Pendiq 2.0 User Manual
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Pendiq 2.0 User Manual

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User Manual
0068
DIQ-IFU-02 (Rev.0 2017.03.30)
1

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Summary of Contents for Pendiq Pendiq 2.0

  • Page 1 User Manual 0068 DIQ-IFU-02 (Rev.0 2017.03.30)

  • Page 2: Table Of Contents

    Prime Safety Guidelines Dose Setting Contents product box Injecting your dose Components After the injection Operation buttons Memory function Getting started with your pendiq 2.0 Settings Step 1 – Language Bluetooth Step 2 – Date/Time Turn Bluetooth ON/OFF Step 3 – Cartridge settings/Replacing a cartridge Bluetooth PIN Injection Speaker...
  • Page 3 Cleaning und maintenance Language Diabetes Management App Date/Time Glossary TimeBlock Specifications Add a TimeBlock Display symbols Change a TimeBlock Warning & Errors Delete a TimeBlock Icon description Dose limit Technical information Dose limit for a day (1 Day) Factory default settings Dose limit for injections (1 Time) Electro-Magnetic Compatibility Default setting Product warranty...

  • Page 4: Introduction

    Introduction The digital insulin pen pendiq 2.0 is designed to This manual gives you instructions on how to deliver insulin for the insulin-required diabetes use and maintain your pendiq 2.0. mellitus. With this pen you can adjust every dose up to increments as small as 0.1 U (0.001ml) and...

  • Page 5: Safety Guidelines

    Inject only into the body areas suggested regarding your condition before using the by the official national endocrinologist pendiq 2.0, and carefully read the safety association, your healthcare professional guidelines provided in this user manual. or your physician. Consult your healthcare professional, if...
  • Page 6 2.0 and the cartridge Do not modify or disassemble the pendiq holder are firmly screwed together. 2.0. Do not use the pendiq 2.0 if any part of your pendiq 2.0 looks broken or Always remove possible air bubbles before damaged.
  • Page 7 The pen is not designed for the blind or The manufacturer shall not be held liable visually impaired without a trained assistant. for any problems, damages or malfunctions arising from a Force Majeure or other Make sure the insulin cartridge in the setting events beyond the control of the matches the insulin cartridge manufacturer manufacturer.
  • Page 8 Do not expose the pendiq 2.0 to high Do not expose the pendiq 2.0 to temperature and/or humidity. flammable and/or combustible mixtures. pendiq 2.0 is not water-proof and holds no protection against the ingress of water Do not expose the pendiq 2.0 to any or moisture.
  • Page 9 Only one type of insulin cartridge (Basal/ Do not use NPH or premix insulin with the Bolus) can be used with one pendiq 2.0. Do pendiq 2.0. not use different insulin cartridges (Basal/ Bolus) for one device. Do not use a non-sterilized or damaged pen needle.
  • Page 10 Bluetooth connection between the pendiq infectious diseases. Otherwise, it may 2.0 and a smartphone app. cause incorrect insulin delivery, leakage of insulin and unintended needle injury, etc.
  • Page 11 The manufacturer is not responsible for the safety, dosage accuracy and functionality as We recommend not using the device if you are an individual with no diabetes. well as any damages caused by the usage of insulin cartridges that are not adequate for the pendiq 2.0.
  • Page 12 Insulin injection syringe Make sure to inform your family, friends and colleagues Alcohol swab where to find the kit. Emergency food for hypoglycemia Diabetic patient identity card with all necessary info Micro USB cable for charging the battery of the pendiq 2.0...

  • Page 13: Contents Product Box

    Contents product box Digital insulin pen pendiq 2.0 Check if all the following components are included in the pendiq 2.0 box: User Manual English User Manual German USB cable USB adapter Cartridge holder Novo Nordisk Warranty card...

  • Page 14: Components

    Components Pen cap Product body (D~G) Cartridge holder Cartridge holder (for Novo Nordisk cartridge) Operation buttons OLED screen Micro USB port Plunger...

  • Page 15: Operation Buttons

    Operation buttons button is used button is used - to turn on the pen - to decrease a number - to confirm an operation or setting - to select a setting - to inject a dose - to go back in the menu button is used - to increase a number - to select a setting - to go forward in the menu...
  • Page 16 Please visit our homepage www.pendiq.com/downloads to see a menu tree of the pendiq 2.0.

  • Page 17: Getting Started With Your Pendiq 2.0

    Getting started with your pendiq 2.0 When you use your pendiq 2.0 for the first The pendiq 2.0 has no OFF button. time, follow the steps below to get started. The screen turns itself off after 60 seconds Before you use your pendiq 2.0 for the first when no button is pressed.

  • Page 18: Step 1 - Language

    Step 1 – Language Press for 3 seconds to turn on the display for the first time. The initial language Press to start. Select language The initial setup setting screen appears. You will see the word, and press will automatically The factory language is “Deutsch“...

  • Page 19: Step 2 - Date/Time

    Step 2 – Date/Time Injections in the injection history displayed with date and time. After you have Press Press to start completed the initial select the month with setting the Therefore, it is language setting, and confirm with year. The year starts important to set the setup will continue flashing.
  • Page 20 Press Press Press set the hour and set the day and set the minute. confirm with confirm with Press and hold to increase number by 10.
  • Page 21 Initial setup is now complete. Press The display will show the home “Date/Time Set. Done” display “Last Inj.”. will appear on the display. As there is no injection history “Done” will flash three saved yet “--” will be displayed times. on the home screen.

  • Page 22: Step 3 - Cartridge Settings/Replacing A Cartridge

    Step 3 – Cartridge settings / Replacing a cartridge Before you can use your pendiq 2.0 for injection, you need to setup the cartridge settings and insert a cartridge. You can first use the pendiq 2.0 for injection after completing the Press for 3 seconds Press cartridge settings.
  • Page 23 Press Press once and “New cartridge” will appear and the name of select the insulin “Replace Cart.” will the cartridge manufacturer flashes. type (Basal/Bolus). appear. Press to select the insulin cartridge manufacturer of the insulin cartridge you Press to confirm. Press to enter.
  • Page 24 “Insert cartridge“ screen “Rewinding“ screen will appear and the plunger will will appear after the be automatically rewound. plunger is fully rewound. NOTE: You can stop the plunger by Now you can insert a new cartridge. pressing anytime. The screen will return to “Remain.
  • Page 25 Pull off the cartridge holder cover. Unscrew the cartridge holder from the body. If you are replacing a car- tridge, remove the empty cartridge and dispose of it carefully.
  • Page 26 Insert a new insulin cartridge into the cartridge holder. When inserting a cartridge, make sure the insulin Screw the cartridge holder and the body cartridge you are inserting matches firmly together. the insulin cartridge manufacturer you selected in the cartridge setting.
  • Page 27 When the plunger Press once and the After inserting the stops moving forward, remaining amount of cartridge, press “Completed!” will flash insulin will be displayed. three times on the display. The plunger will now move forward until it The screen will makes contact with the automatically return to rubber of the insulin...

  • Page 28: Injection

    In case of a blockage during the injection or priming of the pen, the pendiq 2.0 will display a warning message and sound an audible warning tone.

  • Page 29: Attaching A Pen Needle

    Attaching a pen needle Take a new pen needle and remove the protective seal. Attach the needle by firmly screwing it onto the threads at the end of the cartridge holder. Remove the outer protective cap and the inner needle cap from the needle.

  • Page 30: Prime

    Press from the screen. home screen “Last Inj.” to start. Hold the pendiq 2.0 with the needle pointing up in order to remove any air bubbles. Press until you see bubbles of insulin appearing at the tip of the needle.

  • Page 31: Dose Setting

    Dose setting When have Press to adjust the dose. The default dose limit for a finished the priming single injection is 60.0U. You can increase the dose limit in the process, press “Settings Menu”. enter dose setting. Press to increase/decrease the number by 0.1U. The factory setting Press and hold to increase/decrease the number by 1.
  • Page 32 If you cancel the injection after priming by pressing the button, a prime dose of 0.5U for every time you pressed will be subtracted from the remaining insulin amount.

  • Page 33: Injecting Your Dose

    Injecting your dose Firmly hold your pendiq insert the needle into the injection area using The number on the The display will count Press to start injection technique display will count down from 15 seconds the injection. recommended by down from the dose to 0 second.
  • Page 34 If you believe you have After the 15 seconds After the injection the set an incorrect dose, the pen will sound remaining amount of pull out the needle from two short beeps to insulin in the cartridge the injection site indicate the end of the will be displayed on immediately.

  • Page 35: After The Injection

    After the injection Carefully place the outer cap back on the pen needle and unscrew it from the cartridge holder. Dispose of the used needle as advised by your healthcare professional or according to local regulations.

  • Page 36: Memory Function

    Memory function With the pendiq 2.0, users are able to check their injection history with the date, time and the amount of insulin delivered. The “Last Inj.” home From the home screen screen displays the dose, “Last Inj.” press The details of your last date &...
  • Page 37 Press to go through your Press to return to home display “Last Inj.”. injecti on history and check the details of previous injecti ons. Press in the “Memory” Press to move forward. menu if you want to jump to straight to injecti on mode (Prime).

  • Page 38: Settings

    Settings In the “Settings Menu” of the pendiq 2.0 pen, you can turn the Bluetooth on and off, change the language, Date/Time, volume of the speaker, set TimeBlocks and dose limits, reset the pen to factory settings and review the software version...

  • Page 39: Bluetooth

    The pendiq 2.0 is equipped with Bluetooth Smart which makes it possible to transfer data from your pendiq 2.0 to a smartphone app. It is only possible to transfer data when the Bluetooth is activated on the pendiq 2.0 pen, and the pendiq 2.0 is connected to the smartphone app.

  • Page 40: Turn Bluetooth On/Off

    Turn Bluetooth ON/OFF Press for 3 Bluetooth menu Press Press seconds to turn on the button until you will appear. “Remain. Ins.” power in case the pen reach “Settings screen will appear. is turned off. Menu” screen. The home screen Press “Last Inj.”...
  • Page 41 The word “Always” Press and “ON/ Press will start flashing. OFF” will start flashing. select Bluetooth “ON”, and press Press Press again to confirm. select “Always” or and “OFF” will start “Temp.”. flashing.
  • Page 42 Temp. (Temporarily): Only Always: Even when the pendiq 2.0 is turned off, when the pendiq 2.0 is turned the Bluetooth connection between the pendiq on, the Bluetooth connection 2.0 and the smartphone app is always active. between the pendiq 2.0 and the smartphone app is active.
  • Page 43 Press and “Done” will If Bluetooth is set to When the Bluetooth flash thrice. “Temp.”, the message is activated a little “Bluetooth loading...” Bluetooth icon will The screen will automatically will appear when you be displayed at the change to Bluetooth setting turn on the pen whilst bottom right corner.

  • Page 44: Bluetooth Pin

    2.0 pen. With a personal PIN number for The home screen the Bluetooth connection only you “Last Inj.” will appear on can access your pendiq 2.0 pen via the screen. the smartphone app.
  • Page 45 Press The Bluetooth The factory default Press and “PIN button until you setting will appear. Num.” will start PIN number (0000) reach “Settings will be displayed. flashing. Menu” screen. Press again to enter Bluetooth Press Press to confirm. Press to enter. setting.
  • Page 46 Forgot your PIN and the word “Done” will word “Edit”. You can enter a 4 number? Restore the flash thrice. digit personal PIN number. pendiq 2.0 to factory The screen will automatically settings. Press to change the number change to “Bluetooth PIN”...

  • Page 47: Speaker

    Speaker Press for 3 Press Press Press seconds to turn on the button until you reach “Speaker”. “Remain. Ins.” power in case the pen reach “Settings screen will appear. is turned off. Press Menu” screen. “Vol.” will start The home screen Press to enter.
  • Page 48 Even though the Press and “Done” will Press volume is set to flash thrice. The screen adjust the volume zero (mute), you will automatically change (0~4). You will hear will hear an audible back to “Speaker” setting the sound of the alarm for warnings.

  • Page 49: Language

    Language Press for 3 seconds to Press Press turn on the power in case “Remain. Ins.” button until you the pen is turned off. screen will appear. reach “Settings Menu” screen. The home screen “Last Inj.” will appear on the Press to enter.
  • Page 50 The screen will Press until Press automatically you reach the language select the language change back to setting. you wish to use. “Language” setting. Confirm with Press to enter. Press several “Done” will flash times to return to thrice on the display. home screen.

  • Page 51: Date/Time

    Date / Time In case you are travelling or need to adjust the time due to summer/ winter time changeover, Press for 3 Press Press follow the next steps. seconds to turn on “Remain. Ins.” button until you the power in case screen will appear.
  • Page 52 The year starts Press Press Press flashing. Press until you reach the select the month set day and confirm to adjust the Date/Time setting. and confirm with with year and confirm Press to enter. with...
  • Page 53 Press Press to set Press . Date/Time “Done“ will flash thrice on the display. set the hour and the minute. confirm with The screen will automatically Press and hold change back to “Date/Time” to increase/decrease Menu. the number by 10. Press several times to return to home screen.

  • Page 54: Timeblock

    TimeBlock TimeBlock means that you can pre- If you only use TB-1 with this setting, the program a fixed dose for a TimeBlock of TimeBlock lasts 24h and a dose of 0.5 U is your choice. presented to you for each injection. The starting time of a TimeBlock is You can add and delete other TimeBlocks automatically the ending time of the...
  • Page 55 Setting TimeBlocks is convenient because you can pre-program up to 5 TimeBlocks for a day, each TimeBlock delivering a pre-programmed dose. duration in hours TB-1 TB-2 TB-3 TB-4 TB-5...
  • Page 56 Example for three TimeBlocks: TB-1 (06:00, 6.5U) TB-2 (14:00, 10U) TB-3 (19:00, 8U) Time 6:00 18:00 6:00 TB-1 TB-3 TB-2 06:00, 6.5U 14:00, 10U 19:00, 8U...
  • Page 57 TB-1 TB-3 TimeBlock 1 starts at 06:00 o’clock and ends TimeBlock 3 starts at 19:00 o’clock and with the starting time of TB-2 at 14:00 o’clock ends with the starting time of TB-1 at 06:00 During this time a dose of 6.5U will be preset o’clock.

  • Page 58: Add A Timeblock

    Add a TimeBlock Press for 3 seconds Press . “Remain. Press to turn on the power in Ins.” screen will button until you case the pen is turned reach “Settings appear. off. Menu” screen. The home screen “Last Press to enter.
  • Page 59 Press . “New” Press until Press to set will start flashing. the “TimeBlock” the hour. menu will appear. Press Press to confirm. confirm adding a TB.
  • Page 60 Press to confirm. Press to set Press to adjust the insulin dose. the minute. Press Press and hold Press turn the alarm for the to increase/ increase/decrease the TimeBlock “On” or “Off.” decrease the number number by 0.1U. by 10. Press and hold This means that the pen to increase/decrease the...
  • Page 61 The screen will change back to Press TimeBlock “Add” menu. To set more “Done” will flash TimeBlocks follow the steps 5 to 11. thrice on the screen. You can set up to 5 TimeBlocks. Press several times to return to home screen.

  • Page 62: Change A Timeblock

    Change a TimeBlock Press for 3 Press . “Remain. Press seconds to turn on Ins.” screen will button until you the power in case the appear. reach “Settings pen is turned off. Menu” screen. Press to enter. The home screen “Last Inj.”...
  • Page 63 Press . The screen will Press Press . “New” will change to “Modify” setting until the “TimeBlock” start flashing. and “Edit” will start flashing. menu will appear. With the button you can switch between the “Modify” and “Add” screen.
  • Page 64 Choose “Modify” and Press to enter the TimeBlock press to see the and “Edit” will start flashing. TimeBlocks (TB 1 ~ TB 5). Press again to confirm. Press to cancel. Press to select the TimeBlock (TB 1 ~ TB 5) Follow the steps 6-10 in chapter you wish to modify.

  • Page 65: Delete A Timeblock

    Delete a TimeBlock Follow the steps 1-6 in the chapter “Change a TimeBlock”. Press in the “Modify” Press to enter Press setting to see the set the TimeBlock and once and “Delete” TimeBlocks. “Edit” will start will start flashing. flashing. Press to select the Press...
  • Page 66 Press again to “Done” will flash thrice. The TimeBlock is confirm deletion now deleted. of TimeBlock. The screen will automatically change back to “Modify” screen. Press several times to return to home screen “Last Inj.”.

  • Page 67: Dose Limit

    Dose limit The default dose limit is 60.0U for each injection and 80.0U for one day. It is possible to change the dose limit for the day and for each injection to avoid overdose.

  • Page 68: Dose Limit For A Day (1 Day)

    Dose limit for a day (1 Day) & Dose limit for injections (1 Time) Press Press Press to enter and Press for 3 “Remain. Ins.” button until you then press until seconds to turn on screen will appear. you reach “Dose Limit” reach “Settings the power in case Menu”...
  • Page 69 1 day dose limit can be set between 80.0U and With you can choose 160.0U. between setting a dose limit for a day 1 time dose limit can be set between 60.0U and (1 day) or for injections (1 time). 100.0U.
  • Page 70 Press and “Done” will flash thrice on the screen. The screen will automatically change back to “Dose limit” menu. Press to go back in the menu and return to home screen “Last Inj.”.

  • Page 71: Default Setting

    Default setting Press for 3 Press to enter Press Press seconds to turn on “Remain. Ins.” button until you and then press the power in case screen will appear. until you reach reach “Settings the pen is turned off. “Default Set.” screen. Menu”...
  • Page 72 After the system of the pendiq 2.0 is restored back to factory default settings, the language will be switched back to the factory setting (German). Press to confirm and Press “Done” will flash thrice. “Really?” will start After the system of the pendiq 2.0 The screen will flashing.

  • Page 73: Version

    Version Press for 3 Press Press Press to enter and then press seconds to turn on “Remain. Ins.” button until you until you reach “Version” the power in case screen will appear. reach “Settings screen. the pen is turned Menu” screen. off.

  • Page 74: Battery

    Open the USB port cover on the side of your pen. Take the micro USB cable that was delivered with the pendiq 2.0 box and plug in the end of the USB connection into the USB port of the pen.
  • Page 75 Battery empty. Only red LED blinking to prevent device malfunction. Do not use a USB cable other than the USB cable contained in the pendiq 2.0 box. Do not try to change or remove the battery. It cannot be replaced.

  • Page 76: Cleaning Und Maintenance

    Inappropriate cleaning may damage the Do not use grease or lubricants. pendiq 2.0. Do not expose the pendiq 2.0 to the direct sun Do not use any liquid when cleaning the light or the dust. pendiq 2.0. The pendiq 2.0 is not water-proof.

  • Page 77: Diabetes Management App

    Bluetooth on your displayed and it is possible to change the settings of smartphone and the pendiq 2.0 from the app. Any changes made in your pendiq 2.0. the app will be applied to the pendiq 2.0 in real time.
  • Page 78 Co., Ltd., #305, 187, Techno 2-ro, Yuseong-gu, Visit the homepage Daejeon, South-Korea (hereinafter referred to www.diamesco.com to download as “Diamesco”), and is not a product of Pendiq the user manual of the “dialife“ GmbH. app. The liability of pendiq GmbH for damages...

  • Page 79: Glossary

    Glossary 1 Day Dose limit for one day 1 Time Dose limit for single injection Always Bluetooth on always Basal Long-acting insulin Berlin Berlin-Chemie, insulin cartridge manufacturer Blue LED Bluetooth working status Bolus Regular or rapid-acting insulin Dose Limit Injection dose limit...
  • Page 80 Green LED Normal operation and charging status Pendiq 2.0 hardware version Last Inj. Last injection Lilly Lilly, insulin cartridge manufacturer New Inj. New injection Novo Novo Nordisk, insulin cartridge manufacturer Novo cartridge holder A cartridge holder for Novo Nordisk insulin cartridges PIN Num.
  • Page 81 Red LED Abnormal operation, error or warning Remain. Ins. Remaining insulin Replace Cart. Replace cartridge Rewinding The plunger is moved backwards during cartridge replacement Pendiq 2.0 software version Sanofi Sanofi-Aventis, insulin cartridge manufacturer Set. Setting Default Set. Factory default setting Temp.

  • Page 82: Specifications

    Specifications Display symbols Below a description of the icons that can appear on the pendiq 2.0 screen. Settings Menu Bluetooth Menu Bluetooth ON - Displayed on bottom right corner Error Bluetooth PIN number Replace Cartridge Menu Cartridge...
  • Page 83 Flashes while rewinding the plunger Flashes while the plunger moves forward Prime and injection Please wait TimeBlock Menu Adding a new TimeBlock Air removal while pressing button in injection menu TimeBlock edit Menu...
  • Page 84 Language Menu Setting error Date/Time Menu Displayed at the bottom right while setting “Year” on Date/Time menu Displayed at the bottom right while setting “Time” on Date/Time menu Displayed for a fully charged battery Flashes when charging the battery...
  • Page 85 Default Set. Menu Dose Limit Menu Bluetooth PIN number Speaker Menu Mute in volume setting Injection error...

  • Page 86: Warning & Errors

    2.0, the display will show this warning with a red LED light blinking. An error occurred An error occurred Remaining battery during priming.
  • Page 87 An error occurred An error occurred The motor function during the opera- during charging is limited while the tion of the motor. the battery. pen is charging and no injections can be carried out during. The maximum num- The maximum ber of Time Blocks has dose limit for one been reached.
  • Page 88 If Bluetooth is set to In case that you do not see insulin bubbles at the tip of the “Temp.”, the message needle after you pressed several times, the pen needle “Bluetooth loading...” may be blocked. will appear every time When there is a blockage during the prime process, the you turn on the pen screen will display a warning message (Error) with a sound.
  • Page 89 When there is a blockage during the injection, the screen will display a warning message (Error) with a sound. The dose deliverance will stop on the display. The injection memory will save the actual dose delivered minus a 0.1U tolerance. Press to cancel the warning and return to “Remain.

  • Page 90: Icon Description

    Icon description Recommendation Manufacturer Prohibition Serial number Type BF applied part Reference number Class II equipment Appointed agent in the EC Direct Current Protect from humidity Electromagnetic compatibility IEC 60601-2-24 Specific references regarding Material classification (only GER) storage and/or handling Disposal note (only EU) The date of manufacture Attention, consult accompanying documents...

  • Page 91: Technical Information

    Technical Information Name pendiq 2.0 Manufacturer Diamesco Co., Ltd. Daejeon, 34025 Korea Length 189mm Weight 65g (Insulin cartridge and pen needle excluded) Cartridge Capacity 3ml (300.0U) Increment 0.1U Dose accuracy ±5% Dose limit 0.5~60.0U (default), max 1 day 160U, max 1 time 100u (adjust) Units per second 1.6U/sec.
  • Page 92 Memory (Injection history) About 1,000 injections USB voltage and current USB 5V, 500mAh USB charger Input: 100-240 VAC, 50/60 Hz, 0.5A Output: 5 VDC, 1A Storage conditions Temperature : -10~40°C / 14~ 104°F Humidity : 10~90%RH Atmospheric Pressure : 66~106kpa Operation conditions Temperature : 0~40°C / 32~ 104°F Humidity : 20~70%RH...
  • Page 93 10 days (12 injection / 1 day / Bluetooth OFF) Type of protection against Internal powered equipment electric shock Degree of protection against Type BF applied part electric shock Degree of protection against IPX0 (The pendiq 2.0 is not water-proof) the ingress of water Operating mode Injection...

  • Page 94: Factory Default Settings

    Factory Default Settings 1 Day dose limit 80.0U 1 Time dose limit 60.0U Minimum dose per injection 0.5U Display turns itself off (when no button is pressed) after 60 seconds Power-on Press for 3 seconds Countdown after the injection 15 seconds Unit 0.1U Unit display...

  • Page 95: Electro-Magnetic Compatibility

    Electro-Magnetic Compatibility (EMC) Instructions and manufacturer declarations – Electromagnetic Emission: This unit is intended for use in the electromagnetic environment specified below. In addition, the user should use this product in the following environment. Emission Test Compatibility Electromagnetic environment - Guideline This unit uses RF energy for internal functions only. RF Emission CISPR 11 Group 1 As a result, RF emissions are very low and do not interfere...
  • Page 96 Instructions and manufacturer declarations - Electromagnetic immunity: This unit is intended for use in the electromagnetic environment specified below. In addition, the user should use this product in the following environment. Immunity Test IEC60601 Test Level Compatibility Level Electromagnetic environment - Guideline The floor must be wood, concrete or Electrostatic Air: ±...
  • Page 97 Immunity Test IEC60601 Test Level Compatibility Level Electromagnetic environment - Guideline <5% UT <5% UT (95% drop from UT) (95% drop from UT) 0.5 Cycle 0.5 Cycle The mains supply should be of the quality of a 40% UT 40% UT commercial or hospital environment. (60% drop from UT) (60% drop from UT) Surge 5 Cycle...
  • Page 98 Remarks : UT is the a.c main voltage prior to applying the test level. *Remark 1) Input/output Line test is not applicable because there is no input/output line. *Remark 2) Tests between line and ground are not applicable since there is no connection terminal. Instructions and manufacturer declarations - Electromagnetic immunity. This unit is intended for use in the electromagnetic environment specified below. In addition, the user should use this product in the following environment.
  • Page 99 Immunity Test IEC60601 Test Level Compatibility Level Electromagnetic environment - Guideline Where P is the maximum output rating (W) of the other transmitter to the transmitter manu- facturer, and d is the recommended separation distance in meters. The field strength of fixed RF transmitters (*Remark 3) determined in an electromagnetic site survey should be less than the compliance level of each frequency range.
  • Page 100 Remark 1: The high frequency range is applied at 80MHz and 800MHz. Remark 2: This Guideline may not apply in all situations. Electromagnetic propagation is affected by the absorption and reflection of structures, objects and people. *Remark 3) Field strengths of fixed transmitters such as wireless (handheld/wireless) telepho- nes and land mobile radios, amateur radios, AM and FM radio stations and base stations for TV broadcasts are theoretically unpredictable.
  • Page 101 Recommended separation distance between portable and mobile RF communication equipment and this equipment: This equipment should be used in an electromagnetic environment capable of controlling emitted RF disturbances. The user is encouraged to try to correct the interference by maintaining the minimum separation of the equipment from the portable or mobile RF communications equipment (transmitter), as re- commended below, based on the maximum power of the communication equipment.
  • Page 102 Transmitter distance according to frequency, m Maximum output 150kHz ~ 80MHz 80MHz ~ 800MHz 800MHz ~ 2.5GHz rating of the transmitter d = 1.2 √P d = 1.2 √P d = 1.2 √P 0.01 0.12 0.12 0.23 0.38 0.38 0.73 For a transmitter with a maximum output rating not listed above, the recommended separation distance d (m) can be estimated using the equation for the frequency of the transmitter.

  • Page 103: Product Warranty

    The data on the pendiq 2.0 will be used for In the unlikely event of failure during the two inspection but will be deleted when the years of warranty, please fill out the warranty assessment is completed.

  • Page 104: General Information

    General Information Distributor in the EU Manufacturer pendiq GmbH Diamesco Co., Ltd. Baerler Strasse 100 #305, 187, Techno 2-ro, 47441 Moers, Germany Yuseong-gu, Daejeon, South-Korea info@pendiq.com www.diamesco.com www.pendiq.com pendiq 2.0 meets the requirements of the standards of IEC 60601-2-24 and ISO 13485.
  • Page 105 GmbH. Lilly® is a registered trademark of Eli Lilly and Company. Berlin-Chemie® is a registered trademark of the Berlin-Chemie AG. Sanofi-Aventis® is a registered trademark of the sanofi-aventis-group. Novo Nordisk® is a registered trademark of Novo Nordisk A/S.
  • Page 106 PZN 13231681 Shadow black (black) PZN 13231698 Arctic white (white) PZN 13231735 Lime green (green) PZN 13231706 Funky orange (orange) PZN 13231741 Sky blue (blue)
  • Page 107 MDD and that the medical device fulfills the requirements of the Medical Device Directive (93/42/EEC). Please check our website www.pendiq.com or www.diamesco.com for an updated issue of this manual since issued in March 2017. Technical changes reserved.
  • Page 108 GmbH Baerler Straße 100 47441 Moers Germany Customer service 0800 7990900 (free-of-charge from a German landline) info@pendiq.com www.pendiq.com...

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