to view the individual days in the month Tap Send report to send the data by email 5 2 14 Blood glucose dat...

Page 50: ...e when you start the VitaDock app b Tap on the Personal settings icon and log out of the current user profile by tapping on Sign out Once you have logged out of your user profile you can create another user profile on the next screen To do this tap on the Add another user field at the bottom You can then create an additional user profile 5 2 15 Adding further user profiles ...

Page 51: ...lete the user profile The deleted user profile is shown in grey For a period of 14 days you have the option of reactivating the deleted user profile by tapping on it After 14 days the user profile is automatically deleted completely from the app Caution The user profile all the readings and entries are irreversibly deleted There is no way to restore them 5 2 16 Deleting user profiles ...

Page 52: ...ule Contact the service centre if the error message appears again Low battery Recharge the battery for your Apple device at the latest when capacity falls below 20 Test result is lower than 20 mg dL 1 1 mmol L Repeat the test If the result does not change perform a control test If the result is positive consult your doctor Test result is higher than 600 mg dL 33 3 mmol L Repeat the test If the res...

Page 53: ...detergent Never use abrasive detergents or strong brushes Never use cleaning agents on the module Never immerse the module in water Do not allow water or other liquids to penetrate the module Dry the module with a lint free cloth after cleaning Make sure that dirt dust blood control solution water or alcohol do not penetrate the test strip slot or get onto the buttons on the inside of the module D...

Page 54: ...magnetic compatibility The system complies with the EN 60601 1 2 standard for electromagnetic compatibility Enquire at MEDISANA for details on this measurement data The monitor is certified in accordance with the require ments of EU guidelines 98 79 for in vitro diagnostic devices The lancets and lancing device correspond to the requirements of EC Directive 93 42 for medical products The lancets a...

Page 55: ...manner Test strips lancets Always dispose of the test strips and lancets in a way that prevents injury and the spread of infection to others Consult your local authority or your supplier for infor mation about disposal The packaging can be reused or recycled Please dispose properly of any packaging material no longer required 6 5 Accessories Inquire at your local supplier or service centre 100 Glu...

Page 56: ... 33 3 mmol L Measuring time approx 5 seconds Memory depends on memory of the connected Apple device Calibration Plasma Operating Temperature 10 C 40 C conditions 50 F 104 F maximum relative humidity 90 Storage transport Temperature 2 C 30 C conditions 35 6 F 86 F maximum relative humidity 90 Blood sample volumes 0 6 µl Sample material Fresh blood from the finger tip palm of the hand or lower arm c...

Page 57: ...l or workmanship will be corrected free of charge within the warranty period 3 Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts 4 The following is excluded under the warranty a All damage which has arisen due to improper treatment e g nonobservance of the user in structions b All damage which is due to repairs or tampering by the customer or...

Page 58: ...re excluded even if the damage to the unit is accepted as a warranty claim MEDISANA AG Jagenbergstraße 19 41468 NEUSS Germany eMail info medisana de Internet www medisana de For service accessories and spare parts please contact Medisana Healthcare UK Limited Emery House Greatbridge Road Romsey Hampshire SO51 0AD United Kingdom Tel 44 0844 888 20 32 eMail customerservice medisana co uk web www med...

Page 59: ...MEDISANA AG Jagenbergstraße 19 41468 NEUSS GERMANY E Mail info medisana de Internet www medisana de 79306 01 2012 VitaDock Vers 1 2 5 ...

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