Pendiq 13231681 User Manual Download Page 104

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104

Distributor

in the EU

pendiq GmbH

Baerler Strasse 100

47441 Moers, Germany

[email protected]

www.pendiq.com

pendiq 2.0 meets the requirements of the

standards of IEC 60601-2-24 and ISO 13485.

Manufacturer

Diamesco Co., Ltd.

#305,

187, Techno 2-ro,

Yuseong-gu, Daejeon, South-Korea

www.diamesco.com

General Information

Summary of Contents for 13231681

Page 1: ...1 User Manual DIQ IFU 02 Rev 0 2017 03 30 0068 ...

Page 2: ...ep 1 Language Step 2 Date Time Step 3 Cartridge settings Replacing a cartridge Injection Attaching a pen needle Prime Dose Setting Injecting your dose After the injection Memory function Settings Bluetooth Turn Bluetooth ON OFF Bluetooth PIN Speaker Contents 4 5 13 14 15 17 18 19 22 28 29 30 31 33 35 36 38 39 41 45 47 page ...

Page 3: ... TimeBlock Dose limit Dose limit for a day 1 Day Dose limit for injections 1 Time Default setting Version Battery Cleaning und maintenance Diabetes Management App Glossary Specifications Display symbols Warning Errors Icon description Technical information Factory default settings Electro Magnetic Compatibility Product warranty General Information ...

Page 4: ...unction you can review your injection history with the date time and amount of insulin delivered The Bluetooth function lets you transfer data from your pendiq 2 0 to a Diabetes Management Solution This manual gives you instructions on how to use and maintain your pendiq 2 0 Please read this manual thoroughly and familiarize yourself with the information before using the pen We advise you to keep ...

Page 5: ...nal if you encounter abnormal blood glucose levels Do not share this pen with other people to prevent infection Inject only into the body areas suggested by the official national endocrinologist association your healthcare professional or your physician You should change the injection area for each injection After discussing the injection areas with your healthcare professional follow the instruct...

Page 6: ...re each injection The pendiq 2 0 is a technical medical device Use the pendiq 2 0 properly Alwayschecktheremaininginsulinamount before each injection to ensure that there are enough units left for your dose Always remove the pen needle before changing the cartridge Do not modify or disassemble the pendiq 2 0 Do not use the pendiq 2 0 if any part of your pendiq 2 0 looks broken or damaged Contact y...

Page 7: ... purpose as shocks and impacts may damage the pen The pen is not designed for the blind or visually impaired without a trained assistant Make sure the insulin cartridge in the setting matches the insulin cartridge manufacturer Novo Lilly Sanofi you are using If they do not match the pen cannot recognize the exact residual amount of insulin in the cartridge and the amount of units displayed may the...

Page 8: ... the pendiq 2 0 in a refrigerator Do not expose the pen to heat or direct sun light Do not expose the pendiq 2 0 to flammable and or combustible mixtures Do not expose the pendiq 2 0 to any electromagnetic waves and or frequency CT MRI X ray etc The pen may suffer damages when exposed to electromagnetic waves Always make sure that the battery is fully charged It is recommended to fully charge the ...

Page 9: ... 100 insulin of the manufacturers Novo Nordisk Lilly Sanofi Aventis and Berlin Chemie Do not use insulin cartridges from manufacturers other than the manufacturers stated above Do not use NPH or premix insulin with the pendiq 2 0 Do not use a non sterilized or damaged pen needle Healthcare professionals strongly recommend not reusing a pen needle Using a new needle for each injection will minimize...

Page 10: ...herwise it may cause incorrect insulin delivery leakage of insulin and unintended needle injury etc Pleasefollowtheinstructionsandthesafety guidelines of the pen needle manufacturer as disregard may cause infection and or damage in the injection area The manufacturer is not responsible for any problems caused by the malfunction of the Bluetooth connection between the pendiq 2 0 and a smartphone ap...

Page 11: ...sponsible for the safety dosage accuracy and functionality as well as any damages caused by the usage of insulin cartridges that are not adequate for the pendiq 2 0 We recommend not using the device if you are an individual who has not been prescribed by a doctor to inject insulin All users under the age of 14 should be under supervision of a trained parent or a healthcare professional when inject...

Page 12: ... to find the kit Emergency kit should include Blood glucose meter and strips Blood or urine ketone meter and strips Spare insulin cartridge prescribed by doctor Insulin injection syringe Alcohol swab Emergency food for hypoglycemia Diabetic patient identity card with all necessary info Micro USB cable for charging the battery of the pendiq 2 0 Emergency Kit Recommended ...

Page 13: ...lin pen pendiq 2 0 User Manual English User Manual German USB cable USB adapter Cartridge holder Novo Nordisk Warranty card Contents product box Check if all the following components are included in the pendiq 2 0 box ...

Page 14: ...14 A B C C1 D E F G 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: ...o forward in the menu button is used to decrease a number to select a setting to go back in the menu button is used to turn on the pen to confirm an operation or setting to inject a dose button is used to enter the menu to return to previous screen to cancel an operation or setting ...

Page 16: ...16 Please visit our homepage www pendiq com downloads to see a menu tree of the pendiq 2 0 ...

Page 17: ... Read the chapter Battery for more information The pendiq 2 0 has no OFF button The screen turns itself off after 60 seconds when no button is pressed When going through the menu you can always return to the home screen by pressing The device will come with factory default settings Before you can use your pendiq 2 0 for injection you need to complete the initial setup Follow the next steps to get ...

Page 18: ...ou wish to use You can choose between German 1 and English 2 Press for 3 seconds to turn on the display for the first time The initial language setting screen appears The factory language is German Select language and press Done will appear on the display The initial setup will automatically continue to Date Time setting ...

Page 19: ...t a correct Date Time before making the first injection Press to start with setting the year The year starts flashing Press or to adjust the year and confirm with Press or to select the month and confirm with After you have completed the initial language setting the setup will continue with the initial Date Time setting ...

Page 20: ...20 Press or to set the hour and confirm with Press or to set the minute Press and hold or to increase number by 10 Press or to set the day and confirm with ...

Page 21: ...Set Done will appear on the display Done will flash three times Initial setup is now complete The display will show the home display Last Inj As there is no injection history saved yet will be displayed on the home screen ...

Page 22: ...played 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 cartridge settings Follow the next steps when you insert a cartridge for the first time or want to replace a cartridge Always have the new cartridge ready at hand Step 3 Cartridge settings Replacing a cartridge ...

Page 23: ...s Press to confirm New cartridge will appear and the name of the cartridge manufacturer flashes Press or to select the insulin cartridge manufacturer of the insulin cartridge you wish to insert YoucanselectbetweenNovoNordisk Sanofi Lilly and Berlin Chemie Select an insulin cartridge manufacturer and press ...

Page 24: ...ill be automatically rewound NOTE You can stop the plunger by pressing anytime The screen will return to Remain Ins screen and you can start over Insert cartridge screen will appear after the plunger is fully rewound Now you can insert a new cartridge ...

Page 25: ...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: ...e body firmly together Insert a new insulin cartridge into the cartridge holder When inserting a cartridge make sure the insulin cartridge you are inserting matches the insulin cartridge manufacturer you selected in the cartridge setting ...

Page 27: ... until it makes contact with the rubber of the insulin cartridge When the plunger stops moving forward Completed will flash three times on the display The screen will automatically return to Replace Cart menu Press once and the remaining amount of insulin will be displayed ...

Page 28: ...euseapenneedle Whenapenneedleis reused a blockage in the pen needle can occur and the flow of the medicine is obstructed 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: ...edle 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: ...rd Prime will appear on the screen 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 Press for 3 seconds to turn on the power in case the pen is turned off ...

Page 31: ...dosage for an injection is 0 5U Press or to adjust the dose The default dose limit for a single injection is 60 0U You can increase the dose limit in the Settings Menu Press or to increase decrease the number by 0 1U Press and hold or to increase decrease the number by 1 Press to cancel the dose setting and return to the Remain Ins screen ...

Page 32: ...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: ... sound one short beep to indicate the end of the injection The display will count down from 15 seconds to 0 second This is how long it is recommended to keep the needle inserted in the injection area Firmly hold your pendiq 2 0 and insert the needle into the injection area using the injection technique recommended by your healthcare professional ...

Page 34: ...d of the countdown The pen needle can now be removed from the injection area After the injection the remaining amount of insulin in the cartridge will be displayed on the screen If you believe you have set an incorrect dose pull out the needle from the injection site immediately ...

Page 35: ...lly 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 After the injection ...

Page 36: ...me and the amount of insulin delivered The details of your last injection are always displayed on the home screen Last Inj when you turn on the power The Last Inj home screen displays the dose date time and insulin type of the last injection From the home screen Last Inj press and Memory menu will appear ...

Page 37: ...rn to home display Last Inj Press in the Memory menu if you want to jump to straight to injection mode Prime Press to go through your injection history and check the details of previous injections Press to move forward ...

Page 38: ...gs 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 of the pen ...

Page 39: ...o 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 To activate Bluetooth on your pendiq 2 0 pen follow the next steps Bluetooth ...

Page 40: ...onds to turn on the power in case the pen is turned off The home screen Last Inj will appear on the screen Press and Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter Bluetooth menu will appear ...

Page 41: ...41 Press and ON OFF will start flashing Press again and OFF will start flashing Press or to select Bluetooth ON and press to confirm The word Always will start flashing Press or to select Always or Temp ...

Page 42: ...that you can change edit settings on the pendiq 2 0 via the smartphone app even when the pen is not in nearby reach Be aware that the battery consumption is high in Always mode Temp Temporarily Only when the pendiq 2 0 is turned on the Bluetooth connection between the pendiq 2 0 and the smartphone app is active The advantage of this setting is that it will save battery ...

Page 43: ...h setting menu Press several times to return to home screen If Bluetooth is set to Temp the message Bluetooth loading will appear when you turn on the pen whilst Bluetooth is activated When the Bluetooth is activated a little Bluetooth icon will be displayed at the bottom right corner ...

Page 44: ...reen will appear The pendiq 2 0 will come with a factory PIN number for the Bluetooth connection When you receive the pendiq 2 0 it is important that you change and choose a personal PIN number for your pendiq 2 0 pen With a personal PIN number for the Bluetooth connection only you can access your pendiq 2 0 pen via the smartphone app Bluetooth PIN ...

Page 45: ...l appear Press again to enter Bluetooth setting Press and PIN Num will start flashing Press The factory default PIN number 0000 will be displayed Press to confirm Press or button until you reach Settings Menu screen Press to enter ...

Page 46: ...ast Inj press several times Please keep your personal PIN number safe at all times Forgot your PIN number Restore the pendiq 2 0 to factory settings The screen will now display the word Edit You can enter a 4 digit personal PIN number Press to change the number from 0 to 9 Press to move the cursor from right to left Press to confirm your personal PIN number ...

Page 47: ...the pen is turned off The home screen Last Inj will appear on the screen Press and Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter Press or to reach Speaker Press and Vol will start flashing Factory setting Vol 3 ...

Page 48: ...of the volume Press and Done will flash thrice The screen will automatically change back to Speaker setting menu Press several times to return to home screen Last Inj Even though the volume is set to zero mute you will hear an audible alarm for warnings 0 1 2 3 4 ...

Page 49: ...ds to turn on the power in case the pen is turned off The home screen Last Inj will appear on the screen Press and Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter Language ...

Page 50: ...nguage setting Press to enter Press or to select the language you wish to use Confirm with Done will flash thrice on the display The screen will automatically change back to Language setting Press several times to return to home screen ...

Page 51: ...mer winter time changeover follow the next steps Press for 3 seconds to turn on the power in case the pen is turned off The home screen Last Inj will appear on the screen Press and Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter ...

Page 52: ... or until you reach the Date Time setting Press to enter The year starts flashing Press or to adjust the year and confirm with Press or to select the month and confirm with Press or to set day and confirm with ...

Page 53: ...th Press or to set the minute Press and hold or to increase decrease the number by 10 Press Date Time Done will flash thrice on the display The screen will automatically change back to Date Time Menu Press several times to return to home screen ...

Page 54: ...e than for example 30 0 U for each injection You set the dose of TB 1 to 30 0 U and for each injection adjust the dose from there TimeBlock means that you can pre program a fixed dose for a TimeBlock of your choice The starting time of a TimeBlock is automatically the ending time of the previous TimeBlock The TimeBlocks programmed will auto matically be repeated every 24 hours unless the TimeBlock...

Page 55: ...55 Setting TimeBlocks is convenient because you can pre program up to 5 TimeBlocks for a day each TimeBlock delivering a pre programmed dose 0 duration in hours 12 24 TB 1 TB 2 TB 3 TB 4 TB 5 ...

Page 56: ...56 Example for three TimeBlocks TB 1 06 00 6 5U TB 2 14 00 10U TB 3 19 00 8U 6 00 Time 18 00 6 00 TB 1 06 00 6 5U 14 00 10U 19 00 8U TB 2 TB 3 ...

Page 57: ...of TB 1 all three TimeBlocks will be repeated TimeBlock 1 starts at 06 00 o clock and ends with the starting time of TB 2 at 14 00 o clock During this time a dose of 6 5U will be preset for your injection TimeBlock 2 starts at 14 00 o clock and ends with the starting time of TB 3 at 19 00 o clock During this time a dose of 10U will be preset for your injection TB 1 TB 3 TB 2 ...

Page 58: ...o turn on the power in case the pen is turned off The home screen Last Inj will appear on the screen Press Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter Add a TimeBlock 1 2 3 ...

Page 59: ...59 Press or to set the hour Press to confirm Press or until the TimeBlock menu will appear Press New will start flashing Press to confirm adding a TB 4 5 6 ...

Page 60: ...m with Press or to adjust the insulin dose Press or to increase decrease the number by 0 1U Press and hold or to increase decrease the number by 1 Press to confirm Press or to turn the alarm for the TimeBlock On or Off This means that the pen will sound a beep at the start of a TimeBlock 7 8 9 ...

Page 61: ...one will flash thrice on the screen The screen will change back to TimeBlock Add menu To set more TimeBlocks follow the steps 5 to 11 You can set up to 5 TimeBlocks Press several times to return to home screen 10 11 ...

Page 62: ...s for 3 seconds to turn on the power in case the pen is turned off The home screen Last Inj will appear on the screen Press Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter 1 2 3 ...

Page 63: ...ntil the TimeBlock menu will appear Press New will start flashing Press The screen will change to Modify setting and Edit will start flashing With the or button you can switch between the Modify and Add screen 4 5 6 ...

Page 64: ...cks TB 1 TB 5 Press to select the TimeBlock TB 1 TB 5 you wish to modify Press to enter the TimeBlock and Edit will start flashing Press again to confirm Press to cancel Follow the steps 6 10 in chapter Add a TimeBlock on how to set the time and dose ...

Page 65: ...o see the set TimeBlocks Press to select the TimeBlock TB 1 TB 5 you wish to delete Press to enter the TimeBlock and Edit will start flashing Press or once and Delete will start flashing Press Follow the steps 1 6 in the chapter Change a TimeBlock 1 2 3 ...

Page 66: ...s again to confirm deletion of TimeBlock Done will flash thrice The TimeBlock is now deleted The screen will automatically change back to Modify screen Press several times to return to home screen Last Inj 5 4 ...

Page 67: ...67 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: ...nds to turn on the power in case the pen is turned off The home screen Last Inj will appear on the screen Press and Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter and then press or until you reach Dose Limit screen Press to enter ...

Page 69: ...ections 1 time Choose and press to confirm 1 day dose limit can be set between 80 0U and 160 0U 1 time dose limit can be set between 60 0U and 100 0U Press or to adjust dose limit Press or to increase decrease the number by 0 1U Press and hold or to increase decrease the number by 1 ...

Page 70: ...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: ...er in case the pen is turned off The home screen Last Inj will appear on the screen Press and Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter and then press or until you reach Default Set screen Press to enter ...

Page 72: ...s restored back to factory default settings the language Date Time TimeBlock 1 day dose limit 1 time dose limit Speaker and Bluetooth PIN Number settings must be set again Press and Really will start flashing Press to confirm and Done will flash thrice The screen will automatically change back to Default setting menu Press to go back in the menu and return to home screen Last Inj ...

Page 73: ... The home screen Last Inj will appear on the screen Press and Remain Ins screen will appear Press or button until you reach Settings Menu screen Press to enter and then press or until you reach Version screen The software and hard ware version information is displayed on the screen ...

Page 74: ...ction into the USB port of the pen Connect USB cable with your computer or with the USB adapter to charge your pen While the pen is charging the LED light will show a flashing green light When your pen is completely charged the LED light shows a consistent green light and you can remove the charger from your pen If not removed the green LED light turns itself off ...

Page 75: ... or remove the battery It cannot be replaced Remaining battery 20 10 5 1 Warning signals Battery icon blinking Battery icon and red LED blinking Warning Battery empty displayed on the screen Battery icon and red LED blinking Battery empty Only red LED blinking to prevent device malfunction Battery status ...

Page 76: ... 0 is not water proof Do not immerse the pendiq 2 0 into any liquid Do not use any chemicals when cleaning the pendiq 2 0 Do not use grease or lubricants Do not expose the pendiq 2 0 to the direct sun light or the dust Carefully wipe the pendiq 2 0 body the cartridge holder and the cartridge holder cover with a dry or lightly damp cloth ...

Page 77: ...be displayed in the app and you can enter data from your glucometer The app can display all data in a diary and in a graph Also the current status of your pendiq 2 0 will be displayed and it is possible to change the settings of the pendiq 2 0 from the app Any changes made in theappwillbeappliedtothependiq2 0inrealtime 1 Search dialife in the Google Playstore or Apple Appstore and install it Downl...

Page 78: ...ejeon South Korea hereinafter referred to as Diamesco and is not a product of Pendiq GmbH The liability of pendiq GmbH for damages resulting from the distribution application use use or malfunctions of this application software shall therefore in accordance with the conditions set out under http www pendiq com en legal notes be excluded Visit the homepage www diamesco com to download the user manu...

Page 79: ...D Bolus Dose Limit Dose limit for one day Dose limit for single injection Bluetooth on always Long acting insulin Berlin Chemie insulin cartridge manufacturer Bluetooth working status Regular or rapid acting insulin Injection dose limit Glossary ...

Page 80: ...eration and charging status Pendiq 2 0 hardware version Last injection Lilly insulin cartridge manufacturer New injection Novo Nordisk insulin cartridge manufacturer A cartridge holder for Novo Nordisk insulin cartridges Bluetooth PIN number Bluetooth PIN number change Air removal process before injection ...

Page 81: ...et Temp Abnormal operation error or warning Remaining insulin Replace cartridge The plunger is moved backwards during cartridge replacement Pendiq 2 0 software version Sanofi Aventis insulin cartridge manufacturer Setting Factory default setting Bluetooth on temporarily ...

Page 82: ...elow 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 Specifications ...

Page 83: ...s 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: ...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: ...85 Default Set Menu Dose Limit Menu Bluetooth PIN number Speaker Menu Mute in volume setting Injection error ...

Page 86: ... memory function Remaining battery is 5 If you try to make an in jection before you have set the cartridge settings and with no cartridge in serted in the pendiq 2 0 the display will show this warning with a red LED light blinking An error occurred during the opera tion of the motor An error occurred during priming ...

Page 87: ... charging and no injections can be carried out during An error occurred during the opera tion of the motor An error occurred during charging the battery The maximum dose limit for one day is reached The maximum num ber of Time Blocks has been reached ...

Page 88: ...er you pressed several times the pen needle may be blocked When there is a blockage during the prime process the screen will display a warning message Error with a sound Press to cancel the warning and return to Remain Ins menu screen Press again to return to Last Inj screen A syringe with a cross is displayed on the screen Change the pen needle and press The syringe will disappear and you can pri...

Page 89: ...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 Ins menu screen Press again to return to Last Inj screen A syringe with a cross is displayed on the screen Change the pen needle and press The syringe will disappear and you can make a new injection ...

Page 90: ... references regarding storage and or handling The date of manufacture Caution Recommendation Prohibition Type BF applied part Class II equipment Direct Current Electromagnetic compatibility IEC 60601 2 24 Material classification only GER Disposal note only EU Attention consult accompanying documents CE certificate number ...

Page 91: ...Increment Dose accuracy Dose limit Units per second Battery pendiq 2 0 Diamesco Co Ltd Daejeon 34025 Korea 189mm 65g Insulin cartridge and pen needle excluded 3ml 300 0U 0 1U 5 0 5 60 0U default max 1 day 160U max 1 time 100u adjust 1 6U sec 3 7V 190mAh Lithium Polymer battery ...

Page 92: ... conditions Operation conditions About 1 000 injections USB 5V 500mAh Input 100 240 VAC 50 60 Hz 0 5A Output 5 VDC 1A Temperature 10 40 C 14 104 F Humidity 10 90 RH Atmospheric Pressure 66 106kpa Temperature 0 40 C 32 104 F Humidity 20 70 RH Atmospheric Pressure 66 106kpa ...

Page 93: ...tric shock Degree of protection against electric shock Degree of protection against the ingress of water Operating mode 3 years 2 years 10 days 12 injection 1 day Bluetooth OFF Internal powered equipment Type BF applied part IPX0 The pendiq 2 0 is not water proof Injection ...

Page 94: ...nimum dose per injection Display turns itself off when no button is pressed after Power on Countdown after the injection Unit Unit display Cartridge capacity Bluetooth PIN number 80 0U 60 0U 0 5U 60 seconds Press for 3 seconds 15 seconds 0 1U U 0 01ml 3ml 300 0U 0000 ...

Page 95: ...sion IEC61000 3 2 2014 Voltage fluctuations IEC61000 3 3 2013 Compatibility Class B Group 1 Class A Pass Electromagnetic environment Guideline Emission Test This unit uses RF energy for internal functions only As a result RF emissions are very low and do not interfere with nearby electronic equipment This unit is suitable for use in all facilities including those directly connected to the low volt...

Page 96: ...nthetic the relative humidity should be at least 30 The floor must be wood concrete or ceramic tile If the flooring is synthetic the relative humidity should be at least 30 The mains supply should be of the quality of a commercial or hospital environment Immunity Test Compatibility Level IEC60601 Test Level Electromagnetic environment Guideline Instructions and manufacturer declarations Electromag...

Page 97: ...from UT 25 Cycle 5 UT 95 drop from UT 300 Cycle The mains supply should be of the quality of a commercial or hospital environment If the user needs to continue to use during a power outage it is recommended that the unit be powered by an uninterruptible power supply or a battery Thepowerfrequencymagneticfieldshouldhave thegeneralpositionlevelcharacteristicsofa typicalcommercialorhospitalenvironmen...

Page 98: ... d 1 2 P800MHZ 2 5GHZ 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 envir...

Page 99: ...e 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 Remark 4 Interference may occur near equip ment marked with the following sym Immunity Test Compatibility Level IEC60601 Test Level Electromagnetic environment Guideline ...

Page 100: ... the area where this equipment is used exceeds the applicable RF compliance level it should be observed that the product is operating normally If abnormal performance is observed additional measures may be required such as changing the orientation or position of this product Remark 4 The field strength must be less than 3 V m in the frequency range of 50kHz 80MHz Remark 1 The high frequency range ...

Page 101: ...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: ...rk 1 Separate distances in the high frequency range are applied at 80MHz and 800MHz Remark 2 This Guide Line may not apply to all situations Electromagnetic propagation is influenced by the absorp tion and reflection of structures objects and people 150kHz 80MHz d 1 2 P 80MHz 800MHz d 1 2 P 800MHz 2 5GHz d 1 2 P Maximum output rating of the transmitter Transmitter distance according to frequency m...

Page 103: ... the damaged or defective pendiq 2 0 to the following address pendiq GmbH Customer service Baerler Strasse 100 47441 Moers Germany Please state the reason of your reclamation on the warranty card The pens send back to us will be recycled after the technical inspection according to legal regulations The data on the pendiq 2 0 will be used for inspection but will be deleted when the assessment is co...

Page 104: ... 100 47441 Moers Germany info pendiq com www pendiq com pendiq 2 0 meets the requirements of the standards of IEC 60601 2 24 and ISO 13485 Manufacturer Diamesco Co Ltd 305 187 Techno 2 ro Yuseong gu Daejeon South Korea www diamesco com General Information ...

Page 105: ...lin 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 Bluetooth is a registered trademark of Bluetooth SIG Inc and is used under license agreement All trademarks are acknowledged ...

Page 106: ...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: ...ity with the 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 DIQ IFU 02 Rev 0 2017 03 30 0068 ...

Page 108: ...108 www pendiq com pendiq GmbH Baerler Straße 100 47441 Moers Germany Customer service 0800 7990900 free of charge from a German landline info pendiq com ...

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