UCB Medical Devices AVA ava User Manual 15 2AHK9 AVA

UCB Medical Devices S.A. ava 15 2AHK9 AVA

15_2AHK9-AVA_User Manual

UserManualUser Manual Ref: q-011957 v. 4.0, June 2016Ref: q-011957 v. 4.0, June 2016CIMZIA is a registered trademark of the UCB Group of Companies
2 ContentsChapter 1: Important information about ava 5Important information 6ava set up 10Additional important information 10Chapter 2: Getting to know ava 11ava 12CIMZIA medication cassette 14ava’s medication dosing 16Changing your CIMZIA dosing 19ava accessories 20ava operating environment 23Storing ava 23Cleaning ava 24Battery saving mode 25Chapter 3: Learning to use ava 27Training cassette 28Using the training cassette 30Chapter 4: Injecting CIMZIA with ava 43Preparing your CIMZIA medication cassette 44Setting up for your CIMZIA injection 46Selecting and preparing your injection site 48Giving your CIMZIA injection 50Disposal of Used Medication Cassettes 59Optional Actions During an Injection: 62Pausing your injection 62103Immunity test Test level Compliance level / performance criterionElectromagnetic environment - guidanceConducted RF ETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2IEC 61000-4-610Vrms150kHz – 80 MHz(AM, modulation depth 80%, sinusoidal audio signal of 1 kHz)10VrmsCT for transmitters, CR for receiversNoneRadiated RFETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2ISO 11608-1ISO 11608-4IEC 61000-4-310 V/m26 MHz -2700 MHz(1 kHz, modulation depth 80%)10 V/mCT for transmitters, CR for receiversNoneNOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
3CIMZIA Injection speed settings 63Chapter 5: More information about ava 65Viewing the injection log 66Charging the battery 70Chapter 6: Troubleshooting 73Removing a cassette if the needle cap is lost or if needle is severely bent 74What to do if ava has problems identifying a cassette by the Radio Frequency Identification (RFID) 75Warning message priority 76High priority alarms 77Medium priority alarms 79Low priority alarms 80Instructions 86Cassette Warnings 89Other Non-Alarm Screens 91Chapter 7: Technical Information about ava 95Technical data 96Explanation of ava symbols 97Electromagnetic Compatibility Tables 98Guidance and manufacturer’s declaration – electromagnetic emission 99Guidance and manufacturer’s declaration – electromagnetic immunity 101
4 This page is intentionally left blank.
1Chapter 1: Important information about avaThis section contains important information you must be aware of before starting to use ava.1
6 Chapter 1: Important information about avaImportant informationMake sure you read and understand these ava instructions.Read these instructions for use before you start using ava to inject. However, only use ava to inject your medication after you, or someone you know, has received training from your healthcare provider.ava must only be used in the way described in these instructions.Always follow the warnings and cautions in the instructions or on the device itself.ava is an electromechanical device and should be handled with care. WARNING: ava is an injection device for delivering a fi xed dose of CIMZIA. It is for use by one person only. DO NOT share the device or allow anyone else to inject themselves with it, as doing so may result in injury. DO NOT use ava if it does not appear to be working properly and DO NOT attempt to repair a faulty ava.ava must only be used with pre-fi lled cassettes of CIMZIA as prescribed by your healthcare provider.CIMZIA medication cassettes are single-use only and must be discarded in a biohazards (sharps) container immediately after use. DO NOT re-use a cassette.
7Contact your healthcare provider when you need more CIMZIA medication cassettes.Be sure to store the CIMZIA medication cassettes properly: • Store CIMZIA medication cassettes in the refrigerator between 36ºF to 46ºF ( 2ºC to 8ºC). • Keep this medication out of sight and reach of children.• DO NOT freeze CIMZIA.• Protect CIMZIA medication cassettes from light. Store CIMZIA medication cassettes in the carton they came in.• The CIMZIA medication cassette contains a glass syringe. DO NOT drop or crush the cassette.DO NOT use CIMZIA medication cassette if:• Any name other than CIMZIA is on the carton and/or cassette label.• The expiration date on each cassette or its outer carton has passed.• The carton is torn or the tamper evident seal is missing or broken when you receive it.• The cassette has been frozen or if it has been left in direct sunlight.• The CIMZIA solution in the cassette is not clear to colorless to light yellow, if it looks cloudy, or if it has large or colored particles in it.• The red medication level indicator is not right at the top of the cassette.
8 Chapter 1: Important information about avaDO NOT shake the cassette before use.Keep your ava and CIMZIA medication cassettes out of the sight and reach of children. Be sure to store ava properly:• Store ava in its closed storage case to limit exposure to dirt, dust, liquid and other substances.• Keep ava at room temperature between 68ºF to 77ºF (20ºC to 25ºC).• DO NOT freeze ava or place it in the refrigerator.WARNING: Do not operate ava near strong electromagnetic sources like an x-ray machine in a medical facility or a security machine at an airport. However, using your ava near common-household electronic devices should not be a problem. The expected lifetime for ava under normal use is up to 3 years, after which it must be replaced. When it is nearing its end of life, ava will automatically show the message ‘Device is nearing end of life!’. As soon as you see this message, contact your healthcare provider or local helpline for a replacement device.!Device is nearingend of life!
9 After another 10 injections when the message above first appears, ava will stop working and display the warning ‘Device at end of life!’. ava contains no harmful or toxic components. The device does not contain any personal information. However, ava is considered biohazardous waste and must not be disposed of in household waste. Dispose of your used ava according to your community guidelines, observing all Federal, State and local regulations or contact the helpline for information on safe disposal of ava. WARNING: ava should be handled with care. DO NOT drop. If ava is dropped, check that no broken parts are visible. Turn ava on. If you see an ‘Error! Do not use. Helpline code’ warning message - DO NOT use it. Make a note of the four digit Helpline Code number and contact your local helpline for support.CAUTION: Avoid spilling liquid on your ava. Never rinse or put ava under water. If ava has been exposed to liquid, wipe it with a clean, dry cloth, turn it on and check for error messages.!Device atend of life!!Error!Do not use.Helpline codexxxx
10 Chapter 1: Important information about avaava set upYour new ava device needs to be set up by your healthcare provider. Please make sure to schedule an appointment with your healthcare provider to have your medication dose set up in ava. You should also receive training on the correct use at the same time.DO NOT forget to bring ava to your appointment.You can practice using ava even before your healthcare provider has set up ava for you. The training cassette can be used at any time before or after the medication dose has been set up.Additional important informationThe use of ava is not approved or recommended for the following circumstances:• users less than 18 years of age• users who are legally blind• users who are unable to self-inject as determined by a health care providerYour healthcare provider will determine if you are able to use ava. Ask your health care provider if you are not sure.
2Chapter 2: Getting to know avaThis section is a guide to ava and CIMZIA medication cassettes, showing the controls and the names of the main parts. You will also fi nd information on how to take care of your ava and CIMZIA medication cassettes.2
12 Chapter 2: Getting to know avaavaUse this illustration to identify the controls and the names of ava’s parts.Cassette/Injection PortOn/Off (Power) ButtonStart/PauseButtonSkin SensorScroll wheelInformationScreenMicro-USB Port
13Information screenava’s screen will display step-by-step instructions and any advice or warning messages.Scroll wheelThis wheel lets you adjust the speed of your injection.Skin sensorThe skin sensor detects when the injection port is fully in contact with your skin. Micro-USB PortThis is where you connect the battery charger or your computer to view your injection log.On/Off (Power) ButtonUse this button to turn ava on or off.Start/Pause buttonPressing this button will begin administering an injection. It can also be used to pause and re-start the delivery of CIMZIA during an injection.Cassette/Injection portThis is where the CIMZIA, or training cassette, is loaded and where the needle comes out during a CIMZIA injection.
14 Chapter 2: Getting to know avaCIMZIA medication cassetteThis illustration shows a CIMZIA medication cassette for use with ava.Needle capSyringeMedication information chipSide viewTop viewMedication level indicatorEnd capCassette bodyNeedle (inside cap)
15Cassette bodyThis plastic cassette body contains the glass syringe of CIMZIA.Needle (inside cap)The single-use needle is safely covered by the needle cap until you are ready to inject.Medication level indicatorThis red plastic indicator enables you to see the level of CIMZIA in a cassette. When the syringe is full the indicator is at the top of the syringe. When the syringe is empty the indicator is at the bottom of the syringe.Medication information chipThis microchip enables ava to identify the type of cassette and check other information about it. Needle capThis part covers the needle whenever it is not inside ava ready for an injection. Keep the needle cap to remove the cassette after an injection.
16 Chapter 2: Getting to know avaava’s medication dosingava delivers your medication from CIMZIA medication cassettes as shown below. This illustration also shows the labels you will see on your CIMZIA medication cassettes.LOT: EXP:Part# xxxxxxCIA79918Acertolizumab pegolStore at 36° to 46°F (2° to 8°C).Do not freeze. Protect from light. Single use.Mfd. by UCB Inc., Smyrna, GA, USACIA79917ACIA79919ANCD 50474-xxxx-xx Rx Onlyinjection 200mg/mL cassettecertolizumab pegolEach medication cassette contains 1mL of Cimzia. For subcutaneous injection use only. Use only with the Cimzia ava device.
17ava can only be used with CIMZIA medication cassettes. However, before ava accepts CIMZIA medication cassettes it must be set up by your healthcare provider according to your prescribed dose of CIMZIA. This is indicated by the following screen. If you have not done so already, take an appointment with your healthcare provider to have your new ava set up for you. Remember to bring ava to your appointment. In the meantime, you can practice using ava with the training cassette that is provided in your ava storage case. See Chapter 3 for more information.Your healthcare provider will set up ava according to your prescription. If your healthcare provider prescribes the loading doses, ava is programmed to deliver your loading dose injections at weeks 0, 2 and 4 and then automatically switches to the maintenance dosing regimen which has been selected by your healthcare provider for you. The loading dose regimen consists of two injections given every 2 weeks at the start of your CIMZIA treatment (week 0) and then at week 2 and the final loading dose injections are given at week 4. !Consult yourphysician toset devicedosage!
18 Chapter 2: Getting to know avaOnce the last injection of your loading dose has been delivered at week 4, ava indicates this by displaying the message ‘Loading dose complete.’.This message will be followed by either ‘You are on maintenance dose 1 inj. every 2 weeks.’ or ‘You are on maintenance dose 2 inj. every 4 weeks.’ depending on which maintenance dose has been selected for you. Loading dosecomplete.You are on maintenancedose 2 inj. every 4 weeks.You are on maintenancedose 1 inj. every 2 weeks.
19Changing your CIMZIA dosing In case your healthcare provider needs to change your dose, ava will need to be set up again. Please make sure you bring ava to your next appointment where your healthcare provider will set up ava for your new medication dosing.
20 Chapter 2: Getting to know avaava accessoriesava is supplied with a storage case containing additional items you will fi nd useful. When not in use, keep ava and accessories securely inside the storage case to protect them from dust or accidental damage. Keep ava with all accessories out of the sight and reach of children. All of ava’s accessories are designed for the life of the product.Storage CaseThe storage case has an internal compartment which is covered by a lid. To open the lid, slide a fi nger under the small lever and lift. The charger, USB cable and spare needle caps are placed under this internal lid. LBL4_CIM_PS6
21An electrical battery chargerCharge ava only with this battery charger. When charging ava make sure to keep the cable out of reach of children and keep it secure to avoid the risk of tripping over it.The Storage Case containsA USB cableUse this USB cable to connect ava to your computer to view your injection log. When viewing the injection log make sure to keep the cable out of reach of children and keep it secure to avoid the risk of tripping over it.ava welcome bookletA booklet introducing you to ava.
22 Chapter 2: Getting to know avaA training cassetteUse this training cassette to help you practice injections with ava. The training cassette is reuseable and does not contain a needle or medication. It can be used at any time and as often as you like, even before ava has been set up for your medication dose.CAUTION: Never replace the training cassette by a CIMZIA medication cassette! Your medication cassettes must be stored between 36°F to 46°F (2°C - 8°C) and must never be transported inside of the storage case.Two spare needle capsThese are extra caps to remove used cassettes from ava in case you dispose of the needle cap from the medication cassette.The helpline support number is 1-800-xxx-xxxx.ava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ALBL4_CIM_PS6ava Training CassetteFor training purposes only.Contains no needle or medication.ava Training CassetteFor training purposes only.Contains no needle or medication. spare needle capx2
23ava operating environmentWhen operating ava make sure you observe the following environmental requirements.Operating temperature41°F to 104°F (5°C to 40°C) Humidity 15 – 90% relative humidity, non-condensingAtmospheric Pressure700 hPa to 1060 hPaIt is recommended to avoid using ava in direct sunlight as the display may be more difficult to read.WARNING: This medical equipment is not intended for use in oxygen-rich environments. Storing avaWhen you are not using ava or you are travelling, it is recommended that you store it, together with the accessories, inside the storage case. This will help prevent ava from being exposed to dust and dirt and getting damaged. Use the handle to carry the storage case.Be sure to store ava properly:• Store ava in its closed storage case to limit exposure to dirt, dust, liquid and other substances.• Keep ava at room temperature between 68ºF to 77ºF (20ºC to 25ºC).• DO NOT freeze ava or place it in the refrigerator.
24 Chapter 2: Getting to know avaCleaning avaIf needed, you may clean the exterior surface of ava with a solution of mild soap and water using a damp cloth. You may also clean it with a commercially available, alcohol based, colorless disinfectant.CAUTION: Do not use a scouring powder or an abrasive sponge as it will damage the surface.DO NOT attempt to clean the inside of the cassette port. DO NOT insert your finger or any objects other than a cassette into the cassette port.DO NOT clean ava while there is a cassette inserted into the cassette port.CAUTION: Avoid spilling liquid on your ava. Never rinse or put ava under water. If ava has been exposed to liquid, wipe it with a clean, dry cloth, turn it on and check for error messages.The helpline support Number is 1800-xxx-xxx.
25Battery saving mode If ava is inactive for 60 seconds, the screen will dim automatically to preserve battery. Pressing any button will restore the normal screen brightness and you can continue the procedure.If left inactive for 3 minutes, ava will automatically turn off, unless you have not completed your injection. You will need to re-start any procedure from the beginning, if the device turns off.
26 Chapter 2: Getting to know avaThis page is intentionally left blank.
3Chapter 3: Learning to use avaThis section teaches you how to use ava with a training cassette that does not contain a needle or medication.By using a ‘training cassette’, you can get used to operating ava. This section does not cover the safety precautions you have to take when injecting CIMZIA. You can fi nd that information in Chapter 4, “Injecting CIMZIA with ava”.3
28 Chapter 3: Learning to use avaTraining cassetteThere is a training cassette included in your ava kit to help you practice injections. The training cassette has no needle or medicine. When it is time to inject your medicine, use the CIMZIA medication cassettes only, not the training cassette.NOTE: The training cassette is reuseable. DO NOT discard.For trainingpurposesonly. Contains noneedle or medication.CIA79970ABatch no.: xxxxxxxxxxxxUCB Inc.CIA79969A1950 Lake Park Dr.Smyrna, GAava Training Cassetteava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ABody label 1For trainingpurposesonly. Contains noneedle or medication.CIA79970ABatch no.: xxxxxxxxxxxxUCB Inc.CIA79969A1950 Lake Park Dr.Smyrna, GAava Training Cassetteava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ACap labelBody label 2For trainingpurposesonly. Contains noneedle or medication.CIA79970ABatch no.: xxxxxxxxxxxxUCB Inc.CIA79969A1950 Lake Park Dr.Smyrna, GAava Training Cassetteava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ATraining Cassette: contains no needle and no medicationava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ALBL4_CIM_PS6ava Training CassetteFor training purposes only.Contains no needle or medication.ava Training CassetteFor training purposes only.Contains no needle or medication. Cassette bodyCap
29Your training cassette has• no needle• no medicine inside.You can use it to practice injecting with ava. It can be used• before your healthcare provider has set up your medication dose on ava• after your medication dose has been set up• as often as you would like• Make sure you keep the training cassette. DO NOT throw it away.NOTE: When using the training cassette you are practicing the injection steps without actually injecting any medication. The screens you will see on the display when using the training cassette are the same you will see when using your cassettes containing medication.Using this training cassette will teach you how ava guides you through the injection process. The training cassette cap is colored bright green and the cassette body is gray. WARNING: See Chapter 4 for full injection instructions using a CIMZIA medication cassette.If you drop the training cassette, check the cassette to make sure there are no broken parts before inserting into ava.
30 Chapter 3: Learning to use ava Using the training cassetteTurn on ava by holding down the ‘On/Off ’ button for 1 second, or until the screen lights up and you hear a sound.NOTE: ava should arrive with the battery charged, but, if ava does not turn on, or it displays the message ‘Low battery. Please charge battery.’, the battery will need charging before you start. See Chapter 5 for instructions on how to re-charge the battery.If your healthcare provider has not set up your device, you will see the following message. You can still insert the training cassette to practice the injection process.1!Low battery!Please chargebattery.!Consult yourphysician toset devicedosage!
31The message ‘Inspect and then insert medication.’ will be displayed. If ava has been used before it will also briefl y show your current dose and schedule. For example, if you are on the loading dose you will see the following messages.Take the training cassette from the storage case. DO NOT try to remove the green capYou are on loading dose2 inj. every 2 weeks.Inspect andthen insertmedication.ava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ALBL4_CIM_PS6ava Training CassetteFor training purposes only.Contains no needle or medication.ava Training CassetteFor training purposes only.Contains no needle or medication. 2
32 Chapter 3: Learning to use avaPush the fl at end of the training cassette fi rmly into the cassette port of ava until you hear a click. DO NOT twist the training cassette; it is shaped so that it can only be inserted the correct way.DO NOT keep any other medication cassettes near ava while using the training cassette.Let go of the cap. ava will now check the training cassette and will display the message ‘You are in training mode’. WARNING: If you do not see this message turn off ava by holding down the power button and remove the cassette. Make sure you are using a training cassette. Go back to Step 1 on page 30.ava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ALBL4_CIM_PS6ava Training CassetteFor training purposes only.Contains no needle or medication.ava Training CassetteFor training purposes only.Contains no needle or medication. 3You are in training mode.
33NOTE: You are now in training mode. ava will behave as if you had inserted a real medication cassette. ava will now check the cassette and display ‘Medication cassette accepted’. After a short pause, ava will automatically pull the cassette further in.The currently selected injection speed is briefly displayed. You can change this setting using the ‘scroll wheel’ on the side of ava to any of the four available settings.NOTE: The injection speed can only be changed when a cassette is inserted into the cassette/injection port. You can only adjust the injection speed before performing or when pausing your injection.This setting controls the speed at which medication is injected. This setting does not change the speed of the needle being inserted, just the speed at which CIMZIA is injected.Medicationcassetteaccepted.slowest This is yourcurrent speedsetting. 4
34 Chapter 3: Learning to use avaYou can practice changing the speed by rotating the scroll wheel on the side of the device. The screen will update to show the four available speeds. Rotate the wheel to see how the highlighting moves from one speed to another. If you want to change the speed, scroll until the highlight shows the new speed and leave it there for five seconds. The new speed has been set and will be kept for future injections, or until you choose to change it again.The ‘Remove and save the needle cap.’ message is displayed.fastfastestslowslowestRemove andsave needle cap.5
35When you are ready, remove the cap by pulling it fi rmly downwards.NOTE: KEEP THE CAP. This is important as you will need it to remove the Training cassette after the simulated injection. DO NOT throw the green cap into the sharps container.Choose a place on your stomach or your upper thighs (as shown in the diagram) to practice using ava. Your healthcare provider will help you identify suitable sites to inject. ava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ALBL4_CIM_PS6ava Training CassetteFor training purposes only.Contains no needle or medication.ava Training CassetteFor training purposes only.Contains no needle or medication. 67
36 Chapter 3: Learning to use avaFind a comfortable position sitting down to give your injection. Try to relax the muscles around the injection site as this will make injecting more comfortable.Place the orange skin sensor against your skin at the cleaned injection site, with ava’s screen facing you so you can see it. The ‘Start/Pause’ button must be in a position where you can use it comfortably without moving your ava. These diagrams show how to position ava.Position ava at a right angle on your skin to ensure the injection is done correctlyWhen ava senses contact with your skin the message ‘When ready press > once’ is displayed.When readypress once.
37Press the ‘Start/Pause’ button; you will hear the motor inside ava move the cassette and the simulated training injection will begin. The screen will display an indicator to show the progress of the injection. Hold ava firmly against your skin the entire time.If you need to pause during an injection, for example to change the injection speed, press the ‘Start/Pause’ button at any time, DO NOT remove ava from your skin. If this were a CIMZIA medication cassette , pressing the ‘Start/Pause’ button would pause the flow of medication, but it would leave the needle in the skin.The message ‘Pausing. When ready press > once’ will be displayed.Press to pause injection. 8PausingWhen readypress once.
38 Chapter 3: Learning to use avaWhen you are ready to re-start, press the ‘Start/Pause’ button again to complete the injection.When the training injection is complete, the message ‘Injection complete. Please remove from skin.’ will be shown on the screen.Remove ava from your skin.PausingWhen readypress once.Injection complete.Please removefrom skin.Press to pause injection. 9
39The messages ‘Needle uncapped! Handle with care!’ and ‘Please replace needle cap.’ will be displayed until the cap is replaced.Insert the cap. Let go of the cap while ava will release and eject the training cassette.!Needleuncapped!Handle with care!Please replaceneedle cap.ava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ALBL4_CIM_PS6ava Training CassetteFor training purposes only.Contains no needle or medication.ava Training CassetteFor training purposes only.Contains no needle or medication. 1011
40 Chapter 3: Learning to use avaWhen the message ‘Remove and discard used cassette.’ appears on the information screen, pull out the training cassette.NOTE: Unlike medication cassettes, the training cassette can be re-used at any time.ava will show your next injection date unless it is a new device which has never injected any medication, followed by a ‘Please turn off the device.’.ava Training CassetteFor training purposes only.Contains no needle or medication.CIA79968ALBL4_CIM_PS6ava Training CassetteFor training purposes only.Contains no needle or medication.ava Training CassetteFor training purposes only.Contains no needle or medication. Remove anddiscard usedmedication.12Please turno the device.Sunday31DecemberYour next injection date.
41NOTE: Your next injection date will only be shown if you have already completed an injection with a medication cassette.Press the ‘On/Off’ power button until ava turns off.You have successfully completed a training injection.If you want to use the training cassette again for more practice, re-start ava and repeat the training.Please turno the device.
42 Chapter 3: Learning to use avaThis page is intentionally left blank.
4 Chapter 4: Injecting CIMZIA with avaThis section is a step-by-step guide to injecting CIMZIA with ava, from preparation to completion.Read through the whole chapter before injecting CIMZIA with ava.4
44 Chapter 4: Injecting CIMZIA with avaPreparing your CIMZIA medication cassetteNOTE: ava will have to be set up by your healthcare provider for your medication dosing before you can inject CIMZIA. Make sure that you also have received injection training by your healthcare provider before injecting CIMZIA on your own. The following are the supplies you will need to give your CIMZIA injection:• ava device.• 1 CIMZIA medication cassette. You may need 2 CIMZIA medication cassettes to give higher doses.• 1 or 2 alcohol wipes (located in your CIMZIA pack).• 1 or 2 clean cotton balls or gauze pads.• 1 puncture-resistant sharps disposal container. See Step 19 "Disposal of Used Medication Cassettes" on page 59.If you do not have everything you need, ask your healthcare provider.
45CIMZIA comes in a carton containing 2 medication cassettes. Use a new medication cassette for each injection.These instructions are for 1 injection only. Your healthcare provider will have prescribed a particular dose of CIMZIA for you. This may mean that you may need more than one injection at a time to deliver your prescribed dose. If required, ava will tell you if you need to perform a second injection and will guide you through this process.2 alcohol swabs 2 alcohol wipes
46 Chapter 4: Injecting CIMZIA with avaSetting up for your CIMZIA injectionTake the carton containing CIMZIA medication cassettes out of the refrigerator. Check the expiration date on the medication cassette carton and label.If the expiration date has passed, do not use the cassette. Call your pharmacist for questions about the expiration date. DO NOT use if the tamper evident seal is missing or broken on the carton when you receive it. If this is the case, contact your pharmacist.Remove the medication cassette from the box and let it warm to room temperature. This will take 30 to 45 minutes. DO NOT warm the medication cassette in any other way. If you are not using the second medication cassette, put the carton containing the remaining medication cassette back in the refrigerator.If any condensation appears on the outside of the cassette, wipe it off with a clean dry cloth to avoid getting moisture into ava.DO NOT try to remove the needle cap.DO NOT try to remove the syringe that is inside the medication casette.130 to 45 minutes2
47Find a clean, fl at work surface, such as a table.Inspect the liquid in the medication cassette to check that it is clear to pale yellow and free from particles. DO NOT inject the medicine if it is cloudy or discolored. Call your healthcare provider or pharmacist if you have any questions about your CIMZIA medication cassette. Inspect the cassette and make sure that the red medication level indicator is at the top of the syringe within the cassette body, as shown here. The cassette may contain air bubbles. This is normal. DO NOT try to remove air bubbles before injection. Injecting CIMZIA which contains air bubbles is harmless.Gather all the supplies you will need for an injection.Wash your hands with soap and warm water and dry thoroughly with a clean towel.34LBL3_CIM_PS_6Rx OnlyLBL3_CIM_PS_6CIA79919ANCD 50474-xxxx-xx Rx Onlyinjection 200mg/mL cassettecertolizumab pegolEach medication cassette contains 1mL of Cimzia. For subcutaneous injection use only. Use only with the Cimzia ava device. Rx Only56
48 Chapter 4: Injecting CIMZIA with avaSelecting and preparing your injection sitePrepare the supplies you need for your injection on a clean surface: medication cassette(s) warmed to room temperature, alcohol wipe (located in the CIMZIA pack) and cotton balls.Choose your injection site(s) on your stomach or upper thighs (see Figure).• Choose a new injection site each time you use a CIMZIA medication cassette.• Each new injection should be given at least 1 inch from the site you used before. If you choose your stomach, avoid the 2 inches around your belly button (navel).7ALCOHOLSWABALCOHOLSWAB
49• DO NOT inject into areas where your skin is tender, bruised, red or hard, or where you have scars or stretch marks. • Change injection sites between your stomach and upper thighs to reduce the chance of having a skin reaction.• You may want to write down the site you use for injection to help you remember to use a different site each time you inject.Clean your injection site with an alcohol wipe. Let the area dry completely.8
50 Chapter 4: Injecting CIMZIA with avaGiving your CIMZIA injectionTurn on ava by pressing the ‘On/Off’ button for 1 second, or until the screen lights up and you hear the sound.NOTE: ava should arrive with the battery charged, but, if ava does not turn on, or it displays the message ‘Low battery. Please charge battery!’, the battery will need charging before you start. See Chapter 5 for instructions on how to re-charge the battery.ava will show you your current dose and frequency. Then the message ‘Inspect and then insert medication.’ will be shown. 9!Low battery!Please chargebattery.(example screen only.) Your ava may show a different dose.Inspect andthen insertmedication.You are on loading dose2 inj. every 2 weeks.
51Take the CIMZIA medication cassette which you have let warm up to room temperature for 30 to 45 minutes. If any condensation appears on the outside of the cassette, wipe it off with a clean dry cloth to avoid getting moisture into ava. DO NOT try to remove the needle cap. Push the fl at end of the medication cassette fi rmly into the cassette port of ava until you hear a click. DO NOT twist the medication cassette; it is specially shaped to ensure it is correctly inserted.DO NOT keep other other medication cassettes near ava while injecting.Let go of the needle cap.LBL3_CIM_PS_6Rx Only10LBL3_CIM_PS_6Rx Only11 step 10
52 Chapter 4: Injecting CIMZIA with avaava will check the medication cassette and display the message ‘Medication cassette accepted.’ if it is correct. After a short pause, ava will automatically pull the cassette further in and release the needle cap.After ava has pulled in the medication cassette, the currently selected injection speed is briefly displayed. You can change this setting using the ‘scroll wheel’ on the side of your ava to any of the four available settings.NOTE: The injection speed can only be changed when a cassette is inserted into the cassette/injection port. You can only adjust the injection speed before performing or when pausing your injection.This setting controls the speed at which medication is injected. This setting does not change the speed of the needle being inserted, just the speed at which CIMZIA is injected. See "CIMZIA Injection speed settings" on page 63 for more information.Medicationcassetteaccepted.fastfastestslowslowest12
53The ‘Remove and save needle cap.’ message is displayed.Only remove the needle cap when you are ready to inject.When you are ready, remove the needle cap by pulling it fi rmly downwards.NOTE: KEEP THE NEEDLE CAP. This is important because you will need it to remove the empty medication cassette after injecting.Only remove the needle cap when you are ready to inject. To ensure the sterility of your medication cassette complete your injection within 5 minutes. However, there is no need to rush your injection; 5 minutes will allow you plenty of time to begin injecting. The remaining time is displayed on the information screen.Remove andsave needle cap.LBL3_CIM_PS_6Rx Only135Please inject within 5 minutes. ref from 35
54 Chapter 4: Injecting CIMZIA with avaFind a comfortable position sitting down to give your injection. Try to relax the muscles around the injection site as this will make injecting more comfortable.Place the orange skin sensor against your skin at the cleaned injection site, with ava’s screen facing you so you can see it. The ‘Start/Pause’ button must be in a position where you can use it comfortably without moving your ava. This diagram shows how to position ava.Position ava at right angle on your skin to ensure the injection is done correctly.DO NOT try to inject through your clothing. ava must be placed on clean dry skin.DO NOT try to trigger the skin sensor in any other way other than as instructed above.”14
55When ava senses contact with your skin the message ‘When ready press > once’ is displayed.Press the ‘Start/Pause’ button. You will hear the motor inside ava move the cassette and the injection will begin. The screen will display an indicator to show the progress of the injection. Throughout the injection process, continue to hold ava firmly against your skin the entire time. You can temporarily pause the flow of medication by pressing the ‘Start/Pause’ . DO NOT remove ava from the skin during a pause. Refer to "Optional Actions During an Injection: Pausing your injection" on page 62 for more information.When readypress once.Press to pause injection. 15
56 Chapter 4: Injecting CIMZIA with avaWhen the injection is complete, the message ‘Injection complete. Please remove from skin.’ will be shown on the screen.Remove ava from your skin. Place a dry cotton ball or gauze pad over the injection site for several seconds. Do not rub the injection site. Do not use an alcohol wipe as it may cause stinging. If there is a little bleeding cover the injection site with a small bandage.The messages ‘Needle uncapped! Handle with care!’ and ‘Please replace needle cap’ will be displayed until the cap is replaced. Injection complete.Please removefrom skin.Press to pause injection. 16!Needleuncapped!Handle with care!Please replaceneedle cap.
57Insert the needle cap. NOTE: If you threw away your needle cap, you can use one of the spare needle caps that come with your ava.Let go of the needle cap. ava will release and eject the empty medication cassette. When the message ‘Remove and discard used cassette.’ appears on the information screen, pull out the CIMZIA medication cassette.LBL3_CIM_PS_6Rx OnlyLBL3_CIM_PS_6Rx OnlyRemove anddiscard usedmedication.17
58 Chapter 4: Injecting CIMZIA with avaInspect the used cassette to make sure that all of the CIMZIA has been injected.Make sure that the red medication level indicator is at the bottom of the syringe within the cassette body.LBL3_CIM_PS_6Rx Only18
59 Disposal of Used Medication CassettesFollow these instructions for disposal of your medication cassettes with needles attached: • Put your used medication cassettes in an FDA-cleared sharps disposal container right away after use.• DO NOT throw away (dispose of) medication cassettes in your household trash.• If you do not have an FDA-cleared sharps container, you may use a household container that: - Is made of heavy duty plastic. - Can be closed with a tight fi tting, puncture-resistant lid, without sharps being able to come out. - Upright and stable during use. - Leak-resistant. - Properly labeled to warn of hazardous waste inside the container.• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps LBL3_CIM_PS_6Rx Only19
60 Chapter 4: Injecting CIMZIA with avadisposal, and for specific information about sharps disposal in the state that you live in go to FDA’s website at www.fda.gov/safesharpsdisposal.• DO NOT recycle your used sharps disposal container. If you have completed all your doses, go to step 20.If your prescribed dose requires a second injection, go to step 10 on page 51. When you have completed injecting your prescribed full dose of CIMZIA ava will display your next injection date followed by how much battery charge you have left. Finally, ava will notify you to please turn off the device.Sunday31DecemberYour next injection date.20Please turno the device.Enoughbattery for next injection.
61Press the ‘On/Off ’ power button to turn off ava.If your prescribed dose requires you to administer a second injection, the message ‘You have 1 injection left.’ will be displayed.Repeat the procedure, starting at step 10 on page 51, to deliver a second injection.NOTE: If you do not do this immediately, the warning message ‘Your dosage is incomplete!’ will be displayed. This is repeated until you administer the second injection.You have successfully completed the injection.Please turno the device.21You have 1injection left.!Your dosageis incomplete!
62 Chapter 4: Injecting CIMZIA with avaOptional Actions During an Injection: Pausing your injectionIf you need to pause during an injection of CIMZIA, for example to change the injection speed, press the ‘Start/Pause’ button at any time. DO NOT remove ava from your skin, because pressing the ‘Start/Pause’ button pauses the flow of medication, but it leaves the needle in the skin.The message ‘Pausing. When ready press > once’ will be displayed.When you are ready to re-start, press the ‘Start/Pause’ button again to complete the injection.PausingWhen readypress once.
63CIMZIA Injection speed settingsava can be set to inject CIMZIA at any one of four different speeds. This setting does not change the speed of the needle being inserted, just the speed at which CIMZIA is injected. Decide on the best setting for your personal preference. The medication injection time varies approximately between 7 to 18 seconds assuming the CIMZIA medication cassette has warmed up to room temperature. By default, the injection speed is set to ‘fast’ when you initially receive ava.NOTE: The injection speed can only be changed while a CIMZIA medication cassette is inserted into the cassette/injection port. You can only adjust the injection speed before performing or when pausing your injection.When a CIMZIA medication cassette is inserted, the injection speed is briefly displayed. You can change this injection speed setting by rotating the ‘scroll wheel’ on the side of ava.Rotating the scroll wheel highlights each of the four available speed settings. Don’t press the wheel, just turn it.Rotate the wheel until the new speed is highlighted and leave it there for five seconds. The new setting will flash and be kept for future injections, or until you choose to change it again.fastfastestslowslowest
64 Chapter 4: Injecting CIMZIA with avaThis page is intentionally left blank.
5 Chapter 5: More information about avaThe section tells you about viewing your injection log and how to charge the battery.5
66 Chapter 5: More information about avaViewing the injection logava automatically records your injection history and this ‘injection log’ can be seen by connecting ava to a computer. NOTE: You can only view your injection log; the information in the injection log fi le cannot be changed. Treatment should not be altered based on the information contained in the injection log. Dosing changes can only be made by your healthcare provider.Please make sure that you take ava with you every time you see you healthcare provider as it facilitates review of the injection log and is useful in case your healthcare provider decides to change your medication dosing.
67Using the supplied USB cable, plug the smaller end into the micro-USB port on the top of ava. Use the small tab on the micro-USB to orient it correctly for easy insertion to into ava. With the tab and the UCB logo facing the information screen, keep it parallel to the plastic housing. This is the same port that you normally use to charge the battery. DO NOT twist or bend the UCB connector once it is plugged into ava. Plug the other end into a free USB port on your computer. When ava is connected to your computer, it will behave like a USB drive.ava will switch on automatically and display this screen.When you connect ava to a computer for the first time, it may take about a minute to appear as a drive on your computer.1You are inPC mode.2
68 Chapter 5: More information about avaIf needed, your computer will automatically install the necessary driver before connecting to ava as a USB drive. When the computer recognizes ava, the name ‘ava’ will appear automatically in the list of connected devices. Wait for AVA_LOG.html fi le to appear in the directory, then open it by double clicking on it. Your injection log will open in your internet browser, and will show an overview of your injection history (in date order) like this example.Your computer does not have to be connected to the internet to access your injection log. Without an internet connection, your injection log will simply not show the ava logo in the top right corner.345Your Injection LogYour current prescription: Cimzia® Your current regimen: Maintenance Dose: 2 injections every 4 weeksDevice serial number: 332500AF Remaining number of injections you can perform with ava: 118Next injection date is: 27 Jan 2015 Last update: 31 Dec 2014Injection due on Injection made on Injection Status Code(s) Drug Regimen Interrupted Injections30 Dec 201430 Dec 201402 Dec 201402 Dec 201402 Dec 201420 Dec 201420 Dec 201402 Dec 201402 Dec 201402 Dec 2014DeliveredDeliveredDeliveredIncompleteIncomplete---------C---Mnt.4wkMnt.4wkMnt.4wkMnt.4wkMnt.4wk00000Code descriptions:A: Low batteryB: USB plugged during injectionC: Injection ow constrictedD: Injection timed outCode descriptions:A: Low batteryB: USB plugged during injectionC: Injection ow constrictedD: Injection timed outDrug regimen keyLdg.2wk = Loading Dose: 2 injections every 2 weeksMnt.2wk = Maintenance Dose: 1 injection every 2 weeksMnt.4wk = Maintenance Dose: 2 injections every 4 weeksEnd of logAVA_LOG.html
69When you are finished, close your web browser and unplug ava from your computer.ava will turn off automatically. The injection log provides information regarding your next injection date and lists your previously administered injections. An explanation of the different columns of the injection log is provided below.Injection due onThis is the date when you should be making your next injection. Injection made onava records the actual date when you make your next injection. Injection dates which are more than 3 days before your scheduled injection due date or 3 days after this date are displayed in orange instead of black font. Injection statusDelivered: This means that the entire content of your CIMZIA medication cassette has been injected successfully. Incomplete: This means that not the entire content of the CIMZIA syringe has been injected. You only have received a partial dose. If applicable, ava may add a code to an injection entry depending on whether during an injection the battery was low (A) or the USB cable was plugged in (B), there was a problem with the flow of medication (C) or the injection was not performed within the allotted time of 5 minutes and has timed out (D).
70 Chapter 5: More information about avaCharging the batteryava is powered by a rechargeable battery and it is important that you always have enough charge to complete an injection. Do not try to replace the battery. The battery does not need replacing during the lifetime of ava.If ava’s battery does not have sufficient charge to complete an injection the message ‘Low battery! Please charge battery.’ will be displayed. You will not be allowed to start an injection until the battery has been charged.If ava does not turn on, the battery probably needs to be charged.If at the end of injecting the battery is completely empty, ava will show ‘Low battery! Please charge battery.’.!Low battery!Please chargebattery.Low battery!Please chargebattery.
71To charge ava, plug the provided charger into a power outlet and connect the other end to the micro-USB port on the top of ava.DO NOT twist or bend the USB connector once it is plugged into ava.ava will turn on and show the status of the battery and begin charging. If possible, DO NOT disconnect the charger before the battery is fully charged. Only use the provided charger to charge ava.In case ava does not display the “Charging...” screen, make sure the charger is connected to a live electrical outlet and the micro-USB plug is connected to ava. If ava still does not charge, call your local helpline for a replacement charger.It takes approximately 2-3 hours to fully charge. When the battery is fully charged, the message ‘Battery full. Please unplug charger.’ will be displayed.Unplug the charger. ava will turn off automatically. Charging...1Battery full,please unplugcharger.2
72 Chapter 5: More information about avaNOTE: ava will show the battery status every time an injection is completed. It will display the message ‘Enough battery for next injection.’ or, if you need to charge ava before your next injection, the message ‘Not enough battery to inject.’ will be displayed. At the end of injecting, if your battery is completely empty, ava will show ‘Low battery! Please charge battery.’.Not enoughbattery to inject.Enoughbattery for next injection.Low battery!Please chargebattery.If you charge the battery and ava still doesn’t turn on, call helpline at 1-800-xxxxxWARNING: DO NOT try to charge ava during an injection. If you connect ava to charge during the injection process ava will stop the injection and will display the message ‘USB cable connected! Unplug immediately!’. You will not be able to progress with the injection until you unplug the charger. !USB cableconnected!Unplug immediately!
6Chapter 6: Troubleshooting In this section you can fi nd information on how to troubleshoot problems and you can fi nd an explanation of all the warnings and cautions which ava may display.6
74 Chapter 6: Troubleshooting Removing a cassette if the needle cap is lost or if needle is severely bentFollowing an injection the needle cap is required to remove the used cassette from ava. If you have accidentally lost the original needle cap of your cassette you can use one of the spare needle caps. There are two green spare needle caps which you can fi nd in the storage case.You can also use the spare needle cap to remove a medication cassette in case the needle is bent and is not allowing you to use the original medication cassette cap. DO NOT attempt to remove a cassette by any other means due to the risk of an acccidental needle stick injury. NEVER insert any foreign objects such as tools or fi ngers into the cassette port.spare needle capx2Spare needle cap
75What to do if ava has problems identifying a cassette by the Radio Frequency Identification (RFID)If you have a problem with ava identifying an inserted cassette, make sure you do not have any other cassettes (medication cassette or training cassette) immediately next to ava. You may also find it helpful to use ava away from or temporarily turn off household appliances which might cause interference such as television sets, radios, microwaves or mobile phones etc. Generally, a distance of a few feet from potentially interfering appliances should be sufficient to avoid any problems.Always make sure you are not using ava near strong sources of magnetic and electromagnetic radiation such as x-ray machines at airports or hospital equipment.
76 Chapter 6: Troubleshooting Warning message priority When using ava you may see warning messages displayed. To help you to understand importance of these messages the following symbols have been used:!Messages with this symbol are High Priority Alarms and may represent a danger and must be acted upon immediately.Messages with this symbol are Medium Priority Alarms and in most cases require you to consult with your physician before proceeding.Messages with this symbol are Low Priority Alarms providing instructions of important next steps which need to be performed.Messages with this symbol are instructions which must be completed.Messages with this symbol indicate medication cassette actions which are not possible or allowed.These symbols indicate the alarm priority and will be shown together with additional instructions.!!!
77High priority alarmsMESSAGE EXPLANATIONAs a patient you should never attempt to enter this menu nor try to modify the setting of your medication dose. If you encounter this message by error, simply turn off ava by pressing the power button for 3 seconds. This message signifies that you are about to enter the dose setting mode on ava. This set up menu is intended only for your healthcare provider and is used to set up your specific medication dose in ava.If you accessed this message by mistake, press the On/Off (Power) button until ava turns offava has a self-test procedure to make sure it is working properly before use. This warning shows that an error was detected during this test.For your own safety ava will not allow you to proceed. A four digit ‘error helpline code’ will be displayed.Contact your local helpline for support and tell them the 4-digit error code.!Entering dosesetting mode.Only for physician!!Error!Do not use.Helpline codexxxx
78 Chapter 6: Troubleshooting MESSAGE EXPLANATIONFollowing a partial or completed injection the needle cap has not yet been replaced. Although the needle is safely retracted inside ava, it remains exposed inside the device until the needle cap is replaced. Handle with care, until you have replaced the needle cap to avoid accidental needle stick injury. DO NOT attempt to insert a finger inside of the cassette port.If you have interrupted an injection and delivered only a partial dose, you should try to complete your injection before replacing the needle cap. This warning will be displayed if you connect ava to the electrical charger or to your PC during an injection. You must immediately unplug the micro-USB cable from the charging port before proceeding to minimize the risk of electric shock. You cannot finish your injection while ava is connected to the charger or a computer. Unplug the micro-USB cable and then finish your injection. !Needleuncapped!Handle with care!!USB cableconnected!Unplug immediately!
79Medium priority alarmsMESSAGE EXPLANATIONIf for some reason during your loading dose regimen you have not been using ava for more than 70 days to inject CIMZIA, you will see this message. Consult with your physician how to proceed with your CIMZIA injections.ava uses an internal calendar to keep track of when your next injection is due. If you turn on ava more than 3 days before your next injection is due, ava will display this message to warn you that it is too soon to inject and performing an injection now may result in an overdose of CIMZIA.This warning does not stop you from injecting; however, you should always consult with your physician before performing an out-of-schedule injection. !Incorrectmedicationdosing interval!!Injecting ahead of scheduled date!
80 Chapter 6: Troubleshooting Low priority alarmsMESSAGE EXPLANATIONThis message indicates that ava has detected a ‘needle injection error’. This may be due to a blocked needle, frozen CIMZIA or other reason.DO NOT try to inject using this cassette. Replace the needle cap and remove the cassette. Dispose of it in your biohazard (sharps) container. You can inject with a different cassette. When you first receive ava the medication dose corresponding to your specific prescription has not been set up yet in ava. Contact your healthcare provider to have ava set up for the exact amount of CIMZIA you should take. When you see your healthcare provider make sure you bring ava along. You should also receive injection training at the same time.In the meantime, to practice the injection process with ava you can proceed to insert the training cassette. However, you will not be able to inject your medication until your specific medication dose has been set. !Cassette error! Refer to user manual!!Consult yourphysician toset devicedosage!
81MESSAGE EXPLANATIONWhen this warning is displayed ava must be replaced and no more injections can be made with this device.ava has been designed to be used for up to 3 years and it has been programmed to prevent use after this time. Contact your healthcare provider or local helpline for a replacement device.ava can operate within the temperature range of 5°C – 40°C (41°F – 104°F) at 15 – 90% relative humidity. Outside of these temperatures ava will display this message.If you see this message store ava at the appropriate operating temperature. Allow enough time until ava has reached the normal operating temperature. This can be checked by turning ava on. This message should not be displayed before proceeding. !Device atend of life!!Device isout oftemperaturerange!
82 Chapter 6: Troubleshooting MESSAGE EXPLANATIONWhen ava first displays this warning it can still be used for another 10 injections (plus any use of the training cassette) before it must be replaced. ava has been designed to be used for up to 3 years and it has been programmed to prevent use after this time. To ensure your safety and reduce the risk of device failure, ava will soon have to be replaced.You may also see the warning ‘Please replace device by calling helpline’. After another 10 injections ava will stop working and display the warning ‘Device at end of life. Please do not use’.Contact your healthcare provider or local helpline for a replacement device.ava displays this message if you insert a cassette too soon after you have turned ava on. !Device is nearingend of life!!Earlymedicationinsertion!
83MESSAGE EXPLANATIONIf skin contact is lost during an injection, ava automatically stops the injection and withdraws the needle. Not all the CIMZIA will have been injected and this warning indicates that your injection is not complete. If an injection is interrupted due to loss of skin contact, small amounts of medication may be lost. Multiple interrupted injections may lead to a medication underdose.To complete your injection, choose a new injection site and follow the instructions given in "Chapter 4: Injecting CIMZIA with ava" on page 43.This warning indicates that ava has found a technical problem with the cassette. Replace the needle cap and remove the cassette from ava. Once the cassette has been removed ava will automatically carry out a self-test. In case there is a problem with ava, the high-priority alarm message ‘Error! Do not use. Helpline code’ will be shown. Provide the error code to the helpline. If ava does not show an error code, ask the helpline for instructions how to proceed.!Injection not complete!Reposition on skin.!Insertionerror!Refer to usermanual.
84 Chapter 6: Troubleshooting MESSAGE EXPLANATIONava contains a rechargeable battery. This message indicates ava needs recharging. Only use the charger which is supplied with your ava kit to recharge the device. Please refer to "Chapter 5: More information about ava" on page 65 for more information.This warning indicates that you must complete your injection immediately. ava's battery is almost empty and you must inject before it needs charging. This message indicates that you have missed your previous scheduled dose.ava automatically records your injection history and when your next dose is due. You need to consult with your healthcare provider how to correct your dosing.In case you see this screen please contact your local helpline for a replacement device. !Low battery!Please chargebattery.!Low battery!Please injectimmediately!!Scheduledinjection datemissed!!Softwareerror!
85MESSAGE EXPLANATIONFor patients whose full dose requires two injections, this warning is displayed when you have not yet completed your full dose. You have only injected one of the two required medication cassettes and need to proceed injecting with the remaining medication cassette to complete your prescribed dose.!Your dosageis incomplete!
86 Chapter 6: Troubleshooting InstructionsMESSAGE EXPLANATIONThis message advises you to contact your healthcare provider. This message indicates that you have missed your previous scheduled dose. ava automatically records your injection history and when your next dose is due. You need to consult with your healthcare provider how to correct your dosing. This message informs you not to hold on to the needle cap of the cassette while inserting or removing the cassette from ava.This message indicates that the internal battery is empty and needs to be recharged.ava must be charged before it can be used. Make sure you only use the charger supplied with ava. Refer to "Charging the battery" on page 70 for help with charging ava.!Consult yourphysician!!Follow physician’sinstructionsfor dosing!!Let go ofneedle cap!Low battery!Please chargebattery.
87MESSAGE EXPLANATIONThis message is displayed if you turn on ava too far in advance of your next injection due date.ava will also show you your next date for injection. You may want to inject anyway, if your healthcare provider has given you specific instruction to inject your next dose early. DO NOT inject unless you have received specific instructions to do so.Otherwise, make a note of the date of your next injection (shown on ava’s screen). Next, turn off ava.ava has been designed to be used for up to 3 years and it has been programmed to prevent use after this time. To ensure your safety and to reduce the risk of device failure, ava will have to be replaced when this message appears.Contact your healthcare provider or local helpline for a replacement device.!Contact yourphysician.Only injectif instructed.!Pleasereplace deviceby calling helpline.
88 Chapter 6: Troubleshooting MESSAGE EXPLANATIONThis message advises you to read the relevant information in the user manual.This message indicates that the needle cap has been removed. The needle is still retracted inside ava and remains exposed inside the device until the needle cap is replaced. Handle with care, until you have replaced the needle cap.Please readinstructionsin user manual.!Please replaceneedle cap.
89Cassette WarningsMESSAGE EXPLANATIONThis warning indicates that the CIMZIA medication cassette has passed its expiration date. ava displays this warning to prevent you from injecting expired medication and will reject the cassette. Remove the cassette and contact your healthcare provider.This message indicates that this is a used cassette (for example; the needle cap has been removed before). For your safety, ava will not allow the use of any cassette where the needle cap has been removed before as the needle is no longer sterile. ava will eject the cassette. Remove it and discard it in a sharps container. This warning indicates that ava does not recognize the cassette you have loaded as one containing CIMZIA. Please contact your healthcare provider to obtain the correct medication for you.ava will reject the cassette. Remove the cassette and return it to your pharmacist.Medicationhas expired.Do not use.This is a used medication.Do not use.This is not yourmedication.Do not use.
90 Chapter 6: Troubleshooting MESSAGE EXPLANATIONThis message indicates that the cassette which has been inserted is not an authentic CIMZIA medication cassette.ava must only be used with genuine CIMZIA medication cassettes.Contact your local helpline for advice. The helpline may instruct you to keep the cassette for investigation by the manufacturer. ava will reject the cassette. Remove it from ava. This warning is displayed if ava has been left for more than 5 minutes after the needle cap has been removed and before an injection was started. With the needle cap removed, the needle’s sterility seal has been broken and it is important that you inject as soon as possible. ava will no longer accept this cassette.Insert the needle cap and remove the cassette from ava. Put the cassette in your biohazard (sharps) container. Medicationnot authentic.Do not use.Time to injectexceeded.Do not use.
91Other Non-Alarm ScreensMESSAGE EXPLANATIONWhen starting ava, one of the following three screens will be displayed to remind you which dose and frequency (regimen) ava is set to use. The first time ava is used you will not see any of these screens because ava still needs to be set up by your healthcare provider. The dose and frequency displayed must correspond to your current prescription. If you believe the displayed dose does not correspond to your current prescription contact your healthcare provider. This particular message is displayed if you are on Loading Dose (2 injections every 2 weeks). NOTE: If your healthcare provider prescribed the loading dose to you, ava will automatically transition from the loading dosing when completed to your prescribed maintenance dose.This particular message is displayed to indicate ava is set to the Maintenance Dose (1 injection every 2 weeks).You are on loading dose2 inj. every 4 weeks.You are on maintenancedose 1 inj. every 2 weeks.
92 Chapter 6: Troubleshooting MESSAGE EXPLANATIONThis particular message is displayed to indicate ava is set to the Maintenance Dose (2 injections every 4 weeks).This message is displayed to inform you when your loading dosing is complete. During loading dosing you have administered 2 injections every 2 weeks at weeks 0, 2 and 4. Now your loading dosing has finished and ava automatically transitions to your prescribed maintenance dosing as set up by your healthcare provider. This message indicates that you have finished injecting and should now turn off ava to preserve battery life.If you do not turn it off, ava will automatically turn off after 3 minutes. You are on maintenancedose 2 inj. every 4 weeks.Loading dosecomplete.Please turno the device.
93MESSAGE EXPLANATIONThis screen indicates the date that your next injection is due.The date displayed depends on when you last injected and your prescribed dose and dosing frequency. This picture shows a sample date – yours will vary.Sunday31DecemberYour next injection date.
94 Chapter 6: Troubleshooting This page is intentionally left blank.
7Chapter 7: Technical Information about ava7
96 Chapter 7: Technical Information about avaTechnical dataModel Name avaDimensions H : 203 [mm], W: 68 [mm], D: 56 [mm]; H: 8 [in.], W: 2.68 [in.], D: .2.2 [in.]Weight 245 g; 8.6 oz. Serial Number Unique 8 alphanumeric digit identifying each individual devicePower Supply Internally powered, rechargeable Lithium Ion Battery, 3.7V DC, 1620 mAh minimumBattery Charger Emerson / Artesyn DA12-M, 90 - 264V~ 0.15 A @240V (max), 47 / 63 Hz, output : 5V DC, 2.0 A (max)orFriwo Fox 12 Medical, Type FW8000MUSB/05100-240V~,0.15 A@ 240V (max), 50-60 Hz, output: 5V DC, 2.2 A (max)Classification Ingress Protection IP 52 (ava is protected only against occasional liquid droplets but it is not protected against water spillage)Applied part type BF Electromagnetic CompatibilityElectromagnetic compatibility in accordance with EN60601-1-2 (see EMC tables)Operating Environment 5°C – 40°C (41°F – 104°F) at 20 – 90% relative humidityPressure Limits Atmospheric pressure limits: ava can be used between 700 to 1060 hPa, at ambient pressure between 700 to 1060 hPaStorage Conditions -20°C – 60°C (-4°F – 140°F) at no humidity requirementDose Accuracy nominal injectable volume 1.0 ml min. volume 0.95 mlWarranty ava does not have any user serviceable parts. Opening or attempting to disassemble ava will void any device warranty. This medical equipment complies with the following international standards: ISO 60601 and ISO 11608
97Explanation of ava symbolsManufacturer of avaManufacturing date of avaSerial numberRefer to instruction manualApplied part type BF (electrical isolation)Direct current (d.c.), ava requires 5V direct current to recharge the battery. RFID tagava identifies cassettes via an RFID (radio frequency identification) chip.Dispose of safely according to your local regulationsThis symbol denotes the atmospheric pressure limits of ava under which it can be used. IP52 Level of ingress protection. This rating describes how well ava is protected against dust and liquids entering the interior of the device.The first digit of the IP rating describes the level of protection against solid particles entering through the housing of ava into the device. The rating of 5 means that the ingress of dust is not entirely prevented.The second digit of the IP rating describes the protection against the ingress of liquids into ava. The two (2) rating means that ava is only protected against drops of water. Avoid spilling any liquid onto ava.Make sure you keep ava dry storing it inside the storage case and only use a damp cloth if ava needs cleaning.Prescription only
98 Chapter 7: Technical Information about avaElectromagnetic Compatibility TablesMedical electrical equipment requires special precautions regarding EMC (electromagnetic compatibility) and needs to be used in accordance to the EMC information provided below.Portable or mobile RF communications equipment (e.g., mobile phones, pagers…) can affect ava.ava is intended for use in the electromagnetic environment specified below. The user should ensure that ava is used in such an environment.Wireless Functionality Radio Frequency Identification (RFID) nominal frequency 13.56MHz +/-423,75 kHz subcarriersEffective Radiofrequency Radiated Power Output200 mWOperating Range < 1 cm outside of avaModulation On-Off Keying (OOK)Bandwidth of Receiving Section~ 846 kHzWireless Quality of Service RequirementRFID reader provides Received Signal Strength Indicator (RSSI). In case of single RFID read or write failure ava automatically performs a retry. Wireless Security MeasuresCritical information on the cassette RFID chip is AES128 encrypted with CTR mode of operation. ava complies with the applicable EMC and telecommunications standardsETSI EN 300 330-2 V1.6.1ETSI EN 301 489-1,ETSI EN 301 489-3,FCC Part 15 (10-01-2014 Edition)
99Guidance and manufacturer’s declaration – electromagnetic emissionEmissions test Compliance Electromagnetic environment - guidanceRF emissions CISPR 11ETSI EN 301 489-1 ETSI EN 301 489-3IEC 60601-1-2EN 55022Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissions CISPR 11ETSI EN 301 489-1ETSI EN 301 489-3 IEC 60601-1-2:2014 EN 55022Class B The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes.FCC Title 47 CFR Part 15, subpart B and C15B: Class B This device complies with Part 15 of the Federal Communications Commission (FCC) Rules. The FCC ID for this device is reported on the device label. Operation is subject to the following two conditions:• This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause undesired operation.• Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.Harmonic emissionsETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2 EN 61000-3-2Applicable for the battery charger connected to the device, covered by Telecom RequirementsBattery Charger < 75 watt. No limits apply. Therefore the charger is in compliance with Harmonic requirements.
100 Chapter 7: Technical Information about avaEmissions test Compliance Electromagnetic environment - guidanceVoltage fluctuations and flickerETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2 EN 61000-3-3Applicable for the battery charger connected to the device, covered by Telecom RequirementsDevice’s charger is assumed not to generate Voltage Fluctuations and Flicker and is therefore deemed to comply without testing. EN 61000-3-3, clause 6.1. “Tests need not be made on equipment which is unlikely to produce significant voltage fluctuation and flicker.”Electromagnetic compatibility and radio spectrum mattersETSI EN 300 330-2 V1.6.113.56 MHz RFID deviceTransmitter technical characteristics: Product Class 1Receiver classification: Receiver Class 313.56 MHz RFID device.The device is equipped with a RFID R/W circuit operating on passive tags at a frequency of 13.56 MHz and is therefore classified as an inductive application, of which the parameters to comply with are described in the Electronic Communication Committee recommendation ERC/REC 70-03.Information to the User (FCC Title 47 CFR Part 15.105 (b))Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.• Consult the dealer or an experienced radio/TV technician for help.
101Guidance and manufacturer’s declaration – electromagnetic immunityImmunity test Test level Compliance level / performance criterionElectromagnetic environment - guidanceElectrostatic discharge (ESD)ETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2ISO 11608-1ISO 11608-4IEC 61000-4-2±2, ±4, ±6 and ±8 kV contact discharge±2, ±4, ±8, ±10, ±13 and ±15 kV air discharge±8 kV contact discharge±15 kV air dischargeNoneFast Transient / burstETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2IEC 61000-4-4±2 kV for power supply lines±1 kV for input/output linesTT for transmitters,TR for receiversMains power quality should be that of a typical commercial or hospital environment.SurgesETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2IEC 61000-4-4±1 kV; ±2 kV Common modeTT for transmitters,TR for receivers
102 Chapter 7: Technical Information about avaImmunity test Test level Compliance level / performance criterionElectromagnetic environment - guidanceVoltage dips and interruptionsETSI EN 301 489-1ETSI EN 301 489-3IEC 60601-1-2IEC 61000-4-11Reduction of the supply voltage of 100% for 20 msReduction of the supply voltage of 60% for 200 msReduction of the supply voltage of 100% for 5000 msCT for transmitters, CR for receivers for ETSI EN 301 489 seriesCT for SRD class 1 transmitters, CR for SRD class 1 receivers for ETSI EN 301 489 SeriesTT for SRD class 2 or class 3 transmitters, TR for SRD class 2 or class 3 receivers for ETSI EN 301 489 seriesTT for transmitters,TR for receiversMains power quality should be that of a typical commercial or hospital environment.Power frequency magnetic fieldIEC 60601-1-2IEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Navigation menu