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Ever Pharma D-mine Pump, Instructions For Use Manual

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Ever Pharma D-mine Pump Instructions For Use Manual Download Page 76

150

151

10

10.3  

 
    SOURCES OF INTERFERENCE

• 

The   EVER   Pharma  D‑

mine

®

 Pump has been tested as a class B, group 1  medical device in accordance with 

IEC 60601‑1‑2: 2014. It is intended for use in clinics, hospitals and domestic environments.

• 

The   EVER  Pharma D‑

mine

®

 Pump delivers apomorphine. Using the device in the vicinity of strong electromagnetic 

fields can impair or impede performance. In such cases, the  EVER  Pharma D‑

mine

®

 Pump may signal that an error 

has occurred.

• 

Avoid using the  EVER  Pharma D‑

mine

®

 Pump in the vicinity of active electrosurgical instruments and within RF 

shielded rooms for MRT at medical facilities where the electromagnetic wave intensity is high.

• 

The use of the  EVER  Pharma D‑

mine

®

 Pump in the vicinity of or in connection with other devices should be avoided 

because this can lead to malfunctions.

• 

The use of accessories, converters or cables that are not intended for or supplied with the  EVER  Pharma D‑

mine

®

 

Pump can result in increased electromagnetic emissions, reduced electromagnetic immunity, and malfunctioning 
of the pump.

ELECTROMAGNETIC EMISSIONS

• 

Portable RF communications equipment (including peripheral devices, such as antenna cables and external antennae) 
should not be used at a distance of less than 30 cm or 12 inches from any part of the  EVER  Pharma D‑

mine

®

 Pump, 

including cables. Such equipment includes mobile phones, wireless phones, and wireless computer devices. 
Otherwise the performance of the  EVER  Pharma D‑

mine

®

 Pump may be reduced.

RF emissions CISPR 11

Group 1

Class B

Harmonic emissions
IEC 61000‑3‑2

Class A

Voltage fluctuations/flicker 
emissions 
IEC 61000‑3‑3

dmax < 4%

dmax < 4%

Summary of Contents for Pharma D-mine Pump

Page 1: ...EVER Pharma D mine Pump Instructions for use ...

Page 2: ...WELCOME ...

Page 3: ...Parkinson s disease The pump is connected to your body via an infusion set and provides your body with a continuous supply of apomorphine This form of therapy is referred to as apomorphine pump therapy Dacepton Dopaceptin and Dopaton are regional brand names for apomorphine by EVER Pharma Before starting drug administration you fill the drug from the vial into the reservoir with the aid of the pum...

Page 4: ...ical supervision physicians nurses If used improperly infusion pumps pose a serious health risk to the patient The instructions for use of the infusion set used must be followed Special attention should be paid to the sterile handling and the regular change of the injection site Patients with cognitive impairment should not use the pump The decision on a sufficient qualification is incumbent on th...

Page 5: ...ng the docking station for use 35 2 2 Recharge able battery and basic settings 37 3 Reservoir and infusion set 43 3 1 Inserting the reservoir 45 3 2 Connecting the infusion set 53 3 3 Checking the readiness of the pump 57 3 4 Starting and stopping drug delivery 58 4 Daily routine 59 4 1 Menu control 61 4 2 Delivering a bolus 62 4 3 Changing the infusion set 65 4 4 Changing the reservoir 69 4 5 Vie...

Page 6: ...period 96 6 1 3 Setting basal period 1 98 6 1 4 Finalising the programming 99 6 2 Setting the bolus 100 6 3 Entering the name of the drug 102 7 Error messages and notices 103 7 1 Overview 105 7 2 Alarms 106 7 3 Warnings 110 7 4 Notices 111 7 5 Error messages on the docking station 117 7 5 1 The mains connection signal light on the docking station is not lit 117 7 5 2 Signal light on the docking st...

Page 7: ...e steps described in the instructions for use are numbered Follow the sequence indicated when operating the pump 9 Useful information on the use and maintenance of your pump 131 9 1 Disposable accessories 133 9 2 Accessories Replacement parts 133 9 2 1 Carrying bag 134 9 2 2 Rechargeable battery 139 9 3 Cleaning 140 9 4 Storage 140 9 5 Warranty 141 9 6 Disposal 142 10 Appendix 143 10 1 Symbols 145...

Page 8: ...geable battery can be charged at any time in the docking station DOCKING STATION The docking station has two functions Charging the two rechargeable batteries and as a holder for the pump and vial during preparation MAINS ADAPTER WITH INPUT CONNECTOR Use the power supply with one of the three included country plugs CARRYING BAG The carrying bag provides a comfortable option to carry the pump on yo...

Page 9: ...It is already pre attached to the reservoir when you remove the reservoir from the packaging INFUSION SET The infusion set connects the pump to your body The infusion set like the reservoir must only be used once and should be replaced at the latest when a new reservoir is used VIAL The drug which has been prescribed to you by your physician is supplied in a 20 mL vial All disposable accessories m...

Page 10: ... adapter battery or docking station that is damaged The reservoir the adapter and the infusion set are sterile in their packaging Do not use sterile products if their packaging is damaged or missing While using the pump Handle the device with clean hands In particular avoid all contact between the connection components of your pump and cosmetic products such as soaps perfumes body lotions etc Alwa...

Page 11: ...echargeable battery release button Charging contacts Reservoir compartment Reservoir release button Bolus button 1 1 THE EVER PHARMA D mine Pump Screen Function buttons Heading Device error indicator Text sections Button labelling Data interface ...

Page 12: ... The two text sections display the most important information concerning the operation and control of the pump The function button section at the bottom provides a description of each of the function buttons BUTTON LOCK When the screen is switched off the function buttons are also locked To disable the button lock proceed as follows 1 Press any function button The screen will switch on 2 Press The...

Page 13: ...scending tone sequence Finished three short acoustic signals descending tone sequence THE MAIN SCREEN OF THE PUMP 1 Current time 2 State of charge of the rechargeable battery 3 Drug name 4 Time left until the reservoir will be empty The value indicates how long the amount left in the reservoir will last if the drug is delivered at the basal rate currently set The actual time will be shorter if you...

Page 14: ...for mains connection Signal light for spare rechargeable battery Signal light for rechargeable battery for pump SIGNAL LIGHTS MAINS CONNECTION OFF The docking station is not connected to the power supply GREEN The docking station is connected properly to the power supply If the docking station fails the rechargeable batteries cannot be charged Do not forget to take the docking station with you ...

Page 15: ...onnected to docking station char ging is in progress YELLOW FLASHING Error during charging of rechargeable battery for pump see Section 7 5 2 GREEN Rechargeable battery in the pump fully charged The pump and rechargeable battery can be removed from the docking station at any time without damaging them It is not necessary to completely recharge the rechargeable battery ...

Page 16: ...while charging see Section 7 5 2 GREEN Spare rechargeable battery fully charged OFF The spare rechargeable battery is not inserted YELLOW The spare rechargeable battery is inserted charging is in progress SPARE RECHARGEABLE BATTERY ...

Page 17: ...2 32 PREPARING THE PUMP FOR USE 2 1 Preparing the docking station for use 2 2 Rechargeable battery and basic settings ...

Page 18: ...r The input connector will snap into place with an audible click Connecting the docking station to a socket Connect the docking station to a socket The signal light directly next to the connection will light up green 2 1 PREPARING THE DOCKING STATION FOR USE Use only the docking station supplied with the device to charge the pump and the rechargeable batteries ...

Page 19: ... docking station The rechargeable battery will snap into place with an audible click Inserting the rechargeable battery into the pump Remove the pump and the second rechargeable battery from the packaging Insert the rechargeable battery into the pump The rechargeable battery will snap into place with an audible click The pump will emit a short acoustic signal Greeting Confirm the greeting with The...

Page 20: ...desired sound volume of the audible alerts with the and buttons Press to save the setting This setting only affects audible alerts This does not change the alarms Setting the language Press the and buttons until the desired language has a blue frame around it Then press All texts on the screen of the pump are now displayed in the selected language Start the settings process The pump guides you thr...

Page 21: ...You can select between min 0 0 mg h and max 15 0 mg h Please refer to the package insert and observe the maximum drug dose allowed per hour Setting the number of boluses Set the number of boluses permitted using the and buttons then press It is possible to adjust the bolus delivery amount to between 0 0 mg to max 10 0 mg 0 to max 20 boluses possible Timespan of 6 h to 24 h possible Lockout time of...

Page 22: ...ry settings displayed and in particular the daily dose are correct If this is the case press If the settings displayed are not correct press and return to page 38 Confirming the settings Confirm completion of the settings with For the instructions for applying and starting the pump see Section 3 1 You have now set the same basal rate for 24 hours In the menu you can also set different basal rates ...

Page 23: ... whether the vial is new Only use completely filled apomorphine vials in accordance with your prescription The use of expired incompletely filled or damaged vials can impair the efficacy of the therapy and endanger your health Never use a reservoir if its packaging is damaged If the packaging is damaged the reservoir is no longer sterile and could be contaminated Never use a reservoir more than on...

Page 24: ...ttons to select New reservoir and confirm with Selecting Same reservoir will return you to the main menu Same reservoir is not displayed when the reservoir is first inserted Confirming the self test The self test is complete Did you hear the two acoustic signals If so confirm the completion of the test with If you did not hear any acoustic signals or only one acoustic signal then proceed to Sectio...

Page 25: ...e providedforthispurposeinthedocking station The seal of the vial is sterilised If contamination is suspected you should disinfect the cap with an alcohol swab Remove protective cap Take a new drug vial and remove the orange cap from the vial Attaching the pump with reservoir and adapter to the vial Attach the pump with reservoir and tightened adapter to the vial vertically from above as depicted ...

Page 26: ...n error message is displayed during filling return to step 3 A small residual amount will always remain in the vial Observing the filling process Air bubbles will form in the liquid during the filling process You can observe how the stopper moves in the reservoir through the viewing window The filling process is complete once the vial is empty and the stopper is all the way at the bottom Filling r...

Page 27: ...h If the infusion set connection is not adequately tightened it could start leaking leading to an incorrect dose or no delivery of the drug Overtightening the threaded connection can damage the connection point If the port on the reservoir is soiled replace the soiled reservoir with a new one Only use infusion sets with the following characteristics Needle diameter between 28 and 31 gauge To proce...

Page 28: ...station Then press Observing and stopping the priming cycle Observe the infusion set during the priming cycle It takes a few seconds until liquid becomes visible in the tube The drug is then slowly pushed in the direction of the needle on the infusion set Pump ready Pump and reservoir are now ready for use If you wish to prime the infusion set then press Yes Press No to skip this step The infusion...

Page 29: ...fusion set is properly connected to the reservoir and that none of the drug solution is leaking at the t hreaded connection BEFORE YOU CAN START DRUG DELIVERY THE RESERVOIR MUST BE FILLED WITH THE DRUG AND THE PUMP MUST BE CONNECTED TO YOUR BODY CHECKING THE READINESS OF THE PUMP Check the following points by referring to the information on the main screen The time that has been set is correct The...

Page 30: ...usion set change the rechargeable battery change the time change delivery settings take off the device Starting drug delivery Press and hold Start and do and do not release the button until you hear an acoustic signal approx 3 seconds Check the viewing window from time to time to verify whether the filling level of the reservoir is decreasing In this way you can tell whether the delivery function ...

Page 31: ...the main screen 2 Menu navigation The pump displays the main menu The selected function is always highlighted in blue Use the button to select the desired function then press Press to return to the main screen 4 1 MENU CONTROL In the case of an alarm drug delivery is not possible In this case all disabled functions are displayed in grey in the menu and cannot be selected ...

Page 32: ...uire a bolus The bolus function is disabled when The lockout time set by your physician has not yet elapsed The limited number of boluses defined by your physician has already been exceeded In these cases your pump will display the symbol next to the bolus dose Pressing the bolus button Press and hold the bolus button Once you press the bolus button the screen shown above will appear Press and hol...

Page 33: ... 3 CHANGING THE INFUSION SET You must discontinue delivery before you disconnect the infusion set from your body Section 3 4 Disablethebuttonlockandpress Stop Then press Select Change infusion set in the menu Then proceed as described in section 3 4 Here you can skip the placement of the pump in the docking station Disconnect the infusion set from your body first and then from the pump Dispose of ...

Page 34: ... the priming cycle It takes a few seconds until liquid becomes visible in the tube The drug solution is then slowly pushed in the direction of the tip of the needle Pump ready Pump and reservoir are now ready for use If you wish to prime the infusion set then press Yes Press No to skip this step The infusion set will not be primed Proceed with Step 6 Put on infusion set If the infusion set connect...

Page 35: ...the infusion set is properly connected to the reservoir and that none of the drug solution is leaking at the threaded connection 4 4 CHANGING THE RESERVOIR To change the reservoir you need a new vial with apomorphine from EVER Pharma a new reservoir a new infusion set a docking station to maintain the pump upright Check whether you have received the correct drug and whether the vial is new Wash yo...

Page 36: ... pump and remove the reservoir from the device Dispose of it with the household waste Proceed with Section 3 1 Inserting the reservoir Stopping drug delivery Press and hold Stop until you hear an acoustic signal You can then release the button If Start instead of Stop is displayed then delivery has already stopped Selecting delivery settings Select Delivery settings in the menu and press Bolus set...

Page 37: ...the precise values for each time period Selecting the basal profile time period You can see the settings for the first time period of your basal profile Press to view all time periods consecutively Press to return to the delivery settings Basal rate Details Select Basal rate Details and press Selecting the delivery settings Select Delivery settings in the menu and press 4 5 3 BASAL RATE DETAILS 24...

Page 38: ...HISTORY 1 Stopping drug delivery Stop drug delivery before changing the rechargeable battery unless delivery has already stopped automatically e g due to an alarm Section 3 4 Inserting a charged battery Remove the charged spare battery from the docking station and insert it into the pump The pump will switch on Insert the empty rechargeable battery in the docking station to recharge it in order to...

Page 39: ...ction 3 4 2 Remove the infusion set Remove the infusion set from your body and from the reservoir and dispose of it in accordance with the instructions for use of the infusion set Check whether the pump is contaminated If so follow the cleaning instructions in Section 9 3 3 Removing the reservoir Remove the reservoir from your pump and dispose of it with the household waste in accordance with Sect...

Page 40: ...78 79 5 5 1 Adjusting the sound volume 5 2 Viewing or changing the device settings 5 3 Resetting the settings DEVICE SETTINGS ...

Page 41: ...s Select Device settings in the main menu and press Select sound volume function Select Sound volume in the Device settings menu and press Adjust sound volume You can set the desired sound volume of notice signals with the and function buttons Press to save the value that has been set 5 1 ADJUSTING THE SOUND VOLUME ...

Page 42: ...ings menu and press Select language Select the desired language using the button and confirm by pressing All text on the screen of your pump is now displayed in the selected language Press to return to Device settings Confirm language setting Confirm with Yes to execute the desired change Press No to return to the Device settings menu ...

Page 43: ...TIME Set hour Set the current hour using the and buttons and confirm by pressing Set minutes Repeat the process for the minute value of the current time and confirm by pressing Restart drug delivery Press to return to the main screen Restart drug delivery here Section 3 4 Changing the time impacts drug delivery volumes for the current day Depending on the change some of the daily dose might be rep...

Page 44: ...ct reservoir warning time Select the Reservoir warning time function in the Device settings menu and press You can select between 1 h and max 8 h Set advance warning time Use the and buttons to set the desired advance warning time and finalise by pressing 5 2 3 SETTING THE ADVANCE WARNING TIME FOR THE RESERVOIR Select identification function Use the button in the Device settings menu to scroll to ...

Page 45: ...the release code Page 161 Set the release code for changing delivery settings using buttons 1 and 2 Press to return to the delivery settings screen Confirm reset Press Yes if you wish to permanently delete the delivery settings and the entire history Press No to return to the Device settings menu The basic settings should be adjustedbymedicalprofessionals When the settings are reset all delivery s...

Page 46: ...90 91 6 6 1 Programming the basal rate 6 2 Setting the bolus 6 3 Entering the name of the drug DELIVERY SETTINGS ...

Page 47: ...tings should be adjustedbymedicalprofessionals Use the delivery settings to control the amount of the drug that is delivered at the basal rate or with a bolus Improper changes may have serious consequences for your health ...

Page 48: ...Any previous values will be overwritten Sections 6 1 1 to 6 1 4 guide you step by step through the programming process The basal rate can only be set if delivery has been stopped 6 1 PROGRAMMING THE BASAL RATE 6 1 1 PREPARING FOR PROGRAMMING Gather the necessary information before you start programming a basal rate profile The information presented in this table has been randomly selected and is i...

Page 49: ...of basal period 1 for example 6 00 AM and confirm with For security reasons the device will lock automatically after 3 minutes of inactivity Any previous entries will be deleted Repeat programming starting with Step 1 in this section Set end Use and to set the end of basal period 1 for example 7 00 AM and confirm with If basal period 1 is also the last of the day then the end time should be set to...

Page 50: ... of basal period 2 The same applies for all subsequent basal periods You therefore only need to enter the end time and relevant basal rate for all subsequent basal periods Confirm profile The pump will display an overview of all basal periods with your basal rates the total of all drug deliveries and the delivery time periods Check all settings against your table If everything is correct then pres...

Page 51: ... hours The minimum lockout time after delivery of a bolus The Change button is only enabled when drug delivery has been stopped Navigating to the bolus settings display Navigate to the Delivery settings in the menu and select Bolus Press Change and enter the release code Page 161 Define the bolus settings Define the bolus settings in the same way as when preparing the device for first time Section...

Page 52: ...e code Page 161 Select the name of the physician prescribed drug using the and buttons then press The selected name is always displayed on the main screen Dacepton Dopaceptin and Dopaton are regional brand names for apomorphine by EVER Pharma 7 7 1 Overview 7 2 Alarms 7 3 Warnings 7 4 Notices 7 5 Error messages on the docking station 7 6 Troubleshooting ERROR MESSAGES AND NOTICES ...

Page 53: ...sages can be triggered differing in terms of urgency 1 Alarm with error message Signal sequence two consecutive equally short acoustic signals that repeat every 16 seconds 2 Device error Signal sequence same as the sequence for ERRORS at slightly higher pitch 3 Warning Signal sequence four short acoustic signals two each in alternation 4 Notice No acoustic signal 7 1 OVERVIEW 7 ...

Page 54: ...a known error message with a text message The screen will provide the reason for the interruption and corresponding instructions to resolve the issue The alarm will remain displayed on the screen until you acknowledge the message with Alarm Reason for alarm What should I do Reservoir empty The amount of drug remaining in the reservoir is less than the set basal rate or bolus dose Press to acknowle...

Page 55: ...ibed in Section 9 5 and start filling a new reservoir Proceed here in accordance with the instructions in Section 4 4 Alarm Reason for alarm What should I do Device error The red signal light to the right above the screen will flash The internal pump monitoring system has detected a technical error e g sensor failure etc Drug delivery has stopped 1 Replace the rechargeable battery An empty or defe...

Page 56: ...es on the pages below descri be the various notices and trouble shooting measures Notices appear only once If you do not acknowledge a notice the notice is only displayed until the screen is switched off Warning Reason for alarm What should I do Battery low The Battery low warning will appear when the remaining battery capacity falls below 20 Press to acknowledge the warning and replace the rechar...

Page 57: ... performed by medical professionals only Section 6 provides corresponding instructions Notice Why did it occur What should I do i Pump not ready You have attempted to start the pump before executing the Prepare the infusion set function Press to acknowledge the notice and prepare the infusion set in accordance with the instructions in Section 4 3 i Battery too low for filling The Battery too low f...

Page 58: ...the set value falls below the original value by at least 50 Press to acknowledge the notice and check to ensure that you have entered the correct value Notice Why did it occur What should I do i Vial incorrect The Vial incorrect notice will appear when an invalid or previously used vial is detected by the pump Press to acknowledge the notice dispose of the vial with the household waste and fill th...

Page 59: ...e notice and follow the instructions for stopping the pump in Section 3 4 i Filling aborted The Filling aborted notice will appear when you remove the reservoir during the filling process Press to acknowledge the notice reinsert the reservoir and continue the filling process in accordance with the instructions in Section 3 1 i Error while filling The Error while filling notice will appear when an ...

Page 60: ...n the pump as quickly as possible Spare rechargeable battery flashes yellow Rechargeable battery defective Replace the rechargeable battery in the pump as quickly as possible and replace the defective rechargeable battery with a new one Contact Customer Service If one of the signal lights on the docking station is flashing one of the following errors has occurred This section gives some common exa...

Page 61: ... still don t hear an acoustic signal or only one acoustic signal during the self test then the pump is defective Contact Customer Service Description What should I do The reservoir compartment or other parts of the pump are contaminated or contain water Stop drug delivery and disconnect the infusion set from body Remove the rechargeable battery from the device Remove any contaminants grains of san...

Page 62: ...ime has elapsed The bolus dose exceeds the amount of drug remaining in the reservoir Description What should I do The rechargeable battery is empty or not fully charged If the rechargeable battery is empty or not fully charged this may be due to the following The rechargeable battery was removed prematurely from the docking station Make sure not to remove the rechargeable battery from the docking ...

Page 63: ...y displayed on the screen If there is no visible damage on the pump and rechargeable battery then you can continue treatment with a new reservoir Change the reservoir and infusion set in accordance with the instructions in Section 3 1 If the pump is defective contact Customer Service Incorrect screen display If the buttons cannot be unlocked then briefly remove the rechargeable battery from the pu...

Page 64: ...the required storage conditions especially for the reservoir and vial Be sure to make enquiries as to the availability of your usual medical team at home or an appropriate medical team at your destination Take the entire system including pump and accessories with you Never forget the docking station with the second rechargeable battery Make sure that you can recharge the batteries at your destinat...

Page 65: ... DUST HEAT HUMIDITY The EVER Pharma D mine Pump is maintenance free and requires no annual safety inspection The EVER Pharma D mine Pump must be inspected regularly to ensure that it is clean complete and undamaged The pump performs a self test prior to each filling of a new reservoir Section 3 1 8 4 REGULAR TESTING Never take your EVER Pharma D mine Pump near a magnetic resonance tomography MRT s...

Page 66: ...130 131 9 9 1 Disposable accessories 9 2 Accessories Replacement parts 9 3 Cleaning 9 4 Storage 9 5 Warranty 9 6 Disposal USEFUL INFORMATION ON THE USE AND MAINTENANCE OF YOUR PUMP ...

Page 67: ...our EVER Pharma D mine Pump by prescription from a medical professional Only use infusion sets with a needle diameter between 28 and 31 gauge You can obtain the accessories for your EVER Pharma D mine Pump directly from the Ever Pharma subsidiary in your country Carrying bag Rechargeable battery Docking station 9 ...

Page 68: ...enables you to carry the pump across your upper body CARRIER OPTION A Pull both ends of the strap through the hook with each loop side facing outward Secure the strap by pressing the hook side of the strap to the loop side of the strap You can adjust each side to the carrying length that is optimal for you Ensure hook and loop fastening is fully pressed together so none on strap sticks out ...

Page 69: ...letely close the carrying bag Check to ensure that the opening for pressing the bolus button is completely accessible Slide the hooks all the way back to prepare the carrier Protruding hooks could impair carrying comfort Carrier option B enables you to carry the pump secured to your belt CARRIER OPTION B ...

Page 70: ...ly charge the EVER Pharma D mine Pump rechargeable battery with a docking station designed specifically for this purpose 9 2 2 RECHARGEABLE BATTERY The opening on the carrying bag should never point down ward because the pump could fall out and become damaged Never damage or take apart a rechargeable battery Leaking rechargeable battery contents can result in chemical burns on the skin Do not heat...

Page 71: ... Section 4 8 and remove the rechargeable battery from the pump You can safely store all pump components in the packaging until you restart the pump 9 5 WARRANTY EVER Pharma GmbH grants notwithstanding any statutory or contractual warranty you may have under any agreement with your authorized dealer a limited guarantee on materi als and or workmanship for two years from date of delivery to the firs...

Page 72: ... reservoirs vials and adapters with the household waste Defective rechargeable batteries must never be discarded with the household waste Always take defective batteries to the local collection point provided for this purpose 9 6 DISPOSAL 10 10 1 Symbols 10 2 Technical data 10 3 Electromagnetic radiation and interference immunity 10 4 Drug delivery 10 5 Settings 10 6 Abbreviations and glossary 10 ...

Page 73: ... Rechargeable battery almost empty Alarm Rechargeable battery empty Alarm Reservoir empty No reservoir or reservoir is filling Filling level 0 Alarm Notice Warning message Unlock buttons Reservoir Filling level 75 Reservoir Filling level 50 Reservoir is filling Filling level 25 Reservoir not during filling Filling level 25 10 1 SYMBOLS ON THE SCREEN ...

Page 74: ...nada Conformity marking in accordance with the European Medical Device Directive and number of the notified body Do not discard with household waste Batch number Protect from moisture Protect from heat and sunlight Temperature limit For single use only Do not use if packaging is damaged Sterilisation by irradiation Use by Pyrogen free Item number Serial number Manufacturer Date of manufacture Equi...

Page 75: ...ic shock Class II ME Equipment Operating mode Suitable for continuous operation and internally supplied with power Protection class IP 42 Sterilisation method for reservoir Gamma Use in oxygen rich environment No Maximum infusion pressure 4 bar Occlusion alarm threshold 4 bar Maximum time period to occlusion alarm 10 min Applied part Infusion set Type BF Unintended bolus Basal rate 4 8 mg h 70 µL ...

Page 76: ...the vicinity of or in connection with other devices should be avoided because this can lead to malfunctions The use of accessories converters or cables that are not intended for or supplied with the EVER Pharma D mine Pump can result in increased electromagnetic emissions reduced electromagnetic immunity and malfunctioning of the pump ELECTROMAGNETIC EMISSIONS Portable RF communications equipment ...

Page 77: ...PM 217 Hz 780 MHz PM 217 Hz 9 V m 710 MHz PM 217 Hz 745 MHz PM 217 Hz 780 MHz PM 217 Hz 28 V m 810 MHz PM 18 Hz 870 MHz PM 18 Hz 930 MHz PM 18 Hz 28 V m 810 MHz PM 18 Hz 870 MHz PM 18 Hz 930 MHz PM 18 Hz 28 V m 1720 MHz PM 217 Hz 1845 MHz PM 217 Hz 1970 MHz PM 217 Hz 28 V m 1720 MHz PM 217 Hz 1845 MHz PM 217 Hz 1970 MHz PM 217 Hz IEC 60601 test level Compliance level Recommended separa tion distan...

Page 78: ...45 90 135 180 225 270 and 315 0 UT 1 cycle at 0 and 70 UT 25 cycles 50 Hz 30 cycles 60Hz at 0 Power failure 0 UT 250 cycles 50Hz 300 cycles 60Hz Power frequency magnetic fields 50 60 Hz IEC 61000 4 8 30 A m 30 A m Recommended separation distance between portable and mobile RF communications equipment and the Ever Pharma D mine Pump Separation distance according to frequency of transmitter m Rated ...

Page 79: ...o 20 per time period 6h to 24h Lockout time 15 min to 90 min 10 4 DRUG DELIVERY 10 5 SETTINGS TRUMPET CURVE Equipment and conditions Delivery rate 4 8 mg h Orbit administration set Ambient conditions 22 C unregulated relative humidity 3 2 8 2 6 2 4 2 2 2 1 8 1 6 1 4 1 2 1 0 8 0 6 0 4 0 2 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 prozentualer Flussfehle...

Page 80: ...ol max tol min 0 00 1 00 2 00 3 00 4 00 5 00 6 00 0 00 2 00 4 00 6 00 8 00 10 00 flow mg h Zeit h Anlaufdiagramm flow is mg h set flow mg h tol min tol max tol max Apomorphine Name of the active pharmaceutical ingredient used for treatment of Parkinson s disease The brand name of your drug may differ from this name If you are not sure you are using the correct drug discontinue the treatment and co...

Page 81: ...Font Software may be modified altered or added to and in particular the designs of glyphs or characters in the Fonts may be modified and additional glyphs or characters may be added to the Fonts only if the fonts are renamed to names not containing either the words Bitstream or the word Vera This License becomes null and void to the extent applicable to Fonts or Font Software that has been modifie...

Page 82: ...162 REMOVABLE PATIENT FORM FOR PHYSICIANS BOLUS SETTINGS Bolus dose mg Number of boluses Time period h Lockout time min ...

Page 83: ...nstructions for use D mine_IFUPump_64210_UK_V02 Revision 01 2019 Phone 43 7665 20555 0 Fax 43 7665 20555 910 Email office everpharma com www everpharma com www d minecare com EVER Neuro Pharma GmbH Oberburgau 3 A 4866 Unterach Austria Distributor EVER Pharma UK Ltd Suite 2 38 South Bar Banbury Oxon OX16 9AE United Kingdom Phone 0800 254 01 74 E Mail info uk everpharma com ...

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