CardioDock 2 - Blood pressure monitor MEDISANA - Free user manual and instructions

USER MANUAL CardioDock 2 MEDISANA

GB Instruction Manual Description of the system Contents 1 Explanation of symbols 2 Safety Information 3 Useful Information 4 Getting started 5 Operation 6 Miscellaneous 7 Warranty

Downloaded from www.vandenborre.be3 GB Contents English Description of the system

2.1 Tips for your well being

2.2 Important considerations

2.3 Information about the software

3 Useful Information

3.1 Items supplied and packaging

3.2 What is blood pressure?

3.3 How do you measure with CardioDock?

3.4 Why measure at home with CardioDock?

3.5 Blood pressure classification for adults

3.6 Influencing and evaluating readings

3.7 CardioDock as a charger for iPhone / iPad /

iPod touch 4 Getting started

5.1 Putting on the upper arm pressure cuff

5.2 Correct position for taking readings

5.3 Taking blood pressure readings

5.5 3MAM measurement

5.6 Displaying and managing the measurements

Cardio diary Sending a report

5.7 Adding further user profiles

5.8 Deleting user profiles

6.2 Care and maintenance

6.5 Technical specifications

7.1 Warranty and repair terms

Downloaded from www.vandenborre.be3 1 Explanation of symbols 5 GB This instruction manual belongs to this device. It contains important information about starting up and operation. Read the instruction manual thoroughly. Non-observance 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. Classification: Type BF Lot number Manufacturer Date of manufacture English Downloaded from www.vandenborre.be2 Safety Information 6 GB IMPORTANT INFORMATION! RETAIN FOR FUTURE USE! Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use. Should you give this device to another person, it is vital that you also pass on these instructions for use. Safety Information

2.1 Tips for your well being

Proper use Contraindications The system is intended for measuring the blood pressure from the upper arm of an adult. It should be used together with Apple (iOS 5.0 or higher) devices (iPhone 3GS, 4, 4S / iPod touch 3 and 4 generation / iPad 1 + 2).

The system is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children. The device is not suitable for persons with acute arrhythmia. rd th Downloaded from www.vandenborre.be2 Safety Information 7 GB English Irregularity of pulse or arrhythmia can lead to difficul- ties in recording a correct reading when measure- ments are taken using oscillometric blood pressure devices. This device is electronically equipped to detect arrhythmia and what are known as movement artefacts, which it indicates on the display with the icon . In this case, the reading may be imprecise. Inform your doctor so that he or she can assess the situation. If you should suffer from conditions such as arterial occlusive disease, please consult your doctor be- fore using the unit. The unit may not be used to check the heart rate of patients with a pacemaker. Pregnant patients should take their own personal state of health into consideration and take all necessary precautions before using the unit. If in doubt, consult your doctor. Should you experience discomfort or other com- plaints during measurement, for example pain in the upper arm, please take the following action: Press the Start/Stop button on the CardioDock or the Stop button on the display to deflate the cuff imme- diately. Loosen the cuff and remove it from your arm. Please contact either your supplier or MEDISANA directly. Do not use the cuff on open wounds, in order to prevent the spread of infection. Patients with a weak pulse should raise their arm and open and close their hand around 10 times before taking a reading. This exercise optimizes the pulse and the measuring process.

Downloaded from www.vandenborre.be2 Safety Information 8 GB WARNING Do not take any therapeutic measures based on your own measurements! Never change the quantity of medication prescribed by your doctor!

2.2 Important considerations

The CardioDock is only to be used for the specific purpose described in this instruction manual. The system is not intended for commercial use. Any misuse will void the warranty. On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Do not operate the system in the vicinity of strong transmitters such as microwave and shortwave appliances. This may impair the correct functioning of the unit. To ensure CardioDock readings are accurate, keep at a minimum distance of about 30 cm from other wireless devices. If a call or a text message is received during a read- ing, the procedure is cancelled. The cuff deflates. This module is not designed to be used by persons (including children) with limited physical, sensory or mental abilities, or by persons with insufficient experience and/or knowledge, unless under obser- vation by a person responsible for their safety, or unless they have been instructed in the use of the device.

Downloaded from www.vandenborre.be9 GB 2 Safety Information English Children must be supervised to ensure that they do not play with the device. Do not use the module if it does not work properly, if it has been dropped or has fallen into water or become damaged. Do not use the module in damp environments. Protect the module from moisture. Should moisture enter the unit, stop using it immediately. In this case, please contact either your supplier or MEDISANA directly. If a fault occurs, do not try to repair the module yourself. Attempts to do so will void the warranty. Refer all servicing to authorized service personnel. Do not drop the module and protect it against im- pact and strong vibration. Always keep the module clean and store it in a safe place. Protect the module from direct sunlight to prolong its service life. For cleaning, follow the instructions in 6.2 Care and maintenance, page 31.

2.3 Information about the software

Make sure that your Apple device is running on the latest operating system. For information about soft- ware updates, see the instructions for your Apple device. Make sure that your VitaDock app is updated at regular intervals. For information about App updates, see the instructions for your Apple device. Users should set password protection in the device settings and protect their user profile in VitaDock with a password. The app shows a window with a warning when you change settings. Before the changes come into effect, you have to confirm the warning message. For the module to function correctly, the Apple device has to be sufficiently charged. Users should have a power supply 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.

Downloaded from www.vandenborre.be3 Useful Information 11 GB Thank you very much

3.1 Items supplied and packaging

English Thank you for your confidence in us and congratula- tions on your purchase! By purchasing the CardioDock blood pressure mo- dule, you have gained a high-quality product made by MEDISANA. Experience the new standard in blood and pulse measurement. Measure your blood pressure easily and accurately with your iPod touch, iPad or iPhone. To derive the most success and to enjoy your CardioDock blood pressure module for a very long time, we recommend that you read the following information on the use and care of the appliance carefully.

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. G The following parts are included:

• 1 USB cable for charging battery

• 1 Instruction manual If you notice any transport damage during unpacking, please contact your supplier without delay. Downloaded from www.vandenborre.be3 Useful Information 12 GB WARNING Please ensure that the polythene packing is kept away from the reach of children! Risk of suffocation!

3.2 What is blood pressure?

3.3 How do you measure with CardioDock?

Blood pressure is the pressure created in the blood vessels by each heart beat. When the heart contracts (= systolic) and pumps blood into the arteries, it brings about a rise in pressure. The highest value is known as the systolic pressure and is the first value to be measured. When the cardiac muscle relaxes to take in fresh blood, the pressure in the arteries also falls. Once the arteries are relaxed, a second reading is taken – the diastolic pressure. G The CardioDock blood pressure module, combined with the VitaDock app, turns your iPod touch, iPad or iPhone into an effective blood pressure device for use on the upper arm. The pressure is read by a pressure sensor that uses a microprocessor to evaluate the vibrations created when the pressure cuff is pumped up and re- leased over an artery. G Downloaded from www.vandenborre.be13 GB

3.4 Why measure at home with CardioDock?

THEREFORE WE RECOMMEND: Take a blood pressure reading daily and on a regular basis, even if you are experiencing no apparent complaints. 3 Useful Information English MEDISANA has had many years of experience in the field of blood pressure measurement. The high pre- cision of the devices has been confirmed by clinical tests, carried out according to international standards. One strong argument in favour of taking blood pres- sure at home is the fact that the readings are taken in familiar surroundings under relaxed conditions. The most important reading is the so called „baseline value“, the one taken before breakfast, directly after getting up in the morning. With CardioDock, you can see for the first time what effect your daily life has on your blood pressure. VitaDock uses your readings to create individual graphs clearly showing your blood pressure values. As far as it is possible, you should always try to take your blood pressure at the same time and under the same conditions each day. This ensures comparable results and helps in detecting the first signs of high blood pressure. If high blood pressure remains unde- tected, it increases the risk of further cardiovascular diseases.

3.5 Blood pressure classification for adults

The table on the right shows the reference values for normal and high blood pressure, discounting age and sex. The table represents the guidelines from the World Health Organisation (WHO).

3.6 Influencing and evaluating readings

Measure your blood pressure several times, then record and compare the results. Do not draw any conclusions from a single reading. Your blood pressure readings should always be evaluated by a doctor who is also familiar with your personal medical history. Take regular readings and inform your doctor from time to time. When taking readings, remember that the daily values are influenced by several factors. Smoking, consumption of alcohol, drugs and physical exertion influence the measured values in various ways.

Downloaded from www.vandenborre.be15 GB WARNING Blood pressure that is too low represents just as great a health risk as blood pressure that is too high! Fits of dizziness may lead to dangerous situations arising (e.g. on stairs or in traffic)!

3.7 CardioDock as a charger for iPhone /

Measure your blood pressure before meals. Before taking readings, allow yourself at least five minutes rest. If the systolic and diastolic readings seem unusual (too high or too low) on several occasions, despite correct use of the unit, please inform your doctor. This also applies to the rare occasions when an irregular or very weak pulse prevents you from taking readings.

The CardioDock blood pressure module is more than just a blood pressure reader. It is also a charg- er and docking station for your iPod touch, your iPhone or your iPad. The iPad can only be charged properly, when using the iPad charging unit. You can also use the blood pressure module while looking at photos, surfing the web or reading your e-mails. G Downloaded from www.vandenborre.be4 Getting Started 16 GB

battery Charging the blood pressure module's The CardioDock blood pressure module has an integra- ted lithium ion battery (3,7 V , 500 mAh). G

For charging the CardioDock battery, connect the CardioDock unit with an iPhone or iPad charging unit via the supplied USB cable. When CardioDock unit and iPhone are connected, the state of charge is dis- played in the lower part of the VitaDock screen. When the start/stop button of the CardioDock unit is highlighted in blue, the state of charge of the battery is over 20 %. Should the charge level drop be- low 20 %, the LED colour changes from blue to yellow. Please charge the battery now. Avoid letting the battery run down completely, as this shortens the battery's service life. During the charging process, the start button is high- lighted in yellow, until the battery is fully charged. When the battery is completely charged, the LED shortly lights up in blue, before the unit automatically switches off.

If the LED of the start/stop button is flashing alternatively in yellow and blue, the battery is defective.

MEDISANA is setting new standards in mobile health with VitaDock. VitaDock app , the central software application for displaying and evaluating the body’s vital signs and health values, includes software for: - the blood pressure and pulse module CardioDock

The GlucoDock-, ThermoDock- and TargetScale-soft- ware is only fully functioning if the relevant modules or scales are used. G To operate your new module for iPod touch, iPad and iPhone, you have to install the free VitaDock app. You can download it from Apple’s app store and then install it. CardioDock-blood pressure

To download the software, you need an Apple ID with an e-mail address and password, as well as an active Internet connection. Downloading the software may be subject to charges from your telephone provider. G To find the VitaDock (app) in the App Store, enter the search term “VitaDock“. G Once the software has been successfully installed, the new “VitaDock“ icon appears on your device. English

Before using for the first time Check the date and time settings on your iPod touch, iPad or iPhone. The date and time are important for evaluating the readings. Start the CardioDock by touching the icon . The display briefly shows the “Vita Dock“ start page and then automatically switches to an entry screen for your perso- nal data.

You can create a total of 4 user profiles in the VitaDock. 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 activa- ting a password for using the VitaDock app.

To do this, touch the “Password” text field and specify a password. You are asked to enter it twice, to make sure of it. If you activate the password function, you have to enter the password each time the app restarts. For more information, see page 28-29.

Downloaded from www.vandenborre.be19 GB Choose: “WHO” standard or “custom” settings. (WHO table on page 14) If you chose “Custom” settings, enter the target blood pressure values specified by your doctor: Systolic Diastolic Pulse Save your entries. “CardioDock” settings Touch the “CardioDock” icon . After you save your data, you enter the VitaDock universe. Touch the “Setting” icon . 4 Getting Started English Downloaded from www.vandenborre.be20 GB „CardioDock“ display Disclaimer New reading (page 22) Result of last reading Systolic and diastolic (mmHg) display of the readings as per WHO standard (page 14). CardioDock statistics (page 26) CardioDock diary (page 27) 3MAM reading (page 25) Result of last reading Pulse/min „Disclaimer“ display When a VitaDock module is connected, the module’s serial number appears in the masthead. The serial numbers of all the modules used with VitaDock are displayed here and saved. „Zoom“ Once you have made all the CardioDock settings, you can zoom out and slide the display to reach the other applications ( CardioDock, GlucoDock, ThermoDock and TargetScale). Touching the icons takes you directly to the programme. 4 Getting Started Downloaded from www.vandenborre.be5.1 Putting on the upper arm pressure cuff

5.2 Correct position for taking readings

b). Pull the cuff tight and close the Velcro fastener (ill.1 c). Only position the cuff on the right arm if it cannot be used on the left arm. Always carry out measure- ments on the same arm.

First attach the free end of the cuff’s air tube to the designated connector on the unit. Slip the preformed cuff over the bare left upper arm.

Position the air hose in the middle of your arm in line with your middle finger (ill.1 a). The lower edge of the cuff should be 1 - 2 cm above the crease of the elbow (ill.1 If possible, take the reading while seated. Relax your arm and place it comfortably, on a table for instance. Keep still during the measurement: Do not move and do not talk as this may alter the mea- surements. The correct measuring position when sitting is shown in ill.2. In special cases the measurement can also be taken when lying down. The correct measuring po- sition when lying down is shown in ill.3.

The cuff should always be at the same height as your heart. Downloaded from www.vandenborre.be5 Operation 22 GB

5.3 Taking blood pressure readings

To avoid disruption from an incoming call or text message during a reading, we recommend switching the iPhone to flight mode. G

You can activate the CardioDock’s blood pressure measuring mode in two ways:

Plug & play: Insert the Apple device, when switched on, into the CardioDock module. Select the user profile and enter the password, if necessary. The VitaDock app starts automatically in blood pressure 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 “CardioDock” application and tap on the “new” icon . The “NEW MEASUREMENT STEP 1” window opens. You are prompted to the CardioDock module (or enter the value manually). Insert the Apple device in the CardioDock module. Downloaded from www.vandenborre.be23 GB

2. Once you have put on the

upper arm cuff and are in the measuring position, start the reading. Start the blood pressure measurement by touching “Start” or pressing the start/stop button on the CardioDock module.

3. The module automatically

pumps up the cuff. Remain at rest during the reading: Do not move and do not talk. While the cuff is pumping up, the pulse icon flashes. The rising pressure is shown as an increasing number, the pulse is shown as a wave. Important: - You can cancel the measure- ment at any time by touching the “STOP” field or pressing the start/stop button on the module. The air escapes from the cuff. - If a call or a text message is received during the reading, the measurement is cancelled. The cuff deflates. 5 Operation English

The unit inflates the cuff until sufficient pressure has up for a measurement. Next, the device lets the air out of the cuff and shows the reading. built

Display: Systolic pressure Diastolic pressure Pulse rate Touch the field “ADD COMMENT” to open the entry field for comments about the reading.

2. Optional comments:

activity, sport) Activity (infirm, rest, normal - Mood - Notes Comments are displayed in the statistics and in the log- book. 5 Operation Downloaded from www.vandenborre.be25 GB

5.5 3MAM measurement

The readings, particularly if your blood pressure fluctuates. Three readings are taken one after the other, and a weighted average is calculated from this. 3MAM measurement can give you more precise

5 Operation English You can start the 3MAM measurement in the VitaDock app by touching the 3MAM- symbol in the CardioDock display. 3 readings are taken. There is a pause of 15 seconds bet- ween each reading. The dis- play shows the time remain- ing until the next reading. The follow-on measurements start automatically; remain sitting calmly during the pro- cess. When the last measurement is complete, the result is dis- played: You can add comments and save it, as normal. Downloaded from www.vandenborre.be26 GB

ments Displaying and managing the measure- You can access the test results at any time. Touch the relevant icon to access the results. G

Touching the “stats” icon loads the CardioDock statistics

The display shows the readings from the last three days. Systolic = white circle Diastolic = green dot 3MAM = red circle 5 Operation Rotate your device by 90° and touch the relevant field to view additional test results: 1 day, 1 week, 1, 3, 6 month, 1 year or overall.

1 Day The measurements for one day are displayed. You can display the overview: mood and activity by sliding the display to the left. Downloaded from www.vandenborre.be27 GB

Touching the “diary” icon loads the CardioDock diary for the active user profile. Tap the arrows to page through the log book.

5.6.3 Sending a report

You have the option of sending monthly reports for the active user profile by e-mail – to your doctor, for example. To set up the email address to send a report, see your iPhone/iPod touch/iPad manual. When the CardioDock display is shown, touch the icon and slide the display to “Global Settings”. Touch the “report“ icon to display the monthly reports. Touch 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 e-mail. 5 Operation English Downloaded from www.vandenborre.be28 GB You have the option of creating up to three additional user profiles in the VitaDock app. Touch “Personal settings” icon and log out of the current user profile by touching “Sign out”. Once you have logged out of your user profile, you can create another user profile on the next screen. To do this, touch “Add another user” field at the bottom. You can then create an additional user profile.

5.7 Adding further user profiles

5 Operation The red highlighted input fields have to be filled in. Downloaded from www.vandenborre.be29 GB Close the actual user profile and touch "Edit". The option of deleting the profile appears to the right of the user profile. Touch “Delete“ to delete 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 touching 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.

5.8 Deleting user profiles

5 Operation English Downloaded from www.vandenborre.be6 Miscellaneous 30 GB

Unusual reading - Repeat the test. - The cuff is not positioned correctly or the cuff is too small.

the reading. You did not keep to the correct posture during

or body or you are excited or nervous. During the reading, you spoke, moved your arm

doctor. If you get another unusual reading, contact your Irregular pulse (arrhythmia)

acute irregular pulse. This device is not suitable for persons with an The cuff does not pump up properly - Check that the air hose is fitted correctly. - The air hose is pinched or is leaking. The device does not respond

the blood pressure module. The Apple device is not connected properly to - The battery is too weak. - Separate the Apple device and the module, re- start the software and reconnect the Apple device to the module. - The LED of the start/stop-button flashes alternately yellow and blue: The CardioDock battery is defective. - The cuff is leaking. Downloaded from www.vandenborre.be6 Miscellaneous

6.2 Care and maintenance

Never use strong detergents or hard brushes. Clean the unit using a soft cloth lightly moistened with a mild soapy solution. Do not allow any water to get into the unit. Do not use the unit again until it is completely dry. Do not expose the unit to direct sunlight, and pro- tect it from dust and moisture. Only inflate the cuff when it is in position around the upper arm. Keep the cuff clean. If it gets dirty, separate it from the device and clean it with mild soapy water. Rinse it thoroughly with cold water and let it dry in the air. Do not put the cuff in a dryer and do not iron it. Even if you do not use the device for a long time, charge it fully once a month. Put the module back in its carrying case after each use. Servicing and calibration The unit has been calibrated by the manufacturer for a period of two years’ use. In the case of com- mercial use, the unit must be serviced and recali- brated at least once every two years. This cali- bration will be charged for and can be carried out by an appropriate authority or an authorised service centre - in accordance with the regulations for users of medical equipment.

Your CardioDock blood pressure module is a high- precision instrument. Handle with care to avoid da- maging the electronics and prevent defects. Observe the following instructions:

Downloaded from www.vandenborre.be6 Miscellaneous 32 GB

This blood pressure monitor meets the requirements of the EU standard 93/42/EEC for non-invasive blood pressure monitors. It is certified in accordance with EC Guidelines and carries the CE symbol (conformity symbol) „CE 0483“. G Electromagnetic compatibility: The device complies with the EN 60601-1-2 standard for electromagnetic compatibility. Enquire at MEDISANA for details on this measure- ment data.

The blood pressure monitor corresponds to European standards EN 60601-1/+A1/+A2, EN 60601-1-2, EN 1060-1/+A1, EN 1060-3/+A1. G This module must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, re- gardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner. G Please remove the battery before disposing of the device / unit. Do not dispose of old batteries with your household waste, but at a battery collection station at a recycling site or in a shop. Consult your local autho- rity or your supplier for information about disposal. G Downloaded from www.vandenborre.be33 GB 6 Miscellaneous English

6.5 Technical specifications

Product name CardioDock Blood pressure module Runs on Apple devices:

- iPod touch 3 and 4 generation - iPad 1 and 2 iPhone 3GS, 4, 4S Operating system Power supply via USB (5 V or integrated battery , 500mAh) (3,7 V , 500 mAh) Measuring technique Pressure generation Deflation Blood pressure measuring range 30 – 280 mmHg Pulse measuring range Maximum error tolerance for static pressure Maximum error tolerance for pulse rate Apple iOS 5.0 or higher

The packaging can be reused or recycled. Please dispose properly of any packaging material no longer required. rd th Downloaded from www.vandenborre.be34 GB 6 Miscellaneous Memory depends on memory of the connected Apple iPhone, iPad or iPod touch device Operating conditions Storage conditions -20°C to +55°C, 15 % to 90% humidity Dimensions (ø x H) Cuff size Weight +10°C to +40°C, 15 % to 90% humidity approx. 120 mm x 93,5 mm 22 – 32 cm adult cuff for average upper arm circumference (size M) approx. 213 g

In accordance with our policy of continual product improvement, we reserve the right to make technical and visual changes without notice. Downloaded from www.vandenborre.be7 Warranty 35 GB

7.1 Warranty and repair terms

English The following warranty terms apply:

1. The warranty period for MEDISANA products is three

years from date of purchase. In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.

2. Defects in material or workmanship will be removed

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 treat- ment, e.g. non-observance of the user instructions. b. All damage which is due to repairs or tampering by the customer or unauthorised third parties. c. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre. d. Accessories which are subject to normal wear and tear (cuffs, batteries etc.).

5. Liability for direct or indirect consequential losses

caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim. Please contact your dealer or the service centre in case of a claim under the warranty. If you have to return the unit, please enclose a copy of your receipt and state what the defect is. G Downloaded from www.vandenborre.be7 Warranty 36 GB MEDISANA AG Jagenbergstraße 19 41468 NEUSS Germany E-mail: 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 : customerservice@medisana.co.uk web: www.medisana.co.uk E-mail Downloaded from www.vandenborre.beFrançais 1 FR Downloaded from www.vandenborre.be2 FR Description du système Prise de raccordement de votre iPhone, iPad ou iPod