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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

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Summary of Contents for Ever Pharma D-mine Pump

  • Page 1 EVER  Pharma D‑ mine Pump ® Instructions for use...
  • Page 2 WELCOME...
  • Page 3 You have decided in consultation with your physician to ad‑ names for apomorphine by EVER Pharma. minister your apomorphine therapy using an EVER  Pharma D‑mine Pump. In order to ensure that you can safely hand‑ Before starting drug administration, you fill the drug from the ®...
  • Page 4 ® infusion of 5 mg/mL apomorphine, which is available as a health risk to the patient. medicinal product in a 20‑mL vial from EVER Neuro Pharma Please read these instructions for use carefully and com‑ GmbH. •...

  • Page 5: Table Of Contents

    Checking the readiness of the pump Your EVER  Pharma D‑mine Pump box ® 3.4. Starting and stopping drug delivery Disposable accessories Notes for use of your EVER  Pharma D‑mine ® Pump and for your safety Daily routine 4.1. Menu control General information on operating the system 4.2.
  • Page 6 7.5.1. The mains connection signal light on the docking station is not lit 5.3. Resetting the settings 7.5.2. Signal light on the docking station is flashing 7.6. Troubleshooting Delivery settings Your EVER  Pharma D‑mine ® Pump in everyday life 6.1. Programming the basal rate 6.1.1. Preparing for programming 8.1.
  • Page 7 INTRODUCTION Useful information on the use and maintenance of your pump The following symbols will help you to quickly find the information you need in these instructions for use: 9.1. Disposable accessories 9.2. Accessories/Replacement parts 9.2.1. Carrying bag This symbol indicates general notices and tips. 9.2.2.

  • Page 8: Pump

    PUMP YOUR EVER  PHARMA D‑ mine Pump BOX CONTAINS: ® The pump controls administration of the drug. It functions only in conjunction with a reservoir and a rechargeable battery. RECHARGEABLE BATTERIES EVER  Pharma D‑mine ® Pump The rechargeable batteries supply the necessary power to the Two rechargeable pump.

  • Page 9: Disposable Accessories

    D‑mine ® Pump RESERVOIR DISPOSABLE ACCESSORIES The reservoir serves as a receptacle for the drug. It must only be used once and is replaced each time a new vial is used. Adapter ADAPTER Reservoir The adapter connects the reservoir to the vial during the filling Infusion set process.

  • Page 10: Notes For Use Of Your Ever  Pharma D-Mine Pump And For Your Safety

    D‑mine Pump AND FOR YOUR SAFETY ® To avoid health risks, observe the following warnings and safety notes when using the EVER Pharma D‑mine Pump. ® Please read these warnings and safety notes carefully before using the pump for the first time.
  • Page 11 THE EVER  PHARMA D‑ ® Pump Reservoir Data interface compartment Device error indicator Bolus button Heading Reservoir release button Viewing window Text sections Rechargeable Screen battery release button Charging Button labelling Function buttons contacts Rechargeable battery...
  • Page 12 BOLUS BUTTON SCREEN FUNCTION BUTTONS BUTTON LOCK The bolus button enables fast delivery of a bolus. The pump is equipped with an illuminated colour screen Three function buttons are provided for operating the pump. When the screen is switched off, the function buttons are Section which provides you with important information concerning These are located below the screen.
  • Page 13 THE MAIN SCREEN OF THE PUMP ACOUSTIC SIGNALS Your pump brings important events during operation to your attention with the aid of acoustic signals. Current time You can adjust the volume of these signals. State of charge of the rechargeable battery Drug name Time left until the reservoir will be empty Alarm signals...

  • Page 14: Operating The Docking Station

    OPERATING THE SIGNAL LIGHTS MAINS DOCKING STATION CONNECTION The docking station has three functions: • Charging the two rechargeable batteries • Holder for the vial • Holder for the pump during preparation Signal light for spare • If the docking station fails, the rechargeable batteries cannot rechargeable battery be charged.
  • Page 15 RECHARGEABLE BATTERY FOR PUMP YELLOW YELLOW, FLASHING GREEN pump rechargeable No device in the docking station Rechargeable battery for pump Error during charging of rechargeable Rechargeable battery in the pump battery can be removed from 7.5.2 or rechargeable battery for pump not connected to docking station, char‑...
  • Page 16 SPARE RECHARGEABLE BATTERY YELLOW YELLOW, FLASHING GREEN The spare rechargeable battery is not The spare rechargeable battery is Error while charging, Spare rechargeable battery fully 7.5.2 inserted. inserted, charging is in progress Section charged...

  • Page 17: Preparing The Pump For Use

    PREPARING THE PUMP FOR USE 2.1 Preparing the docking station for use 2.2 Rechargeable battery and basic settings...

  • Page 18: Preparing The Docking Station For Use

    PREPARING THE DOCKING STATION FOR USE Attaching the input connector to the Connecting the docking station to a Use only the docking station mains adapter socket supplied with the device to charge Remove the docking station from the Connect the docking station to a the pump and the rechargeable batteries.

  • Page 19: Rechargeable Battery And Basic Settings

    2.2  RECHARGEABLE BATTERY AND BASIC SETTINGS The basic settings of the device can only be adjusted by medical professionals. Insert the spare rechargeable battery signal light spare As soon as the spare rechargeable Inserting the rechargeable battery Greeting If the pump has been stored for a into the docking station rechargeable battery will light up...
  • Page 20 Setting the language Start the settings process Setting the drug Setting the hour Setting the minutes Adjust sound volume Press the buttons until The pump guides you through the Select name drug Press until the current Repeat the process above until the You can set the desired sound volume the desired language has a blue frame settings step by step.
  • Page 21 Set basal rate Confirm basal rate Setting the bolus dose Setting the number of boluses Setting the time period Setting the lockout time You can alter the value in increments Check the daily dose. Press if the You can alter the bolus dose in Set the number of boluses permitted Set the desired period of time using Set the desired lockout time using...

  • Page 22: Reservoir And Infusion Set

    RESERVOIR AND INFUSION SET Confirming the bolus settings Confirming the settings 3.1 Inserting the reservoir Check to ensure that the delivery Confirm completion of the settings settings displayed, and in particular with 3.2 Connecting the infusion set the daily dose, are correct. If this is the 3.3 Checking the readiness of the pump case, press For the instructions for applying and...

  • Page 23: Inserting The Reservoir

    Check whether you have received the correct drug, a new reservoir and infusion set, and whether the vial is new. • a new vial with apomorphine from EVER Pharma Only use completely filled apomorphine vials in accordance with your prescription. The use of expired, incompletely •...
  • Page 24 Preparing a new reservoir Attach the reservoir to the pump Selecting the reservoir Self‑test of the pump Confirming the self‑test Prepare vial Wash your hands thoroughly Insert the reservoir into the opening The pump detects that a reservoir has The pump performs a self‑test. Here, The self‑test is complete.
  • Page 25 Remove protective cap Insert vial Confirm with Attaching the pump with reservoir The vial must always be held Take a new drug vial and remove the Place vial space and adapter to the vial Confirm with upright when attaching the pump. orange cap from the vial.
  • Page 26 The pump must remain upright during the entire filling process. If Turning the pump Starting the filling process Filling reservoir Observing the filling process Confirming the completion of filling not, air could get into the reservoir. Turn your pump with the vial attached Press to start filling the reservoir.

  • Page 27: Connecting The Infusion Set

    CONNECTING THE INFUSION CONNECTING, PREPARING, AND PRIMING THE INFUSION SET To proceed immediately with the Immediately after attaching the Connect infusion set After removing the vial, the port for the infusion set is readily connection of an infusion set, remove infusion set: Remove and dispose Check to ensure that the threaded Confirm the procedure with...
  • Page 28 Stand pump with the infusion set in Pump is being prepared Pump ready Observing and stopping the priming It may be necessary to perform docking station The pump will switch on for a few Pump and reservoir are now ready for cycle multiple priming cycles until the liquid is visible in the tube.

  • Page 29: Checking The Readiness Of The Pump

    CHECKING THE READINESS OF THE PUMP 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: Continuing the priming cycle Put on infusion set...

  • Page 30: Daily Routine

    STARTING AND STOPPING DRUG DELIVERY You can start and stop delivery of the drug using the function buttons. An interruption is only necessary if you DAILY ROUTINE wish to • change the reservoir 4.1 Menu control • change the infusion set 4.2 Delivering a bolus Starting drug delivery Stopping drug delivery...

  • Page 31: Menu Control

    MENU CONTROL From the main screen, you can access 2 Menu navigation the function selection by unlocking The pump displays the main menu. the function buttons and opening the The selected function is always menu: highlighted in blue. Use the button to select the In the case of an alarm, drug 1 Disabling the button lock...

  • Page 32: Delivering A Bolus

    DELIVERING A BOLUS A separate button above the screen is provided for The bolus function is disabled when: delivering a bolus. • The lockout time set by your physician has not yet elapsed. You can deliver the quantity of the drug that has been set •...

  • Page 33: Changing The Infusion Set

    CHANGING THE INFUSION SET Safely dispose of the infusion set. To do so, refer to the instructions for use of the infusion set. Bolus is delivered The pump will indicate completion Following completion of the bolus de‑ The pump will emit the "Ready"...
  • Page 34 CONNECTING, PREPARING, AND PRIMING THE INFUSION SET Connect infusion set Pump ready Observing and stopping the priming Check to ensure that the threaded Confirm the procedure with Pump and reservoir are now ready for cycle connection on the reservoir is clean. use.

  • Page 35: Changing The Reservoir

    To change the reservoir, you need: Check whether you have received the correct drug and whether the vial is new. • a new vial with apomorphine from EVER Pharma Wash your hands thoroughly before working with sterile • a new reservoir parts.

  • Page 36: Viewing The Delivery Settings

    VIEWING THE DELIVERY SETTINGS 4.5.1 VIEWING THE BOLUS SETTINGS Stopping drug delivery Removing used infusion sets Removing used reservoirs Press and hold Stop   until you Remove the infusion set in use from Press the release button on the pump hear an acoustic signal.

  • Page 37: Basal Rate: Graph

    4.5.3 BASAL RATE: DETAILS There are two ways of viewing your basal profile: • as an overview in a 24h graph • with the precise values for each time period 4.5.2 BASAL RATE: GRAPH Selecting the delivery settings Basal rate: Details Selecting the basal profile time Select Delivery settings...

  • Page 38: Viewing The History

    VIEWING THE CHANGING HISTORY THE RECHAR‑ GE ABLE BATTERY The pump's History function allows you to review all the important events of the last three days. The following information is saved: • Filling of the reservoir and the infusion set •...

  • Page 39: Removing And Recharging The Pump

    REMOVING AND RECHARGING THE PUMP Stopping drug delivery Placing the pump in the docking station Stop drug delivery. Place your pump in the docking station. The device will Section switch on the screen and emit a confirmation signal that the rechargeable battery is being recharged in the pump.

  • Page 40: Device Settings

    DEVICE SETTINGS 5.1 Adjusting the sound volume 5.2 Viewing or changing the device settings 5.3 Resetting the settings...

  • Page 41: Adjusting The Sound Volume

    ADJUSTING THE SOUND VOLUME The sound volume for notice signals Select sound volume function Adjust sound volume can be adjusted with choice of three Select Sound volume in the Device You can set the desired sound levels. settings menu and press volume of notice signals with the function buttons.

  • Page 42: Viewing Or Changing The Device Settings

    VIEWING OR CHANGING THE DEVICE SETTINGS 5.2.1 SETTING THE LANGUAGE Set language Select language Confirm language setting Select Language in the Device Select the desired language using Confirm with to execute the settings menu and press button and confirm by desired change.

  • Page 43: Setting The Time

    5.2.2 SETTING THE TIME Stop drug delivery Select time function Set hour Set minutes Restart drug delivery Changing the time impacts drug Change the time setting during breaks Select Time in the Device settings Set the current hour using the Repeat the process for the minute Press to return to the main...

  • Page 44: Setting The Advance Warning Time For The Reservoir

    5.2.3 SETTING THE ADVANCE WARNING TIME FOR THE RESERVOIR 5.2.4 DISPLAYING THE DEVICE IDENTIFICATION Reservoir warning time function Select reservoir warning time Set advance warning time Select identification function Display identification function allows you to set the time when your Select the Reservoir warning time Use the...

  • Page 45: Resetting The Settings

    RESETTING THE SETTINGS The basic settings should be adjusted by medical professionals. When the settings are reset, all delivery settings and the entire history are permanently deleted. The settings cannot be restored. Reset function Enter code Confirm reset Select the Reset function in the Enter the release code.

  • Page 46: Delivery Settings

    DELIVERY SETTINGS 6.1 Programming the basal rate 6.2 Setting the bolus 6.3 Entering the name of the drug...
  • Page 47 The basic settings should be adjusted by medical professionals. delivery settings 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: Preparing For Programming

    PROGRAMMING THE BASAL RATE You can program the daily course of drug delivery (basal rate) in up to five freely selectable time periods (basal periods). The following is applicable here: 6.1.1 PREPARING FOR • The last defined time period lasts to the start PROGRAMMING •...

  • Page 49: Setting Basal Period 1

    6.1.2 SETTING BASAL PERIOD 1 Select Basal rate: Details Select change Enter code Set start Set end Set basal rate Select the Basal rate: Details item in Basal period 1 is already automatically Enter the release code. – to set the start of –...

  • Page 50: Finalising The Programming

    6.1.3 SETTING THE REMAINING BASAL PERIODS 6.1.4 FINALISING THE PROGRAMMING The end of basal period 1 is Set end Set basal rate Once you have covered the whole Confirm profile automatically the start of basal – to set the end of the –...
  • Page 51 SETTING THE BOLUS The bolus comprises of three settings: • bolus dose, i.e. the amount of apomorphine delivered as an additional dose each time you Start drug delivery on the main screen to continue the therapy. press the bolus button. •...

  • Page 52: Entering The Name Of The Drug

    7.4 Notices buttons, then press . The selected name is always displayed on the main 7.5 Error messages on the docking station screen. Dacepton , Dopaceptin ® ® 7.6 Troubleshooting Dopaton are regional brand names for ® apomorphine by EVER Pharma.

  • Page 53: Overview

    OVERVIEW Your pump continuously monitors the system operation automatically informs you of important changes in the operating state. One of the following four types of messages can be triggered, differing in terms of urgency: Alarm with error message Signal sequence: two consecutive, equally short acoustic signals that repeat every 16 seconds Device error...

  • Page 54: Alarms

    Alarm Reason for alarm What should I do? ALARMS The amount of drug remaining in the Press to acknowledge the alarm and The pump will trigger an alarm if a reservoir is less than the set basal rate or change the infusion set and reservoir Reservoir empty user response is required in order to bolus dose.
  • Page 55 Alarm Reason for alarm What should I do? Alarm Reason for alarm What should I do? The infusion route (reservoir, Press to acknowledge the alarm and The internal pump monitoring system has 1. Replace the rechargeable battery infusion set, cannula) is blocked. remove the infusion set from body.

  • Page 56: Warnings

    7.4  WARNINGS NOTICES Warnings on the pump require the user to respond within a defined time period. In the event of a warning, drug delivery continues unchanged. The pump will emit Notices are messages concerning an acoustic signal to notify the user of the message. The warning will remain the condition of the pump.
  • Page 57 Notice Why did it occur? What should I do? Notice Why did it occur? What should I do? The "USB connection" notice will appear when Wait until the data are ready to be exported. You have attempted to start the pump before Press to acknowledge the notice and prepare the pump is connected to a PC and the data are...
  • Page 58 Notice Why did it occur? What should I do? Notice Why did it occur? What should I do? Press to acknowledge the notice and wait The "Bolus maximum reached" notice will appear The "Vial incorrect" notice will appear when an Press to acknowledge the notice, dispose until the lockout time has elapsed.

  • Page 59: Error Messages On The Docking Station

    ERROR MESSAGES ON Notice Why did it occur? What should I do? THE DOCKING STATION Press to acknowledge the notice and follow The "Stop button pressed too long" notice will the instructions for stopping the pump in Section appear when the stop button has been pressed and held for longer than 30 seconds.

  • Page 60: Signal Light On The Docking Station Is Flashing

    7.6  7.5.2 SIGNAL LIGHT ON THE DOCKING STATION IS FLASHING TROUBLESHOOTING If one of the signal lights on the docking station is flashing, one of the following errors has occurred: Signal light Colour Meaning What should I do? Rechargeable flashes yellow The pump is not completely Check whether the pump has been battery for...
  • Page 61 Description What should I do? Description What should I do? The pump was Stop drug delivery and disconnect the infusion set from body. Remove the reservoir and the infusion set. The reservoir Stop drug delivery and disconnect the infusion set from body. Remove the rechargeable battery from the Remove the rechargeable battery from the device.
  • Page 62 Description What should I do? Description What should I do? Pump will not If the pump will not stop, this may be due to the following: The rechargeable If the rechargeable battery is empty or not fully charged, this may be due to the following: stop battery is empty The "Stop"...

  • Page 63: Your Ever  Pharma D-Mine ® Pump In Everyday Life

    Change the reservoir and infusion set in accordance with the instructions in "OFF" state If the pump is defective, contact Customer Service. EVER  PHARMA D- mine ® Incorrect screen If the buttons cannot be unlocked, then briefly remove the rechargeable battery from the pump and PUMP IN EVERYDAY LIFE reinsert.
  • Page 64 TRAVELLING It is not a problem to take your pump with you when travelling. But please observe the following aspects when doing so: • When you change the time on the pump to a different station with the second rechargeable battery. time zone, this immediately affects drug delivery.

  • Page 65: Contact With Water, Dust, Heat, Humidity

    ELECTROMAGNETIC DANGER ZONES Never take your EVER  Pharma D‑mine ® Pump near a magnetic Be careful not to expose the EVER Pharma  resonance tomography (MRT) scanner. D‑ mine ® Pump directly to light, radiation, and The EVER  Pharma D‑mine Pump conforms to all ®...

  • Page 66: Useful Information On The Use And Maintenance Of Your Pump

    USEFUL INFORMATION ON THE USE AND MAINTENANCE OF YOUR PUMP 9.1 Disposable accessories 9.2 Accessories/Replacement parts 9.3 Cleaning 9.4 Storage 9.5 Warranty 9.6 Disposal...

  • Page 67: Disposable Accessories

    EVER Pharma D‑mine Pump by EVER  Pharma D‑mine Pump directly from the ® ® prescription from a medical professional. Ever Pharma subsidiary in your country. Only use infusion sets with a needle diameter • Carrying bag between 28 and 31 gauge. • Rechargeable battery •...

  • Page 68: 9.2.1. Carrying Bag

    Carrier option A enables you to carry Pull both ends of the strap through Secure the strap by pressing the hook You can adjust each side to the EVER  Pharma D‑mine Pump carrying the pump across your upper body. the hook with each loop side facing...
  • Page 69 CARRIER OPTION B Place the pump in the carrying bag. Completely close the carrying bag. Carrier option B enables you to carry Slide the hooks all the way back to Make sure that the infusion set is Check to ensure that the opening for the pump secured to your belt.

  • Page 70: Rechargeable Battery

    Follow the instructions below when Defective rechargeable batteries is completely accessible. handling the rechargeable battery: must never be discarded with household waste. Always take Only charge the EVER  Pharma defective batteries to the local D‑mine ® Pump rechargeable collection point provided for this battery with a docking station purpose.

  • Page 71: Cleaning

    (evidenced by invoice). rantee will, at EVER’s sole choice and discretion, either be can also use a washing up liquid or mild cleaning pump. You can safely store all pump components repaired or replaced.

  • Page 72: Disposal

    DISPOSAL The EVER  Pharma  D‑mine Pump and rechargeable batteries ® are accepted by authorised dealers for disposal. The applicable hygiene and disposal regulations must be followed when disposing of disposable articles and drugs. • Dispose of reservoirs, vials, and adapters with the APPENDIX household waste.
  • Page 73 10.1 SYMBOLS ON THE SCREEN Reservoir Rechargeable battery Alarm Filling level 100% Notice Reservoir Rechargeable battery Filling level 75% is being charged Warning message Reservoir Warning Unlock buttons Filling level 50% Rechargeable battery almost empty Reservoir is filling Bolus currently disabled Filling level 25% Alarm Rechargeable battery...

  • Page 74: Technical Data

    10.2 SYMBOLS ON THE PRODUCT TECHNICAL DATA Marking for conformity with Conformity marking in accordance Protect from moisture Length 114.3 Dimensions standards in the USA and Canada with the European Medical Device MEDICAL — (with reservoir, Width 61.4 Directive and number of the CARDIO, VASCULAR AND PULMONARY EQUIPMENT without adapter)
  • Page 75 Typical operating time with one charge days Service life of a rechargeable battery Number of charging cycles cycles Applied part Infusion set Type days View Entries per day History Unintended bolus Basal rate 4.8 mg/h < 70 µL Export up to 12,500 entries Maximum delivery Protection against...

  • Page 76: Sources Of Interference 150

    SOURCES OF INTERFERENCE • 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, ®...
  • Page 77 ELECTROMAGNETIC IMMUNITY Recommended separa‑ IEC 60601 test level Compliance level IEC 60601 test level Compliance level tion distance �� = 1.2 �� 80 MHz - 800 MHz Electrostatic discharge (ESD) RF interference +/‑ 8 kV contact +/‑ 8 kV contact 3 Vrms 3 Vrms +/‑2 kV, +/‑4kV, +/‑8kV +/‑15kV air +/‑2 kV, +/‑4kV, +/‑8kV +/‑15kV air IEC 61000‑4‑2...
  • Page 78 The EVER  Pharma D‑mine Pump is suitable for use in an electromagnetic environment in which radiated RF disturbances ® are controlled. Customers and users of the EVER  Pharma D‑mine Pump can help prevent electromagnetic interference ® by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EVER ...

  • Page 79: Drug Delivery

    10.5 10.4 TRUMPET CURVE SETTINGS DRUG DELIVERY Up to 5 time periods over the 1 to 8 hours Programming of the Reservoir warning time course of 24 hours adjustable in increments of -0.2 -0.2 -0.2 -0.2 basal rate Time periods adjustable in 1 hour -0.4 -0.4 -0.4 -0.4...

  • Page 80: Abbreviations And Glossary

    10.6 START‑UP DIAGRAM ABBREVIATIONS AND GLOSSARY Anlaufdiagramm Anlaufdiagramm Anlaufdiagramm Anlaufdiagramm Anlaufdiagramm Start-up diagram 6.00 Apomorphine Name of the active pharmaceutical ingredient used for treatment of Parkinson's 6.00 6.00 6.00 6.00 disease. The brand name of your drug may differ from this name. If you are not sure 5.00 5.00 5.00...

  • Page 81: Licence Terms - Font "Dejavu

    DECLARATION OF CONFORMITY Basal rate for basal Start Basal rate period 3 EVER Pharma GmbH hereby declares that the device conforms to the pertinent provisions of EU Medical Device Directive mg/h 93/42/EEC Basal rate for basal Start Basal rate (MDD 93/42/EEC) and Directive 2014/53/EU (RED 2014/53/EU) for radio equipment.
  • Page 82 BOLUS SETTINGS REMOVABLE PATIENT FORM FOR PHYSICIANS Bolus dose Number of boluses Time period Lockout time...
  • Page 83 REF 64201 www.d‑minecare.com 0044 EVER  Pharma D‑mine Pump instructions for use ® D‑mine_IFUPump_64210_UK_V02 Revision: 01/2019 EVER Pharma, Dacepton , Dopaceptin and Dopaton are trademarks of EVER Neuro Pharma GmbH. ® ® ® © 2018 EVER Neuro Pharma GmbH. All rights reserved.

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